As filed with the Securities and Exchange Commission on September
16, 2015
Registration No. 333-205261
UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
______________
Amendment no. 2
to
FORM S-1
REGISTRATION STATEMENT
Under The Securities Act of 1933
__________________
CAPSTONE THERAPEUTICS
CORP.
(Exact name of registrant as specified in its charter)
________________
DELAWARE |
2834 |
86-0585310 |
(State or other jurisdiction of incorporation or organization) |
(Primary Standard Industrial Classification Code Number) |
(I.R.S. Employer
Identification No.) |
________________
1275 West Washington Street, Suite 104
Tempe, Arizona 85281
(602) 286-5520
(Address, including zip code, and telephone number,
including area code, of registrant’s principal executive offices)
________________
John M. Holliman, III, Chairman
and Principal Executive Officer
Capstone Therapeutics Corp.
1275 West Washington Street, Suite 104
Tempe, Arizona 85281
(602) 286-5520
(Name, address, including zip code, and telephone number,
including area code, of agent for service)
________________
Copy to:
Steven P. Emerick
Quarles & Brady LLP
One Renaissance Square, Two North Central Avenue
Phoenix, Arizona 85004
(602) 230-5517
_______________
Approximate date of commencement of proposed sale to the public:
From time to time after the effective date of this registration statement.
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. X
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. ☐ _______________
If this Form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. ☐ _______________
If this Form is a post-effective amendment filed pursuant to Rule
462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. ☐ _______________
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated
filer,” “accelerated filer” and “small reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer: ☐ Accelerated filer:
☐ Non-accelerated filer ☐ Smaller reporting company: X
CALCULATION OF REGISTRATION
FEE
Title of each class of Securities to be Registered (1) | |
Proposed Maximum Aggregate Offering Price | |
Amount of Registration Fee (2) |
Units consisting of Common Stock and Warrants (3) | |
$ | 10,000,000 | | |
$ | 1,162.00 | |
Common Stock Issuable Upon Exercise of Warrants in the Units (3) | |
| | | |
| | |
Warrants to be issued to Placement Agent (4) (5) | |
| - | | |
| - | |
Common Stock Issuable Upon Exercise of Placement Agent Warrants (3) | |
| | | |
| | |
Total | |
| | | |
$ | 1,162.00 | |
| (1) | Any additional shares of common stock to be issued as a result of stock splits, stock dividends, or
similar transactions shall be covered by this registration statement as provided in Rule 416. |
| (2) | Calculated pursuant to Rule 457(o) of the Securities Act of 1933, as amended, based upon estimate
of proposed maximum offering price. |
| (3) | Pursuant to the Tax Benefit Preservation Plan (“Benefit Plan”), dated as of June 24, 2014,
between the Company and Computershare Inc., each share of common stock has an attached right that entitles the registered holder
to purchase from the Company one one-hundredth of a share of Series A Preferred Stock, par value $0.0005 per share (the “Preferred
Shares”), of the Company at an exercise price of $5.00 per one-hundredth of a Preferred Share, subject to adjustment, on
the terms set forth in the Benefit Plan. At September 14, 2015, the rights are not exercisable and trade only with shares of the
Company’s common stock. |
| (4) | No fee required pursuant to Rule 457 under the Securities Act of 1933, as amended. See “Plan
of Distribution”. |
| (5) | Estimated pursuant to Rule 457(g) of the Securities Act of 1933, as amended, solely for the purpose
of calculating the registration fee. |
__________________
The registrant hereby amends this registration statement on such
date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically
states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act
of 1933, as amended, or until the registration statement shall become effective on such date as the Commission, acting pursuant
to said Section 8(a), may determine.
The information in this prospectus is not complete
and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission
is effective. This prospectus is not an offer to sell these securities or the solicitation of an offer to buy these securities
in any state in which such offer, solicitation, or sale is not permitted.
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PRELIMINARY PROSPECTUS |
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SUBJECT TO COMPLETION |
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DATED SEPTEMBER 16, 2015 |
PROSPECTUS
CAPSTONE THERAPEUTICS CORP.
Units,
each consisting of one share of Common Stock and one Warrant to purchase one-half of a share of Common Stock
We are offering up to
Units (the “Units”), each consisting of one share of common stock and one warrant to purchase one-half of a share
of common stock. The shares of common stock and warrants will immediately separate after purchase and will be issued separately.
The warrants are exercisable for a five-year period at an exercise price of $ , which is %
of the offering price for each Unit. Our common stock currently is quoted on the OTCQB Market under the symbol “CAPS.”
The last reported sale price of our common stock on the OTCQB Market on September 10, 2015 was $.21 per share.
Investing in our securities involves risks. See “Risk Factors”
beginning on Page 7 of this prospectus.
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Per Unit |
Total |
Offering price per Unit |
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Placement agent’s fees (1) |
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Offering proceeds, before expenses, to Capstone |
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(1)
We have also agreed to issue to Wainwright warrants to purchase up to a number of shares of common stock equal to 5% of the aggregate
number of shares included in the units sold in this offering (or 2.5% of the aggregate number of shares included in the units sold
to the reduced fee investors in this offering) and to reimburse Wainwright for its non-accountable expenses in an amount equal
to the greater of 1% of the aggregate gross proceeds raised in this offering or $50,000. See the “Plan of Distribution”
section of this prospectus for more information on the placement agent arrangements.
H.C. Wainwright & Co., LLC (“Wainwright”)
is acting as the exclusive placement agent for this offering. The placement agent will not purchase or sell any Units in this offering,
nor will it be required to arrange for the purchase and sale of any specific number or dollar amount of Units, other than to use
its “reasonable best efforts” to arrange for the sale of Units by us. We have agreed to pay Wainwright a cash fee equal
to 7.25% of the aggregate gross proceeds from this offering, provided that such fee will equal to 4% of the aggregate gross proceeds
from sales to certain specified insiders and current stockholders of the company (the “reduced fee investors”) in this
offering. Wainwright may engage one or more sub-agents or selected dealers in connection with this offering. There is no minimum
number of Units required to be purchased in this offering. There is no arrangement to place the funds from this offering in an
escrow, trust or similar account, which means these funds will be immediately available for use by us. We currently expect the
offering to end not later than , 2015.
We have also agreed to indemnify Wainwright
for any claim related to or resulting from the activities on our behalf, except for any claim finally judicially determined to
have resulted from the indemnitee’s gross negligence or willful misconduct.
Investing in the Units involves a high degree
of risk and should be purchased only by persons who can afford to lose their entire investment. Before buying any Units, you should
carefully read the discussion of material risks of investing in our securities under the heading “Risk Factors and Forward-Looking
Statements” beginning on page 7 of this prospectus.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy of
the disclosures in this prospectus. Any representation to the contrary is a criminal offense.
We expect to deliver the Units to investors
against payment therefor from time to time, commencing on or about ,
2015.
-------------------------
H.C. Wainwright & Co.
The date of this prospectus is ,
2015.
TABLE OF CONTENTS
Page
ABOUT THIS PROSPECTUS |
1 |
PROSPECTUS SUMMARY |
1 |
RISK FACTORS AND FORWARD LOOKING STATEMENTS |
7 |
PLAN OF DISTRIBUTION |
16 |
INFORMATION WITH RESPECT TO THE COMPANY |
17 |
Competition |
21 |
DESCRIPTION OF PROPERTY |
24 |
LEGAL PROCEEDINGS |
25 |
OUR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS |
25 |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
26 |
DIRECTORS AND EXECUTIVE OFFICERS |
32 |
TRANSACTIONS WITH RELATED PERSONS |
41 |
DESCRIPTION OF OUR CAPITAL STOCK |
41 |
LEGAL MATTERS |
44 |
EXPERTS |
44 |
WHERE YOU CAN FIND MORE INFORMATION |
45 |
ABOUT THIS
PROSPECTUS
You should rely only on the information contained in this prospectus.
We have not authorized anyone to provide you with different information. No one is making offers to sell or seeking offers to buy
these securities in any jurisdiction where the offer, solicitation or sale is not permitted. You should assume that the information
contained in this prospectus is accurate as of the date on the front of this prospectus only, regardless of the time of delivery
of this prospectus or any sale of our common stock. Our business, financial condition, results of operations and prospects may
have changed since that date.
The information in this prospectus may not contain all of the information
that may be important to you. You should read the entire prospectus before making an investment decision. To obtain additional
information that may be important to you, you should also read the exhibits to the registration statement of which this prospectus
is a part and the additional information described below under the heading “Where You Can Find More Information.”
When used in this prospectus, the terms “Capstone,” OrthoLogic,”
“we,” “our,” “us” and the “Company” refer to Capstone Therapeutics Corp. References
to our joint venture or “JV” or “LipimetiX” refer to LipimetiX Development, Inc.
The address and telephone number of our principal executive offices
are 1275 West Washington Street, Suite 104, Tempe, Arizona 85281; telephone (602) 286-5520.
PROSPECTUS
SUMMARY
This summary highlights selected information from this prospectus
and does not contain all of the information that you need to consider in making your investment decision. You should carefully
read the entire prospectus, including the risks of investing discussed under “Risk Factors and Forward-Looking Statements”
beginning on page 7 of this prospectus, and the exhibits to the registration statement of which this prospectus is a part.
We are a biopharmaceutical company primarily focused
on the development of a family of Apolipoprotein E (“ApoE”) mimetic peptides to serve a variety of therapeutic indications
in reducing plasma cholesterol and triglycerides. We embrace the capital-efficient business model of virtual pharmaceutical development
pursuant to which we have minimized the number of full-time employees and outsource various aspects of pre-clinical, regulatory
and clinical development.
All of our current development activities are conducted
through our majority-owned joint venture, LipimetiX Development, Inc., which was formed to develop an Apo E mimetic peptide molecule,
AEM-28 (“AEM-28”), and its analogs. We own 60% of the outstanding common shares of the JV and all of the outstanding
preferred shares. We have entered into a Stockholders Agreement pursuant to which certain of our JV partners have the right to
appoint a majority of the JV’s board of directors unless certain triggering events occur, and pursuant to which we have consent
rights over a broad spectrum of business decisions including annual budgets. Our JV is managed under contract by Benu BioPharma
Inc., which is composed of three individuals who are the principal minority stockholders in our JV. For additional information,
see the “Ownership, Management and Governance of our JV” section of this prospectus.
Concurrent with the development activities for
AEM-28, the JV has performed limited pre-clinical studies that have identified analogs of AEM-28, including one referred to as
AEM-28-14, that have the potential of increased efficacy, higher human dose toleration and an extended composition of matter patent
life. The JV has a development plan to pursue regulatory approval and commercialization of AEM-28, or one or more of its analogs,
as treatment in orphan (rare disease) indications, including acute pancreatitis (“AP”) and homozygous familial hypercholesterolemia
(“HoFH”), and potentially in acute coronary syndrome, peripheral artery disease and metabolic syndrome. HoFH has been
designated by the FDA as an orphan indication. We believe that AP should also qualify for orphan indication designation.
Most of the proceeds of this offering will be made
available to our JV to fund the continued development of AEM-28 and its analogs and the remainder will be used to fund our continuing
operations. We have not agreed with our JV regarding the manner in which offering proceeds will be made available to the JV. Proceeds
from the offering could be made available through loans or equity contributions by us to the JV, or in some combination of debt
and equity. If all of the Units offered hereby are sold, we believe that we will have sufficient funds for our JV to complete the
preclinical development and possibly Phase 1a and Phase1b/2a clinical trials as well for AEM 28-14, but we cannot predict the total
cost of these efforts which depends on, among other things, successful and timely outcomes in our preclinical and clinical studies.
In any event, our JV will require substantial additional capital, and/or a development partner, to complete the clinical trials
and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies’ approval, if any,
for our JV’s product candidates. We may seek to obtain the necessary additional funding through the issuance of debt and/or
equity securities by us or our JV in one or more private or public offerings in the future (which could include bridge financing
from certain of our significant existing stockholders), through a strategic partner arrangement or otherwise. In addition, our
JV currently is exploring potential sub-licensing of AEM-28 and/or its analogs for development in indications not being actively
pursued by the joint venture.
Apolipoprotein E (Apo E)
Apo E is in a class of protein, called an apolipoprotein,
that occurs throughout the body. Apo E is essential for the normal metabolism of cholesterol and triglycerides. After a meal, especially
high fat meals, like pizza with beer, the postprandial (or post-meal) lipid load is packaged in lipoproteins and secreted into
the blood stream. The apolipoproteins, including Apo E, function to help transport the lipids and cholesterol to various organs
in the body and assist in the conversion of these lipids to various fats, sugars and cholesterol that serve as key component of
all cell membranes and as the basis of all steroid hormones. Specific receptors on the liver help clear the excess cholesterol
and lipid rich lipoproteins from the blood. A certain amount of cholesterol content is essential for human life, but too much lipid
content decreases the liver’s ability to clear lipoproteins, which can lead to atherosclerosis, the buildup of cholesterol
rich lesions and plaques in the arteries. Atherosclerosis is the major cause of cardiovascular disease, peripheral artery disease
and cerebral artery disease, and can cause heart attack, loss of limbs and stroke. Defective lipid metabolism plays an important
role in the development of adult onset diabetes mellitus (Type 2 diabetes), and diabetics are particularly vulnerable to atherosclerosis,
heart and peripheral artery diseases. Apo E is naturally occurring and is a public domain molecule that has been extensively researched
since the 1980’s. The importance of Apo E as a key mediator of lipid and cholesterol metabolism is illustrated by the fact
that the liver has a specific class of receptors that bind only Apo E. More recent research has demonstrated that Apo E has unique
protective effects on the artery wall. One of the leading lipid/atherosclerosis laboratories in the U.S. is at the University of
Alabama at Birmingham (“UAB”). In 2010, our JV’s founding scientist, Dr. Dennis Goldberg, licensed a group of
Apo E molecules for commercial development from UAB. Specifically, these molecules are classed as Apo E mimetic peptides. The UAB
scientists engineered the 299 amino acid native Apo E into a smaller 28 amino acid molecule that can be delivered therapeutically.
Our lead peptide, AEM-28, contains an amino acid sequence that anchors into a lipoprotein surface while also providing the human
binding domain to the Apo E receptor in the liver. In effect, AEM-28 acts like a docking system, attaching itself to lipids in
the blood stream while its other binding domain seeks heparan sulfate proteoglycan (Apo E) receptors in the liver. The liver then
processes these excess lipids and excretes them from the body. This sequence is part of a process called “reverse cholesterol
transport” and is the body’s natural mechanism for reducing cardiovascular risk.
Description of Drug Candidates, Clinical Results and Target Markets
In December 2014, we announced the completion and
results of the investigational Phase 1b/2a human clinical trial for AEM-28 in cholesterol and triglyceride reduction. The top-line
data from the Phase 1a (reported on September 2, 2014) and Phase 1b/2a blended protocol was statistically analyzed. The Medical
Safety Committee, in reviewing safety-related aspects of the clinical trial, observed
a generally acceptable safety profile. Analysis of biomarker data from the human studies showed what we believe is a statistically
significant reduction of Very Low Density Lipiprotein (“VLDL”) cholesterol and triglycerides of approximately 70% each
in fasted patients at one hour post-treatment. In particular, efficacy measurements analyzing pharmacodynamics yielded statistical
significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker endpoints, which included:
· | | p < 0.05 favoring AEM-28 vs. placebo within the first 12 hours post infusion at
the highest dose tested of 3.54mg/kg in VLDL, equating to a maximum 76% drop in VLDL vs. baseline and a 56% net maximum reduction
of VLDL vs. placebo; |
· | | p < 0.05 favoring AEM-28 vs. placebo within the first 12 hours post infusion at
the 2 mg/kg dose in VLDL, equating to a maximum 70% drop in VLDL vs. baseline and a 41% net maximum reduction of VLDL vs. placebo; |
· | | p < 0.025 favoring AEM-28 vs. placebo within the first 12 hours post infusion at
the highest dose tested of 3.54 mg/kg in triglycerides, equating to a maximum 74% drop in triglycerides vs. baseline and a 55%
average net maximum reduction of triglycerides vs. placebo; and |
· | | p < 0.025 favoring AEM-28 vs. placebo within the first 12 hours post infusion at
the 2 mg/kg dose in triglycerides, equating to a 71% drop in triglycerides vs. baseline and a 45% net maximum reduction of triglycerides
vs. placebo. |
VLDL and Triglycerides. The combination
of Low Density Lipoprotein (“LDL”) and VLDL cholesterol are termed Non- High Density Lipoprotein (“Non-HDL”)
cholesterol. These Non-HDL lipoproteins are a combination of proteins and lipids which allow fat and cholesterol to move around
the body so they may be taken up by target cells. Triglycerides (“TGs”) are found in VLDL and chylomicron remnants
in blood plasma. TGs play an important role in metabolism as energy sources while VLDL and chylomicron remnants serve as transporters
of dietary fat. When the amount of VLDL and TGs is properly regulated by the body’s natural systems, the vascular and metabolic
systems are in sync and functioning well. However, problems develop when these lipoproteins and lipids get out of balance, often
leading to severe cardiovascular and endocrinal diseases. When in overabundance in blood plasma, these large, buoyant molecules
are a primary contributor to atherosclerosis, or arterial plaque, which can unpredictably create an arterial occlusion and cause
a heart attack.
Acute Pancreatitis with High Triglycerides.
In 2015, we retained a consultancy to conduct a market assessment study for AEM-28 in acute pancreatitis (“AP”)
with high triglycerides. The consultancy’s report concluded that the AP indication represents a significant unmet clinical
need for a therapeutic that could rapidly reduce TGs. The schedule that follows below discusses the epidemiology and etiology of
AP. There are an estimated 74,000 hospitalizations for all types of AP in the U.S. each year with approximately 45,000 presenting
with severe levels of TG equal to or greater than 1,000 mg/dL. This patient population is possibly an ideal fit for AEM-28 as a
therapeutic agent.
ETIOLOGY / EPIDEMIOLOGY |
≈ % (1) |
U.S.
Patients |
Severe TGs
≥ 1,000 mg/dL |
Gallbladder/Stones |
25% |
18,500 |
No |
Alcohol |
50% |
37,000 |
Yes |
Genetic/Familial |
7% |
5,698 |
Yes |
Other/Idiopathic
(Diabetes/Obesity/Pregnancy) |
18% |
13,320 |
Yes |
TOTAL HOSPITALIZATIONS |
100% |
74,000 |
45,000 (2) |
| (1) | JOP.J. Pancreas, 11/9/2011, “Controversies in Etiology of Acute Pancreatitis, A. Khan et al. |
| (2) | Fletcher Spaght, 3/17/2015, “Market Assessment for Acute Pancreatitis”, M. Hoult et al.
|
Whereas we anticipate that AP with high TGs will
qualify as an orphan indication (since the patient population is below 200,000 in the U.S.), we believe that it is nonetheless
a sizable orphan market. Clinicians often treat these patients with fibrates or fish oil to reduce TGs, but fibrates and fish oil
take weeks if not longer to have an effect in reducing TGs. A drug that rapidly reduces TGs could diminish the severity of AP (especially
if administered at early onset) and could offer a significant economic savings to the healthcare system from faster discharge.
If clinical trials are successful and regulatory approval is granted, we believe that AEM-28 could potentially be added to the
AP treatment protocol in the emergency room for patients with elevated TGs.
Based on our consultant’s report, we also
believe that a market of 110,000 refractory hypertriglyceridemics exists in the U.S. These patients are at high risk for AP and
other TG-related indications and could be candidates for a weekly infusion of a TG-reducing therapeutic such as AEM-28. We believe
that this chronic market, at a projected 5.7 million doses annually, represents another significant market opportunity, albeit
requiring successful clinical outcomes studies.
Given the above, we plan to prioritize AP with
high TGs as our JV’s indication of choice for AEM-28 (and analogs) commercialization. Because AEM-28 has previously received
orphan drug designation (see below), we believe that the new analogs will also be so designated by the FDA for AP. As a result,
the clinical/regulatory pathway for AP should require less expensive clinical trials according to orphan regulatory precedent.
Homozygous Familial Hypercholesterolemia (HoFH).
In 2012, AEM-28 received orphan designation from FDA for a rare disease indication, called homozygous familial hypercholesterolemia
(“HoFH”). This is a very small global population of individuals who are born with no LDL receptors in the liver and
are unable to clear LDL (the “bad” cholesterol) through a natural pathway. Historically, these patients have experienced
cardiovascular complications in their teens and twenties often leading to early death. Standard of care therapy was a process called
apheresis, which is a mechanical filtering of the lipid fat from the patient’s entire blood volume, akin to the kidney dialysis
process. In 2013, two pharmaceutical therapies were approved in the U.S., Aegerion’s Juxtapid and Sanofi-Genzyme’s
Kynamro. Juxtapid has proven the market with an impressive revenue ramp while revenue data for Kynamro is not publicly available.
We believe that AEM-28, or the new analogs, if approved, could compete favorably with these other drugs due to potentially increased
efficacy and fewer and less severe side effects.
AEM-28-14 and Analogs
Although AEM-28 is well researched by scientists
at our academic research partner, The University of Alabama at Birmingham Research Foundation (“UABRF”), it has a relatively
short remaining patent life (to 2020). If AEM-28 were approved by the FDA as an orphan drug in the U.S., it would have seven years
of marketing exclusivity after registration. Accordingly, AEM-28 remains a potentially valuable commercial asset, but only in orphan
indications.
Collaboration with UABRF under an exclusive license
agreement (see “Patents, Licenses and Proprietary Rights”, below) has resulted in the discovery of new Apo E mimetic
peptides. Recently, our joint venture has been testing an analog of AEM-28, which we refer to as AEM-28-14. Early preclinical testing
has yielded encouraging results suggesting that AEM-28-14 may be more tolerable and more efficacious than AEM-28. In July 2015,
our joint venture announced the conversion of its provisional patent application for AEM-28-14 seeking 21 years of composition
of matter patent protection.
AEM-28-14 and the other analogs are significant
in that their potential 21-year patent life could allow our joint venture and/or its potential future strategic partners to develop
AEM-28-14 for “clinical outcomes” indications that typically require very large, lengthy clinical trials. These markets
include acute coronary syndrome, peripheral artery disease and metabolic syndrome, each of which currently represents a multi-billion
dollar annual market for drug therapies. Now, with AEM-28-14, we believe that our JV has a product candidate that not only has
the potential to serve sizable orphan markets, but also has the potential to serve much larger markets for chronic indications.
The JV filed for additional patent protection in
October 2014 for a new and proprietary formulation to increase safe delivery of AEM-28 and its analogs to humans. In the Australia
clinical trials, at the highest tested dose of 3.54 mg/kg, some cases of mild venous irritation and infusion site reaction were
observed. The JV has tested the new formulation with an analog of AEM, which we refer to as AEM-28-02, in multiple animal
models, resulting in an approximate 6X increase in maximum tolerated dose (MTD) and what appears to be an improved tolerability
profile. AEM-28-02 was the first of the new generation chimeric Apo E peptides discovered. AEM-28-14 is the most potent of
the newly-discovered chimeric Apo E mimetic peptides, and a single 50 ug injection of AEM-28-14 decreased cholesterol 98% in Apo
E null mice with no observed adverse effects. AEM-28-14 (or analogs) combined with the new formulation may allow safe delivery
at higher doses than those previously tested in humans.
Business Matters
Legal. In June 2015, we settled our long-pending
qui tam lawsuit for a one-time payment of $50,000. The lawsuit had been filed under seal in March 2005 in the U.S. District Court
for the District of Massachusetts against us and substantially all other companies that sold bone growth stimulation devices during
the period 1998-2003. The complaint asserted a variety of claims, including False Claims Act violations. We sold our bone growth
stimulation device business in 2003 and first learned of this lawsuit in September 2009.
Net Operating Loss. We have accumulated
approximately $146 million in federal and $33 million in state net operating loss carry forwards as of December 31, 2014, which
are presently eligible to offset some future tax liability. At the maximum U.S. corporate income tax rate, the potential tax benefit
could be as high as $51 million, or $1.25 per share (based on 40,885,411 shares outstanding at September 14, 2015), provided we
generate income in sufficient amounts prior to the expiration of these carry forwards, which expire beginning in 2023 for federal
and 2015 for state net operating loss carry forwards. We view our net operating loss carryforwards and other tax attributes to
reduce our future taxable income, if any (collectively, “Tax Benefits”), as potentially valuable assets. However, if
we experience an “ownership change,” as defined in Section 382 of the Internal Revenue Code (the “Code”),
whether as a result of this offering or otherwise, our ability to use the Tax Benefits could be severely limited, and the timing
of the usage of the Tax Benefits could be substantially delayed, which could significantly impair the value of the Tax Benefits
even if we subsequently generate taxable income. In June 2014, our Board adopted a Tax Benefit Preservation Plan intended to act
as a deterrent to persons acquiring our common stock in certain transactions that would constitute or contribute to such an “ownership
change” without the approval of our Board. See, "Description of Our Capital Stock" below, for a description of
the Tax Benefit Preservation Plan.
For additional discussion regarding this offering,
please see the Joint Development Venture September 2015 Supplemental Information attached hereto as Exhibit A, which should be
read in conjunction with the “Risk Factors” section in this prospectus.
The Offering |
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Issuer |
Capstone Therapeutics Corp. |
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Securities offered |
Up to Units. Each Unit will consist of one share of common stock and one warrant to purchase one-half of a share of common stock. The shares of common stock and warrants will immediately separate after purchase and will be issued separately. |
|
Offering price |
We will offer and sell the Units at a price of $ per Unit which will be fixed for the duration of the offering. |
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Description of the warrants |
The warrants are exercisable for a five-year period at an exercise price of $ , which is % of the offering price for each Unit. |
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Common stock outstanding before this offering |
The number of shares of our common stock outstanding immediately before
this offering is 40,885,411, excluding the following:
• Options to purchase 4,062,706 shares of our common stock, the exercise price of which range from $0.16 per share to $5.39
per share as follows:
- Options to purchase 1,245,000 shares at exercise prices
of $.16 to $.22 per share
- Options to purchase 598,000 shares at exercise prices of $.24 to $.45 per share
- Options to purchase 620,000 shares at an exercise price of $.25 per share
- Options to purchase 504,000 shares at exercise prices of $.58 to
$.82 per share
- Options to purchase 914,706 shares at exercise prices of $1.02 to $1.75 per share
- Options to purchase 181,000 shares at exercise prices of $4.90 to $5.39 per share
• Warrants outstanding to purchase 46,706 shares of our common stock with an exercise price of $6.39 per share, and warrants
outstanding to purchase 117,423 shares of our common stock with an exercise price of $1.91 per share.
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|
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Common stock to be outstanding after this offering |
Assuming the purchase of all of the Units offered in this prospectus,
the number of shares of our common stock outstanding immediately after this offering will be
( if one-half of the number of Units offered in this prospectus
are purchased).
The amounts above do not include:
• Shares of common stock issuable upon exercise of the
warrants included in the Units ( shares if all of the Units offered in this prospectus
are purchased, and shares if one-half of the Units offered in this prospectus are purchased).
• Shares of common stock issuable upon exercise of the
warrants issued to H.C. Wainwright in conjunction with this sale of securities ( shares
if all of the Units offered in this prospectus are purchased, and shares if one-half
of the Units offered in this prospectus are purchased)
• 4,226,835 shares of common stock issuable upon the exercise
of the outstanding stock options and warrants described above.
In addition, we have reserved 1,000,000 shares of our common stock
for issuance pursuant to our 2015 Equity Incentive Plan, for which options to purchase 620,000 shares are outstanding as of September
14, 2015. As of September 14, 2015, we have 3,442,706 shares of our common stock reserved for issuance under our 2005 Equity Incentive
Plan, which expired in April 2015.
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Use of proceeds |
Assuming the sale of all of the Units offered in this prospectus, we
will receive net proceeds, after deducting the cash fee payable to the placement agent equal to 7.25% of aggregate gross proceeds
(and assuming that no investors in this offering are Reduced Fee Investors, for which a reduced placement agent fee of 4% is applicable),
and estimated expenses of the offering of $ , as follows:
• $ from the
sale of the Units; and
• Up to $ from the future
exercise of warrants included in the Units.
This is a best efforts offering and we may sell all, some or none of
the Units offered.
We intend to use the net proceeds of this offering for research and
development activities, principally through our JV, to which we will transfer the funds on terms to be negotiated , and for our
working capital and general corporate purposes. See “Use of Proceeds” for additional information.
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Risk factors |
You should read the “Risk Factors” section of, and all of the other information set forth in, or incorporated by reference in, this prospectus to consider carefully before deciding whether to invest in the Units offered by this prospectus.
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OTCQB Market symbol |
CAPS |
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RISK FACTORS
AND FORWARD LOOKING STATEMENTS
Safe Harbor
We may from time to time make written or oral forward-looking
statements, including statements contained in our filings with the SEC and our reports to stockholders. The safe harbor for forward-looking
statements contained in the Private Securities Litigation Reform Act of 1995 protects companies from liability for their forward
looking statements if they comply with the requirements of that Act. This prospectus contains forward-looking statements made pursuant
to that safe harbor. These forward-looking statements relate to future events or to our future financial performance, and involve
known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or
achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied
by these forward-looking statements. In some cases, you can identify forward-looking statements by the use of words such as “may,”
“could,” “expect,” “intend,” “plan,” “seek,” “anticipate,”
“believe,” “estimate,” “predict,” “potential,” “continue,” or the negative
of these terms or other comparable terminology. You should not place undue reliance on forward-looking statements since they involve
known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could materially
affect actual results, levels of activity, performance or achievements. Factors that may cause actual results to differ materially
from current expectations, which we describe in more detail below include, but are not limited to:
| · | the impact of our actions to preserve cash, including implementation of a virtual operating model; |
| · | unfavorable results of product candidate development efforts, including through our joint venture; |
| · | unfavorable results of pre-clinical or clinical testing, including through our joint venture; |
| · | delays in obtaining, or failure to obtain FDA or comparable foreign agency approvals; |
| · | increased regulation by the FDA or comparable foreign agencies; |
| · | the introduction of competitive products; |
| · | impairment of license, patent or other proprietary rights; |
| · | the impact of present and future joint venture, collaborative or partnering agreements or the lack
thereof; |
| · | failure to successfully implement our drug development strategy for AEM-28 and its analogs; and |
| · | failure to obtain additional funds required to complete clinical trials and supporting research and
production efforts necessary to obtain FDA or comparable foreign agency approval for product candidates or secure development agreements
with pharmaceutical manufacturers. |
If one or more of these or other risks or uncertainties
materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from what we projected.
Any forward-looking statement you read in this prospectus reflects our current views with respect to future events and is subject
to these and other risks, uncertainties and assumptions relating to our operations, results of operations, business strategy and
liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the
reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information
becomes available in the future.
Risks Related to Our Business and Industry
The audit opinion from our independent accounting
firm, Moss Adams, LLC, on our December 31, 2014 financial statements, included in our Form 10-K filed with the SEC on March 16,
2015 includes an explanatory paragraph as to an uncertainty with respect to the our ability to continue as a going concern.
We had accumulated deficit balances of $186.2 million
and $187.7 million as of December 31, 2014 and June 30, 2015, respectively. Our net loss for the year ended December 31, 2014 was
$4.2 million, and our net loss for the three and six months ended June 30, 2015 was $0.8 million and $1.5 million, respectively.
We currently have no pharmaceutical products being sold or ready for sale and do not expect to be able to introduce any pharmaceutical
products or generate any revenue for at least several years. We expect to incur losses for at least the next several years. Our
cash reserves are the primary source of our working capital. These circumstances raise substantial doubt about the Company’s
ability to continue as a going concern.
We are a biopharmaceutical company with no
revenue generating operations and high investment costs. Therefore, we will require additional funding to realize revenue from
any of our JV’s product candidates, and we may never realize any revenue if our JV’s product candidates cannot be commercialized.
Our current level of funds is not sufficient to
support continued research to develop our JV’s product candidates, and the proceeds of this offering will not be sufficient
to fund all the research expenses necessary to achieve commercialization of any of our JV’s product candidates. We will require
substantial additional capital, and/or a development partner, to complete the clinical trials and supporting research and production
efforts necessary to obtain FDA or comparable foreign agencies’ approval, if any, for our JV’s product candidates.
We may not receive any revenue from our JV’s product candidates until we receive regulatory approval and begin commercialization
of our JV’s product candidates. We cannot predict whether, or when, that might occur.
This offering is a best efforts offering and there
is no minimum offering amount. Accordingly, we may sell all, some or none of the Units offered. We can give no assurances regarding
the amount of proceeds that will be generated from this offering or how much further development of our JV’s product candidates
the proceeds will fund before more funding is necessary. To the extent we sell less than all of the Units in this offering, we
will need to seek additional funding sooner than otherwise would be the case. There is no assurance that we can obtain needed funding
from third parties on terms acceptable to us, or at all. New sources of funds, including raising capital through the sales of our
debt or equity securities, joint venture or other forms of joint development arrangements, sales of development rights, or licensing
agreements, may not be available or may only be available on terms that would have a material adverse impact on our existing stockholders’
interests.
We caution that our future cash expenditure levels
are difficult to forecast because the forecast is based on assumptions about the level of future operations, including the number
of research projects we pursue, the pace at which we pursue them, the quality of the data collected and the requests of the FDA
or comparable foreign agencies to expand, narrow or conduct additional clinical trials and analyze data. Changes in any of these
assumptions can change significantly our estimated cash expenditure levels.
Our JV partners have significant rights as
minority-interest stockholders of our JV. Although we own 60% of the outstanding shares of our JV’s common stock, the minority
stockholders of the JV have the right to appoint a majority of the JV’s board of directors.
Pursuant to a Stockholders Agreement among all
the stockholders of our JV, we have agreed that the board of directors of the JV will be composed of three individuals designated
by the minority stockholders and two individuals designated by us. Consequently, our JV partners’ designees, and not our
designees, control the JV’s board of directors. If the JV fails to operate substantially in accordance with its annual budget,
including the milestones specified therein, or fails to comply with its obligations under the Stockholders Agreement, we will thereafter
have the right to appoint a majority of the members of the JV’s board of directors.
Under the Stockholders Agreement, the consent of
stockholders acting by a majority in interest is required for a broad range of actions, including annual budgets and operational
milestones. Because we are the majority stockholder, these consent rights protect our interests in the JV. However, there is a
risk that these consent rights may be insufficient to protect our interests or may result in impasses with respect to the JV’s
management and operation, the resolution of which might result in actions, agreements or consequences that we might view as suboptimal.
There is no assurance that the minority stockholders of the JV will share the same economic, business or legal interests or goals
that we have for the JV's business. See “Ownership, Management and Governance of our JV” below.
Our business is subject to stringent regulation,
and if we do not obtain regulatory approval for our JV's product candidates, we will not be able to generate revenue.
Our JV’s research, development, pre-clinical
and clinical trial activities and the manufacture and marketing of any products that it may successfully develop are subject to
an extensive regulatory approval process by the FDA and other regulatory agencies in the United States and abroad. The process
of obtaining required regulatory approvals for pharmaceutical products is lengthy, expensive and uncertain, and any such regulatory
approvals may entail limitations on the indicated usage of a product, which may reduce the product’s market potential.
None of our JV's product candidates has been approved
for sale. In order to obtain FDA or comparable foreign agency approval to commercialize any product candidate, a New Drug Application
(NDA) (or comparable foreign agency form) must be submitted demonstrating, among other things, that the product candidate is safe
and effective for use in humans for each target indication. Our or our JV’s regulatory submissions may be delayed, or we
or our JV may cancel plans to make submissions for product candidates for many reasons, including unfavorable results from or delays
in preclinical or clinical trials and lack of sufficient available funding.
If we experience delays in our JV’s clinical
trials, we will incur additional costs and our opportunities to monetize product candidates will be deferred. Delays could occur
for many reasons, including the following:
| · | the FDA or other health regulatory authorities, or institutional review boards, do not approve a clinical
study protocol or place a clinical study on hold; |
| · | suitable patients do not enroll in a clinical study in sufficient numbers or at the expected rate,
or data is adversely affected by trial conduct or patient drop out; |
| · | patients experience serious adverse events, including adverse side effects of our JV’s product
candidates; |
| · | patients in the placebo or untreated control group exhibit greater than expected improvements or fewer
than expected adverse events; |
| · | third-party clinical investigators do not perform the clinical studies on the anticipated schedule
or consistent with the clinical study protocol and good clinical practices, or other third-party organizations do not perform data
collection and analysis in a timely or accurate manner; |
| · | service providers, collaborators or co-sponsors do not adequately perform their obligations in relation
to the clinical study or cause the study to be delayed or terminated; |
| · | we experience difficulties in obtaining sufficient quantities of the particular product candidate
or any other components needed for pre-clinical testing or clinical trials; |
| · | regulatory inspections of manufacturing facilities, which may, among other things, require us or a
co-sponsor to undertake corrective action or suspend the clinical studies; |
| · | the interim results of the clinical study are inconclusive or negative; |
| · | the clinical study, although approved and completed, generates data that is not considered by the
FDA or others to be sufficient to demonstrate safety and efficacy; |
| · | changes in governmental regulations or administrative actions affect the conduct of the clinical trial
or the interpretation of its result; |
| · | there is a change in the focus of our JV’s development efforts or a re-evaluation of its clinical
development strategy; and |
| · | we lack of sufficient funds to pay for development costs.
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Consequently, we cannot assure that we or our JV
will make submissions to the FDA or comparable foreign agencies in the timeframe that we have planned, or at all, or that our and
our JV’s submissions will be approved by the FDA or comparable foreign agencies. Even if regulatory clearance is obtained,
post-market evaluation of our JV’s future products, if required, could result in restrictions on a product’s marketing
or withdrawal of a product from the market as well as possible civil and criminal sanctions.
If our JV’s product candidates do not
gain market acceptance or our competitors develop and market products that are more effective than our JV’s product candidates,
our commercial opportunities will be reduced or eliminated.
Even if our JV brings one or more products to market,
there is no assurance that our JV will be able to successfully manufacture or market the products or that potential customers will
buy them. Market acceptance will depend on our ability to demonstrate to physicians and patients the benefits of the future products
in terms of safety, efficacy, and convenience, ease of administration and cost effectiveness, as well as on our JV’s ability
to continue to develop product candidates to respond to competitive and technological changes. In addition, we believe that market
acceptance depends on the effectiveness of our marketing strategy, the pricing of our JV’s future products and the reimbursement
policies of government and third-party payors. Physicians may not prescribe our JV’s future products, and patients may determine,
for any reason, that our JV’s product is not useful to them. Insurance companies and other third party payors may determine
not to reimburse for the cost of the product.
Competition in the pharmaceutical and biotechnology
industries is intense and is expected to increase. Several biotechnology and pharmaceutical companies, as well as academic laboratories,
universities and other research institutions, are involved in research and/or product development for indications targeted for
use by AEM-28 and its analogs. Most of our competitors have significantly greater research and development capabilities, experience
in obtaining regulatory approvals and manufacturing, marketing, financial and managerial resources than we have.
Our competitors may succeed in developing products
that are more effective than the ones we have under development or that render our proposed products or technologies noncompetitive
or obsolete. In addition, certain of our competitors may achieve product commercialization before we do. If any of our competitors
develops a product that is more effective than one that our JV is developing or plans to develop, or is able to obtain FDA or comparable
foreign agencies’ approval for commercialization before we do, we may not be able to achieve significant market acceptance
for certain of our JV’s products, which would have a material adverse effect on our JV’s business.
For a summary of the competitive conditions relating
to indications which we are currently considering for AEM-28 and its analogs, see “Competition” in this prospectus.
If we cannot protect our joint venture’s
AEM-28 and other patents, or our JV’s intellectual property generally, our JV’s ability to develop and commercialize
its future products will be severely limited.
Our success will depend in part on our joint venture’s
ability to maintain and enforce patent protection for AEM-28 and its analogs and each resulting product. Without patent protection,
other companies could offer substantially identical products for sale without incurring the sizable discovery, development and
licensing costs that our joint venture has incurred. Our JV’s ability to recover these expenditures and realize profits upon
the sale of products would then be diminished.
AEM-28 is patented and patent applications for
the AEM-28 analogs have be filed. There have been no successful challenges to the patents. However, if there were to be a challenge
to these patents or any of the patents for product candidates, a court may determine that the patents are invalid or unenforceable.
Even if the validity or enforceability of a patent is upheld by a court, a court may not prevent alleged infringement on the grounds
that such activity is not covered by the patent claims. Any litigation to enforce our JV’s rights to use its or its licensors’
patents will be costly, time consuming and may distract management from other important tasks.
As is commonplace in the biotechnology and pharmaceutical
industries, we employ, or engage as consultants, individuals who were previously employed at other biotechnology or pharmaceutical
companies, including our competitors or potential competitors. To the extent our employees are involved in research areas which
are similar to those areas in which they were involved at their former employers, we may be subject to claims that such employees
and/or we have inadvertently or otherwise used or disclosed the alleged trade secrets or other proprietary information of the former
employers. Litigation may be necessary to defend against such claims, which could result in substantial costs and be a distraction
to management and which may have a material adverse effect on us, even if we are successful in defending such claims.
We also rely on trade secrets, know-how and other
proprietary information. We seek to protect this information, in part, through the use of confidentiality agreements with employees,
consultants, advisors and others. Nonetheless, we cannot assure that those agreements will provide adequate protection for our
trade secrets, know-how or other proprietary information and prevent their unauthorized use or disclosure. The risk that other
parties may breach confidentiality agreements or that our trade secrets become known or independently discovered by competitors,
could adversely affect us by enabling our competitors, who may have greater experience and financial resources, to copy or use
our trade secrets and other proprietary information in the advancement of their products, methods or technologies.
Our success also depends on our JV’s
ability to operate and commercialize products without infringing on the patents or proprietary rights of others.
Third parties may claim that our JV or its licensors
or suppliers are infringing their patents or are misappropriating their proprietary information. In the event of a successful claim
against our JV or its licensors or suppliers for infringement of the patents or proprietary rights of others, our JV may be required
to, among other things:
· | | pay substantial damages; |
· | | stop using our JV’s technologies; |
· | | stop certain research and development efforts; |
· | | develop non-infringing products or methods; and |
· | | obtain one or more licenses from third parties. |
A license required under any such patents or proprietary rights may
not be available to our JV, or may not be available on acceptable terms. If our JV or its licensors or suppliers are sued for infringement,
our JV could encounter substantial delays in, or be prohibited from, developing, manufacturing and commercializing its product
candidates.
Our reliance on third party clinical research
organizations and other consultants could have a material effect on our JV’s ability to conduct clinical trials and perform
research and development. Product development costs to our JV and our JV’s potential collaborators will increase, and our
JV’s business may be negatively impacted, if we experience delays in testing or approvals or if our JV needs to perform more
or larger clinical trials than planned.
To obtain regulatory approvals for new products,
our JV must, among other things, initiate and successfully complete multiple clinical trials demonstrating to the satisfaction
of the FDA or other regulatory authority that our JV’s product candidates are sufficiently safe and effective for a particular
indication. We currently rely on third party clinical research organizations and other consultants to assist our JV in designing,
administering and assessing the results of those trials and to perform research and development with respect to product candidates.
In relying on those third parties, we are dependent upon them to timely and accurately perform their services. If third party organizations
do not accurately collect and assess the trial data, our JV may discontinue development of viable product candidates or continue
allocating resources to the development and marketing of product candidates that are not efficacious. Either outcome could result
in significant financial harm to us.
The loss of key management and scientific
personnel may hinder our JV’s ability to execute our business plan.
As a small company our success depends on the continuing
contributions of our management team and scientific consultants, and maintaining relationships with the network of medical and
academic centers in the United States and centers that conduct our clinical trials. We have reduced our staff to two administrative
employees and utilize consultants to perform a variety of administrative, regulatory or research tasks. We have entered into consulting
agreements with various former key employees, but there is no assurance that these persons will be available in the future to the
extent their services may be needed.
If we are not successful in retaining the services
of former key employees it could materially adversely affect our business prospects, including our ability to explore partnering
or development activities.
Our joint venture is managed under contract by
Benu BioPharma Inc., which is comprised of three individuals (Dennis I. Goldberg, Ph.D., Phillip M. Friden, Ph.D., and Eric M.
Morrel, Ph.D.). These individuals are minority stockholders in our JV.
Although there is a services contract with Benu
BioPharma Inc., there is no direct agreement with these individuals for continued services and they are under no legal obligation
to remain with Benu BioPharma Inc. We can give no assurance that all or any of these individuals will continue to provide services
to our joint venture. Should any of these individuals not continue to provide services to our joint venture, it could have a material
adverse effect on our joint venture’s ability or cost to develop AEM-28 and its analogs.
Possible side effects of our JV’s product
candidates may be serious and life threatening. If one of our JV’s product candidates reveals safety or fundamental efficacy
issues in clinical trials, it could adversely impact the development path for our JV’s other current product candidates for
that peptide. We face an inherent risk of liability in the event that the use or misuse of our JV’s future products results
in personal injury or death.
The occurrence of any unacceptable side effects
during or after pre-clinical and clinical testing of our JV’s product candidates, or the perception or possibility that our
JV’s product candidates cause or could cause such side effects, could delay or prevent approval of our JV’s products
and negatively impact its business. The use of our JV’s product candidates in clinical trials may expose us
and our JV to product liability claims, which could result in financial losses. Our clinical liability insurance coverage may
not be sufficient to cover claims that may be made against us or our JV. In addition, we may not be able to maintain insurance
coverage at a reasonable cost or in sufficient amounts or scope to protect us and our JV against losses. Any claims against us
or our JV, regardless of their merit, could severely harm our financial condition, strain our management and other resources and
adversely impact or eliminate the prospects for commercialization of the product which is the subject of any such claim.
Risks Related to our Common Stock
The trading volume in our common stock is
limited and our stock price is volatile, and therefore stockholders may not be able to sell their shares in desired amounts at
the reported trading prices.
The trading price for our common stock, which is
traded in the over-the-counter market, has varied significantly in the past (from a high of $9.32 to a low of $0.12 during the
period of January 1, 2004 through December 31, 2014) and may vary in the future due to a number of factors, including:
· | | announcement of the results of, or delays in, preclinical and clinical studies; |
· | | fluctuations in our operating results; |
· | | developments in litigation to which we or a competitor is subject; |
· | | announcements and timing of potential partnering, development collaboration or licensing
transactions, merger, acquisitions, divestitures, capital raising activities or issuance of preferred stock; |
· | | announcements of technological innovations or new products by us or our competitors; |
· | | FDA and other regulatory actions; |
· | | developments with respect to our or our competitors’ patents or proprietary
rights; |
· | | public concern as to the safety of products developed by us or others; and |
· | | changes in stock market analyst recommendations regarding us, other drug development
companies or the pharmaceutical industry generally. |
Our common stock is thinly traded, in part because
over-the-counter trading volumes are generally significantly lower than those on stock exchanges. The trading volume for our common
stock often varies widely from day to day. Because of the low trading volume, a relatively small amount of trading may greatly
affect the trading price, the trading price may be subject to amplified decreases upon the occurrence of events affecting our business,
and investors should not consider an investment in our common stock to be liquid. In addition, the broader stock market has from
time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular
companies, and these broad market fluctuations may be even more pronounced for our thinly traded stock.
We have not agreed with our JV regarding
the manner in which offering proceeds will be made available to the JV. To the extent that our JV partners do not experience dilution
from the deployment of offering proceeds to the JV, the current and/or future value of our investment in the JV may be negatively
impacted.
Most of the proceeds of this offering will be made
available to our JV to fund the continued development of AEM-28 and its analogs. There is currently no agreement between the JV
and us regarding the manner in which the proceeds of this offering will be deployed to the JV. Although we own 60% of the outstanding
shares of our JV’s common stock, the JV’s board of directors is controlled by individuals designated by the JV's minority
stockholders, and therefore any agreement regarding the manner in which the offering proceeds are made available to the JV will
require the approval of directors designated by the minority stockholders of the JV. Proceeds from the offering could be made available
through loans or equity contributions by us to the JV, or in some combination of debt and equity. To the extent that offering proceeds
are made available to the JV as a loan, which has no dilutive effect on our JV partners, any increase in the valuation of the JV
resulting from the JV’s use of the offering proceeds to continue product development would be realized by our JV partners
to the extent of their collective equity ownership of the JV. If offering proceeds are made available to the JV as equity, then
we and the JV will need to agree as to the dilutive effect that any such equity contribution will have on our JV partners' collective
equity ownership of the JV.
We intend to seek an arrangement in which we will
make an equity contribution to the JV in exchange for an additional equity interest that results in the dilution of the minority
stockholders of the JV that approximates the dilution that our stockholders experience as a result of this offering (pro-rated
by the portion of the net offering proceeds that we contribute to the JV relative to the aggregate net offering proceeds that we
receive). However, there is no assurance that we will be able to agree on such terms or other terms favorable to Capstone.
Future share issuances may have dilutive
and other material effects on our stockholders.
We are authorized to issue 150,000,000 shares of
common stock. As of September 14, 2015, there were 40,885,411 shares of common stock issued and outstanding. However, the total
number of shares of our common stock issued and outstanding does not include shares reserved in anticipation of the exercise of
options, warrants or additional investment rights. As of September 14, 2015, we had options outstanding to purchase approximately
4,062,706 shares of our common stock, the exercise price of which ranges between $0.16 per share to $5.39 per share, warrants outstanding
to purchase 46,706 shares of our common stock with an exercise price of $6.39 per share, and warrants outstanding to purchase 117,423
shares of our common stock with an exercise price of $1.91 per share, and we have reserved shares of our common stock for issuance
in connection with the potential exercise thereof. To the extent additional options are granted and exercised or additional stock
is issued, the holders of our common stock will experience further dilution. At September 14, 2015, 380,000 shares remain available
to grant under the 2015 Equity Incentive Plan.
In addition, in the event that any future financing
or consideration for a future acquisition should be in the form of, be convertible into or exchangeable for, equity securities,
investors will experience additional dilution.
Certain provisions of our certificate of
incorporation and bylaws will make it difficult for stockholders to change the composition of our board of directors(“Board”)
and may discourage takeover attempts that some of our stockholders may consider beneficial.
Certain provisions of our certificate of incorporation
and bylaws may have the effect of delaying or preventing changes in control if our Board determines that such changes in control
are not in the best interests of the Company and our stockholders. These provisions include, among other things, the following:
· | | a classified Board with three-year staggered terms; |
· | | advance notice procedures for stockholder proposals to be considered at stockholders’
meetings; |
· | | the ability of our Board to fill vacancies on the board; |
· | | a prohibition against stockholders taking action by written consent; |
· | | supermajority voting requirements for the stockholders to modify or amend our bylaws
and specified provisions of our certificate of incorporation, and |
· | | the ability of our Board to issue up to 2,000,000 shares of preferred stock without
stockholder approval. |
These provisions are not intended to prevent a
takeover, but are intended to protect and maximize the value of our stockholders’ interests. While these provisions have
the effect of encouraging persons seeking to acquire control of our company to negotiate with our Board, they could enable our
Board to prevent a transaction that some, or a majority, of our stockholders might believe to be in their best interests and, in
that case, may prevent or discourage attempts to remove and replace incumbent directors. In addition, we are subject to the provisions
of Section 203 of the Delaware General Corporation Law, which prohibits business combinations with interested stockholders. Interested
stockholders do not include stockholders whose acquisition of our securities is pre-approved by our Board under Section 203.
In June 2014, our Board adopted a Tax Benefit Preservation Plan (“Benefit
Plan”) with Computershare, pursuant to which each outstanding share of our common stock has attached one preferred stock
purchase right. Each share of our common stock subsequently issued prior to the expiration of the Benefit Plan will likewise have
attached one right. Under specified circumstances involving an “ownership change,” as defined in Section 382 of the
Internal Revenue Code (the “Code”), the right under the Benefit Plan that attaches to each share of our common stock
will entitle the holder thereof to purchase 1/100 of a share of our Series A preferred stock for a purchase price of $5.00 (subject
to adjustment), and to receive, upon exercise, shares of our common stock having a value equal to two times the exercise price
of the right.
By adopting the Benefit Plan, our Board sought
to protect our ability to use our net operating loss carryforwards and other tax attributes to reduce our future taxable income,
if any (collectively, “Tax Benefits”). We view our Tax Benefits as highly valuable assets that are likely to inure
to our benefit and the benefit of our stockholders if in the future we generate taxable income. However, if we experience an “ownership
change,” our ability to use the Tax Benefits could be substantially limited, and the timing of the usage of the Tax Benefits
could be substantially delayed, which could significantly impair the value of the Tax Benefits. The Benefit Plan is intended to
act as a deterrent to persons acquiring our common stock in certain transactions that would constitute or contribute to such an
“ownership change” without the approval of our Board. The Benefit Plan expires June 24, 2016.
We may issue additional shares of preferred
stock that have greater rights than our common stock and also have dilutive and anti-takeover effects.
We have 2,000,000 shares of authorized preferred
stock, the terms of which may be fixed by our Board. We presently have no outstanding shares of preferred stock. Our Board has
the authority, without stockholder approval, to create and issue one or more series of such preferred stock and to determine the
voting, dividend and other rights of holders of such preferred stock. If we raise additional funds to continue development of AEM-28
and its analogs, or operations, we may issue preferred stock. The issuance of any of such series of preferred stock may have an
adverse effect on the holders of common stock.
In connection with the Benefit Plan, our Board
approved the designation of 1,000,000 shares of Series A Preferred Stock. The Benefit Plan and the exercise of rights to purchase
Series A Preferred Stock, pursuant to the terms thereof, may delay, defer or prevent a change in control without the approval of
the Board. In addition to the anti-takeover effects of the rights granted under the Benefit Plan, the issuance of preferred stock,
generally, could have a dilutive effect on our stockholders. The Benefit Plan expires June 24, 2016.
We have not previously paid dividends on
our common stock and we do not anticipate doing so in the foreseeable future.
We have not in the past paid any dividends on our
common stock and do not anticipate that we will pay any dividends on our common stock in the foreseeable future. Any future decision
to pay a dividend on our common stock and the amount of any dividend paid, if permitted, will be made at the discretion of our
Board.
USE OF PROCEEDS
The following table sets forth the net proceeds
that we may receive in this offering based upon our current estimate of expenses.
|
If all of the Units offered in this offering are sold: |
If one-half of the Units offered in this offering are sold: |
Gross proceeds from Units sold in this offering |
|
|
Gross proceeds from exercise of warrants sold in this offering |
|
|
Total gross proceeds |
|
|
Less placement agent fees (1) |
|
|
Less other expenses (2) |
|
|
Net proceeds |
|
|
(1) Cash fee payable to the placement agent equal to 7.25% of
aggregate gross proceeds (assuming that no investors in this offering are Reduced Fee Investors, for which a reduced placement
agent fee of 4% is applicable).
(2) For additional information on other expenses, see the “Other
Expenses of Issuance and Distribution” section in this prospectus.
We intend to use most of the net proceeds we receive
from the sale of securities to extend the development of AEM-28 and its analogs, and the remainder for other general corporate
purposes, including working capital needs. In particular, planned uses by the JV of the net proceeds from the offering, if and
to the extent such proceeds are sufficient, include:
| · | pre-clinical (toxicology and pharmacokinetic) studies to support an IND filing or an equivalent thereof
for AEM-28-14 or another of the new analogs; |
| · | CRO oversight of human clinical trials and preparation of clinical study reports; |
| · | Phase 1/2 human studies of AEM-28 or its analogs in normal healthy volunteers and patients with high
fasted triglycerides; |
| · | management fees to the JV’s management company, Benu Biopharma, Inc., for turn-key project management;
and formulation, CMC and GMP drug material manufacturing. |
In addition, if and to the extent offering proceeds
are sufficient, we expect to use a portion of the proceeds to fund the approximately $1,200,000 in annual administrative, accounting
and legal costs associated with maintaining a publicly-held corporation subject to SEC periodic reporting.
If we receive net offering proceeds in an amount
equal to $7,600,000, then the estimated uses (on a consolidated basis for the Company and the JV) of the net proceeds from the
offering would be as follows:
| |
Estimated Use of Net Offering Proceeds | |
Estimated Percentage of Total Net Offering Proceeds |
Formulation and Manufacturing of AEM-28-14 | |
$ | 1,200,000 | | |
| 16 | % |
Animal Toxicology / Pharmacokinetics (PK) Studies of AEM-28-14 | |
$ | 1,100,000 | | |
| 14 | % |
Preparation and Submission of Regulatory Dossiers for AEM-28-14 | |
$ | 200,000 | | |
| 3 | % |
Phase 1a Clinical Trials of AEM-28-14 | |
$ | 800,000 | | |
| 11 | % |
Phase 1b Clinical Trials of AEM-28-14 | |
$ | 800,000 | | |
| 11 | % |
Phase 2 Clinical Trials of AEM-28-14 | |
$ | 2,100,000 | | |
| 28 | % |
General Corporate Purposes | |
$ | 1,400,000 | | |
| 18 | % |
TOTAL | |
$ | 7,600,000 | | |
| 100 | % |
The foregoing table is based upon the assumption that we receive $7,600,000
in net proceeds from the offering. If we receive substantially less than $7,600,000 in net offering proceeds, then at a minimum,
we estimate that the amount of proceeds that would be used for the JV’s Phase 2 clinical trials of AEM-28-14 would be decreased.
If we receive substantially more that $7,600,000 in net offering proceeds, then we may use a portion of such additional proceeds
for further development of AEM-28 and its analogs.
If all of the Units offered hereby are sold, we
believe that we will have sufficient funds for our JV to complete the preclinical development and possibly Phase 1a and Phase1b/2a
clinical trials as well for AEM 28-14, but we cannot predict the total cost of these efforts which depends on, among other things,
successful and timely outcomes in our preclinical and clinical studies. In any event, our JV will require substantial additional
capital, and/or a development partner, to complete the clinical trials and supporting research and production efforts necessary
to obtain FDA or comparable foreign agencies’ approval, if any, for our JV’s product candidates. We may seek to obtain
the necessary additional funding through the issuance of debt and/or equity securities by us or our JV in one or more private or
public offerings in the future (which could include bridge financing from certain of our significant existing stockholders), through
a strategic partner arrangement or otherwise. In addition, our JV currently is exploring potential sub-licensing of AEM-28 and/or
its analogs for development in indications not being actively pursued by the joint venture.
We have not agreed with our JV regarding the manner
in which offering proceeds will be made available to the JV. Proceeds from the offering could be made available through loans or
equity contributions by us to the JV, or in some combination of debt and equity. For additional discussion regarding risks related
to this uncertainty, see the risk factor “We have not agreed with our JV regarding the manner in which offering proceeds
will be made available to the JV. To the extent that our JV partners do not experience dilution from the deployment of offering
proceeds to the JV, the value of our investment in the JV will be negatively impacted” in the “Risk Factors”
section in this prospectus.
This is a best efforts offering with no minimum.
Accordingly, we may sell all, some or none of the offered Units and the ultimate amount of net proceeds cannot be predicted.
PLAN OF DISTRIBUTION
We are offering up to
Units, each consisting of one share of common stock and one warrant to purchase one-half of a share of common stock, for an offering
price of $ per Unit. Pursuant to an engagement letter agreement, dated as
of June 16, 2015, we have engaged H.C. Wainwright & Co., LLC (“Wainwright” or the “placement agent”)
as our placement agent for this offering. Wainwright is not purchasing or selling any Units in this offering, nor are they required
to arrange for the purchase and sale of any specific number or dollar amount of Units, other than to use its “reasonable
best efforts” to arrange for the sale of Units by us. Therefore, we may not sell the entire amount of Units being offered.
Wainwright may retain one or more sub-agents or selected dealers in connection with the offering.
Upon the closing of this offering, we will pay
Wainwright a cash fee equal to seven and one-quarter percent (7.25%) of the aggregate gross proceeds to us from the sale of the
Units in the offering, provided that such cash fee will be four percent (4%) of aggregate gross proceeds on any sales of Units
to certain specified insiders and current stockholders of the company (the “reduced fee investors”) in this offering.
We will also reimburse Wainwright for its non-accountable expenses in an amount equal to the greater of one percent (1%) of the
aggregate gross proceeds in the offering or $50,000.
As additional compensation, we will issue to
Wainwright warrants to purchase a number of shares of common stock equal to five percent (5%) (or two and one half percent (2.5%)
of the number of shares of common stock included in the Units sold to the reduced fee investors) of the number of shares of common
stock included in the Units sold in this offering (excluding the shares of common stock that may be issued upon exercise of the
warrants included in the Units) (the “placement agent warrants”). The placement agent warrants will have the same terms
as the warrants issued to purchasers in the offering, provided that the placement agent warrants will not have anti-dilution protection
pursuant to FINRA Rule 5110(f)(2)(G)(vi) and the placement agent warrants shall have an exercise price equal to the greater of
the exercise price of the warrants issued to the purchasers in the offering or 125% of the public offering per share in the offering.
Pursuant to FINRA Rule 5110(g)(1), neither the placement agent warrants nor any shares of common stock issued upon exercise of
the placement agent warrants may be sold, transferred, assigned, pledged, or hypothecated, or be subject to any hedging, short
sale, derivative, put, or call transaction that would result in the effective economic disposition of such securities by any person
for a period of 180 days immediately following the date of effectiveness or commencement of sales of this offering, except the
transfer of any security (i) by operation of law or by reason of reorganization, (ii) to any FINRA member firm participating in
the offering and the officers and partners thereof, if all securities so transferred remain subject to the lock-up restriction
described above for the remainder of the time period, (iii) if the aggregate amount of our securities held by the holder of the
placement agent warrants or related person does not exceed 1% of the securities being offered, (iv) that is beneficially owned
on a pro-rata basis by all equity owners of an investment fund, provided that no participating member manages or otherwise directs
investments by the fund, and participating members in the aggregate do not own more than 10% of the equity in the fund, or (v)
the exercise or conversion of any security, if all securities received remain subject to the lock-up restriction set forth above
for the remainder of the time period.
Subject to certain exceptions, until twelve
months after the consummation of this offering, the placement agent has a right of first refusal to act as lead underwriter, placement
agent, manager, or agent for any public or private equity or debt offerings in which we may engage during that period. The foregoing
right will not apply to any offering of equity or debt securities by Lipimetix Development, Inc.
The placement agent may be deemed to be an underwriter
within the meaning of Section 2(a)(11) of the Securities Act of 1933, as amended (the “Securities Act”), and any commissions
received by it and any profit realized on the sale of the securities by it while acting as principal might be deemed to be underwriting
discounts or commissions under the Securities Act. The placement agent will be required to comply with the requirements of the
Securities Act and the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including, without limitation,
Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of
shares of common stock and warrants to purchase shares of common stock by the placement agent. Under these rules and regulations,
the placement agent may not (i) engage in any stabilization activity in connection with our securities; and (ii) bid for or purchase
any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange
Act, until they have completed their participation in the distribution.
The engagement letter agreement provides that
we will indemnify the placement agent for any claim (including claims under the Securities Act) related to or resulting from the
activities on our behalf, except for any claim finally judicially determined to have resulted from the indemnitee’s gross
negligence or willful misconduct. We have been advised that, in the opinion of the SEC, indemnification for liabilities under the
Securities Act is against public policy as expressed in the Securities Act and is therefore unenforceable.
State Blue Sky Information
We intend to offer and sell the securities offered
hereby to institutional investors in certain states. However, we will not make any offer of these securities in any jurisdiction
where the offer is not permitted or exempted.
INFORMATION
WITH RESPECT TO THE COMPANY
The Company
We are a biopharmaceutical company primarily focused
on the development of a family of ApoE mimetic peptides to serve a variety of therapeutic indications in reducing plasma cholesterol
and triglycerides. We embrace the capital-efficient business model of virtual pharmaceutical development pursuant to which we have
minimized the number of full-time employees and outsource various aspects of pre-clinical, regulatory and clinical development.
All of our current development activities are conducted
through our majority-owned joint venture, LipimetiX Development, Inc., which was formed to develop an Apo E mimetic peptide molecule,
AEM-28, and its analogs. We own 60% of the outstanding common shares of the JV and all of the outstanding preferred shares. We
have entered into a Stockholders Agreement pursuant to which certain of our JV partners have the right to appoint a majority of
the JV’s board of directors unless certain triggering events occur, and pursuant to which we have consent rights over a broad
spectrum of business decisions including annual budgets. Our JV is managed under contract by Benu BioPharma Inc., which is comprised
of three individuals (Dennis I. Goldberg, Ph.D., Phillip M. Friden, Ph.D., and Eric M. Morrel, Ph.D.) who are principal minority
stockholders in our JV. For additional information, see the “Ownership, Management and Governance of our JV” section
of this prospectus.
Concurrent with the development activities for
AEM-28, the JV has performed limited pre-clinical studies that have identified analogs of AEM-28, including one referred to as
AEM-28-14, that have the potential of increased efficacy, higher human dose toleration and an extended composition of matter patent
life. The JV has a development plan to pursue regulatory approval and commercialization of AEM-28, or one or more of its analogs,
as treatment in orphan (rare disease) indications, including AP and HoFH, and potentially in acute coronary syndrome, peripheral
artery disease and metabolic syndrome. HoFH has been designated by the FDA as an orphan indication. We believe that AP should also
qualify for orphan indication designation.
Our JV received allowance from regulatory authorities
in Australia permitting our JV to proceed with the recently completed clinical trials. The Phase 1a clinical trial commenced in
Australia in April 2014 and the Phase 1b/2a clinical trial commenced in Australia in June 2014. The clinical trials for AEM-28
were randomized, double-blinded, placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics
of six escalating single doses (Phase 1a in healthy patients with elevated cholesterol) and multiple ascending doses of the three
highest doses from Phase 1a (Phase 1b/2a in patients with hypercholesterolemia and healthy subjects with elevated cholesterol and
high Body Mass Index). The Phase 1a clinical trial consisted of 36 patients and the Phase 1b/2a consisted of 15 patients. Both
clinical trials were completed in 2014 and the Medical Safety Committee, reviewing all safety-related aspects of the clinical trials,
observed a generally acceptable safety profile. As first-in-man studies, the primary endpoint was safety; yet efficacy measurements
analyzing pharmacodynamics yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid
biomarker endpoints.
We and our JV do not have sufficient funding as
of September 14, 2015 to continue additional material development activities of AEM-28 and its analogs.
Most of the proceeds of this offering will be made
available to our JV to fund the continued development of AEM-28 and its analogs and the remainder will be used to fund our continuing
operations. If all of the Units offered hereby are sold, we believe that we will have sufficient funds for our JV to complete the
preclinical development and possibly Phase 1a and Phase1b/2a clinical trials as well for AEM 28-14, but we cannot predict the total
cost of these efforts which depends on, among other things, successful and timely outcomes in our preclinical and clinical studies.
In any event, our JV will require substantial additional capital, and/or a development partner, to complete the clinical trials
and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies’ approval, if any,
for our JV’s product candidates. We may seek to obtain the necessary additional funding through the issuance of debt and/or
equity securities by us or our JV in one or more private or public offerings in the future (which could include bridge financing
from certain of our significant existing stockholders), through a strategic partner arrangement or otherwise. In addition, our
JV currently is exploring potential sub-licensing of AEM-28 and/or its analogs for development in indications not being actively
pursued by the joint venture.
We intend to continue limiting our internal operations
to a virtual operating model while monitoring and participating in the management of our JV’s AEM-28 and analogs development
activities.
Company History
Prior to November 26, 2003, we developed, manufactured
and marketed proprietary, technologically advanced orthopedic products designed to promote the healing of musculoskeletal bone
and tissue, with particular emphasis on fracture healing and spine repair. Our product lines, which included bone growth stimulation
and fracture fixation devices, are referred to as our “Bone Device Business.” In November 2003, we sold our Bone Device
Business.
In August 2004, we purchased substantially all
of the assets and intellectual property of Chrysalis Biotechnology, Inc., including its exclusive worldwide license for Chrysalin
for all medical indications. Subsequently, our efforts were focused on research and development of Chrysalin with the goal of commercializing
our products in fresh fracture healing. (In March 2012, we returned all rights to the Chrysalin intellectual property and no longer
have any interest in, or rights to Chrysalin.)
In February 2006, we purchased certain assets and
assumed certain liabilities of AzERx, Inc. Under the terms of the transaction, we acquired an exclusive license for the core intellectual
property relating to AZX100, an anti-fibrotic peptide. In 2014, we terminated the license agreement with AzTE for the core intellectual
property relating to AZX100 and returned all interest in and rights to the AZX100 intellectual property to the licensor.
In August 2012, we entered into our joint venture
with LipimetiX, LLC to develop the Apo E mimetic molecule AEM-28 and its analogs. We have contributed $6 million to our JV. We
also have a revolving loan agreement with the JV to advance the JV funds for operations in an amount not to exceed a net (net of
expected tax credits or other funds obtained) of $700,000, with the net amount due December 31, 2015. At June 30, 2015, outstanding
advances on the revolving loan agreement totaled $739,000. Our cash contribution to our joint venture represents a substantial
proportion of our available cash.
We were incorporated as a Delaware corporation
in July 1987 as IatroMed, Inc. We changed our name to OrthoLogic Corp. in July 1991. Effective October 1, 2008, OrthoLogic Corp.
commenced doing business under the trade name of Capstone Therapeutics, and we formally changed our name to Capstone Therapeutics
Corp. on May 21, 2010.
Ownership, Management and Governance of our JV
Our JV was formed in August 2012 as a Delaware
limited liability company under the name LipimetiX Development, LLC. In June 2015, the JV converted to a Delaware corporation and
changed its name to LipimetiX Development, Inc.
Ownership of our JV
The authorized shares of our JV’s capital
stock consist of (i) 2,000,000 shares of common stock, which is designated as either Class A-1 Common Stock or Class A-2 Common
Stock (collectively, the “JV Common Stock”), of which 1,000,000 shares are currently outstanding, and (ii) 10,000,000
shares of preferred stock, all of which is designated as Series A Preferred Stock (the “JV Preferred Stock”), of which
5,000,000 shares are currently outstanding.
The rights and preferences of the Class A-1 Common
Stock and the Class A-2 Common Stock are identical, except that the amount of dividends and distributions, if any, that would otherwise
be payable to UABRF as the sole holder of Class A-2 Common, is reduced by any amounts paid to UABRF in excess of $100,000 pursuant
to certain provisions of the Exclusive License Agreement with UABRF.
The Series A Preferred Stock is non-voting, non-convertible
and non-participating. There are no mandatory dividends payable in respect of the Series A Preferred Stock. Prior to our JV declaring
or paying dividends on the JV Common Stock, or making any liquidating distributions to the holders of the JV Common Stock, the
holders of the Series A Preferred Stock are entitled to receive an amount per share of Series A Preferred Stock at least equal
to the original issue price of the Series A Preferred Stock, which is $1 per share (subject to appropriate adjustment in the event
of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series A Preferred Stock).
Once the original issue price has been paid in full, the holders of the Series A Preferred Stock are not entitled to receive any
further dividends or liquidating distributions from the JV.
The following table sets forth the percentages
of the outstanding shares of JV Common Stock and JV Preferred Stock held by us and the other stockholders. The other stockholders
of our JV are sometimes referred to as our “JV partners” in this prospectus. The minority stockholders of the JV other
than UABRF are sometimes referred to as the “LX Minority Stockholders” in this prospectus.
Stockholder |
JV Common Stock (1) |
JV Preferred Stock |
Capstone Therapeutics Corp. |
60% |
100% |
LX Minority Stockholders (2) |
32% |
- |
UABRF |
8% |
- |
Total |
100% |
100% |
| (1) | All of the JV Common Stock held by us and by the LX Minority Stockholders is Class A-1 Common Stock.
All of the JV Common Stock held by UABRF is Class A-2 Common Stock. |
| (2) | Consists of all stockholders of the JV other than Capstone and UABRF. |
The LX Minority Stockholders include Dennis I.
Goldberg, Ph.D., Phillip M. Friden, Ph.D. and Eric M. Morrel, Ph.D. (the “Benu Principals”), who are the principals
of Benu BioPharma Inc. (“Benu”), which manages the JV pursuant to the management contract described below. The Benu
Principals collectively own 24% of the outstanding JV Common Stock, which represents 75% of all shares held by the LX Minority
Stockholders.
Management and Governance of our JV
Our JV is managed by Benu pursuant to a Management
Agreement among the JV, Benu and the Benu Principals. Pursuant to the Management Agreement, Benu provides all management and operational
personnel to perform the day-to-day management of the JV (other than certain accounting and finance services that we provide pursuant
to an Accounting Services Agreement between us and the JV). These management services include business development, research and
development, regulatory affairs, product development, technical operations, assisting in intellectual property strategy and management,
and developing and managing clinical trials. Pursuant to the Management Agreement, all services provided by Benu are rendered by
or under the direction of Dr. Goldberg. The Benu Principals are also the officers of the JV (Dr. Goldberg is President, Dr. Friden
is Vice President, Product Development and Dr. Morrel is Vice President, Clinical Research).
Pursuant to the Management Agreement, Benu is required
to cause the Benu Principals to devote their full business time and effort, as needed, to the performance of the services under
the Management Agreement. However, there is no direct agreement with the individual Benu Principals for continued services and
they are under no legal obligation to remain with Benu. For additional discussion regarding risks related to the loss of the Benu
Principals, see the risk factor “The loss of key management and scientific personnel may hinder our JV’s ability
to execute our business plan” in the “Risk Factors” section in this prospectus.
The JV paid to Benu a management fee of approximately
$63,000 per month during the initial 27 months of the term ending in October 2014. Commencing in November 2014 and ending in March
2015, Benu received a reduced management fee in the amount of $35,000 per month. We currently receive an accounting services fee
from the JV of $1,000 per month pursuant to the Accounting Services Agreement.
Pursuant to a Stockholders Agreement among all
the stockholders of the JV, we have agreed that the board of directors of the JV will be composed of three individuals designated
by the LX Minority Stockholders, acting by a majority in interest, and two individuals designated by us. Consequently, the LX Minority
Stockholders’ designees, and not our designees, control the JV’s board of directors. Because the Benu Principals collectively
own 75% of the outstanding JV Common Shares held by the LX Minority Stockholders, the Benu Principals have the power to control
the JV’s board of directors. The JV board of directors currently is composed of the following persons:
LipimetiX Development Board of Directors
Dennis I. Goldberg, Ph.D. (1)
Phillip M. Friden, Ph.D. (1)
Eric M. Morrel, Ph.D. (1)
John M. Holliman, III (our Executive Chairman
and Principal Executive Officer) (2)
Randolph C. Steer, MD, Ph.D. (our Chief Medical
Officer) (2)
___________________________
(1) Designee of LX Minority Stockholders.
(2) Designee of Capstone.
If the JV fails to operate substantially in accordance
with its annual budget (which must be approved by stockholders holding at least a majority of the outstanding shares of the JV’s
voting stock), including the milestones in the budget, or fails to comply with any of its obligations under the Stockholders Agreement,
the stockholders of the JV, acting by a majority in interest, thereafter would be entitled to appoint a majority of the members
of the board of directors.
The Stockholders Agreement provides that certain
actions require the consent of stockholders, acting by a majority in interest. These actions include:
| · | Issuing any shares of capital stock; |
| · | Making dividends or distributions; |
| · | Entering into or amending any sale, license or partnering agreements relating to AEM-28 or any other
compound then under development by the JV, including the Exclusive License Agreement with UABRF; |
| · | Incurring indebtedness other than trade payables incurred in the ordinary course of business or as
may otherwise be set forth in the JV’s budget; |
| · | Entering into, amending or terminating any related party transaction or agreement, including the management
agreement with Benu BioPharma Inc.; |
| · | Entering into or amending any material contract outside the ordinary course of business; |
| · | Effecting a sale of the JV, whether through a merger, consolidation or sale of assets; and |
| · | Amending the certificate of incorporation or bylaws. |
Additionally, pursuant to the Stockholders Agreement,
the JV may not be liquidated or dissolved without the consent of stockholders holding at least 75% of the outstanding shares of
JV Common Stock. The JV’s annual budget, including the operational and other milestones contained therein, also must be approved
by stockholders holding at least a majority of the outstanding shares of the JV’s voting stock. Because we do not have the
right to appoint a majority of the members of the JV’s board of directors, these stockholder consent rights are necessary
to protect our interests in the JV. However, there is a risk that these consent rights may be insufficient to protect our interests
or may result in impasses with respect to the JV’s management and operation, the resolution of which might result in actions,
agreements or consequences that we might view as suboptimal.
Competition
The biopharmaceutical industry is characterized
by intense competition and confidentiality. Well known cardiovascular drug classes include the statins and PCSK9s (currently in
regulatory approval process). Our drug candidates, if approved, would not compete directly for the same patient population as statins
and PCSK9s. In the orphan indication of HoFH, two drugs received FDA approval in 2013 and are currently being marketed: Juxtapid
from Aegerion and Kynamro from Sanofi/Genzyme. In the AP indication, the standard of care drugs for reducing triglycerides include
fish oil and fibrates, both of which usually take weeks to show an effect. We are currently unaware of any other drugs approved
or in development for reducing triglycerides in AP. We may not be aware of the other biotechnology, pharmaceutical companies or
public institutions that are developing pharmaceuticals or devices that may compete with our potential products. We also may not
be aware of all the other competing products our known competitors are pursuing. In addition, these biotechnology companies and
public institutions compete with us in recruiting for research personnel and subjects, which may affect our ability to complete
our research studies. For additional discussion regarding the risks associated with our competition, see the risk factor “If
our JV’s product candidates do not gain market acceptance or our competitors develop and market products that are more effective
than our JV’s product candidates, our commercial opportunities will be reduced or eliminated” in the “Risk
Factors” section in this prospectus.
Description of Drug Candidates, Clinical Results and Target Markets.
Apo E is a 299 amino acid protein that plays an
important role in lipoprotein metabolism. AEM-28 is a 28 amino acid mimetic of Apo E and AEM-28-14 (an analog of AEM-28) is a 28
amino acid mimetic of Apo E (with an aminohexanoic acid group) and both contain a domain that anchors into a lipoprotein surface
while also providing the Apo E receptor binding domain, which allows clearance through the heparan sulfate proteoglycan (HSPG)
receptors (Syndecan-1) in the liver.
VLDL and Triglycerides
The combination of Low Density Lipoprotein (“LDL”)
and Very Low Density Lipoprotein (“VLDL”) cholesterol are termed Non- High Density Lipoprotein (“Non-HDL”)
cholesterol. These Non-HDL lipoproteins are a combination of proteins and lipids which allow fat and cholesterol to move around
the body so they may be taken up by target cells. Triglycerides (TGs) are found in VLDL and chylomicron remnants in blood plasma.
TGs play an important role in metabolism as energy sources while VLDL and chylomicron remnants serve as transporters of dietary
fat. When the amount of VLDL and TGs is properly regulated by the body’s natural systems, the vascular and metabolic systems
are in sync and functioning well. However, problems develop when these lipoproteins and lipids get out of balance, often leading
to severe cardiovascular and endocrinal diseases. When in overabundance in blood plasma, these large, buoyant molecules are a primary
contributor to atherosclerosis, or arterial plaque, which can unpredictably create an arterial occlusion and cause a heart attack.
In December 2014, we and our joint venture, LipimetiX
Development, Inc., announced the completion and results of the investigational Phase 1b/2a human clinical trial for its lead Apo
E mimetic peptide molecule, AEM-28, in cholesterol and triglyceride reduction. The top-line data from the Phase 1a (reported on
September 2, 2014) and Phase 1b/2a blended protocol was statistically analyzed. The Medical Safety Committee,
in reviewing safety-related aspects of the clinical trial, observed a generally acceptable safety profile. Analysis
of biomarker data from the human studies showed what we believe is a statistically significant reduction of VLDL cholesterol and
triglycerides of approximately 70% each in fasted patients at one hour post-treatment. In particular, efficacy measurements analyzing
pharmacodynamics yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker
endpoints, which included:
· | | p < 0.05 favoring AEM-28 vs. placebo within the first 12 hours post infusion at
the highest dose tested of 3.54mg/kg in VLDL, equating to a maximum 76% drop in VLDL vs. baseline and a 56% net maximum reduction
of VLDL vs. placebo; |
· | | p < 0.05 favoring AEM-28 vs. placebo within the first 12 hours post infusion at
the 2 mg/kg dose in VLDL, equating to a maximum 70% drop in VLDL vs. baseline and a 41% net maximum reduction of VLDL vs. placebo; |
· | | p < 0.025 favoring AEM-28 vs. placebo within the first 12 hours post infusion at
the highest dose tested of 3.54 mg/kg in triglycerides, equating to a maximum 74% drop in triglycerides vs. baseline and a 55%
average net maximum reduction of triglycerides vs. placebo; and |
· | | p < 0.025 favoring AEM-28 vs. placebo within the first 12 hours post infusion at
the 2 mg/kg dose in triglycerides, equating to a 71% drop in triglycerides vs. baseline and a 45% net maximum reduction of triglycerides
vs. placebo. |
Acute Pancreatitis with High Triglycerides
In 2015, our JV retained a consultancy to conduct
a market assessment study for AEM-28 in acute pancreatitis (“AP”) with high triglycerides. The consultancy’s
report concluded that the AP indication represents a significant unmet clinical need for a therapeutic that could rapidly reduce
triglycerides. The schedule that follows below discusses the epidemiology and etiology of AP. There are an estimated 74,000 hospitalizations
for all types of AP in the U.S. each year with approximately 45,000 presenting with severe TGs equal to or greater than 1,000 mg/dL.
This patient population is possibly an ideal fit for AEM-28 as a therapeutic agent.
ETIOLOGY/EPIDEMIOLOGY |
≈ % (1) |
U.S.
Patients |
Severe TGs
≥ 1,000 mg/dL |
Gallbladder/Stones |
25% |
18,500 |
No |
Alcohol |
50% |
37,000 |
Yes |
Genetic/Familial |
7% |
5,698 |
Yes |
Other/Idiopathic
(Diabetes/Obesity/Pregnancy) |
18% |
13,320 |
Yes |
TOTAL HOSPITALIZATIONS |
100% |
74,000 |
45,000 (2) |
(1) JOP.J. Pancreas, 11/9/2011, “Controversies in
Etiology of Acute Pancreatitis, A. Khan et al.
(2) Fletcher Spaght, 3/17/2015, “Market Assessment
for Acute Pancreatitis”, M. Hoult et al.
Whereas we anticipate that AP with high TGs will
qualify as an orphan indication (since the patient population is below 200,000 in the U.S.), we believe that it is nonetheless
a sizable orphan market. Clinicians often treat these patients with fibrates or fish oil to reduce TGs, but fibrates and fish oil
take weeks if not longer to have an effect in reducing TGs. A drug that rapidly reduces TGs could diminish the severity of AP (especially
if administered at early onset) and could offer a significant economic savings to the healthcare system from faster discharge.
If clinical trials are successful and regulatory approval is granted, we believe that AEM-28 could potentially be added to the
AP treatment protocol in the emergency room for patients with elevated TGs.
Based on our consultant’s report, we also
believe that a market of 110,000 refractory hypertriglyceridemics exists in the U.S. These patients are at high risk for AP and
other TG-related indications and could be candidates for a weekly infusion of a TG-reducing therapeutic such as AEM-28. We believe
that this chronic market, at a projected 5.7 million doses annually, represents another significant market opportunity, albeit
requiring successful clinical outcomes studies.
Given the above, we plan to prioritize AP with
high TGs as our JV’s indication of choice for AEM-28-14 commercialization. Because AEM-28 has previously received orphan
drug designation (see below), we believe that the new analogs will also be so designated by the FDA for AP. As a result, the clinical/regulatory
pathway for AP should require shorter, less expensive clinical trials according to orphan regulatory precedent.
Homozygous Familial Hypercholesterolemia (HoFH)
In 2012, AEM-28 received orphan designation from
FDA for a rare disease indication, called homozygous familial hypercholesterolemia (“HoFH”). This is a very small global
population of individuals who are born with no LDL receptors in the liver and are unable to clear LDL (the “bad” cholesterol)
through a natural pathway. Historically, these patients have experienced cardiovascular complications in their teens and twenties
often leading to early death. Standard of care therapy was a process called apheresis, which is a mechanical filtering of the lipid
fat from the patient’s entire blood volume, akin to the kidney dialysis process. In 2013, two pharmaceutical therapies were
approved in the U.S., Aegerion’s Juxtapid and Sanofi-Genzyme’s Kynamro. Juxtapid has proven the market with an impressive
revenue ramp while revenue data for Kynamro is not publicly available. We believe that AEM-28, or the new analogs, if approved,
could compete favorably with these other drugs due to potentially increased efficacy and fewer and less severe side effects.
AEM-28-14 and Analogs
Although AEM-28 is well researched and characterized
by scientists at our academic research partner, The University of Alabama at Birmingham Research Foundation, it has a relatively
short remaining patent life (to 2020). If AEM-28 were approved by the FDA, as an orphan drug in the U.S., it would have seven years
of marketing exclusivity after registration. Accordingly, AEM-28 remains a potentially valuable commercial asset, but only in orphan
indications.
Our joint venture has an exclusive license agreement
with UABRF (see “Patents, Licenses and Proprietary Rights”, below) that provides for new technology developments and
which has resulted in the discovery of new Apo E mimetic peptides. Recently, our joint venture has been testing an analog of AEM-28,
which we refer to as AEM-28-14. In preclinical testing, AEM-28-14 is showing itself to be potentially more tolerable and more efficacious
than AEM-28. In July 2015, our joint venture announced the conversion of its provisional patent application for AEM-28-14 as a
unique and novel molecule seeking 21 years of composition of matter patent protection.
AEM-28-14 and the other analogs are significant
in that their potential 21-year patent life could allow our joint venture and/or its potential future strategic partners to develop
AEM-28-14 and the other analogs for “clinical outcomes” indications that typically require very large, lengthy clinical
trials. These markets include acute coronary syndrome (which we estimate to be $10 billion in annual market size), peripheral artery
disease (which we estimate to be $3 billion in annual market size) and metabolic syndrome (which we estimate to be an approximate
$35 billion annual market for all drug therapies). Now, with AEM-28-14, we believe that our JV has a product candidate that not
only serves sizable orphan markets, but also serves much larger indications potentially representing several billion dollars in
annual product revenue.
Marketing and Sales
AEM-28 and its analogs are not currently available
for sale and we do not expect them to be available for sale for some time into the future, if ever. Thus, neither we nor our JV
currently have any marketing or sales staff.
Manufacturing
Currently, third parties certified under Good
Manufacturing Practices manufacture AEM-28 and its analogs for our JV in limited amounts for its clinical and pre-clinical studies.
Our JV uses a primary manufacturer for the peptides used in its human clinical trials, but secondary manufacturers are available
as needed.
Patents, Licenses and Proprietary Rights
Our JV has an Exclusive License Agreement (the
“License Agreement”) with the UABRF that grants an exclusive worldwide license to practice, commercialize and exploit
the licensed patents and the exclusive license to make, have made, research, develop, use, lease, offer to sell, sell, import and
export products, which would (without the license infringe one of more of the Licensed Patents). The License rights may be sublicensed
by our JV with some restrictions. All products, as well as any ideas, inventions, developments, improvements, works of authorship,
know-how, research, techniques, processes, methods, materials, results, data and other information and work product arising out
of the JV’s practice of the licensed patents is owned by the JV, and UABRF does not have any right or license to use the
same.
Under the License Agreement, the JV is required
to pay patent filing, maintenance and other related patent fees, annual maintenance fees of $25,000 until the first commercial
sale of a licensed product and various milestone payments of $50,000 to $500,000 as each licensed product is developed and obtains
FDA approval. Once the first commercial sale of a licensed product occurs, the JV is required to pay a royalty of 3% on net sales
of licensed products during the term of the License Agreement as well as 30% of royalty payments received by the JV from sales
of licensed products by sublicensees, provided that the aggregate royalty does not exceed 3% of the sales of licensed products
by the sublicensees in the applicable jurisdiction. The License Agreement provides for a minimum royalty payment of $500,000 to
$1,000,000 per year commencing on January 1 of the first calendar year following the year in which the first commercial sale occurs.
UABRF will also receive 5% of non-royalty income received. The License Agreement terminates upon the expiration of all valid patent
claims within the licensed patents.
Capstone Therapeutics is a registered United
States domestic trademark of Capstone Therapeutics Corp.
Insurance
Our business entails the risk of product liability
claims. We maintain a product liability and general liability insurance policy and an umbrella excess liability policy. There can
be no assurance that liability claims will not exceed the coverage limit of such policies or that such insurance will continue
to be available on commercially reasonable terms or at all. Consequently, product liability claims or claims arising from our clinical
trials could have a material adverse effect on our business, financial condition and results of operations. We have not experienced
any material liability claims to date resulting from our clinical trials.
Employees
As of September 14, 2015, we had two full time
administrative employees in our operations and utilize consultants to perform a variety of administrative, regulatory or research
tasks. We have entered into consulting agreements with various former key employees, but there is no assurance that these persons
will be available in the future to the extent their services may be needed. As a research and development business, we believe
that the success of our business will depend in part on our ability to identify, attract and retain qualified research personnel,
both as employees and as consultants. We face competition from private companies and public institutions for qualified research
personnel. None of our employees are represented by a union and we consider our relationship with our employees to be good.
DESCRIPTION
OF PROPERTY
We lease 2,845 square feet of office space in
a facility in Tempe, Arizona, which is an approximately 100,000 square foot facility designed and constructed for industrial purposes
and is located in an industrial district. In July 2007, we entered into a five-year lease for 17,000 square feet of space in this
Tempe facility, which became effective March 1, 2008. We amended this lease, effective March 1, 2013, to extend the lease for two
additional years and reduce the square feet rented to 2,845. On October 1, 2014 we amended this lease to extend the term to February
29, 2016. We believe the facility is well-maintained and adequate for use through the end of our lease term.
LEGAL
PROCEEDINGS
In June 2015, we settled our long-pending qui
tam lawsuit for a one-time payment of $50,000. The lawsuit had been filed under seal by Jeffrey J. Bierman, as Relator/Plaintiff,
on March 28, 2005 in the United States District Court for the District of Massachusetts against us and substantially all sellers
of bone growth stimulation devices during the period 1998-2003. The complaint asserted a variety of claims, including False Claims
Act violations. We sold our bone growth stimulation device business in 2003 and first learned of this lawsuit in September 2009.
OUR
COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market Information
Our common stock commenced trading on Nasdaq on
January 28, 1993 and was delisted by Nasdaq on July 21, 2011. Our common stock is currently traded on the OTCQB under the symbol
“CAPS.” The following table sets forth, for the fiscal periods indicated, the range of high and low sales prices of
our common stock. The OTCQB prices set forth below reflect inter-dealer prices, without adjustment for retail mark-up, markdown
or commission, and may not necessarily represent the prices of actual transactions.
| |
2015 | |
2014 | |
2013 |
| |
High | |
Low | |
High | |
Low | |
High | |
Low |
First Quarter | |
$ | 0.24 | | |
$ | 0.17 | | |
$ | 0.38 | | |
$ | 0.24 | | |
$ | 0.26 | | |
$ | 0.17 | |
Second Quarter | |
$ | 0.25 | | |
$ | 0.13 | | |
$ | 0.33 | | |
$ | 0.21 | | |
$ | 0.24 | | |
$ | 0.17 | |
Third Quarter | |
| | | |
| | | |
$ | 0.39 | | |
$ | 0.21 | | |
$ | 0.42 | | |
$ | 0.17 | |
Fourth Quarter | |
| | | |
| | | |
$ | 0.27 | | |
$ | 0.19 | | |
$ | 0.38 | | |
$ | 0.21 | |
As of September 14, 2015, 40,885,411 shares of
our common stock were outstanding and held by approximately 779 stockholders of record. The last reported sale price of our common
stock on the OTCQB Market on September 10, 2015 was $.21 per share.
Dividends
We have never paid a cash dividend on our common
stock. We do not intend to pay any cash dividends on our common stock in the foreseeable future.
Securities Authorized for Issuance under Equity Compensation Plan
The following provides tabular disclosure of the
number of securities to be issued upon the exercise of outstanding options, the weighted average exercise price of outstanding
options, and the number of securities remaining available for future issuance under equity compensation plans as of December 31,
2014, aggregated into two categories - plans that have been approved by stockholders and plans that have not. See Note 5 to the
Financial Statements included in our Annual Report on Form 10-K, filed with the SEC on March 16, 2015, and Form S-8 filed with
the SEC on June 22, 2015, for additional information on our equity compensation plans.
| |
Number of securities to be issued upon exercise of outstanding options, warrants and rights | |
Weighted average exercise price of outstanding options, warrants and rights | |
Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) |
| |
| |
| |
|
Plan Category: | |
(a) | |
(b) | |
(c) |
Equity Compensation Plans approved by Security Holders | |
| 3,022,706 | | |
$ | 1.06 | | |
| 495,519 | |
Equity Compensation Plans not approved by Security Holders | |
| N/A | | |
| N/A | | |
| N/A | |
Total | |
| 3,022,706 | | |
$ | 1.06 | | |
| 495,519 | |
MANAGEMENT’S
DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following is management’s discussion
of significant events in the year ended December 31, 2014 and the three- and six-month period ended June 30, 2015 and factors that
affected our financial condition and results of operations for those periods. This should be read in conjunction with our financial
statements and related notes that appear in this prospectus and the “Risk Factors” section in this prospectus.
Most of the proceeds of this offering will be made
available to our JV to fund the continued development of AEM-28 and its analogs. Some development may relate to applications that
are different from the applications on which our JV’s previous clinical trials focused. Our financial condition and results
of operations for historic periods are not necessarily indicative of future results or performance.
Overview of the Business
We are a biopharmaceutical company primarily focused
on the development of a family of ApoE mimetic peptides to serve a variety of therapeutic indications in reducing plasma cholesterol
and triglycerides. Previously, we were focused on the development and commercialization of two product platforms: AZX100 and Chrysalin
(TP508). Since March 2012, we no longer have any interest in or rights to Chrysalin. In 2012 we wound down internal operations,
ceased clinical development of AZX100 in dermal scarring, formerly our principal product candidate, and moved to a more virtual
operating model. In 2014, we terminated the license agreement with AzTE for the core intellectual property relating to AZX100 and
returned all interest in and rights to the AZX100 intellectual property to the licensor.
Concurrent with the development activities for
AEM-28, the JV has performed limited pre-clinical studies that have identified analogs of AEM-28, including one referred to as
AEM-28-14, that have the potential of increased efficacy, higher human dose toleration and an extended composition of matter patent
life. The JV has a development plan to pursue regulatory approval and commercialization of AEM-28, or one or more of its analogs,
as treatment in orphan (rare disease) indications, including AP and HoFH, and potentially in acute coronary syndrome, peripheral
artery disease and metabolic syndrome. HoFH as been designated by the FDA as an orphan indication. We believe that AP should also
qualify for orphan indication designation.
For additional discussion regarding our and our
JV’s business, including a description of our JV’s current peptide product candidates, see “Information with
respect to the Company” in this prospectus.
Critical Accounting Policies
The preparation of financial statements in accordance
with accounting principles generally accepted in the United States of America requires that management make a number of assumptions
and estimates that affect the reported amounts of assets, liabilities, and expenses in our financial statements and accompanying
notes. Management bases its estimates on historical experience and various other assumptions believed to be reasonable. Although
these estimates are based on management’s best knowledge of current events and actions that may impact us in the future,
actual results may differ from these estimates and assumptions. Our critical accounting policies are those that affect, or could
affect our financial statements materially and involve a significant level of judgment by management.
Below are the accounting policies and related risks
described in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 16, 2015, for the year
ended December 31, 2014, which are those that depend most heavily on management’s judgments and estimates. As of September
14, 2015, there have been no material changes to any of these critical accounting policies.
Income Taxes: Accounting Standards Codification
Topic 740 “Income Taxes” requires that a valuation allowance be established when it is more likely than not that all
or a portion of a deferred tax asset will not be realized. Changes in valuation allowances from period to period are included in
the tax provision in the period of change. In determining whether a valuation allowance is required, we take into account all evidence
with regard to the utilization of a deferred tax asset, including past earnings history, expected future earnings, the character
and jurisdiction of such earnings, unsettled circumstances that, if unfavorably resolved, would adversely affect utilization of
a deferred tax asset, carryback and carryforward periods, and tax strategies that could potentially enhance the likelihood of realization
of a deferred asset. We have evaluated the available evidence about future taxable income and other possible sources of realization
of deferred tax assets and have established a valuation allowance for all of our deferred tax assets of approximately $57 million
at December 31, 2014.
In March 2014, LipimetiX Development, LLC (for
more information, see Note 9 in the Financial Statements for the year ended December 31, 2014 included in this prospectus) formed
a wholly-owned Australian subsidiary, LipimetiX Australia Pty Ltd, to conduct Phase 1a and Phase1b/2a clinical trials in Australia.
Currently Australian tax regulations provide for a refundable research and development tax credit equal to 45% of qualified expenditures.
Subsequent to the end of its Australian tax years, LipimetiX Australia Pty Ltd has submitted, or intends to submit, claims for
a refundable research and development tax credit. The transitional Australian tax periods/years granted for LipimetiX Australia
Pty Ltd end on June 30, 2014, December 31, 2014 and thereafter December 31 of each succeeding year. For the tax period ended June
30, 2014, LipimetiX Australia Pty Ltd received a refundable research and development tax credit of AUD$227,000. For the tax period
ended December 31, 2014 a AUD$242,000 refundable tax credit, for research and development expenditures has been recorded by LipimetiX
Australia Pty Ltd, as it is more likely than not, that the recorded refundable research and development tax credit at December
31, 2014 will be approved and received.
Patents: Patent license rights at December
31, 2014 were recorded at $1,045,000, their estimated fair value on the date they were acquired, August 3, 2012. Their cost is
amortized on a straight-line basis over the key patent life of eighty months. At December 31, 2014, accumulated amortization totaled
$379,000. If a change in conditions occurs, that indicates a material change in the future utility of the patent license rights,
an evaluation will be performed to determine if impairment of the asset has occurred, and if so, the impairment will be recorded.
Future utility of the patent license rights is dependent upon our ability to raise additional funding to continue development of
AEM-28 and its analogs or to complete a sale, licensing or other transactions.
Our Joint Venture: As discussed in Note
9 “Joint Venture for Development of Apo E Mimetic Peptide Molecule AEM-28 and Analogs” in Notes to Financial Statements
for the year ended December 31, 2014 included in this prospectus, we entered into a joint venture in which it has contributed $6,000,000,
and the noncontrolling interests have contributed certain patent license rights. Neither we nor the noncontrolling interests have
an obligation to contribute additional funds to our JV or to assume any joint venture liabilities or to provide a guarantee of
either joint venture performance or any joint venture liability. The financial position and results of operations of our JV are
presented on a consolidated basis with our financial position and results of operations. Intercompany transactions have been eliminated.
Joint venture losses will be recorded on the basis of common ownership equity interests (currently 60% us / 40% noncontrolling
interests) until common ownership equity is reduced to $0. Subsequent joint venture losses will be allocated to the preferred ownership
equity (100% us). Subsequent to March 31, 2013, all joint venture losses are being allocated to us. We have a revolving loan agreement
with our JV to advance the joint venture funds for operations in an amount not to exceed a net (net of expected tax credits or
other funds obtained) of $700,000, with the net amount due December 31, 2015. At June 30, 2015, outstanding advances on the revolving
loan agreement totaled $739,000.
Losses incurred by our JV in excess of the capital
accounts of our JV will be allocated to us to the extent of net outstanding advances. At December 31, 2014, outstanding advances
on the revolving loan agreement totaled $500,000.
Losses allocated to the noncontrolling interests
represent an additional potential loss for us as the noncontrolling interests are not obligated to contribute assets to our JV
to the extent they have a negative capital account and depending on the ultimate outcome of our JV, we could potentially absorb
all losses associated with our JV. At December 31, 2014, losses totaling $667,000 have been allocated to the noncontrolling interests.
We record a contingent loss when it is probable that a loss has been incurred and the amount is reasonably estimable. There is
significant judgment required in both the probability determination and as to whether an exposure can be reasonably estimated.
In the opinion of management, there was not at least a reasonable possibility that we may have incurred a material loss with respect
to this loss contingency.
Fair value measurements: We determine the
fair value measurements of our applicable assets and liabilities based on a three-tier fair value hierarchy, which prioritizes
the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted market prices
in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly
observable; and Level 3, defined as unobservable inputs for which little or no market data exists, therefore requiring an entity
to develop its own assumptions.
Stock based compensation: Effective January
1, 2006, we adopted SFAS No. 123 (revised 2004), “Share-Based Payment”, now Accounting Standards Codification Topic
718 “Stock Compensation” (“ASC 718”). ASC 718 requires all share-based payments, including grants of stock
options, restricted stock units and employee stock purchase rights, to be recognized in our financial statements based on their
respective grant date fair values. Under this standard, the fair value of each employee stock option and employee stock purchase
right is estimated on the date of grant using an option pricing model that meets certain requirements. We currently use the Black-Scholes
option pricing model to estimate the fair value of our share-based payments. The determination of the fair value of share-based
payment awards utilizing the Black-Scholes model is affected by our stock price and a number of assumptions, including expected
volatility, expected life, risk-free interest rate and expected dividends. We use the historical volatility adjusted for future
expectations. The expected life of the stock options is based on historical data and future expectations. The risk-free interest
rate assumption is based on observed interest rates appropriate for the terms of our stock options and stock purchase rights. The
dividend yield assumption is based on our history and expectation of dividend payouts. The fair value of our restricted stock units
is based on the fair market value of our common stock on the date of grant. Stock-based compensation expense recognized in our
financial statements in 2006 and thereafter is based on awards that are ultimately expected to vest. We recognize compensation
cost for an award with only service conditions that has a graded vesting schedule on a straight line basis over the requisite service
period as if the award was, in-substance, a multiple award. However, the amount of compensation cost recognized at any date must
at least equal the portion of grant-date fair value of the award that is vested at that date. For non-employees, this expense is
recognized as the service is provided in accordance with ASC Topic 505-550 “Equity-Based Payments to Non-Employees.”
The amount of stock-based compensation expense in 2006 and thereafter is reduced for estimated forfeitures. Forfeitures are required
to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
We evaluate the assumptions used to value stock awards on a quarterly basis. If factors change and we employ different assumptions,
stock-based compensation expense may differ significantly from what we have recorded in the past.
ASC 718 requires the benefits associated with tax
deductions that are realized in excess of recognized compensation cost to be reported as a financing cash flow rather than as an
operating cash flow as previously required. Subsequent to the adoption of ASC 718 on January 1, 2006, we have not recorded any
excess tax benefit generated from option exercises, due to our net operating loss carryforwards, which cause such excess to be
unrealized.
Recent Accounting Pronouncements: In June
2014, the Financial Accounting Standards Board issued Accounting Standard Update (“ASU”) No. 2014-10, Development
Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest
Entities Guidance in Topic 810, Consolidation removes the definition of a development stage entity and all incremental financial
reporting requirements from U.S. GAAP for development stage entities. Topic 915 Development Stage Entities will be removed
from the FASB Accounting Standards Codification™. The elimination of the development stage entity financial reporting
requirements is effective for annual reporting periods beginning after December 15, 2014. A public business entity may adopt this
guidance early for any annual reporting period or interim period for which financial statements have not been issued. The adoption
of this accounting standard update had no impact on our condensed consolidated financial statements. We had previously presented
our financial statements with development stage entity disclosures. We adopted this accounting standard update in our third quarter
ending September 30, 2014, and accordingly, have omitted development stage information and disclosures from our presentation.
Joint Venture Accounting: As discussed in
Note 9 to Financial Statements for the year ended December 31, 2014 included in this prospectus, “Joint Venture for Development
of Apo E Mimetic Peptide Molecule AEM-28 and Analogs”, the Company entered into a joint venture in which it has contributed
$6,000,000, and the noncontrolling interests have contributed certain patent license rights. Neither the Company nor the noncontrolling
interests have an obligation to contribute additional funds to the joint venture or to assume any joint venture liabilities or
to provide a guarantee of either joint venture performance or any joint venture liability. The financial position and results of
operations of the joint venture are presented on a consolidated basis with the financial position and results of operations of
the Company. Intercompany transactions have been eliminated. Joint venture losses will be recorded on the basis of common ownership
equity interests (60% Company / 40% noncontrolling interests) until common ownership equity is reduced to $0. Subsequent joint
venture losses will be allocated to the preferred ownership equity (100% Company). Subsequent to March 31, 2013, all joint venture
losses are being allocated to the Company. The Company has a revolving loan agreement with the joint venture to advance the joint
venture funds for operations in an amount not to exceed a net (net of expected tax credits or other funds obtained) of $700,000,
with the net amount due December 31, 2015. At June 30, 2015, outstanding advances on the revolving loan agreement totaled $739,000.
Losses incurred by the joint venture in excess of the capital accounts of the joint venture will be allocated to the Company to
the extent of net outstanding advances.
In August 2014, the Financial Accounting Standards
Board issued Accounting Standard Update (“ASU”) No. 2014-15, Presentation of Financial Statements – Going
Concern (Subtopic 205-40)(“Update”): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going
Concern, providing a requirement under U.S. GAAP for an entity’s management to evaluate whether there are conditions or events,
considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within
one year after the date the financial statements are issued; and if those conditions exist, to disclose that fact, the conditions
and the potential effects on the entity’s ability to meet its obligations. The Update will be effective for an annual period
ending after December 15, 2016, with early application permitted. We have not elected early application, however, if additional
funds are not obtained to continue the development of AEM-28 or its analogs, or operations, it will impair our ability to continue
as a going concern. If we do not continue as a going concern, we may incur additional losses, up to, and possibly exceeding, our
net joint venture investment and revolving loan balance.
Results of Operations Comparing Year Ended December 31, 2014 and
2013
General and Administrative (“G&A”)
Expenses: G&A expenses related to our ongoing operations were $1,453,000 in 2014 compared to $1,169,000 in 2013. Administration
expenses increased primarily due to costs related to the qui tam litigation, and investor relations activities.
Research and Development Expenses: Research
and development expenses were $3,071,000 for 2014 compared to $3,124,000 for 2013. Our research and development expenses in 2014
and 2013 included the operating expenses of LipimetiX Development, Inc., which totaled (net of intercompany transactions) $2,354,000
for 2014, and $2,652,000 for 2013. The joint ventures’ initial planned research activities have been substantially completed
as of December 31, 2014.
Interest and Other Expenses (Income), Net:
Interest and Other Expenses (Income), Net, decreased from $158,000 of Income in 2013 to $43,000 of Expense in 2014 due to the receipt
of $152,000 in the first quarter of 2013 from the conversion of an insurance company, in which we were a policyholder, from mutual
to private ownership versus $60,000 in 2014. In 2014 this income was offset by a foreign exchange loss of $120,000 related to our
joint ventures’ Australian activities.
Income Tax Benefit: Income tax benefit in
2014 consisted of a $400,000 refundable Australian research and development tax credit, as described in Notes 4 and 7 to the December
31, 2014 financial statements included in this Prospectus, related to our joint ventures’ Australian clinical trial activities.
Net Loss attributable to Capstone Therapeutics
stockholders: We incurred a net loss in 2014 of $4.2 million compared to a net loss of $3.9 million in 2013. Net loss includes
operations of LipimetiX Development, Inc., which totaled (net of intercompany transactions) $2,354,000 for 2014, and $2,652,000
for 2013, net of net loss allocated to noncontrolling interests of $0 for 2014 and $193,000 for 2013. The joint ventures’
initial planned research activities have been substantially completed as of December 31, 2014.
Results of Operations Comparing Year Ended December 31, 2013 and
2012
General and Administrative (“G&A”)
Expenses: G&A expenses related to our ongoing operations were $1,169,000 in 2013 compared to $1,764,000 in 2012. Administration
expenses declined primarily due to a decrease in our lease expenses caused by a reduction in office space occupied, effective March
1, 2013, and the reduction from four employees to two employees in the second quarter of 2012.
Research and Development Expenses: Research
and development expenses were $3,124,000 for 2013 compared to $2,385,000 for 2012. Our research and development expenses increased
in 2013 compared to 2012 primarily due to the operating expenses of LipimetiX Development, Inc., which totaled (net of intercompany
transactions) $2,652,000 for 2013, and $1,133,000 for 2012, partially offset by a decline of AZX100 research activity.
Interest and Other Income, Net: Interest
and Other Income, Net, increased from $96,000 in 2012 to $158,000 in 2013 due to the receipt of $152,000 in the first quarter of
2013 from the conversion of an insurance company, in which we were a policyholder, from mutual to private ownership, while 2012
included a gain of $80,000 from the sale of lab equipment.
Net Loss attributable to Capstone Therapeutics
stockholders: We incurred a net loss in 2013 of $3.9 million compared to a net loss of $3.6 million in 2012. The net loss from
2013 benefited from a reduction in internal operations, but this beneficial effect was offset by inclusion of the operating expenses
of LipimetiX Development, Inc. Net loss includes operating expenses of LipimetiX Development, Inc., which totaled (net of intercompany
transactions) $2,652,000 for 2013, and $1,133,000 for 2012, net of net loss allocated to noncontrolling interests of $193,000 for
2013 and $473,000 for 2012.
Results of Operations Comparing Three-Month Period Ended June 30,
2015 to the Corresponding Period in 2014
General and Administrative (“G&A”)
Expenses: G&A expenses related to our ongoing operations were $552,000 in the second quarter of 2015 compared to $222,000
in the second quarter of 2014. Administration expenses increased primarily due to costs related to the qui tam litigation, filing
of a Form S-1, and investor relations activities. We expect that we may have elevated general and administrative costs, compared
to 2014 levels, while we continue fund raising activities.
Research and Development Expenses: Research
and development expenses were $283,000 for the second quarter of 2015 compared to $1,172,000 for the second quarter of 2014. Our
research and development expenses varied in the second quarter of 2015 compared to the same period in 2014 primarily due to the
inclusion and fluctuation of operating expenses of the JV, which totaled (net of intercompany transactions) $150,000 for the three
months ended June 30, 2015, and $987,000 for the three months ended June 30, 2104. As discussed above, we have significantly reduced
our development activities of AEM-28 and its analogs, including AEM-28-14, as we attempt to obtain additional funding.
Income Tax Benefit: Income tax benefit in
2015 consisted of a refundable Australian research and development tax credit, as described in Note D to the financial statements
included in this Quarterly Report on Form 10-Q, related to our joint venture’s Australian clinical trial activities.
Net Loss attributable to Capstone Therapeutics
stockholders: We incurred a net loss in the second quarter of 2015 of $0.8 million compared to a net loss of $1.4 million in
the second quarter of 2014. Net loss is affected by the items discussed above in General and Administrative Expenses, Income Tax
Benefit, and the inclusion of the operating expenses of JV, which totaled (net of intercompany transactions) $150,000 for the three
months ended June 30, 2015 and $987,000 for the three months ended June 30, 2014. As discussed above, we have significantly reduced
our development activities of AEM-28 and its analogs, including AEM-28-14, as we attempt to obtain additional funding.
Results of Operations Comparing Six-Month Period Ended June 30,
2015 to the Corresponding Period in 2014
General and Administrative (“G&A”)
Expenses: G&A expenses related to our ongoing operations were $1,024,000 in 2015 compared to $674,000 in 2014. Administration
expenses increased primarily due to costs related to the qui tam litigation, filing of a Form S-1 and investor relations activities.
We expect that we may have elevated general and administrative costs, compared to 2014 levels, while we continue fund raising activities.
Research and Development Expenses: Research
and development expenses were $633,000 for 2015 compared to $1,802,000 for 2014. Our research and development expenses varied in
the first six months of 2015 compared to the same period in 2014 primarily due to the inclusion and fluctuation of operating expenses
of the JV, which totaled (net of intercompany transactions) $347,000 for the six months ended June 30, 2015, and $1,405,000 for
the six months ended June 30, 2104. As discussed above, we have significantly reduced our development activities of AEM-28 and
its analogs, including AEM-28-14, as we attempt to obtain additional funding.
Interest and Other Expenses (Income), Net:
Interest and Other Expenses (Income), Net, decreased from $63,000 of Income in 2014 to $9,000 of Expense in 2015 due to the receipt
of $60,000 in 2014 from the conversion of an insurance company, in which we were a policyholder, from mutual to private ownership,
while in 2015 the Company incurred a foreign exchange loss of $12,000 related to our joint venture’s Australian activities.
Income Tax Benefit: Income tax benefit in
2015 consisted of a refundable Australian research and development tax credit, as described in Note D to the financial statements
included in this Quarterly Report on Form 10-Q, related to our joint venture’s Australian clinical trial activities.
Net Loss attributable to Capstone Therapeutics
stockholders: We incurred a net loss in the first six months of 2015 of $1.5 million compared to a net loss of $2.4 million
in the first six months of 2014. Net loss is affected by the items discussed above and the inclusion of the operating expenses
of JV, which totaled (net of intercompany transactions) $347,000 for the six months ended June 30, 2015 and $1,405,000 for the
six months ended June 30, 2014. As discussed above, we have significantly reduced our development activities of AEM-28 and its
analogs, including AEM-28-14, as we attempt to obtain additional funding.
Liquidity and Capital Resources
Since the sale of our Bone Device Business in November
2003, we have primarily relied on our cash and investments to finance all of our operations, the focus of which, since August 2012,
has been research and development of our JV’s product candidates.
On August 3, 2012, we entered into our joint venture,
LipimetiX Development, Inc, to develop Apo E mimetic peptide molecule AEM-28 and its analogs. We have contributed $6 million to
our JV. We also have a revolving loan agreement with the JV to advance the JV funds for operations in an amount not to exceed a
net (net of expected tax credits or other funds obtained) of $700,000, with the net amount due December 31, 2015. At June 30, 2015,
outstanding advances on the revolving loan agreement totaled $739,000. Our cash contribution to our joint venture represents a
substantial proportion of our available cash.
At June 30, 2015, we had cash and cash equivalents
of $1.0 million. We intend to continue limiting our internal operations to a virtual operating model in 2015, however, without
additional funding, we will not continue development of AEM-28 and its analogs, including AEM-28-14, past completion of the limited
projects currently under way. We are exploring strategic options for both the Company and our joint venture. Lack of additional
funding within the next 12 months, would impair our ability to continue our current operations and our ability to continue as a
going concern.
Funding permitting, our planned operations in 2015
consist of continuing monitoring and participating in the management of the JV’s AEM-28 and its analogs, including AEM-28-14,
development activities, and maintaining the required level of corporate governance and reporting required to comply with Securities
and Exchange Commission rules and regulations.
Most of the proceeds of this offering will be made
available to our JV to fund the continued development of AEM-28 and its analogs and the remainder will be used to fund our continuing
operations. If all of the Units offered hereby are sold, we believe that we will have sufficient funds for our JV to complete the
preclinical development and possibly Phase 1a and Phase1b/2a clinical trials as well for AEM 28-14, but we cannot predict the total
cost of these efforts which depends on, among other things, successful and timely outcomes in our preclinical and clinical studies.
In any event, our JV will require substantial additional capital, and/or a development partner, to complete the clinical trials
and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies’ approval, if any,
for our JV’s product candidates. We may seek to obtain the necessary additional funding through the issuance of debt and/or
equity securities by us or our JV in one or more private or public offerings in the future (which could include bridge financing
from certain of our significant existing stockholders), through a strategic partner arrangement or otherwise. In addition, our
JV currently is exploring potential sub-licensing of AEM-28 and/or its analogs for development in indications not being actively
pursued by the joint venture.
The amount of net proceeds which we will receive
from this offering is uncertain. To the extent we sell less than all of the Units in this offering, we will need to seek additional
funding sooner than otherwise would be the case. Because neither the timing nor the amount of future funding needs can be predicted,
we cannot provide any assurance that we will have sufficient resources for our JV to continue its development work as planned.
There is no assurance that we will be able to obtain the necessary additional funding from third parties on terms acceptable to
us, or at all. New sources of funds, including raising capital through the sales of our debt or equity securities, joint venture
or other forms of joint development arrangements, sales of development rights, or licensing agreements, may not be available or
may only be available on terms that would have a material adverse impact on our existing stockholders’ interests. If our
JV cannot complete its development work as planned due to a lack of funds, the value of our investment would be materially impaired,
as would be our ability to continue as a going concern.
Our JV’s future research and development
and other expenses will vary significantly from prior periods and will depend on the outcomes of pre-clinical and clinical trials,
our and our JV’s decisions regarding future development and other factors.
DIRECTORS
AND EXECUTIVE OFFICERS
The following table sets forth our directors executive
officers along with their respective ages and positions as of September 14, 2015.
Name |
Age |
Title |
John M. Holliman, III |
62 |
Executive Chairman and Principal Executive Officer |
Randolph C. Steer, MD, Ph.D. |
66 |
Consultant / Chief Medical Officer |
Les M. Taeger |
65 |
Senior Vice President, Chief Financial Officer and Principal Financial and Accounting Officer |
Eric W. Fangmann |
45 |
Director (1) |
Fredric J. Feldman, Ph.D. |
75 |
Director (2) (3) |
Elwood D. Howse, Jr. |
75 |
Director (1) (2) (3) |
(1) | | Member of the Audit Committee |
(2) | | Member of the Compensation Committee |
(3) | | Member of the Corporate Governance/Nominating Committee |
On April 28, 2014, the Board increased the number
of directors to four and Eric W. Fangmann was elected to fill the fourth Board seat at our Annual Meeting held on June 12, 2014.
The Audit Committee of the Board, which is a separately-designated
standing committee established in accordance with Section 3(a)(58)(A) of the Exchange Act, consists of Mr. Howse (Chairman) and
Mr. Fangmann.
In particular, all Audit Committee members possess
the required level of financial literacy, at least one member of the Audit Committee meets the current standard of requisite financial
management expertise and the Board has determined that Elwood D. Howse, Jr., the Chairman of the Audit Committee, is an “audit
committee financial expert” as defined in Item 407(d) of Regulation S-K. Additionally, Mr. Howse and Mr. Fangmann are “independent
directors”, as defined in Nasdaq Listing Rule 5605(a)(2).
The employment of Mr. Holliman and Dr. Steer was
terminated effective October 31, 2011. They continue to perform many of their previous duties and responsibilities under consulting
agreements.
The following is a brief account of the business
experience during the past five years of each of our directors and executive officers, including principal occupations and employment
during that period and the name and principal business of any corporation or other organization in which such occupation and employment
were carried on.
John M. Holliman, III
John M. Holliman III has served as Executive Chairman
and Principal Executive Officer of the Company since April 2006 and has served as a director of the Company since September 1987
and as Chairman of the Board of Directors since August 1997. Since February 1993 he has been a general partner of entities which
are the general partners of Valley Ventures, LP (formerly known as Arizona Growth Partners, LP), Valley Ventures II, LP, Valley
Ventures III, LP, Valley Ventures III Annex, LP, all of which are venture capital funds that invest principally in life science
companies.
John M. Holliman, III has over thirty years of
business experience, including service on the boards of over forty companies, commercial lending experience with major financial
institutions, and has been active in venture capital financing for over thirty years, concentrating in the medical/biotech industries.
Mr. Holliman earned a BBA in Finance and a MBA from Southern Methodist University and a Master of International Management from
the Thunderbird School of Global Management. During his career Mr. Holliman has gained substantial executive and board level experience
in business, finance and operations. The Board believes the experience and knowledge of Mr. Holliman qualifies him to serve on
our board.
Randolph C. Steer, MD, Ph.D.
Randolph C. Steer, MD, Ph.D. served as President
of the Company from April 5, 2006 until October 31, 2011. Since then, Dr. Steer has provided scientific, regulatory and clinical
consulting services to the Company. Dr. Steer has been an independent pharmaceutical, biotechnology and medical devices consultant
since 1989, and has provided services to the Company since 2002. He has a broad scientific, medical and business background, including
extensive experience in pre-clinical, clinical and regulatory affairs, having held key management positions in leading corporations
and having served as an advisor to many companies in the United States and abroad. Dr. Steer has also advised numerous venture
capital firms, investment banks and independent investors on the commercial development of drugs, biologics, diagnostics and medical
devices. He has served as Associate Director of Medical Affairs at Marion Laboratories; Medical Director at Ciba Consumer Pharmaceuticals
(Ciba-Geigy Corporation); Vice President, Senior Vice President and Member of the Executive Committee at Physicians World Communications
Group; Chairman, President and Chief Executive Officer of Advanced Therapeutics Communications International, a global drug regulatory
group, and Chairman and Chief Executive Officer of Vicus.com, Inc. He is a member of the Board of Trustees of the Mayo Clinic and
the Board of Directors of Techne Corporation and Vital Therapies, and was a member of the Board of Directors of BioCryst Pharmaceuticals
from 1994 to 2009. Dr. Steer received his MD degree from the Mayo Medical School and his Ph.D. from the University of Minnesota,
where he also completed a residency and subspecialty training in clinical and chemical pathology. He is a Fellow of the American
College of Clinical Pharmacology.
Les M. Taeger
Les M. Taeger joined the Company as Senior Vice
President and Chief Financial Officer on January 16, 2006. Mr. Taeger most recently served as Chief Financial Officer of CardioTech
International, Inc. (currently AdvanSource Biomaterials Corporation) (“CardioTech”). CardioTech was a publicly-traded,
medical device company that developed, manufactured and sold advanced products for the treatment of cardiovascular disease. From
September 2000 to February 2004, when Mr. Taeger became Chief Financial Officer of CardioTech, Mr. Taeger served as Chief Financial
Officer of Gish Biomedical, Inc. (“Gish”). Gish, which became a subsidiary of CardioTech pursuant to a merger transaction
involving the companies in April 2003, specialized in the manufacture and sale of products used in open-heart surgery, vascular
access and orthopedic surgery. Prior to his employment with CardioTech and Gish, Mr. Taeger was employed for over five years as
Chief Financial Officer of Cartwright Electronics, Inc., a division of Meggitt, PLC. Mr. Taeger is a Certified Public Accountant,
with a Bachelor’s degree in accounting.
Eric W. Fangmann
Eric W. Fangmann has served as a director of the
Company since June 2014. Mr. Fangmann has been the Chief Financial Officer for Lloyd I. Miller, III, since 2011. Mr. Fangmann is
also the Acting President and Acting Chief Financial Officer for Pharmos Corporation, a pharmaceutical company, since 2012. Mr.
Fangmann was previously an independent accounting and finance consultant who was principally engaged by public and private entities
to assist in independent analysis and other projects. Mr. Fangmann was appointed by the Board of Directors of Synergy Brands Inc.
in 2011 as its chief financial officer and treasurer, and was appointed as officer and/or director of certain of its subsidiaries,
to serve in such capacities on an interim basis in connection with certain filings under Chapter 7 of the U.S. bankruptcy code.
From 2005 to 2010, Mr. Fangmann served as Executive Vice President Technology of Frontera Investment, Inc., a publicly held cash
and loan company. Prior to that, Mr. Fangmann has served principally in senior management accounting and finance functions for
both public and private entities such as The Upper Deck Company, LLC, PriceSmart, Inc. and Teletrac, Inc. From 1992 to 1996, Mr.
Fangmann worked in the audit division of Arthur Andersen. Mr. Fangmann also serves on the board of directors of Alliance Semiconductor
and Global Agora, LLC. Mr. Fangmann holds a B.S. in Accountancy - Cum Laude from the University of Missouri, Columbia, Missouri.
Mr. Fangmann was introduced and recommended to
the Board as a nominee for director by Lloyd I. Miller, III, a significant stockholder. The Board believes Mr. Fangmann’s
diverse financial experience brings important experience to the Board and qualifies him to serve on our Board.
Fredric J. Feldman, Ph.D.
Fredric J. Feldman, Ph.D. has been the President
of FJF Associates, a consultant to health care venture capital and emerging companies, since February 1992 and has served as a
director of the Company since 1991. From September 1995 to June 1996, he was the Chief Executive Officer of Biex, Inc., a women’s
healthcare company. He served as Chief Executive Officer of Oncogenetics, Inc., a cancer genetics reference laboratory, from 1992
to 1995. Between 1988 and 1992, Dr. Feldman was the President and Chief Executive Officer of Microgenics Corporation, a medical
diagnostics company.
Dr. Feldman received his Ph.D. in analytical chemistry
from the University of Maryland. He has been a director of a number of public and private companies involved in the healthcare
industry. The Board believes that Dr. Feldman’s over 40 years of operating, scientific and business experience in the medical/biotech
industry qualifies him for service on our board.
Elwood D. Howse, Jr.
Elwood D. Howse, Jr. has served as a director of
the Company since September 1987. In 1982, Mr. Howse founded Cable, Howse and Ragen, investment banking and stock brokerage firm,
subsequently known as Ragen MacKenzie. In 1977, Mr. Howse co-founded Cable & Howse Ventures, an early stage venture capital
firm focused on technology. In 1976, he served as Vice President, Corporate Finance, for Foster & Marshall, a northwest stock
brokerage firm. In 1974 he was the Chief Financial Officer of Seattle Stevedore Company and the Miller Produce Company. Mr. Howse
has served as a corporate director and advisor to various public, private and non-profit enterprises. He served on the board of
the National Venture Capital Association and is past President of the Stanford Business School Alumni Association. He currently
serves on the boards of directors of Formotus, Inc., BeneSol Corporation, Stella Therapeutics, Inc. and not-for-profit, Junior
Achievement of Washington. Mr. Howse holds a BS in Engineering from Stanford University and an MBA from Stanford Graduate School
of Business.
The Board believes that Mr. Howse’s education
and experience, particularly Mr. Howse’s financial experience, which qualifies him to be designated as our financial expert
on our Audit Committee, brings important financial and business experience to the board and qualifies him to serve on our board.
Director Compensation
The following table sets forth compensation awarded
to, earned by or paid to our directors during the last fiscal year. Mr. Holliman is not included in this table and his compensation
as a director is included in the Summary Compensation Table in “Compensation of Executives” below.
Name |
Fees Earned or Paid in Cash
($)
|
Stock
Awards
($)
|
Option
Awards
($)
(1)
|
Non-Equity Incentive Plan Compensation
($)
|
Nonqualified
Deferred
Compensation
Earnings
($)
|
All Other
Compensation
($)
|
Total
($)
|
(a) |
(b) |
(c) |
(d) |
(e) |
(f) |
(g) |
(h) |
Fredric J. Feldman, Ph.D.
Elwood D. Howse, Jr.
Eric W. Fangmann
|
49,000
49,000
12,000
|
|
4,000
4,000
8,000
|
-
-
-
|
-
-
-
|
-
-
-
|
53,000
53,000
20,000
|
| (1) | Fair value of the grants at the date of the grants was determined using the Black-Scholes model as
described in Note 5 in Notes to Financial Statements included in our Annual Report on Form 10-K for the year ended December 31,
2014.
|
During the year ended December 31, 2014, we paid
directors Board Fees of $6,000 per quarter. All directors are eligible for a grant of non-qualified stock options pursuant to our
2005 Equity Incentive Plan. On June 10, 2005, the Board approved an annual award to each director of a non-qualified stock option
to purchase 10,000 shares of our common stock. On January 1, 2014, we granted to each then-current director (Mr. Holliman, Dr.
Feldman and Mr. Howse) non-qualified options to acquire 10,000 shares at an exercise price of $0.26 per share (fair value of $2,000).
We also granted to Mr. Howse and Dr. Feldman non-qualified stock options to acquire 12,000 shares at an exercise price of $0.30
per share on February 6, 2014 (fair value of $2,000), Mr. Holliman non-qualified stock options to acquire 22,000 shares at an exercise
price of $0.30 per share on February 6, 2014 (fair value of $5,000), and Mr. Fangmann non-qualified stock options to acquire 50,000
shares at an exercise price of $0.21 on June 12, 2014 (fair value of $8,000). These options vested immediately and were granted
at the closing market price on the date of grant. All options have been granted with ten-year terms.
The Board also approved a cash award on January
1, 2014 to each then-current director ($15,000 to Mr. Holliman, $25,000 to Dr. Feldman, and $25,000 to Mr. Howse) in lieu of the
annual award of our restricted common stock.
The following table sets forth the equity awards
held by our directors that were outstanding at the end of our last fiscal year.
Directors Outstanding Equity Awards at Fiscal Year End
Name |
Option Awards |
|
Number of Securities Underlying Unexercised Options
(#)
Exercisable
|
Number of Securities Underlying Unexercised Options
(#)
Unexercisable
|
Equity Incentive Plan Awards: Number of Securities Underlying Unexercised
Unearned Options
(#)
|
Options
Exercise Price
($)
|
Option
Expiration Date
|
(a) |
(b) |
(c) |
(d) |
(e) |
(f) |
John M. Holliman, III |
200,000 |
|
|
1.75 |
5/12/2016 |
|
50,000 |
|
|
1.02 |
2/21/2018 |
|
125,000 |
|
|
0.45 |
2/3/2019 |
|
100,000 |
|
|
0.82 |
2/4/2020 |
|
25,000 |
|
|
0.70 |
10/30/2018 |
|
65,000 |
|
|
0.17 |
5/18/2022 |
|
65,000 |
|
|
0.16 |
8/9/2022 |
|
51,000 |
|
|
0.21 |
2/28/2023 |
* |
20,167 |
1,833 |
|
0.30 |
2/6/2024 |
Eric W. Fangmann |
50,000 |
|
|
0.24 |
6/12/2024 |
|
|
|
|
|
|
Various directors: |
|
|
|
|
|
(1)(2)(3) |
10,000 |
|
|
4.90 |
1/2/2016 |
(1)(2)(3) |
25,000 |
|
|
1.75 |
5/12/2016 |
(1)(2)(3) |
10,000 |
|
|
1.43 |
1/1/2017 |
(1)(2)(3) |
10,000 |
|
|
1.35 |
1/1/2018 |
(1)(3) |
25,000 |
|
|
0.70 |
10/30/2018 |
(1)(2)(3) |
10,000 |
|
|
0.42 |
1/1/2019 |
(1)(2)(3) |
10,000 |
|
|
0.72 |
1/1/2020 |
(1)(2)(3) |
10,000 |
|
|
0.58 |
1/1/2021 |
(1)(2)(3) |
10,000 |
|
|
0.26 |
1/1/2022 |
(1)(2) |
35,000 |
|
|
0.17 |
5/18/2022 |
(1)(2) |
42,500 |
|
|
0.16 |
8/9/2022 |
(1)(2)(3) |
10,000 |
|
|
0.17 |
1/1/2023 |
(1)(3) |
27,000 |
|
|
0.21 |
2/28/2023 |
(1)(2)(3) |
10,000 |
|
|
0.26 |
1/1/2024 |
(1)(3) * |
11,000 |
1,000 |
|
0.30 |
2/6/2024 |
(1) Feldman, Fred
(2) Holliman, John
(3) Howse, Elwood
* Vested on February 6, 2015.
Executive Compensation
The Compensation Committee, at its meeting held
at the beginning of each fiscal year, formulates its recommendations regarding which compensation components will be adjusted for
the upcoming year and what the performance bonus for the prior year will be.
At the first Compensation Committee meeting of
the year, the Compensation Committee reviews the Executive Chairman’s and other executive officers’ compensation and
bonuses and presents its recommendations to the Board. The final total compensation package decision regarding the Executive Chairman
is made by the Independent Directors in an Executive Session without the Executive Chairman or other members of management present,
and the final decisions on other executives’ total compensation packages are made by the full Board.
The following discussion is provided to facilitate
investors’ understanding of the named executive officer compensation information included in this prospectus.
Officer and Key Consultant Compensation
On October 13, 2011, the Board adopted a plan to
preserve cash during ongoing partnering efforts. Included in the actions taken was the termination of the employment of John M.
Holliman, III, Executive Chairman and Randolph C. Steer, MD, Ph.D., President. These individuals have continued as consultants,
rather than as employees, at consulting rates which would equate to approximately $100,000 per year for Mr. Holliman and $120,000
per year for Dr. Steer. As employees, their base compensation had been $200,000 for Mr. Holliman and $325,000 for Dr. Steer. Les
M. Taeger, Chief Financial Officer and Senior Vice President has continued as an employee, but his base compensation was reduced
from $242,000 per year to $120,000 (increased to $135,000 for 2014) per year. All of these officers had also been eligible for
an annual bonus based on individual and Company performance goals of up to 40% of their base compensation. The Board’s actions
included cancellation of our bonus plan. The vested outstanding stock options held by each executive will continue to be exercisable
while such executive is serving as a consultant to the Company.
Equity-Based Compensation
We provide a certain level of cash compensation
to each executive as both a short-term reward and to focus executive performance on short-term goals that are part of our long-term
strategies. Additionally, we use a combination of stock option grants and common stock awards to generate a commitment to, and
a long-term investment in, the Company. Grants and awards were determined based on the position and competitive factors, as well
as substantial compensation reductions effective October 31, 2011.
Stock Option Grants
In 2014, we granted options to employees to purchase
74,000 shares of our common stock with the exercise price determined by the closing market price on the date of grant ($0.26 to
$0.30) and an aggregate grant date fair value of $16,000. These grants included grants to the named executives (options to purchase
32,000 shares to Mr. Holliman, options to purchase 22,000 shares to Dr. Steer, and options to purchase 15,000 shares to Mr. Taeger).
Common Stock Awards
We did not grant any common stock awards in 2014.
Fringe Benefits, Perquisites and Retirement Benefits.
Our executive employee participates in group health,
dental, life, and disability programs on the same basis as other employees. No perquisites are provided to executives that in aggregate
exceed $10,000 per year.
Joint Venture Bonus Plan
On August 9, 2012, our Board approved a performance-based
incentive compensation plan (the “JV Bonus Plan”) for our executive and consultants who were primarily responsible
for identifying the investment opportunity for the development of Apo E mimetic peptide AEM-28 and its analogs, a class of Cardiovascular
drugs targeting indications related to lowering blood cholesterol levels, completing the formation of our JV, and who will participate
in the management of our JV.
Our joint venture Bonus Plan provides for a bonus
pool, shared 40% by Mr. Holliman, 40% by Dr. Steer and 20% by Mr. Taeger, of 2.5% of the cash or in-kind distributions from our
JV to us after we have received the return of our initial $6,000,000 investment. The individuals’ interest in the bonus pool
vested 50% upon Board approval of the JV Bonus Plan (August 9, 2012) and vested 50% upon the presentation by our JV to its members
of quantitative/qualitative safety and efficacy results from all protocol-designated endpoints of the AEM-28 Phase 1b/2a clinical
trial. The bonuses under the JV Bonus Plan are fully vested at December 31, 2014; however, no amounts have been earned as of September
14, 2015.
Summary Compensation Table
The following table sets forth, with respect to
the years ended December 31, 2014, 2013 and 2012, compensation awarded to, earned by or paid to our principal executive officer,
principal financial officer and key consultant who were serving at the end of the last completed fiscal year (the “named
executive officers”).
Name |
Year |
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Awards
($) (1)
|
Non-Equity
Incentive Plan
Compensation
($)
|
Nonqualified Deferred Compensation Earnings ($) |
All
Other
Compensation
($)
|
Total
($)
|
(a) |
(b) |
(c) |
(d) |
(e) |
(f) |
(g) |
(h) |
(i) |
(j) |
John M. Holliman, III
Executive Chairman
(Principal
Executive
Officer)
|
2014
2013
2012
|
100,000
100,000
100,000
|
-
-
-
|
-
-
3,000
|
7,000
7,000
14,000
|
-
-
-
|
-
-
-
|
31,000(1)
41,000(1)
16,000(1)
|
138,000
148,000
133,000
|
Randolph C. Steer, MD, Ph.D.,
Consultant
(former President)
|
2014
2013
2012
|
120,000
120,000
120,000
|
15,000
-
25,000
|
-
-
-
|
5,000
9,000
12,000
|
-
-
-
|
-
-
-
|
-
-
-
|
140,000
129,000
157,000
|
Les M. Taeger
Chief Financial Officer
(Principal Financial Officer)
|
2014
2013
2012
|
135,000
120,000
120,000
|
-
-
25,000
|
-
-
-
|
3,000
6,000
8,000
|
-
-
-
|
-
-
-
|
-
-
-
|
138,000
126,000
153,000
|
| (1) | Mr. Holliman is a member of the Board, and as a director, received compensation of $31,000, $41,000
and $16,000, in cash, in 2014, 2013 and 2012, respectively, and an annual grant of an option to purchase 10,000 shares of our common
stock. Mr. Holliman received total director’s compensation (Board fees, stock awards and option grants) of $38,000, $48,000
and $20,000 in 2014, 2013 and 2012, respectively, as more fully described in the “Compensation of Directors” section
of this prospectus. |
Fair value of the grants at the date of the grants was determined using
the Black-Scholes model as described, for 2014, in Note 5 to the Financial Statements included in our Annual Report on Form 10-K,
filed with the SEC on March 16, 2015, for 2013, in Note 5 to our Annual Report on Form 10-K filed with the SEC on March 27, 2014
and for 2012, in Note 5 to our Annual Report on form 10-K filed with the SEC on March 14, 2013.
Option Grants / Stock Awards
The following table sets forth information about stock option grants
and stock awards during our last fiscal year to the executive officers named in the Summary Compensation Table.
Name |
Grant
Date
|
All Other Stock
Awards: Number of Shares of Stock or Units (#)
|
All Other Option
Awards: Number of Securities
Underlying Options (#)
|
Exercise or Base Price of Option Awards
($/Share)
|
Grant Date Fair Value of Stock and Option Awards (1)
($)
|
(a) |
(b) |
(i) |
(j) |
(k) |
(l) |
John M. Holliman, III
Executive Chairman
|
1/1/14
2/6/14
|
-
-
|
10,000
22,000
|
0.26
0.30
|
2,000
5,000
|
Randolph C. Steer, MD, Ph.D.
Consultant
|
2/6/14
|
-
|
22,000
|
0.30
|
5,000
|
Les M. Taeger
Chief Financial Officer
|
2/6/14
|
- |
15,000
|
0.30
|
3,000
|
(1) Fair value of the grants at the date of the grants was determined
using the Black-Scholes model as described in Note 5 to the Financial Statements included in our Annual Report on Form 10-K filed
with the SEC on March 16, 2015.
Outstanding Equity Awards at Fiscal Year End
The following table sets forth information about
stock option grants and stock awards outstanding at the end or our last fiscal year held by the executive officers named in the
Summary Compensation Table.
Name |
Option Awards |
|
Number of Securities Underlying Unexercised Options (#) |
Number of Securities Underlying Unexercised Options (#) |
Option
Exercise Price
($)
|
Option
Expiration Date
|
(a) |
(b) |
(c) |
(e) |
(f) |
John M. Holliman, III |
10,000 |
- |
4.90 |
1/2/2016 |
|
25,000 |
- |
1.75 |
5/12/2016 |
|
200,000 |
- |
1.75 |
5/12/2016 |
|
10,000 |
- |
1.43 |
12/31/2017 |
|
10,000 |
- |
1.35 |
12/31/2018 |
|
50,000 |
- |
1.02 |
2/21/2018 |
|
25,000 |
- |
0.70 |
10/30/2018 |
|
10,000 |
- |
0.42 |
1/1/2019 |
|
125,000 |
- |
0.45 |
2/3/2019 |
|
10,000 |
- |
0.72 |
1/1/2020 |
|
100,000 |
- |
0.82 |
2/4/2020 |
|
10,000 |
- |
0.58 |
1/1/2021 |
|
10,000 |
- |
0.26 |
1/1/2022 |
|
65,000 |
- |
0.17 |
5/18/2022 |
|
65,000 |
- |
0.16 |
8/9/2022 |
|
10,000 |
- |
0.17 |
1/1/2023 |
|
51,000 |
- |
0.21 |
2/28/2023 |
|
10,000 |
- |
0.26 |
1/1/2024 |
* |
20,167 |
1,833 |
0.30 |
2/6/2024 |
Randolph C. Steer, MD, Ph.D. |
200,000 |
- |
1.75 |
5/12/2016 |
|
50,000 |
- |
1.53 |
5/21/2017 |
|
50,000 |
- |
1.02 |
2/21/2018 |
|
75,000 |
- |
0.45 |
2/3/2019 |
|
50,000 |
- |
0.82 |
2/4/2020 |
|
50,000 |
- |
0.67 |
1/17/2021 |
|
65,000 |
- |
0.17 |
5/18/2022 |
|
65,000 |
|
0.16 |
8/9/2022 |
|
51,000 |
- |
0.21 |
2/28/2023 |
|
10,000 |
- |
0.35 |
10/25/2023 |
* |
20,167 |
1,833 |
0.3 |
2/6/2024 |
Les M. Taeger |
150,000 |
- |
5.15 |
1/16/2016 |
|
150,000 |
- |
1.70 |
6/2/2016 |
|
14,706 |
- |
1.02 |
2/21/2018 |
|
50,000 |
- |
0.45 |
2/3/2019 |
|
35,000 |
- |
0.82 |
2/4/2020 |
|
25,000 |
- |
0.67 |
1/17/2021 |
|
45,000 |
- |
0.17 |
5/18/2022 |
|
45,000 |
- |
0.16 |
8/9/2022 |
|
29,000 |
- |
0.21 |
2/28/2023 |
|
10,000 |
- |
0.35 |
10/25/2023 |
* |
13,750 |
1,250 |
0.30 |
2/6/2024 |
* Vested on February 6, 2015.
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth information regarding
the beneficial ownership of our common stock at September 14, 2015 with respect to (i) each person known to the Company to own
beneficially more than five percent of the outstanding shares of our common stock, (ii) each director of the Company, (iii) each
of the named executive officers and (iv) all directors and executive officers of the Company as a group. At September 14, 2015
there were 40,885,411 shares of our common stock outstanding.
|
|
Common Stock |
|
|
Beneficially Owned (1) |
Beneficial Owner |
|
Number |
|
Percentage of Class |
Eric W. Fangmann (2) |
|
160,000 |
|
less than 1% |
Fredric J. Feldman (3) |
|
592,064 |
|
1.4 |
John M. Holliman, III (4) |
|
1,680,170 |
|
4.0 |
Elwood D. Howse, Jr. (5) |
|
589,203 |
|
1.4 |
Randolph C. Steer (6) |
|
923,298 |
|
2.2 |
Les M. Taeger (7) |
|
803,280 |
|
1.9 |
BVF Group (8) |
|
7,755,688 |
|
19.0 |
Lloyd Miller, III (9) |
|
7,926,389 |
|
19.4 |
All directors and executive officers as a group (10) |
|
4,748,015 |
|
10.7 |
|
|
|
|
|
| (1) | Beneficial ownership is determined in accordance with the rules of the SEC and generally includes
voting or investment power with respect to securities. In accordance with SEC rules, shares, which may be acquired upon exercise
of stock options which are currently exercisable or which become exercisable within 60 days of the date of the table, are deemed
beneficially owned by the optionee. Except as indicated by footnote, and subject to community property laws where applicable, the
persons or entities named in the table above have sole voting and investment power with respect to all shares of common stock shown
as beneficially owned by them. |
| (2) | Includes 160,000 shares Mr. Fangmann has a right to acquire upon exercise of stock options. |
| (3) | Includes 366,500 shares Dr. Feldman has a right to acquire upon exercise of stock options. Voting
and investment power shared with spouse. |
| (4) | Includes 1,168,000 shares Mr. Holliman has a right to acquire upon exercise of stock options. |
| (5) | Includes 366,500 shares Mr. Howse has a right to acquire upon exercise of stock options. |
| (6) | Includes 878,000 shares Dr. Steer has a right to acquire upon exercise of stock options. |
| (7) | Includes 758,706 shares Mr. Taeger has a right to acquire upon exercise of stock options. |
| (8) | BVF Group (Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P. BVF Investments, L.L.C.,
Investment 10, L.L.C., BVF Partners, L.P., BVF Inc.) is not a related party or otherwise affiliated with the Company, its directors
or officers, and the principal business office of the Reporting Persons comprising the Group is located at 900 North Michigan Avenue,
Suite 1100, Chicago, IL 60611. |
| (9) | Lloyd Miller, III is not a related party or otherwise affiliated with the Company, its directors or
officers, except that Lloyd Miller, III recommended Eric W. Fangmann to be a Company Board of Director member and Eric W. Fangmann
is the Chief Financial Officer of various business entities associated with Mr. Miller, and the principal business office of the
Reporting Person is located at 222 Lakeview Avenue, Suite 160-365, West Palm Beach, Florida 33401. |
| (10) | Includes 3,697,706 shares directors and executive officers have a right to acquire upon exercise of
stock options. |
The address of each of the listed stockholders,
unless noted otherwise, is in care of Capstone Therapeutics Corp., 1275 West Washington Street, Suite 104, Tempe, AZ 85281.
TRANSACTIONS
WITH RELATED PERSONS
Our Board reviews transactions with related parties,
but has no formal policies in place with respect to such reviews or the approval of such transactions. Since January 1, 2014, there
have been no transactions with directors, executive officers or other related parties which were material to the Company.
We have entered into indemnity agreements with
all of our directors and officers for the indemnification of and advancing of expenses to such persons to the fullest extent permitted
by law.
DESCRIPTION
OF OUR CAPITAL STOCK
Our restated certificate of incorporation (“Restated Certificate”)
provides that we have the authority to issue 150 million shares of $0.0005 par value common stock and 2 million shares of $0.0005
par value preferred stock.
There are 40,885,411 shares of our common stock outstanding as of
September 14, 2015, excluding the following:
· | | Options outstanding to purchase 4,062,706 shares of our common stock, the exercise
price of which ranges between $0.16 per share to $5.39 per share, which consists of: |
| o | Options to purchase 1,245,000 shares at exercise prices of $.16 to $.22 per share |
| o | Options to purchase 598,000 shares at exercise prices of $.24 to $.45 per share |
| o | Options to purchase 620,000 shares at an exercise price of $.25 per share |
| o | Options to purchase 504,000 shares at exercise prices of $.58 to $.82 per share |
| o | Options to purchase 914,706 shares at exercise prices of $1.02 to $1.75 per share |
| o | Options to purchase 181,000 shares at exercise prices of $4.90 to $5.39 per share |
· | | Warrants outstanding to purchase 46,706 shares of our common stock with an exercise
price of $6.39 per share, and warrants outstanding to purchase 117,423 shares of our common stock with an exercise price of $1.91
per share. |
There are no shares of our preferred stock outstanding as of September
14, 2015.
The following is a summary of the material provisions of our common
stock and preferred stock. This summary does not purport to be exhaustive and is qualified in its entirety by reference to applicable
Delaware law and our Restated Certificate and bylaws.
Common Stock
The holders of common stock are entitled to one vote per share on
all matters to be voted upon by the stockholders. Stockholders are not entitled to cumulate their votes for the election of directors.
Subject to preferences that may be applicable to any outstanding shares of preferred stock, the holders of common stock are entitled
to receive ratably such dividends, if any, as may be declared from time to time by the Board out of funds legally available for
that purpose. In the event of our liquidation, dissolution or winding up, the holders of common stock are entitled to share ratably
in all assets remaining after payment of liabilities, subject to prior distribution rights of preferred stock, if any, then outstanding.
The common stock has no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund provisions
applicable to the common stock. All outstanding shares of common stock are fully paid and nonassessable, and the shares of common
stock to be issued upon completion of this offering will be fully paid and nonassessable.
The transfer agent for our common stock is Computershare Inc. (“Computershare”)
Preferred Stock
Under our Restated Certificate, the Board has the authority, without
further action by our stockholders, to issue up to 2 million shares of preferred stock in one or more series and to fix the variations
in the powers, preferences, rights, qualifications, limitations or restrictions of the preferred stock, including dividend rights,
conversion rights, voting rights, terms of redemption and liquidation preferences, any or all of which may be greater than the
rights of our common stock. The Board, without stockholder approval, can issue preferred stock with voting, conversion or other
rights that could adversely affect the voting power and other rights of the holders of our common stock. As a result, preferred
stock could be issued quickly with terms that will delay or prevent a change of control or make removal of management more difficult.
In addition, the issuance of preferred stock may have the effect of decreasing the market price of our common stock and may adversely
affect the voting and other rights of our common stock. At present, there are no shares of preferred stock outstanding and we have
no current plans to issue any shares of preferred stock.
Unit Warrants to be Sold in this Offering
The warrants included in the Units offered in
this offering will be issued in a form filed as an exhibit to the registration statement of which this prospectus is a part. You
should review a copy of the form of warrant for a complete description of the terms and conditions applicable to the warrants.
The following is a brief summary of the warrants and is subject in all respects to the provisions contained in the form of warrant.
We are offering up to
Units, each consisting of one share of common stock and one warrant to purchase one-half of a share of common stock. The shares
of common stock and warrants will immediately separate after purchase and will be issued separately. The warrants are exercisable
for a five-year period at an exercise price of $ , which is %
of the offering price for each Unit.
There is no market for the warrants and we do
not expect one to develop.
Except as expressly set forth in the warrants,
the warrant holders will not have any of the rights or privileges of holders of common stock unless and until the warrants are
exercised and the underlying shares of common stock are issued. However, upon the holder’s exercise of its warrant after
the occurrence of various specified fundamental transactions, the holder will be entitled to receive consideration from the fundamental
transaction to the same extent that the holder would have participated therein if it had exercised its warrant in full immediately
prior to such fundamental transaction.
No fractional shares of common stock will be
issued in connection with the exercise of a warrant. In lieu of fractional shares, we will, at our election, either pay to the
holder a cash adjustment in respect of such fraction in an amount equal to such fraction multiplied by the warrant exercise price
or round up to the next whole share.
A warrant may be transferred by a holder, in
whole or in part, upon surrender of the warrant, properly endorsed (by the holder executing an assignment in the form attached
to the warrant). Notwithstanding the foregoing, a holder is not required to physically surrender its warrant unless such holder
has assigned its warrant in full. Any warrant, if properly assigned in accordance with the terms thereof, may be exercised by a
new holder for the purchase of warrant shares without having a new warrant issued.
The exercise price and the number of shares
of common stock issuable upon the exercise of each warrant are subject to adjustment upon the happening of certain events, such
as recapitalizations, reorganizations, mergers or consolidations and certain dilutive issuances. The holders will also have preemptive
rights to participate in certain future equity issuances by the Company.
The warrants provide that, except as approved
by the Company, no exercise will be effected, and the holder of a warrant will not have the right to exercise a warrant, if after
giving effect to the exercise the holder, together with any affiliates, would beneficially own in excess of 4.99% of the number
of shares of our common stock outstanding immediately after giving effect to the issuance of shares upon exercise of such warrant.
Tax Benefit Preservation Plan (“Benefit Plan”)
In this prospectus, unless the context requires otherwise, all references
to our common stock include the accompanying rights. In June 2014, our Board adopted a Tax Benefit Preservation Plan (“Benefit
Plan”) with Computershare, pursuant to which each outstanding share of our common stock has attached one preferred stock
purchase right. Each share of our common stock subsequently issued prior to the expiration of the Benefit Plan will likewise have
attached one right.
Under specified circumstances, the right under
the Benefit Plan that attaches to each share of our common stock will entitle the holder thereof to purchase 1/100 of a share of
our Series A preferred stock for a purchase price of $5.00 (subject to adjustment), and to receive, upon exercise, shares of our
common stock having a value equal to two times the exercise price of the right. By adopting the Benefit Plan, our Board sought
to protect our ability to use our net operating loss carryforwards and other tax attributes to reduce our future taxable income,
if any (collectively, “Tax Benefits”). We view our Tax Benefits as highly valuable assets that are likely to inure
to our benefit and the benefit of our stockholders if in the future we generate taxable income. However, if we experience an “ownership
change,” our ability to use the Tax Benefits could be substantially limited, and the timing of the usage of the Tax Benefits
could be substantially delayed, which could significantly impair the value of the Tax Benefits. The Benefit Plan is intended to
act as a deterrent to persons acquiring our common stock in certain transactions that would constitute or contribute to such an
“ownership change”, as defined in Section 382 of the Internal Revenue Code (the “Code”), without the approval
of our Board. The Benefit Plan expires June 24, 2016.
At September 14, 2015, the rights are not exercisable and trade only
with our common stock.
Delaware Law
We are subject to the provisions of Section 203 of the Delaware General
Corporation Law. In general, this statute prohibits a publicly held Delaware corporation from engaging in a “business combination”
with an “interested stockholder” for a period of three years after the date that the person became an interested stockholder
unless (with certain exceptions) the business combination or the transaction in which the person became an interested stockholder
is approved in a prescribed manner. Generally, a “business combination” includes a merger, asset or stock sale, or
other transaction resulting in a financial benefit to the stockholder. Generally, an “interested stockholder” is a
person who, together with affiliates and associates, owns (or within three years prior, did own) 15% or more of the corporation’s
voting stock.
Certain Anti-Takeover Provisions
Stockholders’ rights and related matters are governed by Delaware
corporate law, our Restated Certificate and our bylaws. Certain provisions of the Restated Certificate and bylaws which are summarized
below may discourage or have the effect of delaying or deferring potential changes in control of the Company. The Board believes
that these provisions are in the best interests of stockholders because they will encourage a potential acquirer to negotiate with
the Board, which will be able to consider the interests of all stockholders in a change-in-control situation. However, the cumulative
effect of these terms may be to make it more difficult to acquire and exercise control of the Company and to make changes in our
management.
The Restated Certificate provides for the approval of the holders
of two-thirds of our outstanding voting stock for a merger or a consolidation with, or a sale by us of all or substantially all
of our assets to, any person, firm or corporation, or any group thereof, which owns, directly or indirectly, 5% or more of any
class of our voting securities (an “Interested Person”). In addition, two-thirds approval is required with respect
to other transactions involving any such Interested Person, including among other things, purchase by us or any of our subsidiaries
of all or substantially all of the assets or stock of an Interested Person and any other transaction with an Interested Person
which requires stockholder approval under Delaware law. The two-thirds voting requirement is not applicable to any transaction
approved by the Board if a majority of the members of the Board voting to approve such transaction were elected prior to the date
on which the other party became an Interested Person or certain other conditions are met (the “Continuing Directors”).
The Restated Certificate provides that each director will serve for
a three-year term and that approximately one-third of the directors are to be elected annually. Candidates for directors shall
be nominated only by the Board or by a stockholder who gives us written notice no later than 20 days before the annual meeting
or, in the case of a special meeting, the close of business on the 15th day following the date on which notice of such
special meeting is first given to the stockholders. We may have three to nine directors as determined from time to time by our
Board, which currently consists of four members. Between stockholder meetings, our Board may appoint new directors to fill vacancies
or newly created directorships. The Restated Certificate does not provide for cumulative voting at stockholder meetings for the
election of directors. Stockholders controlling at least 50% of the outstanding common stock can elect the entire Board, while
stockholders controlling 49% of the outstanding common stock may not be able to elect any directors. A director may be removed
from office only for cause and only by the affirmative vote of a majority of the combined voting power of the then outstanding
shares of capital stock entitled to vote generally in the election of directors.
The Restated Certificate further provides that stockholder action
must be taken at a meeting of stockholders and may not be effected by any consent in writing. Special meetings of stockholders
may be called only by the President, a majority of the Board or the holders of at least 35% of the outstanding shares of capital
stock entitled to vote.
The Restated Certificate provides further that the foregoing provisions
of the Restated Certificate and bylaws may be amended or repealed only with the affirmative vote of at least two-thirds of the
shares entitled to vote, unless the amendment is recommended for stockholder approval by a majority of the Continuing Directors.
These provisions exceed the usual majority vote requirement of Delaware law and are intended to prevent the holders of less than
two-thirds of the voting power from circumventing the foregoing terms by amending the Restated Certificate or bylaws. These provisions,
however, enable the holders of more than one-third of the voting power to prevent amendments to the foregoing anti-takeover provisions
of the Restated Certificate or bylaws even if they were favored by the holders of a majority of the voting power.
The effect of such provisions of our Restated Certificate and bylaws
may be to make more difficult the accomplishment of a merger or other takeover or change in control of the Company. To the extent
that these provisions have this effect, removal of our incumbent Board and management may be rendered more difficult. Furthermore,
these provisions may make it more difficult for stockholders to participate in a tender or exchange offer for common stock and
in so doing may diminish the market value of the common stock.
Limitations on Personal Liability of Directors
Delaware law authorizes a Delaware corporation to eliminate or limit
the personal liability of a director to the corporation and its stockholders for monetary damages for breach of certain fiduciary
duties as a director. We believe that such a provision is beneficial in attracting and retaining qualified directors, and accordingly
the Restated Certificate includes a provision eliminating liability for monetary damages for any breach of fiduciary duty as a
director, except: (1) for any breach of the duty of loyalty to the Company or our stockholders; (2) for acts or omissions not in
good faith or which involve intentional misconduct or a knowing violation of law; (3) for any transaction from which the director
derived an improper personal benefit; or (4) for unlawful payments of dividends or unlawful stock repurchases or redemptions as
provided in Section 174 of the Delaware General Corporation Law. Thus, pursuant to Delaware law, our directors are not insulated
from liability for breach of their duty of loyalty (requiring that, in making a business decision, directors act in good faith
and in the honest belief that the action was taken in the best interest of the corporation). The foregoing provisions of the Restated
Certificate may reduce the likelihood of derivative litigation against directors and may discourage or deter stockholders or management
from bringing a lawsuit against directors for breaches of the fiduciary duties, even though an action, if successful, might otherwise
have benefited us and our stockholders. Further, we have entered into indemnity agreements with all of our directors and officers
for the indemnification of and advancing of expenses to such persons to the fullest extent permitted by law. We have also obtained
insurance for the benefit of our officers and directors insuring such persons against certain liabilities, including liabilities
under the securities laws.
LEGAL MATTERS
The validity of the securities to be sold pursuant to this prospectus
is being passed upon for us by our counsel, Quarles & Brady LLP, Phoenix, Arizona.
EXPERTS
The consolidated financial statements of Capstone
Therapeutics Corp. as of December 31, 2014 and 2013, and for the years then ended, included in this prospectus have been so included
in reliance on the report of Moss Adams LLP, an independent registered public accounting firm, as stated in their report appearing
with such financial statements (which report includes an explanatory paragraph as to an uncertainty with respect to the Company’s
ability to continue as a going concern), and given on the authority of said firm as experts in accounting and auditing.
WHERE YOU
CAN FIND MORE INFORMATION
We have filed with the Securities and Exchange Commission, Washington,
D.C. 20549, under the Securities Act of 1933, a registration statement on Form S-1 relating to the shares of common stock and warrants
offered hereby. This prospectus does not contain all of the information set forth in the registration statement and the exhibits
and schedules thereto. For further information with respect to our company and the shares and warrants we are offering by this
prospectus you should refer to the registration statement, including the exhibits and schedules thereto.
You may inspect a copy of the registration statement without charge
at the Public Reference Section of the Securities and Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549 on official
business days during the hours of 10:00 am to 3:00 pm. The public may obtain information on the operation of the Public Reference
Room by calling the Securities and Exchange Commission at 1-800-SEC-0330. The Securities and Exchange Commission also maintains
an Internet site that contains reports, proxy and information statements and other information regarding registrants that file
electronically with the Securities and Exchange Commission. The Securities and Exchange Commission’s World Wide Web address
is http://www.sec.gov.
We file periodic reports, proxy statements and other information
with the Securities and Exchange Commission in accordance with requirements of the Exchange Act. These periodic reports, proxy
statements and other information are available for inspection and copying at the regional offices, public reference facilities
and Internet site of the Securities and Exchange Commission referred to above.
Information contained on our website is not a prospectus and does
not constitute a part of this prospectus. You should rely only on the information contained in or provided in this prospectus.
We have not authorized anyone else to provide you with different information. You should not assume the information in this prospectus
is accurate as of any date other than the date on the front of this prospectus.
INDEX TO THE FINANCIAL
STATEMENTS OF
CAPSTONE THERAPEUTICS
CORP.
|
Page |
Report of Independent Registered Public Accounting Firm |
F-2 |
Consolidated Balance Sheets at December 31, 2014 and 2013 |
F-3 |
Consolidated Statements of Operations for the years ended December 31, 2014 and 2013 |
F-4 |
Consolidated Statements of Changes in Equity for the period from December 31, 2012 to December 31, 2014 |
F-5 |
Consolidated Statements of Cash Flows for the years ended December 31, 2014 and 2013 |
F-6 |
Condensed Consolidated Balance Sheets at June 30, 2015 (unaudited) and December 31, 2014 |
F-19 |
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2015 and 2014 (unaudited) |
F-20 |
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2015 and 2014 (unaudited) |
F-21 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM*
* To be provided by amendment.
CAPSTONE THERAPEUTICS CORP.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
2,164 |
|
|
$ |
6,258 |
|
Other current assets
|
|
|
555 |
|
|
|
233 |
|
Total current assets
|
|
|
2,719 |
|
|
|
6,491 |
|
|
|
|
|
|
|
|
|
|
Patent license rights, net
|
|
|
666 |
|
|
|
823 |
|
Furniture and equipment, net
|
|
|
- |
|
|
|
3 |
|
Total assets
|
|
$ |
3,385 |
|
|
$ |
7,317 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
124 |
|
|
$ |
88 |
|
Other accrued liabilities
|
|
|
158 |
|
|
|
12 |
|
Total current liabilities
|
|
|
282 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
Capstone Therapeutics Corp. Stockholders' Equity
|
|
|
|
|
|
|
|
|
Common Stock $.0005 par value;
|
|
|
20 |
|
|
|
20 |
|
100,000,000 shares authorized; 40,885,411 shares outstanding
|
|
|
|
|
|
in 2014 and 2013
|
|
|
|
|
|
|
|
|
Additional paid-in capital
|
|
|
189,268 |
|
|
|
189,215 |
|
Accumulated deficit
|
|
|
(186,185 |
) |
|
|
(182,018 |
) |
|
|
|
|
|
|
|
|
|
Total Capstone Therapeutics Corp. stockholders' equity
|
|
|
3,103 |
|
|
|
7,217 |
|
Noncontrolling interest
|
|
|
- |
|
|
|
- |
|
Total equity
|
|
|
3,103 |
|
|
|
7,217 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
$ |
3,385 |
|
|
$ |
7,317 |
|
See notes to consolidated financial
statements
CAPSTONE THERAPEUTICS CORP.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
|
|
Years ended December 31,
|
|
|
|
2014
|
|
|
2013
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES
|
|
|
|
|
|
|
General and administrative
|
|
$ |
1,453 |
|
|
$ |
1,169 |
|
Research and development
|
|
|
3,071 |
|
|
|
3,124 |
|
Total operating expenses
|
|
|
4,524 |
|
|
|
4,293 |
|
|
|
|
|
|
|
|
|
|
Interest and other expenses (income), net
|
|
|
43 |
|
|
|
(158 |
) |
Loss from operations before taxes
|
|
|
4,567 |
|
|
|
4,135 |
|
Income tax benefit
|
|
|
(400 |
) |
|
|
(21 |
) |
Net Loss
|
|
|
4,167 |
|
|
|
4,114 |
|
|
|
|
|
|
|
|
|
|
Less: Net Loss attributable to the noncontrolling
|
|
|
|
|
|
interest
|
|
|
- |
|
|
|
(193 |
) |
Net Loss attributable to Capstone Therapeutics
|
|
|
|
|
|
|
|
|
Corp. stockholders
|
|
$ |
4,167 |
|
|
$ |
3,921 |
|
Per Share Information:
|
|
|
|
|
|
|
|
|
Net loss, basic and diluted, attributable to
|
|
|
|
|
|
|
|
|
Capstone Therapeutics Corp. stockholders
|
|
$ |
0.10 |
|
|
$ |
0.10 |
|
Basic and diluted shares outstanding
|
|
|
40,885 |
|
|
|
40,885 |
|
See notes to consolidated financial statements
CAPSTONE THERAPEUTICS CORP.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(in thousands)
|
|
Capstone Therapeutics Corp. Stockholders' Equity
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Additional
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Paid in Capital
|
|
|
Deficit
|
|
|
Interest
|
|
|
Total
|
|
Balance December 31, 2012
|
|
|
40,885 |
|
|
$ |
20 |
|
|
$ |
189,181 |
|
|
$ |
(178,097 |
) |
|
$ |
193 |
|
|
$ |
11,297 |
|
Stock-based compensation cost
|
|
|
- |
|
|
|
- |
|
|
|
34 |
|
|
|
- |
|
|
|
- |
|
|
|
34 |
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(3,921 |
) |
|
|
(193 |
) |
|
|
(4,114 |
) |
Balance December 31, 2013
|
|
|
40,885 |
|
|
|
20 |
|
|
|
189,215 |
|
|
|
(182,018 |
) |
|
|
- |
|
|
|
7,217 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation cost
|
|
|
- |
|
|
|
- |
|
|
|
53 |
|
|
|
- |
|
|
|
- |
|
|
|
53 |
|
Net loss
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(4,167 |
) |
|
|
- |
|
|
|
(4,167 |
) |
Balance December 31, 2014
|
|
|
40,885 |
|
|
$ |
20 |
|
|
$ |
189,268 |
|
|
$ |
(186,185 |
) |
|
$ |
- |
|
|
$ |
3,103 |
|
See notes to consolidated financial statements
CAPSTONE THERAPEUTICS CORP.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
|
Years Ended December 31,
|
|
|
|
2014
|
|
|
2013
|
|
|
|
|
|
|
|
|
OPERATING ACTIVITIES
|
|
|
|
|
|
|
Net loss
|
|
$ |
(4,167 |
) |
|
$ |
(4,114 |
) |
Non cash items:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
160 |
|
|
|
173 |
|
Non-cash stock-based compensation
|
|
|
53 |
|
|
|
34 |
|
Change in other operating items:
|
|
|
|
|
|
|
|
|
Other current assets
|
|
|
(322 |
) |
|
|
150 |
|
Accounts payable
|
|
|
36 |
|
|
|
(145 |
) |
Other accrued liabilities
|
|
|
146 |
|
|
|
(49 |
) |
Cash flows used in operating activities
|
|
|
(4,094 |
) |
|
|
(3,951 |
) |
INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
Proceeds from sale of assets
|
|
|
- |
|
|
|
4 |
|
Cash flows provided by investing activities
|
|
|
- |
|
|
|
4 |
|
FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
Cash flows provided by financing activities
|
|
|
- |
|
|
|
- |
|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
(4,094 |
) |
|
|
(3,947 |
) |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
|
|
6,258 |
|
|
|
10,205 |
|
CASH AND CASH EQUIVALENTS, END OF PERIOD
|
|
$ |
2,164 |
|
|
$ |
6,258 |
|
See notes to consolidated financial statements
CAPSTONE THERAPEUTICS CORP.
NOTES TO FINANCIAL STATEMENTS
1. | | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
Overview of the Business
Capstone Therapeutics Corp. is a biotechnology
company committed to developing a pipeline of novel peptides and other molecules aimed at helping patients with under-served medical
conditions. Previously, we were focused on the development and commercialization of two product platforms: AZX100 and Chrysalin
(TP508). Since March 2012, we no longer have any interest in or rights to Chrysalin. In 2012 we wound down internal operations,
ceased clinical development of AZX100 in dermal scarring, formerly our principal drug candidate, and moved to a more virtual operating
model. In 2014, we terminated the License Agreement for AZX100 intellectual property and returned all interest in and rights to
the AZX100 intellectual property to the Licensor (AzTE).
On August 3, 2012, we entered into a joint venture,
LipimetiX Development, LLC, (the “JV”) to develop Apo E mimetic peptide molecule AEM-28 and its analogs. The JV has
a development plan to pursue regulatory approval of AEM-28, or an analog, as treatment for Homozygous Familial Hypercholesterolemia
(granted Orphan Drug Designation by FDA in 2012) and other hyperlipidemic indications. The initial development plan extended through
Phase 1a and 1b/2a clinical trials and was completed in the fourth quarter of 2014. The clinical trials have a safety primary endpoint
and an efficacy endpoint targeting reduction of cholesterol and triglycerides.
The JV received allowance from regulatory authorities
in Australia permitting the JV to proceed with the planned clinical trials. The Phase 1a clinical trial commenced in Australia
in April 2014 and the Phase 1b/2a clinical trial commenced in Australia in June 2014. The clinical trials for AEM-28 are randomized,
double-blinded, placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of six escalating
single doses (Phase 1a in healthy patients with elevated cholesterol) and multiple ascending doses of the three highest doses from
Phase 1a (Phase 1b/2a in patients with Hypercholesterolemia and healthy subjects with elevated cholesterol and high Body Mass Index).
The Phase 1a clinical trial consisted of 36 patients and the Phase 1b/2a consisted of 15 patients. Both clinical trials were completed
in 2014 and the Medical Safety Committee, reviewing all safety-related aspects of the clinical trials, observed a generally acceptable
safety profile. As first-in-man studies, the primary endpoint was safety; yet efficacy measurements analyzing pharmacodynamics
yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker endpoints.
Concurrently with the development activities with
AEM-28, the JV has performed limited pre-clinical studies that have identified an analog of AEM-28, referred to as AEM-28-02, and
a new phospholipid formulation, that has the potential of equivalent efficacy, higher human dose toleration and an extended patent
life (application filed in 2014).
The JV and Company intend to explore fundraising,
partnering or licensing to obtain additional funding to continue development activities of AEM-28 and AEM-28-02.
The JV and the Company do not have sufficient funding
at this time to continue additional material development activities of AEM-28 and its analogs. The JV may conduct future clinical
trials in Australia, the USA, and other regulatory jurisdictions if regulatory approvals, additional funding, and other conditions
permit. The JV may also fund research or studies to investigate AEM-28-02 for treatment of acute coronary syndrome and other indications.
The Company intends to limit its internal operations
to a virtual operating model while continuing monitoring and participating in the management of LipimetiX Development LLC’s
AEM-28 and analogs development activities and maintaining the required level of corporate governance and reporting required to
comply with Securities and Exchange Commission rules and regulations.
Description of Current Peptide Drug Candidates.
Apo E Mimetic Peptide Molecule – AEM-28
and its analogs
Apolipoprotein E is a 299 amino acid protein that
plays an important role in lipoprotein metabolism. AEM-28 is a 28 amino acid mimetic of Apo E and AEM-28-02 (an analog of AEM-28)
is a 28 amino acid mimetic of Apo E (with an aminohexanoic acid group and a phospholipid) and both contain a domain that anchors
into a lipoprotein surface while also providing the Apo E receptor binding domain, which allows clearance through the heparan sulfate
proteoglycan (HSPG) receptors (Syndecan-1) in the liver. AEM-28 and AEM-28-02, as Apo E mimetics, have the potential to restore
the ability of these atherogenic lipoproteins to be cleared from the plasma, completing the reverse cholesterol transport pathway,
and thereby reducing cardiovascular risk. This is an important mechanism of action for AEM-28 and AEM-28-02. For patients that
lack LDL receptors (Homozygous Familial Hypercholesterolemia-HoFH), or have hypercholesterolemia, AEM-28 or AEM-28-02 may provide
a therapeutic solution. Our joint venture has an Exclusive License Agreement with the University of Alabama at Birmingham Research
Foundation for AEM-28 and certain of its analogs.
Company History
Prior to November 26, 2003, we developed, manufactured
and marketed proprietary, technologically advanced orthopedic products designed to promote the healing of musculoskeletal bone
and tissue, with particular emphasis on fracture healing and spine repair. Our product lines, which included bone growth stimulation
and fracture fixation devices, are referred to as our “Bone Device Business.” In November 2003, we sold our Bone Device
Business.
In August 2004, we purchased substantially all
of the assets and intellectual property of Chrysalis Biotechnology, Inc. (“CBI”), including its exclusive worldwide
license for Chrysalin for all medical indications. Subsequently, our efforts were focused on research and development of Chrysalin
with the goal of commercializing our products in fresh fracture healing. (In March 2012, we returned all rights to the Chrysalin
intellectual property and no longer have any interest in, or rights to Chrysalin.)
In February 2006, we purchased certain assets and
assumed certain liabilities of AzERx, Inc. Under the terms of the transaction, we acquired an exclusive license for the core intellectual
property relating to AZX100, an anti-fibrotic peptide. In 2014, we terminated the License Agreement with AzTE (Licensor) for the
core intellectual property relating to AZX100 and returned all interest in and rights to the AZX100 intellectual property to the
Licensor.
On August 3, 2012, we entered into a joint venture,
LipimetiX Development, LLC, (see Note 9 below) to develop Apo E mimetic peptide molecule AEM-28 and analogs.
Our development activities represent a single operating
segment as they shared the same product development path and utilized the same Company resources. As a result, we determined that
it is appropriate to reflect our operations as one reportable segment.
OrthoLogic Corp. commenced doing business under
the trade name of Capstone Therapeutics on October 1, 2008, and we formally changed our name from OrthoLogic Corp. to Capstone
Therapeutics Corp. on May 21, 2010.
In this Annual Report, references to “we”,
“our”, the “Company”, “Capstone Therapeutics”, “Capstone”, and “OrthoLogic”
refer to Capstone Therapeutics Corp. References to our Bone Device Business refer to our former business line of bone growth stimulation
and fracture fixation devices, including the OL1000 product line, SpinaLogic®, OrthoFrame® and OrthoFrame/Mayo. References
to our joint venture refer to LipimetiX Development, LLC.
Basis of presentation and Management’s
Plans. The accompanying financials statements have been prepared assuming the Company will continue as a going concern, which
contemplates the realization of assets and satisfaction of liabilities in the normal course of business.
As discussed above, Management has determined that
the Company will require additional capital above its current cash and working capital balances to further develop AEM-28 and its
analogs. Accordingly, the Company has significantly reduced its development activities. Relating to future corporate strategy,
the duration and timing of resolution of the qui tam lawsuit could affect the board’s decision relating to: (a) engaging
in a strategic/merger transaction, (b) conducting a private or public offering of debt or equity securities for capital to renew
a more active development of AEM-28 and its analogs, and (c) a liquidating distribution to the shareholders. These financial statements
do not include any adjustments that might result from the outcome of this uncertainty of corporate strategy.
Use of estimates. The preparation of financial
statements in accordance with accounting principles generally accepted in the United States of America requires that management
make a number of assumptions and estimates that affect the reported amounts of assets, liabilities, and expenses in our financial
statements and accompanying notes. Management bases its estimates on historical experience and various other assumptions believed
to be reasonable. Although these estimates are based on management’s assumptions regarding current events and actions that
may impact the Company in the future, actual results may differ from these estimates and assumptions.
Our significant estimates include income taxes,
contingencies, accounting for stock-based compensation, accounting for the Australian refundable research and development tax credit,
and accounting for the formation and consolidation of LipimetiX Development, LLC.
Fair value measurements.
We determine the fair value measurements of our applicable assets and liabilities based on a three-tier fair value hierarchy,
which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as observable inputs such as quoted
market prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly
or indirectly observable; and Level 3, defined as unobservable inputs for which little or no market data exists, therefore requiring
an entity to develop its own assumptions.
Cash and cash equivalents.
Cash and cash equivalents consist of cash deposited with financial institutions, including money market accounts, and
investments purchased with an original or remaining maturity of three months or less when acquired.
Furniture and equipment. Furniture and equipment
are stated at cost. Depreciation is calculated on a straight-line basis over the estimated useful lives of the various assets,
which range from three to seven years. Leasehold improvements are amortized over the life of the asset or the period of the respective
lease using the straight-line method, whichever is the shortest.
Research and development expenses. Research
and development represents costs incurred for research and development activities, including costs incurred to fund the pre-clinical
and clinical testing of our product candidates. Research and development costs are generally expensed when incurred. Nonrefundable
advance payments are capitalized and recorded as expense when the respective product or service is delivered.
Accrued Clinical. Accrued clinical
represents the liability recorded for the costs incurred for our human clinical trials. Total patient costs are based on the specified
clinical trial protocol, recognized over the period of time service is provided to the subject. We
had no active clinical trials at December 31, 2014
Stock-based compensation. We account for
share-based compensation arrangements in accordance with ASC Topic 718 “Compensation - Stock Compensation” (“ASC
718”). ASC 718 requires all share-based payments, including grants of stock options, restricted stock units and employee
stock purchase rights, to be recognized in our financial statements based on their respective grant date fair values. Under this
standard, the fair value of each grant is estimated on the date of grant using a valuation model that meets certain requirements.
We use the Black-Scholes option pricing model to estimate the fair value of our share-based payment awards. The determination of
the fair value of share-based payment awards utilizing the Black-Scholes model was affected by our stock price and a number of
assumptions, including expected volatility, expected term, risk-free interest rate and an expected dividend yield. We used our
historical volatility as adjusted for future expectations. The expected life of the stock options was based on historical data
and future expectations of when the awards will be exercised. The risk-free interest rate assumption was based on observed interest
rates with durations consistent with the expected terms of our stock options. The dividend yield assumption was based on our history
and expectation of dividend payouts. The fair value of our restricted stock units was based on the fair market value of our common
stock on the date of grant. We evaluated the assumptions used to value our share-based payment awards on a quarterly basis. For
non-employees, expense was recognized as the service was provided and when performance was complete in accordance with ASC Topic
505 – 550 “Equity-Based Payments to Non-Employees.”
Effective January 1, 2006, stock-based compensation
expense recognized in our financial statements has been based on awards that were ultimately expected to vest. We recognized compensation
cost for an award with only service conditions that had a graded vesting schedule on a straight line basis over the requisite service
period as if the award was, in-substance, a multiple award. However, the amount of compensation cost recognized at any date was
at least equal to the portion of grant-date fair value of the award that was vested at that date. The amount of stock-based compensation
expense is reduced for estimated forfeitures. Forfeitures were required to be estimated at the time of grant and revised, if necessary,
in subsequent periods if actual forfeitures differed from those estimates.
ASC 718 requires the benefits associated with tax
deductions that are realized in excess of recognized compensation cost to be reported as a financing cash flow rather than as an
operating cash flow as previously required. Subsequent to the adoption of ASC 718 on January 1, 2006, we have not recorded any
excess tax benefit generated from option exercises, due to our net operating loss carryforwards, which cause such excess benefits
to be unrealized.
The Company recorded stock-based compensation of
$53,000 in 2014 and $34,000 in 2013, which increased the net loss. Loss per weighted average basic and diluted shares outstanding
increased by less than $0.01 per share in 2014 and $0.01 per share in 2013 due to stock-based compensation.
Loss per common share.
In determining loss per common share for a period, we use weighted average shares outstanding during the period for primary
shares and we utilize the treasury stock method to calculate the weighted average shares outstanding during the period for diluted
shares. Utilizing the treasury stock method for the year ended December 31, 2014, 252,500 shares were determined to be outstanding
and excluded from the calculation of loss per share because they were anti-dilutive. At December 31, 2014, options and warrants
to purchase 3,186,835 shares of our common stock, at exercise prices ranging from $0.16 to $6.39 per share, were outstanding.
Income Taxes. Under ASC Topic 740 “Income
Taxes” (“ASC 740”), income taxes are recorded based on current year amounts payable or refundable, as well as
the consequences of events that give rise to deferred tax assets and liabilities. We base our estimate of current and deferred
taxes on the tax laws and rates that are estimated to be in effect in the periods in which deferred tax liabilities or assets are
expected to be settled or realized. Pursuant to ASC 740, we have determined that the deferred tax assets at December 31, 2014 and
2013 require a full valuation allowance given that it is not “more-likely-than-not” that the assets will be recovered.
We adopted the provisions of Financial Accounting
Standards Board (“FASB”) Interpretation No. 48, “Accounting for Uncertainty in Income Taxes-an interpretation
of FASB Statement No. 109” (now ASC 740) on January 1, 2007. ASC 740 clarifies the accounting for uncertainty in income taxes
recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial
statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC 740 also provides guidance
on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition.
Subsequent to adoption of ASC 740, each period
we evaluate the tax years that remain open for assessment for federal and state tax purposes. At December 31, 2014, tax years 2010
through 2014 remain open.
We may, from time-to-time, be assessed interest
or penalties by major tax jurisdictions, although any such assessments historically have been minimal and immaterial to our financial
results. The Company recognizes accrued interest and penalties, if applicable, related to unrecognized tax benefits in income tax
expense. During the years ended December 31, 2014 and 2013, the Company did not recognize a material amount in interest and penalties.
Patents. Patent license rights were recorded
at $1,045,000, their estimated fair value on the date they were acquired, August 3, 2012. Their cost will be amortized on a straight-line
basis over the key patent life of eighty months. At December 31, 2014, accumulated amortization totaled $379,000. If a change in
conditions occurs, that indicates a material change in the future utility of the patent license rights, an evaluation will be performed
to determine if impairment of the asset has occurred, and if so, the impairment will be recorded.
Joint Venture Accounting. The Company entered
into a joint venture in which it has contributed $6,000,000, and the noncontrolling interests have contributed certain patent license
rights. Neither the Company nor the noncontrolling interests have an obligation to contribute additional funds to the joint venture
or to assume any joint venture liabilities or to provide a guarantee of either joint venture performance or any joint venture liability.
The financial position and results of operations of the joint venture are presented on a consolidated basis with the financial
position and results of operations of the Company. Intercompany transactions have been eliminated. Joint venture losses were recorded
on the basis of common ownership equity interests (60% Company / 40% noncontrolling interests) until common ownership equity was
reduced to $0. Subsequent joint venture losses are being allocated to the preferred ownership equity (100% Company). Subsequent
to March 31, 2013, all joint venture losses are being allocated to the Company. The Company has a revolving loan agreement with
the joint venture to advance the joint venture funds for operations in an amount not to exceed a net (net of expected tax credits
or other funds obtained) of $700,000, with the net amount due June 30, 2015. Losses incurred by the joint venture in excess of
the capital accounts of the joint venture will be allocated to the Company to the extent of net outstanding advances.
Legal and Other Contingencies
As discussed in Note 10 “Contingency –
Legal Proceedings”, the Company is subject to legal proceedings and claims that arise in the course of business. The Company
records a liability when it is probable that a loss has been incurred and the amount is reasonably estimable. There is significant
judgment required in both the probability determination and as to whether an exposure can be reasonably estimated. In the opinion
of management, there was not at least a reasonable possibility the Company may have incurred a material loss with respect to loss
contingencies. However, the outcome of legal proceedings and claims brought against the Company are subject to significant uncertainty.
Therefore, if the qui tam legal matter is resolved against the Company in excess of management’s expectations, the
Company’s financial statements could be materially adversely affected.
Legal costs related to contingencies are expensed
as incurred and were not material in either 2014 or 2013.
Recent Accounting Pronouncements
In June 2014, the Financial Accounting Standards
Board issued Accounting Standard Update (“ASU”) No. 2014-10, Development Stage Entities (Topic 915): Elimination
of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation
removes the definition of a development stage entity and all incremental financial reporting requirements from U.S. GAAP for development
stage entities. Topic 915 Development Stage Entities will be removed from the FASB Accounting Standards Codification™.
The elimination of the development stage entity financial reporting requirements is effective for annual reporting periods beginning
after December 15, 2014. A public business entity may adopt this guidance early for any annual reporting period or interim period
for which financial statements have not been issued. The adoption of this accounting standard update had no impact on our condensed
consolidated financial statements. We had previously presented our financial statements with development stage entity disclosures.
We adopted this accounting standard update in our third quarter ending September 30, 2014, and accordingly, have omitted development
stage information and disclosures from our presentation.
In August 2014, the Financial Accounting Standards
Board issued Accounting Standard Update (“ASU”) No. 2014-15, Presentation of Financial Statements – Going
Concern (Subtopic 205-40)(“Update”): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going
Concern, providing a requirement under U.S. GAAP for an entity’s management to evaluate whether there are conditions or events,
considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within
one year after the date the financial statements are issued; and if those conditions exist, to disclose that fact, the conditions
and the potential effects on the entity’s ability to meet its obligations. The Update will be effective for an annual period
ending after December 15, 2016, with early application permitted. We have not elected early application, however, if additional
funds are not obtained to continue the development of AEM-28 or its analogs, or operations, it will impair our ability to continue
as a going concern. If we do not continue as a going concern, the Company may incur additional losses, up to, and possibly exceeding,
$932,000, the Company’s net joint venture investment and revolving loan balance at December 31, 2014.
At December 31, 2014 and December 31, 2013, investments
were classified as held-to-maturity securities. As of December 31, 2014 and 2013, all investments were in investments with maturities
less than 90 days and are included in cash and cash equivalents.
3. | | FURNITURE
AND EQUIPMENT
|
The components of furniture and equipment at December 31 are as follows (in thousands):
|
|
December 31,
|
|
|
|
2014
|
|
|
2013
|
|
Machinery and equipment
|
|
$ |
221 |
|
|
$ |
221 |
|
Furniture and fixtures
|
|
|
34 |
|
|
|
34 |
|
Leasehold improvements
|
|
|
- |
|
|
|
- |
|
|
|
|
255 |
|
|
|
255 |
|
Less accumulated depreciation and amortization
|
|
|
(255 |
) |
|
|
(252 |
) |
Total
|
|
$ |
- |
|
|
$ |
3 |
|
Depreciation and leasehold improvement amortization
expenses for the years ended December 31, 2014 and 2013 were $3,000 and $11,000, respectively.
The components of deferred income taxes at December
31 are as follows (in thousands):
|
|
December 31
|
|
|
|
2014
|
|
|
2013
|
|
Accruals and reserves
|
|
$ |
1 |
|
|
$ |
1 |
|
Valuation allowance
|
|
|
(1 |
) |
|
|
(1 |
) |
Total current
|
|
|
- |
|
|
|
- |
|
NOL, AMT and general business
|
|
|
|
|
|
|
|
|
credit carryforwards
|
|
|
56,868 |
|
|
|
56,050 |
|
Difference in basis of fixed assets
|
|
|
3 |
|
|
|
3 |
|
Accruals and reserves
|
|
|
28 |
|
|
|
274 |
|
Difference in basis of intangibles
|
|
|
110 |
|
|
|
13 |
|
Difference in currency exchange rate
|
|
|
46 |
|
|
|
|
|
Valuation allowance
|
|
|
(57,055 |
) |
|
|
(56,340 |
) |
Total non current
|
|
|
- |
|
|
|
- |
|
Total deferred income taxes
|
|
$ |
- |
|
|
$ |
- |
|
ASC 740 requires that a valuation allowance be
established when it is more-likely-than-not that all or a portion of a deferred tax asset will not be realized. Changes in valuation
allowances from period-to-period are included in the tax provision in the period of change. In determining whether a valuation
allowance is required, we take into account all evidence with regard to the utilization of a deferred tax asset including past
earnings history, expected future earnings, the character and jurisdiction of such earnings, unsettled circumstances that, if unfavorably
resolved, would adversely affect utilization of a deferred tax asset, carryback and carryforward periods, and tax strategies that
could potentially enhance the likelihood of realization of a deferred tax asset. Management has evaluated the available evidence
about future taxable income and other possible sources of realization of deferred tax assets and has established a valuation allowance
of approximately $57 million at December 31, 2014 and $56 million at December 31, 2013. The valuation allowance as of December
31, 2014 and 2013 includes approximately $2.7 million for net operating loss carry forwards that relate to stock compensation expense
for income tax reporting purposes that upon realization, would be recorded as additional paid-in capital. The valuation allowance
reduces deferred tax assets to an amount that management believes will more likely than not be realized.
The components of the income tax provision (benefit)
are as follows (in thousands):
|
|
Years Ended December 31
|
|
|
|
2014
|
|
|
2013
|
|
Provision (benefit) for income taxes
|
|
|
|
|
Current
|
|
$ |
(400 |
) |
|
$ |
(21 |
) |
Deferred
|
|
|
- |
|
|
|
- |
|
Income tax provision (benefit)
|
|
$ |
(400 |
) |
|
$ |
(21 |
) |
The 2014 income tax benefit results from the Australian
refundable research and development tax credit as explained in Note 7. The 2013 income tax benefit results from Arizona state income
tax legislation passed in 2010 that provides for the refund of 75 percent of the 2012 Arizona state research and development tax
credit for entities that would otherwise not be able to utilize their 2012 Arizona research and development tax credits to reduce
2012 Arizona state income taxes currently payable.
We have accumulated approximately $146 million
in federal and $33 million in state net operating loss carryforwards (“NOLs”) and approximately $6 million of research
and development and alternative minimum tax credit carryforwards. The federal NOLs expire between 2023 and 2034. The Arizona state
NOL’s expire between 2015 and 2034. The availability of these NOL’s to offset future taxable income could be limited
in the event of a change in ownership, as defined in Section 382 of the Internal Revenue Code.
A reconciliation of the difference between the
provision (benefit) for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows for the years
ended December 31, 2014 and 2013:
|
|
Years Ended December 31
|
|
|
|
2014
|
|
|
2013
|
|
Income tax provision (benefit) at statutory rate
|
|
$ |
(1,417 |
) |
|
$ |
(1,333 |
) |
State income taxes
|
|
|
(165 |
) |
|
|
(138 |
) |
Research credits
|
|
|
(435 |
) |
|
|
(74 |
) |
Expiration of state NOL
|
|
|
649 |
|
|
|
548 |
|
Other
|
|
|
252 |
|
|
|
324 |
|
Change in valuation allowance
|
|
|
716 |
|
|
|
652 |
|
Net provision (benefit)
|
|
$ |
(400 |
) |
|
$ |
(21 |
) |
The number of common shares reserved for issuance
under the OrthoLogic 1987 option plan was 4,160,000 shares. This plan expired during October 1997. In May 1997, our stockholders
adopted a new stock option plan (the “1997 Plan”). The 1997 Plan reserved for issuance 1,040,000 shares of Common Stock.
Subsequent to its original adoption, the Board of Directors and stockholders approved amendments to the 1997 Plan that increased
the number of shares of common stock reserved for issuance to 4,190,000. The 1997 Plan expired in March 2007. In May 2006, our
stockholders approved the 2005 Equity Incentive Plan (the “2005 Plan”) and reserved 2,000,000 shares of our common
stock for issuance. Our stockholders approved the reservation of an additional 1,750,000 shares of common stock for issuance under
the 2005 Plan, which increased the total shares available for grant under the 2005 Plan to 3,750,000 shares. At December 31, 2014,
495,519 shares remained available to grant under the 2005 Plan (the 1997 plan and the 2005 plan are collectively referred to as
“The Plans”). The 2005 Plan expires in April 2015. Two types of options may be granted under the Plans: options intended
to qualify as incentive stock options under Section 422 of the Internal Revenue Code (the “Code”) and other options
not specifically authorized or qualified for favorable income tax treatment by the Code. All eligible employees may receive more
than one type of option. Any director or consultant who is not an employee of the Company shall be eligible to receive only nonqualified
stock options under the Plans.
The Plans provide that in the event of a takeover
or merger of the Company in which 100% of the equity of the Company is purchased or a sale of all or substantially all of the Company’s
assets, 75% of all unvested employee options will vest immediately and the remaining 25% will vest over the following twelve month
period. If an employee or holder of stock options is terminated as a result of or subsequent to the acquisition, 100% of that individual’s
stock option will vest immediately upon employment termination.
We used the Black-Scholes model with the following
assumptions to determine the total fair value of $53,000 and $34,000 for options to purchase 223,000 and 255,000 shares of our
common stock issued during 2014 and 2013, respectively.
|
2014
|
|
2013
|
Risk free interest rate
|
1.7%
|
|
0.7%
|
Volatility
|
100%
|
|
77%
|
Expected term from vesting
|
4.2 Years
|
|
4.6 Years
|
Dividend yield
|
0%
|
|
0%
|
Summary
Non-cash stock compensation cost for the year ended
December 31, 2014 totaled $53,000, and was recorded as a general and administrative expense in the Statement of Operations for
the year ended December 31, 2014.
Non-cash stock compensation cost for the year ended
December 31, 2013, totaled $34,000. In the Statement of Operations for the year ended December 31, 2013, non-cash stock compensation
expense of $33,000 was recorded as a general and administrative expense and $1,000 was recorded as a research and development expense.
No options were exercised in the years ended December
31, 2014 and 2013.
At December 31, 2014, the remaining unamortized
non-cash stock compensation costs totaled less than $1,000.
A summary of option activity under our stock option
plans for the years ended December 31, 2014 and 2013 is as follows:
|
|
2014
|
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
at the beginning of the year:
|
|
|
3,225,806 |
|
|
$ |
1.52 |
|
|
|
|
|
|
3,218,264 |
|
|
$ |
1.71 |
|
Granted
|
|
|
223,000 |
|
|
$ |
0.27 |
|
|
|
|
|
|
255,000 |
|
|
$ |
0.22 |
|
Exercised
|
|
|
- |
|
|
$ |
- |
|
|
|
|
|
|
- |
|
|
$ |
- |
|
Expired / Forfeited
|
|
|
(426,100 |
) |
|
$ |
4.17 |
|
|
|
|
|
|
(247,458 |
) |
|
$ |
2.65 |
|
Outstanding at end of year
|
|
|
3,022,706 |
|
|
$ |
1.06 |
|
|
|
4.96 |
|
|
|
3,225,806 |
|
|
$ |
1.52 |
|
Options exercisable at year-end
|
|
|
3,015,374 |
|
|
$ |
1.06 |
|
|
|
4.77 |
|
|
|
3,115,384 |
|
|
$ |
1.57 |
|
Options vested and expected
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
to vest at year end
|
|
|
3,017,685 |
|
|
$ |
1.06 |
|
|
|
4.83 |
|
|
|
3,150,504 |
|
|
$ |
1.55 |
|
The Company had no unvested common stock share
awards as of December 31, 2014 or December 31, 2013, and no common stock awards were made in 2014 or 2013.
It is the Company’s policy to issue options
from stockholder approved incentive plans. However, if the options are issued as an inducement for an individual to join the Company,
the Company may issue stock options outside of stockholder approved plans. The options granted to employees under stockholder approved
incentive plans have a ten-year term and normally vest over a two to four-year period of service. All stock options are granted
with an exercise price equal to the current market value on the date of grant and, accordingly, stock options have no intrinsic
value on the date of grant. Based on the closing market price of the Company’s common stock at December 31, 2014 of $0.23,
stock options exercisable or expected to vest at December 31, 2014, have intrinsic value of $41,000.
Warrants
At December 31, 2014, the Company has fully vested
warrants outstanding to purchase 46,706 shares of the Company’s common stock with an exercise price of $6.39 per share, which
expire in February 2016, and fully vested warrants outstanding to purchase 117,423 shares of the Company’s common stock with
an exercise price of $1.91 per share, which expire in July 2016. No warrants were exercised during the years ended December 31,
2014 or 2013.
Rent expense for the years ended December 31, 2014
and 2013, was $64,000 and $82,000, respectively.
In 2007, the Company entered into a lease for 17,000
square feet of space in a Tempe, Arizona office and research facility. This lease calls for monthly rental payments of $22,000,
plus a proportionate share of building operating expenses and property taxes. The term of this lease was sixty months from March
1, 2008. In January of 2013, this lease was amended to extend the lease to February 28, 2015, with the rentable square feet of
space reduced to 2,845 square feet and monthly rental payments of approximately $5,000 plus a proportionate share of building operating
expenses and property taxes. On October 1, 2014 this lease was extended to February 29, 2016 with a monthly rental payment of approximately
$5,000 plus a proportionate share of building operating expenses and property taxes.
7. | | Australian Refundable Research & Development
Credit |
In March 2014, LipimetiX Development LLC, (see
Note 9 in the financial statement included in this Form 10-K) formed a wholly-owned Australian subsidiary, Lipimetix Australia
Pty Ltd, to conduct Phase 1a and Phase1b/2a clinical trials in Australia. Currently Australian tax regulations provide for a refundable
research and development tax credit equal to 43.5% of qualified expenditures. Subsequent to the end of its Australian tax years,
Lipimetix Australia Pty Ltd intends to submit claims for a refundable research and development tax credit. The transitional Australian
tax periods/years granted for Lipimetix Australia Pty Ltd end on June 30, 2014, December 31, 2014 and thereafter December 31 of
each succeeding year. For the tax year ended June 30, 2014, Lipimetix Australia Pty Ltd received a refundable research and development
tax credit of AUD$227,000. For the tax year ended December 31, 2014 a AUD$242,000 refundable research and development tax credit
has been recorded by Lipimetix Australia Pty Ltd, as it is more likely than not that the recorded refundable research and development
tax credit at December 31, 2014 will be approved and received.
8. | | AUTHORIZED PREFERRED STOCK |
We have 2,000,000 shares of authorized preferred
stock, the terms of which may be fixed by our Board of Directors. We presently have no outstanding shares of preferred stock.
Our Board of Directors has the authority, without stockholder approval, to create and issue one or more series of such preferred
stock and to determine the voting, dividend and other rights of holders of such preferred stock. If we raise additional funds to
continue development of AEM-28 and its analogs, or operations, we may issue preferred stock. The issuance of any of such series
of preferred stock may have an adverse effect on the holders of common stock.
In connection with the Tax Benefit Preservation
Plan (“Benefit Plan”) dated June 24, 2014, between the Company and Computershare (formerly Bank of New York), our Board
of Directors approved the designation of 1,000,000 shares of Series A Preferred Stock. The Benefit Plan and the exercise of rights
to purchase Series A Preferred Stock, pursuant to the terms thereof, may delay, defer or prevent a change in control without the
approval of the Board. In addition to the anti-takeover effects of the rights granted under the Benefit Plan, the issuance of preferred
stock, generally, could have a dilutive effect on our stockholders. The Benefit Plan expires June 24, 2016.
9. | | JOINT VENTURE FOR DEVELOPMENT OF APO E MIMETIC PEPTIDE MOLECULE AEM-28 AND ANALOGS |
On August 3, 2012, we entered into a Contribution
Agreement with LipimetiX LLC to form a joint venture, LipimetiX Development, LLC (“JV”), to develop Apo E mimetic molecules,
including AEM-28 and its analogs. The Company contributed $6 million, which included $1 million for 600,000 voting common ownership
units, representing 60% ownership in the JV, and $5 million for 5,000,000 non-voting preferred ownership units, which have preferential
distribution rights.
LipimetiX LLC contributed all intellectual property
rights for Apo E mimetic molecules it owned and assigned its Exclusive License Agreement between the University of Alabama at Birmingham
Research Foundation (“UABRF”) and LipimetiX, LLC, for the UABRF intellectual property related to Apo E mimetic molecules
AEM-28 and its analogs to the JV, in return for 400,000 voting common ownership units representing 40% ownership in JV, and $378,000
in cash (for certain initial patent-related costs and legal expenses).
LipimetiX LLC was formed by the principals of Benu
BioPharma, Inc. (“Benu”) and UABRF to commercialize UABRF’s intellectual property related to Apo E mimetic molecules,
including AEM-28 and analogs. Benu is composed of Dennis I. Goldberg, Ph.D., Phillip M. Friden, Ph.D. and Eric M. Morrel, Ph.D.
The Exclusive License Agreement, as amended, calls for payment of patent filing, maintenance and other related patent fees, as
well as a royalty of 3% on Net Sales of Licensed Products during the Term of the Agreement. The Agreement terminates upon the expiration
of all Valid Patent Claims within the Licensed Patents, which are currently estimated to expire between 2019 and 2034. The Agreement,
as amended, also calls for annual maintenance payments of $25,000, various milestone payments of $50,000 to $500,000 and minimum
royalty payments of $500,000 to $1,000,000 per year commencing on January 1 of the first calendar year following the year in which
the First Commercial Sale occurs. UABRF will also receive 5% of Non Royalty Income received.
Concurrent with entering into the Contribution
Agreement and the First Amendment and Consent to Assignment of Exclusive License Agreement between LipimetiX LLC, UABRF and the
Company, the Company and LipimetiX LLC entered into a Limited Liability Company Agreement for JV which establishes a Joint Development
Committee (“JDC”) to manage JV development activities. The JDC is composed of three members appointed by LipimetiX
LLC and two members appointed by the Company. Non-development JV decisions, including the issuance of new equity, incurrence of
debt, entry into strategic transactions, licenses or development agreements, sales of assets and liquidation, will be decided by
a majority vote of the common ownership units.
The JV, on August 3, 2012, entered into a Management
Agreement with Benu to manage JV development activities for a monthly fee of approximately $63,000 during the twenty-seven month
development period, and an Accounting Services Agreement with the Company to manage JV accounting and administrative functions.
The current accounting services fee is $1,000 a month. Commencing in November 2014, Benu has received a reduced monthly management
fee in the amount of $35,000.
The joint venture formation was as follows ($000’s):
Patent license rights |
|
$ |
1,045 |
|
Noncontrolling interests |
|
|
( 667 |
) |
Cash paid at formation |
|
$ |
378 |
|
Patent license rights were recorded at their estimated
fair value and are being amortized on a straight-line basis over the key patent life of eighty months.
The financial position and results of operations
of the joint venture are presented on a consolidated basis with the financial position and results of operations of the Company.
Intercompany transactions have been eliminated. The joint venture agreement requires profits and losses to be allocated on the
basis of common ownership equity interests (60% Company / 40% noncontrolling interests). However, for the Company’s consolidated
financial statement, joint venture losses were recorded on the basis of common ownership equity interests (60% Company / 40% noncontrolling
interests) until common ownership equity was reduced to $0. Subsequent joint venture losses have been allocated to the preferred
ownership equity (100% Company). Subsequent to March 31, 2013, all joint venture losses have been allocated to the Company. The
Company has a revolving loan agreement with the joint venture to advance the joint venture funds for operations in an amount not
to exceed a net (net of expected tax credits or other funds obtained) of $700,000, with the net amount due June 30, 2015. Losses
incurred by the joint venture in excess of the capital accounts of the joint venture will be allocated to the Company to the extent
of net outstanding advances. At December 31, 2014, outstanding advances on the revolving loan agreement totaled $500,000.
The joint venture incurred operating expenses,
prior to the elimination of intercompany transactions, of $2,388,000 in 2014 and $6,235,000 for the period from August 3, 2012
(inception) to December 31, 2014, of which $2,388,000 and $5,568,000, respectively, have been allocated to the Company. The joint
venture operating expenses are included in research and development expenses in the condensed consolidated statements of operations.
Neither the Company nor the noncontrolling interests
have an obligation to contribute additional funds to the joint venture or to assume any joint venture liabilities or to provide
a guarantee of either joint venture performance or any joint venture liability. Losses allocated to the noncontrolling interests
represent an additional potential loss for the Company as the noncontrolling interests are not obligated to contribute assets to
the joint venture to the extent they have a negative capital account, and depending on the ultimate outcome of the joint venture,
the Company could potentially absorb all losses associated with the joint venture. From formation of the joint venture, August
3, 2012, through December 31, 2014, losses totaling $667,000 have been allocated to the noncontrolling interests. If the joint
venture or Company is unable to obtain additional funding, the ability of the joint venture to continue development of AEM-28 and
its analogs would be impaired as would the joint venture’s ability to continue operations. If the joint venture does not
continue as a going concern, at December 31, 2014 the Company would incur an additional loss of $667,000 for the joint venture
losses allocated to the noncontrolling interests.
10. | | CONTINGENCY – LEGAL PROCEEDINGS |
In April 2009, we became aware of a qui tam
complaint that was filed under seal by Jeffrey J. Bierman as Relator/Plaintiff on March 28, 2005 in the United States District
Court for the District of Massachusetts against OrthoLogic and other companies that allegedly manufactured bone growth stimulation
devices, including Orthofix International N.V., Orthofix, Inc., DJO Incorporated, Reable Therapeutics, Inc., the Blackstone Group,
L.P., Biomet, Inc., EBI, L.P., EBI Holdings, Inc., EBI Medical Systems, Inc., Bioelectron, Inc., LBV Acquisition, Inc., and Smith
& Nephew, Inc. By order entered on March 24, 2009, the court unsealed the amended complaint. The amended complaint alleges
various causes of action under the federal False Claims Act and state and city false claims acts premised on the contention that
the defendants improperly promoted the sale, as opposed to the rental, of bone growth stimulation devices. The amended complaint
also includes claims against the defendants for, among other things, allegedly misleading physicians and purportedly causing them
to file false claims and for allegedly violating the Anti-kickback Act by providing free products to physicians, waiving patients’
insurance co-payments, and providing inducements to independent sales agents to generate business. The Relator/Plaintiff is seeking
civil penalties under various state and federal laws, as well as treble damages, which, in the aggregate could exceed the financial
resources of the Company.
The United States Government declined to intervene
or participate in the case. On September 4, 2009, the Relator/Plaintiff served the amended complaint on the Company. We sold our
bone growth stimulation business in November 2003 and have had no further activity in the bone growth stimulation business since
that date. We intend, in conjunction with the other defendants, to defend this matter vigorously and believe that at all times
our billing practices in our bone growth stimulation business complied with applicable laws. On December 4, 2009, the Company,
in conjunction with the other defendants, moved to dismiss the amended complaint with prejudice. In response to that motion, Relator/Plaintiff
filed a second amended complaint. On August 17, 2010, the Company, in conjunction with the other defendants, moved to dismiss the
second amended complaint with prejudice. That motion was denied by the court on December 8, 2010. On January 28, 2011, we, in conjunction
with the other defendants, filed our answer to the second amended complaint. No trial date has been set. Discovery in the case
is now open.
Based upon the currently available information,
we believe that the ultimate resolution of this matter will not have a material effect on our financial position, liquidity or
results of operations. However, because of many questions of law and facts that may arise, the outcome of this litigation is uncertain.
If we are unable to successfully defer or otherwise dispose of this litigation, and the Relator/Plaintiff is awarded the damages
sought, the litigation would have a material adverse effect on our financial position, liquidity and results of operations and
we would not be able to continue our business as it is presently conducted.
CAPSTONE THERAPEUTICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| |
June 30, | |
December 31, |
| |
2015 | |
2014 |
| |
(unaudited) | |
|
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 1,037 | | |
$ | 2,164 | |
Other current assets | |
| 509 | | |
| 555 | |
Total current assets | |
| 1,546 | | |
| 2,719 | |
| |
| | | |
| | |
Patent license rights, net | |
| 588 | | |
| 666 | |
Furniture and equipment, net | |
| - | | |
| - | |
Total assets | |
$ | 2,134 | | |
$ | 3,385 | |
| |
| | | |
| | |
LIABILITIES AND EQUITY | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
| 211 | | |
| 124 | |
Other accrued liabilities | |
| 140 | | |
| 158 | |
Total current liabilities | |
| 351 | | |
| 282 | |
| |
| | | |
| | |
Equity | |
| | | |
| | |
Capstone Therapeutics Corp. Stockholders' Equity | |
| | | |
| | |
Common Stock $.0005 par value; 150,000,000 shares authorized; 40,885,411 shares in 2015 and 2014 issued and outstanding | |
| 20 | | |
| 20 | |
Additional paid-in capital | |
| 189,416 | | |
| 189,268 | |
Accumulated deficit | |
| (187,653 | ) | |
| (186,185 | ) |
Total Capstone Therapeutics Corp. stockholders' equity | |
| 1,783 | | |
| 3,103 | |
Noncontrolling interest | |
| - | | |
| - | |
Total equity | |
| 1,783 | | |
| 3,103 | |
| |
| | | |
| | |
Total liabilities and equity | |
$ | 2,134 | | |
$ | 3,385 | |
See notes to unaudited condensed consolidated
financial statements
CAPSTONE THERAPEUTICS
Corp.
CONDENSED CONSOLIDATED
Statements of Operations
(in thousands, except per share data)
(Unaudited)
| |
Three months ended June 30, | |
Six months ended June 30, |
| |
2015 | |
2014 | |
2015 | |
2014 |
OPERATING EXPENSES | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 552 | | |
$ | 222 | | |
$ | 1,024 | | |
$ | 674 | |
Research and development | |
| 283 | | |
| 1,172 | | |
| 633 | | |
| 1,802 | |
Total operating expenses | |
| 835 | | |
| 1,394 | | |
| 1,657 | | |
| 2,476 | |
| |
| | | |
| | | |
| | | |
| | |
Interest and other expenses (income), net | |
| (47 | ) | |
| (3 | ) | |
| 9 | | |
| (63 | ) |
Loss from operations before taxes | |
| 788 | | |
| 1,391 | | |
| 1,666 | | |
| 2,413 | |
Income tax benefit | |
| (36 | ) | |
| - | | |
| (198 | ) | |
| - | |
NET LOSS | |
| 752 | | |
| 1,391 | | |
| 1,468 | | |
| 2,413 | |
Less: Net Loss attributable to the noncontrolling interest | |
| - | | |
| - | | |
| - | | |
| - | |
Net Loss attributable to Capstone | |
| | | |
| | | |
| | | |
| | |
Therapeutics Corp. stockholders | |
$ | 752 | | |
$ | 1,391 | | |
$ | 1,468 | | |
$ | 2,413 | |
Per Share Information: | |
| | | |
| | | |
| | | |
| | |
Net loss, basic and diluted, attributable to | |
| | | |
| | | |
| | | |
| | |
Capstone Therapeutic Corp. stockholders | |
$ | 0.02 | | |
$ | 0.03 | | |
$ | 0.04 | | |
$ | 0.06 | |
Basic and diluted shares outstanding | |
| 40,885 | | |
| 40,885 | | |
| 40,885 | | |
| 40,885 | |
See notes to unaudited condensed consolidated
financial statements
CAPSTONE THERAPEUTICS
Corp.
CONDENSED CONSOLIDATED
Statements of CASH FLOWS
(in thousands)
(Unaudited)
| |
Six months ended
June 30, |
| |
2015 | |
2014 |
OPERATING ACTIVITIES | |
| | | |
| | |
Net loss | |
$ | (1,468 | ) | |
$ | (2,413 | ) |
Non cash items: | |
| | | |
| | |
Depreciation and amortization | |
| 78 | | |
| 81 | |
Non-cash stock compensation | |
| 148 | | |
| 49 | |
Change in other operating items: | |
| | | |
| | |
Other current assets | |
| 46 | | |
| (112 | ) |
Accounts payable | |
| 87 | | |
| 24 | |
Other accrued liabilities | |
| (18 | ) | |
| 306 | |
Cash flows used in operating activities | |
| (1,127 | ) | |
| (2,065 | ) |
INVESTING ACTIVITIES | |
| | | |
| | |
Cash flows provided by investing activities | |
| - | | |
| - | |
FINANCING ACTIVITIES | |
| - | | |
| | |
Cash flows provided by financing activities | |
| - | | |
| | |
NET DECREASE IN CASH AND CASH EQUIVALENTS | |
| (1,127 | ) | |
| (2,065 | ) |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | |
| 2,164 | | |
| 6,258 | |
CASH AND CASH EQUIVALENTS, END OF PERIOD | |
$ | 1,037 | | |
$ | 4,193 | |
See notes to unaudited condensed consolidated
financial statements
CAPSTONE THERAPEUTICS CORP.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2015
Note A. OVERVIEW OF BUSINESS
| | Description of the Business |
Capstone Therapeutics Corp. (the “Company”,
“we”, “our” or “us”) is a biotechnology company committed to developing a pipeline of novel
peptides and other molecules aimed at helping patients with under-served medical conditions. Previously, we were focused on the
development and commercialization of two product platforms: AZX100 and Chrysalin (TP508). Since March 2012, we no longer have any
interest in or rights to Chrysalin. In 2012 we wound down internal operations, ceased clinical development of AZX100 in dermal
scarring, formerly our principal drug candidate, and moved to a more virtual operating model. In 2014, we terminated the License
Agreement for AZX100 intellectual property and returned all interest in and rights to the AZX100 intellectual property to the Licensor
(AzTE).
On August 3, 2012, we entered into a joint venture,
LipimetiX Development, LLC, (now LipimetiX Development, Inc.), (the “JV”), to develop Apo E mimetic peptide molecule
AEM-28 and its analogs. The JV has a development plan to pursue regulatory approval of AEM-28, or an analog, as treatment for Homozygous
Familial Hypercholesterolemia (granted Orphan Drug Designation by FDA in 2012), Acute Hypertriglyceridemic Pancreatitis, and other
hyperlipidemic indications. The initial development plan extended through Phase 1a and 1b/2a clinical trials and was completed
in the fourth quarter of 2014.
The JV received allowance from regulatory authorities
in Australia permitting the JV to proceed with the planned clinical trials. The Phase 1a clinical trial commenced in Australia
in April 2014 and the Phase 1b/2a clinical trial commenced in Australia in June 2014. The clinical trials for AEM-28 were randomized,
double-blinded, placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of six escalating
single doses (Phase 1a in healthy patients with elevated cholesterol) and multiple ascending doses of the three highest doses from
Phase 1a (Phase 1b/2a in patients with hypercholesterolemia and healthy volunteers with elevated cholesterol and high Body Mass
Index). The Phase 1a clinical trial consisted of 36 patients and the Phase 1b/2a consisted of 15 patients. Both clinical trials
were completed in 2014 and the Medical Safety Committee, reviewing all safety-related aspects of the clinical trials, observed
a generally acceptable safety profile. As first-in-man studies, the primary endpoint was safety; yet efficacy measurements analyzing
pharmacodynamics yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker
endpoints.
Concurrent with the clinical development activities
with AEM-28, the JV has performed pre-clinical studies that have identified an analog of AEM-28, referred to as AEM-28-14, and
a new phospholipid formulation, that has the potential of equivalent efficacy, higher human dose toleration and an extended composition
of matter patent life (application filed with the U.S. Patent and Trademark Office in 2015).
The JV and the Company are exploring fundraising,
partnering or licensing, to obtain additional funding to continue development activities of AEM-28 and its analogs, including AEM-28-14
and operations.
The JV and the Company do not have sufficient
funding at this time to continue additional material development activities of AEM-28 and its analogs, including AEM-28-14. The
JV may conduct future clinical trials in Australia, the USA, and other regulatory jurisdictions if regulatory approvals, additional
funding, and other conditions permit.
The Company, funding permitting, intends to
continue limiting its internal operations to a virtual operating model while monitoring and participating in the management of
JV’s AEM-28 and analogs development activities and maintaining the required level of corporate governance and reporting required
to comply with Securities and Exchange Commission rules and regulations.
Description of Current Peptide Drug Candidates.
Apo E Mimetic Peptide Molecule – AEM-28
and its analogs
Apolipoprotein E is a 299 amino acid protein
that plays an important role in lipoprotein metabolism. AEM-28 is a 28 amino acid mimetic of Apo E and AEM-28 and its analogs,
including AEM-28-14 is a 28 amino acid mimetic of Apo E (with an aminohexanoic acid group and a phospholipid), and both contain
a domain that anchors into a lipoprotein surface while also providing the Apo E receptor binding domain, which allows clearance
through the heparan sulfate proteoglycan (HSPG) receptors (Syndecan-1) in the liver. AEM-28 and its analogs, including AEM-28-14,
as Apo E mimetics, have the potential to restore the ability of these atherogenic lipoproteins to be cleared from the plasma, completing
the reverse cholesterol transport pathway, and thereby reducing cardiovascular risk. This is an important mechanism of action for
AEM-28 and its analogs, including AEM-28-14. For patients that lack LDL receptors (Homozygous Familial Hypercholesterolemia-HoFH),
have acute pancreatitis, or have hypercholesterolemia, AEM-28 and its analogs may provide a therapeutic solution. Our joint venture
has an Exclusive License Agreement with the University of Alabama at Birmingham Research Foundation for AEM-28 and certain of its
analogs.
Company History
Prior to November 26, 2003, we developed, manufactured
and marketed proprietary, technologically advanced orthopedic products designed to promote the healing of musculoskeletal bone
and tissue, with particular emphasis on fracture healing and spine repair. Our product lines, which included bone growth stimulation
and fracture fixation devices, are referred to as our “Bone Device Business.” In November 2003, we sold our Bone Device
Business.
In August 2004, we purchased substantially all
of the assets and intellectual property of Chrysalis Biotechnology, Inc., including its exclusive worldwide license for Chrysalin,
a peptide, for all medical indications. Subsequently, our efforts were focused on research and development of Chrysalin with the
goal of commercializing our products in fresh fracture healing. (In March 2012, we returned all rights to the Chrysalin intellectual
property and no longer have any interest in, or rights to Chrysalin.)
In February 2006, we purchased certain assets
and assumed certain liabilities of AzERx, Inc. Under the terms of the transaction, we acquired an exclusive license for the core
intellectual property relating to AZX100, an anti-fibrotic peptide. In 2014, we terminated the License Agreement with AzTE (Licensor)
for the core intellectual property relating to AZX100 and returned all interest in and rights to the AZX100 intellectual property
to the Licensor.
On August 3, 2012, we entered into a joint venture
(see Note B below), to develop Apo E mimetic peptide molecule AEM-28 and its analogs.
Our development activities represent a single
operating segment as they shared the same product development path and utilized the same Company resources. As a result, we determined
that it is appropriate to reflect our operations as one reportable segment.
OrthoLogic Corp. commenced doing business under
the trade name of Capstone Therapeutics on October 1, 2008, and we formally changed our name from OrthoLogic Corp. to Capstone
Therapeutics Corp. on May 21, 2010.
In these notes, references to “we”,
“our”, “us”, the “Company”, “Capstone Therapeutics”, “Capstone”, and
“OrthoLogic” refer to Capstone Therapeutics Corp. References to our joint venture or “JV”, refer to LipimetiX
Development, Inc. (formerly LipimetiX Development, LLC).
Financial Statement Presentation and Management’s
Plan
The accompanying financials statements have
been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business.
The report from our Independent Registered Public
Accounting Firm on our consolidated financial statements for the year ended December 31, 2014 included in our Annual Report on
Form 10-K expressed substantial doubt about the Company’s ability to continue as a going concern.
Management has determined that the Company will
require additional capital above its current cash and working capital balances to further develop AEM-28 and its analogs or continue
operations. Accordingly, the Company has reduced its development activities. The Company’s corporate strategy is to raise
funds by possibly engaging in a strategic/merger transaction, or conducting a private or public offering of debt or equity securities
for capital. These financial statements do not include any adjustments that might result from the outcome of the uncertainty of
the Company successfully implementing its corporate strategy.
In the opinion of management, the unaudited
condensed interim financial statements include all adjustments necessary for the fair presentation of our financial position, results
of operations, and cash flows, and all adjustments were of a normal recurring nature. The results of operations for the interim
periods are not necessarily indicative of the results to be expected for the complete fiscal year. The financial statements include
the consolidated results of Capstone Therapeutics Corp. and our 60% owned subsidiary, LipimetiX Development, Inc. Intercompany
transactions have been eliminated.
Certain information and footnote disclosures
normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed
or omitted pursuant to Securities and Exchange Commission rules and regulations, although we believe that the disclosures herein
are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in
conjunction with the financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December
31, 2014. Information presented as of December 31, 2014 is derived from audited financial statements.
Use of Estimates
The preparation of financial statements in accordance
with accounting principles generally accepted in the United States requires that management make a number of assumptions and estimates
that affect the reported amounts of assets, liabilities, and expenses in our financial statements and accompanying notes. Management
bases its estimates on historical experience and various other assumptions believed to be reasonable. Although these estimates
are based on management’s assumptions regarding current events and actions that may impact us in the future, actual results
may differ from these estimates and assumptions.
Legal and Other Contingencies
The Company is subject to legal proceedings
and claims that arise in the ordinary course of business. The Company records a liability when it is probable that a loss has been
incurred and the amount is reasonably estimable. There is significant judgment required in both the probability determination and
as to whether an exposure can be reasonably estimated. In the opinion of management, there was not at least a reasonable possibility
the Company may have incurred a material loss with respect to loss contingencies.
Joint Venture Accounting
The Company entered into a joint venture in
which it has contributed $6,000,000, and the noncontrolling interests have contributed certain patent license rights. Neither the
Company nor the noncontrolling interests have an obligation to contribute additional funds to the joint venture or to assume any
joint venture liabilities or to provide a guarantee of either joint venture performance or any joint venture liability. The financial
position and results of operations of the joint venture are presented on a consolidated basis with the financial position and results
of operations of the Company. Intercompany transactions have been eliminated. Joint venture losses were recorded on the basis of
common ownership equity interests (60% Company / 40% noncontrolling interests) until common ownership equity was reduced to $0.
Subsequent joint venture losses are being allocated to the preferred ownership equity (100% Company). Subsequent to March 31, 2013,
all joint venture losses are being allocated to the Company. The Company has a revolving loan agreement with the joint venture
to advance the joint venture funds for operations in an amount not to exceed a net (net of expected tax credits or other funds
obtained) of $700,000, with the net amount due September 30, 2015. Losses incurred by the joint venture in excess of the capital
accounts of the joint venture will be allocated to the Company to the extent of net outstanding advances.
Cash and Cash Equivalents
At June 30, 2015, cash and cash equivalents
included money market accounts.
Recent Accounting Pronouncements
In August 2014, the Financial Accounting
Standards Board issued Accounting Standard Update (“ASU”) No. 2014-15, Presentation of Financial Statements
– Going Concern (Subtopic 205-40)(“Update”): Disclosure of Uncertainties about an Entity’s Ability to Continue
as a Going Concern, providing a requirement under U.S. GAAP for an entity’s management to evaluate whether there are conditions
or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern
within one year after the date the financial statements are issued; and if those conditions exist, to disclose that fact, the conditions
and the potential effects on the entity’s ability to meet its obligations. The Update will be effective for an annual period
ending after December 15, 2016, with early application permitted. We have not elected early application. However, if additional
funds are not obtained to continue the development of AEM-28 or its analogs, or operations, it will impair our ability to continue
as a going concern. If we do not continue as a going concern, the Company may incur additional losses, up to, and possibly exceeding
our net joint venture investment and revolving loan balance.
Note B. JOINT VENTURE FOR DEVELOPMENT OF APO E MIMETIC PEPTIDE
MOLECULE AEM-28 AND ANALOGS
On August 3, 2012, we entered into a Contribution
Agreement with LipimetiX, LLC to form a joint venture, LipimetiX Development, LLC (“JV”), to develop Apo E mimetic
molecules, including AEM-28 and its analogs. In June 2015, the JV converted from a limited liability company to a corporation,
LipimetiX Development, Inc. The Company contributed $6 million, which included $1 million for 600,000 voting common ownership units
(now common stock), representing 60% ownership in the JV, and $5 million for 5,000,000 non-voting preferred ownership units (now
preferred stock), which have preferential distribution rights.
LipimetiX, LLC contributed all intellectual
property rights for Apo E mimetic molecules it owned and assigned its Exclusive License Agreement between The University of Alabama
at Birmingham Research Foundation (“UABRF”) and LipimetiX, LLC, for the UABRF intellectual property related to Apo
E mimetic molecules AEM-28 and its analogs to the JV, in return for 400,000 voting common ownership units (now common stock) representing
40% ownership in JV, and $378,000 in cash (for certain initial patent-related costs and legal expenses).
LipimetiX, LLC was formed by the principals
of Benu BioPharma, Inc. (“Benu”) and UABRF to commercialize UABRF’s intellectual property related to Apo E mimetic
molecules, including AEM-28 and analogs. Benu is composed of Dennis I. Goldberg, Ph.D., Phillip M. Friden, Ph.D. and Eric M. Morrel,
Ph.D. The Exclusive License Agreement, as amended, calls for payment of patent filing, maintenance and other related patent fees,
as well as a royalty of 3% on Net Sales of Licensed Products during the Term of the Agreement. The Agreement terminates upon the
expiration of all Valid Patent Claims within the Licensed Patents, which are currently estimated to expire between 2019 and 2035.
The Agreement, as amended, also calls for annual maintenance payments of $25,000, various milestone payments of $50,000 to $500,000
and minimum royalty payments of $500,000 to $1,000,000 per year commencing on January 1 of the first calendar year following the
year in which the First Commercial Sale occurs. UABRF will also be paid 5% of Non Royalty Income received.
Concurrent with entering into the Contribution
Agreement and the First Amendment and Consent to Assignment of Exclusive License Agreement between LipimetiX, LLC, UABRF and the
Company, the Company and LipimetiX, LLC entered into a Limited Liability Company Agreement for JV which established a Joint Development
Committee (“JDC”) to manage JV development activities. Upon conversion by the JV from a limited liability company to
a corporation, the parties entered into a Stockholders Agreement for the JV, and the JDC was replaced by a Board of Directors (JV
Board). The JV Board is composed of three members appointed by the non-Company ownership group and two members appointed by the
Company. Non-development JV decisions, including the issuance of new equity, incurrence of debt, entry into strategic transactions,
licenses or development agreements, sales of assets and liquidation, and approval of annual budgets, will be decided by a majority
vote of the common stockholders.
The JV, on August 3, 2012, entered into a Management
Agreement with Benu to manage JV development activities for a monthly fee of approximately $63,000 during the twenty-seven month
development period, and an Accounting Services Agreement with the Company to manage JV accounting and administrative functions.
The current accounting services fee is $1,000 a month. Commencing in November 2014, and ending in March 2015, Benu received a reduced
monthly management fee in the amount of $35,000. Subsequent to March 2015, no management fee has been paid to Benu for their services.
The joint venture formation was as follows ($000’s):
Patent license rights | |
$ | 1,045 | |
Noncontrolling interests | |
| (667 | ) |
Cash paid at formation | |
$ | 378 | |
Patent license rights were recorded at their
estimated fair value and are being amortized on a straight-line basis over the key patent life of eighty months.
The financial position and results of operations
of the joint venture are presented on a consolidated basis with the financial position and results of operations of the Company.
Intercompany transactions have been eliminated. The joint venture agreement requires profits and losses to be allocated on the
basis of common ownership equity interests (60% Company / 40% noncontrolling interests). However, for the Company’s consolidated
financial statement, joint venture losses were recorded on the basis of common ownership equity interests (60% Company / 40% noncontrolling
interests) until common ownership equity was reduced to $0. Subsequent joint venture losses have been allocated to the preferred
ownership equity (100% Company). Subsequent to March 31, 2013, all joint venture losses have been allocated to the Company. The
Company has a revolving loan agreement with the joint venture to advance the joint venture funds for operations in an amount not
to exceed a net (net of expected tax credits or other funds obtained) of $700,000, with the net amount due September 30, 2015.
Losses incurred by the joint venture in excess of the capital accounts of the joint venture will be allocated to the Company to
the extent of net outstanding advances. At June 30, 2015, outstanding advances on the revolving loan agreement totaled $739,000.
The joint venture incurred net operating expenses,
prior to the elimination of intercompany transactions, of $351,000 in the six month period ended June 30, 2015 and $6,586,000 for
the period from August 3, 2012 (inception) to June 30, 2015, of which $351,000 and $5,919,000, respectively, have been recorded
by the Company. The joint venture operating expenses are included in research and development expenses in the condensed consolidated
statements of operations.
Neither the Company nor the noncontrolling interests
have an obligation to contribute additional funds to the joint venture or to assume any joint venture liabilities or to provide
a guarantee of either joint venture performance or any joint venture liability. Losses allocated to the noncontrolling interests
represent an additional potential loss for the Company as the noncontrolling interests are not obligated to contribute assets to
the joint venture to the extent they have a negative capital account, and depending on the ultimate outcome of the joint venture,
the Company could potentially absorb all losses associated with the joint venture. From formation of the joint venture, August
3, 2012, through June 30, 2015, losses totaling $667,000 have been allocated to the noncontrolling interests. If the joint venture
or Company is unable to obtain additional funding, the ability of the joint venture to continue development of AEM-28 and its analogs,
including AEM-28-14, would be impaired as would the joint venture’s ability to continue operations. If the joint venture
does not continue as a going concern, at June 30, 2015 the Company would incur an additional loss of $667,000 for the joint venture
losses allocated to the noncontrolling interests.
Note C. CONTINGENCY – LEGAL PROCEEDINGS
In April 2009, we became aware of a qui tam
complaint that was filed under seal by Jeffrey J. Bierman as Relator/Plaintiff on March 28, 2005 in the United States District
Court for the District of Massachusetts (the “Court”) against OrthoLogic and other companies that manufactured bone
growth stimulation devices, including Orthofix International N.V., Orthofix, Inc., DJO Incorporated, Reable Therapeutics, Inc.,
the Blackstone Group, L.P., Biomet, Inc., EBI, L.P., EBI Holdings, Inc., EBI Medical Systems, Inc., Bioelectron, Inc., LBV Acquisition,
Inc., and Smith & Nephew, Inc. By order entered on March 24, 2009, the court unsealed the amended complaint. The amended complaint
alleges various causes of action under the federal False Claims Act and state and city false claims acts premised on the contention
that the defendants improperly promoted the sale, as opposed to the rental, of bone growth stimulation devices. The amended complaint
also includes claims against the defendants for, among other things, allegedly misleading physicians and purportedly causing them
to file false claims and (except for OrthoLogic) for allegedly violating the Anti-kickback Act by providing free products to physicians,
waiving patients’ insurance co-payments, and providing inducements to independent sales agents to generate business. The
Relator/Plaintiff is seeking civil penalties under various state and federal laws, as well as treble damages, which, in the aggregate
could exceed the financial resources of the Company.
The United States Government declined to intervene
or participate in the case. On September 4, 2009, the Relator/Plaintiff served the amended complaint on the Company. We sold our
bone growth stimulation business in November 2003 and have had no further activity in the bone growth stimulation business since
that date. We have, in conjunction with the other defendants, defended this matter vigorously and believe that at all times our
billing practices in our bone growth stimulation business complied with applicable laws. On December 4, 2009, the Company, in conjunction
with the other defendants, moved to dismiss the amended complaint with prejudice. In response to that motion, Relator/Plaintiff
filed a second amended complaint. On August 17, 2010, the Company, in conjunction with the other defendants, moved to dismiss the
second amended complaint with prejudice. That motion was denied by the court on December 8, 2010. On January 28, 2011, we, in conjunction
with the other defendants, filed our answer to the second amended complaint. No trial date was set. Discovery in the case is closed.
In May 2015, the Company and Relator/Plaintiff
entered into an agreement to settle the qui tam action against the Company for a one-time payment of $50,000. The Court
approved the parties’ Settlement Agreement in June 2015 by signing an Order of Dismissal and this matter is now closed.
Note D. Australian Refundable Research & Development Credit
In March 2014, LipimetiX Development LLC, (see
Note B) formed a wholly-owned Australian subsidiary, Lipimetix Australia Pty Ltd, to conduct Phase 1a and Phase1b/2a clinical trials
in Australia. Currently Australian tax regulations provide for a refundable research and development tax credit equal to 45% of
qualified expenditures. Subsequent to the end of its Australian tax years, Lipimetix Australia Pty, Ltd intends to submit claims
for a refundable research and development tax credit. The transitional Australian tax periods/years granted for Lipimetix Australia
Pty, Ltd end on June 30, 2014, December 31, 2014 and thereafter December 31 of each succeeding year. For the tax year ended June
30, 2014, Lipimetix Australia Pty, Ltd received a refundable research and development tax credit of AUD$227,000. At December 31,
2014 a AUD$242,000 development tax credit was recorded by Lipimetix Australia Pty, Ltd, and at June 30, 2015, an additional AUD$251,000
has been accrued, as it is more likely than not that the recorded refundable research and development tax credit will be approved
and received. At June 30, 2015, and December 31, 2014, AUD$493,000 (US$ 380,000), and AUD$242,000 (US$196,000), respectively, have
been accrued and are included in other current assets in our condensed consolidated balance sheets.
PART II
INFORMATION NOT REQUIRED
IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution.
The estimated expenses in connection with the issuance and distribution
of the securities covered by this registration statement, all of which will be paid by the registrant, are as follows:
SEC registration fee (actual) | |
$ | 1,162 | |
Blue sky fees | |
$ | 5,935 | |
Printing and engraving expenses | |
$ | * | |
Legal fees and expenses | |
$ | * | |
Accounting fees and expenses | |
$ | * | |
Miscellaneous | |
$ | * | |
Total | |
$ | * | |
* To be provided by amendment.
Item 14. Indemnification of Directors and Officers.
Section 145 of the General Corporation Law of the State of Delaware,
or DGCL, empowers a Delaware corporation to indemnify any person who was or is a party, or is threatened to be made a party to
any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other
than an action by or in the right of such corporation) by reason of the fact that such person is or was an officer or director
of such corporation, or is or was serving at the request of such corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise. The indemnity may include expenses (including attorneys’
fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such
action, suit or proceeding, provided that such person acted in good faith and in a manner he reasonably believed to be in or not
opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause
to believe such person’s conduct was unlawful.
A Delaware corporation may indemnify past or present officers and
directors of such corporation or of another corporation or other enterprise at the former corporation’s request, in an action
by or in the right of the corporation to procure a judgment in its favor under the same conditions, except that no indemnification
is permitted without judicial approval if the officer or director is adjudged to be liable to the corporation. Where an officer
or director is successful on the merits or otherwise in defense of any action referred to above, or in defense of any claim, issue
or matter therein, the corporation must indemnify such person against the expenses (including attorneys’ fees) which such
person actually and reasonably incurred in connection therewith. Section 145 further provides that any indemnification shall be
made by the corporation only as authorized in each specific case upon a determination that indemnification of such person is proper
because he has met the applicable standard of conduct (i) by the stockholders, (ii) by a majority vote of the directors who are
not parties to such action, suit or proceeding, even though less than a quorum, (iii) by a committee of such directors designated
by majority vote of such directors, even though less than a quorum, or (iv) by independent legal counsel in a written opinion,
if there are no such disinterested directors, or if such disinterested directors so direct. Section 145 further provides that indemnification
pursuant to its provisions is not exclusive of other rights of indemnification to which a person may be entitled under any bylaw,
agreement, vote of stockholders or disinterested directors or otherwise.
We have directors’ and officers’ insurance which provides
for indemnification of our officers and directors and certain other persons against liabilities and expenses incurred by any of
them in certain stated proceedings and under certain stated conditions. We have also entered into separate indemnification agreements
with each of our directors and certain officers that may require us, among other things, to indemnify such directors and officers
against certain liabilities that may arise by reason of their status or service as directors or officers to the maximum extent
permitted under Delaware law.
Our restated certificate of incorporation provides that indemnification
shall be available to the fullest extent permitted by the DGCL for all current or former directors or officers.
Item 15. Recent Sale of Unregistered Securities
NONE
Item 16. Exhibits.
See the Exhibit Index following the “Signatures” page
in this registration statement, which Exhibit Index is incorporated herein by reference.
Item 17. Undertakings.
(b)
The undersigned registrant hereby undertakes:
(1)
to file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) to include any prospectus required by Section 10(a)(3) of the Securities Act; (ii) to reflect in the prospectus any facts or
events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding
the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would
not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be
reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume
and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration
Fee” table in the effective registration statement; and (iii) to include any material information with respect to the plan
of distribution not previously disclosed in the registration statement or any material change to such information in the registration
statement;
(2)
that, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment
shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof;
(3)
to remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering;
(4)
that, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
| (i) | each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the
registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and |
| (ii) | each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration
statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of
providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in
the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date
of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability
purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date
of the registration statement relating to the securities in the registration statement to which the prospectus relates, and the
offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however,
that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration
statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement
that was made in the registration statement or prospectus that was part of the registration statement or made in any such document
immediately prior to such effective date; and |
| (iii) | each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an
offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall
be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided,
however, that no statement made in a registration statement or prospectus that is part of the registration statement or made
in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the
registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any
statement that was made in the registration statement or prospectus that was part of the registration statement or made in any
such document immediately prior to such date of first use; |
(5)
that, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the
initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned
registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser,
if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant
will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
| (i) | Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required
to be filed pursuant to Rule 424; |
| (ii) | Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant
or used or referred to by the undersigned registrant; |
| (iii) | The portion of any other free writing prospectus relating to the offering containing material information
about the undersigned registrant or its securities provided by or on behalf of an undersigned registrant; and |
| (iv) | Any other communication that is an offer in the offering made by the undersigned registrant to the
purchaser. |
(c)
The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of
1933, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange
Act of 1934 that is incorporated by reference in this registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.
(d)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers
and controlling persons of the registrant pursuant to the provisions described under Item 15 above, or otherwise, the registrant
has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as
expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other
than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection
with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by
controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against
public policy as expressed in the Act and will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the requirements for filing this Amendment No. 2 to the
Registration Statement on Form S-1 and has duly caused this registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Tempe, State of Arizona, on September 16, 2015.
|
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CAPSTONE THERAPEUTICS CORP. |
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By: /s/ John M. Holliman, III |
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John M. Holliman, III |
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Executive Chairman |
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints John M. Holliman, III and Les M. Taeger, and each of them, his true and lawful attorneys-in-fact
and agents, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities,
to sign any and all amendments (including post-effective amendments) to this registration statement and to sign any registration
statement for the same offering that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act of 1933, as
amended, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and
Exchange Commission, and any other regulatory authority, granting unto said attorneys-in-fact and agents, and each of them, full
power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises,
as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact
and agents or any of them, or their substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Amendment No. 2 to the Registration Statement on Form S-1 has been signed by the following persons in the capacities and on
the date indicated.*
Signature |
Title |
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/s/ John M. Holliman,
III
John M. Holliman, III |
Executive Chairman (Principal Executive Officer),
Chairman of the Board and Director |
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/s/ Les M. Taeger
Les M. Taeger |
Senior Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer) |
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/s/ Eric W. Fangmann
Eric W. Fangmann. |
Director |
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/s/ Frederic J. Feldman
Frederic J. Feldman, Ph.D. |
Director |
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/s/ Elwood D. Howse, Jr.
Elwood D. Howse, Jr. |
Director |
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*Each of the above signatures is affixed as of September 16, 2015.
CAPSTONE THERAPEUTICS
CORP.
(the “Company”)
EXHIBIT INDEX TO
FORM S-1 REGISTRATION
STATEMENT
THE FOLLOWING EXHIBITS
ARE FILED WITH OR INCORPORATED BY REFERENCE IN THIS REGISTRATION STATEMENT:
Exhibit No.
|
Description
|
Incorporated by Reference To: |
Filed Herewith: |
|
|
|
|
1.1 |
Engagement Agreement, dated June 26, 2015, by and between Capstone Therapeutics Corp. and H.C. Wainwright & Co., LLC |
|
X |
2.1 |
Certificate of Conversion of Lipimetix Development, LLC, effective as of June 25, 2015 |
Exhibit 2.1 to the Company’s Registration Statement on Form S-1 filed with the SEC on June 26, 2015 |
|
2.2 |
Plan of Conversion of Lipimetix Development, LLC, effective as of June 25, 2015 |
Exhibit 2.2 to the Company’s Registration Statement on Form S-1 filed with the SEC on June 26, 2015 |
|
3.1 |
Second Amended and Restated Certificate of Incorporation, as amended through June 22, 2015, including the Amended and Restated Certificate of Designation of Series A Preferred Stock, executed June 24, 2014 |
Exhibit 3.1 to the Company’s Registration Statement on Form S-1 filed with the SEC on June 26, 2015 |
|
3.2 |
Bylaws of the Company |
Exhibit 4.2 to the Company’s Registration Statement on Form S-8 filed with the SEC on June 23, 2015 |
|
3.3 |
Certificate of Incorporation of Lipimetix Development, Inc., Bylaws of LipimetiX Development, Inc. |
Exhibit 3.3 to the Company’s Registration Statement on Form S-1 filed with the SEC on June 26, 2015 |
|
|
|
|
|
4.1 |
Class A Warrant Agreement dated February 24, 2006, between OrthoLogic Corp. and PharmaBio Development Inc. (d/b/a NovaQuest) |
Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on March 3, 2006 |
|
4.2 |
Class A Warrant Agreement dated June 30, 2006 by and between OrthoLogic Corp. and PharmaBio Development Inc. |
Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 6, 2006 |
|
4.3 |
Amended and Restated Class B Warrant Agreement dated February 24, 2006, and amended and restated as of June 30, 2006, between OrthoLogic Corp. and PharmaBio Development Inc. (d/b/a NovaQuest) (asterisks located within exhibit denote information that has been redacted pursuant to a request for confidential treatment filed with the SEC) |
Exhibit 4.4 to the Company’s Amendment No. 1 to Registration Statement on Form 8-A/A filed with the SEC on May 25, 2010. |
|
4.4 |
Tax Benefit Preservation Plan, dated as of June 24, 2014, by and between Capstone Therapeutics Corp. and Computershare Inc., as rights agent. |
Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 24, 2014 |
|
4.5 |
Form of Warrant |
|
X |
5.1 |
Opinion of Quarles & Brady LLP (***) |
|
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10.1 |
Form of Indemnification Agreement (*) |
Exhibit 10.16 to the Company’s Amendment No. 2 to Registration Statement on Form S-1 (No. 33-47569) filed with the SEC on January 25, 1993 |
|
10.2 |
1997 Stock Option Plan of the Company, as amended and approved by the stockholders (1) |
Exhibit 4.3 to the Company’s Registration Statement on Form S-8 filed with the SEC on March 2, 2005 |
|
10.3 |
Form of Incentive Stock Option Grant Letter for use in connection with the Company’s 1997 Stock Option Plan (**) |
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 4, 2005 |
|
10.4 |
Form of Non-qualified Stock Option Grant Letter for use in connection with the Company’s 1997 Stock Option Plan (**) |
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 19, 2006 |
|
10.5 |
Director Compensation Plan, effective June 10, 2005 (1) |
Exhibit 10.2 to the Company’s Quarterly Report Form 10-Q for the quarterly period ended June 30, 2005 filed with the SEC on August 9, 2005 |
|
10.6 |
Employment Agreement dated January 10, 2006 between the Company and Les M. Taeger (1) |
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 11, 2006 (the “January 11th 8-K”) |
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10.7 |
Intellectual Property, Confidentiality and Non-Competition Agreement between the Company and Les M. Taeger dated January 10, 2006 (1) |
Exhibit 10.2 to the January 11th 8-K |
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10.8 |
Common Stock and Warrant Purchase Agreement by and between OrthoLogic Corp. and PharmaBio Development Inc., dated February 24, 2006. |
Exhibit 10.1 to the Company’s Registration Statement on Form S-3 filed with the SEC on April 13, 2006 (April 2006 S-3) |
|
10.9 |
Registration Rights Agreement by and between OrthoLogic Corp. and PharmaBio Development Inc., dated February 24, 2006 |
Exhibit 4.8 to the Company’s Amendment No. 1 to Registration Statement on Form 8-A/A filed with the SEC on May 25, 2010. |
|
10.10 |
Registration Rights Agreement by and between OrthoLogic Corp., AzERx, Inc., and Certain Shareholders, dated February 27, 2006 |
Exhibit 10.3 to the Company’s April 2006 S-3 |
|
10.11 |
Amended and Restated License Agreement dated February 23, 2006 by and between OrthoLogic Corp. and Arizona Science Technology Enterprises, LLC |
Exhibit 10.5 to the Company’s Registration Statement on Form S-3 filed with the SEC on April 25, 2006 |
|
10.12 |
2005 Equity Incentive Plan (2005 Plan) (1) |
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 18, 2006 |
|
10.13 |
Form of Incentive Stock Option Grant Letters for Grants under the 2005 Plan (**) |
Exhibit 10.1 to the Company’s Report on Form 10-Q for the quarterly period ended June 30, 2006, filed on August 8, 2006 (“June 2006 10-Q”) |
|
10.14 |
Form of Non-Qualified Stock Options Grant Letter for Grants under the 2005 Plan (**) |
Exhibit 10.2 to the Company’s June 2006 10-Q |
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10.15 |
Form of Restricted Stock Grant Letters for Grants under the 2005 Plan (**) |
Exhibit 10.4 to the Company’s Current Report on Form 8-K filed with the SEC on May 18, 2006 |
|
10.16 |
Amendment to Employment Agreement dated January 10, 2006 between OrthoLogic Corp. and Les Taeger (1) |
Exhibit 10.3 to the Company’s June 2006 10-Q |
|
10.17 |
Contribution Agreement by and among LipimetiX, LLC, Capstone Therapeutics Corp., LipimetiX Development, LLC, The UAB Research Foundation, Dennis I. Goldberg, Ph.D., Philip M. Friden, Ph.D., Eric Morrell, Ph.D., G. M. Anantharamaiah, Ph.D., Palgunachari Mayakonda, Ph.D., Frederick Meyer, Ph.D., Michael Webb, and Jeffrey Elton, Ph.D., effective as of August 3, 2012. |
Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 |
|
10.18 |
Limited Liability Company Agreement of LipimetiX Development, LLC, by and among LipimetiX Development, LLC, Capstone Therapeutics Corp., and the other members and managers party thereto, effective as of August 3, 2012. |
Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 |
|
10.19 |
First Amendment and Consent to Assignment of Exclusive License Agreement by and among The UAB Research Foundation, LipimetiX, LLC and LipimetiX Development, LLC, dated as of August 3, 2012. |
Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 |
|
10.20 |
Management Agreement by and among LipimetiX Development, LLC, Benu BioPharma, Inc., Dennis I. Goldberg, Ph.D., Phillip M. Friden, Ph.D., and Eric M. Morrel, Ph.D., effective as of August 3, 2012. |
Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 |
|
10.21 |
Accounting Services Agreement by and among LipimetiX Development, LLC and Capstone Therapeutics Corp., effective as of August 3, 2012 |
Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 |
|
10.22 |
Escrow Agreement by and among Capstone Therapeutics Corp., LipimetiX Development, LLC dated as of August 3, 2012 |
Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 |
|
10.23 |
Exclusive License Agreement between the UAB Research Foundation and LipimetiX LLC dated August 26, 2011 |
Exhibit 10.7 to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2012, filed with the SEC on August 10, 2012 |
|
10.24 |
Second Amendment to Exclusive License Agreement between the UAB Research Foundation and LipimetiX, LLC, last signed on January 26, 2015 |
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on January 30, 3015 |
|
10.25 |
Capstone Therapeutics Corp. Joint Venture Bonus Plan |
Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2012, filed with the SEC on November 8, 2012 |
|
10.26
|
Accounting Services Agreement Amendment #1, dated August 23, 2013
|
Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for
the period ended September 30, 2013, filed with the SEC on November 12, 2013
|
|
10.27 |
Capstone Therapeutics Corp. 2015 Equity Incentive Compensation Plan |
Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 22, 2015 |
|
10.28 |
Form of Incentive Stock Option Grant Letter for Grants under the 2015 Equity Incentive Plan |
Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on June 22, 2015 |
|
10.29 |
Form of Non-Qualified Stock Option Grant Letter for Grants to Directors under the 2015 Equity Incentive Plan |
Exhibit 10.3 to the Company’s Current Report on Form 8-K filed with the SEC on June 22, 2015 |
|
10.30 |
Form of Non-Qualified Stock Option Grant Letter for Grants to Consultants under the 2015 Equity Incentive Plan |
Exhibit 10.4 to the Company’s Current Report on Form 8-K filed with the SEC on June 22, 2015 |
|
10.31 |
Stockholders Agreement, dated as of June 23, 2015, by and among LipimetiX Development, Inc. and the stockholders named therein |
Exhibit 10.31 to the Company’s Registration Statement on Form S-1 filed with the SEC on June 26, 2015 |
|
10.32 |
Form of Securities Purchase Agreement |
|
X |
23.1 |
Consent of Moss Adams LLP (***) |
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23.2 |
Consent of Quarles & Brady LLP (***) |
|
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24.1 |
Powers of Attorney |
(Included on the Signature Page) |
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* Capstone Therapeutics Corp. has entered into separate indemnification
agreements with each of its current directors and executive officers that differ only in party names and dates. Pursuant to the
instructions accompanying Item 601 of Regulation S-K, Capstone has filed the form of such indemnification agreement.
** Capstone Therapeutics from time to time issues stock options to
its employees, officers and directors pursuant to its 2005 and 2015 Stock Option Plans, as amended. The incentive stock option
grant letters and non-qualified stock option grant letters that evidence these issuances differ only in such terms as the identity
of the recipient, the grant date, the number of securities covered by the award, the price(s) at which the recipient may acquire
the securities and the vesting schedule. Pursuant to the instructions accompanying Item 601 of Regulation S-K, Capstone has filed
the form of such incentive stock option grant letter and non-qualified stock option grant letter.
*** To be provided by amendment.
(1) Management Contract or compensatory plan or arrangement
|
E-4
EXHIBIT 1.1
June 16, 2015
STRICTLY CONFIDENTIAL
John M. Holliman, III
Chairman and CEO
Capstone Therapeutics Corp.
1275 West Washington Street
Suite 104
Tempe, AZ 85281
Dear Mr. Holliman:
This letter agreement (this “Agreement”)
constitutes the agreement between Capstone Therapeutics Corp. (excluding the Company’s subsidiary, Lipimetix Development,
Inc., the “Company”) and H.C. Wainwright & Co., LLC (“Wainwright”) that Wainwright shall
serve as the exclusive agent, advisor or underwriter in any offering (each, an “Offering”) of securities of
the Company (“Securities”) during the Term (as defined below) of this Agreement The terms of each Offering and
the Securities issued in connection therewith shall be mutually agreed upon by the Company and Wainwright and nothing herein implies
that Wainwright would have the power or authority to bind the Company and nothing herein implies that the Company shall have an
obligation to issue any Securities. It is understood that Wainwright’s assistance in an Offering will be subject to the satisfactory
completion of such investigation and inquiry into the affairs of the Company as Wainwright deems appropriate under the circumstances
and to the receipt of all internal approvals of Wainwright in connection with the transaction. The Company expressly acknowledges
and agrees that Wainwright’s involvement in an Offering is strictly on a reasonable best efforts basis and that the consummation
of an Offering will be subject to, among other things, market conditions. The execution of this Agreement does not constitute a
commitment by Wainwright to purchase the Securities and does not ensure a successful Offering of the Securities or the success
of Wainwright with respect to securing any other financing on behalf of the Company. Wainwright may retain other brokers, dealers,
agents or underwriters on its behalf in connection with an Offering. Michael Mirsky shall be the lead representative for Wainwright
as relates to this Agreement.
A.
Compensation; Fees. At the closing of each Offering (each, a “Closing”), the Company shall compensate Wainwright as follows:
i. The Company shall pay to Wainwright a cash fee, or as to an underwritten Offering an underwriter
discount, equal to 7.25% of the aggregate gross proceeds raised in each Offering (reduced to 4% of the gross proceeds raised in
each Offering from each of: Biotechnology Value Fund (and its affiliated funds), Lloyd I. Miller, III (and his affiliated entities),
Denny Howell, James Stuckert, John M. Holliman, III, Terence E. Winters, Michael Heaberg, Michael Dwyer, Chris Basta, Deerfield
Management and David Cohn (each a “Reduced Fee Investor”)).
ii. Additionally, Wainwright shall receive a cash fee equal to 7.25% of the proceeds from the exercise
of Warrants issued in conjunction with an Offering (reduced to 4% of the proceeds from Reduced Fee Investors, and no fee will be
paid on the proceeds of warrants issued to Wainwright in conjunction with an Offering) payable within two business days of (but
only in the event of) the receipt by the Company of any proceeds from the exercise of any warrants or options sold in each Offering.
iii. Existing Company investors set forth on Schedule A hereto providing a bridge loan of
up to $2,000,000 to the Company (the “Bridge Financing”) shall be excluded from any Wainwright cash or warrant fees.
The Company will consult with Wainwright on any Bridge Financing.
2.
Warrant Coverage. The Company shall issue to Wainwright or its designees at each Closing, warrants (the “Wainwright
Warrants”) to purchase that number of shares of common stock of the Company equal to 5% of the aggregate number of shares
of Common Stock placed in each Offering (if the Securities are convertible or include a “greenshoe” or “additional
investment” option component, such shares of Common Stock underlying such Securities or options) (reduced to 2.5% with respect
to a Reduced Fee Investor). If the Securities included in an Offering are non-convertible, the Wainwright Warrants shall be determined
by dividing the gross proceeds raised in such Offering divided by the then market price of the Common Stock. The Wainwright Warrants
shall have the same terms as the warrants issued to investors in the applicable Offering. If no warrants are issued to investors
in an Offering, the Wainwright Warrants shall be in a customary form reasonably acceptable to Wainwright, have a term of 5 years
and an exercise price equal to 135% of the then market price of the Common Stock.
3.
Expense Allowance. Out of the proceeds of each Closing, the Company also agrees to pay Wainwright a non-accountable expense
allowance of the greater of (a) 1% of the gross proceeds raised in such Offering or (b) $50,000 (provided, however,
that such reimbursement amount in no way limits or impairs the indemnification and contribution provisions of this Agreement).
.
4.
Tail Fee. Wainwright shall be entitled to compensation under clauses (1) and (2) hereunder, calculated in the manner set
forth therein, with respect to any public or private offering or other financing or capital-raising transaction of any kind (“Tail
Financing”) to the extent that such financing or capital is provided to the Company by investors whom Wainwright has
introduced to the Company during the Term or by investors that have participated in an Offering during the Term, if such Tail Financing
is consummated at any time within the 12-month period following the expiration or termination of this Agreement. If not previously
identified in writing by Wainwright to the Company (including, by way of e-mail) upon each Closing, and at the end of the Term,
Wainwright shall promptly send the Company a written list (including by way of e-mail) of the investors subject to the tail rights
granted under this Section (A)(4).
5.
Right of First Refusal. If within the 12-month period following consummation of each Offering, the Company or any of its
subsidiaries (other than Lipimetix Development, Inc.) (a) decides to finance or refinance any indebtedness using a manager or agent,
Wainwright (or any affiliate designated by Wainwright) shall have the right to act as lead manager, lead placement agent or lead
agent with respect to such financing or refinancing; or (b) decides to raise funds by means of a public offering or a private placement
of equity or debt securities using an underwriter or placement agent, Wainwright (or any affiliate designated by Wainwright) shall
have the right to act as lead underwriter or lead placement agent for such financing. Wainwright will notify the Company of their
exercise of the Right of First Refusal outlined in (a) or (b) above, within thirty (30) days of receipt of notification from the
Company of the Company’s intent to engage in one or more of the activities outlined in (a) or (b) above. If Wainwright or
one of its affiliates decides to accept any such engagement, the agreement governing such engagement will contain, among other
things, provisions for customary fees for transactions of similar size and nature and the provisions of this Agreement, including
indemnification, which are appropriate to such a transaction.
B.
Term and Termination of Engagement; Exclusivity. The term of Wainwright’s exclusive engagement will begin on the date
hereof and end 9 months after the date hereof (the “Term”). Notwithstanding anything to the contrary contained
herein, the Company agrees that the provisions relating to the payment of fees, reimbursement of expenses, indemnification and
contribution, confidentiality, conflicts, independent contractor and waiver of the right to trial by jury will survive any termination
of this Agreement. During Wainwright’s engagement hereunder: (i) the Company will not, and will not permit its representatives
to, other than in coordination with Wainwright, contact or solicit institutions, corporations or other entities or individuals
as potential purchasers of the Securities and (ii) the Company will not pursue any financing transaction which would be in lieu
of an Offering. Furthermore, the Company agrees that during Wainwright’s engagement hereunder, all inquiries, whether direct
or indirect, from prospective investors will be referred to Wainwright and will be deemed to have been contacted by Wainwright
in connection with an Offering.
C.
Information; Reliance. The Company shall furnish, or cause to be furnished, to Wainwright all information requested by Wainwright
for the purpose of rendering services hereunder (all such information being the “Information”). In addition,
the Company agrees to make available to Wainwright upon request from time to time the officers, directors, accountants, counsel
and other advisors of the Company. The Company recognizes and confirms that Wainwright (a) will use and rely on the Information,
including any documents provided to investors in each Offering (the “Offering Documents” which shall include
any Purchase Agreements (as defined below)), and on information available from generally recognized public sources in performing
the services contemplated by this Agreement without having independently verified the same; (b) does not assume responsibility
for the accuracy or completeness of the Offering Documents or the Information and such other information; and (c) will not make
an appraisal of any of the assets or liabilities of the Company. Upon reasonable request, the Company will meet with Wainwright
or its representatives to discuss all information relevant for disclosure in the Offering Documents and will cooperate in any investigation
undertaken by Wainwright thereof, including any document included or incorporated by reference therein. At each Offering, at the
request of Wainwright, the Company shall deliver such legal letters, comfort letters and officer’s certificates, all in form
and substance satisfactory to Wainwright and its counsel as is customary for such Offering. Wainwright shall be a third party beneficiary
of any representations, warranties, covenants and closing conditions made by the Company in any Offering Documents, including representations,
warranties, covenants and closing conditions made to any investor in an Offering.
D.
Related Agreements. At each Offering, the Company shall enter into the following additional agreements:
1.
Underwritten Offering. If an Offering is an underwritten Offering, the Company and Wainwright shall enter into a reasonable
and customary underwriting agreement.
2.
Best Efforts Offering. If an Offering is on a best efforts basis, the sale of Securities to the investors in the Offering
will be evidenced by a purchase agreement (“Purchase Agreement”) between the Company and such investors in a
form reasonably satisfactory to the Company and Wainwright. Prior to the signing of any Purchase Agreement, officers of the Company
with responsibility for financial affairs will be available to answer inquiries from prospective investors.
3.
Escrow and Settlement. In respect of each Offering, the Company and Wainwright shall enter into an escrow agreement with
a third party escrow agent, which may also be Wainwright’s clearing agent, pursuant to which Wainwright’s compensation
and expenses shall be paid from the gross proceeds of the Securities sold. If the Offering is settled in whole or in part via delivery
versus payment (“DVP”), Wainwright shall arrange for its clearing agent to provide the funds to facilitate such settlement.
The Company shall bear the cost of the escrow agent and shall reimburse Wainwright for the actual out of pocket cost of such clearing
agent settlement and financing, if any.
4.
FINRA Amendments. Notwithstanding anything herein to the contrary, in the event that Wainwright determines that any of the
terms provided for hereunder shall not comply with a FINRA rule, including but not limited to FINRA Rule 5110, then the Company
shall agree to amend this Agreement (or include such revisions in the final underwriting) in writing upon the request of Wainwright
to comply with any such rules; provided that any such amendments shall not provide for terms that are less favorable to the Company.
E.
Confidentiality. In the event of the consummation or public announcement of any Offering, Wainwright shall have the right
to disclose its participation in such Offering, including, without limitation, the Offering at its cost of “tombstone”
advertisements in financial and other newspapers and journals.
F.
Indemnity.
1. In connection with the Company’s
engagement of Wainwright as Offering agent, the Company hereby agrees to indemnify and hold harmless Wainwright and its affiliates,
and the respective controlling persons, directors, officers, members, shareholders, agents and employees of any of the foregoing
(collectively the “Indemnified Persons”), from and against any and all claims, actions, suits, proceedings (including
those of shareholders), damages, liabilities and expenses incurred by any of them (including the reasonable fees and expenses of
counsel), as incurred, (collectively a “Claim”), that are (A) related to or arise out of (i) any actions taken
or omitted to be taken (including any untrue statements made or any statements omitted to be made) by the Company, or (ii) any
actions taken or omitted to be taken by any Indemnified Person in connection with the Company’s engagement of Wainwright,
or (B) otherwise relate to or arise out of Wainwright’s activities on the Company’s behalf under Wainwright’s
engagement, and the Company shall reimburse any Indemnified Person for all reasonable expenses (including the reasonable fees and
expenses of counsel) as incurred by such Indemnified Person in connection with investigating, preparing or defending any such claim,
action, suit or proceeding, whether or not in connection with pending or threatened litigation in which any Indemnified Person
is a party. The Company will not, however, be responsible for any Claim, or any Indemnified Person seeking expenses for such Claim
(including the reasonable fees and expenses of counsel), if the Claim is finally judicially determined to have resulted from the
gross negligence or willful misconduct of any person seeking indemnification for such Claim. The Company further agrees that no
Indemnified Person shall have any liability to the Company for or in connection with the Company’s engagement of Wainwright
except for any Claim incurred by the Company as a result of such Indemnified Person’s gross negligence or willful misconduct.
2. The Company further agrees that
it will not, without the prior written consent of Wainwright, settle, compromise or consent to the entry of any judgment in any
pending or threatened Claim in respect of which indemnification may be sought hereunder (whether or not any Indemnified Person
is an actual or potential party to such Claim), unless such settlement, compromise or consent includes an unconditional, irrevocable
release of each Indemnified Person from any and all liability arising out of such Claim.
3. Promptly upon receipt by an
Indemnified Person of notice of any complaint or the assertion or institution of any Claim with respect to which indemnification
is being sought hereunder, such Indemnified Person shall notify the Company in writing of such complaint or of such assertion or
institution but failure to so notify the Company shall not relieve the Company from any obligation it may have hereunder, except
and only to the extent such failure results in the forfeiture by the Company of substantial rights and defenses. If the Company
so elects or is requested by such Indemnified Person, the Company will assume the defense of such Claim, including the employment
of counsel reasonably satisfactory to such Indemnified Person and the payment of the fees and expenses of such counsel. In the
event, however, that legal counsel to such Indemnified Person reasonably determines that having common counsel would present such
counsel with a conflict of interest or if the defendant in, or target of, any such Claim, includes an Indemnified Person and the
Company, and legal counsel to such Indemnified Person reasonably concludes that there may be legal defenses available to it or
other Indemnified Persons different from or in addition to those available to the Company, then such Indemnified Person may employ
its own separate counsel to represent or defend him, her or it in any such Claim and the Company shall pay the reasonable fees
and expenses of such counsel. Notwithstanding anything herein to the contrary, if the Company fails timely or diligently to defend,
contest, or otherwise protect against any Claim, the relevant Indemnified Party shall have the right, but not the obligation, to
defend, contest, compromise, settle, assert crossclaims, or counterclaims or otherwise protect against the same, and shall be fully
indemnified by the Company therefor, including without limitation, for the reasonable fees and expenses of its counsel and all
amounts paid as a result of such Claim or the compromise or settlement thereof. In addition, with respect to any Claim in which
the Company assumes the defense, the Indemnified Person shall have the right to participate in such Claim and to retain his, her
or its own counsel therefor at his, her or its own expense.
4. The Company agrees that if any
indemnity sought by an Indemnified Person hereunder is held by a court to be unavailable for any reason then (whether or not Wainwright
is the Indemnified Person), the Company and Wainwright shall contribute to the Claim for which such indemnity is held unavailable
in such proportion as is appropriate to reflect the relative benefits to the Company, on the one hand, and Wainwright on the other,
in connection with Wainwright’s engagement referred to above, subject to the limitation that in no event shall the amount
of Wainwright’s contribution to such Claim exceed the amount of fees actually received by Wainwright from the Company pursuant
to Wainwright’s engagement. The Company hereby agrees that the relative benefits to the Company, on the one hand, and Wainwright
on the other, with respect to Wainwright’s engagement shall be deemed to be in the same proportion as (a) the total value
paid or proposed to be paid or received by the Company pursuant to the applicable Offering (whether or not consummated) for which
Wainwright is engaged to render services bears to (b) the fee paid or proposed to be paid to Wainwright in connection with such
engagement.
5. The Company’s indemnity,
reimbursement and contribution obligations under this Agreement (a) shall be in addition to, and shall in no way limit or otherwise
adversely affect any rights that any Indemnified Party may have at law or at equity and (b) shall be effective whether or not the
Company is at fault in any way.
G.
Limitation of Engagement to the Company. The Company acknowledges that Wainwright has been retained only by the Company,
that Wainwright is providing services hereunder as an independent contractor (and not in any fiduciary or agency capacity) and
that the Company’s engagement of Wainwright is not deemed to be on behalf of, and is not intended to confer rights upon,
any shareholder, owner or partner of the Company or any other person not a party hereto as against Wainwright or any of its affiliates,
or any of its or their respective officers, directors, controlling persons (within the meaning of Section 15 of the Securities
Act or Section 20 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), employees or agents.
Unless otherwise expressly agreed in writing by Wainwright, no one other than the Company is authorized to rely upon this Agreement
or any other statements or conduct of Wainwright, and no one other than the Company is intended to be a beneficiary of this Agreement.
The Company acknowledges that any recommendation or advice, written or oral, given by Wainwright to the Company in connection with
Wainwright’s engagement is intended solely for the benefit and use of the Company’s management and directors in considering
a possible Offering, and any such recommendation or advice is not on behalf of, and shall not confer any rights or remedies upon,
any other person or be used or relied upon for any other purpose. Wainwright shall not have the authority to make any commitment
binding on the Company. The Company, in its sole discretion, shall have the right to reject any investor introduced to it by Wainwright.
H.
Limitation of Wainwright’s Liability to the Company. Wainwright and the Company further agree that neither Wainwright
nor any of its affiliates or any of its their respective officers, directors, controlling persons (within the meaning of Section
15 of the Securities Act or Section 20 of the Exchange Act), employees or agents shall have any liability to the Company, its security
holders or creditors, or any person asserting claims on behalf of or in the right of the Company (whether direct or indirect, in
contract, tort, for an act of negligence or otherwise) for any losses, fees, damages, liabilities, costs, expenses or equitable
relief arising out of or relating to this Agreement or the services rendered hereunder, except for losses, fees, damages, liabilities,
costs or expenses that arise out of or are based on any action of or failure to act by Wainwright or any of its affiliates or any
of its their respective officers, directors, controlling persons (within the meaning of Section 15 of the Securities Act or Section
20 of the Exchange Act), employees or agents, and that are finally judicially determined to have resulted from the gross negligence
or willful misconduct of Wainwright or any of its affiliates or any of its their respective officers, directors, controlling persons
(within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act), employees or agents.
I.
Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York applicable
to agreements made and to be fully performed therein. Any disputes that arise under this Agreement, even after the termination
of this Agreement, will be heard only in the state or federal courts located in the City of New York, State of New York. The parties
hereto expressly agree to submit themselves to the jurisdiction of the foregoing courts in the City of New York, State of New York.
The parties hereto expressly waive any rights they may have to contest the jurisdiction, venue or authority of any court sitting
in the City and State of New York. In the event of the bringing of any action, or suit by a party hereto against the other party
hereto, arising out of or relating to this Agreement, the party in whose favor the final judgment or award shall be entered shall
be entitled to have and recover from the other party the costs and expenses incurred in connection therewith, including its reasonable
attorneys’ fees. Any rights to trial by jury with respect to any such action, proceeding or suit are hereby waived by Wainwright
and the Company.
J.
Notices. All notices hereunder will be in writing and sent by certified mail, hand delivery, overnight delivery or fax,
if sent to Wainwright, to H. C. Wainwright & Co. LLC, at the address set forth on the first page hereof, e-mail: notices@hcwco.com,
Attention: Head of Investment Banking, and if sent to the Company, to the address set forth on the first page hereof, fax number
602-286-5284 Attention: John M. Holliman, III, Chief Executive Officer. Notices sent by certified mail shall be deemed received
five days thereafter, notices sent by hand delivery or overnight delivery shall be deemed received on the date of the relevant
written record of receipt, and notices delivered by fax shall be deemed received as of the date and time printed thereon by the
fax machine.
K.
Conflicts. The Company acknowledges that Wainwright and its affiliates may have and may continue to have investment banking
and other relationships with parties other than the Company pursuant to which Wainwright may acquire information of interest to
the Company. Wainwright shall have no obligation to disclose such information to the Company or to use such information in connection
with any contemplated transaction.
L.
Anti-Money Laundering. To help the United States government fight the funding of terrorism and money laundering, the federal
laws of the United States requires all financial institutions to obtain, verify and record information that identifies each person
with whom they do business. This means we must ask you for certain identifying information, including a government-issued identification
number (e.g., a U.S. taxpayer identification number) and such other information or documents that we consider appropriate to verify
your identity, such as certified articles of incorporation, a government-issued business license, a partnership agreement or a
trust instrument.
M.
Miscellaneous. The Company represents and warrants that it has all requisite power and authority to enter into and carry
out the terms and provisions of this Agreement and the execution, delivery and performance of this Agreement does not breach or
conflict with any agreement, document or instrument to which it is a party or bound. This Agreement shall not be modified or amended
except in writing signed by Wainwright and the Company. This Agreement shall be binding upon and inure to the benefit of both Wainwright
and the Company and their respective assigns, successors, and legal representatives. This Agreement constitutes the entire agreement
of Wainwright and the Company with respect to this Offering and supersedes any prior agreements with respect to the subject matter
hereof. If any provision of this Agreement is determined to be invalid or unenforceable in any respect, such determination will
not affect such provision in any other respect, and the remainder of the Agreement shall remain in full force and effect. This
Agreement may be executed in counterparts (including facsimile counterparts), each of which shall be deemed an original but all
of which together shall constitute one and the same instrument.
*********************
In acknowledgment that the foregoing correctly
sets forth the understanding reached by Wainwright and the Company, please sign in the space provided below, whereupon this letter
shall constitute a binding Agreement as of the date indicated above.
Very truly yours,
H.C. WAINWRIGHT & CO., LLC
By /s/ Mark W. Viklund
Name: Mark W. Viklund
Title: CEO
Accepted and Agreed:
CAPSTONE tHERAPEUTICS
CORP.
By /s/ John M. Holliman, III
Name: John M. Holliman, III
Title: Chairman and CEO
8
EXHIBIT 4.5
COMMON STOCK PURCHASE WARRANT
CAPSTONE THERAPEUTICS CORP.
Warrant Shares: _______ |
Initial Exercise Date: _______, 2015 |
THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”)
certifies that, for value received, _____________ or its assigns (the “Holder”) is entitled, upon the terms
and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date hereof (the
“Initial Exercise Date”) and on or prior to the close of business on the five (5) year anniversary of the Initial
Exercise Date (the “Termination Date”) but not thereafter, to subscribe for and purchase from Capstone Therapeutics
Corp., a Delaware corporation (the “Company”), up to ______ shares (as subject to adjustment hereunder, the
“Warrant Shares”) of Common Stock. The purchase price of one share of Common Stock under this Warrant shall
be equal to the Exercise Price, as defined in Section 2(b).
Section 1. Definitions. Capitalized
terms used and not otherwise defined herein shall have the meanings set forth in that certain Securities Purchase Agreement (the
“Purchase Agreement”), dated __________, 2015, among the Company and the purchasers signatory thereto.
Section 2. Exercise.
a)
Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or
after the Initial Exercise Date and on or before the Termination Date by delivery to the Company (or such other office or agency
of the Company as it may designate by notice in writing to the registered Holder at the address of the Holder appearing on the
books of the Company) of a duly executed facsimile copy (or e-mail attachment) of the Notice of Exercise in the form annexed hereto.
Within three (3) Trading Days following the date of exercise as aforesaid, the Holder shall deliver the aggregate Exercise Price
for the shares specified in the applicable Notice of Exercise by wire transfer or cashier’s check drawn on a United States
bank unless the cashless exercise procedure specified in Section 2(c) below is available and is specified in the applicable Notice
of Exercise. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee
or notarization) of any Notice of Exercise form be required. Notwithstanding anything herein to the contrary, the Holder shall
not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available
hereunder and the Warrant has been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for
cancellation within three (3) Trading Days of the date the final Notice of Exercise is delivered to the Company. Partial exercises
of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect
of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant
Shares purchased. The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date
of such purchases. The Company shall deliver any objection to any Notice of Exercise within one (1) Business Day of receipt of
such notice. The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions
of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available
for purchase hereunder at any given time may be less than the amount stated on the face hereof.
b)
Exercise Price. The exercise price per share of the Common Stock under this Warrant shall be $_____, subject
to adjustment hereunder (the “Exercise Price”).
c)
Cashless Exercise. If at the time of exercise hereof there is no effective registration statement registering, or
the prospectus contained therein is not available for the issuance of the Warrant Shares to the Holder, then this Warrant may also
be exercised, in whole or in part, at such time by means of a “cashless exercise” in which the Holder shall be entitled
to receive a number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where:
(A) = the VWAP on the Trading Day immediately
preceding the date on which Holder elects to exercise this Warrant by means of a “cashless exercise,” as set forth
in the applicable Notice of Exercise;
(B) = the Exercise Price of this
Warrant, as adjusted hereunder; and
(X) = the number of Warrant Shares
that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means
of a cash exercise rather than a cashless exercise.
If
Warrant Shares are issued in such a cashless exercise, the parties acknowledge and agree that in accordance with Section 3(a)(9)
of the Securities Act, the Warrant Shares shall take on the registered characteristics of the Warrants being exercised. The
Company agrees not to take any position contrary to this Section 2(c).
“VWAP” means, for
any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted
on a Trading Market, the daily volume weighted average price of the Common Stock for such date (or the nearest preceding date)
on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day
from 9:30 a.m. (New York City time) to 4:02 p.m. (New York City time)), (b) if OTCQB or OTCQX is not a Trading Market, the
volume weighted average price of the Common Stock for such date (or the nearest preceding date) on OTCQB or OTCQX as applicable,
(c) if the Common Stock is not then listed or quoted for trading on OTCQB or OTCQX and if prices for the Common Stock are then
reported in the “Pink Sheets” published by OTC Markets, Inc. (or a similar organization or agency succeeding to its
functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (d) in all other cases,
the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Board
of Directors of the Company, the fees and expenses of which shall be paid by the Company.
Notwithstanding anything herein to
the contrary, if, on the Termination Date, there is no effective Registration Statement registering, or no current prospectus available
for, the resale of the Warrant Shares by the Holder, this Warrant shall be automatically exercised via cashless exercise pursuant
to this Section 2(c).
d)
Mechanics of Exercise.
i. Delivery of
Warrant Shares Upon Exercise. The Company shall cause the Warrant Shares purchased hereunder to be transmitted by the Transfer
Agent to the Holder by crediting the account of the Holder’s or its designee’s balance account with The Depository
Trust Company through its Deposit or Withdrawal at Custodian system (“DWAC”) if the Company is then a participant
in such system and either (A) there is an effective registration statement permitting the issuance of the Warrant Shares to or
resale of the Warrant Shares by Holder or (B) this Warrant is being exercised via cashless exercise, and otherwise by physical
delivery of a certificate, registered in the Company’s share register in the name of the Holder or its designee, for the
number of Warrant Shares to which the Holder is entitled pursuant to such exercise to the address specified by the Holder in the
Notice of Exercise by the date that is two (2) Trading Days after the delivery to the Company of the Notice of Exercise (such date,
the “Warrant Share Delivery Date”), provided that the Company shall not be obligated to deliver Warrant Shares
hereunder unless the Company has received the aggregate Exercise Price on or before the Warrant Share Delivery Date. The Warrant
Shares shall be deemed to have been issued, and Holder or any other person so designated to be named therein shall be deemed to
have become a holder of record of such shares for all purposes, as of the date the Warrant has been exercised, with payment to
the Company of the Exercise Price (or by cashless exercise, if permitted) and all taxes required to be paid by the Holder, if any,
pursuant to Section 2(d)(vi) prior to the issuance of such shares, having been paid. If the Company fails for any reason to deliver
to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, the Company shall pay to the
Holder, in cash, as liquidated damages and not as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based
on the VWAP of the Common Stock on the date of the applicable Notice of Exercise), $10 per Trading Day (increasing to $20 per Trading
Day on the fifth Trading Day after such liquidated damages begin to accrue) for each Trading Day after such Warrant Share Delivery
Date until such Warrant Shares are delivered or Holder rescinds such exercise.
ii. Delivery of
New Warrants Upon Exercise. If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder
and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant
evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall
in all other respects be identical with this Warrant.
iii. Rescission
Rights. If the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares pursuant to Section 2(d)(i)
by the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise.
iv. Compensation
for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise. In addition to any other rights available to the Holder,
if the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares in accordance with the provisions
of Section 2(d)(i) above pursuant to an exercise on or before the Warrant Share Delivery Date, and if after such date the Holder
is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise
purchases, shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated
receiving upon such exercise (a “Buy-In”), then the Company shall (A) pay in cash to the Holder the amount,
if any, by which (x) the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common
Stock so purchased exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the Company was required
to deliver to the Holder in connection with the exercise at issue times (2) the price at which the sell order giving rise to such
purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent
number of Warrant Shares for which such exercise was not honored (in which case such exercise shall be deemed rescinded) or deliver
to the Holder the number of shares of Common Stock that would have been issued had the Company timely complied with its exercise
and delivery obligations hereunder. For example, if the Holder purchases Common Stock having a total purchase price of $11,000
to cover a Buy-In with respect to an attempted exercise of shares of Common Stock with an aggregate sale price giving rise to such
purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the
Holder $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the
Buy-In and, upon request of the Company, evidence of the amount of such loss. Nothing herein shall limit a Holder’s right
to pursue any other remedies available to it hereunder, at law or in equity including, without limitation, a decree of specific
performance and/or injunctive relief with respect to the Company’s failure to timely deliver shares of Common Stock upon
exercise of the Warrant as required pursuant to the terms hereof.
v. No Fractional
Shares or Scrip. No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant.
As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at
its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by
the Exercise Price or round up to the next whole share.
vi. Charges, Taxes
and Expenses. Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other
incidental expense in respect of the issuance of such Warrant Shares, all of which taxes and expenses shall be paid by the Company,
and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided,
however, that in the event Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when
surrendered for exercise shall be accompanied by the Assignment Form attached hereto duly executed by the Holder and the Company
may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto. The
Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository
Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery
of the Warrant Shares.
vii. Closing of
Books. The Company will not close its stockholder books or records in any manner which prevents the timely exercise of this
Warrant, pursuant to the terms hereof.
e)
Holder’s Exercise Limitations. The Company shall not effect any exercise of this Warrant, and a Holder shall
not have the right to exercise any portion of this Warrant, pursuant to Section 2 or otherwise, to the extent that, after giving
effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s
Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates), would beneficially
own in excess of the Beneficial Ownership Limitation (as defined below). The Beneficial Ownership Limitation is intended
to apply for purposes of (i) Section 382 of the Internal Revenue Code of 1986, as amended (“Section 382”) and
(ii) Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of the foregoing sentence,
the number of shares of Common Stock beneficially owned by the Holder and its Affiliates shall include the number of shares of
Common Stock issuable upon exercise of this Warrant with respect to which such determination is being made, but shall exclude the
number of shares of Common Stock which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant
beneficially owned by the Holder or any of its Affiliates and (ii) exercise or conversion of the unexercised or nonconverted portion
of any other securities of the Company (including, without limitation, any other Common Stock Equivalents) subject to a limitation
on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates.
Except as set forth in the preceding sentence, for purposes of this Section 2(e), beneficial ownership shall be calculated in accordance
with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder
that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act
and the Holder is solely responsible for any schedules required to be filed in accordance therewith. To the extent that the limitation
contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securities
owned by the Holder together with its Affiliates) and of which portion of this Warrant is exercisable shall be in the sole discretion
of the Holder, provided that the submission of a Notice of Exercise shall be deemed to be the Holder’s determination whether,
and shall be deemed to be the Holder’s representation and certification that, this Warrant is exercisable (in relation to
other securities owned by the Holder together with any Affiliates) and of which portion of this Warrant is exercisable, in each
case subject to the Beneficial Ownership Limitation; provided, however, that the Company shall have the right, but
not the obligation, at the Company’s expense, to verify or confirm the accuracy of such determination by the Holder of whether
this Warrant is exercisable and of which portion of this Warrant is exercisable. In addition, a determination as to any group status
as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated
thereunder. For purposes of this Section 2(e), in determining the number of outstanding shares of Common Stock, a Holder may rely
on the number of outstanding shares of Common Stock as reflected in (A) the Company’s most recent periodic or annual report
filed with the Commission, as the case may be, (B) a more recent public announcement by the Company or (C) a more recent written
notice by the Company or the Transfer Agent setting forth the number of shares of Common Stock outstanding. Upon the written
or oral request of a Holder, the Company shall within two Trading Days confirm orally and in writing to the Holder the number of
shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined
after giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates
since the date as of which such number of outstanding shares of Common Stock was reported. The “Beneficial Ownership Limitation”
shall be 4.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares
of Common Stock issuable upon exercise of this Warrant. The provisions of this paragraph shall be construed and implemented in
a manner otherwise than in strict conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof)
which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or
supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall
apply to a successor holder of this Warrant. Without limiting the foregoing provisions of this Section 2(e), the Company shall
use its reasonable best efforts, at the Company’s expense, to cooperate with the Holder in coordinating with the Transfer
Agent to effect broker-assisted “cashless” (same day) exercises of this Warrant in a manner such that the Holder (together
with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s
Affiliates) will not, for purposes of Section 382, exceed the Beneficial Ownership Limitation.
Section 3. Certain Adjustments.
a)
Stock Dividends and Splits. If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend
or otherwise makes a distribution or distributions on shares of its Common Stock or any other equity or equity equivalent securities
payable in shares of Common Stock (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Company
upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines
(including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues by
reclassification of shares of the Common Stock any shares of capital stock of the Company, then in each case the Exercise Price
shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding treasury shares,
if any) outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding
immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted
such that the aggregate Exercise Price of this Warrant shall remain unchanged. Any adjustment made pursuant to this Section 3(a)
shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend
or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or re-classification.
b)
Subsequent Equity Sales. If the Company or any Subsidiary thereof, as applicable, at any time while this Warrant
is outstanding, shall sell or grant any option to purchase, or sell or grant any right to reprice, or otherwise dispose of or issue
(or announce any offer, sale, grant or any option to purchase or other disposition) any Common Stock or Common Stock Equivalents,
at an effective price per share less than the Exercise Price then in effect (such lower price, the “Base Share Price”
and such issuances collectively, a “Dilutive Issuance”) (it being understood and agreed that if the holder of
the Common Stock or Common Stock Equivalents so issued shall at any time, whether by operation of purchase price adjustments, reset
provisions, floating conversion, exercise or exchange prices or otherwise, or due to warrants, options or rights per share which
are issued in connection with such issuance, be entitled to receive shares of Common Stock at an effective price per share that
is less than the Exercise Price, such issuance shall be deemed to have occurred for less than the Exercise Price on such date of
the Dilutive Issuance at such effective price), then simultaneously with the consummation of each Dilutive Issuance the Exercise
Price shall be reduced and only reduced to equal the Base Share Price. Such adjustment shall be made whenever such Common Stock
or Common Stock Equivalents are issued. Notwithstanding the foregoing, no adjustments shall be made, paid or issued under this
Section 3(b) in respect of an Exempt Issuance. The Company shall notify the Holder, in writing, no later than the Trading Day following
the issuance or deemed issuance of any Common Stock or Common Stock Equivalents subject to this Section 3(b), indicating therein
the applicable issuance price, or applicable reset price, exchange price, conversion price and other pricing terms (such notice,
the “Dilutive Issuance Notice”). For purposes of clarification, whether or not the Company provides a Dilutive
Issuance Notice pursuant to this Section 3(b), upon the occurrence of any Dilutive Issuance, the Holder is entitled to receive
a number of Warrant Shares based upon the Base Share Price regardless of whether the Holder accurately refers to the Base Share
Price in the Notice of Exercise. If the Company enters into a Variable Rate Transaction, despite the prohibition thereon in the
Purchase Agreement, the Company shall be deemed to have issued Common Stock or Common Stock Equivalents at the lowest possible
conversion or exercise price at which such securities may be converted or exercised.
c)
[RESERVED]
d)
[RESERVED]
e)
Fundamental Transaction. If, at any time while this Warrant is outstanding, (i) the Company, directly or indirectly,
in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (ii) the Company,
directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially
all of its assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender offer or exchange
offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to sell,
tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the
outstanding Common Stock, (iv) the Company, directly or indirectly, in one or more related transactions effects any reclassification,
reorganization or recapitalization of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively
converted into or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one or more
related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation,
a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person or group of Persons whereby such other
Person or group acquires more than 50% of the outstanding shares of Common Stock (not including any shares of Common Stock held
by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to,
such stock or share purchase agreement or other business combination) (each a “Fundamental Transaction”), then,
upon any subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant Share that would have
been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, at the option of the Holder
(without regard to any limitation in Section 2(e) on the exercise of this Warrant), the number of shares of Common Stock of the
successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the
“Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number
of shares of Common Stock for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard
to any limitation in Section 2(e) on the exercise of this Warrant). For purposes of any such exercise, the determination of the
Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration
issuable in respect of one share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Exercise
Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the
Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received
in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon
any exercise of this Warrant following such Fundamental Transaction. The Company shall cause any successor entity in a Fundamental
Transaction in which the Company is not the survivor (the “Successor Entity”) to assume in writing all of the
obligations of the Company under this Warrant and the other Transaction Documents in accordance with the provisions of this Section
3(e) pursuant to written agreements in form and substance customary for transactions of such type and shall, at the option of the
Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument
substantially similar in form and substance to this Warrant which is exercisable for a corresponding number of shares of capital
stock of such Successor Entity (or its parent entity) equivalent to the shares of Common Stock acquirable and receivable upon exercise
of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to such Fundamental Transaction, and
with an exercise price which applies the exercise price hereunder to such shares of capital stock (but taking into account the
relative value of the shares of Common Stock pursuant to such Fundamental Transaction and the value of such shares of capital stock,
such number of shares of capital stock and such exercise price being for the purpose of protecting the economic value of this Warrant
immediately prior to the consummation of such Fundamental Transaction). Upon the occurrence of any such Fundamental Transaction,
the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundamental Transaction,
the provisions of this Warrant and the other Transaction Documents referring to the “Company” shall refer instead to
the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Company
under this Warrant and the other Transaction Documents with the same effect as if such Successor Entity had been named as the Company
herein.
f)
Calculations. All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a
share, as the case may be. For purposes of this Section 3, the number of shares of Common Stock deemed to be issued and outstanding
as of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding.
g)
Notice to Holder.
i. Adjustment
to Exercise Price. Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3, the Company shall promptly
mail to the Holder a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of
Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.
ii. Notice to
Allow Exercise by Holder. If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common
Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company
shall authorize the granting to all holders of the Common Stock rights or warrants to subscribe for or purchase any shares of capital
stock of any class or of any rights, (D) the approval of any stockholders of the Company shall be required in connection with any
reclassification of the Common Stock, any consolidation or merger to which the Company is a party, any sale or transfer of all
or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Stock is converted into
other securities, cash or property, or (E) the Company shall authorize the voluntary or involuntary dissolution, liquidation or
winding up of the affairs of the Company, then, in each case, the Company shall cause to be mailed to the Holder at its last address
as it shall appear upon the Warrant Register of the Company, at least 10 Business Days prior to the applicable record or effective
date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution,
redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Stock of record
to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such
reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date
as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common
Stock for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share
exchange; provided that the failure to mail such notice or any defect therein or in the mailing thereof shall not affect the validity
of the corporate action required to be specified in such notice. To the extent that any notice provided in this Warrant constitutes,
or contains, material, non-public information regarding the Company or any of the Subsidiaries, the Company shall publicly disclose
such information on a Current Report on Form 8-K that is filed with the Commission. The Holder shall remain entitled to exercise
this Warrant during the period commencing on the date of such notice to the effective date of the event triggering such notice
except as may otherwise be expressly set forth herein.
Section 4. Transfer of Warrant.
a)
Transferability. This Warrant and all rights hereunder (including, without limitation, any registration rights) are
transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent,
together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its
agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer. Upon such surrender
and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or
assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue
to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this Warrant shall promptly be cancelled.
Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company
unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within
three (3) Trading Days of the date the Holder delivers an assignment form to the Company assigning this Warrant full. The Warrant,
if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having
a new Warrant issued.
b)
New Warrants. This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid
office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued,
signed by the Holder or its agent or attorney. Subject to compliance with Section 4(a), as to any transfer which may be involved
in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or
Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated
the initial issuance date of this Warrant and shall be identical with this Warrant except as to the number of Warrant Shares issuable
pursuant thereto.
c)
Warrant Register. The Company shall register this Warrant, upon records to be maintained by the Company for that
purpose (the “Warrant Register”), in the name of the record Holder hereof from time to time. The Company may
deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any
distribution to the Holder, and for all other purposes, absent actual notice to the contrary.
Section 5. Miscellaneous.
a)
No Rights as Stockholder Until Exercise. This Warrant does not entitle the Holder to any voting rights, dividend
rights or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i), except as
expressly set forth in Section 3.
b)
Loss, Theft, Destruction or Mutilation of Warrant. The Company covenants that upon receipt by the Company of evidence
reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to
the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which, in
the case of the Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock
certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such
cancellation, in lieu of such Warrant or stock certificate.
c)
Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration of
any right required or granted herein shall not be a Business Day, then, such action may be taken or such right may be exercised
on the next succeeding Business Day.
d)
Authorized Shares.
The Company covenants that, during the
period the Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient number of shares
to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant. The Company further
covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of executing
stock certificates to execute and issue the necessary Warrant Shares upon the exercise of the purchase rights under this Warrant.
The Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided
herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common
Stock may be listed. The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights
represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant
Shares in accordance herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes, liens
and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously
with such issue).
Except and to the extent as waived or
consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation
or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other
voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times
in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate
to protect the rights of Holder as set forth in this Warrant against impairment. Without limiting the generality of the foregoing,
the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately
prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may
validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant and (iii) use commercially
reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction
thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.
Before taking any action which would
result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company
shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory
body or bodies having jurisdiction thereof.
e)
Jurisdiction. All questions concerning the construction, validity, enforcement and interpretation of this Warrant
shall be determined in accordance with the provisions of the Purchase Agreement.
f)
Restrictions. The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not
registered, and the Holder does not utilize cashless exercise, will have restrictions upon resale imposed by state and federal
securities laws.
g)
Nonwaiver and Expenses. No course of dealing or any delay or failure to exercise any right hereunder on the part
of Holder shall operate as a waiver of such right or otherwise prejudice the Holder’s rights, powers or remedies. Without
limiting any other provision of this Warrant or the Purchase Agreement, if the Company willfully and knowingly fails to comply
with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such
amounts as shall be sufficient to cover any costs and expenses including, but not limited to, reasonable attorneys’ fees,
including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise
enforcing any of its rights, powers or remedies hereunder.
h)
Notices. Any notice, request or other document required or permitted to be given or delivered to the Holder by the
Company shall be delivered in accordance with the notice provisions of the Purchase Agreement.
i)
Limitation of Liability. No provision hereof, in the absence of any affirmative action by the Holder to exercise
this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to
any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability
is asserted by the Company or by creditors of the Company.
j)
Remedies. The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of
damages, will be entitled to specific performance of its rights under this Warrant. The Company agrees that monetary damages would
not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees
to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.
k)
Successors and Assigns. Subject to applicable securities laws, this Warrant and the rights and obligations evidenced
hereby shall inure to the benefit of and be binding upon the successors and permitted assigns of the Company and the successors
and permitted assigns of Holder. The provisions of this Warrant are intended to be for the benefit of any Holder from time to time
of this Warrant and shall be enforceable by the Holder or holder of Warrant Shares.
l)
Amendment. This Warrant may be modified or amended or the provisions hereof waived with the written consent of the
Company and the Holder.
m)
Severability. Wherever possible, each provision of this Warrant shall be interpreted in such manner as to be effective
and valid under applicable law, but if any provision of this Warrant shall be prohibited by or invalid under applicable law, such
provision shall be ineffective to the extent of such prohibition or invalidity, without invalidating the remainder of such provisions
or the remaining provisions of this Warrant.
n)
Headings. The headings used in this Warrant are for the convenience of reference only and shall not, for any purpose,
be deemed a part of this Warrant.
********************
(Signature Page Follows)
IN WITNESS WHEREOF, the Company has caused this
Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.
|
capstone therapeutics Corp.
|
|
By:__________________________________________
Name:
Title: |
NOTICE OF EXERCISE
To: capstone therapeutics
corp.
(1)
The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant
(only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer
taxes, if any.
(2)
Payment shall take the form of (check applicable box):
[ ] in lawful money of the United States
by wire transfer or cashier’s check drawn on a United States bank; or
[ ] if permitted by the terms of the
Warrant, the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection
2(c), to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise
procedure set forth in subsection 2(c).
(3)
Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:
_______________________________
The Warrant Shares shall be delivered to the following DWAC Account
Number:
_______________________________
_______________________________
_______________________________
[SIGNATURE OF HOLDER]
Name of Investing Entity: ________________________________________________________________________
Signature of Authorized Signatory of Investing Entity: _________________________________________________
Name of Authorized Signatory: ___________________________________________________________________
Title of Authorized Signatory: ____________________________________________________________________
Date: ________________________________________________________________________________________
EXHIBIT B
ASSIGNMENT FORM
(To assign the foregoing Warrant, execute
this form and supply required information. Do not use this form to purchase shares.)
FOR VALUE RECEIVED, the foregoing Warrant and
all rights evidenced thereby are hereby assigned to
Name: |
____________________________________ |
|
(Please Print) |
Address: |
|
Phone Number:
Email Address: |
(Please Print)
______________________________________
______________________________________
|
Dated: _______________ __, ______ |
|
Holder’s
Signature: ______________ |
|
Holder’s
Address: _______________ |
|
Exhibit 10.32
SECURITIES
PURCHASE AGREEMENT
This Securities Purchase Agreement (this “Agreement”)
is dated as of ____, 2015, among Capstone Therapeutics Corp., a Delaware corporation (the “Company”), and each
purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser”
and collectively the “Purchasers”).
WHEREAS, subject to the terms and conditions
set forth in this Agreement and pursuant to an effective registration statement under the Securities Act of 1933, as amended (the
“Securities Act”), the Company desires to issue and sell to each Purchaser, and each Purchaser, severally and
not jointly, desires to purchase from the Company, securities of the Company as more fully described in this Agreement.
NOW, THEREFORE, IN CONSIDERATION of the mutual
covenants contained in this Agreement, and for other good and valuable consideration the receipt and adequacy of which are hereby
acknowledged, the Company and each Purchaser agree as follows:
ARTICLE I.
DEFINITIONS
1.1
Definitions. In addition to the terms defined elsewhere in this Agreement, for all purposes of this Agreement, the
following terms have the meanings set forth in this Section 1.1:
“Acquiring Person” shall
have the meaning ascribed to such term in Section 4.5.
“Action” shall
have the meaning ascribed to such term in Section 3.1(j).
“Affiliate” means
any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control
with a Person as such terms are used in and construed under Rule 405 under the Securities Act.
“Board of Directors”
means the board of directors of the Company.
“Business Day”
means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which
banking institutions in the State of New York are authorized or required by law or other governmental action to close.
“Closing” means
the closing of the purchase and sale of the Securities pursuant to Section 2.1.
“Closing Date”
means the Trading Day on which all of the Transaction Documents have been executed and delivered by the applicable parties thereto,
and all conditions precedent to (i) the Purchasers’ obligations to pay the Subscription Amount and (ii) the Company’s
obligations to deliver the Securities, in each case, have been satisfied or waived, but in no event later than the third Trading
Day following the date hereof.
“Commission” means
the United States Securities and Exchange Commission.
“Common Stock”
means the common stock of the Company, par value $0.0005 per share, and any other class of securities into which such securities
may hereafter be reclassified or changed.
“Common Stock Equivalents”
means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock,
including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible
into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.
“Company Counsel”
means Quarles & Brady LLP, with offices located at One Renaissance Square, Two North Central Avenue, Phoenix, Arizona 85004-2391.
“Disclosure Schedules”
means the Disclosure Schedules of the Company delivered concurrently herewith.
“EGS” means Ellenoff
Grossman & Schole LLP, with offices located at 1345 Avenue of the Americas, New York, New York 10105-0302.
“Escrow Agent”
means Signature Bank, a New York State chartered bank, with offices at 261 Madison Avenue, New York, New York 10016.
“Escrow Agreement”
means the escrow agreement entered into prior to the date hereof, by and among the Company, the Escrow Agent and the placement
agent pursuant to which the Purchasers shall deposit Subscription Amounts with the Escrow Agent to be applied to the transactions
contemplated hereunder.
“Evaluation Date”
shall have the meaning ascribed to such term in Section 3.1(s).
“Exchange Act”
means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
“Exempt Issuance”
means the issuance of (a) shares of Common Stock or options to employees, officers, directors, consultants or contractors of the
Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board
of Directors or a majority of the members of a committee of non-employee directors established for such purpose for services rendered
to the Company, (b) securities upon the exercise or exchange of or conversion of any Securities issued hereunder and/or other securities
exercisable or exchangeable for or convertible into shares of Common Stock issued and outstanding on the date of this Agreement,
provided that such securities have not been amended since the date of this Agreement to increase the number of such securities
or to decrease the exercise price, exchange price or conversion price of such securities (other than in connection with stock splits
or combinations) or to extend the term of such securities, (c) securities issued pursuant to acquisitions or strategic transactions
approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a Person
(or to the equityholders of a Person) which is, itself or through its subsidiaries, an operating company or an owner of an asset
in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to
the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose
of raising capital or to an entity whose primary business is investing in securities, and (d) securities issued in connection
with any stock split, stock dividend or recapitalization.
“FCPA” means the
Foreign Corrupt Practices Act of 1977, as amended.
“FDA” shall have
the meaning ascribed to such term in Section 3.1(hh).
“FDCA” shall have
the meaning ascribed to such term in Section 3.1(hh).
“GAAP” shall have
the meaning ascribed to such term in Section 3.1(h).
“Indebtedness”
shall have the meaning ascribed to such term in Section 3.1(aa).
“Intellectual Property Rights”
shall have the meaning ascribed to such term in Section 3.1(p).
“Liens” means a
lien, charge, pledge, security interest, encumbrance, right of first refusal, preemptive right or other restriction.
“Material Adverse Effect”
shall have the meaning assigned to such term in Section 3.1(b).
“Material Permits”
shall have the meaning ascribed to such term in Section 3.1(n).
“Participation Maximum”
shall have the meaning ascribed to such term in Section 4.11(a).
“Per Share Purchase Price”
equals $_______, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar
transactions of the Common Stock that occur after the date of this Agreement.
“Person” means
an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability
company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
“Pharmaceutical Product”
shall have the meaning ascribed to such term in Section 3.1(hh).
“Placement Agent”
means H.C. Wainwright & Co., LLC.
“Pre-existing 5% Stockholder”
means any Purchaser that (together with such Purchaser’s Affiliates, and any other Persons acting as a group together with
such Purchaser or any of such Purchaser’s Affiliates) immediately prior to the Closing beneficially owns, for purposes of
Section 382 of the Internal Revenue Code of 1986, as amended, shares of Common Stock in excess of 4.99% of the outstanding shares
of Common Stock or voting power of the Company.
“Pre-Notice” shall
have the meaning ascribed to such term in Section 4.11(b).
“Pro Rata Portion”
shall have the meaning ascribed to such term in Section 4.11(e).
“Proceeding” means
an action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding,
such as a deposition), whether commenced or threatened.
“Prospectus” means
the final prospectus filed for the Registration Statement.
“Prospectus Supplement”
means the supplement to the Prospectus complying with Rule 430A of the Securities Act that is filed with the Commission and delivered
by the Company to each Purchaser at the Closing.
“Purchaser Party”
shall have the meaning ascribed to such term in Section 4.8.
“Registration Statement”
means the effective registration statement with Commission file No. 333-205261 which registers the sale of the Shares, the Warrants
and the Warrant Shares to the Purchasers.
“Required Approvals”
shall have the meaning ascribed to such term in Section 3.1(e).
“Rule 144” means
Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to
time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as
such Rule.
“Rule 424” means
Rule 424 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to
time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as
such Rule.
“Rule 430A” means
Rule 430A promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to
time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as
such Rule
“SEC Reports” shall
have the meaning ascribed to such term in Section 3.1(h).
“Securities” means
the Shares, the Warrants and the Warrant Shares.
“Securities Act”
means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
“Shares” means
the shares of Common Stock issued or issuable to each Purchaser pursuant to this Agreement.
“Short Sales” means
all “short sales” as defined in Rule 200 of Regulation SHO under the Exchange Act (but shall not be deemed to include
the location and/or reservation of borrowable shares of Common Stock).
“Subscription Amount”
means, as to each Purchaser, the aggregate amount to be paid for Shares and Warrants purchased hereunder as specified below such
Purchaser’s name on the signature page of this Agreement and next to the heading “Subscription Amount,” in United
States dollars and in immediately available funds.
“Subsequent Financing”
shall have the meaning ascribed to such term in Section 4.11(a).
“Subsequent Financing Notice”
shall have the meaning ascribed to such term in Section 4.11(b).
“Subsidiary” means
any subsidiary of the Company as set forth on Schedule 3.1(a), and shall, where applicable, also include any direct or indirect
subsidiary of the Company formed or acquired after the date hereof.
“Trading Day” means
a day on which the principal Trading Market is open for trading.
“Trading Market”
means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question:
the NYSE MKT, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, the New York Stock Exchange,
OTCQB or OTCQX (or any successors to any of the foregoing).
“Transaction Documents”
means this Agreement, the Warrants and any other documents or agreements executed in connection with the transactions contemplated
hereunder.
“Transfer Agent”
means Computershare Inc., the current transfer agent of the Company, with a mailing address of 480 Washington Boulevard, Jersey
City, New Jersey 07310 and a facsimile number of (201) 680-4606, and any successor transfer agent of the Company.
“Variable Rate Transaction”
shall have the meaning ascribed to such term in Section 4.12(b).
“Warrants” means,
collectively, the Common Stock purchase warrants delivered to the Purchasers at the Closing in accordance with Section 2.2(a) hereof,
which Warrants shall be exercisable immediately and have a term of exercise equal to five years, in the form of Exhibit A
attached hereto.
“Warrant Shares”
means the shares of Common Stock issuable upon exercise of the Warrants.
ARTICLE II.
PURCHASE AND SALE
2.1
Closing. On the Closing Date, upon the terms and subject to the conditions set forth herein, substantially concurrent
with the execution and delivery of this Agreement by the parties hereto, the Company agrees to sell, and the Purchasers, severally
and not jointly, agree to purchase, up to an aggregate of $___,000,000 of Shares and Warrants. Each Purchaser shall deliver to
the Escrow Agent (subject to the last sentence of this Section 2.1), via wire transfer or a certified check, immediately available
funds equal to such Purchaser’s Subscription Amount as set forth on the signature page hereto executed by such Purchaser
and the Company shall deliver to each Purchaser its respective Shares and a Warrant as determined pursuant to Section 2.2(a), and
the Company and each Purchaser shall deliver the other items set forth in Section 2.2 deliverable at the Closing. Upon satisfaction
of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of EGS or such other
location as the parties shall mutually agree. Unless otherwise directed by the Placement Agent, settlement of the Shares shall
occur via “Delivery Versus Payment” (“DVP”) (i.e., on the Closing Date, the Company shall
issue the Shares registered in the Purchasers’ names and addresses and released by the Transfer Agent directly to the account(s)
at the Placement Agent identified by each Purchaser; whereupon payment therefor shall be made by wire transfer to the Company).
2.2
Deliveries.
(a)
On or prior to the Closing Date, the Company shall deliver or cause to be delivered to each Purchaser the following:
(i)
this Agreement duly executed by the Company;
(ii)
a legal opinion of Company Counsel, substantially in the form of Exhibit B attached hereto;
(iii)
subject to the last sentence of Section 2.1, a copy of the irrevocable instructions to the Transfer Agent instructing the
Transfer Agent to deliver on an expedited basis via The Depository Trust Company Deposit or Withdrawal at Custodian system (“DWAC”)
Shares equal to such Purchaser’s Subscription Amount divided by the Per Share Purchase Price, registered in the name of such
Purchaser;
(iv)
a Warrant registered in the name of such Purchaser to purchase up to a number of shares of Common Stock equal to ___% of
such Purchaser’s Shares, with an exercise price equal to $_____, subject to adjustment therein (such Warrant certificate
may be delivered within three Trading Days after the Closing Date); and
(v)
the Prospectus and Prospectus Supplement (which may be delivered in accordance with Rule 172 under the Securities Act).
(b)
On or prior to the Closing Date, each Purchaser shall deliver or cause to be delivered to the Company or the Escrow Agent,
as applicable, the following:
(i)
this Agreement duly executed by such Purchaser; and
(ii)
to the Escrow Agent, such Purchaser’s Subscription Amount by wire transfer to the account specified in writing by
the Escrow Agreement or as otherwise directed by the Placement Agent for delivery to the account of the Company.
2.3
Closing Conditions.
(a) The obligations of the Company
hereunder in connection with the Closing are subject to the following conditions being met:
(i)
the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material
Adverse Effect, in all respects) on the Closing Date of the representations and warranties of the Purchasers contained herein (unless
as of a specific date therein in which case they shall be accurate as of such date);
(ii)
all obligations, covenants and agreements of each Purchaser required to be performed at or prior to the Closing Date shall
have been performed; and
(iii)
the delivery by each Purchaser of the items set forth in Section 2.2(b) of this Agreement.
(b)
The respective obligations of the Purchasers hereunder in connection with the Closing are subject to the following conditions
being met:
(i)
the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material
Adverse Effect, in all respects) when made and on the Closing Date of the representations and warranties of the Company contained
herein (unless as of a specific date therein);
(ii)
all obligations, covenants and agreements of the Company required to be performed at or prior to the Closing Date shall
have been performed;
(iii)
the delivery by the Company of the items set forth in Section 2.2(a) of this Agreement;
(iv)
there shall have been no Material Adverse Effect with respect to the Company since the date hereof; and
(v)
from the date hereof to the Closing Date, trading in the Common Stock shall not have been suspended by the Commission or
the Company’s principal Trading Market, and, at any time prior to the Closing Date, trading in securities generally as reported
by Bloomberg L.P. shall not have been suspended or limited, or minimum prices shall not have been established on securities whose
trades are reported by such service, or on any Trading Market, nor shall a banking moratorium have been declared either by the
United States or New York State authorities nor shall there have occurred any material outbreak or escalation of hostilities or
other national or international calamity of such magnitude in its effect on, or any material adverse change in, any financial market
which, in each case, in the reasonable judgment of such Purchaser, makes it impracticable or inadvisable to purchase the Securities
at the Closing.
ARTICLE III.
REPRESENTATIONS AND WARRANTIES
3.1
Representations and Warranties of the Company. Except as set forth in the Disclosure Schedules, which Disclosure
Schedules shall be deemed a part hereof and shall qualify any representation or otherwise made herein to the extent of the disclosure
contained in the corresponding section of the Disclosure Schedules, the Company hereby makes the following representations and
warranties to each Purchaser:
(a)
Subsidiaries. All of the direct and indirect subsidiaries of the Company are set forth on Schedule 3.1(a).
Except as set forth on Schedule 3.1(a), the Company owns, directly or indirectly, all of the capital stock or other equity
interests of each Subsidiary free and clear of any Liens, and all of the issued and outstanding shares of capital stock of each
Subsidiary are validly issued and are fully paid, non-assessable and free of preemptive and similar rights to subscribe for or
purchase securities. If the Company has no subsidiaries, all other references to the Subsidiaries or any of them in the Transaction
Documents shall be disregarded.
(b)
Organization and Qualification. The Company and each of the Subsidiaries is an entity duly incorporated or otherwise
organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization, with
the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted.
Neither the Company nor any Subsidiary is in violation nor default of any of the provisions of its respective certificate or articles
of incorporation, bylaws or other organizational or charter documents. Each of the Company and the Subsidiaries is duly qualified
to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of
the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified
or in good standing, as the case may be, could not have or reasonably be expected to result in: (i) a material adverse effect on
the legality, validity or enforceability of any Transaction Document, (ii) a material adverse effect on the results of operations,
assets, business, prospects or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii)
a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under
any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse Effect”) and no Proceeding has been
instituted in any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority
or qualification.
(c)
Authorization; Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate
the transactions contemplated by this Agreement and each of the other Transaction Documents and otherwise to carry out its obligations
hereunder and thereunder. The execution and delivery of this Agreement and each of the other Transaction Documents by the Company
and the consummation by it of the transactions contemplated hereby and thereby have been duly authorized by all necessary action
on the part of the Company and no further action is required by the Company, the Board of Directors or the Company’s stockholders
in connection herewith or therewith other than in connection with the Required Approvals. This Agreement and each other Transaction
Document to which it is a party has been (or upon delivery will have been) duly executed by the Company and, when delivered in
accordance with the terms hereof and thereof, will constitute the valid and binding obligation of the Company enforceable against
the Company in accordance with its terms, except (i) as limited by general equitable principles and applicable bankruptcy, insolvency,
reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, (ii)
as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and (iii)
insofar as indemnification and contribution provisions may be limited by applicable law.
(d)
No Conflicts. The execution, delivery and performance by the Company of this Agreement and the other Transaction
Documents to which it is a party, the issuance and sale of the Securities and the consummation by it of the transactions contemplated
hereby and thereby do not and will not (i) conflict with or violate any provision of the Company’s or any Subsidiary’s
certificate or articles of incorporation, bylaws or other organizational or charter documents, or (ii) conflict with, or constitute
a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any Lien
upon any of the properties or assets of the Company or any Subsidiary, or give to others any rights of termination, amendment,
acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other
instrument (evidencing a Company or Subsidiary debt or otherwise) or other understanding to which the Company or any Subsidiary
is a party or by which any property or asset of the Company or any Subsidiary is bound or affected, or (iii) subject to the Required
Approvals, conflict with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction
of any court or governmental authority to which the Company or a Subsidiary is subject (including federal and state securities
laws and regulations), or by which any property or asset of the Company or a Subsidiary is bound or affected; except in the case
of each of clauses (ii) and (iii), such as could not have or reasonably be expected to result in a Material Adverse Effect.
(e)
Filings, Consents and Approvals. The Company is not required to obtain any consent, waiver, authorization or order
of, give any notice to, or make any filing or registration with, any court or other federal, state, local or other governmental
authority or other Person in connection with the execution, delivery and performance by the Company of the Transaction Documents,
other than consents and waivers that have already been obtained and other than: (i) the filings required pursuant to Section 4.4
of this Agreement, (ii) the filing with the Commission of the Prospectus Supplement, (iii) application(s) to each applicable Trading
Market for the listing of the Shares and Warrant Shares for trading thereon in the time and manner required thereby and (iv) such
filings as are required to be made under applicable state securities laws (collectively, the “Required Approvals”).
(f)
Issuance of the Securities; Registration. The Securities are duly authorized and, when issued and paid for in accordance
with the applicable Transaction Documents, will be duly and validly issued, fully paid and nonassessable, free and clear of all
Liens imposed by the Company. The Warrant Shares, when issued in accordance with the terms of the Warrants, will be validly issued,
fully paid and nonassessable, free and clear of all Liens imposed by the Company. The Company has reserved from its duly authorized
capital stock the maximum number of shares of Common Stock issuable pursuant to this Agreement and the Warrants. The Company has
prepared and filed the Registration Statement in conformity with the requirements of the Securities Act, which became effective
on _____________, 2015 (the “Effective Date”), including the Prospectus, and such amendments and supplements
thereto as may have been required to the date of this Agreement. The Registration Statement is effective under the Securities Act
and no stop order preventing or suspending the effectiveness of the Registration Statement or suspending or preventing the use
of the Prospectus has been issued by the Commission and no proceedings for that purpose have been instituted or, to the knowledge
of the Company, are threatened by the Commission. The Company, if required by the rules and regulations of the Commission, shall
file the Prospectus with the Commission pursuant to Rule 424(b) and Rule 430A. At the time the Registration Statement and any amendments
thereto became effective, at the date of this Agreement and at the Closing Date, the Registration Statement and any amendments
thereto conformed and will conform in all material respects to the requirements of the Securities Act and did not and will not
contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to
make the statements therein not misleading; and the Prospectus and any amendments or supplements thereto, at time the Prospectus
or any amendment or supplement thereto was issued and at the Closing Date, conformed and will conform in all material respects
to the requirements of the Securities Act and did not and will not contain an untrue statement of a material fact or omit to state
a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not
misleading.
(g)
Capitalization. The capitalization of the Company is as set forth on Schedule 3.1(g). The Company has not
issued any capital stock since its most recently filed periodic report under the Exchange Act, other than pursuant to the exercise
of employee stock options under the Company’s stock option plans, the issuance of shares of Common Stock to employees pursuant
to the Company’s employee stock purchase plans and pursuant to the conversion and/or exercise of Common Stock Equivalents
outstanding as of the date of the most recently filed periodic report under the Exchange Act. No Person has any right of first
refusal, preemptive right, right of participation, or any similar right to participate in the transactions contemplated by the
Transaction Documents. Except as a result of the purchase and sale of the Securities or as set forth on Schedule 3.1(g),
there are no outstanding options, warrants, scrip rights to subscribe to, calls or commitments of any character whatsoever relating
to, or securities, rights or obligations convertible into or exercisable or exchangeable for, or giving any Person any right to
subscribe for or acquire, any shares of Common Stock or the capital stock of any Subsidiary, or contracts, commitments, understandings
or arrangements by which the Company or any Subsidiary is or may become bound to issue additional shares of Common Stock or Common
Stock Equivalents or capital stock of any Subsidiary. The issuance and sale of the Securities will not obligate the Company or
any Subsidiary to issue shares of Common Stock or other securities to any Person (other than the Purchasers) and will not result
in a right of any holder of Company securities to adjust the exercise, conversion, exchange or reset price under any of such securities.
There are no outstanding securities or instruments of the Company or any Subsidiary that contain any redemption or similar provisions,
and there are no contracts, commitments, understandings or arrangements by which the Company or any Subsidiary is or may become
bound to redeem a security of the Company or such Subsidiary. The Company does not have any stock appreciation rights or “phantom
stock” plans or agreements or any similar plan or agreement. All of the outstanding shares of capital stock of the Company
are duly authorized, validly issued, fully paid and nonassessable, have been issued in compliance with all federal and state securities
laws, and none of such outstanding shares was issued in violation of any preemptive rights or similar rights to subscribe for or
purchase securities. No further approval or authorization of any stockholder, the Board of Directors or others is required for
the issuance and sale of the Securities. Except as set forth on Schedule 3.1(g), there are no stockholders agreements, voting
agreements or other similar agreements with respect to the Company’s capital stock to which the Company is a party or, to
the knowledge of the Company, between or among any of the Company’s stockholders.
(h)
SEC Reports; Financial Statements. The Company has filed all reports, schedules, forms, statements and other documents
required to be filed by the Company under the Securities Act and the Exchange Act, including pursuant to Section 13(a) or 15(d)
thereof, for the two years preceding the date hereof (or such shorter period as the Company was required by law or regulation to
file such material) (the foregoing materials, including the exhibits thereto and documents incorporated by reference therein, together
with the Prospectus and the Prospectus Supplement, being collectively referred to herein as the “SEC Reports”)
on a timely basis or has received a valid extension of such time of filing and has filed any such SEC Reports prior to the expiration
of any such extension. As of their respective dates, the SEC Reports complied in all material respects with the requirements of
the Securities Act and the Exchange Act, as applicable, and none of the SEC Reports, when filed, contained any untrue statement
of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements
therein, in the light of the circumstances under which they were made, not misleading. The Company has not been an issuer subject
to Rule 144(i) under the Securities Act at any time during the five years preceding the date hereof. The financial statements of
the Company included in the SEC Reports comply in all material respects with applicable accounting requirements and the rules and
regulations of the Commission with respect thereto as in effect at the time of filing. Such financial statements have been prepared
in accordance with United States generally accepted accounting principles applied on a consistent basis during the periods involved
(“GAAP”), except as may be otherwise specified in such financial statements or the notes thereto and except
that unaudited financial statements may not contain all footnotes required by GAAP, and fairly present in all material respects
the financial position of the Company and its consolidated Subsidiaries as of and for the dates thereof and the results of operations
and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit
adjustments.
(i)
Material Changes; Undisclosed Events, Liabilities or Developments. Since the date of the latest audited financial
statements included within the SEC Reports, except as specifically disclosed in a subsequent SEC Report filed prior to the date
hereof, (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a
Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables
and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required
to be reflected in the Company’s financial statements pursuant to GAAP or disclosed in filings made with the Commission,
(iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution
of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of
its capital stock and (v) the Company has not issued any equity securities to any officer, director or Affiliate, except pursuant
to existing Company stock option plans. The Company does not have pending before the Commission any request for confidential treatment
of information. Except for the issuance of the Securities contemplated by this Agreement or as set forth on Schedule 3.1(i),
no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur or
exist with respect to the Company or its Subsidiaries or their respective businesses, prospects, properties, operations, assets
or financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this
representation is made or deemed made that has not been publicly disclosed at least 1 Trading Day prior to the date that this representation
is made.
(j)
Litigation. Except as set forth on Schedule 3.1(j), there is no action, suit, inquiry, notice of violation,
proceeding or investigation pending or, to the knowledge of the Company, threatened against or affecting the Company, any Subsidiary
or any of their respective properties before or by any court, arbitrator, governmental or administrative agency or regulatory authority
(federal, state, county, local or foreign) (collectively, an “Action”) which (i) adversely affects or challenges
the legality, validity or enforceability of any of the Transaction Documents or the Securities or (ii) could, if there were an
unfavorable decision, have or reasonably be expected to result in a Material Adverse Effect. Neither the Company nor any Subsidiary,
nor any director or officer thereof, is or has been the subject of any Action involving a claim of violation of or liability under
federal or state securities laws or a claim of breach of fiduciary duty. There has not been, and to the knowledge of the Company,
there is not pending or contemplated, any investigation by the Commission involving the Company or any current or former director
or officer of the Company. The Commission has not issued any stop order or other order suspending the effectiveness of any registration
statement filed by the Company or any Subsidiary under the Exchange Act or the Securities Act.
(k)
Labor Relations. No material labor dispute exists or, to the knowledge of the Company, is imminent with respect to
any of the employees of the Company, which could reasonably be expected to result in a Material Adverse Effect. None of the Company’s
or its Subsidiaries’ employees is a member of a union that relates to such employee’s relationship with the Company
or such Subsidiary, and neither the Company nor any of its Subsidiaries is a party to a collective bargaining agreement, and the
Company and its Subsidiaries believe that their relationships with their employees are good. To the knowledge of the Company, no
executive officer of the Company or any Subsidiary, is, or is now expected to be, in violation of any material term of any employment
contract, confidentiality, disclosure or proprietary information agreement or non-competition agreement, or any other contract
or agreement or any restrictive covenant in favor of any third party, and the continued employment of each such executive officer
does not subject the Company or any of its Subsidiaries to any liability with respect to any of the foregoing matters. The Company
and its Subsidiaries are in compliance with all U.S. federal, state, local and foreign laws and regulations relating to employment
and employment practices, terms and conditions of employment and wages and hours, except where the failure to be in compliance
could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(l)
Compliance. Neither the Company nor any Subsidiary: (i) is in default under or in violation of (and no event has
occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company or any Subsidiary
under), nor has the Company or any Subsidiary received notice of a claim that it is in default under or that it is in violation
of, any indenture, loan or credit agreement or any other agreement or instrument to which it is a party or by which it or any of
its properties is bound (whether or not such default or violation has been waived), (ii) is in violation of any judgment, decree
or order of any court, arbitrator or other governmental authority or (iii) is or has been in violation of any statute, rule, ordinance
or regulation of any governmental authority, including without limitation all foreign, federal, state and local laws relating to
taxes, environmental protection, occupational health and safety, product quality and safety and employment and labor matters, except
in each case as could not have or reasonably be expected to result in a Material Adverse Effect.
(m)
Environmental Laws. The Company and its Subsidiaries (i) are in compliance with all federal, state, local and
foreign laws relating to pollution or protection of human health or the environment (including ambient air, surface water, groundwater,
land surface or subsurface strata), including laws relating to emissions, discharges, releases or threatened releases of chemicals,
pollutants, contaminants, or toxic or hazardous substances or wastes (collectively, “Hazardous Materials”) into
the environment, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport
or handling of Hazardous Materials, as well as all authorizations, codes, decrees, demands, or demand letters, injunctions, judgments,
licenses, notices or notice letters, orders, permits, plans or regulations, issued, entered, promulgated or approved thereunder
(“Environmental Laws”); (ii) have received all permits licenses or other approvals required of them under applicable
Environmental Laws to conduct their respective businesses; and (iii) are in compliance with all terms and conditions of any such
permit, license or approval where in each clause (i), (ii) and (iii), the failure to so comply could be reasonably expected to
have, individually or in the aggregate, a Material Adverse Effect.
(n)
Regulatory Permits. The Company and the Subsidiaries possess all certificates, authorizations and permits issued
by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as
described in the SEC Reports, except where the failure to possess such permits could not reasonably be expected to result in a
Material Adverse Effect (“Material Permits”), and neither the Company nor any Subsidiary has received any notice
of proceedings relating to the revocation or modification of any Material Permit.
(o)
Title to Assets. The Company and the Subsidiaries have good and marketable title in fee simple to all real property
owned by them and good and marketable title in all personal property owned by them that is material to the business of the Company
and the Subsidiaries, in each case free and clear of all Liens, except for (i) Liens as do not materially affect the value of such
property and do not materially interfere with the use made and proposed to be made of such property by the Company and the Subsidiaries
and (ii) Liens for the payment of federal, state or other taxes, for which appropriate reserves have been made therefor in accordance
with GAAP and, the payment of which is neither delinquent nor subject to penalties. Any real property and facilities held under
lease by the Company and the Subsidiaries are held by them under valid, subsisting and enforceable leases with which the Company
and the Subsidiaries are in compliance in all material respects.
(p)
Intellectual Property. The Company and the Subsidiaries have, or have rights to use, all patents, patent applications,
trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual
property rights and similar rights necessary or required for use in connection with their respective businesses as described in
the SEC Reports and which the failure to so have could have a Material Adverse Effect (collectively, the “Intellectual
Property Rights”). Except as set forth on Schedule 3.1(p), none of, and neither the Company nor any Subsidiary
has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired, terminated or been abandoned,
or is expected to expire or terminate or be abandoned, within two (2) years from the date of this Agreement. Neither the Company
nor any Subsidiary has received, since the date of the latest audited financial statements included within the SEC Reports, a written
notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe upon the rights of any
Person, except as could not have or reasonably be expected to not have a Material Adverse Effect. To the knowledge of the Company,
all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any of the Intellectual
Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality
and value of all of their Intellectual Property Rights, except where failure to do so could not, individually or in the aggregate,
reasonably be expected to have a Material Adverse Effect.
(q)
Insurance. The Company and the Subsidiaries are insured by insurers of recognized financial responsibility against
such losses and risks and in such amounts as are prudent and customary in the businesses in which the Company and the Subsidiaries
are engaged, including, but not limited to, directors and officers insurance coverage at least equal to $5,000,000. Neither the
Company nor any Subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when
such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without
a significant increase in cost.
(r)
Transactions With Affiliates and Employees. Except as set forth in the SEC Reports or on Schedule 3.1(r),
none of the officers or directors of the Company or any Subsidiary and, to the knowledge of the Company, none of the employees
of the Company or any Subsidiary is presently a party to any transaction with the Company or any Subsidiary (other than for services
as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services
to or by, providing for rental of real or personal property to or from, providing for the borrowing of money from or lending of
money to or otherwise requiring payments to or from any officer, director or such employee or, to the knowledge of the Company,
any entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee,
stockholder, member or partner, in each case in excess of $120,000 other than for (i) payment of salary or consulting fees for
services rendered, (ii) reimbursement for expenses incurred on behalf of the Company and (iii) other employee benefits, including
stock option agreements under any stock option plan of the Company.
(s)
Sarbanes-Oxley; Internal Accounting Controls. Except as set forth on Schedule 3.1(s), the Company and the
Subsidiaries are in compliance with any and all applicable requirements of the Sarbanes-Oxley Act of 2002 that are effective as
of the date hereof, and any and all applicable rules and regulations promulgated by the Commission thereunder that are effective
as of the date hereof and as of the Closing Date. Except as set forth on Schedule 3.1(s), the Company and the Subsidiaries
maintain a system of internal accounting controls sufficient to provide reasonable assurance that: (i) transactions are executed
in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit
preparation of financial statements in conformity with GAAP and to maintain asset accountability, (iii) access to assets is permitted
only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is
compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. Except
as set forth on Schedule 3.1(s), the Company and the Subsidiaries have established disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Company and the Subsidiaries and designed such disclosure controls
and procedures to ensure that information required to be disclosed by the Company in the reports it files or submits under the
Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules
and forms. The Company’s certifying officers have evaluated the effectiveness of the disclosure controls and procedures of
the Company and the Subsidiaries as of the end of the period covered by the most recently filed periodic report under the Exchange
Act (such date, the “Evaluation Date”). The Company presented in its most recently filed periodic report under
the Exchange Act the conclusions of the certifying officers about the effectiveness of the disclosure controls and procedures based
on their evaluations as of the Evaluation Date. Since the Evaluation Date, there have been no changes in the internal control over
financial reporting (as such term is defined in the Exchange Act) of the Company and its Subsidiaries that have materially affected,
or is reasonably likely to materially affect, the internal control over financial reporting of the Company and its Subsidiaries.
(t)
Certain Fees. Except as set forth in the Prospectus Supplement, no brokerage or finder’s fees or commissions
are or will be payable by the Company or any Subsidiary to any broker, financial advisor or consultant, finder, placement agent,
investment banker, bank or other Person with respect to the transactions contemplated by the Transaction Documents. The Purchasers
shall have no obligation with respect to any fees or with respect to any claims made by or on behalf of other Persons for fees
of a type contemplated in this Section that may be due in connection with the transactions contemplated by the Transaction Documents.
(u)
Investment Company. The Company is not, and is not an Affiliate of, and immediately after receipt of payment for
the Securities, will not be or be an Affiliate of, an “investment company” within the meaning of the Investment Company
Act of 1940, as amended. The Company shall conduct its business in a manner so that it will not become an “investment company”
subject to registration under the Investment Company Act of 1940, as amended.
(v)
Registration Rights. Except as set forth on Schedule 3.1(v), no Person has any right to cause the Company
or any Subsidiary to effect the registration under the Securities Act of any securities of the Company or any Subsidiary.
(w)
Listing and Maintenance Requirements. The Common Stock is registered pursuant to Section 12(b) or 12(g) of the Exchange
Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the
registration of the Common Stock under the Exchange Act nor has the Company received any notification that the Commission is contemplating
terminating such registration. The Company has not, in the 12 months preceding the date hereof, received notice from any Trading
Market on which the Common Stock is or has been listed or quoted to the effect that the Company is not in compliance with the listing
or maintenance requirements of such Trading Market. The Company is, and has no reason to believe that it will not in the foreseeable
future continue to be, in compliance with all such listing and maintenance requirements. The Common Stock is currently eligible
for electronic transfer through the Depository Trust Company or another established clearing corporation and the Company is current
in payment of the fees to the Depository Trust Company (or such other established clearing corporation) in connection with such
electronic transfer.
(x)
Application of Takeover Protections. The Company and the Board of Directors have taken all necessary action, if any,
in order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under
a rights agreement) or other similar anti-takeover provision under the Company’s certificate of incorporation (or similar
charter documents) or the laws of its state of incorporation that is or could become applicable to the Purchasers as a result of
the Purchasers and the Company fulfilling their obligations or exercising their rights under the Transaction Documents, including
without limitation as a result of the Company’s issuance of the Securities and the Purchasers’ ownership of the Securities.
(y)
Disclosure. Except with respect to the material terms and conditions of the transactions contemplated by the Transaction
Documents, the Company confirms that neither it nor any other Person acting on its behalf has provided any of the Purchasers or
their agents or counsel with any information that it believes constitutes or might constitute material, non-public information
which is not otherwise disclosed in the Prospectus Supplement. The Company understands and confirms that the Purchasers will rely
on the foregoing representation in effecting transactions in securities of the Company. All of the disclosure furnished by or on
behalf of the Company to the Purchasers regarding the Company and its Subsidiaries, their respective businesses and the transactions
contemplated hereby, including the Disclosure Schedules to this Agreement, is true and correct and does not contain any untrue
statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in light
of the circumstances under which they were made, not misleading. As of the dates on which such press releases were disseminated,
the press releases disseminated by the Company during the twelve months preceding the date of this Agreement taken as a whole do
not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary
in order to make the statements therein, in light of the circumstances under which they were made and when made, not misleading.
The Company acknowledges and agrees that no Purchaser makes or has made any representations or warranties with respect to the transactions
contemplated hereby other than those specifically set forth in Section 3.2 hereof.
(z)
No Integrated Offering. Assuming the accuracy of the Purchasers’ representations and warranties set forth in
Section 3.2, neither the Company, nor any of its Affiliates, nor any Person acting on its or their behalf has, directly or indirectly,
made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause this
offering of the Securities to be integrated with prior offerings by the Company for purposes of any applicable shareholder approval
provisions of any Trading Market on which any of the securities of the Company are listed or designated.
(aa)
Solvency. Except as set forth on Schedule 3.1(aa), based on the consolidated financial condition of the Company
as of the Closing Date, after giving effect to the receipt by the Company of the proceeds from the sale of the Securities hereunder,
(i) the fair saleable value of the Company’s assets exceeds the amount that will be required to be paid on or in respect
of the Company’s existing debts and other liabilities (including known contingent liabilities) as they mature, (ii) the Company’s
assets do not constitute unreasonably small capital to carry on its business as now conducted and as proposed to be conducted including
its capital needs taking into account the particular capital requirements of the business conducted by the Company, consolidated
and projected capital requirements and capital availability thereof, and (iii) the current cash flow of the Company, together with
the proceeds the Company would receive, were it to liquidate all of its assets, after taking into account all anticipated uses
of the cash, would be sufficient to pay all amounts on or in respect of its liabilities when such amounts are required to be paid.
The Company does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing
and amounts of cash to be payable on or in respect of its debt). The Company has no knowledge of any facts or circumstances which
lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization laws of any jurisdiction
within one year from the Closing Date. Schedule 3.1(aa) sets forth as of the date hereof all outstanding secured and unsecured
Indebtedness of the Company or any Subsidiary, or for which the Company or any Subsidiary has commitments. For the purposes of
this Agreement, “Indebtedness” means (x) any liabilities for borrowed money or amounts owed in excess of $50,000
(other than trade accounts payable incurred in the ordinary course of business), (y) all guaranties, endorsements and other contingent
obligations in respect of indebtedness of others, whether or not the same are or should be reflected in the Company’s consolidated
balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar
transactions in the ordinary course of business; and (z) the present value of any lease payments in excess of $50,000 due under
leases required to be capitalized in accordance with GAAP. Neither the Company nor any Subsidiary is in default with respect to
any Indebtedness.
(bb)
Tax Status. Except for matters that would not, individually or in the aggregate, have or reasonably be expected to
result in a Material Adverse Effect, the Company and its Subsidiaries each (i) has made or filed all United States federal, state
and local income and all foreign income and franchise tax returns, reports and declarations required by any jurisdiction to which
it is subject, (ii) has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined
to be due on such returns, reports and declarations and (iii) has set aside on its books provision reasonably adequate for the
payment of all material taxes for periods subsequent to the periods to which such returns, reports or declarations apply. There
are no unpaid taxes in any material amount claimed to be due by the taxing authority of any jurisdiction, and the officers of the
Company or of any Subsidiary know of no basis for any such claim.
(cc)
Foreign Corrupt Practices. Neither the Company nor any Subsidiary, nor to the knowledge of the Company or any Subsidiary,
any agent or other person acting on behalf of the Company or any Subsidiary, has (i) directly or indirectly, used any funds for
unlawful contributions, gifts, entertainment or other unlawful expenses related to foreign or domestic political activity, (ii)
made any unlawful payment to foreign or domestic government officials or employees or to any foreign or domestic political parties
or campaigns from corporate funds, (iii) failed to disclose fully any contribution made by the Company or any Subsidiary (or made
by any person acting on its behalf of which the Company is aware) which is in violation of law, or (iv) violated in any material
respect any provision of FCPA.
(dd)
Accountants. The Company’s accounting firm is Moss Adams LLP. To the knowledge and belief of the Company, such
accounting firm is a registered public accounting firm as required by the Exchange Act.
(ee)
Acknowledgment Regarding Purchasers’ Purchase of Securities. The Company acknowledges and agrees that each
of the Purchasers is acting solely in the capacity of an arm’s length purchaser with respect to the Transaction Documents
and the transactions contemplated thereby. The Company further acknowledges that no Purchaser is acting as a financial advisor
or fiduciary of the Company (or in any similar capacity) with respect to the Transaction Documents and the transactions contemplated
thereby and any advice given by any Purchaser or any of their respective representatives or agents in connection with the Transaction
Documents and the transactions contemplated thereby is merely incidental to the Purchasers’ purchase of the Securities. The
Company further represents to each Purchaser that the Company’s decision to enter into this Agreement and the other Transaction
Documents has been based solely on the independent evaluation of the transactions contemplated hereby by the Company and its representatives.
(ff)
Acknowledgement Regarding Purchaser’s Trading Activity. Anything in this Agreement or elsewhere herein to
the contrary notwithstanding (except for Sections 3.2(f) and 4.14 hereof), it is understood and acknowledged by the Company that:
(i) none of the Purchasers has been asked by the Company to agree, nor has any Purchaser agreed, to desist from purchasing or
selling, long and/or short, securities of the Company, or “derivative” securities based on securities issued by the
Company or to hold the Securities for any specified term; (ii) past or future open market or other transactions by any Purchaser,
specifically including, without limitation, Short Sales or “derivative” transactions, before or after the closing
of this offering or future private placement transactions, may negatively impact the market price of the Company’s publicly-traded
securities; (iii) any Purchaser, and counter-parties in “derivative” transactions to which any such Purchaser is a
party, directly or indirectly, presently may have a “short” position in the Common Stock, and (iv) each Purchaser
shall not be deemed to have any affiliation with or control over any arm’s length counter-party in any “derivative”
transaction. The Company further understands and acknowledges that (y) one or more Purchasers may engage in hedging activities
at various times during the period that the Securities are outstanding, including, without limitation, during the periods that
the value of the Warrant Shares deliverable with respect to Securities are being determined, and (z) such hedging activities (if
any) could reduce the value of the existing stockholders' equity interests in the Company at and after the time that the hedging
activities are being conducted. The Company acknowledges that such aforementioned hedging activities do not constitute a
breach of any of the Transaction Documents.
(gg)
Regulation M Compliance. The Company has not, and to its knowledge no one acting on its behalf has, (i) taken,
directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security
of the Company to facilitate the sale or resale of any of the Securities, (ii) sold, bid for, purchased, or, paid any compensation
for soliciting purchases of, any of the Securities, or (iii) paid or agreed to pay to any Person any compensation for soliciting
another to purchase any other securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to
the Company’s placement agent in connection with the placement of the Securities.
(hh)
FDA. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”)
under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured,
packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical
Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed
by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration,
investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices,
good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the
failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge,
threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint,
or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received
any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket
clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing
of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall,
suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any
Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries,
(iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent
decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws,
rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have
a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material
respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the
FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed,
produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product
being developed or proposed to be developed by the Company.
(ii)
Office of Foreign Assets Control. Neither the Company nor any Subsidiary nor, to the Company's knowledge, any director,
officer, agent, employee or affiliate of the Company or any Subsidiary is currently subject to any U.S. sanctions administered
by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”).
(jj)
U.S. Real Property Holding Corporation. The Company is not and has never been a U.S. real property holding corporation
within the meaning of Section 897 of the Internal Revenue Code of 1986, as amended, and the Company shall so certify upon Purchaser’s
request.
(kk)
Bank Holding Company Act. Neither the Company nor any of its Subsidiaries or Affiliates is subject to the Bank Holding
Company Act of 1956, as amended (the “BHCA”) and to regulation by the Board of Governors of the Federal Reserve
System (the “Federal Reserve”). Neither the Company nor any of its Subsidiaries or Affiliates owns or controls,
directly or indirectly, five percent (5%) or more of the outstanding shares of any class of voting securities or twenty-five percent
or more of the total equity of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve. Neither
the Company nor any of its Subsidiaries or Affiliates exercises a controlling influence over the management or policies of a bank
or any entity that is subject to the BHCA and to regulation by the Federal Reserve.
(ll)
Money Laundering. The operations of the Company and its Subsidiaries are and have been conducted at all times in
compliance with applicable financial record-keeping and reporting requirements of the Currency and Foreign Transactions Reporting
Act of 1970, as amended, applicable money laundering statutes and applicable rules and regulations thereunder (collectively, the
“Money Laundering Laws”), and no Action or Proceeding by or before any court or governmental agency, authority
or body or any arbitrator involving the Company or any Subsidiary with respect to the Money Laundering Laws is pending or, to the
knowledge of the Company or any Subsidiary, threatened.
3.2
Representations and Warranties of the Purchasers. Each Purchaser, for itself and for no other Purchaser, hereby represents
and warrants as of the date hereof and as of the Closing Date to the Company as follows (unless as of a specific date therein):
(a)
Organization; Authority. Such Purchaser is either an individual or an entity duly incorporated or formed, validly
existing and in good standing under the laws of the jurisdiction of its incorporation or formation with full right, corporate,
partnership, limited liability company or similar power and authority to enter into and to consummate the transactions contemplated
by this Agreement and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of this Agreement
and performance by such Purchaser of the transactions contemplated by this Agreement have been duly authorized by all necessary
corporate, partnership, limited liability company or similar action, as applicable, on the part of such Purchaser. Each Transaction
Document to which it is a party has been duly executed by such Purchaser, and when delivered by such Purchaser in accordance with
the terms hereof, will constitute the valid and legally binding obligation of such Purchaser, enforceable against it in accordance
with its terms, except: (i) as limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium
and other laws of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating
to the availability of specific performance, injunctive relief or other equitable remedies and (iii) insofar as indemnification
and contribution provisions may be limited by applicable law.
(b)
Understandings or Arrangements. Such Purchaser is acquiring the Securities as principal for its own account and has
no direct or indirect arrangement or understandings with any other persons to distribute or regarding the distribution of such
Securities (this representation and warranty not limiting such Purchaser’s right to sell the Securities pursuant to the Registration
Statement or otherwise in compliance with applicable federal and state securities laws). Such Purchaser is acquiring the Securities
hereunder in the ordinary course of its business.
(c)
Purchaser Status. At the time such Purchaser was offered the Securities, it was, and as of the date hereof it is,
and on each date on which it exercises any Warrants, it will be an “accredited investor” as defined in Rule 501under
the Securities Act.
(d)
Experience of Such Purchaser. Such Purchaser, either alone or together with its representatives, has such knowledge,
sophistication and experience in business and financial matters so as to be capable of evaluating the merits and risks of the prospective
investment in the Securities, and has so evaluated the merits and risks of such investment. Such Purchaser is able to bear the
economic risk of an investment in the Securities and, at the present time, is able to afford a complete loss of such investment.
(e)
Access to Information. Such Purchaser acknowledges that it has had the opportunity to review the Transaction Documents
(including all exhibits and schedules thereto) and the SEC Reports and has been afforded, (i) the opportunity to ask such questions
as it has deemed necessary of, and to receive answers from, representatives of the Company concerning the terms and conditions
of the offering of the Securities and the merits and risks of investing in the Securities; (ii) access to information about the
Company and its financial condition, results of operations, business, properties, management and prospects sufficient to enable
it to evaluate its investment; and (iii) the opportunity to obtain such additional information that the Company possesses or can
acquire without unreasonable effort or expense that is necessary to make an informed investment decision with respect to the investment.
Such Purchaser acknowledges and agrees that neither the Placement Agent nor any Affiliate of the Placement Agent has provided such
Purchaser with any information or advice with respect to the Securities nor is such information or advice necessary or desired.
Neither the Placement Agent nor any Affiliate has made or makes any representation as to the Company or the quality of the Securities
and the Placement Agent and any Affiliate may have acquired non-public information with respect to the Company which such Purchaser
agrees need not be provided to it. In connection with the issuance of the Securities to such Purchaser, neither the Placement
Agent nor any of its Affiliates has acted as a financial advisor or fiduciary to such Purchaser.
(f)
Certain Transactions and Confidentiality. Other than consummating the transactions contemplated hereunder, such Purchaser
has not, nor has any Person acting on behalf of or pursuant to any understanding with such Purchaser, directly or indirectly executed
any purchases or sales, including Short Sales, of the securities of the Company during the period commencing as of the time
that such Purchaser first received a term sheet (written or oral) from the Company or any other Person representing the Company
setting forth the material pricing terms of the transactions contemplated hereunder and ending immediately prior to the execution
hereof. Notwithstanding the foregoing, in the case of a Purchaser that is a multi-managed investment vehicle whereby separate portfolio
managers manage separate portions of such Purchaser’s assets and the portfolio managers have no direct knowledge of the investment
decisions made by the portfolio managers managing other portions of such Purchaser’s assets, the representation set forth
above shall only apply with respect to the portion of assets managed by the portfolio manager that made the investment decision
to purchase the Securities covered by this Agreement. Other than to other Persons party to this Agreement or to such Purchaser’s
representatives, including, without limitation, its officers, directors, partners, legal and other advisors, employees, agents
and Affiliates, such Purchaser has maintained the confidentiality of all disclosures made to it in connection with this transaction
(including the existence and terms of this transaction). Notwithstanding the foregoing, for avoidance of doubt, nothing contained
herein shall constitute a representation or warranty, or preclude any actions, with respect to the identification of the availability
of, or securing of, available shares to borrow in order to effect Short Sales or similar transactions in the future
(g)
Limited Ownership. The purchase of the Shares and Warrants issuable to such Purchaser at the Closing will not result
in such Purchaser (individually or together with any other person or entity with whom such Purchaser has identified, or will have
identified, itself as part of a “group” in a public filing made with the Commission involving the Company’s securities)
acquiring, or obtaining the right to acquire, in excess of 4.99% of the outstanding shares of Common Stock or voting power of the
Company on a post-transaction basis that assumes that the Closing shall have occurred. Such Purchaser does not presently intend
to, along or together with others, make a public filing with the Commission to disclose that it has (or that it together with such
other persons or entities have) acquired, or obtained the right to acquire, as a result of the Closing (when added to any other
securities of the Company that it or they then own or have the right to acquire), in excess of 4.99% of the outstanding shares
of Common Stock or the voting power of the Company on a post-transaction basis that assumes that the Closing shall have occurred.
For purposes of clarity, the Purchaser or any Affiliate of the Purchaser will not be required, by itself or as part of a “group”,
to file a Schedule 13G or Schedule 13D as a result of the purchase of Shares and Warrants by the Purchaser pursuant hereto. Notwithstanding
anything herein to the contrary, this Section 3.2(g) shall not apply to any Pre-Existing 5% Stockholder.
The Company acknowledges and agrees that the representations
contained in this Section 3.2 shall not modify, amend or affect such Purchaser’s right to rely on the Company’s representations
and warranties contained in this Agreement or any representations and warranties contained in any other Transaction Document or
any other document or instrument executed and/or delivered in connection with this Agreement or the consummation of the transaction
contemplated hereby.
ARTICLE IV.
OTHER AGREEMENTS OF THE PARTIES
4.1
Warrant Shares. If all or any portion of a Warrant is exercised at a time when there is an effective registration
statement to cover the issuance or resale of the Warrant Shares or if the Warrant is exercised via cashless exercise in accordance
with terms of the Warrant, the Warrant Shares issued pursuant to any such exercise shall be issued free of all legends. If at any
time following the date hereof the Registration Statement (or any subsequent registration statement registering the sale or resale
of the Warrant Shares) is not effective or is not otherwise available for the sale or resale of the Warrant Shares, the Company
shall immediately notify the holders of the Warrants in writing that such registration statement is not then effective and thereafter
shall promptly notify such holders when the registration statement is effective again and available for the sale or resale of the
Warrant Shares (it being understood and agreed that the foregoing shall not limit the ability of the Company to issue, or any Purchaser
to sell, any of the Warrant Shares in compliance with applicable federal and state securities laws). The Company shall use best
efforts to keep a registration statement (including the Registration Statement) registering the issuance or resale of the Warrant
Shares effective during the term of the Warrants.
4.2
Furnishing of Information. Until the earlier of the time that (i) no Purchaser owns Securities or (ii) the Warrants
have expired, the Company covenants to timely file (or obtain extensions in respect thereof and file within the applicable grace
period) all reports required to be filed by the Company after the date hereof pursuant to the Exchange Act even if the Company
is not then subject to the reporting requirements of the Exchange Act.
4.3
Integration. The Company shall not sell, offer for sale or solicit offers to buy or otherwise negotiate in respect
of any security (as defined in Section 2 of the Securities Act) that would be integrated with the offer or sale of the Securities
for purposes of the rules and regulations of any Trading Market such that it would require shareholder approval prior to the closing
of such other transaction unless shareholder approval is obtained before the closing of such subsequent transaction.
4.4
Securities Laws Disclosure; Publicity. The Company shall (a) by 9:00 a.m. (New York City time) on the Trading Day
immediately following the date hereof, issue a press release disclosing the material terms of the transactions contemplated hereby,
and (b) file a Current Report on Form 8-K, including the Transaction Documents as exhibits thereto, with the Commission within
the time required by the Exchange Act. From and after the issuance of such press release, the Company represents to the Purchasers
that it shall have publicly disclosed all material, non-public information delivered to any of the Purchasers by the Company or
any of its Subsidiaries, or any of their respective officers, directors, employees or agents in connection with the transactions
contemplated by the Transaction Documents. In addition, effective upon the issuance of such press release, the Company acknowledges
and agrees that any and all confidentiality or similar obligations under any agreement, whether written or oral, between the Company,
any of its Subsidiaries or any of their respective officers, directors, agents, employees or Affiliates on the one hand, and any
of the Purchasers or any of their Affiliates on the other hand, shall terminate. Notwithstanding the foregoing, the Company shall
not publicly disclose the name of any Purchaser, or include the name of any Purchaser in any filing with the Commission or any
regulatory agency or Trading Market, without the prior written consent of such Purchaser, except (a) as required by federal securities
law in connection with the filing of final Transaction Documents with the Commission and (b) to the extent such disclosure is required
by law or Trading Market regulations, in which case the Company shall provide the Purchasers with prior notice of such disclosure
permitted under this clause (b).
4.5
Shareholder Rights Plan. No claim will be made or enforced by the Company or, with the consent of the Company, any
other Person, that any Purchaser is an “Acquiring Person” under any control share acquisition, business combination,
poison pill (including any distribution under a rights agreement) or similar anti-takeover plan or arrangement in effect or hereafter
adopted by the Company, or that any Purchaser could be deemed to trigger the provisions of any such plan or arrangement, by virtue
of receiving Securities under the Transaction Documents or under any other agreement between the Company and the Purchasers.
4.6
Non-Public Information. Except with respect to the material terms and conditions of the transactions contemplated
by the Transaction Documents, which shall be disclosed pursuant to Section 4.4, the Company covenants and agrees that neither it,
nor any other Person acting on its behalf will provide any Purchaser or its agents or counsel with any information that constitutes,
or the Company reasonably believes constitutes, material non-public information, unless prior thereto such Purchaser shall have
consented to the receipt of such information and agreed with the Company to keep such information confidential. The Company understands
and confirms that each Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company.
To the extent that the Company delivers any material, non-public information to a Purchaser without such Purchaser’s consent,
the Company hereby covenants and agrees that such Purchaser shall not have any duty of confidentiality to the Company, any of its
Subsidiaries, or any of their respective officers, directors, agents, employees or Affiliates, or a duty to the Company, any of
its Subsidiaries or any of their respective officers, directors, agents, employees or Affiliates not to trade on the basis of,
such material, non-public information, provided that the Purchaser shall remain subject to applicable law. To the extent that any
notice provided pursuant to any Transaction Document constitutes, or contains, material, non-public information regarding the Company
or any Subsidiaries, the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form
8-K. The Company understands and confirms that each Purchaser shall be relying on the foregoing covenant in effecting transactions
in securities of the Company.
4.7
Use of Proceeds. Except as set forth on Schedule 4.7 attached hereto, the Company shall use the net proceeds
from the sale of the Securities hereunder for working capital purposes and shall not use such proceeds: (a) for the satisfaction
of any portion of the Company’s debt (other than payment of trade payables in the ordinary course of the Company’s
business and prior practices), (b) for the redemption of any Common Stock or Common Stock Equivalents, (c) for the settlement of
any outstanding litigation or (d) in violation of FCPA or OFAC regulations.
4.8
Indemnification of Purchasers. Subject to the provisions of this Section 4.8, the Company will indemnify and hold
each Purchaser and its directors, officers, shareholders, members, partners, employees and agents (and any other Persons with a
functionally equivalent role of a Person holding such titles notwithstanding a lack of such title or any other title), each Person
who controls such Purchaser (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act), and the
directors, officers, shareholders, agents, members, partners or employees (and any other Persons with a functionally equivalent
role of a Person holding such titles notwithstanding a lack of such title or any other title) of such controlling persons (each,
a “Purchaser Party”) harmless from any and all losses, liabilities, obligations, claims, contingencies, damages,
costs and expenses, including all judgments, amounts paid in settlements, court costs and reasonable attorneys’ fees and
costs of investigation that any such Purchaser Party may suffer or incur as a result of or relating to (a) any breach of any of
the representations, warranties, covenants or agreements made by the Company in this Agreement or in the other Transaction Documents
or (b) any action instituted against the Purchaser Parties in any capacity, or any of them or their respective Affiliates, by any
stockholder of the Company who is not an Affiliate of such Purchaser Party, with respect to any of the transactions contemplated
by the Transaction Documents (unless such action is based upon a breach of such Purchaser Party’s representations, warranties
or covenants under the Transaction Documents or any agreements or understandings such Purchaser Party may have with any such stockholder
or any violations by such Purchaser Party of state or federal securities laws or any conduct by such Purchaser Party which constitutes
fraud, gross negligence, willful misconduct or malfeasance). If any action shall be brought against any Purchaser Party in respect
of which indemnity may be sought pursuant to this Agreement, such Purchaser Party shall promptly notify the Company in writing,
and the Company shall have the right to assume the defense thereof with counsel of its own choosing reasonably acceptable to the
Purchaser Party. Any Purchaser Party shall have the right to employ separate counsel in any such action and participate in the
defense thereof, but the fees and expenses of such counsel shall be at the expense of such Purchaser Party except to the extent
that (i) the employment thereof has been specifically authorized by the Company in writing, (ii) the Company has failed after a
reasonable period of time to assume such defense and to employ counsel or (iii) in such action there is, in the reasonable opinion
of counsel, a material conflict on any material issue between the position of the Company and the position of such Purchaser Party,
in which case the Company shall be responsible for the reasonable fees and expenses of no more than one such separate counsel.
The Company will not be liable to any Purchaser Party under this Agreement (y) for any settlement by a Purchaser Party effected
without the Company’s prior written consent, which shall not be unreasonably withheld or delayed; or (z) to the extent, but
only to the extent that a loss, claim, damage or liability is attributable to any Purchaser Party’s breach of any of the
representations, warranties, covenants or agreements made by such Purchaser Party in this Agreement or in the other Transaction
Documents. The indemnification required by this Section 4.8 shall be made by periodic payments of the amount thereof during the
course of the investigation or defense, as and when bills are received or are incurred. The indemnity agreements contained herein
shall be in addition to any cause of action or similar right of any Purchaser Party against the Company or others and any liabilities
the Company may be subject to pursuant to law.
4.9
Reservation of Common Stock. As of the date hereof, the Company has reserved and the Company shall continue to reserve
and keep available at all times, free of preemptive rights, a sufficient number of shares of Common Stock for the purpose of enabling
the Company to issue Shares pursuant to this Agreement and Warrant Shares pursuant to any exercise of the Warrants.
4.10
Listing or Quotation of Common Stock. While any Warrants remain outstanding, the Company hereby agrees to use best
efforts to maintain the listing or quotation of the Common Stock on the Trading Market on which it is currently quoted or listed,
and concurrently with the Closing, the Company shall apply to list or quote all of the Shares and Warrant Shares on such Trading
Market and promptly secure the eligibility for quotation or listing of all of the Shares and Warrant Shares on such Trading Market,
if necessary. The Company further agrees, if the Company applies to have the Common Stock traded on any other Trading Market, it
will then include in such application all of the Shares and Warrant Shares, and will take such other action as is necessary to
cause all of the Shares and Warrant Shares to be listed or quoted on such other Trading Market as promptly as possible. The Company
will then take all action reasonably necessary to continue the listing and trading of its Common Stock on a Trading Market and
will comply in all respects with the Company’s reporting, filing and other obligations under the bylaws or rules of the Trading
Market. The Company shall use best efforts to maintain the eligibility of the Common Stock for electronic transfer through the
Depository Trust Company or another established clearing corporation, including, without limitation, by timely payment of fees
to the Depository Trust Company or such other established clearing corporation in connection with such electronic transfer.
4.11
Participation in Future Financing.
(a)
From the date hereof until the date that is the _________ month anniversary of the Closing Date, upon any issuance by the
Company or any of its Subsidiaries of Common Stock or Common Stock Equivalents for cash consideration, Indebtedness or a combination
of units thereof (a “Subsequent Financing”), each Purchaser shall have the right to participate in up to an
amount of the Subsequent Financing equal to _____% of the Subsequent Financing (the “Participation Maximum”)
on the same terms, conditions and price provided for in the Subsequent Financing.
(b)
At least two (2) Trading Days prior to the closing of the Subsequent Financing, the Company shall deliver to each Purchaser
a written notice of its intention to effect a Subsequent Financing (“Pre-Notice”), which Pre-Notice shall ask
such Purchaser if it wants to review the details of such financing (such additional notice, a “Subsequent Financing Notice”).
Upon the request of a Purchaser, and only upon a request by such Purchaser, for a Subsequent Financing Notice, the Company shall
promptly, but no later than one (1) Trading Day after such request, deliver a Subsequent Financing Notice to such Purchaser.
The Subsequent Financing Notice shall describe in reasonable detail the proposed terms of such Subsequent Financing, the amount
of proceeds intended to be raised thereunder and the Person or Persons through or with whom such Subsequent Financing is proposed
to be effected and shall include a term sheet or similar document relating thereto as an attachment.
(c)
Any Purchaser desiring to participate in such Subsequent Financing must provide written notice to the Company by not later
than 5:30 p.m. (New York City time) on the second (2nd) Trading Day after all of the Purchasers have received the Pre-Notice that
such Purchaser is willing to participate in the Subsequent Financing, the amount of such Purchaser’s participation, and representing
and warranting that such Purchaser has such funds ready, willing, and available for investment on the terms set forth in the Subsequent
Financing Notice. If the Company receives no such notice from a Purchaser as of such second (2nd) Trading Day, such Purchaser shall
be deemed to have notified the Company that it does not elect to participate.
(d)
If by 5:30 p.m. (New York City time) on the second (2nd) Trading Day after all of the Purchasers have received the Pre-Notice,
notifications by the Purchasers of their willingness to participate in the Subsequent Financing (or to cause their designees to
participate) is, in the aggregate, less than the total amount of the Subsequent Financing, then the Company may effect the remaining
portion of such Subsequent Financing on the terms and with the Persons set forth in the Subsequent Financing Notice.
(e)
If by 5:30 p.m. (New York City time) on the second (2nd) Trading Day after all of the Purchasers have received the Pre-Notice,
the Company receives responses to a Subsequent Financing Notice from Purchasers seeking to purchase more than the aggregate amount
of the Participation Maximum, each such Purchaser shall have the right to purchase its Pro Rata Portion (as defined below) of the
Participation Maximum. “Pro Rata Portion” means the ratio of (x) the Subscription Amount of Securities
purchased on the Closing Date by a Purchaser participating under this Section 4.11 and (y) the sum of the aggregate Subscription
Amounts of Securities purchased on the Closing Date by all Purchasers participating under this Section 4.11.
(f)
The Company must provide the Purchasers with a second Subsequent Financing Notice, and the Purchasers will again have the
right of participation set forth above in this Section 4.11, if the Subsequent Financing subject to the initial Subsequent Financing
Notice is not consummated for any reason on the terms set forth in such Subsequent Financing Notice within thirty (30) Trading
Days after the date of the initial Subsequent Financing Notice.
(g)
The Company and each Purchaser agree that if any Purchaser elects to participate in the Subsequent Financing, the transaction
documents related to the Subsequent Financing shall not include any term or provision whereby such Purchaser shall be required
to agree to any restrictions on trading as to any of the Securities purchased hereunder or be required to consent to any amendment
to or termination of, or grant any waiver, release or the like under or in connection with, this Agreement, without the prior written
consent of such Purchaser.
(h)
Notwithstanding anything to the contrary in this Section 4.11 and unless otherwise agreed to by such Purchaser, the Company
shall either confirm in writing to such Purchaser that the transaction with respect to the Subsequent Financing has been abandoned
or shall publicly disclose its intention to issue the securities in the Subsequent Financing, in either case in such a manner such
that such Purchaser will not be in possession of any material, non-public information, by the tenth (10th) Business
Day following delivery of the Subsequent Financing Notice. If by such tenth (10th) Business Day, no public disclosure
regarding a transaction with respect to the Subsequent Financing has been made, and no notice regarding the abandonment of such
transaction has been received by such Purchaser, such transaction shall be deemed to have been abandoned and such Purchaser shall
not be deemed to be in possession of any material, non-public information with respect to the Company or any of its Subsidiaries.
(i)
Notwithstanding the foregoing, this Section 4.11 shall not apply in respect of an Exempt Issuance.
4.12
Subsequent Equity Sales.
(a)
From the date hereof until 90 days after the Closing Date, neither the Company nor any Subsidiary shall issue, enter into
any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or Common Stock Equivalents.
(b)
From the date hereof until 24 months after the Closing Date, the Company shall be prohibited from effecting or entering
into an agreement to effect any issuance by the Company or any of its Subsidiaries of Common Stock or Common Stock Equivalents
(or a combination of units thereof) involving a Variable Rate Transaction. “Variable Rate Transaction” means
a transaction in which the Company (i) issues or sells any debt or equity securities that are convertible into, exchangeable or
exercisable for, or include the right to receive additional shares of Common Stock either (A) at a conversion price, exercise price
or exchange rate or other price that is based upon and/or varies with the trading prices of or quotations for the shares of Common
Stock at any time after the initial issuance of such debt or equity securities, or (B) with a conversion, exercise or exchange
price that is subject to being reset at some future date after the initial issuance of such debt or equity security or upon the
occurrence of specified or contingent events directly or indirectly related to the business of the Company or the market for the
Common Stock or (ii) enters into any agreement, including, but not limited to, an equity line of credit, whereby the Company may
issue securities at a future determined price. Any Purchaser shall be entitled to obtain injunctive relief against the Company
to preclude any such issuance, which remedy shall be in addition to any right to collect damages.
(c)
Notwithstanding the foregoing, this Section 4.12 shall not apply in respect of an Exempt Issuance, except that no Variable
Rate Transaction shall be an Exempt Issuance.
4.13
Equal Treatment of Purchasers. No consideration (including any modification of any Transaction Document) shall be
offered or paid to any Person to amend or consent to a waiver or modification of any provision of the Transaction Documents unless
the same consideration is also offered to all of the parties to the Transaction Documents. For clarification purposes, this provision
constitutes a separate right granted to each Purchaser by the Company and negotiated separately by each Purchaser, and is intended
for the Company to treat the Purchasers as a class and shall not in any way be construed as the Purchasers acting in concert or
as a group with respect to the purchase, disposition or voting of Securities or otherwise.
4.14
Certain Transactions and Confidentiality. Each Purchaser, severally and not jointly with the other Purchasers, covenants
that neither it nor any Affiliate acting on its behalf or pursuant to any understanding with it will execute any purchases or sales,
including Short Sales of any of the Company’s securities during the period commencing with the execution of this Agreement
and ending at such time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial
press release as described in Section 4.4. Each Purchaser, severally and not jointly
with the other Purchasers, covenants that until such time as the transactions contemplated by this Agreement are publicly disclosed
by the Company pursuant to the initial press release as described in Section 4.4, such Purchaser will maintain the confidentiality
of the existence and terms of this transaction and the information included in the Disclosure Schedules. Notwithstanding
the foregoing and notwithstanding anything contained in this Agreement to the contrary, the Company expressly acknowledges and
agrees that (i) no Purchaser makes any representation, warranty or covenant hereby that it will not engage in effecting transactions
in any securities of the Company after the time that the transactions contemplated by this Agreement are first publicly announced
pursuant to the initial press release as described in Section 4.4, (ii) no Purchaser shall be restricted or prohibited from effecting
any transactions in any securities of the Company in accordance with applicable securities laws from and after the time that the
transactions contemplated by this Agreement are first publicly announced pursuant to the initial press release as described in
Section 4.4 and (iii) no Purchaser shall have any duty of confidentiality or duty not to trade in the securities of the Company
to the Company or its Subsidiaries after the issuance of the initial press release as described in Section 4.4. Notwithstanding
the foregoing, in the case of a Purchaser that is a multi-managed investment vehicle whereby separate portfolio managers manage
separate portions of such Purchaser’s assets and the portfolio managers have no direct knowledge of the investment decisions
made by the portfolio managers managing other portions of such Purchaser’s assets, the covenant set forth above shall only
apply with respect to the portion of assets managed by the portfolio manager that made the investment decision to purchase the
Securities covered by this Agreement.
4.15
Capital Changes. Until the date that is 180 days after the Closing Date, the Company shall not undertake a reverse
or forward stock split or reclassification of the Common Stock without the prior written consent of the Purchasers holding a majority
in interest of the Shares, other than a reverse stock split of the Common Stock that is necessary, in the good faith determination
of the Board of Directors, in connection with the application by the Company to list the Common Stock on a national securities
exchange.
4.16
Exercise Procedures. The form of Notice of Exercise included in the Warrants set
forth the totality of the procedures required of the Purchasers in order to exercise the Warrants. No additional legal opinion,
other information or instructions shall be required of the Purchasers to exercise their Warrants. Without limiting the preceding
sentences, no ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee
or notarization) of any Notice of Exercise form be required in order to exercise the Warrants. The Company shall honor exercises
of the Warrants and shall deliver Warrant Shares in accordance with the terms, conditions and time periods set forth in the Transaction
Documents.
ARTICLE V.
MISCELLANEOUS
5.1
Termination. This Agreement may be terminated by any Purchaser, as to such Purchaser’s obligations hereunder
only and without any effect whatsoever on the obligations between the Company and the other Purchasers, by written notice to the
other parties, if the Closing has not been consummated on or before _________ ___, 2015; provided, however, that
no such termination will affect the right of any party to sue for any breach by any other party (or parties); provided further,
however, that no Purchaser may terminate this Agreement pursuant to this Section 5.1 if the sole reason for the failure
to consummate the Closing is such Purchaser’s failure to satisfy closing conditions applicable to such Purchaser.
5.2
Fees and Expenses. Except as expressly set forth in the Transaction Documents to the contrary, each party shall pay
the fees and expenses of its advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such
party incident to the negotiation, preparation, execution, delivery and performance of this Agreement. The Company shall pay all
Transfer Agent fees (including, without limitation, any fees required for same-day processing of any instruction letter delivered
by the Company and any exercise notice delivered by a Purchaser), stamp taxes and other taxes and duties levied in connection with
the delivery of any Securities to the Purchasers.
5.3
Entire Agreement. The Transaction Documents, together with the exhibits and schedules thereto, the Prospectus and
the Prospectus Supplement, contain the entire understanding of the parties with respect to the subject matter hereof and thereof
and supersede all prior agreements and understandings, oral or written, with respect to such matters, which the parties acknowledge
have been merged into such documents, exhibits and schedules.
5.4
Notices. Any and all notices or other communications or deliveries required or permitted to be provided hereunder
shall be in writing and shall be deemed given and effective on the earliest of: (a) the date of transmission, if such notice or
communication is delivered via facsimile or email attachment at the facsimile number or email address as set forth on the signature
pages attached hereto at or prior to 5:30 p.m. (New York City time) on a Trading Day, (b) the next Trading Day after the date of
transmission, if such notice or communication is delivered via facsimile or email attachment at the facsimile number or email address
as set forth on the signature pages attached hereto on a day that is not a Trading Day or later than 5:30 p.m. (New York City time)
on any Trading Day, (c) the second (2nd) Trading Day following the date of mailing, if sent by U.S. nationally recognized
overnight courier service or (d) upon actual receipt by the party to whom such notice is required to be given. The address for
such notices and communications shall be as set forth on the signature pages attached hereto. To the extent that any notice provided
pursuant to any Transaction Document constitutes, or contains, material, non-public information regarding the Company or any Subsidiaries,
the Company shall simultaneously publicly disclose such information on a Current Report on Form 8-K that is filed with the Commission.
5.5
Amendments; Waivers. No provision of this Agreement may be waived, modified, supplemented or amended except in a
written instrument signed, in the case of an amendment, by the Company and the Purchasers who purchased at least a majority in
interest of the Shares based on the initial Subscription Amounts hereunder or, in the case of a waiver, by the party against whom
enforcement of any such waived provision is sought, provided that if any amendment, modification or waiver disproportionately and
adversely impacts a Purchaser (or several Purchasers), the consent of such disproportionately impacted Purchaser (or such Purchasers
holding at least a majority in interest of the Shares held by all such disproportionally impacted Purchasers based on the initial
Subscription Amounts hereunder) shall also be required. No waiver of any default with respect to any provision, condition or requirement
of this Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent default or a waiver of
any other provision, condition or requirement hereof, nor shall any delay or omission of any party to exercise any right hereunder
in any manner impair the exercise of any such right. Any proposed amendment or waiver that disproportionately, materially and adversely
affects the rights and obligations of any Purchaser relative to the comparable rights and obligations of the other Purchasers shall
require the prior written consent of such adversely affected Purchaser, Any amendment effected in accordance with accordance with
this Section 5.5 shall be binding upon each Purchaser and holder of Securities and the Company.
5.6
Headings. The headings herein are for convenience only, do not constitute a part of this Agreement and shall not
be deemed to limit or affect any of the provisions hereof.
5.7
Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their successors
and permitted assigns. The Company may not assign this Agreement or any rights or obligations hereunder without the prior written
consent of each Purchaser (other than by merger). Any Purchaser may assign any or all of its rights under this Agreement to any
Person to whom such Purchaser assigns or transfers any Securities, provided that such transferee agrees in writing to be bound,
with respect to the transferred Securities, by the provisions of the Transaction Documents that apply to the “Purchasers.”
5.8
No Third-Party Beneficiaries. The Placement Agent shall be the third party beneficiary of the representations and
warranties of the Company in Section 3.1 and the representations and warranties of the Purchasers in Section 3.2. This Agreement
is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit
of, nor may any provision hereof be enforced by, any other Person, except as otherwise set forth in Section 4.8 and this Section
5.8.
5.9
Governing Law. All questions concerning the construction, validity, enforcement and interpretation of the Transaction
Documents shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without
regard to the principles of conflicts of law thereof. Each party agrees that all legal Proceedings concerning the interpretations,
enforcement and defense of the transactions contemplated by this Agreement and any other Transaction Documents (whether brought
against a party hereto or its respective affiliates, directors, officers, shareholders, partners, members, employees or agents)
shall be commenced exclusively in the state and federal courts sitting in the City of New York. Each party hereby irrevocably submits
to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan for the adjudication
of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with
respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any
Action or Proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such Action or Proceeding
is improper or is an inconvenient venue for such Proceeding. Each party hereby irrevocably waives personal service of process and
consents to process being served in any such Action or Proceeding by mailing a copy thereof via registered or certified mail or
overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and
agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall
be deemed to limit in any way any right to serve process in any other manner permitted by law. If any party shall commence an Action
or Proceeding to enforce any provisions of the Transaction Documents, then, in addition to the obligations of the Company under
Section 4.8, the prevailing party in such Action or Proceeding shall be reimbursed by the non-prevailing party for its reasonable
attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such Action
or Proceeding.
5.10
Survival. The representations and warranties contained herein shall survive the Closing and the delivery of the Securities.
5.11
Execution. This Agreement may be executed in two or more counterparts, all of which when taken together shall be
considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered
to each other party, it being understood that the parties need not sign the same counterpart. In the event that any signature is
delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create
a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect
as if such facsimile or “.pdf” signature page were an original thereof.
5.12
Severability. If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction
to be invalid, illegal, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth herein
shall remain in full force and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use
their commercially reasonable efforts to find and employ an alternative means to achieve the same or substantially the same result
as that contemplated by such term, provision, covenant or restriction. It is hereby stipulated and declared to be the intention
of the parties that they would have executed the remaining terms, provisions, covenants and restrictions without including any
of such that may be hereafter declared invalid, illegal, void or unenforceable.
5.13
Rescission and Withdrawal Right. Notwithstanding anything to the contrary contained in (and without limiting any
similar provisions of) any of the other Transaction Documents, whenever any Purchaser exercises a right, election, demand or option
under a Transaction Document and the Company does not timely perform its material obligations therein within the time periods provided
therein, then such Purchaser may rescind or withdraw, in its sole discretion from time to time upon written notice to the Company,
any relevant notice, demand or election in whole or in part without prejudice to its future actions and rights, provided that,
solely with respect to such Purchaser’s right of rescission or withdrawal as described in this Section 5.13, such right of
rescission or withdrawal shall be subject to any cure period in the applicable provision of the Transaction Documents; provided,
however, that in the case of a rescission of an exercise of a Warrant, the applicable Purchaser shall be required to return
any shares of Common Stock subject to any such rescinded exercise notice concurrently with the return to such Purchaser of the
aggregate exercise price paid to the Company for such shares and the restoration of such Purchaser’s right to acquire such
shares pursuant to such Purchaser’s Warrant (including, issuance of a replacement warrant certificate evidencing such restored
right).
5.14
Replacement of Securities. If any certificate or instrument evidencing any Securities is mutilated, lost, stolen
or destroyed, the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation thereof (in
the case of mutilation), or in lieu of and substitution therefor, a new certificate or instrument, but only upon receipt of evidence
reasonably satisfactory to the Company of such loss, theft or destruction. The applicant for a new certificate or instrument under
such circumstances shall also pay any reasonable third-party costs (including customary indemnity) associated with the issuance
of such replacement Securities.
5.15
Remedies. In addition to being entitled to exercise all rights provided herein or granted by law, including recovery
of damages, each of the Purchasers and the Company will be entitled to specific performance under the Transaction Documents. The
parties agree that monetary damages may not be adequate compensation for any loss incurred by reason of any breach of obligations
contained in the Transaction Documents and hereby agree to waive and not to assert in any Action for specific performance of any
such obligation the defense that a remedy at law would be adequate.
5.16
Payment Set Aside. To the extent that the Company makes a payment or payments to any Purchaser pursuant to any Transaction
Document or a Purchaser enforces or exercises its rights thereunder, and such payment or payments or the proceeds of such enforcement
or exercise or any part thereof are subsequently invalidated, declared to be fraudulent or preferential, set aside, recovered from,
disgorged by or are required to be refunded, repaid or otherwise restored to the Company, a trustee, receiver or any other Person
under any law (including, without limitation, any bankruptcy law, state or federal law, common law or equitable cause of action),
then to the extent of any such restoration the obligation or part thereof originally intended to be satisfied shall be revived
and continued in full force and effect as if such payment had not been made or such enforcement or setoff had not occurred.
5.17
Independent Nature of Purchasers’ Obligations and Rights. The obligations of each Purchaser under any Transaction
Document are several and not joint with the obligations of any other Purchaser, and no Purchaser shall be responsible in any way
for the performance or non-performance of the obligations of any other Purchaser under any Transaction Document. Nothing contained
herein or in any other Transaction Document, and no action taken by any Purchaser pursuant hereto or thereto, shall be deemed to
constitute the Purchasers as a partnership, an association, a joint venture or any other kind of entity, or create a presumption
that the Purchasers are in any way acting in concert or as a group with respect to such obligations or the transactions contemplated
by the Transaction Documents. Each Purchaser shall be entitled to independently protect and enforce its rights including, without
limitation, the rights arising out of this Agreement or out of the other Transaction Documents, and it shall not be necessary for
any other Purchaser to be joined as an additional party in any Proceeding for such purpose. Each Purchaser has been represented
by its own separate legal counsel in its review and negotiation of the Transaction Documents. For reasons of administrative convenience
only, each Purchaser and its respective counsel have chosen to communicate with the Company through EGS. EGS does not represent
any of the Purchasers and only represents the Placement Agent. The Company has elected to provide all Purchasers with the same
terms and Transaction Documents for the convenience of the Company and not because it was required or requested to do so by any
of the Purchasers. It is expressly understood and agreed that each provision contained in this Agreement and in each other Transaction
Document is between the Company and a Purchaser, solely, and not between the Company and the Purchasers collectively and not between
and among the Purchasers.
5.18
Liquidated Damages. The Company’s obligations to pay any partial liquidated damages or other amounts owing
under the Transaction Documents is a continuing obligation of the Company and shall not terminate until all unpaid partial liquidated
damages and other amounts have been paid notwithstanding the fact that the instrument or security pursuant to which such partial
liquidated damages or other amounts are due and payable shall have been canceled.
5.19
Saturdays, Sundays, Holidays, etc. If the last or appointed day for the taking of any action or the expiration
of any right required or granted herein shall not be a Business Day, then such action may be taken or such right may be exercised
on the next succeeding Business Day.
5.20
Construction. The parties agree that each of them and/or their respective counsel have reviewed and had an opportunity
to revise the Transaction Documents and, therefore, the normal rule of construction to the effect that any ambiguities are to be
resolved against the drafting party shall not be employed in the interpretation of the Transaction Documents or any amendments
thereto. In addition, each and every reference to share prices and shares of Common Stock in any Transaction Document shall be
subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions
of the Common Stock that occur after the date of this Agreement.
5.21
WAIVER OF JURY TRIAL. IN ANY ACTION, SUIT, OR PROCEEDING IN ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY
OTHER PARTY, THE PARTIES EACH KNOWINGLY AND INTENTIONALLY, TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY ABSOLUTELY,
UNCONDITIONALLY, IRREVOCABLY AND EXPRESSLY WAIVES FOREVER TRIAL BY JURY.
(Signature Pages Follow)
IN WITNESS WHEREOF, the parties hereto have
caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated
above.
CAPSTONE THERAPEUTICS CORP.
|
Address for Notice:
1275 West Washington Street, Suite 104
Tempe, Arizona 85281
Fax: (480) 661-6262
E-mail: |
By:__________________________________________
Name:
Title:
With a copy to (which shall not constitute notice):
|
|
Steven P. Emerick
Quarles & Brady LLP
One Renaissance Square, Two North Central AvenuePhoenix, Arizona 85004
Fax: (602) 417-2980 |
|
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK
SIGNATURE PAGE FOR PURCHASER FOLLOWS]
[PURCHASER SIGNATURE PAGES TO CAPS SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused
this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated
above.
Name of Purchaser: ________________________________________________________
Signature of Authorized Signatory of Purchaser: _________________________________
Name of Authorized Signatory: _______________________________________________
Title of Authorized Signatory: ________________________________________________
Email Address of Authorized Signatory: _________________________________________
Facsimile Number of Authorized Signatory: _______________________________________
Address for Notice to Purchaser:
Address for Delivery of Securities to Purchaser (if not same as address for notice):
Subscription Amount: $_________________
Shares: _________________
Warrant Shares: __________________
EIN Number: _______________________
o Notwithstanding anything
contained in this Agreement to the contrary, by checking this box (i) the obligations of the above-signed to purchase the securities
set forth in this Agreement to be purchased from the Company by the above-signed, and the obligations of the Company to sell such
securities to the above-signed, shall be unconditional and all conditions to Closing shall be disregarded, (ii) the Closing shall
occur on the third (3rd) Trading Day following the date of this Agreement and (iii) any condition to Closing contemplated
by this Agreement (but prior to being disregarded by clause (i) above) that required delivery by the Company or the above-signed
of any agreement, instrument, certificate or the like or purchase price (as applicable) shall no longer be a condition and shall
instead be an unconditional obligation of the Company or the above-signed (as applicable) to deliver such agreement, instrument,
certificate or the like or purchase price (as applicable) to such other party on the Closing Date.
[SIGNATURE PAGES CONTINUE]
37
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