Filed Pursuant to Rule 424(b)(2)
Registration No. 333-237745
PROSPECTUS
NEUROTROPE, INC.
$100,000,000
COMMON STOCK
PREFERRED STOCK
DEBT SECURITIES
WARRANTS
RIGHTS
UNITS
This prospectus will allow us to issue,
from time to time at prices and on terms to be determined at or prior to the time of the offering, up to $100,000,000 of any combination
of the securities described in this prospectus, either individually or in units. We may also offer common stock or preferred stock
upon conversion of or exchange for the debt securities; common stock or preferred stock or debt securities upon the exercise of
warrants or rights.
This prospectus describes the general terms
of these securities and the general manner in which these securities will be offered. We will provide you with the specific terms
of any offering in one or more supplements to this prospectus. The prospectus supplements will also describe the specific manner
in which these securities will be offered and may also supplement, update or amend information contained in this document. You
should read this prospectus and any prospectus supplement, as well as any documents incorporated by reference into this prospectus
or any prospectus supplement, carefully before you invest.
Our securities may be sold directly by
us to you, through agents designated from time to time or to or through underwriters or dealers. For additional information on
the methods of sale, you should refer to the section entitled “Plan of Distribution” in this prospectus and in the
applicable prospectus supplement. If any underwriters or agents are involved in the sale of our securities with respect to which
this prospectus is being delivered, the names of such underwriters or agents and any applicable fees, commissions or discounts
and over-allotment options will be set forth in a prospectus supplement. The price to the public of such securities and the net
proceeds that we expect to receive from such sale will also be set forth in a prospectus supplement.
Our common stock is listed on The Nasdaq
Capital Market, under the symbol “NTRP.” On April 24, 2020, the last reported sale price of our common stock on The
Nasdaq Capital Market was $1.35 per share.
As of April 24, 2020 the aggregate market
value of our common stock held by non-affiliates pursuant to General Instruction I.B.6. of Form S-3 was approximately $28,874,288,
which was calculated based on 21,548,330 outstanding shares of our common stock, of which 21,231,094 shares are held by non-affiliates,
and a price of $1.36 per share, the closing sale price of our common stock reported on The Nasdaq Capital Market on April 23, 2020.
As a result, we are currently eligible to offer and sell up to an aggregate of approximately $9.53 million of our securities
pursuant to General Instruction I.B.6 of Form S-3. During the prior twelve calendar month period that ends on the date of this
prospectus, we have not offered or sold any securities pursuant to General Instruction I.B.6 on Form S-3. Pursuant to General Instruction
I.B.6 of Form S-3, in no event will we sell shares pursuant to this prospectus with a value of more than one-third of the aggregate
market value of our common stock held by non-affiliates in any 12-month period, so long as the aggregate market value of our common
stock held by non-affiliates is less than $75 million.
Investing in our securities involves
a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks that we have
described on page 6 of this prospectus under the caption “Risk Factors.” We may include specific risk factors in supplements
to this prospectus under the caption “Risk Factors.” This prospectus may not be used to sell our securities unless
accompanied by a prospectus supplement.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus
is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is April
24,
2020.
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus is part of a registration
statement that we filed with the Securities and Exchange Commission, or SEC, utilizing a “shelf” registration process.
Under this shelf registration process, we may offer shares of our common stock, preferred stock, various series of debt securities
and/or warrants or rights to purchase any of such securities, either individually or in units, in one or more offerings, with a
total value of up to $100,000,000. This prospectus provides you with a general description of the securities we may offer. Each
time we offer a type or series of securities under this prospectus, we will provide a prospectus supplement that will contain specific
information about the terms of that offering.
This prospectus does not contain all of
the information included in the registration statement. For a more complete understanding of the offering of the securities, you
should refer to the registration statement, including its exhibits. The prospectus supplement may also add, update or change information
contained or incorporated by reference in this prospectus. However, no prospectus supplement will offer a security that is not
registered and described in this prospectus at the time of its effectiveness. This prospectus, together with the applicable prospectus
supplements and the documents incorporated by reference into this prospectus, includes all material information relating to the
offering of securities under this prospectus. You should carefully read this prospectus, the applicable prospectus supplement,
the information and documents incorporated herein by reference and the additional information under the heading “Where You
Can Find More Information” before making an investment decision.
You should rely only on the information
we have provided or incorporated by reference in this prospectus or any prospectus supplement. We have not authorized anyone to
provide you with information different from that contained or incorporated by reference in this prospectus. No dealer, salesperson
or other person is authorized to give any information or to represent anything not contained or incorporated by reference in this
prospectus. You must not rely on any unauthorized information or representation. This prospectus is an offer to sell only the securities
offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. You should assume that the information
in this prospectus or any prospectus supplement is accurate only as of the date on the front of the document and that any information
we have incorporated herein by reference is accurate only as of the date of the document incorporated by reference, regardless
of the time of delivery of this prospectus or any sale of a security.
We further note that the representations,
warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference
in the accompanying prospectus were made solely for the benefit of the parties to such agreement, including, in some cases, for
the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty
or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly,
such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
This prospectus may not be used to
consummate sales of our securities, unless it is accompanied by a prospectus supplement. To the extent there are inconsistencies
between any prospectus supplement, this prospectus and any documents incorporated by reference, the document with the most recent
date will control.
Unless the context indicates otherwise,
all references in this registration statement to “Neurotrope,” the “Company,” “we,” “us”
and “our” refer to Neurotrope, Inc. and its wholly-owned consolidated operating subsidiary, Neurotrope BioScience,
Inc. All references in this prospectus to “Neurotrope BioScience” refer solely to Neurotrope BioScience, Inc.
PROSPECTUS SUMMARY
The following is a summary of what we
believe to be the most important aspects of our business and the offering of our securities under this prospectus. We urge you
to read this entire prospectus, including the more detailed consolidated financial statements, notes to the consolidated financial
statements and other information incorporated by reference from our other filings with the SEC or included in any applicable prospectus
supplement. Investing in our securities involves risks. Therefore, carefully consider the risk factors set forth in any prospectus
supplements and in our most recent annual and quarterly filings with the SEC, as well as other information in this prospectus and
any prospectus supplements and the documents incorporated by reference herein or therein, before purchasing our securities. Each
of the risk factors could adversely affect our business, operating results and financial condition, as well as adversely affect
the value of an investment in our securities.
Overview
We are a biopharmaceutical company with
product candidates in pre-clinical and clinical development. Neurotrope BioScience began operations in October 2012. We are principally
focused on developing a product platform based upon a drug candidate called bryostatin for the treatment of Alzheimer’s disease
(“AD”), which is in the clinical testing stage. We are also evaluating potential therapeutic applications of bryostatin
for other neurodegenerative or cognitive diseases and dysfunctions, such as Fragile X syndrome, Multiple Sclerosis, and Niemann-Pick
Type C disease, which have undergone pre-clinical testing. In addition, we are also in the early stages of testing bryostatin activity
which may lead to applications in Leukemia and Lymphoma. Neurotrope has been a party to a technology license and services agreement
with the original Blanchette Rockefeller Neurosciences Institute (“BRNI”) (which has been known as Cognitive Research
Enterprises, Inc. (“CRE”) since October 2016), and its affiliate NRV II, LLC, which we collectively refer to herein
as “CRE,” pursuant to which we now have an exclusive non-transferable license to certain patents and technologies required
to develop our proposed products. Neurotrope BioScience was formed for the primary purpose of commercializing the technologies
initially developed by BRNI for therapeutic applications for AD or other cognitive dysfunctions. These technologies have been under
development by BRNI since 1999 and, until March 2013, had been financed through funding from a variety of non-investor sources
(which include not-for-profit foundations, the National Institutes of Health, which is part of the U.S. Department of Health and
Human Services, and individual philanthropists). From March 2013 forward, development of the licensed technology has been funded
principally through the Company in collaboration with CRE. Licensing agreements have been culminated with Stanford University for
the exclusive use of synthetic bryostatin and for the potential use of bryostatin-like compounds, called Bryologs, for certain
therapeutic indications.
Results of Phase 2 Clinical Trial
On May 1, 2017, we reported certain relevant
top-line results from our Phase 2 exploratory clinical trial based on a preliminary analysis of a limited portion of the complete
data set generated. A comprehensive analysis of these data from the Phase 2 exploratory trial evaluating Bryostatin-1 as
a treatment of cognitive deficits in moderate to severe Alzheimer’s disease were recently published in the Journal
of Alzheimer's Disease, vol. 67, no. 2, pp. 555-570, 2019. A total of 147 patients were enrolled into the study; 135
patients in the mITT population (as defined below) and 113 in the Completer population (as defined below). This study was the first
repeat dose study of bryostatin-1 in patients with late stage AD (defined as a Mini Mental State Exam 2 (“MMSE-2”)
of 4-15), in which two dose levels of bryostatin-1 were compared with placebo to assess safety and preliminary efficacy (p <
0.1, one-tailed) after 12 weeks of treatment. The pre-specified primary endpoint, the Severe Impairment Battery (the “SIB”)
(used to evaluate cognition in severe dementia), compared each dose of bryostatin-1 with placebo at Week 13 in two sets of patients:
(1) the modified intent-to-treat (the “mITT”) population, consisting of all patients who received study drug and had
at least one efficacy/safety evaluation, and (2) the Completer population, consisting of those patients within the mITT population
who completed the 13-week dosing protocol and cognitive assessments.
These announced top-line results indicated
that the 20 µg dose, administered after two weekly 20 µg doses during the first two weeks and every other week thereafter,
met the pre-specified primary endpoint in the Completer population, but not in the mITT population. Among the patients who completed
the protocol (n = 113), the patients on the 20 µg dose at 13 weeks showed a mean increase on the SIB of 1.5 vs. a decrease
in the placebo group of -1.1 (net improvement of 2.6, p < 0.07), whereas, in the mITT population, the 20 µg group had
a mean increase on the SIB of 1.2 vs. a decrease in the placebo group of -0.8 (net improvement of 2.0, p < 0.134). At the pre-specified
5 week secondary endpoint, the Completer patients in the 20 µg group showed a net improvement of 4.0 SIB (p < .016), and
the mITT population showed a net improvement of 3.0 (p < .056). Unlike the 20 µg dose, there was no therapeutic signal
observed with the 40 µg dose.
The Alzheimer Disease Cooperative Study
Activities of Daily Living Inventory Severe Impairment version (the “ADCS-ADL-SIV”) was another pre-specified secondary
endpoint. The p values for the comparisons between 20 µg and placebo for the ADCS-ADL endpoint at 13 weeks were 0.082 for
the Completers and 0.104 for the mITT population.
Together, these initial results after preliminary
analysis of this exploratory trial, provided signals that bryostatin-1, at the 20 µg dose, caused sustained improvement in
important functions that are impaired in patients with moderate to severe Alzheimer’s disease, i.e., cognition and the ability
to care for oneself. Since many of the patients in this study were already taking donepezil and/or memantine, the efficacy of bryostatin-1
was evaluated in the top line results over and above the standard of care therapeutics.
The safety profile of bryostatin-1 20 µg
was minimally different from the placebo group except for a higher incidence of diarrhea and infusion reactions (11% versus 2%
for diarrhea and 17% versus 6% for infusion reactions). Fewer adverse events were reported in patients in the 20 µg group,
compared to the 40 µg group. Patients dosed with 20 µg had a dropout rate less than or identical to placebo, while
patients dosed at 40 µg experienced poorer safety and tolerability, and had a higher dropout rate. Treatment emergent adverse
events (“TEAEs”) were mostly mild or moderate in severity. TEAEs, including serious adverse events, were more common
in the 40 µg group, as compared to the 20 µg and placebo groups. The mean age of patients in the study was 72 years
and similar across all three treatment groups.
Following presentation of the top line
results in July 2017 at the Alzheimer’s Association International Conference in London, a much more extensive analysis
of a complete set of the Phase 2 trial data was conducted.
On January 5, 2018, we announced that a
pre-specified exploratory analysis of the comprehensive data set from our recent Phase 2 trial in patients with advanced AD found
evidence of sustained improvement in cognition in patients receiving the 20 μg bryostatin regimen. As specified in the Statistical
Analysis Plan (“SAP”), analysis of patients who did not receive memantine, an approved AD treatment, as baseline therapy
showed greater SIB improvement. These findings suggested that this investigational drug could potentially treat Alzheimer’s
disease itself and help reduce and/or reverse the progression of AD, in addition to alleviating its symptoms.
Comprehensive follow-on analyses found
that patients in the 20 μg treatment arm showed a sustained improvement in cognition over baseline compared to the placebo group
at an exploratory endpoint week 15 (30 days after last dose at week 11). These data were observed in the study population as a
whole as well as in the Completers study group.
This follow-on analysis of the data evaluated
SIB scores of patients at 15 weeks, 30 days after all dosing had been completed – a pre-specified exploratory endpoint. For
the 20 μg group, patients in the mITT population (n=34) showed an overall improvement compared to controls (n=33) of 3.59 (p=0.0503)
and in the Completers population (n=34) showed an overall improvement compared to controls (n=33) of 4.09 (p=0.0293). In
summary, patients on the 20 μg dose showed a persistent SIB improvement 30 days after all dosing had been completed. These p-values
and those below are one-tailed.
Additional analyses compared 20 µg
dose patients who were on baseline therapy of Aricept vs. patients off Aricept. No significant differences were observed. Another
analysis compared the 20 µg dose patients who were on or off baseline therapy of memantine. The secondary analysis comparing
SIB scores in non-memantine versus memantine patients found the following:
|
|
·
|
At week 15, non-memantine patients in the mITT Group treated with 20 μg (n=14) showed an SIB improvement of 5.88, while the placebo patients (n=11) showed a decline in their SIB scores of -0.05 for an overall treatment Δ of 5.93 from baseline (p=0.0576).
|
|
|
·
|
At week 15, non-memantine patients in the Completers Group treated with 20 μg (n=14) showed an SIB improvement of 6.24, while the placebo patients (n=11) showed a decline in their SIB scores of -0.12 for an overall treatment Δ of 6.36 from baseline (p=0.0488).
|
|
|
·
|
Patients taking memantine as background therapy in the 20 μg (n=20) and control (n=22) groups showed no improvement in SIB scores.
|
Memantine, an NMDA receptor antagonist,
is marketed under the brand names Namenda®, Namenda® XR, and Namzaric® (a combination of memantine and donepezil) for
the treatment of dementia in patients with moderate-to-severe AD. It has been shown to delay cognitive decline and help reduce
disease symptoms.
Further follow-on analyses used trend analyses
(testing the dependence of treatment effect on repeated doses).
In the trend analyses, we found that the
SIB values did not increase over time for the placebo patients resulting in slopes that were non-significantly different from zero
(e.g. ‘zero-slopes’). In contrast, the SIB slopes for the 20 μg bryostatin patients who did not receive baseline
memantine were found to be statistically significant (p<.001), giving a slope (95% CI) = 0.38 (0.18, 0.57) SIB points per week
in the random intercept model, and a slope (95% CI) = 0.38 (0.18, 0.59) points per week in the random intercept and slope model.
These results provided evidence that SIB improvement (drug benefit) increased as the number of successive bryostatin doses increased
for the 20 μg patient cohort.
Confirmatory Phase 2 Clinical Trial
On May 4, 2018, we announced a confirmatory,
100 patient, double-blinded clinical trial for the safe, effective 20 μg dose protocol for advanced AD patients not taking memantine
as background therapy to evaluate improvements in SIB scores with an increased number of patients. We engaged Worldwide Clinical
Trials, Inc. (“WCT”), in conjunction with consultants and investigators at leading academic institutions, to collaborate
on the design and conduct of the trial, which began in April 2018. During July 2018, the first patient was enrolled in this study.
Pursuant to a new Services Agreement (the “New Services Agreement”) with WCT dated as of May 4, 2018, WCT provided
services relating to the trial. The total estimated budget for the services, including pass-through costs, drug supply and other
statistical analyses, was approximately $7.8 million. Of the total estimated study costs, as of September 30, 2019, we have incurred
approximately $7.2 million in expenses of which WCT has represented a total of approximately $6.8 million and approximately $400,000
of expenses have been incurred to other trial-related vendors and consultants. In addition, we paid $1.2 million to WCT as prepaid
deposits of which we have utilized the entire amount.
On September 9, 2019, the Company issued
a press release announcing that the confirmatory Phase 2 study of bryostatin-1 in moderate to severe AD did not achieve statistical
significance on the primary endpoint, which was changed from baseline to Week 13 in the SIB total score.
An average increase in SIB total score
of 1.3 points and 2.1 points was observed for the bryostatin-1 and placebo groups, respectively, at Week 13. There were multiple
secondary outcome measures in this trial, including the changes from baseline at Weeks 5, 9 and 15 in the SIB total score. No statistically
significant difference was observed in the change from baseline in SIB total score between the bryostatin -1 and placebo treatment
groups.
The confirmatory Phase 2 multicenter trial
was designed to assess the safety and efficacy of bryostatin-1 as a treatment for cognitive deficits in patients with moderate
to severe AD — defined as a Mini Mental State Exam 2 (“MMSE-2”) score of 4-15 – who are not currently taking
memantine. Patients were randomized 1:1 to be treated with either bryostatin -1 20μg or placebo, receiving 7 doses over 12 weeks.
Patients on memantine, an NMDA receptor antagonist, were excluded unless they had been discontinued from memantine treatment for
a 30-day washout period prior to study enrollment. The primary efficacy endpoint was the change in the SIB score between the baseline
and week 13. Secondary endpoints included repeated SIB changes from baseline SIB at weeks 5, 9, 13 and 15.
On January 22, 2020, we announced the completion
of an additional analysis in connection with the confirmatory Phase 2 study, which examined moderately severe to severe AD patients
treated with byrostatin-1 in the absence of memantine. To adjust for the baseline imbalance observed in the study, a post-hoc analysis
was conducted using paired data for individual patients, with each patient as his/her own control. For
the pre-specified moderate stratum (i.e., MMSE-2 baseline scores 10-15), the baseline value and the week 13 value were used, resulting
in pairs of observations for each patient. The changes from baseline for each patient were calculated and a paired t-test
was used to compare the mean change from baseline to week 13 for each patient. A total of 65 patients had both baseline and week
13 values, from which there were 32 patients in the bryostatin-1 treatment group and 33 patients in the placebo group.
There was a statistically significant improvement over baseline (4.8 points) in the mean SIB at week 13 for subjects in the bryostatin-1
treatment group (32 subjects), paired t-test p < 0.0076, 2-tailed. In the placebo group (33 subjects), there was also a statistically
significant increase from baseline in the mean SIB at week 13, for paired t-test p < 0.0144, consistent with the placebo effect
seen in the overall 203 study. For the pre-specified severe stratum (i.e., MMSE-2 baseline scores 4-9), there was no statistically
significant change from baseline for either the treatment or placebo group.
In connection with the additional analysis,
we also announced the receipt of a $2.7 million award from the National Institutes of Health to support an additional Phase 2 clinical
study focused on the moderate stratum for which we saw improvement in the 203 study. We are planning to meet with the Food and
Drug Administration (“FDA”) to present the totality of the clinical data for bryostatin-1. We are continuing to determine
how to proceed with respect to our current development programs for bryostatin-1.
Other Development Projects
To the extent resources permit, we may
pursue development of selected technology platforms with indications related to the treatment of various disorders, including neurodegenerative
disorders such as AD, based on our currently licensed technology and/or technologies available from third party licensors or collaborators.
For example, we have entered into a Cooperative
Research and Development Agreement (“CRADA”) with the National Cancer Institute (NCI) for the research and clinical
development of Bryostatin-1. Under the CRADA, Neurotrope will collaborate with the NCI’s Center for Cancer Research, Pediatric
Oncology Branch (POB) to develop a Phase I clinical trial testing the safety and toxicity of Bryostatin-1 in children and young
adults with CD22 + leukemia and B-cell lymphoma. In the growing era of highly effective immunotherapies targeting cell-surface
antigens (e.g., CAR-T cell therapy), and the recognition that antigen modulation plays a critical role in evasion of response to
immunotherapy, the ability for Bryostatin-1 to upregulate CD22 may serve a synergistic role in enhancing the response to a host
of CD22 targeted therapies. Under the CRADA, Bryostatin-1 is expected to be tested in the clinic to evaluate its ability to modulate
CD22 in patients with relapsed/refractory CD22+ disease, while evaluating safety, toxicity and overall response.
Nemours Agreement
On September 5, 2018, we announced a collaboration
with The Nemours / Alfred I. duPont Hospital for Children (“Nemours”),
a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X syndrome (“Fragile X”).
In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other
functional aspects such as anxiety, repetitive behavior, executive functioning, and social behavior. The total estimated cost of
this proposed trial to us is approximately $100,000.
Recent Developments
Review of Strategic Alternatives
On October 8, 2019, we announced our plans
to explore strategic alternatives to maximize shareholder value. These alternatives could include, but are not limited to, merger
or acquisition transactions, issuing or transferring shares of our common stock, or the license, purchase, spin-off or sale of
specific assets, in addition to other potential actions aimed at increasing stockholder value. There can be no assurance that the
review of strategic alternatives will result in the identification or consummation of any transaction. We
are continuing to determine how to proceed with respect to our current development programs for bryostatin-1 in our effort to maximize
shareholder value.
NIH Award
On January 22, 2020, we announced the
receipt of a $2.7 million award from the National Institutes of Health to support an additional Phase 2 clinical study focused
on the moderate stratum for which we saw improvement in the 203 study. The grant provides for funds in the first year of approximately
$1.0 million and funding in year 2 of approximately $1.7 million subject to satisfactory progress of the project. We are planning
to meet with the Food and Drug Administration to present the totality of the clinical data for bryostatin-1. We are continuing
to determine how to proceed with respect to our current development programs for bryostatin-1.
Corporate Information
Neurotrope, Inc. is a Nevada
corporation with its principal business office at 1185 Avenue of the Americas, 3rd Floor, New York, New York 10036. Our
telephone number is 973-242-0005 and our website can be found at www.neurotrope.com. Through our website,
we make available, free of charge, our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form
8-K and any amendments to those reports, as soon as reasonably practicable after such material is electronically filed
with, or furnished to, the Securities and Exchange Commission, or SEC. Information contained on, or that can be accessed
through, our website is not and shall not be deemed to be a part of this prospectus.
Offerings Under This Prospectus
Under this prospectus, we may offer shares
of our common stock, preferred stock, various series of debt securities and/or warrants or rights to purchase any of such securities,
either individually or in units, with a total value of up to $100,000,000, from time to time at prices and on terms to be determined
by market conditions at the time of the offering. This prospectus provides you with a general description of the securities we
may offer. Each time we offer a type or series of securities under this prospectus, we will provide a prospectus supplement that
will describe the specific amounts, prices and other important terms of the securities, including, to the extent applicable:
The prospectus supplement also may add,
update or change information contained in this prospectus or in documents we have incorporated by reference into this prospectus.
However, no prospectus supplement will fundamentally change the terms that are set forth in this prospectus or offer a security
that is not registered and described in this prospectus at the time of its effectiveness.
We may sell the securities directly to
investors or to or through agents, underwriters or dealers. We, and our agents or underwriters, reserve the right to accept or
reject all or part of any proposed purchase of securities. If we offer securities through agents or underwriters, we will include
in the applicable prospectus supplement:
|
|
·
|
the names of those agents or underwriters;
|
|
|
·
|
applicable fees, discounts and commissions to be paid to them;
|
|
|
·
|
details regarding over-allotment options, if any; and
|
|
|
·
|
the net proceeds to us.
|
This prospectus may not be used to consummate
a sale of any securities unless it is accompanied by a prospectus supplement.
RISK FACTORS
Please carefully consider the risk factors
described in our periodic reports filed with the SEC, which are incorporated by reference in this prospectus. Before making an
investment decision, you should carefully consider these risks as well as other information we include or incorporate by reference
in this prospectus or include in any applicable prospectus supplement. Additional risks and uncertainties not presently known to
us or that we deem currently immaterial may also impair our business operations or adversely affect our results of operations or
financial condition.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus contains forward-looking
statements, including, without limitation, in the section captioned “Management’s Discussion and Analysis of Financial
Condition and Results of Operations,” and elsewhere. Any and all statements contained in this prospectus that are not statements
of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,”
“should,” “could,” “project,” “estimate,” “pro-forma,” “predict,”
“potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,”
“help,” “believe,” “continue,” “intend,” “expect,” “future,”
and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements.
However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this
prospectus may include, without limitation, statements regarding (i) the plans and objectives of management for future operations,
including plans or objectives relating to the development of commercially viable pharmaceuticals, (ii) a projection of income (including
income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial
items, (iii) our future financial performance, including any such statement contained in a discussion and analysis of financial
condition by management or in the results of operations included pursuant to the rules and regulations of the SEC, and (iv) the
assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above.
The forward-looking statements are not
meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based
upon our current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of
risks and uncertainties and other influences, many of which we have no control over. Actual results and the timing of certain events
and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties.
Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ
materially from expected or desired results may include, without limitation, our inability to obtain adequate financing, the significant
length of time associated with drug development and related insufficient cash flows and resulting illiquidity, our inability to
expand our business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification,
volatility in the price of our raw materials, existing or increased competition, results of arbitration and litigation, stock volatility
and illiquidity, and our failure to implement our business plans or strategies. A description of some of the risks and uncertainties
that could cause our actual results to differ materially from those described by the forward-looking statements in this prospectus
appears in the section captioned “Risk Factors” and elsewhere in this prospectus. Readers should carefully review this
prospectus in its entirety, including, but not limited to, our financial statements and the notes thereto and the risks described
herein. We advise you to carefully review the reports and documents we file from time to time with the SEC, particularly our annual
reports on Form 10-K, our quarterly reports on Form 10-Q and our current reports on Form 8-K.
Readers are cautioned not to place undue
reliance on forward-looking statements because of the risks and uncertainties related to them and to the risk factors. We disclaim
any obligation to update the forward-looking statements contained in this prospectus to reflect any new information or future events
or circumstances or otherwise.
RATIO OF EARNINGS TO FIXED CHARGES
Any time debt securities are offered pursuant
to this prospectus, we will provide a table setting forth our ratio of earnings to fixed charges on a historical basis in the applicable
prospectus supplement, if required.
USE OF PROCEEDS
We cannot assure you that we will receive
any proceeds in connection with securities which may be offered pursuant to this prospectus. Unless otherwise indicated in the
applicable prospectus supplement, we intend to use any net proceeds from the sale of securities under this prospectus for our operations
and for other general corporate purposes, including, but not limited to, our research and development programs and the development
of new programs, general working capital and possible future acquisitions. We have not determined the amounts we plan to spend
on any of the areas listed above or the timing of these expenditures. As a result, our management will have broad discretion to
allocate the net proceeds, if any, we receive in connection with securities offered pursuant to this prospectus for any purpose.
Pending application of the net proceeds as described above, we may initially invest the net proceeds in short-term, investment-grade,
interest-bearing securities or apply them to the reduction of short-term indebtedness.
PLAN OF DISTRIBUTION
General Plan of Distribution
We may offer securities under this prospectus
from time to time pursuant to underwritten public offerings, negotiated transactions, block trades or a combination of these methods.
We may sell the securities (1) through underwriters or dealers, (2) through agents or (3) directly to one or more
purchasers, or through a combination of such methods. We may distribute the securities from time to time in one or more transactions
at:
|
|
·
|
a fixed price or prices, which may be changed from time to time;
|
|
|
·
|
market prices prevailing at the time of sale;
|
|
|
·
|
prices related to the prevailing market prices; or
|
We may directly solicit offers to purchase
the securities being offered by this prospectus. We may also designate agents to solicit offers to purchase the securities from
time to time. We will name in a prospectus supplement any underwriter or agent involved in the offer or sale of the securities.
If we utilize a dealer in the sale of the
securities being offered by this prospectus, we will sell the securities to the dealer, as principal. The dealer may then resell
the securities to the public at varying prices to be determined by the dealer at the time of resale.
If we utilize an underwriter in the sale
of the securities being offered by this prospectus, we will execute an underwriting agreement with the underwriter at the time
of sale, and we will provide the name of any underwriter in the prospectus supplement which the underwriter will use to make re-sales
of the securities to the public. In connection with the sale of the securities, we, or the purchasers of the securities for whom
the underwriter may act as agent, may compensate the underwriter in the form of underwriting discounts or commissions. The underwriter
may sell the securities to or through dealers, and the underwriter may compensate those dealers in the form of discounts, concessions
or commissions.
With respect to underwritten public offerings,
negotiated transactions and block trades, we will provide in the applicable prospectus supplement information regarding any compensation
we pay to underwriters, dealers or agents in connection with the offering of the securities, and any discounts, concessions or
commissions allowed by underwriters to participating dealers. Underwriters, dealers and agents participating in the distribution
of the securities may be deemed to be underwriters within the meaning of the Securities Act of 1933, as amended, or the Securities
Act, and any discounts and commissions received by them and any profit realized by them on resale of the securities may be deemed
to be underwriting discounts and commissions. We may enter into agreements to indemnify underwriters, dealers and agents against
civil liabilities, including liabilities under the Securities Act, or to contribute to payments they may be required to make in
respect thereof.
If so indicated in the applicable prospectus
supplement, we will authorize underwriters or other persons acting as our agents to solicit offers by certain institutions to purchase
securities from us pursuant to delayed delivery contracts providing for payment and delivery on the date stated in the prospectus
supplement. Each contract will be for an amount not less than, and the aggregate amount of securities sold pursuant to such contracts
shall not be less nor more than, the respective amounts stated in the prospectus supplement. Institutions with whom the contracts,
when authorized, may be made include commercial and savings banks, insurance companies, pension funds, investment companies, educational
and charitable institutions and other institutions, but shall in all cases be subject to our approval. Delayed delivery contracts
will not be subject to any conditions except that:
|
|
·
|
the purchase by an institution of the securities covered under that contract shall not at the time of delivery be prohibited under the laws of the jurisdiction to which that institution is subject; and
|
|
|
·
|
if the securities are also being sold to underwriters acting as principals for their own account, the underwriters shall have purchased such securities not sold for delayed delivery. The underwriters and other persons acting as our agents will not have any responsibility in respect of the validity or performance of delayed delivery contracts.
|
Shares of our common stock sold pursuant
to the registration statement of which this prospectus is a part will be authorized for quotation and trading on The Nasdaq Capital
Market. The applicable prospectus supplement will contain information, where applicable, as to any other listing, if any, on The
Nasdaq Capital Market or any securities market or other securities exchange of the securities covered by the prospectus supplement.
We can make no assurance as to the liquidity of or the existence of trading markets for any of the securities.
In order to facilitate the offering of
the securities, certain persons participating in the offering may engage in transactions that stabilize, maintain or otherwise
affect the price of the securities. This may include over-allotments or short sales of the securities, which involve the sale by
persons participating in the offering of more securities than we sold to them. In these circumstances, these persons would cover
such over-allotments or short positions by making purchases in the open market or by exercising their over-allotment option. In
addition, these persons may stabilize or maintain the price of the securities by bidding for or purchasing the applicable security
in the open market or by imposing penalty bids, whereby selling concessions allowed to dealers participating in the offering may
be reclaimed if the securities sold by them are repurchased in connection with stabilization transactions. The effect of these
transactions may be to stabilize or maintain the market price of the securities at a level above that which might otherwise prevail
in the open market. These transactions may be discontinued at any time.
In compliance with the guidelines of the
Financial Industry Regulatory Authority, Inc., or FINRA, the maximum consideration or discount to be received by any FINRA
member or independent broker dealer may not exceed 8% of the aggregate amount of the securities offered pursuant to this prospectus
and any applicable prospectus supplement.
The underwriters, dealers and agents may
engage in other transactions with us, or perform other services for us, in the ordinary course of their business.
DESCRIPTION OF CAPITAL STOCK
General
The following description of our capital
stock and provisions of our articles of incorporation, as amended (the “Articles of Incorporation”), and amended and
restated bylaws (the “Bylaws”) are summaries and are qualified by reference to the Articles of Incorporation and the
Bylaws that are on file with the SEC.
Authorized Capital Stock
Our Articles of Incorporation authorizes
us to issue 150,000,000 shares of common stock, par value $0.0001 per share, and 50,000,000 shares of preferred stock, par value
$0.0001 per share.
Common Stock
The holders of our common stock are entitled
to receive dividends out of assets or funds legally available for the payment of dividends at such times and in such amounts as
our Board of Directors (the “Board”) from time to time may determine. To date, we have not paid dividends on our
common stock. Holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders.
There is no cumulative voting of the election of directors then standing for election. Our common stock is not entitled to pre-emptive
rights and is not subject to conversion or redemption. Upon liquidation, dissolution or winding up of the Company, the assets legally
available for distribution to stockholders are distributable ratably among the holders of our common stock after payment of liabilities,
accrued dividends and liquidation preferences, if any. Each outstanding share of our common stock is duly and validly issued, fully
paid and non-assessable.
As of April 24, 2020, we had
21,548,330 shares of our common stock issued and outstanding held by approximately 233 stockholders of record.
Preferred Stock
We have the authority to issue up to 50,000,000
shares of preferred stock. The shares of preferred stock may be issued from time to time in one or more series, each of which will
have such distinctive designation or title as shall be determined by our Board prior to the issuance of any shares thereof. Preferred
stock will have such voting powers, full or limited, or no voting powers, and such preferences and relative, participating, optional
or other special rights and such qualifications, limitations or restrictions thereof, as shall be stated in such resolution or
resolutions providing for the issue of such class or series of preferred stock as may be adopted from time to time by the Board
prior to the issuance of any shares thereof. The number of authorized shares of preferred stock may be increased or decreased (but
not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the voting power
of all the then outstanding shares of our capital stock entitled to vote generally in the election of the directors, voting together
as a single class, without a separate vote of the holders of the preferred stock, or any series thereof, unless a vote of any such
holders is required pursuant to any preferred stock designation.
While we do not currently have any plans
for the issuance of additional preferred stock, the issuance of such preferred stock could adversely affect the rights of the holders
of common stock and, therefore, reduce the value of the common stock. It is not possible to state the actual effect of the issuance
of any shares of preferred stock on the rights of holders of the common stock until the Board determines the specific rights of
the holders of the preferred stock; however, these effects may include:
|
|
·
|
Restricting dividends on the common stock;
|
|
|
·
|
Diluting the voting power of the common stock;
|
|
|
·
|
Impairing the liquidation rights of the common stock; or
|
|
|
·
|
Delaying or preventing a change in control of the Company without further action by the stockholders.
|
As of April 24, 2020, we had 4,007.5 shares of Series D Convertible
Preferred Stock, par value $0.0001 per share, convertible into an aggregate of 2,428,788 shares of common stock, issued and outstanding.
Series D Convertible Preferred Stock
Rank.
Except with respect
to any current series of preferred stock of senior rank to the Series D Convertible Preferred Stock in respect of the preferences
as to dividends, distributions and payments upon the liquidation, dissolution and winding up of the Company and any current or
future series of preferred stock of pari passu rank to the Series D Convertible Preferred Stock in respect of the preferences as
to dividends, distributions and payments upon the liquidation, dissolution and winding up of the Company, all shares of capital
stock shall be junior in rank to all Series D Convertible Preferred Stock with respect to the preferences as to dividends, distributions
and payments upon the liquidation, dissolution and winding up of the Company (the “Junior Stock”).
Dividends.
Holders of Series
D Convertible Preferred Stock are entitled to receive dividends on shares of Series D Convertible Preferred Stock, on an as if
converted to common stock basis, to and in the same form as dividends actually paid on shares of common stock when, as and if such
dividends are paid on shares of common stock.
Liquidation.
In the event of
a liquidation event, the holders of Series D Convertible Preferred Stock shall be entitled to receive in cash out of our assets,
whether from capital or from earnings available for distribution to its stockholders, before any amount shall be paid to the holders
of any of shares of Junior Stock, an amount per share of Series D Convertible Preferred Stock equal to the amount per share such
holder would receive if such holder converted such Series D Convertible Preferred Stock into common stock immediately prior to
the date of such payment.
Conversion.
Each share of
Series D Convertible Preferred Stock shall be convertible, at any time and from time to time at the option of the holder thereof,
into that number of shares of common stock determined by dividing the stated value of such share by the conversion price. Each
share of Series D Convertible Preferred Stock has a stated value of $1,000. The conversion price is $1.65 per share of common stock
and is subject to adjustment described below. This right to convert is limited by the beneficial ownership limitation described
below.
Beneficial
Ownership Limitation.
We shall not effect
any conversion of Series D Convertible Preferred Stock, and a holder shall have no right to convert any portion of Series D Convertible
Preferred Stock, to the extent that, after giving effect to such conversion, such holder, together with such holder’s affiliates,
and any persons acting as a group together with such holder or any such affiliate, would beneficially own in excess of 4.99% of
the number of shares of common stock outstanding immediately after effect to the issuance of shares of common stock upon such conversion.
By written notice to us, a holder may increase or decrease such percentage to any other percentage not in excess of 9.99%. Beneficial
ownership of the holder and its affiliates will be determined in accordance with Section 13(d) of the Securities Exchange
Act of 1934, as amended, and the rules and regulations promulgated thereunder.
Stock dividends
and stock splits.
If we pay a stock
dividend or otherwise make a distribution payable in shares of common stock on shares of common stock, subdivide or combine outstanding
common stock, or reclassify common stock, the conversion price will be proportionately adjusted.
Voting Rights.
Except as otherwise provided in the Certificate of Designations,
Preferences and Rights of Series D Preferred Stock or required by law, Series D Convertible Preferred Stock shall have no voting
rights.
Fractional Shares.
No fractional shares of common stock will be issued upon conversion
of Series D Convertible Preferred Stock. Rather, we shall round up to the next whole share.
Options
As of April 24, 2020, we had outstanding stock
options to purchase an aggregate of 2,326,573 shares of our common stock with a weighted average exercise price equal to $12.71
per share.
Warrants
As of April 24, 2020, we had the following
warrants outstanding:
|
|
·
|
Series A Warrants to purchase 49,449 shares of our common stock at an exercise price of $0.32 per share, with an expiration date five years from the date of issuance. These warrants were issued on November 16, 2015.
|
|
|
·
|
Series C Warrants to purchase 78,616 shares of our common stock at an exercise price of $0.32 per share, with an expiration date of five years from the date of issuance. These warrants were issued on November 16, 2015.
|
|
|
·
|
Series E Warrants, which are contingent upon the exercise of the Series C Warrants, to purchase 819,914 shares of our common stock at an exercise price of $32.00 per share, with an expiration date that is five years from the date of the initial exercise of the Series C Warrants. These warrants will begin to expire on November 28, 2021, based upon the dates that the Series C Warrants were exercised.
|
|
|
·
|
Series F Warrants to purchase 3,772,908 shares of our common stock at an exercise price of $12.80 per share, with an expiration date five years from the date of issuance. These warrants were issued on November 16, 2016.
|
|
|
·
|
Series G Warrants to purchase 4,916,603 shares of our common stock at an exercise price of $4.37 per share, with an expiration date five years from the initial exercise date. These warrants have an exercise date beginning June 17, 2019.
|
|
|
·
|
Series H Warrants to purchase 10,909,100 shares of our common
stock at an exercise price of $1.65 per share, with an expiration date five years from the initial exercise date. These
warrants were issued on January 22, 2020.
|
|
|
·
|
Placement agent warrants to purchase 19,541 shares of our common stock at an exercise price of $0.32 per share. 13,932 of these warrants will expire on August 23, 2023, and 5,609 will expire on November 13, 2020.
|
|
|
·
|
Placement agent warrants to purchase 382,887 shares of our common stock at an exercise price of $6.40 per share which expire on November 17, 2021.
|
|
|
·
|
Placement agent and consultant warrants to purchase 100,240 shares of our common stock at an exercise price of $6.25 per share which expire on June 19, 2024.
|
|
|
·
|
Placement agent warrants to purchase 200,000 shares of our common stock at an exercise price of $1.65 per share which expire on January 22, 2025.
|
|
|
·
|
Advisor warrants to purchase 90,000 shares of our common stock at an exercise price of $7.13 per share which expire June 1, 2024.
|
|
|
·
|
Advisor warrants to purchase 24,000 shares of our common stock at an exercise price of $7.12 per share which expire June 5, 2024.
|
|
|
·
|
Advisor warrants to purchase 114,000 shares of our common stock at an exercise price of $5.31 per share which expire September 1, 2024.
|
|
|
·
|
Advisor warrants to purchase 114,000 shares of our
common stock at an exercise price of $0.86 per share which expire December 1, 2024.
|
|
|
·
|
Advisor warrants to purchase 140,000 shares of our common stock
at an exercise price of $1.13 per share which expire March 2, 2025
|
The warrants contain customary provisions
for adjustment in the event of stock splits, subdivision or combination, mergers, and similar events. The holders of the warrants
have the right to exercise the warrants by means of a cashless exercise in certain circumstances.
Convertible Securities
As of the date hereof, other than the common
stock options, placement agent and consultant warrants, advisor warrants, the Series A Warrants, Series C Warrants, Series E Warrants,
the Series F Warrants, the Series G Warrants, and the Series H Warrants described above, the Company does not have any outstanding
convertible securities.
Anti-Takeover Effects of Our Shareholder
Rights Plan and Provisions of Nevada State Law
Our Shareholder Rights Plan
Overview
On September 9, 2019, our Board adopted
a shareholder rights plan (the “Rights Plan”). The Rights Plan is intended to protect the interests of our stockholders
and enable them realize the full potential value of their investment by reducing the likelihood that any person or group gains
our control through open market accumulation or other tactics without appropriately compensating all stockholders. Pursuant to
the Rights Plan, we issued, by means of a dividend, one preferred share purchase right for each outstanding share of the our common
stock to shareholders of record on the close of business on September 19, 2019. Initially, these Rights (as defined below) will
trade with, and be represented by, the shares of our common stock. The Rights will generally
become exercisable only if any person (or any persons acting as a group) acquires 15% or more of our outstanding common stock (the
“Acquiring Person”) in a transaction not approved by the Board, subject to certain exceptions, as explained below.
If
the Rights become exercisable, all holders of Rights, other than the Acquiring Person, will be entitled to acquire shares of the
our common stock at a 50% discount or we may exchange each Right held by
such holders for one share of its common stock. In such situation, Rights held by the Acquiring Person would become void and will
not be exercisable. If any person at the time of the first public announcement of the Rights Plan owned more than the triggering
percentage then that stockholder’s existing ownership percentage will be grandfathered, although, with certain exceptions,
the Rights will become exercisable if at any time after the announcement of the Rights Plan such stockholder increases its ownership
of our common stock.
Unless
earlier redeemed, terminated or exchanged pursuant to the terms of the Rights
Plan, the Rights will expire at the close of business on September 8, 2021. The Board may terminate the Rights Plan before that
date if the Board determines that there is no longer a threat to shareholder value.
Key Features
On September 9,
2019, the Board declared a dividend of one preferred share purchase right (a “Right”), payable on September 19, 2019,
for each share of our common stock, par value $0.0001 per share, outstanding on September 19, 2019, to the stockholders of record
on that date. In connection with the distribution of the Rights, we entered into a Rights Agreement (the “Rights Agreement”),
dated as of September 9, 2019, with Philadelphia Stock Transfer, Inc., as rights agent. Each Right entitles the registered holder
to purchase from one one-thousandth of a share of our Series C Preferred Stock, par value $0.0001 per share (the “Preferred
Shares”), at a price of $20 per one one-thousandth of a Preferred Share represented by a Right, subject to adjustment. Each one
one-thousandth of a Preferred Share entitles the holder thereof to receive (i) the same
dividends and liquidation rights as if the holder held one share of common stock and will be treated the same as one share of common
stock in the event of a merger, consolidation or other share exchange and (ii) one vote on all matters submitted to
a vote of our stockholders, in each case subject to adjustment as described in the Certificate of Designations, Preferences and
Rights of Series C Preferred Stock. Until a right is exercised, the holder thereof,
as such, will have no rights as a stockholder of the Company, including, without limitation, the right to vote or to receive dividends.
Nevada’s control share laws
We may in the future become subject to
Nevada’s control share laws. A corporation is subject to Nevada’s control share law if it has more than 200 stockholders
of record, at least 100 of whom are residents of Nevada, and if the corporation does business in Nevada, including through an affiliated
corporation. This control share law may have the effect of discouraging corporate takeovers. The Company currently has fewer than
100 stockholders of record who are residents of Nevada and does not do business in Nevada.
The control share law focuses on the acquisition
of a “controlling interest,” which means the ownership of outstanding voting shares that would be sufficient, but for
the operation of the control share law, to enable the acquiring person to exercise the following proportions of the voting power
of the corporation in the election of directors: (1) one-fifth or more but less than one-third; (2) one-third or more but less
than a majority; or (3) a majority or more. The ability to exercise this voting power may be direct or indirect, as well as individual
or in association with others.
The effect of the control share law is
that an acquiring person, and those acting in association with that person, will obtain only such voting rights in the control
shares as are conferred by a resolution of the stockholders of the corporation, approved at a special or annual meeting of stockholders.
The control share law contemplates that voting rights will be considered only once by the other stockholders. Thus, there is no
authority to take away voting rights from the control shares of an acquiring person once those rights have been approved. If the
stockholders do not grant voting rights to the control shares acquired by an acquiring person, those shares do not become permanent
non-voting shares. The acquiring person is free to sell the shares to others. If the buyer or buyers of those shares themselves
do not acquire a controlling interest, the shares are not governed by the control share law any longer.
If control shares are accorded full voting
rights and the acquiring person has acquired control shares with a majority or more of the voting power, a stockholder of record,
other than the acquiring person, who did not vote in favor of approval of voting rights for the control shares, is entitled to
demand fair value for such stockholder’s shares.
In addition to the control share law, Nevada
has a business combination law, which prohibits certain business combinations between Nevada corporations and “interested
stockholders” for two years after the interested stockholder first becomes an interested stockholder, unless the corporation’s
board of directors approves the combination in advance. For purposes of Nevada law, an interested stockholder is any person who
is: (a) the beneficial owner, directly or indirectly, of 10% or more of the voting power of the outstanding voting shares of the
corporation, or (b) an affiliate or associate of the corporation and at any time within the previous two years was the beneficial
owner, directly or indirectly, of 10% or more of the voting power of the then-outstanding shares of the corporation. The definition
of “business combination” contained in the statute is sufficiently broad to cover virtually any kind of transaction
that would allow a potential acquirer to use the corporation’s assets to finance the acquisition or otherwise to benefit
its own interests rather than the interests of the corporation and its other stockholders.
The effect of Nevada’s business combination
law is to potentially discourage a party interested in taking control of the Company from doing so if it cannot obtain the approval
of our Board.
Limitations on Liability and Indemnification of Officers
and Directors
Under the Nevada Revised Statutes, our
directors and officers are not individually liable to us or our stockholders for any damages as a result of any act or failure
to act in their capacity as an officer or director unless it is proven that:
|
|
·
|
His act or failure to act constituted a breach of his fiduciary duty as a director or officer; and
|
|
|
·
|
His breach of these duties involved intentional misconduct, fraud or a knowing violation of law.
|
Nevada law allows corporations to provide
broad indemnification to its officers and directors. At the present time, our Articles of Incorporation and our Bylaws also provide
for broad indemnification of our current and former directors, trustees, officers, employees and other agents. We have also entered
into indemnification agreements with each of our directors and officers, pursuant to which we have agreed to indemnify such individuals
against certain liabilities that arise by reason of their status as directors and officers to the fullest extent permitted by applicable
law.
Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to our directors, officers and controlling persons, we have been advised that
in the opinion of the Securities and Exchange Commission, such indemnification is against public policy as expressed in the Securities
Act and is, therefore, unenforceable.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Philadelphia
Stock Transfer, Inc.
Nasdaq Capital Market Listing
Our common stock has been publicly traded
on The Nasdaq Capital Market under the symbol “NTRP” since March 29, 2017.
DESCRIPTION OF DEBT SECURITIES
The following description, together with
the additional information we include in any applicable prospectus supplements, summarizes the material terms and provisions of
the debt securities that we may offer under this prospectus. While the terms we have summarized below will apply generally to any
future debt securities we may offer pursuant to this prospectus, we will describe the particular terms of any debt securities that
we may offer in more detail in the applicable prospectus supplement. If we so indicate in a prospectus supplement, the terms of
any debt securities offered under such prospectus supplement may differ from the terms we describe below, and to the extent the
terms set forth in a prospectus supplement differ from the terms described below, the terms set forth in the prospectus supplement
shall control.
We may sell from time to time, in one or
more offerings under this prospectus, debt securities, which may be senior or subordinated. We will issue any such senior debt
securities under a senior indenture that we will enter into with a trustee to be named in the senior indenture. We will issue any
such subordinated debt securities under a subordinated indenture, which we will enter into with a trustee to be named in the subordinated
indenture. We use the term “indentures” to refer to either the senior indenture or the subordinated indenture, as applicable.
The indentures will be qualified under the Trust Indenture Act of 1939, as in effect on the date of the indenture. We use the term
“debenture trustee” to refer to either the trustee under the senior indenture or the trustee under the subordinated
indenture, as applicable.
The following summaries of material provisions
of the senior debt securities, the subordinated debt securities and the indentures are subject to, and qualified in their entirety
by reference to, all the provisions of the indenture applicable to a particular series of debt securities.
General
Each indenture will provide that debt securities
may be issued from time to time in one or more series and may be denominated and payable in foreign currencies or units based on
or relating to foreign currencies. Neither indenture will limit the amount of debt securities that may be issued thereunder, and
each indenture will provide that the specific terms of any series of debt securities shall be set forth in, or determined pursuant
to, an authorizing resolution and/or a supplemental indenture, if any, relating to such series.
We will describe in each prospectus supplement
the following terms relating to a series of debt securities:
|
|
·
|
the title or designation;
|
|
|
·
|
the aggregate principal amount and any limit on the amount that may be issued;
|
|
|
·
|
the currency or units based on or relating to currencies in which debt securities of such series are denominated and the currency or units in which principal or interest or both will or may be payable;
|
|
|
·
|
whether we will issue the series of debt securities in global form, the terms of any global securities and who the depositary will be;
|
|
|
·
|
the maturity date and the date or dates on which principal will be payable;
|
|
|
·
|
the interest rate, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the date or dates interest will be payable and the record dates for interest payment dates or the method for determining such dates;
|
|
|
·
|
whether or not the debt securities will be secured or unsecured, and the terms of any secured debt;
|
|
|
·
|
the terms of the subordination of any series of subordinated debt;
|
|
|
·
|
the place or places where payments will be payable;
|
|
|
·
|
our right, if any, to defer payment of interest and the maximum length of any such deferral period;
|
|
|
·
|
the date, if any, after which, and the price at which, we may, at our option, redeem the series of debt securities pursuant to any optional redemption provisions;
|
|
|
·
|
the date, if any, on which, and the price at which we are obligated, pursuant to any mandatory sinking fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities;
|
|
|
·
|
whether the indenture will restrict our ability to pay dividends, or will require us to maintain any asset ratios or reserves;
|
|
|
·
|
whether we will be restricted from incurring any additional indebtedness;
|
|
|
·
|
a discussion on any material or special U.S. federal income tax considerations applicable to a series of debt securities;
|
|
|
·
|
the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof; and
|
|
|
·
|
any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities.
|
We may issue debt securities that provide
for an amount less than their stated principal amount to be due and payable upon declaration of acceleration of their maturity
pursuant to the terms of the indenture. We will provide you with information on the federal income tax considerations and other
special considerations applicable to any of these debt securities in the applicable prospectus supplement.
Conversion or Exchange Rights
We will set forth in the prospectus supplement
the terms, if any, on which a series of debt securities may be convertible into or exchangeable for our common stock or our other
securities. We will include provisions as to whether conversion or exchange is mandatory, at the option of the holder or at our
option. We may include provisions pursuant to which the number of shares of our common stock or our other securities that the holders
of the series of debt securities receive would be subject to adjustment.
Information Concerning the Debenture Trustee
The debenture trustee, other than during
the occurrence and continuance of an event of default under the applicable indenture, undertakes to perform only those duties as
are specifically set forth in the applicable indenture. Upon an event of default under an indenture, the debenture trustee under
such indenture must use the same degree of care as a prudent person would exercise or use in the conduct of his or her own affairs.
Subject to this provision, the debenture trustee is under no obligation to exercise any of the powers given it by the indentures
at the request of any holder of debt securities unless it is offered reasonable security and indemnity against the costs, expenses
and liabilities that it might incur.
Payment and Paying Agents
Unless we otherwise indicate in the applicable
prospectus supplement, we will make payment of the interest on any debt securities on any interest payment date to the person in
whose name the debt securities, or one or more predecessor securities, are registered at the close of business on the regular record
date for the interest.
We will pay principal of and any premium
and interest on the debt securities of a particular series at the office of the paying agents designated by us, except that unless
we otherwise indicate in the applicable prospectus supplement, we will make interest payments by check which we will mail to the
holder. Unless we otherwise indicate in a prospectus supplement, we will designate the corporate trust office of the debenture
trustee in the City of New York as our sole paying agent for payments with respect to debt securities of each series. We will name
in the applicable prospectus supplement any other paying agents that we initially designate for the debt securities of a particular
series. We will maintain a paying agent in each place of payment for the debt securities of a particular series.
All money we pay to a paying agent or the
debenture trustee for the payment of the principal of or any premium or interest on any debt securities which remains unclaimed
at the end of two years after such principal, premium or interest has become due and payable will be repaid to us, and the holder
of the security thereafter may look only to us for payment thereof.
Governing Law
The indentures and the debt securities will be governed by and
construed in accordance with the laws of the State of Nevada, except to the extent that the Trust Indenture Act is applicable.
Subordination of Subordinated Debt Securities
Our obligations pursuant to any subordinated
debt securities will be unsecured and will be subordinate and junior in priority of payment to certain of our other indebtedness
to the extent described in a prospectus supplement. The subordinated indenture does not limit the amount of senior indebtedness
we may incur. It also does not limit us from issuing any other secured or unsecured debt.
DESCRIPTION OF WARRANTS
General
We may issue warrants to our stockholders
to purchase shares of our common stock. We may offer warrants separately or together with one or more debt securities, common stock
or rights, or any combination of those securities in the form of units, as described in the applicable prospectus supplement. Each
series of warrants will be issued under a separate warrant agreement to be entered into between us and a bank or trust company,
as warrant agent. The warrant agent will act solely as our agent in connection with the certificates relating to the rights of
the series of certificates and will not assume any obligation or relationship of agency or trust for or with any holders of rights
certificates or beneficial owners of rights. The following description sets forth certain general terms and provisions of the rights
to which any prospectus supplement may relate. The particular terms of the warrant to which any prospectus supplement may relate
and the extent, if any, to which the general provisions may apply to the rights so offered will be described in the applicable
prospectus supplement. To the extent that any particular terms of the warrant, warrant agreement or warrant certificates described
in a prospectus supplement differ from any of the terms described below, then the terms described below will be deemed to have
been superseded by that prospectus supplement. We encourage you to read the applicable warrant agreement and warrant certificate
for additional information before you decide whether to purchase any of our rights.
We will provide in a prospectus supplement
the following terms of the warrants being issued:
|
|
·
|
the specific designation and aggregate number of, and the price at which we will issue, the warrants;
|
|
|
·
|
the currency or currency units in which the offering price, if any, and the exercise price are payable;
|
|
|
·
|
the designation, amount and terms of the securities purchasable upon exercise of the warrants;
|
|
|
·
|
if applicable, the exercise price for shares of our common stock and the number of shares of common stock to be received upon exercise of the warrants;
|
|
|
·
|
if applicable, the exercise price for shares of our preferred stock, the number of shares of preferred stock to be received upon exercise, and a description of that series of our preferred stock;
|
|
|
·
|
if applicable, the exercise price for our debt securities, the amount of debt securities to be received upon exercise, and a description of that series of debt securities;
|
|
|
·
|
the date on which the right to exercise the warrants will begin and the date on which that right will expire or, if you may not continuously exercise the warrants throughout that period, the specific date or dates on which you may exercise the warrants;
|
|
|
·
|
whether the warrants will be issued in fully registered form or bearer form, in definitive or global form or in any combination of these forms, although, in any case, the form of a warrant included in a unit will correspond to the form of the unit and of any security included in that unit;
|
|
|
·
|
any applicable material U.S. federal income tax consequences;
|
|
|
·
|
the identity of the warrant agent for the warrants and of any other depositaries, execution or paying agents, transfer agents, registrars or other agents;
|
|
|
·
|
the proposed listing, if any, of the warrants or any securities purchasable upon exercise of the warrants on any securities exchange;
|
|
|
·
|
if applicable, the date from and after which the warrants and the common stock, preferred stock and/or debt securities will be separately transferable;
|
|
|
·
|
if applicable, the minimum or maximum amount of the warrants that may be exercised at any one time;
|
|
|
·
|
information with respect to book-entry procedures, if any;
|
|
|
·
|
the anti-dilution provisions of the warrants, if any;
|
|
|
·
|
any redemption or call provisions;
|
|
|
·
|
whether the warrants may be sold separately or with other securities as parts of units; and
|
|
|
·
|
any additional terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the warrants.
|
Each warrant will entitle the holder of
rights to purchase for cash the principal amount of shares of common stock or other securities at the exercise price provided in
the applicable prospectus supplement. Warrants may be exercised at any time up to the close of business on the expiration
date for the rights provided in the applicable prospectus supplement.
Holders may exercise warrants as described
in the applicable prospectus supplement. Upon receipt of payment and the warrant certificate properly completed and duly executed
at the corporate trust office of the rights agent or any other office indicated in the prospectus supplement, we will, as soon
as practicable, forward the shares of common stock or other securities, as applicable, purchasable upon exercise of the rights.
If less than all of the warrants issued in any rights offering are exercised, we may offer any unsubscribed securities directly
to persons other than stockholders, to or through agents, underwriters or dealers or through a combination of such methods, including
pursuant to standby arrangements, as described in the applicable prospectus supplement.
Warrant Agent
The warrant agent for any warrants we offer
will be set forth in the applicable prospectus supplement.
DESCRIPTION OF RIGHTS
General
We may issue rights to our stockholders
to purchase shares of our common stock or the other securities described in this prospectus. We may offer rights separately or
together with one or more additional rights, debt securities, common stock or warrants, or any combination of those securities
in the form of units, as described in the applicable prospectus supplement. Each series of rights will be issued under a separate
rights agreement to be entered into between us and a bank or trust company, as rights agent. The rights agent will act solely as
our agent in connection with the certificates relating to the rights of the series of certificates and will not assume any obligation
or relationship of agency or trust for or with any holders of rights certificates or beneficial owners of rights. The following
description sets forth certain general terms and provisions of the rights to which any prospectus supplement may relate. The particular
terms of the rights to which any prospectus supplement may relate and the extent, if any, to which the general provisions may apply
to the rights so offered will be described in the applicable prospectus supplement. To the extent that any particular terms of
the rights, rights agreement or rights certificates described in a prospectus supplement differ from any of the terms described
below, then the terms described below will be deemed to have been superseded by that prospectus supplement. We encourage you to
read the applicable rights agreement and rights certificate for additional information before you decide whether to purchase any
of our rights.
We will provide in a prospectus supplement
the following terms of the rights being issued:
|
|
·
|
the date of determining the stockholders entitled to the rights distribution;
|
|
|
·
|
the aggregate number of shares of common stock or other securities purchasable upon exercise of the rights;
|
|
|
·
|
the aggregate number of rights issued;
|
|
|
·
|
whether the rights are transferrable and the date, if any, on and after which the rights may be separately transferred;
|
|
|
·
|
the date on which the right to exercise the rights will commence, and the date on which the right to exercise the rights will expire;
|
|
|
·
|
the method by which holders of rights will be entitled to exercise;
|
|
|
·
|
the conditions to the completion of the offering, if any;
|
|
|
·
|
the withdrawal, termination and cancellation rights, if any;
|
|
|
·
|
whether there are any backstop or standby purchaser or purchasers and the terms of their commitment, if any;
|
|
|
·
|
whether stockholders are entitled to oversubscription rights, if any;
|
|
|
·
|
any applicable U.S. federal income tax considerations; and
|
|
|
·
|
any other terms of the rights, including terms, procedures and limitations relating to the distribution, exchange and exercise of the rights, as applicable.
|
Each right will entitle the holder of rights
to purchase for cash the principal amount of shares of common stock or other securities at the exercise price provided in the applicable
prospectus supplement. Rights may be exercised at any time up to the close of business on the expiration date for the rights provided
in the applicable prospectus supplement.
Holders may exercise rights as described
in the applicable prospectus supplement. Upon receipt of payment and the rights certificate properly completed and duly executed
at the corporate trust office of the rights agent or any other office indicated in the prospectus supplement, we will, as soon
as practicable, forward the shares of common stock or other securities, as applicable, purchasable upon exercise of the rights.
If less than all of the rights issued in any rights offering are exercised, we may offer any unsubscribed securities directly to
persons other than stockholders, to or through agents, underwriters or dealers or through a combination of such methods, including
pursuant to standby arrangements, as described in the applicable prospectus supplement.
Rights Agent
The rights agent for any rights we offer
will be set forth in the applicable prospectus supplement.
DESCRIPTION OF UNITS
The following description, together with
the additional information that we include in any applicable prospectus supplements summarizes the material terms and provisions
of the units that we may offer under this prospectus. While the terms we have summarized below will apply generally to any units
that we may offer under this prospectus, we will describe the particular terms of any series of units in more detail in the applicable
prospectus supplement. The terms of any units offered under a prospectus supplement may differ from the terms described below.
We will incorporate by reference from reports
that we file with the SEC, the form of unit agreement that describes the terms of the series of units we are offering, and any
supplemental agreements, before the issuance of the related series of units. The following summaries of material terms and provisions
of the units are subject to, and qualified in their entirety by reference to, all the provisions of the unit agreement and any
supplemental agreements applicable to a particular series of units. We urge you to read the applicable prospectus supplements related
to the particular series of units that we may offer under this prospectus, as well as any related free writing prospectuses and
the complete unit agreement and any supplemental agreements that contain the terms of the units.
General
We may issue units consisting of common
stock, one or more debt securities, warrants or rights for the purchase of common stock and/or debt securities in one or more series,
in any combination. Each unit will be issued so that the holder of the unit is also the holder of each security included in the
unit. Thus, the holder of a unit will have the rights and obligations of a holder of each security included in the unit. The unit
agreement under which a unit is issued may provide that the securities included in the unit may not be held or transferred separately,
at any time or at any time before a specified date.
We will describe in the applicable prospectus
supplement the terms of the series of units being offered, including:
|
|
·
|
the designation and terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately;
|
|
|
·
|
any provisions of the governing unit agreement that differ from those described below; and
|
|
|
·
|
any provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units.
|
The provisions described in this section,
as well as those set forth in any prospectus supplement or as described under “Description of Capital Stock,” “Description
of Debt Securities,” “Description of Warrants” and “Description of Rights” will apply to each unit,
as applicable, and to any common stock, debt security, warrant or right included in each unit, as applicable.
Unit Agent
The name and address of the unit agent
for any units we offer will be set forth in the applicable prospectus supplement.
Issuance in Series
We may issue units in such amounts and
in such numerous distinct series as we determine.
Enforceability of Rights by Holders
of Units
Each unit agent will act solely as our
agent under the applicable unit agreement and will not assume any obligation or relationship of agency or trust with any holder
of any unit. A single bank or trust company may act as unit agent for more than one series of units. A unit agent will have no
duty or responsibility in case of any default by us under the applicable unit agreement or unit, including any duty or responsibility
to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a unit may, without the consent
of the related unit agent or the holder of any other unit, enforce by appropriate legal action its rights as holder under any security
included in the unit.
LEGAL MATTERS
Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C., New York, New York, will pass upon the validity of the issuance of the securities to be offered by this prospectus.
EXPERTS
The consolidated financial statements of
Neurotrope, Inc. as of December 31, 2019 and 2018, and for each of the years in the two-year period ended December 31,
2019, have been incorporated by reference in this registration statement in reliance upon the report of Friedman LLP, independent
registered public accounting firm, and upon the authority of said firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the reporting requirements
of the Securities Exchange Act of 1934, as amended, and file annual, quarterly and current reports, proxy statements and other
information with the SEC. You may read and copy these reports, proxy statements and other information at the SEC’s public
reference facilities at 100 F Street, N.E., Room 1580, Washington, D.C. 20549. You can request copies of these documents by
writing to the SEC and paying a fee for the copying cost. Please call the SEC at 1-800-SEC-0330 for more information about the
operation of the public reference facilities. SEC filings are also available at the SEC’s web site at http://www.sec.gov.
This prospectus is only part of a registration
statement on Form S-3 that we have filed with the SEC under the Securities Act and therefore omits certain information contained
in the registration statement. We have also filed exhibits and schedules with the registration statement that are excluded from
this prospectus, and you should refer to the applicable exhibit or schedule for a complete description of any statement referring
to any contract or other document. You may inspect a copy of the registration statement, including the exhibits and schedules,
without charge, at the public reference room or obtain a copy from the SEC upon payment of the fees prescribed by the SEC.
We also maintain a website at www.neurotropebioscience.com,
through which you can access our SEC filings. The information set forth on, or accessible from, our website is not part of this
prospectus.
INCORPORATION OF INFORMATION BY REFERENCE
The SEC allows us to “incorporate
by reference” information that we file with them. Incorporation by reference allows us to disclose important information
to you by referring you to those other documents. The information incorporated by reference is an important part of this prospectus,
and information that we file later with the SEC will automatically update and supersede this information. This prospectus omits
certain information contained in the registration statement, as permitted by the SEC. You should refer to the registration statement
and any prospectus supplement filed hereafter, including the exhibits, for further information about us and the securities we may
offer pursuant to this prospectus. Statements in this prospectus regarding the provisions of certain documents filed with, or incorporated
by reference in, the registration statement are not necessarily complete and each statement is qualified in all respects by that
reference. Copies of all or any part of the registration statement, including the documents incorporated by reference or the exhibits,
may be obtained upon payment of the prescribed rates at the offices of the SEC listed above in “Where You Can Find More Information.”
The documents we are incorporating by reference are:
|
|
·
|
the description of our common stock and Series C Preferred Stock contained in our Registration Statements on Form 8-A, filed on March 27, 2017 and September 9, 2019, pursuant to Section 12(b) of the Exchange Act; and
|
|
|
·
|
all reports and other documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after the date of this prospectus and prior to the termination or completion of the offering of securities under this prospectus shall be deemed to be incorporated by reference in this prospectus and to be a part hereof from the date of filing such reports and other documents.
|
Unless otherwise noted, the SEC file number
for each of the documents listed above is 000-55275.
In addition, all reports and other documents
filed by us pursuant to the Exchange Act after the date of the initial registration statement and prior to effectiveness of the
registration statement shall be deemed to be incorporated by reference into this prospectus.
Any statement contained in this prospectus
or in a document incorporated or deemed to be incorporated by reference into this prospectus will be deemed to be modified or superseded
for purposes of this prospectus to the extent that a statement contained in this prospectus or any other subsequently filed document
that is deemed to be incorporated by reference into this prospectus modifies or supersedes the statement. Any statement so modified
or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
You may request, orally or in writing,
a copy of any or all of the documents incorporated herein by reference. These documents will be provided to you at no cost, by
contacting: Investor Relations, Neurotrope, Inc., 1185 Avenue of the Americas, 3rd Floor, New York, New York 10036,
or call (973) 242-0005.
You should rely only on information contained
in, or incorporated by reference into, this prospectus and any prospectus supplement. We have not authorized anyone to provide
you with information different from that contained in this prospectus or incorporated by reference in this prospectus. We are
not making offers to sell the securities in any jurisdiction in which such an offer or solicitation is not authorized or in which
the person making such offer or solicitation is not qualified to do so or to anyone to whom it is unlawful to make such offer
or solicitation.
NextTrip (NASDAQ:NTRP)
Graphique Historique de l'Action
De Oct 2024 à Nov 2024
NextTrip (NASDAQ:NTRP)
Graphique Historique de l'Action
De Nov 2023 à Nov 2024
