As filed with the Securities and Exchange Commission
on October 22, 2021
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933
SYNTHETIC BIOLOGICS, INC.
(Exact Name of Registrant as Specified in Its
Charter)
Nevada
(State or Other Jurisdiction of
Incorporation or Organization)
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13-3808303
(I.R.S. Employer
Identification Number)
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9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
(734) 332-7800
(Address, Including Zip Code, and Telephone
Number, Including Area Code, of Registrant’s Principal Executive Offices)
Steven A. Shallcross
Chief Executive Officer and Chief Financial
Officer
Synthetic Biologics, Inc.
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
(734) 332-7800
(Name, Address, Including Zip Code, and
Telephone Number, Including Area Code of Agent for Service)
With copies to:
Leslie Marlow, Esq.
Hank Gracin, Esq.
Patrick J. Egan, Esq.
Gracin & Marlow, LLP
The Chrysler Building
405 Lexington Avenue, 26th Floor
New York, New York 10174
(212) 907-6457
Approximate date of commencement of proposed
sale to the public: From time to time after the effective date of this registration statement.
If the only securities being registered on this
Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ¨
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, other than securities
offered only in connection with dividend or interest reinvestment plans, 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 registration statement
pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 462(e) under the Securities Act, check the following box. ¨
If this Form is a registration statement
pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 413(b) under the Securities Act, check the following box. ¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ¨
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Accelerated filer ¨
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Non-accelerated filer x
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Smaller reporting company x
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Emerging growth company ¨
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If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided to Section 7(a)(2)(B) of the Securities Act. ¨
CALCULATION OF REGISTRATION FEE
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Title of each class of
securities to be registered
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Amount to be
registered(1)(2)
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Proposed maximum
offering price
per share(3)
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Proposed maximum
aggregate
offering price
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Amount of
registration fee
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Common Stock, $0.001 par value per share issuable upon exercise
of warrants(4)
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6,344,966
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$0.69
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$4,378,027
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$405.84
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(1)
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Pursuant to Rule 416 under the Securities Act of 1933, as amended (the “Securities Act”), this registration statement
also covers such additional shares as may hereafter be offered or issued to prevent dilution resulting from stock splits, stock dividends,
recapitalizations or certain other capital adjustments.
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(2)
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Represents shares of common stock underlying warrants issued to investors in the Registrant’s previous underwritten follow-on
offering that closed in October 2018.
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(3)
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Represents the per share exercise price of the warrants, which is $0.69.
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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 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said
Section 8(a), may determine.
EXPLANATORY NOTE
The Registrant previously filed a registration
statement on Form S-1, as amended (File No. 333-227400), which the Securities and Exchange Commission (the “SEC”)
declared effective on October 10, 2018 (the “Form S-1 Registration Statement”). The Form S-1 Registration Statement
expired on October 10, 2021. In the offering registered pursuant to the Securities Act of 1933, as amended (the “Securities
Act”), under the Form S-1 Registration Statement, the Registrant offered and sold an aggregate of (i) 2,520,000 Class A
Units, with each Class A Unit offered to the public at a public offering price of $1.15, with each Class A Unit consisting of
one share of the Registrant’s common stock (the “Common Stock”), and one five-year warrant to purchase one
share of common stock (the “Class A Warrants”), and (ii) 15,723 Class B Units, with each Class B
Unit offered to the public at a public offering price of $1,000 per Class B Unit and consisting of one share of the Registrant’s
Series B Preferred Stock, with a stated value of $1,000 and convertible into shares of common stock at the stated value divided
by a conversion price of $1.15 per share, with all shares of Series B Preferred Stock convertible into an aggregate of 13,672,173 shares
of common stock, and issued with an aggregate of 13,672,173 warrants (the “Class B Warrants” and together with
the Class A Warrants, the “October 2018 Warrants”).
This Registration Statement is intended to ensure
that an effective registration statement covers all shares of common stock issuable upon exercise of the outstanding and unexercised
October 2018 Warrants. As of the date of this registration statement, an aggregate of 6,344,966 shares of common stock are issuable
upon exercise of 6,344,966 outstanding and unexercised October 2018 Warrants.
The information contained in this
prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these
securities in any jurisdiction where the offer or sale is not permitted.
Subject to Completion, Dated October 22,
2021
PROSPECTUS
6,344,966 Shares of Common Stock Issuable Upon
Exercise of Outstanding Warrants
This prospectus relates to the offer and sale
by us of 6,344,966 shares of our common stock, par value $0.001 per share, that are issuable at an exercise price of $0.69 per share from
time to time upon the exercise of outstanding warrants that we issued in October 2018 (the “October 2018 Warrants”)
as part of a follow-on underwritten public offering. We will receive the proceeds from any cash exercises of the outstanding October 2018
Warrants. Each October 2018 Warrant is exercisable at any time until its expiration date, which is October 15, 2023 (the date
that is five years from the date on which the October 2018 Warrants were initially issued by us in a firm commitment public offering).
No securities are being offered pursuant to this prospectus other than the 6,344,966 shares of our common stock that will be issued
upon exercise of the previously issued and outstanding October 2018 Warrants.
Our common stock is listed on the NYSE American
LLC under the symbol “SYN.” The last reported sale price of our common stock on the NYSE American LLC on October 20,
2021 was $0.438 per share. We urge prospective purchasers of our common stock to obtain current information about the market prices of
our common stock.
Investing in our securities involves a high
degree of risk. You should review carefully the risks and uncertainties described under the heading “Risk Factors”
contained in the applicable prospectus supplement and in any free writing prospectuses we have authorized for use in connection with
a specific offering, and under similar headings in the other documents that are incorporated by reference into this prospectus.
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 , 2021
TABLE OF CONTENTS
You should rely only on the information we
have provided or incorporated by reference in this prospectus or in any prospectus supplement. We have not authorized anyone to provide
you with information different from that contained or incorporated by reference in this prospectus or in any prospectus supplement. This
prospectus and any prospectus supplement 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 contained in this prospectus and in any prospectus supplement is accurate
only as of their respective dates and that any information we have incorporated 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 prospective supplement or any sale of securities.
The registration statement, including the exhibits and the documents incorporated herein by reference, can be read on the Securities and
Exchange Commission website or at the Securities and Exchange Commission offices mentioned under the heading “Where You Can Find
More Information.”
ABOUT THIS PROSPECTUS
This prospectus is not an offer or solicitation
in respect to these securities in any jurisdiction in which such offer or solicitation would be unlawful. This prospectus is
part of a registration statement that we filed with the Securities and Exchange Commission (the “SEC”). We have
not authorized anyone else to provide you with different information or additional information. You should not assume that
the information in this prospectus, or any supplement or amendment to this prospectus, is accurate at any date other than the date indicated
on the cover page of such documents.
Unless otherwise stated or the context otherwise
requires, references in this prospectus to “Synthetic” the “Company,” “we,” “our” and
“us” refer to Synthetic Biologics, Inc., a Nevada corporation, and its consolidated subsidiaries, unless otherwise specified.
When we refer to “you,” we mean the holders of the applicable series of securities.
This prospectus and the information incorporated
herein by reference include trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and
trade names included or incorporated by reference into this prospectus, any applicable prospectus supplement or any related free writing
prospectus are the property of their respective owners.
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PROSPECTUS SUMMARY
The items in the following summary are described
in more detail elsewhere in this prospectus and in the documents incorporated by reference herein. This summary provides an overview of
selected information and does not contain all the information you should consider before investing in our securities. Therefore, you should
carefully read the entire prospectus, any prospectus supplement and any free writing prospectus that we have authorized for use in connection
with this offering, including the “Risk Factors” section and other documents or information included or incorporated by reference
in this 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 Securities and Exchange
Commission, (the “SEC”), or included in any applicable prospectus supplement, before making any investment decision.
Overview
We are a diversified
clinical-stage company developing therapeutics designed to treat gastrointestinal (GI) diseases in areas of high unmet need. Our lead
clinical development candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam
antibiotics within the GI tract to prevent microbiome damage, Clostridioides difficile infection (CDI), overgrowth of
pathogenic organisms, the emergence of antimicrobial resistance (AMR), and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic
cell transplant (HCT) recipients, and (2) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP)
produced under cGMP conditions and intended to treat both local GI and systemic diseases.
We plan to explore and
evaluate a range of strategic options, which may include: in-licensing opportunities; evaluation of potential acquisitions; or other potential
strategic transactions. In the meantime, we remain focused on working with our clinical development partners to advance the planned Phase
1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT patients, and advancing the clinical development program for SYN-020 intestinal
alkaline phosphatase (IAP) in multiple potential indications.
We are continuing to
assess the potential impact of the COVID-19 pandemic. We are in close contact with our clinical development partners in order to assess
the impact of COVID-19 on our studies and current timelines and costs. While we currently do not anticipate any interruptions in our operations
due to COVID-19, it is possible that if the COVID-19 pandemic were to increase in severity for an extended period of time, we could once
again experience delays in our clinical trials which could result in significant disruptions to our clinical development timelines due
to the COVID-19 pandemic, which would adversely affect our business, financial condition, results of operations and growth prospects.
In response to the spread
of COVID-19 as well as public health directives and orders, we have implemented a number of measures designed to ensure employee safety
and business continuity. We have limited access to our offices and are allowing our administrative employees to continue their work outside
of our offices in order to support the community efforts to reduce the transmission of COVID-19 and protect employees, complying with
guidance from federal, state and local government and health authorities. The full extent to which the COVID-19 outbreak will directly
or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain
and cannot be accurately predicted. The effects of the governmental orders and our work-from-home policies may negatively impact productivity,
disrupt our business and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity
of the restrictions and other limitations on our ability to conduct our business in the ordinary course.
Company History
Our predecessor, Sheffield Pharmaceuticals, Inc.,
was incorporated in 1986, and in 2006 engaged in a reverse merger with Pipex Therapeutics, Inc., a Delaware corporation formed in
2001. After the merger, we changed our name to Pipex Pharmaceuticals, Inc., and in October 2008 we changed our name to Adeona
Pharmaceuticals, Inc. On October 15, 2009, we engaged in a merger with a wholly owned subsidiary for the purpose of reincorporating
in the State of Nevada. After reprioritizing our focus on the emerging area of synthetic biologics and entering into our first collaboration
with Intrexon, we amended our Articles of Incorporation to change our name to Synthetic Biologics, Inc. on February 15, 2012.
Corporate Information
Our executive offices are located at 9605
Medical Center Drive, Suite 270, Rockville, Maryland 20850. Our telephone number is (301) 417-4364, and our website address
is www.syntheticbiologics.com. The information contained on our website is not part of and should not be construed as
being incorporated by reference into this prospectus supplement.
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Summary
Risk Factors
The following is a summary of the key risks
relating to our Company. You should review carefully the risks and uncertainties more fully described under the heading “Risk
Factors” contained in the applicable prospectus supplement and in any free writing prospectuses we have authorized for
use in connection with a specific offering, and under similar headings in the other documents that are incorporated by reference
into this prospectus.
Business Risks
· We
will need to raise additional capital and may be unable to raise the necessary capital to operate our business or obtain funding on acceptable
terms or at all, which may reduce or eliminate our development programs or commercialization efforts.
· The
continued impact of the COVID-19 pandemic on our planned operations and clinical studies.
· We
have a history of incurring substantial losses and negative operating cash flow and expect to continue to incur significant operating
and capital expenditures.
· We
have no significant sources of revenue and may never generate significant revenue.
· Our
research and development efforts may not succeed in developing a commercially successful product or technology.
· We
are largely dependent on the success of our lead product candidates, SYN-004 and SYN-020, which require significant additional clinical
testing before we can seek regulatory approval and we cannot be certain that these product candidates will receive regulatory approval
or be successfully commercialized.
· We
may not be able to retain rights licensed to us by others to commercialize key products and may not be able to establish or maintain
the relationships we need to develop, manufacture, and market our products.
· We
face strong competition and may not be able to compete effectively and our competitors may develop and/or gain FDA approval of our product
candidates for a different indication.
· Our
ability to develop, manufacture and market our product candidates may be delayed or impaired for reasons that are beyond our control
due to our reliance on third party suppliers for raw materials and services.
· We
may not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our product
candidates.
· We
rely extensively on our information technology systems and are vulnerable to damage and interruption and any failure to maintain
the security of information relating to our customers, employees and suppliers, whether as a result of cybersecurity attacks or otherwise,
could expose us to litigation, government enforcement actions and costly response measures, and could disrupt our operations and harm
our reputation.
Regulatory Risks
· We
may not be able to obtain the necessary regulatory approvals in the U.S. and/or other countries.
· Clinical
trials are expensive, time consuming, and difficult to design and implement, and may return results that may not support our product
candidate claims and the results of preclinical studies and completed clinical trials are not necessarily predictive of future results.
· We
may have difficulties in enrolling patients in our clinical trials, or experience delays in enrollment, which could result in increased
costs and/or delay our ability to generate revenue.
· Patients
who are administered our product candidates may experience unexpected side effects or other safety risks that could cause a halt in their
clinical development, preclude approval of our product candidates or limit their commercial potential.
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· Our
product candidates, if approved for sale, may not gain acceptance among physicians, patients and the medical community, thereby limiting
our potential to generate revenues.
· We
currently have no marketing, sales or distribution organization and have no experience in marketing products as a company. If we are unable
to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, we
may not be able to generate product revenue.
Intellectual Property Risks
· If
product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization
of our product candidates.
· We
rely on patent applications and various regulatory exclusivities to protect some of our product candidates and our ability to compete
may be limited or eliminated if we are not able to protect our products. Additionally, litigation or other proceedings relating to protecting
our intellectual property is costly and time consuming.
Risks Related To our Securities
· Our
failure to continue to meet the
other listing requirements could result in a de-listing of our common stock.
· We
expect to seek to raise additional capital in the future, which may be dilutive to stockholders or impose operational restrictions.
· The
market price of our common stock has been and may continue to be volatile and adversely affected by various factors.
Risks Related
To This Offering
· Resales
of our common stock in the public market by our stockholders may cause the market price of our common stock to fall.
· There
may be further sales or other dilution of our equity, which may adversely affect the market price of our common stock.
· Our
management will have broad discretion over the use of the net proceeds from this offering and you may not agree with how we use
the proceeds and the proceeds may not be invested successfully.
· If
the holders of the October 2018 Warrants exercise the 2018 Warrants, they may experience immediate and substantial dilution in the
book value per share of common stock they hold.
October 2018 Underwritten Public Offering
On October 15, 2018, we closed an underwritten
public offering pursuant to which we received gross proceeds of approximately $18.6 million before deducting underwriting discounts,
commissions and other offering expenses payable by us and sold an aggregate of (i) 2,520,000 Class A Units (the “Class A
Units”), with each Class A Unit consisting of one share of our common stock, $0.001 par value per share (the “common
stock”), and one five-year warrant to purchase one share of common stock at an initial exercise price of $1.38 per
share, which subsequently was reduced to $0.69 per share (the “Class A Warrants”), with each Class A Unit to
be offered to the public at a public offering price of $1.15, and (ii) 15,723 Class B Units (the “Class B Units”),
with each Class B Unit offered to the public at a public offering price of $1,000 per Class B Unit and consisting of one
share of our Series B Convertible Preferred Stock (the “Series B Preferred Stock”), with a stated value of $1,000 and
convertible into shares of our common stock at the stated value divided by a conversion price of $1.15 per share, with all shares
of Series B Preferred Stock convertible into an aggregate of 13,672,173 shares of common stock, and issued with an aggregate
of 13,672,173 warrants (the “Class B Warrants”, and together with the Class A Warrants, the “October 2018
Warrants”). In addition, pursuant to the underwriting agreement that we had entered into with A.G.P./Alliance Global Partners (the
“Underwriters”), as representative of the underwriters, we granted the Underwriters a 45day option (the “Over-allotment
Option”) to purchase up to an additional 2,428,825 shares of common stock and/or additional October 2018 Warrants
to purchase an additional 2,428,825 shares of common stock. The Underwriters partially exercised the Over-allotment Option by
electing to purchase from us additional October 2018 Warrants to purchase 1,807,826 shares of common stock.
On November 16, 2020, the exercise price
of the October 2018 Warrants was reduced from $1.38 per warrant per full share of our common stock to $0.69 per October 2018
Warrant per full share of common stock in accordance with the anti-dilution terms of the October 2018 Warrants. The reduction was
the result of the issuance of shares of common stock by us through our “at the market offering” facility. The effect of the
change in the exercise price of the October 2018 Warrants as a result of the triggering of the down round protection clause in the
warrants was recorded as a deemed dividend of $880,000 during the year ended December 31, 2020, which reduces the income available
to common stockholders. The exercise price and the number of shares of common stock purchasable upon the exercise of each October 2018
Warrant are subject to adjustment upon the happening of certain events, such as stock dividends, distributions, and split.
The Registration Statement of which this prospectus
is a part is intended to ensure that an effective registration statement covers all shares of common stock issuable upon exercise of the
outstanding and unexercised October 2018 Warrants. As of the date of this prospectus, an aggregate of 6,344,966 shares of common
stock remain issuable upon exercise of the October 2018 Warrants, which expire on October 15, 2023.
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THE OFFERING
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Common stock offered by us pursuant to this prospectus
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6,344,966 shares of common stock issuable upon exercise of the October 2018 Warrants, which warrants are exercisable until October 15, 2023 (the fifth anniversary of the original issuance date of the October 2018 Warrants) at an exercise price of $0.69 per share.
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Common stock to be outstanding after this
offering if all of the October 2018 Warrants
are exercised
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138,387,505 shares.(1)
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Use of proceeds
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The amount of proceeds from this offering will
depend upon the number of shares of our common stock issued upon exercise of the October 2018 Warrants. There can be no assurance
that any warrants will be exercised.
We intend to use the net proceeds, if any,
from this offering for general corporate purposes, which may include, among other things, for clinical trials for our product candidates,
paying general and administrative expenses and accounts payable, increasing our working capital, funding research and development
and funding capital expenditures. We may also use a portion of the net proceeds for licensing or acquiring intellectual property
to incorporate into our products and product candidates or our research and development programs and to in-license, acquire or invest
in other businesses or products, although we have no commitments or agreements with respect to any such licenses, acquisitions or
investments as of the date of this prospectus supplement. See “Use of Proceeds.”
The net proceeds from any disposition of the shares
of common stock covered hereby would be received by the investors selling such shares. We will not receive any of the proceeds from any
such sale of the common stock offered by this prospectus other than the net proceeds of any October 2018 Warrants exercised for cash.
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Risk factors
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See “Risk Factors” beginning on page 3 of
this prospectus and the other information included in, or incorporated by reference into, this prospectus for a discussion of certain
factors you should carefully consider before deciding to invest in shares of our common stock.
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NYSE American LLC Symbol
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“SYN”
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(1) Based
on 132,042,537 shares of common stock issued and outstanding on October 21, 2021.
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RISK FACTORS
Investing in our securities involves a high degree
of risk. Before deciding whether to invest in our securities, you should consider carefully the risks and uncertainties described below
and any related free writing prospectus, and discussed under the section entitled “Risk Factors” contained in our most recent
Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q, as such filings may be updated by subsequent annual,
quarterly and other reports that are incorporated by reference into this prospectus in their entirety. The risks described in these documents
are not the only ones we face, but those that we consider to be material. There may be other unknown or unpredictable economic, business,
competitive, regulatory or other factors that could have material adverse effects on our future results. Past financial performance may
not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future
periods. If any of these risks actually occurs, our business, financial condition, results of operations or cash flows could be seriously
harmed. This could cause the trading price of our common stock to decline, resulting in a loss of all or part of your investment. Please
also read carefully the section below entitled “Special Note Regarding Forward-Looking Statements.”
Risks Related to this Offering
Resales
of our common stock in the public market by our stockholders may cause the market price of our common stock to fall.
We may issue
common stock from time to time, including in connection with the exercise of the October 2018 Warrants. The issuance from time to
time of these new shares of our common stock, or our ability to issue new shares of common stock from time to time, could result in resales
of our common stock by our current stockholders concerned about the potential dilution of their holdings. In turn, these resales could
have the effect of depressing the market price for our common stock.
There
may be future sales or other dilution of our equity, which may adversely affect the market price of our common stock.
We are generally
not restricted from issuing additional common stock, including any securities that are convertible into or exchangeable for, or that represent
the right to receive, common stock. The market price of our common stock could decline as a result of sales of common stock or securities
that are convertible into or exchangeable for, or that represent the right to receive, common stock after this offering or the perception
that such sales could occur.
Our
management will have broad discretion over the use of the net proceeds from this offering and you may not agree with how we use the proceeds,
and the proceeds may not be invested successfully.
We have
not designated any portion of the net proceeds from this offering to be used for any particular purpose. Accordingly, our management will
have broad discretion as to the use of the net proceeds from this offering and could use them for purposes other than those contemplated
at the time of the commencement of the offering of the October 2018 Warrants and as of the date of this prospectus. Accordingly,
you will be relying on the judgment of our management with regard to the use of these net proceeds, and you will not have the opportunity,
as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that, pending their use,
we may invest the net proceeds in a way that does not yield a favorable, or any, return for our company.
If
the holders of the October 2018 Warrants exercise the October 2018 Warrants, they may experience immediate and substantial dilution
in the book value per share of the common stock they hold.
This offering
involves the offer and sale by us of up to 6,344,966 shares of our common stock that are currently issuable upon the exercise of the October 2018
Warrants. The exercise price of the October 2018 Warrants at the time of exercise may be substantially higher than the book value
per share of our common stock, and the holders of the October 2018 Warrants may suffer immediate and substantial dilution in the net
tangible book value of the common stock acquired upon exercise of October 2018 Warrants. The exercise of outstanding stock options
and other outstanding warrants may result in further dilution of your investment. See “Dilution” for a more detailed discussion
of the dilution you may incur in connection with this offering.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements contained or incorporated
by reference in this prospectus may include forward-looking statements that reflect our current views with respect to our ongoing and
planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking
statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,”
“plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,”
“will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the
federal securities laws or otherwise.
All forward-looking statements involve inherent
risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated
in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk
Factors” in this prospectus and under the captions “Risk Factors,” “Business,” and “Management’s
Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and
our subsequent Quarterly Reports on Form 10-Q, all of which you should review carefully. Please consider our forward-looking statements
in light of those risks as you read this prospectus. We undertake no obligation to publicly update or review any forward-looking statement,
whether as a result of new information, future developments or otherwise.
If one or more of these or other risks or uncertainties
materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All
subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified
in their entirety by this Note. Before purchasing any of our securities, you should consider carefully all of the factors set forth or
referred to in this prospectus that could cause actual results to differ.
USE OF PROCEEDS
The amount of proceeds from this offering will
depend upon the number of shares of our common stock issued upon exercise of the October 2018 Warrants. There can be no assurance
that any warrants will be exercised.
We intend to use the net proceeds, if any, from
this offering for general corporate purposes, which may include, among other things, for clinical trials for our product candidates, paying
general and administrative expenses and accounts payable, increasing our working capital, funding research and development and funding
capital expenditures. We may also use a portion of the net proceeds for licensing or acquiring intellectual property to incorporate into
our products and product candidates or our research and development programs and to in-license, acquire or invest in other businesses
or products, although we have no commitments or agreements with respect to any such licenses, acquisitions or investments as of the date
of this prospectus supplement.
The net proceeds from any disposition of the shares
of common stock covered hereby would be received by the investors selling such shares. We will not receive any of the proceeds from any
such sale of the common stock offered by this prospectus other than the net proceeds of any October 2018 Warrants exercised for cash.
DILUTION
If you purchase shares of our common stock in
this offering, you will experience dilution to the extent of the difference between the offering price per share and the as adjusted net
tangible book value per share after giving effect to this offering.
As of June 30, 2021, our net tangible
book value was approximately $73.7 million, or approximately $0.558 per share of common stock. “Net tangible book value” is
total assets minus the sum of liabilities and intangible assets. “Net tangible book value per share” is net tangible
book value divided by the total number of shares outstanding.
After giving effect to the issuance of the
common stock to investors exercising the October 2018 Warrants for cash at $0.69 per share, our as adjusted net tangible book
value as of June 30, 2021 would have been approximately $78.1 million or $0.564 per share of common stock. This represents an
immediate increase in net tangible book value of $0.006 per share to our existing stockholders and an immediate dilution in net
tangible book value of $0.126 per share to investors exercising the October 2018 Warrants at a price of $0.69 per share, which
is the exercise price of the outstanding Warrants. The following table illustrates this dilution per share to investors
participating in this offering:
Exercise price per share
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$
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0.69
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Net tangible book value per share as of June 30, 2021
|
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$
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0.558
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|
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Increase in net tangible book value per share attributable to existing investors in this offering
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$
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0.006
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|
|
|
|
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As adjusted net tangible book value per share after giving effect to this offering
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|
|
|
|
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$
|
0.564
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Dilution per share to new investors
|
|
|
|
|
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$
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0.126
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The foregoing discussion and table do not take
into account further dilution to new investors that could occur upon the exercise of outstanding options or warrants having a per share
exercise price less than the exercise price of the October 2018 Warrants. In addition, we may choose to raise additional capital
due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.
To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities
could result in further dilution to our stockholders.
DIVIDEND POLICY
We have never paid cash dividends on our common
stock. Moreover, we do not anticipate paying periodic cash dividends on our common stock for the foreseeable future. We intend to use
all available cash and liquid assets in the operation and growth of our business, subject to terms of any preferred stock or debt securities.
Any future determination about the payment of dividends will be made at the discretion of our board of directors and will be subject to
the rights of any outstanding preferred stock and will depend upon our earnings, if any, capital requirements, operating and financial
conditions and on such other factors as our board of directors deems relevant.
DESCRIPTION OF OUR CAPITAL STOCK
Authorized Capital
Our authorized capital consists of 200,000,000
shares of common stock, par value $0.001 per share, and 10,000,000 shares of preferred stock, par value $0.001 per share. As of October 21,
2021, we had 132,042,537 shares of common stock were issued and outstanding, and no shares
of preferred stock were issued and outstanding.
Common Stock
Authorized Shares of common stock. We
currently have authorized 200,000,000 million shares of common stock. As of October 21, 2021, we had 132,042,537
shares of common stock outstanding.
Voting Rights. The holders of the common
stock are entitled to one vote for each share held of record on all matters submitted to a vote of the stockholders, including the election
of directors, and do not have cumulative voting rights. Accordingly, the holders of a majority of the shares of the common stock entitled
to vote in any election of directors can elect all of the directors standing for election.
Dividend Rights. Subject to preferences
that may be applicable to any then outstanding preferred stock, the holders of common stock are entitled to receive dividends, if any,
as may be declared from time to time by our board of directors out of legally available funds.
Liquidation Rights. In the event of our
liquidation, dissolution or winding up, holders of the common stock will be entitled to share ratably in the net assets legally available
for distribution to stockholders after the payment of all of our debts and other liabilities, subject to the satisfaction of any liquidation
preference granted to the holders of any then outstanding shares of preferred stock.
Other Rights and Preferences. The holders
of the common stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable
to the common stock. The rights, preferences and privileges of the holders of the common stock are subject to, and may be adversely affected
by, the rights of the holders of shares of any series of our preferred stock that we may designate and issue in the future.
Fully Paid and Nonassessable. All of our
outstanding shares of common stock are fully paid and nonassessable.
Preferred Stock
Our Board of Directors has the authority, without
action by our stockholders, to designate and issue up to 10,000,000 shares of preferred stock in one or more series or classes and to
designate the rights, preferences and privileges of each series or class, which may be greater than the rights of our common stock, of
which (i) 120,000 shares had been designated as Series A Preferred Stock, none of which is outstanding, and (ii) 10,000,000
shares that have been designated as Series B Preferred Stock, none of which is outstanding. It is not possible to state the actual
effect of the issuance of any shares of preferred stock upon the rights of holders of our common stock until our Board of Directors determines
the specific rights of the holders of the preferred stock however, the effects might include:
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restricting dividends on our common stock;
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●
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diluting the voting power of our common stock;
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●
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impairing liquidation rights of our common stock; or
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●
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delaying or preventing a change in control of us without further action by our stockholders.
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The Board of Directors’ authority to issue
preferred stock without stockholder approval could make it more difficult for a third-party to acquire control of our company, and could
discourage such attempt. We have no present plans to issue any additional shares of preferred stock.
Options
As of October 21, 2021, options to purchase
an aggregate of 3,997,418 shares of common stock were outstanding under our equity incentive plans.
Anti-Takeover Effects of Certain Provisions
of our Articles of Incorporation and Bylaws
Our Articles of Incorporation and Bylaws contain
certain provisions that may have anti-takeover effects, making it more difficult for or preventing a third party from acquiring control
of the Registrant or changing our board of directors and management. According to our Articles of Incorporation and Bylaws, the holders
of the common stock do not have cumulative voting rights in the election of our directors. The lack of cumulative voting makes it more
difficult for other stockholders to replace our board of directors or for a third party to obtain control of our company by replacing
its Board of Directors.
Authorized but Unissued Shares
Our authorized but unissued shares of common stock
will be available for future issuance without stockholder approval. We may use additional shares of common stock for a variety of purposes,
including future public offerings to raise additional capital, to fund acquisitions and as employee compensation. The existence of authorized
but unissued shares of common stock could render more difficult or discourage an attempt to obtain control of us by means of a proxy contest,
tender offer, merger or otherwise.
Anti-Takeover Effects of Nevada Law
Business Combinations
The “business combination” provisions
of Sections 78.411 to 78.444, inclusive, of the Nevada Revised Statutes (“NRS”) generally prohibit a Nevada corporation with at least 200 stockholders from engaging
in various “combination” transactions with any interested stockholder for a period of two years after the date of the transaction
in which the person became an interested stockholder, unless the transaction is approved by the board of directors prior to the date the
interested stockholder obtained such status or the combination is approved by the board of directors and thereafter is approved at a meeting
of the stockholders by the affirmative vote of stockholders representing at least 60% of the outstanding voting power held by disinterested
stockholders, and extends beyond the expiration of the two-year period, unless:
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·
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the combination was approved by the board of directors prior to the person becoming an interested stockholder
or the transaction by which the person first became an interested stockholder was approved by the board of directors before the person
became an interested stockholder or the combination is later approved by a majority of the voting power held by disinterested stockholders;
or
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·
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if the consideration to be paid by the interested stockholder is at least equal to the highest of: (a) the
highest price per share paid by the interested stockholder within the two years immediately preceding the date of the announcement of
the combination or in the transaction in which it became an interested stockholder, whichever is higher, (b) the market value per
share of common stock on the date of announcement of the combination and the date the interested stockholder acquired the shares, whichever
is higher, or (c) for holders of preferred stock, the highest liquidation value of the preferred stock, if it is higher.
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A “combination” is generally defined
to include mergers or consolidations or any sale, lease exchange, mortgage, pledge, transfer, or other disposition, in one transaction
or a series of transactions, with an “interested stockholder” having: (a) an aggregate market value equal to 5% or more
of the aggregate market value of the assets of the corporation, (b) an aggregate market value equal to 5% or more of the aggregate
market value of all outstanding shares of the corporation, (c) 10% or more of the earning power or net income of the corporation,
and (d) certain other transactions with an interested stockholder or an affiliate or associate of an interested stockholder.
In general, an “interested stockholder”
is a person who, together with affiliates and associates, owns (or within two years, did own) 10% or more of a corporation’s voting
stock. The statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage attempts
to acquire our company even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above
the prevailing market price.
Control Share Acquisitions
The “control share” provisions
of Sections 78.378 to 78.3793, inclusive, of the Nevada Revised Statutes apply to “issuing corporations” that are Nevada
corporations with at least 200 stockholders, including at least 100 stockholders of record who are Nevada residents, and that
conduct business directly or indirectly in Nevada. The control share statute prohibits an acquirer, under certain circumstances,
from voting its shares of a target corporation’s stock after crossing certain ownership threshold percentages, unless the
acquirer obtains approval of the target corporation’s disinterested stockholders. The statute specifies three thresholds:
one-fifth or more but less than one-third, one-third but less than a majority, and a majority or more, of the outstanding voting
power. Generally, once an acquirer crosses one of the above thresholds, those shares in an offer or acquisition and acquired within
90 days thereof become “control shares” and such control shares are deprived of the right to vote until disinterested
stockholders restore the right. These provisions also provide that if control shares are accorded full voting rights and the
acquiring person has acquired a majority or more of all voting power, all other stockholders who do not vote in favor of authorizing
voting rights to the control shares are entitled to demand payment for the fair value of their shares in accordance with statutory
procedures established for dissenters’ rights.
A corporation may elect to not be governed by,
or “opt out” of, the control share provisions by making an election in its articles of incorporation or bylaws, provided that
the opt-out election must be in place on the 10th day following the date an acquiring person has acquired a controlling interest, that
is, crossing any of the three thresholds described above. We have not opted out of the control share statutes, and will be subject to
these statutes if we are an “issuing corporation” as defined in such statutes.
The effect of the Nevada control share statutes
is that the acquiring person, and those acting in association with the acquiring person, will obtain only such voting rights in the control
shares as are conferred by a resolution of the stockholders at an annual or special meeting. The Nevada control share law, if applicable,
could have the effect of discouraging takeovers of our company.
Transfer Agent and Registrar
The transfer agent and registrar for the common
stock is Equiniti Trust Company (formerly known as Corporate Stock Transfer, Inc.). The transfer agent’s address is 3200 Cherry
Creek Drive South, Suite 430, Denver, Colorado 80209, telephone number (303) 282-4800.
Listing on the NYSE American
Our common stock is listed on the NYSE American under the symbol “SYN.”
DESCRIPTION OF WARRANTS
Warrants
The following summary of the October 2018
Warrants is not complete and is subject to, and qualified in its entirety by, the provisions of the forms of warrant and warrant agency
agreement, the form of which is filed as an exhibit to the registration statement of which this prospectus forms a part. Prospective investors
should carefully review the terms and provisions of the form of warrant agent agreement for a complete description of the terms and conditions
of the common warrants.
Warrants
As of October 21, 2021, we had issued and
outstanding a total of 6,344,966 warrants to purchase our common stock outstanding at a weighted-average price of $0.69.
Overview of October 2018 Warrants and
the October 2018 Underwritten Public Offering
Overview. As stated above, the October 2018
Warrants are exercisable at a price of $0.69 per share of common stock and expire on October 15, 2023..
Form. The October 2018 Warrants
were issued in electronic book entry form. The form of warrant and the warrant agency agreement are each filed as an exhibit to the registration
statement of which this prospectus forms a part.
Exercisability. The October 2018
Warrants are exercisable at any time after their original issuance and will expire on the fifth anniversary of the original issuance date.
The October 2018 Warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed
exercise notice and by payment in full in immediately available funds for the number of shares of common stock purchased upon such exercise.
If at the time of exercise, there is no effective registration statement registering, or no current prospectus available for, the issuance
of the shares of common stock to the holder, then the common warrant may only be exercised through a cashless exercise, in which case
the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in
the warrant. No fractional shares of common stock will be issued in connection with the exercise of a warrant. In lieu of fractional shares,
we will pay the holder an amount in cash equal to the fractional amount multiplied by the fair market value of any such fractional shares.
Exercise Limitations. Under the October 2018
Warrants, we may not effect the exercise of any warrant, and a holder will not be entitled to exercise any portion of any warrant, which,
upon giving effect to such exercise, would cause (i) the aggregate number of shares of our common stock beneficially owned by the
holder (together with its affiliates) to exceed [4.99%/9.99%] of the number of shares of our common stock outstanding immediately after
giving effect to the exercise, or (ii) the combined voting power of our securities beneficially owned by the holder (together with
its affiliates) to exceed [4.99%/9.99%] of the combined voting power of all of our securities then outstanding immediately after giving
effect to the exercise, as such percentage ownership is determined in accordance with the terms of the October 2018 Warrants. However,
any holder may increase or decrease such percentage to any other percentage not in excess of 9.99% upon at least 61 days’ prior
notice from the holder to us.
Exercise Price. The exercise price
per whole share of our common stock purchasable upon the exercise of the October 2018 Warrants is $0.69 and may be adjusted in the
event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our
common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders. Subject to certain
exceptions, the October 2018 Warrants provide for adjustment of the exercise price if we or any of our subsidiaries, as applicable,
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 shares of our common stock or common stock equivalents, at an effective price per share that is less than the exercise
price then in effect (such lower price, the “Base Share Price” and such issuances collectively, a “Dilutive Issuance”).
In the event a Dilutive Issuance occurs, the exercise price shall be reduced to equal the Base Share Price.
On November 16, 2020, the exercise price
of the October 2018 Warrants was reduced from $1.38 per warrant per full share of our common stock to $0.69 per October 2018
Warrant per full share of common stock in accordance with the anti-dilution terms of the October 2018 Warrants.
Transferability. Subject to applicable
laws, the October 2018 Warrants may be offered for sale, sold, transferred or assigned without our consent.
Exchange Listing. We have not applied and
do not plan on applying to list the October 2018 Warrants on the NYSE American, any other national securities exchange or any other
nationally recognized trading system.
Fundamental Transactions. In the event
of a fundamental transaction, as described in the October 2018 Warrants and generally including any reorganization, recapitalization
or reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets,
our consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding common stock, or any person
or group becoming the beneficial owner of 50% of the voting power represented by our outstanding common stock, the holders of the common
warrants will be entitled to receive upon exercise of the October 2018 Warrants the kind and amount of securities, cash or other
property that the holders would have received had they exercised the October 2018 Warrants immediately prior to such fundamental
transaction without regard to any limitations on exercise contained in the October 2018 Warrants. In the event of a fundamental transaction,
we are required to cause any successor entity to assume all of our obligations under the October 2018 Warrants.
Right as a Stockholder. Except by virtue
of such holder’s ownership of shares of our common stock, the holder of a warrant does not have the rights or privileges of a holder
of our common stock, including any voting rights, until the holder exercises the warrant.
PLAN OF DISTRIBUTION
The common stock referenced on the cover page of
this prospectus will be offered solely by us and will be issued and sold upon the exercise of the outstanding October 2018 Warrants
issued in 2018 described herein. We will deliver shares of our common stock upon exercise of the October 2018 Warrants; however,
no fractional shares will be issued. The October 2018 Warrants are exercisable for a total of 6,344,966 shares of our common stock
(subject to adjustment), and no more of these October 2018 Warrants will be issued by us. Each of these October 2018 Warrants
contains instructions for exercise. In order to exercise any of these Warrants, the holder must deliver to us or our transfer agent the
information required in the October 2018 Warrants, along with payment for the exercise price of the shares of common stock to be
purchased. If, however, we are unable to offer and sell the shares underlying the October 2018 Warrants pursuant to this prospectus
due to the ineffectiveness of the registration statement of which this prospectus is a part, then the October 2018 Warrants may be
exercised on a “net” or “cashless” basis.
LEGAL MATTERS
The validity of the issuance of the securities offered hereby has
been passed upon for us by Parsons Behle & Latimer, Reno, Nevada.
EXPERTS
The consolidated financial statements as of December 31, 2020
and 2019, and for each of the two years in the period ended December 31, 2020, incorporated by reference in this Prospectus and the Registration
statement have been so incorporated in reliance on the report of BDO USA, LLP, an independent registered public accounting firm, incorporated
herein by reference, given on the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus is part of a registration statement
we filed with the SEC. This prospectus does not contain all of the information set forth in the registration statement and the exhibits
to the registration statement. For further information with respect to us and the securities we are offering under this prospectus, we
refer you to the registration statement and the exhibits and schedules filed as a part of the registration statement. Neither we nor any
agent, underwriter or dealer has authorized any person to provide you with different information. We are not making an offer of these
securities in any state where the offer is not permitted. You should not assume that the information in this prospectus is accurate as
of any date other than the date on the front page of this prospectus, regardless of the time of delivery of this prospectus or any
sale of the securities offered by this prospectus.
We file annual, quarterly and current reports,
proxy statements and other information with the SEC. Our SEC filings are available to the public at the SEC’s website at www.sec.gov.
Additional information about Synthetic Biologics, Inc. is contained at our website, www.syntheticbiologics.com.
Information on our website is not incorporated by reference into this prospectus. We make available on our website our SEC filings as
soon as reasonably practicable after those reports are filed with the SEC. The following Corporate Governance documents are also
posted on our website: Code of Ethics and the Charters for the Audit Committee, Compensation Committee and Nominating and Governance Committee
of the Board of Directors.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to “incorporate by reference”
the information we file with it which means that we can disclose important information to you by referring you to those documents instead
of having to repeat the information in this prospectus. The information incorporated by reference is considered to be part of this prospectus,
and later information that we file with the SEC will automatically update and supersede this information. We incorporate by reference
the documents listed below and any future filings made with the SEC (other than any portions of any such documents that are not deemed
“filed” under the Exchange Act in accordance with the Exchange Act and applicable SEC rules) under Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act after (i) the date of the initial registration statement and prior to the effectiveness of the
registration statement, and (ii) the date of this prospectus and before the completion of the offerings of the shares of our common
stock included in this prospectus.
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Our Current Reports on Form 8-K and Form 8-K/A (File No. 001-12584) filed with
the SEC on January 6, 2021, January 19, 2021, January 27, 2021, January 29, 2021, February 1, 2021, February 4, 2021, February 8, 2021, February 10, 2021, February 12, 2021, February 19, 2021,
April 1, 2021 (other than as indicated therein), April 14, 2021 (other than as indicated therein), May 3, 2021, May 26, 2021 and June 29, 2021 (other than as indicated therein), September 21, 2021, October 6, 2021 and October 14, 2021;
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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.
We will furnish without charge to you, on written
or oral request, a copy of any or all of the documents that are incorporated by reference into this prospectus and the documents
we file with the SEC that are incorporated by reference herein, but not delivered with the prospectus, including exhibits which are specifically
incorporated by reference into such documents. You should direct any requests for documents to Synthetic Biologics, Inc., Attn: Steven
A. Shallcross, Chief Executive Officer and Chief Financial Officer, 9605 Medical Center Drive, Suite 270, Rockville, Maryland 20850,
or telephoning us at (301) 417-4364.
You should rely only on information contained
in, or incorporated by reference into, this prospectus and the documents we file with the SEC that are incorporated by reference herein.
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.
6,344,966 Shares of common stock Issuable Upon
Exercise of Outstanding Warrants
PROSPECTUS
, 2021
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14.
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Other Expenses of Issuance and Distribution.
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The following sets forth the estimated costs and expenses, all of which
shall be borne by the Registrant, in connection with the offering of the securities pursuant to this Registration Statement:
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Amount
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SEC registration fee
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$
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406
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Legal fees and expenses
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30,000
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Accountant’s fees and expenses
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5,000
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Transfer agent and registrar fees and expenses
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2,000
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Miscellaneous
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2,594
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Total
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40,000
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Item 15.
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Indemnification of Directors and Officers.
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Section 78.138 of the Nevada Revised Statute
provides that a director or officer is not individually liable to the corporation or its stockholders or creditors for any damages as
a result of any act or failure to act in his capacity as a director or officer unless it is proven that (1) his act or failure to
act constituted a breach of his fiduciary duties as a director or officer and (2) his breach of those duties involved intentional
misconduct, fraud or a knowing violation of law.
This provision is intended to afford directors
and officers protection against and to limit their potential liability for monetary damages resulting from suits alleging a breach of
the duty of care by a director or officer. As a consequence of this provision, stockholders of our company will be unable to recover monetary
damages against directors or officers for action taken by them that may constitute negligence or gross negligence in performance of their
duties unless such conduct falls within one of the foregoing exceptions. The provision, however, does not alter the applicable standards
governing a director’s or officer’s fiduciary duty and does not eliminate or limit the right of our company or any stockholder
to obtain an injunction or any other type of non-monetary relief in the event of a breach of fiduciary duty.
The Registrant’s Articles of Incorporation,
as amended, and amended and restated bylaws provide for indemnification of directors, officers, employees or agents of the Registrant
to the fullest extent permitted by Nevada law (as amended from time to time). Section 78.7502 of the Nevada Revised Statute provides
that such indemnification may only be provided if the person acted in good faith and in a manner he or she reasonably believed to be in,
or not opposed to, the best interest of the Registrant and, with respect to any criminal action or proceeding, had no reasonable cause
to behave his conduct was unlawful.
Item 16. Exhibits.
(a)
Exhibits.
The following exhibits are either filed as part of this Registration
Statement on Form S-3 or are incorporated herein by reference:
Exhibit
Number
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Description
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3.1
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Certificate of Incorporation, as amended(Incorporated by reference to (i) Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 16, 2008, File No. 001-12584, (ii) Exhibit 3.1 of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2001 filed August 14, 2001, File No. 001-12584; and (iii) Exhibits 3.1, 4.1 and 4.2 of the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1998 filed August 14, 1998, File No. 001-12584.)
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3.2
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Articles of Merger (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 19, 2009, File No. 001-12584.)
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3.3
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Certificate of Merger filed with the Secretary of State of Delaware (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed October 19, 2009, File No. 001-12584.)
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3.4
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Articles of Incorporation filed with the Nevada Secretary of State (Incorporated by reference to Exhibit 3.3 of the Registrant’s Current Report on Form 8-K filed October 19, 2009, File No. 001-12584.)
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3.5
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Amended and Restated Bylaws Adopted and Effective October 31, 2011 (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed November 2, 2011, File No. 001-12584.)
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3.6
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Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed February 16, 2012, File No. 001-12584.)
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3.7
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Certificate of Amendment to Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed May 18, 2015, File No. 001-12584.)
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3.8
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Certificate of Amendment to Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed September 8, 2017, File No. 001-12584.)
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3.9
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Certificate of Designations for Series A Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed September 12, 2017, File No. 001-12584.)
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3.10
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Certificate of Change Pursuant to NRS 78. 209 (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed August 13, 2018, File No. 001-12584.)
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3.11
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Certificate of Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed September 26, 2018, File No. 001-12584.)
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3.12
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Certificate of Designations for Series B Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed October 15, 2018, File No. 001-12584.)
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3.13
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Certificate of Amendment to Certificate of Designations for Series B Preferred Stock to Certificate of Incorporation (Incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed October 15, 2018, File No. 001-12584.)
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3.14
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Certificate of Amendment to the Certificate
of Designation for the Series A Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 of the Registrant’s
Current Report on Form 8-K/A filed on February 1, 2021 File No. 001-12584.)
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4.1
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Specimen Stock Certificate (Incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-3 filed on July 3, 2013, File No. 333-189794.)
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4.2
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Warrant Agency Agreement, dated October 15, 2018, by and between Synthetic Biologics, Inc. and Corporate Stock Transfer, Inc. (including the form of warrant certificate) (Incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed October 15, 2018, File No. 001-12584.)
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4.3
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Description of Securities of Synthetic Biologics, Inc. (Incorporated by reference to Exhibit 4.7 of the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed March 4, 2021, File No. 001-12584.)
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5.1*
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Legal opinion of Parsons Behle & Latimer
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23.1*
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Consent of Independent Registered Public Accounting Firm (BDO USA, LLP)
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23.2*
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Consent of Parsons Behle & Latimer (included in Exhibit 5.1(a))
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24.1*
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Power of Attorney (included on the signature page)
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(a) 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 of 1933;
(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 SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and
price represent no more than a 20 percent 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; provided , however , that the undertakings set forth in paragraphs
(1)(i), (1)(ii) and (1)(iii) above do not apply if the information required to be included in a post-effective amendment by
those paragraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of
the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement or is contained in a form of prospectus
filed pursuant to Rule 424(b) that is a part of 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 that 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 effectivenes; 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 the undersigned registrant; and
(iv) Any other communication
that is an offer in the offering made by the undersigned registrant to the purchaser.
(b) 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 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee
benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by
reference in the 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.
(c) 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 foregoing provisions, 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 Securities Act of 1933 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 Securities Act of 1933 and will be governed by
the final adjudication of such issue.
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for
filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Rockville, State of Maryland, October 22, 2021.
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SYNTHETIC BIOLOGICS, INC.
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By:
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/s/ Steven A. Shallcross
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Chief Executive Officer,
Chief Financial Officer and Director
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POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each
person whose signature appears below hereby constitutes and appoints Steven A. Shallcross, as his true and lawful agent, proxy and attorney-in-fact,
with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to (i) act
on, sign and file with the Securities and Exchange Commission any and all amendments (including post-effective amendments) to this registration
statement together with all schedules and exhibits thereto and any subsequent registration statement filed pursuant to Rule 462(b) under
the Securities Act of 1933, as amended, together with all schedules and exhibits thereto, (ii) act on, sign and file such certificates,
instruments, agreements and other documents as may be necessary or appropriate in connection therewith, (iii) act on and file any
supplement to any prospectus included in this registration statement or any such amendment or any subsequent registration statement filed
pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and (iv) take any and all actions which may be necessary
or appropriate to be done, as fully for all intents and purposes as he might or could do in person, hereby approving, ratifying and confirming
all that such agent, proxy and attorney-in-fact or any of his substitutes may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities
Act of 1933, as amended, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.
Signature
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Title
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Date
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/s/ Steven A. Shallcross
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Chief Executive Officer,
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October 22, 2021
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Steven A. Shallcross
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Chief Financial Officer and Director
(Principal Executive Officer, Principal Financial
Officer and Principal Accounting Officer)
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/s/ Jeffrey J. Kraws
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Chairman
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October 22, 2021
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Jeffrey J. Kraws
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/s/ Jeffrey Wolf
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Director
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October 22, 2021
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Jeffrey Wolf
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/s/ John Monahan, Ph.D.
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Director
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October 22, 2021
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John Monahan, Ph.D.
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