ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement that we filed with the U.S. Securities and Exchange Commission (the “SEC”),
using a “shelf” registration process. By using a shelf registration statement, we may sell securities from time to
time and in one or more offerings up to a total dollar amount of $300,000,000 of securities as described in this prospectus. Each
time that we offer and sell securities, we will provide a prospectus supplement to this prospectus that contains specific information
about the securities being offered and sold and the specific terms of that offering. The prospectus supplement may also add, update
or change information contained in this prospectus with respect to that offering. If there is any inconsistency between the information
in this prospectus and the applicable prospectus supplement, you should rely on the prospectus supplement. Before purchasing any
securities, you should carefully read both this prospectus and the applicable prospectus supplement and any related free writing
prospectus, together with the additional information described under the heading “Where You Can Find More Information”
and “Incorporation of Certain Documents by Reference.”
THIS
PROSPECTUS MAY NOT BE USED TO CONSUMMATE A SALE OF SECURITIES UNLESS IT IS ACCOMPANIED BY A PROSPECTUS SUPPLEMENT
Neither
we, nor any agent, underwriter or dealer has authorized any person to give any information or to make any representation other
than those contained or incorporated by reference in this prospectus, any applicable prospectus supplement or any related free
writing prospectus prepared by or on behalf of us or to which we have referred you. This prospectus, any applicable supplement
to this prospectus or any related free writing prospectus does not constitute an offer to sell or the solicitation of an offer
to buy any securities other than the registered securities to which they relate, nor does this prospectus, any applicable supplement
to this prospectus or any related free writing prospectus constitute an offer to sell or the solicitation of an offer to buy securities
in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction.
You
should not assume that the information contained in this prospectus, any applicable prospectus supplement or any related free
writing prospectus is accurate on any date subsequent to the date set forth on the front of the document or that any information
we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even
though this prospectus, any applicable prospectus supplement or any related free writing prospectus is delivered, or securities
are sold, on a later date.
This
prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made
to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents.
Copies of some of the documents referred to herein have been filed, will be filed or will be incorporated by reference as exhibits
to the registration statement of which this prospectus is a part, and you may obtain copies of those documents as described below
under the section entitled “Where You Can Find More Information.”
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.
INDUSTRY
AND MARKET DATA
We
obtained the industry and market data in this prospectus from our own research as well as from industry and general publications,
surveys and studies conducted by third parties. These data involve a number of assumptions and limitations, and you are cautioned
not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and
the future performance of the industry in which we operate is necessarily subject to a high degree of uncertainty and risk due
to a variety of factors, including those described in “Risk Factors” and elsewhere in this prospectus and in the documents
incorporated by reference in this prospectus. These and other factors could cause results to differ materially from those expressed
in the estimates made by the independent parties and by us.
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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 and any 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 ongoing Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic
hematopoietic cell transplant (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 persists,
for an extended period of time, we could experience 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.
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 this prospectus, 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.
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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 (coronavirus) 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.
• 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.
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• 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 regain compliance with the NYSE American stockholders’ equity listing requirements or 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.
The
Securities That May Be Offered
We
may offer shares of our common stock and preferred stock, various series of debt securities and /or warrants to purchase
any of such securities, either individually or in combination with other securities or as units, with a total value of
up to $300,000,000 from time to time under this prospectus, together with the applicable prospectus supplement and any
related free writing prospectus, at prices and on terms to be determined by market conditions at the time of any 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:
• designation
or classification;
• aggregate
principal amount or aggregate offering price;
• maturity;
• original
issue discount;
• rates
and times of payment of interest or dividends;
• redemption,
conversion, exercise, exchange or sinking fund terms;
• ranking;
• restrictive
covenants;
• voting
or other rights;
• conversion
or exchange prices or rates and, if applicable, any provisions for changes to or adjustments in the conversion or exchange
prices or rates and in the securities or other property receivable upon conversion or exchange; and
• a
discussion of material United States federal income tax considerations, if any.
The
prospectus supplement and any related free writing prospectus that we may authorize to be provided to you may also add,
update or change information contained in this prospectus or in documents we have incorporated by reference. However,
no prospectus supplement or free writing prospectus will offer a security that is not registered and described in this
prospectus at the time of the effectiveness of the registration statement of which this prospectus is a part.
We
may sell the securities directly to investors or to or through agents, underwriters or dealers. We, and our agents, underwriters
or dealers reserve the right to accept or reject all or part of any proposed purchase of securities. If we do offer securities
to or through agents, underwriters or dealers, we will include in the applicable prospectus supplement:
• the
names of those agents, underwriters or dealers;
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• 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 SECURITIES UNLESS IT IS ACCOMPANIED BY A PROSPECTUS
SUPPLEMENT.
Common
Stock
We
may issue shares of our common stock from time to time. We currently have authorized 200,000,000 shares of common stock,
par value $0.001 per share. We may offer shares of common stock alone or underlying the registered securities convertible
into or exercisable for our common stock. Each holder of our common stock is entitled to one vote for each share on all
matters submitted to a vote of the stockholders, including the election of directors. Under our Articles of Incorporation
as amended and amended and restated bylaws our stockholders do not have cumulative voting rights. Because of this, the
holders of a majority of the shares of common stock entitled to vote in any election of directors can elect all of the
directors standing for election, if they should so choose. Subject to preferences that may be applicable to any then-outstanding
preferred stock, holders of common stock are entitled to receive ratably those dividends, if any, as may be declared from
time to time by the board of directors out of legally available funds. In the event of our liquidation, dissolution or
winding up, holders of common stock are 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 and the satisfaction of any liquidation preference
granted to the holders of any then-outstanding shares of preferred stock. Holders of 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 common stock are subject to, and may be adversely affected by,
the rights of the holders of shares of any series of preferred stock.
Preferred
Stock
We
may issue shares of our preferred stock from time to time, in one or more series. Under our Articles of Incorporation,
as amended, our board of directors has the authority, without further action by the stockholders (unless such stockholder
action is required by applicable law or the rules of any stock exchange or market on which our securities are then traded),
to designate and issue up to 10,000,000 shares of preferred stock in one or more series (of which 120,000 shares have
been designated Series A Preferred Stock and none of which are outstanding and 15,723 of which have been designated as
Series B Preferred Stock and none of which are outstanding), to establish from time to time the number of shares to be
included in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series
and any qualifications, limitations or restrictions thereon and to increase or decrease the number of shares of any such
series, but not below the number of shares of such series then outstanding. Any authorized and undesignated shares of
preferred stock may be issued from time to time in one or more series pursuant to a resolution or resolutions providing
for such issue duly adopted by our Board of Directors (authority to do so being hereby expressly vested in the Board of
Directors). The Board of Directors is further authorized, subject to limitations prescribed by law, to fix by resolution
or resolutions the designations, powers, preferences and rights, and the qualifications, limitations or restrictions thereof,
of any wholly unissued series of preferred stock, including without limitation authority to fix by resolution or resolutions
the dividend rights, dividend rate, conversion rights, voting rights, rights and terms of redemption (including sinking
fund provisions), redemption price or prices, and liquidation preferences of any such series, and the number of shares
constituting any such series and the designation thereof, or any of the foregoing.
The
rights, preferences, privileges and restrictions granted to or imposed upon any series of preferred stock that we offer
and sell under this prospectus and applicable prospectus supplements will be set forth in a certificate of designation
relating to the series. We will incorporate by reference into the registration statement of which this prospectus is a
part the form of any certificate of designation that describes the terms of the series of preferred stock we are offering
before the issuance of shares of that series of preferred stock. You should read any prospectus supplement and any free
writing prospectus that we may authorize to be provided to you related to the series of preferred stock being offered,
as well as the complete certificate of designation that contains the terms of the applicable series of preferred stock.
Our
board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect
the voting power or other rights of the holders of the common stock. The issuance of preferred stock, while providing flexibility
in connection with possible acquisitions and other corporate purposes, could, among other things, have the effect of delaying,
deferring or preventing a change in our control that may otherwise benefit holders of our common stock and may adversely affect
the market price of the common stock and the voting and other rights of the holders of 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 common stock until the board of
directors determines the specific rights attached to that preferred stock. We have no current plans to issue any shares of preferred
stock.
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In
this prospectus, we have summarized certain general features of the preferred stock under “Description of Capital
Stock—Preferred Stock.” We urge you, however, to read the applicable prospectus supplement (and any related
free writing prospectus that we may authorize to be provided to you) related to the series of preferred stock being offered,
as well as the complete certificate of designation that contains the terms of the applicable series of preferred stock.
Debt
Securities
We
may issue debt securities from time to time, in one or more series, as either senior or subordinated debt or as senior
or subordinated convertible debt. The senior debt securities will rank senior with any other unsecured and unsubordinated
debt. The subordinated debt securities will be subordinate and junior in right of payment, to the extent and in the manner
described in the instrument governing the debt, to all of our senior indebtedness. Convertible debt securities will be
convertible into or exchangeable for our common stock or other securities. Conversion may be mandatory or at the holder’s
option and would be at prescribed conversion rates.
Any
debt securities issued under this prospectus will be issued under one or more documents called indentures, which are contracts
between us and a national banking association or other eligible party, as trustee. In this prospectus, we have summarized
certain general features of the debt securities. We urge you, however, to read the applicable prospectus supplement (and
any free writing prospectus that we may authorize to be provided to you) related to the series of debt securities being
offered, as well as the complete indentures that contain the terms of the debt securities. A form of indenture has been
filed as an exhibit to the registration statement of which this prospectus is a part, and supplemental indentures and
forms of debt securities containing the terms of the debt securities being offered will be filed as exhibits to the registration
statement of which this prospectus is a part or will be incorporated by reference from reports that we file with the SEC.
Warrants
We
may issue warrants for the purchase of common stock and/or preferred stock and/or debt securities in one or more series.
We may issue warrants independently or in combination with common stock and/or preferred stock. In this prospectus, we
have summarized certain general features of the warrants under “Description of Warrants.”
We
urge you, however, to read the applicable prospectus supplement (and any related free writing prospectus that we may authorize
to be provided to you) related to the particular series of warrants being offered, as well as the form of warrant and/or
the warrant agreement and warrant certificate, as applicable, that contain the terms of the warrants. We will file as
exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from reports
that we file with the SEC, the form of warrant and/or the warrant agreement and warrant certificate, as applicable, that
contain the terms of the particular series of warrants we are offering, and any supplemental agreements, before the issuance
of such warrants.
Warrants
may be issued under a warrant agreement that we enter into with a warrant agent. We will indicate the name and address
of the warrant agent, if any, in the applicable prospectus supplement relating to a particular series of warrants.
Units
We
may offer units consisting of any combination of our common stock, preferred stock, debt securities and/or warrants to purchase
any of these securities in one or more series. We may evidence each series of units by unit certificates that we will issue under
a separate agreement. We may enter into unit agreements with a unit agent. Each unit agent will be a bank or trust company that
we select. We will indicate the name and address of the unit agent in the applicable prospectus supplement relating to a particular
series of units. This prospectus contains only a summary of certain general features of the units. The applicable prospectus supplement
will describe the particular features of the units being offered thereby. You should read any prospectus supplement and any free
writing prospectus that we may authorize to be provided to you related to the series of units being offered, as well as the complete
unit agreements that contain the terms of the units. Specific unit agreements will contain additional important terms and provisions
and will be incorporated by reference into the registration statement of which this prospectus is apart from reports we file with
the SEC.
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RISK
FACTORS
An
investment in our securities involves a high degree of risk. You should consider carefully the risks discussed under the section
captioned “Risk Factors” contained in our most recent annual report on Form 10-K and in our subsequent quarterly reports
on Form 10-Q, as updated by our subsequent filings under the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), each of which is incorporated by reference in this prospectus in its entirety, together with other information in
this prospectus, and the information and documents incorporated by reference in this prospectus, and any free writing prospectus
that we have authorized for use in connection with this offering before you make a decision to invest in our securities. If any
of these events actually occur, our business, operating results, prospects or financial condition could be materially and adversely
affected. This could cause the trading price of our common stock to decline and you may lose all or part of your investment.
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
Unless
otherwise set forth in the applicable prospectus supplement, we intend to use the net proceeds, if any, from the sales of securities
offered by this prospectus 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.
The
amounts and timing of our actual expenditures will depend on numerous factors, including our development and commercialization
efforts, as well as the amount of cash used in our operations. We therefore cannot estimate with certainty the amount of net proceeds
to be used for the purposes described above. We may find it necessary or advisable to use the net proceeds for other purposes,
and we will have broad discretion in the application of the net proceeds. Pending the uses described above, we plan to invest
the net proceeds from this offering in short-term, investment-grade, interest-bearing securities.
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 April 29, 2021, 132,042,538 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 April 29, 2021, we
had 132,042,538 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.
In
this prospectus, we have summarized certain general features of our common stock under “Description of Capital Stock—Common
Stock.” We urge you, however, to read the applicable prospectus supplement (and any related free writing prospectus that
we may authorize to be provided to you) related to any common stock being offered.
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. 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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diluting the voting
power of our common stock;
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impairing liquidation
rights of our common stock; or
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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 shares of preferred
stock.
Warrants
As
of April 29, 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.
The Warrants are immediately exercisable at a
price of $0.69 per share of common stock and expire on October 15, 2023. 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 Warrants
may only be exercised through a cashless exercise. No fractional shares of common stock will be issued in connection with the exercise
of a Warrant. In lieu of fractional shares, the holder will receive an amount in cash equal to the fractional amount multiplied by the
fair market value of any such fractional shares.
Options
As of April 29, 2021, options to purchase an aggregate
of 3,997,418 shares of common stock were outstanding under our equity incentive plans.
Stockholder Registration Rights
Pursuant to the terms of the registration rights
agreement that we entered into with Intrexon and an affiliated entity, we were required to file a registration statement with respect
to securities issued and are required to maintain the effectiveness of such registration statement. The failure to do so could result
in the payment of damages by us. The registration statement was declared effective on April 29, 2013.
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
and preferred stock will be available for future issuance without stockholder approval. We may use additional shares of common stock and
preferred 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 and preferred 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 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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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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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 NRS 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 DEBT SECURITIES
We
may issue debt securities from time to time, in one or more series, as either senior or subordinated debt or as senior or subordinated
convertible debt. While the terms we have summarized below will apply generally to any debt securities that we may offer under
this prospectus, we will describe the particular terms of any debt securities that we may offer in more detail in the applicable
prospectus supplement. The terms of any debt securities offered under a prospectus supplement may differ from the terms described
below. Unless the context requires otherwise, whenever we refer to the indenture, we also are referring to any supplemental indentures
that specify the terms of a particular series of debt securities.
We
will issue the debt securities under the indenture that we will enter into with the trustee named in the indenture. The indenture
will be qualified under the Trust Indenture Act of 1939, as amended, or the Trust Indenture Act. We have filed the form of indenture
as an exhibit to the registration statement of which this prospectus is a part, and supplemental indentures and forms of debt
securities containing the terms of the debt securities being offered will be filed as exhibits to the registration statement of
which this prospectus is a part or will be incorporated by reference from reports that we file with the SEC.
The
following summary of material provisions of the debt securities and the indenture is subject to, and qualified in its entirety
by reference to, all of the provisions of the indenture applicable to a particular series of debt securities. We urge you to read
the applicable prospectus supplements and any related free writing prospectuses related to the debt securities that we may offer
under this prospectus, as well as the complete indenture that contains the terms of the debt securities.
General
The
indenture will not limit the amount of debt securities that we may issue. It provides that we may issue debt securities up to
the principal amount that we may authorize and may be in any currency or currency unit that we may designate. Except for the limitations
on consolidation, merger and sale of all or substantially all of our assets contained in the indenture, the terms of the indenture
do not contain any covenants or other provisions designed to give holders of any debt securities protection against changes in
our operations, financial condition or transactions involving us.
We
may issue the debt securities issued under the indenture as “discount securities,” which means they may be sold at
a discount below their stated principal amount. These debt securities, as well as other debt securities that are not issued at
a discount, may be issued with “original issue discount,” or OID, for U.S. federal income tax purposes because of
interest payment and other characteristics or terms of the debt securities. Material U.S. federal income tax considerations applicable
to debt securities issued with OID will be described in more detail in any applicable prospectus supplement.
We
will describe in the applicable prospectus supplement the terms of the series of debt securities being offered, including:
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the
title of the series of debt securities;
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any
limit upon the aggregate principal amount that may be issued;
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the
maturity date or dates;
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the
form of the debt securities of the series;
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the
applicability of any guarantees;
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whether
or not the debt securities will be secured or unsecured, and the terms of any secured
debt;
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whether
the debt securities rank as senior debt, senior subordinated debt, subordinated debt
or any combination thereof, and the terms of any subordination;
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if
the price (expressed as a percentage of the aggregate principal amount thereof) at which
such debt securities will be issued is a price other than the principal amount thereof,
the portion of the principal amount thereof payable upon declaration of acceleration
of the maturity thereof, or if applicable, the portion of the principal amount of such
debt securities that is convertible into another security or the method by which any
such portion shall be determined;
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the
interest rate or rates, which may be fixed or variable, or the method for determining
the rate and the date interest will begin to accrue, the dates interest will be payable
and the regular record dates for interest payment dates or the method for determining
such dates;
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our
right, if any, to defer payment of interest and the maximum length of any such deferral
period;
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if
applicable, the date or dates after which, or the period or periods during which, and
the price or prices at which, we may, at our option, redeem the series of debt securities
pursuant to any optional or provisional redemption provisions and the terms of those
redemption provisions;
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the
date or dates, if any, on which, and the price or prices at which we are obligated, pursuant
to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or
at the holder’s option to purchase, the series of debt securities and the currency
or currency unit in which the debt securities are payable;
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the
denominations in which we will issue the series of debt securities, if other than denominations
of $1,000 and any integral multiple thereof;
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any
and all terms, if applicable, relating to any auction or remarketing of the debt securities
of that series and any security for our obligations with respect to such debt securities
and any other terms which may be advisable in connection with the marketing of debt securities
of that series;
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whether
the debt securities of the series shall be issued in whole or in part in the form of
a global security or securities; the terms and conditions, if any, upon which such global
security or securities may be exchanged in whole or in part for other individual securities;
and the depositary for such global security or securities;
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if
applicable, the provisions relating to conversion or exchange of any debt securities
of the series and the terms and conditions upon which such debt securities will be so
convertible or exchangeable, including the conversion or exchange price, as applicable,
or how it will be calculated and may be adjusted, any mandatory or optional (at our option
or the holders’ option) conversion or exchange features, the applicable conversion
or exchange period and the manner of settlement for any conversion or exchange;
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if
other than the full principal amount thereof, the portion of the principal amount of
debt securities of the series which shall be payable upon declaration of acceleration
of the maturity thereof;
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additions
to or changes in the covenants applicable to the particular debt securities being issued,
including, among others, the consolidation, merger or sale covenant;
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additions
to or changes in the events of default with respect to the securities and any change
in the right of the trustee or the holders to declare the principal, premium, if any,
and interest, if any, with respect to such securities to be due and payable;
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additions
to or changes in or deletions of the provisions relating to covenant defeasance and legal
defeasance;
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additions
to or changes in the provisions relating to satisfaction and discharge of the indenture;
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additions
to or changes in the provisions relating to the modification of the indenture both with
and without the consent of holders of debt securities issued under the indenture;
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the
currency of payment of debt securities if other than U.S. dollars and the manner of determining
the equivalent amount in U.S. dollars;
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whether
interest will be payable in cash or additional debt securities at our or the holders’
option and the terms and conditions upon which the election may be made;
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the
terms and conditions, if any, upon which we will pay amounts in addition to the stated
interest, premium, if any and principal amounts of the debt securities of the series
to any holder that is not a “United States person” for federal tax purposes;
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any
restrictions on transfer, sale or assignment of the debt securities of the series; and
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any
other specific terms, preferences, rights or limitations of, or restrictions on, the
debt securities, any other additions or changes in the provisions of the indenture, and
any terms that may be required by us or advisable under applicable laws or regulations.
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Conversion
or Exchange Rights
We
will set forth in the prospectus supplement the terms 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 settlement upon conversion or exchange and 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.
Consolidation,
Merger or Sale
Unless
we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the indenture will not
contain any covenant that restricts our ability to merge or consolidate, or sell, convey, transfer or otherwise dispose of our
assets as an entirety or substantially as an entirety. However, any successor to or acquirer of such assets (other than a subsidiary
of ours) must assume all of our obligations under the indenture or the debt securities, as appropriate.
Events
of Default under the Indenture
Unless
we provide otherwise in the prospectus supplement applicable to a particular series of debt securities, the following are events
of default under the indenture with respect to any series of debt securities that we may issue:
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if
we fail to pay any installment of interest on any series of debt securities, as and when
the same shall become due and payable, and such default continues for a period of 90
days; provided, however, that a valid extension of an interest payment period by us in
accordance with the terms of any indenture supplemental thereto shall not constitute
a default in the payment of interest for this purpose;
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if
we fail to pay the principal of, or premium, if any, on any series of debt securities
as and when the same shall become due and payable whether at maturity, upon redemption,
by declaration or otherwise, or in any payment required by any sinking or analogous fund
established with respect to such series; provided, however, that a valid extension of
the maturity of such debt securities in accordance with the terms of any indenture supplemental
thereto shall not constitute a default in the payment of principal or premium, if any;
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if
we fail to observe or perform any other covenant or agreement contained in the debt securities
or the indenture, other than a covenant specifically relating to another series of debt
securities, and our failure continues for 90 days after we receive written notice of
such failure, requiring the same to be remedied and stating that such is a notice of
default thereunder, from the trustee or holders of at least 25% in aggregate principal
amount of the outstanding debt securities of the applicable series; and
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if
specified events of bankruptcy, insolvency or reorganization occur.
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If
an event of default with respect to debt securities of any series occurs and is continuing, other than an event of default specified
in the last bullet point above, the trustee or the holders of at least 25% in aggregate principal amount of the outstanding debt
securities of that series, by notice to us in writing, and to the trustee if notice is given by such holders, may declare the
unpaid principal of, premium, if any, and accrued interest, if any, due and payable immediately. If an event of default specified
in the last bullet point above occurs with respect to us, the principal amount of and accrued interest, if any, of each issue
of debt securities then outstanding shall be due and payable without any notice or other action on the part of the trustee or
any holder.
The
holders of a majority in principal amount of the outstanding debt securities of an affected series may waive any default or event
of default with respect to the series and its consequences, except defaults or events of default regarding payment of principal,
premium, if any, or interest, unless we have cured the default or event of default in accordance with the indenture. Any waiver
shall cure the default or event of default.
Subject
to the terms of the indenture, if an event of default under an indenture shall occur and be continuing, the trustee will be under
no obligation to exercise any of its rights or powers under such indenture at the request or direction of any of the holders of
the applicable series of debt securities, unless such holders have offered the trustee reasonable indemnity. The holders of a
majority in principal amount of the outstanding debt securities of any series will have the right to direct the time, method and
place of conducting any proceeding for any remedy available to the trustee, or exercising any trust or power conferred on the
trustee, with respect to the debt securities of that series, provided that:
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the
direction so given by the holder is not in conflict with any law or the applicable indenture;
and
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subject
to its duties under the Trust Indenture Act, the trustee need not take any action that
might involve it in personal liability or might be unduly prejudicial to the holders
not involved in the proceeding.
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A
holder of the debt securities of any series will have the right to institute a proceeding under the indenture or to appoint a
receiver or trustee, or to seek other remedies only if:
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the
holder has given written notice to the trustee of a continuing event of default with
respect to that series;
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the
holders of at least 25% in aggregate principal amount of the outstanding debt securities
of that series have made written request,
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such
holders have offered to the trustee indemnity satisfactory to it against the costs, expenses
and liabilities to be incurred by the trustee in compliance with the request; and
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the
trustee does not institute the proceeding, and does not receive from the holders of a
majority in aggregate principal amount of the outstanding debt securities of that series
other conflicting directions within 90 days after the notice, request and offer.
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These
limitations do not apply to a suit instituted by a holder of debt securities if we default in the payment of the principal, premium,
if any, or interest on, the debt securities.
We
will periodically file statements with the trustee regarding our compliance with specified covenants in the indenture.
Modification
of Indenture; Waiver
We
and the trustee may change an indenture without the consent of any holders with respect to specific matters:
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to
cure any ambiguity, defect or inconsistency in the indenture or in the debt securities
of any series;
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to
comply with the provisions described above under “Description of Debt Securities—Consolidation,
Merger or Sale;”
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to
provide for uncertificated debt securities in addition to or in place of certificated
debt securities;
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to
add to our covenants, restrictions, conditions or provisions such new covenants, restrictions,
conditions or provisions for the benefit of the holders of all or any series of debt
securities, to make the occurrence, or the occurrence and the continuance, of a default
in any such additional covenants, restrictions, conditions or provisions an event of
default or to surrender any right or power conferred upon us in the indenture;
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to
add to, delete from or revise the conditions, limitations, and restrictions on the authorized
amount, terms, or purposes of issue, authentication and delivery of debt securities,
as set forth in the indenture;
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to
make any change that does not adversely affect the interests of any holder of debt securities
of any series in any material respect;
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to
provide for the issuance of and establish the form and terms and conditions of the debt
securities of any series as provided above under “Description of Debt Securities—General”
to establish the form of any certifications required to be furnished pursuant to the
terms of the indenture or any series of debt securities, or to add to the rights of the
holders of any series of debt securities;
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to
evidence and provide for the acceptance of appointment under any indenture by a successor
trustee; or
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to
comply with any requirements of the SEC in connection with the qualification of any indenture
under the Trust Indenture Act.
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In
addition, under the indenture, the rights of holders of a series of debt securities may be changed by us and the trustee with
the written consent of the holders of at least a majority in aggregate principal amount of the outstanding debt securities of
each series that is affected. However, unless we provide otherwise in the prospectus supplement applicable to a particular series
of debt securities, we and the trustee may make the following changes only with the consent of each holder of any outstanding
debt securities affected:
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extending
the fixed maturity of any debt securities of any series; • reducing the principal
amount, reducing the rate of or extending the time of payment of interest, or reducing
any premium payable upon the redemption of any series of any debt securities; or
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reducing
the percentage of debt securities, the holders of which are required to consent to any
amendment, supplement, modification or waiver.
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Discharge
Each
indenture provides that we can elect to be discharged from our obligations with respect to one or more series of debt securities,
except for specified obligations, including obligations to:
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register
the transfer or exchange of debt securities of the series;
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replace
stolen, lost or mutilated debt securities of the series;
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pay
principal of and premium and interest on any debt securities of the series;
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maintain
paying agencies;
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hold
monies for payment in trust;
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recover
excess money held by the trustee;
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compensate
and indemnify the trustee; and
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appoint
any successor trustee.
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In
order to exercise our rights to be discharged, we must deposit with the trustee money or government obligations sufficient to
pay all the principal of, any premium, if any, and interest on, the debt securities of the series on the dates payments are due.
Form,
Exchange and Transfer
We
will issue the debt securities of each series only in fully registered form without coupons and, unless we provide otherwise in
the applicable prospectus supplement, in denominations of $1,000 and any integral multiple thereof. The indenture provides that
we may issue debt securities of a series in temporary or permanent global form and as book-entry securities that will be deposited
with, or on behalf of, The Depository Trust Company, or DTC, or another depositary named by us and identified in a prospectus
supplement with respect to that series. To the extent the debt securities of a series are issued in global form and as book-entry,
a description of terms relating such securities will be set forth in the applicable prospectus supplement.
At
the option of the holder, subject to the terms of the indenture and the limitations applicable to global securities described
in the applicable prospectus supplement, the holder of the debt securities of any series can exchange the debt securities for
other debt securities of the same series, in any authorized denomination and of like tenor and aggregate principal amount.
Subject
to the terms of the indenture and the limitations applicable to global securities set forth in the applicable prospectus supplement,
holders of the debt securities may present the debt securities for exchange or for registration of transfer, duly endorsed or
with the form of transfer endorsed thereon duly executed if so required by us or the security registrar, at the office of the
security registrar or at the office of any transfer agent designated by us for this purpose. Unless otherwise provided in the
debt securities that the holder presents for transfer or exchange, we will impose no service charge for any registration of transfer
or exchange, but we may require payment of any taxes or other governmental charges.
We
will name in the applicable prospectus supplement the security registrar, and any transfer agent in addition to the security registrar,
that we initially designate for any debt securities. We may at any time designate additional transfer agents or rescind the designation
of any transfer agent or approve a change in the office through which any transfer agent acts, except that we will be required
to maintain a transfer agent in each place of payment for the debt securities of each series.
If
we elect to redeem the debt securities of any series, we will not be required to:
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issue,
register the transfer of, or exchange any debt securities of that series during a period
beginning at the opening of business 15 days before the day of mailing of a notice of
redemption of any debt securities that may be selected for redemption and ending at the
close of business on the day of the mailing; or
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register
the transfer of or exchange any debt securities so selected for redemption, in whole
or in part, except the unredeemed portion of any debt securities we are redeeming in
part.
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Information
Concerning the Trustee
The
trustee, other than during the occurrence and continuance of an event of default under an 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 trustee
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 trustee is under no obligation to exercise any of the powers given it by the indenture 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 that we will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in the applicable
prospectus supplement, we will designate the corporate trust office of the trustee 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 trustee for the payment of the principal of or any premium or interest on any debt securities
that 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 debt security thereafter may look only to us for payment thereof.
Governing
Law
The
indenture and the debt securities will be governed by and construed in accordance with the internal laws of the State of New York,
except to the extent that the Trust Indenture Act is applicable.
DESCRIPTION
OF WARRANTS
Warrants
We
may issue warrants for the purchase of common stock, preferred stock or debt securities. We may issue warrants independently or
in combination with other securities. In this prospectus, we have summarized certain general features of the warrants. We urge
you, however, to read the applicable prospectus supplement (and any related free writing prospectus that we may authorize to be
provided to you) related to the particular series of warrants being offered, as well as any warrant agreements and warrant certificates
that contain the terms of the warrants. We will file as exhibits to the registration statement of which this prospectus is a part,
or will incorporate by reference from reports that we file with the SEC, the form of warrant and/or the warrant agreement and
warrant certificate, as applicable, that contain the terms of the particular series of warrants we are offering, and any supplemental
agreements, before the issuance of such warrants.
Any
warrants issued under this prospectus may be evidenced by warrant certificates. Warrants also may be issued under an applicable
warrant agreement that we enter into with a warrant agent. We will indicate the name and address of the warrant agent, if applicable,
in the prospectus supplement relating to the particular series of warrants being offered.
The
following description, together with the additional information that we include in any applicable prospectus supplement and in
any related free writing prospectus that we may authorize to be distributed to you, summarizes the material terms and provisions
of the warrants that we may offer under this prospectus, which may be issued in one or more series. While the terms we have summarized
below will apply generally to any warrants that we may offer under this prospectus, we will describe the particular terms of any
series of warrants in more detail in the applicable prospectus supplement and in any related free writing prospectus that we may
authorize to be distributed to you. The following description of warrants will apply to the warrants offered by this prospectus
unless we provide otherwise in the applicable prospectus supplement. The applicable prospectus supplement for a particular series
of warrants may specify different or additional terms.
The
summary below and that contained in any prospectus supplement is qualified in its entirety by reference to all of the provisions
of the warrant and/or the warrant agreement and warrant certificate, as applicable, applicable to a particular series of securities.
We urge you to read the applicable prospectus supplements and any related free writing prospectuses related to the warrants that
we may offer under this prospectus, as well as the complete warrant and/or the warrant agreement and warrant certificate, as applicable,
that contains the terms of the warrants.
General
We
will describe in the applicable prospectus supplement the terms of the series of warrants being offered, including:
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the offering price
and aggregate number of warrants offered;
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the currency for
which the warrants may be purchased;
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if applicable, the
number of warrants issued with each such security;
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the
number of shares of common stock, as the case may be, purchasable upon the exercise of one warrant and the price at which these
shares may be purchased upon such exercise;
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the effect of any
merger, consolidation, sale or other disposition of our business on the warrant agreements and the warrants;
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the terms of any
rights to redeem or call the warrants;
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any
provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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the dates on which
the right to exercise the warrants will commence and expire;
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the manner in which
the warrant agreements and warrants may be modified;
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a discussion of
any material or special U.S. federal income tax considerations of holding or exercising the warrants;
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the terms of the
securities issuable upon exercise of the warrants; and
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any other specific
terms, preferences, rights or limitations of or restrictions on the warrants.
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Before
exercising their warrants, holders of warrants will not have any of the rights of holders of the securities purchasable upon such
exercise, including the right to receive dividends, if any, or payments upon our liquidation, dissolution or winding up or to
exercise voting rights, if any:
Exercise
of Warrants
Each
warrant will entitle the holder to purchase the securities that we specify in the applicable prospectus supplement at the exercise
price that we describe in the applicable prospectus supplement. The warrants may be exercised as set forth in the prospectus supplement
relating to the warrants offered. Unless we otherwise specify in the applicable prospectus supplement, warrants may be exercised
at any time up to the close of business on the expiration date set forth in the prospectus supplement relating to the warrants
offered thereby. After the close of business on the expiration date, unexercised warrants will become void.
Upon
receipt of payment and the warrant or warrant certificate, as applicable, properly completed and duly executed at the corporate
trust office of the warrant agent, if any, or any other office, including ours, indicated in the prospectus supplement, we will,
as soon as practicable, issue and deliver the securities purchasable upon such exercise. If less than all of the warrants (or
the warrants represented by such warrant certificate) are exercised, a new warrant or a new warrant certificate, as applicable,
will be issued for the remaining warrants.
Enforceability
of Rights by Holders of Warrants
Each
warrant agent, if any, will act solely as our agent under the applicable warrant agreement and will not assume any obligation
or relationship of agency or trust with any holder of any warrant. A warrant agent may act as warrant agent for more than one
issue of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant
agreement or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand
upon us. Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce
by appropriate legal action its right to exercise, and receive the securities purchasable upon exercise of, its warrants.
Governing
Law
Unless
we otherwise specify in the applicable prospectus supplement, the warrants and any warrant agreements will be governed by and
construed in accordance with the laws of the State of New York.
DESCRIPTION
OF UNITS
Units
We
may issue units consisting of any combination of our common stock, preferred stock, debt securities, and warrants. We will issue
each unit so that the holder of the unit is also the holder of each security included in the unit. As a result, the holder of
a unit will have the rights and obligations of a holder of each included security. 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.
The
summary below and that contained in any prospectus supplement is qualified in its entirety by reference to all of the provisions
of the unit agreement and/or unit certificate, and depositary arrangements, if applicable. We urge you to read the applicable
prospectus supplements and any related free writing prospectuses related to the units that we may offer under this prospectus,
as well as the complete unit agreement and/or unit certificate, and depositary arrangements, as applicable, that contain the terms
of the units.
We
will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from
reports that we file with the SEC, the form of unit agreement and/or unit certificate, and depositary arrangements, as applicable,
that contain the terms of the particular series of units we are offering, and any supplemental agreements, before the issuance
of such units.
The
applicable prospectus supplement, information incorporated by reference or free writing prospectus may describe:
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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;
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any
provisions for the issuance, payment, settlement, transfer, or exchange of the units
or of the securities composing the units;
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whether
the units will be issued in fully registered or global form; and
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any
other terms of the units.
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The
applicable provisions described in this section, as well as those described under “Description of Capital Stock,”
“Description of Debt Securities” and “Description of Warrants” above, will apply to each unit and to each
security included in each unit, respectively.
LEGAL
OWNERSHIP OF SECURITIES
We
can issue securities in registered form or in the form of one or more global securities. We describe global securities in greater
detail below. We refer to those persons who have securities registered in their own names on the books that we or any applicable
trustee or depositary maintain for this purpose as the “holders” of those securities. These persons are the legal
holders of the securities. We refer to those persons who, indirectly through others, own beneficial interests in securities that
are not registered in their own names, as “indirect holders” of those securities. As we discuss below, indirect holders
are not legal holders, and investors in securities issued in book-entry form or in street name will be indirect holders.
Book-Entry
Holders
We
may issue securities in book-entry form only, as we will specify in the applicable prospectus supplement. This means securities
may be represented by one or more global securities registered in the name of a financial institution that holds them as depositary
on behalf of other financial institutions that participate in the depositary’s book-entry system. These participating institutions,
which are referred to as participants, in turn, hold beneficial interests in the securities on behalf of themselves or their customers.
Only
the person in whose name a security is registered is recognized as the holder of that security. Global securities will be registered
in the name of the depositary or its participants. Consequently, for global securities, we will recognize only the depositary
as the holder of the securities, and we will make all payments on the securities to the depositary. The depositary passes along
the payments it receives to its participants, which in turn pass the payments along to their customers who are the beneficial
owners. The depositary and its participants do so under agreements they have made with one another or with their customers; they
are not obligated to do so under the terms of the securities.
As
a result, investors in a global security will not own securities directly. Instead, they will own beneficial interests in a global
security, through a bank, broker or other financial institution that participates in the depositary’s book-entry system
or holds an interest through a participant. As long as the securities are issued in global form, investors will be indirect holders,
and not legal holders, of the securities.
Street
Name Holders
We
may terminate a global security or issue securities that are not issued in global form. In these cases, investors may choose to
hold their securities in their own names or in “street name.” Securities held by an investor in street name would
be registered in the name of a bank, broker or other financial institution that the investor chooses, and the investor would hold
only a beneficial interest in those securities through an account he or she maintains at that institution.
For
securities held in street name, we or any applicable trustee or depositary will recognize only the intermediary banks, brokers
and other financial institutions in whose names the securities are registered as the holders of those securities, and we or any
such trustee or depositary will make all payments on those securities to them. These institutions pass along the payments they
receive to their customers who are the beneficial owners, but only because they agree to do so in their customer agreements or
because they are legally required to do so. Investors who hold securities in street name will be indirect holders, not holders,
of those securities.
Legal
Holders
Our
obligations, as well as the obligations of any applicable trustee or third party employed by us or a trustee, run only to the
legal holders of the securities. We do not have obligations to investors who hold beneficial interests in global securities, in
street name or by any other indirect means. This will be the case whether an investor chooses to be an indirect holder of a security
or has no choice because we are issuing the securities only in global form.
For
example, once we make a payment or give a notice to the holder, we have no further responsibility for the payment or notice even
if that holder is required, under agreements with its participants or customers or by law, to pass it along to the indirect holders
but does not do so. Similarly, we may want to obtain the approval of the holders to amend an indenture, to relieve us of the consequences
of a default or of our obligation to comply with a particular provision of an indenture, or for other purposes. In such an event,
we would seek approval only from the holders, and not the indirect holders, of the securities. Whether and how the legal holders
contact the indirect holders is up to the legal holders.
Special
Considerations for Indirect Holders
If
you hold securities through a bank, broker or other financial institution, either in book-entry form because the securities are
represented by one or more global securities or in street name, you should check with your own institution to find out:
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how
it handles securities payments and notices;
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whether
it imposes fees or charges;
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how
it would handle a request for the holders’ consent, if ever required;
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whether
and how you can instruct it to send you securities registered in your own name so you
can be a holder, if that is permitted in the future;
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how
it would exercise rights under the securities if there were a default or other event
triggering the need for holders to act to protect their interests; and
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if
the securities are in book-entry form, how the depositary’s rules and procedures
will affect these matters.
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Global
Securities
A
global security is a security that represents one or any other number of individual securities held by a depositary. Generally,
all securities represented by the same global securities will have the same terms.
Each
security issued in book-entry form will be represented by a global security that we issue to, deposit with and register in the
name of a financial institution or its nominee that we select. The financial institution that we select for this purpose is called
the depositary. Unless we specify otherwise in the applicable prospectus supplement, The Depository Trust Company, New York, New
York, known as DTC, will be the depositary for all securities issued in book-entry form.
A
global security may not be transferred to or registered in the name of anyone other than the depositary, its nominee or a successor
depositary, unless special termination situations arise. We describe those situations below under “—Special Situations
When a Global Security Will Be Terminated.” As a result of these arrangements, the depositary, or its nominee, will be the
sole registered owner and legal holder of all securities represented by a global security, and investors will be permitted to
own only beneficial interests in a global security. Beneficial interests must be held by means of an account with a broker, bank
or other financial institution that in turn has an account with the depositary or with another institution that does. Thus, an
investor whose security is represented by a global security will not be a legal holder of the security, but only an indirect holder
of a beneficial interest in the global security.
If
the prospectus supplement for a particular security indicates that the security will be issued as a global security, then the
security will be represented by a global security at all times unless and until the global security is terminated. If termination
occurs, we may issue the securities through another book-entry clearing system or decide that the securities may no longer be
held through any book-entry clearing system.
Special
Considerations for Global Securities
As
an indirect holder, an investor’s rights relating to a global security will be governed by the account rules of the investor’s
financial institution and of the depositary, as well as general laws relating to securities transfers. We do not recognize an
indirect holder as a holder of securities and instead deal only with the depositary that holds the global security.
If
securities are issued only as global securities, an investor should be aware of the following:
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an
investor cannot cause the securities to be registered in his or her name, and cannot
obtain non-global certificates for his or her interest in the securities, except in the
special situations we describe below;
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an
investor will be an indirect holder and must look to his or her own bank or broker for
payments on the securities and protection of his or her legal rights relating to the
securities, as we describe above;
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an
investor may not be able to sell interests in the securities to some insurance companies
and to other institutions that are required by law to own their securities in non-book-entry
form;
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an
investor may not be able to pledge his or her interest in the global security in circumstances
where certificates representing the securities must be delivered to the lender or other
beneficiary of the pledge in order for the pledge to be effective;
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the
depositary’s policies, which may change from time to time, will govern payments,
transfers, exchanges and other matters relating to an investor’s interest in the
global security;
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we
and any applicable trustee have no responsibility for any aspect of the depositary’s
actions or for its records of ownership interests in the global security, nor will we
or any applicable trustee supervise the depositary in any way;
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the
depositary may, and we understand that DTC will, require that those who purchase and
sell interests in the global security within its book-entry system use immediately available
funds, and your broker or bank may require you to do so as well; and
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financial
institutions that participate in the depositary’s book-entry system, and through
which an investor holds its interest in the global security, may also have their own
policies affecting payments, notices and other matters relating to the securities.
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There
may be more than one financial intermediary in the chain of ownership for an investor. We do not monitor and are not responsible
for the actions of any of those intermediaries.
Special
Situations When a Global Security Will Be Terminated
In
a few special situations described below, a global security will terminate and interests in it will be exchanged for physical
certificates representing those interests. After that exchange, the choice of whether to hold securities directly or in street
name will be up to the investor. Investors must consult their own banks or brokers to find out how to have their interests in
securities transferred to their own names, so that they will be direct holders. We have described the rights of holders and street
name investors above.
A
global security will terminate when the following special situations occur:
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if
the depositary notifies us that it is unwilling, unable or no longer qualified to continue
as depositary for that global security and we do not appoint another institution to act
as depositary within 90 days;
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if
we notify any applicable trustee that we wish to terminate that global security; or
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if
an event of default has occurred with regard to securities represented by that global
security and has not been cured or waived.
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The
applicable prospectus supplement may also list additional situations for terminating a global security that would apply only to
the particular series of securities covered by the prospectus supplement. When a global security terminates, the depositary, and
neither we nor any applicable trustee, is responsible for deciding the names of the institutions that will be the initial direct
holders.
PLAN
OF DISTRIBUTION
We
may sell the securities from time to time pursuant to underwritten public offerings, negotiated transactions, block trades or
a combination of these methods. We may sell the securities to or through underwriters or dealers, through agents, or directly
to one or more purchasers. We may distribute securities from time to time in one or more transactions:
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at
a fixed price or prices, which may be changed;
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at
market prices prevailing at the time of sale;
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at
prices related to such prevailing market prices; or
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We
may also sell equity securities covered by this registration statement in an “at the market” offering as defined in
Rule 415(a)(4) under the Securities Act. Such offering may be made into an existing trading market for such securities in transactions
at other than a fixed price on or through the facilities of the NYSE American, LLC or any other securities exchange or quotation
or trading service on which such securities may be listed, quoted or traded at the time of sale.
Such
at the market offerings, if any, may be conducted by underwriters acting as principal or agent.
A
prospectus supplement or supplements (and any related free writing prospectus that we may authorize to be provided to you) will
describe the terms of the offering of the securities, including, to the extent applicable:
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the
name or names of any underwriters, dealers or agents, if any;
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the
purchase price of the securities and the proceeds we will receive from the sale;
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any
over-allotment options under which underwriters may purchase additional securities from
us;
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any
agency fees or underwriting discounts and other items constituting agents’ or underwriters’
compensation;
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any
public offering price;
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any
discounts or concessions allowed or reallowed or paid to dealers; and
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any
securities exchange or market on which the securities may be listed.
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Only
underwriters named in the prospectus supplement are underwriters of the securities offered by the prospectus supplement.
If
underwriters are used in the sale, they will acquire the securities for their own account and may resell the securities from time
to time in one or more transactions at a fixed public offering price or at varying prices determined at the time of sale. The
obligations of the underwriters to purchase the securities will be subject to the conditions set forth in the applicable underwriting
agreement. We may offer the securities to the public through underwriting syndicates represented by managing underwriters or by
underwriters without a syndicate. Subject to certain conditions, the underwriters will be obligated to purchase all of the securities
offered by the prospectus supplement. Any public offering price and any discounts or concessions allowed or reallowed or paid
to dealers may change from time to time. We may use underwriters with whom we have a material relationship. We will describe in
the prospectus supplement, naming the underwriter, the nature of any such relationship.
We
may sell securities directly or through agents we designate from time to time. We will name any agent involved in the offering
and sale of securities, and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, our agent will act on a best-efforts basis for the period of its appointment.
We
may authorize agents or underwriters to solicit offers by certain types of institutional investors to purchase securities from
us at the public offering price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment
and delivery on a specified date in the future. We will describe the conditions to these contracts and the commissions we must
pay for solicitation of these contracts in the prospectus supplement.
We
may provide agents and underwriters with indemnification against civil liabilities related to this offering, including liabilities
under the Securities Act, or contribution with respect to payments that the agents or underwriters may make with respect to these
liabilities. Agents and underwriters may engage in transactions with, or perform services for, us in the ordinary course of business.
All
securities we offer, other than common stock, will be new issues of securities with no established trading market. Any underwriters
may make a market in these securities, but will not be obligated to do so and may discontinue any market making at any time without
notice. We cannot guarantee the liquidity of the trading markets for any securities.
Any
underwriter may engage in overallotment, stabilizing transactions, short covering transactions and penalty bids. Overallotment
involves sales in excess of the offering size, which create a short position. Stabilizing transactions permit bids to purchase
the underlying security so long as the stabilizing bids do not exceed a specified maximum. Short covering transactions involve
purchases of the securities in the open market after the distribution is completed to cover short positions. Penalty bids permit
the underwriters to reclaim a selling concession from a dealer when the securities originally sold by the dealer are purchased
in a stabilizing or covering transaction to cover short positions. Those activities may cause the price of the securities to be
higher than it would otherwise be. If commenced, the underwriters may discontinue any of the activities at any time. These transactions
may be effected on any exchange or over-the-counter market or otherwise.
Any
underwriters who are qualified market makers on the NYSE American, LLC may engage in passive market making transactions
in the securities on the NYSE American, LLC in accordance with Rule 103 of Regulation M, during the business day prior to the
pricing of the offering, before the commencement of offers or sales of the securities. Passive market makers must comply with
applicable volume and price limitations and must be identified as passive market makers. In general, a passive market maker must
display its bid at a price not in excess of the highest independent bid for such security; if all independent bids are lowered
below the passive market maker’s bid, however, the passive market maker’s bid must then be lowered when certain purchase
limits are exceeded. Passive market making may stabilize the market price of the securities at a level above that which might
otherwise prevail in the open market and, if commenced, may be discontinued at any time.
LEGAL
MATTERS
Gracin
& Marlow, LLP, New York, New York will pass upon certain legal matters relating to the issuance and sale of the debt securities,
warrants and units offered hereby on our behalf and Parsons Behle & Latimer, Reno, Nevada will pass on certain legal matters
related to the issuance and sale of the common stock and preferred stock offered hereby on our behalf. Additional legal matters
may be passed upon for us or any underwriters, dealers, of agents, by counsel that we will name in the applicable prospectus supplement.
As
of the date of this prospectus, an attorney of Gracin & Marlow, LLP beneficially owns securities exercisable to purchase shares
of our common stock that represent less than 1% of our outstanding shares of common stock.
EXPERTS
The
consolidated financial statements as of December 31, 2020 and 2019, and for the years then ended, 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) and May 3, 2021;
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Our
definitive proxy statement on Schedule 14A filed with the SEC on August 4, 2020 (File
No. 001-12584); and
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The
description of our common stock set forth in our registration statement on Form 8-A12B,
filed with the SEC on June 20, 2007 (File No. 000-12584), as updated by the description
of our common stock filed as Exhibit 4.7 to our Annual Report on Form 10-K for the year
ended December 31, 2020, including any amendments or reports filed for the purpose of
updating such description.
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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 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.
DISCLOSURE
OF SECURITIES AND EXCHANGE COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Our
amended and restated bylaws and Articles of Incorporation, as amended, contain provisions that permit us to indemnify our directors
and officers to the full extent permitted by Nevada law, and our Articles of Incorporation, as amended, contain provisions that
eliminate the personal liability of our directors in each case for monetary damages to us or our stockholders for breach of their
fiduciary duties, except to the extent that Nevada law prohibits indemnification or elimination of liability. These provisions
do not limit or eliminate our rights or the rights of any stockholder to seek an injunction or any other non-monetary relief in
the event of a breach of a director’s or officer’s fiduciary duty. In addition, these provisions apply only to claims
against a director or officer arising out of his or her role as a director or officer and do not relieve a director or officer
from liability if he or she engaged in willful misconduct or a knowing violation of the criminal law or any federal or state securities
law.
The
rights of indemnification provided in our amended and restated bylaws are not exclusive of any other rights that may be available
under any insurance or other agreement, by vote of stockholders or disinterested directors or otherwise.
Insofar
as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling
us pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC this type of indemnification is
against public policy as expressed in the Securities Act and is therefore unenforceable.
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 May 3, 2021
PROSPECTUS
Up
to $75,000,000 of Shares
Common
Stock
We have entered into an Amended and Restated At
Market Issuance Sales Agreement, dated February 9, 2021 (the “Original Amended and
Restated At Market Issuance Sales Agreement”), with B. Riley Securities, Inc. (“B. Riley”) and A.G.P./Alliance
Global Partners (“AGP” and together with B. Riley, the “sales agents”), as amended by Amendment No. 1 thereto
dated May 3, 2021 (“Amendment No. 1”), relating to shares of our common stock offered by this prospectus. Amendment
No. 1 will be effective at the time that the registration statement of which this prospectus is a part is declared effective by the Securities
and Exchange Commission (the “SEC”). In this prospectus, unless the context indicates otherwise, we refer to the Original
Amended and Restated At Market Issuance Sales Agreement, as amended by Amendment No. 1, as the “sales agreement.”
In accordance with the terms of the sales agreement,
we may offer and sell shares of our common stock pursuant to this prospectus having an aggregate offering price of up to $75,000,000 from
time to time through or to B. Riley or AGP acting as sales agents or principals. We have previously issued and sold an aggregate of 91,487,681
shares of our common stock for aggregate gross proceeds of approximately $83.6 million pursuant to the Original Amended and Restated At
Market Issuance Sales Agreement under our separate Registration Statement on Form S-3 (File No. 333-224728), utilizing a prior prospectus
and related prospectus supplements thereto.
On April
29, 2021, the last reported sale price of our common stock on the NYSE American LLC was $0.585 per
share.
Sales of our common stock, if any, under this
prospectus will be made by any method permitted that is deemed an “at the market offering” as defined in Rule 415 under the
Securities Act of 1933, as amended (the “Securities Act”). The sales agents are not required to sell any specific amount but
will act as our sales agents using commercially reasonable efforts consistent with their respective normal trading and sales practices.
There is no arrangement for funds to be received in any escrow, trust or similar arrangement.
The sales agents will be entitled to compensation
at a commission rate equal to up to 3.0% of the gross sales price per share sold. In connection with the sale of the common stock on our
behalf, each sales agent will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation
of the sales agents will be deemed to be underwriting commissions or discounts. We have also agreed to provide indemnification and contribution
to the sales agents with respect to certain liabilities, including liabilities under the Securities Act.
Investing in our common stock involves a high
degree of risk. Before making an investment decision, please read the information under the heading “Risk Factors”
beginning on page S-7 of this prospectus and in the documents 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 passed upon the adequacy or accuracy of this prospectus.
Any representation to the contrary is a criminal offense.
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B.
Riley Securities
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A.G.P.
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The
date of this prospectus is , 2021
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus relates to part of a registration statement on Form S-3 that we have filed with the Securities and Exchange Commission
(the “SEC”) utilizing a “shelf” registration process. Under this shelf registration process, we may sell
any combination of the securities described in our base prospectus included in the shelf registration statement in one or more
offerings up to a total aggregate offering price of $300,000,000. The $75,000,000 of shares of common stock that may be offered,
issued and sold under this prospectus is included in the $300,000,000 of securities that may be offered, issued and sold by us
pursuant to our shelf registration statement. In connection with such offers and when accompanied by the base prospectus included
in the registration statement of which this prospectus is a part, this prospectus will be deemed a prospectus supplement to such
base prospectus.
This
prospectus relates to the offering of our shares of common stock. Before buying any of our shares of common stock that we are
offering, we urge you to carefully read this prospectus, together with the information incorporated by reference as described
under the headings “Where You Can Find More Information” and “Incorporation of Certain Documents by Reference”
in this prospectus. These documents contain important information that you should consider when making your investment decision.
This
prospectus describes the terms of this offering of our shares of common stock and also adds to and updates information contained
in the documents incorporated by reference into this prospectus. To the extent there is a conflict between the information contained
in this prospectus, on the one hand, and the information contained in any document incorporated by reference into this prospectus
that was filed with the SEC before the date of this prospectus, on the other hand, you should rely on the information in this
prospectus. If any statement in one of these documents is inconsistent with a statement in another document having a later date
(for example, a document incorporated by reference into this prospectus) the statement in the document having the later date modifies
or supersedes the earlier statement.
You
should rely only on the information contained in or incorporated by reference in this prospectus and in any free writing prospectus
that we have authorized for use in connection with this offering. We have not, and the sales agents have not, authorized anyone
to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely
on it. We are not, and the sales agents are not, making an offer to sell these shares of common stock in any jurisdiction where
the offer or sale is not permitted. You should assume that the information appearing in this prospectus, the documents incorporated
by reference in this prospectus, and in any free writing prospectus that we have authorized for use in connection with this offering,
is accurate only as of the date of those respective documents. Our business, financial condition, results of operations and prospects
may have changed since those dates. You should carefully read this prospectus, the documents incorporated by reference in this
prospectus, and any free writing prospectus that we have authorized for use in connection with this offering, in their entirety
before making an investment decision.
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 this 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 contains and incorporates by reference market data and industry statistics and forecasts that are based on independent
industry publications and other publicly available information. Although we believe that these sources are reliable, we do not
guarantee the accuracy or completeness of this information and we have not independently verified this information. Although we
are not aware of any misstatements regarding the market and industry data presented in this prospectus and the documents incorporated
herein by reference, these estimates involve risks and uncertainties and are subject to change based on various factors, including
those discussed under the heading “Risk Factors” in this prospectus and under similar headings in the other documents
that are incorporated by reference into this prospectus. Accordingly, investors should not place undue reliance on this information.
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.
INDUSTRY
AND MARKET DATA
We
obtained the industry and market data in this prospectus from our own research as well as from industry and general publications,
surveys and studies conducted by third parties. These data involve a number of assumptions and limitations, and you are cautioned
not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and
the future performance of the industry in which we operate is necessarily subject to a high degree of uncertainty and risk due
to a variety of factors, including those described in “Risk Factors” and elsewhere in this prospectus and in the documents
incorporated by reference in this prospectus. These and other factors could cause results to differ materially from those expressed
in the estimates made by the independent parties and by us.
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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 highlights selected information contained elsewhere in this prospectus. This summary
is not intended to be complete and does not contain all of the information that you should consider before deciding to
invest in our common stock. You should read this entire prospectus carefully, especially the “Risk Factors”
section beginning on page S-7 and other documents or information included or incorporated by reference in this prospectus
before making an investment decision. Unless the context requires otherwise, references in this prospectus to “Synthetic,”
“the Company,” “we,” “us” and “our” refer to Synthetic Biologics, Inc.
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 ongoing Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic
hematopoietic cell transplant (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 persists,
for an extended period of time, we could experience 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)
401-4364, 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.
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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 (coronavirus) 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 regain compliance with the NYSE American stockholders’ equity listing requirements or 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.
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Risks Related to This Offering
• Our management team may invest or spend the proceeds of this offering in ways with which you may not agree or in ways which may
not yield a significant return.
• If you purchase shares of our common stock sold in this offering, you will experience immediate and substantial dilution in the
net tangible book value of your shares. In addition, we may issue additional equity or convertible debt securities in the future, which
may result in additional dilution to investors.
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THE
OFFERING
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Issuer
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Synthetic
Biologics, Inc.
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Common
stock to be offered by us pursuant to this prospectus
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Shares
of our common stock having an aggregate offering price of up to $75,000,000.
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Common
stock to be outstanding after the offering
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Up
to 260,247,666 shares, assuming sales of 128,205,128 shares of our common stock in this offering at an offering price of $0.585 per
share, which was the last reported sale price of our common stock on the NYSE American on April 29, 2021. The actual number
of shares issued will vary depending on the sales price under this offering.
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Manner
of offering
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Sales of the shares will be made in sales deemed to be “at the
market offerings” as defined in Rule 415 promulgated under the Securities Act, through or to the Agents as sales agents or principals.
See the section entitled “Plan of Distribution” on page S-14 of this prospectus.
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Use of proceeds
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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 complementary
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. See “Use of Proceeds” on page S-6.
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Risk
factors
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You
should read the “Risk Factors” section of this prospectus and in the documents
incorporated by reference into this prospectus for a discussion of factors to consider
before deciding to purchase shares of our common stock.
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NYSE American Trading
Symbol
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SYN
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Unless
we indicate otherwise, all information in this prospectus is based on 132,042,538 shares outstanding as of
April 29, 2021. The number of shares outstanding as used throughout this prospectus, unless otherwise indicated,
excludes:
• 3,997,418
shares issuable upon the exercise of outstanding stock options with a weighted-average exercise price of $2.35 per share;
• 2,460,000
shares of common stock which were reserved for future equity awards that may be granted in the future under our equity
incentive plans; and
• 6,344,966
shares of our common stock reserved for issuance upon the exercise of outstanding warrants, each with a weighted-average
exercise price of $0.69 per share.
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RISK
FACTORS
Investing
in our common stock involves a high degree of risk, and you should be able to bear the complete loss of your investment. You should
consider carefully the risks described below and those described under the section captioned “Risk Factors” contained
in our Annual Report on Form 10-K for the year ended December 31, 2020, any subsequent Annual Reports on Form 10-K, any subsequent
Quarterly Reports on Form 10-Q or Current Reports on Form 8-K, and all other information contained or incorporated by reference
into this prospectus and documents incorporated by reference into this prospectus before deciding whether to purchase any of the
common stock being offered under this prospectus. If any of the risks actually occur, our business, consolidated financial condition
or results of operations could be adversely affected. In such case, the trading price of our common stock could decline and you
could lose all or part of your investment. Our actual results could differ materially from those anticipated in the forward-looking
statements made throughout this prospectus as a result of different factors, including the risks we face described below.
Risks
Related to this Offering
Our
management team may invest or spend the proceeds of this offering in ways with which you may not agree or in ways which may not
yield a significant return.
Our management will have broad discretion over
the use of proceeds from this offering. The net proceeds from this offering, if any, will be used primarily 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. Our management will have
considerable discretion in the application of the net proceeds, and you will not have the opportunity, as part of your investment decision,
to assess whether the proceeds are being used appropriately. The net proceeds may be used for corporate purposes that do not increase
our operating results or enhance the value of our common stock. The failure of our management to use these funds effectively could have
a material adverse effect on our business, cause the market price of our common stock to decline and impair the commercialization of our
products and/or delay the development of our product candidates. Pending their use, we may invest the net proceeds from this offering
in short-term, investment-grade, interest-bearing instruments and U.S. government securities. These investments may not yield a favorable
return to our stockholders.
If
you purchase shares of our common stock sold in this offering, you will experience immediate and substantial dilution in the net
tangible book value of your shares. In addition, we may issue additional equity or convertible debt securities in the future,
which may result in additional dilution to investors.
The
price per share of our common stock being offered may be higher than the net tangible book value per share of our outstanding common
stock prior to this offering. Assuming that an aggregate of 128,205,128 shares of our common stock are sold at a price of $0.585 per
share, the last reported sale price of our common stock on the NYSE American on April 29, 2021, new investors in this offering will
incur immediate dilution of $0.001 per share. For a more detailed discussion of the foregoing, see the section entitled
“Dilution” below. To the extent outstanding stock options or warrants are exercised, there will be further dilution to
new investors.
You
may experience future dilution as a result of future equity offerings.
In
order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible
into or exchangeable for our common stock at prices that may not be the same as the price per share in this offering. We may sell
shares or other securities in any other offering at a price per share that is less than the price per share paid by investors
in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders.
The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common
stock, in future transactions may be higher or lower than the price per share paid by investors in this offering.
Because
we do not intend to declare cash dividends on our shares of common stock in the foreseeable future, stockholders must rely on
appreciation of the value of our common stock for any return on their investment.
We
have never declared or paid cash dividends on our common stock. We currently anticipate that we will retain future earnings for
the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends on our common
stock in the foreseeable future. In addition, the terms of any existing or future preferred stock or debt agreements may preclude
us from paying dividends. As a result, we expect that only appreciation of the price of our common stock, if any, will provide
a return to investors in this offering for the foreseeable future.
Resales
of our common stock in the public market during this offering by our stockholders may cause the market price of our common stock
to fall.
We
may issue common stock from time to time in connection with this offering. This issuance from time to time of these new shares
of our common stock, or our ability to issue these shares of common stock in this offering, 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.
The shares of common stock offered under
this prospectus may be sold in “at the market offerings”, and investors who buy shares at different times will likely pay
different prices.
Investors
who purchase shares under this prospectus at different times will likely pay different prices, and so may experience different
outcomes in their investment results. We will have discretion, subject to market demand, to vary the timing, prices, and numbers
of shares sold, and there is no minimum or maximum sales price. Investors may experience declines in the value of their shares
as a result of share sales made at prices lower than the prices they paid.
The
actual number of shares we will issue under the sales agreement at any one time or in total, is uncertain.
Subject
to certain limitations in the sales agreement and compliance with applicable law, we have the discretion to deliver placement
notices to the sales agents at any time throughout the term of the sales agreement. The number of shares that are sold by the
sales agents as our sales agents after we deliver a placement notice will fluctuate based on the market price of the common stock
and the trading volume of our common stock during the sales period and limits we set with each sales agent.
Our
stock price has fluctuated in the past, has recently been volatile and may be volatile in the future, and as a result, investors
in our common stock could incur substantial losses.
Our stock price has fluctuated in the past, has
recently been volatile and may be volatile in the future. By way of example, on February 8, 2021, the price of our common stock closed
at $1.17 per share while on April 19, 2021, our stock price closed at $0.52 per share with no discernable announcements or developments
by the company or third parties. On January 5, 2021, the intra-day sales price of our common stock fluctuated between a reported low sale
price of $0.93 and a reported high sales price of $1.70. We may incur rapid and substantial decreases in our stock price in the foreseeable
future that are unrelated to our operating performance or prospects. In addition, the recent outbreak of the novel strain of coronavirus
(COVID-19) has caused broad stock market and industry fluctuations. The stock market in general and the market for biotechnology and pharmaceutical
companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.
As a result of this volatility, investors may experience losses on their investment in our common stock. The market price of our common
stock could fluctuate significantly in response to various factors and events, including:
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investor
reaction to our business strategy;
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the success of competitive
products or technologies;
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our continued compliance
with the listing standards of the NYSE American;
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regulatory or legal
developments in the United States and other countries, especially changes in laws or regulations applicable to our products;
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results of our clinical
trials;
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actions taken by
regulatory agencies with respect to our products, clinical studies, manufacturing process or sales and marketing terms;
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variations in our
financial results or those of companies that are perceived to be similar to us;
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the success of our
efforts to acquire or in-license additional products or product candidates;
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developments concerning
our collaborations or partners;
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developments or
disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent
protection for our products;
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•
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our ability or inability
to raise additional capital and the terms on which we raise it;
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•
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declines in the
market prices of stocks generally;
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•
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trading volume of
our common stock;
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•
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sales of our common
stock by us or our stockholders;
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•
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general economic,
industry and market conditions; and
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•
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other events or
factors, including those resulting from such events, or the prospect of such events, including war, terrorism and other international
conflicts, public health issues including health epidemics or pandemics, such as the recent outbreak of the novel coronavirus
(COVID-19), and natural disasters such as fire, hurricanes, earthquakes, tornados or other adverse weather and climate conditions,
whether occurring in the United States or elsewhere, could disrupt our operations, disrupt the operations of our suppliers
or result in political or economic instability.
|
These
broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance.
Further, recent increases are significantly inconsistent with any improvements in actual or expected operating performance, financial
condition or other indicators of value, including our loss per share of $0.66 and $0.98 for the years ended December 31, 2020
and 2019. Since the stock price of our common stock has fluctuated in the past, has been recently volatile and may be volatile
in the future, investors in our common stock could incur substantial losses. In the past, following periods of volatility in the
market, securities class-action litigation has often been instituted against companies. Such litigation, if instituted against
us, could result in substantial costs and diversion of management’s attention and resources, which could materially and
adversely affect our business, financial condition, results of operations and growth prospects. There can be no guarantee that
our stock price will remain at current prices or that future sales of our common stock will not be at prices lower than those
sold to investors.
Additionally,
recently, securities of certain companies have experienced significant and extreme volatility in stock price due short sellers
of shares of common stock, known as a “short squeeze.” These short squeezes have caused extreme volatility in those
companies and in the market and have led to the price per share of those companies to trade at a significantly inflated rate that
is disconnected from the underlying value of the company. Many investors who have purchased shares in those companies at an inflated
rate face the risk of losing a significant portion of their original investment as the price per share has declined steadily as
interest in those stocks have abated. While we have no reason to believe our shares would be the target of a short squeeze, there
can be no assurance that we won’t be in the future, and you may lose a significant portion or all of your investment if
you purchase our shares at a rate that is significantly disconnected from our underlying value.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking
statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), these statements 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 the documents we file
with the SEC that are incorporated by reference herein 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 and the documents we file with the
SEC that are incorporated by reference herein. It is not possible for our management to predict all risks, nor can we assess the
impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not
place undue reliance on these forward-looking statements.
You
should not assume that the information contained in this prospectus is accurate as of any date other than the date on the front
of this prospectus, or that any information incorporated by reference into this prospectus is accurate as of any date other than
the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking
statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking
statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means
that actual events are bearing out as expressed or implied in such forward-looking statements.
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 shares of
common stock, you should consider carefully all of the factors set forth or referred to in this prospectus and the documents we
file with the SEC that are incorporated by reference herein that could cause actual results to differ.
USE
OF PROCEEDS
We
may issue and sell shares of our common stock having aggregate gross proceeds of up to $75,000,000 from time to time under the
sales agreement. Because there is no minimum offering amount required as a condition to close this offering, the actual total
offering amount, commissions and proceeds to us, if any, are not determinable at this time. The amount of proceeds from this offering
will depend upon the number of shares of our common stock sold and the market price at which they are sold. There can be no assurance
that we will be able to sell any shares under or fully utilize the sales agreement with the sales agents as a source of financing.
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.
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.
DILUTION
If
you invest in our common stock, your interest will be diluted immediately to the extent of the difference between the offering
price and the adjusted net tangible book value per share of our common stock after this offering.
Our
net tangible book value on December 31, 2020 was approximately $5,300,000, or $0.18 per share. “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.
Pro forma
net tangible book value per share represents the amount of our total tangible assets as adjusted to take into account: (i) net cash proceeds
of approximately $66,000,000 from the issuance of an additional 78,685,315 shares of our common stock in “at the market offerings”
pursuant to the original sales agreement through B. Riley and/or AGP as sales agent; (ii) the issuance 8,996,768 shares of our common
stock upon the conversions of shares of our Series A Preferred Stock, (iii) the issuance 3,454,783 shares of our common stock upon the
conversions of our Series B Preferred Stock and (iv) the net cash proceeds of $8.0 million from the issuance of 11,655,747 shares of our
common stock upon the exercise of previously issued warrants, all subsequent to December 31, 2020. After giving effect to these transactions,
our pro forma net tangible book value per share as of December 31, 2020 would have been approximately $0.60 per share.
After giving effect to the foregoing transactions
and the sale of shares of common stock in this offering in the aggregate amount of $75,000,000 at an assumed approximate offering price
of $0.585 per share, which is the last reported sale price of our common stock on the NYSE American on April 29, 2021 and after deducting
estimated offering commissions and estimated aggregate offering expenses payable by us, our pro forma as adjusted net tangible book value
as of December 31, 2020 would have been approximately $152,009,741 or $0.584 per share of common stock. This represents an immediate
decrease in pro forma net tangible book value of $0.016 per share to our existing stockholders and an immediate dilution in net tangible
book value of $0.001 per share to investors participating in this offering. The following table illustrates this dilution per share to
investors participating in this offering:
|
Assumed public offering price per share
|
|
|
|
|
|
$
|
0.585
|
|
|
Pro forma net tangible book value per share as of December 31, 2020
|
|
$
|
0.60
|
|
|
|
|
|
|
Decrease in pro forma net tangible book value per share attributable to new investors purchasing our common stock in this offering
|
|
$
|
(0.016
|
)
|
|
|
|
|
|
Pro forma as adjusted net tangible book value per share after giving effect to this offering
|
|
|
|
|
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$
|
0.584
|
|
|
Dilution per share to investors purchasing our common stock in this offering
|
|
|
|
|
|
$
|
0.001
|
|
The
above discussion and table is based on 132,042,538 shares of our common stock outstanding as of December 31, 2020 as adjusted
for the adjustments set forth above and excludes as of April 29, 2021:
|
|
•
|
3,997,418
shares issuable upon the exercise of outstanding stock options with a weighted-average
exercise price of $2.35 per share;
|
|
|
•
|
2,460,000
shares of common stock which were reserved for future equity awards that may be granted
in the future under our equity incentive plans; and
|
|
|
•
|
6,344,966
shares of our common stock reserved for issuance upon the exercise of outstanding warrants,
each with a weighted-average exercise price of $0.69 per share.
|
The
above illustration of dilution per share to investors participating in this offering assumes no exercise of outstanding options
to purchase our common stock or outstanding warrants to purchase shares of our common stock. To the extent that any of these outstanding
options or warrants are exercised or we issue additional shares under our equity incentive plans, there will be further dilution
to new investors. 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.
PLAN
OF DISTRIBUTION
On May 3, 2021, we entered into Amendment No.
1 to the Original Amended and Restated At Market Issuance Sales that we entered into on February 9, 2021 with B. Riley and AGP, pursuant
to which we may offer and sell shares of our common stock pursuant to this prospectus having an aggregate offering price of up to $75,000,000
from time to time through or to B. Riley or AGP acting as sales agents or principals, subject to certain limitations, as described below.
Amendment No. 1 will be effective at the time that the registration statement of which this prospectus
is a part is declared effective by the SEC. We have previously issued and sold an aggregate of 91,487,681 shares of our common
stock for aggregate gross proceeds of approximately $83.6 million pursuant to the Original Amended and Restated At Market Issuance Sales
Agreement under our separate Registration Statement on Form S-3 (File No. 333-224728), utilizing a prior prospectus and related prospectus
supplement and supplement thereto.
The
sales, if any, of shares of our common stock made under the sales agreement will be made by any method that is deemed an “at
the market offering” as defined in Rule 415 promulgated under the Securities Act. We may instruct the sales agents not to
sell common stock if the sales cannot be effected at or above the price designated by us from time to time. We or the sales agents
may suspend the offering of common stock upon notice and subject to other conditions.
The
sales agents will offer our common stock subject to the terms and conditions of the sales agreement as agreed upon by us and the
sales agents. Each time we wish to issue and sell common stock under the sales agreement, we will notify the sales agents of the
number of shares to be issued, the time period during which such sales are requested to be made, any limitation on the number
of shares that may be sold in one day, any minimum price below which sales may not be made and other sales parameters as we deem
appropriate. Once we have so instructed the sales agents, unless either the sales agent declines to accept the terms of the notice,
the sales agents has agreed to use their respective commercially reasonable efforts consistent with their respective normal trading
and sales practices to sell such shares up to the amount specified on such terms. The obligations of the sales agents under the
sales agreement to sell our common stock are subject to a number of conditions that we must meet.
We
will pay the sales agents’ commissions for their respective services in acting as agent in the sale of common stock. The
sales agents will be paid a commission in an amount equal to up to 3.0% of the gross sales price per share sold. Because there
is no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions
and proceeds to us, if any, are not determinable at this time. We have also agreed to reimburse the sales agents for certain specified
expenses, including the fees and disbursements of its legal counsel in an amount not to exceed $30,000. We estimate that the total
expenses for the offering, excluding commissions and reimbursements payable to the sales agents under the terms of the sales agreement,
will be approximately $150,000.
Settlement
for sales of common stock will generally occur on the second business day following the date on which any sales are made, or on
some other date that is agreed upon by us and the sales agents in connection with a particular transaction, in return for payment
of the net proceeds to us. There is no arrangement for funds to be received in an escrow, trust or similar arrangement.
In connection with the sale of the common stock
on our behalf, the sales agents will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation
of the sales agents will be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification and contribution
to the sales agents against certain civil liabilities, including liabilities under the Securities Act.
The
offering of our common stock pursuant to the sales agreement will terminate upon the earlier of (i) the sale of all of our common
stock subject to the sales agreement, or (ii) termination of the sales agreement as provided therein. We may terminate the sales
agreement at any time upon five days’ prior notice to the sales agents and the sales agents may terminate the sales agreement
at any time upon ten days’ prior notice to us.
B.
Riley and AGP and their respective affiliates may in the future provide various investment banking and other financial services
for us and our affiliates, for which services they may in the future receive customary fees. To the extent required by Regulation
M, B. Riley and AGP will not engage in any market making activities involving our common stock while the offering is ongoing under
this prospectus.
This
summary of the material provisions of the sales agreement does not purport to be a complete statement of its terms and conditions.
Copies of the sales agreement (including Amendment No. 1 thereto) have been filed as Exhibits 1.1 and 1.2 to the registration
statement of which this prospectus is a part.
This
prospectus in electronic format may be made available on websites maintained by the sales agents and the sales agents may distribute
this prospectus electronically.
LEGAL
MATTERS
Gracin
& Marlow, LLP, New York, New York is representing us in connection with the offering. The validity of the securities offered
hereby will be passed upon for us by Parsons Behle & Latimer, Reno, Nevada. Duane Morris LLP, New York, New York is acting
as counsel for the sales agents in connection with this offering.
As
of the date of this prospectus, an attorney of Gracin & Marlow, LLP beneficially owns securities exercisable to purchase shares
of our common stock that represent less than 1% of our outstanding shares of common stock.
EXPERTS
The
consolidated financial statements of Synthetic Biologics, Inc. as of December 31, 2020 and 2019, and for the years then ended, incorporated
by reference in this prospectus 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 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) and May 3, 2021;
|
|
|
•
|
Our
definitive proxy statement on Schedule 14A filed with the SEC on August 4, 2020 (File
No. 001-12584); and
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|
|
•
|
The
description of our common stock set forth in our registration statement on Form 8-A12B,
filed with the SEC on June 20, 2007 (File No. 000-12584), as updated by the description
of our common stock filed as Exhibit 4.7 to our Annual Report on Form 10-K for the year
ended December 31, 2020, including any amendments or reports filed for the purpose of
updating such description.
|
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 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 and the documents we file with the SEC that
are incorporated by reference herein. 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.
Up
to $75,000,000
Common
Stock
Prospectus
|
B. Riley Securities
|
A.G.P.
|
,
2021
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
|
Item 14.
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Other Expenses
of Issuance and Distribution.
|
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:
|
|
|
Amount
|
|
|
SEC registration fee
|
|
$
|
21,941
|
|
|
FINRA filing fee
|
|
|
45,500
|
|
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Printing and engraving expenses
|
|
|
(1
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)
|
|
Legal fees and expenses
|
|
|
(1
|
)
|
|
Accountant’s fees and expenses
|
|
|
(1
|
)
|
|
Transfer agent and registrar fees and expenses
|
|
|
(1
|
)
|
|
Miscellaneous
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
Total
|
|
$
|
(1
|
)
|
|
|
(1)
|
These
fees are calculated based on the securities offered and the number of issuances and,
accordingly, cannot be estimated at this time.
|
|
Item 15.
|
Indemnification
of Directors and Officers.
|
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.
The
following exhibits are either filed as part of this Registration Statement on Form S-3 or are incorporated herein by reference:
|
Exhibit Number
|
|
Description
|
|
1.1
|
|
Amended and Restated At Market Issuance Sales Agreement, dated February 9, 2021, by and among Synthetic Biologics, Inc., B. Riley Securities, Inc. and A.G.P./Alliance Global Partners (Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed February 9, 2021, File No. 001-12584.)
|
|
|
|
|
|
1.2
|
|
Amendment No. 1 to the Amended and Restated At Market Issuance Sales Agreement (Incorporated by reference to Exhibit 1.1 of the Registrant’s Current Report on Form 8-K filed May 3, 2021, File No. 001-12584.)
|
|
|
|
|
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1.3**
|
|
Form of Underwriting Agreement
|
|
|
|
|
|
3.1
|
|
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.)
|
|
|
|
|
|
3.2
|
|
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.)
|
|
|
|
|
|
3.3
|
|
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.)
|
|
|
|
|
|
3.4
|
|
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.)
|
|
|
|
|
|
3.5
|
|
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
|
|
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.)
|
|
|
|
|
|
3.7
|
|
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.)
|
|
|
|
|
|
3.8
|
|
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.)
|
|
|
|
|
|
3.9
|
|
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.)
|
|
|
|
|
|
3.10
|
|
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.)
|
|
|
|
|
|
3.11
|
|
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.)
|
|
|
|
|
|
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 Match 4, 2021, File No. 001-12584.)
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4.4*
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Form of Indenture
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4.5**
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Form of Debt Securities
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4.6**
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Form of Common Stock
Warrant Agreement and Warrant Certificate
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4.7**
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Form of Preferred
Stock Warrant Agreement and Warrant Certificate
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4.8**
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Form of Debt Securities
Warrant Agreement and Warrant Certificate
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4.9**
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Specimen Preferred
Stock Certificate and Form of Certificate of Designation of Preferred Stock
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5.1(a)*
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Legal opinion of Parsons Behle & Latimer
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5.1(b)*
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Legal opinion of Gracin & Marlow, LLP
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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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23.3*
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Consent of Gracin
& Marlow, LLP (included in Exhibit 5.1(b))
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24.1*
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Power of Attorney
(included on the signature page)
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25.1***
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Statement of Eligibility
of Trustee under the Indenture
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**
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To be filed, if
applicable, by amendment or by a report filed under the Exchange Act and incorporated herein by reference.
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***
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To
be filed, if applicable, in accordance with the requirements of Section 305(b)(2) of the Trust Indenture Act of 1939 and Rule
5b-3 thereunder.
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Item
17. Undertakings
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:
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(i)
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To
include any prospectus required by Section 10(a)(3) of the Securities Act;
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(ii)
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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 20 percent change in the maximum aggregate offering price set forth in the
“Calculation of Registration Fee” table in the effective registration statement;
and
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(iii)
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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;
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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, as amended, or the Exchange
Act, that are incorporated by reference in this registration statement or are contained in a form of prospectus filed pursuant
to Rule 424(b) that is part of this registration statement.
(2)
That, for the purpose of determining any liability under the Securities Act, 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 to any purchaser:
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(i)
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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
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(ii)
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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 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.
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(5)
That, for the purpose of determining liability of the registrant under the Securities Act 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:
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(i)
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any
preliminary prospectus or prospectus of the undersigned registrant relating to the offering
required to be filed pursuant to Rule 424;
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(ii)
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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;
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(iii)
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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
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(iv)
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any
other communication that is an offer in the offering made by the undersigned registrant
to the purchaser.
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(6)
That, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report
pursuant to Section 13(a) or 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s
annual report pursuant to Section 15(d) of the Exchange Act) 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.
(7)
To file an application for the purpose of determining the eligibility of the trustee to act under subsection (a) of Section 310
of the Trust Indenture Act in accordance with the rules and regulations prescribed by the SEC under Section 305(b)(2) of the Trust
Indenture Act.
Insofar
as indemnification for liabilities arising under the Securities Act 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
SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the
event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred
or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding)
is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant
will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act 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, May 3, 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.
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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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May
3, 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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May
3, 2021
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Jeffrey
J. Kraws
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/s/
Jeffrey Wolf
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Director
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May
3, 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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May
3, 2021
|
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John Monahan, Ph.D.
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