Filed Pursuant to Rule
424(b)(5)
Registration No. 333-203323
(To Prospectus dated April 10, 2015)
655,321 Shares
Common Stock
This prospectus relates to the resale by
the stockholder listed in the section titled “Selling Stockholder”, and we refer to the stockholder as the Selling
Stockholder (the “Selling Stockholder”) of up to 655,321 shares of our common stock, par value $0.001 per share (the
“Shares”). The Shares were acquired by the Selling Stockholder in connection with an asset purchase agreement that
we executed on November 8, 2012 (the “Asset Purchase Agreement”) with Prev ABR, LLC (“PREV”).
All of the Shares described above were
previously issued upon the attainment of certain milestones in connection with the Asset Purchase Agreement. We will not
receive any proceeds from the disposition of the Shares.
Our common stock is traded on NYSE MKT
under the symbol “SYN”. On April 7, 2015, the last reported sale price for the common stock was $2.04 per share. We
urge prospective purchasers of our common stock to obtain current information about the market prices of our common stock. The
prices at which the Selling Stockholder may sell the Shares in this offering will be determined by the prevailing market price
for the shares of common stock or in negotiated transactions.
Our executive offices are located at 155
Gibbs Street, Suite 412, Rockville, Maryland 20850 and our administrative offices are located at 617 Detroit Street, Suite 100,
Ann Arbor, Michigan 48104. Our telephone number is (734) 332-7800.
Investing in our common stock involves
risks. Risks associated with an investment in our common stock are described in “Risk Factors” on page 3.
Neither the Securities and Exchange
Commission nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy
of the prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is April
21, 2015.
TABLE OF CONTENTS
The registration statement containing
this prospectus, including the exhibits to the registration statement, provides additional information about us and the common
stock offered under this prospectus. The registration statement, including the exhibits and the documents incorporated herein by
reference, can be read on the Securities and Exchange Commission website or at the Securities and Exchange Commission offices mentioned
under the heading “Where You Can Find More Information.”
ABOUT THIS PROSPECTUS
This prospectus is not an offer or solicitation
in respect to these securities in any jurisdiction in which such offer or solicitation would be unlawful. This prospectus
is part of a registration statement that we filed with the Securities and Exchange Commission (the “SEC”). The
registration statement that contains this prospectus (including the exhibits to the registration statement) contains additional
information about our company and the securities offered under this prospectus. That registration statement can be read
at the SEC website or at the SEC’s offices listed under the heading “Where You Can Find More Information.” We
have not authorized anyone else to provide you with different information or additional information. You should not
assume that the information in this prospectus, or any supplement or amendment to this prospectus, is accurate at any date other
than the date indicated on the cover page of such documents.
PROSPECTUS SUMMARY
Our Business
We are a clinical-stage biotechnology
company developing pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome.
We are developing an oral biologic to protect the gut microbiome (gastrointestinal (GI) microflora) from intravenous (IV) antibiotics
for the prevention of C. difficile infection, an oral statin treatment to reduce the impact of methane producing organisms on irritable
bowel syndrome with constipation (IBS-C) and a monoclonal antibody combination for the treatment of Pertussis. In addition, we
are developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction
in MS.
Product Pipeline:
Summary of Pathogen-Specific
Therapy Programs:
| • | C.
difficile infections (CDI): We are in clinical development of a novel second-generation oral enzyme candidate,
SYN-004, for co-administration with commonly used IV beta-lactam antibiotics, intended to protect the microbiome and prevent the
development of and severe effects from CDI. CDIs are a leading type of hospital acquired infection (HAI) and are frequently associated
with IV antibiotic treatment. Designed to be given orally and co-administered with certain IV beta-lactam antibiotics (e.g., penicillins
and cephalosporins), SYN-004 is intended to protect the gut while the IV antibiotics fight the primary infection. SYN-004 is believed
to not only have a similar profile to its first-generation predecessor, which demonstrated protection of the microbiome (gut flora)
during treatment with certain penicillins, but also has the potential to act against a broader spectrum of IV beta-lactam antibiotics.
Beta-lactam antibiotics are a mainstay in hospital infection management and include the commonly used penicillin and cephalosporin
classes of antibiotics. SYN-004’s target market is significant and represented by annual U.S. hospitals purchases of approximately
118 million doses of IV beta-lactam antibiotics which are administered to approximately 14 million patients.* Currently there
are no approved treatments designed to protect the gut microbiome from the damaging effects of IV antibiotics. This worldwide
market could represent a multi-billion dollar opportunity for us. In December 2014, the U.S. Patent and Trademark Office (USPTO)
issued Patent No. 8,894,994 that has claims to compositions of matter and pharmaceutical compositions of beta-lactamases, including
SYN-004, and carries a patent term to at least 2031. We also have an extensive patent estate on other aspects of this program
which includes patent applications that could carry a term to at least 2035. In the fourth quarter of 2014, we initiated our randomized,
double-blind placebo-controlled Phase 1a clinical trial, reported positive topline safety and tolerability results from the Phase
1a clinical trial, and initiated the Phase 1b clinical trial evaluating multiple ascending doses of SYN-004. In February 2015,
we reported positive topline results from the Phase 1b clinical trial of escalating doses of oral SYN-004, with no safety or tolerability
issues reported at dose levels and dose regimens both meeting and exceeding those expected to be studied in upcoming clinical
trials. In March 2015, we reported positive pharmacokinetics data from both Phase 1 clinical trials, with supportive evidence
that SYN-004 should have no effect on the IV antibiotic in the bloodstream, allowing the antibiotic to fight the primary infection.
We also initiated a Phase 2a clinical trial to evaluate the GI antibiotic-degrading effects and the safety of SYN-004. The initiation
of a Phase 2b proof-of-concept clinical trial is expected in the second half of 2015, with Phase 2b topline data anticipated during
the second half of 2015. |
| * | This information is an estimate derived from the use
of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year
2012. IMS expressly reserves all rights, including rights of copying, distribution and republication. |
| • | IBS-C: In December 2013, through
our majority-owned subsidiary, Synthetic Biomics, Inc., we entered into a worldwide exclusive license agreement with Cedars-Sinai
Medical Center (CSMC) for the right to develop products for therapeutic and prophylactic treatments of acute and chronic diseases,
including the development of SYN-010 to target IBS-C. An investigational team led by Mark Pimentel, M.D., at CSMC discovered that
SYN-010 may reduce the production of methane gas by certain gastrointestinal (GI) microorganisms. Methane produced by these organisms
is perceived as an underlying cause of pain, bloating, and constipation associated with IBS-C, and may contribute to the pathology
of other diseases. SYN-010 is a modified release formulation of a statin being designed to reduce the impact of methane producing
organisms on IBS-C. A 505(b)(2) regulatory pathway is anticipated for the development of SYN-010. We licensed an extensive intellectual
property portfolio from CSMS including granted use patents and pending patent applications for SYN-010. Additional worldwide patent
filings having composition of matter claims, which were recently filed by CSMC and licensed to us, could extend patent protection
of SYN-010 to 2035. Based on guidance from the members on our IBS clinical advisory board, we plan to file an Investigational
New Drug (IND) application with the U.S. FDA to support the initiation of Phase 2 clinical trials in the second quarter of 2015,
with Phase 2 topline data anticipated during the second half of 2015. |
| • | Pertussis: In December 2012, in collaboration with Intrexon Corporation
(NYSE: XON) (Intrexon), we initiated development of a monoclonal antibody (mAb) therapy for the treatment of Pertussis
infections, more commonly known as whooping cough. Combining two mAbs, SYN-005 is designed to target and neutralize
pertussis toxin as a prophylaxis for
high-risk newborns and in order to reduce the mortality rate in infected infants. To further the
development of this potential therapy for Pertussis, we entered into an agreement with The University of Texas at Austin
(UT) to license the rights to certain
research and pending patents related to pertussis antibodies. We have patents pending on
compositions and uses of SYN-005 and we have an issued U.S. patent on other pertussis mAbs from UT. According to the World
Health Organization, each year, B. pertussis infection is estimated to cause up to 300,000 deaths worldwide,
primarily among unvaccinated infants. Positive preclinical research findings for SYN-005 were reported in April 2014, and
again in September 2014, for our proprietary mAb combination therapy for treating Pertussis, in non-human primate studies.
In September 2014 we received a U.S.
Orphan Drug designation for SYN-005 for the treatment of Pertussis. We intend to seek
non-dilutive funding to support preclinical and clinical development of SYN-005 for prophylaxis and treatment of Pertussis,
including the anticipated filing of an
IND application in 2015 and the anticipated initiation of a Phase 1 clinical trial during the
second half of 2015, with topline Phase 1 data expected during 2015. |
| • | Acinetobacter infections: In
September 2012, in collaboration with Intrexon, we initiated efforts to develop a mAb therapy for the treatment of Acinetobacter
infections. Many strains of Acinetobacter are multidrug-resistant and pose an increasing global threat to hospitalized
patients, wounded military personnel and those affected by natural disasters. A treatment for Acinetobacter infections
represents a billion dollar market opportunity. This program is in the discovery stage and the generation of a panel of antibodies
to treat this infection is ongoing. |
Summary of Multiple Sclerosis
Program:
| • | Relapsing-Remitting
MS: Patient follow-up is complete in the UCLA-led Phase 2, investigator-initiated, randomized (n = 158), double-blinded,
placebo-controlled trial which evaluated our drug candidate, Trimesta, in women with relapsing-remitting MS at 16 sites across
the U.S. In April 2014, the principal investigator presented positive Phase 2 topline efficacy and safety results. In September
2014, the lead principal investigator presented additional Phase 2 clinical outcome data, including more detailed results on improvements
in cognitive and disability measures, at the 2014 Joint Americas and European Committees for Treatment and Research in Multiple
Sclerosis Meeting (ACTRIMS-ECTRIMS) in Boston. The data as reported by the lead principal investigator for the UCLA-led Phase
2 study provided supportive data for the potential of Trimesta to have a novel dual mechanism of action for both the anti-inflammatory
effects that improve relapse rate, and a neuroprotective effect that improves standard measures of disability and cognition. Further
analyses of the magnetic resonance imaging (MRI) data are ongoing, with topline data expected from the principal investigator
during the first half of 2015. This investigator-initiated Phase 2 clinical trial was supported by grants exceeding $8 million,
awarded primarily by the National Multiple Sclerosis Society (NMSS) in partnership with the NMSS’s Southern California chapter,
and the National Institutes of Health. Annual worldwide sales of MS therapies are forecasted to be approximately $17.8 billion
in 2019. We have licensed issued method of treatment patents in the U.S. for MS therapy with estriol and estriol combination therapies
(including estriol with Copaxone®) from UCLA, and numerous new provisional patent applications have been filed based on the
Phase 2 clinical results. We are engaging with the neurology community and potential strategic partners, as we determine next
steps for Trimesta. |
| • | Cognitive
Dysfunction in MS: Trimesta is also being developed for the treatment of cognitive dysfunction in female MS patients.
This 12-month, UCLA-led, randomized, double-blind, placebo-controlled investigator-initiated Phase 2 clinical trial is being conducted
at four sites in the United States. The primary endpoint is the effect on cognitive function as assessed by Paced Auditory Serial
Addition Test (PASAT). Patient enrollment is ongoing. The majority of the costs of this trial are being funded by grants from
foundations and charitable organizations through direct funding to the principal investigator and we have pledged approximately
$500,000 to UCLA to partially fund this trial, payable over three years. An estimated 50 – 65% of MS patients
are expected to develop disabilities due to cognitive dysfunction and there is currently no approved treatment for this indication. |
Since our inception in January
2001, our efforts and resources have been focused primarily on acquiring and developing our product candidates, our clinical trials,
raising capital, manufacturing and recruiting personnel. To date, we have financed our operations primarily through public and
private sales of our common stock, and we expect to continue to seek to obtain the required capital in a similar manner. We have
incurred an accumulated deficit of $101.0 million through December 31, 2014. We cannot provide any assurance that we will be able
to achieve profitability on a sustained basis, if at all, obtain the required funding, obtain the required regulatory approvals,
or complete additional corporate partnering or acquisition transactions.
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 155 Gibbs Street, Suite
412, Rockville, Maryland 20850. We also maintain an administrative and finance office in Ann Arbor, Michigan. Our telephone number
is (732) 332-7800, 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.
As used in this prospectus supplement, unless the context otherwise
requires, references to “Synthetic,” “we,” “us,” “our,” and similar references
refer to Synthetic Biologics, Inc.
RISK
FACTORS
An
investment in our common stock 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, or 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 common stock. 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 Form10-Q, all of which you should review carefully. Please
consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying 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 shares of common stock, 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
We will not receive any proceeds from the
disposition by the Selling Stockholder of any of the Shares covered by 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. Any future determination about
the payment of dividends will be made at the discretion of our board of directors 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.
SELLING STOCKHOLDER
This prospectus covers the disposition
by the Selling Stockholder identified below, or its transferee(s), of a total of 655,321 shares of our common stock. All of
the Shares included in this offering were issued as described below.
The Selling Stockholder has indicated to
us that neither it nor any of its affiliates has held any position or office or had any other material relationship with us in
the past three years except as described below.
The following table sets forth the
number of shares of the common stock owned by the Selling Stockholder as of April 1, 2015 and after giving effect to this
offering assuming all of the shares covered hereby are sold by the Selling Stockholder. The percentage of beneficial
ownership is based on 72,725,987 shares of our common stock outstanding as of April 1, 2015.
Selling Stockholder | |
Beneficial Ownership Before the Sale of all Shares Covered by this Prospectus | | |
Percentage of Beneficial Ownership Before the Sale of all Shares Covered by this Prospectus | |
Total Shares Offered By Selling Stockholder in the Offering Covered by this Prospectus | | |
Beneficial Ownership After the Sale of all Shares Covered by this Prospectus(1) | |
Percentage of Beneficial Ownership After the Sale of all Shares Covered by this Prospectus |
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PREV ABR, LLC(2) | |
| 655,321 | | |
* | |
| 655,321 | | |
* | |
* |
*less than 1%
| (1) | These numbers assume the Selling Stockholder sells all
of the Shares being registered in this prospectus, which are being registered in this prospectus. |
| (2) | Mike Floyd is the manager of PREV and has voting and
disposition power over PREV. |
On November 28, 2012, a closing was held
for the transaction contemplated by the Asset Purchase Agreement we entered into with PREV pursuant to which we acquired the C.
diff program assets of PREV, including pre-Investigational New Drug (IND) package, Phase 1 and Phase 2 clinical data,
manufacturing process data and all issued and pending U.S. and international patents. Pursuant to the Asset Purchase Agreement,
we paid PREV an initial cash payment of $100,000 upon execution of the Asset Purchase Agreement and at closing paid an additional
cash payment of $135,000 and issued 625,000 unregistered shares of our common stock to PREV. In addition, upon the achievement
of the milestones set forth below, PREV may be entitled to receive additional consideration payable 50% in cash and 50% in our
stock, subject to PREV’s option to receive the entire payment in shares of our stock: (i) upon commencement of an IND; (ii)
upon commencement of a Phase 1 clinical trial; (iii) upon commencement of a Phase 2 clinical trial; (iv) upon commencement of a
Phase 3 clinical trial; (v) upon Biologic License Application (BLA) filing in the U.S. and for territories outside of the U.S.
(as defined in the Asset Purchase Agreement); and (vi) upon BLA approval in the U.S. and upon approval in territories outside the
U.S. The future stock issuances are subject to prior approval of the NYSE MKT, LLC. No royalties are payable to PREV under
the Asset Purchase Agreement. In lieu of receiving any cash payment for achieving the first three milestones, PREV has exercised
its option to receive the full milestone payment in 655,321 shares of our common stock. The number of shares of common stock issued
upon achievement of each milestone was based upon the average of the opening and closing prices of our stock on the date each milestone
was achieved as specified in the Asset Purchase Agreement.
PLAN OF DISTRIBUTION
We are registering the Shares previously
issued to the Selling Stockholder to permit the resale of these shares of common stock by the holder of the common stock from time
to time after the date of this prospectus. We will not receive any of the proceeds from the sale by the Selling Stockholder of
the shares of common stock. We will bear all fees and expenses incident to our obligation to register the shares of common stock.
The Selling Stockholder, or its pledges,
donees, transferees, or any of its successors in interest selling shares received from the Selling Stockholder as a gift, partnership
distribution or other non-sale related transfer after the date of this prospectus, may sell all or a portion of the Shares beneficially
owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. If the
shares of common stock are sold through underwriters or broker-dealers, the Selling Stockholder will be responsible for underwriting
discounts or commissions or agent's commissions. The Shares may be sold in one or more transactions at fixed prices, at prevailing
market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. The Selling Stockholder
will act independently of us in making decisions with respect to the timing, manner and size of each sale. These sales may be affected
in transactions, which may involve crosses or block transactions:
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on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale; |
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in the over-the-counter market; |
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in transactions otherwise than on these exchanges or systems or in the over-the-counter market; |
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through the writing of options, whether such options are listed on an options exchange or otherwise; |
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ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
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block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
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purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
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an exchange distribution in accordance with the rules of the applicable exchange; |
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privately negotiated transactions; |
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short sales; |
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through the distribution of the common stock by any Selling Stockholder to its partners, members or stockholders; |
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through one or more underwritten offerings on a firm commitment or best efforts basis; |
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sales pursuant to Rule 144; |
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broker-dealers may agree with the Selling Stockholder to sell a specified number of such shares at a stipulated price per share; |
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a combination of any such methods of sale; and |
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any other method permitted pursuant to applicable law. |
The Selling Stockholder may also transfer
the Shares by gift. The Selling Stockholder may engage brokers and dealers, and any brokers or dealers may arrange for other brokers
or dealers to participate in effecting sales of the Shares. These brokers, dealers or underwriters may act as principals, or as
an agent of a Selling Stockholder. Broker-dealers may agree with the Selling Stockholder to sell a specified number of the Shares
at a stipulated price per security. If the broker-dealer is unable to sell the Shares acting as agent for the Selling Stockholder,
it may purchase as principal any unsold Shares at the stipulated price. Broker-dealers who acquire Shares as principals may thereafter
resell the Shares from time to time in transactions in any stock exchange or automated interdealer quotation system on which the
Shares are then listed, at prices and on terms then prevailing at the time of sale, at prices related to the then-current market
price or in negotiated transactions. Broker-dealers may use block transactions and sales to and through broker-dealers, including
transactions of the nature described above.
The Selling Stockholder may also sell the
Shares in accordance with Rule 144 under the Securities Act, rather than pursuant to this prospectus, regardless of whether the
Shares are covered by this prospectus.
If the Selling Stockholder effects such
transactions by selling Shares to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents
may receive commissions in the form of discounts, concessions or commissions from the Selling Stockholder or commissions from purchasers
of the shares of common stock for whom they may act as agent or to whom they may sell as principal (which discounts, concessions
or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types of transactions
involved). In connection with sales of the Shares or otherwise, the Selling Stockholder may enter into hedging transactions with
broker-dealers, which may in turn engage in short sales of the Shares in the course of hedging in positions they assume. The Selling
Stockholder may also sell Shares short and deliver Shares covered by this prospectus to close out short positions and to return
borrowed shares in connection with such short sales. The Selling Stockholder may also loan or pledge Shares to broker-dealers that
in turn may sell such shares.
The Selling Stockholder may pledge or grant a security interest in some or all of the Shares owned by it and, if it defaults in the performance of its secured obligations, the pledgees or secured parties may offer and sell the Shares from time to time pursuant to this prospectus or any amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending, if necessary, the list of Selling Stockholders to include the pledgee, transferee or other successors in interest as Selling Stockholder under this prospectus. The Selling Stockholder also may transfer and donate the Shares in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus. |
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In addition, the Selling Stockholder may,
from time to time, sell the Shares short, and, in those instances, this prospectus may be delivered in connection with the short
sales and the Shares offered under this prospectus may be used to cover short sales.
The Selling Stockholder and any broker-dealer
participating in the distribution of the Shares may be deemed to be “underwriters” within the meaning of the Securities
Act, and any commission paid, or any discounts or concessions allowed to, any such broker-dealer may be deemed to be underwriting
commissions or discounts under the Securities Act. At the time a particular offering of the Shares is made, a prospectus supplement,
if required, will be distributed which will set forth the aggregate amount of Shares being offered and the terms of the offering,
including the name or names of any broker-dealers or agents, any discounts, commissions and other terms constituting compensation
from the Selling Stockholder and any discounts, commissions or concessions allowed or reallowed or paid to broker-dealers. The
Selling Stockholder may indemnify any broker-dealer that participates in transactions involving the sale of the Shares against
certain liabilities, including liabilities arising under the Securities Act.
Under the securities laws of some states,
the Shares may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the Shares
may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or
qualification is available and is complied with.
There can be no assurance that the Selling
Stockholder will sell any or all of the Shares registered pursuant to the registration statement, of which this prospectus forms
a part.
The Selling Stockholder and any other person
participating in such distribution will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder,
including, without limitation, Regulation M of the Exchange Act, which may limit the timing of purchases and sales of any of the
shares of common stock by the Selling Stockholders and any other participating person. Regulation M may also restrict the ability
of any person engaged in the distribution of the Shares to engage in market-making activities with respect to the shares of common
stock. All of the foregoing may affect the marketability of the Shares and the ability of any person or entity to engage in market-making
activities with respect to the Shares.
The Shares offered hereby were
originally issued to the Selling Stockholder pursuant to an exemption from the registration requirements of the Securities
Act. We agreed to register the Shares under the Securities Act, We will pay all expenses of the registration of the Shares
estimated to be $30,000 in total, including, without limitation, SEC filing fees.
Once sold under the registration statement,
of which this prospectus forms a part, the Shares will be freely tradable in the hands of persons other than our affiliates.
DESCRIPTION OF SECURITIES
Our authorized capital consists of 100
million shares of common stock, par value $0.001 per share, and 10 million shares of preferred stock, par value $0.001 per share.
As of April 1, 2015, 72,725,987 shares of common stock and no shares of preferred stock were outstanding.
Common Stock
Holders of shares of common stock have
the right to cast one vote for each share of common stock in their name on the books of our company, whether represented in person
or by proxy, on all matters submitted to a vote of holders of common stock, including election of directors. There is no right
to cumulative voting in election of directors. Except where a greater requirement is provided by statute, by our articles of incorporation,
or by our bylaws, the presence, in person or by proxy duly authorized, of the one or more holders of a majority of the outstanding
shares of our common stock constitutes a quorum for the transaction of business. The vote by the holders of a majority of outstanding
shares is required to effect certain fundamental corporate changes such as liquidation, merger, or amendment of our articles of
incorporation.
There are no restrictions in our articles
of incorporation or bylaws that prevent us from declaring dividends. We have not declared any dividends, and we do not plan to
declare any dividends in the foreseeable future.
Holders of shares of our common stock are
not entitled to preemptive or subscription or conversion rights, and no redemption or sinking fund provisions are applicable to
our common stock. All outstanding shares of common stock are, and the shares of common stock sold in the offering will when issued
be fully paid and non-assessable.
Outstanding
Warrants
As of April 1, 2015, we had issued and
outstanding a total of 7,974,794 warrants to purchase our common stock outstanding at a weighted-average price of $1.80.
Outstanding Options
As of April 1, 2015, we had issued and
outstanding a total of 6,531,106 options to purchase our common stock outstanding at a weighted-average price of $1.97.
LEGAL MATTERS
Parsons Behle & Latimer, Reno, Nevada will pass upon certain
legal matters relating to the issuance and sale of the common stock offered hereby on behalf of Synthetic Biologics, Inc.
EXPERTS
The financial statements of Synthetic Biologics, Inc. as of
December 31, 2014 and 2013 and for each of the three years ended in the period ended December 31, 2014 and management’s assessment
of the effectiveness of internal control over financial reporting as of December 31, 2014 incorporated by reference in this Prospectus
have been so incorporated in reliance on the reports of BDO USA, LLP, an independent registered accounting firm, incorporated herein
by reference, given on authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports,
proxy statements and other information with the SEC. You may read and copy any document we file at the SEC’s public reference
room located at 100 F Street N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information
on the operation of the public reference room. Our public filings are also available to the public at the SEC’s web site
at http://www.sec.gov.
This prospectus is part of a registration
statement on Form S-3 that we have filed with the SEC under the Securities Act. This prospectus does not contain all of the
information in the registration statement. We have omitted certain parts of the registration statement, as permitted by the rules
and regulations of the SEC. You may inspect and copy the registration statement, including exhibits, at the SEC’s public
reference room or Internet site.
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 between the date of this prospectus
and the termination of the offering:
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Our annual report on Form 10-K for the fiscal year ended December 31, 2014 filed with the SEC on March 16, 2015 (File No. 001-12584); |
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Our
current reports on Form 8-K filed with the SEC on January 12, 2015 (with respect to Item 5.02 of Form 8-K) and March 19,
2015 (File No. 001-12584); |
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Our preliminary proxy statement on Schedule 14A filed with the SEC on March 23, 2015 (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). |
You may obtain, free of charge, a copy
of any of these documents (other than exhibits to these documents unless the exhibits are specifically incorporated by reference
into these documents or referred to in this prospectus) by writing or calling us at the following address and telephone number:
Synthetic Biologics, Inc., 617 Detroit Street, Suite 100 Ann Arbor,
Michigan 48104. (734) 332-7800.
DISCLOSURE OF SECURITIES AND EXCHANGE
COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Our amended and restated bylaws 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, contains 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.
655,321 Shares
Common Stock
You should rely only on the information
contained or incorporated by reference in this prospectus. We have not authorized anyone to provide you with different information.
You should not assume that the information contained or incorporated by reference in this prospectus is accurate as of any date
other than the date of this prospectus. We are not making an offer of these securities in any state where the offer is not permitted.
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