As filed with the Securities and Exchange Commission on April 10, 2015 |
Registration No. 333- |
UNITED STATES SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES
ACT OF 1933
SYNTHETIC BIOLOGICS, INC.
(Exact Name of Registrant as Specified
in Its Charter)
|
|
|
Nevada
(State or Other Jurisdiction
of
Incorporation or Organization) |
|
13-3808303
(I.R.S.
Employer
Identification Number) |
155 Gibbs Street, Suite 412
Rockville, Maryland 20850
(734) 332-7800
(Address, Including
Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)
617 Detroit Street, Suite 100 |
Ann Arbor, Michigan 48104 |
(Mailing Address and zip code)
Jeffrey Riley
Chief Executive Officer and President
Synthetic Biologics, Inc.
155 Gibbs Street, Suite 412
Rockville, Maryland 20850
(734) 332-7800
(Name, Address, Including Zip Code, and
Telephone Number, Including Area Code of Agent for Service)
With copies to:
Leslie Marlow, Esq.
Gracin & Marlow, LLP
The Chrysler Building
405 Lexington Avenue, 26th Floor
New York, New York 10174
(212) 907-6457
Approximate date of commencement of proposed sale to the public:
From time to time after the effective date of this registration statement.
If
the only securities being registered on this form are being offered pursuant to dividend or interest reinvestment plans, please
check the following box. ¨
If
any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415
under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans,
check the following box. þ
If
this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration statement number of the earlier effective registration statement
for the same offering. ¨
If this form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of
the earlier effective registration statement for the same offering.
If
this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become
effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box.
¨
If
this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following
box. ¨
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated
filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
|
|
|
|
|
|
|
Large accelerated filer ¨ |
|
Accelerated filer þ |
|
Non-accelerated
filer ¨
(Do not check if a smaller reporting
company) |
|
Smaller reporting
company ¨ |
CALCULATION OF REGISTRATION FEE
Title of Each Class of Securities to be Registered | |
Amount to be Registered (1) | |
Proposed Maximum Offering Price per Security(2) | | |
Proposed Maximum Aggregate Offering Price | | |
Amount of Registration Fee(3) | |
| |
| |
| | |
| | |
| |
Common stock, par value $0.001 per share | |
655,321 shares | |
$ | 2.05 | | |
$ | 1,343,408 | | |
$ | 156.11 | |
| (1) | There
is also being registered hereunder an indeterminate number of additional shares of common stock as shall be issuable pursuant
to Rule 416 to prevent dilution resulting from stock splits, stock dividends or similar transactions. |
| (2) | Estimated solely for the purpose of calculating the
registration fee in accordance with Rule 457(c) of the Securities Act based upon a $2.05 per share average of high and low prices
of the registrant’s common stock on the NYSE MKT on April 7, 2015. |
| (3) | A
fee of $156.11 is being paid with the filing of this registration statement. |
The registrant hereby amends this
registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file
a further amendment which specifically states that this registration statement shall thereafter become effective in
accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such
date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
_________________________________________
The
information contained in this prospectus is not complete and may be changed. The Selling Stockholder may not sell these securities
until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an
offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale
is not permitted. |
PROSPECTUS
SUBJECT
TO COMPLETION, 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 , 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 |
| |
| | | |
| |
| | | |
| |
|
| |
| | | |
| |
| | | |
| |
|
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:
|
● |
on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale; |
|
● |
in the over-the-counter market; |
|
● |
in transactions otherwise than on these exchanges or systems or in the over-the-counter market; |
|
● |
through the writing of options, whether such options are listed on an options exchange or otherwise; |
|
● |
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
|
● |
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; |
|
● |
purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
|
● |
an exchange distribution in accordance with the rules of the applicable exchange; |
|
● |
privately negotiated transactions; |
|
● |
short sales; |
|
● |
through the distribution of the common stock by any Selling Stockholder to its partners, members or stockholders; |
|
● |
through one or more underwritten offerings on a firm commitment or best efforts basis; |
|
● |
sales pursuant to Rule 144; |
|
● |
broker-dealers may agree with the Selling Stockholder to sell a specified number of such shares at a stipulated price per share; |
|
● |
a combination of any such methods of sale; and |
|
● |
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. |
|
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:
|
● |
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); |
|
● |
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); |
|
● |
Our preliminary proxy statement on Schedule 14A filed with the SEC on March 23, 2015 (File No. 001-12584); and |
|
|
|
|
● |
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.
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
|
|
Item 14. |
Other Expenses of Issuance and Distribution. |
The following table sets forth the estimated
fees and expenses in connection with the shelf registration of the common stock registered under this registration statement, other
than any underwriting discounts and commissions. The actual amounts of such fees and expenses will be determined from time to time.
All amounts shown are estimates except for the Securities and Exchange Commission (the “SEC”) registration fee.
SEC registration fee | |
$ | 156 | |
Legal fees and expenses | |
| 15,000 | |
Accounting fees and expenses | |
| 10,000 | |
Transfer agent and registrar fees and expenses | |
| 1,500 | |
Printing and engraving expenses | |
| 1,000 | |
Miscellaneous | |
| 2,344 | |
| |
| | |
Total | |
$ | 30,000 | |
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 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.
| 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 | By-Laws
(Incorporated by reference to (i) Exhibit 3.4 of the Registrant’s Current Report on Form 8-K filed October 19, 2009 and
(ii) Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed June 3, 2010(File No. 001-12584).) |
| 3.6 | 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).) |
| 3.7 | 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).) |
| 5.1 | Legal
opinion of Parsons Behle & Latimer* |
| 10.1 | Asset
Purchase Agreement dated November 8, 2012 between Synthetic Biologics, Inc. and Prev ABR LLC (Incorporated by reference to Exhibit
10.1 of the Registrant’s Current Report on Form 8-K filed November 13, 2012(File No. 001-12584).) |
| 21 | List
of Subsidiaries (Incorporated by reference to Exhibit 21 to the Registrant’s Annual Report on Form 10-K filed on March 16,
2015(File No. 001-12584).) |
| 23.1 | Consent
of Independent Registered Public Accounting Firm (BDO USA, LLP) * |
| 23.2 | Consent
of Parson Behle & Latimer (included in Exhibit 5.1)* |
| 24.1 | Powers
of Attorney for our directors (included on signature page)* |
(a) The undersigned registrant
hereby undertakes:
(1) To file, during
any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) To
include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To
reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if
the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high
end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b)
if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii) To
include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement;
provided, however , that the undertakings
set forth in paragraphs (1)(i), (1)(ii) and (1)(iii) above do not apply if the information required to be included in a post-effective
amendment by those paragraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to Section
13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement or
is contained in a form of prospectus filed pursuant to Rule 424(b) that is a part of the registration statement.
(2) That, for the
purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be
a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof.
(3) To remove from
registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination
of the offering.
(4) That, for the
purpose of determining liability under the Securities Act of 1933 to any purchaser:
(i) Each prospectus
filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the
filed prospectus was deemed part of and included in the registration statement; and
(ii) Each prospectus
required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B
relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required
by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the
earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities
in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that
is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to
the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement
or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference
into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of
contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or
prospectus that was part of the registration statement or made in any such document immediately prior to such effective date; and
(iii)
Each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration
statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included
in the registration statement as of the date it is first used after effectiveness; provided, however, that no statement
made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or
deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will,
as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the
registration statement or prospectus that was part of the registration statement or made in any such document immediately prior
to such date of first use.
(5) That, for the
purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution
of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant
pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if
the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant
will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
(i) Any preliminary
prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
(ii) Any free writing
prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned
registrant;
(iii) The portion
of any other free writing prospectus relating to the offering containing material information about the undersigned registrant
or its securities provided by or on behalf of the undersigned registrant; and
(iv) Any other communication
that is an offer in the offering made by the undersigned registrant to the purchaser.
(b) The undersigned registrant hereby
undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s
annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of
an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated
by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(c) Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers,
and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as
expressed in the Securities Act of 1933 and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer, or
controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such
director, officer, or controlling person in connection with the securities being registered, the registrant will, unless in
the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of
1933 and will be governed by the final adjudication of such issue.
(6) If this registration statement
is permitted by Rule 430A, that:
(i) For
purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of
prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus
filed by the registrant pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act of 1933 shall be
deemed to be part of this registration statement as of the time it was declared effective.
(ii) For the purpose of determining
any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus 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.
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing
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, April 10, 2015.
|
|
SYNTHETIC BIOLOGICS, INC. |
|
|
|
|
|
|
|
|
|
|
|
|
|
By: |
/s/ Jeffrey Riley |
|
|
|
|
Chief Executive Officer,
President and Director |
|
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
|
|
|
|
|
By: |
/s/ C. Evan Ballantyne |
|
|
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
|
POWER OF ATTORNEY
We, the undersigned hereby severally constitute
and appoint each of Jeffrey Riley and C. Evan Ballantyne our true and lawful attorney and agent, with full power to each to sign
for us, and in our names in the capacities indicated below, any and all amendments to this registration statement, any subsequent
registration statements pursuant to Rule 462 of the Securities Act of 1933, as amended, and to file the same, with all exhibits
thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact
and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to
be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them or their substitute or substitutes, may lawfully do or cause
to be done by virtue hereof. This power of attorney may be executed in counterparts.
Pursuant to the requirements of the Securities
Act 1933, this report has been signed by the following persons on behalf of the Registrant and in the capacities and on the dates
indicated.
/s/ Jeffrey Riley
Jeffrey Riley |
|
Chief Executive Officer,
President and Director |
|
April 10, 2015 |
|
|
(Principal Executive Officer)
|
|
|
/s/ C. Evan Ballantyne |
|
Chief Financial Officer |
|
April 10, 2015 |
C. Evan Ballantyne |
|
(Principal Financial and Accounting Officer) |
|
|
|
|
|
|
|
/s/ Jeffrey J. Kraws
Jeffrey J. Kraws |
|
Chairman |
|
April 10, 2015 |
|
|
|
|
|
|
|
|
|
|
/s/ Scott L. Tarriff
Scott L. Tarriff |
|
Director |
|
April 10, 2015 |
|
|
|
|
|
|
|
|
|
|
/s/ Jeffrey Wolf
Jeffrey Wolf |
|
Director |
|
April 10, 2015 |
EXHIBIT 5.1
April 10, 2015
The Board of Directors
Synthetic Biologics, Inc.
155 Gibbs Street, Suite 412
Rockville, MD 20850
|
Re: |
Synthetic Biologics, Inc.
Form S-3 dated as of April 10, 2015 |
Gentlemen:
We have acted as special
Nevada counsel to Synthetic Biologics, Inc., a Nevada corporation (the “ Company ”), in connection with
its filing on the date hereof with the Securities and Exchange Commission (the “ Commission ”) of a registration
statement on Form S-3 (as amended, the “ Registration Statement ”), under the Securities Act of 1933,
as amended (the “Act ”), relating to the registration for issue and sale by the Company of 655,321 shares
of common stock (the “Securities”).
This opinion is being
furnished in connection with the requirements of Item 601(b)(5) of Regulation S-K under the Act, and no opinion is expressed herein
as to any matter pertaining to the contents of the Registration Statement or related applicable Prospectus or the Sales Agreement
Prospectus, other than as expressly stated herein with respect to the issuance of the Securities.
As such counsel, we
have examined such matters of fact and questions of law as we have considered appropriate for purposes of this letter. With your
consent, we have relied upon certificates and other assurances of officers of the Company and others as to factual matters without
having independently verified such factual matters. We are opining herein as to the Nevada Revised Statutes (the “NRS”),
and we express no opinion with respect to the applicability thereto, or the effect thereon, of the laws of any other jurisdiction
or, in the case of Nevada, any other laws, or as to any matters of municipal law or the laws of any local agencies within any state
or of federal law, including, without limitation, federal securities law.
Materials Reviewed
In arriving at the
opinions expressed below we have reviewed and relied upon the following:
|
1. |
Articles of Incorporation of Adeona Pharmaceuticals, Inc. (20080829837-57) filed with the Nevada Secretary of State on December 23, 2008. |
|
2. |
Articles of Merger (20090740844-88) filed with the Nevada Secretary of State on October 15, 2009, along with the Agreement and Plan of Merger attached thereto. |
|
3. |
Amended and Restated By-Laws of Adeona Pharmaceuticals, Inc., adopted and effective as of October 31, 2011 (unsigned). |
|
4. |
The Certificate of Good
Standing of the Company issued by the Nevada Secretary of State, on April 6, 2015 |
|
5. |
Secretary’s
Certificate from the Secretary of the Company dated April 10, 2015 |
|
6. |
Minutes of the Board of Directors of the Company, dated as of April 7, 2015 |
(the “Reliance Documents”)
In connection with
this opinion, we have examined and relied upon the representations and warranties as to factual matters contained in and made pursuant
to the Reliance Documents, Registration Statement and upon such other documents as in our judgment are necessary or appropriate
to enable us to render the opinions expressed herein.
The Board of Directors
Synthetic Biologics, Inc.
April 10, 2015
Our knowledge of the
Company and its legal and other affairs is limited by the scope of our engagement, which scope includes the delivery of this opinion
letter. We do not represent the Company with respect to all legal matters or issues. The Company may employ other independent counsel
and, to our knowledge, handles certain matters and issues without the assistance of independent counsel.
In our examination
of the foregoing, we have assumed, without independent investigation or verification: (i) the genuineness of all signatures on
all agreements, instruments and other documents submitted to us; (ii) the legal capacity and authority of all persons or entities
executing all agreements, instruments and other documents submitted to us; (iii) the authenticity and completeness of all agreements,
instruments, corporate records, certificates and other documents submitted to us as originals; (iv) that all agreements, instruments,
corporate records, certificate and other documents submitted to us as certified, electronic, facsimile, conformed, photostatic
or other copies conform to authentic originals thereof, and that such originals are authentic and complete; (v) the due authorization,
execution and delivery of all instruments, agreements, and other documents by the parties thereto; (vi) that the statements contained
in the certificates and comparable documents of public officials, officers and representatives of the Company and other persons
on which we have relied for the purposes of this letter are true and correct; and (vii) that the officers and directors of the
Company have properly exercised their fiduciary duties. We have assumed that the issuance and sale of the Securities by the Company
will not, in each case, violate or constitute a default or breach under (i) any agreement or instrument to which the Company is
subject, (ii) any law, rule or regulation to which the Company is subject, (iii) any judicial or regulatory order or decree of
any governmental authority, or (iv) any consent, approval, license, authorization or validation of, or filing, recording or registration
with any governmental authority.
We have further assumed
that: (i) the Registration Statement and any amendments thereto will have become effective under the Act and comply with all applicable
laws at the time the Securities are offered or issued as contemplated by the Registration Statement; (ii) an appropriate prospectus
supplement, free writing prospectus or term sheet relating to the Securities offered thereby will be prepared and filed with the
Commission in compliance with the Act and will comply with all applicable laws at the time the Securities are offered or issued
as contemplated by the Registration Statement; (iii) all Securities will be issued and sold in compliance with the applicable provisions
of the Act and the Securities or Blue Sky Laws of various states and in the manner stated in the Registration Statement and the
applicable prospectus supplement; (iv) any purchase, underwriting, warrant, deposit, unit or similar agreement (collectively the
“Securities Agreements”) relating to the Securities being offered will be duly authorized, executed and delivered by
the Company and other parties thereto; and (v) the number of shares of Common Stock offered pursuant to the Registration Statement
does not exceed, at the time of issuance, the authorized but unissued shares of Common Stock.
Opinions
Subject to the foregoing and the other matters
set forth herein, it is our opinion that, as of the date hereof that the Securities have been duly authorized and are validly issued
and are fully paid and non-assessable.
This opinion is for
your benefit in connection with the Registration Statement and may be relied upon by you and by persons entitled to rely upon it
pursuant to the applicable provisions of the Act. We consent to your filing this opinion as an exhibit to the Registration Statement
and to the reference to our firm contained in each of the Prospectus under the heading “Legal Matters.” We further
consent to the incorporation by reference of this letter and consent into any registration statement or post-effective amendment
to the Registration Statement filed pursuant to Rule 462(b) under the Act with respect to the Securities. In giving such consent,
we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Act or the rules
and regulations of the Commission thereunder.
|
Very truly yours, |
|
|
|
PARSONS BEHLE & LATIMER |
EXHIBIT 23.1
Consent of Independent Registered Public
Accounting Firm
Synthetic Biologics, Inc.
Rockville, Maryland
We hereby consent to the incorporation
by reference in the Prospectus constituting a part of this Registration Statement of our reports dated March 16, 2015, relating
to the consolidated financial statements and the effectiveness of Synthetic Biologics, Inc.’s internal control over financial
reporting, appearing in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014.
We also consent to the reference to us
under the caption “Experts” in the Prospectus.
/s/ BDO USA, LLP
BDO USA, LLP
Troy, Michigan
April 10, 2015
Synthetic Biologics (AMEX:SYN)
Historical Stock Chart
From Apr 2024 to May 2024
Synthetic Biologics (AMEX:SYN)
Historical Stock Chart
From May 2023 to May 2024