As filed with the
Securities and Exchange Commission on August 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
![](tlogo.jpg)
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) |
9605 Medical Center Drive, Suite 270
Rockville, Maryland 20850
(734) 332-7800
(Address, Including Zip Code, and Telephone
Number, Including Area Code, of Registrant’s Principal Executive Offices)
617 Detroit Street,
Suite 100
Ann Arbor, Michigan
48104
(Mailing Address and Zip Code of Administrative
Offices)
Jeffrey Riley
Chief Executive Officer and President
Synthetic Biologics, Inc.
9605 Medical
Center Drive, Suite 270
Rockville, Maryland 20850
(734) 332-7800
(Name, Address, Including Zip Code, and
Telephone Number, Including Area Code of Agent for Service)
With copies to:
Leslie Marlow, Esq.
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 x |
|
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 Share | | |
Proposed Maximum Aggregate Offering Price | | |
Amount of Registration Fee | |
Warrants(4) | |
| – | | |
| – | | |
| – | | |
| – | |
Shares of Common Stock underlying Warrants | |
| 7,029,808 | (2) | |
$ | 1.75 | (3) | |
$ | 12,302,164 | (5) | |
$ | 1,430 | |
TOTAL | |
| 7,029,808 | | |
| – | | |
$ | 12,302,164 | | |
$ | 1,430 | |
| (1) | Pursuant to Rule 416 under the Securities Act of 1933, as amended (the “Securities Act”),
this Registration Statement shall also cover any additional shares of the Registrant’s common stock that become issuable
by reason of any stock split, stock dividends, recapitalization, or other similar transactions. |
| (2) | Represents shares of common stock underlying warrants issued to investors in our previous registered
direct offering. |
| (3) | Represents the per share Exercise Price of the warrants described in footnote (2) above. |
| (4) | No fee pursuant to Rule 457(g) under the Securities Act. |
| (5) | Calculated pursuant to Rule 457(g) under the Securities Act. |
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 in this
preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed
with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek
an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to Completion,
dated August 10, 2015.
PROSPECTUS
7,029,808 Shares of Common Stock Issuable
Upon Exercise of Outstanding Warrants
This prospectus relates to the offer and sale by us of 7,029,808
shares of our common stock, par value $0.001 per share, that are issuable at an exercise price of $1.75 per share from time to
time upon the exercise of currently outstanding warrants that we issued in October 2014 as part of a registered direct offering.
We will receive the proceeds from any cash exercises of the warrants. Each warrant is exercisable at any time until its expiration
date, which date is five years from the date of issuance of the warrant. If all of the warrants are exercised, we will receive
aggregate proceeds of $12,302,164. No securities are being offered pursuant to this prospectus other than the shares of our common
stock that will be issued upon exercise of those currently outstanding warrants.
INVESTING IN OUR SECURITIES INVOLVES RISKS. SEE THE
“RISK FACTORS”ON PAGE 6 OF THIS PROSPECTUS AND ANY SIMILAR SECTION CONTAINED IN THE DOCUMENTS INCORPORATED BY
REFERENCE INTO THIS PROSPECTUS CONCERNING FACTORS YOU SHOULD CONSIDER BEFORE INVESTING IN OUR SECURITIES.
Our common stock is traded on NYSE MKT under the symbol
“SYN”. On August 6, 2015, the last reported sale price for the common stock was $3.10 per share. We urge
prospective purchasers of our common stock to obtain current information about the market prices of our common stock.
Our executive offices are located at 9605
Medical Center Drive, Suite 270, 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.
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 company
developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. Our lead candidates in Phase 2
development include SYN-004 which is designed to protect the gut microbiome (gastrointestinal (GI) microflora) from the
effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and
antibiotic-associated diarrhea (AAD), and SYN-010 which is intended to reduce the impact of methane-producing organisms
in the gut microbiome to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, we
are developing a Phase 2 oral estriol drug, Trimesta™, for the treatment of relapsing-remitting multiple sclerosis (MS)
and cognitive dysfunction in MS, and in collaboration with Intrexon Corporation (NYSE:XON), a preclinical stage monoclonal
antibody combination for the treatment of Pertussis, and novel discovery stage biotherapeutics for the treatment of
phenylketonuria (PKU).
Product Pipeline:
Summary of Microbiome Programs:
|
· |
C. difficilei
infections (CDI): We are in clinical development of a novel second-generation oral
enzyme, SYN-004, to degrade commonly used IV beta-lactam antibiotics in the GI tract, intended
to protect the microbiome and prevent the development of and severe effects from CDI and AAD.
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 protect the gut from 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 November 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. In March 2015, we also initiated a Phase 2a
clinical trial to evaluate the GI antibiotic-degrading effects and the safety of SYN-004.
In June 2015, the first participant was dosed in a second Phase 2a clinical trial of SYN-004,
to evaluate the GI antibiotic-degrading effects and the safety of SYN-004, in the presence
of the proton pump inhibitor (PPI), esomeprazole. Topline data is expected from the first
Phase 2a clinical trial during the third quarter of 2015, and from the second Phase 2a clinical
trial during the second half of 2015. In July 2015, we reported data from the first four of
12 expected participants in the first Phase 2a open-label clinical trial; the data showed
that SYN-004 degraded IV ceftriaxone in the chyme of the four healthy participants with functioning
ileostomies without affecting the ceftriaxone in the bloodstream. The initiation of a Phase
2b proof-of-concept clinical trial of SYN-004 is expected in the third quarter of 2015. This
randomized, placebo-controlled clinical trial is expected to enroll approximately 370 patients
at up to 75 global clinical sites. An interim analysis of blinded data from the Phase 2b clinical
trial is anticipated during the second half of 2015. The initiation of pivotal Phase 3 clinical
trial(s) are anticipated during 2016. |
|
* |
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. SYN-010 is our proprietary modified-release
formulation of the classic statin, lovastatin, that is intended to reduce methane-production by certain microorganisms (M. smithii)
in the gut while minimizing disruption to the microbiome. SYN-010 is intended to act primarily in the intestinal lumen while avoiding
systemic absorption, thereby targeting the cause of IBS-C, not just the symptoms. An investigational team led by Mark Pimentel,
M.D. at CSMC discovered that lovastatin 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. In May 2015, preclinical results were presented in a poster at Digestive
Disease Week® (DDW) 2015 demonstrating that lovastatin prevented proliferation of methanogens in the small intestines
of rats with minimal impact on remaining microbiome. In his practice, Dr. Pimentel translated the use of statins to reduce methane
in humans by evaluating commercial lovastatin formulations in select IBS-C patients, demonstrating that lovastatin prevented methane
production by methanogens in human stool. Using stringent disease diagnosis criteria to ensure market relevance and a population
most likely to receive a diagnosis and prescription drug treatment, there are an estimated 40.7 million cases of IBS reported in
the U.S., Europe and Japan, and it has been reported that up to 20 percent of all IBS patients have IBS-C. The estimated global
sales for IBS therapeutics for 2015 are $669.3 million, and global sales are expected to be greater than $1.5 billion in 2023*.
A 505(b)(2) regulatory pathway is anticipated for the development of SYN-010. We licensed an intellectual property portfolio from
CSMC 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. Our
Investigational New Drug (IND) application was submitted to the U.S. Food and Drug Administration (FDA) in May 2015. In June 2015,
we initiated our first Phase 2 placebo-controlled clinical trial of SYN-010. This clinical trial is expected to enroll approximately
60 patients who will be randomly assigned in a 1:1:1 ratio to one of three groups, including two different SYN-010 dose groups
and a placebo group. Patients are scheduled to receive single oral doses of SYN-010 each day for 28 days. The primary objective
of this clinical trial is to evaluate the change from baseline in breath methane, as determined by a lactulose breath test, in
methane-positive patients with IBS-C after seven days of treatment with one of two formulations of SYN-010 compared with placebo.
Secondary endpoints include Improvement in the number of complete spontaneous bowel movements (CSBM) per week, and improvement
in abdominal pain and bloating per standard scales required per FDA guidance. We anticipate
reporting topline results from the first Phase 2 clinical trial during the second half of 2015. We also anticipate initiating the
second SYN-010 Phase 2 clinical trial during the second half of 2015, with topline results from this trial expected during the
first half of 2016. The primary endpoint of the second Phase 2 is to evaluate the ability of SYN-010 to sustain the reduction in
breath methane levels, and secondary endpoints include evaluating pain, bloating and CSBM. The initiation of pivotal Phase 3 clinical
trial(s) are anticipated during 2016. |
|
* |
GlobalData, Irritable Bowel Syndrome - Global Drug Forecast and Market Analysis to 2023, December 2014
|
Summary of Multiple Sclerosis Program:
|
· |
Relapsing-Remitting MS:
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 University of California, Los Angeles (UCLA). In April
2014, positive Phase 2 topline efficacy and safety results was presented by the lead principal investigator of the UCLA Phase 2
investigator initiated randomized (n=158) double-blinded placebo trial which evaluated our drug candidate, Trimesta, in woman with
relapsing remitting MS at 16 sites in the U.S. 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 supported 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. Numerous new provisional patent applications have been filed based on the Phase
2 clinical results. 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. In July
2015, through our wholly owned subsidiary, we entered into amended license and clinical trial agreements with The Regents of UCLA.
We were also informed by UCLA that MRI analyses are ongoing to evaluate changes in the brain that correlate with improvements seen
in clinical outcomes, and we expect to report topline MRI data 30 days following our receipt of this data from UCLA. We continue
to engage 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 lead 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. |
|
· |
Pertussis: In December 2012, in collaboration with Intrexon Corporation, 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. In April 2015, positive
preclinical findings were reported in two posters at ECCMID 2015 (European Congress of Clinical Microbiology and Infectious Diseases).
We are seeking 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 and the anticipated initiation of a Phase 1 clinical trial. |
|
· |
Phenylketonuria (PKU): In
August 2015, we entered into a third worldwide exclusive channel collaboration with Intrexon Corporation through which we
intend to develop and commercialize novel biotherapeutics for the treatment of patients with PKU. We will utilize Intrexon
Corporation’s ActoBiotics™ platform providing a
proprietary method of delivering therapeutic protein and peptides to the gastrointestinal tract through food-grade microbes.
This program is in the discovery stage. |
|
· |
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. |
All of our programs are supported by growing patent estates that we either own or exclusively license.
In total, each potential product has issued patents that provide protection, and we have approximately 100 U.S. and foreign patents
and over 55 U.S. and foreign patents pending.
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 $127.0 million through June 30, 2015. 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.
Recent Developments
On August 10, 2015, we expanded our relationship with
Intrexon Corporation and entered into an Exclusive Channel Collaboration Agreement (the “Channel Agreement”) with
Intrexon Corporation that governs a “channel collaboration” arrangement in which we will use Intrexon
Corporation’s technology relating to the development and commercialization of novel biotherapeutics (a
“Collaboration Product”) for the treatment of patients with PKU. We have agreed to pay Intrexon Corporation a
technology access fee by the issuance of 937,500 shares of common stock, having a value equal to $3 million as of August 7,
2015, within ten days of approval of the issuance by the NYSE MKT. In addition, upon the achievement of certain milestones,
we agreed to pay Intrexon Corporation milestone payments of up to $27 million for each product developed. We will pay
Intrexon Corporation royalties on annual net sales of Collaboration Products, calculated on a product-by-product basis equal
to a percent of net sales (ranging from mid-single digits on the first $100 million of net sales to mid-teen digits on net
sales in excess of $750 million).
On July 21, 2015, we completed a public offering of 15.3 million
shares of common stock, including the fully exercised over-allotment option by the underwriters covering 2.0 million shares, at
an offering price of $3.00 per share. The total gross proceeds of the offering, including the exercise in full of the over-allotment
option, were approximately $46.0 million. Net proceeds, after deducting the underwriters' discount and other estimated expenses,
were approximately $42.6 million.
On July 8, 2015, Putney Drug Corp., our subsidiary, and The
Regents of UCLA, entered into an amendment to the License Agreement, dated July 11, 2005 (as amended previously), and an amendment
to the Clinical Trial Agreement, dated as of April 29, 2010.
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
$127.0 million through June 30, 2015. 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 9605
Medical Center Drive, Suite 270, 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. and our subsidiaries.
THE
OFFERING
Common stock offered by us pursuant to this prospectus |
|
7,029,808 shares of common stock issuable upon the exercise of the warrants issued to the investors in our October 2014 registered direct offering, which are exercisable until October 2019 at an exercise price of $1.75 per share. |
|
|
|
Common stock to be outstanding after this offering if all of the warrants are exercised |
|
Up to 95,544,894 shares. |
|
|
|
Use of Proceeds |
|
We intend to use the net proceeds of this offering for working capital and general corporate purposes. See “Use of Proceeds” for further information |
|
|
|
Risk Factors |
|
See “Risk Factors” beginning on page 6 of this
prospectus and the other information included in, or incorporated by reference into, this prospectus for a discussion of
certain factors you should carefully consider before deciding to invest in shares of our common stock. |
|
|
|
NYSE MKT symbol |
|
“SYN” |
Except as otherwise indicated,
all information in this prospectus supplement is based on 88,515,086 shares outstanding on August 6, 2015 and excludes:
|
• |
7,467,762 shares of our common stock subject to options outstanding as of August 6, 2015 having a weighted-average exercise price of $2.01 per share; |
|
• |
2,170,466 shares of our common stock that have been reserved for issuance in connection with future grants under our stock option plans as of August 6, 2015; and |
|
• |
879,091 shares of our common stock that have been reserved for issuance upon exercise of outstanding warrants as of
August 6, 2015 having a weighted-average exercise price of $2.09 per share. |
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 (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
If all of the warrants are exercised, we
estimate that the net proceeds of this offering will be approximately $12.3 million. We currently intend to use the net proceeds
from this offering for working capital and general corporate purposes.
This expected use of the net proceeds from
this offering represents our intentions based upon our current plans and business conditions.
Pending our use of the net proceeds from
this offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment
grade, interest bearing instruments and U.S. government securities
We cannot currently determine with absolute
certainty how we will use the proceeds from this offering. As a result, our management will retain broad discretion in the allocation
and use of the net proceeds from this offering. We will pay all of the costs associated with registering the securities covered
by this prospectus.
DILUTION
If you invest in our common stock, your
interest will be diluted immediately to the extent of the difference between the exercise price and the adjusted net tangible book
value per share of our common stock after this offering.
Our net tangible book value on June
30, 2015 was approximately $(13.7) million, or $(0.19) per share. “Net tangible book value” is total assets minus
the sum of liabilities and intangible assets. “Net tangible book value per share” is net tangible book value
divided by the total number of shares outstanding.
After giving effect to the sale of
7,029,808 shares of common stock to investors exercising warrants for cash at $1.75 per share our as adjusted net tangible
book value as of June 30, 2015 would have been approximately $(1.4) million, or $(0.02) per share of common stock. This represents
an immediate increase in net tangible book value of $0.17 per share to our existing stockholders and an immediate dilution in
net tangible book value of $1.73 per share to investors exercising the warrants at a price of $1.75 per share. The following
table illustrates this dilution per share to investors participating in this offering:
Exercise price per share |
|
|
|
|
|
$ |
1.75 |
|
Net tangible book
value per share as of June 30, 2015 |
|
$ |
(0.19 |
) |
|
|
|
|
Increase in net tangible book value per share attributable to new investors in this offering |
|
$ |
0.17 |
|
|
|
|
|
As adjusted net tangible book value per share after giving effect to this offering |
|
|
|
|
|
$ |
(.02 |
) |
Dilution per share to new investors |
|
|
|
|
|
$ |
1.73 |
|
The above illustration of dilution per
share to investors participating in this offering assumes no exercise of outstanding options to purchase our common stock or outstanding
warrants to purchase shares of our common stock.
The above discussion and table
are based on 73,179,305 shares of our common stock outstanding as of June 30, 2015, which does not include the following, all
as of June 30, 2015:
• 7,467,762
shares issuable upon the exercise of outstanding stock options with a weighted-average exercise price of $2.01 per share;
• 2,170,466
shares of common stock which were reserved for future equity awards that may be granted in the future under our equity incentive
plans; and
• 883,779 shares
of our common stock reserved for issuance upon the exercise of outstanding warrants, each with a weighted-average exercise price
of $2.08 per share.
To the extent that any of these outstanding options or warrants
are exercised, there will be further dilution to new investors.
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.
DESCRIPTION OF CAPITAL STOCK
Authorized Capital
Our authorized capital consists
of 250 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 August 6, 2015, 88,596,568 and 88,515,086 of common stock were issued and outstanding, and no shares
of preferred stock were issued and outstanding.
Common Stock
We may issue shares of our common stock
from time to time. Holders of shares of common stock have the right to cast one vote for each share of common stock in their name
on our books, 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. Upon our liquidation, dissolution or winding up, holders of
our common stock are entitled to share ratably in all assets remaining after payment of liabilities and the liquidation preferences
of any outstanding shares of preferred stock.
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.
DESCRIPTION OF WARRANTS
Warrants
As of August 6, 2015, we had issued
and outstanding a total of 7,029,808 warrants which were issued in October 2014 as a part of a registered direct offering.
Exercisability.
Each warrant is exercisable at any time after the closing date (October 10, 2014) and expire in five years after
issuance (October 10, 2019). The warrants are exercisable, at the option of each holder, in whole or in part by delivering to
us a duly executed exercise notice and payment in full for the number of shares of our common stock purchased upon such
exercise, except in the case of a cashless exercise as discussed below.
Cashless Exercise.
The holder may exercise the warrant on a cashless basis. When exercised on a cashless basis, a portion of the warrant is cancelled
in payment of the purchase price payable in respect of the number of shares of our common stock purchasable upon such exercise.
Exercise Price.
Each warrant represents the right to purchase up to one half of a share of common stock at an exercise price of $1.75 per
share. The exercise price per share is subject to adjustment for stock dividends, distributions, subdivisions, combinations, or
reclassifications. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of the warrant
to the extent that, after giving effect to the exercise, the holder, together with its affiliates, would beneficially own in excess
of 4.99% or 9.99%, depending on the holder’s initial election, of the number of shares of our common stock outstanding immediately
after giving effect to its exercise. The holder may elect to increase or decrease this beneficial ownership limitation to any other
percentage, but not in excess of 19.9% of the total number of issued and outstanding shares of common stock (including for such
purpose the shares of common stock issuable upon such exercise), provided that any such increase or decrease will not be effective
until 61 days after such written notice is delivered.
Fundamental
Transactions. In the event we effect certain mergers, consolidations, sales of substantially all of our assets, tender or
exchange offers, reclassification or share exchange in which our common stock is effectively converted into or exchanged for
other securities, cash or property, we consummate a business combination in which another person acquires 50% of the
outstanding shares of our common stock, or any person or group becomes the beneficial owner of 50% of the aggregate ordinary
voting power represented by our issued and outstanding common stock (a “Fundamental Transaction”), then, upon any
subsequent exercise of the warrants, the holders of warrants will have the right to receive any shares of the acquiring
corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of
common stock then issuable upon exercise in full of the warrants. Except in connection with a Fundamental Transaction in
which the consideration for each share of common stock is at least 300% of the exercise price of the warrant, we or the
successor entity will, at the holder’s option, purchase the unexercised portion of the warrant from the holder (i) in
the case of an all cash transaction or a transaction in which the consideration consists partially of cash or securities of a
successor entity to the extent of the percentage of the cash consideration, for an amount of cash equal to equal to the
Black-Scholes value of the remaining unexercised portion of the warrant on the date of the consummation of the
transaction and (ii) in the case of any other Fundamental Transaction or in a transaction in which the consideration consists
partially of cash or securities of a successor entity to the extent the consideration is represented by securities, for a
number of shares of common stock equal to the Black Scholes value of the portion of the warrant subject to redemption divided
by 95% of the closing sale price of the common stock on the day preceding the date on which the Fundamental Transaction is
consummated.
Transferability.
Subject to applicable laws and restrictions, a holder may transfer a warrant upon surrender of the warrant to us with a completed
and signed assignment in the form attached to the warrant. The transferring holder will be responsible for any tax that liability
that may arise as a result of the transfer.
Exchange Listing.
There is no established public trading market for the warrants, and we do not expect a market to develop. In addition, we do not
intend to apply for listing of the warrants on any securities exchange or recognized trading system.
Rights as Stockholder.
Except as set forth in the warrant, the holder of a warrant, solely in such holder’s capacity as a holder of a warrant, will
not be entitled to vote, to receive dividends, or to any of the other rights of our stockholders.
Amendments and Waivers.
The provisions of each warrant may be modified or amended or the provisions thereof waived with the written consent of us and the
holder.
PLAN OF DISTRIBUTION
The common stock referenced on the cover page of this prospectus
will be offered solely by us and will be issued and sold upon the exercise of the warrants described herein. We will deliver shares
of our common stock upon exercise of the warrants we issued in October 2014. These warrants are exercisable for a total of 7,029,808
shares of our common stock, and no more of these warrants will be issued. We will not issue fractional shares upon exercise of
these warrants. Each of these warrants contains instructions for exercise. In order to exercise any of these warrants, the holder
must deliver to us or our transfer agent the information required in the warrants, along with payment for the exercise price of
the shares of common stock to be purchased.
LEGAL MATTERS
Gracin & Marlow, LLP, New York, New
York will pass upon certain legal matters related to the issuance and sale of the warrants offered on our behalf and Parsons Behle
& Latimer, Reno, Nevada will pass upon certain legal matters relating to the issuance and sale of the common stock offered
hereby on our behalf.
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 quarterly report on Form 10-Q for
the quarter ended March 31, 2015 filed with the SEC on May 11, 2015 and our quarterly report on Form 10-Q for the quarter
ended June 30, 2015 filed with the SEC on August 10, 2015 (File No. 001-12584); |
|
• |
Our current reports on Form 8-K filed
with the SEC on January 12, 2015, March 19, 2015, May 4, 2015, May 18, 2015, June 16, 2015, July 9, 2015, July 17, 2015 and
August 10, 2015 (File No. 001-12584); |
|
• |
Our definitive proxy statement on Schedule 14A filed with the SEC on April 13, 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 and Articles
of Incorporation 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.
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. 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 | |
$ | 1,430 | |
Legal fees and expenses | |
| 10,000 | |
Accounting fees and expenses | |
| 5,000 | |
Transfer agent and registrar fees and expenses | |
| 2,000 | |
Miscellaneous | |
| 1,570 | |
| |
| | |
Total | |
$ | 20,000 | |
|
* |
These fees are estimated fees. |
|
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)). |
|
3.8 |
Certificate of Amendment to the Articles of Incorporation (Incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed May 18, 2015 (File No. 001-12584)). |
|
4.1 |
Specimen Stock Certificate evidencing shares of Common Stock (Incorporated by reference to Exhibit 4.1 of Registrant’s registration statement on Form S-3 filed on July 3, 2013 (File No. 333-189794)). |
|
4.2 |
Form of Warrant (Incorporated by reference to Exhibit 4.1 of the Registrant’s Current Report on Form 8-K filed October 10, 2014 (File No. 001-12584)). |
|
5.1(a) |
Legal opinion of Gracin & Marlow, LLP* |
|
5.1(b) |
Legal opinion of Parsons Behle & Latimer* |
|
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 Gracin & Marlow, LLP (included in Exhibit 5.1(a))* |
|
23.3 |
Consent of Parson Behle & Latimer (included in Exhibit 5.1(b))* |
|
24.1 |
Powers of Attorney for our directors (included on signature page)* |
|
*Filed herewith |
|
|
Item 17. |
Undertakings. |
(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.
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933,as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements
for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Rockville, State of Maryland, August 10, 2015.
|
|
SYNTHETIC BIOLOGICS, INC. |
|
|
|
|
|
|
|
|
By: |
/s/ Jeffrey Riley |
|
|
|
Chief Executive Officer, |
|
|
|
President and Director |
|
|
|
(Principal Executive Officer) |
|
|
By: |
/s/ Steven A. Shallcross |
|
|
|
Chief Financial Officer |
|
|
|
|
(Principal Financial and Accounting Officer) |
|
POWER OF ATTORNEY
We, the undersigned hereby severally constitute
and appoint each of Jeffrey Riley and Steven A. Shallcross 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 |
|
Chief Executive Officer, |
|
|
Jeffrey Riley |
|
President and Director |
|
August 10, 2015 |
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
/s/ Steven A. Shallcross |
|
Chief Financial Officer |
|
|
Steven A. Shallcross |
|
(Principal Financial and Accounting Officer) |
|
August 10, 2015 |
|
|
|
|
|
/s/ Jeffrey J. Kraws |
|
Chairman |
|
August 10, 2015 |
Jeffrey J. Kraws |
|
|
|
|
|
|
|
|
|
/s/ Scott L. Tarriff |
|
Director |
|
August 10, 2015 |
Scott L. Tarriff |
|
|
|
|
|
|
|
|
|
/s/ Jeffrey Wolf |
|
Director |
|
August 10, 2015 |
Jeffrey Wolf |
|
|
|
|
EXHIBIT 5.1(a)
GRACIN & MARLOW, LLP.
The Chrysler Building
405 Lexington Avenue, 26th Floor
New York, New York 10174
Telephone (212) 907-6457
Facsimile: (212) 208-4657
August 10, 2015
The Board of Directors
Synthetic Biologics, Inc.
155 Gibbs Street, Suite 412
Rockville, MD 20850
|
Re: |
Synthetic Biologics, Inc. Form S-3 |
Gentlemen:
We have acted as 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 ”), covering the offer and sale of the following
securities warrants to purchase 7,029,808 shares of common stock, par value $0.001 per share (the “Common Stock”),
of the Company that were issued to the investors pursuant to subscription agreements dated October 10, 2014 (the “Warrants”),
as well as the shares of Common Stock issuable upon exercise of the Warrant (the “Warrant Shares”).
This opinion is being
furnished in connection with the requirements of Item 601(b)(5) of Regulation S-K under the Act.
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 laws of the State of New York, and we express
no opinion with respect to the applicability thereto, or the effect thereon, of the laws of any other jurisdiction any other laws,
or as to any matters of municipal law or the laws of any local agencies within any state.
Subject to the foregoing
and the other matters set forth herein, it is our opinion that, as of the date hereof:
The Warrants constitute
a valid and binding agreement of the Company enforceable against the Company in accordance with its terms, subject to applicable
bankruptcy, insolvency, fraudulent conveyance, moratorium and similar laws affecting creditors’ rights generally and equitable
principles of general applicability.
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 Securities Act of 1933, as amended (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 the prospectus
that forms a part of the Registration Statement under the heading “Legal Matters.” 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, |
|
|
|
|
|
/s/ Gracin & Marlow, LLP |
|
|
Gracin & Marlow, LLP |
|
EXHIBIT 5.1(b)
August 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 August 10, 2015 |
Gentlemen:
We have acted as 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 ”), covering the offer and sale of the following
securities warrants to purchase 7,029,808 shares of common stock, par value $0.001 per share (the “Common Stock”),
of the Company that were issued to the investors pursuant to subscription agreements dated October 10, 2014 (the “Warrants”),
as well as the shares of Common Stock issuable upon exercise of the Warrant (the “Warrant Shares”).
This opinion is being
furnished in connection with the requirements of Item 601(b)(5) of Regulation S-K under the Securities Act of 1933, as amended
(the “Act”), and no opinion is expressed herein as to any matter pertaining to the contents of the Registration
Statement or the prospectus that forms a part of the Registration Statement (the “Prospectus”), other
than as expressly stated herein with respect to the issuance of the Warrants and the Warrant Shares. In that regard, our opinion
is limited to issuances of the Warrant Shares, since the Company has obtained the opinion of a different firm with respect to the
Warrants..
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.
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 Registration Statement, and upon such other documents as in our judgment are necessary or appropriate to enable us to render
the opinions expressed herein.
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 Warrants and the Warrant
Shares 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 Securities Act and comply
with all applicable laws at the time the Warrant Shares are offered or issued as contemplated by the Registration Statement; (ii)
if required by law, an appropriate prospectus supplement, free writing prospectus or term sheet relating to the Warrant Shares
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 Warrant Shares are offered or issued as contemplated by the Registration Statement; (iii) all Warrant Shares 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 any applicable prospectus supplement; (iv) any purchase, underwriting,
warrant, deposit, unit or similar agreement (collectively the “Securities Agreements”) relating to the Warrant Shares
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:
The Warrant Shares,
when issued and sold by the Company and delivered by the Company upon valid exercise thereof and against receipt of the exercise
price therefor, in accordance with and in the manner described in the Registration Statement and the Warrants, will be validly
issued, 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.” 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 |
|
August 10, 2015 |
|
Synthetic Biologics (AMEX:SYN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Synthetic Biologics (AMEX:SYN)
Historical Stock Chart
From Jul 2023 to Jul 2024