Full Press Release Details
Synthetic Biologics Reports Third Quarter
2015 Financial Results and Operational Highlights
-- Initiated Phase 2b Proof-of-Concept
Clinical Trial for the Prevention of C. difficile Infection and
Antibiotic Associated Diarrhea --
-- Initiated Second Phase 2 Clinical
Trial to Evaluate the Sustainability of Reduced Methane Production in
Patients with Irritable Bowel Syndrome with Constipation
-- Conference Call Today, November
5, 2015, at 4:30 p.m. EST --
MD, November 5, 2015 - Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical-stage
company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported financial
results for the three and nine months ended September 30, 2015, and provided an operational update.
"Phase 2 clinical trials for our
two lead gut microbiome-focused drug candidates are ongoing and demonstrate the achievement of important milestones for Synthetic
Biologics," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "During the third quarter, we initiated
the Phase 2b proof-of-concept clinical trial to evaluate the effectiveness of SYN-004 to protect the gut microbiome from the effects
of certain commonly used intravenous beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated
diarrhea. We also initiated the second Phase 2 clinical trial for SYN-010 to evaluate its ability to sustain reduced levels of
methane in the gut of breathe-methane positive patients with irritable bowel syndrome with constipation, and to assess key clinical
outcomes including the frequency of complete spontaneous bowel movements, abdominal pain and bloating."
Mr. Riley concluded, "We look forward
to reporting the progress of our gut microbiome-focused Phase 2 clinical trials for SYN-004 and SYN-010, and anticipate reporting
topline results from both programs by the end of this year."
Clinical Program Progress
Prevention of C. difficile infection
and antibiotic-associated diarrhea (AAD) - SYN-004:
Treatment of irritable bowel syndrome
with constipation (IBS-C) - SYN-010:
TrimestaTM, an oral estriol
drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS:
A separate UCLA-led, multi-center U.S. Phase 2 trial is underway focused exclusively on cognition utilizing Trimesta with a variety
of currently marketed MS drugs
Pertussis (whooping cough) -
Phenylketonuria (PKU) - SYN-200:
Three and Nine Months Ended September
30, 2015 Financial Results
and administrative expenses increased to $1.6 million and $5.5 million for the three and nine months ended September 30, 2015,
respectively, compared to $1.2 million and $4.2 million for the same periods in 2014. The increases of approximately 32% and 33%
for the three and nine months ended September 30, 2015, respectively, are primarily the result of increased legal fees
associated with SEC filings and collaborative agreements. Non-cash charges related to stock-based
compensation were $387,000 and $1.3 million for the three and nine months ended September 30, 2015, respectively, compared to
$377,000 and $1.3 million for the same periods in 2014.
and development expenses increased to $10.0 million and $24.0 million for the three and nine months ended September 30, 2015,
respectively, compared to $3.7 million and $9.2 million for the same periods in 2014. The increases of approximately 172% and
160% for the three and nine months ended September 30, 2015, respectively, are primarily the result of increased program costs
associated with expanded clinical development, manufacturing and research activities for our gut microbiome-focused pipeline,
including the C. difficile prevention and IBS-C programs. During the three months ended September 30, 2015, the
Company entered into an ECC with Intrexon Corporation for the development of a treatment for patients with PKU; 937,500 shares
of common stock were issued to Intrexon Corporation as payment of the technology access fee that resulted in a non-cash charge
of $3.0 million. Non-cash charges related to stock-based compensation were $259,000 and $757,000
for the three and nine months ended September 30, 2015, respectively, compared to $232,000 and $550,000 for the same periods in
Other income was $4.1 million for the
three months ended September 30, 2015, compared to $1,000 for the same period in 2014. This increase was primarily the result
of non-cash income of $4.1 million related to the change in fair market value of warrants due to the decrease in the stock price
from the previous quarter. Other expense was $3.9 million for the nine months ended September 30, 2015, compared to other income
of $97,000 for the same period in 2014. This decrease was primarily the result of non-cash expense of $3.9 million related to
the change in fair market value of warrants due to the increase in the stock price from December 31, 2014. There was no non-cash
income or expense relating to fair value warrants for the three and nine months ended September 30, 2014.
Cash and cash equivalents as of September
30, 2015 were $31.8 million.
Synthetic Biologics will hold a conference
call today, Thursday, November 5, 2015, at 4:30 p.m. EST. The dial-in information for the call is as follows: U.S. toll
free: 1-888-347-5280 and International: +1 412-902-4280.
Participants are asked to dial in 15 minutes
before the start of the call to register. The call will also be webcast over the Internet at https://www.webcaster4.com/Webcast/Page/1096/11196.
An archive of the call will be available for approximately 90 days at the same URL https://www.webcaster4.com/Webcast/Page/1096/11196,
beginning approximately one hour after the call's conclusion.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN)
is a clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The
Company's lead candidates in Phase 2 development include: (1) SYN-004 which is designed to protect the gut microbiome from the
effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated
diarrhea (AAD), and (2) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to
treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a Phase
2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and in collaboration
with Intrexon Corporation (XON), a preclinical stage monoclonal antibody for the prevention and treatment of Pertussis and discovery
stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics' website
release includes forward-looking statements on Synthetic Biologics' current expectations and projections about future events.
In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential,"
"continue," "expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions
and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding
anticipated timing of reporting topline results from both the SYN-004 and SYN-010 programs, anticipated number of
patients and sites for the SYN-004 Phase 2b clinical trial, continued enrollment in the Phase 2a SYN-004 clinical trial, and expected
timing of the reporting of topline MRI data. Important factors that could cause actual results
to differ materially from those reflected in Synthetic Biologics' forward-looking statements include, among others, a failure
to receive the necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, a failure of Synthetic
Biologics' clinical trials, and those conducted by investigators, to be commenced or completed on time or to achieve desired
results, a failure of Synthetic Biologics' clinical trials to receive anticipated funding, a failure of Synthetic Biologics'
products for the prevention and treatment of diseases to be successfully developed or commercialized, Synthetic Biologics'
inability to maintain its licensing agreements, a failure to successfully integrate new management and other factors described
in Synthetic Biologics' report on Form 10-K for the year ended December 31, 2014 and any other filings with the SEC.
The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation
to update any forward-looking statements contained in this release on account of new information, future events, or otherwise,
except as required by law.
For further information, please contact:
Synthetic Biologics:
Kris Maly, Vice President, Corporate Communication,