Full Press Release Details
Synthetic Biologics Reports Second Quarter
2015 Financial Results and Operational Highlights
- Achieved Planned Milestones for
Company's Lead Microbiome Drug Candidates -
- Enhanced Senior Management Team
to Maximize Strategic Opportunities -
- Strengthens Balance Sheet to Support
Microbiome Clinical Trials -
- Conference Call Today, August 10,
2015, at 8:30 a.m. EDT -
MD, August 10, 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 six months ended June 30, 2015, and provided an operational update.
"We continue to successfully execute
against our planned milestones and are encouraged by the progress of our two lead microbiome drug candidates," said Jeffrey
Riley, Chief Executive Officer. "We initiated Phase 2a clinical trials for 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). We also initiated a Phase 2 clinical trial for SYN-010 to evaluate the efficacy in reducing
the production of methane in the gut which is perceived as the underlying cause of pain, bloating and constipation associated with
irritable bowel syndrome and constipation (IBS-C)."
Mr. Riley added, "This continued
progress combined with investor interest related to the microbiome enabled us to strengthen our balance sheet with net proceeds
of $42.6 million in a successful July public offering. Our increased cash position provides resources to support our lead microbiome
drug candidates' continued progress in the clinic. And, with the recent additions of industry veterans with proven track
records to our management team, we are better positioned to develop operational and commercial strategies as we navigate through
clinical trials. Looking ahead, we feel confident that we will achieve our milestones and look forward to reporting important microbiome
program developments including, topline data from the two SYN-004 Phase 2a trials and topline data from the first SYN-010 Phase
2 trial. Accomplishing each of these milestones would position us to create value for our shareholders while we work to address
significant unmet medical needs with our novel microbiome drug candidates."
Clinical Program Progress
Prevention of C. difficile infection
TrimestaTM, an oral estriol
drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS:
Pertussis (whooping cough) - SYN-005:
Operational Update - Expanded
Three and Six Months Ended June 30,
2015 Financial Results
and administrative expenses increased to $2.2 million and $3.9 million for the three and six months ended June 30, 2015, respectively,
compared to $1.8 million and $2.9 million for the same periods in 2014. The increase of approximately 22% for the three months
ended June 30, 2015 is primarily the result of increased employee costs and legal fees, offset by a decrease in stock-based
compensation expense. The increase of approximately 34% for the six months ended June 30, 2015
is primarily the result of increased employee costs, legal fees and audit fees related to the additional procedures required under
the accelerated filer status. Non-cash charges related to stock-based compensation were $335,000 and $915,000 for the three and
six months ended June 30, 2015, respectively, compared to $645,000 and $899,000 for the same periods in 2014.
Research and development expenses increased
to $7.5 million and $14.0 million for the three and six months ended June 30, 2015, respectively, compared to $2.8 million and
$5.6 million for the same periods in 2014. The increases of approximately 165% and 152% for the three and six months ended June
30, 2015, respectively, are primarily the result of increased program costs associated with expanded clinical development, manufacturing
and research activities for our microbiome-focused pipeline, including the Company's C. difficile and IBS-C programs.
For the six months ended June 30, 2015, research and development expenses also include a $1.0 million expense for achieving the
third milestone as set forth in the Asset Purchase Agreement with Prev ABR LLC, dated November 28, 2012, related to the C. difficile
program. Prev ABR LLC exercised its option to receive the milestone payments in shares of Synthetic Biologics' common stock
that were issued in April 2015. Non-cash charges related to stock-based compensation were $252,000 and $498,000 for the three and
six months ended June 30, 2015, respectively, compared to $210,000 and $318,000 for the same periods in 2014.
Other expense was $3.9 million and $8.0
million for the three and six months ended June 30, 2015, respectively, compared to other income of $95,000 and $96,000 for the
same periods in 2014. Other expense for the three and six months ended June 30, 2015 was primarily the result of a non-cash charge
of $3.9 million and $8.0 million, respectively, related to the change in fair value of warrants due to the increase in the stock
price from the previous quarter. There was no non-cash income or expense relating to fair value warrants for the three and six
months ended June 30, 2014.
cash equivalents at June 30, 2015 was $4.8 million. Subsequent to the end of the second quarter, a public offering was completed
for net proceeds of approximately $42.6 million. The strengthened balance sheet provides the Company with the resources to fund
its clinical development programs.
Synthetic Biologics will hold a conference
call today, Monday, August 10, 2015, at 8:30 a.m. EDT. 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/1096/9809.
An archive of the call will be available for approximately 90 days at the same URL, https://www.webcaster4.com/Webcast/Page/1096/9809,
beginning approximately one hour after the call's conclusion.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN)
is a microbiome-focused, clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific
diseases. The Company's lead candidates in Phase 2 development include 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 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, 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 a monoclonal antibody combination for the treatment of Pertussis. For more information, please visit Synthetic Biologics'
website at www.syntheticbiologics.com.
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 the
timing of planned Phase 2 clinical trials and expected date of data from clinical trials, continued successful execution against
planned milestones, expected achievement of milestones and impact of achievement of milestones. 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, VP, Corporate
Communication, (734) 332-7800, info@syntheticbiologics.com