Synthetic Biologics Reports First Quarter 2014 Financial Results and
-- Conference Call Today, May 15, 2014, at 8:30 a.m. (EDT) --
ROCKVILLE, Md., May 15, 2014
ROCKVILLE, Md., May 15, 2014 /PRNewswire/ --Synthetic Biologics, Inc. (NYSE
MKT: SYN), a developer of novel anti-infective biologic and drug candidates
targeting specific pathogens that cause serious infections and diseases, today
reported financial results for the three months ended March 31, 2014, and
provided an operational progress update.
Synthetic Biologics, Inc. Logo.
Recent Operational Highlights
Prevention of C. difficile (C. diff.) Infections – SYN-004 Oral Enzyme
SYN-004, Synthetic Biologics' lead anti-infective product candidate, is
believed to be the first and only therapy designed to neutralize intravenous
(IV) antibiotics in the gut. It is intended to protect and maintain the
balance of bacterial flora in the gastrointestinal tract, to potentially
prevent the devastating effects of C. diff. The U.S. Centers for Disease
Control and Prevention (CDC) has classified C. diff as an "urgent public
health threat"[i], surpassing Methicillin-resistant Staphylococcus aureus
(MRSA) as the number one hospital-acquired infection in the United States. C.
diff is a multidrug-resistant bacterium that infects 1.1 million U.S. patients
oSynthetic Biologics plans to initiate a 28-day bridging toxicology study
next month, followed by the filing of an IND (Investigational New Drug)
oThe Company expects to initiate Phase Ia and Ib clinical trials in the
second half of 2014, with preliminary topline data expected by year-end
2014. A Phase II efficacy study is expected to begin in the first half of
ocGMP manufacturing is currently underway to support these preclinical and
clinical SYN-004 studies.
oSynthetic Biologics added international patents providing composition of
matter coverage for various aspects of the C. diff program. These new
patents strengthen the Company's C. diff IP portfolio, which now includes
over 25 issued U.S. and international patents.
Pertussis (Whooping Cough) – SYN-005 Monoclonal Antibody (mAb) Combination
SYN-005, a unique combination of two humanized antibodies designed to
neutralize pertussis toxin, a major cause of Pertussis-mediated infant
morbidity and mortality, is being developed under an exclusive channel
collaboration with Intrexon Corporation (NYSE: XON), and Synthetic Biologics'
academic collaborator, The University of Texas at Austin. Despite widespread
vaccination, Pertussis rates in the United States continue to rise steadily,
and according to the World Health Organization, B. pertussis infection causes
an estimated 300,000 deaths worldwide each year, primarily among young,
oPositive preclinical data from two non-human primate studies was reported,
supporting the association of SYN-005 with favorable decreases in white
blood cell counts within two days and achievement of nearly normal levels
within one week.
oSynthetic Biologics expects to start a Phase I clinical trial during the
first quarter of 2015, after filing an IND based on non-human-primate and
murine findings. Topline data is expected to be available within
approximately 90 days of the start of the trial. This is expected to be
followed by a Phase II trial, with topline results expected in the second
half of 2015.
oAn additional patent application around pertussis antibodies has been
filed and the Company is finalizing plans for cGMP manufacturing of
oThe Company intends to request Orphan Drug designation for SYN-005 for the
treatment of Pertussis.
Constipation-Predominant Irritable Bowel Syndrome (C-IBS) – SYN-010 Oral
Dr. Mark Pimentel, M.D., of Cedars-Sinai Medical Center (CSMC), led the
investigational team whose critical discoveries into the underlying cause of
gas, pain and constipation associated with C-IBS established the foundation of
Synthetic Biologics' C-IBS program, and are the basis for developing an oral
treatment to reduce the impact of methane-producing organisms on conditions
such as C-IBS. Of the 40 million IBS patients in the United States[iii],
approximately 13.2 million have C-IBS[iv].
oSynthetic Biologics expects to initiate a Phase II clinical trial of
SYN-010 in C-IBS during the second half of 2014 under a corporate IND,
with topline data expected during mid-2015.
oSynthetic Biologics formed a Clinical Advisory Board (CAB) to support
development of its C-IBS program, appointing Dr. Mark Pimentel as
Chairman. The CAB is in the process of expanding with the addition of
other prominent thought leaders and researchers.
Relapsing-Remitting Multiple Sclerosis (RRMS) – Trimesta™ (oral estriol)
Trimesta's differentiated mechanism of action, combined with the convenience
of once-daily oral dosing, potentially make it an ideal added therapy to
address this underserved $14.1 billion worldwide market[v]. Based on previous
research findings,[vi] Trimesta may offer both inflammatory and
neuroprotective benefits for patients with MS when taken in combination with
Copaxone®. Available MS therapies demonstrate anti-inflammatory and/or
immunomodulatory responses but they are not considered neuroprotective.
oLead investigator Rhonda Voskuhl, M.D. from the University of California,
Los Angeles (UCLA) David Geffen School of Medicine, presented topline
efficacy and safety results from the investigator-initiated Phase II trial
evaluating adjunctive Trimesta in women with RRMS at the American Academy
of Neurology's Annual Meeting.
oThe UCLA-led Phase II study was designed to show statistical
significance at 12 months for the MS relapse rate reduction in
patients treated with Trimesta plus Copaxone compared to patients
given placebo plus Copaxone. The trial was only powered to trend
toward statistical significance at the 24-month time point.
oAccording to the protocol, the results of topline data demonstrate
that Trimesta met the pre-specified goal of the study with rapid
onset of activity observed for Trimesta plus Copaxone compared to
placebo plus Copaxone.
oThe burden is so high for showing efficacy as an adjunctive therapy,
on top of an already effective standard of care, Dr. Voskuhl and her
team hoped to see an approximately 29% reduction in MS relapse rate,
per the study protocol. Impressively, a statistically significant 47%
decrease in relapse rate was observed at 12 months of therapy
(p-value = 0.03 / powered for significance level of 0.05), as well as
a clear trend toward a 32% reduction at 24 months (p-value = 0.15 /
powered for significance level of 0.10), which far surpassed the
oThe Trimesta study also demonstrated a clinically significant
near-normalization of cognitive scores at 12 months of therapy in
women taking Trimesta plus Copaxone. This outcome is of high
importance for MS specialists and patients and we believe it is the
result of oral estriol's unique neuroprotective effect.
oIn addition, adjunctive oral Trimesta plus injectable standard of
care Copaxone was generally safe and well tolerated by women in the
oBy demonstrating the therapeutic potential and safety of Trimesta in the
Phase II exploratory trial, Synthetic Biologics achieved a key goal of the
Trimesta program -- providing further support to enable the Company to
attract a strategic partner to accelerate development of this innovative
therapy for MS.
oA separate ongoing Phase II trial utilizing Trimesta with a variety of
currently marketed MS drugs, including Copaxone®, Avonex^®, Betaseron^®,
Extavia^®, Rebif^®, Gilenya®, Aubagio® and Tecfidera®, is focused
exclusively on cognition and is currently enrolling patients at 4 sites in
the United States.
"Synthetic Biologics' fundamental business mission is to develop novel
anti-infectives to address significant unmet medical needs. We have built a
strong pipeline of innovative anti-infective biologic and drug candidates, and
we are committed to advancing these programs through preclinical studies,
toward human clinical development," stated Jeffrey Riley, CEO of Synthetic
Biologics. "We are on track to meet our goal of moving three anti-infective
programs into the clinic during the coming 12 months. We look forward to
reporting the progress of our anti-infective programs, and updating
shareholders on our discussions with potential MS partners."
Three Months Ended March 31, 2014 Financial Results
General and administrative expenses were $1.1 million for both the three
months ended March 31, 2014 and March 31, 2013. Charges related to stock-based
compensation were $255,000 for the three months ended March 31, 2014, compared
to $353,000 for the same period in 2013.
Research and development expenses increased to $2.7 million for the three
months ended March 31, 2014, compared to $1.1 million for the same period in
2013. The increase of 143% is primarily the result of increased program costs
associated with expanded research, development and manufacturing activities
within our anti-infective pipeline, including the Company's C. diff, C-IBS and
Pertussis programs. Charges related to stock-based compensation were $107,000
for the three months ended March 31, 2014, compared to $104,000 for the same
period in 2013.
Other income was $1,000 for the three months ended March 31, 2014, compared to
$12,000 for the same period in 2013.
Synthetic Biologics will hold a conference call today, Thursday, May 15, 2014,
at 8:30 am EDT. During the call, Jeffrey Riley, Synthetic Biologics' Chief
Executive Officer, will provide an update of the Company's anti-infective drug
pipeline for serious infections and diseases, including the prevention of C.
difficile infections, reducing the impact of methane producing organisms on
constipation-predominant irritable bowel syndrome (C-IBS) and the treatment of
Pertussis, as well as its multiple sclerosis program. C. Evan Ballantyne,
Synthetic Biologics' Chief Financial Officer, will review the Company's
financial results for the three months ended March 31, 2014.
Interested parties should call 1-877-870-4263 (U.S. toll free), 1-855-669-9657
(Canada toll free), or +1 412-317-0790 (International), fifteen minutes before
the start of the call to register. Registered callers on the toll free line
may ask to be placed in the queue for the Question & Answer Session. The call
will also be webcast over the Internet at
http://www.videonewswire.com/event.asp?id=99332. If you are unable to
participate during the live conference call, the webcast will be available for
replay at the same URL, http://www.videonewswire.com/event.asp?id=99332, for
30 days after the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused
on the development of novel anti-infective biologic and drug candidates
targeting specific pathogens that cause serious infections and diseases. The
Company is developing an oral treatment to reduce the impact of methane
producing organisms on constipation-predominant irritable bowel syndrome
(C-IBS), an oral biologic to protect the gastrointestinal microflora from the
effects of IV antibiotics for the prevention of Clostridium difficile (C.
difficile) infection, a series of monoclonal antibodies for the treatment of
Pertussis and Acinetobacter infections, and a biologic targeted at the
prevention and treatment of a root cause of a subset of IBS. In addition, the
Company is developing an oral estriol drug for the treatment of
relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS.
For more information, please visit Synthetic Biologics' website at
Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
This 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 advancing Synthetic Biologics' clinical
programs, Synthetic Biologics' opportunities and its position in the
infectious disease market, the anticipated timing and results of the Synthetic
Biologics' clinical trials and development efforts and the expected size of
the future market for sales of Synthetic Biologics' therapies. The
forward-looking statements are subject to risks and uncertainties that could
cause actual results to differ materially from those set forth or implied by
any forward-looking statements. 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' monoclonal antibodies
for the treatment of infectious diseases to be successfully developed or
commercialized, Synthetic Biologics' inability to maintain its licensing
agreements, or a failure by Synthetic Biologics or its strategic partners to
successfully commercialize products and other factors described in Synthetic
Biologics' report on Form 10-K for the year ended December 31, 2013 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
Synthetic Biologics, Inc. and Subsidiaries
(in thousands, except share and per share amounts)
Condensed Consolidated Balance
March 31, December 31,
Cash and cash equivalents $ 11,155 $ 14,625
Prepaid expenses and other 1,332 1,591
Property and equipment, net 38 37
Deposits and other assets 6 4
Total Assets $ 12,531 $ 16,257
Liabilities and Equity
Current liabilities $ 773 $ 1,027
Synthetic Biologics, Inc. and 11,758 15,230
Total Liabilities and Equity $ 12,531 $ 16,257
Condensed Consolidated Statements
For the three months ended
Operating Costs and Expenses
General and administrative $ 1,122 $ 1,122
Research and development 2,717 1,118
Total Operating Costs and Expenses 3,839 2,240
Loss from Operations (3,839) (2,240)
Interest income 1 11
Other income - 1
Total Other Income, net 1 12
Net Loss (3,838) (2,228)
Net Loss Attributable to - -
Net Loss Attributable to Synthetic
Biologics, Inc. and $ (3,838) $ (2,228)
Net Loss Per Share - Basic and $ $ (0.05)
Net Loss Per Share Attributable to $
Synthetic Biologics, Inc. (0.07) $ (0.05)
Weighted average number of common
outstanding - Basic and Dilutive 58,324,260 44,601,396
[i] U.S. Centers for Disease Control Web site:
Accessed: March 26, 2014.
[ii] 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.
[iii] GlobalData EPI Database Report – Prevalent Cases, March 2014.
[iv] American College of Gastroenterology website:
Accessed: May 14, 2014.
[v] Credit Suisse. Multiple Sclerosis-Evolution or Revolution Report. March
[vi] Sicotte, NL, et al. Treatment of Multiple Sclerosis with the Pregnancy
Hormone Estriol. Ann Neurol 2002; 52:421–428.
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Contact: Synthetic Biologics, Inc.: Kris Maly, VP, Corporate Communication,
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Investors: Joshua Drumm, Ph.D., Tiberend Strategic Advisors, Inc., (212)
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