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.
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 annually[ii].
- Synthetic Biologics plans to initiate a 28-day bridging
toxicology study next month, followed by the filing of an IND
(Investigational New Drug) application.
- The 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 2015.
- cGMP manufacturing is currently underway to support these
preclinical and clinical SYN-004 studies.
- Synthetic 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, unvaccinated
infants.
- Positive 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.
- Synthetic 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.
- An additional patent application around pertussis antibodies
has been filed and the Company is finalizing plans for cGMP
manufacturing of SYN-005.
- The 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 Compound
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].
- Synthetic 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.
- Synthetic 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.
- Lead 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.
- The 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.
- According 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.
- The 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 investigator's expectations.
- The 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.
- In addition, adjunctive oral Trimesta plus injectable standard
of care Copaxone was generally safe and well tolerated by women in
the study.
- By 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.
- A 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.
Conference Call
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 www.syntheticbiologics.com.
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 by law.
Synthetic
Biologics, Inc. and Subsidiaries
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
Condensed
Consolidated Balance Sheets
|
|
|
|
|
March
31,
|
|
December
31,
|
|
2014
|
|
2013
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
11,155
|
|
$
14,625
|
Prepaid
expenses and other current assets
|
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 subsidiaries equity
|
11,758
|
|
15,230
|
Total Liabilities
and Equity
|
$
12,531
|
|
$
16,257
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
For the three
months ended
March 31,
|
|
2014
|
|
2013
|
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)
|
Other
Income
|
|
|
|
Interest
income
|
1
|
|
11
|
Other
income
|
-
|
|
1
|
Total Other
Income, net
|
1
|
|
12
|
Net
Loss
|
(3,838)
|
|
(2,228)
|
Net Loss
Attributable to Non-controlling Interest
|
-
|
|
-
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
$
(3,838)
|
|
$
(2,228)
|
Net Loss Per Share
- Basic and Dilutive
|
$
(0.07)
|
|
$
(0.05)
|
Net Loss Per Share
Attributable to Synthetic Biologics, Inc.
and Subsidiaries
|
$
(0.07)
|
|
$
(0.05)
|
Weighted average
number of common shares
outstanding - Basic and Dilutive
|
58,324,260
|
|
44,601,396
|
[i] U.S. Centers for Disease Control Web site:
http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf#page=51
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:
http://patients.gi.org/topics/irritable-bowel-syndrome/#tabs3
Accessed: May 14, 2014.
[v] Credit Suisse. Multiple Sclerosis-Evolution or Revolution
Report. March 18, 2013.
[vi] Sicotte, NL, et al. Treatment of Multiple Sclerosis with the
Pregnancy Hormone Estriol. Ann Neurol 2002; 52:421–428.
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