ROCKVILLE, Md., May 11, 2015 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a microbiome-focused,
clinical-stage company developing therapeutics to protect the
microbiome while targeting pathogen-specific diseases, reported
financial results for the three months ended March 31, 2015, and provided an operational
update.
"We've made great progress during the first quarter of 2015,"
said Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics. "We've advanced our C.
difficile program into Phase 2 clinical trials, plan to
initiate Phase 2 clinical trials for our irritable bowel syndrome
with constipation (IBS-C) program before the end of June, and
expect to have Phase 2 data from both programs focused on
protecting the microbiome by year end. Due to the nature of these
microbiome programs, the time spent in the clinic is less than the
typical drug development program, and we are positioned to create
value for our shareholders at multiple points during the remainder
of 2015."
Mr. Riley added, "We've recently expanded our leadership team
with the appointment of Steve
Shallcross as our Chief Financial Officer beginning
June 1st, and Maureen Early joining the team in the newly
created position of Vice President, Commercial. We are very
optimistic about the potential of Synthetic Biologics to meet unmet
medical needs while generating significant returns for our
shareholders."
Clinical Programs Update
Prevention of C. difficile infection – SYN-004:
- Completed Phase 1a and 1b clinical trials; reported positive
topline safety and tolerability data from both studies
- Reported positive pharmacokinetic (PK) results from both the
Phase 1a and 1b clinical trials, with supportive evidence for no
active enzyme absorption into bloodstream observed
- Initiated a Phase 2a clinical trial to evaluate
gastrointestinal (GI) antibiotic-degrading effects and safety
- Presenting poster of late-breaking preclinical data for
protection of microbiome at Digestive Disease Week®
(May 2015)
- Presenting poster of clinical data for protection of microbiome
at American Society of Microbiology 2015 (June 2015)
- Expect topline data from Phase 2a clinical trial (2Q 2015)
- Plan to initiate a Phase 2b proof-of-concept clinical trial (2H
2015); expect topline data (2H 2015)
IBS-C – SYN-010:
- Poster presentation of preclinical data by lead principal
investigator of Cedars-Sinai Medical Center at Digestive Disease
Week® (May 2015)
- Expect to submit an Investigational New Drug (IND) application
to initiate clinical trials (2Q 2015)
- Plan to initiate Phase 2 clinical trials (2Q 2015); expect
topline data (2H 2015)
Pertussis (whooping cough) – SYN-005:
- Presented two posters at ECCMID 2015 (European Congress of
Clinical Microbiology and Infectious Diseases) that highlighted
positive preclinical data regarding the monoclonal antibody
combination, SYN-005, for the treatment and prophylaxis of whooping
cough
- Seeking non-dilutive funding to support preclinical and
clinical development (ongoing)
RRMS – Trimesta™:
- MRI brain scan analyses underway by University of California, Los Angeles (UCLA) to evaluate changes in the brain that
correlate with improvements seen in clinical outcomes; topline data
expected from UCLA (2Q 2015)
- As previously disclosed, active discussions with a number of
potential strategic partners may accelerate development of
Trimesta, pending data from UCLA
(ongoing)
- A separate multi-center U.S. Phase 2 trial is underway focused
exclusively on cognition utilizing Trimesta with a variety of
currently marketed MS drugs
Three Months Ended March 31,
2015 Financial Results
General and administrative expenses increased to $1.7 million for the three months ended
March 31, 2015, compared to
$1.1 million for the same period in
2014. This increase of approximately 53% is primarily the result of
increased employee costs, audit fees related to the additional
procedures required under the accelerated filer status and stock
compensation expense for the three months ended March 31, 2015. Non-cash charges related to
stock-based compensation were $582,000 for the three months ended March 31, 2015, compared to $255,000 for the same period in 2014.
Research and development expenses increased to $6.5 million for the three months ended
March 31, 2015, compared to
$2.7 million for the same period in
2014. This increase of approximately 139% is primarily the result
of increased program costs associated with expanded clinical
development, manufacturing and research activities within our
pathogen-specific, microbiome-focused pipeline, including the
Company's C. difficile, IBS-C and Pertussis programs.
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, issued in April
2015. Non-cash charges related to stock-based compensation
were $246,000 for the three months
ended March 31, 2015, compared to
$107,000 for the same period in
2014.
Other expense was $4.2 million for
the three months ended March 31,
2015, compared to other income of $1,000 for the same period in 2014. Other expense
for the three months ended March 31,
2015 is primarily the result of a non-cash charge of
$4.2 million related to the change in
fair value of warrants. The increase in the fair value of the
warrants was due to the increase in the stock price from the
previous period. There was no non-cash income or expense relating
to fair value warrants for the three months ended March 31, 2014.
Cash at March 31, 2015 was
$12.0 million compared to
$17.5 million at December 31, 2014.
Conference Call
Synthetic Biologics will hold a conference call today,
Monday, May 11, 2015, at 4:30 p.m. EDT. The dial-in information for the
call is as follows: U.S. toll free: 1-888-347-5280, Canada toll free: 1-855-669-9657 and
International: +1 412-902-4280.
Participants are asked to dial in 15 minutes before the start of
the call to register. Registered callers 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=102272.
An archive of the call will be available for approximately 90
days at the same URL,
http://www.videonewswire.com/event.asp?id=102272, 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 is developing an oral
biologic to protect the gut microbiome from intravenous (IV)
antibiotics for the prevention of C. difficile infection and
an oral statin treatment to reduce the impact of methane producing
organisms on irritable bowel syndrome with constipation (IBS-C). In
addition, the Company is developing a monoclonal antibody
combination for the treatment of Pertussis in collaboration with
Intrexon Corporation (NYSE: XON), and a Phase 2 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.
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 the planned Phase 2
clinical trials, expected date of data from clinical trials and the
expected date of submission of IND application for SYN-010. 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' 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.
- Financial Tables Follow -
|
Synthetic
Biologics, Inc. and Subsidiaries
|
|
|
(in thousands,
except share and per share amounts)
|
|
|
|
|
Condensed
Consolidated Balance Sheets
|
|
|
March
31,
2015
|
|
December 31,
2014
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
12,049
|
|
$
17,525
|
Prepaid
expenses and other current assets
|
1,574
|
|
1,548
|
Property
and equipment, net
|
75
|
|
65
|
Deposits
and other assets
|
18
|
|
6
|
Total
Assets
|
$
13,716
|
|
$
19,144
|
Liabilities and
Equity (Deficit)
|
|
|
|
Current
liabilities
|
$
15,341
|
|
$
9,588
|
Synthetic Biologics, Inc. and subsidiaries equity
(deficit)
|
(1,625)
|
|
9,556
|
Total Liabilities
and Equity
|
$
13,716
|
|
$
19,144
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
(Unaudited)
|
|
|
|
|
For the three
months ended March 31,
|
|
|
2015
|
|
2014
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
1,713
|
|
$
1,122
|
Research
and development
|
|
6,494
|
|
2,717
|
Total Operating
Costs and Expenses
|
|
8,207
|
|
3,839
|
Loss from
Operations
|
|
(8,207)
|
|
(3,839)
|
Other Income
(Expense)
|
|
|
|
|
Change
in fair value of warrant liability
|
|
(4,152)
|
|
-
|
Interest
income
|
|
1
|
|
1
|
Total Other
Income, net
|
|
(4,151)
|
|
1
|
Net
Loss
|
|
(12,358)
|
|
(3,838)
|
Net Loss
Attributable to Non-controlling Interest
|
|
-
|
|
-
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
|
$
(12,358)
|
|
$
(3,838)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.17)
|
|
$
(0.07)
|
Net Loss Per Share
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
|
$
(0.17)
|
|
$
(0.07)
|
Weighted average
number of common shares outstanding - Basic
and Dilutive
|
|
72,673,959
|
|
58,324,260
|
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SOURCE Synthetic Biologics, Inc.