ROCKVILLE, Md., March 16, 2015 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of pathogen-specific
therapies for serious infections and diseases, with a focus on
protecting the microbiome, today reported financial results for the
year ended December 31, 2014, and
provided an operational update.
"During the past year Synthetic Biologics made important
advances in furthering our goal of building a late-stage,
pathogen-specific, microbiome-focused portfolio with strong opinion
leader support and a solid investor base," said Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics. "This year we plan to initiate Phase 2
clinical trials in two programs – SYN-004, a preventive therapeutic
for C. difficile infection, and SYN-010, a treatment for
irritable bowel syndrome with constipation (IBS-C), with topline
data expected from both programs by year end. In addition, we are
making good progress with previously reported partnering
discussions on our relapsing-remitting multiple sclerosis (RRMS)
program."
Clinical Programs Update
SYN-004 is a first-in-class oral enzyme preventive
therapy designed to protect the gut microbiome from the unintended
harmful effects of intravenous (IV) antibiotics, for the
prevention of C. difficile infection.
- Established Clinical Advisory Board and strengthened
intellectual property portfolio
- Completed Phase 1a and 1b clinical trials; reported positive
topline safety and tolerability data from both studies
- Plan to initiate a Phase 2a clinical trial to evaluate
gastrointestinal (GI) antibiotic-degrading effects and safety (1Q
2015); expect topline data (1H 2015)
- Presenting poster of late-breaking preclinical data for
protection of microbiome at Digestive Disease Week® (May 2015)
- Plan to initiate a Phase 2b proof-of-concept clinical trial (2H
2015); expect topline data (2H 2015)
SYN-010 is a proprietary, modified-release statin
formulation optimal for reducing methane-production by certain
microorganisms in the gut to treat the underlying cause of pain,
bloating, and constipation associated with IBS-C.
- Established Clinical Advisory Board and strengthened
intellectual property portfolio
- A 505(b)(2) regulatory pathway is anticipated for
development
- 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 (1H 2015)
- Plan to initiate Phase 2 clinical trials (2Q 2015); expect
topline data (2H 2015)
SYN-005 is a novel combination of two monoclonal
antibodies designed to treat Pertussis (whooping cough) by
targeting and neutralizing pertussis toxin.
- Strengthened intellectual property portfolio
- Reported positive preclinical research findings from non-human
primate studies
- Granted U.S. Orphan Drug designation by the FDA
- Seeking non-dilutive funding to support clinical development
(ongoing)
TrimestaTM (oral estriol) may offer a
differentiated mechanism of action in the treatment of RRMS,
as demonstrated in clinical trials. Based on Phase 2 clinical
findings, Trimesta may offer both anti-inflammatory (decrease in
relapse rate) and neuroprotective (improvements in disability and
cognition) benefits for patients with MS when taken in combination
with Copaxone®.
- Expanded efficacy and safety results from the
investigator-initiated Phase 2 trial evaluating adjunctive Trimesta
in women with RRMS including positive results on cognitive and
disability scores at 12 months, attesting to Trimesta's unique
neuroprotective properties, were presented at the ACTRIMS-ECTRIMS
meeting in Boston in September 2014 by the trial's lead
investigator.
- Strengthened intellectual property portfolio
- As previously disclosed, active discussions with a number of
potential strategic partners may accelerate development of Trimesta
(ongoing)
- MRI brain scan analyses underway to evaluate changes in the
brain that correlate with improvements seen in clinical outcomes;
topline data expected from the principal investigator during the
first half of 2015
- 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, including Copaxone®, Avonex®,
Betaseron®, Extavia®, Rebif®, Gilenya®, Aubagio® and
Tecfidera®
Year Ended December 31, 2014
Financial Results
General and administrative expenses were $6.0 million for the year ended December 31, 2014, compared to $5.8 million for the same period in 2013. This
increase is primarily the result of supplemental compensation
granted by the Board of Directors to executive officers and
increased stock-based compensation expense during the year ended
December 31, 2014, which was offset
by the decrease of bad debt expense of $763,000 associated with the note and interest
receivables from the sale of Adeona Clinical Laboratory that were
determined uncollectible during the year ended December 31, 2013. Non-cash charges related to
stock-based compensation were $1.6
million for the year ended December
31, 2014, compared to $1.3
million for the same period in 2013.
Research and development expenses increased to $14.5 million for the year ended December 31, 2014, compared to $6.5 million for the same period in 2013. This
increase of 123% 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. Non-cash charges
related to stock-based compensation were $803,000 for the year ended December 31, 2014, compared to $375,000 for the same period in 2013.
Other income was $718,000 for the
year ended December 31, 2014,
compared to other income of $21,000
for the same period in 2013. The increase in other income is
primarily due to non-cash income of $620,000 from the change in fair value of
warrants for the year ended December 31,
2014. The decrease in fair value of the warrants was due to
the decline in our stock price and the reduction in the time to
maturity. There was no non-cash income or expense relating to fair
value warrants for the year ended December
31, 2013.
Cash at December 31, 2014 was
$17.5 million compared to
$14.6 million at December 31, 2013.
Conference Call
Synthetic Biologics will hold a conference call today,
Monday, March 16, 2015, at
8:30 a.m. (ET), during which Mr.
Riley will provide an operational update and C. Evan Ballantyne, Synthetic Biologics' Chief
Financial Officer, will review the Company's financial results for
the year ended December 31, 2014.
Interested parties should call 1-888-347-5280 (U.S. toll free),
1-855-669-9657 (Canada toll free),
or +1 412-902-4280 (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=101639. 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=101639, for 30 days after
the call.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage
biotechnology company developing pathogen-specific therapies for
serious infections and diseases, with a focus on protecting the
microbiome. The Company is developing an oral biologic to protect
the gut microbiome from intravenous (IV) antibiotics for the
prevention of C. difficile infection, an oral statin
treatment to reduce the impact of methane producing organisms on
irritable bowel syndrome with constipation (IBS-C), and in
collaboration with Intrexon Corporation (NYSE: XON), a monoclonal
antibody combination for the treatment of Pertussis. 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. 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 topline data from clinical
trials, the expected date of submission of IND application for
SYN-010, and the 505 (b)(2) regulatory pathway anticipated for
development of 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, or a failure by
Synthetic Biologics 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
|
|
|
December
31,
|
|
2014
|
|
2013
|
Assets
|
|
|
|
Cash and
cash equivalents
|
$
17,525
|
|
$
14,625
|
Prepaid
expenses and other current assets
|
1,548
|
|
1,591
|
Property
and equipment, net
|
65
|
|
37
|
Deposits
and other assets
|
6
|
|
4
|
Total
Assets
|
$
19,144
|
|
$
16,257
|
Liabilities and
Equity
|
|
|
|
Current
liabilities
|
$
9,588
|
|
$
1,027
|
Synthetic Biologics, Inc. and subsidiaries
equity
|
9,556
|
|
15,230
|
Total Liabilities
and Equity
|
$
19,144
|
|
$
16,257
|
|
|
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
|
|
For the years
ended
December 31,
|
|
|
2014
|
|
2013
|
Operating Costs
and Expenses
|
|
|
|
|
General
and administrative
|
|
$
6,013
|
|
$
5,832
|
Research
and development
|
|
14,489
|
|
6,507
|
Total Operating
Costs and Expenses
|
|
20,502
|
|
12,339
|
Loss from
Operations
|
|
(20,502)
|
|
(12,339)
|
Other Income
(Expense)
|
|
|
|
|
Change
in fair value of warrant liability
|
|
620
|
|
-
|
Interest
income
|
|
3
|
|
33
|
Other
income (expense)
|
|
95
|
|
(12)
|
Total Other
Income, net
|
|
718
|
|
21
|
Net
Loss
|
|
(19,784)
|
|
(12,318)
|
Net Loss
Attributable to Non-controlling Interest
|
|
-
|
|
(1)
|
Net Loss
Attributable to Synthetic Biologics, Inc. and
Subsidiaries
|
|
$ (19,784)
|
|
$
(12,317)
|
Net Loss Per Share
- Basic and Dilutive
|
|
$
(0.32)
|
|
$
(0.27)
|
Net Loss Per
ShareAttributable to Synthetic Biologics, Inc. and
Subsidiaries
|
|
$
(0.32)
|
|
$
(0.27)
|
Weighted average
number of common shares outstanding - Basic and
Dilutive
|
|
61,945,356
|
|
45,667,813
|
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SOURCE Synthetic Biologics, Inc.