ROCKVILLE, Md., Aug. 14, 2013 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused
on the prevention and treatment of serious infectious diseases,
today reported financial results for the three and six months ended
June 30, 2013 and provided an
operational update.
The Company's development portfolio includes three
anti-infective product candidates, two of which are being developed
in collaboration with Intrexon Corporation (NYSE: XON), and an oral
multiple sclerosis (MS) product candidate in Phase II development.
The relapsing-remitting MS clinical trial is expected to be
completed in January 2014, with key
data to be released shortly thereafter.
Conference call
scheduled for 4:00pm EDT today. To participate, please
call
|
1-800-860-2442
(U.S. toll free), 1-866-605-3852 (Canada), or +1 412-858-4600
(International),
|
fifteen minutes
before the start of the call to register. The call will also be
webcast over the Internet at
|
http://www.videonewswire.com/event.asp?id=95523.
|
"Our lead anti-infective candidate SYN-004 for the prevention of
C. difficile (C. diff) infections, is a second generation
compound designed to address a broader population than its
predecessor, which successfully completed a proof-of-concept Phase
II study in Europe," said
Jeffrey Riley, Synthetic Biologics'
CEO. "Manufacturing of SYN-004 is underway, and with completion of
that we will be able to commence toxicology bridging studies,
followed by the start of clinical trials in 2014."
"In addition, we are making excellent progress in our
collaboration with Intrexon for antibody programs, which currently
covers treatment candidates for Pertussis and
Acinetobacter infections. We expect to initiate IND-enabling
studies of our Pertussis candidate before year end," said
Mr. Riley.
Mr. Riley continued, "In developing and interlinking cutting
edge cellular technologies for a broad range of applications as
Intrexon does, an antibody discovery platform has been created that
is powered to yield novel molecular entities intended to treat
diseases for which current therapies are inadequate. Our
collaboration with Intrexon is a prime example of how two
innovative companies can work together to pursue significant
medical advances."
"The Company's C. diff and Acinetobacter
candidates may qualify for expedited review programs at the FDA for
the treatment of serious conditions with unmet medical needs, such
as are addressed by the GAIN Act. The expedited programs
established by the FDA not only point to the urgency for new
medications for devastating diseases, but also potentially shorten
the time to market," concluded Mr. Riley.
The Company's core competencies in anti-infectives have been
strengthened with the recent appointment of industry veteran
Lewis Barrett to the post of Senior
Vice President, Commercial Strategy. Mr. Barrett was formerly
Assistant Vice President, Established Products at Pfizer and Vice
President Global Business Manager, Infectious Diseases at Wyeth
Pharmaceuticals.
Operational Highlights
SYN-004 Product Candidate for Point-of-Care Prevention for
C. diff Infections
- This second generation candidate is believed to be the only
product under development to prevent, rather than treat, C.
diff infections. Healthcare-acquired infections with C.
diff are potentially lethal and affect 1.1 million
patients,[1] adding roughly $8.2
billion to U.S. hospital costs[2] annually.
SYN-004 is designed to be administered along with target IV
antibiotics to prevent C. diff. In July 2013, the SYN-004 manufacturing process was
initiated with the evaluation of beta-lactamase protein expression
in Fujifilm Diosynth Biotechnologies UK Limited's
pAVEway™ platform. Synthetic Biologics
expects to initiate a clinical program for this second generation
candidate in 2014.
"We believe SYN-004 is a breakthrough candidate within a market
where no approved prophylactic for C. diff currently
exists," Mr. Riley noted. "As strange as it may seem, the only
treatments available to patients are more antibiotics or fecal
transplantation."
Monoclonal Antibody (mAb) Programs in Collaboration with
Intrexon Corporation
- Our mAb product candidate for treatment of Pertussis,
which is intended to neutralize the pertussis toxin, will undergo
initial preclinical testing in the third quarter and is expected to
enter IND-enabling studies before year end. Pertussis, or
whooping cough, is responsible for 300,000 deaths annually
worldwide[3] (primarily infants)
and afflicts 41,000 people in the U.S. each
year[4].
- Our mAb for Acinetobacter infections is currently in the
discovery stage. The urgency to develop a treatment against
this deadly pathogen remains high. Mortality rates as high as 43
percent have been reported[5], and
incidence of the disease is reportedly increasing, especially among
wounded military in field medical settings and natural disaster
victims in emergency trauma units.
Phase II Study of MS Candidate,
Trimesta™
- Topline results from a 164-patient relapsing-remitting MS Phase
II trial at 15 centers are due in the first half of 2014.
- In June 2013, Rhonda R. Voskuhl, M.D., was the keynote speaker
at our investor day focused on MS. Dr. Voskuhl holds the titles of
Professor, Department of Neurology, the Jack H. Skirball Chair in
MS Research, and Director of the MS Program at UCLA School of
Medicine, and is the lead investigator of the Phase II Trimesta™
clinical trial for relapsing-remitting MS. During the event, Dr.
Voskuhl led an in-depth discussion about the MS space and the role
of oral estriol (Trimesta™) in the treatment of MS (the archived
webcast of this event is available at
www.syntheticbiologics.com).
- In April 2013, we announced that
U.S. Patent No. 8,372,826 was issued to the Regents of the
University of California which includes
claims to the use of our drug candidate, Trimesta™ (oral estriol),
in combination with glatiramer acetate injection (Copaxone®).
Copaxone® is the number one selling MS drug with approximately
$4.2 billion in annual sales,
marketed exclusively by Teva Pharmaceutical Industries Ltd.
Copaxone® is expected to face generic competition as certain patent
terms begin to expire in
2014.[6]
Upcoming Milestones
- Relapsing-remitting Phase II MS clinical trial:
- Final patient final visit expected January 2014
- Top-line results expected 1H 2014
- C. diff Program:
- Initiation of cGMP manufacturing expected 3Q 2013
- Initiation of clinical trials expected 2H 2014
- Pertussis Program:
- Initiation of preclinical program expected 3Q 2013
- Initiation of IND-enabling study expected 4Q 2013
- Acinetobacter Program:
- Discovery stage in collaboration with Intrexon
Three and Six Months Ended June 30,
2013 Financial Results
General and administrative expenses were $1.3 million and $2.4
million for the three and six months ended June 30, 2013, respectively, compared to
$1.2 million and $2.6 million for the same periods in 2012. The
decrease of 10% for the six month period ended June 30, 2013 is primarily the result of
decreased outside legal and consulting fees. Non-cash charges
related to stock-based compensation were $299,000 and $652,000 for the three and six months ended
June 30, 2013, respectively, compared
to $287,000 and $786,000 for the same periods in 2012.
Research and development expenses were $1.2 million and $2.3
million for the three and six months ended June 30, 2013, respectively, compared to
$547,000 and $933,000 for the same periods in 2012. These
increases of 120% and 149%, respectively, are primarily the result
of additional employee costs and increased program costs associated
with our infectious disease programs. Non-cash charges related to
stock-based compensation were $109,000 and $212,000 for the three and six months ended
June 30, 2013, respectively, compared
to $113,000 and $122,000 for the same periods in 2012.
Other expense was $36,000 for the
three months ended June 30, 2013,
compared to other income of $7,000
for the same period in 2012. Other expense was $24,000 for the six months ended June 30, 2013, compared to other income of
$12,000 for the same period in
2012.
Cash at June 30, 2013 was
$6.9 million compared to $10.0 million at December
31, 2012.
Conference Call
Synthetic Biologics will hold a conference call today,
Wednesday, August 14, 2013, at
4:00 pm EDT. During the call,
Jeffrey Riley, Synthetic Biologics'
Chief Executive Officer, will provide a brief update of the
Company's MS clinical program and its infectious disease pipeline,
including its oral enzyme candidate for the prevention of C.
diff infections and monoclonal antibody candidates for the
treatment of Pertussis and Acinetobacter infections.
Evan Ballantyne, Synthetic
Biologics' Chief Financial Officer, will review the Company's
financial results for the second quarter ended June 30, 2013.
Interested parties should call 1-800-860-2442 (U.S. toll free),
1-866-605-3852 (Canada), or +1
412-858-4600 (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=95523. 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=95523 for 30 days after
the call.
About Synthetic Biologics, Inc.
Synthetic Biologics (NYSE MKT: SYN) is a biotechnology company
focused on the development of biologics for the prevention and
treatment of serious infectious diseases. The Company is developing
an oral enzyme for the prevention of C. difficile
infections, and a series of monoclonal antibody therapies for the
treatment of Pertussis and Acinetobacter infections.
In addition, the Company is developing a drug candidate for the
treatment of relapsing-remitting multiple sclerosis and cognitive
dysfunction in multiple sclerosis. For more information, please
visit Synthetic Biologics' website at
www.syntheticbiologics.com.
To download Synthetic Biologics' investor relations mobile
device app, which allows users access to the Company's SEC
documents, press releases and events, please click on the following
links to download the IRapp on your iPhone and iPad or your Android
mobile device.
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 our
clinical programs, the opportunities and our position in the
infectious disease market, the anticipated contributions of
Lewis Barrett, the anticipated
timing and results of our development efforts and the expected size
of the future market for sales of therapies for C. difficile
infection, Pertussis and Acinetobacter. 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 our therapeutics, a failure of our clinical
trials to be commenced or completed on time or to achieve desired
results, a failure of our clinical trials to receive anticipated
funding, a failure of our monoclonal antibodies for the treatment
of infectious diseases to be successfully developed or
commercialized, our inability to maintain our licensing agreements,
or a failure by us or our strategic partners to successfully
commercialize products and other factors described in Synthetic
Biologics' report on Form 10-K for the year ended December 31, 2012 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.
[1]
|
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.
|
[2]
|
Agency for Healthcare
Research and Quality. Healthcare and Cost Utilization Project.
Statistical Brief #124. Clostridium difficile Infections
(CDI) in Hospital Stays, 2009. January 2012. Available at
http://www.hcup-us.ahrq.gov/reports/statbriefs/sb124.pdf.
|
[3]
|
World Health
Organization. Pertussis: Immunization surveillance, assessment and
monitoring.
http://www.who.int/immunization_monitoring/diseases/pertussis_surveillance/en/
|
[4]
|
Centers for Disease
Control and Prevention. 2012 Provisional Pertussis Surveillance
Report. January 4, 2013.
|
[5]
|
Falagas, ME,
Bliziotis, LA, and Siempos, II. Attributable mortality of
Acinetobacter baumannii infections in critically ill
patients: a systematic review of matched cohort and case-control
studies. Critical Care 2006, 10:R48.
|
[6]
|
Teva Pharmaceutical
Industries Ltd. Form 20-F filed with the SEC for the year ended
December 31, 2012.
|
- Financial Tables to Follow -
Synthetic
Biologics, Inc. and Subsidiaries
|
(in thousands,
except share and per share amounts)
|
(Unaudited)
|
|
|
Condensed
Consolidated Balance Sheets
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2013
|
|
2012
|
|
Assets
|
|
|
|
|
Cash
|
$
6,877
|
|
$
9,954
|
|
Prepaid
expenses and other current assets
|
1,880
|
|
2,509
|
|
Note
receivable, current
|
700
|
|
-
|
|
Property
and equipment, net
|
155
|
|
223
|
|
Long-term note receivable
|
-
|
|
700
|
|
Deposits
and other assets
|
15
|
|
37
|
|
Total
assets
|
$
9,627
|
|
$
13,423
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
Current
liabilities
|
$
229
|
|
$
395
|
|
Stockholders' equity
|
9,398
|
|
13,028
|
|
Total liabilities
and stockholders' equity
|
$
9,627
|
|
$
13,423
|
|
|
|
|
Condensed
Consolidated Statements of Operations
|
|
|
For the three
months ended
June
30,
|
|
For the six months
ended
June
30,
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
Operating Costs
and Expenses
|
|
|
|
|
|
|
|
General
and administrative
|
$
1,258
|
|
$
1,176
|
|
$
2,380
|
|
$
2,644
|
Research
and development
|
1,203
|
|
547
|
|
2,321
|
|
933
|
Total operating costs
and expenses
|
2,461
|
|
1,723
|
|
4,701
|
|
3,577
|
Loss from
Operations
|
(2,461)
|
|
(1,723)
|
|
(4,701)
|
|
(3,577)
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
Interest
income
|
10
|
|
-
|
|
21
|
|
-
|
Other
income (expense)
|
(46)
|
|
7
|
|
(45)
|
|
12
|
Total other income
(expense), net
|
(36)
|
|
7
|
|
(24)
|
|
12
|
Loss from
Continuing Operations
|
(2,497)
|
|
(1,716)
|
|
(4,725)
|
|
(3,565)
|
Income (Loss) from
Discontinued Operations
|
-
|
|
(156)
|
|
-
|
|
493
|
Net
Loss
|
$
(2,497)
|
|
$
(1,872)
|
|
$
(4,725)
|
|
$
(3,072)
|
Net Income (Loss)
Per Share - Basic and Dilutive
|
|
|
|
|
|
|
|
Continuing operations
|
$
(0.06)
|
|
$
(0.05)
|
|
$
(0.11)
|
|
$
(0.11)
|
Discontinued operations
|
-
|
|
-
|
|
-
|
|
0.02
|
Net Loss Per
Share
|
$
(0.06)
|
|
$
(0.05)
|
|
$
(0.11)
|
|
$
(0.09)
|
Weighted average
number of common shares
outstanding - Basic
and Dilutive
|
44,654,414
|
|
33,011,460
|
|
44,628,051
|
|
32,507,312
|
SOURCE Synthetic Biologics, Inc.