ROCKVILLE, Md., Nov. 14, 2012 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics
and innovative medicines for serious infections and diseases, today
reported financial results for the three and nine months ended
September 30, 2012 and summarized
operational highlights.
Operational Highlights
Completed Successful Capital Raise
- Increased cash position with net proceeds of $10.1 million from the sale of approximately 6.8
million shares of common stock to new and existing investors in a
private placement financing. Existing investors and an affiliate of
R.J. Kirk constituted a majority of
the participating investors in this transaction.
Ramping Up Infectious Disease Programs
- Entered into an agreement with Prev AbR LLC to acquire its
clinical-stage and related beta-lactamase assets targeted for the
prevention of Clostridium difficile (C. diff)
infection, the leading cause of hospital acquired infections (HAI),
that may occur secondary to treatment with antibiotics. CDI is a
widespread and often drug resistant infectious disease, resulting
in more than 337,000 hospitalizations, 30,000 deaths[1] and
aggregate costs associated with stays in the hospital of
$8.2 billion[2] in the U.S. during
2009.
- Initiated efforts to develop a monoclonal antibody (mAb)
therapy for the treatment of Acinetobacter, a
multidrug-resistant pathogen that is a leading cause of
hospital-acquired infections. Our Intrexon collaboration enables us
to have access to a comprehensive suite of proprietary mAb
technologies including the mAbLogix™ and LEAP™ platforms, to
develop fully human mAbs to neutralize acinetobacter pathogens. In
addition to Acinetobacter, we expect to utilize Intrexon's
technologies to target two other infectious disease
indications.
- Engaged Lewis (Lew) Barrett,
former Assistant Vice President, Established Products at Pfizer and
Vice President Global Business Manager, Infectious Diseases at
Wyeth Pharmaceuticals. As an advisor, Mr. Barrett will provide his
expertise for the development and commercialization of infectious
diseases.
- Appointed Charles B. Shoemaker,
Ph.D., to serve as a member of our Scientific Advisory Board to aid
in the research process for our infectious disease program. Dr.
Shoemaker has over 30 years of experience as a scientist in
academia, government agencies and the biotechnology industry. He
also serves as Professor of Biomedical Sciences at Tufts University's Cummings School of Veterinary
Medicine, where he develops treatments for the prevention and cure
of toxins from Clostridium difficile, E. coli, anthrax and
ricin, among other microbial toxins.
Strengthened Management Team
- Appointed Andrew Bristol, Ph.D.
as Vice President of Research and Development, guiding the research
development team in the mAbs drug development process. Dr. Bristol
has over 20 years of experience in cancer research and drug
development with a focus on monoclonal antibodies and cancer
vaccines.
- Promoted Michael Kaleko, M.D.,
Ph.D. to Senior Vice President of Research Development, to further
expand the synthetic biologic and infectious disease programs.
"We are making considerable strides in our infectious disease
programs, with our progress to develop mAbs for infectious diseases
and through our efforts to acquire a C. diff program.
Utilizing Intrexon's proprietary mAb technologies, we have
successfully initiated development for the first mAb candidate,
Acinetobacter, a debilitating multi-drug resistant disease
with a multi-billion dollar market opportunity. We expect to hit
milestones in the mAb discovery phase for this disease during 2013.
In order to quickly advance our infectious disease platform, we've
strengthened our R&D management team and Scientific Advisory
board, which has enhanced our position in the biotech space," said
Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics.
"Our recent private placement has increased our cash position,
allowing us to further advance our clinical programs, as well as
develop our preclinical and discovery projects. We look forward to
announcing our additional infectious disease targets, as well as
the progress of our C. diff program," concluded Mr.
Riley.
Three and Nine Months Ended September
30, 2012 Financial Results
As part of management's plan to streamline our focus, we sold
the clinical reference lab on March 8,
2012. Laboratory revenues for the three and nine months
ended September 30, 2012 and
September 30, 2011 were charged to
discontinued operations, resulting in no revenues for these
periods. In addition, the gain on the sale of the clinical
reference lab of $677,000 was
included in discontinued operations for the nine months ended
September 30, 2012.
General and administrative expenses were $1.1 million and $3.7
million for the three and nine months ended September 30, 2012, respectively, compared to
$582,000 and $2.3 million for the same periods in 2011. These
increases of 84% and 59%, respectively, are primarily the result of
additional employee costs, the expansion of our investor relation
activities and legal fees. Charges related to stock-based
compensation were $279,000 and
$1.1 million for the three and nine
months ended September 30, 2012,
respectively, compared to $51,000 and
$861,000 for the same periods in
2011.
Research and development expenses were $763,000 and $1.7
million for the three and nine months ended September 30, 2012, respectively, compared to
$289,000 and $801,000 for the same periods in 2011. These
increases of 164% and 112%, respectively, are primarily the result
of additional employee costs and increased program costs associated
with our expanded pipeline, including the initiation of development
efforts for a monoclonal antibody (mAb) therapy for the treatment
of Acinetobacter infections and of our preclinical program for the
development of a DNA-based therapy for the treatment of pulmonary
arterial hypertension (PAH). Charges related to stock-based
compensation were $116,000 and
$238,000 for the three and nine
months ended September 30, 2012,
respectively, compared to $6,000 and
$20,000 for the same periods in
2011.
Other income was $10,000 for the
three months ended September 30,
2012, compared to other expense of $159,000 for the same period in 2011. Other
income was $22,000 for the nine
months ended September 30, 2012,
compared to other expense of $1.7
million for the same period in 2011. Other expense for the
nine months ended September 30, 2011
related to the estimated fair value of the warrants associated with
the January 2011 and April 2011 financings, adjusted for the change in
their fair value at September 30,
2012.
Cash at September 30, 2012 was
$4.6 million compared to $6.7 million at December
31, 2011. As of October 31,
2012, we had approximately $14.2
million in cash.
About Synthetic Biologics, Inc.
Synthetic Biologics is a biotechnology company focused on the
development of product candidates for serious infections and
diseases. Synthetic Biologics is developing a biologic for the
prevention of C. diff infection, and a series of monoclonal
antibodies (mAbs) for the treatment of serious infectious diseases,
including Acinetobacter. The Company is also developing a
synthetic DNA-based therapy for the treatment of pulmonary arterial
hypertension (PAH). In addition, the Company is developing a drug
candidate for the treatment of relapsing-remitting multiple
sclerosis (MS) and cognitive dysfunction in MS, and designing a
clinical development pathway for the treatment of amyotrophic
lateral sclerosis (ALS). For more information, please visit
Synthetic Biologics' website at www.syntheticbiologics.com.
mAbLogix™ and LEAP™ are registered trademarks of Intrexon
Corporation.
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 our continued focus of
our efforts in the field of synthetic biology and advancing our
clinical programs and the expected size of the future market for
sales of therapies for CDI 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 gene therapy to receive market acceptance, 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, including our
agreement with Intrexon, our inability to successfully integrate
new management, 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/A for the year ended
December 31, 2011 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 data)
|
|
Condensed Consolidated Balance
Sheets
|
|
September 30,
|
|
December 31,
|
|
2012
|
|
2011
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash
|
$
4,577
|
|
$
6,678
|
Accounts receivable, net
|
122
|
|
405
|
Other
|
151
|
|
16
|
Assets of discontinued
operations
|
-
|
|
23
|
Property and equipment, net
|
249
|
|
323
|
Long-term note receivable
|
700
|
|
-
|
Deposits and other assets
|
27
|
|
31
|
Total
assets
|
$
5,826
|
|
$
7,476
|
Liabilities and Stockholders'
Equity
|
|
|
|
Current liabilities
|
$
417
|
|
$
417
|
Stockholders' equity
|
5,409
|
|
7,059
|
Total
liabilities and stockholders' equity
|
$
5,826
|
|
$
7,476
|
|
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
For the
three months ended
September 30,
|
|
For the
nine months ended
September 30,
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
Operating Costs and Expenses
|
|
|
|
|
|
|
|
General and administrative
|
$
1,073
|
|
$
582
|
|
$
3,717
|
|
$
2,339
|
Research and development
|
763
|
|
289
|
|
1,696
|
|
801
|
Total
operating costs and expenses
|
1,836
|
|
871
|
|
5,413
|
|
3,140
|
Loss
from Continuing Operations
|
(1,836)
|
|
(871)
|
|
(5,413)
|
|
(3,140)
|
Other
Income (Expense)
|
|
|
|
|
|
|
|
Warrant expense
|
-
|
|
-
|
|
-
|
|
(1,492)
|
Change in fair value of warrant
liability
|
-
|
|
(165)
|
|
-
|
|
(242)
|
Other income (expense)
|
10
|
|
6
|
|
22
|
|
55
|
Total
other income (expense), net
|
10
|
|
(159)
|
|
22
|
|
(1,679)
|
Loss
from Continuing Operations
|
(1,826)
|
|
(1,030)
|
|
(5,391)
|
|
(4,819)
|
Income
(Loss) from Discontinued Operations
|
(104)
|
|
(68)
|
|
389
|
|
(145)
|
Net
Loss and Comprehensive Loss
|
$
(1,930)
|
|
$
(1,098)
|
|
$
(5,002)
|
|
$
(4,964)
|
Net
Income (Loss) Per Share - Basic and Dilutive
|
|
|
|
|
|
|
|
Continuing Operations
|
$
(0.05)
|
|
$
(0.04)
|
|
$
(0.16)
|
|
$
(0.18)
|
Discontinued Operations
|
-
|
|
-
|
|
0.01
|
|
-
|
Net
Loss Per Share
|
$
(0.05)
|
|
$
(0.04)
|
|
$
(0.15)
|
|
$
(0.18)
|
Weighted
average number of common shares outstanding - Basic and
Dilutive
|
33,383,226
|
|
28,089,492
|
|
32,801,415
|
|
27,075,730
|
[1] U.S. Department of Health & Human Services. Agency for
Healthcare Research and Quality. January 25,
2012. Available at http://www.ahrq.gov/news/nn/nn012512.htm.
Accessed November 5, 2012.
[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.
SOURCE Synthetic Biologics, Inc.