ANN ARBOR, Mich., Aug. 14, 2012 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics
and innovative medicines for unmet medical needs, today reported
financial results for the three and six months ended June 30, 2012 and summarized operational
highlights.
Operational Highlights
Expanding Synthetic Biologic Programs
- Enhanced our relationship with Intrexon by entering into a
second worldwide exclusive channel collaboration for the
development and commercialization of a series of monoclonal
antibody (mAb) therapies for the treatment of certain infectious
diseases not adequately addressed by existing therapies. Utilizing
Intrexon's comprehensive suite of proprietary technologies, initial
discovery efforts will target three infectious disease
indications.
- Initiated preclinical research for the development of a
synthetic DNA-based therapy for pulmonary arterial hypertension
(PAH), utilizing the UltraVector® platform and RheoSwitch
Therapeutic System® of our collaborator, Intrexon.
- Appointed biologics expert and gene therapy veteran,
Michael Kaleko, M.D., Ph.D., to
serve as Scientific Director. Dr. Kaleko has worked in the field of
gene therapy since its inception in the mid-1980s and has extensive
experience developing vector platforms, inducible transcription
systems and product candidates in multiple disease areas.
Advancing Clinical Trial Programs
- Strengthened our clinical and regulatory functions by
recruiting the former Chief Medical Officer of Clinical Data, Inc.,
Carol Reed, M.D., to serve as Senior
Vice President of Clinical & Regulatory Affairs. Dr. Reed, who
led the design and management of two consecutive successful Phase
III clinical trials and FDA approval for VIIBRYD®, is responsible
for the design and implementation of all aspects of clinical
development and clinical trials, as well as regulatory
initiatives.
- Completed enrollment of 164 patients in a randomized,
double-blind, placebo-controlled, multi-center Phase II clinical
trial evaluating the efficacy and safety of our proprietary oral
formulation of estriol (Trimesta™) for the treatment of
relapsing-remitting multiple sclerosis (MS) in women. According to
various reports, sales of oral disease-modifying therapies for MS,
of which Trimesta™, if and when approved, would be in a drug class,
is expected to reach $5 billion
annually by 2017.
- Initiated patient enrollment in a second randomized,
double-blind, placebo-controlled Phase II clinical trial of
Trimesta™ for the treatment of cognitive dysfunction in MS.
Charitable organizations have pledged to financially support a
majority of this new MS clinical trial. As of August 1, 2012, 11 of 64 patients have been
enrolled into this trial and patient recruitment continues.
Board of Directors – Improved Corporate Governance
- Improved corporate governance and strengthened the Board by
separating the roles of Chairman and Chief Executive Officer with
the appointment of Jeffrey J. Kraws
to serve as independent, non-executive Chairman of the Board. Mr.
Kraws has served on the Board of Directors since January 2006.
"We continue to broaden our reach within the synthetic biologics
area as evidenced by the recent expansion of our relationship with
Intrexon for the development of monoclonal antibodies to treat
infectious diseases. These discovery programs enhance our product
pipeline and further emphasize our commitment to the development of
new treatment options for unmet medical needs," said Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics. "We look forward to announcing more about our
infectious disease targets and program progress in the near
future."
Three and Six Months Ended June 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 six months ended
June 30, 2012 and June 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 six months ended June 30,
2012.
General and administrative expenses were $1.2 million and $2.6
million for the three and six months ended June 30, 2012, respectively, compared to
$524,000 and $1.8 million for the same periods in 2011. These
increases of 124% and 50%, respectively, are primarily the result
of additional employee costs, the expansion of our investor
relation activities and legal fees related to various Securities
and Exchange Commission filings. Charges related to stock-based
compensation were $287,000 and
$786,000 for the three and six months
ended June 30, 2012, respectively,
compared to $51,000 and $810,000 for the same periods in 2011.
Research and development expenses were $547,000 and $933,000 for the three and six months ended
June 30, 2012, respectively, compared
to $281,000 and $512,000 for the same periods in 2011. These
increases of 95% and 82%, respectively, are primarily the result of
additional employee costs and increased program costs associated
with our expanded pipeline, including the initiation of our
preclinical program for the treatment of PAH and our clinical trial
for the treatment of cognitive dysfunction in MS.
Other income was $7,000 for the
three months ended June 30, 2012,
compared to other expense of $761,000
for the same period in 2011. Other income was $12,000 for the six months ended June 30, 2012, compared to other expense of
$1.5 million for the same period in
2011. Other expense for the three and six months ended June 30, 2011 included $760,000 and $1.6
million, respectively, relating 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 the end
of each period.
Cash at June 30, 2012 was
$5.9 million compared to $6.7 million at December
31, 2011. As of July 31, 2012,
we had approximately $5.6 million in
cash.
About Synthetic Biologics, Inc.
Synthetic Biologics is a biotechnology company focused on the
development of product candidates to address serious diseases and
unmet medical needs. Synthetic Biologics is developing the
following synthetic biologic candidates: a series of monoclonal
antibodies (mAbs) for the treatment of serious infectious diseases
not adequately addressed by existing therapies and a synthetic
DNA-based therapy for the treatment of pulmonary arterial
hypertension (PAH). The Company is also developing drug candidates
for the treatment of relapsing-remitting multiple sclerosis (MS),
cognitive dysfunction in MS, amyotrophic lateral sclerosis (ALS)
and fibromyalgia (partnered with Meda AB). For more information,
please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
UltraVector® and RheoSwitch Therapeutic System® 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 oral disease-modifying therapies for MS. 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, 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
|
|
June
30,
|
|
December 31,
|
|
2012
|
|
2011
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash
|
$
5,932
|
|
$
6,678
|
Accounts receivable, net
|
245
|
|
405
|
Other
|
94
|
|
16
|
Assets of discontinued
operations
|
-
|
|
23
|
Property and equipment, net
|
254
|
|
323
|
Long-term note receivable
|
700
|
|
-
|
Deposits and other assets
|
20
|
|
31
|
Total
assets
|
$
7,245
|
|
$
7,476
|
Liabilities and Stockholders'
Equity
|
|
|
|
Current liabilities
|
$
395
|
|
$
417
|
Stockholders' equity
|
6,850
|
|
7,059
|
Total
liabilities and stockholders' equity
|
$
7,245
|
|
$
7,476
|
|
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
For the
three months ended
June 30,
|
|
For the
six months ended
June 30,
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
Operating Costs and Expenses
|
|
|
|
|
|
|
|
General and administrative
|
$
1,176
|
|
$
524
|
|
$
2,644
|
|
$
1,757
|
Research and development
|
547
|
|
281
|
|
933
|
|
512
|
Total
operating costs and expenses
|
1,723
|
|
805
|
|
3,577
|
|
2,269
|
Loss
from Continuing Operations
|
(1,723)
|
|
(805)
|
|
(3,577)
|
|
(2,269)
|
Other
Income (Expense)
|
|
|
|
|
|
|
|
Warrant expense
|
-
|
|
(776)
|
|
-
|
|
(1,492)
|
Change in fair value of warrant
liability
|
-
|
|
16
|
|
-
|
|
(78)
|
Other income (expense)
|
7
|
|
(1)
|
|
12
|
|
50
|
Total
other income (expense), net
|
7
|
|
(761)
|
|
12
|
|
(1,520)
|
Loss
from Continuing Operations
|
(1,716)
|
|
(1,566)
|
|
(3,565)
|
|
(3,789)
|
Income
(Loss) from Discontinued Operations
|
(156)
|
|
(114)
|
|
493
|
|
(77)
|
Net
Loss and Comprehensive Loss
|
$
(1,872)
|
|
$
(1,680)
|
|
$
(3,072)
|
|
$
(3,866)
|
Net
Income (Loss) Per Share - Basic and Dilutive
|
|
|
|
|
|
|
|
Continuing Operations
|
$
(0.05)
|
|
$
(0.06)
|
|
$
(0.11)
|
|
$
(0.14)
|
Discontinued Operations
|
-
|
|
-
|
|
0.02
|
|
-
|
Net
Loss Per Share
|
$
(0.05)
|
|
$
(0.06)
|
|
$
(0.09)
|
|
$
(0.14)
|
Weighted
average number of common shares outstanding - Basic and
Dilutive
|
33,011,460
|
|
27,885,479
|
|
32,507,312
|
|
26,560,448
|
SOURCE Synthetic Biologics, Inc.