ANN ARBOR, Mich., May 15, 2012 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE Amex: SYN), a developer of synthetic
DNA-based therapeutics and innovative disease-modifying medicines
for serious illnesses, today reported financial results for the
three months ended March 31, 2012 and
summarized operational highlights.
Operational Highlights
Management Team – Strengthened Clinical Development and
Regulatory Affairs Functions
- Recruited 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.
Synthetic Biologics – Focus on DNA-Based Therapeutics
- 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 Corporation.
- Appointed 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.
Multiple Sclerosis (MS) – Two Phase II Clinical Trials
Ongoing
- 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 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, that 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.
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 focus our efforts on establishing our presence
in the field of 'next generation' gene therapy and on advancing our
strong mid-to-late stage clinical programs," said Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics. "We've strengthened our management team,
improved our corporate governance practices and maintained a cash
position consistent with current needs."
Three Months Ended March 31,
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 months ended
March 31, 2012 and March 31, 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 three months ended March
31, 2012.
General and administrative expenses increased by 19% to
$1.5 million for the three months
ended March 31, 2012, compared to
$1.2 million for the same period in
2011. This change is primarily the result of increased salary and
consulting fees associated with strengthening our senior management
team and expanding our emphasis on investor outreach. Non-cash
charges related to stock-based compensation decreased to
$499,000 for the three months ended
March 31, 2012, from $759,000 for the same period in 2011.
Research and development expenses were $386,000 for the three months ended March 31, 2012, compared to $231,000 for the same period in 2011. This 67%
increase is primarily driven by the expansion of our 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, net, was $5,000 for
the three months ended March 31,
2012. Other expense, net, was $759,000 for the three months ended March 31, 2011, and included a $810,000 charge related to the estimated fair
value of the warrants associated with the January 2011 financing adjusted for the change in
their fair value at the end of the period, offset by other income
of $63,000 related to the settlement
of accounts payable previously accrued in prior periods.
Cash at March 31, 2012 was
$6.8 million compared to $6.7 million at December
31, 2011. As of April 30,
2012, we had approximately $6.5
million in cash.
About Synthetic Biologics, Inc.
Synthetic Biologics is a biotechnology company focused on the
development of synthetic DNA-based therapeutics and innovative
disease-modifying medicines for serious illnesses. Synthetic
Biologics is developing, or has partnered the development of,
product candidates for the treatment of pulmonary arterial
hypertension (PAH), relapsing-remitting multiple sclerosis (MS),
cognitive dysfunction in MS, fibromyalgia and amyotrophic lateral
sclerosis (ALS). 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 gene therapy 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, 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.
- Financial Tables to Follow -
Synthetic Biologics, Inc. and
Subsidiaries
|
(in
thousands, except share and per share amounts)
|
|
Condensed Consolidated Balance
Sheets
|
|
March
31,
|
|
December 31,
|
|
2012
|
|
2011
|
|
(Unaudited)
|
|
(Audited)
|
Assets
|
|
|
|
Cash
|
$
6,802
|
|
$
6,678
|
Accounts receivable, net
|
440
|
|
405
|
Other current assets
|
83
|
|
16
|
Assets of discontinued operations
|
-
|
|
23
|
Property and equipment, net
|
303
|
|
323
|
Long-term note receivable
|
700
|
|
-
|
Deposits and other
assets
|
21
|
|
31
|
Total
assets
|
$
8,349
|
|
$
7,476
|
Liabilities and Stockholders'
Equity
|
|
|
|
Current liabilities
|
$
443
|
|
$
417
|
Stockholders' equity
|
7,906
|
|
7,059
|
Total
liabilities and stockholders' equity
|
$
8,349
|
|
$
7,476
|
|
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
For the
three months ended
March 31,
|
|
2012
|
|
2011
|
Operating Costs and Expenses
|
|
|
|
General and
administrative
|
$
1,468
|
|
$
1,233
|
Research and development
|
386
|
|
231
|
Total
operating costs and expenses
|
1,854
|
|
1,464
|
Loss
from Continuing Operations
|
(1,854)
|
|
(1,464)
|
Other
Income (Expense)
|
|
|
|
Warrant expense
|
-
|
|
(716)
|
Change in fair value of warrant
liability
|
-
|
|
(94)
|
Loss on the sale of equipment
|
-
|
|
(5)
|
Other income
|
5
|
|
56
|
Total
other income (expense), net
|
5
|
|
(759)
|
Net
Loss from Continuing Operations
|
(1,849)
|
|
(2,223)
|
Net
Income from Discontinued Operations
|
649
|
|
37
|
Net
Loss
|
$
(1,200)
|
|
$
(2,186)
|
Net
Income (Loss) Per Share - Basic and Dilutive
|
|
|
|
Continuing Operations
|
$
(0.06)
|
|
$
(0.09)
|
Discontinued Operations
|
0.02
|
|
-
|
Net
Loss Per Share
|
$
(0.04)
|
|
$
(0.09)
|
Weighted
average number of common shares
outstanding - Basic and Dilutive
|
32,003,164
|
|
25,220,694
|
SOURCE Synthetic Biologics, Inc.