ANN ARBOR, Mich., March 30, 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 year ended December 31, 2011 and
summarized operational highlights.
Operational Highlights
Synthetic Biologics – Prioritizes Focus on DNA-Based
Therapeutics
- Executed a worldwide exclusive collaboration with Intrexon
Corporation (Intrexon) in November
2011 to develop a synthetic DNA-based therapy for pulmonary
arterial hypertension (PAH). We intend to utilize Intrexon's
UltraVector® platform and RheoSwitch Therapeutic System® that
provide precise and continuous in vivo cellular production
of prostacyclin synthase to the pulmonary arteries of PAH
patients.
- Established an office near the Human Therapeutics Division of
Intrexon in Maryland to enhance
our collaboration.
- Recruited gene medicine industry pioneer, John Monahan, Ph.D., to serve as Senior Vice
President of Research & Development. Dr. Monahan most recently
served as founder and CEO of Avigen, Inc.
- Divested our clinical reference lab, a non-core asset,
concentrating our focus on developing DNA-based medicines.
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.
Executive Management Team and Board of Directors –
Strengthened by New Members
- Jeffrey Riley was appointed as
President and Chief Executive Officer. Mr. Riley has more than 20
years of experience in the biotechnology and pharmaceutical
industries, including Pfizer and SmithKline Beecham.
- C. Evan Ballantyne was appointed
as Chief Financial Officer. Mr. Ballantyne was the former CFO of
Clinical Data, Inc.
- Scott L. Tarriff and
Nelson K. Stacks, pharmaceutical and
life science veterans, were appointed to the Board of
Directors.
"During the past four months we've focused our efforts on an
early but very promising program in 'next generation' gene therapy
and continued to advance our strong late stage clinical programs,"
said Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics. "We've augmented our management
team, added significant strength to our board, and furthered our
product pipeline while maintaining a cash position consistent with
current needs."
Mr. Riley added, "Over the longer term, we believe our
collaboration with Intrexon will provide us with the ability to
tackle unmet medical needs, such as PAH, and to establish our
presence in the emerging field of DNA-based therapeutics."
Year Ended December 31, 2011
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 year ended December 31, 2011 were charged to discontinued
operations, resulting in no revenues for the period.
Revenues for the year ended December 31,
2010 were $2.6 million.
Revenues consisted of a $2.1 million
upfront payment from Meda AB sublicense of flupirtine for
fibromyalgia and $489,000 of grant
revenues from the Qualifying Therapeutic Discovery Project
Program.
Total costs and expenses for the year ended December 31, 2011 were $5.9 million, compared to $3.7 million for the same period in 2010. As
described below, the year-over-year growth in total costs and
expenses of $2.2 million was
primarily related to non-cash charges.
General and administrative expenses increased by 22% to
$2.6 million for the year ended
December 31, 2011, compared to
$2.1 million for the same period in
2010. This change is primarily the result of non-cash charges
related to stock-based compensation which increased to $919,000 for the year ended December 31, 2011, from $310,000 for the same period in 2010.
Research and development expenses were $3.3 million for the year ended December 31, 2011, compared to $1.6 million for the same period in 2010. This
111% increase is primarily driven by a $1.7
million one-time non-cash charge for the fair market value
of the common stock issued to Intrexon Corporation as consideration
for the exclusive collaboration agreement entered into in
November 2011.
Other income and expense, net, was $1.7
million for the year ended December
31, 2011, compared to $112,000
for the same period in 2010. This increase was related to the
$1.7 million estimated fair value of
the warrants issued in connection with the January 2011 and April
2011 financings.
Cash at December 31, 2011 was
$6.7 million compared to $2.6 million at December
31, 2010. As of March 26,
2012, we had approximately $6.9
million in cash, including $1.4
million from recent warrant exercises.
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, relapsing-remitting multiple sclerosis, cognitive
dysfunction in multiple sclerosis, 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 the intended use of
certain Intrexon intellectual property, the benefits of our
collaboration with Intrexon 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 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
|
|
(formerly
Adeona Pharmaceuticals, Inc.)
|
|
(in
thousands, except share and per share amounts)
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets (Audited)
|
|
|
December
31,
|
|
|
2011
|
|
2010
|
|
Assets
|
|
|
|
|
Cash
|
$
6,678
|
|
$
2,649
|
|
Other current
assets
|
421
|
|
682
|
|
Assets of discontinued
operations
|
23
|
|
214
|
|
Property and equipment,
net
|
323
|
|
475
|
|
Other assets
|
31
|
|
91
|
|
Total assets
|
$
7,476
|
|
$
4,111
|
|
Liabilities and Stockholders'
Equity
|
|
|
|
|
Current
liabilities
|
$
417
|
|
$
500
|
|
Other
liabilities
|
-
|
|
32
|
|
Stockholders'
equity
|
7,059
|
|
3,579
|
|
Total liabilities and
stockholders' equity
|
$
7,476
|
|
$
4,111
|
|
|
|
|
|
|
Condensed Consolidated
Statements of Operations (Audited)
|
|
|
For the
years ended
December 31,
|
|
|
|
|
|
|
|
2011
|
|
2010
|
|
Revenues
|
$
-
|
|
$
2,614
|
|
Operating Costs and
Expenses
|
|
|
|
|
General and
administrative
|
2,588
|
|
2,117
|
|
Research and
development
|
3,340
|
|
1,580
|
|
Total operating costs and
expenses
|
5,928
|
|
3,697
|
|
Loss from Continuing
Operations
|
(5,928)
|
|
(1,083)
|
|
Other Income
(Expense)
|
|
|
|
|
Warrant expense
|
(1,492)
|
|
-
|
|
Change in fair value of
warrant liability
|
(242)
|
|
-
|
|
Other income (expense),
net
|
36
|
|
(112)
|
|
Total other (expense)
|
(1,698)
|
|
(112)
|
|
Net Loss from Continuing
Operations
|
(7,626)
|
|
(1,195)
|
|
Net Loss from Discontinued
Operations
|
(523)
|
|
(516)
|
|
Net Loss
|
$
(8,149)
|
|
$
(1,711)
|
|
Net Loss Per Share - Basic and
Dilutive
|
|
|
|
|
Continuing
Operations
|
$
(0.27)
|
|
$
(0.06)
|
|
Discontinued
Operations
|
(0.02)
|
|
(0.02)
|
|
Net Loss Per
Share
|
$
(0.29)
|
|
$
(0.08)
|
|
Weighted average number of
common shares
outstanding - Basic and
Dilutive
|
27,710,428
|
|
22,393,568
|
|
|
|
|
|
|
|
SOURCE Synthetic Biologics, Inc.