Full Press Release Details
Synthetic Biologics Reports
2011 Year End Financial Results
-- Company Prioritizes Focus on Synthetic
DNA-Based Therapeutics --
Ann Arbor, MI, March 30, 2012 -
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
Multiple Sclerosis (MS) - Two
Phase II Clinical Trials Ongoing
Management Team and Board of Directors - Strengthened by New Members
"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 |
For further information, please contact:
Vice President of Corporate Communication
(734) 332-7800, Ext. 22