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Synthetic Biologics Reports Year End

Key Takeaway: Synthetic Biologics Reports Year End 2012 Financial Results -- Strengthening Infectious Disease Portfolio to Include C. difficile, Pertussis and Acinetobacter Targets -- Rockville, MD, April 16, 2013 - Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focus

Full Press Release Details

Synthetic Biologics Reports Year End
2012 Financial Results
-- Strengthening Infectious Disease
Portfolio to Include C. difficile, Pertussis and Acinetobacter Targets --
Rockville, MD, April 16, 2013 -
Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of biologics focused on the prevention and treatment of serious infectious
diseases, today reported financial results for the year ended December 31, 2012 and summarized recent operational highlights.
Operational Highlights:
Expanding Infectious Disease Portfolio
Ongoing Phase II Multiple Sclerosis
(MS) Clinical Trials
Corporate Highlights:
Completed Successful Capital Raise
"During 2012, we targeted our resources
toward strengthening our infectious disease portfolio, specifically to address the increasing need for therapies to prevent and
treat infections caused by C. difficile, Pertussis and Acinetobacter. We believe there is a major void in the market
when it comes to developing such therapies, mainly due to these bacteria becoming immune to current antibiotics and the evolving
strains of bacteria that are often stronger," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.
"We are excited about our opportunity
to develop a novel therapy to prevent C. difficile infections. The highly-experienced Synthetic Biologics' team is
driving the C. difficile program toward the clinic. In addition, we are working with Intrexon's comprehensive suite
of proprietary technologies to move our promising early-stage programs for the treatment of Pertussis and Acinetobacter
infections forward. We are committed to building a strong public presence and dedicate ourselves to the virtually untapped infectious
disease market," concluded Mr. Riley.
Year Ended December 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 years ended December 31, 2012 and December
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 year ended December 31, 2012.
General and administrative expenses increased
to $5.0 million for the year ended December 31, 2012, compared to $2.6 for the same period in 2011. The increase of 94% is primarily
the result of additional employee costs, the expansion of our investor relation activities and legal fees. Charges related to stock-based
compensation were $1.5 million for the year ended December 31, 2012, compared to $919,000 for the same period in 2011.
Research and development expenses were
$12.3 million for the year ended December 31, 2012, compared to $3.3 million for the same period in 2011. The increase of 268%
is primarily the result of recording the fair value of the common stock issued to Intrexon as consideration for the infectious
disease collaboration ($7.8 million) and the fair value of the common stock issued for the acquisition of the C. difficile
program assets ($1.2 million). Charges related to stock-based compensation were $400,000 for the year ended December 31, 2012,
compared to $54,000 for the same periods in 2011.
Other income was $15,000 for the year ended
December 31, 2012, compared to other expense of $1.7 million for the same period in 2011. Other expense for the year ended December
31, 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 December 31, 2011.
Cash as of December 31, 2012 was $10.0
million compared to $6.7 million as of December 31, 2011. As of March 27, 2013, our cash balance was approximately $8.7 million.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN)
is a biotechnology company focused on the development of biologics for the prevention and treatment
of serious infectious diseases. The Company is developing an oral enzyme for the prevention of C. difficile infections,
and a series of monoclonal antibody therapies for the treatment of Pertussis and Acinetobacter infections. In addition,
the Company is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction
in multiple sclerosis. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.
Copaxone is a registered trademark
of Teva Pharmaceutical Industries Ltd.
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, the opportunities in the infectious disease market,
the anticipated results of our development efforts and the expected size of the future market for sales of therapies for CDI ,
Pertussis 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 our monoclonal antibodies for the treatment of infectious diseases to be successfully developed or commercialized,
our inability to maintain our licensing agreements, including our agreements 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 for the year ended December 31, 2012 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
-- Financial Tables to Follow--
Synthetic Biologics, Inc. and Subsidiaries
(in thousands, except share and per share amounts)
Condensed Consolidated Balance Sheets
December 31,
2012 2011
Assets
Cash $ 9,954 $ 6,678
Accounts receivable, net - 405
Prepaid expenses and other current assets 2,509 16
Assets of discontinued operations - 23
Property and equipment, net 223 323
Long-term note receivable 700 -
Other assets 37 31
Total assets $ 13,423 $ 7,476
Liabilities and Stockholders' Equity
Current liabilities $ 395 $ 417
Stockholders' equity 13,028 7,059
Total liabilities and stockholders' equity $ 13,423 $ 7,476
Condensed Consolidated Statements of Operations
For the years ended December 31,
2012 2011
Operating Costs and Expenses
General and administrative $ 5,012 $ 2,588
Research and development 12,287 3,340
Total operating costs and expenses 17,299 5,928
Loss from Operations (17,299 ) (5,928 )
Other Income (Expense)
Warrant expense - (1,492 )
Change in fair value of warrant liability - (242 )
Interest income 33 14
Other income (expense) (18 ) 22
Total other income (expense), net 15 (1,698 )
Loss from Continuing Operations (17,284 ) (7,626 )
Income (Loss) from Discontinued Operations 216 (523 )
Net Loss and Comprehensive Loss $ (17,068 ) $ (8,149 )
Net Income (Loss) Per Share - Basic and Dilutive
Continuing operations $ (0.50 ) $ (0.27 )
Discontinued operations 0.01 (0.02 )
Net Income (Loss) Per Share $ (0.49 ) $ (0.29 )
Weighted average number of common shares outstanding - Basic and Dilutive 34,896,592 27,710,428
For further information, please contact:
Vice President, Corporate Communication
(734) 332-7800, Ext. 22
Last updated: Apr 16, 2013