ROCKVILLE, Md., April 16, 2013 /PRNewswire/ -- 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 ResultsAs 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 as required by law. -- Financial Tables to Follow --Synthetic Biologics, Inc. and Subsidiaries(in thousands, except share and per share amounts)Condensed Consolidated Balance SheetsDecember 31,20122011AssetsCash
,678Accounts receivable, net
-405Prepaid expenses and other current assets
2,50916Assets of discontinued operations
-23Property and equipment, net
223323Long-term note receivable
7,476Liabilities and Stockholders' EquityCurrent liabilities
13,0287,059Total liabilities and stockholders' equity$
7,476Condensed Consolidated Statements of OperationsFor the years ended
December 31,20122011Operating Costs and ExpensesGeneral and administrative
2,588Research and development
12,2873,340Total operating costs and expenses
17,2995,928Loss from Operations(17,299)(5,928)Other Income (Expense)Warrant expense
-(1,492)Change in fair value of warrant liability
3314Other income (expense)
(18)22Total other income (expense), net
15(1,698)Loss from Continuing Operations(17,284)(7,626)Income (Loss) from Discontinued Operations216(523)Net Loss and Comprehensive Loss$
(8,149)Net Income (Loss) Per Share - Basic and DilutiveContinuing operations
0.01(0.02)Net Income (Loss) Per Share$
(0.29)Weighted average number of common shares
outstanding - Basic and Dilutive
|SOURCE Synthetic Biologics, Inc.|
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