ANN ARBOR — The pharmaceutical startup Synthetic Biologics Inc. (NYSE Amex: SYN) reported a larger loss for the year ended Dec. 31, but also a host of promising operational highlights.
The company said it established a worldwide exclusive collaboration of Intrexon Corp. in November to develop a synthetic DNA-based therapy for pulmonary arterial hypertension.
The company also added former Avigen Inc. CEO John Monahan to serve as senior vice president of research an development, and divested a clinical reference lab the company said wasn’t core to its business.
Synthetic Biologics currently has two Phase II clinical trials under way of its proprietary oral formulation of the female hormone estriol, called 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. Another trial is under way of Trimesta for treatment of cognitive dysfunction in MS.
The company sold its clinical reference lab March 8. Laboratory revenues for the year ended Dec. 31 were charged to discontinued operations, resulting in no revenues for the period.
Revenues for the year ended Dec. 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 Dec. 31, 2011 were $5.9 million, compared to $3.7 million for the same period in 2010. 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 percent to $2.6 million for the year ended Dec. 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 Dec. 31, 2011, from $310,000 for the same period in 2010.
Research and development expenses were $3.3 million for the year ended Dec. 31, 2011, compared to $1.6 million for the same period in 2010. This 111 percent 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 Corp. 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 Dec. 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 Dec. 31, 2011 was $6.7 million compared to $2.6 million at Dec. 31, 2010. As of March 26, 2012, we had approximately $6.9 million in cash, including $1.4 million from recent warrant exercises.
More at www.syntheticbiologics.com.