Alnylam posts $9.9 million second quarter GAAP net loss

By Jennifer Lanning Drey

Eugene, Ore., July 26 - Alnylam Pharmaceuticals reported a $9.9 million, or $0.31 per share, GAAP net loss on revenues of $6.0 million for the second quarter, according to a company news release.

The company reported an $11.1 million, or $0.54 per share, net loss, in the second quarter of 2005 on revenues of $1.1 million, according to the release.

Alnylam had cash, cash equivalents and marketable securities of $123.3 million at June 30 compared to $80 million at Dec. 31, 2005.

The company said its second quarter performance reflected a particularly active period for the company, especially with developments related to ALN-RSV01, its lead RNAi therapeutic for treatment of respiratory syncytial virus (RSV).

During the second quarter, the company presented results from two phase 1 clinical trials for ALN-RSV01 that demonstrated the drug to be safe and well-tolerated when administered intranasally in relevant doses, said John Maraganore, chief executive officer of Alnylam, during a company conference call held Wednesday.

"These results represent a very important step in our efforts to develop direct RNAi therapeutics for respiratory disease indication," he said.

The company is planning to begin two additional phase 1 studies on the drug in the second half of 2006, Maraganore said. One of the trials will be an experimental infection study in adult volunteers, and the other will be an inhalation trial, he said.

"The robust clinical data and encouraging preclinical results we've reported gives us great confidence to advance this clinical program to additional clinical trials," said Barry Greene, chief operating officer of Alnylam during Wednesday's call.

The company is also taking the necessary steps to initiate clinical trials of ALN-RSV01 for patients naturally infected with RSV in the first half of 2007, he said.

Pandemic flu advancements

Alnylam said its pandemic influenza program, being developed in collaboration with Novartis AG, also advanced during the second quarter.

Alnylam's goal is to submit an Investigational New Drug Application for ALN-FLU01, its pandemic flu treatment candidate, by the end of the year, Greene said.

Last week, the company submitted a response to a request for proposal from the Department of Health and Human Services asking for funding related to development of an RNAi therapeutic to treat pandemic flu.

Maraganore said Alnylam could receive notification on the funding in the fall.

Also during the second quarter, Alnylam signed a cooperative research and development agreement with the United States Army Medical Research Institute of Infections Diseases in which the entities agreed to collaborate to discover RNAi therapeutics targeting viral organisms that could pose a biological threat to the military or public health of the United States.

"This is an encouraging effort as there is significant interest by federal authorities in the application of RNAi as a rapid response platform for biodefense needs," said Maraganore.

Additional programs underway

Alnylam has also agreed to collaborate with the University of Texas Southwestern Medical Center on the discovery and development of RNAi therapeutics targeting proprotein convertase subtilisn/kexin type 9 (PCSK9), which is a gene involved in the metabolism of LDL-cholesterol.

"We believe [PCSK9] is a remarkable disease target for potential break-through treatments of hypocholesteremia and ischemia complications of acute coronary syndromes," said Maraganore.

In addition, Alnylam is on track to announce its next clinical development product in the second half of the year, said Greene.

"Our goal is for it to be an Alnylam wholly owned program," he said.

Alnylam, a biopharmaceutical company developing novel therapeutics based on RNAi, has headquarters in Cambridge, Mass.

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