GenVec Inc. Reports Operating Results (10-K)

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Mar 11, 2011
GenVec Inc. (GNVC, Financial) filed Annual Report for the period ended 2010-12-31.

Genvec Inc. has a market cap of $54 million; its shares were traded at around $0.4176 with and P/S ratio of 3.9.

Highlight of Business Operations:

In January 2010, we announced a collaboration with Novartis to discover and develop novel treatments for hearing loss and balance disorders. Under terms of the agreement, we licensed the world-wide rights to our preclinical hearing loss and balance disorders program to Novartis. We received a $5.0 million upfront payment and Novartis purchased $2.0 million of our common stock. If certain clinical, regulatory, and sales milestones were met, we were eligible, at the inception of the agreement, to receive up to an additional $206.6 million in milestone payments in addition to royalties on future sales.

In August 2010, we entered into an additional agreement with Novartis, for the supply of services relating to development materials in connection with our collaboration in hearing loss and balance disorders. Under this additional agreement, GenVec could receive approximately $13 million over four years to manufacture clinical trial material for up to two lead product candidates. In 2010, we recognized approximately $4.4 million for services performed under this agreement.

virus shedding. There is no approved vaccine for HSV-2. Although antiviral regimens have become a standard of care, their inconvenience, cumulative cost and potential for drug resistance further underscore the need for safe, new approaches to reducing HSV-2 lesions, shedding, and transmission. Estimated costs of treating HSV-2 in the United States alone are close to $1 billion, primarily for drugs and outpatient medical care. In March 2008, we received a $600,000 Phase 1 SBIR grant from the NIH for our HSV-2 program. This is intended to support work being conducted in a collaborative effort by GenVec, the Vaccine and Infectious Disease Institute at Fred Hutchinson Cancer Research Center, and the University of Washington. We completed work under this grant in February 2011.

In April 2008, we received a Small Business Innovation and Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to support our malaria vaccine program. This grant, valued at approximately $600,000, is being used to develop enhancements to our vectors for vaccine applications against malaria. We are currently performing work under this grant and we are expecting work to continue through March 2012. In July 2009, we received a grant from the NIAID, valued at approximately $600,000 to identify new antigens for malaria vaccine development. We are currently performing work under this grant and we are expecting work to continue through June 2012.

In September 2006, we entered into an additional agreement directly with the NIAID that initially provided up to $52 million over five years, consisting of a base year and four option years. The agreement provided for an initial $7 million commitment with an additional $45 million remaining if the NIAID exercised its annual renewal options in full. Under the agreement, we support the transfer of our manufacturing and purification processes to the VRC to further clinical development of an HIV vaccine, including development of a larger-scale manufacturing and product-release process necessary for further clinical grade HIV vaccine production. We also receive funding for the continued development of next-generation HIV vaccine candidates. In connection with the agreement, we granted the NIAID a non-exclusive research license for our proprietary adenovector, production cell line, manufacturing process, and formulation technologies for HIV vaccines. In September 2010, the NIAID executed its fourth option period and the program entered its fifth year of funding during the fourth quarter of 2010. GenVec will receive up to $141,000 for the fifth contract year, which will support the generation of HIV vaccine candidates with GenVecs alternate adenovirus serotype technology. Through December 31, 2010, the NIAID had funded approximately $19.0 million under the agreement.

In February 2010, we signed a new contract with the DHS to continue the development of adenovector-based vaccines against FMD. Under this new agreement, we will receive $3.8 million in program funding the first year and an additional $0.7 million if DHS exercises its renewal option under the contract. In June 2010, the DHS exercised its renewal option for $0.7 million. Under this contract, we will use our adenovector technology to develop additional FMD-serotype candidate vaccines and also explore methods to increase the potency and simplify the production process of adenovector-based FMD vaccines.

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