LEXINGTON, Mass., Feb. For the nine months ended September 30, 2013, the company reported a net loss attributable to common stockholders of $27.4 million, or $0.99 per share, basic and diluted, compared with a net loss attributable to common stockholders of $6.5 million, or $0.28 per share, basic and diluted, for the nine months ended September 30, 2012. HerpV contains a defined mixture of peptides representing HSV-2 antigens plus Agenus’ QS-21 Stimulon® adjuvant. Cash used in operating activities for the first quarter ended March 31, 2013 was $3.9 million compared to cash provided by operating activities of $11.3 million for the same period in 2012. As a result of various corporate transactions, net loss for the six months ended June 30, 2013 increased compared to the net loss for the same period in 2012 primarily due to revenue generated in 2012 from one-time payments received and to $6.2 million of non-recurring non-cash charges in 2013. Their QS-21 Stimulon Adjuvant aims to strengthen the body’s immune response to a vaccine’s antigen and is being tested on Malaria, Melanoma, Shingles, Alzheimer’s Disease, Genital Herpes, and Non-Small Cell Lung Cancer. A booster injection of HerpV will be given at six months after treatment to evaluate the potential durability of treatment effect.
In a separate Phase II study newly diagnosed GBM patients were given surgery plus temazolomode and radiation, plus Prophage vaccine, in a single arm open label study, with median progression-free survival of 18 months, vs. The reduction of severe malaria cases and malaria hospitalizations by 15% and 17%, respectively, were not statistically significant. Segment 6 encodes NA (neuraminidase). Previous results from one year follow-up of the Phase 3 trial showed that efficacy of RTS,S was 56% against clinical malaria and 47% against severe malaria for the 5-17 month-old age group and 31% against clinical malaria and 37% against severe malaria in the 6-12 week-old age group. The increase in net loss attributable to common stockholders for the year ended December 31, 2013 compared to the net loss attributable to common stockholders for the same period in 2012, was primarily due to $6.2 million of non-recurring non-cash charges incurred during 2013 and one-time payments of $13.4 million received during 2012. No new safety signals were observed during this longer follow-up period. The primary aim of the study is to test the biological efficacy of the HerpV vaccine as measured by effect on genital HSV-2 viral shedding.
Some of the treatment areas include brain cancer, lung cancer, melanoma, genital herpes, shingles, malaria and tuberculosis. These statements speak only as of the date of this call and Agenus undertakes no obligation to update or revise these statements. These new data support GSK’s plans to submit a regulatory application in 2014 for a Scientific Opinion of the European Medicines Agency (EMA) on RTS,S safety, efficacy and quality. The highly targeted mode of action of GSK CIs against specific cancer antigens expressed by tumor cells may allow selection of patients eligible for the treatment depending on the expression of the tumor antigens. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+. GSK will continue the study until the second co-primary endpoint is assessed. QS-21 Stimulon is designed to strengthen the body’s immune response to a vaccine’s antigen, thus making it more effective.
Agenus’ GMP QS-21 Stimulon has become a key component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to be essential for several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. QS-21 Stimulon has been widely studied and approximately 50,000 patients have received vaccines containing the adjuvant. In the first quarter of 2012, revenue of $13.4 million was generated primarily due to one-time payments received to an extended agreement with GlaxoSmithKline and to a license of non-core technologies. When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties. Agenus is generally entitled to receive milestone payments as QS-21 Stimulon containing programs advance, as well as royalties for 10 years after commercial launch, with some exceptions. Agenus Inc. HerpV, one of the most clinically advanced HSV-2 therapeutic vaccine candidates in development, is currently in a Phase 2 randomized, double-blind, multicenter study.
The company is focused on immunotherapeutic products based on strong platform technologies with multiple product candidates advancing through the clinic, including several product candidates that have advanced into late-stage clinical trials through corporate partners. This broad spectrum of herpes antigens is intended to allow for more accurate immune targeting and surveillance, reducing the likelihood of immune escape. The vaccine is based on Agenus’ HSP platform technology, and contains Agenus’ proprietary QS-21 Stimulon adjuvant. I would like to note that HerpV is the most advanced therapeutic vaccine in clinical development today. The company is focused on immunotherapeutic products based on strong platform technologies with multiple product candidates advancing through the clinic, including several product candidates that have advanced into late-stage clinical trials through corporate partners. We can also target geographies that are not priorities for the other players. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release.
Therefore, the gene flow in and out of this population, and not natural selection, was more important in the short term. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. HerpV is a recombinant therapeutic vaccine candidate for the treatment of genital herpes, which is caused by the herpes simplex virus-2 (HSV-2). When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties.