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Agenus Reports First Quarter 2013 Financial Results

LEXINGTON, Mass., April 24, 2013 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN), a biotechnology company working to develop novel immunology based treatments for cancers and infectious diseases, today announced its financial results and business highlights for the first quarter ended March 31, 2013.

The company reported a net loss attributable to common stockholders of $8.8 million, or $0.35 per share, basic and diluted, for the first quarter of 2013, compared with net income attributable to common stockholders in the first quarter of 2012 of $6.6 million, or $0.29 per share, basic and diluted.

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. Cash and cash equivalents were $17.2 million as of March 31, 2013.

Net loss for the first quarter of 2013 compared to net income in 2012 is a result of various corporate transactions. In the first quarter of 2013, the company's preferred stock restructuring, which reduced the dividend requirements for its Series A-1 preferred securities, resulted in a non-cash deemed dividend of $2.9 million. In the first quarter of 2012, revenue of $13.4 million was generated primarily due to one-time payments received through an expanded agreement with GlaxoSmithKline (GSK) and through a license of non-core technologies.

"After the close of the quarter, we successfully restructured and significantly reduced our debt," said Garo H. Armen, Ph.D., chairman and CEO of Agenus. "This year we expect Phase 3 data from GSK's MAGE-A3 vaccine programs, Phase 2 data for HerpV to treat genital herpes, and Phase 2 data for Prophage Series to treat newly diagnosed and recurrent glioma. Positive results from these studies could represent breakthrough advances in research related to therapeutic vaccines."

Recent Highlights

  • Agenus has completed screening for enrollment of the Phase 2 randomized, double-blind, multicenter study for HerpV, a recombinant "off-the-shelf" therapeutic vaccine candidate for the treatment of genital herpes in Herpes Simplex Virus 2 (HSV-2) positive subjects. HerpV contains QS-21 Stimulon ®1 adjuvant ("QS-21 Stimulon"). This study is testing the biological efficacy of the HerpV vaccine as measured by effect on genital viral shedding. The Phase 2 data are anticipated during the fourth quarter of 2013.
  • In a plenary session presentation, Orin Bloch, MD, of the Department of Neurological Surgery, University of California San Francisco (UCSF) will present an abstract that reports on outcomes with HSPPC-96 vaccination in patients with newly diagnosed glioma at the 81 st   American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in New Orleans, Louisiana on May 1st.
  • In early April, Agenus retired its outstanding $39 million 8.00% senior secured convertible notes due August 2014. These Notes were exchanged for $10 million in cash, 2,500,000 shares of common stock and a twenty percent revenue interest from QS-21 Stimulon partnered programs. In addition, the company entered into two separate $5 million debt transactions for $10 million total in notes plus 500,000 share warrants. Following these transactions, Agenus' total debt obligation outstanding is $10 million, down from $39 million.
  • Agenus reduced the dividend rate on its convertible preferred stock by exchanging Series A for Series A-1, thereby reducing the annual rate from 2.5% to 0.6325%. In exchange for the reduced dividend rate, Agenus issued the preferred stockholder 666,666 shares of common stock, $0.01 par value.

Between Agenus and its partners, a total of 19 vaccine programs are in clinical development of which 17 contain QS-21 Stimulon. They include, but are not limited to:

  • Phase 3: GSK's RTS,S for malaria 2
  • Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with resected melanoma 2
  • Phase 3: GSK's MAGE-A3 cancer immunotherapy for selected patients with resected non-small cell lung cancer 2
  • Phase 3: GSK's HZ/su for shingles 2
  • Phase 2: Janssen's  ACC-001 for Alzheimer's disease

Agenus' pipeline programs include:

  • Phase 2: HerpV (contains QS-21 Stimulon) for genital herpes
  • Phase 2: Prophage Series G-100 for newly diagnosed glioma
  • Phase 2: Prophage Series G-200 for recurrent glioma

Saponin Platform: QS-21 Stimulon ® Adjuvant

Agenus' QS-21 Stimulon adjuvant is one of the most widely tested vaccine adjuvants under development. QS-21 Stimulon is designed to strengthen the body's immune response to a vaccine's antigen, thus making it more effective. QS-21 Stimulon is a key component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to play an important role in several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. Licensees of QS-21 Stimulon include GSK and Janssen Alzheimer Immunotherapy. 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.

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