Immunology

Agenus Inc. (NASDAQ: AGEN), a biopharmaceutical company developing a portfolio of immuno-oncology candidates, including checkpoint modulators (CPMs), heat shock protein vaccines and adjuvants, today announced its financial results and business highlights for the fourth quarter and year ended December 31, 2013.

"We began 2014 with the acquisition of an exciting new platform of fully-human checkpoint antibodies. This platform has generated six lead discovery programs in immuno-oncology," said Garo H. Armen, PhD, chairman and CEO of Agenus. "This transformative acquisition along with our strengthened balance sheet from our recent financing enables us to rigorously pursue our cancer immuno-oncology strategy with a broad portfolio of innovative products. I look forward to reporting progress from all of our platforms this year, which include QS-21 Stimulon adjuvant, heat shock protein vaccines and checkpoint modulators."

On February 12, 2014, Agenus completed the acquisition of 4-Antibody AG, a private European-based biopharmaceutical company. The 4-Antibody assets include the Retrocyte Display^® technology platform which is designed to enable rapid discovery and optimization of fully human antibodies against a wide array of molecular targets. 4-Antibody has applied Retrocyte Display to create therapeutic antibodies to six checkpoint targets that regulate immune response to cancers and other diseases. 4-Antibody has multiple preclinical immune CPM programs in development including GITR and OX40 agonists and antagonists of TIM-3, LAG-3, PD-1 and CTLA-4. These programs are being pursued through a strategic collaboration with the Ludwig Cancer Research.

Fourth Quarter 2013 and Full Year Financial Update

For the fourth quarter, Agenus reported a net loss attributable to common stockholders of $5.8 million, or $0.16 per share, basic and diluted, compared with a net loss attributable to common stockholders for the fourth quarter of 2012 of $5.6 million, or $0.23 per share, basic and diluted.

For the year ended December 31, 2013, the company incurred a net loss attributable to common stockholders of $33.2 million, or $1.12 per share, basic and diluted, compared with a net loss attributable to common stockholders of $12.1 million, or $0.51 per share, basic and diluted, for the comparable period in 2012.

Cash and cash equivalents were $27.4 million as of December 31, 2013. Subsequent to year end, the company's cash position includes net proceeds of approximately $56 million from a registered public offering completed in the first quarter of 2014.

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. 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 charge of $2.9 million. In the second quarter of 2013, the Company retired its outstanding 8.0% senior secured convertible notes due August 2014 in the principal amount of $39 million resulting in a non-cash loss of $3.3 million. In 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.

Recent and Fourth Quarter 2013 Highlights:

• Identified three CPM lead candidates that will advance into IND-enabling development. These include two GITR agonists and a CTLA-4 antagonist, which are the result of research collaboration with Ludwig Cancer Research.
• Completed an underwritten registered public offering resulting in net proceeds of approximately $56 million.
• Announced initiation of a randomized Phase 2 trial with Prophage and Yervoy^® (ipilimumab) for the treatment of Stage III and IV metastatic melanoma. The combination has the potential to trigger a more effective immune response against the tumor than Yervoy alone.
• Appointed Robert B. Stein, MD, PhD, to the newly-created position of Chief Scientific Officer (CSO).
• Phase 2 data published in Neuro-Oncology demonstrated that over 90% of patients with recurrent glioblastoma multiforme (GBM) treated with Prophage were alive at six months after surgery and 30% were alive at twelve months.
• An independent editorial by John Sampson, MD, PhD, The Dr. Robert H. Wilkins and Gloria Wilkins Professor of Neurosurgery and Professor of Immunology and Pathology at Duke University Medical Center called the results 'impressive' and said they represent a potentially 'very promising therapy' in patients in desperate need of new treatments.
• Prophage for the treatment of brain cancer was selected as a 2013 Top Project to Watch in oncology. This selection was made through Elsevier Business Intelligence's panel of independent experts who screen hundreds of programs and weigh their potential as future products.
• Reported statistically significant top-line results from its Phase 2 randomized, double-blind, multi-center study for HerpV, a recombinant therapeutic vaccine candidate for the treatment of patients with herpes simplex virus-2 (HSV-2). HerpV contains a defined mixture of peptides representing HSV-2 antigens plus Agenus' QS-21 Stimulon®adjuvant.

Additional milestones anticipated in 2014 include: