LEXINGTON, Mass.–(BUSINESS WIRE)– 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’s net loss attributable to common stockholders for the second quarter of 2013 was $11.2 million, or $0.40 per share, basic and diluted, compared to a net loss attributable to common stockholders of $7.1 million, or $0.31 per share, basic and diluted, for the second quarter of 2012. Its products under development include QS-21 Stimulon adjuvant, which is in Phase III clinical trials for the treatment of malaria, melanoma, non-small cell lung cancer, and shingles, as well as for the treatment of various infectious diseases, multiple cancer types, and Alzheimers disease; and HerpV, a therapeutic vaccine candidate that is in Phase II clinical trial for the treatment of genital herpes. The Phase 2 study (designated as protocol C-400-02) has screened over 100 HSV-2 positive subjects and enrollment has been closed. Agenus management believes it has sufficient funds to operate the company through 2014. New Phase 3 data for GSK’s RTS,S malaria vaccine candidate, which contains Agenus’ QS-21 Stimulon adjuvant, were presented at a Multilateral Initiative on Malaria Pan African Conference in Durban, South Africa.
HA determines the extent and severity of a viral infection in a host organism. Centers for Disease Control and Prevention, 776,000 people in the United States get new herpes infections annually and one out of six people aged 14 to 49 years has genital HSV-2 infection. Cash and cash equivalents were $27.4 million as of December 31, 2013. GSK currently has 9 active Phase 3 studies underway for the HZ/su vaccine candidate. HerpV contains QS-21 Stimulon. While we are not yet perceived as an important beneficiary of this exciting trend I expect that we will soon be. Reference to these risks and uncertainties is made in today’s press release and they are disclosed in more detail in our most recent filings with the U.S.
Separately, Agenus received $11.4 million from the sale of our common stock in at-the-market offerings. CIs are designed to trigger a specific immune response against tumor cells expressing these proteins, rallying antibodies and T-cells to recognize and attack the cancer cells in a highly specific manner and eventually eliminate them. 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. A recent analysis from a Phase 2 trial in patients with newly diagnosed glioblastoma multiforme (GBM) treated with Prophage Series G-100 (HSPPC-96) in combination with the current standard of care (radiation and temozolomide) showed an almost 18 month median progression free survival, which represents a 160% increase versus current standard of care alone.2 Median overall survival (OS), the primary endpoint of the trial, is 23.3 months and remains durable in patients treated with HSPPC-96 versus the standard of care alone, which is 14.6 months.2 Based on these findings, Agenus plans to hold an end of Phase 2 meeting with the US Food and Drug Administration to discuss a Phase 3 trial that could potentially lead to marketing approval of the HSPPC-96 vaccine as a treatment for patients with newly diagnosed GBM. In exchange for the reduced dividend rate, Agenus issued the preferred stockholder 666,666 shares of common stock, $0.01 par value. If further analysis shows that the predefined gene signature subset data are successful, there is the potential that a regulatory filing could be considered. GSK anticipates that these data will be available in 2015.
In the first quarter of 2013, the company’s preferred stock restructuring which reduced the dividend requirements for Series A-1 preferred securities resulted in a non-cash deemed dividend of $2.9 million. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. QS-21 Stimulon is being studied in 21 vaccine indications, which include GSK’s Phase 3 vaccine programs for RTS,S for malaria, MAGE-A3 cancer immunotherapeutic for non-small cell lung cancer and melanoma and HZ/su for shingles. Licensees of QS-21 Stimulon include GSK and Janssen Alzheimer Immunotherapy. Agenus is generally entitled to receive milestone payments as QS-21Stimulon-containing programs advance, as well as royalties for 10 years after commercial launch, with some exceptions. HerpV is a recombinant therapeutic vaccine candidate for the treatment of genital herpes, which is caused by the herpes simplex virus-2 (HSV-2). The vaccine is based on Agenus’ HSP platform technology, and contains Agenus’ proprietary QS-21 Stimulon adjuvant.
HerpV is the most clinically advanced HSV-2 therapeutic vaccine and is currently in a Phase 2 randomized, double-blind, multicenter study. As I mentioned earlier, our HerpV randomized double blind, multi-cancer Phase 2 trial in individuals infected with HerpV 2 is fully screened for enrolment. Agenus Inc. We began to work on this 3 years ago. Further, the diversity of antigens in HerpV increases the chance of providing efficacy for a wide segment of the patient population. Within a given season, adaptive evolution is infrequent and had an overall weak effect as evidenced from the data gathered from the 413 genomes. Patients received three treatments at two-week intervals.
Patient enrollment is underway for the large-scale, randomized Phase 2 trial of Prophage in combination with Avastin® in patients with surgically resectable recurrent GBM. All patients who received HerpV and were evaluable for immune response showed a statistically significant CD4+ T cell response (100%; 7/7) to HSV-2 antigens as detected by IFNγ Elispot, and the majority of those patients demonstrated a CD8+ T cell response (75%; 6/8). All patients who received HerpV and were evaluable for immune response showed a statistically significant CD4+ T cell response (100%; 7/7) to HSV-2 antigens as detected by IFNγ Elispot, and the majority of those patients demonstrated a CD8+ T cell response (75%; 6/8). The Melanoma Phase 3 data is anticipated during the second half of this year and non-small cell lung cancer study is expected to readout around the end of this year. Our guidance for this year’s burn rate is between $35 million and $40 million. The Prophage Series vaccines are currently being studied in both newly diagnosed and recurrent GBM. J Clin Oncol 2000; 18(12): 2444-2458.
This trial is investigating the combination of G-200 and Avastin in a three-arm randomized study of 222 patients with surgically resectable recurrent GBM. Patient enrollment is underway for the large-scale, randomized Phase 2 trial of Prophage Series G-200 in combination with Avastin® in patients with surgically resectable recurrent GBM. In this trial, G-100 is being used with the standard of care, which includes Temodar® (Merck; temozolomide) and radiation. In this trial, G-100 is being used with the standard of care, which includes Temodar® (Merck; temozolomide) and radiation. It is believed that the efficacy of G-100 could potentially be enhanced through this combination regimen. We believe that a therapeutic vaccine that showed efficacy with a good safety profile could represent a paradigm shift for both doctors and patients in helping to prevent or delay recurrence of cancer. Eastern Time today.
To access the live call, dial 647-426-1845. The call will also be webcast and will be accessible from the company’s website at www.agenusbio.com/webcast/. A replay will be available approximately two hours after the call through midnight Eastern Time on December 23, 2013. The replay number is 416-915-1035 and the access code is 402191. The replay will also be available on the company’s website approximately two hours after the live call. A replay will be available approximately two hours after the call through midnight Eastern Time on August 25, 2013. The trial is targeted to include 374 cancer patients by the end of enrollment.
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. For more information, please visit www.agenusbio.com. This earnings release contains forward-looking statements, including statements regarding development and clinical trial activities, data read-outs and timelines of the company and its licensees and collaborators, potential benefit of product candidates in development, and potential revenue streams from our partnering and licensing arrangements. ^ “Unique new flu virus found in bats”. These risks and uncertainties include, among others, decisions by regulatory authorities, physicians, patients, and our existing and potential licensees and collaborators; the possibility that clinical trial results will not be favorable; the inability to secure favorable partnering arrangements; the ability to raise capital; and the factors described under the Risk Factors section of our Annual Report on Form 10-Q filed for the period ended June 30, 2013 and other reports filed with the Securities and Exchange Commission. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended September 30, 2013. These statements speak only as of the date of this document, and Agenus undertakes no obligation to update or revise the statements.
These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. The second item on the agenda is a proposal to approve an amendment for the company’s 2009 equity incentive plan. We know that the immune system is necessary to protect us against infection.