![]() Corporate Presentation March 2011 Exhibit 99.1 |
![]() 2 Forward-Looking Statement This presentation contains forward-looking statements including statements regarding the company’s lead product candidates Oncophage ® , Prophage Series, formerly known as Oncophage, (vitespen; formerly HSPPC-96), QS-21 Stimulon ® and HerpV, formerly AG-707, (including, but not limited to, the timing of product development, launch and product revenues), the successful development of the Company’s products by collaborative partners, the company’s clinical trials (including, but not limited to, trial initiation, enrollment, completion, analysis and interpretation of results), the confirmation of Oncophage subgroup analyses, the regulatory approval process (including, but not limited to, dates and locations of filings), research programs and other future events and operations. These forward-looking statements involve uncertainties and risks that are described under Risk Factors of the Company’s Form 10-Q as filed with the Securities and Exchange Commission for the period ended September 30, 2010. Actual results could differ materially from these forward-looking statements. |
![]() 3 A New Name • Our pipeline has moved beyond autologous antigen-based technologies • Our strategy focuses advancing our platform technologies through collaboration • www.agenusbio.com |
![]() 4 Agenus Investment Highlights • QS-21 vaccine adjuvant: Royalty potential in 2013-2014 • Oncophage® • Prophage Series of therapeutic cancer vaccines advancing in clinic • HerpV in genital herpes |
![]() 5 Product and Clinical Pipeline Product Indication Phase 1 Phase 2 Phase 3 Market Oncophage for Renal Cell Carcinoma in Russia Prophage for Glioma (recurrent) Prophage for Glioma (newly diagnosed) QS-21 in Non-Small Cell Lung Cancer QS-21 in Melanoma QS-21 in Malaria QS-21 in Shingles partnered with GSK partnered with GSK partnered with GSK partnered with GSK QS-21 in Alzheimer’s Disease QS-21 in multiple undisclosed vaccines partnered with Janssen HerpV for Genital Herpes |
![]() 6 QS-21: Maturing Pipeline, Addressing 10B+ Market • Clinical indications under investigation (global incidence) – NSCLC (lung: 1.5m)* – Alzheimer's disease (prevalence: 26.6m)** – Malaria (250m)** – HIV (2.6m)** – AML (leukemias: 331k)* – Tuberculosis (9.3m)** – Varicella-zoster (US: 1m)*** – Prostate cancer (783k)* – Breast cancer (1.3m)* – Melanoma (132k)**** 22 14 4 0 5 10 15 20 25 Total Vaccines Clinical Phase 3 QS-21 Pipeline *ACS Global Cancer Facts & Figures 2007 **Wikipedia ***NIAID ****WHO |
![]() 7 QS-21: Significant Clinical Progress • GlaxoSmithKline – Phase 3 NSCLC study launched in 2007 (MAGE-A3) • Phase 3 (n=2,270) ongoing; largest trial conducted in NSCLC • Phase 2b (n=180): 25% reduction in recurrence vs. placebo – Phase 3 melanoma study launched Dec. 2008 (MAGE-A3) • Phase 3: n=1,300 – Phase 3 malaria study launched March 2009 • Phase 3: n=16,000, last patient expected to be dosed Feb. 2011 • Phase 2: 53% reduction in clinical episodes of malaria – Phase 3 shingles study launched in 2010 • Two Phase 3 studies, n=15,000 per study – GSK/Abbott MAGE-A3 diagnostic agreement • JANSSEN(J&J)/Pfizer – Phase 2 Alzheimer’s disease study launched in 2007 – Janssen/GE collaboration to identify early markers of Alzheimer’s |
![]() 8 The PROPHAGE Series of Cancer Vaccines |
![]() 9 PROPHAGE Series: 1 st Approved Cancer Vaccine • Patient-specific HSP-based therapeutic cancer vaccine • Theoretically applicable to almost any cancer • >850 patients worldwide safely treated in 8 cancers • Simple out-patient injection • Manufactured in less than 10 hours • Phase 3 adjuvant RCC data has strengthened over time |
![]() 10 PROPHAGE Series Clinical Overview • Signals of clinical activity observed in 8 cancers (US incidence)* – Kidney (58,240) – Melanoma (68,130) – Brain (22,020) – Colorectal (142,570) – Lung (222,520)** – Pancreatic (43,140) – Gastric (21,000) – Non-Hodgkin’s lymphoma (65,540) • Efficacy signals include tumor-specific and innate immune responses, tumor responses, RFS, PFS, OS across tumor types • Efficacy appears most pronounced in earlier-stage patients • Combination trials allow for more advanced disease • Well tolerated; low toxicity profile *ACS Cancer Facts Figures 2010 **Manufacturing feasibility only |
![]() Oncophage® Demonstrates Statistical Significance in ECOG Intermediate Risk RCC Patients |
![]() 12 Overall Survival, Intermediate-Risk |
![]() 13 PROPHAGE Opportunity: Glioma • Over 20,000 cases of brain cancer diagnosed each year in the US • Phase 2 trial underway in newly diagnosed glioma – Actively enrolling patients (n=50); recently expanded to 10 sites – Prophage + standard of care [radiation therapy plus Temodar (temozolomide)] – No significant toxicities observed to date • Phase 1/2 trial in recurrent glioma – Phase 2 portion actively enrolling patients (n=30) – Phase 2 survival data • Median survival 44 weeks, compared to historical median of 26 weeks • 70% of patients survived beyond 36 weeks • 40% survived up to or longer than 1 year • All patients tested mounted innate immune response, 92% mounted adaptive CD4/CD8 t-cell response • Potential for accelerated registration pathway in the US • Investigator-sponsored (UCSF); funded by NCI, patient advocacy groups |
![]() NCCN Practice Guidelines (2011) Treatment NCCN Practice Guidelines (2011) Treatment Overview: Recurrent GBM Overview: Recurrent GBM Agents listed in the practice guidelines Median OS Months Platinum Based Regimens¹ 7.4 PCV² 7.6 Cyclophosphamide³ 4.0 Carmustine wafer 4 7.5 Temozolomide 5 Not Reported/median PFS 5 mos. Bevacizumab 6 9.2 Prophage Series G-200 7 >10 months 1 Yung WK, et al. J Clin Oncol 1991 (Population included AA and GBM) ,2 Kappelle AC, et al. Neurology 2001 (Procarbazine, Lomustine, Vincristine combination), 3 Chamberlain MC, Tsao-Wei, DD. Cancer 2004 4 Brem et al. Lancet 1995, 5 Perry et al. Cancer 2008, 6 Friedman et al. J Clin Oncol 2009, 7 Parsa et al. 18th International Conference for Brain Tumor Research and Therapy |
![]() NCCN Practice Guidelines (2011) NCCN Practice Guidelines (2011) Treatment Overview: Newly Diagnosed GBM Treatment Overview: Newly Diagnosed GBM Agents listed in the practice guidelines Median PFS/OS Months Carmustine wafer¹ PFS 5.9 OS 13.9 Radiation/Temozolomide² PFS 6.9 OS 14.6 XRT/TMZ + Prophage Series G-100 (n=15) N/A 1 Westphal et al. Neuro-Oncology 2003 2 Stupp et al. NEJM 2005 |
![]() 16 "Significant Advances" (p< 0.05) in Epithelial Malignancies in Patients Not Selected on the Basis of Molecular Characteristics Drug Tumor Survival Gain (months) • Gemcitabine Pancreas 1.5 • Bevacizumab Colon 2.2 • Erlotinib Pancreas 0.4 • Bevacizumab NSCLC 2 • Sorafenib Renal 2 • Temozolamide GBM 2.5 • Docetaxel Prostate 2.4 • Topotecan Cervix 2.3 • Cetuximab Colon 1.5 • Erlotinib NSCLC 2 • Cetuximab NSCLC 1.2 • Bevacizumab Breast 1.5 Data from Stewart DJ, Kurzrock R. Cancer: the road to Amiens. J Clin Oncol 2009;27:328–33. |
![]() 17 A New Era for Cancer Vaccines • Provenge FDA approval • Ipilimumab imminent FDA PDUFA date • Rationale for combinations with vaccines • Newly-created opportunity to use combinations |
![]() 18 Genital Herpes and HerpV Overview • Genital herpes is the most prevalent viral STD – Approximately 55 million Americans/Europeans affected – 80% of patients suffer symptomatic recurrences • Virus establishes life-long latency • HerpV is an off-the-shelf HSP-based therapeutic vaccine candidate for treatment of genital herpes • Contains 32 immunogenic peptides of the herpes genome • Promising Phase 1 results – 100% of evaluable patients receiving HerpV+QS-21 had CD4+T-cell response – 63% had CD8+ T-cell response; seeing both is unprecedented – Safety profile established • Potential to partner for Phase 2 and beyond • Potential platform technology |
![]() 19 2011 Goals and Objectives • Continued clinical advancement of QS-21 vaccine adjuvant – Possible Phase 3 data announcements • Partnerships for Oncophage® in RCC in Europe/Russia • Advancement of Prophage in glioma (brain cancer) – Recurrent glioma data presentation mid-year – Exploration of accelerated US regulatory pathway – Initiation of pediatric trial mid-year – Potential for partnership • Initiation of Prophage Series combination trials • Development of HerpV in genital herpes – Data publication mid-year – Potential for partnership opportunity • In-licensing agreements and new corporate/academic collaborations |
![]() 20 Balance Sheet December 31, 2010 ($ millions) Cash and short-term investments $19.8 Other current assets 1.1 Net plant and equipment 6.2 Other long-term assets 3.8 Total assets $30.9 Current liabilities $40.1 Long-term liabilities 5.5 Stockholders’ equity (14.7) Total liabilities and stockholders’ equity $30.9 |