Building a Sustainable, Fully Integrated Biotechnology Company March 7, 2011 Exhibit 99.1 |
Forward Looking Statements • This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. • These statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. • Such forward-looking statements include statements regarding: the therapeutic potential of Infinity’s Hedgehog pathway, FAAH, PI3K and Hsp90 chaperone inhibitors; the potential of IPI-926 in addressing chondrosarcoma , pancreatic cancer and other cancers, presentation of rationale for development of IPI-926 in chondrosarcoma, clinical trial enrollment expectations, an investigator sponsored trial program with IPI-926, presentation of data from Infinity’s trials of IPI-926 pancreatic cancer and chondrosarcoma and of IPI-504 in combination with docetaxel, plans for additional Phase 2 trials of IPI-926, announcement of data and future plans for the company’s Hsp90 program, the commencement of Phase 1 development of IPI-145, Phase 2 development of IPI-940 by Purdue; completing transition activities to enable Phase 2 development by Purdue; the naming of a new drug development candidate, estimates of 2011 financial performance (including cash burn and year-end cash and investments balance), and the expectation that Infinity will have capital to support its current operating plan into 2014. • Such forward-looking statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that Infinity’s strategic alliance with Purdue/Mundipharma will continue for its expected term or that these entities will fund Infinity’s programs as agreed, or that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases. Further, there can be no guarantee that any positive developments in Infinity’s product portfolio will result in stock price appreciation. Infinity’s expectations could also be affected by risks and uncertainties relating to: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites, and publication review bodies; Infinity's ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures, including in connection with business development activities; market acceptance of any products Infinity or its partners may successfully develop; and, Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidate it is developing. • These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission on November 9, 2010. • Further, any forward-looking statements contained in this presentation speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. • All trademarks used in this presentation are the property of their respective owners. • Our Internet website is http://www.infi.com. We regularly use our website to post information regarding our business, product development programs and governance. We encourage investors to use www.infi.com, particularly the information in the section entitled “Investors/Media,” as a source of information about Infinity. References to www.infi.com in this presentation are not intended to, nor shall they be deemed to, incorporate information on www.infi.com into this presentation by reference. 2 |
Building a Sustainable, Fully Integrated Biotechnology Company 3 EXPERIENCED TEAM • Seasoned cross-functional leadership • Augmented in 2010 with key hires in clinical, medical affairs and commercial FINANCIAL STRENGTH • $345M in current and committed capital • Strong strategic alliances • Infinity retains U.S. rights for oncology/inflammation INNOVATIVE PRODUCT PORTFOLIO • Diverse and growing, with 4 candidates in the clinic • Broad commercial potential in oncology/inflammation |
Advancing Pipeline with Broad Commercial Potential 4 |
Hedgehog Program A Fundamentally New Approach to Treating a Broad Range of Cancers 5 |
6 IPI-926: Significant Anti-Cancer Opportunity by Inhibiting Malignant Activation of the Hedgehog Pathway Targeting the Tumor Cell (ligand independent) Targeting the Tumor Cell (ligand dependent) Targeting the Microenvironment Status: Phase 2 trial ongoing in pancreatic cancer Next milestone: Presentation of Phase 1b data in 2011 Status: On-target activity in Phase 1 trial in solid tumors Next milestone: Follow-up Phase 1 data in basal cell carcinoma in 2011 Status: Phase 2 trial ongoing in chondrosarcoma Next milestone: Additional Phase 2 trials planned for in 2011 |
Evidence of Clinical Activity in BCC Patients 7 Rudin et al. ESMO 2010 Patients with BCC Who Have Not Had Prior Treatment with a Hh Inhibitor |
Evidence of Clinical Activity in BCC Patients 8 Patient A Baseline 6 Months Rudin et al. ESMO 2010 |
Evidence of Clinical Activity in BCC Patients 9 Patient B Baseline 4 Months Rudin et al. ESMO 2010 |
Targeting the Tumor Cell: Phase 1 Objectives Achieved Well tolerated – Majority of related adverse events were Grade 1 or 2 – Primary related adverse events: Grade 1 and 2 fatigue and nausea – No Grade 4 or 5 related adverse events observed Pharmacokinetic profile supports once daily dosing Evidence of on target clinical activity observed in BCC patients 10 |
Targeting the Tumor Microenvironment: Pancreatic Cancer • Devastating disease – 4 th leading cause of cancer death in the U.S. – Estimated 43,000 new cases annually • Lowest survival rate of all major cancers – Average survival is < 6 months – 5-year survival < 5% • Highly resistant to treatment with many drugs • Historically considered an “undruggable” tumor – Gemcitabine approved with median survival of 5.7 months 11 |
Tumor with Circulating Contrast Agent MRI Tumor Image Dense Pancreatic Tumor Microenvironment Limits Perfusion 12 Tumor Contrast Agent MRI images of transgenic mouse model of pancreatic cancer. Tumor |
IPI-926 Enhances Delivery of Gemcitabine to Tumor 13 Vehicle Gemcitabine alone IPI-926 + gemcitabine Current standard of care in pancreatic cancer Tumor cell nuclei Fluorescent contrast agent |
Strong Preclinical Rationale for IPI-926 in Pancreatic Cancer 14 IPI-926 + gemcitabine doubles median survival in pancreatic cancer model |
Phase 2 Trial of IPI-926 in Pancreatic Cancer Ongoing 15 • Phase 1b: Determine safety profile and MTD • Phase 2: Evaluate safety and efficacy – Primary endpoint is overall survival; secondary endpoints include progression free survival, time to progression, overall response rate – Rigorous design to mitigate Phase 3 risk Dose Escalation MTD 1:1 Randomization IPI-926 (QD) + gemcitabine (n = 60) Placebo + gemcitabine (n = 60) Phase 1b Phase 2 |
Targeting the Tumor: Major Unmet Medical Need in Chondrosarcoma • Rare, life-threatening bone cancer with limited treatment options – Highly resistant to chemotherapy and radiotherapy – Therapeutic standard is surgery – No effective treatments and no established standard of care for patients with metastatic or locally advanced, inoperable disease • Strong rationale for IPI-926 in chondrosarcoma – Preclinical rationale to be presented during an AACR symposium • Granted orphan drug designation by FDA in this indication 16 |
2:1 Randomizatio n Rigorous Phase 2 Trial of IPI-926 in Chondrosarcoma Underway • Randomized, double blind, placebo controlled study in patients with metastatic or locally advanced, inoperable chondrosarcoma • Primary endpoint is progression free survival • Secondary endpoints include time to progression, overall survival, overall response rate and response duration ~100 Patients IPI-926 (QD) Placebo Progression - crossover to IPI-926 |
IPI-926: Summary • Strong preclinical rationale for all three settings of malignant pathway activation • On-target activity demonstrated in basal cell carcinoma – Plans to present follow-on data • Phase 2 trial in pancreatic cancer advancing – Plans to present Phase 1b data • Phase 2 trial in chondrosarcoma advancing – Plans to present preclinical data at AACR • Additional Phase 2 studies planned for 2011 18 |
Additional Pipeline Opportunities 19 |
Hsp90 Program Overview • IPI-504 well-tolerated in multiple studies at biologically active doses – Phase 2 mBC with Herceptin ® – Phase 2 study NSCLC – Phase 1b solid tumor with docetaxel • Two NSCLC studies ongoing – Phase 1b study with docetaxel – Validation in NSCLC patients with ALK rearrangements (IST) • IPI-493 in two Phase 1 dose escalation studies • Data and future plans anticipated in 2011 20 Sequist et al., Journal of Clinical Oncology, 2010. |
IPI-145: Selectively Inhibiting PI3K Delta and Gamma 21 • Oral, dual-specific inhibitor of PI3K delta and gamma – PI3K plays a key role in cell proliferation and survival, differentiation, trafficking and immunity – Delta and gamma isoforms are strongly implicated in broad range of inflammatory conditions and hematologic cancers • IPI-145 has demonstrated activity in several preclinical models of inflammation • Phase 1 development expected to begin in H2’11 |
• Novel, oral agent designed to potentiate the body’s natural pain relief • Encouraging preliminary data from Phase 1 trial – Marked FAAH inhibition and increased anandamide levels – No observed dose-limiting toxicities • Purdue and Mundipharma exercised rights for worldwide development and commercialization – Expected to begin Phase 2 development in pain in 2011 IPI-940: Leveraging Scientific Insights Beyond Oncology 22 |
Strategic Alliances Provide Funding and Access to Global Markets 23 Hedgehog, PI3K and early discovery • R&D funding from Mundipharma • INFI to develop and register product candidates globally • INFI to commercialize products in the U.S. • Mundipharma to commercialize products ex-U.S. FAAH • Transferred to Purdue and Mundipharma following successful Phase 1 in 2010 • Purdue and Mundipharma responsible for development and global commercialization |
Financial Strength to Drive Value Creation 24 $195 M Committed R&D Funding for 2011-12 $50 M Line of Credit¹ (Balloon note at prime, matures 2019) Cash and Investments (as of 12/31/10, unaudited) Current and Committed Capital $345 Million 1 Line of credit may be drawn for any corporate purpose. |
2011 Financial Guidance Cash Runway into 2014 • Projected 2011 cash burn of $30M - $40M • Anticipate year-end cash and investments balance of $60M - $70M – Based on current operating plan; excludes $50M line of credit from Purdue • Approximately 26.5 million shares outstanding 25 |
Pipeline Advancements in 2011 Hedgehog (IPI-926) Begin Phase 2 portion of pancreatic cancer study Present Phase 1b data in pancreatic cancer Begin additional Phase 2 studies Initiate investigator sponsored trial program Hsp90 (IPI-504 and IPI-493) Present Phase 1 data of IPI-504 in combination with docetaxel Announce future plans for Hsp90 program PI3K (IPI-145) Begin Phase 1 study in H2 FAAH (IPI-940) Complete transition activities to Purdue to enable Phase 2 studies in pain Discovery Name a new development candidate 26 |
Achieving Our Mission: Sustainable, Fully Integrated Biotech EXPERIENCED TEAM FINANCIAL STRENGTH INNOVATIVE PRODUCT PORTFOLIO |
Building a Sustainable, Fully Integrated Biotechnology Company January 2011 |