Innovation. Evolution. Impact. Exhibit 99.1 |
Innovation. Evolution. Impact. 2 Safe Harbor Statement • 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; future development activity for IPI-504, IPI-493, IPI-926, IPI-940 and IPI-145; the presentation of clinical data for IPI-504, IPI-493 and IPI-926; estimates of 2010 financial performance; the continuation of the Purdue/Mundipharma alliance; and the expectation that Infinity will have capital to support its current operating plan into 2013. • 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; Infinity’s license and development agreement with Intellikine 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 2 |
Innovation. Evolution. Impact. Infinity: Innovation. Evolution. Impact. 3 |
Innovation. Evolution. Impact. Financial Strength to Create Value Substantial Capital to Invest in Pipeline and Access External Opportunities 4 January 1, 2011: Est. $225M - $235M in Capital |
Innovation. Evolution. Impact. Strategic Partnerships Enabling INFI To Become a Fully Integrated Biopharmaceutical Company • 100% R&D funding for partnered programs, including Hedgehog, PI3K, FAAH and early discovery programs • INFI leads all discovery and development efforts through registration for programs other than FAAH • Retention of valuable commercial rights and downstream financial participation – INFI has U.S. commercialization rights to all programs other than FAAH – Significant royalties on ex-U.S. sales and U.S. sales of FAAH inhibitors • Access to worldwide leadership in pain management and ex-US commercial markets |
Innovation. Evolution. Impact. Developing a Pipeline of Broadly Applicable, Targeted Therapies 6 IPI-926 Hedgehog Pain Oncology Autoimmune and Inflammatory Disease IPI-145 PI3K / IPI-940 FAAH IPI-504; IPI-493 Hsp90 |
Broadly Applicable, Targeted Therapies in Oncology |
Innovation. Evolution. Impact. 8 IPI-926: Significant Anti-Cancer Opportunity by Inhibiting Malignant Activation of the Hedgehog Pathway Targeting the Microenvironment Targeting the Tumor Cell Targeting Residual Disease |
Innovation. Evolution. Impact. Mean (±SD) Plasma IPI-926 Concentrations Following a Single 130 mg Dose and Following Repeated Once-Daily Administration of 130 mg IPI-926 . IPI-926 Phase 1 Study in Advanced or Metastatic Solid Tumors PK Profile Supports Once Daily Dosing 9 Rudin et al. ESMO 2010 |
Innovation. Evolution. Impact. 10 Rudin et al. ESMO 2010 IPI-926 Phase 1 Study Evidence of Clinical Activity in BCC Patients Patients with BCC Who Have Not Had Prior Treatment with a Hh-Inhibitor |
Innovation. Evolution. Impact. • The majority of related AEs were Grade 1 or 2 • No Grade 4 or 5 related AEs have been observed • Primary related AEs were Grade 1 and 2 fatigue and nausea 11 Rudin et al. ESMO 2010 IPI-926 Phase 1 Study Favorable Tolerability Profile |
Innovation. Evolution. Impact. IPI-926: Strong Preclinical Rationale for Targeting Minimal Residual Disease 12 1 Travaglione et al., 2008 AACR 3 Mandley et al., 2010 AACR 2 Proctor et al., 2010 AACR Phase 2 study in minimal residual disease setting expected to begin in 2011 |
Innovation. Evolution. Impact. Pancreatic Cancer: A Difficult-to-Treat, Devastating Disease • Fourth leading cause of cancer in the U.S. – Estimated 40,000 new cases expected in 2010 • Highest mortality 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 13 IPI-926 represents a fundamentally new approach to treating pancreatic cancer |
Innovation. Evolution. Impact. IPI-926: Strong Preclinical Rationale for Targeting the Tumor Microenvironment 14 1 Olive et al., 21 May 2009 Science 2 Travaglione et al., 2010 AACR |
Innovation. Evolution. Impact. IPI-926: Phase 1b/2 Study in Pancreatic Cancer • 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 15 |
Innovation. Evolution. Impact. IPI-926: Significant Potential Across a Broad Range of Difficult-to-Treat Cancers 16 • Preclinical models support development in all three modes of action • Promising Phase 1 data in BCC recently reported • Phase 2 study in residual disease setting anticipated in 2011 • Rigorous Phase 1b/2 study in pancreatic cancer study ongoing Targeting the Microenvironment Targeting the Tumor Cell Targeting Residual Disease |
Innovation. Evolution. Impact. 17 Hsp90 chaperone stabilizes oncoproteins Hsp90 inhibitors combinable with best available therapies Inhibiting Hsp90 degrades oncoproteins, stopping tumor growth IPI-504 and IPI-493: Broadly Attacking Oncoproteins through Hsp90 Chaperone Inhibition |
Innovation. Evolution. Impact. IPI-504 i.v.: Current Status • Well-tolerated in multiple studies at biologically active doses – Phase 2 mBC with Herceptin ® – Phase 2 study NSCLC – Phase 1b solid tumor with Taxotere ® • Two NSCLC studies ongoing – Validation in NSCLC patients with ALK rearrangements (IST) – Phase 1b study with Taxotere ® • No additional trials planned at this time – Any future studies will be based on data and market insights 18 1 Sequist et al., 2010 ASCO |
Innovation. Evolution. Impact. IPI-493 Oral: Distinct Pharmaceutical Properties • Phase 1 program underway – Two ongoing Phase 1 studies – one in hematologic malignancies and one in solid tumors – Studies designed to assess efficacy and dosing regimen – Demonstration of client protein degradation by IPI-493 a key milestone for further investment • Data and articulation of future plans for Hsp90 program anticipated in 2011 19 |
Broadly Applicable, Targeted Therapies in Pain and Inflammation |
Innovation. Evolution. Impact. 21 IPI-940: Combating the Magnitude of Neuropathic Pain by Inhibiting Fatty Acid Amide Hydrolase (FAAH) |
Innovation. Evolution. Impact. IPI-940: Novel Agent Enabling the Body’s Natural Analgesia • Novel, oral agent designed to potentiate the magnitude and duration of body’s natural analgesia • Encouraging preliminary data from single-dose study of IPI-940 in normal healthy adult volunteers – Marked FAAH inhibition and increased anandamide levels observed – No observed dose-limiting toxicities or clinically significant changes in clinical laboratory values • Additional Phase 1 development of IPI-940 is ongoing • Purdue and Mundipharma exercised rights for worldwide development and commercialization 22 |
Innovation. Evolution. Impact. IPI-940: Targeting Broad Areas of Unmet Need Purdue Plans to Begin Phase 2 Studies in Pain in 2011 • Neuropathic pain – Postherpetic neuralgia – HIV pain – Peripheral diabetic neuropathy – Chemotherapy-induced neuropathy – Trigeminal neuralgia – Fibromyalgia • Osteoarthritis pain • Anxiety and depression • Inflammatory conditions 23 |
Innovation. Evolution. Impact. 24 IPI-145: PI3K Inhibitor Leveraging Oncology Expertise to Address Significant Untapped Opportunity in Autoimmune/Inflammatory Disease and Oncology |
Innovation. Evolution. Impact. PI3K : Distinct and Overlapping Roles in Immunity, with Significant Therapeutic Potential • PI3K plays key regulatory role in cell proliferation and survival, cell differentiation, cell trafficking and immunity • Delta and gamma isoforms are restricted to immune system cells – Strongly implicated in broad range of immune-mediated inflammatory and allergic disorders and hematologic cancers 25 |
Innovation. Evolution. Impact. IPI-145: Differentiated Product Candidate Rapidly Advancing to the Clinic • IPI-145 is a novel, orally available, small molecule dual-specific inhibitor of PI3K and PI3K – Demonstrated activity in preclinical models of rheumatoid arthritis, allergy, and inflammation – Phase 1 development expected to begin in 2011 • Research collaboration with Intellikine to identify additional differentiated PI3K and/or PI3K inhibitors for development 26 |
Innovation. Evolution. Impact. Key 2010 Development Objectives IPI-926 (Hedgehog Pathway Inhibitor) Phase 1 data presentation Phase 2 initiation in pancreatic cancer IPI-504 (Hsp90 Chaperone Inhibitor) Phase 2 data presentation in NSCLC Phase 2 data read-out in HER2+ breast cancer IPI-493 (Hsp90 Chaperone Inhibitor) Phase 1 initiation in hematological malignancies IPI-940 (FAAH Inhibitor) Phase 1 completion IPI-145 (PI3K Inhibitor) Advance IND-enabling studies 27 |
Innovation. Evolution. Impact. Our Vision for Creating Value for Patients and Shareholders • World-class organization and pipeline – Global discovery and development – U.S. commercialization • Strategic partnering of products, on attractive financial terms, for market access – Ex-U.S. (e.g., Mundipharma) – Products best served by a GP sales force (e.g., FAAH program) • Operational capabilities and financial strength to access additional external opportunities 28 |
Innovation. Evolution. Impact. Infinity: Innovation. Evolution. Impact. 29 |
Innovation. Evolution. Impact. |