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 August 4, 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 Integrated Team Proven drug developers and company builders Financial Strength Cash runway into 2013 Ownership of Valuable Product Rights Establishing commercial infrastructure in US Diverse Pipeline of Broadly Applicable Targeted Therapies Spanning Oncology and Autoimmune/Inflammatory Diseases Four candidates in the clinic Fifth new IND planned for 2011 |
Innovation. Evolution. Impact. Financial Strength to Create Value 4 ~$288M to aggressively invest in pipeline and access external opportunities ~$288M ~$120M ~$120M in Cash & Investments at 6/30/10 ~$238M $150M in Committed R&D Funding for 2010 & 2011 ($32.5M received 1H10) $50M Line of Credit (10 year balloon note at prime) |
Innovation. Evolution. Impact. Financial Strength: Aggressive Investment, Cash Runway into 2013 • ~$288 million to invest in pipeline and access external opportunities • Projected 2010 cash burn of $35–45M • Anticipated year-end cash and investments balance of $85–95M – Based on current operating plan; excludes $50M line of credit from Purdue 5 |
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 7 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. 9 IPI-926: Significant Anti-Cancer Opportunity by Inhibiting Malignant Activation of the Hedgehog Pathway Signal to tumor progenitor cell Signal to tumor microenvironment Signal to tumor cell |
Innovation. Evolution. Impact. IPI-926: Inhibiting Multiple Modes of Malignant Activation to Prolong Survival 10 1 Olive et al., 21 May 2009 Science 2 Travaglione et al., 2010 AACR IPI-926 + gemcitabine doubles median survival in pancreatic cancer model¹ IPI-926 + Abraxane ® significantly decreased tumor growth (77%) and increased tumor perfusion in pancreatic cancer model² Days Post Implant Final IPI-926 dose On treatment Re-growth Final nab-paclitaxel dose Signal to tumor progenitor cell Signal to tumor microenvironment Signal to tumor cell |
Innovation. Evolution. Impact. IPI-926: Inhibiting Multiple Modes of Malignant Activation to Prolong Survival 11 IPI-926 in SCLC model¹ 1 Travaglione et al., 2008 AACR 3 Mandley et al., 2010 AACR Days Post Implant Mice randomized +/- IPI-926 Last day of E/P treatment E/P - IPI-926 E/P -Vehicle Vehicle IPI-926 82% 2 Proctor et al., 2010 AACR IPI-926 in castration resistant prostate cancer model² IPI-926 in NSCLC model³ 70% 36% 70% Begin dosing IPI-926 + docetaxel Final docetaxel dose Signal to tumor progenitor cell Signal to tumor microenvironment Signal to tumor cell |
Innovation. Evolution. Impact. IPI-926: Inhibiting Multiple Modes of Malignant Activation to Prolong Survival 12 IPI-926 results in 100% survival in medulloblastoma model³ 3 Olson et al., 2009 AACR Days IPI-926 Vehicle Signal to tumor progenitor cell Signal to tumor microenvironment Signal to tumor cell |
Innovation. Evolution. Impact. Advanced basal cell carcinoma, medulloblastoma IPI-926: Targeting a Broad Range of Difficult to Treat Cancers 13 IPI-926 in Phase 1b/2 study (combination with gemcitabine) in pancreatic cancer and Ph 1 study in advanced solid tumors Preliminary Phase 1 data anticipated in 2010 Pancreatic cancer Small cell lung, non-small cell lung, ovarian and prostate cancers; heme malignancies Improve Access of Chemo to Tumor Delay Tumor Re-Growth Induce Apoptosis |
Innovation. Evolution. Impact. 14 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 new trials planned at this time – Any future studies will be based on data and market insights 15 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 • Phase 1 data and articulation of future plans anticipated in 2011 16 |
Broadly Applicable, Targeted Therapies in Pain and Inflammation |
Innovation. Evolution. Impact. 18 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 • Ongoing evaluation in Phase 1 study in normal, healthy volunteers – Consists of single- and multiple-ascending dose studies • Phase 1 completion anticipated in 2010 19 |
Innovation. Evolution. Impact. IPI-940: Targeting Broad Areas of Unmet Need • Neuropathic pain – Postherpetic neuralgia – HIV pain – Peripheral diabetic neuropathy – Chemotherapy-induced neuropathy – Trigeminal neuralgia – Fibromyalgia • Osteoarthritis pain • Anxiety and depression • Inflammatory conditions 20 |
Innovation. Evolution. Impact. 21 IPI-145; PI3K Inhibitors: Leveraging Oncology Expertise to Address Significant Untapped Opportunity in Autoimmune/ Inflammatory Disease and Oncology Tyrosine kinase receptors G-coupled protein receptors PIP2 PI3K- PI3K- , , PH domain Kinase domain |
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 22 Adaptive Innate Expression Diseases Function T- and B-cells Activation Proliferation Migration Mast Cells Neutrophils Activation Leukocyte Chemotaxis Microglial Activation Endothelial Activation GvD Cancer Asthma Lung Inflammation RA, MS Heme Cells ALE Atherosclerosis Sepsis |
Innovation. Evolution. Impact. IPI-145: Only PI3K Dual-Selective Inhibitor for Autoimmune-Inflammatory Disease • 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 in autoimmune-inflammatory conditions expected to begin in 2011 • Research collaboration with Intellikine to identify additional differentiated PI3K and/or PI3K inhibitors for development in oncology 23 |
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 24 |
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. – Products best served by a GP sales force • Operational capabilities and financial strength to access additional external opportunities 25 |
Innovation. Evolution. Impact. Infinity: Innovation. Evolution. Impact. 26 Integrated Team Proven drug developers and company builders Financial Strength Cash runway into 2013 Ownership of Valuable Product Rights Establishing commercial infrastructure in US Diverse Pipeline of Broadly Applicable Targeted Therapies Spanning Oncology and Autoimmune/Inflammatory Diseases Four candidates in the clinic Fifth new IND planned for 2011 |
Innovation. Evolution. Impact. |