Building a Fully Integrated Biopharmaceutical Company April 2012 Exhibit 99.1 |
2 • 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, Hsp90 and PI3K inhibitors and the ability to achieve proof of concept in each of these programs by the end of 2013; the potential for data from the ongoing clinical trials to lead to multiple registration paths; the potential of saridegib and Hedgehog pathway inhibition in addressing chondrosarcoma and myelofibrosis; the potential of IPI-145 and PI3K inhibition in addressing hematologic malignancies and inflammation; the potential of combination therapy based on retaspimycin HCl in addressing non-small cell lung cancer, the future market size of non-small lung cancer therapeutics, and the expectation that Infinity: will report data in the second half of 2012 from the Phase 2 trial of saridegib in patients with myelofibrosis, the dose- escalation portion of the Phase 1b/2 trial of retaspimycin HCl in combination with everolimus in patients with NSCLC, and each of the Phase 1 trials of IPI-145; will complete enrollment in the second half of 2012 in the Phase 2 trial of saridegib in patients with chondrosarcoma and the Phase 2 trial of retaspimycin HCl in combination with docetaxel in patients with NSCLC; and will commence future clinical development of its product candidates, including a Phase 2 trial of IPI-145 in inflammation in the second half of this year. Such forward-looking statements also include estimates of 2012 financial performance and the expectation that Infinity will have a cash runway to support its current operating plan through key inflection points. • Such 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 Mundipharma will continue for its expected term or that it will fund Infinity’s programs as agreed, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases, or that development of any of Infinity’s product candidates will continue. Further, there can be no guarantee that any positive developments in Infinity’s product portfolio will result in stock price appreciation. Management’s expectations could also be affected by risks and uncertainties relating to: Infinity’s 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; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing its product candidates; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates 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 annual report on Form 10-K for the year ended December 31, 2011, filed with the U.S. Securities and Exchange Commission on March 13, 2012. • 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. Forward Looking Statements |
Sustainable model for value creation 3 Breakthrough Science Deep, Diverse Pipeline High-value, Enabling Partnerships Full U.S. Commercial Rights Building a Fully Integrated Biopharmaceutical Company |
• Broad pipeline – Six ongoing clinical trials across three novel targets • Tailored development strategies – Randomized, double-blind, placebo controlled trials based on compelling scientific or clinical data – Single-arm, exploratory trials designed to confirm intriguing hypotheses with minimal investment • Data anticipated from all ongoing trials by YE13 4 Advancing a Diverse Pipeline: R&D Strategy |
5 1H’12 1H’13 2H’13 2H’12 Hedgehog: Saridegib Hsp90: Retaspimycin HCl PI3K: IPI-145 Chondrosarcoma NSCLC (mKRAS) Myelofibrosis NSCLC (Heavy smokers) Inflammation Hematologic Malignancies 2012 2013 Randomized, double-blind, placebo-controlled trial. Data Data Data Data Data Data Promising Pipeline Based on Breakthrough Science Phase 1 Phase 1 Phase 2 Phase 2 Phase 1b/2 Phase 2 |
Saridegib (IPI-926): Addressing Cancers with High Unmet Need by Targeting the Hedgehog Pathway |
Importance of the Hedgehog pathway 7 Saridegib: Establishing a Leadership Position in Underserved, Life-Threatening Diseases • Known to drive a broad range of cancers through multiple mechanisms, including signaling to – Tumor cells directly – Tumor microenvironment – Tumor progenitor cells Program status • Well-tolerated and clinically active in Phase 1 • Two Phase 2 trials ongoing exploring distinct biological mechanisms • Robust biomarker strategy • Disrupts malignant activation of the Hedgehog pathway by inhibiting the target Smoothened Saridegib (IPI-926) |
• Randomized, double-blind, placebo-controlled trial – Enrolling patients with metastatic or locally advanced, unresectable chondrosarcoma – Primary endpoint: Progression-free survival – Trial design reviewed with FDA and EMA prior to study • Anticipate enrollment completion 2H’12 and data 1H’13 ~140 Patients Saridegib 160 mg (QD) (N = ~94) Placebo (N = ~46) Progression - crossover to saridegib 8 Saridegib: Global, Randomized Phase 2 Trial in Chondrosarcoma 2:1 Randomization |
• Hedgehog signaling is activated in ~ 70% chondrosarcomas • In xenografts derived from primary human chondrosarcoma tumors, administration of saridegib led to: – Down-regulation of the Hedgehog pathway in tumor cells – Loss of tumor cells; decreased in tumor growth 9 Read, AACR 2011. Saridegib Control Activated Gli-1 in Chondrosarcoma Saridegib in Chondrosarcoma: Strong Preclinical Rationale Tumor cells Cartilage matrix Calcified matrix Decreased tumor cells Nuclear Gli-1 |
Saridegib 160 mg (QD) (N = up to 35) Saridegib 160 mg (QD) (N = up to 35) Saridegib 160 mg (QD) (N = 12) 10 • Open-label, exploratory trial with option for expansion – Primary endpoint: Response rate according to International Working Group Criteria – No spontaneous remissions in this disease • First cohort of patients enrolled • Data anticipated in 2H’12 Expansion Saridegib: Phase 2 Trial in Myelofibrosis |
• Blood cancer characterized by bone marrow failure and enlarged spleen due to pathogenic fibrosis • In myelofibrosis, Hedgehog ligand expressed in bone marrow • Current treatments target symptoms, not underlying disease 11 Tkachuk and Hirshmann, Wintrobe’s Atlas of Clinical Hematology, 2007. Saridegib in Primary Myelofibrosis: Hedgehog Pathway Plays Key Role in Pathogenic Fibrosis Healthy Bone Marrow Myelofibrosis Fibrosis Bone Bone Red and white blood cells |
*Estimates based upon G7 countries (US, UK, IT, DE, ES, FR, JP) 12 Saridegib: First-in-Class Potential in Chondrosarcoma and Myelofibrosis Chondrosarcoma Myelofibrosis Market size Ultra-orphan* ~30,000 patients* Unmet need Resistant to radiation and chemotherapy Primary treatment option is surgery No current treatments address underlying cause of disease Potential for franchise expansion Other sarcomas Other fibrotic diseases and heme malignancies |
Retaspimycin HCl (IPI-504) Targeting Non-Small Cell Lung Cancer Through Hsp90 Inhibition |
Function of Hsp90 • “Chaperone” protein necessary for stability and function of certain ‘client’ proteins, including oncoproteins Retaspimycin HCl (IPI-504) • Selective, potent, naturally-derived Hsp90 inhibitor • Well-defined and manageable safety profile with QW dosing Program status: • Well-tolerated and clinically active in combination with docetaxel in NSCLC • Two clinical trials in NSCLC 14 Retaspimycin HCl: Leading the Field in Hsp90 |
• Randomized, double-blind, placebo-controlled trial • Anticipate enrollment completion 2H’12 and data 2H’13 15 ~200 smokers w/ 2 nd - or 3 rd -line NSCLC (docetaxel naïve) Follow-up for OS Follow-up for OS Docetaxel + Retaspimycin HCl (N = ~100) Docetaxel + placebo (N = ~100) Retaspimycin HCl: Phase 2 Trial in NSCLC Patients with a Smoking History R Primary endpoint: Overall survival Secondary endpoints: Predictive biomarkers, progression free survival, overall response rate |
16 Encouraging Phase 1b data • Partial response in 6 patients (ORR = 26%) • Stable disease in 7 patients • Well-tolerated – No unexpected or overlapping toxicities – No dose reductions or discontinuations due to liver function tests – No ocular toxicities Riely et al., ASCO 2011. Retaspimycin HCl Phase 1b Trial: Clinically Active in Combination with Docetaxel |
17 *Hanna et al, J Clin Oncol, 22:1589-97. Retaspimycin HCl: Responses Observed in Patients with Historically Poor Prognoses 8% 26% 33% 43% 0% 10% 20% 30% 40% 50% Historical 2nd-line Docetaxel* NSCLC patients in trial (N=23) Smokers (N=18) Squamous Cell Carcinoma (N=7) Patient Populations Retaspimycin HCl Plus Docetaxel: Overall Response Rate |
Retaspimycin HCl + everolimus (N = 12) Retaspimycin HCl + everolimus (N = 12) Determine recommended Phase 2 dose in mKRAS NSCLC • Small, open-label exploratory trial with option for expansion – Primary efficacy endpoint: Response rate – Neither drug active as single agent in these patients • Strong preclinical rationale: Evidence of substantial tumor regression in a NSCLC model* • Topline data from dose-escalation portion of trial anticipated 2H’12 18 Retaspimycin HCl + everolimus (N = up to 45) Retaspimycin HCl + everolimus (N = up to 45) Expansion Phase 1b Phase 2 *De Raedt et al., 2011; Cancer Cell 13;20(3):400-13. Retaspimycin HCl: Phase 1b/2 Trial in NSCLC Patients with mKRAS |
Current NSCLC market is ~ $3.5B and is projected to grow to $9.8B in 2018 References: Decision Resources NSCLC Pharmacor Report, March 2011. G7 regions: US, UK, IT, DE, ES, FR, JP; Roberts et al., 2010; J Clin Oncol 28(31):4769-4777. Janjigian et al., 2010; Cancer 116(3):670-675. 19 Retaspimycin HCl Has Significant Commercial Potential Patient Population % of Overall NSCLC Population Number of Patients Number of Stage IIIb/IV Patients Heavy smokers Squamous cell KRAS mutant 70% 35% 30% ~291,000 ~145,000 ~125,000 ~183,000 ~91,000 ~79,000 |
IPI-145: Potential Best-in-Class Opportunity for Inflammation and Hematologic Malignancies |
21 ADAPTIVE Graft vs. Host Disease INNATE Atherosclerosis Sepsis Cancer Asthma Crohn’s Disease Lupus Rheumatoid Arthritis The Power of PI3K- , Inhibition |
Function of PI3K- and PI3K- • Involved in key immune cell functions, including cell proliferation, survival and cellular trafficking • Inhibiting both isoforms may be beneficial in both hematologic cancers and inflammatory conditions IPI-145 • Potent, oral inhibitor of both delta and gamma isoforms • Active in preclinical models of inflammation Program status: • Phase 1 trial in healthy volunteers completed to enable development in inflammation • Phase 1 in patients with hematologic malignancies ongoing 22 IPI-145: Only PI3K- Inhibitor in the Clinic , |
23 In-house data IPI-145 Is More Potent than Delta-Selective Inhibitor with Promising Clinical Activity |
IPI-145 Phase 2 in Inflammation 24 • Phase 1 double-blind, randomized, placebo controlled trial – Trial completed – Data anticipated in 2H’12 • Phase 2 trial in inflammation expected to begin this year • Multiple large commercial opportunities IPI-145: Dual Clinical Development Paths in Inflammation and Hematological Malignancies Phase 1 in Healthy Subjects • Single Ascending Dose • Multi Ascending Dose |
25 • Phase 1 dose escalation under way • Phase 1 data anticipated 2H’12 • First-in-class and best-in-class commercial opportunities – Indications validated with a -specific inhibitor (e.g., CLL, iNHL, mantle cell) – Indications in which a -specific inhibitor showed little activity (e.g., DLBC, AML, MM) – Indications untested by a -specific inhibitor IPI-145: Dual Clinical Development Paths in Inflammation and Hematological Malignancies IPI-145 Phase 1 in Hematologic Malignancies • Dose escalation Phase 1 Expansion in Select Cohorts |
Strong Financial Foundation to Reach Key Inflection Points |
2012 Committed R&D Funding from Mundipharma Cash and Investments Current and Committed Capital* >$370 Million * As of December 31, 2011. 2013 Committed R&D Funding from Mundipharma 27 Cash Runway Into 2014 $115.9M $110.0M $147.5M 0 50 100 150 200 250 300 350 |
• Projected 2012 revenue of ~$114M • Anticipate year-end cash and investments balance of $75M - $85M • Projected 2012 cash burn of $30M - $40M • Approximately 26.9 million shares outstanding as of March 31, 2012 28 2012 Financial Guidance |
29 1H’12 1H’13 2H’13 2H’12 Hedgehog: Saridegib Hsp90: Retaspimycin HCl PI3K: IPI-145 Chondrosarcoma NSCLC (mKRAS) Myelofibrosis NSCLC (Heavy smokers) Inflammation Hematologic Malignancies 2012 2013 Randomized, double-blind, placebo-controlled trial. Promising Pipeline Based on Breakthrough Science Phase 2 Phase 1b/2 Phase 2 Phase 1 Phase 1 Data Data Data Data Data Data Phase 2 |
Building a Fully Integrated Biopharmaceutical Company April 2012 |