 Building a Sustainable, Fully Integrated Biotechnology Company November 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, Hsp90, PI3K and FAAH inhibitors; the potential of IPI-926 and Hedgehog pathway inhibition in addressing chondrosarcoma, pancreatic cancer and myelofibrosis; the potential of combination therapy based on retaspimycin HCl in addressing non-small cell lung cancer; Phase 2 development of IPI-940 in pain by Purdue; expansion of the Phase 2 trial of IPI-926 in myelofibrosis and the Phase 2 trial of retaspimycin HCl in combination with everolimus in non- small cell lung cancer, 2011 financial guidance (including total revenues, operating 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; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing its product candidates; 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 for the quarter ended September 30, 2011 filed with the U.S. Securities and Exchange Commission on November 8, 2011. • 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 |
          • Clear registration paths • Multiple possible indications • Substantial market potential • Full U.S. commercial rights in oncology/inflammation INFI in 2011: Considerable Near-Term Momentum • Well-financed, with capital into 2014 • Purdue/Mundipharma alliance enables robust clinical development and approval strategies; provides access to markets ex-US & those best served by a GP sales force • Compelling scientific rationale • Intriguing Phase 1b clinical data • Underserved markets Novel candidates in development • Rigorous trials • Companion biomarker strategy Active phase 2 trials 3 |
 Seven Clinical Studies Initiated in 2011 4 |
 IPI-926: Addressing Difficult-to-Treat Cancers by Targeting the Hedgehog Pathway |
 IPI-926: Overview 6 • Disrupts malignant activation of the Hedgehog pathway by inhibiting Smoothened – Hedgehog pathway known to drive multiple difficult-to-treat cancers • Product strategy – Target areas with large unmet need – Leverage strong scientific rationale – Pursue tractable clinical development path – Deliver product with significant commercial potential |
 Trial 1: Rigorous Phase 2 Trial of IPI-926 in Pancreatic Cancer 7 • Primary endpoint is overall survival – Secondary endpoints include progression free survival, time to progression, overall response rate • Rigorous design to mitigate Phase 3 risk • Enrollment completed Dose Escalation MTD IPI-926 (QD) + gemcitabine (n = 60) Placebo + gemcitabine (n = 60) Phase 1b Phase 2 |
 Large unmet need • ~35,000 deaths / year in the U.S. alone • Average survival <6 months • 5-year survival <5% Resistant to therapy • Gemcitabine approved Rx with only a ~6 wk survival benefit • Multiple failures in Phase 2 and Phase 3 Treating Pancreatic Cancer Requires a Fundamentally Novel Approach 8 |
 IPI-926 Enhances Delivery of Gemcitabine to Tumor 9 Vehicle Gemcitabine alone IPI-926 + gemcitabine Current standard of care in pancreatic cancer Tumor cell nuclei Fluorescent contrast agent IPI-926 + gemcitabine doubles median survival in a mouse model of pancreatic cancer (Olive et al. 2009, Science 324: 1457-61.) |
 Encouraging Activity and Tolerability Observed in Phase 1b • IPI-926 + gemcitabine led to a 31% response rate – Overall response rate to gemcitabine is historically <10%* • Favorable PK and safety profile – No interaction between IPI- 926 and gemcitabine – Most common AEs were fatigue and nausea – Combination did not reveal unique or more severe AEs 10 Stephenson et al., ASCO 2011. *Moore, et al. J Clin Oncol 25:1960-6.; Seitz et al. Oncology 18:43-7. |
  Expand trial up to 45 patients Expand trial up to 45 patients 12 patients 11 Trial 2: Exploratory Phase 2 Trial of IPI-926 in Myelofibrosis • No current treatments for underlying disease – Agents in development reduce spleen size, address symptoms • Trial design – Expansion will be based on response rate observed in first cohort – Dose: 160 mg IPI-926 administered orally once daily – Primary endpoint: Response rate according to International Working Group Criteria |
 2:1 Randomization Trial 3: Randomized Phase 2 Trial of IPI-926 in Chondrosarcoma • Global trial at approximately 50 sites • Randomized, double-blind, single-agent, placebo controlled study in metastatic or locally advanced, inoperable chondrosarcoma – Trial design reviewed with FDA and EMA prior to study • Primary endpoint is progression free survival – Secondary endpoints include time to progression, overall survival, overall response rate and response duration ~140 Patients IPI-926 (QD) Placebo Progression - crossover to IPI-926 12 |
 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) • Highly potent, selective, water soluble Hsp90 inhibitor Program strategy; determine optimal: Dose and schedule Combination agents Indications Current status: Two clinical trials in NSCLC 14 Heat Shock Protein 90 (Hsp90): An Important Cancer Target |
 Retaspimycin HCl: Potential Breakthrough Approach to NSCLC Pursuing multiple development paths as combination therapy 15 |
 Trial 4. Phase 2 Trial of Retaspimycin HCl in NSCLC Patients with a Smoking History 16 ~200 smokers w/ 2 nd - or 3 rd -line NSCLC (docetaxel naïve) • 1° Endpoint: OS • 2° Endpoints: PFS, ORR, Safety • Exploratory: Biomarkers, PG markers Follow-up for OS Follow-up for OS Docetaxel (q3w) + Retaspimycin HCl (weekly) (N=100) Docetaxel (q3w) + placebo (weekly) (N=100) • Dosing Schedule – Retaspimycin HCl: 450 mg/m 2 IV QW – Docetaxel: 75 mg/m 2 IV Q3W R |
 Phase 1b Trial: Clinically Active in Combination with Docetaxel 17 Compelling Phase 1b data • Partial response seen in 6 patients (ORR = 26%) • Stable disease seen in 7 patients Riely et al., ASCO 2011. |
 Responses Observed in Patients with Historically Poor Prognoses • In exploratory analyses, patients with the highest response rates fell into overlapping categories: – Current or former smokers (ORR = 33%) – Those with squamous cell carcinoma (ORR = 43%) 18 Historical 2 nd 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 Riely et al., ASCO 2011. |
 Phase 1b Trial: Favorable Safety Profile • All toxicities were manageable • No unexpected or overlapping toxicities seen • GI toxicities were primarily Grade 1 or Grade 2 • No significant ocular toxicities were observed • No dose reductions or discontinuations in response to liver function tests 19 Riely et al., ASCO 2011. |
 Phase 2 : Evaluate safety and activity Phase 1b: Determine recommended Phase 2 dose in mKRAS NSCLC Dosing Schedule • Retaspimycin HCl: 450 mg/m 2 IV QW • Everolimus: 5-10 mg oral QD Trial 5: Phase 1b/2 Trial of Retaspimycin HCl in NSCLC Patients with mKRAS 1° efficacy endpoint: Response Rate • Phase 2 portion of study may be expanded up to 45 patients based on response rate observed in first cohort • Expected ORR to either agent alone in KRAS mutant NSCLC = 0% 20 |
 % NSCLC Patients by Cell Type (2009) % Stage IIIb/IV NSCLC Patients by Smoking Status (2009) NSCLC: Significant Commercial Opportunity % NSCLC Patients by Mutation Status (2009) 21 Squamous Cell Carcinoma 35% Adenocarcinoma 47% Large Cell Carcinoma 18% > 15 pack years 70% Non-smokers & = 15 pack years 30% KRAS 30% Non-KRAS 70% ~145,000 ~182,000 ~125,000 Sources: Decision Resources NSCLC Pharmacor Report, June 2009; Cancer. 2010 February 1; 116(3): 670–675. doi: 10.1002/cncr.24813. Estimates based upon G7 regions (US, UK, IT, DE, ES, FR, JP) Phase 1b/2 trial of retaspimycin HCl + everolimus Phase 2 trial of retaspimycin HCl + docetaxel |
 IPI-145: Potential Best In-Class Opportunity for Inflammation and Hematologic Malignancies |
 IPI-145: Novel PI3-Kinase Inhibitor • IPI-145 is a potent, oral inhibitor of PI3K- and PI3K- – PI3K plays a role in hematologic malignancies and inflammatory conditions • Compelling human proof-of-concept of PI3K- inhibition in heme malignancies – IPI-145 is 3- to 30-fold more potent inhibitor of PI3K- than PI3K- inhibitor with reported data • Data suggest inhibition of PI3K- is important, particularly in inflammation – IPI-145 has shown compelling preclinical activity in several models of inflammation 23 |
 PI3K- , : Distinct and Overlapping Roles Collaborating in Inflammation and Oncology T- and B-cells: Activation Function Survival Mast cells Neutrophils Monocytes Eosinophils Leukocyte chemotaxis Microglial activation Tumor associated immune cells Graft vs Host Disease Asthma Rheumatoid Arthritis Crohn’s Disease Lupus Atherosclerosis Sepsis Solid tumor Adaptive Innate Diseases Cancer 24 |
 Trials 6 & 7: Dual Clinical Development Path with IPI-145 IPI-145 Phase 1 in Hematologic Malignancies • Dose Escalation •Expansion Cohorts Phase 1 in Healthy Subjects • Single Ascending Dose • Multi Ascending Dose Phase 2 in Inflammation Phase 2 in Hematologic Malignancies 25 |
 IPI-940: Targeting Pain Through Inhibition of FAAH 26 |
 • IPI-940 inhibits FAAH and is designed to potentiate the effect of anandamide – Constitutively active FAAH degrades anandamide, the body’s natural source of pain relief • Encouraging data from Phase 1 trial in healthy volunteers – Marked FAAH inhibition and increased anandamide levels – No observed dose-limiting toxicities • Purdue and Mundipharma exercised rights for worldwide development and commercialization – Purdue expected to begin Phase 2 development in pain IPI-940: Phase 2-Ready FAAH Inhibitor 27 |
 Strong Financial Foundation to Reach Key Inflection Points 28 |
 Strategic Alliances Provide Funding and Access to Global Markets 29 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. • Access to ex-US markets: Mundipharma to commercialize products ex-U.S. • INFI entitled to royalty of 10% to 20% on ex-U.S. sales FAAH • Purdue and Mundipharma responsible for global development and commercialization • Access to GP sales force: Purdue and Mundipharma responsible for global commercialization • INFI entitled to royalty of 10% to 20% on global sales |
 Financial Strength to Drive Value Creation 30 $50M Line of Credit 1 (Balloon note at prime, matures 2019) Cash and Investments (as of 9/30/11) Current and Committed Capital $256 Million 1 Line of credit may be drawn for any corporate purpose. ~$131M Committed R&D Funding Remaining in 2011 and 2012 (as of 9/30/11) |
 2011 Financial Guidance: Cash Runway into 2014 • Projected 2011 revenue of $90M - $95M • Projected 2011 operating cash burn of $30M - $40M • Anticipate year-end cash and investments balance of $110M - $120M – Based on current operating plan; excludes $110M R&D funding commitment from Mundipharma for 2012 • Approximately 26.7 million shares outstanding 31 |
       INFI in 2011: Considerable Near-Term Momentum • Compelling scientific rationale • Intriguing Phase 1b clinical data • Underserved markets Novel candidates in development • Rigorous trials • Companion biomarker strategy Active phase 2 trials • Well-financed, with capital into 2014 • Purdue/Mundipharma alliance enables robust clinical development and approval strategies; provides access to markets ex-US & those best served by a GP sales force • Clear registration paths • Multiple possible indications • Substantial market potential • Full U.S. commercial rights in oncology/inflammation |
 Building a Sustainable, Fully Integrated Biotechnology Company November 2011 |