Building a Sustainable, Fully Integrated Biotechnology Company January 2011 Exhibit 99.1 |
Forward Looking Statements 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, FAAH, PI3K and Hsp90 chaperone inhibitors; the presentation of data from Infinity’s Phase 1b trials of IPI-926 in combination with Gemzar® and IPI-504 in combination with Taxotere®, the commencement of Phase 2 development of IPI-926 in pancreatic cancer and other indications as well as an investigator sponsored trial program, the articulation of future plans for the company’s Hsp90 program, the commencement of Phase 1 development of IPI-145, the completion of transition activities to facilitate Phase 2 development of IPI-940 by Purdue, the naming of a new drug development candidate, estimates of 2011 financial performance, 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. |
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 IPI-926 Hedgehog Pain Oncology Inflammation IPI-145 PI3K / IPI-940 FAAH IPI-504; IPI-493 Hsp90 IPI-145 PI3K / IPI-940 FAAH |
Hedgehog Program A Fundamentally New Approach to Treating a Broad Range of Cancers 5 |
IPI-926: Significant Anti-Cancer Opportunity by Inhibiting Malignant Activation of the Hedgehog Pathway 6 Targeting the Microenvironment Targeting the Tumor Cell Targeting Residual Disease • Preclinical models support development of IPI-926 in all three settings • Promising Phase 1 data in BCC reported at ESMO 2010 • Rigorous Phase 1b/2 trial in pancreatic cancer ongoing – Gemzar ® +/- IPI-926 • Additional trials expected to begin in 2011 |
Targeting the Tumor Cell: On-Target Activity Observed in Phase 1 Trial IPI-926 Phase 1 Dose Escalation • Patients with advanced / metastatic solid tumors • Oral once daily dosing on 28 day cycles • Basal cell carcinoma (BCC) patient cohort included 7 |
Evidence of Clinical Activity in BCC Patients 8 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 9 Patient A Baseline 6 Months Rudin et al. ESMO 2010 |
Evidence of Clinical Activity in BCC Patients 10 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 11 |
Targeting the Tumor Microenvironment: Pancreatic Cancer • Devastating disease – 4 th leading cause of cancer death in the U.S. – Estimated 40,000 new cases annually • 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 – Gemzar ® approved with median survival of 5.7 months 12 |
Clinically Relevant Transgenic Model Particularly Important for Pancreatic Cancer 13 Genetically and histologically identical to human pancreatic cancer Characteristic Chemosensitivity Mirrors human tumor microenvironment Tumor Xenograft Transgenic Mouse X X 100% (unlike human pancreatic cancer) 12% (like human pancreatic cancer) |
John Griffiths Laboratory Dense Pancreatic Tumor Microenvironment Limits Perfusion Magnetic Resonance Imaging (MRI) • Transgenic mouse • Fluorescent contrast injected into interstitial space • Monitored for 10 Minutes 14 |
Tumor with Circulating Contrast Agent MRI Tumor Image Dense Pancreatic Tumor Microenvironment Limits Perfusion 15 Tumor Contrast Agent MRI images of transgenic mouse model of pancreatic cancer. Tumor |
IPI-926 Enhances Delivery of Gemzar ® to Tumor 16 Vehicle Gemzar Alone IPI-926 + Gemzar Current standard of care in pancreatic cancer Tumor cell nuclei Fluorescent contrast agent |
Strong Preclinical Rationale for IPI-926 in Pancreatic Cancer 17 IPI-926 + Gemzar ® doubles median survival in pancreatic cancer model |
Rapidly Advancing IPI-926 Development Program 18 “It is a major advance to incorporate such basic preclinical findings so quickly into the design and interpretation of human studies.” – Van Dyke, Nature Medicine, 2010 |
Phase 1b/2 Trial of IPI-926 in Pancreatic Cancer 19 • 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 Randomization IPI-926 + Gemzar® Placebo + Gemzar® Phase 1b Phase 2 |
IPI-926: Summary • Strong preclinical rationale for all three settings of malignant pathway activation – Targeting tumor cell – Targeting tumor microenvironment – Targeting minimal residual disease • On-target activity demonstrated in basal cell carcinoma • Pancreatic cancer trial advancing – Plans to present Phase 1b data and start Phase 2 trial in 2011 • Additional Phase 2 studies planned for 2011 20 |
Hsp90 Program Targeting Cancer Through Chaperone Protein Inhibition 21 |
IPI-504 and IPI-493: Broadly Attacking Oncoproteins Through Hsp90 Chaperone Inhibition • Hsp90 plays a role in regulating the stability of key cancer- causing proteins through its role as a protein chaperone – Oncogenic client proteins of Hsp90 include EML4-ALK, BCR-ABL, mutant EGFR, mutant FLT3 and HER2 • Inhibition of Hsp90 chaperone leads to tumor growth inhibition and cancer cell death • Clinical trials ongoing for IPI-504 (I.V.) and IPI-493 (oral) 22 |
Overview of 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 Taxotere ® • Two NSCLC studies ongoing – Phase 1b study with Taxotere ® – Validation in NSCLC patients with ALK rearrangements (IST) 23 Sequist et al., Journal of Clinical Oncology, 2010. |
Hsp90 Program Summary • IPI-504: Two ongoing studies • IPI-493: Two ongoing Phase 1 studies designed to assess safety 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 24 |
Additional Pipeline Opportunities 25 |
IPI-145: Selectively Inhibiting PI3K Delta and Gamma • Phosphoinositide-3-kinase (PI3K) plays key role in many cellular processes – 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 inflammatory conditions and hematologic cancers • Promising clinical activity observed with delta-selective PI3K inhibitors in heme malignancies 26 |
IPI-145 Is More Potent than Delta-Selective Inhibitor with Promising Clinical Activity Co-stimulation with 10µg/ml -IgM and 3µg/ml -CD40 IPI-145 CAL-101 27 |
IPI-145: Differentiated Product Candidate Rapidly Advancing to the Clinic • Oral, dual-specific inhibitor of PI3K and PI3K • Demonstrated activity in several preclinical models of inflammation • Phase 1 development expected to begin in H2’11 28 |
• 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 29 |
Ongoing Discovery Efforts to Fuel Pipeline • Research collaboration with Intellikine to identify additional differentiated PI3K and/or PI3K inhibitors for development • Bcl-2 specific and dual Bcl-2/Bcl-xL inhibitors (licensed to Novartis) • Additional efforts directed toward emerging targets – Cancer metabolism, apoptosis, protein homeostasis, inflammation • Expect to name a new development candidate in 2011 30 |
Strategic Alliances Provide Funding and Access to Global Markets 31 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 32 $195 M Committed R&D Funding for 2011-12 $50 M Line of Credit 1 (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 33 |
Pipeline Advancements in 2011 Hedgehog (IPI-926) • Present Phase 1b data in pancreatic cancer • • Begin additional Phase 2 studies • Initiate broad investigator sponsored trial program Hsp90 (IPI-504 and IPI-493) • Present Phase 1 data of IPI-504 in combination with Taxotere ® • 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 34 |
Achieving Our Mission: Sustainable, Fully Integrated Biotech EXPERIENCED TEAM FINANCIAL STRENGTH INNOVATIVE PRODUCT PORTFOLIO |
Building a Sustainable, Fully Integrated Biotechnology Company January 2011 |