NASDAQ: INFI Infinity Pharmaceuticals R&D Update and First Quarter 2008 Results May 5, 2008 Exhibit 99.2 |
2 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 those regarding future clinical trial activity for retaspimycin, IPI-493 and IPI- 926; the presentation of clinical data for retaspimycin; estimates of 2008 financial performance; and the expectation that Infinity will have cash to support its current operating plan into 2010. • Such statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from Infinity's current expectations. For example, there can be no guarantee that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases. In particular, expectations could 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; Infinity's dependence on its collaboration with MedImmune/AstraZeneca; Infinity's ability to obtain additional funding required to conduct its research, development and commercialization activities; unplanned cash requirements and expenditures; 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 Infinity’s expectations are described in greater detail under the caption "Risk Factors" included Infinity's quarterly report on Form 10-k for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on March 14, 2008. • 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. |
3 Introduction Steven Holtzman Chair, President, and Chief Executive Officer |
4 R&D Update: Hedgehog pathway and Hsp90 programs Julian Adams, Ph.D., Chief Scientific Officer & President of R&D |
5 Additional Tumor #2 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 i.v.: Retaspimycin (IPI-504) GIST/STS NSCLC HRPC Taxotere ® Combo Additional Tumor #1 Additional Combinations Hsp90 oral: IPI-493 Hedgehog Pathway: IPI-926 Bcl-2/Bcl-xL* Early Discovery Continued commitment to aggressively advance pipeline through key milestones FPI mid-year 2008 FPI 2H 2008 Add’l in 2008 In 1H08 In 1H08 GIST P3 in preparation *Transitioned to Novartis |
6 Additional Tumor #2 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 i.v.: Retaspimycin (IPI-504) GIST/STS NSCLC HRPC Taxotere ® Combo Additional Tumor #1 Additional Combinations Hsp90 oral: IPI-493 Hedgehog Pathway: IPI-926 Bcl-2/Bcl-xL* Early Discovery Continued commitment to aggressively advance pipeline through key milestones FPI mid-year 2008 FPI 2H 2008 Add’l in 2008 In 1H08 In 1H08 GIST P3 in preparation *Transitioned to Novartis |
7 The Hedgehog signaling pathway *Chen et al., 2002 G&D 16:2743 |
8 The Hedgehog signaling pathway *Chen et al., 2002 G&D 16:2743 |
9 The Hedgehog signaling pathway Cyclopamine *Chen et al., 2002 G&D 16:2743 |
10 Genetic mutation medulloblastoma basal cell carcinoma Pathway activation pancreatic, gastric, prostate, glioma Tumor progenitor cells SCLC, glioblastoma, breast, multiple myeloma Hedgehog pathway implicated in variety of solid tumors and heme. malignancies |
11 Infinity’s Hedgehog inhibitor: IPI-926 HO O NH H H H H H 1 st generation 2 nd generation Solubility Chemical stability Potency (15nM in cell based assay) Selectivity Metabolic stability IPI-926 Oral bioavailability Long half-life In vivo activity + cyclopamine O H H O NH H H H • Issued composition of matter patent • Infinity-discovered & 100% owned royalty-free worldwide |
12 Human Smo overexpressed in C3H10 cells Competition with BODIPY-labeled cyclopamine IPI-926 binds Smoothened with higher affinity than cyclopamine |
13 Oral administration of IPI-926 inhibits Gli1 mRNA expression in tumors 0 1000 2000 3000 4000 5000 6000 7000 veh 4 mg/kg 10 mg/kg 20 mg/kg |
14 Daily oral administration of IPI-926 shows dose dependent inhibition of tumor growth -500.00 0.00 500.00 1000.00 1500.00 2000.00 2500.00 3000.00 3500.00 4000.00 4500.00 15 20 25 30 35 40 45 50 55 60 65 Days VEH--30% HPBCD in WFI IPI-926 @ 4mg/kg IPI-926 @ 10mg/kg IPI-926 @ 20mg/kg Treatment phase 4/7 fully regressed B837Tx tumor Ptch/Hic model of medulloblastoma Pink et al., 2008 AACR |
15 Once-daily administration of IPI-926 resulted in 100% survival during treatment period 0 1 2 3 4 5 6 7 8 9 10 11 10 14 18 22 26 30 34 38 42 46 50 Days post implant Veh IPI-926 @ 40mg/kg Start of TX End of TX Mice bearing orthotopically implanted B837Tx tumor Pink et al., 2008 AACR |
16 Vehicle Days Post Implant IPI-926 significantly delays tumor re-growth following tumor debulking in SCLC model Travaglione et al., 2008 AACR |
17 Vehicle IPI-926 Days Post Implant IPI-926 significantly delays tumor re-growth following tumor debulking in SCLC model Once-daily, oral administration of IPI-926 Travaglione et al., 2008 AACR |
18 E/P -Vehicle Vehicle IPI-926 Days Post Implant Last day of E/P treatment IPI-926 significantly delays tumor re-growth following tumor debulking in SCLC model Travaglione et al., 2008 AACR |
19 E/P - IPI-926 E/P -Vehicle Vehicle IPI-926 Days Post Implant Mice randomized +/- IPI-926 5 weeks total of IPI-926 follow-up treatment 40 mg/kg, PO QD 82% IPI-926 significantly delays tumor re-growth following tumor debulking in SCLC model Last day of E/P treatment Travaglione et al., 2008 AACR |
20 Hedgehog program milestones 2009 • Preliminary Phase 1 data • Initiate Phase 2 trials 2008 • Preclinical data at AACR • File IND • Initiate Phase 1 clinical trial |
21 Continued progress with Hsp90: four clinical trials ongoing, oral entering clinic this quarter Additional Tumor #2 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 i.v.: Retaspimycin (IPI-504) GIST/STS NSCLC HRPC Taxotere ® Combo Additional Tumor #1 Additional Combinations Hsp90 oral: IPI-493 Hedgehog Pathway: IPI-926 Bcl-2/Bcl-xL* Early Discovery FPI mid-year 2008 FPI 2H 2008 Add’l in 2008 In 1H08 In 1H08 GIST P3 in preparation *Transitioned to Novartis |
22 IPI-504 demonstrates activity as single agent in Iressa ® (gefitinib)-resistant NSCLC Days Post-implant IPI-504 Vehicle, IP Gefitiinb Vehicle, PO 100mpk IPI-504, IP 100mpk Gefitinib, PO 500 1000 1500 2000 2500 3000 12 15 19 22 26 27 32 IPI-504: i.p. BIW Gefitinib: PO QD Iressa ® (gefitinib)-resistant (T790M) H1975 xenograft model Janne et al., 2008 AACR |
23 IPI-504 demonstrates activity in combination with Iressa ® (gefitinib) in NSCLC Vehicle 50mpk IPI-504 50mpk Gefitinib 50 mpk IPI-504 + 50 mpk Gefitinib IPI-504: PO QOD Gefitinib: PO QD Days 30 40 50 1500 1000 500 HCC827 GR5 xenograft model Janne et al., 2008 AACR 60 |
24 9 14 19 24 29 34 39 44 49 54 59 64 69 74 79 0 250 500 750 1000 1250 1500 1750 2000 Days Post Implant Untreated 100mg/kg IPI-504 30mg/kg Trastuzumab 100mg/kg IPI-504 + 30mg/kg Trastuzumab N87 (HER2+, trastuzumab-sensitive) xenograft Leow et al., 2008 AACR IPI-504 demonstrates activity in combination with Herceptin ® (trastuzumab) in HER2 breast Last dose |
25 Hsp90 program aggressively moving forward in 2008 • IPI-504 on track with potential to enter trial designed for registration in GIST to start third quarter 2008 – Update on data from the Phase 1 study of IPI-504 in GIST to be reported in oral presentation at ASCO Annual Meeting • Clinical trials of IPI-504 in NSCLC, HRPC, and in combination with Taxotere are on-going – Anticipate data from NSCLC and HRPC trials in 2H08 • IPI-493, oral Hsp90 inhibitor, continues to advance through IND- enabling studies – Phase 1 study anticipated for 1H08 |
26 Business and Financial Update Adelene Perkins, Executive Vice President and Chief Business Officer |
27 Sustaining excellence through our strategic alliances • Transition of Bcl-2 program to Novartis in February 2008 – Research term of the collaboration concluded, lead series transferred to Novartis – INFI has no further performance obligations – INFI recognized remaining deferred revenue from up-front license fee – INFI entitled to receive milestones and royalties on successful development and commercialization by Novartis • Strong partnership on Hsp90 program, building relationships with AstraZeneca team – Leveraging AZ’s late-stage oncology capabilities and expertise – AstraZeneca senior oncology leadership involvement – Infinity leadership of IPI-504 GIST registration trial |
28 1Q08 financial results: continued strong balance sheet and cash runway Results • $105 million cash and equivalents as of 3/31/08 • Revenue: $11.4 million – Increase in 1Q08 vs. 1Q07 primarily due to recognition of the remaining deferred revenue from Novartis relating to the Bcl-2 collaboration • R&D Expense: $8.5 million – Net of $4.4 million MedImmune reimbursement, total R&D investment of $12.9M • G&A Expense: $3.8 million • Net income: $0.4 million Reiterate Guidance • Projected 2008 net cash burn: $35-45 million – Burn rate well-controlled: 50% cost- sharing of Hsp90 program with AZ • Cash to support current plan into 2010 – Sufficient capital to achieve key value creation milestones |
29 2008 Milestones Steve Holtzman, Chair, President, and Chief Executive Officer |
30 Increasing momentum of progress in 2008 2H 2008 • Initiate registration trial of retaspimycin in GIST • Initiate IPI-926 Phase 1 trial • Present preliminary Phase 2 NSCLC data • Present preliminary Phase 2 HRPC data 1H 2008 • Present updated Phase 1 GIST data (ASCO) • Initiate additional Phase 2 trials with retaspimycin • Initiate IPI-493 oral Phase 1 trial |
31 Additional Tumor #2 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 i.v.: Retaspimycin (IPI-504) GIST/STS NSCLC HRPC Taxotere ® Combo Additional Tumor #1 Additional Combinations Hsp90 oral: IPI-493 Hedgehog Pathway: IPI-926 Bcl-2/Bcl-xL* Early Discovery Continued commitment to aggressively advance pipeline through key milestones FPI mid-year 2008 FPI 2H 2008 Add’l in 2008 In 1H08 In 1H08 GIST P3 in preparation *Transitioned to Novartis |