Infinity R&D and Business Update Third Quarter Financial Results October 30, 2008 Exhibit 99.2 |
2 Forward-Looking Statements • This press release 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 utility of Hsp90 and Hedgehog pathway inhibition to treat cancer; the ability of IPI-504 to be the first-to-market Hsp90 inhibitor; future clinical trial activity for IPI-504; the presentation of clinical data for IPI-504; the achievement of annual clinical objectives; 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 the company'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, or that any preclinical data will be replicated in clinical trials. In particular, management's 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. FDA 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 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 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 June 30, 2008, as filed with the Securities and Exchange Commission on August 6, 2008. • Further, any forward-looking statements contained in this press release 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. |
3 Introduction Steven Holtzman Chair and Chief Executive Officer |
4 4 Solid tumors Hsp90 oral: IPI-493 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 i.v.: IPI-504 (retaspimycin hydrochloride) GIST NSCLC Docetaxel Combo Add’l Solid Tumor Solid tumors Hedgehog Pathway: IPI-926 Bcl-2/Bcl-xL* Discovery Programs Initiated RING trial INFI: Late-stage oncology pipeline *Transitioned to Novartis February 2008 Initiated Phase 1 Initiated Phase 1 Expanded Phase 2 |
5 Clinical Update: Hsp90 and Hedgehog Pathway Programs Julian Adams, Ph.D., President of R&D & Chief Scientific Officer |
6 6 Solid tumors Hsp90 oral: IPI-493 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 i.v.: IPI-504 (retaspimycin hydrochloride) GIST NSCLC Docetaxel Combo Add’l Solid Tumor Solid tumors Hedgehog Pathway: IPI-926 Bcl-2/Bcl-xL* Discovery Programs Initiated RING trial INFI: Late-stage oncology pipeline *Transitioned to Novartis February 2008 Initiated Phase 1 Initiated Phase 1 Expanded Phase 2 |
7 First Phase 3 registration study: RING trial Retaspimycin hydrochloride in GIST Trial under Special Protocol Assessment and EMEA advice • Study designed in consultation with international group of KOLs – Randomized, double-blind, placebo-controlled study – Approx. 200 patients; >50 sites worldwide – Patients with progressive GIST despite treatment with imatinib and sunitinib • Primary endpoint: Progression-free survival (PFS) – Secondary endpoints: disease control rate, time to progression & overall survival • Efficient trial design – Trial opened in 3Q08; enrollment commenced in October 2008 – Trial anticipated to be completed by year end 2010 7 |
8 Expanding potential of IPI-504 beyond GIST • Expanding Phase 2 study in Stage IIIb/IV NSCLC – Study designed to evaluate 2 equal groups: mEGFR and wild-type EGFR • Potential to expand if 1 patient demonstrates clinical benefit – Enrolled 10 patients in each group • >1 patient in each arm met expansion criterion of extended stable disease – Expanding study to enroll additional 19 patients in each arm – Full Phase 2 data anticipated by mid-2009 8 |
9 Expanding potential of IPI-504 beyond GIST • Expanding Phase 2 study in Stage IIIb/IV NSCLC – Study designed to evaluate 2 equal groups: mEGFR and wild-type EGFR • Potential to expand if 1 patient demonstrates clinical benefit – Enrolled 10 patients in each group • >1 patient in each arm met expansion criterion of extended stable disease – Expanding study to enroll additional 19 patients in each arm – Full Phase 2 data anticipated by mid-2009 • Phase 1b combo with docetaxel – Patients with advanced solid tumors – Establish safety, MTD, and optimal schedule of administration • Additional clinical studies of IPI-504 planned to start by early 2009 9 |
10 10 Infinity’s second Hsp90 inhibitor, oral IPI-493, enters clinical development • Phase 1 clinical trial in patients with advanced solid tumors – Dose-escalation study evaluating safety and tolerability – Identify dose and schedule for further clinical development – Assess biological activity using RECIST and disease-specific markers • Novel, orally delivered formulation of 17-AG • Strong pharmaceutical properties in vivo and in vitro – Oral availability – Selectivity for cancer cells over normal cells – Potent and selective Hsp90 inhibition |
11 Significant anti-tumor activity with oral IPI-493 in preclinical model of TKI-resistant NSCLC 0 500 1000 1500 2000 2500 3000 3500 18 21 25 28 32 Days Post Implant Vehicle 50 75 100 IPI-493 (mg/kg) Dosing: QOD, PO, 10ml/kg 87% 0 500 1000 1500 2000 2500 3000 3500 18 21 25 28 32 Days Post Implant Vehicle 50 75 100 IPI-493 (mg/kg) 0 500 1000 1500 2000 2500 3000 3500 18 21 25 28 32 Days Post Implant Vehicle 50 75 100 IPI-493 (mg/kg) Dosing: QOD, PO, 10ml/kg 87% Lee et al., 2008 EORTC |
12 12 Solid tumors Hsp90 oral: IPI-493 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 i.v.: IPI-504 (retaspimycin hydrochloride) GIST NSCLC Docetaxel Combo Add’l Solid Tumor Solid tumors Hedgehog Pathway: IPI-926 Bcl-2/Bcl-xL* Discovery Programs Initiated RING trial INFI: Late-stage oncology pipeline *Transitioned to Novartis February 2008 Initiated Phase 1 Initiated Phase 1 Expanded Phase 2 |
13 13 Novel Hedgehog pathway inhibitor, oral IPI-926, enters clinical development • Phase 1 clinical trial in patients with advanced solid tumors – Dose-escalation study evaluating safety and tolerability – Identify dose and schedule for further clinical development – Assess anti-tumor activity and examine pharmacodynamic markers of biological activity • IPI-926 demonstrates oral availability, long plasma half-life and duration of action, and good distribution to tumor tissue – Potent and selective Hedgehog signaling inhibition in preclinical models |
14 Genetic mutation medulloblastoma basal cell carcinoma Pathway activation pancreatic, gastric, prostate, glioma, SCLC Tumor progenitor cells SCLC, glioblastoma, breast, multiple myeloma Hedgehog pathway implicated in a variety of cancers Hh in Cancer |
15 Genetic mutation medulloblastoma basal cell carcinoma Pathway activation pancreatic, gastric, prostate, glioma, SCLC IPI-926 demonstrates activity in multiple preclinical settings Tumor progenitor cells SCLC, glioblastoma, breast, multiple myeloma Hh in Cancer |
16 0.00 10.00 20.00 30.00 40.00 50.00 60.00 70.00 80.00 90.00 100.00 Vehicle IPI-926 @ 40mpk 0.00 200.00 400.00 600.00 800.00 1000.00 1200.00 40 45 50 55 60 65 70 Days (post implant) Vehicle: 30% HPBCD N=13 IPI5926 @ 40mg/kg N=12 IPI-926: 40% IPI-926 demonstrates significant tumor growth inhibition in pancreatic cancer model IPI-926 down-regulates Hedgehog signal in tumor stroma IPI-926 Tumor Surrounding stromal tissue SHH Gli 1 Travaglione et al., 2008 EORTC |
17 Business Update Adelene Q. Perkins, President & Chief Business Officer |
18 Third quarter financial results • $80.8 million in cash and investments (not including $15 million milestone from AstraZeneca) as of 9/30/08 – Began 2008 with $114 million in cash and investments – Earned $15 million milestone from AstraZeneca with start of RING trial in October 2008; revenue will be recorded and cash will be received in 4Q08 • Revenue: $2.5 million • R&D Expense: $11.7 million – Net of $4.2 million AstraZeneca reimbursement, total R&D investment of $15.9 million • G&A Expense: $3.8 million • Net loss: ($12.4) million |
19 Strong balance sheet and cash runway • Burn rate well-controlled – 50% cost-sharing of Hsp90 program with AstraZeneca • Projected year end cash of approximately $80 million – Low end of previous net cash burn guidance of $35-$45 million for 2008 • Cash to support current plan into 2010 – Sufficient capital to achieve key value-creation milestones |
20 2008 Milestones Steve Holtzman, Chair and Chief Executive Officer |
21 Executing on our R&D and business strategy Initiate additional IPI-504 clinical studies By early 2009 Initiate IPI-493 Phase 1 clinical trial Preliminary update on IPI-504 Phase 2 data in NSCLC Initiate RING Ph 3 registration trial of IPI-504 in GIST Secure SPA for IPI-504 Phase 3 GIST study Present IPI-504 Phase 1 GIST data (ASCO) IPI-504 & IPI-493: Hsp90 inhibitors Initiate Phase 1 clinical study Present preclinical data (AACR) IPI-926: Hedgehog pathway inhibitor |
22 22 Solid tumors Hsp90 oral: IPI-493 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 i.v.: IPI-504 (retaspimycin hydrochloride) GIST NSCLC Docetaxel Combo Add’l Solid Tumor Solid tumors Hedgehog Pathway: IPI-926 Bcl-2/Bcl-xL* Discovery Programs Initiated RING trial INFI: Late-stage oncology pipeline *Transitioned to Novartis February 2008 Initiated Phase 1 Initiated Phase 1 Expanded Phase 2 By early 2009 |