NASDAQ: INFI September 2009 Infinity Innovative. Independent. Inspired. Exhibit 99.1 |
Innovative. Independent. Inspired. 2 Safe Harbor Statement 2 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 future clinical trial activity for IPI-504 and IPI-493; the presentation of clinical data for IPI-504 and IPI-493; the filing of an IND for IPI-940; estimates of 2009 financial performance; the continuation of the Purdue/Mundipharma alliance and the exercise of warrants held by Purdue, and the expectation that Infinity will have capital to support its current operating plan into 2013. • 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. In addition, Infinity’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. 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; 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 in August 2009. • 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. |
Innovative. Independent. Inspired. Infinity: Uniquely positioned for success Full ownership of industry-leading Hsp90 chaperone inhibitors U.S. commercialization rights to all oncology programs Worldwide royalties up to 20% on neuropathic pain program 3 Financial strength Value-creating asset ownership Innovative pipeline Cash and funding to support operating plan into 2013 Phase 2: Hsp90 chaperone inhibition Phase 1: Hedgehog pathway inhibition Near IND: Neuropathic pain (FAAH) World-class discovery organization |
Innovative. Independent. Inspired. Financial strength today to aggressively invest in pipeline – without dilution • $150 million in cash & equivalents as of June 30, 2009 • Purdue / Mundipharma collaboration – Access to $50 million line of credit (interest at prime; payment due 2019) – Up to $175 million in R&D funding through 2011*; options to extend through 2013 • ~ 26 million shares outstanding – Up to $200 million in proceeds from Purdue exercisable warrants (6 million shares at exercise price of $15 to $40 per share) 4 *As of 7/1/2009, assuming Purdue funding through 2011. Funding from Purdue includes ~$25M in 2H2009, up to $65M in 2010 (committed), and up to $85M in 2011 |
Innovative. Independent. Inspired. 5 5 Infinity: Developing Breakthrough Therapeutics 5 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 Chaperone Inhibitors Hsp90 IV: IPI-504 (retaspimycin hydrochloride) NSCLC HER2+ mBC Solid Tumors Hsp90 oral: IPI-493 Solid Tumors Hedgehog Pathway: IPI-926 Solid Tumors FAAH: IPI-940 Bcl-2/Bcl-xL* Discovery Programs *Transitioned to Novartis Pipeline at July 2009 Herceptin® Combination Taxotere® Combination |
Innovative. Independent. Inspired. 6 Hsp90 Chaperone Inhibition Program: New angle of attacking oncoproteins |
Innovative. Independent. Inspired. 7 7 Hsp90 chaperone function 7 • Hsp90 chaperone stabilizes the oncoprotein, enabling growth signaling and tumor cell proliferation. |
Innovative. Independent. Inspired. 8 8 Hsp90 chaperone inhibition: A new angle for targeting oncoproteins 8 • Currently, targeted therapies inhibit oncoproteins in distinctly different ways that do not affect the critical function of Hsp90. • Through the inhibition of Hsp90, oncoproteins can now be targeted from an entirely new angle mAB TKI |
Innovative. Independent. Inspired. 9 9 Hsp90 chaperone inhibition: Arresting tumor cell growth 9 • When the chaperone function of Hsp90 is inhibited, oncoproteins become unstable, unfolded, and unable to signal. • Unfolded oncoproteins will then be degraded rapidly by the proteasome, arresting tumor cell growth. |
Innovative. Independent. Inspired. 10 10 Infinity’s Hsp90 chaperone inhibition program 10 Broad medical & commercial potential Lung cancer Breast cancer Additional tumors –IPI-504 IV (retaspimycin hydrochloride) –IPI-493 oral |
Innovative. Independent. Inspired. 11 11 Infinity’s Hsp90 chaperone inhibition program Broad medical & commercial potential 11 Lung cancer Non-small cell 180,000 US incidence • IPI-504 Ph 2 in NSCLC (ASCO 2009) 14% ORR in wtEGFR patients • IPI-504 Ph 1b combo with Taxotere (ASCO 2009) Generally well-tolerated; combinable • Molecular characterization ongoing • Clinical data expected 2010 • Future plans: Fall 2009 |
Innovative. Independent. Inspired. 12 12 Infinity’s Hsp90 chaperone inhibition program Broad medical & commercial potential 12 Lung cancer Non-small cell 180,000 US incidence • IPI-504 Ph 2 in NSCLC (ASCO 2009) 14% ORR in wtEGFR patients • IPI-504 Ph 1b combo with Taxotere (ASCO 2009) Generally well-tolerated; combinable • Molecular characterization ongoing • Clinical data expected 2010 • Future plans: Fall 2009 Breast cancer HER2+ 45,000 US incidence • IPI-504 Ph 2 in HER2+ mBC, combination with Herceptin® underway Demonstrated potency and tumor growth inhibition in preclinical models • Clinical data expected 2010 |
Innovative. Independent. Inspired. 13 13 Infinity’s Hsp90 chaperone inhibition program Broad medical & commercial potential 13 Lung cancer Non-small cell 180,000 US incidence • IPI-504 Ph 2 in NSCLC (ASCO 2009) 14% ORR in wtEGFR patients • IPI-504 Ph 1b combo with Taxotere (ASCO 2009) Generally well-tolerated; combinable • Molecular characterization ongoing • Clinical data expected 2010 • Future plans: Fall 2009 Breast cancer HER2+ 45,000 US incidence • IPI-504 Ph 2 in HER2+ mBC, combination with Herceptin® underway Demonstrated potency and tumor growth inhibition in preclinical models • Clinical data expected 2010 Additional tumors • IPI 493 oral Ph 1 study underway • Additional opportunities with IPI-504 • Additional IPI-504 study anticipated by early 2010 |
Innovative. Independent. Inspired. 14 Hedgehog Program |
Innovative. Independent. Inspired. 15 The Hedgehog pathway: A promising new focus for targeted drug therapy 15 15 • The Hedgehog pathway is not active in most adult cells • Smoothened (Smo) -- which can promote growth of certain cancers – is held in an inactive state by Patched (Ptc) • Gli transcription factors do not enter the nucleus to promote transcription Malignant activation of the Hedgehog pathway may be implicated in many insidious cancers including pancreatic, ovarian, small cell lung, breast, brain, and basal cell (skin) cancers |
Innovative. Independent. Inspired. 16 The role of Smoothened in malignant activation of the Hedgehog pathway 16 16 • In certain cancers, such as small cell lung cancer, tumor cells produce Hh ligand that binds to Ptc, allowing Smo to initiate a signaling cascade through Gli • Gli dependent transcription of genes can now promote tumor survival and growth |
Innovative. Independent. Inspired. 17 Malignant activation of the Hedgehog pathway can also affect the tumor microenvironment Travaglione et al., 2008 EORTC • In certain cancers, such as pancreatic cancer, tumor derived Hh ligands act through Smo on stromal cells in the tumor microenvironment • Stromal cells in the microenvironment provide support for growth and survival of tumor cells |
Innovative. Independent. Inspired. 18 Infinity’s IPI-926 inhibits the Hedgehog pathway 18 18 • IPI-926 inhibits Smo, preventing the signaling cascade that otherwise leads to tumor cell growth and survival IPI-926 IPI-926 in ongoing Ph 1 clinical trial |
Innovative. Independent. Inspired. 19 19 Significant anti-tumor activity with IPI-926 in small cell lung cancer model Days Post Implant 5 weeks total of IPI-926 follow-up treatment; 40 mg/kg, PO QD Travaglione et al., 2008 AACR |
Innovative. Independent. Inspired. 20 IPI-926 + Gemcitabine provides a survival benefit in pancreatic cancer model IPI-926 depletes tumor stroma through down-regulation of Hh signaling, resulting in increased drug delivery to the tumor Olive et al., 2009 Science 0 15 30 45 60 75 90 0 20 40 60 80 100 Days of Treatment Vehicle Gem IPI-926 IPI-926/Gem Model resembling human pancreatic cancer responds poorly to gemcitabine due to lack of tumor perfusion |
Innovative. Independent. Inspired. Compelling potential path forward for Phase 2 development • Recent Science article highlights promising role of IPI-926 in chemo-resistant pancreatic cancer model • Evidence for Hh inhibition as maintenance therapy in chemo-responsive tumor models, including SCLC and ovarian • IPI-926 moving well through Phase 1 study 21 |
Innovative. Independent. Inspired. 22 Early Pipeline: Neuropathic Pain |
Innovative. Independent. Inspired. Fatty acid amide hydrolase (FAAH): 23 23 Next Generation Innovation: IPI-940 for neuropathic pain 23 Advance IPI-940 to IND by year-end 2009 FAAH inhibition increases the duration of anandamide’s analgesic effect, prolonging pain relief at the site of release CB1 Anandamide |
Innovative. Independent. Inspired. 24 24 Infinity: Developing Breakthrough Therapeutics 24 Discovery Preclinical Phase 1 Phase 2 Phase 3 Hsp90 Chaperone Inhibitors Hsp90 IV: IPI-504 (retaspimycin hydrochloride) NSCLC HER2+ mBC Solid Tumors Hsp90 oral: IPI-493 Solid Tumors Hedgehog Pathway: IPI-926 Solid Tumors FAAH: IPI-940 Bcl-2/Bcl-xL* Discovery Programs *Transitioned to Novartis Pipeline at July 2009 Herceptin® Combination Taxotere® Combination |
Innovative. Independent. Inspired. 25 25 • Report IPI-504 NSCLC Ph 2 data, mid-2009 • Report IPI-504 Ph 1b Taxotere® combo data, mid-2009 • Advance oral IPI-493 Ph 1 • Initiate additional trials (including HER2+ mBC) 25 2009 R&D Milestones Hsp90: IPI-504 and IPI-493 oral • Advance IPI-940 to IND FAAH: IPI-940 • Report IPI-926 preclinical data, multiple tumor models, mid-2009 Hedgehog: IPI-926 |
Innovative. Independent. Inspired. 26 26 Business and Commercial Objectives 26 • Build market presence – Infinity to commercialize all oncology products in U.S. – Potential to partner Hsp90 for ex-U.S. marketing – Purdue/Mundipharma ex-U.S. marketing • Identify strategic opportunities to enhance profile • Maintain strong financial profile – Cash into 2013 – Opportunities for additional capital including Purdue warrants, Hsp90 partnering |
Innovative. Independent. Inspired. 27 Financial Strength: Aggressive Investment, Cash into 2013 2009 Key objectives • Advance Hsp90 trials • Advance Hedgehog trial • IND in neuropathic pain (FAAH) Total investment $80 – 90M $157M 2009 starting cash* 2009 ending cash $127 – 137M *$127M on 12/31/08, plus $30M Purdue equity investment 1/7/09 ** After $12.5M residual funding from AstraZeneca Net cash burn (Purdue funds non-Hsp90) ($20 - 30M)** 27 2010-2012 • Advance late-stage Hsp90 program • Initiate addt’l Hh and FAAH studies • Strategically enhance pipeline $375 – 425M ($140 – 170M) Additional sources of cash $50M Purdue line of credit • Up to $200M Purdue warrants • Partner Hsp90 ex-U.S. |
Innovative. Independent. Inspired. Infinity: Uniquely positioned for success Full ownership of industry-leading Hsp90 chaperone inhibitors US Commercialization rights to all oncology programs Worldwide royalties to 20% on neuropathic pain program 28 Financial strength Value-creating asset ownership Innovative pipeline Cash and funding to support operating plan into 2013 Phase 2: Hsp90 chaperone inhibition Phase 1: Hedgehog pathway inhibitor Near IND: Neuropathic pain (FAAH) World-class discovery organization |
Innovative. Independent. Inspired. 29 29 Infinity Innovative. Independent. Inspired. 29 |