Data from Phase 1 trial of IPI-145 in hematologic malignancies to be presented at ASH: Infinity announced that data from its ongoing Phase 1, open-label, dose-escalation trial of IPI-145 in patients with advanced hematologic malignancies will be presented at the 54^th American Society of Hematology (ASH) Annual Meeting and Exhibition being held in Atlanta, Georgia, from December 8 – 11, 2012. IPI-145 is a potent, oral inhibitor of PI3K-delta and -gamma in development for the treatment of hematologic malignancies and inflammatory disorders. The poster, entitled “Clinical safety and activity in a Phase 1 trial of IPI-145, a potent inhibitor of phosphoinositide-3-kinase (PI3K)-delta,gamma, in patients with advanced hematologic malignancies” (Abstract #3663), will be presented on Monday, December 10, 2012, from 6:00 p.m. to 8:00 p.m. ET in the Georgia World Congress Center, Hall B1-B2.

Data from Phase 1 trial of IPI-145 in healthy subjects to be presented at ACR: Infinity will present data from its completed Phase 1 trial of IPI-145 in healthy adult subjects during a poster session at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) 2012 Annual Meeting being held in Washington, DC, from November 10 – 14, 2012. The poster, entitled “The potent phosphoinositide-3-kinase-delta, gamma inhibitor IPI-145 is active in preclinical models of arthritis and well tolerated in healthy adult subjects” (Abstract #338), will be presented on Sunday, November 11, 2012, from 9:00 a.m. to 6:00 p.m. ET in the Walter E. Washington Convention Center, Poster Hall B.

Enrollment completed in Phase 2 trial of retaspimycin HCl plus docetaxel in NSCLC: Infinity today announced that it has completed enrollment in its Phase 2, double-blind, randomized, placebo-controlled trial of retaspimycin hydrochloride (HCl) in combination with docetaxel in non-small cell lung cancer (NSCLC) patients with a history of smoking. Retaspimycin HCl is an intravenously administered, potent and selective heat shock protein 90 (Hsp90) inhibitor. The company expects to report topline overall survival data from this trial in the first half of 2013.

Phase 1b/2 trial of retaspimycin HCl plus everolimus in NSCLC ongoing: Infinity today reported that its Phase 1b/2 trial of retaspimycin HCl in combination with everolimus in NSCLC patients with an activating KRAS mutation is continuing. The Phase 1b portion of the study is designed to determine the recommended dose and schedule for the combination treatment. Infinity expects to provide topline data from the Phase 1b portion of the trial in the first half of 2013.

Steve H. Holtzman resigns from Infinity’s board of directors: Infinity today announced that Mr. Steven H. Holtzman, the company’s founder, has resigned from his positions as chair and a member of Infinity’s board of directors. Mr. Holtzman resigned to avoid the potential for a conflict of interest between his role as a member of Infinity’s board of directors and his role as executive vice president, corporate development of Biogen Idec Inc. that could have arisen from both companies having product development programs focused on inflammatory disorders. Mr. Holtzman has entered into a three-year agreement with Infinity to act as a strategic advisor to the company on non-conflicting matters. Mr. Holtzman served as Infinity’s chair and chief executive officer from the company’s founding in 2001 through 2009. Ms. Perkins has been named chair of Infinity’s board of directors.

At September 30, 2012, Infinity had total cash, cash equivalents and available-for-sale securities of $189.4 million, compared to $104.6 million at June 30, 2012. In August, Infinity completed an underwritten registered public offering of 6,095,000 shares of common stock at $14.50 per share. The net proceeds to Infinity from the offering are approximately $83 million. In September, Infinity also received $27.5 million in cash and extinguished its long-term debt following the completion of the sale and issuance of 5,416,565 shares of its common stock to Purdue Pharma L.P.

Gain related to the previous strategic alliance with Purdue and Mundipharma was $46.6 million for the third quarter of 2012. Infinity does not have any future research and development (R&D) obligations to Purdue and Mundipharma.

Infinity did not record any revenue during the third quarter of 2012, as the previous strategic alliance with Purdue and Mundipharma ended in July 2012. Total revenue was $23.3 million for the same period in 2011, which was composed of $22.3 million for reimbursed R&D services performed under the strategic alliance with Purdue and Mundipharma and $1.0 million from the amortization of deferred revenue associated with the grant of rights and licenses under this alliance.

R&D expense for the third quarter of 2012 was $21.5 million, compared to $29.4 million for the same period in 2011. The decrease in R&D expense for the third quarter of 2012 compared to the same period in 2011 was primarily related to the discontinuation of development of the company’s Hedgehog pathway program.

General and administrative (G&A) expense for the third quarter of 2012 was $6.3 million, compared to $5.5 million for the same period in 2011. The increase in G&A expense for the third quarter of 2012 compared to the same period in 2011 was related primarily to a charge taken in connection with restructuring activities associated with its reduction in headcount previously announced.

Net income for the third quarter of 2012 was $18.4 million, or a basic earnings per common share of $0.57 and a diluted earnings per common share of $0.52, compared to a net loss of $11.9 million, or a basic and diluted loss per common share of $0.45, for the same period in 2011.

Revenue: Infinity expects total revenue for 2012 to be $47.1 million, composed of $45.0 million for reimbursed R&D services from Mundipharma and $2.1 million due to the amortization of deferred revenue. Infinity does not expect to recognize any revenue in future periods from the previous strategic alliance with Purdue and Mundipharma.

Operating expenses: Infinity expects operating expenses for 2012 to range from $125 million to $135 million, revised from an earlier expectation of $135 million to $145 million.

Net loss: Infinity expects a net loss for 2012 to range from $35 million to $45 million.

Cash and investments: Infinity expects to end 2012 with a year-end cash and investments balance ranging from $155 million to $165 million, revised from an earlier expectation of $65 million to $75 million.

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