Infinity Reports Third Quarter 2012 Financial Results

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today highlighted its recent clinical and business progress and reported its financial results for the third quarter of 2012.

“We have made strong progress across all aspects of our business during the third quarter and now look forward to reporting near-term data for both our PI3K and Hsp90 programs,” stated Adelene Q. Perkins, president and chief executive officer at Infinity. “Data from clinical trials of IPI-145 will be presented at two medical meetings this quarter. We have also completed patient enrollment in our Phase 2 trial of retaspimycin HCl plus docetaxel in non-small cell lung cancer, and we expect to report topline data from that trial in the first half of 2013. Data from both of these programs will help to inform our development plans in 2013 and beyond.”

Recent Highlights

• 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.Infinity will also host an investor reception on Monday, December 10, 2012, from 8:00 p.m. to 10:00 p.m. ET to discuss IPI-145 and to review the data presented at ASH. The reception will be webcast beginning at 8:45 p.m. ET and can be accessed in the “investors/media” section of Infinity’s website, www.infi.com. A replay of the event will also be available.

• 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.

“As Infinity’s founding chief executive officer, Steve established our culture of Citizen-Ownership and built a strong foundation for the company that positions us to achieve our mission of sustainably discovering, developing and delivering important new medicines to patients and creating significant value for shareholders,” said Ms. Perkins. “Steve’s vision, inspiration and counsel have been invaluable to me on a personal and professional level, as well as to the company. We are grateful for his leadership, passion and guidance over the past 11 years and look forward to working with him as a strategic advisor going forward.”

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