Infinity is also evaluating IPI-493 in two Phase 1, dose escalation studies to determine the optimal dose and schedule for future development. In one study, IPI-493 is being evaluated in patients with advanced hematologic malignancies to assess safety and tolerability in this patient population, as well as to assess pharmacokinetic parameters and effects of IPI-493 on pharmacodynamic markers of biological activity. The other study is being conducted in patients with advanced solid tumors. Infinity anticipates reporting data from its Phase 1 program and articulating future development plans for IPI-493 in 2011.
FAAH Inhibitor Program
Infinity also continues to progress the Phase 1 development program for its fourth clinical candidate, IPI-940, a selective, orally administered inhibitor of the fatty acid amide hydrolase (FAAH) enzyme for the potential treatment of a broad range of neuropathic and inflammatory pain conditions. This Phase 1 development program, being conducted in normal, healthy volunteers, includes both single- and multiple-ascending dose studies. Infinity anticipates completing Phase 1 development of IPI-940 in 2010.
Second Quarter 2010 Financial Results
Infinity ended the second quarter of 2010 with $120.0 million in cash and investments. Total revenue for the second quarter of 2010 was $18.4 million, comprised of $17.7 million for reimbursed research and development (R&D) services and $0.7 million from the amortization of deferred revenue associated with the grant of licenses under Infinity's strategic alliance with Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Ltd. R&D expense was $19.0 million for the second quarter of 2010. Reimbursed expenses related to Infinity's alliance with Purdue and Mundipharma for the quarter are recorded as R&D expense, as well as collaborative R&D revenue. The primary driver of the remaining R&D expense was Infinity's investment in the development of its Hsp90 chaperone inhibitor program. General and administrative expense was $5.2 million for the second quarter of 2010. Infinity's net loss for the second quarter of 2010 was $6.2 million. Basic and diluted loss per common share was $0.24.Financial Guidance
The PI3Kdelta/gamma program licensed from Intellikine is part of Infinity's existing strategic alliance with Mundipharma and is governed by the same terms as Infinity's internally-discovered programs. Such terms include Mundipharma's funding of Infinity's R&D expenses for the PI3K program through the later to occur of December 31, 2013 and the commencement of Phase 3 clinical development, subject to aggregate funding caps across the partnered portfolio under a three-year rolling plan, and reimbursement of 50% of R&D expenses thereafter. In addition, Mundipharma has commercialization rights outside of the United States to any successfully developed products, subject to the payment of royalties of up to 20% on net sales.
By virtue of the expansion of Infinity's portfolio to include the PI3K program, Infinity expects to exceed the $65 million cap for 2010 set forth in the research plan under the Mundipharma/Purdue alliance and to fund those excess costs itself. As a result, Infinity now anticipates a cash burn of between approximately $35-45 million during 2010 and estimates a year-end cash and investments balance of between $85-95 million. This guidance does not include any amounts that Infinity may draw under the $50 million line of credit available from Purdue Pharma L.P. In the absence of additional funding or business development activities, and based on current operating plans, Infinity expects that its current cash and investments, together with R&D funding from Purdue and Mundipharma and proceeds from the line of credit, remain sufficient to fund the company's operations into 2013. The company believes that these resources will enable Infinity to reach key development milestones and continue evaluating additional external opportunities to strategically enhance its pipeline.
SOURCE Infinity Pharmaceuticals, Inc.