Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its anticipated pipeline goals and provided financial guidance for 2013. In the first half of 2013, Infinity expects to report data from both of its wholly owned clinical programs, phosphoinositide-3-kinase (PI3K) and heat shock protein 90 (Hsp90), that will inform potential paths to registration. Each program targets areas of unmet patient need such as advanced hematologic malignancies, inflammatory diseases and non-small cell lung cancer (NSCLC). “Our pipeline, experienced leadership team and financial position provide the foundation from which we are poised to execute our product development and business strategy as we continue to build a fully integrated biopharmaceutical company,” stated Adelene Q. Perkins, Infinity’s president and chief executive officer. “We have worldwide commercial rights to our entire portfolio of product development candidates and are entering the year with a strong balance sheet that allows us to independently advance our programs while we consider potential partnerships to complement our capabilities.” Pipeline Expanded with IPI-443, a Potent PI3K-Delta,Gamma Inhibitor Infinity today also announced its second potent, oral PI3K-delta,gamma inhibitor, IPI-443. Nonclinical studies of IPI-443 are now under way, which are designed to enable the initiation of Phase 1 clinical development. “PI3K inhibition has therapeutic potential across both hematologic malignancies and inflammatory diseases,” stated Julian Adams, Ph.D., president of R&D at Infinity. “We believe that we have the potential to develop best-in-class PI3K inhibitors and are pleased that IPI-443, our second product candidate targeting PI3K-delta,gamma, has the potential to further maximize our development opportunities across multiple disease pathways and indications.” 2013 Program Goals Infinity is developing a portfolio of PI3K inhibitors which includes IPI-145 and IPI-443, potent, oral inhibitors of PI3K-delta and PI3K-gamma, as well as retaspimycin hydrochloride (HCl), a potent and selective Hsp90 inhibitor. Infinity anticipates achieving the following development milestones in 2013: IPI-145 in Hematologic Malignancies
- 1H2013: Initiate up to five cohort expansions in the ongoing Phase 1 trial in patients with advanced hematologic malignancies
- 1H2013: Define the recommended Phase 2 dose
- 2013: Initiate at least two additional trials
- 1H2013: Initiate a Phase 2 trial in patients with rheumatoid arthritis
- 2H2013: Provide update on Phase 2a trial in patients with mild, allergic asthma
- 2H2013: Complete nonclinical studies of IPI-443 to enable Phase 1 development
- 1H2013: Report topline overall survival data from Phase 2 trial in combination with docetaxel
- 1H2013: Provide update on Phase 1b/2 trial in combination with everolimus
- Operating Expenses: Infinity expects operating expenses for 2013 to range from $115 million to $125 million.
- Net Loss: Infinity expects net loss for 2013 to range from $115 million to $125 million.
- Cash and Investments: Infinity expects to end 2013 with a year-end cash and investments balance ranging from $210 million to $220 million. Based on its current operating plan and exclusive of any business development activities, Infinity’s financial foundation provides a cash runway into 2015.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the Company’s expectations about: the timing of data from clinical trials of its PI3K and Hsp90 programs; its ability to execute on its strategic plans; its current cash position; the therapeutic potential of its PI3K inhibitors and retaspimycin HCl; its 2013 research and development goals, including without limitation clinical development plans, for its PI3K program and its Hsp90 program; and its financial guidance for 2013 with respect to operating expenses, net loss and cash and investments. Such statements are subject to numerous important 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 will report data in the time frames it has estimated, that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases or that development of any of Infinity’s product candidates will continue. Further, there can be no guarantee that any positive developments in Infinity’s product portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Infinity’s 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 obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity’s competitors for diseases in which Infinity is currently developing its product candidates; 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 current report on Form 8-K filed with the Securities and Exchange Commission (SEC) on December 12, 2012, and other filings filed by Infinity with the SEC. 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.
i Weinberg RA (2007) Cytoplasmic signaling circuitry programs many of the traits of cancer. In Jeffcock E, Zayatz E, and Mickey RK (Eds.) The biology of cancer (pp. 179-183). New York, NY: Garland Science, Taylor & Francis Group.ii Flinn, I.W., Horwitz, S.M., Patel, M., Younes, A., Porter, J., Sweeney, J., Allen, K., Kelly, P., Kahl, B. Clinical Safety and Activity in a Phase 1 Trial of IPI-145, a Potent Inhibitor of Phosphoinositide-3-Kinase-(δ,γ) in Patients with Advanced Hematologic Malignancies. Poster presented at the 54th Annual Meeting of the American Society for Hematology (ASH), Atlanta, GA, 2012. iii Whitesell L and Lindquist SL. Hsp90 and the chaperoning of cancer. Nat Rev Cancer 2005, 5(10):761-772. iv Workman P, Burrows F, Neckers L, Rosen N. Drugging the cancer chaperone Hsp90: Combinatorial therapeutic exploitation of oncogene addiction and tumor stress. Ann NY Acad Sci 2007, 1113:202-216. v Taipale M, Jarosz DF, Lindquist S. Hsp90 at hub of protein homeostasis: Emerging mechanistic insights. Nat Rev Mol Cell Bio 2010, 11:515-528. vi Riely GJ, Gettinger SN, Stoller RG, Gabrail NY, Weiss GJ, Tunkey C, et al. Safety and activity of IPI-504 (restaspimycin HCl) and docetaxel in pretreated patients with metastatic non-small cell lung cancer (NSCLC). Poster presented at the 47th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, 2011.