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.
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