News Column

Infinity Reports Second Quarter 2014 Financial Results and Provides Company Update

August 20, 2014

By a News Reporter-Staff News Editor at Biotech Week -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced its second quarter 2014 financial results and ongoing progress with IPI-145, an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (see also Pharmaceutical Companies).

"Over the past quarter, we have continued to progress our clinical development program for IPI-145. We look forward to advancing IPI-145 through monotherapy studies in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia designed to enable registration and also to initiating new studies which further our strategy of combining IPI-145 with both current standards of care and novel, targeted therapies," stated Adelene Perkins, chair, president and chief executive officer at Infinity. "Our goal is to transform the treatment paradigm for blood cancers by helping more patients achieve deeper and more durable responses while also liberating patients from chemotherapy."

Additionally, in a press release issued yesterday, Infinity announced that the company purchased an option to buy out all future royalty payments due to Millennium: The Takeda Oncology Company for worldwide for sales in oncology of IPI-145. In exchange for a one-time, upfront payment of $5.0 million, Infinity received an option to terminate its obligation to pay Millennium future royalties related to the sale of IPI-145 in oncology. Infinity may exercise this option by providing written notice and payment to Millennium of a one-time exercise fee of $52.5 million on or before March 31, 2015.

"The amendment to our agreement with Millennium underscores our belief that IPI-145 has the potential to become the best-in-class PI3K inhibitor treatment for multiple forms of blood cancers," stated Larry Bloch, executive vice president, chief financial officer and chief business officer of Infinity. "We are pleased to have the flexibility of this option, which could provide long-term value for our shareholders." Infinity continues to anticipate the following clinical milestones in 2014: IPI-145 in Hematologic Malignancies Initiate DYNAMO+RTM, a Phase 3 study of IPI-145 in combination with rituximab in patients with relapsed follicular lymphoma (FL).

Initiate a Phase 2 study in treatment-naive patients with iNHL.

Initiate at least one additional clinical study. IPI-145 in Inflammation Report topline data from ASPIRA, a Phase 2 study in patients with moderate-to-severe rheumatoid arthritis.

Report topline data from the Phase 2a study in patients with mild, allergic asthma. PI3K Pipeline Expansion Determine the development strategy for IPI-443, Infinity's next-generation inhibitor of PI3K-delta,gamma, based on the results of the Phase 2 studies of IPI-145 in inflammatory diseases. Second Quarter 2014 Financial Results As of June 30, 2014, Infinity had total cash, cash equivalents and available-for-sale securities of $141.7 million, compared to $172.1 million at March 31, 2014.

Infinity did not record any revenue during the second quarter of 2014 or 2013.

Research and development (R&D) expense for the second quarter of 2014 was $28.2 million, compared to $26.1 million for the same period in 2013. The increase in R&D expense for the second quarter of 2014 compared to the same period in 2013 was primarily due to higher clinical development expenses for IPI-145.

General and administrative (G&A) expense was $7.1 million for the second quarter of 2014, compared to $6.7 million for the same period in 2013. The increase in G&A expense for the second quarter of 2014 compared to the same period in 2013 was primarily due to an increase in early commercial development costs.

Interest expense was $2.9 million during the second quarter of 2014, compared to none recorded for 2013. The increase in interest expense for the second quarter of 2014 compared to the same period in 2013 was related to the amortization of the loan commitment asset recognized under Infinity's debt facility agreement with Deerfield Management Company, L.P.

Keywords for this news article include: Infinity Pharmaceuticals Inc., Pharmaceutical Companies, Oncology, Investment and Finance, Biotechnology Companies.

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Source: Biotech Week

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