On August 6, 2015 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its second quarter 2015 financial results and ongoing progress with duvelisib an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (Press release, Infinity Pharmaceuticals, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076561 [SID:1234507068]). Infinity also announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the investigation of duvelisib for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. The FDA established the Fast Track designation process to facilitate the development and expedite the review of investigational medicines intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMOTM, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and DUOTM, a Phase 3 study in patients with CLL.

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"The quarter was marked by continued clinical development progress for duvelisib, particularly with DYNAMO and DUO. The first completion of enrollment in either DYNAMO or DUO, both of which we expect to occur in the second half of this year, will trigger a $130 million milestone payment from AbbVie, our global development and commercialization partner for duvelisib in oncology," stated Adelene Perkins, Infinity’s chair, president and chief executive officer. "We are also pleased to have recently received Fast Track designation for the investigation of duvelisib for the treatment of chronic lymphocytic leukemia, which supports our belief in the potential of duvelisib to help fill an important medical need. We look forward to leveraging the opportunities that Fast Track designation allows in order to maximize the possibility of an accelerated path to approval."

Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. In addition to the DYNAMO and DUO studies, Infinity is continuing to enroll patients in CONTEMPO, a Phase 1b/2 study in treatment-naïve patients with follicular lymphoma, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a BTK inhibitor. Infinity also expects that the first clinical study of duvelisib in combination with venetoclax, AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor, will begin this year.

At the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), preclinical data were presented showing in vitro synergy between duvelisib and venetoclax, and the combination of duvelisib plus venetoclax showed greater inhibition of lymphoma tumor growth compared to each of these agents alone. These preclinical data provide support for the first clinical study combining duvelisib and venetoclax in patients with hematologic malignancies.

Second Quarter 2015 Financial Results

At June 30, 2015, Infinity had total cash, cash equivalents and available-for-sale securities of $199.5 million, compared to $233.6 million at March 31, 2015.
Revenue during the second quarter of 2015 was $4.9 million for research and development (R&D) services associated with the strategic collaboration with AbbVie for duvelisib in oncology. Infinity did not record any revenue in the second quarter of 2014.
R&D expense for the second quarter of 2015 was $34.1 million, compared to $28.2 million for the second quarter of 2014. The increase in R&D expense was primarily due to higher contingent cash compensation and expenses related to early discovery programs.
General and administrative (G&A) expense was $9.4 million for the second quarter of 2015, compared to $7.1 million for the same period in 2014. The increase in G&A expense was primarily related to higher contingent cash compensation.
Net loss for the second quarter of 2015 was $38.4 million, or a basic and diluted loss per common share of $0.78, compared to $38.0 million, or a basic and diluted loss per common share of $0.78, for the same period in 2014.
Conference Call Information

Infinity will host a conference call today at 8:30 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 72290673. An archived version of the webcast will be available on Infinity’s website for 30 days.

Infinity R&D Day, October 6, 2015

Infinity will host an R&D Day in New York City on Tuesday, October 6, 2015, from 7:30 a.m. to 12:00 p.m. ET. The event will be webcast beginning at 8:00 a.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.

About Duvelisib

Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.[i] Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.[ii] Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.

Duvelisib is being evaluated in registration-focused studies, including DYNAMOTM, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUOTM, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.