Company Overview of Infinity Pharmaceuticals, Inc.
Infinity Pharmaceuticals, Inc., a drug discovery and development company, discovers, develops, and delivers medicines to patients with difficult-to-treat diseases. Its lead product candidate includes IPI-145, an oral inhibitor of the delta and gamma isoforms of phosphoinositide-3-kinase (PI3K) for the treatment of hematologic malignancies. The company is developing DYNAMO, which is in Phase II study to evaluate the safety and efficacy of IPI-145 dosed at 25 mg; DYNAMO+R that is in Phase III randomized study to evaluate IPI-145 dosed at 25 mg in combination with rituximab, a monoclonal antibody treatment; and DUO, which is in randomized Phase III monotherapy study evaluating IPI-145 dosed at ...
780 Memorial Drive
Cambridge, MA 02139
Key Executives for Infinity Pharmaceuticals, Inc.
Chairman of The Board, Chief Executive Officer and President
Total Annual Compensation: $568.5K
Chief Financial Officer, Chief Business Officer, Executive Vice President and Treasurer
Total Annual Compensation: $390.0K
President of Research & Development
Total Annual Compensation: $479.5K
Chief Scientific Officer and Executive Vice President
Total Annual Compensation: $381.0K
Compensation as of Fiscal Year 2014.
Infinity Pharmaceuticals, Inc. Key Developments
Infinity Announces Completion of Target Enrollment in DUO™
Nov 17 15
Infinity Pharmaceuticals, Inc. announced that it has reached target enrollment of 300 patients in DUO™, a randomized Phase 3 monotherapy study evaluating the safety and efficacy of duvelisib compared to ofatumumab (an anti-CD20 antibody) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The primary endpoint of this study is progression free survival (PFS). Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity is jointly developing duvelisib with AbbVie, its strategic development and commercialization partner for duvelisib in oncology. Infinity recently completed patient enrollment in DYNAMO™, a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib in approximately 120 patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study is overall response rate. Topline data from the study are anticipated in the third quarter of 2016. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to duvelisib for both the treatment of patients with follicular lymphoma (FL), the most common form of iNHL, who have received at least two prior therapies and for the treatment of patients with CLL who have received at least one prior therapy. The DYNAMO and DUO studies are part of DUETTS™, a broad clinical development program evaluating duvelisib in patients with iNHL and CLL. In addition to DYNAMO and DUO, Infinity is enrolling 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 Bruton's tyrosine kinase (BTK) inhibitor. Infinity expects three additional clinical studies to be initiated this year: BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL; FRESCO, a Phase 2 study in patients with relapsed/refractory follicular lymphoma; and the first clinical study of duvelisib in combination with venetoclax, AbbVie's first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor. Infinity is planning to close enrollment in DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma and is planning to meet with the FDA to ascertain that BRAVURA can serve as a confirmatory study if DYNAMO supports an accelerated approval.
Infinity Pharmaceuticals, Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2015; Provides Earnings Guidance for 2015; Provides Update on Progress of its Pipeline, Including duvelisib
Nov 5 15
Infinity Pharmaceuticals, Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2015. For the quarter, collaboration revenue was $90.7 million, compared to $160.6 million in the third quarter of 2014. Revenue included a $75.2 million license fee associated with the $130 million milestone payment from AbbVie for the completion of patient enrollment in DYNAMO and $15.5 million in research and development (R&D) services. Income from operations was $43.3 million against $107.7 million last year. Income before income taxes was $43.0 million against $103.2 million last year. Net income for the third quarter of 2015 was $42.5 million, or $0.84 per diluted share against $103.2 million, or $2.03 per diluted share last year.
For the nine months, collaboration revenue was $100 million, compared to $160.6 million last year. Loss from operations was $87.9 million against income from operations of $31.2 million last year. Loss before income taxes was $88.7 million against income before income taxes of $22.9 million last year. Net loss was $89.2 million, or $1.82 per diluted share against net income of $22.9 million, or $0.46 per diluted share last year.
For 2015, Infinity expects revenue to range from $100 million to $120 million and net loss to range from $125 million to $145 million.
The company announced ongoing progress with its pipeline, including duvelisib, an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. Infinity also announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the investigation of duvelisib for the treatment of patients with follicular lymphoma (FL) who have received at least two prior therapies. In addition to the DYNAMO and DUO studies, Infinity is conducting CONTEMPO, a Phase 1b/2 study in treatment-naïve FL patients, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a Bruton’s tyrosine kinase (BTK) inhibitor. Infinity expects three additional clinical studies to begin this year, including the first clinical study of duvelisib in combination with venetoclax, AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor. Infinity and AbbVie are jointly developing duvelisib in oncology.
Infinity Pharmaceuticals, Inc., Q3 2015 Earnings Call, Nov 05, 2015
Oct 28 15
Infinity Pharmaceuticals, Inc., Q3 2015 Earnings Call, Nov 05, 2015
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