Infinity third quarter total revenue increases marginally to $23.3 million

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today highlighted its recent clinical and business progress and announced its third quarter 2011 financial results. During the quarter, the company continued to advance its diverse pipeline of novel development candidates designed to target molecular pathways responsible for a broad range of difficult-to-treat diseases.

“Backed by our financial strength, we are well positioned to obtain key data to inform the registration paths for our product candidates without the need for additional financing.”

"We've made significant progress across our pipeline over the past few months, including the completion of enrollment ahead of schedule for our Phase 2 trial of IPI-926 for pancreatic cancer and the initiation of a Phase 2 trial of IPI-926 in myelofibrosis. With the recent initiation of two Phase 1 trials of IPI-145, we now have seven clinical trials under way," stated Adelene Q. Perkins, president and chief executive officer of Infinity. "Backed by our financial strength, we are well positioned to obtain key data to inform the registration paths for our product candidates without the need for additional financing."

Recent pipeline highlights include the following:

• Completion of patient enrollment in Phase 2 trial of IPI-926 in pancreatic cancer: Infinity completed enrollment of its Phase 2 randomized, double-blind, placebo-controlled trial of IPI-926, a novel, oral small molecule that inhibits Smoothened, a key component of the Hedgehog pathway. The trial is designed to compare IPI-926 in combination with gemcitabine (also known as Gemzar^®) to placebo plus gemcitabine in 122 patients with metastatic pancreatic cancer. The primary endpoint of the trial is overall survival.
• Initiation of Phase 2 trial of IPI-926 in myelofibrosis: Infinity initiated an exploratory Phase 2 clinical trial of IPI-926 in up to 45 patients with myelofibrosis, an incurable malignancy of the bone marrow that is characterized by the replacement of normal bone marrow by fibrotic tissue and the production of blood cells in other organs, such as the spleen and liver. The single-arm Phase 2 trial is designed to evaluate the safety and efficacy of IPI-926 administered orally once daily. The primary endpoint of the trial is response rate according to the International Working Group Criteria.
• Presentation of preclinical data supporting continued development of IPI-926: Infinity continues to illustrate the strong scientific rationale for developing IPI-926 in a range of indications. Data recently presented or accepted for presentation at key upcoming scientific meetings include the following:
  
  
  • Pancreatic Cancer: At the recently held American Association for Cancer Research (AACR) Tumor Microenvironment Complexity Meeting, Infinity researchers presented preclinical data of IPI-926 in combination with nab-paclitaxel, a chemotherapy, in a xenograft model of pancreatic cancer. Data showed that treatment with IPI-926 led to increased tumor perfusion and enhanced drug delivery and provide further rationale for evaluating IPI-926 in combination with chemotherapy in pancreatic cancer.
    
    In addition, Infinity researchers will present data of IPI-926 in a preclinical model of pancreatic cancer liver metastasis at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held November 12 - 16, 2011, in San Francisco, Calif. The poster presentation will take place Monday, November 14, 2011, from 12:30 p.m. - 2:30 p.m. PT (Abstract #B145).
  • Chondrosarcoma: At the upcoming 11^th International Conference on Cancer-Induced Bone Disease being held November 30 - December 3, 2011, in Chicago, Ill., Infinity researchers will present data of IPI-926 in a xenograft model of chondrosarcoma, a rare and life-threatening cancer of the cartilage. The preclinical data support Infinity's ongoing Phase 2 double-blind, randomized, placebo-controlled trial of IPI-926 in patients with metastatic or locally advanced, inoperable chondrosarcoma. The primary endpoint of the trial is progression-free survival. The trial is expected to enroll approximately 140 patients and is being conducted at approximately 50 sites worldwide.

• Initiation of two Phase 1 trials of IPI-145: Infinity initiated two Phase 1 clinical trials of IPI-145, a potent, oral inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma. The first Phase 1 trial is a double-blind, randomized, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of IPI-145 in healthy adult subjects. The second Phase 1 trial is an open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics and clinical activity of IPI-145 in patients with advanced hematologic malignancies.
• Publication of preclinical data of retaspimycin HCl in Cancer Cell: Data were published in Cancer Cell from a preclinical study of retaspimycin HCl (also known as IPI-504), Infinity's novel heat shock protein 90 (Hsp90) inhibitor, in combination with rapamycin, an mTOR inhibitor. The data illustrated that the combination of retaspimycin HCl and rapamycin resulted in substantial tumor regression in a mutant KRAS/p53 null transgenic model of non-small cell lung cancer (NSCLC).¹ These findings, which for the first time show that administration of a targeted agent can lead to substantial tumor regression in this model, provide preclinical rationale for Infinity's ongoing Phase 1b/2 trial of retaspimycin HCl in combination with everolimus (also known as Afinitor^®), an mTOR inhibitor, in NSCLC patients with a KRAS mutation. The objectives of the Phase 1b portion of the trial are to determine the recommended dose for the combination treatment and to evaluate the safety and clinical activity of retaspimycin HCl in combination with everolimus. The primary endpoint of the Phase 2 portion of the trial is overall response rate.

Third Quarter 2011 Financial Results

• At September 30, 2011, Infinity had total cash, cash equivalents and available-for-sale securities of $75.3 million, compared to $82.3 million at June 30, 2011.
• Total revenue for the third quarter of 2011 was $23.3 million, compared to $22.5 million for the same period in 2010. In the third quarter of 2011, revenue consisted of $22.3 million for reimbursed research and development (R&D) services and $1.0 million from the amortization of deferred revenue associated with the grant of rights and licenses under Infinity's strategic alliance with Mundipharma International Corporation Ltd. and Purdue Pharmaceutical Products L.P., compared to $21.5 million and $1.0 million, respectively, for the same period in 2010.
• R&D expense for the third quarter of 2011 was $29.4 million, compared to $38.7 million for the same period in 2010. The decrease in R&D expense for the third quarter of 2011 compared to the same period in 2010 was due primarily to a $13.5 million up-front license fee related to the in-licensing of the company's PI3K program during the third quarter of 2010, partially offset by expense related to the achievement of a $3.0 million milestone in the PI3K program during the same period in 2011 and higher clinical expenses. Reimbursed expenses related to Infinity's alliance with Mundipharma and Purdue are recorded as R&D expense, as well as collaborative R&D revenue.
• General and administrative expense for the third quarter of 2011 was $5.5 million, compared to $5.0 million for the same period in 2010.
• Net loss for the third quarter of 2011 was $11.9 million, or a basic and diluted loss per common share of $0.45, compared to $21.0 million, or a basic and diluted loss per common share of $0.80, for the same period in 2010.

Source Infinity Pharmaceuticals, Inc.