Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today reported its second quarter 2013 financial results and provided an update on its clinical pipeline. Infinity today announced that, in the fourth quarter of 2013, it expects to initiate a Phase 3 trial of IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This randomized study is designed to evaluate the safety and efficacy of IPI-145 dosed at 25 mg twice daily (BID) compared to ofatumumab in approximately 300 relapsed or refractory patients. In June 2013, Infinity initiated a Phase 2, open-label, single-arm study designed to evaluate the safety and efficacy of IPI-145 dosed at 25 mg BID in approximately 120 patients with refractory indolent non-Hodgkin lymphoma (iNHL). These monotherapy trials are supported by encouraging data presented at medical meetings earlier this year that showed IPI-145 was clinically active and well tolerated in a broad range of hematologic malignancies, including CLL/SLL and iNHL. “With the ongoing Phase 2 trial in patients with iNHL and our planned Phase 3 study in patients with CLL or SLL, Infinity expects to have two important clinical trials of IPI-145 in patients with blood cancer under way by the end of the year. These two clinical trials are key components of Infinity’s strategy for rapidly progressing IPI-145 toward registration with the goal of establishing IPI-145 as the best-in-class PI3K inhibitor for the treatment of patients with blood cancer,” commented Adelene Q. Perkins, Infinity’s chair and chief executive officer. “In addition to the anticipated initiation of our Phase 3 trial of IPI-145, in the second half of the year we expect to report topline data from our Phase 2 study of our Hsp90 inhibitor, retaspimycin HCl, in patients with non-small cell lung cancer and topline data from our Phase 2a study of IPI-145 in patients with mild, allergic asthma.” Pipeline highlights include the following:
- Phase 3 monotherapy study of IPI-145 in CLL/SLL expected to begin in 4Q13: Infinity today announced that it anticipates initiating a Phase 3 study of IPI-145 in patients with CLL/SLL in the fourth quarter of 2013. This randomized study is designed to evaluate the safety and efficacy of IPI-145 dosed at 25 mg BID compared to ofatumumab in approximately 300 patients with relapsed or refractory CLL and SLL. The primary endpoint of the study is progression-free survival.This Phase 3 trial is supported by data from the ongoing Phase 1 study that showed IPI-145 was well tolerated with a 55 percent response rate in patients with CLL, with 12 partial responses among 22 patients evaluable for response. Partial responses were defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria.1 Additionally, stable disease was reported in nine patients, seven of whom had nodal responses. Responses occurred early, with a median time to response of 1.9 months (range: 1.8 – 5.6 months). These Phase 1 data were reported in June at the American Society of Clinical Oncology (ASCO) Annual Meeting and the 12th International Conference on Malignant Lymphoma (ICML).2,3
- Phase 2 monotherapy study of IPI-145 in patients with iNHL initiated: In June, Infinity announced the initiation of a Phase 2, open-label, single-arm study designed to evaluate the safety and efficacy of IPI-145 dosed at 25 mg BID in approximately 120 patients with iNHL whose disease is refractory to radioimmunotherapy or to both rituximab and chemotherapy. Patients enrolled in the study must have progressed within six months of receiving their last therapy. The primary endpoint of the study is response rate according to the International Working Group (IWG) criteria.4In June, Infinity reported Phase 1 data at ASCO and ICML showing that IPI-145 was well tolerated with a 68 percent response rate in patients with iNHL. Among 19 patients evaluable for response, three patients had complete responses and 10 patients had partial responses.5,6 Responses occurred early, with a median time to response of 1.8 months (range: 1.7 – 4.1 months).
- IPI-145 granted orphan drug designation by FDA for follicular lymphoma: Infinity today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation for IPI-145 for the treatment of follicular lymphoma, the most common subtype of iNHL. In the U.S., an orphan drug designation by the FDA provides incentives for sponsors to develop products for rare diseases, including clinical trial design assistance, tax credits and a waiver of Prescription Drug User Fee Act (PDUFA) fees. In May 2013, Infinity announced that the FDA and European Medicines Agency (EMA) had granted orphan drug designation for IPI-145 for the treatment of CLL/SLL.
- Data from clinical studies of retaspimycin HCl in NSCLC anticipated in 2H13: Infinity expects to report topline data from its Phase 2, randomized, double-blind, placebo-controlled study of retaspimycin HCl in combination with docetaxel (a chemotherapy) in patients with non-small cell lung cancer (NSCLC) in the second half of 2013. The study is designed to evaluate the anti-tumor activity, tolerability and safety of retaspimycin HCl in combination with docetaxel compared to placebo plus docetaxel in patients with second- or third-line NSCLC who are naïve to docetaxel treatment and have a smoking history. Efficacy endpoints of this study include overall survival in the total patient population, in patients with squamous cell histology and in patients with a novel, pre-specified biomarker identified by Infinity. This study is supported by data from a Phase 1b study in which retaspimycin HCl in combination with docetaxel was well tolerated and clinically active in heavily pretreated patients with NSCLC.7Infinity is also conducting a Phase 1b/2 study of retaspimycin HCl in combination with everolimus in patients with NSCLC with a KRAS mutation. The dose-exploration phase of this study is still ongoing, and the company expects to provide an update on this study in the second half of 2013.
- Data from Phase 2a study of IPI-145 in asthma anticipated in 2H13: Infinity expects to provide topline data from its Phase 2a study of IPI-145 in patients with mild, allergic asthma during the second half of 2013. Endpoints of this multi-dose, two-way crossover study include safety, pharmacokinetics and FEV1 (forced expiry volume in one second), a standard measure of lung function.Infinity is also enrolling patients with moderate to severe rheumatoid arthritis (RA) in ASPIRA (Adult Study of PI3K Inhibition in RA), a Phase 2, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety and pharmacokinetics of three dose levels of IPI-145 given twice daily for 12 weeks in combination with methotrexate compared to treatment with placebo plus methotrexate. The study is expected to enroll approximately 316 patients. The primary efficacy endpoint of the study is ACR20 response rate, which is defined as the proportion of people who achieve at least a 20 percent improvement in American College of Rheumatology (ACR) response criteria.
- At June 30, 2013, Infinity had total cash, cash equivalents and available-for-sale securities of $277.2 million, compared to $303.1 million at March 31, 2013.
- Infinity did not record any revenue during the second quarter of 2013. Total revenue was $21.9 million for the same period in 2012, which was composed of $20.9 million for reimbursed research and development (R&D) services performed under a previous strategic alliance with Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited and $1.0 million from the amortization of deferred revenue associated with the grant of rights and licenses under this alliance.
- R&D expense for the second quarter of 2013 was $26.1 million, compared to $28.5 million for the same period in 2012. The decrease in R&D expense for the second quarter of 2013 compared to the same period in 2012 was primarily related to the discontinuation of development of the company’s Hedgehog pathway program.
- General and administrative (G&A) expense was $6.7 million for the second quarter of 2013, compared to $7.7 million for the same period in 2012. The decrease in G&A expense in the second quarter of 2013 compared to the same period in 2012 was primarily due to lower consulting expenses.
- Infinity did not record any interest expense during the second quarter of 2013. Interest expense was $0.7 million during the same period of 2012 before Infinity extinguished its debt to Purdue Pharma L.P. in September 2012.
- Net loss for the second quarter of 2013 was $32.6 million, or a basic and diluted loss per common share of $0.68, compared to $14.7 million, or a basic and diluted loss per common share of $0.54, for the same period in 2012.
Infinity’s current financial expectations for 2013 are as follows:
- Operating Expenses: Infinity expects operating expenses for 2013 to range from $135 million to $145 million, compared to prior expectations of $115 million to $125 million.
- Net Loss: Infinity expects net loss for 2013 to range from $135 million to $145 million, compared to prior expectations of $115 million to $125 million.
- Cash and Investments: Infinity expects to end 2013 with a year-end cash and investments balance ranging from $190 million to $200 million, compared to prior expectations of $210 million to $220 million. Based on its current operating plan and exclusive of any business development activities, Infinity believes that it has sufficient cash and investments to support its operations into 2015.
|INFINITY PHARMACEUTICALS, INC.|
|Condensed Consolidated Balance Sheets|
|June 30, 2013||December 31, 2012|
|Cash, cash equivalents and available-for-sale securities, including long term||$277,237||$326,635|
|Other current assets||5,146||3,731|
|Property and equipment, net||4,179||4,079|
|Other long-term assets||1,161||1,215|
|Current liabilities||$ 20,846||$ 18,663|
|Due to Millennium, less current portion||6,353||6,252|
|Other long-term liabilities||618||540|
|Total stockholders’ equity||259,906||310,205|
|Total liabilities and stockholders’ equity||$287,723||$335,660|
|INFINITY PHARMACEUTICALS, INC.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share amounts)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Collaborative research and development revenue from Purdue entities||$||—||$||21,911||$||—||$||47,113|
|Research and development||26,080||28,532||46,311||57,083|
|General and administrative||6,675||7,666||14,105||14,477|
|Total operating expenses||32,755||36,198||60,416||71,560|
|Loss from operations||(32,755||)||(14,287||)||(60,416||)||(24,447||)|
|Other income (expense):|
|Income from Massachusetts tax incentive award||—||193||—||193|
|Investment and other income||164||127||499||247|
|Total other income (expense)||164||(374||)||499||(935||)|
|Basic and diluted loss per common share||$||(0.68||)||$||(0.54||)||$||(1.25||)||$||(0.94||)|
|Basic and diluted weighted average number of common shares outstanding||47,915,726||27,061,435||47,785,620||26,919,146|