Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today reported its third quarter 2013 financial results and provided an update on its clinical pipeline. Earlier today, Infinity announced that five abstracts describing clinical and preclinical data for IPI-145, the company’s oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, will be presented at the American Society of Hematology (ASH) 2013 Annual Meeting, which is being held December 7-10 in New Orleans, Louisiana. Based on encouraging Phase 1 data for IPI-145 in advanced hematologic malignancies (or blood cancers), Infinity is conducting a Phase 2 study designed to evaluate the safety and efficacy of IPI-145 in patients with indolent non-Hodgkin lymphoma (iNHL) and is planning to initiate a Phase 3 study of IPI-145 in patients with chronic lymphocytic leukemia (CLL) in the fourth quarter of 2013. “We are focused on rapidly progressing IPI-145 in the clinic, with the goal of establishing IPI-145 as the best-in-class PI3K inhibitor for the treatment of blood cancers. We are continuing to enroll patients in our Phase 2 study of IPI-145 in iNHL and are on track to start our Phase 3 study of IPI-145 in CLL by the end of the year. These two monotherapy trials are key components of our registration strategy,” commented Adelene Q. Perkins, Infinity’s chair and chief executive officer. “In addition to these monotherapy trials, we expect to announce additional studies in 2014 and beyond that are designed to continue to differentiate IPI-145 from other agents in development for blood cancers.” Recent developments include the following:
- New Data Supporting the Potential of IPI-145 in Blood Cancers to Be Presented at ASH: In a separate press release issued earlier today, Infinity announced that five abstracts have been accepted for presentation at the ASH 2013 Annual Meeting. Key results to be presented during the meeting include updated data from Infinity’s Phase 1 study evaluating the safety, clinical activity and pharmacokinetics of IPI-145 in patients with CLL. Updated topline Phase 1 data on the activity of IPI-145 in patients with iNHL and T-cell lymphoma will also be reported. Additionally, the company will present preclinical and/or translational data supporting the potential of IPI-145 across a range of hematologic malignancies, including iNHL, CLL, diffuse large B‐cell lymphoma (DLBCL) and T‐cell acute lymphoblastic leukemia (ALL).Infinity will host a reception on Sunday, December 8, 2013, from 11:00 a.m. to 12:30 p.m. CT (12:00 p.m. to 1:30 p.m. ET) in New Orleans to review its PI3K program in hematologic malignancies and discuss the IPI-145 data being presented at the ASH 2013 Annual Meeting. The event will be webcast and can be accessed in the Investors/Media section of Infinity's website at www.infi.com. An archived version of the webcast will also be available.IPI-145 also has therapeutic potential in inflammatory diseases, and Infinity is conducting a Phase 2 trial of IPI-145 in patients with rheumatoid arthritis as well as an exploratory, signal-finding Phase 2a study of IPI-145 in mild, allergic asthma.
- Leadership Team Expanded: In September, Infinity announced the appointment of David A. Roth, M.D., as senior vice president, clinical development and medical affairs. In this role, Dr. Roth is responsible for the clinical development organization and clinical operations as well as medical affairs. Dr. Roth brings to Infinity over 20 years of experience in hematology and oncology research and development. Dr. Roth joined Infinity from Pfizer Inc. where he most recently served as a vice president in Pfizer’s oncology business unit.
- Topline Data from Phase 2 Study of Retaspimycin HCl Reported: In September, Infinity reported topline data from its Phase 2 study of retaspimycin HCl, an Hsp90 inhibitor, in patients with non-small cell lung cancer (NSCLC). In this double-blind, randomized, placebo-controlled study, retaspimycin HCl did not meet its pre-specified efficacy endpoints for demonstrating an improvement in overall survival in the total patient population or in patients with squamous cell carcinoma. The company will not initiate any new trials with retaspimycin HCl.
- At September 30, 2013, Infinity had total cash, cash equivalents and available-for-sale securities of $250.9 million, compared to $277.2 million at June 30, 2013.
- Infinity did not record any revenue during the third quarter of 2013 or 2012.
- Research and development (R&D) expense for the third quarter of 2013 was $26.9 million, which compares to $21.5 million for the same period in 2012. The increase in R&D expense for the third quarter of 2013 compared to the same period in 2012 was related to clinical development of IPI-145, partially offset by the discontinuation of development of the company’s Hedgehog pathway program.
- General and administrative (G&A) expense was $7.3 million for the third quarter of 2013, which compares to $6.3 million for the same period in 2012. The increase in G&A expense for the third quarter of 2013 compared to the same period in 2012 was primarily related to increased stock-based compensation expense as well as market development activities as the company advances IPI-145 into late-stage development.
- Net loss for the third quarter of 2013 was $33.9 million, or a basic and diluted loss per common share of $0.71, which compares to net income of $18.4 million, or a basic earnings per common share of $0.57 and a diluted earnings per common share of $0.52, for the same period in 2012.
|INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Balance Sheets (unaudited) (in thousands)|
|September 30, 2013||December 31, 2012|
|Cash, cash equivalents and available-for-sale securities, including long term||$250,857||$326,635|
|Other current assets||4,701||3,731|
|Property and equipment, net||4,089||4,079|
|Other long-term assets||1,165||1,215|
|Current liabilities||$ 23,536||$ 18,663|
|Due to Millennium, less current portion||6,405||6,252|
|Other long-term liabilities||611||540|
|Total stockholders’ equity||230,260||310,205|
|Total liabilities and stockholders’ equity||$260,812||$335,660|
|INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations (unaudited) (in thousands, except share and per share amounts)|
|Three Months Ended September 30,||Nine months ended September 30,|
|Collaborative research and development revenue from Purdue entities||$||—||$||—||$||—||$||47,114|
|Research and development||26,857||21,495||73,168||78,578|
|General and administrative||7,319||6,294||21,424||20,771|
|Total operating expenses||34,176||27,789||94,592||99,349|
|Gain on termination of Purdue entities alliance||—||46,555||—||46,555|
|Income (loss) from operations||(34,176||)||18,766||(94,592||)||(5,680||)|
|Other income (expense):|
|Income from Massachusetts tax incentive award||—||—||—||193|
|Investment and other income||238||170||737||416|
|Total other income (expense)||238||(363||)||737||(1,299||)|
|Net income (loss)||$||(33,938||)||$||18,403||$||(93,855||)||$||(6,979||)|
|Earnings (loss) per common share:|
|Weighted average number of common shares outstanding:|