Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its full-year 2012 financial results and ongoing progress with IPI-145, its potent, oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and retaspimycin HCl, its potent and selective inhibitor of heat shock protein 90 (Hsp90), and anticipates reporting clinical data from both these programs this year. Infinity also announced today that it initiated five new expansion cohorts in its trial of IPI-145 in patients with advanced hematologic malignancies. “We made important progress on our product development goals last year, reporting encouraging preliminary data from our Phase 1 trial of IPI-145 in patients with advanced hematologic malignancies, initiating a Phase 2a trial of IPI-145 in patients with asthma, and completing enrollment in our Phase 2, double-blind, randomized, placebo-controlled trial of retaspimycin HCl in non-small cell lung cancer,” stated Adelene Q. Perkins, Infinity’s president and chief executive officer. “We entered 2013 in a strong financial position with approximately $327 million in cash and investments and anticipate this will be a year of fundamental progress for Infinity, as data generated from our ongoing trials will inform our potential registration paths as we continue building a sustainable, fully-integrated biopharmaceutical company.” In December 2012, Infinity reported encouraging preliminary data at the Annual Meeting of the American Society for Hematology (ASH) showing clinical activity at each of the doses of IPI-145 evaluated from 8 mg through 75 mg twice daily (BID), indicating a potential broad therapeutic window. Infinity has now defined 75 mg BID as the maximum tolerated dose and has leveraged the adaptive approach of its Phase 1 trial to continue to explore the safety, pharmacokinetics and activity of IPI-145 at 75 mg BID in five additional expansion cohorts of patients with the following hematologic malignancies: 1. Chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma and mantle cell lymphoma2. T-cell lymphomas3. Aggressive B-cell lymphomas4. Myeloid neoplasms5. T-cell or B-cell acute lymphoblastic leukemia/lymphoma
“We are pleased to have completed the dose-escalation phase of our Phase 1 trial of IPI-145, enabling us to initiate additional expansion cohorts and advance the program toward registration studies,” said Julian Adams, Ph.D., president of research and development at Infinity. “Furthermore, these high dose expansion cohorts allow us to increase our patient experience in a broad range of hematologic malignancies and to further optimize the dose of IPI-145. In patients with chronic lymphocytic leukemia, indolent non-Hodgkin lymphoma and mantle cell lymphoma, the evaluation of a 75 mg BID expansion cohort relative to the 25 mg BID expansion cohort initiated in July 2012 will allow us to determine whether there is an enhanced benefit to treating these patients at a higher dose.”Expected 2013 Development MilestonesInfinity is developing a portfolio of PI3K inhibitors which includes IPI-145 and IPI-443, potent, oral inhibitors of PI3K-delta and PI3K-gamma, as well as retaspimycin hydrochloride (HCl), a potent and selective Hsp90 inhibitor. Infinity anticipates achieving the following development milestones in 2013: IPI-145
- 2013: Initiate at least two additional trials in patients with hematologic malignancies
- 2013: Report additional data from ongoing Phase 1 trial in patients with advanced hematologic malignancies
- 1H2013: Initiate a Phase 2 trial in patients with rheumatoid arthritis
- 2H2013: Provide update on Phase 2a trial in patients with mild, allergic asthma
- 2H2013: Complete nonclinical studies of IPI-443 to enable Phase 1 development
- 1H2013: Report topline overall survival data from Phase 2 trial in combination with docetaxel
- 1H2013: Provide update on Phase 1b/2 trial in combination with everolimus
- At December 31, 2012, Infinity had total cash, cash equivalents and available-for-sale securities of $326.6 million, compared to $115.9 million at December 31, 2011, and $189.4 million at September 30, 2012.
- Total revenue for full-year 2012 was $47.1 million, compared to $92.8 million for 2011. In 2012, revenue consisted of $45.0 million related to reimbursed research and development (R&D) services and $2.1 million related to the amortization of deferred revenue related to the grant of rights and licenses under Infinity’s previous strategic alliance with Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited and compared to $88.5 million and $4.3 million, respectively, for 2011.
- A non-recurring gain related to the previous strategic alliance with Purdue and Mundipharma was $46.6 million for full-year 2012. Infinity does not have any future research and development (R&D) obligations to Purdue and Mundipharma.
- R&D expense for full-year 2012 was $118.6 million, compared to $108.6 million for 2011. The increase in R&D expense in 2012 compared to 2011 was primarily due to the December 2012 amended and restated agreement with Millennium: The Takeda Oncology Company, including recording the full release payment of $15M payable in installments as well as development milestones for IPI-145 and IPI-443, partially offset by the discontinuation of development of the company’s Hedgehog pathway program.
- General and administrative (G&A) expense was $27.9 million for full-year 2012, compared to $22.7 million for the same period in 2011. The increase in G&A expense in 2012 compared to 2011 was primarily due to higher stock-based compensation expense, early commercial development activities and corporate development activities.
- Net loss for full-year 2012 was $54.0 million, or a basic and diluted loss per common share of $1.70, compared to $40.0 million, or a basic and diluted loss per common share of $1.50, for 2011.
|INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share amounts) (unaudited)|
|December 31,2012||December 31,2011|
|Cash, cash equivalents and available-for-sale securities, including long term||$||326,635||$||115,937|
|Other current assets||3,731||2,703|
|Property and equipment, net||4,079||4,582|
|Other long-term assets||1,215||1,268|
|Due to Millennium, less current portion||6,252||—|
|Long-term debt due to Purdue entities, net of debt discount||—||37,553|
|Deferred revenue from Purdue entities, less current portion||—||42,147|
|Other long-term liabilities||540||371|
|Total stockholders’ equity||310,205||15,433|
|Total liabilities and stockholders’ equity||$||335,660||$||124,490|
|INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (unaudited)|
|Three Months EndedDecember 31,||Twelve Months EndedDecember 31,|
|Collaborative research and development revenue from Purdue entities||$||—||$||22,324||$||47,114||$||92,773|
|Research and development||40,016||29,893||118,595||108,582|
|General and administrative||7,110||6,043||27,882||22,719|
|Total operating expenses||47,126||35,936||146,477||131,301|
|Gain on termination of Purdue entities alliance||—||—||46,555||—|
|Loss from operations||(47,126||)||(13,612||)||(52,808||)||(38,528||)|
|Other income (expense):|
|Income from Massachusetts tax incentive award||—||—||193||—|
|Interest and investment income||142||93||559||327|
|Total other expense||142||(449||)||(1,156||)||(1,514||)|
|Basic and diluted loss per common share||$||(1.15||)||$||(0.53||)||$||(1.70||)||$||(1.50||)|
|Basic and diluted weighted average number of common shares outstanding||40,855,124||26,708,351||31,711,264||26,620,278|