Infinity Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Update

2022-11-14

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– MARIO-3 Update in Patients with 1L TNBC showing 52% increase in one-year progression free survival rate in ITT patient population compared to Impassion130 benchmark – – Business development discussions advancing with goal of announcing a partnership in Q1 2023 – – Cash runway into 2024 with $47.2 million in cash and cash equivalents at end of Q3 2022– – Investor conference call to be held today at 8:30 AM ET – CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Infinity Pharmaceuticals Inc. (NASDAQ: INFI) (“Infinity” or the “Company”), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, today announced its third quarter 2022 financial results, provided a business update, and in a separate press release provided more mature data from the Phase 2 MARIO-3 1L TNBC clinical trial. “Our top priority is entering into a strategic partnership to advance eganelisib development and pave the way to eventual approval. Current business development discussions are directed towards an initial, focused development plan in a randomized controlled setting. It is our goal to announce a partnership, and the focus of the next clinical study for eganelisib, in the first quarter of 2023,” said Adelene Perkins, Chief Executive Officer and Chair of Infinity. “We are encouraged by the long-term benefit seen in front-line TNBC patients reported earlier today from MARIO-3. These data are consistent with the long-term benefit seen in other indications in which eganelisib has been studied, giving us multiple potential paths forward to be prioritized with a prospective partner.” MARIO-3 Clinical Update: The Company reported today an update from its MARIO-3 study of eganelisib in combination with atezolizumab and nab-paclitaxel in front-line metastatic triple negative breast cancer (TNBC) patients: (Press release here) Encouraging one-year progression free survival rates in MARIO-3 1L TNBC study regardless of PD-L1 status 52% increase in one-year progression free survival rate in ITT patient population compared to IMpassion130 benchmark No new safety signals were observed during the extended period on treatment, and the MARIO-3 safety pro to be consistent with expectations for the three component drugs. Third Quarter 2022 Financial Results: At September 30, 2022, Infinity had total cash and cash equivalents of $47.2 million, compared to $80.7 million at December 31, 2021. Research and development expenses for the third quarter of 2022 were $7.7 million, compared to $7.1 million in the same period in 2021. The increase is primarily related to higher compensation expense due to additional staff to support the future development of eganelisib. General and administrative expenses were $3.5 million for the third quarter of 2022, compared to $3.8 million in the same period in 2021. The decrease is primarily related to a decrease in professional services. Net loss for the third quarter of 2022 was $10.7 million, or a basic and diluted loss per common share of $0.12, compared to a net loss of $10.7 million, or a basic and diluted loss per common share of $0.12 in the same period in 2021. 2022 Financial Outlook: Infinity’s 2022 financial guidance remains as follows: Net Loss: Infinity continues to expect net loss for 2022 to range from $40 million to $50 million. Cash and Investments: Infinity continues to expect to end 2022 with a cash and cash equivalents balance ranging from $35 million to $45 million, which provides a cash runway into 2024. Infinity’s financial guidance does not include additional funding or business development activities even as we move toward a strategic partnership on eganelisib which is our goal to announce in the first quarter of 2023. Conference Call Information Infinity will host a conference call today, November 14, 2022, at 8:30 AM ET to discuss these financial results and business updates. To access the conference call, please register at . Upon registering, each participant will be provided with call details and access codes. All participants are encouraged to join 10 minutes prior to the start time. A live webcast of the conference call can be accessed from the Events & Presentations page in the Investors/Media section of Infinity’s website at . An archived version of the webcast will be available on Infinity's website for 30 days following the event. About Infinity and Eganelisib Infinity Pharmaceuticals, Inc. (“Infinity” or the “Company”), is a clinical-stage biotechnology company developing eganelisib (IPI-549), a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which is designed to address a fundamental biologic mechanism of immune suppression in cancer in multiple clinical studies. MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq® and Abraxane® in front-line TNBC and in combination with Tecentriq and Avastin® in front-line RCC. MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo® in I/O naïve urothelial cancer. For more information on Infinity, please refer to Infinity's website at . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include the Company’s guidance with respect to net loss, cash and cash equivalents and cash runway; plans to evaluate and establish potential partnerships; and the Company's ability to execute on its strategic plans. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. For example, there can be no guarantee that eganelisib will successfully complete necessary preclinical and clinical development phases or will be successful in establishing a strategic partnership to further the development of eganelisib. Further, there can be no guarantee that any positive developments in Infinity's product portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the cost, timing and results of clinical trials and other development activities that may be delayed or disrupted by the COVID-19 pandemic or otherwise; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; Infinity's ability to obtain and maintain requisite regulatory approvals; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop eganelisib; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for eganelisib. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's annual report and quarterly reports filed with the Securities and Exchange Commission (SEC), and in other filings that Infinity makes with the SEC, available through the Company’s website at . Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity does not undertake and expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Opdivo® is a registered trademark of Bristol Myers Squibb. Tecentriq® is a registered trademark of Genentech, Inc. Abraxane® is a registered trademark of Abraxis BioScience, LLC., a wholly owned subsidiary of Bristol Myers Squibb Company. Avastin® is a registered trademark of Genentech, Inc. INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) September 30, 2022 December 31, 2021 Cash and cash equivalents $ 47,182 $ 80,726 Other current assets 2,168 1,542 Property and equipment, net 906 1,241 Other long-term assets 1,335 1,276 Total assets $ 51,591 $ 84,785 Accounts payable and accrued expenses $ 14,200 $ 13,300 Liabilities related to sale of future royalties, net1 47,753 48,727 Operating lease liability, less current portion 480 917 Long-term liabilities 32 270 Total stockholders’ (deficit) equity (10,874 ) 21,571 Total liabilities and stockholders’ (deficit) equity $ 51,591 $ 84,785 1 The company is not obligated to repay any of the liabilities related to sale of future royalties but these are recorded as a liability on the balance sheet in accordance with accounting guidance for royalty monetization. INFINITY PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Royalty revenue $ 712 $ 428 $ 2,050 $ 1,407 Operating expenses: Research and development 7,663 7,073 25,448 23,231 General and administrative 3,501 3,847 10,672 10,911 Royalty expense 429 258 1,236 848 Total operating expenses 11,593 11,178 37,356 34,990 Loss from operations (10,881 ) (10,750 ) (35,306 ) (33,583 ) Other income (expense): Investment and other income 209 82 302 107 Non-cash interest expense1 (45 ) (45 ) (135 ) (135 ) Total other income (expense) 164 37 167 (28 ) Net loss $ (10,717 ) $ (10,713 ) $ (35,139 ) $ (33,611 ) Basic and diluted loss per common share: $ (0.12 ) $ (0.12 ) $ (0.39 ) $ (0.40 ) Basic and diluted weighted average number of common shares outstanding: 89,392,079 88,766,912 89,211,208 84,433,435 1 The liabilities related to sale of future royalties will be amortized using the effective interest method over the life of the arrangements.