On August 9, 2022 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, reported its second quarter 2022 financial results, unveiled new positive data from the Phase 2 MARIO-275 clinical trial, and provided a business update (Press release, Infinity Pharmaceuticals, AUG 9, 2022, View Source [SID1234617914]).

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"Today, we are pleased to announce positive survival data that shows approximately a doubling of patient survival at the two-year landmark analysis, a durable benefit for urothelial cancer patients being treated with eganelisib plus nivolumab versus standard-of-care nivolumab monotherapy. This impressive magnitude of benefit is particularly meaningful given this is a second line patient population whose cancer has progressed following treatment with a platinum-based chemotherapy," said Robert Ilaria, Jr., MD, Chief Medical Officer of Infinity.

"Based on the positive eganelisib data generated to-date in several indications and settings, we remain in discussions with multiple parties regarding potential partnerships to further advance the development of eganelisib," said Adelene Perkins, Chief Executive Officer and Chair of Infinity. "At this stage in eganelisib’s clinical development, and given the current market environment, we have decided to prioritize establishing potential partnerships before beginning new efficacy studies, including MARIO-4 in TNBC and the MARIO-P platform study. Infinity has a track record of fiscal discipline, and this approach allows us to focus our current resources on ongoing clinical trials, extend our cash runway into 2024, and provide the flexibility to accommodate potential partners’ input on the prioritization and design of our next studies. These initiatives support our commitment to advancing development of eganelisib across multiple oncology indications to maximize value for patients and shareholders."

Positive MARIO-275 Clinical Trial Results in Second Line Urothelial Cancer:

At two-year landmark survival analysis of MARIO-275 as of July 29, 2022, 45% of patients in the eganelisib plus nivolumab arm are alive compared to 24% of patients in the nivolumab control arm, a near doubling of survival benefit.
Durable survival benefit was also seen in the PD-L1-negative subgroup, with 38% of patients alive at two years in the eganelisib plus nivolumab arm versus 17% in the control group, over a doubling of survival in this patient population underserved by checkpoint inhibitors alone.
No new safety signals were observed during the extended period on treatment.
Second Quarter 2022 Financial Results:

At June 30, 2022, Infinity had total cash, cash equivalents and available-for-sale securities of $56.6 million, compared to $80.7 million at December 31, 2021.
Research and development expenses for the second quarter of 2022 were $8.8 million, compared to $8.0 million in the same period in 2021. The increase is primarily related to an increase in compensation expense due primarily to new hires during the period and an increase in consulting expense, partially offset by a decrease in clinical development expenses.
General and administrative expenses were $3.5 million for the second quarter of 2022 as well as for the second quarter of 2021.
Net loss for the second quarter of 2022 was $12.0 million, or a basic and diluted loss per common share of $0.13, compared to a net loss of $11.3 million, or a basic and diluted loss per common share of $0.13 in the same period in 2021.
2022 Financial Outlook: Net Loss: Infinity expects net loss for 2022 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2022 with a cash, cash equivalents and available for sale securities 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.
Conference Call Information

Infinity will host a conference call today, August 9, 2022, at 4:30 PM EDT to discuss these financial results and business updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial (800) 715-9871 (domestic) and (646) 307-1963 (international) five minutes prior to start time. The conference ID number is 3032412. An archived version of the webcast will be available on Infinity’s website for 30 days.