On July 30, 2020 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its second quarter 2020 financial results and provided an update on the company, including its second quarter progress with eganelisib (also known as IPI-549), the company’s first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition (Press release, Infinity Pharmaceuticals, JUL 30, 2020, View Source [SID1234562567]).

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"We have made important clinical progress this quarter including the generation of early, but encouraging signals of clinical activity in the triple negative breast cancer cohort of MARIO-3," said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals. "While these data are preliminary, we are excited by the potential to bring eganelisib to the front-line setting for the deadliest form of breast cancer and plan to present these data later this year."

Ms. Perkins continued, "We are also pleased that the dose reduction implemented for MARIO-275 from 40mg QD to 30mg QD has enabled the continued treatment of patients previously enrolled in the study. We will conduct an interim efficacy analysis on these patients by the end of the year which will inform next steps."

Key Q2 2020 Updates:

Clinical and Regulatory:

MARIO-275: MARIO-275 is the company’s ongoing controlled, randomized Phase 2 study evaluating eganelisib in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial cancer (aUC), in collaboration with Bristol Myers Squibb, or BMS.
Infinity implemented a dose reduction from 40mg QD to 30mg QD which has reduced the reversible liver enzyme elevations which were reported at the first scheduled MARIO-275 Independent Data Monitoring Committee (IDMC) meeting. Infinity will continue treatment of the currently enrolled patients and conduct an interim efficacy analysis by the end of the year which will inform next steps.
MARIO-3: MARIO-3 is the company’s ongoing Phase 2 study in collaboration with Roche/Genentech to evaluate eganelisib in novel triple combination in the front-line setting with Tecentriq and Abraxane in triple negative breast cancer (TNBC) and with Tecentriq and Avastin in renal cell cancer (RCC).
Early, encouraging clinical activity has been observed in the TNBC cohort of MARIO-3. Infinity plans to present these initial clinical data later this year.
The majority of identified sites are up and running. Infinity has observed an increase in site initiation and patient screening, and Infinity is working closely with the CRO on enrollment initiatives.
Enrollment completion is expected in the RCC cohort by the end of 2020 and the TNBC cohort by the end of Q1 2021.
MARIO-1: Infinity plans to share clinical and translational data from MARIO-1 later this year.
Arcus Collaboration: A Phase 1b collaboration study with Arcus Biosciences, which is being conducted by Arcus, is evaluating a checkpoint-inhibitor free, novel triple-combination regimen of eganelisib + AB928 (dual adenosine receptor antagonist) + Doxil in up to approximately 40 advanced TNBC patients.
COVID-19 Impact: As the situation with COVID-19 continues to evolve, the company is diligently evaluating impacts on enrollment, site initiations, patient treatment and protocol compliance. Infinity continues to work closely with trial sites to support the continued treatment of patients in compliance with study protocols and is proactively working to mitigate disruptions to enrollment and trial timelines.
Corporate:

Dr. Brian Schwartz joined Infinity in a consulting Chief Physician role in April. He is actively providing guidance and insight across Infinity’s clinical programs, leveraging his deep experience in clinical development, particularly in oncology. Dr. Schwartz brings an impressive track record of experience and success, most recently serving as Chief Medical Officer at ArQule up until its acquisition by Merck. Dr. Schwartz is providing guidance and insight across Infinity’s clinical programs, leveraging his deep experience in clinical development, particularly in oncology.
Second Quarter 2020 Financial Results:

At June 30, 2020, Infinity had total cash, cash equivalents and available-for-sale securities of $42.7 million, compared to $50.3 million at March 31, 2020.
Research and development expense for the second quarter of 2020 was $6.1 million, compared to $6.1 million for the same period in 2019.
General and administrative expense was $2.9 million for the second quarter of 2020, compared to $3.8 million for the same period in 2019. The decrease is primarily related to a decrease in consulting and stock compensation.
Net loss for the second quarter of 2020 was $9.5 million, or a basic and diluted loss per common share of $0.16, compared to a net loss of $10.5 million, or a basic and diluted loss per common share of $0.18 for the same period in 2019.
2020 Financial Outlook:

Net Loss: Infinity expects net loss for 2020 to range from $35 million to $45 million.

Cash and Investments: Infinity expects to end 2020 with a year-end cash, cash equivalents and available-for-sale securities balance ranging from $20 million to $30 million.

Cash Runway: Based on its current operational plans, Infinity expects that its existing cash, cash equivalents and available-for-sale securities, will be adequate to satisfy the company’s capital needs into 2H2021. Infinity’s financial guidance does not include potential additional funding or business development activities, a potential $5 million milestone payment from BVF based on PellePharm’s ongoing Phase 3 clinical trial of patidegib topical gel in Gorlin Syndrome, or any milestones from, or the sale of the company’s equity interest in, PellePharm.

Conference Call Information

Infinity will host a conference call today, July 30, 2020, at 4:30 p.m. ET to discuss these financial results and company 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 (877) 316-5293 (domestic) and (631) 291-4526 (international) five minutes prior to start time. The conference ID number is 7893533. An archived version of the webcast will be available on Infinity’s website for 30 days.