On March 29, 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 full year 2021 financial results and provided corporate highlights (Press release, Infinity Pharmaceuticals, MAR 29, 2022, View Source [SID1234611111]).

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"Based on the strength and breadth of eganelisib’s activity across mTNBC and mUC as well as ovarian cancer, SCCHN, and melanoma, we raised $92 million in early 2021 to advance eganelisib to its first registration-enabling study by the end of this year. We have prioritized front-line TNBC based on prolonged progression-free survival in both PD-L1(+) and PD-L1(-) patients relative to the IMPassion130 reference benchmark. In addition, encouraging overall survival data from a randomized, controlled study in patients with second line urothelial cancer provides another attractive future registrational path. Importantly, in both TNBC and UC, supporting translational data show on-mechanism modulation of the tumor microenvironment to reduce immune suppression," said Adelene Perkins, Chief Executive Officer and Chair of Infinity.

Ms. Perkins continued, "With the additions of Dr. Robert Ilaria as our CMO and Dr. Stéphane Peluso as our CSO, in 2022 we are leveraging our data and financial resources to initiate MARIO-4, a randomized, double-blind Phase 3 study of eganelisib in a triplet combination regimen in front-line mTNBC. In parallel, we plan to initiate MARIO-P, our platform study to evaluate eganelisib in additional combinations and indications where eganelisib may increase the effectiveness of available therapies. As we prepare for the initiation of our first eganelisib registration study, we are very pleased to have Sujay Kango rejoining Infinity. He previously served as our executive vice president and chief commercial officer and now will be providing commercial insights as a member of our board of directors."

Key 2021 Updates:

MARIO-3: Updated data from the Company’s ongoing Phase 2 study evaluating eganelisib in a novel triple combination with Tecentriq (atezolizumab) and Abraxane (nab-paclitaxel) in unresectable locally advanced mTNBC was presented at SABCS in December 2021. This included 50 patients enrolled and evaluable for safety and 44 evaluable for efficacy as of the October 2, 2021 data cutoff date, with a median duration of follow-up of 9.9 months.

Tumor reduction:
Of evaluable patients, tumor reduction was observed in 92.8% patients with PD-L1 (+) tumors and 85.2% patients with PD-L1 (-) tumors.
Progression free survival (PFS):
In patients with PD-L1(+) tumors, median PFS in MARIO-3 was 11.0 months, a 47% improvement in mPFS compared to the 7.5 months reported for atezolizumab and nab-paclitaxel in IMpassion130.
In patients with PD-L1(-) tumors, median PFS in MARIO-3 was 7.3 months, a 30% improvement compared to the 5.6 months reported for atezolizumab and nab-paclitaxel in IMpassion130.
Safety:
MARIO-3 safety profile was consistent with expectations for the three component drugs and did not show any new safety signals compared to the IMpassion130 benchmark trial.
MARIO-275: Updated data from the Company’s randomized, placebo-controlled Phase 2 study evaluating the efficacy and safety of eganelisib in combination with Opdivo (nivolumab) in platinum-refractory, I/O naïve patients with locally advanced or metastatic urothelial cancer (UC) were presented at ASCO (Free ASCO Whitepaper) GU in February 2021 with OS data in July 2021 and January 2022.

Median overall survival (mOS) in the PD-L1(-) population (30 patients) was 15.4 months (4.7, NE) on the eganelisib plus nivolumab combination arm and 7.9 months (1.9, NE) on the control arm of nivolumab alone, with a hazard ratio of 0.60 (0.21, 1.71), reflecting a 40% lower probability of death on the combination arm, which was subsequently updated in January 2022 to a hazard ratio of 0.58, reflecting a 42% lower probability of death on the combination arm.
At the one-year landmark, 59% of patients in the ITT population receiving the eganelisib plus nivolumab combination remained alive, compared to 32% in the nivolumab control arm.
2021-2022 Corporate Updates:

Appointed Stéphane Peluso, Ph.D., as Chief Scientific Officer, joining Infinity from Ipsen.
Appointed Robert Ilaria, Jr., M.D. as Chief Medical Officer, joining Infinity from Bristol Myers Squibb.
Appointed Brian Schwartz, M.D., to Board of Directors, transitioning from consulting Chief Physician to the Board.
Appointed Mr. Sujay Kango to Board of Directors effective March 30, 2022. Mr. Kango is an experienced executive with more than 25 years of experience in the pharmaceutical and biotechnology industries. He has been instrumental in successfully transforming earlier stage organizations to later-stage development and commercial global biotech companies. He joined Acceleron Pharma in 2018, where he most recently served as the executive vice president and chief commercial officer. Under his leadership the team launched luspatercept, led multiple rare disease franchises, and established N.America and international presence for Acceleron. He played a key leadership role in Acceleron’s $11.5B acquisition by Merck in the second half of 2021. Mr. Kango has additionally led multiple global product launches across several therapeutic areas including oncology-hematology, rare diseases, immunology, and virology. Previously Mr. Kango was vice president of global commercial development for oncology at AbbVie and the co-chair of the oncology therapy area committee, prior to which he served as the executive vice president and chief commercial officer at Infinity Pharmaceuticals. Mr. Kango also served as vice president, global marketing, and sales operations at Onyx Pharmaceuticals, an Amgen subsidiary. Prior to Onyx, he held several leadership positions including vice president hepatitis franchise and integrated oncology business unit at Merck & Co., global commercial leader-Procrit/Eprex at Ortho-Biotech, and various sales and marketing positions at Schering-Plough. Mr. Kango also serves as a director of MEI Pharma. Mr. Kango earned a B.S. in Microbiology and an M.B.A. from McNeese State University.
Anticipated 2022 Milestones:

Initiate MARIO-4, a front-line metastatic TNBC randomized, double-blind, pivotal trial by year-end 2022
Infinity will finalize the MARIO-4 trial design following its meeting with global regulatory authorities
Progression free survival and overall survival as key endpoints
PD-L1 negative patients: eganelisib will be evaluated in combination with chemotherapy and a checkpoint inhibitor (the eganelisib triplet regimen) vs chemotherapy
PD-L1 positive patients: the eganelisib triplet regimen will be evaluated vs chemotherapy and a checkpoint inhibitor
Initiate MARIO-P, a study to evaluate the clinical benefit of eganelisib in combination regimens in additional solid tumor indications, on a rolling basis in 3Q 2022
Additional Eganelisib Clinical and Translational Data Releases in 2H 2022:

MARIO-3 study update in metastatic TNBC patients
MARIO-275 study update in urothelial cancer patients
MARIO-3 study in renal cell carcinoma patients
Investigator-sponsored study in head and neck squamous cell carcinoma patients sponsored by Dr. Ezra Cohen
Full Year 2021 Financial Results:

At December 31, 2021, Infinity had total cash, cash equivalents and available-for-sale securities of $80.7 million, compared to $34.1 million at December 31, 2020.
Research and development expense for 2021 was $31.6 million, compared to $26.8 million in 2020. The increase is primarily related to an increase in clinical development expenses, an increase in compensation expense due primarily to new hires during the year, and an increase in consulting expense to support continued development of eganelisib.
General and administrative expense was $14.2 million for 2021, compared to $12.4 million for 2020. The increase in G&A expense is primarily due to an increase in stock compensation, professional services, and consulting expense.
Net loss for 2021 was $45.3 million, or a basic and diluted loss per common share of $0.53, compared to a net loss of $40.5 million, or a basic and diluted loss per common share of $0.68 in 2020.
Financial Outlook: Infinity’s 2022 financial guidance remains as follows:

Net Loss: Infinity expects net loss for 2022 to range from $45 million to $55 million.
Cash and Investments: Infinity expects to end 2022 with a year-end cash, cash equivalents and available for sale securities balance ranging from $25 million to $35 million. Infinity expects to have cash for at least 12 months from the filing of its annual report on Form 10-K. Infinity’s financial guidance does not include additional funding or business development activities.
Conference Call Information

Infinity will host a conference call today, March 29, 2022, at 4:30 PM EDT 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 7567637. An archived version of the webcast will be available on Infinity’s website for 30 days.