On May 3, 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 first quarter 2022 financial results and provided a corporate update (Press release, Infinity Pharmaceuticals, MAY 3, 2022, View Source [SID1234613395]).
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"We are pleased to further advance the development of eganelisib, building on our encouraging MARIO-3 results, by initiating our first registration study, MARIO-4, in front-line metastatic TNBC by the end of this year." Ms. Perkins continued, "In parallel, we are also planning to start our platform clinical program, MARIO-P, on a rolling basis. MARIO-P is being designed to rapidly expand eganelisib development in additional combinations and indications where it may increase the effectiveness of available therapies. We continue to leverage eganelisib’s unique mechanism of action and differentiated clinical data to advance our clinical development program and maximize the value of eganelisib for patients and shareholders."
Anticipated 2022 Clinical Studies:
Initiate MARIO-4, a randomized, double-blind, registrational trial in front-line metastatic TNBC, by year-end 2022
Complete the MARIO-4 trial design, including confirmation of key endpoints (e.g, progression free survival and overall survival), following meeting with global regulatory authorities
Evaluate eganelisib in both PD-L1 negative and PD-L1 positive patients:
-Experimental arm: eganelisib triplet regimen (eganelisib + chemo + checkpoint inhibitor)
-PD-L1 (-) control arm: chemotherapy alone
-PD-L1 (+) control arm: chemotherapy plus checkpoint inhibitor
Initiate MARIO-P, a clinical program designed to rapidly evaluate the clinical benefit of eganelisib in combination regimens in additional solid tumor indications, on a rolling basis starting in 3Q 2022. Expected tumor types to include ovarian cancer, non-small cell lung cancer, soft tissue sarcoma and prostate cancer
Eganelisib Clinical/Translational Data in 2H 2022:
MARIO-3 study in metastatic TNBC patients
MARIO-275 study 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
First Quarter 2022 Financial Results:
At March 31, 2022, Infinity had total cash, cash equivalents and available-for-sale securities of $67.1 million, compared to $80.7 million at December 31, 2021.
Research and development expense for the first quarter of 2022 was $9.0 million, compared to $8.2 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, partially offset by a decrease in clinical development expenses to support continued development of eganelisib.
General and administrative expense was $3.7 million for the first quarter of 2022, compared to $3.6 million for the same period in 2021. The increase in G&A expense is primarily due to an increase in stock compensation, partially offset by a decrease in professional services.
Net loss for the first quarter of 2022 was $12.4 million, or a basic and diluted loss per common share of $0.14, compared to a net loss of $11.6 million, or a basic and diluted loss per common share of $0.15 in the same period in 2021.
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’s financial guidance does not include additional funding or business development activities.
Conference Call Information
Infinity will host a conference call today, May 3, 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 6618485. An archived version of the webcast will be available on Infinity’s website for 30 days.