On March 28, 2023 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a potential first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported its full year 2022 financial results (Press release, Infinity Pharmaceuticals, MAR 28, 2023, View Source [SID1234629442]). The Company previously announced on February 23, 2023 its execution of a definitive merger agreement with MEI Pharma for a strategic combination of Infinity and MEI, which is expected to close in mid-2023, subject to approvals by MEI Pharma and Infinity shareholders and other customary closing conditions.

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Infinity’s Full Year 2022 Financial Results:

At December 31, 2022, Infinity had total cash and cash equivalents of $38.3 million, compared to $80.7 million at December 31, 2021.
Research and development expenses for 2022 were $32.4 million, compared to $31.6 million in 2021. The increase is primarily related to an increase in compensation expenses due primarily to additional staff for the development of eganelisib and an increase in consulting, partially offset by a decrease in clinical development expenses.
General and administrative expenses were $13.5 million for 2022, compared to $14.2 million for 2021. The decrease in G&A expense is primarily due to a decrease in consulting and compensation expenses, partially offset by an increase in information technology support expenses.
Net loss for 2022 was $44.4 million, or a basic and diluted loss per common share of $0.50, compared to a net loss of $45.3 million, or a basic and diluted loss per common share of $0.53 in 2021.
Proposed Merger of Infinity Pharmaceuticals with MEI Pharma:

As previously announced (press release here) and as approved by the respective Boards of Directors of both companies, on February 23, 2023 MEI and Infinity entered into a merger agreement for an all-stock transaction with the intent to form a company combining the expertise and resources of MEI and Infinity to advance a robust pipeline of three clinical-stage oncology drug candidates. All three clinical-stage development programs have the potential, in combination with current therapies, to overcome known resistance mechanisms and meaningfully improve patient outcomes.

If the merger is consummated, the combined company is projected to have a ~$100M cash balance at closing which is expected to fund operations through mid-2025. Importantly, clinical data expected over the next 12 to 24 months from the combined company’s clinical-stage oncology development pipeline consists of three differentiated programs:

Eganelisib, an oral immuno-oncology macrophage reprogramming product candidate, which, subject to U.S. Food and Drug Administration review, is planned to be evaluated in combination with the PD-1 targeted checkpoint inhibitor pembrolizumab (KEYTRUDA) as first line therapy in patients with relapsed/metastatic head and neck squamous cell carcinoma (HNSCC). The primary endpoint of the Phase 2 study will be overall survival. In the second half of 2024 we plan to have initial data on safety and progression free survival.
Voruciclib, an oral CDK9 inhibitor, currently being studied in combination with venetoclax (VENCLEXTA) in patients with hematologic malignancies. MEI has provided guidance that the ongoing Phase 1b trial is expected to report initial results from the combination regimen around the end of 2023.
ME-344, a novel tumor selective mitochondrial inhibitor targeting the OXPHOS pathway, to be evaluated in combination with bevacizumab (AVASTIN) in patients with relapsed colorectal cancer. MEI has provided guidance that data from the Phase 1b trial to support opening enrollment in an expansion cohort are expected to be reported around the end of 2023.
In anticipation of the merger, Infinity is investing in merger-related activities, including transaction costs, in preparation for the potential initiation of a Phase 2 study of eganelisib in HNSCC, subject to FDA review, and corporate restructuring costs including severance and retention payments.

If the merger is not consummated, Infinity expects to have a cash runway on a stand-alone basis into the second half of 2023, compared to its most recent guidance of cash runway into 2024. This shorter cash runway is a result of expenditures related to merger activities and the advancement of eganelisib. If Infinity does not successfully consummate the merger, Infinity expects to evaluate strategic alternatives and if Infinity is unable to enter into another strategic transaction, the Company’s board of directors may conclude that it is in the best interest of stockholders to cease normal operations and wind down the Company through bankruptcy or dissolution proceedings.

Focus of Eganelisib Development Following the Proposed Merger as Announced on Feb 23, 2023:

Global Phase 2 Study of Eganelisib in Front Line Head and Neck Cancer Patients

The lead and most advanced program for the combined company is planned to be eganelisib. With data supporting multiple paths forward for eganelisib, a study in head and neck squamous cell carcinoma (HNSCC) was prioritized based on the ability to leverage encouraging progression-free survival data generated in head and neck cancer patients in Infinity’s MARIO-1 clinical trial. In addition to the encouraging data from MARIO-1, the planned initiation of a randomized, controlled Phase 2 clinical study combining eganelisib with pembrolizumab or pembrolizumab in front line recurrent metastatic HNSCC patients was prioritized because:

Pembrolizumab is an approved standard of care in the study population and an appropriate control arm for the study.
Patients with recurrent or metastatic HNSCC with a PD-L1 combined positive score of 1 or greater have relatively short median progression free survival (3.2 months) and median overall survival (12.3 months) when treated with pembrolizumab monotherapy (Burtness et al Lancet 2019).
We believe that the combination regimen of eganelisib plus pembrolizumab has the potential to demonstrate progression free survival and overall survival benefits for front line recurrent metastatic HNSCC patients in a reasonably short period of time.
There are a significant number of patients in need.
Eganelisib data in HNSCC Patients from MARIO-1 Study:

The prioritized HNSCC Phase 2 study follows an encouraging signal from our MAcrophage Reprogramming in Immuno-Oncology-1, or MARIO-1, study, a Phase 1/1b clinical study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity for eganelisib — both as a monotherapy and in combination with nivolumab — in 224 patients with advanced solid tumors. As of the study’s December 13, 2021 database lock, the median progression free survival, or mPFS, rate of 3.7 months (1.9, 5.5) was observed in the HNSCC cohort in patients with immediate prior progression on CPI therapy. The mPFS for all patients receiving pembrolizumab monotherapy was 2.3 months in KEYNOTE-048, the benchmark study investigating pembrolizumab monotherapy, pembrolizumab plus chemotherapy, or cetuximab plus chemotherapy as a first-line therapy in recurrent or metastatic HNSCC patients. However, we caution you that the risks in cross-trial comparisons limit our ability to reach definitive conclusions without a prospective, adequately powered, randomized controlled trial. Further, in MARIO-1, a disease control rate, or DCR, of 36.4% (4 of 11 patients), an overall response rate, or ORR, of 18.2% (2 of 11 patients), and an mPFS rate of 5.3 months (1.9, 11.1) were observed in the HNSCC cohort in patients with immediate prior progression on CPI therapy and two or fewer prior lines of therapy. Reversible hepatic and skin adverse events were the most common toxicities observed when eganelisib was combined with nivolumab in patients across all combination cohorts of the MARIO-1 study in patients with advanced solid tumors.

Encouraging data with eganelisib has been generated in other patient populations including in patients with front-line metastatic triple negative breast cancer, or mTNBC, from the MARIO-3 TNBC study, and in CPI-naïve platinum refractory second line urothelial cancer patients in the MARIO-275 study, as summarized in the Company’s Annual Report on Form 10-K for 2022 filed on March 28, 2023.