MEI Pharma(US:MEIP)2025-02-12 21:00Financial Performance - MEI Pharma reported an initial payment of $0.5 million and a reimbursement of $55,000 from the sale of ME-344, with potential future milestone payments up to $62.0 million based on regulatory and revenue achievements[104]. - The company recognized no revenue during the six months ended December 31, 2024, a decrease of $65.3 million compared to the same period in 2023 due to the recognition of all deferred revenue from the KKC Commercialization Agreement[153]. - As of June 30, 2023, the company had $64.9 million in aggregate deferred revenue related to the KKC Commercialization Agreement, with $64.5 million allocated to the U.S. License[148]. - Research and development expenses decreased by $3.6 million to $0.3 million for the three months ended December 31, 2024, compared to $3.9 million for the same period in 2023, primarily due to the cessation of all clinical studies[150]. - General and administrative expenses decreased by $4.9 million to $3.1 million for the three months ended December 31, 2024, compared to $8.0 million for the same period in 2023[151]. - Total research and development expenses for the six months ended December 31, 2024, were $3.5 million, down from $7.4 million in the same period in 2023[155]. - General and administrative expenses for the six months ended December 31, 2024, were $8.3 million, a decrease of $6.2 million compared to $14.5 million for the same period in 2023[156]. - Net cash used in operating activities for the six months ended December 31, 2024, was $15.1 million, compared to $29.5 million for the same period in 2023[160]. - The company had $23.7 million in cash and cash equivalents as of December 31, 2024, and expects to fund operations for at least the next 12 months[159]. - Net cash provided by investing activities for the six months ended December 31, 2024, was $35.2 million, an increase from $29.5 million in the same period in 2023[161]. - The company has accumulated losses of $398.9 million since inception and anticipates continued operating losses and negative cash flows for the foreseeable future[158]. Clinical Development - The company has ceased all ongoing clinical trial efforts for voruciclib following the exploration of strategic alternatives announced on July 22, 2024[107]. - Voruciclib completed a Phase 1 trial in patients with acute myeloid leukemia (AML) in combination with venetoclax, with 31% of patients achieving disease control at doses ≥ 100 mg[119]. - In a recent Phase 1 clinical trial, voruciclib was well tolerated at doses up to 200 mg, with no dose limiting toxicities reported[116]. - The median age of patients enrolled in the voruciclib and venetoclax combination study was 67 years, with a median of 2 prior therapies[118]. - Voruciclib demonstrated a reduction in Mcl-1 expression in approximately 50% of evaluable patients, supporting its potential as a therapeutic agent[120]. - The company has discontinued the clinical development of voruciclib while continuing certain nonclinical activities related to its drug candidate assets[102]. - Voruciclib was well tolerated at doses up to 300 mg with no dose limiting toxicities observed, and the most common grade 3 adverse event was myelosuppression associated with AML[121]. - In a study, 44% of patients showed a rebound of peripheral blast counts between Day 14 and Day 28 after stopping voruciclib while continuing venetoclax[122]. - Voruciclib demonstrated anti-tumor activity in a Phase 1 study with 100% response rate in BRAF/MEK naive patients, including two partial responses and one complete response[123]. - ME-344 is being developed to enhance biological activity and improve patient convenience, with a new formulation aimed at increasing commercial opportunity[125]. - In a Phase 1b study of ME-344 combined with bevacizumab, 25% of evaluable patients completed 16 weeks of therapy without disease progression, exceeding the 20% threshold[138]. - The median progression-free survival (PFS) in the first cohort of the ME-344 study was 1.9 months, with a 4-month PFS rate of 31.2%[138]. - Zandelisib development was discontinued outside Japan due to regulatory guidance, with all ongoing clinical studies being closed[144]. - KKC was granted a co-exclusive license for zandelisib, with an initial non-refundable payment of $100 million and potential milestone payments in Japan[146]. - ME-344 has shown potential to enhance venetoclax activity against AML, targeting metabolic vulnerabilities in resistant AML cells[142]. - The combination of ME-344 and bevacizumab demonstrated significant biologic activity, with mean relative Ki67 decreases of 23% in treated patients compared to an increase of 186% in the control group[138]. Strategic Alternatives - The company is evaluating strategic alternatives, including potential transactions and an orderly wind down of operations, to maximize asset value for stockholders[102]. - The strategic alternatives review may include out-licensing opportunities and merger and acquisition possibilities[102]. - MEI Pharma's leadership underwent changes, with the appointment of Justin J. File as Acting CEO following the departure of former executives[103].