MEI Pharma Announces Q3 FY 2024 Results and Highlights

MEI Pharma, Inc., a clinical-stage pharmaceutical company, has reported its financial results for the quarter ending March 31, 2024, while highlighting significant corporate developments. The company focuses on developing innovative drug candidates to overcome resistance mechanisms in standard cancer therapies.

David Urso, the President and CEO, expressed optimism about the progress made with their drug candidates, voruciclib and ME-344. Voruciclib, an oral CDK9 inhibitor, remains the primary focus, especially in its combination with venetoclax for treating relapsed/refractory acute myeloid leukemia (AML). Venetoclax is a standard treatment for AML, but often, the disease progresses, necessitating additional therapy. Voruciclib aims to serve as a mutation-agnostic therapy, potentially benefiting a broader range of patients.

In January 2024, the company shared a Trials in Progress poster on the Phase 1b study of ME-344 combined with bevacizumab (Avastin®) for refractory metastatic colorectal cancer at the ASCO Gastrointestinal Cancers Symposium. Moreover, the ongoing Phase 1 study of voruciclib plus venetoclax showed promising anti-leukemic activity, including complete responses in heavily pretreated AML patients. This resulted in the initiation of an expansion cohort in March 2024.

The company also reported encouraging results from an April 2024 analysis of the Phase 1b study of ME-344 in combination with bevacizumab. Twenty-five percent of evaluable patients with relapsed metastatic colorectal cancer exhibited no disease progression at Week 16, surpassing the 20% threshold required to expand the study. Despite this, MEI decided to focus on developing a new formulation of ME-344 to enhance biological activity and ease of administration.

Additionally, MEI’s Board of Directors has agreed to prioritize the clinical development of voruciclib while also advancing the new ME-344 formulation. They have opted not to proceed with a second return of capital to conserve resources and extend the company's operational cash runway.

In terms of financials, MEI began the fourth fiscal quarter with $56.6 million in cash. For the nine months ending March 31, 2024, operational costs amounted to $32.5 million, a decrease from $41.2 million in the same period of the previous year. This reduction is attributed to the winding down of the zandelisib program and lower clinical spending. Research and development expenses also saw a decrease, from $15.1 million to $5.2 million for the quarter ending March 31, 2024, primarily due to reduced costs associated with the zandelisib program and a reduction in personnel. General and administrative costs were reduced to $4.6 million, down from $7.2 million in the same quarter the previous year, mainly due to a headcount reduction and lower legal expenses.

MEI did not report any revenue for the quarter ending March 31, 2024, compared to $5.9 million in the previous year, due to the recognition of all noncash deferred revenue related to the terminated Kyowa Kirin Commercialization Agreement. Despite this, MEI believes its cash reserves are sufficient to fund operations for the next 12 months.

MEI Pharma remains committed to developing its drug pipeline, including voruciclib and ME-344, to offer innovative cancer treatments. The company aims to provide updates on the voruciclib clinical trial throughout 2024 and on the new ME-344 formulation by the first half of 2025.