MEI Pharma Board of Directors Aligns on Strategy to Advance Voruciclib and ME-344 - Seite 2

Mr. Datoo continued: “As we move forward, we have every confidence that execution of the strategy is in good hands with the MEI leadership team. They have significant experience in the clinical development of oncology therapeutics and are well suited to achieve success for patients and for the Company’s shareholders.”

Return of Capital Determination

As previously disclosed, the Company’s October 31, 2023 Cooperation Agreement with stockholders, including Anson Funds and Cable Car Capital, provided that a potential second return of capital could be authorized by the Board under certain circumstances as outlined in that agreement, subject to the exercise of the Board’s fiduciary duties. Since data reported from Cohort 1 of the Phase 1b study exceeded a criterion for the potential second return of capital stated in the Agreement, the trigger for a return of capital was not met. The Board further unanimously determined, after deciding not to proceed with Cohort 2, that in the exercise of its fiduciary duties under applicable law, and in light of its views on what path is in the best interests of the Company’s stockholders, the Company would not proceed with any additional potential return of capital as permitted under the Cooperation Agreement.

Strategic Overview

The strategy unanimously approved by the MEI Board of Directors provides for advancing clinical development of voruciclib, an investigational selective oral cyclin-dependent kinase 9 (“CDK9”) inhibitor, to new value inflection points by the end of calendar year 2025 and for enabling a new formulation of ME-344, an investigational inhibitor of mitochondrial oxidative phosphorylation (“OXPHOS”). The plan builds on encouraging recently reported voruciclib clinical data and ME-344 data separately reported today.

Specifically with respect to voruciclib, the development objective is to optimize voruciclib for a Phase 3 study in combination with venetoclax (Venclexta) in patients with relapsed and refractory (“R/R”) acute myeloid leukemia (“AML”). Under the plan, the ongoing voruciclib development strategy will be guided by future clinical trial results and applicable regulatory authority advice. Subject to positive Phase 1 data later this year, MEI plans to amend the ongoing Phase 1 study to add a Phase 2 study arm, with enrollment in the Phase 2 arm anticipated to begin in 2025. This is anticipated to generate Phase 2 data by the end of 2025. Contingent on the success of the Phase 1/2 study, MEI plans to have the program ready to initiate a Phase 3 registration trial during 2026.