On September 26, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2023 (Press release, MEI Pharma, SEP 26, 2023, View Source [SID1234635411]).
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"Over just the next few quarters we look forward to data readouts from two ongoing clinical studies of voruciclib and ME-344, advancing our strategy of assessing drug candidates in combinations with standard-of-care therapies to overcome known resistance mechanisms and address clear medical needs," said David M. Urso, president and chief executive officer of MEI Pharma. "Focusing on the execution of these two clinical studies – voruciclib evaluated in combination with Venclexta in acute myeloid leukemia and ME-344 in combination with Avastin in colorectal cancer – we expect data readouts beginning with voruciclib early in calendar 2024 and in the first half of 2024 for ME-344. Positive data from the studies would provide important support for the further development of these therapies to address significant unmet medical needs among patients with acute myeloid leukemia and colorectal cancer."
Fiscal Year 2023 and Recent Highlights
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In August 2023, MEI announced the dosing of the first patient in a Phase 1b study evaluating ME-344 in combination with bevacizumab (AVASTIN) in patients with previously treated metastatic colorectal cancer. ME-344 is a novel mitochondrial inhibitor targeting energy production through the OXPHOS pathway, which is important for supporting tumor cell survival and proliferation for many forms of cancer, including colorectal cancer. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, and other antiangiogenics, inhibit energy production through glycolysis and, thereby, increase tumor reliance on mitochondrial energy production, providing an opportunity to evaluate a combination with ME-344 to inhibit energy production in tumor cells and induce an antitumor effect. The Company anticipates announcing safety and efficacy data from the first cohort of 20 patients in the first half of 2024.
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In July 2023, at the Company’s Special Meeting of Stockholders, MEI did not obtain the necessary stockholder votes to approve a merger agreement for an all-stock transaction pursuant to which Infinity Pharmaceuticals would have become a wholly-owned subsidiary of the Company. The certified results showed that 59.70% of outstanding shares were voted, of which 47.86% voted in favor of the proposed transaction, and 51.44% against. Accordingly, MEI terminated the merger agreement.
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In June 2023, in connection with the Company’s succession plan, David M. Urso was appointed president and chief executive officer and also joined the Company’s board of directors. Mr. Urso replaced Daniel P. Gold, Ph.D., president and chief Executive officer of MEI since 2010. Dr. Gold continues to serve on MEI’s board. In June 2023, also as part of the Company’s succession planning, it was announced that Jay File would be appointed chief financial officer, replacing Brian Drazba. Mr. File’s appointment became effective on August 1, 2023.
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In May 2023, MEI announced an update to the ongoing Phase 1 study evaluating voruciclib, its oral cyclin-dependent kinase 9 (CDK9) inhibitor, alone and in combination with venetoclax (Venclexta), a BCL2 inhibitor, in patients with acute myeloid leukemia (AML) or B-cell malignancies. The Company announced that early results demonstrated that voruciclib alone or in combination with venetoclax was generally well tolerated with no significant myelosuppression. The results further demonstrated encouraging clinical activity in heavily pretreated patients administered with voruciclib alone and at the initial dose level in combination with venetoclax. These early results are consistent with the hypothesis that voruciclib may address a common venetoclax resistance mechanism by inhibiting MCL-1 via CDK9 inhibition.
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In May 2023, MEI regained compliance with the Nasdaq minimum bid requirement after the Company implemented a 1-for-20 reverse stock split in April 2023. The reverse stock split was approved by MEI’s stockholders on January 5, 2023.
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In March 2023, the Safety Review Committee of the Phase 1 study evaluating voruciclib plus venetoclax completed a safety assessment of the initial dose escalation cohort evaluating the combination in patients with AML and recommended opening the next cohort. The combination stage of the study started after completing the single-agent dose exploration stage of the Phase 1 study in patients with either AML or B-cell malignancies.
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In December 2022, MEI announced a realignment of its clinical development efforts following the discontinuation of zandelisib, its PI3K delta inhibitor drug candidate. As part of the realignment, the Company disclosed plans to streamline the organization towards the development of its two earlier clinical-stage assets, voruciclib and ME-344. We currently have 41 employees, which reflects a 61% reduction in full-time employees since our announcement in December 2022.
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In December 2022, after receiving new guidance in an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA), MEI and Kyowa Kirin announced the discontinuation of global development of zandelisib outside of Japan. The two companies concluded that a clinical trial consistent with the new FDA guidance, including modification of the then ongoing Phase 3 COASTAL trial, would likely not be feasible to complete within a time period that would support further investment. Kyowa Kirin, after meeting with the Pharmaceuticals and Medical Devices Agency (PMDA), subsequently discontinued zandelisib development in Japan after determining that conducting a randomized study consistent with that agency’s guidance to support a marketing application would also likely not be feasible to complete within a time period that would support further investment. In July 2023, the Company and Kyowa Kirin mutually entered a termination agreement between the parties pursuant to which MEI regained full global rights to zandelisib, subject to Kyowa Kirin receiving some limited rights to use zandelisib for compassionate use.
Expected Drug Candidate Pipeline Developments
Voruciclib – Oral CDK9 inhibitor in Phase 1 Study
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Report clinical data from the ongoing Phase 1 clinical trial evaluating voruciclib plus Venclexta (venetoclax) in patients with AML early in calendar 2024.
ME-344 – Mitochondrial inhibitor in Phase 1b Study
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Report clinical data from the Phase 1b clinical trial evaluating ME-344 plus Avastin (bevacizumab) in patients with relapsed colorectal cancer in the first half of calendar-year 2024.
Fiscal Year 2023 Financial Results
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As of June 30, 2023, MEI had $100.7 million in cash, cash equivalents, and short-term investments with no outstanding debt.
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For the year ended June 30, 2023, cash used in operations was $52.5 million, compared to $48.7 million during the year ended June 30, 2022. The increase in cash used in operations was primarily due to changes in working capital associated with the close down of zandelisib activities with Kyowa Kirin.
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Research and development expenses were $52.5 million for the year ended June 30, 2023, compared to $85.6 million for the year ended June 30, 2022. The decrease was primarily related to a reduction in zandelisib costs as we continued the close down of development activities announced in December 2022.
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General and administrative expenses increased by $2.6 million to $33.1 million for the year ended June 30, 2023, compared to $30.5 million for the year ended June 30, 2022. The net increase was primarily related to severance costs due to our staggered reductions in the workforce announced in December 2022 and higher external professional services offset by a decrease in noncash stock-based compensation.
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MEI recognized revenue of $48.8 million for the year ended June 30, 2023, compared to $40.7 million for the year ended June 30, 2022. The increase in revenue primarily results from the discontinuation of the zandelisib program in December 2022 under our global License, Development and Commercialization Agreement with Kyowa Kirin that resulted in the recognition of $16.6 million of previously deferred revenue related to performance obligations that are being closed and $8.6 million of previously deferred revenue related to performance obligations associated with clinical trials that have not commenced and will no longer be initiated.
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Net loss was $31.8 million, or $4.78 per share, for the year ended June 30, 2023, compared to net loss of $54.5 million, or $8.75 per share for the year ended June 30, 2022. The Company had 6,662,857 shares of common stock outstanding as of June 30, 2023, compared with 6,657,602 shares as of June 30, 2022.
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The adjusted net loss (a non-GAAP measure) for the year ended June 30, 2023 and 2022, excluding noncash gains recognized for changes in the fair value of warrants, was $33.4 million and $75.2 million, respectively
The Company believes its cash balance is sufficient to fund operations for at least the next 12 months, and through the reporting of clinical data readouts from the ongoing and planned voruciclib and ME-344 Phase 1 and Phase 1b clinical programs, respectively.
Conference Call & Webcast Information
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When: September 26, 2023, 5:00 p.m. ET
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Dial-in: 1-833-974-2378 (United States) or 1-412-317-5771 (International)
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