On February 9, 2023 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended December 31, 2022, and highlighted recent corporate events (Press release, MEI Pharma, FEB 9, 2023, View Source [SID1234627064]).
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"MEI anticipates reporting key clinical data readouts on two clinical-stage oncology candidates, voruciclib and ME-344, around the end of the calendar year for each program," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "These clinical data will inform future plans in two promising areas of oncology drug development: CDK9 inhibition and mitochondrial inhibition, respectively. With approximately $124 million at the end of the quarter, we remain well capitalized to pursue these objectives and estimate that we will be able to fund operations for two years based upon our current development plans."
Second Quarter Fiscal Year 2023 Recent Developments
In December 2022, MEI Pharma and Kyowa Kirin announced that after receiving the most recent guidance in a late November meeting with the U.S. Food and Drug Administration, the companies jointly decided to discontinue global development of zandelisib, an orally administered investigational phosphatidylinositol 3-kinase delta ("PI3Kd") inhibitor, outside of Japan for B-cell malignancies. Kyowa Kirin is continuing the Phase 2 MIRAGE study evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas, and will explore the potential for a marketing authorization submission to Japanese health authorities based on data from the MIRAGE and TIDAL clinical trials.
In December 2022, MEI announced that it is realigning its clinical development efforts following the discontinuation of global development outside Japan of zandelisib. As part of the announced program realignment and workforce reduction, the company is resizing its organization to support continued development of voruciclib and ME-344, while concurrently supporting the winding down of the zandelisib program outside of Japan. The company additionally announced that it had engaged Torreya Partners as financial advisor to help explore additional strategic opportunities.
In December 2022, MEI received notice from the U.S. Food and Drug Administration that it may proceed to initiate the Phase 1 study evaluating ME-344 plus Avastin(bevacizumab) in relapsed colorectal cancer patients. The study is expected to dose the first patient in the first half of calendar year 2023.
In November 2022, MEI dosed the first patient in the Phase 1b study evaluating voruciclib in combination with Venclexta (venetoclax), a BCL2 inhibitor. Initially the study is evaluating patients with acute myeloid leukemia (AML) after failure of prior standard therapies to assess safety and possible synergies for the combination treatment. Pending results from this ongoing study, the company may also evaluate the combination in patients across multiple indications with relapsed and refractory B-cell malignancies.
In November 2022, MEI and Kyowa Kirin announced topline data from the Phase 2 MIRAGE study evaluating zandelisib in Japanese patients with indolent B-cell Non-Hodgkin’s Lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and Waldenström’s macroglobulinemia in Japan. The data demonstrated a 75.4% objective response rate and 24.6% of patients achieved a complete response as determined by Independent Review Committee assessment. Additionally, 14.8% of patients discontinued therapy due to any treatment emergent adverse event.
Expected Drug Candidate Pipeline Developments
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
Report key clinical data from the ongoing Phase 1b trial evaluating voruciclib plus Venclexta (venetoclax) in patients with acute myeloid leukemia around calendar year-end 2023.
ME-344 – Tumor selective mitochondrial inhibitor
Initiate a Phase 1b clinical trial evaluating ME-344 plus Avastin in relapsed colorectal cancer patients in the first half of calendar year 2023.
Report key clinical data from the Phase 1b clinical trial evaluating ME-344 plus Avastin in patients with relapsed colorectal cancer around calendar year-end 2023.
Zandelisib – Oral PI3K delta inhibitor for the treatment of indolent B-cell Non-Hodgkin’s Lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma, and Waldenström’s macroglobulinemia in Japan
Provide an update on Kyowa Kirin’s plans for continued zandelisib development in Japan for patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas.
Second Quarter Fiscal Year 2023 Financial Results
As of December 31, 2022, MEI had $124.2 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended December 31, 2022, cash used in operations was $14.3 million, compared to $18.6 million used in operations (after adjusting for the receipt of a $10.0 million milestone payment from Kyowa Kirin during the quarter ended December 31, 2021). The decrease in cash used in operations is due to a reduction in zandelisib costs as we discontinued the program and initiated the close down of development activities and changes in working capital.
Research and development expenses were $15.3 million for the quarter ended December 31, 2022, compared to $21.5 million for the quarter ended December 31, 2021. The decrease was primarily related to a reduction in zandelisib costs as we discontinued the program and initiated the closing down of development activities during the quarter ended December 31, 2022.
General and administrative expenses were $8.5 million for the quarter ended December 31, 2022, compared to $7.9 million for the quarter ended December 31, 2021. The increase primarily relates to personnel costs, including costs related to severance from a workforce reduction, professional services and general corporate expenses.
MEI recognized revenue of $32.7 million for the quarter ended December 31, 2022, compared to $11.8 million for the quarter ended December 31, 2021. As a result of the discontinuation of the zandelisib program, we updated our estimated costs to complete each development performance obligation under the license agreement with Kyowa Kirin. This resulted in a higher progress towards completion and revenue for performance obligations that will not commence.
Net income was $10.3 million, or $0.08 per share, for the quarter ended December 31, 2022, compared to net loss of $12.2 million, or $0.10 per share for the quarter ended December 31, 2021. The Company had 133,260,865 shares of common stock outstanding as of December 31, 2022, compared with 132,904,545 shares as of December 31, 2021.
The adjusted net income (a non-GAAP measure) for the quarter ended December 31, 2022, excluding non-cash expenses related to changes in the fair value of the warrants, was $9.8 million, compared to an adjusted net loss of $17.6 million for the quarter ended December 31, 2021.