On November 14, 2022 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended September 30, 2022, and highlighted recent corporate events (Press release, MEI Pharma, NOV 14, 2022, View Source [SID1234624002]).
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"As we move through fiscal year 2023 and continue to assess FDA concerns regarding the risk benefit analysis of marketed PI3Kδ inhibitors to treat indolent lymphomas, as well as the impact of these concerns and other global factors on our Phase 3 COASTAL study, we also look forward to reporting advances across our clinical development pipeline. This includes reporting updated data from multiple zandelisib studies at the ASH (Free ASH Whitepaper) annual meeting in December, and also reporting advances in our other development programs, including initiation of a trial evaluating voruciclib’s potential to synergize with venetoclax in patients with AML, and a trial evaluating the combination of ME-344 plus bevacizumab in patients with relapsed and refractory colorectal cancer," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We remain well capitalized with $138 million to advance our pipeline and continue operations for approximately two years."
First Quarter Fiscal Year 2023 Recent Developments and Financial Highlights
Earlier in November, MEI Pharma and Kyowa Kirin announced the acceptance of three abstracts reporting data for zandelisib, an investigational phosphatidylinositol 3-kinase delta inhibitor in clinical development for the treatment of B-cell malignancies, to be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) 2022 annual meeting to be held December 10-13, 2022.
In September, we announced that Christine A. White, M.D. will be retiring as chair of the board. She will be replaced by board member Charles V. Baltic. This will be effective as of the Company’s fiscal 2023 annual meeting of shareholders. Additionally, in November, Cheryl L. Cohen also informed the Company that she will not stand for election to the board at the Company’s annual meeting of shareholders.
In July, MEI Pharma and Kyowa Kirin announced publication in The Lancet Oncology of data from Phase 1b clinical study of zandelisib in patients with relapsed or refractory B-cell malignancy.
Expected Drug Candidate Pipeline Developments
Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies
Report new zandelisib data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022, including a presentation of updated data from the follicular lymphoma cohort in the Phase 2 TIDAL study and a presentation of data from the Phase 1b study cohort evaluating zandelisib plus Brukinsa (zanubrutinib) to treat indolent B-cell malignancies.
Dose the first patient in the Phase 2 CORAL study evaluating zandelisib plus Venclexta (venetoclax) and rituximab in patients with chronic lymphocytic leukemia by year-end 2022.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
Dose the first patient cohort of voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia by year-end 2022 in the Phase 1 study.
ME-344 – Tumor selective mitochondrial inhibitor
Initiate a Phase 1b study evaluating ME-344 plus Avastin (bevacizumab) in relapsed colorectal cancer patients in the first half of calendar year 2023.
First Quarter Fiscal Year 2023 Financial Results
As of September 30, 2022, MEI had $138.4 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended September 30, 2022, cash used in operations was $14.8 million, compared to $7.7 million used in operations for the quarter ended September 30, 2021. The increase in cash used in operations is due to the favorable impact of a $10.0 million milestone payment received from Kyowa Kirin in the comparable quarter in 2021 with no corresponding payment in 2022 and other changes in working capital balances.
Research and development expenses were $19.5 million for the quarter ended September 30, 2022, compared to $20.0 million for the quarter ended September 30, 2021. The decrease was primarily related to costs to support ongoing zandelisib and voruciclib studies.
General and administrative expenses were $7.5 million for the quarter ended September 30, 2022, compared to $7.9 million for the quarter ended September 30, 2021. The decrease primarily relates to lower personnel costs, professional services and general corporate expenses.
MEI recognized revenue of $8.7 million for the quarter ended September 30, 2022, compared to $7.8 million for the quarter ended September 30, 2021. The increase in recognized revenue relates to progress towards completion of our performance obligations, offset by decreased reimbursement of expenses under the license agreement with Kyowa Kirin.
Net loss was $16.6 million, or $0.12 per share, for the quarter ended September 30, 2022, compared to net loss of $17.5 million, or $0.16 per share for the quarter ended September 30, 2021. The Company had 133,260,865 shares of common stock outstanding as of September 30, 2022, compared with 112,678,498 shares as of September 30, 2021.
The adjusted net loss (a non-GAAP measure) for the quarter ended September 30, 2022, excluding non-cash expenses related to changes in the fair value of the warrants, was $17.7 million, compared to an adjusted net loss of $20.1 million for the quarter ended September 30, 2021.