On May 6, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended March 31, 2021 and highlighted recent corporate progress (Press release, MEI Pharma, MAY 6, 2021, View Source [SID1234579350]).
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"The first several months of 2021 have been very eventful for MEI, highlighted by the completion of enrollment in the follicular lymphoma efficacy population arm of the zandelisib TIDAL study. In addition, we recently reported preclinical data at AACR (Free AACR Whitepaper) 2021, demonstrating the ability of voruciclib to downregulate MYC and synergize with KRAS inhibitors in KRAS mutant cancers," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "While we continue to work diligently to advance the clinical development of voruciclib and ME-344, we anticipate additional important milestones from the zandelisib program this calendar year, including top-line TIDAL data by the end of 2021, the initiation of our Phase 3 COASTAL study evaluating zandelisib in combination with rituximab in patients with second line follicular or marginal zone lymphomas expected to start around mid-year, and clinical data updates from the ongoing Phase 1b study at the ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) and ICML annual meetings."
Anticipated Calendar Year 2021 Drug Candidate Pipeline Developments
Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies
Reporting of topline data from the Phase 2 TIDAL study in the fourth quarter from the follicular lymphoma primary efficacy population. The complete data from the follicular lymphoma arm of the Phase 2 TIDAL study data are intended to be submitted to FDA to support an accelerated approval application.
Initiation around mid-2021 of enrollment in COASTAL, a Phase 3 study evaluating zandelisib in combination with rituximab in follicular and marginal zone lymphoma patients who received one or more prior lines of treatment. This study is intended to support FDA approval for additional indications and act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
Clinical data updates from the Phase 1b study of zandelisib at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings, including the combination with zanubrutinib.
Voruciclib – CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
Program updates, including data from the Phase 1 program evaluating voruciclib in patients with acute myeloid leukemia and B-cell malignancies.
ME-344 – Tumor selective mitochondrial inhibitor
Initiation of a Phase 2 pilot study of ME-344 in solid tumors in the first half of calendar 2022.
Recent and Third Quarter Fiscal Year 2021 Corporate Highlights
In April 2021, MEI completed enrollment in the follicular lymphoma primary efficacy population of the global Phase 2 TIDAL study evaluating zandelisib. Topline data from the study is on track to be reported in the fourth quarter. The complete Phase 2 TIDAL study data are intended to be submitted to FDA to support accelerated approval applications.
In April 2021, MEI reported preclinical data demonstrating that voruciclib, an orally administered cyclin-dependent kinase (CDK) inhibitor that is potent against CDK9, downregulates MYC by inhibiting MYC transcription and stabilization, and synergizes with KRAS inhibitors in KRAS mutant cancers. The research was featured as an E-Poster Session presentation titled, "Voruciclib, a CDK9 inhibitor, downregulates MYC and inhibits proliferation of KRAS mutant cancers in preclinical models" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021.
In January 2021, MEI announced that the Phase 1b trial arm exploring zandelisib in combination with zanubrutinib in collaboration with BeiGene, Ltd. completed the dose optimization stage in patients with B-cell malignancies and is expanding into disease specific B-cell malignancy cohorts. The Safety Review Committee recommended moving forward with a dosing regimen found to be generally well tolerated and active following a planned safety analysis.
Third Quarter Fiscal Year 2021 Financial Results
As of March 31, 2021, MEI had $164.6 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended March 31, 2021, cash used in operations was $15.6 million, compared to $10.3 million for the same period in 2020. The increase in cash used in operations primarily relates to costs associated with our clinical development programs. For the nine months ended March 31, 2021, cash used in operations was $20.7 million, compared to $34.9 million for the same period in 2020. The year-to-date decrease in cash used in operations reflects $20.9 million of cash received from the Japanese taxing authorities as a refund of withholding tax associated with the Kyowa Kirin commercialization agreement signed in April 2019, offset by increased costs associated with our clinical development programs.
Research and development expenses were $17.9 million for the quarter ended March 31, 2021, compared to $9.0 million for the quarter ended March 31, 2020. The increase was primarily related to increased development costs associated with zandelisib, including increased activity in the TIDAL study and start-up costs related to the Phase 3 study, as well as increased personnel costs to support clinical trial activities.
General and administrative expenses were $6.2 million for the quarter ended March 31, 2021, compared to $3.9 million for the quarter ended March 31, 2020. The increase primarily relates to personnel costs and general corporate expenses incurred during the quarter ended March 31, 2021.
MEI recognized revenues of $2.4 million for the quarter ended March 31, 2021, compared to $1.2 million for the quarter ended March 31, 2020. The increase in revenue primarily related to the license agreement with Kyowa Kirin and included the recognition of fees allocated to research and development obligations.
Net loss was $31.3 million, or $0.28 per share, for the quarter ended March 31, 2021, compared to net loss of $4.3 million, or $0.04 per share for the quarter ended March 31, 2020. The Company had 112,591,778 shares of common stock outstanding as of March 31, 2021, compared with 105,998,677 shares as of March 31, 2020.
The adjusted net loss for the quarter ended March 31, 2021, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $22.0 million, compared to an adjusted net loss of $12.1 million for the quarter ended March 31, 2020.