On February 4, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended December 31, 2020 (Press release, MEI Pharma, FEB 4, 2021, View Source [SID1234574646]).
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"We remain well positioned and focused on advancing zandelisib toward commercialization to deliver an improved therapeutic option to people living with B-cell malignancies," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We anticipate multiple important milestones from the zandelisib program this year, including topline data from our Phase 2 TIDAL study in the fourth quarter as we closely monitor for potential negative impacts related to the ongoing COVID 19 pandemic on the study, as well as more broadly across our business and development pipeline. In addition we look forward to reporting clinical data updates from the ongoing Phase 1b study and the continued expansion of the zandelisib clinical program evaluating additional indications and combinations, in particular the start of the Phase 3 study evaluating zandelisib in combination with rituximab in patients with second line follicular lymphoma around mid-year."
Dr. Gold continued: "Beyond the zandelisib development program, this year we look forward to the potential for more advances across our pipeline, including clinical data updates from the Phase 1 voruciclib program and our plans to advance ME-344 into a Phase 2 pilot study evaluating patients with solid tumors."
Anticipated Calendar Year 2021 Drug Candidate Pipeline Developments
Zandelisib – PI3K delta inhibitor for the treatment of various B-cell malignancies
Completion of enrollment in the Phase 2 TIDAL study evaluating zandelisib as a monotherapy for patients with relapsed or refractor follicular lymphoma followed by the reporting of top line clinical data from the Phase 2 TIDAL study.
Initiation of a second arm in the Phase 2 TIDAL study enrolling patients with relapsed or refractory marginal zone lymphoma.
Initiation of the Phase 3 study of zandelisib in combination with rituximab evaluating follicular and marginal zone lymphoma patients who received one or more prior lines of treatment; this study is intended to act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma.
Clinical updates for the Phase 1b study of zandelisib, 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.
ME-344 – tumor selective mitochondrial inhibitor
Update plans for a potential Phase 2 pilot study of ME-344 in solid tumors.
Recent and Second Quarter Fiscal Year 2021 Corporate Highlights
In January 2021, the Phase 1b trial arm exploring zandelisib in combination with zanubrutinib (marketed as BRUKINSA), developed by BeiGene, Ltd., enrolled the first patient in a disease specific expansion cohort. The phase 1b study arm evaluating the combination is conducted under a clinical collaboration with BeiGene to evaluate safety and efficacy for the treatment of patients with various relapsed or refractory B-cell malignancies.
In January 2021, MEI announced that the Phase 1b trial arm exploring zandelisib in combination with zanubrutinib in collaboration with BeiGene completed the safety evaluation 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.
In October 2020, Kyowa Kirin Co. Ltd. and MEI announced that the first patient was dosed in the pivotal Phase 2 study of zandelisib in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) in Japan. This Phase 2, multicenter is intended to support regulatory approval in Japan.
Second Quarter Fiscal Year 2021 Financial Results
As of December 31, 2020, MEI had $180.1 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended December 31, 2020, cash provided by operations was $4.1 million compared to $10.5 million used in operations for the quarter ended December 31, 2019. Cash provided by operations in the 2020 period reflects $20.9 million cash received from the Japanese taxing authorities as a refund of withholding tax associated with the Kyowa Kirin commercialization agreement signed in April 2020.
Research and development expenses were $22.2 million for the quarter ended December 31, 2020, compared to $8.3 million for the quarter ended December 31, 2019. 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 $5.7 million for the quarter ended December 31, 2020, compared to $4.2 million for the quarter ended December 31, 2019. The increase primarily relates to general corporate expenses and personnel costs incurred during the quarter ended December 31, 2020.
MEI recognized revenue of $9.2 million for the quarter ended December 31, 2020, compared to $1.0 million for the quarter ended December 31, 2019. 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, and reflect Kyowa Kirin’s share of zandelisib costs which were $9.9 million for the quarter ended December 31, 2020.
Net loss was $11.5 million, or $0.10 per share, for the quarter ended December 31, 2020, compared to net loss of $20.2 million, or $0.26 per share for the quarter ended December 31, 2019. The Company had 112,527,860 shares of common stock outstanding as of December 31, 2020, compared with 105,998,677 shares as of December 31, 2019.
The adjusted net loss for the quarter ended December 31, 2020, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure), was $18.5 million, compared to an adjusted net loss of $11.8 million for the quarter ended December 31, 2019.