On September 2, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2021 (Press release, MEI Pharma, SEP 2, 2021, View Source [SID1234587206]).
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"Fiscal year 2021 was very successful for MEI; it was highlighted by multiple data updates that continue to support the potential of the unique intermittent dosing therapy schedule we designed for zandelisib, both as a monotherapy and in combination with other therapies across a range of B-cell malignances. To that end, we are continuing to expand the clinical program with studies designed to broaden zandelisib’s potential, like the Phase 3 COASTAL study in second line or later follicular lymphoma and the planned start of a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with relapsed chronic lymphocytic leukemia," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "As we expect to report top-line data from the potentially registrational Phase 2 TIDAL study by the end of the calendar year, we are diligently advancing our pre-commercialization activities, including the building out of our commercial infrastructure, in preparation for the potential commercialization of zandelisib."
Dr. Gold continued: "In addition to advancing zandelisib clinical development, this past year also brought other exciting pipeline developments supporting new clinical development plans for voruciclib, our oral CDK9 inhibitor, to explore its potential to synergize with KRAS inhibitors, and plans for a Phase 2 study of ME-344 plus bevacizumab evaluating patients with colorectal cancer. We are proud of our progress over the last fiscal year and committed to maintaining our overall focus on the development and commercialization of novel, best-in-class, cancer therapies intended to improve outcomes for patients."
Expected Drug Candidate Pipeline Developments
Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies
Report 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 the U.S. Food and Drug Administration (FDA) to support an accelerated approval marketing application.
Initiation of a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia.
Updates from the arm of a Phase 1b study evaluating zandelisib plus zanubrutinib, including in expansion cohorts enrolling patients with relapsed or refractory mantle cell and follicular lymphomas.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
Program updates, including data from the monotherapy portion of 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 study of ME-344 in relapsed colorectal cancer in the mid calendar year 2022.
Fiscal Year 2021 and Recent Select Drug Candidate Pipeline Highlights
Zandelisib
Completed enrollment in the follicular lymphoma primary efficacy population of 91 patients, and enrollment in the complete study population of 120 patients, of the global Phase 2 TIDAL study. Topline data from the study is expected to be reported in the fourth quarter of the calendar year. If successful, the complete Phase 2 TIDAL study data are intended to be submitted to the U.S. FDA to support accelerated approval applications under 21 CFR Part 314.500, Subpart H.
Initiated 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.
The dosing of the first patient in the global Phase 3 COASTAL study evaluating zandelisib in combination with rituximab, announced in August 2021, triggered a $10,000,000 milestone payment payable to MEI from Kyowa Kirin Co. pursuant to the 2020 global license, development and commercialization agreement between the companies. Receipt of the milestone payment is expected in the quarter ending September 30, 2021.
Initiated a second arm in the Phase 2 TIDAL study evaluating zandelisib as a monotherapy for the treatment of adults with relapsed and refractory marginal zone lymphoma. Subject to results from TIDAL, data from the study are intended to support accelerated approval applications with the FDA under 21 CFR Part 314.500, Subpart H.
Presented clinical data at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Virtual Congress from a Phase 1b study of zandelisib in combination with zanubrutinib (marketed as BRUKINSA), an inhibitor of Bruton’s tyrosine kinase developed by BeiGene, Ltd., in patients with relapsed or refractory B-cell malignancies. The data demonstrated that the combination was generally well tolerated in the 20 patients enrolled in the safety evaluation cohort. The combination administered on an optimized dosing regimen did not result in additive toxicity to each agent alone. Further, 100% of patients (n=16) with r/r indolent B-cell malignancies and chronic lymphocytic leukemia (CLL) achieved an objective response.
Presented clinical data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 and the 16th Annual International Conference on Malignant Lymphoma from a Phase 1b study of zandelisib as a monotherapy or plus rituximab demonstrating a 95% overall response rate (ORR) with rituximab and a 78% ORR as a monotherapy in patients with relapsed or refractory follicular lymphoma. Data presented also demonstrated that a median duration of response was not reached. Zandelisib was generally well-tolerated, demonstrating an 8% discontinuation rate due to any treatment emergent adverse event.
Initiated a pivotal Phase 2 study by Kyowa Kirin of zandelisib in patients with indolent B-cell non-Hodgkin’s lymphoma without small lymphocytic lymphoma, lymphoplasmacytic lymphoma and Waldenström’s macroglobulinemia in Japan.
Voruciclib
Reported preclinical data demonstrating that voruciclib is potent against CDK9, has single agent activity against multiple KRAS-mutant cancer cell lines and synergistically inhibits growth of KRAS mutant cancers in combination with KRAS inhibitors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. MEI is now expanding the clinical development of voruciclib into KRAS-mutated cancers, adding to the ongoing program evaluating voruciclib in patients with acute myeloid leukemia and B-cell malignancies.
Fiscal Year 2021 and Recent Corporate Highlights
During fiscal year 2021, MEI announced changes to its management team. In August 2021, MEI announced the planned transition and retirement of Brian Drazba as chief financial officer. The company initiated a search for a new chief financial officer. In July 2021, MEI appointed Tina C. Beamon, J.D. as chief compliance officer. In April 2021, MEI announced the retirement of Robert Mass and the promotion of Robert Ghalie as chief medical officer. In September 2020, MEI appointed Brian T. Powl as senior vice president, marketing.
Fiscal Year 2021 Financial Results
As of June 30, 2021, MEI had $153.4 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the year ended June 30, 2021, net cash used in operations was $52.4 million, compared to $45.3 million for 2020, excluding upfront cash payments from Kyowa Kirin. The increase primarily relates to increased costs associated with our clinical development programs.
Research and development expenses were $69.4 million for the year ended June 30, 2021, compared to $34.1 million for 2020. The increase was primarily related to increased development costs associated with zandelisib, including start-up costs related to the Phase 3 COASTAL study, increased drug manufacturing costs, and increased consulting fees to support clinical trial activities.
General and administrative expenses were $24.4 million for the year ended June 30, 2021, compared to $16.7 million for 2020. The increase primarily relates to increased professional services costs, increased personnel costs associated with increased headcount to support our activities, including preparation for commercial launch of zandelisib, and general corporate expenses incurred during 2021.
MEI recognized revenues of $25.5 million for the year ended June 30, 2021, compared to $28.9 million for 2020. The decrease in revenue primarily related to the license agreement with Kyowa Kirin and included the recognition of fees allocated to research and development obligations. Revenue also includes recognition of fees allocated to performance obligations in accordance with the Helsinn License Agreement.
Net loss was $50.6 million, or $0.45 per share, for the year ended June 30, 2021, compared to net loss of $46.0 million, or $0.51 per share for 2020. The Company had 112,614,643 shares of common stock outstanding as of June 30, 2021, compared with 111,513,689 shares as of June 30, 2020.
The adjusted net loss for the year ended June 30, 2021, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $68.7 million, compared to an adjusted net loss of $23.1 million for 2020.
Conference Call and Webcast
MEI Pharma will host a conference call with simultaneous webcast today, September 2, 2021, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial 1-833-974-2378 (United States) or 1-412-317-5771 (International). Please ask to join the MEI Pharma earnings call.
The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.