On August 28, 2019 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, 2019 (Press release, MEI Pharma, AUG 28, 2019, View Source [SID1234539062]).
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"It was a very productive year, with each of the four clinical-stage programs within our oncology portfolio advancing in development, led by ME-401 and the initiation of our global Phase 2 study which may support an accelerated approval of a marketing application with FDA, the BeiGene clinical collaboration to combine ME-401 with zanubrutinib, BeiGene’s BTK inhibitor, and a regional licensing deal with Kyowa Kirin for the development and commercialization of ME-401 in Japan," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We were also pleased to report the progress made from all our programs as featured at key medical meetings including ICML 2019, ASCO (Free ASCO Whitepaper) 2019 and ASH (Free ASH Whitepaper) 2018."
Dr. Gold continued: "Looking to the year ahead, we are in a great position to continue strengthening our foundation and creating value through data generation across our development pipeline, evaluating drug combination opportunities, unlocking innovations like the intermittent schedule for ME-401, and exploring additional collaboration and licensing opportunities to most effectively leverage the potential of our drug candidates."
Fiscal Year 2019 and Recent Highlights
ME-401 for B-Cell Malignancies
In October 2018, MEI (the Company) entered into a clinical collaboration to evaluate in patients with B-cell malignancies the safety and efficacy of ME-401 in combination with BeiGene’s zanubrutinib, an investigational Bruton’s tyrosine kinase ("BTK") inhibitor
In October 2018, MEI entered into a license, development and commercialization agreement granting Kyowa Kirin Company exclusive rights to develop and commercialize ME-401 in Japan. MEI received a $10.0 million upfront payment and is eligible to receive up to $87.5 million in additional development and commercialization milestones, and royalties on sales.
In December 2018, the Company initiated the ongoing Phase 2 clinical trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma which may support an accelerated approval of a marketing application with FDA.
In December 2018, at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the Company presented interim results from the ongoing Phase 1b study demonstrating that ME-401 continues to be associated with overall high objective response rates as a single agent and in combination with rituximab. Lower rates of Grade 3 adverse events of special interest were observed in patients on the intermittent dosing schedule.
In June 2019, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the International Conference on Malignant Lymphoma (ICML), the Company presented updated data from the ongoing ME-401 Phase 1b study demonstrating an 80% overall response rate in patients with relapsed or refractory follicular lymphoma and an 83% overall response rate in patients with relapsed or refractory follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma. The intermittent dosing schedule demonstrated comparable overall response rates with a lower rate of delayed Grade 3 adverse events of special interest (≤10%) compared to the continuous dosing schedule.
Voruciclib for B-Cell Malignancies and Acute Myeloid Leukemia ("AML")
In December 2018 at ASH (Free ASH Whitepaper), the Company presented preclinical data demonstrating that voruciclib synergistically induced apoptosis at clinically relevant concentrations when combined with venetoclax (marketed as Venclexta) in human derived AML cells lines and patient samples.
ME-344 for Solid Tumors
In June 2019 at ASCO (Free ASCO Whitepaper), the Company presented the data from an investigator-initiated study of ME-344 in combination with bevacizumab (marketed as Avastin) in patients with early HER2-negative breast cancer. The data demonstrated proof of biologic anti-tumor activity as measured by a statistically significant reduction in Ki67, a measure of cell proliferation that is highly correlated with tumor response, in patients treated with ME-344 compared to an increase in the group receiving saline.
Pracinostat for Myelodysplastic Syndrome ("MDS")
In December 2018 at ASH (Free ASH Whitepaper), the Company and Helsinn Healthcare presented interim results from the ongoing Phase 2 study evaluating pracinostat in combination with azacitidine for the treatment of patients with IPSS-R high/very high-risk of MDS. The data demonstrate a 9% discontinuation rate due to adverse events, a substantially lower rate than observed in an earlier Phase 2 study, as well as an encouraging 36% complete response rate among patients receiving at least 6 cycles of treatment.
In February 2019, the Company and Helsinn Healthcare published data in the medical journal, Blood Advances, from a Phase 2 study evaluating the safety and efficacy of pracinostat in combination with azacitidine for the treatment of patients suffering from AML who cannot undergo treatment with intensive chemotherapy. The full article can be found here.
Corporate Highlights
In July 2018, the Company announced that David M. Urso, J.D., senior vice president of corporate development and general counsel, was promoted to chief operating officer. Mr. Urso continues as the Company’s general counsel and head of corporate development.
In July 2019, Tamar Howson, M.S., MBA a highly experienced business development executive with over 30 years of service in the pharmaceutical and biotechnology industry joined the Board of Directors.
Fiscal Year 2019 Financial Results
As of June 30, 2019, MEI had $79.8 million in cash, cash equivalents, short-term investments, and common stock proceeds receivable, with no outstanding debt.
For the year ended June 30, 2019, cash used in operations was $39.4 million, compared to $21.0 million for 2018
Research and development expenses were $32.3 million for the year ended June 30, 2019, compared to $17.0 million for 2018. The increase was primarily related to increased activities in all clinical programs including development costs associated with ME-401 and voruciclib.
General and administrative expenses were $14.6 million for the year ended June 30, 2019, compared to $9.8 million for 2018. The increase primarily relates to professional services expenses, share-based compensation, and general corporate expenses incurred during the year ended June 30, 2019.
MEI recognized revenues of $4.9 million for the year ended June 30, 2019, compared to $1.6 million for the year ended June 30, 2018. Revenues resulted from the recognition of fees allocated to research and development activities related to the Helsinn and Kyowa Kirin license agreements. Revenue increased due to higher levels of research and development activities during the year ended June 30, 2019.
Net loss was $16.8 million, or $0.24 per share, for the fiscal year ended June 30, 2019, compared to net loss of $40.1 million, or $0.97 per share for 2018. The Company had 73,544,576 shares of common stock outstanding as of June 30, 2019, compared with 70,406,283 shares as of June 30, 2018.
The adjusted net loss for the fiscal year ended June 30, 2019, 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 $44.5 million.
Conference Call and Webcast
MEI Pharma will host a conference call with simultaneous webcast today, August 28, 2019, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial (866) 939-3921 (United States) or (678) 302-3550 (International), conference ID 48926540. 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.