MEI Pharma Reports First Quarter Fiscal Year 2020 Results and Operational Highlights

On November 7, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its first quarter ended September 30, 2019 (Press release, MEI Pharma, NOV 7, 2019, View Source [SID1234550625]).

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"During this past quarter, our primary focus remained on advancing the clinical development of ME-401, as well as voruciclib, while continuing to explore additional clinical collaborations and partnering opportunities to effectively leverage the potential of our drug candidates for patients," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "As reported at the MEI Investor and Analyst event in October, the ME-401 intermittent dosing regimen continues to demonstrate high activity with a well-tolerated safety profile, supporting the Phase 2 TIDAL study in patients with relapsed or refractory follicular lymphoma. We are also focused on the expansion of the investigation of the ME-401 intermittent dosing regimen across a variety of B-cell malignancies in combination with other therapies, like Rituxan or zanubrutinib, an investigational BTK inhibitor as per our clinical collaboration agreement with BeiGene."

Recent Highlights

In October 2019, at MEI’s Investor and Analyst Event, the company reported updated data from the ongoing Phase 1b study of ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta. The data demonstrate:
Overall response rates of 78% in relapsed or refractory (r/r) follicular lymphoma (FL) and 89% in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
Rates of Grade 3 adverse events of special interest related to ME-401 exposure were observed in <10% of patients dosed on an intermittent schedule (IS).
Median duration of response not yet reached in patients with FL or CLL/SLL on the IS regimen. Median follow-up for FL and CLL/SLL patients is 9.2 months (range 3.4-20.7 months) and 7.4 months (range 2.6-14.7 months), respectively.
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.
First Quarter Fiscal Year 2020 Financial Results

As of September 30, 2019, MEI had $65.9 million in cash, cash equivalents and short-term investments, with no outstanding debt.
For the quarter ended September 30, 2019, cash used in operations was $14.1 million, compared to $12.8 million for 2018.
Research and development expenses were $9.0 million for the quarter ended September 30, 2019, compared to $6.1 million for 2018. The increase was primarily related to increased development costs associated with ME-401 and increased headcount and professional services to support our development activities.
General and administrative expenses were $4.1 million for the quarter ended September 30, 2019, compared to $3.4 million for 2018. The increase primarily relates to increased headcount and increased professional services expenses to support our activities.
Revenues were $1.2 million for the quarter ended September 30, 2019, resulting from the recognition of fees allocated to research and development activities related to the Helsinn and Kyowa Kirin License Agreements. This compares with revenues of $0.5 million for the quarter ended September 30, 2018, resulting from the recognition of fees allocated to research and development activities related to the Helsinn License Agreement.
Net loss was $3.0 million, or $0.04 per share, for the quarter ended September 30, 2019, compared to net loss of $14.5 million, or $0.21 per share for 2018. The net loss decreased primarily as a result of a non-cash gain related to changes in the fair value of warrants issued in connection with the May 2018 financing. The company had 73,634,927 shares of common stock outstanding as of September 30, 2019, compared with 71,115,444 shares as of September 30, 2018.
The adjusted net loss for the quarter ended September 30, 2019, excluding a non-cash gain related to changes in the fair value of the warrants (a non-GAAP measure), was $12.3 million, compared to an adjusted net loss of $9.6 million for 2018.