On May 9, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), a pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer, reported results for its third quarter ended March 31, 2018 (Press release, MEI Pharma, MAY 9, 2018, View Source [SID1234526378]).
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"Over the past quarter we continued making key advances in each of our four clinical programs, as we look forward to important data readouts before mid-year in three of the four programs," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "In particular, we will be presenting data at ASCO (Free ASCO Whitepaper) 2018 from our study evaluating ME-401, an orally administered PI3K delta inhibitor demonstrating potential class leading efficacy in follicular lymphoma. Based on the data in this program, we anticipate progressing into a single-agent registration study later in 2018. In addition, we will present data at ASCO (Free ASCO Whitepaper) 2018 from an investigator-initiated study of ME-344 in HER2-negative breast cancer."
Dr. Gold added: "We also look forward to initiating our Phase 1 study of voruciclib, a selective and orally administered CDK inhibitor differentiated by potent inhibition of CDK9, in relapsed/refractory B lymphocyte malignancies. Finally, we are looking forward to an interim analysis this quarter from the Phase 2 pracinostat study in MDS and the potential to continue advancing the study together with our partner Helsinn."
Recent Program Highlights and Upcoming Milestones
ME-401
An abstract with results from a Phase 1b study in relapsed/refractory CLL and FL has been accepted and will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 1-5 in Chicago, IL.
Pracinostat (partnered with Helsinn Healthcare, SA)
In January 2018, the European Medicines Agency granted Orphan Drug Designation to pracinostat, currently in a Phase 3 study in combination with azacitidine for the treatment of acute myeloid leukemia (AML) in adult patients unfit for induction chemotherapy.
The Company anticipates results from stage 1 of a Phase 2 dose-optimization study in myelodysplastic syndrome (MDS) in the first half of 2018.
Voruciclib
In January 2018, the U.S. Food and Drug Administration cleared the Company’s Investigational New Drug Application (IND) for voruciclib.
The Company expects to initiate a Phase 1 single-agent study in relapsed/refractory B cell malignancies in the first half of 2018.
ME-344
In February 2018, the Company announced that a planned interim review of data supports the continuation of its multicenter, investigator-initiated, study evaluating ME-344 in patients with HER2-negative breast cancer. The interim study data show that ME-344 was generally well-tolerated and, consistent with previous preclinical data, demonstrate the potential to reverse resistance to antiangiogenic therapy.
An abstract featuring interim results from the Phase 1 study in HER2 negative breast cancer in combination with bevacizumab (marketed as Avastin) has been accepted and will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 1-5 in Chicago, IL.
Corporate
In February 2018, the Company announced the appointment of industry veteran Frederick W. Driscoll to its board of directors, who will also serve on the audit committee.
Financial Highlights
As of March 31, 2018, the Company had $36.2 million in cash, cash equivalents and short-term investments, with no outstanding debt. The Company believes its cash position will be sufficient to fund operations into through the first half of calendar year 2019.
Research and development expenses, including cost of research and development revenue, were $4.0 million for the three months ended March 31, 2018, compared to $3.0 million for the three months ended March 31, 2017. The increase was primarily due to increased drug manufacturing expenses for ME-401, expenses related to voruciclib, and increased costs related to salaries, share-based compensation, and other internal costs.
General and administrative expenses were $2.5 million for the three months ended March 31, 2018, compared to $2.2 million for the three months ended March 31, 2017. The increase was primarily due to professional services expenses and share-based compensation.
Revenues were $0.4 million for the three months ended March 31, 2018, compared to $4.5 million for the three months ended March 31, 2017. The decrease was related to lower levels of research and development activities associated with the Helsinn license agreement and $3.8 of upfront license fee revenue recognized for the three months ended March 31, 2017.
Net loss was $5.9 million, or $0.16 per share, for the three months ended March 31, 2018, compared to net loss of $0.6 million, or $0.02 per share for the three months ended March 31, 2017.