On May 9, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its third quarter ended March 31, 2019 (Press release, MEI Pharma, MAY 9, 2019, View Source [SID1234536137]).
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"As progress continues across our pipeline of four clinical-stage oncology candidates, including two in clinical studies that may support future submissions for FDA marketing approval, we are particularly excited with the expanding data set from the ME-401 intermittent dosing schedule as it continues to mature and we look forward to presenting the data at upcoming medical meetings, including next month at ASCO (Free ASCO Whitepaper)," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Our immediate focus for MEI-401 is twofold: executing the ME-401 follicular lymphoma global Phase 2 study, data from which we intend to submit as an accelerated approval marketing application with the FDA, and the expansion of our investigation of ME-401 in combination with Rituxan or zanubrutinib, a BTK inhibitor being investigated pursuant to our BeiGene collaboration, to earlier stages of follicular lymphoma as well as other B-cell malignancies."
Upcoming Program Milestones
Advancement of ME-401 Program for B-Cell Malignancies
Phase 1b study initiation of new arm to evaluate the combination of ME-401 with zanubrutinib under a clinical collaboration with BeiGene.
Updates and presentations of clinical data from the ME-401 clinical development program, including at 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper).
Final Clinical Results: ME-344 for Breast Cancer
Present complete results from the investigator-initiated study of ME-344 in combination with bevacizumab (marketed as Avastin) in patients with breast cancer at ASCO (Free ASCO Whitepaper) 2019.
Phase 1b Study Progress: Voruciclib for B-Cell Malignancies and AML
Report initial clinical results from ongoing Phase 1 study, including single agent dose ranging data and results from the combination with venetoclax in patients with B-cell malignancies and relapsed and refractory acute myeloid leukemia around year end 2019.
Phase 2 Results: Pracinostat for Myelodysplastic Syndrome
Results from the Phase 2 clinical trial, including response and 1-year survival, expected to be available around year end 2019.
Financial Highlights
As of March 31, 2019, MEI had $82.3 million in cash, cash equivalents and short-term investments, with no outstanding debt.
For the three months ending March 31, 2019, cash expenditures for operating activities were $11.3 million, compared to $6.2 million for 2018. For the nine months ending March 31, 2019, cash expenditures for operating activities were $31.4 million, compared to $17.6 million for 2018. The increase in cash used for the nine months ended March 31, 2019 primarily relates to costs associated with our clinical development programs, including start-up costs related to the ME-401 Phase 2 study.
Research and development expenses were $9.1 million for the quarter ended March 31, 2019, compared to $3.1 million for the same period in 2018. Research and development expenses primarily reflect increased costs associated with the development of ME-401.
General and administrative expenses were $3.6 million for the quarter ended March 31, 2019, compared to $2.5 million for the same period in 2018. The increase primarily relates to increased salary and share-based compensation associated with increased headcount, and increased professional services expenses.
The Company recognized revenue of $1.2 million for the quarter ended March 31, 2019, compared to $0.4 million for the same period in 2018. The increase is related to revenues from our agreement with KHK, and to higher levels of research and development activities performed pursuant to the Helsinn license agreement.
Net loss for the quarter ended March 31, 2019, was $17.4 million, or $0.24 per share compared to a net loss of $5.9 million, or $0.16 per share for the same period in 2018. The Company had 71,280,660 shares of common stock outstanding as of March 31, 2019, compared with 37,323,441 shares as of March 31, 2018.
The adjusted net loss, 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) for the quarter ended March 31, 2019, was $12.2 million.