On November 8, 2017 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported results for its first quarter ended September 30, 2017 (Press release, MEI Pharma, NOV 8, 2017, View Source [SID1234521744]).
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"In this first quarter of the new fiscal year we announced an important milestone with the dosing of the first patient in the pivotal Phase 3 study of pracinostat in combination with azacitidine in adults with newly diagnosed acute myeloid leukemia (AML) who are unfit to receive intensive induction chemotherapy. In addition, we announced that we had further strengthened our oncology clinical pipeline with the addition of the clinical-stage cyclin-dependent kinase (CDK) inhibitor voruciclib," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We are well positioned for a momentous year ahead, with a healthy cash balance and a series of key milestones in each of our clinical programs."
Upcoming Milestones
Pracinostat
Expecting results from Stage 1 of a Phase 2 dose-optimization study in myelodysplastic syndrome (MDS) in the first half of 2018.
ME-401
Expecting to initiate combination study with Rituxan in indolent lymphoma & diffuse large B-cell lymphoma (DLBCL) in the fourth quarter of 2017.
Expecting results from proof-of-concept study in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma to be presented at a scientific meeting in the first half of 2018.
Voruciclib
Expecting to initiate Phase1/2 single-agent study in relapsed/refractory B lymphocyte malignancies and subsequently in a combination study with venetoclax (marketed as Venclexta) in the second quarter of 2018.
ME-344
Expecting interim results from the proof-of-concept study in human epidermal growth factor receptor 2 (HER2) negative breast cancer in combination with bevacizumab (marketed as Avastin) in the first half of 2018.
Financial Highlights
As of September 30, 2017, MEI Pharma had $47.0 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 calendar year 2019.
Cash used in operating activities was $6.6 million for the three months ended September 30, 2017, compared to cash provided by operating activities of $8.8 million for 2016. Included in cash expenditures for the three months ended September 30, 2017 was $1.9 million cash paid for the voruciclib acquisition. Included in the cash provided by operating activities in 2016 is the $15 million upfront payment from Helsinn for pracinostat.
Research and development expenses, including cost of research and development revenue, were $6.7 million for the three months ended September 30, 2017, compared to $2.7 million for 2016. The increase was primarily due to the acquisition of voruciclib and increased costs for ME-401, offset by a reduction in expenses related to pracinostat.
General and administrative expenses were $2.5 million for the three months ended September 30, 2017, compared to $2.7 million for 2016. The decrease was primarily due to professional service costs incurred in 2016 related to the Helsinn license agreement.
Revenues were $0.3 million for the three months ended September 30, 2017, compared to $1.1 million in 2016. The decrease is related to activities performed pursuant to the Helsinn license agreement.
Net loss was $8.8 million, or $0.24 per share, for the three months ended September 30, 2017, compared to a net loss of $4.3 million, or $0.12 per share for the three months ended September 30, 2016