MEIP Reports 2Q18 (fiscal year) Results
MEI Pharma Reports Second Quarter Fiscal Year 2018 Results
PR Newswire PR NewswireFebruary 8, 2018
Pipeline advancement continues, including clearance of voruciclib IND by FDA and pracinostat Orphan Drug Designation by EMA
Data readouts in three programs expected in the second quarter of 2018
SAN DIEGO, Feb. 8, 2018 /PRNewswire/ -- MEI Pharma, Inc. (MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today reported results for its second quarter ended December 31, 2017.
"We continue to build on the progress we reported last quarter with important advances in the clinical development programs across our pipeline," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Already in 2018, the Food and Drug Administration cleared the Investigational New Drug Application for voruciclib, and pracinostat was awarded Orphan Drug Designation from the European Medicines Agency for the treatment of acute myeloid leukemia."
Dr. Gold added: "In the coming months we look forward to separate data readouts in three programs: pracinostat's stage 1 of a Phase 2 dose-optimization study in myelodysplastic syndrome (MDS); ME-401's single agent safety and efficacy in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL); and ME-344's interim results from a proof-of-concept study in combination with bevacizumab (marketed as Avastin®) in human epidermal growth factor receptor 2 (HER2) negative breast cancer. In addition, we look forward to the initiation of our Phase 1 single-agent study with voruciclib in relapsed/refractory B lymphocyte malignancies."
Recent Program Highlights
Pracinostat
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 to induction chemotherapy.
MEI-401
In November 2017, the safety review committee found no dose limiting toxicities in the 180mg cohort again with a response rate in excess of 50%. We determined that no further dose escalation was required and we amended the Phase 1b study protocol to open a 45 mg lower dose cohort as well as an additional arm to evaluate the safety and efficacy of ME-401 in combination with rituximab (marketed as Rituxan®) in patients with various B cell malignancies.
Voruciclib
In January 2018, the U.S. Food and Drug Administration cleared the company's Investigational New Drug Application (IND) for voruciclib. Under this IND, MEI Pharma plans to initiate a Phase 1 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of voruciclib in patients with B-cell malignancies.
In December 2017, a preclinical study of voruciclib was published in the journal Nature Scientific Reports. Researchers found that the combination of voruciclib plus the BCL-2 inhibitor venetoclax (marketed as Venclexta™) was capable of inhibiting two master regulators of cell survival, MCL-1 and BCL-2, and achieved synergistic antitumor efficacy in an aggressive subset of Diffuse Large B-cell Lymphoma (DLBCL).
Upcoming Milestones
Pracinostat
Expecting results from stage 1 of a Phase 2 dose-optimization study in MDS in the second quarter of 2018. (This is a one quarter delay--Blade)
ME-401
Expecting results from a Phase 1b study in relapsed/refractory CLL and FL to be presented at a scientific meeting in the second quarter of 2018.
Voruciclib
Expecting to initiate a Phase 1 single-agent study in relapsed/refractory B cell 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 Phase 1 study in HER2 negative breast cancer in combination with bevacizumab (marketed as Avastin®) in the second quarter of 2018.
Financial Highlights
As of December 31, 2017, MEI Pharma had $42.4 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 $11.3 million for the six months ended December 31, 2017, compared to cash provided by operating activities of $5.0 million for the six months ended December 31, 2016. Included in cash expenditures for the six months ended December 31, 2017 was $1.9 million cash paid for the acquisition of voruciclib. Included in the cash provided by operating activities in the six months ended December 31, 2016 was the $15.0 million upfront payment from Helsinn for pracinostat.
Research and development expenses, including cost of research and development revenue, were $4.2 million for the three months ended December 31, 2017, compared to $3.4 million for the three months ended December 31, 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 $2.4 million for the three months ended December 31, 2017, compared to $2.0 million for the three months ended December 31, 2016. The increase was primarily due to professional service costs incurred in the three months ended December 31, 2017 related to the Presage license agreement.
Revenues were $0.4 million for the three months ended December 31, 2017, compared to $17.2 million in the three months ended December 31, 2016. The decrease was related to activities performed pursuant to the Helsinn license agreement.
Net loss was $6.1 million, or $0.16 per share, for the three months ended December 31, 2017, compared to net income of $11.9 million, or $0.32 per share for the three months ended December 31, 2016.
Bladerunner
