On February 7, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its second quarter ended December 31, 2018 (Press release, MEI Pharma, FEB 7, 2019, View Source [SID1234533142]).
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"MEI remains in a strong position to continue to build on the clinical data presented at ASCO (Free ASCO Whitepaper) 2018 and at ASH (Free ASH Whitepaper) 2018 across our pipeline of four clinical-stage oncology candidates – including two candidates in clinical studies that may support future submissions for potential marketing approval by FDA," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "In particular, ME-401 continues to attract increasing notice from physicians for its emerging clinical profile, and there’s been a heightened scientific focus on PI3K delta as a target with the potential to mechanistically match BTK inhibition in importance for targeting B-cell malignancies."
Upcoming Milestones and Recent Program Highlights
Upcoming Milestones
Dosing of the first patient in the global Phase 2 study to support accelerated approval of ME-401 in relapsed or refractory follicular lymphoma in the first calendar quarter of 2019.
Updates and presentations of clinical data from the ME-401 clinical development program, including at select 2019 medical/oncology meetings.
Initial clinical results from the ongoing Phase 1 study of voruciclib, 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, by end of 2019.
Results from the investigator-initiated study of ME-344 in combination with bevacizumab (marketed as Avastin) in patients with breast cancer at a medical/oncology meeting mid-year.
Pracinostat results from the Phase 2 clinical trial evaluating patients with myelodysplastic syndrome, including response and 1-year survival, expected to be available by the end of 2019.
Clinical Development Highlights
In December 2018, the Company opened the first clinical trial sites in its Phase 2 study that will evaluate both a continuous (CS) and intermittent (IS) dosing schedule of ME-401 in patients with third-line follicular lymphoma. The Phase 2 study is intended to support MEI’s accelerated approval registration strategy, if successful.
In December 2018, at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the Company presented data from three clinical programs:
Interim results presented from the ongoing Phase 1b study evaluating ME-401, a selective phosphatidylinositol 3-kinase ("PI3K") delta inhibitor, support the complementary potential of intermittent and continuous dosing schedules of ME-401 to optimize the clinical risk-benefit ratio in patients with relapsed/refractory follicular lymphoma. The data demonstrate that ME-401, as both a single agent and in combination with rituximab, continues to be associated with overall high objective response rates. In addition, low rates of Grade 3 immune-related adverse events (irAEs) were observed in patients on the intermittent dosing schedule while maintaining a high level of clinical response.
Interim results presented from the ongoing Phase 2 study evaluating pracinostat, a histone deacetylase inhibitor, in combination with azacitidine for the treatment of patients with IPSS-R high/very high-risk of Myelodysplastic Syndrome ("MDS") demonstrate a 9% discontinuation rate due to adverse events, a substantially lower rate than observed in an earlier study. Additionally, the data presented demonstrated an encouraging 36% complete response rate among patients receiving at least 6 cycles of treatment.
Preclinical data presented demonstrate that voruciclib, MEI’s orally available CDK9 inhibitor, synergistically induced apoptosis at clinically relevant concentrations when combined with venetoclax (marketed as Venclexta) in human derived acute myeloid leukemia ("AML") cells lines and patient samples. Voruciclib is currently being evaluated in a Phase 1b dose ranging study in patients with B-cell malignancies and AML.
In October 2018, MEI entered into a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational Bruton’s tyrosine kinase ("BTK") inhibitor, for the treatment of patients with B-cell malignancies.
Corporate Highlights
In November 2018, MEI entered into a license, development and commercialization agreement granting Kyowa Hakko Kirin ("KHK") exclusive rights to develop and commercialize ME-401 in Japan. Under the terms of the agreement, MEI received a $10.0 million upfront payment and is eligible to receive up to $87.5M in additional development and commercialization milestones, and royalties on sales.
Financial Highlights
As of December 31, 2018, MEI had $93.4 million in cash, cash equivalents and short-term investments, with no outstanding debt.
For the three months ending December 31, 2018, cash expenditures for operating activities were $7.2 million, compared to $4.7 million for 2017. For the six months ending December 31, 2018, cash expenditures for operating activities were $20.0 million, compared to $11.3 million for 2017. The increase in cash used for the six months ended December 31, 2018 primarily relates to changes in working capital 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 December 31, 2018, compared to $3.4 million for the same period in 2017. Research and development expenses primarily reflect increased costs associated with the development of ME-401.
General and administrative expenses were $3.8 million for the quarter ended December 31, 2018, compared to $2.4 million for the same period in 2017. The increase primarily relates to increased salary and share-based compensation associated with increased headcount, and increased professional services expenses.
The Company recognized revenues of $2.0 million for the quarter ended December 31, 2018, compared to $0.4 million for the same period in 2017. The increase is related to new license revenues from our agreement with KHK, and to higher levels of research and development activities performed pursuant to the Helsinn license agreement.
Net income for the quarter ended December 31, 2018, was $12.0 million, or $0.17 per share compared to a net loss of $6.1 million, or $0.16 per share for the same period in 2017. The Company had 71,131,486 shares of common stock outstanding as of December 31, 2018, compared with 37,052,361 shares as of December 31, 2017.
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 December 31, 2018, was $11.4 million.