MEI Pharma, Inc. (MEIP)

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MEIP reports 2nd quarter fiscal year results


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Company Profile
3611 Valley Centre Drive
Suite 500
San Diego, CA 92130
United States
858-369-7100
http://www.meipharma.com Sector: Healthcare
Industry: Drug Manufacturers - Specialty & Generic
Full Time Employees: 32

MEI Pharma, Inc., a pharmaceutical company, focuses on the clinical development of novel therapies for the treatment of cancer. The company's clinical drug candidate includes Pracinostat, an oral available histone deacetylase inhibitor for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome. Its clinical development portfolio also includes ME-401, an oral inhibitor of phosphatidylinositide 3-kinase delta for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia or follicular lymphoma; ME-344, an isoflavone-derived mitochondrial inhibitor for the treatment of HER2-negative breast cancer; and Voruciclib, an oral cyclin-dependent kinase inhibitor. The company has a license, development, and commercialization agreement with Helsinn Healthcare SA for the development, manufacture, and commercialization of Pracinostat; and license agreement with Presage Biosciences, Inc. to develop, manufacture, and commercialize Voruciclib, a clinical-stage, oral, and selective cyclin-dependent kinase inhibitor; and related compounds.

It also has a clinical collaboration agreement with BeiGene, Ltd. to evaluate the safety and efficacy of ME-401 in combination with BeiGene's zanubrutinib, an investigational BTK inhibitor for the treatment of patients with B-cell malignancies. The company was formerly known as Marshall Edwards, Inc. and changed its name to MEI Pharma, Inc. in July 2012. MEI Pharma, Inc. was founded in 2000 and is based in San Diego, California.


MEI Pharma Reports Second Quarter Fiscal Year 2019 Results and Operational Highlights
PR Newswire PR Newswire•February 7, 2019
-- MEI Remains in Strong Position as ME-401 Advances to Global Phase 2 Study to Support FDA Accelerated Approval --

SAN DIEGO, Feb. 7, 2019 /PRNewswire/ -- MEI Pharma, Inc. (MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, today reported results for its second quarter ended December 31, 2018.

"MEI remains in a strong position to continue to build on the clinical data presented at ASCO 2018 and at ASH 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 Annual Meeting, the Company presented data from three clinical programs:
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.
About MEI Pharma

MEI Pharma, Inc. (MEIP) is a San Diego-based pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer. The Company's portfolio of drug candidates includes pracinostat, an oral HDAC inhibitor that is partnered with Helsinn Healthcare, SA. Pracinostat has been granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for use in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. Pracinostat is also being developed in combination with azacitidine for the treatment of patients with high and very high-risk myelodysplastic syndrome (MDS). MEI Pharma's clinical development pipeline also includes ME-401, a highly differentiated oral PI3K delta inhibitor currently in a Phase 1b study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or FL, and voruciclib, an oral, selective cyclin-dependent kinase (CDK) inhibitor shown to suppress myeloid leukemia cell differentiation protein (MCL1), a known mechanism of resistance to B-cell lymphoma (BCL2) inhibitors. The Company is also developing ME-344, a novel mitochondrial inhibitor currently in an investigator-initiated study in combination with bevacizumab for the treatment of HER2-negative breast cancer. Pracinostat, ME-401, ME-344 and voruciclib are investigational agents and are not approved for use in the U.S. For more information, please visit www.meipharma.com.

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