On May 7, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its third quarter ended March 31, 2020 and highlighted recent corporate progress (Press release, MEI Pharma, MAY 7, 2020, View Source [SID1234557312]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Entering our fiscal fourth quarter, MEI is well positioned as we continue progress across our business, as highlighted by the recent grant of Fast Track designation by FDA for ME-401 and our newly announced global alliance with Kyowa Kirin," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "These key achievements advance our efforts to optimize ME-401 to benefit patients across multiple B-cell malignancies inside and outside the U.S. and, importantly, the $100 million upfront payment from Kyowa Kirin helps extend our cash runway through at least 2023, including the ramp-up of MEI’s commercial activities and the potential launch of ME-401 in the U.S."

Dr. Gold continued: "With respect to the COVID-19 pandemic, all companies conducting clinical trials are facing a unique and challenging situation, and I’d like to thank all health care workers and other essential workers on the frontlines that are caring for the sick and keeping our society functioning. MEI will continue to be proactive in order to minimize the impact to our business, particularly the ongoing ME-401 TIDAL study. While the situation remains fluid, we will continue to focus on keeping the impact on TIDAL modest as we remain in close contact with all our sites to maintain patients on study and keep enrollment ongoing, even if at a somewhat reduced rate."

Recent Highlights

In April 2020, the Company entered a global license, development and commercialization agreement to further develop and commercialize MEI’s ME-401.
MEI and Kyowa Kirin will co-develop and co-promote ME-401 in the U.S.
MEI to book U.S. sales on 50-50 profit and cost sharing.
$100 million in an upfront cash payment to MEI.
$582.5 million in potential development, regulatory and commercial milestones
Kyowa Kirin obtains exclusive commercialization rights ex-U.S.
MEI to receive escalating tiered royalty payments from mid-teens on ex-U.S. sales.
In April 2020, Cheryl L. Cohen, former chief commercial officer of Medivation, Inc. and a product launch and commercialization veteran with over 25 years of service in the pharmaceutical and biotechnology industry, joined the Board of Directors.
In March 2020, the Company was granted Fast Track designation by the U.S. FDA for ME-401 for the treatment of adult patients with relapsed or refractory follicular lymphoma.
Fiscal Third-Quarter Fiscal Year 2020 Financial Results

As of March 31, 2020, MEI had $92.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. Giving effect to the KKC Agreement, our cash, cash equivalents and short-term investments would have been $192.8 million.
For the three months ended March 31, 2020, cash used in operations was $10.3 million, compared to $11.3 million for the same period in 2019. For the nine months ending March 31, 2020, cash used in operations was $34.9 million, compared to $31.4 million for 2019. The increase primarily relates to costs associated with our clinical development programs.
Research and development expenses were $9.0 million for the quarter ended March 31, 2020, compared to $9.1 million for 2019. The decrease was primarily related to decreased drug manufacturing costs associated with ME-401, offset by increased clinical trial costs for the ME-401 TIDAL study and increased personnel and legal patent costs.
General and administrative expenses were $3.9 million for the quarter ended March 31, 2020, compared to $3.6 million for 2019. The increase primarily relates to increased headcount to support our activities.
Revenue was $1.2 million for the quarter ended March 31, 2020, compared to revenue of $1.2 million for the same period in 2019. Revenue resulted from the recognition of fees allocated to research and development activities related to the Helsinn and Kyowa Kirin Japan License Agreements.
Net loss was $4.3 million, or $0.04 per share, for the quarter ended March 31, 2020, compared to net loss of $17.4 million, or $0.24 per share for the same period in 2019. Net loss decreased primarily as a result of a non-cash gain in the current quarter and a non-cash expense in the prior quarter related to changes in the fair value of the warrant liability associated with the May 2018 financing. The Company had 105,998,677 shares of common stock outstanding as of March 31, 2020, compared with 71,280,660 shares as of March 31, 2019.
The adjusted net loss for the quarter ended March 31, 2020, excluding a non-cash gain related to changes in the fair value of the warrants (a non-GAAP measure), was $12.1 million, compared to an adjusted net loss of $12.2 million for 2019.