On May 23, 2022 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended March 31, 2022, and highlighted recent corporate events (Press release, MEI Pharma, MAY 23, 2022, View Source [SID1234614942]).
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"The third fiscal quarter of 2022 was underscored by a meeting with the FDA in which we were informed that data from randomized studies are now needed to adequately assess the benefit-risk of PI3K inhibitor drug candidates, including zandelisib, and where it was emphasized that we should continue efforts with the ongoing randomized COASTAL study. Accordingly, we no longer plan to submit an FDA marketing application under the accelerated approval pathway using the single arm TIDAL study. However, we continue to have confidence in zandelisib’s differentiated therapeutic profile as observed in our data generated to date, and remain committed to advancing the program to a marketing authorization submission with our partner, Kyowa Kirin," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma.
Dr. Gold continued: "While progression free survival is the primary endpoint for COASTAL, we are actively working with our partner, Kyowa Kirin, to determine if a more expeditious approach exists to bring zandelisib to the market sooner which we will then discuss with the FDA and we will plan to provide an update as appropriate. We remain well capitalized with $169 million to advance our pipeline and continue operations for over two years."
Third Quarter Fiscal Year 2022 Recent Developments and Financial Highlights
On May 12, 2022, we announced that two abstracts highlighting data and information for zandelisib, an orally administered investigational phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies, will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress to be held June 9 – 17, 2022.
On April 8, 2022, we announced that two posters reporting preclinical data for zandelisib, an orally administered investigational PI3Kδ inhibitor, and ME-344, a tumor selective mitochondrial inhibitor, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022.
On March 24, 2022, we reported that the FDA had recently informed us of its position that randomized data is now needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib. At this FDA meeting, the agency discouraged a planned filing based on the Phase 2 TIDAL study data and emphasized that the company continues efforts with the ongoing, randomized Phase 3 COASTAL study as planned. Accordingly, in line with the FDA’s recommendation, the company reported it no longer plans to submit an FDA marketing application based on the single arm Phase 2 TIDAL study.
On February 7, 2022, we announced the expansion of our management team with the addition of two experienced industry executives: Alejandro Ricart, M.D., joined as senior vice president, clinical development, a role reporting to Richard Ghalie, M.D., chief medical officer, and Yomara Gomez-Naiden joined as senior vice president, quality, reporting to Daniel P. Gold, Ph.D., chief executive officer.
Expected Drug Candidate Pipeline Developments
Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies
Provide a more complete report of the Phase 2 TIDAL data announced on November 30, 2021 at upcoming medical meetings in 2022.
Initiate CORAL, a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia in the first half of calendar year 2022.
Provide an update from the arm of a Phase 1b study evaluating zandelisib plus zanubrutinib at an upcoming scientific congress in 2022.
Report updated data from the Phase 2 TIDAL study arm in follicular lymphoma intended for an upcoming scientific congress in the fourth calendar year quarter of 2022.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
Initiate Phase 1b study evaluating voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia mid calendar year 2022.
ME-344 – Tumor selective mitochondrial inhibitor
Initiate a Phase 1b study of ME-344 in relapsed colorectal cancer by the end of calendar year 2022.
Third Quarter Fiscal Year 2022 Financial Results
As of March 31, 2022, MEI had $169.0 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended March 31, 2022, cash used in operations was $17.0 million, compared to $15.6 million used in operations for the quarter ended March 31, 2021. The increase in cash used in operations reflects increased development activity in 2022 and changes in working capital balances.
Research and development expenses were $22.3 million for the quarter ended March 31, 2022, compared to $17.9 million for the quarter ended March 31, 2021. The increase was primarily related to costs to support ongoing zandelisib studies, and expenses related to voruciclib and ME-344.
General and administrative expenses were $8.9 million for the quarter ended March 31, 2022, compared to $6.2 million for the quarter ended March 31, 2021. The increase primarily relates to personnel costs, professional services and general corporate expenses.
MEI recognized revenue of $9.7 million for the quarter ended March 31, 2022, compared to $8.1 million for the quarter ended March 31, 2021. The increase in recognized revenue relates to the partial satisfaction of the research and development obligations under the license agreement with Kyowa Kirin.
Net loss was $8.7 million, or $.07 per share, for the quarter ended March 31, 2022, compared to net loss of $25.6 million, or $.23 per share for the quarter ended March 31, 2021. The Company had 133,152,045 shares of common stock outstanding as of March 31, 2022, compared with 112,591,778 shares as of March 31, 2021.
The adjusted net loss for the quarter ended March 31, 2022, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $21.5 million, compared to an adjusted net loss of $16.4 million for the quarter ended March 31, 2021.
Figures for the quarter ended March 31, 2021 and year ended June 30, 2021 shown above and in the following tables for revenue, net loss, net loss per share, and adjusted net loss reflect the previously announced restatement of certain of the Company’s historical financial statements, which was completed today.
Restatement of the Company’s 2021 Quarterly Periods
As disclosed in the Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on May 13, 2022, the Company determined that it made certain errors in the manner in which it recognized revenue from its License, Development, and Commercialization Agreement with Kyowa Kirin Co., Ltd. (the "KKC Commercialization Agreement"), with the result that revenue was overstated in some quarters and understated in other quarters in the Company’s financial statements during 2020 and 2021. The errors relate to the appropriate timing and amounts of revenue recognized over time under the cost-to-cost method associated with the KKC Commercialization Agreement. These errors and the required restatement had no effect on the Company’s previously reported operating expenses, cash flows or cash and short-term investments. The cumulative effect of these errors was a misstatement of deferred revenue and accumulated deficit of $3.9 million. As a result, the Company restated its previously filed annual and quarterly financial statements for periods from June 30, 2020 forward, which were included in the Annual Report on Form 10-K/A for the fiscal year ended June 30, 2021 and Quarterly Reports of Form 10-Q/A for the quarters ended September 30, 2021 and December 31, 2021, filed with the SEC today. For more information concerning the restatement, please see those filings.