On September MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2022 (Press release, MEI Pharma, SEP 8, 2022, View Source [SID1234619287]).
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!
"This past fiscal year was marked by progress on multiple fronts, including the first patient dosed in our Phase 3 COASTAL study, strong zandelisib data reported from the global Phase 2 TIDAL study, reporting of data from our voruciclib and ME-344 programs, and key appointments to our executive team and board of directors," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Further, we remain well capitalized with $153 million to advance our pipeline and continue operations for about two years."
Dr. Gold continued: "Despite a strong start to the fiscal year, our successes have been tempered by changes to the FDA’s approach to accelerated approvals, as now encapsulated by the FDA’s Project FrontRunner, which largely has closed the pathway to marketing authorization based on data from a single-arm study like our Phase 2 TIDAL study. However, the FDA emphasized that we and our partner, Kyowa Kirin, should continue efforts to evaluate zandelisib in our ongoing randomized Phase 3 COASTAL study. We remain confident in zandelisib’s potential to benefit patients with B-cell malignancies as we continue evaluating zandelisib’s unique profile, particularly in combination with other therapies, to provide physicians and their patients new treatment options for cancer."
Expected Drug Candidate Pipeline Developments
Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies
Report complete data from the follicular lymphoma cohort in the Phase 2 TIDAL study by year-end 2022.
Dose the first patient in the Phase 2 CORAL study evaluating zandelisib plus Venclexta (venetoclax) and rituximab in patients with chronic lymphocytic leukemia by year-end 2022.
Provide an update from the Phase 1b study cohort evaluating zandelisib plus Brukinsa (zanubrutinib) at an upcoming scientific congress.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia
Dose the first patient cohort of voruciclib in combination with Venclexta (venetoclax) in patients with acute myeloid leukemia by year-end 2022 in the Phase 1 study.
ME-344 – Tumor selective mitochondrial inhibitor
Initiate a Phase 1b study evaluating ME-344 plus Avastin(bevacizumab) in relapsed colorectal cancer patients in the first half of calendar year 2023.
Fiscal Year 2022 and Recent Select Drug Candidate Pipeline Highlights
Zandelisib
In July 2022, MEI Pharma and Kyowa Kirin announced publication in The Lancet Oncology of data from the Phase 1b clinical study of zandelisib in patients with relapsed or refractory B-cell malignancy.
In June 2022, MEI Pharma and Kyowa Kirin presented ongoing clinical data on zandelisib at both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2022 and European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress.
In March 2022, after meeting with the FDA, MEI Pharma and Kyowa Kirin announced they no longer plan to submit an FDA marketing application under the accelerated approval pathway using the single arm TIDAL study.
In November 2021, MEI Pharma and Kyowa Kirin first reported data from the ongoing global Phase 2 TIDAL study evaluating zandelisib as a single agent in patients with relapsed or refractory follicular lymphoma. The data demonstrate:
Overall response rate of 70.3% in the primary efficacy population; the complete response rate was 35.2%.
9.9% of patients discontinued therapy due to a drug related adverse event.
As of the data cutoff date, the data were not sufficiently mature to accurately estimate the final duration of response in the FL primary efficacy population. At that time, the median follow-up time for response was 8.4 months.
In November 2021, MEI Pharma and Kyowa Kirin announced that the U.S. Food and Drug Administration granted orphan-drug designation to zandelisib for the treatment of follicular lymphoma.
In August 2021, MEI Pharma and Kyowa Kirin announced the first patient dosed in the Phase 3 COASTAL study evaluating zandelisib plus rituximab in patients with relapsed or refractory indolent Non-Hodgkin B-cell lymphoma.
Voruciclib
In November 2021, MEI reported data from the Phase 1 dose-escalation study of voruciclib, an oral CDK9 inhibitor, in patients with relapsed or refractory B-cell malignancies or acute myeloid leukemia at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
ME-344
In April 2022, MEI reported preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) evaluating the combination of ME-344 with venetoclax in standard-of-care-resistant acute myeloid leukemia (AML) cell lines and relapsed or refractory (R/R) AML patient samples.
Fiscal Year 2022 and Recent Corporate Highlights
During fiscal year 2022, MEI announced several additions to its management team. In June 2022, MEI appointed Anne Frese as Senior Vice President, Chief People Officer. In February 2022, MEI appointed Alejandro Ricart, M.D., as Senior Vice President, Clinical Development, and Yomara Gomez-Naiden as Senior Vice President, Quality. In July 2021, MEI appointed Tina C. Beamon, J.D. as Chief Compliance Officer.
In December 2021, MEI completed a public offering of common stock resulting in net proceeds to the Company of approximately $48.7 million.
In November 2021, MEI appointed Sujay Kango to its Board of Directors.
Fiscal Year 2022 Financial Results
As of June 30, 2022, MEI had $153.3 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the year ended June 30, 2022, net cash used in operations was $48.7 million, compared to $52.4 million for 2021. The decrease primarily related to changes in working capital.
Research and development expenses were $85.6 million for the year ended June 30, 2022, compared to $69.4 million for 2021. The increase was primarily related to increased development costs associated with zandelisib, increased drug manufacturing costs, and increased consulting fees to support clinical trial activities.
General and administrative expenses were $30.5 million for the year ended June 30, 2022, compared to $24.4 million for 2021. The increase primarily related to increased personnel costs, professional services costs, and general corporate overhead expenses incurred during 2022.
MEI recognized revenues of $40.7 million for the year ended June 30, 2022, compared to $34.8 million for 2021. The increase in revenue related to increased reimbursement of expenses from Kyowa Kirin due to research and development activity related to zandelisib.
Net loss was $54.5 million, or $0.44 per share, for the year ended June 30, 2022, compared to net loss of $41.3 million, or $0.37 per share for 2021. MEI had 133,152,045 shares of common stock outstanding as of June 30, 2022, compared with 112,614,643 shares as of June 30, 2021.
The adjusted net loss for the year ended June 30, 2022, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $75.2 million, compared to an adjusted net loss of $59.4 million for 2021.
Conference Call and Webcast
MEI Pharma will host a conference call with simultaneous webcast today, September 8, 2022, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial 1-833-974-2378 (United States) or 1-412-317-5771 (International). Please ask to join the MEI Pharma earnings call.
The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.