MEI Pharma Reports First Quarter Fiscal Year 2023 Results and Operational Highlights
-- MEI Begins Second Fiscal Quarter with
“As we move through fiscal year 2023 and continue to assess FDA concerns regarding the risk benefit analysis of marketed PI3Kδ inhibitors to treat indolent lymphomas, as well as the impact of these concerns and other global factors on our Phase 3 COASTAL study, we also look forward to reporting advances across our clinical development pipeline. This includes reporting updated data from multiple zandelisib studies at the ASH annual meeting in December, and also reporting advances in our other development programs, including initiation of a trial evaluating voruciclib’s potential to synergize with venetoclax in patients with AML, and a trial evaluating the combination of ME-344 plus bevacizumab in patients with relapsed and refractory colorectal cancer,” said
First Quarter Fiscal Year 2023 Recent Developments and Financial Highlights
- Earlier in November,
MEI Pharmaand Kyowa Kirin announced the acceptance of three abstracts reporting data for zandelisib, an investigational phosphatidylinositol 3-kinase delta inhibitor in clinical development for the treatment of B-cell malignancies, to be presented at the upcoming American Society of Hematology2022 annual meeting to be held December 10-13, 2022.
- In September, we announced that
Christine A. White, M.D. will be retiring as chair of the board. She will be replaced by board member Charles V. Baltic. This will be effective as of the Company’s fiscal 2023 annual meeting of shareholders. Additionally, in November, Cheryl L. Cohenalso informed the Company that she will not stand for election to the board at the Company’s annual meeting of shareholders.
- In July,
MEI Pharmaand Kyowa Kirin announced publication in The Lancet Oncology of data from Phase 1b clinical study of zandelisib in patients with relapsed or refractory B-cell malignancy.
Expected Drug Candidate Pipeline Developments
Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies
- Report new zandelisib data at the
American Society of HematologyAnnual Meeting in December 2022, including a presentation of updated data from the follicular lymphoma cohort in the Phase 2 TIDAL study and a presentation of data from the Phase 1b study cohort evaluating zandelisib plus Brukinsa® (zanubrutinib) to treat indolent B-cell malignancies.
- 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.
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.
First Quarter Fiscal Year 2023 Financial Results
- As of
September 30, 2022, MEI had $138.4 millionin cash, cash equivalents, and short-term investments with no outstanding debt.
- For the quarter ended
September 30, 2022, cash used in operations was $14.8 million, compared to $7.7 millionused in operations for the quarter ended September 30, 2021. The increase in cash used in operations is due to the favorable impact of a $10.0 millionmilestone payment received from Kyowa Kirin in the comparable quarter in 2021 with no corresponding payment in 2022 and other changes in working capital balances.
- Research and development expenses were
$19.5 millionfor the quarter ended September 30, 2022, compared to $20.0 millionfor the quarter ended September 30, 2021. The decrease was primarily related to costs to support ongoing zandelisib and voruciclib studies.
- General and administrative expenses were
$7.5 millionfor the quarter ended September 30, 2022, compared to $7.9 millionfor the quarter ended September 30, 2021. The decrease primarily relates to lower personnel costs, professional services and general corporate expenses.
- MEI recognized revenue of
$8.7 millionfor the quarter ended September 30, 2022, compared to $7.8 millionfor the quarter ended September 30, 2021. The increase in recognized revenue relates to progress towards completion of our performance obligations, offset by decreased reimbursement of expenses under the license agreement with Kyowa Kirin.
- Net loss was
$16.6 million, or $0.12per share, for the quarter ended September 30, 2022, compared to net loss of $17.5 million, or $0.16per share for the quarter ended September 30, 2021. The Company had 133,260,865 shares of common stock outstanding as of September 30, 2022, compared with 112,678,498 shares as of September 30, 2021.
- The adjusted net loss (a non-GAAP measure) for the quarter ended
September 30, 2022, excluding non-cash expenses related to changes in the fair value of the warrants, was $17.7 million, compared to an adjusted net loss of $20.1 millionfor the quarter ended September 30, 2021.
Non-GAAP Financial Measures
To supplement our consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in
The presentation of adjusted net loss is not meant to be considered in isolation or as a substitute for net loss, the directly comparable financial measure prepared in accordance with GAAP. While we believe adjusted net loss is an important tool for financial and operational decision-making and for evaluating our own operating results over different periods of time, we urge investors to review the reconciliation of this financial measures to the comparable GAAP financial measures included below, and not to rely on any single financial measure to evaluate our business.
We define adjusted net loss, adjusted to exclude non-cash expenses related to changes in the fair value of the warrants. We have presented adjusted net loss because we believe excluding the non-cash expenses related to changes in the fair value of warrants can produce a useful measure for period-to-period comparisons of our business.
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