MEI Pharma Reports Third Quarter Fiscal Year 2024 Results and Operational Highlights
-- Ongoing Phase 1 Study Evaluating Voruciclib Plus Venetoclax Demonstrates Anti-leukemic Activity, Including Complete Responses, Anticipated Decreases in Mcl-1 and No Overlapping Toxicity in Heavily Pretreated R/R AML Patients --
-- Board of Directors Unanimously Aligned on Prioritization of Voruciclib Program Development--
-- MEI Begins Fourth Fiscal Quarter with $56.6 Million in Cash --
SAN DIEGO – May 9, 2024 – MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, today reported results for the three and nine months ended March 31, 2024, and highlighted recent corporate events.
“Over the past several months, MEI has received encouraging clinical data for voruciclib and ME-344 supporting the further development of these programs,” said David Urso, president and chief executive officer of MEI Pharma. “The clinical focus for the rest of the year will be voruciclib, our oral CDK9 inhibitor. We anticipate providing updates from the clinical trial evaluating voruciclib in combination with venetoclax in patients with relapsed/refractory AML, a study designed to provide additional evidence of the anti-leukemic activity of this combination, during the remainder of calendar 2024.”
Mr. Urso continued: “While venetoclax is an established option for patients with AML and is increasingly used as a standard treatment, the disease typically progresses and patients require therapy after venetoclax, which consistently yields limited benefit. While treatments targeting specific patient populations with mutations such as FLT3 and IDH and the menin inhibitors may be an option for some relapsed/refractory AML patients, the majority of patients do not have therapeutically actionable mutations. We believe that voruciclib in combination with venetoclax has potential, as a mutation-agnostic therapy, to benefit the largest number of patients with relapsed/refractory AML.”
Select Third Quarter Fiscal Year 2024 and Recent Highlights
Expected Drug Candidate Pipeline Developments
Voruciclib – Oral CDK9 inhibitor in Phase 1 Study
The Company has completed patient enrollment of the dose expansion cohort evaluating a 300 mg dose of voruciclib administered daily for 14 consecutive days in a 28-day cycle in combination with standard dose venetoclax. Additionally, MEI is enrolling dose escalation cohorts evaluating up to four dose levels of voruciclib starting at 150 mg administered daily for 21 consecutive days in a 28-day cycle in combination with venetoclax.
ME-344 –Inhibitor of Mitochondrial OXPHOS in Phase 1b Study
Select Third Quarter and Nine Months Financial Results for Fiscal Year 2024
The Company believes its cash balance is sufficient to fund operations for at least the next 12 months.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a clinical-stage pharmaceutical company committed to developing novel and differentiated cancer therapies. We build our pipeline by acquiring promising cancer agents and creating value in programs through development, strategic partnerships, out-licensing and commercialization, as appropriate. Our approach to oncology drug development is to evaluate our drug candidates in combinations with standard-of-care therapies to overcome known resistance mechanisms and address clear medical needs to provide improved patient benefit. The drug candidate pipeline includes voruciclib, an oral cyclin-dependent kinase 9 ("CDK9") inhibitor, and ME-344, an intravenous small molecule inhibitor of mitochondrial oxidative phosphorylation. For more information, please visit www.meipharma.com. Follow us on X (formerly Twitter) @MEI_Pharma and on LinkedIn.
Forward-Looking Statements
Certain information contained in this press release that are not historical in nature are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential, safety, efficacy, and regulatory and clinical progress of our product candidates, including the anticipated timing for initiation of clinical trials and release of clinical trial data and our expectations surrounding potential regulatory submissions, approvals and timing thereof, our business strategy and plans; our future financial position, including the sufficiency of our cash, cash equivalents and short-term investments to fund our operations and our ability to fund future capital returns; and the objectives of management for future operations. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and projections about future events. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, but not
limited to our failure to successfully commercialize our product candidates; the availability or appropriateness of utilizing the FDA’s accelerated approval pathway for our product candidates; final data from our pre-clinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; uncertainty regarding the impact of rising inflation and the increase in interest rates as a result; potential economic downturn; geopolitical conflicts; activist investors; our inability to maintain or enter into, and the risks resulting from, our dependence upon collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements. Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical studies and approved by the FDA as being safe and effective for the intended use.
Contact:
David A. Walsey
MEI Pharma
Tel: 858-369-7104
investor@meipharma.com