Anuncio • Apr 12

MEI Pharma, Inc. Announces Strategic Plan to Leverage Recent Positive Voruciclib and ME-344 Clinical Data

MEI Pharma, Inc. reported that the Company’s Board of Directors unanimously agreed on a strategic plan to leverage recent positive voruciclib and ME-344 clinical data to prioritize clinical development of voruciclib while enabling development of a new ME-344 formulation for Phase 1 study. Additionally, the Company’s Board of Directors unanimously determined not to proceed with a second return of capital under the October 31, 2023 Anson Funds and Cable Car Capital cooperation agreement in order to conserve resources and align strategic investment, and thereby extend the Company’s operational runway. As previously disclosed, the Company’s October 31, 2023 Cooperation Agreement with stockholders, including Anson Funds and Cable Car Capital, provided that a potential second return of capital could be authorized by the Board under certain circumstances as outlined in that agreement, subject to the exercise of the Board’s fiduciary duties. Since data reported from Cohort 1 of the Phase 1b study exceeded a criterion for the potential second return of capital stated in the Agreement, the trigger for a return of capital was not met. The Board further unanimously determined, after deciding not to proceed with Cohort 2, that in the exercise of its fiduciary duties under applicable law, and in light of its views on what path is in the best interests of the Company’s stockholders, the Company would not proceed with any additional potential return of capital as permitted under the Cooperation Agreement. The strategy unanimously approved by the MEI Board of Directors provides for advancing clinical development of voruciclib, an investigational selective oral cyclin-dependent kinase 9 (“CDK9”) inhibitor, to new value inflection points by the end of calendar year 2025 and for enabling a new formulation of ME-344, an investigational inhibitor of mitochondrial oxidative phosphorylation (“OXPHOS”). The plan builds on encouraging recently reported voruciclib clinical data and ME-344 data separately reported . Specifically with respect to voruciclib, the development objective is to optimize voruciclib for a Phase 3 study in combination with venetoclax (Venclexta®) in patients with relapsed and refractory (“R/R”) acute myeloid leukemia (“AML”). Under the plan, the ongoing voruciclib development strategy will be guided by future clinical trial results and applicable regulatory authority advice. Subject to positive Phase 1 data later this year, MEI plans to amend the ongoing Phase 1 study to add a Phase 2 study arm, with enrollment in the Phase 2 arm anticipated to begin in 2025. This is anticipated to generate Phase 2 data by the end of 2025. Contingent on the success of the Phase 1/2 study, MEI plans to have the program ready to initiate a Phase 3 registration trial during 2026. With regards to ME-344, the plan is to develop a new formulation for further clinical development to better leverage the opportunity to advance a novel approach to inducing synthetic lethality in tumors in combination with VEGF inhibitors such as bevacizumab (Avastin®). The Company has already initiated research and development activity of the new formulation with encouraging results, with the goal of increasing biological activity, improving convenience of administration and increasing commercial opportunity. Interrupting ME-344 clinical activity and developing a new formulation will immediately reduce ME-344 expenditures. The Company recently reported initiation of enrollment in an expansion cohort of the ongoing Phase 1 study evaluating voruciclib plus venetoclax (Venclexta®), a B-cell lymphoma 2 (“BCL2”) inhibitor, in R/R AML. The decision to open the expansion cohort was based on encouraging initial data demonstrating anti-leukemic activity, including complete responses in heavily pretreated patients. Additionally, at doses of 100 mg or more, initial results from correlative biomarker assay analyses of available samples from patients treated with the combination demonstrated anticipated decreases of myeloid leukemia cell differentiation protein (“Mcl-1”), including a greater decrease in Mcl-1 at higher doses. Reductions in Mcl-1 are consistent with the known mechanism of action of CDK9. Further, there was no evidence of overlapping toxicity with venetoclax and no dose limiting toxicities were observed. Increasingly, venetoclax is being used as a standard treatment in patients with AML, but salvage therapy after venetoclax failure is common and yields limited benefit; only about 10% of patients respond to salvage therapy after venetoclax failure, representing a significant need for patients with AML. While mutation specific therapies, such as FLT3, IDH, and menin inhibitors, may be used in patients with such mutations, the majority of patients with AML do not have therapeutically actionable mutations. Thus, inhibition of CDK9 is a mutation agnostic therapeutic opportunity across the majority of patients with R/R AML, representing an addressable patient population larger than that of any mutation specific therapy. As separately reported, based on initial study results, 25% of evaluable patients with relapsed metastatic colorectal cancer (“mCRC”) enrolled in Cohort 1 of the ongoing Phase 1b study evaluating ME-344 in combination with bevacizumab (Avastin®) reached a predetermined 16-week progression free survival (“PFS”) threshold, exceeding the 20% threshold set in the Clinical Study Protocol. Patients were heavily pretreated and had failed standard therapies for their disease. The combination was also observed to have a generally well-tolerated safety profile. The recently reported data represent new clinical support of the potential of ME-344 in combination with VEGF inhibitors such as bevacizumab to induce synthetic lethality in tumors; this is a novel therapeutic strategy to potentially provide benefit to patients in a well-tolerated manner. Further, there is a significant medical need to provide patients with colorectal cancer new treatment options in light of the fact that deaths from this disease are a leading cause of cancer-related deaths in the U.S. and given that the incidence of colorectal cancer is increasing among those under 55. While the threshold was met to proceed to Cohort 2, the Company believes the best approach to meet the need of patients with mCRC, and potentially patients with other cancers where VEGF inhibitors are standard-of-care, is to continue to advance ME-344 via development of a new formulation, building upon the ME-344 results to date. The Company believes that development of a new formulation represents the optimal approach to leveraging the potential of the program and the novel therapeutic strategy to induce synthetic lethality in tumors via the combination.

Anuncio • Mar 26

MEI Pharma, Inc. Reports Update from Clinical Study Evaluating Oral Cdk9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia

MEI Pharma, Inc. reported initiation of enrollment in a 12-patient expansion cohort in the ongoing Phase 1 study evaluating voruciclib, an investigational selective oral cyclin-dependent kinase 9 inhibitor, in combination with venetoclax (Venclexta®), a B-cell lymphoma 2 inhibitor, in relapsed and refractory acute myeloid leukemia patients. The Safety Review Committee recommended initiating the expansion cohort after observing anti-leukemic activity in multiple heavily pretreated patients in the dose escalation cohorts, including responses, anticipated decreases in myeloid leukemia cell differentiation protein in available patient samples, no overlapping toxicity or dose limiting toxicities, and favorable safety results to date. The Phase 1 study is a multiple stage, open-label, 3+3 dose escalation and expansion study evaluating voruciclib, an oral CDK9 inhibitor, as a monotherapy and in combination with venetoclax, a BCL2 inhibitor. The first stage of the study evaluated the dose and schedule of voruciclib as a single-agent in patients with AML or B-cell malignances after failure of standard therapies. This stage is complete. The second stage of the study, evaluating voruciclib in combination with standard dose venetoclax in patients with R/R AML, has completed enrollment in the dose escalation cohorts evaluating seven voruciclib dose levels from 50 mg every other day to 300 mg daily for two weeks in a four-week cycle. The study is currently enrolling a 12-patient expansion cohort evaluating voruciclib administered at 300 mg daily for two weeks in a four-week cycle in combination with venetoclax. Considering the tolerability results for the combination to date, another arm of the study will evaluate escalating doses of voruciclib administered over three weeks in a four-week cycle in combination with venetoclax to increase dose intensity and potentially optimize patient response. A total of 29 patients with R/R AML, median age 67 years (range 34-89), enrolled in the dose escalation stage of the study evaluating voruciclib in combination with venetoclax. These patients were generally heavily pretreated; the median number of prior therapies was 3 (range 1-7), and 15 (52%) patients had =3 prior lines. Almost all patients (28/29) were treated with venetoclax in an earlier line of therapy. Additionally, 21 (72%) patients were noted as being in an adverse 2017 ELN Risk Category due to adverse cytogenetics and molecular mutations. The primary objectives of the study are to determine the safety and biologic effective dose of voruciclib monotherapy or voruciclib in combination with venetoclax. Secondary objectives of the study include assessing the preliminary efficacy, pharmacokinetics, pharmacodynamics, and biomarkers of voruciclib monotherapy or voruciclib in combination with venetoclax. Voruciclib Plus Venetoclax Combination: Initial Safety and Tolerability Data Voruciclib at doses up to 300 mg administered on 14 consecutive days in a 28-day cycle in combination with standard dose venetoclax was well tolerated with no dose limiting toxicities observed. The maximum tolerated dose of voruciclib administered on this schedule with venetoclax has not been established. There were no discontinuations due to drug-related adverse events. No evidence of overlapping toxicity has been observed to date. The most common (=5% of patients) grade 3 adverse events were myelosuppression associated with AML. Only 1 patient was observed as having a non-hematologic grade 3 drug-related adverse event (diarrhea). Voruciclib Plus Venetoclax Combination: Initial Efficacy Data In the 20 patients administered voruciclib at a dose of 100 mg or more, three patients achieved a response, including two patients that achieved a complete response with incomplete hematologic recovery (CRi) and one patient that achieved a morphologic leukemia-free state (MLFS), in each case having received venetoclax in an earlier line of treatment. Responses lasted 7 months in one patient, 5 months and ongoing in the second patient, and the third patient was referred to stem cell transplant. Further, an additional 14 patients had stable disease which lasted more than 90 days in 5 patients. In the patients administered voruciclib at a dose of 100 mg or more, initial results from correlative biomarker assay studies of available samples from patients treated with the combination demonstrate the anticipated decrease of Mcl-1. Further, the available assays from the dose escalation cohorts demonstrated dose proportional decreases in Mcl-1. Reductions in Mcl-1 are consistent with the known mechanism of action of CDK9, which regulates Mcl-1.

Ratio de cobertura de intereses	n/a
Efectivo	US$7.54m
Patrimonio	US$56.84m
Total pasivo	US$952.00k
Activos totales	US$57.79m

Datos	Última actualización (huso horario UTC)
Análisis de la empresa	2026/05/22 19:18
Precio de las acciones al final del día	2026/05/22 00:00
Beneficios	2026/03/31
Ingresos anuales	2025/06/30

Paquete	Datos	Marco temporal	Ejemplo Fuente EE.UU. ^*
Finanzas de la empresa	10 años	Cuenta de resultados Estado de tesorería Balance	Formulario SEC 10-K Formulario SEC 10-Q
Estimaciones del consenso de analistas	+3 años	Previsiones financieras Objetivos de precios de los analistas	Informes de análisis Blue Matrix
Precios de mercado	30 años	Precios de las acciones Dividendos, escisiones y acciones	Datos de mercado ICE Formulario S-1 de la SEC
Propiedad	10 años	Accionistas principales Información privilegiada	Formulario SEC 4 Formulario SEC 13D
Gestión	10 años	Equipo directivo Consejo de Administración	Formulario SEC 10-K Formulario SEC DEF 14A
Principales avances	10 años	Anuncios de empresas	Formulario SEC 8-K

Analista	Institución
Stephen V. Byrne	BofA Global Research
Leah Rush Cann	Brookline Capital Markets
Daniel Brims	Cantor Fitzgerald & Co.

Salud financiera de hoja de balance de Lite Strategy

Salud financiera controles de criterios 4/6

Información clave

Actualizaciones recientes sobre salud financiera

Will Lite Strategy (NASDAQ:LITS) Spend Its Cash Wisely?

We're Hopeful That MEI Pharma (NASDAQ:MEIP) Will Use Its Cash Wisely

We're Not Very Worried About MEI Pharma's (NASDAQ:MEIP) Cash Burn Rate

Recent updates

Will Lite Strategy (NASDAQ:LITS) Spend Its Cash Wisely?

New minor risk - Insider selling

Insider recently sold US$946k worth of stock

New major risk - Financial position

Lite Strategy, Inc. (NasdaqCM:LITS) announces an Equity Buyback for $25 million worth of its shares.

New minor risk - Market cap size

New major risk - Share price stability

New major risk - Shareholder dilution

MEI Pharma, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.

MEI Pharma, Inc. announced that it has received $99.999401 million in funding from GSR, Litecoin Foundation Ltd., Mozayyx Management LLC, RLH Capital, LLC, Delta Blockchain Fund LP, CoinFund LLC

MEI Pharma, Inc. Announces Board Changes

New minor risk - Share price stability

MEI Pharma, Inc., Annual General Meeting, Jan 30, 2025

MEI Pharma, Inc. Announces Management Changes

MEI Pharma, Inc. Announces Strategic Plan to Leverage Recent Positive Voruciclib and ME-344 Clinical Data

MEI Pharma, Inc. Reports Initial Data from Clinical Study Evaluating ME-344 in Combination with Bevacizumab (Avastin®) in Relapsed Metastatic Colorectal Cancer Patients

MEI Pharma, Inc. Reports Update from Clinical Study Evaluating Oral Cdk9 Inhibitor Voruciclib in Combination with Venetoclax in Patients with Relapsed and Refractory Acute Myeloid Leukemia

MEI Pharma, Inc. has filed a Follow-on Equity Offering in the amount of $10.3 million.

MEI Pharma Reports Clinical Data on Oral CDK9 Inhibitor Voruciclib At ASH2023

MEI Pharma, Inc., Annual General Meeting, Dec 18, 2023

MEI Pharma, Inc. Declares Special Cash Dividend of Common Stock, Payable on December 6, 2023

MEI Pharma Announces Acceptance of Abstract for Presentation at ASH 2023

MEI Pharma, Inc. Announces Board Changes

MEI Pharma, Inc. to Report Fiscal Year 2023 Results on Sep 26, 2023

MEI Pharma, Inc. Announces First Patient Dosed in Clinical Study Evaluating ME-344 Plus Bevacizumab (AVASTIN) in Patients with Previously Treated Metastatic Colorectal Cancer

MEI Pharma, Inc. Announces Chief Financial Officer Changes, Effective as of August 1, 2023

MEI Pharma, Inc. Announces Change of CFO, Effective No Later Than September 1, 2023

MEI Pharma, Inc. Announces Executive Changes

Funicular Fund, LP, managed by Cable Car Capital, LLC, Anson Funds Management LP, Anson Advisors Inc., Anson Management GP LLC, Bruce R. Winson, Amin Nathoo and Moez Kassam submitted a proposal to acquire remaining 85.2% stake in MEI Pharma, Inc. (NasdaqCM:MEIP) for $45.4 million.

MEI Pharma, Inc Announces Update of Ongoing Phase 1 Study Evaluating Oral CDK9 Inhibitor Voruciclib Alone and in Combination with Venetoclax in Patients with Acute Myeloid Leukemia or B-Cell Malignancies

Third quarter 2023 earnings: EPS and revenues exceed analyst expectations

New Forecasts: Here's What Analysts Think The Future Holds For MEI Pharma, Inc. (NASDAQ:MEIP)

Consensus revenue estimates increase by 61%

Price target decreased by 12% to US$2.27

Second quarter 2023 earnings: EPS and revenues exceed analyst expectations

Insufficient new directors

Increases to CEO Compensation Might Be Put On Hold For Now at MEI Pharma, Inc. (NASDAQ:MEIP)

Price target decreased to US$2.90

Consensus revenue estimates increase by 26%

Need To Know: Analysts Are Much More Bullish On MEI Pharma, Inc. (NASDAQ:MEIP)

Price target increased to US$5.83

First quarter 2023 earnings: EPS and revenues exceed analyst expectations

MEI Pharma, Inc., Annual General Meeting, Dec 06, 2022

Consensus forecasts updated

Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behind

Price target decreased to US$4.81

We're Hopeful That MEI Pharma (NASDAQ:MEIP) Will Use Its Cash Wisely

Consensus revenue estimates increase by 11%

Consensus revenue estimates increase by 11%

Need To Know: The Consensus Just Cut Its MEI Pharma, Inc. (NASDAQ:MEIP) Estimates For 2022

Second quarter 2022 earnings: Revenues exceed analysts expectations while EPS lags behind

Newsflash: MEI Pharma, Inc. (NASDAQ:MEIP) Analysts Have Been Trimming Their Revenue Forecasts

No longer forecast to breakeven

MEI Pharma: Another PI3K Delta Progressing To The FDA

Need To Know: Analysts Just Made A Substantial Cut To Their MEI Pharma, Inc. (NASDAQ:MEIP) Estimates

Consensus revenue estimates fall to US$38.1m

Price target increased to US$10.89

Independent Non Executive Director Kevan Clemens has left the company

First quarter 2022 earnings released: US$0.10 loss per share (vs US$0.019 loss in 1Q 2021)

We're Not Very Worried About MEI Pharma's (NASDAQ:MEIP) Cash Burn Rate

Price target increased to US$11.11

Full year 2021 earnings released: US$0.45 loss per share (vs US$0.51 loss in FY 2020)

Forecast to breakeven in 2024

Consensus revenue estimates fall to US$18.3m

Third quarter 2021 earnings released: US$0.28 loss per share (vs US$0.041 loss in 3Q 2020)

Independent Non-Executive Director notifies of intention to sell stock

The Independent Non-Executive Director of MEI Pharma, Inc. (NASDAQ:MEIP), Frederick Driscoll, Just Sold 40% Of Their Holding

Independent Non-Executive Director recently sold US$101k worth of stock

New Forecasts: Here's What Analysts Think The Future Holds For MEI Pharma, Inc. (NASDAQ:MEIP)

Analysts update estimates

Second quarter 2021 earnings released: US$0.10 loss per share (vs US$0.26 loss in 2Q 2020)

Análisis de la situación financiera