Mei Pharma Inc Stock Price, News & Analysis

MEI Pharma, Inc. (NASDAQ: MEIP) has adjourned its annual stockholders' meeting to January 5, 2023, at 9:00 a.m. Pacific Time, allowing investors more time to consider recent company announcements. The record date remains October 13, 2022. Shareholders can participate online and vote electronically. The board continues to recommend voting 'FOR' proposals one through five. MEI has also filed a definitive proxy statement with the SEC, urging stockholders to review it before voting.

MEI Pharma (Nasdaq: MEIP) has announced a strategic realignment focusing on two early-stage clinical oncology assets, voruciclib and ME-344, following the discontinuation of its zandelisib program outside Japan. The workforce will be reduced by about 30% to streamline operations. The company expects its cash and marketable securities to fund operations through clinical milestones for both candidates. Voruciclib is in a Phase 1 study for B-cell malignancies, while ME-344 will enter a Phase 1b study for colorectal cancer. Torreya Partners has been engaged as a financial advisor for potential strategic opportunities.

MEI Pharma and Kyowa Kirin announced the discontinuation of global development for zandelisib, targeting B-cell malignancies, outside Japan after receiving recent FDA guidance. MEI Pharma cited the inability to complete clinical development within a feasible timeframe for further investment as the reason. Although disappointed, Kyowa Kirin will continue clinical trials in Japan and consider regulatory submissions based on the Phase 2 MIRAGE and TIDAL studies. The decision does not relate to clinical data generated to date but reflects regulatory challenges.

MEI Pharma has announced promising interim results from the Phase 2 MIRAGE study of zandelisib, demonstrating a 75.4% objective response rate (ORR) in Japanese patients with indolent B-cell Non-Hodgkin’s Lymphoma (iB-NHL). The study involved 61 patients, with 24.6% achieving a complete response and a median follow-up of 9.5 months. A 14.8% discontinuation rate due to treatment-emergent adverse events was reported. Additionally, results from a Phase 1 study of zandelisib have been published in the International Journal of Hematology.

MEI Pharma (Nasdaq: MEIP) reported its fiscal Q1 results ending September 30, 2022, highlighting a cash position of $138.4 million with no debt. The company recognized revenue of $8.7 million, a slight increase from $7.8 million year-over-year. However, operational cash use rose to $14.8 million compared to $7.7 million in Q1 2021, primarily due to the absence of a prior milestone payment. The net loss was $16.6 million or $0.12 per share, improving from a $17.5 million loss the previous year. MEI aims to advance its clinical pipeline amid ongoing FDA evaluations.

MEI Pharma and Kyowa Kirin have announced the presentation of three abstracts related to zandelisib, a PI3Kδ inhibitor for B-cell malignancies, at the American Society of Hematology Annual Meeting on December 10-13, 2022. The presentations will cover the efficacy and safety of zandelisib, both as a standalone treatment and in combination with zanubrutinib, along with immune-related toxicities. These findings may support ongoing clinical trials and potential marketing approvals globally.

MEI Pharma, Inc. (NASDAQ: MEIP) has announced the grant of inducement stock options totaling 131,000 shares to four new employees as per Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $0.39, equal to the closing stock price on the grant date. They are part of MEI's 2021 Inducement Grant Equity Compensation Plan and vest progressively over a decade. MEI Pharma focuses on advancing new cancer therapies, with its drug candidates currently in clinical trials aimed at marketing approval.

MEI Pharma, Inc. (Nasdaq: MEIP) announced the retirement of Dr. Christine A. White, who will not seek reelection as chair of the board after 12 years of service. Charles V. Baltic III has been elected as the new chair effective immediately after the fiscal year 2023 annual stockholders' meeting. Dr. White's contributions were commended by CEO Daniel P. Gold, highlighting her impact on the company's growth and oncology drug development. Mr. Baltic has a long history with MEI and brings extensive industry experience, which is expected to support the company's mission in advancing cancer therapies.

MEI Pharma reported fiscal year 2022 results with $153 million in cash and a net loss of $54.5 million, or $0.44 per share. The company marked milestones, including the first patient dosed in its Phase 3 COASTAL study and promising data for zandelisib in Phase 2 trials. However, regulatory challenges arose as the FDA modified its approach to accelerated approvals, impacting zandelisib's marketing pathway. Despite this, MEI remains committed to developing therapies for B-cell malignancies, with upcoming updates expected from various clinical studies.