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Truist analyst Robyn Karnauskas downgraded MEI Pharma to Hold from Buy. The analyst cites the company's decision to discontinue the development of its lead drug Zandelisib based on the feedback from the FDA meeting, along with its announcement of a 30% workforce reduction.
BTIG analyst Justin Zelin downgraded MEI Pharma to Neutral from Buy without a price target. The company announced plans to initiate strategic realignment of its portfolio following feedback with partner Kyowa Kirin from the FDA at a late November Meeting, where the parties will discontinue global development of Zandelisib, Zelin tells investors in a research note. The analyst downgrades MEI saying the primary valuation driver was future revenues from Zandelisib. He now awaits further clinical updates from the company's early-stage pipeline assets next year.
MEIP plans to streamline its organization towards the continued clinical development of voruciclib and ME-344. As a result, it plans to initiate a staggered workforce reduction, initially representing approximately 30% of the current workforce in connection with the wind down of the zandelisib development program outside of Japan, which costs are shared with Kyowa Kirin, our global development partner. Following completion of the zandelisib wind down and associated workforce reductions, MEI expects that, along with any additional workforce reductions to be determined to fully align resources going forward, its existing cash, cash equivalents and marketable securities will be sufficient to fund operations through clinical data milestones for both voruciclib and ME-344.
MEI Pharma announced that it plans to initiate a realignment of its clinical development efforts following the discontinuation of global development outside Japan of its PI3K delta inhibitor, zandelisib. As part of the realignment, the company plans to streamline its organization towards the development of two earlier clinical-stage assets, voruciclib and ME-344. Following completion of the workforce reductions, MEI expects its existing cash, cash equivalents and marketable securities will be sufficient to fund operations through clinical data milestones for both voruciclib and ME-344. The company further announced that it has engaged Torreya Partners as financial advisor to help explore additional strategic opportunities.
MEI Pharma and Kyowa Kirin Co. announced that after receiving the most recent guidance from a late November meeting with the U.S. FDA, the companies are discontinuing global development of zandelisib outside of Japan for B-cell malignancies. Kyowa Kirin is continuing the ongoing clinical trials including Phase 2 MIRAGE study evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas and will explore the potential for a submission to Japanese health authorities based on data from the MIRAGE and TIDAL clinical trials.
Kyowa Kirin and MEI Pharma announced topline data from the Phase 2 MIRAGE study evaluating zandelisib, an orally administered investigational phosphatidylinositol 3-kinase delta inhibitor, in patients with indolent B-cell Non-Hodgkin's Lymphoma, or iB-NHL, without small lymphocytic lymphoma, or SLL, lymphoplasmacytic lymphoma, or LPL, and Waldenstrom's macroglobulinemia, or WM, in Japan. The data demonstrated a 75.4% objective response rate, or ORR, and 24.6% of patients achieved a complete response, or CR, as determined by Independent Review Committee assessment. The data is currently insufficiently mature to accurately estimate duration of response. With 9.5 months median duration of follow-up, a discontinuation rate due to any treatment emergent adverse event was 14.8%. The MIRAGE study is a multicenter, open-label, single-arm Phase 2 trial evaluating zandelisib as monotherapy for Japanese patients with relapsed or refractory iB-NHL who received at least two prior systemic therapies. A total of 61 patients were enrolled and the median age of patients was 70 years old. Enrolled patients were generally heavily pretreated; the median number of prior therapies was 3. The primary efficacy endpoint is ORR as assessed by IRRC using a modified Lugano criteria. Patients were administered zandelisib 60 mg once daily for two 28-day cycles as response induction therapy, followed thereafter by 60 mg once daily dosing for the first seven days of each subsequent 28-day cycle, a schedule called Intermittent Dosing Therapy. The primary endpoint of ORR of zandelisib as a single agent was 75.4%, as assessed by IRRC; the complete response rate was 24.6%. As of the data cutoff date, the data are not sufficiently mature to accurately estimate the final DOR. With a median follow-up of 9.5 months, 14.8% of patients discontinued therapy due to any treatment emergent adverse event. Grade 3 adverse events of special interest were AST and ALT elevation in 8.2% of patients, rash in 3.3%, and 1.6% each for diarrhea, colitis and lung infection. We also recently announced the publication of data from the Phase 1 study of zandelisib in Japanese patients with r/r iB-NHL in the International Journal of Hematology. The publication, entitled "Zandelisib in Japanese patients with relapsed or refractory indolent non-Hodgkin's lymphoma: an open-label, multicenter, dose-escalation phase 1 study" is available on the journal website. The publication reported a 100% ORR and that 22.2% of patients achieved CR starting on a continuous daily schedule; patients could be switched to intermittent dosing for an adverse event. No dose-limiting toxicities were observed in the first cycle of therapy, and the maximum tolerated dose was not reached. With 17.5 months median duration of follow-up, zandelisib was generally well tolerated at 60 mg resulting in the recommended phase 2 dose in Japanese patients.
Reports Q1 revenue $8.73M, consensus $5.9M. "As we move through fiscal year 2023 and continue to assess FDA concerns regarding the risk benefit analysis of marketed PI3Kdelta 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 Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We remain well capitalized with $138 million to advance our pipeline and continue operations for approximately two years."
Reports FY22 revenue $40.7M, consensus $46.38M. "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."
