MedinCell ENXTPA:MEDCL Stock Report

MedinCell Appoints Richard Malamut, MD as Chief Medical Officer

Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM

Teva Pharmaceuticals USA, Inc. and MedinCell S.A. announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia. The application included Phase 3 data from two pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia). These studies evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia.

MedinCell S.A. Announces Inclusion of First Participants in New Covid-19 Prophylaxis Clinical Trial SAIVE

MedinCell S.A. announced the first participants of the SAIVE study have been administered on March 25, 2022. SAIVE is a 400-participant, multicenter, randomized, double-blind, placebo-controlled study with an independent Data Monitoring Committee, conducted in the European Union Interim data are expected mid 2022. SAIVE aims at validating the efficacy in prophylaxis against Covid-19 of administration of Ivermectin in oral daily form. It is part of MedinCell’s program to develop a subcutaneous injection that could offer more than 3 months of protection against Covid-19 and its variants. SAIVE follows a Phase 1 clinical study conducted by MedinCell that successfully confirmed the safety of daily, oral Ivermectin administration over a long period of time.

First half 2022 earnings: EPS exceeds analyst expectations while revenues lag behind

First half 2022 results: €0.47 loss per share (up from €0.51 loss in 1H 2021). Revenue: €4.08m (up 30% from 1H 2021). Net loss: €11.8m (loss widened 9.3% from 1H 2021). Revenue missed analyst estimates by 31%. Earnings per share (EPS) exceeded analyst estimates by 54%. Earnings per share (EPS) surpassed analyst estimates by 54%. Over the next year, revenue is forecast to grow 298%, compared to a 14% growth forecast for the industry in France. Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has increased by 11% per year, which means it is tracking significantly ahead of earnings growth.

MedinCell Provides an Update on Its Product Portfolio, Following the FDA Acceptance of New Drug Application for the Product mdc-IRM

MedinCell and Teva announced on August 31, 2021 the FDA acceptance of the New Drug Application for mdc-IRM for patients with schizophrenia. This first long-acting injectable treatment based on MedinCell's technology could be commercialized as early as 2022 by Teva in the U.S. Upcoming portfolio milestones expected: mdc-TJK and mdc-ANG: Announcement of next steps by Teva expected by year-end. mdc-CWM: its partner AIC is targeting FDA approval to initiate Phase 3 efficacy studies before the end of 2021. The start of the safety study has been postponed. mdc-TTG: MedinCell is awaiting the approval of health authorities in several European countries, including France, to initiate a multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial to confirm the prophylactic efficacy of ivermectin in regular, daily, oral form to simulate the continuous release of the active ingredient by a long-acting injectable.