Globenewswire·2025-06-23 11:30Core Viewpoint - Carisma Therapeutics Inc. and OrthoCellix, Inc. have announced a definitive merger agreement to combine in an all-stock transaction, focusing on the development of OrthoCellix's NeoCart® technology for knee cartilage defects and planning to initiate a Phase 3 clinical trial endorsed by the FDA [1][2][4]. Company Overview - Carisma Therapeutics is a biotechnology company specializing in macrophage engineering for therapies targeting fibrosis and cancer [11]. - OrthoCellix is a clinical-stage company developing regenerative cell therapies for orthopedic diseases, with its lead program being the NeoCart® technology aimed at repairing knee cartilage defects [10][3]. NeoCart® Technology - NeoCart® is an autologous cartilage implant technology that utilizes patient cells to repair articular cartilage defects, combining a fortified 3D scaffold with patented bioprocessing technology to produce functional cartilage [3][10]. - The technology has received Regenerative Medicine Advanced Therapy (RMAT) designation and FDA concurrence for a single, confirmatory Phase 3 clinical trial, which is anticipated to launch by the end of 2025 [4][6]. Merger Details - Under the merger agreement, OrthoCellix will merge into a wholly-owned subsidiary of Carisma, with OrthoCellix continuing as a subsidiary and the surviving entity [5][6]. - The merger will result in OrthoCellix stockholders owning approximately 90% of the combined company, while existing Carisma stockholders will own about 10%, subject to adjustments based on Carisma's net cash and financing proceeds [6][8]. Financial Aspects - Carisma plans to enter into subscription agreements for private financing with Ocugen and other investors to support the Phase 3 trial of NeoCart® without additional costs to Ocugen [5][6]. - The merger has been unanimously approved by the boards of both companies and is expected to close in the second half of 2025, pending customary closing conditions [8].