Mesoblast (MESO)2019-02-21 03:38Company and Industry Highlights * Company: Mesoblast (NASDAQ: MESO) * Industry: Biotechnology, Cell Therapy * Date: February 20, 2019 Key Points: 1. Pipeline and Clinical Trials: * Remestemcel-L: Phase 3 trial for steroid-refractory acute graft-versus-host disease (GVHD) completed, BLA submission expected in early 2019. * Revascor: Phase 3 trial for advanced heart failure completed enrollment, expected to complete within 12 months. * MPC-06-ID: Phase 3 trial for chronic low back pain due to disc degeneration completed enrollment, 12-month assessment for safety and efficacy expected in first half of 2019. 2. Financial Highlights: * Cash Position: 13.5 million for six months ended December 31, 2018. * Milestone Payments: Significant increase in milestone payments from licensees Takeda and Tasly. 3. Partnerships and Collaborations: * Tasly: Cardiovascular partnership established, upfront payment of $40 million received. * JCR Pharma: Licensee for TEMCELL in Japan. * Takeda: Licensee for Alofisel in Europe. 4. Regulatory Updates: * Remestemcel-L: Scheduled meeting with FDA in April 2019 for BLA filing. * Revascor: Partner Tasly plans to meet with National Medical Products Administration of China in first half of 2019. * MPC-06-ID: No specific regulatory updates mentioned. 5. Future Outlook: * Company expects to achieve several key milestones in 2019, including BLA submission for Remestemcel-L and completion of Phase 3 trials for Revascor and MPC-06-ID. * Company aims to expand its commercial presence and explore additional licensing opportunities. Additional Important Points: * Rheumatoid Arthritis Program: Company plans to update on further data readout and explore partnership opportunities. * Sales Force: Company building a focused U.S. sales force for Remestemcel-L launch. * Regenerative Medicine Advanced Therapy (RMAT) Designation: Received RMAT designation from FDA for Revascor for reduction of gastrointestinal bleeding in patients with LVADs.