Mesoblast - MESO STOCK NEWS

Mesoblast Limited (Nasdaq: MESO) announced a US$110 million private placement with SurgCenter Development, issuing 60 million shares at A$2.30 each. This price represents a 6.5% discount on the closing price from February 25, 2021. Pro-forma cash on hand is estimated at US$187.5 million. The funding aims to enhance operational strength, support regulatory initiatives, and advance the commercial supply of remestemcel-L and rexlemestrocel-L for various diseases, including chronic heart failure and graft versus host disease. Investors will also receive warrants for 15 million additional shares.

Mesoblast Limited (Nasdaq: MESO) has announced a publication in Pediatrics detailing the successful treatment of two children with life-threatening multisystem inflammatory syndrome (MIS-C) linked to COVID-19 using their MSC product candidate remestemcel-L. The treatment led to normalization of cardiac function and a reduction in inflammation markers. This case highlights the potential of remestemcel-L as a novel therapy for MIS-C, which currently lacks approved treatments. Mesoblast continues to advance its investigational drug programs under existing IND applications.

Mesoblast Limited (Nasdaq:MESO) announced positive results from its Phase 3 trial of rexlemestrocel-L for chronic low back pain (CLBP) due to degenerative disc disease. The study, involving 404 patients, showed that a single injection of rexlemestrocel-L significantly reduced pain for up to 24 months, particularly in patients treated earlier in their disease progression. Additionally, it demonstrated substantial opioid-sparing effects, with notable reductions in opioid use among patients. Mesoblast plans to meet with the FDA to discuss potential approval pathways for this therapy.

Mesoblast Limited (Nasdaq: MESO) will host a corporate update webcast on February 11, 2021, at 9:30 am AEDT. The session aims to provide insights into the company's developments in allogeneic cellular medicines for inflammatory diseases. Mesoblast focuses on severe conditions through its proprietary mesenchymal lineage cell therapy technology. The company has a strong intellectual property portfolio and has completed Phase 3 trials for various products. Archived webcasts will be accessible on their investor page.

Mesoblast Limited (NASDAQ: MESO) reported a significant reduction in cardiac mortality and major vascular events in its Phase 3 trial of rexlemestrocel-L for chronic heart failure. This represents a major advancement for the high-risk NYHA class II patient population. Revenues from royalties on TEMCELL® HS Inj. rose slightly to US$2.1 million. The company ended December 2020 with US$77.5 million in cash and has access to up to US$92.5 million through existing agreements. Mesoblast anticipates meeting the FDA to discuss approval pathways for several candidates, including remestemcel-L.

Mesoblast Limited (NASDAQ: MESO) announced on October 13, 2020, that its Phase 3 trial for remestemcel-L in COVID-19 patients has exceeded 50% enrollment. This trial aims to reduce 30-day mortality in ventilator-dependent patients with acute respiratory distress syndrome (ARDS). Dr. Fred Grossman emphasized the urgent need for effective treatments as ARDS remains a leading cause of COVID-19 mortality. With enrollment expected to conclude by year-end, the trial builds on a pilot study where 75% of patients were discharged after treatment.

Mesoblast (NASDAQ: MESO) announced that the FDA issued a Complete Response Letter for its Biologics License Application for remestemcel-L, a treatment for pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). Although the FDA's advisory committee recognized the treatment's efficacy, the agency requires additional controlled studies for approval. Mesoblast plans to urgently discuss accelerated approval with the FDA. The company is also conducting a Phase 3 trial for remestemcel-L in ventilator-dependent adults with severe COVID-19 related ARDS, with interim results anticipated in November.

Mesoblast Limited (Nasdaq: MESO) announced that the independent Data Safety Monitoring Board (DSMB) has recommended continuing the Phase 3 trial of remestemcel-L for patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. This recommendation follows the first interim analysis, which reviewed primary endpoint data on all-cause mortality. The trial aims to evaluate if remestemcel-L improves survival in ventilated COVID-19 patients, with recruitment expected to complete in Q4 2020.

Mesoblast Limited (NASDAQ: MESO) reported a robust FY2020, marked by a 92% increase in revenues to US$32.2 million. The company’s lead candidate, remestemcel-L (RYONCIL™), received a positive vote from the FDA Advisory Committee for treating steroid-refractory acute graft versus host disease in children, with the approval decision due by September 30, 2020. The company reported a 13% reduction in losses to US$77.9 million and maintained a strong cash position of US$129.3 million.

Future studies on COVID-19 and chronic heart failure are expected to yield significant results.