Mesoblast Limited develops allogeneic cellular medicines for severe inflammatory conditions through a proprietary mesenchymal lineage cell therapy platform. Its commercial and pipeline updates center on Ryoncil® (remestemcel-L-rknd), an FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, and on additional cell therapy programs for chronic low back pain, heart failure, Duchenne muscular dystrophy and inflammatory or autoimmune diseases.
Recurring company news covers Ryoncil launch and revenue trends, clinical and regulatory developments involving rexlemestrocel-L and Ryoncil label-extension programs, FDA clearances and designations, R&D presentations, technology licensing and platform expansion such as CAR-engineered MSC products, and quarterly cash-flow reporting filed with the Australian Securities Exchange.
Mesoblast Limited (Nasdaq: MESO) announced positive results from a Phase 3 trial of rexlemestrocel-L for patients with chronic heart failure. The trial showed a 65% reduction in heart attacks or strokes and an 80% reduction in cardiovascular death among those with high systemic inflammation. The study highlights the potential of cell therapy to address inflammation in heart failure, a major health challenge. Despite these promising results, no reduction in hospitalization rates was observed. The findings were presented at the American Heart Association's annual conference.
Financial and Operational Highlights for Quarter Ended September 30, 2021
Mesoblast Limited (Nasdaq: MESO) reported notable growth in its revenues for the quarter, earning US$2.4 million from TEMCELL® HS Inj. royalties in Japan, marking a 22% increase from the previous quarter and a 90% increase year-over-year. The total net cash usage was US$19.6 million, with about 50% directed towards the remestemcel-L platform. Cash reserves stood at US$116 million. Key upcoming FDA discussions will focus on regulatory approval processes, and the company is collaborating with Novartis on the remestemcel-L treatment for ARDS.
Mesoblast Limited (NASDAQ: MESO) announced promising results for its remestemcel-L therapy in treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children. Published in Bone Marrow Transplantation, the study showed a 64% survival rate at Day 180 compared to 10% with alternative treatments. The findings highlight the drug's potential efficacy and its proposed anti-inflammatory mechanism. The company plans to discuss these results with the FDA to support a resubmission of its Biologics License Application for remestemcel-L.
Mesoblast Limited (Nasdaq:MESO) announced that results from its Phase 3 trial of rexlemestrocel-L for chronic heart failure (CHF) have been selected for late-breaking presentation at the American Heart Association annual meeting in November. This trial involved 565 patients with NYHA class II and III CHF. The co-principal investigator, Dr. Emerson Perin, will present the findings. The trial aims to address inflammation in CHF patients to potentially reduce major cardiac events, marking a significant step for Mesoblast's cellular therapies.
Mesoblast Limited (Nasdaq:MESO) announced operational and financial results for FY2021, ending June 30. The company reported cash on hand of US$136.9 million and a net loss of US$98.8 million. Key highlights include FDA discussions for emergency use authorization of remestemcel-L for COVID ARDS, with a need for an additional clinical study. The company has a collaboration with Novartis for remestemcel-L development. Revenue from TEMCELL royalties increased by 10% to US$7.2 million. Upcoming meetings with the FDA are planned to address CMC items.
Mesoblast Limited (Nasdaq:MESO) announced a webcast to discuss its operational highlights and financial results for Q4 and the full year ending June 30, 2021. The webcast will take place at 7:00 PM EDT on August 30, 2021, with archived access available on the company’s Investor page. Mesoblast is recognized for its allogeneic cellular medicines targeting severe inflammatory diseases, with promising results from Phase 3 trials for rexlemestrocel-L and ongoing developments for other products. The company boasts a strong intellectual property portfolio extending to 2041 and established partnerships in Europe and China.
Mesoblast Limited (Nasdaq: MESO) reported significant operational and financial updates for the quarter ended June 30, 2021. Key highlights include progress on regulatory pathways for its lead product remestemcel-L, which targets steroid-refractory acute graft versus host disease in children and COVID-19-related acute respiratory distress syndrome in adults. The FDA has provided guidance for potential approvals. The company also announced a collaboration with Novartis. Financially, cash on hand stood at $136.4 million, with net cash usage of $20.7 million in the quarter.
Mesoblast Limited (Nasdaq: MESO) presented positive 90-day survival data for remestemcel-L in ventilator-dependent COVID-19 patients with ARDS at the ISCT Scientific Signatures Series. In patients under 65, remestemcel-L reduced mortality by 48% compared to controls (26% vs 44%, p=0.038). The treatment showed an even greater 77% reduction in mortality for those receiving dexamethasone (14% vs 48%, p=0.0037). Despite these benefits, the treatment did not show significance in older patients over 65. Mesoblast is set to meet with the FDA regarding further regulatory pathways.
Mesoblast Limited (Nasdaq: MESO) presented clinical outcomes from its randomized trial of remestemcel-L in COVID-19 ARDS patients at a conference on July 15, 2021. The trial enrolled 222 patients, with 217 randomized to receive standard care or standard care plus remestemcel-L. While the primary endpoint of reducing overall mortality was not met, younger patients (65) showed improved respiratory function and lower mortality rates. A license agreement with Novartis for remestemcel-L’s development is also noted, pending trial result analysis.
Mesoblast Limited (Nasdaq: MESO) has provided an update on its pain management product, rexlemestrocel-L, targeting chronic low back pain (CLBP) due to degenerative disc disease. The company expects to meet with the FDA this quarter to discuss the regulatory pathway following a Phase 3 trial showing durable pain reduction for at least two years. Mesoblast aims to include EU patients in its upcoming U.S. trial, potentially streamlining regulatory processes. A collaboration with Grünenthal could yield up to $112.5 million in milestone payments.