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) reported its operational and financial highlights for the quarter ending December 31, 2022. The revenue from royalties on TEMCELL sales in Japan rose by 36% to US$1.9 million. The company reduced its net cash usage to US$16.5 million, a decrease of 9% year-over-year. Cash on hand was US$67.6 million, with an additional US$40 million available from financing facilities. Mesoblast plans to file the Biologics License Application (BLA) for remestemcel-L for treating children with steroid-refractory graft versus host disease, emphasizing urgent therapeutic needs. Additionally, preparations are underway for a pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain.
Mesoblast Limited (Nasdaq:MESO) announced on December 22, 2022, that Oaktree Capital Management has provided an additional US$30 million availability under a five-year facility, contingent on meeting milestones by September 30, 2023. The company previously drew US$60 million in November 2021. The facility has a 9.75% interest rate for three years, followed by principal amortization. As part of the agreement, Oaktree will receive warrants for 455,000 ADS at US$3.70 each, representing a 15% premium to the 30-day VWAP of US$3.22. Mesoblast specializes in allogeneic cellular therapies for inflammatory diseases.
Mesoblast Limited (NASDAQ: MESO) announced promising long-term survival data for remestemcel-L from its Phase 3 trial for children with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The study showed a 51% overall survival rate at 2 years, significantly higher than the 25-38% reported in recent studies using standard therapies. These results are key for the company's resubmission of the Biologics License Application (BLA) to the FDA, emphasizing remestemcel-L's potential as a life-saving treatment in a market with no approved therapies for children under 12.
Mesoblast Limited (ASX:MSB; Nasdaq:MESO) announced significant long-term survival outcomes for children with steroid-refractory graft versus host disease (SR-aGVHD) treated with remestemcel-L, reporting a 49% survival rate at four years. These results support the BLA resubmission to the FDA. Financial highlights include cash reserves of US$85.5 million and a 22% year-over-year reduction in net cash usage, totaling US$14.3 million. Revenue from royalties was US$1.4 million for the quarter. The company anticipates a potential US approval for remestemcel-L by mid-2023.
Mesoblast Limited (Nasdaq: MESO) reported its Q4 activity for the quarter ending September 30, 2022. The company achieved a net cash usage of US$14.3 million, a 22% reduction year-on-year. Cash reserves totaled US$85.5 million, bolstered by a US$45 million placement in August. Key updates include the resubmission of a Biologics License Application for remestemcel-L addressing steroid-refractory graft versus host disease and significant advancements in the rexlemestrocel-L program targeting chronic low back pain and heart failure.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) announced the submission of substantial new data to the FDA regarding its drug remestemcel-L, aimed at treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). This follows a Complete Response Letter from the FDA in September 2020. The submission signifies progress in the company’s FDA response and highlights the urgent need for effective treatments for SR-aGVHD, which has no approved options for children under 12. The drug is under Fast Track Designation and Priority Review by the FDA.
Mesoblast Limited (Nasdaq: MESO) reports financial results for FY2022, highlighting a cash position of US$60.4 million and pro-forma cash of US$105.5 million after a US$45 million private placement. Total revenue increased 37% to US$10.2 million, driven by royalties from TEMCELL® HS Inj.1 in Japan. The company anticipates BLA resubmission for remestemcel-L in children with SR-aGVHD this quarter and FDA meetings regarding rexlemestrocel-L for chronic heart failure. Significant cost reductions were achieved, with a 35% decrease in net operating spend, totaling US$65.8 million.
Mesoblast Limited (NASDAQ: MESO) will host a webcast on August 30, 2022, at 6:30 PM EDT to discuss operational highlights and financial results for Q4 and the full year ending June 30, 2022. As a leader in allogeneic cellular medicines for inflammatory diseases, Mesoblast has developed a range of late-stage product candidates targeting severe conditions, leveraging its proprietary cell therapy technology. The company maintains a robust intellectual property portfolio and has initiated commercial partnerships in Europe and China for specific product assets.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) has appointed Jane Bell as an Independent Non-Executive Director. Bell brings 22 years of corporate finance experience and diverse healthcare involvement. She is currently the Deputy Chair of Monash Health and has a history of director roles in major healthcare and funds management organizations. Bell expressed enthusiasm about Mesoblast's transition to a commercial entity, especially regarding its potential FDA approval for allogeneic cell therapy. Additionally, Shawn Tomasello is retiring from the Board after four years of service.
Mesoblast Limited (Nasdaq: MESO) reported its operational and financial highlights for the fourth quarter ended June 30, 2022. The company reduced net cash usage for operations by 33% to $13.9 million, with a total of $68.7 million for the year, down 38%. Revenues for Q4 increased 12% to $2.2 million, driven by TEMCELL® HS Inj. royalties. The firm prepares for a Biologics License Application resubmission to the FDA for remestemcel-L to treat children with steroid-refractory graft versus host disease, alongside promising results in COVID-19 and chronic heart failure trials.