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Mesoblast Limited (ASX: MSB; NASDAQ: MESO) is a leading biotechnology company specializing in innovative cell-based medicines. Leveraging its proprietary mesenchymal lineage adult stem cells (MLCs) technology, Mesoblast has established a robust portfolio of advanced cellular medicines. These 'off-the-shelf' allogeneic products use cells from a single donor to treat multiple recipients, eliminating the need for cell matching.
In Japan, Mesoblast's licensee has launched an MLC-based product for acute graft versus host disease (aGVHD) in both children and adults. This marks the first fully approved allogeneic cell-based product in Japan. In the United States, Mesoblast is poised to have its first industrially manufactured allogeneic cell-based product approved.
Mesoblast's lead product candidates include MPC-150-IM for chronic heart failure, MPC-06-ID for chronic low back pain due to disc degeneration, and MSC-100-IV for acute graft versus host disease. The company's pipeline also features remestemcel-L for steroid-refractory aGVHD, moderate to severe acute respiratory distress syndrome (ARDS), and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic low back pain.
Mesoblast boasts a strong global intellectual property portfolio, ensuring protection until at least 2041 in major markets. The company's proprietary manufacturing processes produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, intended to be readily available worldwide. Two of its products have already been commercialized in Japan and Europe by its licensees.
Headquartered in Australia, with locations in the United States and Singapore, Mesoblast is listed on the Australian Securities Exchange and NASDAQ. For more information, visit the official website at www.mesoblast.com.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for rexlemestrocel-L, aimed at treating chronic low back pain (CLBP) linked to disc degeneration. This designation will expedite the development and regulatory review of the treatment, which has shown significant efficacy in a Phase 3 trial involving 404 patients. Key findings include substantial pain reduction over 36 months, especially for patients with shorter CLBP duration. The need for effective, opioid-sparing treatments for CLBP is critical, as this condition affects a significant portion of the US adult population.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) announces the resubmission of its Biologics License Application (BLA) for remestemcel-L to the FDA for treating children with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The resubmission includes new long-term survival data, showing 63% survival at 1 year and 51% at 2 years for treated children, which offers a significant improvement over traditional therapies. If approved, remestemcel-L will be the first treatment available for SR-aGVHD in children under 12, addressing a critical unmet need. The FDA has granted Fast Track and Priority Review designations for the application.
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.
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