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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 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.
On July 11, 2022, Mesoblast Limited (Nasdaq: MESO) announced that its investigational product rexlemestrocel-L for chronic heart failure (CHF) will be featured in a panel discussion on July 14, 2022, hosted by Maxim Group LLC. This therapy aims to reduce inflammation in HFrEF patients, addressing the high rates of cardiac events. With FDA Regenerative Medicine Advanced Therapy and Orphan Drug designations, rexlemestrocel-L is supported by two major placebo-controlled trials. Heart failure affects millions worldwide, presenting a significant market opportunity for Mesoblast's innovative therapies.
Mesoblast Limited (Nasdaq: MESO) announced a webinar on June 16, 2022, discussing chronic low back pain (CLBP) linked to degenerative disc disease.
CEO Silviu Itescu will review the Phase 3 trial results of rexlemestrocel-L, involving 404 patients over three years. Key Opinion Leaders, Douglas P. Beall and Hyun W. Bae, will also present. This event aims to address the treatment landscape and unmet needs in CLBP.
Registration for the webinar is required and will be accessible via Mesoblast's investor page.
Mesoblast Limited (NASDAQ: MESO) reported financial results for Q3 FY2022, highlighting a 40% reduction in operating cash usage to US$15.5 million compared to US$25.8 million last year. Revenue increased 5% to US$2.0 million, with royalties from TEMCELL® HS Inj. contributing US$1.9 million. Notably, cash on hand was US$76.8 million, with potential access to an additional US$40 million. The company is focused on resubmitting its Biologics License Application for remestemcel-L, with a successful mock pre-approval inspection recently completed.
Mesoblast Limited (Nasdaq: MESO) reported significant operational and financial updates for the quarter ending March 31, 2022. Net cash usage for operating activities decreased by 40% to $15.5 million, while revenues rose to $2.1 million, reflecting a 5% increase year-over-year. Notable leadership changes include the appointment of Philip R. Krause, M.D. to the Board, enhancing regulatory expertise. Key updates focus on the imminent BLA resubmission for remestemcel-L, targeting children with steroid-refractory acute graft versus host disease, alongside promising data from ongoing clinical trials in inflammatory bowel disease and COVID-19 ARDS.
On March 23, 2022, Mesoblast Limited (NASDAQ: MESO) announced the appointment of Dr. Philip R. Krause to its Board of Directors. Dr. Krause, former Deputy Director at the FDA’s Office of Vaccines Research, brings extensive regulatory experience to the company. His insights will be crucial as Mesoblast advances its lead products in the market. CEO Dr. Silviu Itescu expressed confidence in Dr. Krause's ability to support ongoing FDA interactions. Mesoblast specializes in allogeneic cell therapies targeting severe inflammatory conditions, leveraging a strong global intellectual property portfolio.
Mesoblast Limited (NASDAQ: MESO) announced financial results and operational updates for Q2 FY2022. The company secured a new $90 million debt facility, with cash on hand at $94.8 million. Notably, net cash usage declined 40% to $18.2 million. Revenues for the quarter totaled $2.4 million, up 7% year-over-year, primarily from TEMCELL® royalties in Japan. Mesoblast is preparing to resubmit its Biologics License Application (BLA) for remestemcel-L in treating steroid-refractory acute graft versus host disease in children, following positive feedback from the FDA regarding potency assays.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) will host a webcast on February 24, 2022, to review its operational highlights and financial results for Q2 2022. This event will start at 5 PM EST and will be archived on the Company’s website. Mesoblast specializes in allogeneic cellular medicines targeting inflammatory diseases, with products in late-stage development for conditions like graft versus host disease and chronic heart failure. Its strong IP portfolio extends to 2041, supporting a robust commercial pipeline.
Mesoblast Limited (NASDAQ: MESO) recently announced positive results from an interim analysis of the first patient cohort in a randomized controlled study of remestemcel-L for treating medically refractory ulcerative colitis and Crohn's colitis. The study, presented at the ECCO Congress, showed rapid mucosal healing and remission in patients receiving a single colonoscopic delivery of remestemcel-L. All patients reported satisfaction with the treatment, and significant improvements were observed in clinical scores and fecal calprotectin levels.
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