Core Insights - Mesoblast has expanded coverage for its product Ryoncil® (remestemcel-L) to 104 million insured lives in the U.S. through government and commercial payers [1][2] - Ryoncil® is the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4] Coverage Expansion - 37 out of 51 states provide fee-for-service Medicaid coverage for Ryoncil®, covering 20 million lives, which is 80% of total Medicaid fee-for-service lives [2] - Mandatory coverage for an additional 24 million lives will begin on July 1, 2025 [2] - Commercial plans cover 84 million lives, excluding medical exceptions policies, indicating that the actual commercial coverage is likely higher [2] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [3] - The company is also developing additional therapies for other inflammatory diseases and conditions such as heart failure and chronic low back pain [5] Intellectual Property - Mesoblast holds a strong global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [6] Manufacturing Capabilities - The company has proprietary manufacturing processes that yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [7]

NEW YORK, April 03, 2025 (GLOBE NEWSWIRE) -- Mesoblast (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the status of its products in relation to the U.S. Government's announcement on tariffs for imported products. Mesoblast believes that its allogeneic cellular products, including Ryoncil® and Revascor®, will not be subject to the tariffs. Mesoblast develops allogeneic products based on its proprietary remestemcel-L and rexlemest ...

Core Viewpoint - Mesoblast Limited has been added to the S&P/ASX 200 Index, effective March 6, 2025, highlighting its significance in the Australian market as a leader in allogeneic cellular medicines for inflammatory diseases [1][2]. Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing its proprietary mesenchymal lineage cell therapy technology [3][5]. - The company has a strong intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection expected to last until at least 2041 in major markets [6]. Product Development - Mesoblast's RYONCIL® (remestemcel-L) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4]. - The company is developing additional therapies for various inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as rexlemestrocel-L for heart failure and chronic low back pain [5]. Manufacturing Capabilities - Mesoblast employs proprietary manufacturing processes that yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [7]. Market Presence - Mesoblast operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (ASX: MSB) and Nasdaq (NASDAQ: MESO) [8].

Silviu Itescu Good morning, everybody. I'm Silviu Itescu. I'm the Chief Executive of Mesoblast. Together with me this morning is Marcelo Santoro our Chief Commercial Officer; and Andrew Chaponnel, our Interim Chief Financial Officer. Today, we're presenting our financial results and operational update for the half year ended December 31, 2024. We could go to Slide 4, please. Mesoblast is the global leader in allogeneic cellular medicines for inflammatory diseases. We have one product already FDA approved, R ...

Financial Performance - Cash balance as of December 31, 2024, was US$38 million (A$61 million), with pro-forma cash approximately US$200 million (A$322 million) after a global private placement raising US$260 million (A$400 million) [20] - Total revenue for the half year ended December 31, 2024, was US$3.2 million, a slight decrease from US$3.4 million in the same period of 2023 [21] - Loss after tax for H1 FY2025 was US$47.9 million, compared to a loss of US$32.5 million in H1 FY2024, indicating a 47% increase in losses [24] - Net operating cash spend was US$20.7 million for H1 FY2025, a 22% reduction compared to H1 FY2024 [20] Research and Development - Research and development expenses increased to US$20.6 million in H1 FY2025 from US$12.6 million in H1 FY2024, reflecting a 63% increase [21] - Mesoblast plans to commence a Phase 3 trial of Ryoncil in adults with steroid-refractory acute graft-versus-host disease (SR-aGVHD), where 100-day survival rates were 73% after treatment [59] - The Phase 3 trial for Rexlemestrocel-L in chronic low back pain (CLBP) is actively enrolling 300 patients in a randomized, placebo-controlled study [82] Product Approvals and Efficacy - FDA approval of RYONCIL in December 2024 led to a US$23.0 million reversal of inventory provision, now recognized as an asset on the balance sheet [20] - RYONCIL is the first FDA-approved off-the-shelf cell therapy for pediatric patients aged 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD) [28] - RYONCIL delivered an overall response rate of 95% at Day 28 in a Phase 3 study, indicating strong efficacy in treating SR-aGvHD [32] - The wholesale acquisition cost (WAC) of RYONCIL is US$194,000 per intravenous infusion, regardless of body weight [45] Market Needs and Opportunities - There is a significant unmet need in pediatric inflammatory bowel disease (IBD), with over 60% of adult and pediatric Crohn's disease patients unable to achieve remission on anti-TNF agents [53] - The annual pediatric incidence of Crohn's disease in the U.S. is approximately 7,000 children, with a prevalence of 60,000-80,000 [54] - Chronic low back pain (CLBP) affects over 7 million patients in the U.S. and Europe, with minimal treatment options available for those refractory to conservative therapy [63] - Heart failure with low ejection fraction (HFrEF) affects approximately 6.5 million patients in the U.S., with a high mortality rate of about 50% at five years [70] Future Plans and Designations - Mesoblast expects to advance its multiple product pipeline toward FDA approvals over the next six to twelve months [82] - The FDA has granted REVASCOR Rare Pediatric Disease Designation and Regenerative Medicine Advanced Therapy designation, indicating its potential for treating serious conditions in children [80] - Ryoncil® will be available for use in steroid-refractory acute graft-versus-host disease (SR-aGvHD) at U.S. hospitals [82] - Studies for inflammatory diseases will commence for both pediatric and adult label extensions [82] - The company is preparing for accelerated approval filing for heart failure treatments [82] Intellectual Property - The company has an extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets [9]

Core Viewpoint - Mesoblast Limited (MESO) has shown a downtrend recently, losing 10.8% over the past week, but a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging to counteract selling pressure [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out, with reduced selling pressure, suggesting a bullish outlook for the stock [2][4]. - A hammer pattern forms when there is a small difference between opening and closing prices, with a long lower wick, indicating that the stock found support after hitting a new low during a downtrend [3][4]. - The occurrence of a hammer pattern at the bottom of a downtrend signals that bears may have lost control, indicating a potential trend reversal [4]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for MESO, which is a bullish indicator, as it typically leads to price appreciation [6]. - The consensus EPS estimate for MESO has increased by 2.5% over the last 30 days, reflecting analysts' agreement on the company's potential for better earnings [7]. - MESO currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which historically outperform the market [8].

Core Insights - Mesoblast Limited has appointed Dr. Gregory George, its largest shareholder, to the Board of Directors, which is expected to enhance the company's operational efficiency as it transitions into a commercial organization [1][3]. Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines aimed at treating severe inflammatory diseases, utilizing its proprietary mesenchymal lineage cell therapy technology [4]. - The company has a strong intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [7]. Leadership and Expertise - Dr. Gregory George has a background as a medical scientist and founded the largest privately owned ambulatory surgical center company in the U.S., bringing valuable operational experience to Mesoblast [2][3]. - The CEO, Dr. Silviu Itescu, emphasized that Dr. George's operational skills will be crucial for Mesoblast's growth and efficiency [3]. Product Development - Mesoblast's RYONCIL® (remestemcel-L) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease in pediatric patients aged 2 months and older [5]. - The company is developing additional therapies for various inflammatory diseases and conditions, including heart failure and chronic low back pain, leveraging its allogeneic stromal cell technology platforms [6]. Manufacturing Capabilities - Mesoblast employs proprietary manufacturing processes that yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8].

NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the progress of the U.S. commercial launch of Ryoncil® (remestemcel-L) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months and older and key upcoming milestones for its late-stage pipeline. "We are committed to making our FDA approved product Ryoncil® available as quickly as po ...

NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the second quarter ended December 31, 2024. ACTIVITY REPORT          On December 18, 2024, Ryoncil® (remestemcel-L) became the first mesenchymal stromal cell (MSC) therapy approved by U.S. FDA for any indication.FDA approved Ryoncil® as the first and only therapy for children aged 2 months and o ...

Shares of Mesoblast Limited (MESO) have soared 80% in one month following the FDA approval of remestemcel-L as the only approved therapy for steroid-refractory acute graft versus host disease (SR-aGVHD) in children aged two months and older, including adolescents and teenagers. The drug has a novel mechanism of action and will be marketed under the brand name Ryoncil in the United States.The approval gave Mesoblast its first approved product in its portfolio. Sales of the drug are expected to provide the co ...