Core Insights - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases and is participating in the Piper Sandler 37th Annual Healthcare Conference in New York from December 2–4, 2025 [1][2] Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [3] - The company has a strong intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection extending through at least 2044 in major markets [6] Product Development - Mesoblast's Ryoncil (remestemcel-L-rknd) 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 these therapies are readily available to patients worldwide [7] Global Presence - The company operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (MSB) and Nasdaq (MESO) [8]

Core Viewpoint - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases and is participating in the Piper Sandler 37th Annual Healthcare Conference in New York from December 2–4, 2025 [1][2]. Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [3]. - The company has a strong intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection until at least 2044 in major markets [6]. Product Development - Mesoblast's Ryoncil® (remestemcel-L-rknd) 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 these therapies are readily available to patients worldwide [7]. Corporate Presence - Mesoblast operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (MSB) and Nasdaq (MESO) [8].

Core Viewpoint - Mesoblast Limited, a leader in allogeneic cellular medicines for inflammatory diseases, provided a trading update and operational overview during the Chief Executive's Annual General Meeting, highlighting significant revenue growth and ongoing development of its therapies [1][2]. Financial Performance - For the quarter ending December 31, 2025, Mesoblast expects gross revenue exceeding US$30.0 million from Ryoncil sales, marking a more than 37% increase from US$21.9 million in the previous quarter [2]. Product Overview - Ryoncil (remestemcel-L-rknd) 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 also developing Ryoncil for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease [5]. Technology and Intellectual Property - Mesoblast has a robust global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection until at least 2044 in major markets [6]. - The proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [7]. Global Presence - Mesoblast operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (MSB) and Nasdaq (MESO) [8].

Core Viewpoint - Mesoblast Limited, a leader in allogeneic cellular medicines for inflammatory diseases, provided a trading update and operational overview during the Chief Executive's Annual General Meeting, highlighting significant revenue growth and ongoing development of its therapies [1][2]. Financial Performance - For the quarter ending December 31, 2025, Mesoblast expects gross revenue exceeding US$30.0 million from Ryoncil® sales, marking a more than 37% increase from US$21.9 million in the previous quarter [2]. Product Overview - Ryoncil® (remestemcel-L-rknd) 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 also developing Ryoncil® for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while rexlemestrocel-L is being developed for heart failure and chronic low back pain [5]. Intellectual Property - Mesoblast holds a robust global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection extending to at least 2044 in major markets [6]. Manufacturing Capabilities - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [7]. Global Presence - Mesoblast operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (MSB) and Nasdaq (MESO) [8].

RYONCIL (remestemcel-L-rknd) - RYONCIL received U S FDA approval in December 2024[10] - RYONCIL is the first and only FDA-approved allogeneic mesenchymal stromal cell (MSC) product[10] - Gross revenue from RYONCIL was US$22 million in Q1 FY26 and is expected to be >US$30 million in Q2 FY26[10] - Over 40 centers have been onboarded, with 45 centers accounting for approximately 80% of U S pediatric BMTs[26,41] - A pivotal study of RYONCIL in adults with severe SR-aGvHD is planned, targeting a market 3-4 times larger than the pediatric market[28,41] - An IND filing for inflammatory colitis in children & adults is planned for Q1 CY26[30,41] Rexlemestrocel-L - Enrollment for the confirmatory Phase 3 trial for Chronic Low Back Pain (CLBP) is expected to be completed in Q1 CY26[36,41] - A BLA filing for accelerated approval in end-stage Chronic Heart Failure (CHF) with LVADs is expected[40,41] - By 36 months, 28% of opioid users who received rexlemestrocel-L + HA were able to eliminate all opioids compared with 8% of saline controls (p=0 0083)[38] Financial Status and Manufacturing - The company had a cash balance of US$145 million as of September 30, 2025[11] - The company is optimizing manufacturing and logistics in the U S to support future growth[41]

Core Insights - Mesoblast Limited is collaborating with the NIH-funded Blood and Marrow Transplant Clinical Trials Network to conduct a pivotal trial of Ryoncil for adults with severe steroid-refractory acute graft versus host disease (SR-aGvHD) [1][2][3] - The trial aims to address the high mortality rates in patients who do not respond to corticosteroids, with survival rates as low as 20-30% by Day 100 after failing ruxolitinib [2] - Ryoncil has shown promising results in pediatric patients, with a 76% survival rate at Day 100 in adults who failed other treatments [2][5] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing a proprietary mesenchymal lineage cell therapy technology platform [4][6] - The company has a strong intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 [7] - Mesoblast is expanding its product offerings, with Ryoncil being developed for additional indications beyond SR-aGvHD, including biologic-resistant inflammatory bowel disease and heart failure [6] Clinical Development - The pivotal trial for Ryoncil will randomize patients as early as possible after corticosteroid refractoriness, comparing ruxolitinib alone versus ruxolitinib combined with Ryoncil [3] - The trial protocol is set to be submitted to the FDA to initiate enrollment in the first quarter of 2026 [3] - The collaboration with BMT CTN is significant as it represents U.S. centers performing approximately 80% of all U.S. allogeneic bone marrow transplants [1][10]

Summary of Mesoblast Conference Call Company Overview - **Company**: Mesoblast (NasdaqGS:MESO) - **Industry**: Allogeneic cellular medicines for inflammatory diseases - **Recent Milestone**: FDA approval received in December 2024, leading to significant developments in the company’s operations and product offerings [4][18] Key Points Discussed Leadership Changes - **New CFO Appointment**: Jim O'Brien appointed as CFO, bringing 25 years of experience in the pharmaceutical and biotech industries [6][14] Product Development and Trials - **Chronic Back Pain Product**: - Ongoing phase three trial enrolling 300 patients, expected to complete enrollment by March 2026 [18][21] - RMAT designation received, indicating a focus on non-opioid solutions for chronic pain, aligning with FDA's guidance on addressing the opioid crisis [18][19] - Data from a previous trial showed that 40% of patients on opioids at baseline had significant reductions in opioid use after treatment [20] - **Ryoncil Commercialization**: - Revenue for the September quarter reached approximately $22 million, with strong adoption from major transplant centers [33][35] - J code established for reimbursement, providing hospitals with pricing certainty and facilitating product adoption [38][40] Future Plans and Market Opportunities - **Label Expansion**: - Plans to initiate trials for adult use of Ryoncil in bone marrow transplant patients and inflammatory bowel diseases [41][50] - Collaboration with NIH for adult trials, with expectations for significant impact on patient outcomes [41][42] - **Heart Failure Product**: - Targeting a market of approximately 1 million patients in the U.S. with ischemia and inflammation [53] - Plans for accelerated approval in patients with LVAD, with a confirmatory study to follow in a larger patient population [53][54] Strategic Focus Areas - **2026 Priorities**: - Revenue growth and expansion into adult markets - Initiation of inflammatory bowel disease studies - Completion of the adult back pain trial and FDA filing for accelerated approval [58][59] Additional Insights - **Regulatory Environment**: The FDA's recent guidance encourages the development of non-opioid drugs, which aligns with Mesoblast's product strategy [54][55] - **Market Dynamics**: The opioid crisis remains a significant concern, with a high number of deaths attributed to opioid overdoses, emphasizing the need for alternative treatments [54] This summary encapsulates the critical developments and strategic directions discussed during the conference call, highlighting Mesoblast's commitment to addressing significant medical needs through innovative therapies.

Core Insights - Mesoblast Limited has appointed James M. O'Brien as the new Chief Financial Officer (CFO) to support its transition to a fully integrated commercial organization [1][2] - The company aims to enhance its financial leadership as it commercializes its product Ryoncil and seeks label expansion [2] Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing proprietary mesenchymal lineage cell therapy technology [3] - The company has a strong intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 in major markets [6] Product Development - Ryoncil (remestemcel-L-rknd) 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] - Mesoblast is developing additional therapies for various inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as heart failure and chronic low back pain [5] Financial Leadership - James M. O'Brien brings extensive experience in financial management from previous roles at Actavis plc, Cognition Therapeutics, and Faron Pharmaceuticals, among others [2] - His expertise includes overseeing corporate finance, reporting, internal controls, and accounting operations, with a history of managing transactions totaling nearly $10 billion [2]

Core Insights - Mesoblast Limited has appointed James M. O'Brien as the new Chief Financial Officer (CFO) to support its transition to a fully integrated commercial organization [1][2] - The company aims to enhance its financial leadership as it commercializes its product Ryoncil® and seeks label expansion [2] Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing proprietary mesenchymal lineage cell therapy technology [3] - The company has a strong intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 in major markets [6] Product Information - Ryoncil® 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] - Mesoblast is developing additional therapies for various inflammatory diseases and conditions, including heart failure and chronic low back pain [5] Financial Leadership - James M. O'Brien brings extensive experience in financial management from previous roles at Actavis plc, Cognition Therapeutics, Inc., and Faron Pharmaceuticals, among others [2] - His expertise includes overseeing corporate finance, reporting, internal controls, and accounting operations, with a history of managing transactions totaling nearly $10 billion [2]

Core Viewpoint - Mesoblast Limited (MESO) has experienced a bearish trend recently, losing 12.3% over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be increasing [1][2]. Technical Analysis - The hammer chart pattern indicates a potential bottom in the stock price, suggesting that selling pressure may be exhausting and that bulls could be gaining control [2][5]. - A hammer pattern forms when there is a small candle body with a long lower wick, typically occurring during a downtrend, signaling a possible reversal if it appears at the bottom of the trend [4][5]. - The effectiveness of the hammer pattern is enhanced when used alongside other bullish indicators, as its strength is dependent on its placement on the chart [6]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for MESO, which is a bullish indicator suggesting potential price appreciation in the near term [7]. - The consensus EPS estimate for MESO has increased by 0.6% over the last 30 days, indicating that analysts expect better earnings than previously predicted [8]. - MESO currently holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10].