mesoblast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases ASX: MSB; Nasdaq: MESO Financial Results and Operational Update for the Year Ended June 30, 2024 August 2024 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achieveme ...

Financial Data and Key Metrics Changes - As of June 30, 2024, the company's cash balance was $63.3 million, with an additional $10 million available from an existing facility contingent on FDA approval of RYONCIL [7] - The net operating cash usage for FY 2024 was $48.5 million, a 23% reduction from $63.3 million in FY 2023, with Q4 cash usage down to $10.2 million from $16.3 million in the prior comparative quarter [7][8] - The loss after tax for FY 2024 was $78.3 million, reflecting a $12.4 million improvement compared to FY 2023 [10] Business Line Data and Key Metrics Changes - The lead product RYONCIL is under FDA review for pediatric steroid-refractory acute graft-versus-host disease, with a PDUFA date set for January 7, 2025 [6][12] - Rexlemestrocel is being developed for multiple indications, including chronic low back pain and heart failure, with ongoing Phase 3 trials [6][20] - REVASCOR is being prepared for potential accelerated approval for heart failure in children and adults, with significant clinical trial results supporting its efficacy [20][28] Market Data and Key Metrics Changes - The company has established a leading position in allogeneic cellular medicines for inflammatory diseases, with over 1,000 patents granted or filed [3][4] - The potential market for RYONCIL includes approximately 30,000 patients undergoing allogeneic bone marrow transplants globally, with a significant unmet need in both pediatric and adult populations [11][12] Company Strategy and Development Direction - The company is focused on a go-to-market strategy for RYONCIL, emphasizing targeted commercialization due to the manageable size of the patient population [30] - Plans include engaging with payers for reimbursement strategies based on successful outcomes from previous trials and comparisons to CAR T therapies [31] - The company aims to leverage partnerships for commercialization in the US and Europe, particularly for the back pain product and cardiovascular indications [32][33] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in the past six months and the potential for FDA approvals, which could lead to the first commercial launch [29] - The company is actively engaging with the FDA regarding regulatory pathways for both pediatric and adult indications of REVASCOR, with plans for pre-BLA meetings to discuss data requirements [36][37] Other Important Information - The company has implemented cost control measures, including voluntary salary reductions for executives and deferral of cash payments for performance incentives until FDA approvals are secured [9][10] - The company has a robust clinical pipeline with multiple products in late-stage development, indicating a strong potential for future revenue generation [5][6] Q&A Session Summary Question: Can you discuss any potential partnerships or collaboration that could accelerate your commercialization effort? - The company has a go-to-market strategy for RYONCIL and is in discussions with payers regarding reimbursement, drawing parallels to CAR T therapies [30][31] - For the back pain product, a commercialization partner in Europe has been established, and similar relationships are being sought in the US [32] Question: When should we expect an update with respect to REVASCOR and the regulatory filing plans? - The company plans to discuss the pediatric indication with the FDA in the second half of the year, with a focus on leveraging the pediatric rare disease voucher designation [36] - Discussions regarding accelerated approval for adults will follow, based on the totality of data from previous studies [37]

NEW YORK, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended June 30, 2024. Mesoblast Chief Executive Silviu Itescu said: "During the past year we have built significant momentum in our interactions with the United States Food and Drug Administration (FDA) across each of our Phase 3 products. I am very pleased that our Bio ...

NEW YORK, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the full year ended June 30, 2024. Corporate Communications / Investors Media Paul Hughes BlueDot Media T: +61 3 9639 6036 Steve Dabkowski E: investors@mesoblast.com T: +61 419 880 486 E: steve@bluedot.net.au The webcast will begin at 6.30pm EDT, Wednesday, August 28; 8.3 ...

NEW YORK, July 30, 2024 (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 fourth quarter ended June 30, 2024. "We are executing on our go-to-market plan to bring Ryoncil to the many children suffering with the devastating disease of acute GVHD. I look forward to an activity update at our full year financials and investor call on August 28th 6.30pm EDT (August 29th ...

"Our BLA resubmission for approval of Ryoncil® (remestemcel-L) in the treatment of children with acute graft versus host disease (SR-aGVHD) was accepted as a complete response, we received feedback from FDA on the potential accelerated approval pathway for Revascor® (rexlemestrocel-L) in end-stage heart failure patients, and our confirmatory Phase 3 trial in inflammatory back pain is actively enrolling with a primary endpoint of pain reduction aligned with FDA." FDA informed Mesoblast at the end of March 20 ...

NEW YORK, July 21, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the confirmatory Phase 3 trial of its allogeneic, immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the United States. The ...

NEW YORK, July 08, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD. The filing comes after Mesoblast was informed by FDA at the end of March that, following additional consideration, the available clinical data from the Phase 3 study MSB-GVHD001 appears sufficient to support submission of ...

NEW YORK, July 08, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD. The filing comes after Mesoblast was informed by FDA at the end of March that, following additional consideration, the available clinical data from the Phase 3 study MSB-GVHD001 appears sufficient to support submission of th ...

NEW YORK, July 01, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today confirmed that it will file its Biologics License Application (BLA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroidrefractory acute graft versus host disease (SR-aGVHD) with the U.S. Food and Drug Administration (FDA) next week. About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic ...