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Mesoblast (MESO) - 2025 Q1 - Quarterly Report
2024-10-18 01:44
Exhibit 99.1 ¶mesoblast ANNUALREPORT 2024 GLOBAL LEADER IN ALLOGENEIC CELLULAR MEDICINES FOR INFLAMMATORY DISEASES CONTENTS CORPORATE GOVERNANCE Mesoblast Limited and its Board of Directors are committed to implementing and achieving an effective corporate governance framework to ensure that the Company is managed effectively and in an honest and ethical way. The Company's Corporate Governance Statement for the financial year ending 30 June 2024 has been approved by the Board and is available on our website ...
Mesoblast Option to Issue Up to US$50 Million Convertible Notes for Product Launch
GlobeNewswire News Room· 2024-09-30 00:55
NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has entered into a convertible note subscription agreement with its largest shareholder Gregory George ("Investor") for issue, at its sole discretion, up to US$50.0 million (A$72.7 million) convertible notes on approval by the United States Food and Drug Administration (FDA) of Mesoblast's lead product candidate Ryoncil® (remestem ...
Mesoblast (MESO) - 2024 Q4 - Annual Report
2024-08-29 11:14
mesol CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future financial performance and involve known and unknown risks, uncertainties and results. levels of activity, performance or achievements to differ materially from any future results. Ievels of activity, performance or achievements expressed or implied such forward- tooking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 ...
Mesoblast (MESO) - 2024 Q4 - Annual Report
2024-08-29 10:09
Financial Performance - Revenue for FY24 was US$5.9 million, a decrease of 21% compared to US$7.5 million in FY23[551]. - Loss before income tax for FY24 was US$88.1 million, compared to US$82.1 million in FY23[551]. - Market capitalization increased by A$206 million (22%) to A$1,130 million as of June 30, 2024, from A$924 million in the previous year[551]. - The company successfully reduced net operating cash usage by 23% in FY24 compared to FY23[553]. - Mesoblast raised US$40 million in December 2023 and US$25 million in March 2024 to strengthen its balance sheet[553]. Cash Flow and Funding - As of June 30, 2024, the company held total cash reserves of $63.0 million, with net cash usage for operating activities reduced by 23% to $48.5 million compared to the previous year[485]. - Net cash outflows in operating activities decreased by $14.8 million from $63.3 million in the year ended June 30, 2023, to $48.5 million in 2024[487]. - Net cash inflows from financing activities decreased by $34.2 million, primarily due to reduced proceeds from private placements[491]. - The company expects to continue incurring losses as it develops and seeks regulatory approvals for its cell-based product candidates, necessitating substantial additional funding[492]. Regulatory and Product Development - The company anticipates significant milestones in the upcoming financial year related to its lead product candidates, with a BLA for remestemcel-L resubmitted to the FDA and a PDUFA goal date set for January 7, 2025[482]. - The FDA supports an accelerated approval pathway for rexlemestrocel-L in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD)[520]. - The confirmatory Phase 3 trial of rexlemestrocel-L for chronic low back pain (CLBP) has commenced enrollment at multiple sites across the United States[522]. - The company resubmitted its Biologics License Application (BLA) for remestemcel-L for pediatric patients with SR-aGVHD, which was accepted by the FDA in July 2024[552]. - Mesoblast entered into an agreement to develop a pivotal trial of remestemcel-L in adults with SR-aGVHD with the Blood and Marrow Transplant Clinical Trials Network[555]. Executive Compensation and Remuneration - The CEO and CMO volunteered a 30% base salary reduction for 12 months, with an option grant approved by shareholders to align their interests with those of shareholders[523]. - The Board decided against awarding any increases to fixed remuneration prior to FDA approval for pediatric SR-aGVHD[524]. - The short-term incentive (STI) key performance indicator performance for FY24 achieved 100% of maximum, but payment is deferred until FDA marketing authorization is obtained[528]. - The remuneration framework received a 94% approval vote from investors at the 2023 AGM, reflecting positive reception of the responsible management of remuneration[525]. - Total statutory remuneration for executive directors in FY24 was A$5,311,610, representing a 66% increase from FY23's A$3,200,854[571]. Employee and Diversity Metrics - As of June 30, 2024, 52% of the company's employee base were female, and 30% of senior executives were female, indicating a commitment to diversity[547]. - The company has only 73 employees, with 57% based in the US, emphasizing the importance of retaining top talent for achieving long-term goals[536]. - The breakdown of employees includes 30 in Research & Development, 4 in Manufacturing, and 39 in Corporate roles in the USA[635]. Risk Management - The company is subject to interest rate risk, share price risk, price risk, and foreign currency exchange risk, with sensitivity analyses conducted to assess these risks[475]. - The company has established a risk management policy to identify and control material risks[629]. Board and Governance - The board of directors consists of seven members, including two executive directors: Silviu Itescu and Eric Rose[621]. - The Audit and Risk Committee oversees auditing and accounting matters, including the selection of independent accountants[628]. - The Nomination and Remuneration Committee is responsible for board appointments and executive remuneration frameworks[627]. - The board aims for a majority of independent directors, adhering to ASX's Corporate Governance Principles[623].
Mesoblast (MESO) - 2024 Q4 - Earnings Call Transcript
2024-08-29 01:04
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]
Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2024
GlobeNewswire News Room· 2024-08-28 23:27
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 ...
Mesoblast Financial Results and Corporate Update Webcast
GlobeNewswire News Room· 2024-08-27 23:25
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 ...
Patient Enrollment Commenced in Pivotal Phase 3 Trial of Rexlemestrocel-L for Chronic Low Back Pain
GlobeNewswire News Room· 2024-07-22 00:45
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 ...
Mesoblast Resubmits Biologics License Application (BLA) with United States Food & Drug Administration (FDA) for Approval of Ryoncil® in Children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)
Newsfilter· 2024-07-09 00:37
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 ...
Mesoblast Resubmits Biologics License Application (BLA) with United States Food & Drug Administration (FDA) for Approval of Ryoncil® in Children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)
GlobeNewswire News Room· 2024-07-09 00:37
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 ...