# EDGAR Filing Document

**Accession Number:** 0001345099
**File Stem:** 0001345099-25-000101
**Filing Date:** 2025-11
**Character Count:** 34488
**Document Hash:** d17edb1456f1930fb1f14763f6b487cf
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001345099-25-000101.hdr.sgml**: 20251125

**ACCESSION NUMBER**: 0001345099-25-000101

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 32

**CONFORMED PERIOD OF REPORT**: 20251125

**FILED AS OF DATE**: 20251125

**DATE AS OF CHANGE**: 20251125

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** MESOBLAST LTD
- **CENTRAL INDEX KEY:** 0001345099
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** C3
- **FISCAL YEAR END:** 0630

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37626
- **FILM NUMBER:** 251515583

**BUSINESS ADDRESS:**
- **STREET 1:** LEVEL 38
- **STREET 2:** 55 COLLINS STREET
- **CITY:** MELBOURNE, VICTORIA
- **STATE:** C3
- **ZIP:** 3000
- **BUSINESS PHONE:** 613 9639 6036

**MAIL ADDRESS:**
- **STREET 1:** LEVEL 38
- **STREET 2:** 55 COLLINS STREET
- **CITY:** MELBOURNE, VICTORIA
- **STATE:** C3
- **ZIP:** 3000

**UNITED STATES <br>SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**Form 6-K** 

**Report of Foreign Private Issuer<br>Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934** 

**For the month of November 2025**

**Commission File Number 001-37626**

**Mesoblast Limited** 

(*Exact name of Registrant as specified in its charter*)

**Not Applicable**

(*Translation of Registrant's name into English)*

**Australia**<br>(*Jurisdiction of incorporation or organization)*

**Silviu Itescu**

**Chief Executive Officer and Executive Director**

**Level 38**

**55 Collins Street**

**Melbourne 3000**

**Australia** 

(*Address of principal executive offices*)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F:

Form 20-F ☑ Form 40-F ☐

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**INFORMATION CONTAINED ON THIS REPORT ON FORM 6-K**

On November 25, 2025, Mesoblast Limited filed with the Australian Securities Exchange the Chair's Annual General Meeting address and CEO presentation to Annual General Meeting, which are attached hereto as <u>Exhibit 99.1</u> and <u>Exhibit 99.2</u>, and are incorporated herein by reference.

On November 25, 2025, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement, which is attached hereto as <u>Exhibit 99.3</u>, and is incorporated herein by reference.

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**SIGNATURES** 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly organized.

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| |
|:---|
| <br>Mesoblast Limited |
| /s/ Paul Hughes |
| Paul Hughes |
| *Company Secretary* |

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Dated: November 25, 2025

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**INDEX TO EXHIBITS**

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| | |
|:---|:---|
| Item | |
| <u>[99.1](exhibit991.htm)</u> | Chair's Annual General Meeting address, dated November 25, 2025. |
| <u>[99.2](exhibit992.htm)</u> | CEO Presentation to Annual General Meeting, dated November 25, 2025. |
| <u>[99.3](exhibit993.htm)</u> | Press release of Mesoblast Ltd, dated November 25, 2025. |

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## Exhibit 99.1

![](exhibit991001.jpg)

CHAIR'S ADDRESS TO SHAREHOLDERS 2025 ANNUAL GENERAL MEETING Good morning shareholders. Welcome to the 2025 Mesoblast Annual General Meeting. Shareholders, it gives me great pleasure to address you in person following a groundbreaking year marked by tremendous progress since we achieved FDA approval for Ryoncil®, truly the greatest milestone in our Company's history. Ryoncil® was approved in December by the United States Food and Drug Administration for steroid- refractory acute graft-versus-host disease in children – the first mesenchymal stromal cell therapy ever approved by the FDA. This milestone is the culmination of many years of scientific, regulatory, and clinical excellence and commitment. I wish to extend my deepest gratitude to our Executive team led very capably and with great resilience by our Chief Executive Dr Silviu Itescu, and to our whole staff for their dedication, creativity, and persistence. The FDA approval of Ryoncil® is not simply a regulatory milestone: it is a turning point in our transition from development to commercialization, and a powerful validation of Mesoblast's scientific platform, manufacturing rigor, and clinical strategy. The commercial launch of Ryoncil® has been executed flawlessly with strong uptake to date and growing sales, which have exceeded our expectations. We are very pleased with the commercial and government reimbursement that is now in place, as we ensure that all children with this devastating disease have access to our life-saving treatment with payor coverage now extending to over 260 million lives in the U.S. as well as successful onboarding and physician adoption. While continuing to manage cash spend carefully, the Mesoblast management team is also expanding Ryoncil® use to additional indications in children and adults with severe inflammatory conditions, making this a very valuable franchise. Achieving a first FDA approval and demonstrating successful product commercialization provides important validation for our whole strategy and value chain of our technology platforms. The learnings from Ryoncil® are being adapted to the rest of the company's pipeline and will hold us in good stead as we work towards further FDA approvals for our cardiovascular and back pain indications for our second-generation stromal cell technology platform. I would like to acknowledge the unique skillsets of my fellow Board members, enhanced this year with the appointments of Dr Gregory George and Ms Lyn Cobley whose operational and financial guidance will be of immeasurable benefit to our management team. In the normal course of business and in line with our commitment to sound governance we will undertake succession planning and rotation of the Board in the coming twelve months to enhance U.S. commercial biotech experience, ensuring the right blend of expertise, tenure and renewal. Finally, to our shareholders — thank you for your patience, belief, and partnership in this journey. We are now a commercial company with an approved therapy, and I remain confident that you will see the compounding rewards of your support. About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Exhibit 99.1

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![](exhibit991002.jpg)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Mesoblast's Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com. Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets. About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast Forward-Looking Statements This press release 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 achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. Release authorized by the Chief Executive. For more information, please contact:

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![](exhibit991003.jpg)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Corporate Communications / Investors Paul Hughes T: +61 3 9639 6036 Media – Global Allison Worldwide Emma Neal T: +1 603 545 4843 E: emma.neal@allisonworldwide.com Media – Australia BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@bluedot.net.au

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## Exhibit 99.2

![](exhibit992001.jpg)

Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases November 2025 ASX: MSB; Nasdaq: MESO Annual General Meeting 2025 Exhibit 99.2

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![](exhibit992002.jpg)

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS This presentation includes forward-looking statements and forecasts 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 achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward- looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "could," and similar expressions or phrases identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and future events , recent changes in regulatory laws, and financial trends that we believe may affect our financial condition, results of operation, business strategy and financial needs. These statements may relate to, but are not limited to: expectations with respect to sales and revenue, expectations regarding the safety or efficacy of, or potential applications for, Mesoblast's adult stem cell technologies; expectations regarding the strength of Mesoblast's intellectual property, the timeline for Mesoblast's regulatory approval process, and the scalability and efficiency of manufacturing processes; expectations about Mesoblast's ability to grow its business and statements regarding its relationships with current and potential future business partners and future benefits of those relationships; statements concerning Mesoblast's share price or potential market capitalization; and statements concerning Mesoblast's capital requirements and ability to raise future capital, among others. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this presentation together with our financial statements and the notes related thereto, as well as the risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, include, without limitation: risks inherent in the development and commercialization of potential products; uncertainty of clinical trial results or regulatory approvals or clearances; government regulation; the need for future capital; dependence upon collaborators; and protection of our intellectual property rights, among others. Accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise. 2

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![](exhibit992003.jpg)

To be the world's leading and most innovative cell therapy company, commercializing off-the-shelf allogeneic cellular medicines to treat serious and life-threatening inflammatory illnesses Our Mission 3

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![](exhibit992004.jpg)

• Continue strong growth in RYONCIL® sales driven by market adoption • Work towards profitability through strong cash flow, judicious use of funds for operations, optimal capital structure • Culture transition to efficient commercial organization (e.g. new Chief Financial Officer, Chief Commercial Officer, new commercial US director) • Expand RYONCIL (remestemcel-L-rknd) label indications and obtain approval for rexlemestrocel-L products • US manufacturing focus to provide increased capacity and cost efficiencies • Appropriate commercial partnering backed by demonstrable value drivers (FDA approval, payer reimbursement, strong revenues) Execution Strategy 4

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![](exhibit992005.jpg)

• Received U.S. FDA approval RYONCIL December 2024 • RYONCIL is the first and only FDA-approved allogeneic mesenchymal stromal cell (MSC) product • Launched April 2025, with revenues growing quarter on quarter • Gross revenue from RYONCIL US$22 million in Q1 FY26 • Expect >US$30 million gross revenue from RYONCIL Q2 FY26 • Initial demand indicates significant unmet need 2025: Approval & Successful Launch 5

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![](exhibit992006.jpg)

Net operating cash usage for Q1 FY26 was $14.9 million Working towards profitability through strong cash flow and judicious use of funds for operations Operating plan includes spend on Phase 3 programs, manufacturing for BLA filing and commercial inventory Retire/refinance existing debt Strong Financial Position Cash balance US$145M at Sep 30, 2025 6

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![](exhibit992007.jpg)

• Team continues to deliver in a highly resilient and agile manner • Capitalize on embedded culture of efficiency, accountability and growth • Expand executive leadership with commercial operational management skills (e.g. new CFO, CCO) • Complement existing Board with global commercial expertise Leadership to Deliver Commercial Excellence CFO: Chief Financial Officer \| CCO: Chief Commercial Officer7

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![](exhibit992008.jpg)

Growth Pipeline Targeting Multiple Inflammation-Based Indications aGVHD: acute graft versus host disease \| TAM: total addressable market \| ARDS: acute respiratory distress syndrome \| COPD: chronic obstructive pulmonary disease \| HFrRF: heart failure reduced ejection fraction \| OA: osteoarthritis Adult aGvHD Pivotal trial as part of second-line regimen TAM children & adults ~US$1B Cardiac HFrEF Ischemic chronic heart failure with inflammation TAM >US$10B Chronic Low Back Pain with degenerative disc disease; confirmatory Phase 3 trial enrolling TAM >US$10B Other Musculoskeletal diseases including knee, hip, shoulder OA Inflammatory Colitis Biologic refractory inflammatory colitis with high risk of colectomy RYONCIL Remestemcel-L Rexlemestrocel-L Inflammatory Lung Disease Clinical data in ARDS, COPD 8

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![](exhibit992009.jpg)

Objectives are to meet projected growth in demand through: • Establishing diversified manufacturing • Focusing on process innovation to increase yield & reduce COGS • Scaling manufacturing operations in U.S. Optimizing & diversifying manufacturing COGS: cost of goods \| CHF: chronic heart failure \| CLBP: chronic low back pain Commercial product for CHF & CLBP to be manufactured in the U.S. 9

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![](exhibit992010.jpg)

• Objectives to unlock pipeline value and accelerate market access • FDA approval and know-how provides confidence for partner investment in development and label expansion • Strong revenues and payer engagement demonstrates pipeline value and enhances shareholder return • Co-development and co-promotional activities will ensure appropriate value retention and returns Strategic Partnerships 10

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![](exhibit992011.jpg)

RYONCIL® Update Steroid-Refractory Acute Graft Versus Host Disease (SR-aGvHD)

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![](exhibit992012.jpg)

Press Release available at www.mesoblast.com 1. Please see the full Prescribing Information at www.ryoncil.com RYONCIL® is the first FDA-approved, off- the-shelf cell therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR- aGvHD), a life-threatening condition with high mortality rates.1

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![](exhibit992013.jpg)

>40 centers onboarded 45 centers ≈ 80% of pediatric BMTs >260 million US lives covered under insurance Specific HCPCS J-Code was assigned by CMS Patient hub established Success of Commercial Launch Expect >US$30M this quarter gross revenue BMT: bone marrow transplant \| HCPCS: Healthcare Common Procedure Coding System \| CMS: Centers for Medicare & Medicaid Services13

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![](exhibit992014.jpg)

Pivotal study of RYONCIL on top of approved second-line therapy in adults with severe SR-aGvHD Working with NIH-funded BMT-CTN, to initiate next quarter Primary endpoint is Day 28 response 44-58% adults with severe SR-aGvHD fail second-line agents, and these have survival of only 25% through 100 days1-3 Significant cross-over of sites already onboarded for use of RYONCIL in children Label Expansion into Adults SR-aGvHD: steroid-refractory acute graft versus host disease \| NIH: National Institute of Health \| BMT CTN: Bone & Marrow Transplant Clinical Trials Network Use of RYONCIL under EAP in patients aged 12 and older with SR-aGvHD who failed ruxolitinib or other second-line agents was associated with 76% survival at Day 1004 RYONCIL in Adult aGvHD 1. Jagasia M, et al. Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial. Blood. 2020 May 14; 135(20): 1739–1749; 2. Abedin S, et al. Ruxolitinib resistance or intolerance in steroid-refractory acute graft versus-host disease — a real-world outcomes analysis. British Journal of Haematology, 2021;195:429–43; 3. Zeiser R, et al. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med 2020;382:1800-1810; 4. Kurtzberg J, et al. Ryoncil (Remestemcel-L) for Third-Line Treatment of SR-aGvHD in Adolescents and Adults [Poster presentation]. 2025 Transplantation & Cellular Therapy Tandem Meetings 14

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![](exhibit992015.jpg)

Label expansion targeting biologic-refractory moderate/severe inflammatory colitis Major unmet need across the adult and pediatric population with high risk of colectomy >3 million people in US alone have IBD with ~15%- 20% on a biologic therapy KOLs engaged on protocol. Plan to file an IND in Q1 CY26 and initiate a study for label expansion Inflammatory Colitis Local administration improves outcomes in patients with biologic- refractory extensive colitis1 RYONCIL in Colitis 1. Lightner A, et al. Abstracts of the 17th Congress of ECCO - European Crohn's and Colitis Organisation. Poster P428. KOL: key opinion leader \| IND: Investigational New Drug application (with FDA) 15

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![](exhibit992016.jpg)

Increase revenue growth to fund multiple label expansion opportunities in pediatric and adult inflammatory diseases Commence registrational study in Q1 CY26 in adults with severe aGvHD to gain access to a market 3-4 times larger File an IND for inflammatory colitis in children & adults in Q1 CY26 and prepare for study commencement in this large opportunity with high unmet Milestones for RYONCIL aGvHD: acute graft versus host disease \| IND: Investigational New Drug application (with FDA) 16

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![](exhibit992017.jpg)

Rexlemestrocel-L Update Chronic Low Back Pain due to Degenerative Disc Disease (CLBP)

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![](exhibit992018.jpg)

First 404-patient randomized controlled Phase 3 trial completed Actively recruiting a 300-patient confirmatory Phase 3 trial across 40 sites in the U.S., primary endpoint 12-month reduction in pain Enrollment expected to be completed in the coming quarter Data readout & BLA filing expected CY27 Commercial manufacturing in U.S. to leverage existing capacity and cost efficiencies Phase 3 CLBP Program On Track >7m patients (est.) suffer from CLBP due to DDD in each of the U.S. and E.U.51-3 CLBP: chronic low back pain \| BLA: Biologics License Application (FDA) \| DDD: degenerative disc disease 1. Decision Resources: Chronic Pain December 2015; 2. LEK & NCI opinion leader interviews, and secondary analysis; 3. Navigant: Commercial Assessment for a Proprietary Cell-Based Therapy for DDD in the U.S. and the EU3 – August 2014 18

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![](exhibit992019.jpg)

Rexlemestrocel + HA Reduces And Eliminates Opioid Use In Phase 3 Trial 19 • Of the 168 patients on opioids in prior Phase 3 trial, a single intra-discal injection of rexlemestrocel-l + HA significantly reduced pain at 12, 24 and 36 months • Pain reduction at 12 months predicted reduction in opioid usage at both 12 and 24 months (p=0.018 and p=0.029, respectively) • 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) • RMAT received for rexlemestrocel-L as potential opioid-sparing therapy in CLBP • September 2025 FDA Draft Guidance on Non-Opioid Analgesics for Chronic Pain: FDA considers opioid elimination an endpoint in itself • Mesoblast to meet with FDA Dec-25 to discuss opioid elimination data from first RCT

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![](exhibit992020.jpg)

REVASCOR® Update (rexlemestrocel-L) Chronic Heart Failure with Reduced Ejection Fraction (HFrEF) and Persistent Inflammation 20

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![](exhibit992021.jpg)

Aligned with FDA on items required for filing BLA for end-stage CHF with LVADs regarding CMC potency assays for commercial product release Commercial manufacturing scale-up in U.S. for capacity, cost efficiencies, and diversification Expect to file BLA for Accelerated Approval Q1 CY26 Aligned with FDA on proposed design and primary endpoint for the confirmatory trial post-approval Strategic partnership discussions for cardiovascular program ongoing CHF Program Update CHF: Chronic Heart Failure \| LVAD: left ventricular assist device \|CMC: chemistry, manufacturing, and controls \| BLA: Biologics License Application (FDA) 21

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![](exhibit992022.jpg)

RYONCIL, first & only FDA approved MSC product ✓On track for gross revenue >US$30 million this quarter ✓Onboarded >40 centers; 45 centers account for ~80% of U.S. pediatric BMTs ✓Initiating label expansion to adult aGvHD; 3-4x larger market v. pediatric ✓Inflammatory colitis trial IND filing Q1 CY26 Rexlemestrocel-L second generation platform ✓Enrollment for CLBP for expected to complete in Q1 CY26 ✓BLA filing for accelerated approval in end-stage CHF with LVADs Optimizing manufacturing & logistics in U.S. to support for future growth US$145m cash on hand at Sep 30, 2025 Management to host investor R&D day in Q1 CY26 Summary & Upcoming Milestones 22

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![](exhibit992023.jpg)

Thank You

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## Exhibit 99.3

![](exhibit993001.jpg)

MESOBLAST TRADING UPDATE AT ANNUAL GENERAL MEETING HIGHLIGHTS CONTINUED STRONG GROWTH IN RYONCIL® REVENUE Melbourne, Australia; November 25 and New York, USA; November 24, 2025: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today provided a trading update, together with a comprehensive operational overview, as part of the Chief Executive's Annual General Meeting (AGM) address. For the quarter ending December 31, 2025, management expects gross revenue of more than US$30.0 million from sales of Ryoncil® (remestemcel-L-rknd). This represents more than 37% increase on the US$21.9 million in gross revenue from Ryoncil® in the prior quarter ended September 30, 2025. About Mesoblast Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company's proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process. Mesoblast's Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com. Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China. About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets. About Mesoblast manufacturing: The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast Forward-Looking Statements This press release includes forward-looking statements and forecasts 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 achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast's preclinical and clinical Exhibit 99.3

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![](exhibit993002.jpg)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;studies, and Mesoblast's research and development programs; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast's ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast's RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast's product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast's ability to enter into and maintain established strategic collaborations; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast's expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast's financial performance; developments relating to Mesoblast's competitors and industry; and the pricing and reimbursement of Mesoblast's product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise, except where required by law or the ASX Listing Rules. Past performance given in this announcement is given for illustrative purposes only and should not be relied on as (and is not) an indication of future performance. Not financial product advice This announcement does not constitute financial product advice or investment advice (nor tax, accounting or legal advice) and has been prepared without taking into account the objectives, financial situation or needs of individuals. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs and seek appropriate professional advice. Disclaimer To the maximum extent permitted by law, Mesoblast and its directors, officers, employees, advisers and agents disclaim any obligation or undertaking to release any updates or revisions to the information to reflect any change in expectations or assumptions, and disclaim all responsibility and liability for these forward-looking statements (including, without limitation, any liability for negligence). Release authorizedby the Chief Executive. For more information, please contact: Corporate Communications / Investors Paul Hughes T: +61 3 9639 6036 Media – Global Allison Worldwide Emma Neal T: +1 603 545 4843 E: emma.neal@allisonworldwide.com Media – Australia BlueDot Media Steve Dabkowski T: +61 419 880 486 E: steve@bluedot.net.au

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