Washington, D.C. 20549

 Form 6-K

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

For the month of May 2019

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
(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 ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Yes ☐ No ☑

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

Yes ☐ No ☑

 

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INFORMATION CONTAINED ON THIS REPORT ON FORM 6-K

On May 31, 2019, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement and investor presentation, which are attached hereto as Exhibit 99.1 and Exhibit 99.2, and are 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.

Dated: May 31, 2019

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INDEX TO EXHIBITS

 

 

Exhibit 99.1

 

 

MESOBLAST REPORTS FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

FOR THE PERIOD ENDED MARCH 31, 2019

 

Major corporate milestone achieved in initiating BLA filing with FDA for Mesoblast’s cell therapy in the treatment of acute graft versus host disease

 

 

Melbourne, Australia, May 31, 2019 and New York, USA, May 30, 2019: Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today reported its financial results and operational highlights for the nine months ended March 31, 2019. Financial results for the period are in line with expectations including the Company’s cash position at March 31, 2019 of US$70.4 million (A$99.3 million).

 

Mesoblast Chief Executive Dr Silviu Itescu stated: “We achieved a significant corporate milestone by initiating our first BLA submission to the FDA. We will focus our efforts on launch activities in preparation for our first product roll-out in the United States, and on our supply chain to meet the projected market demand for this and our follow-on products.”

 

Recent Corporate Highlights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Key Financial Highlights for the Nine Months of FY2019:

 

 

 

 

 

Upcoming Milestones

 

Key milestones anticipated for CY2019 include:

 

 

 

 

 

Detailed Financial Results for the Nine Months Ended March 31, 2019 (nine months of FY2019):

 

 

 

 

 

 

 

 

 

 

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Additional components of loss after income tax also include movements in other items which did not impact current cash reserves, such as income tax benefits, fair value remeasurement of contingent consideration, remeasurement of borrowing arrangements and foreign exchange movements within other operating income and expenses.

 

In the nine months of FY2019, the net loss attributable to ordinary shareholders was 14.02 cents per share for the nine months of FY2019, compared with a loss per share of 3.12 cents for the nine months of FY2018. There was

an after tax loss of US$69.1 million compared to $14.5 million for the nine months of FY2018. The increase in the loss is primarily due to commercial manufacturing investment of US$9.5 million to support potential launch for aGVHD product, and an increase of US$7.5 million in finance costs. In the comparative period of FY2018, the Company recognized a one-off non-cash income tax benefit of US$23.0 million due to a revaluation of tax liabilities given changes in tax rates and a non-cash US$7.9 million gain on remeasurement of contingent consideration for reduction of future payments to third parties.

 

¹TEMCELL^® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.

 

Conference Call Details

There will be a webcast today on the financial results beginning at 6.30pm on Thursday May 30, 2019 EDT; 8:30am on Friday May 31, 2019 AEST.  

 

The live webcast can be accessed via

https://webcasting.boardroom.media/broadcast/5ce635514b5ab5633996c030

 

To access the call only, dial 1 855 881 1339 (U.S.), 1 800 558 698 (toll-free Australia) or +61 2 9007 3187 (outside of the U.S. and Australia). The conference identification code is 10000574.

 

The archived webcast will be available on the Investor page of the Company’s website: www.mesoblast.com

 

About Mesoblast

Mesoblast Limited (ASX: MSB; Nasdaq: MESO) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary technology platform to establish a broad portfolio of late-stage product candidates with three product candidates in Phase 3 trials – acute graft versus host disease, chronic heart failure and chronic low back pain due to degenerative disc disease. Through a proprietary process, Mesoblast selects rare mesenchymal lineage precursor and stem cells from the bone marrow of healthy adults and creates master cell banks, which can be industrially expanded to produce thousands of doses from each donor that meet stringent release criteria, have lot to lot consistency, and can be used off-the-shelf without the need for tissue matching. Mesoblast has facilities in Melbourne, New York, Singapore and Texas and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). www.mesoblast.com

 

Forward-Looking Statements

This announcement 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 product candidates, if approved; regulatory or public

 

 

 

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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.

 

For further information, please contact:

 

 

 

 

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Consolidated Income Statement

 

 

 

 

Consolidated Statement of Comprehensive Income

 

 

 

 

 

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Consolidated Statement of Balance Sheet

 

 

 

 

 

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Consolidated Statement of Cash Flows

 

 

 

 

 

May 2019 Nasdaq: MESO ASX: MSB Operational Highlights and Financial Results for the Nine Months and Quarter Ended March 31, 2019 Exhibit 99.2

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 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 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

Our Mission Mesoblast is committed to bring to market innovative cellular medicines to treat serious and life-threatening illnesses |

Premier Global Cellular Medicines Company Commercialization Innovative Technology Platform1 Innovative technology targets the most severe disease states refractory to conventional therapies Well characterized multimodal mechanisms of action Underpinned by extensive, global IP estate Building focused US sales force for acute GVHD product launch Industrial-scale manufacturing to meet commercial demand First approved products commercialized by licensees in Japan2 and Europe3 Increasing revenues and milestone payments Mesenchymal precursor cells (MPCs) and their culture-expanded progeny mesenchymal stem cells (MSCs). Licensee JCR Pharmaceuticals Co., Ltd. received the first full PMDA approval for an allogeneic cellular medicine in Japan and markets this product under its trademark, TEMCELL® Hs Inj. Licensee Takeda Pharmaceuticals Co Ltd received first central marketing authorization approval from the European Commission for an allogeneic stem cell therapy and markets this product under its trademark, Alofisel®. Late Stage Pipeline Upcoming BLA submission for steroid-refractory acute GVHD 2 blockbuster product candidates completed Phase 3 trial enrollment - heart failure and back pain China cardiovascular partnership established

Recent Corporate Highlights Remestemcel-L for Steroid-Refractory Acute Graft Versus Host Disease FDA has agreed to a rolling Biologics Licence Application (BLA) review of remestemcel-L for the treatment of steroid-refractory acute Graft Versus Host Disease (aGVHD) in children. Initiated the BLA rolling submission, with filing of the first module. The rolling process will provide opportunity for ongoing communication, and during this process the Company expects it will be able to adequately address any substantial matters raised by the FDA. Revascor for Advanced and End-Stage Heart Failure Mesoblast and the International Center for Health Outcomes and Innovation Research at the Icahn School of Medicine at Mount Sinai entered into a Memorandum of Understanding to conduct a confirmatory clinical trial using Revascor for reduction of gastrointestinal (GI) bleeding in end-stage heart failure patients implanted with a left ventricular assist device (LVAD). Phase 3 trial in advanced heart failure has completed patient enrollment, with 566 patients randomized to receive Revascor or placebo. The study, conducted across 55 centers in North America, will complete when sufficient primary endpoint events have accrued.

Recent Corporate Highlights (continued) MPC-06-ID for Chronic Lower Back Pain Phase 3 trial in chronic low back pain has completed enrollment with 404 patients randomized to receive MPC-06-ID or placebo. All assessable patients have now completed at least 12-months of safety and efficacy follow-up. Partnerships and License Arrangements Mesoblast extended its license with JCR Pharmaceuticals Co., Ltd. (JCR) in Japan for use of TEMCELL®1 HS Inj. in patients with Epidermolysis Bullosa. JCR has now filed to extend marketing approval for this indication. Board of Directors – Welcomes New Leadership The Board appointed Joseph R. Swedish as Chairman in April 2019. Mr Swedish brings deep healthcare expertise and a track record in healthcare resource allocation and reimbursement metrics, as the Company enters commercial stage. TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.

2004: Mesoblast is founded in Melbourne, Australia and listed on the ASX 2014: Granted manufacturing pioneer status by Economic Development Board of Singapore 2013: Acquired MSC business from Osiris Therapeutics with trailing earn-out and milestone payments on the MSC business 2011: Entered into manufacturing partnership with Lonza Group in Singapore for MPC medicines 2015: Dual listed on the Nasdaq 2016: TEMCELL® HS Inj (MSC medicine) launched in Japan by Mesoblast licensee JCR 2017: Entered licensing agreement with Takeda for the treatment of certain fistulae; Alofisel ® approved in EU 2018: Entered into partnership agreement with Tasly for cardiovascular assets in China 2019: Initiates first Biologics License Application (BLA) submission to US FDA: remestemcel-L (MSC) for steroid refractory acute graft versus host disease Corporate History Over a decade of scientific, manufacturing, clinical development and corporate transaction experience targeted at bringing to market, cellular medicines for inflammatory diseases 2010: Entered into strategic alliance to develop and commercialize MPC therapeutics 2019: Smith & Nephew acquires Osiris Therapeutics including rights to the trailing earn-out and milestone payments on the MSC business

Partnerships and License Agreements | Exclusive cardiovascular rights in China Mesoblast received US$40 million on closing, eligible to receive additional milestones and royalties Patent license agreement entered in Dec 2017 with Takeda (formerly TiGenix NV) providing exclusive access to certain IP for local treatment of perianal fistulae Mesoblast is eligible to receive up to €20 million in milestone payments plus royalties upon commercial sales of Alofisel ® worldwide JCR has rights to use our MSC technology to treat SR acute GVHD in Japan Its product, TEMCELL ® HS Inj.1, was the first fully approved allogeneic cellular medicine in Japan Royalties and milestones received in last twelve months exceed US$5 million License expanded in Oct 2018 to cover use in treatment of epidermolysis bullosa – a highly debilitating and sometimes lethal skin disease TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.

Commercial and Late-Stage Product Pipeline

Financials |

` For the nine months ending (US$m) March 31, 2019 March 31, 2018 Operating net cash outflows (38.7) (54.8) Investing net cash outflows (0.2) (0.7) Financing net cash inflows 71.6 69.6 Net increase in cash 32.7 14.1 Cash reserves of US$70.4 million as at March 31, 2019 An additional US$35.0 million may be available under existing arrangements with Hercules Capital and NovaQuest, subject to achievement of certain milestones 29% (US$16.1 million) reduction in net operating cash outflows for the nine months ended March 31, 2019, primarily due to the timing of receipts of milestone payments Cash Reserves of US$70.4 million Significant reduction in operating net cash outflows for the nine months |

| 11 For the nine months ending (US$m) March 31, 2019 March 31, 2018 Milestone revenue 11.0 12.8 Commercialization revenue 3.3 2.5 Interest revenue 0.5 0.3 Total revenue 14.8 15.6 28% growth in commercialization revenue from royalty income on sales of TEMCELL® HS. Inj.1 Corporate transactions drive milestone revenues US$10.0 million of milestone revenue from licensee Tasly Pharmaceutical Group in FY2019 US$11.8 million of milestone revenue from licensee Takeda Pharmaceuticals in FY2018 Both periods include US$1.0 million of milestone revenue from JCR Pharmaceuticals TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd. Revenues – Continued Growth in Royalties and Substantial Milestone Revenues from Corporate Transactions |

Profit and Loss for the nine months ending (US$m) March 31, 2019 March 31, 2018 Total Revenue 14.8 15.6 Research and development (48.4) (48.4) Manufacturing (12.9) (3.4) Management & administration (16.0) (16.7) Contingent consideration (3.4) 7.9 Other operating income & expenses (1.0) 1.2 Finance costs (7.9) (0.4) (Loss)/Profit before tax (74.9) (44.1) Income tax benefit 5.8 29.7 (Loss)/Profit after tax (69.1) (14.5) Increase in loss primarily due to the following items: - in the current period: US$9.5 million increase in commercial manufacturing reflects investment to support potential launch for aGVHD product US$7.5 million of increased finance costs on non-dilutive capital inflows from Hercules and NovaQuest - and in the comparative period: a one-off non-cash income tax benefit of US$23.0 million due to a revaluation of tax liabilities given changes in tax rates non-cash US$7.9 million gain on contingent consideration for reduction of future payments to third parties Increased Loss due to Investment in Manufacturing and Financing, and Non-cash Gains in Comparable Period from Revaluation of Tax and Contingent Consideration |

Operational Highlights |

Minimal Treatment Options Market Opportunity Burden of Illness aGVHD is a life-threatening complication that occurs in ~50% of patients receiving allogeneic bone marrow transplants (BMT)1 Steroid-refractory aGVHD is associated with mortality rates as high as 90%1,7 and significant extended hospital stay costs2 There is only one approved treatment for SR-GVHD, and no approved treatment for children under 12 years old, outside Japan In Japan, Mesoblast’s licensee has received the only product approval for SR -aGVHD in both children and adults >30,000 allogeneic BMTs performed annually worldwide (>20K US/EU) ~20% paediatric3,4 Our licensee, JCR Pharmaceuticals Co., Ltd launched TEMCELL® HS Inj.5 in Japan for SR-aGVHD in 2016; reimbursed up to ~US$195k6 SR-aGVHD represents US$ > 700m US/EU market opportunity4,8 Acute Graft Versus Host Disease (aGVHD) Significant market opportunity for remestemcel-L | 1. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology. 2. Anthem-HealthCore/Mesoblast claims analysis (2016). Data on file 3. Niederwieser D, Baldomero H, Szer J. (2016) Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. 4. Source: CIBMTR Current Uses and Outcomes of Hematopoietic Cell Transplantation 2017 Summary. Passweg JR, Baldomero, H (2016) Hematopoietic stem cell transplantation in Europe 2014: more than 40,000 transplants annually. 5. TEMCELL is the registered trademark of JCR Pharmaceuticals Co. Ltd. 6.Based on a JPY = USD 0.009375 spot exchange rate on market close on November 11, 2016. Amounts are rounded. Source: Bloomberg. 7. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantion. Bone Marrow Transplantation. 8.Data on file

Average Additional Hospitalization LOS: 28 days Average Additional Outpatient Visits: 30 Average Additional Prescription Fills: 7 Average Additional All-Cause Cost : ~$500k Pediatric SR aGVHD vs. No GVHD Data on File: HealthCore® Claims Analysis Remestemcel-L: SR-aGVHD is Associated with Significant Burden of Illness in Children (US)1 |

0 7 6 Reaction to Tested Target Profile2 Max Rating Product Attributes ZS Associates June 2018 Qualitative Market Research: MCO Medical Directors n=5, Transplant Center Directors n= 5, Hospital Pharmacy Directors n=5, AMC-based Hem/Oncs / KOLs n=3 Data on file. Most Significant Value Drivers for Remestemcel-L Day 28 overall response rate (especially grade C/D) Day 100 & Day 180 Survival rates No increase in infections Large clinical data set (n ~300) Ability to administer the drug outpatient Median Response (n=20) “Remestemcel-L is Expected to Become Standard of Care” - Multiple Respondents1 Remestemcel-L: Results from Providers/Payers Qualitative US Market Research1 |

Kymriah®3 $500k $475k $100k Branded immune-suppressants 1 $200k Defitelio®2 Yescarta®3 $375k Treatment Indication(s) Treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma(DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma Data on File. Redbook May 2019 –Dosing derived from Defitelio package insert with minimum treatment days of 21 and maximum 60 treatment days as defined in label, 75Kg average weight data from CDC. https://www.reuters.com/article/us-gilead-sciences-fda/fda-approves-gilead-cancer-gene-therapy-price-set-at-373000-idUSKBN1CN35H. US$50k Combination of Branded immune-suppressants + ECP1 Remestemcel-L: Overview of US Product Reimbursement Pricing of Relevant Agents in the Refractory Hematology / Oncology Setting1,2 | Defitelio (defibrotide sodium) Yescarta (axicabtagene cilloleucel) Kymriah (tisagenlecleucel)

20 65% 73% 67% 61% 68% 65% 62% 0% 20% 40% 60% 80% 100% All Patients Grade BGrade CGrade D (n=241)(n=48)(n=73)(n=120) Any SkinAny GIAny Liver (n=114)(n=208)(n=66) Complete Response was 14%, Partial Response was 51% Responses were observed for all GVHD grades and did not differ by baseline organ involvement Kurtzberg et al: Presentation Tandem Feb 2016 Population: steroid-refractory aGVHD pediatric patients 241 pediatric patients undergoing HSCT were enrolled and treated at 50 sites in North America and Europe from 2007-2014 Ages 2 months – 17 years Acute GVHD grades B-D (CIBMTR) Failed steroid treatment and multiple other agents aGVHD not improving after at least 3 days of methylprednisolone (at least 1 mg/kg/day or equivalent) Remestemcel-L: Expanded Access Program (Protocol 275) Overall Day 28 Response in 241 Pediatric aGVHD Patients Receiving Remestemcel-L as First-line or Salvage Therapy After Failing Steroids1 | Response Rate

Remestemcel-L: Expanded Access Program Correlation of Day 28 Overall Response with Day 100 Survival, Using Remestemcel-L as First-line or Salvage Therapy After Failing Steroids and/or Additional Treatments1 Kurtzberg et al: Presentation Tandem Feb 2016 Remestemcel-L in Children with SR-aGVHD who failed multiple other modalities - Survival of Pediatric Patients Treated with Remestemcel-L 28-Day Responders vs Non-responders n=241 In 241 Children under EAP, Overall Response (CR+PR) at Day 28 was 65% (95% CI: 58.9%, 70.9%) Day 100 survival correlated with overall response, and was significantly improved in those who responded at Day 28 (82% vs. 39%, p<0.0001) |

Multi-center, single-arm, open-label study to evaluate efficacy and safety to day 100 (GVHD001) and from day 100 to day 180 (GVHD002) 55 pediatric patients (2 months to 17 years) aGVHD following allogeneic HSCT failing systemic corticosteroid therapy Grade B aGVHD involving liver and/or GI tract with or without concomitant skin disease Grades C and D aGVHD involving skin, liver and/or GI tract Primary endpoint: Overall response at Day 28 Key secondary endpoint: Survival at Day 100 | Remestemcel-L: Phase 3 Pediatric Trial (GVHD001) - First-line therapy in aGVHD after failing steroids1 Data on file.

Subjects Enrolled 55 Age (years) Mean (SD) 7.8 (5.44) Median (minimum, maximum) 7.6 (0.6, 17.9) Gender Male 35 (63.6%) Female 20 (36.4%) Underlying Disease AML 18 (32.7%) ALL 12 (21.8%) Anemia 5 (9.1%) CML 4 (7.3%) Sickle Cell 3 (5.5%) JML 2 (3.6%) MDS 2 (3.6%) Other 9 (16.4%) | Remestemcel-L: Phase 3 Trial Protocol GVHD001 – Demographics1 Data on file.

Baseline Organ Involvement GVHD Grade at Baseline Grade B Grade C Grade D | 89% of subjects had Grade C/D disease at baseline 47% of subjects had Grade D disease at baseline 26% of subjects had Skin involvement only All had stage 3 (n=10) or stage 4 (n=4) disease 38% of subjects had Lower GI involvement only 16/21 had stage 3 (n=6) or stage 4 (n=10) disease 36% of subjects had multi-organ involvement, all with Lower GI 6/20 had all three organs involved 10/20 had Lower GI + Skin 4/20 had Lower GI + Liver Remestemcel-L: Phase 3 Trial Protocol GVHD001 - Disease characteristics reflect aGVHD severity1 Data on file. Skin Only Lower GI Only Two Organs Three Organs

Grade C/D GVHD has Significantly Worse Survival than Grade A/B1

50% 70% 73% 69% 0% 20% 40% 60% 80% Grade B Grade CGrade D (n=6) (n=23)(n=26) All Subjects (n= 55) Data on file Remestemcel-L: Phase 3 Trial Protocol GVHD001 - Primary efficacy overall response at Day 28 was 69%, p=0.00031 | 69% Overall Response rate at Day 28 (29% CR + 40% PR); (95% CI: 55%, 81%) p-value calculated from the binomial distribution, under the assumption of a 0.45 success rate under the null hypothesis 100%

Remestemcel-L: Phase 3 Trial Overall response at Day 28 predicts survival through six months1 | Phase 3 study evaluated remestemcel-L in 55 children to improve overall response rate and survival 89% of children had grade C/D disease, the most severe form and historically associated with up to 90% mortality2,3 Study successfully met the primary endpoint of improved Day 28 Overall Response (OR) 69% vs 45% protocol-defined historical control rate (p=0.0003) Day 100 Overall Survival 75%, with 87% survival in Day 28 responders Day 180 Overall Survival 69%, with 79% survival in Day 28 responders Remestemcel-L infusions well tolerated Findings consistent with previous results in 241 SR-aGVHD children under expanded access program who failed to respond to multiple biologic agents4 Data on file. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation Kurtzberg J. et al. Effect of Human Mesenchymal Stem Cells (remestemcel-L) on Clinical Response and Survival Confirmed in a Large Cohort of Pediatric Patients with Severe High-Risk Steroid-Refractory Acute Graft Versus Host Disease. BBMT. 2016; 22.

Remestemcel-L: Protocol GVHD001/002 survival1 | Data on file. Overall Survival Probability Days Since First Dose of Remestemcel-L Survival in Day 28 Responders Day 100 - 87%; Day 180 - 79%

Remestemcel-L: Regulatory and Commercial Strategy Overview FDA agreed to rolling review of BLA submission Fast Track designation provides eligibility for FDA priority review Ramp-up for inventory build is underway Commercialization strategy in place for product launch Building out efficient, targeted sales force - 15 centers account for ~50% of patients TEMCELL®1 HS Inj. sales experience in Japan informs commercial strategy for the U.S. 1. TEMCELL® HS Inj. is a registered product of JCR Pharmaceuticals Co. Ltd.

| October 2013 Mesoblast acquires MSC-100-IV from Osiris Therapeutics Product Development / Manufacturing Optimization February 2016 JCR Pharmaceuticals Launches Temcell in Japan under New Regenerative Medicine Regulatory Pathway (out-licensee) 2020 SR-aGVHD Pediatric US Launch SR-aGVHD Pediatric Ex-US Launch 2018 Pediatric Phase 3 (US) Top Line Data Mesoblast has over 10 years of experience in hematology-oncology space Remestemcel-L: Positive Phase 3 Results Q12018 Large US Pediatric GVHD Expanded Access Program (>240 patients) SR-aGVHD Adult US/Ex-US Parallel Launch Chronic GVHD Remestemcel-L: Comprehensive Global GVHD Program Label extension Other Indications

Source: Simon-Kucher & Partners 2017. Primary research 2017; Payers n=35, KOLs n=15, Cath lab managers n=4. Corlanor® (ivabradine) approved by FDA (April 2015). ENTRESTO® (sacubitril/valsartan) approved by FDA (July 2015). GlobalData-PharmaPoint Heart Failure (2016); McMurray et al., 2012;Yancy et al., 2013, 2016 ACC/AHAHFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure. Early ACEI or ARB Statins Beta blockers Re-vascularization or valvular surgery Advanced End-Stage Pharmacological Add-on Diuretics for fluid retention Aldosterone antagonists Hydralazine / isosorbide dinitrate Digitalis New Oral Therapies for Class II-IV2 If ACEI / ARB tolerated, sacubitril/valsartan Common Treatment Pathway in Progressive Heart Failure1 Mesoblast Target Market: Advanced and End-Stage HF patients3 Cardiac Resynchronization Therapy (CRT) Implantable Cardioverter-Defibrillator (ICD) LVAD Heart transplants Limited Therapeutic Options Advanced and End-Stage Heart Failure Progressive Vascular (Endothelial) Dysfunction and Heart Failure Class I Class IV

Market Opportunity Burden of Illness Limited Options / Unmet Need Approx. 8 million patients with chronic heart failure by 2030 in US alone1 17-45% globally die within 1 year of hospital admission1 Majority of advanced heart failure patients die within 5 years1 Despite recent advances in newly approved drugs, limited treatment options are available for patients with advanced heart failure2 New therapies to reduce hospitalizations and mortality in patients with advanced heart failure who have failed other therapies Greatest need is in NYHA class III-IV where event rate is highest US healthcare costs for NYHA class II-IV patients $USD115bn/year5 Hospitalizations account for ~69% of expenditure3-5 Multi-billion dollar annual market opportunity in US4,5 | 1. Heart Failure: Preventing disease and death worldwide – European Society of Cardiology 2014., 2. ACC/AHAHFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure., 3. Gurwitz JH, Magid DJ, Smith DH, et al. Contemporary Prevalence and Correlates of Incident Heart Failure with Preserved Ejection Fraction. The American Journal of Medicine. 2013;126(5):393-400. Derived by applying a HF-REF prevalence rate of 32.6% to the U.S. rate of 5.7m U.S. patients., 4.A Reevaluation of the Costs of Heart Failure and its Implications for Allocation of Health Resources in the United States. Voigt J. Clinl.Cardiol. 37, 5, 312-321 (2014)., 5.The Medical and Socioeconomic Burden of Heart Failure: A Comparative Delineation with Cancer. Dimitrios, F. International Journal of Cardiology (2015), doi: 10.1016/j.ijard.2015.10.172. Advanced Heart Failure Revascor – Commercial opportunity

Revascor: Phase 2 Randomized, Controlled Trial Identified Optimal Therapeutic Dose and Target Patient Population for Phase 3 Source: Circ Res. 2015; 117:576-584. Perin E et al. A Phase II Dose-Escalation Study of Allogeneic Mesenchymal Precursor Cells in Patients With Ischemic or Non-Ischemic Heart Failure. LVESV = Left ventricular end systolic volume; LVEDV = Left Ventricular End-Diastolic Volume; EF = Ejection Fraction. LVESV Month 6 - Baseline LVEDV Month 6 - Baseline Objectives Identify a dose response and an optimal therapeutic dose Identify optimal target population for therapeutic effect Evaluate placebo vs. 25, 75, 150MM MPCs injected by endomyocardial catheter in 60 patients with class II/III heart failure and EF<40% Results At 6 months: Dose-dependent effect seen on left ventricular remodeling, with 150MM cell dose (MPC-150-IM) showing greatest effect vs. controls Control 25MM 75MM 150MM Control 25MM 75MM 150MM

Revascor: Therapeutic Benefit on LV Remodeling in Phase 2 Subjects with LVESV >100ml1 Source : Perin et al., Journal of Cardiac Failure 2015; Vol 21(8): S107; 19th Annual Scientific Meeting of the Heart Failure Society of America, Emerson et al. LVESV = Left ventricular end systolic volume; LVEDV = Left Ventricular End-Diastolic Volume; LVEF = Left Ventricular Ejection Fraction. Placebo corrected benefit of 150MM cell dose on cardiac volumes and ejection fraction at 6 months was greatest in patients with more advanced heart failure as defined by baseline LVESV>100ml at baseline Change (Entire cohort) Month 6 minus baseline PBO (n=15) 150M MPC∆, PBO PBO (n=7) 150M MPC∆, PBO P-values (n=15) corrected (n=11) corrected LVESV +20 -7 -27 +46 -8 -54 <0.02 LVEDV +20 -10 -30 +41 -10 -51 <0.03 LVEF -2.3 +0.6 +2.9 -6.4 +1.7 +8.1 <0.05 Change (LVESV>100mL) Month 6 minus baseline ∆ ∆ ∆ ∆ ∆ ∆

Revascor: A Single Dose Prevented Any HF-MACE for 36 Months in Patients at Highest Risk of Recurrent Events and Death (Those with LVESV>100ml) in Phase 2 % HF-MACE Kaplan-Meier Curve over 36 months following treatment in all patients1 HF-MACE Kaplan-Meier Curve over 36 months following treatment in patients with LVESV>100ml2 1. HF-MACE is defined as a composite of cardiac related death or non-fatal heart failure hospitalisations. 2. Circ Res. 2015; 117:576-584. Perin E et al. A Phase II Dose-Escalation Study of Allogeneic Mesenchymal Precursor Cells in Patients With Ischemic or Non-Ischemic Heart Failure 3. Journal of Cardiac Failure 2015; Vol 21(8): S107; 19th Annual Scientific Meeting of the Heart Failure Society of America, Emerson et al. Over 36 months, patients receiving 150M MPC had significantly greater probability of remaining free of a first HF-MACE vs. controls (0% vs. 33%, p = 0.026 by log-rank) All HF-MACE events occurred in controls with baseline Left Ventricular End Systolic Volume (LVESV)>100ml, where the treatment effect size was even greater (0% vs. 71%, p = 0.0007 by log rank) Controls with baseline LVESV>100ml had 11 total/recurrent HF-MACE events over 36 months vs. 0 in matched patients receiving 150M MPCs (p=0.0007) Time to HF-MACE (days)

Trial design is 1:1 randomized, controlled, double blinded; conducted over 55 sites across North America using 150MM cell dose vs control Events-driven Phase 3 trial completed enrollment of 566 patients in February 2019 Primary endpoint: reduction in recurrent heart failure-related major adverse cardiac events such as heart failure-related hospitalizations and cardiac death Secondary endpoint: reduction in terminal cardiac events Target patient population enriched for those likely to be both highest risk for events and greatest responders to Revascor therapy | Advanced Heart Failure Revascor - Phase 3 trial fully enrolled

Market Opportunity Burden of Illness In the US there are approx. 250,000–300,000 patients annually who suffer from advanced systolic heart failure (NYHA Class III–IV)1 Despite optimal medical therapy, mortality exceeds 50% in class IV patients1 LVADs have improved survival, but morbidity remains high with patients on average experiencing greater than two hospitalization annually2 Gastrointestinal (GI) bleeding is the leading cause of non-surgical hospitalizations in LVAD patients2 Device attributable major adverse events (DAEs) can cost on average $USD46.5k per hospitalization2 Ongoing Unmet Need Approx. 4,500 – 5,500 assist devices are implanted annually in the US3, 4 US LVAD market is growing double-digit CAGR and represents significant market growth opportunity3,4 US targeted commercial footprint provides low cost market entry 1Gustafsson G, Rogers J. (2017) Left ventricular assist device therapy in advanced heart failure: patient selection and outcomes, 2 Mehra, MR Salerno C, Cleveland JC (2018) Health care resources use and cost implications in the MOMENTUM 3 long-term outcome study: a randomized controlled trial of a magnetically levitated cardiac pump in advanced heart failure, 3Agency for Healthcare Research and Quality – Healthcare Cost and Utilization Project – claims analysis using ICD-9 37.6 implantation of heart and circulatory assist systems, 4 Data on File End-Stage Heart Failure Revascor – Commercial opportunity in reducing GI bleeding in patients with LVADs

MPCs prolong time-to-first major GI bleeding event and reduced cumulative major GI bleeding events in two randomized controlled trials in LVAD patients1,2 Rate of major GI bleeding events over 6 months in LVAD patients reduced by 70% and 76% with MPCs in two randomized controlled trials Mesoblast internal data post-hoc analysis 2017 (clinicaltrials.gov; identifier: NCT01442129). 2. Presented at American Heart Association Scientific Sessions 2018. End-Stage Heart Failure Revascor – Trials demonstrated reduced GI bleeding events in LVAD patients MPC (n = 20) Control (n = 10) P-value Event Rate (100-Pt-Months) Event Rate (100-Pt-Months) 4.2 14.2 0.06 MPC (n = 106) Control (n = 53) P-value Event Rate (100-Pt-Months) Event Rate (100-Pt-Months) 3.8 15.9 <0.001 Randomized Controlled Trial (LVAD-MPC Study #2) Pilot Randomized Controlled Trial (LVAD-MPC Study #1)

MPCs Reduce Hospitalization Rate from GI Bleeding by 65% in 159-Patient Phase 2 Trial1 1 Presented at American Heart Association Scientific Sessions 2018. End-Stage Heart Failure Revascor – Reduced hospitalization rate from GI bleeding in Phase 2 trial

Key benefits of the Regenerative Medicine Advanced Therapies (RMAT) designation include: Potential eligibility for priority review and accelerated approval Potential to utilize surrogate endpoints for accelerated approval Potential to utilize patient registry data and other sources of “real world evidence” for post approval studies, subject to approval by the FDA Mesoblast received guidance from FDA that reduction in major GI bleeding is a clinically meaningful outcome could be used as an endpoint to support product approval Next steps: Mesoblast entered into a MOU with InCHOIR1 to conduct a confirmatory clinical trial to support marketing approval of Revascor for reduction of GI bleeding in end-stage heart failure patients implanted with a LVAD Schedule meeting with FDA to discuss pathway to filing for BLA for marketing authorization Revascor Has Received RMAT Designation for Use in End-Stage Heart Failure Patients with LVADs End-Stage Heart Failure Revascor – Benefits from an expediated approval path under RMAT 1 InCHOIR = International Center for Health Outcomes and Innovation Research (InCHOIR) at the Icahn School of Medicine at Mount Sinai.

Chronic Low Back Pain (CLBP) MPC-06-ID – Market opportunity in CLBP due to disc degeneration Minimal Treatment Options Market Opportunity Burden of Illness Unmet Need Back pain causes more disability than any other condition1 Inflicts substantial direct and indirect costs on the healthcare system,1 including excessive use of opioids in this patient population2 MPC-06-ID development focused on over ~3.2m patients with CLBP due to degenerative disc disease (DDD) in US alone3,4,5 US market opportunity >$USD $1 billion3,4,5.6 1. Williams, J., NG, Nawi, Pelzter, K. (2015) Risk factors and disability associated with low back pain in older adults in low-and middle-income countries. Results from the WHO Study on global ageing and adult health (SAGE). PloS One. 2015; 10(6): e0127880., 2. Decision Resources: Pain Management Study, Chronic Pain December 2013., 3. Decision Resources: Chronic Pain December 2015., 4. LEK & NCI opinion leader interviews, and secondary analysis., 5. Navigant: Commercial Assessment for a Proprietary Cell-Based Therapy for DDD in the U.S. and the EU3 – August 2014. 6. Data on File. | Novel therapeutic approach for durable improvement in pain and function Potential alternative for opioid use or surgical intervention Treatment options for patients with CLBP who fail conservative therapy include opioids and surgery 50% of opioid prescriptions are for chronic low back pain (CLBP)2

| B: Phase 2: Treatment Success Responders1,2 at both 12 & 24 Months p = 0.050 Subjects with missing data are classified as non-responders. Treatment Success Responders have a 50% reduction in LBP as measured by VAS AND a 15 point improvement in function as measured by ODI at a) 12 months, and b) both 12 and 24 months and no intervention through 24 months. A: Phase 2: Treatment Success Responders1,2 at 12 Months p = 0.032 Chronic Low Back Pain MPC-06-ID – Post-Hoc Phase 2 results provide target endpoints for Phase 3 trial |

Chronic Low Back Pain MPC-06-ID – Ongoing Phase 3 clinical trial | Three-arm study comparing 6-million MPC with or without hyaluronic acid (HA) against saline control Primary efficacy endpoint agreed to with FDA: Overall Treatment Success Composite at both 12 and 24 months as measured by: At least 50% reduction from baseline in Visual Analogue Scale (VAS) pain score at both 12 and 24 months post-treatment; and At least a 15 point decrease from baseline in Oswestry Disability Index (ODI) function score at both 12 and 24 months post-treatment; and No interventions affecting the treated disc through 24 months Study powered to show efficacy for either 6-million MPC arm (with or without HA) 404 patient 2:1 randomized Phase 3 trial completed enrollment March 2018 All patients have completed 12 month safety and efficacy follow-up

Anticipated CY2019 Milestones Remestemcel-L for Steroid-Refractory Acute Graft Versus Host Disease Completion of BLA filing for remestemcel-L in the treatment of steroid refractory aGVHD in children Revascor for Advanced and End-Stage Heart Failure Phase 3 trial in advanced heart failure continues accrual of primary endpoints through to completion Meet with FDA to discuss pathway for approval of Revascor for the reduction of GI bleeding in end-stage heart failure patients implanted with a LVAD Our cardiovascular partner in China, Tasly, to receive guidance on regulatory approval pathway for Revascor from the NMPA of China. MPC-06-ID for Chronic Low Back Pain Patient follow up continues through 24-month assessment of safety and efficacy in the Company’s Phase 3 trial of MPC-06-ID for chronic lower back pain Establish global and/or regional partnerships In advanced discussions on potential blockbuster products