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 August 2018

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 August 30, 2018, 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.

On August 29, 2018, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement, which is attached hereto as Exhibit 99.3, 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.

Dated: August 30, 2018

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INDEX TO EXHIBITS

 

 

Exhibit 99.1

 

 

MESOBLAST REPORTS FOURTH QUARTER AND FULL-YEAR 2018 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

 

Melbourne, Australia; August 30, 2018; and New York, USA, August 29, 2018: Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today reported strong financial results and provided operational highlights for the fourth quarter and full-year ended June 30, 2018 (FY2018).

 

Key financial results for the 12 months ended June 30, 2018

 

 

Corporate highlights

 

Mesoblast entered into a strategic alliance with Tasly Pharmaceutical Group for the development, manufacture and commercialization of MPC-150-IM and MPC-25-IC in the treatment and prevention of chronic heart failure and heart attacks in China.

 

Mesoblast granted TiGenix NV (now fully owned by Takeda Pharmaceutical Co. Ltd) exclusive access to certain of its patents to support global commercialization of Alofisel^® in the local treatment of fistulae. This product is the first allogeneic mesenchymal stem cell therapy to receive approval from the European Commission. As consideration, Mesoblast will receive up to €20 million in payments, as well as single digit royalties on net sales.

 

Mesoblast accessed non-dilutive capital for commercialization of MSC-100-IV (remestemcel-L) through credit facilities with Hercules Capital and NovaQuest.

 

New non-executive Directors Joseph R. Swedish and Shawn Cline Tomasello joined the Board of Directors, bringing substantial commercial and transactional healthcare expertise.

 

Operational highlights and anticipated upcoming milestones

 

MSC-100-IV (remestemcel-L) for pediatric steroid-refractory acute Graft Versus Host Disease (SR-aGVHD):

 

 

 

 

 

 

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MPC-150-IM for Advanced and End-Stage Heart Failure:

 

 

MPC-06-ID for Chronic Low Back Pain:

 

 

Financial Results for the Three Months Ended June 30, 2018 (fourth quarter) (in U.S. Dollars)

 

Loss after tax was significantly reduced by US$6.3 million (23%) for the fourth quarter of FY2018, compared with the fourth quarter of FY2017 due to the items below:

 

 

 

 

 

 

 

 

 

 

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The overall increase in loss after income tax also includes movements in other items which did not impact current cash reserves, such as: fair value remeasurement of contingent consideration, and foreign exchange movements within other operating income and expenses.

 

A non-cash income tax benefit of US$1.0 million was recognized in the fourth quarter of FY2018 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period, compared to US$4.1 million in the fourth quarter of FY2017.

 

The net loss attributable to ordinary shareholders was US$20.8 million, or 4.39 cents loss per share, for the fourth quarter of FY2018, compared with US$27.2 million, or 6.34 cents loss per share, for the fourth quarter of FY2017.

 

At June 30, 2018, the Company had cash reserves of US$37.8 million. As of June 30, 2018, the Company recognized funds receivable from debt financing and unissued capital of US$39.0 million pursuant to a financing facility with NovaQuest. On July 10, 2018 the net proceeds from the financing facility of US$39.0 million were received and recognized in cash reserves. The Company will also receive US$40.0 million from Tasly on closing of the strategic alliance that the two companies announced in July 2018 for cardiovascular therapies in China. This transaction has been approved by the Tianjin Bureau of Ministry of Commerce and the Tianjin Bureau of National Development Reform Commission, and is subject to filing with the State Administration of Foreign Exchange.

 

Mesoblast retains an equity facility for up to A$120 million/US$90 million, to be used at its discretion over the next 12 months to provide additional funds as required.

 

Financial Results for the Year Ended June 30, 2018 (in U.S. Dollars)

 

Loss after tax was significantly reduced by US$41.5 million (54%) for FY2018, compared with FY2017.

 

The main items which reduced loss after income tax were:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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The overall decrease in loss after income tax also includes movements in other items which did not impact current cash reserves, such as: fair value remeasurement of contingent consideration, and foreign exchange movements within other operating income and expenses.

 

A non-cash income tax benefit of US$30.7 million was recognized in FY2018 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period, primarily due to a revaluation of our deferred tax assets and liabilities recognized as a result of changes in tax rates. On December 22, 2017, the United States signed into law the Tax Cuts and Jobs Act (the Tax Act), which changed many aspects of United States corporate income taxation, including a reduction in the corporate income tax rate from 35% to 21%.

 

A non-cash income tax benefit of US$13.4 million was recognized in FY2017 in relation to the net change in deferred tax assets and liabilities recognized on the balance sheet during the period.

 

The net loss attributable to ordinary shareholders was US$35.3 million, or 7.58 cents loss per share, for FY2018, compared with US$76.8 million, or 19.25 cents loss per share, for FY2017.

 

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 6:00 pm EDT on Wednesday, August 29, 2018; 8:00 am Thursday, August 30, 2018 AEST.  

 

The live webcast can be accessed via
http://webcasting.boardroom.media/broadcast/5b7512acb14eaa0d350808c4

 

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 471961.

 

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 timing, progress and results of Mesoblast’s preclinical and clinical studies; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; 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

 

 

 

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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

 

 

 

 

 

 

 

August 2018 Nasdaq: MESO ASX: MSB Operational Highlights and Financial Results for the Year Ending June 30, 2018 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 disruptive cellular medicines to treat serious and life-threatening illnesses |

Premier global cellular medicines company Multiple Revenue Generating Products & Phase 3 Assets Industrial Scale Manufacturing Disruptive Technology Platform1 Immuno-selected, culture expanded cellular medicines Well characterized mechanisms of action targeting multiple pathways Extensive, robust IP estate Targeting the most severe disease states refractory to conventional therapies Unique cell properties enable large scale expansion and use in unrelated recipients Proprietary media formulations meet industrial scale needs ‘Off the shelf’ delineated products with batch to batch consistency and reproducibility 2 approved products commercialized by licensees in Japan2 and Europe3 3 product candidates in U.S. Phase 3 Major near-term data readouts Revenue from approved and late-stage assets will help fund deep product pipeline Mesenchymal precursor cells (MPCs) and their culture-expanded progeny mesenchymal stem cells (MSCs). TEMCELL® Hs Inj licensee JCR Pharmaceuticals Co., Ltd. received the first full PMDA approval for an allogeneic cellular medicine in Japan. Alofisel ® licensee Takeda received first central marketing authorization (MA) approval from the European Commission (EC) for an allogeneic stem cell therapy.

Disruptive cellular medicine technology STRO-1+ Mesenchymal Precursor Cells (MPCs) are at the apex of the hierarchy of mesenchymal lineage cells STRO-1/STRO-3 immuno-selection provides a homogeneous population of MPCs with receptors that respond to activating inflammation and damaged-tissue signals In response to activating signals present in the endogenous environment, MPCs secrete a diverse variety of biomolecules responsible for immunomodulation and tissue repair Targeting multiple pathways may result in greater therapeutic benefits in complex diseases Simmons PJ, et al, Blood. 1991;78:55-62 Gronthos S, et al, J Cell Sci. 2003;116(Pt 9):1827-35 See F, et al, J Cell Mol Med. 2011;15:2117-29 Psaltis PJ, et al, J Cell Physiol. 2010;223(2):530-40

Commercial translation capabilities Technology positioned for scalable, industrialized manufacturing Immune privileged nature of mesenchymal lineage cells enables allogeneic “off the shelf” product candidates Culture expansion scalable to produce anticipated commercial quantities Management know-how in regulatory activities necessary for product approval and commercial launch If successful, we believe MSC-100-IV (remestemcel-L) will likely be the first allogeneic mesenchymal lineage cell product registered for sale in the USA | Lonza contract manufacturing facility in Singapore

IN DEVELOPMENT PLATFORM PRODUCT THERAPEUTIC AREA APPROVAL COMMERCIAL RIGHTS MSC (Bone Marrow) TEMCELL® HS Inj1 Acute GVHD Japan MSC (Adipose) Alofisel2 Perianal Fistula Global MARKETED Commercial products and clinical pipeline Using Mesoblast’s intellectual property and technology platform Mesoblast receives royalty income on sales of TEMCELL® in Japan by its licensee JCR Pharmaceuticals Co Ltd. Mesoblast will receive royalty income on world wide sales of Alofisel® in the local treatment of perianal fistulae by its licensee Takeda Pharmaceuticals . Study funded by the United States National Institutes of Health (NIH) and the Canadian Health Research Institute; conducted by the NIH-funded Cardiothoracic Surgical Trials Network. This chart is figurative and does not purport to show individual trial progress within a clinical program PLATFORM PRODUCT CANDIDATE THERAPEUTIC AREA PRE-CLINICAL PHASE 2 PHASE 3 COMMERCIAL RIGHTS MSC MSC-100-IV Acute GVHD MPC MPC-150-IM Advanced HF (Class II/III) End-Stage HF (Class III/IV)3 MPC MPC-06-ID Chronic Low Back Pain MPC MPC-300-IV Rheumatoid Arthritis Diabetic Nephropathy Includes MSC-100-IV (Crohn’s disease – biologic refractory), MPC-25-IC (Acute Cardiac Ischemia), MPC-25-Osteo (Spinal Fusion) and MPC-75-IA (Knee Osteoarthritis) TIER 1 TIER 2 1st allogeneic regen med approved in Japan 1st allogeneic regen med approved in Europe

Tasly Pharmaceuticals to receive exclusive rights and will fund all development, manufacturing and commercialization activities for MPC-150-IM for the treatment or prevention of chronic heart failure and MPC-25-IC for the treatment or prevention of acute myocardial infarction in China Mesoblast to receive US$40 million on closing US$20 million upfront technology access fee US$20 million in equity at AU$1.86 per share Mesoblast to receive US$25 million on product regulatory approvals in China Mesoblast will receive double-digit escalating royalties on net product sales and six escalating milestone payments upon product candidates reaching certain sales thresholds in China Partners will leverage each other’s clinical trial results to support their respective regulatory submissions in the US and China Strategic partnership in cardiology in China Transaction approved by Tianjin Bureau of Ministry of Commerce and Tianjin Bureau of National Development Reform Commission, subject to filing with State Administration of Foreign Exchange

Financials |

Significant increase in revenue Revenue for the year ending June 30, 2018 (US$m) For the year ending June 30, 2018 June 30, 2017 $Change % Commercialization revenue 3.6 1.4 2.2 152% Milestone revenue 13.3 0.5 12.8 NM Interest revenue 0.4 0.5 (0.1) (22%) Total revenue 17.3 2.4 14.9 NM 2018 revenue increased by US$14.9 million vs 2017 revenue due to: 152% increase in commercialization revenue from royalty income on sales of TEMCELL® 1 HS. Inj. An upfront payment of US$5.9 million (€5.0 million) received upon execution of our patent license agreement with TiGenix NV (now fully owned by Takeda Pharmaceuticals) in December 2017 A future payment from Takeda of US$5.9 million (€5.0 million), due by December 2018, was recognized in FY 2018 An increase of US$1.0 million in sales milestones recognized on sales of TEMCELL 1. TEMCELL® HS Inj. is a registered trademark of JCR Pharmaceuticals Co. Ltd.

Significant reduction in loss after tax Profit and Loss for the year ending June 30, 2018 (US$m) For the year ending June 30, 2018 June 30, 2017 $Change % Total revenue 17.3 2.4 14.9 NM Research and development (65.9) (58.9) (7.0) 12% Manufacturing (5.5) (12.1) 6.6 (54%) Management & administration (21.9) (23.0) 1.1 (5%) Contingent consideration 10.5 (0.1) 10.6 NM Other operating income & expenses 1.3 1.5 (0.2) (12%) Finance costs (1.8) - (1.8) NM Loss before tax (66.0) (90.2) 24.2 (27%) Income tax benefit 30.7 13.4 17.3 NM Loss after tax (35.3) (76.8) 41.5 (54%) Loss after tax reduced by US$41.5 million (54%) for the year ended June 30, 2018 versus the comparative period of FY17 due to: Increased revenue Reduced spend on manufacturing for R&D Non-cash items including an income tax benefit from the revaluation of deferred tax assets and liabilities after US corporate tax rates changes

Significant reduction in operating cash outflows Cash flow highlights (US$m) For the year ending June 30, 2018 June 30, 2017 $Change %Change Operating net cash outflows (75.0) (95.5) 20.5 (21%) Investing net cash (outflows)/inflows (1.2) 0.1 (1.3) NM Financing net cash inflows 68.6 60.0 8.6 14% Forex (0.5) 0.2 (0.7) NM Net increase/(decrease) in cash (8.1) (35.2) 27.1 (77%) Operating net cash outflows reduced by 21% for the year ended June 30, 2018 versus the prior period due to increased revenue and decreased spend on manufacturing for R&D

Cash position strengthened through strategic transactions Balance sheet cash (US$m) June 30, 2018 June 30, 2017 $Change Reported Cash on Hand 37.8 45.8 (8.0) NovaQuest financing agreement 39.0 - 39.0 Tasly strategic alliance 40.0 - 40.0 Pro forma Cash on Hand 116.8 45.8 71.0 Pro forma Cash on Hand at June 30 includes material financing and partnering agreements executed prior to reporting date US$39 million cash received in July 2018 from NovaQuest Capital Management through a strategic financing agreement US$40 million to be received at closing from Tasly Pharmaceutical Group through a strategic alliance executed in July 2018. This transaction has received certain government approvals from the People’s Republic of China and is subject to filing with the State Administration of Foreign Exchange An additional US$50 million may be available under existing arrangements with Hercules Capital and NovaQuest, subject to achievement of certain milestones

Strategic financing transactions US$75 million non-dilutive, four-year credit facility US$35 million drawn on closing in March 2018 US$15 million may be drawn on or before Q4 CY2018, and a further US$25 million on or before Q3 CY2019, as certain milestones are met Interest 9.95% per annum with interest only period up to 30 months upon satisfaction of certain conditions | US$40 million non-dilutive, eight-year credit facility and US$10 million equity investment in June 2018 US$30 million drawn and US$10 million equity at closing Interest only period 48 months Interest and principal payments deferred until after first commercial sale of remestemcel-L for pediatric patients with steroid-refractory acute Graft versus Host Disease Interest 15% per annum, payable from product sales No warrants with either facility; NovaQuest is subordinated to the senior creditor Hercules

MSC-100-IV (remestemcel-L) for Steroid-Refractory Acute Graft vs Host Disease |

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 95%1 and significant extended hospital stay costs2 There are no approved treatments for SR-aGVHD 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 globally (~20K US/EU5) annually, ~22% pediatric3,4 Our licensee, JCR Pharmaceuticals Co., Ltd launched TEMCELL® HS Inj.5 in Japan for SR-aGVHD in 2016; reimbursed up to ~$USD195k6 USD $700m US/EU5 market opportunity. Remestemcel-L (MSC-100-IV): market opportunity for acute Graft Versus Host Disease (aGVHD) 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. Gratwohl A et al Quantitative and qualitative differences in use and trends of hematopoietic stem cell transplantation: a Global Observational Study. Haematologica. 2013 Aug;98(8):1282-90. 4. CIBMTR, Decision resources GVHD Epi Nov 2012. 5. TEMCELL is the registered trademark of JCR Pharmaceuticals Co. Ltd. 6.Based on a ¥JPY = $USD 0.009375 spot exchange rate on as of the market close on November 11, 2016. Amounts are rounded. Source: Bloomberg. |

Operational Update: MSC-100-IV (remestemcel-L) product candidate for steroid refractory aGVHD | 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% mortality 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 survival results expected shortly Remestemcel-L safe and infusions well tolerated1 Findings consistent with previous results in 241 SR-aGVHD children under expanded access who failed to respond to multiple biologic agents2 Data on file from Protocol 280 Clinical Study Reports. 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.

GVHD pathway to market Regulatory Final preparations for Biologics License Application (BLA) filing underway Expected pre-BLA meeting Q4 CY2018 Fast Track designation allows eligibility for priority review and rolling BLA review process Commercial Parallel track commercial planning for pricing, reimbursement and product launch Using real-world sales data of TEMCELL® in Japan to inform commercial strategy for the US 152% increase in annual royalty income on TEMCELL® sales in Japan Rapid penetration of addressable market within two years of launch

MPC-150-IM for Chronic Heart Failure |

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 Therapies2 If ACEI / ARB tolerated, sacubitril/valsartan If HR > 70 BPM, ivabradine Heart Failure Disease Progression Class I Class IV Treatment Pathway in Progressive Heart Failure1 MPC-150-IM: Targeting patients with advanced and end-stage heart failure MPC-150-IM targets Advanced and End-Stage HF patients3 Cardiac Resynchronization Therapy (CRT) Implantable Cardioverter-Defibrillator (ICD) LVAD Heart transplants Limited Therapeutic Options

Market Opportunity Burden of Illness/Limited Options Unmet Need MPC-150-IM: End-stage heart failure market opportunity 50k patients/year in the United States alone have end-stage heart failure1 1-year mortality exceeds 50% in these patients Only ~2K heart transplants are performed in U.S. annually due to limited donors2 LVADs have improved survival, but has high morbidity and 1-year mortality 20-30%1 Reduce morbidity of LVAD therapy (e.g. reduce GI bleeding) Strengthen native heart muscle sufficiently to explant LVAD Increase the number of LVADs implanted/year (currently <5K due to high morbidity and no option to explant temporary LVAD) Gustafsson G, Rogers J. (2017) Left ventricular assist device therapy in advanced heart failure: patient selection and outcomes. European Journal of Heart Failure 19, 595-602., 2. Agency for Healthcare Research and Quality: HCUPnet: ICD-9 principal procedure code 27.51 2014., 3. Medicare provider charge inpatient-DRGALL-FY2014., 4. St. Jude Medical-2016-analyst and investor day. US LVAD market growing double-digit CAGR4 US targeted commercial footprint (top 40 centers represent 75% of volume) provides low cost market entry3 USD >$500m US market opportunity |

MPC-150-IM: End-stage heart failure clinical strategy 159-patient, double-blind, placebo-controlled 2:1 randomized Phase 2b trial, evaluating safety and efficacy of a single injection of MPC-150-IM into the native myocardium of LVAD recipients Study funded by the US National Institutes of Health (NIH) and Canadian Health of Research Institute, and conducted by the NIH-funded Cardiothoracic Surgical Trials Network (CTSN) Study Endpoints: Safety, including GI bleeding Number of temporary weans from LVAD tolerated through 6 months Time to re-hospitalization (through 12 months) Patient survival (through 12 months) Enrollment completed in Q3 CY2017 12 month database lock in Q3 CY2018 Full trial results to be presented at upcoming major cardiovascular conference Mesoblast is in active discussions with the FDA on the regulatory pathway under the Regenerative Medicine Advanced Therapies (RMAT) designation granted in December 2017

Market Opportunity Burden of Illness/Limited Options Unmet Need Est. >8 million patients with chronic heart failure by 2030 in US alone 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 MPC-150-IM: Advanced heart failure market opportunity 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. 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 $115bn/year Hospitalizations account for ~69% of expenditure3-5 Multi-billion dollar annual market opportunity in US for a new treatment that reduces hospitalizations in advanced heart failure |

MPC-150-IM: Phase 3 trial in patients with advanced heart failure 85% of patients enrolled in this events-driven Phase 3 trial Enrollment completion targeted by end CY18 Pre-specified interim futility analysis of the efficacy endpoint in the first 270 patients successfully achieved in April 2017 Data Monitoring Committee recommended continuation of the trial without modification after a scheduled review of available data from 465 randomized patients, including the primary and secondary endpoints of HF-MACE, terminal cardiac events, and all safety data in April 2018 Plan to leverage results with additional clinical data from global trials performed by strategic partners |

MPC-06-ID for Chronic Low Back Pain due to Disc Degeneration |

Minimal Treatment Options Market Opportunity Burden of Illness Unmet Need MPC-06-ID: Chronic low back pain due to degenerative disc disease 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 population 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) MPC-06-ID targets over ~3.2m patients CLBP due to degenerative disc disease (DDD) in US alone2,3,4 Annual US market opportunity >USD 1 billion 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: Chronic Pain December 2015., 3. LEK & NCI opinion leader interviews, and secondary analysis., 4. Navigant: Commercial Assessment for a Proprietary Cell-Based Therapy for DDD in the U.S. and the EU3 – August 2014. Disease modifying therapy for durable improvement in pain and function Potential to prevent progression to opioid use or surgical intervention |

MPC-06-ID: Phase 3 trial in patients with chronic low back pain | Phase 3 study completed enrollment in March 2018 Over 400 patients were enrolled at 48 sites across the US and Australia Patients randomized 1:1:1 to receive saline, 6-million MPCs with hyaluronic acid and 6-million MPCs without hyaluronic acid Primary efficacy composite endpoint requires a patient to achieve: Reduction in pain (50% decrease in Visual Analog Score) and improvement in function (15 point improvement in as measured by the Oswestry Disability Index) No additional intervention at the treated level through 24 months Primary endpoint at 12 and 24 months  

Milestones |

CY 2018 corporate milestones MSC-100-IV for Acute Graft versus Host Disease Successfully met Day 28 primary end point pediatric Phase 3 trial (Q1 CY18) Day 100 survival/safety data pediatric Phase 3 trial (Q2 CY18) Day 180 survival/safety data pediatric Phase 3 trial (Q3 CY18) Pre-BLA meeting (Q4 CY18) MPC-150-IM for Advanced and End-Stage Heart Failure Phase 2b trial full 12 month database lock in end-stage heart failure patients with LVADs (Q3 CY18) Phase 2b results presentation expected at major cardiovascular conference (Q4 CY18) Phase 3 trial in advanced heart failure enrollment completion (H2 CY18) MPC-06-ID for Chronic Low Back Pain Phase 3 trial completed enrollment (Q1 CY18) Completed non-dilutive transactions for commercialization of MSC-100-IV (remestemcel-L) Establish regional commercial partnerships Establish global commercial partnerships

Questions? |

Exhibit 99.3

 

 

MESOBLAST PROVIDES UPDATE ON TRANSACTION WITH TASLY PHARMACEUTICAL GROUP

 

New York, USA, and Melbourne, Australia; August 29, 2018: Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced that Tasly Pharmaceutical Group has received People's Republic of China governmental approvals of Overseas Direct Investment from Tianjin Commission of Commerce and Tianjin Development and Reform Commission to enter into an investment agreement as well as a development and collaboration agreement with Mesoblast to commercialize cell therapies for cardiovascular diseases in China.

 

Under the terms of the agreements with Tasly, on closing Mesoblast will receive US$40 million, comprising a US$20 million upfront technology access fee and US$20 million for equity in Mesoblast purchased by Tasly at AUD$1.86 per share. The transaction is subject to filing with the State Administration of Foreign Exchange.

 

About Tasly Pharmaceutical Group

Tasly Pharmaceutical Group (SHA: 600535) is one of the largest pharmaceutical companies in China with more than 20 years of operational history. Its business focuses on R&D, manufacturing and commercialization of innovative modern traditional Chinese medicine, biologics and chemical drugs in the therapeutic areas of cardiology, metabolism and oncology. Tasly has the only marketed biological product for cardiovascular diseases approved in China. It has one of the largest pharmaceutical sales and marketing teams, including 809 offices established in 29 regions covering all the main therapeutic areas, and a vast distribution network across approximately 20,000 hospitals in China. At 2017, its total annual revenues exceeded US$2.5 billion.

 

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 applicable federal securities laws. Forward- looking statements include, but are not limited to, statements about: the potential benefits of this alliance and the parties’ ability to maintain the alliance; whether the conditions to the transaction will be satisfied in a timely manner, if at all; the parties’ ability to advance product candidates into, enroll and successfully complete, clinical studies, advance their manufacturing capabilities, and obtain regulatory filings and approvals. There are many uncertainties and risks that may cause our 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.

 

 

 

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