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 June 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 June 17, 2019, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement, which is attached hereto as Exhibit 99.1, and is incorporated herein by reference.

On June 18, 2019, Mesoblast Limited filed with the Australian Securities Exchange a new release announcement, which is attached hereto as Exhibit 99.2, 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: June 18, 2019

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INDEX TO EXHIBITS

 

 

Exhibit 99.1

 

 

 

MESOBLAST TO HOST VIRTUAL SYMPOSIUM WITH KEY OPINION LEADER HIGHLIGHTING ACUTE GRAFT VERSUS HOST DISEASE

 

 

New York, USA; and Melbourne, Australia; June 17, 2019: Mesoblast Limited (NASDAQ: MESO; ASX: MSB), global leader in cellular medicines for inflammatory diseases, today announced that it will host a virtual symposium on Monday, June 17 to discuss Mesoblast’s product candidate, remestemcel-L, in steroid refractory acute graft versus host disease (aGVHD) in children, and to include Dr. Susan E. Prockop, a key opinion leader with significant expertise and experience in treating pediatric patients with this life threatening disease. Dr. Prockop is a pediatric oncologist specializing in bone marrow and stem cell transplantation at Memorial Sloan Kettering Cancer Center in New York. She also served as an investigator in Mesoblast’s recent remestemecel-L study in pediatric patients with steroid refractory aGvHD.

 

The webcast event will feature a presentation by Dr. Prockop who will address the current management and treatment options for patients with aGVHD. She will also discuss her experiences with remestemcel-L in patients with steroid refractory aGVHD. Mesoblast senior management will discuss the potential market and commercial opportunities for remestemcel-L should it receive approval from the US Food and Drug Administration (FDA). The Company has agreement from the FDA for submission of a rolling Biologics License Application (BLA) for remestemcel-L in the treatment of aGVHD in children, for which the Company filed the first component of in May of 2019.

 

Interested parties may access the event on Monday, June 17 at 9:00am EDT (11:00 pm AEST) by dialing (866) 939-3921 (US); 1 800 507 265 (Australia) or 0808 238 9578 (UK) using the confirmation code 48733893.

 

The webcast can be accessed live here: http://www.wsw.com/webcast/cc/meso. The webcast will also be accessible on the Investors & Media section of the Company’s website at www.mesoblast.com.

 

About Steroid-refractory Acute Graft Versus Host Disease 

Steroid-refractory acute graft versus host disease (aGVHD) is a life-threatening complication of a bone marrow transplant in patients primarily being treated for blood cancers. There are more than 30,000 allogeneic bone marrow transplants performed globally, with 20-25% occurring in children. Currently, there are no approved products for aGVHD in children outside Japan, where Mesoblast licensee JCR Pharmaceuticals markets TEMCELL^®1 HS Inj. for both children and adults with aGVHD.

 

About Mesoblast

Mesoblast Limited (ASX:MSB; Nasdaq:MESO) has leveraged its proprietary technology platform to establish a broad portfolio of late-stage allogeneic (off-the-shelf) 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 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

 

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

 

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

 

 

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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 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:

  

Julie Meldrum

Corporate Communications

T: +61 3 9639 6036

E: julie.meldrum@mesoblast.com

 

Schond Greenway

Investor Relations

T: +1 212 880 2060

E: schond.greenway@mesoblast.com

 

 

 

 

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Exhibit 99.2

 

 

 

HIGH ECONOMIC BURDEN IN CHILDREN WITH STEROID REFRACTORY ACUTE GRAFT VERSUS HOST DISEASE

 

Mesoblast presents health economics and outcomes research data at 24^th European Hematology Association Congress

 

Melbourne, Australia; and New York, USA; June 18, 2019: Mesoblast Limited (ASX:MSB; Nasdaq: MESO), global leader in cellular medicines for inflammatory diseases, presented health economics and outcomes research data for pediatric acute graft versus host disease (aGVHD) at the 24th European Hematology Association (EHA) Congress in Amsterdam, Netherlands.  Key findings indicated that a steroid refractory state in aGVHD may result in significant deterioration in quality of life (QOL) and additional direct healthcare costs of up to $500,000 on average per patient.  

 

Acute GVHD is a potentially life-threatening complication of an allogeneic bone marrow transplant, with the most severe forms of the disease, Grades C/D or III/IV, frequently being refractory to steroid therapy and associated with mortality rates as high as 90%.^1,2

 

In studies from the United States (US), children with aGVHD have longer hospitalizations (incremental 17.9 – 45.4 days) and increased costs (incremental $114,698 - $224,000) compared to recipients of allogenic bone marrow transplants who did not develop aGVHD.³ In steroid-refractory patients, the magnitude of the burden may be larger, with a preliminary US pediatric claims analysis suggesting additional direct healthcare costs of up to $500,000 on average in steroid-refractory patients compared to those who responded to steroids.⁴

 

Mesoblast recently initiated a rolling Biologic License Application (BLA) to the United States Food and Drug Administration for its product candidate remestemcel-L in children with steroid-refractory aGVHD.

 

The BLA follows completion of Mesoblast’s Phase 3 trial which recruited 55 children with aGVHD - 89% of whom had Grade C/D disease.  The trial successfully met its primary endpoint of increased Day 28 Overall Response compared with a protocol-defined historical control rate (69% vs 45%, p=0.0003). Overall Response at Day 28 predicted highest survival at Day 100 and Day 180, 85% and 79%, respectively. These data are consistent with prior results from an Expanded Access Program in 241 children where remestemcel-L was used as salvage therapy after failure of steroids and other agents.

 

 

About Remestemcel-L

Mesoblast’s lead product candidate, remestemcel-L, is an investigational therapy comprising culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor. Remestemcel-L is administered to patients in a series of intravenous infusions of 60 minutes or less in duration over the course of 4-8 weeks. Remestemcel-L has demonstrated immunomodulatory properties to counteract the inflammatory processes that are implicated in aGVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

 

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 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

 

 

 

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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 in aGVHD; Mesoblast’s ability to advance its aGVHD product candidate into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals for aGVHD; 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:

  

Julie Meldrum

Corporate Communications

T: +61 3 9639 6036

E: julie.meldrum@mesoblast.com

 

Schond Greenway

Investor Relations

T: +1 212 880 2060

E: schond.greenway@mesoblast.com