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 July 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 July 17, 2018, 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.

 

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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: July 18, 2018

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INDEX TO EXHIBITS

 

 

Exhibit 99.1

 

 

 

MESOBLAST ENTERS INTO STRATEGIC CARDIOVASCULAR ALLIANCE FOR CHINA WITH TASLY PHARMACEUTICAL GROUP 

 

New York, USA, and Melbourne, Australia; July 17, 2018:  Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced that it has entered into a strategic alliance with one of China’s largest pharmaceutical companies, Tasly Pharmaceutical Group (SHA: 600535; Tasly), for the development, manufacture and commercialization in China of Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product candidates 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.

 

Key commercial terms of the strategic alliance are as follows:

 

 

In order to potentially expedite development and commercialization of these cardiovascular assets, Tasly and Mesoblast plan to leverage each other’s clinical trial results in China and the United States and other major jurisdictions respectively to support their respective regulatory submissions for MPC-150-IM and MPC-25-IC.

 

Chairman of Tasly Pharmaceutical Group Mr Yan Kaijing said: "We are very excited to partner with Mesoblast, the premier cellular medicines company, to provide innovative products that have the potential to make a major impact on the high growth cardiovascular market in China.  This aligns well with our corporate strategy to be the lead provider of therapies for patients with cardiovascular conditions in China.”

 

Mesoblast Chief Executive Dr Silviu Itescu stated: “Tasly Pharmaceutical Group’s powerful combination of clinical, regulatory and manufacturing expertise, together with one of the largest commercial footprints in cardiology in China, makes it the ideal partner for Mesoblast and opens up the China market to our cardiovascular franchise.”

 

The transaction is subject to governmental approvals from the People’s Republic of China (PRC).

 

Conference Call

Mesoblast will host a conference call to discuss this new strategic alliance on Tuesday July 17, 2018 at 6.30pm EDT; Wednesday, July 18, 2018 at 8.30am AEST.

 

To access the call, please dial 1 855 881 1339 (U.S.), 1 800 558 698 (Australia) or +61 2 9007 3187 (outside of the U.S. and Australia). The conference identification code is 783910.

 

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

 

 

 

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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, with a vast distribution network across approximately 20,000 hospitals in China. As of year 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.

 

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