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 April 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 April 18, 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: April 19, 2018

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INDEX TO EXHIBITS

 

 

Exhibit 99.1

 

MESOBLAST CLINICAL PROGRAM UPDATE FOR MPC-150-IM IN PATIENTS WITH CHRONIC HEART FAILURE

 

New York, USA; and Melbourne, Australia; April 18, 2018: Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today provided an update on the Phase 3 and Phase 2b clinical trials of the Company's proprietary allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM in patients with moderate-to-severe and end-stage advanced chronic heart failure (CHF), respectively. These indications represent major unmet medical needs due to the high rates of morbidity and mortality despite existing therapies. 

 

In the United States alone, there are more than 1.3 million patients with New York Heart Association (NYHA) Class III CHF, 250,000 patients with NYHA Class IV CHF, and 50,000 patients with end-stage CHF, representing a potential multi-billion dollar market opportunity for Mesoblast.

 

Positive clinical signals have been previously published in Phase 2 trials of Mesoblast’s MPC therapy in advanced and end-stage heart failure,^1,2 supporting a common underlying mechanism of action (MOA). The MOA by which MPC-150-IM is thought to exert its effects in these patient populations, based on preclinical evidence, is through reduction of damaging inflammation, maturation of the vasculature, and cardiac repair.

 

Phase 3 DREAM-HF Trial Targeting NYHA Class II/III Patients With Moderate-to-Advanced Chronic Heart Failure

 

 

 

 

Phase 2b Trial Targeting End-State Heart Failure Patients with a Left Ventricular Assist Device (LVAD)

 

 

 

 

 

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About Chronic Heart Failure (CHF)

CHF is a progressive disease and is classified in relation to the severity of the symptoms experienced by the patient. The most commonly used classification system was established by the NYHA and ranges from Class I-II (mild to moderate) to Class III/IV (severe to end-stage). In 2016, more than 15 million patients in the seven major global pharmaceutical markets were estimated to have been diagnosed with CHF³. Prevalence is expected to grow 46% by 2030 in the United States alone, affecting more than 8 million Americans⁴. Approximately half of people who develop heart failure die within 5 years of diagnosis^5,6 . Patients with advanced CHF (NYHA Class III or Class IV) have the highest burden of disease, recurrent hospitalizations and mortality. In the United States alone, the NYHA Class III patient population is estimated at 1.3 million patients and the NYHA class IV population at 250,000 patients. There are approximately 50,000 patients with end-stage class IV heart failure who, despite optimal medical therapy, have a one-year mortality exceeding 50%⁷. The only options to increase survival in these patients are the use of LVADs or of heart transplants, the latter limited by donor availability to less than 3000 patients annually⁸. In the United States and worldwide, CHF results in severe economic, social, and personal costs to patients and their respective healthcare systems⁶. 

References:

 

About Mesoblast

Mesoblast Limited (ASX:MSB; Nasdaq:MESO) is a global leader in developing innovative cell-based medicines. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblast’s allogeneic, ‘off-the-shelf’ cell product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncologic/hematologic conditions.

 

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.

 

 

 

 

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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 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