Full Press Release Details
MESOBLAST PROVIDES UPDATE ON HEART FAILURE TRIAL AND FUNDING OF CLINICAL OPERATIONS
New York, USA; and Melbourne, Australia; 1 July 2016: Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced plans for an early
data readout on its Phase 3 chronic heart failure trial, materially reduced projections for annualized cash burn, and the establishment of an equity facility to provide funding at the Company s discretion for up to three years.
Mesoblast Chief Executive Silviu Itescu said: We believe we can obtain meaningful data by performing a blinded Interim Analysis to assess the heart
failure trial s primary endpoint in Q1 2017. The results will inform our subsequent strategic decisions regarding the program.
are implementing a series of material cost-cutting measures and have realigned existing company resources to focus on our key value drivers. This will ensure we maintain momentum in our key Tier 1 programs: Phase 3 programs for degenerative disc
disease, graft versus host disease and chronic heart failure, as well as the Phase 2 program in biologic refractory rheumatoid arthritis.
financial flexibility, we have established an equity facility which may be used at our sole discretion over the next three years, as needed.
Chronic Heart Failure Program
Approximately 240 patients
have already been enrolled in the Phase 3 heart failure trial to date. The trial s primary endpoint is a comparison of recurrent Heart Failure-Related Major Adverse Cardiovascular Events (HF-MACE) in high-risk heart failure patients receiving
either Mesoblast s product candidate MPC-150-IM or control.
Based on observed HF-MACE event rates in the trial, the Company believes meaningful data
will be generated by bringing forward to Q1 2017 a scheduled Interim Analysis to assess the trial s primary endpoint between cell-treated and control patients. The results will be used to provide evidence based support for strategic decisions
regarding the Phase 3 program, ongoing cardiovascular partnering discussions, and informed use of funds. The anticipated costs incurred to this Interim Analysis will be approximately US$13 million.
To ensure prudent use of cash reserves given the additional expenditure on the Phase 3 heart failure trial, the Company will significantly reduce projected
cash burn for FY17 through re-prioritization of certain projects and operational streamlining. Consequently, Mesoblast s existing cash reserves of approximately US$80 million will provide operational runway for 12 to 15 months, including costs
related to the heart failure trial.
During this period the Company anticipates key data readouts from each of its Tier 1 programs. In parallel, Mesoblast
will continue discussions with potential strategic partners to deliver non-dilutive funding.
Details of implemented cost reductions will be provided in
the upcoming full year financial results.
Key Terms of the Equity Facility Agreement
The Company has entered into an equity facility with Kentgrove Capital which may be used by Mesoblast to meet additional funding requirements over the next
three years, as they arise.
About Kentgrove Capital
Kentgrove Capital is an Australian-based, privately-held investment management firm with an objective of generating strong returns for their investors over the
medium and long term. Kentgrove Capital invests in Australian equities across all industries with a primary strategy to invest in companies they consider to be significantly undervalued and have high growth potential.
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 press release 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. 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.
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Corporate Communications