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MSB - Mesoblast News Story

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Sector
Healthcare
Size
Mid Cap
Market Cap £572.2m
Enterprise Value £588.4m
Revenue £11.8m
Position in Universe 290th / 1907

Mesoblast Operational Highlights and Upcoming Milestones

Wed 31st March, 2021 12:54am
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NEW YORK, March 30, 2021 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO;
ASX:MSB), global leader in allogeneic cellular medicines for inflammatory
diseases, today provided an overview of the Company’s recent operational
highlights, as well as upcoming milestones.

Operational highlights included:
* Successful completion of US$110 million private placement, with pro-forma
cash balance at December 31, 2020, of US$187.5 million


* Private placement was led by US investor group SurgCenter Development
(SurgCenter), one of the largest private operators of ambulatory surgical
centers (ASC) in the US specializing in spine, orthopaedic and total joint
procedures


* Appointment of Philip J. Facchina, Chief Strategy Officer of SurgCenter, to
the Mesoblast Board of Directors


* Results from Phase 3 trial of rexlemestrocel-L (MPC-06-ID) in 404 patients
with chronic low back pain (CLBP) due to degenerative disc disease (DDD)
showed that a single injection of rexlemestrocel-L + hyaluronic acid (HA)
carrier may provide at least two years of pain reduction, with opioid sparing
activity in patients using opioids at baseline


* Significant and durable reductions in CLBP through 24 months were seen
across the entire evaluable study population, and greatest pain reduction was
observed in the pre-specified population with CLBP of shorter duration than
the study median of 68 months


* The results indicate that treatment benefit may be greatest when
inflammation is high and before irreversible fibrosis has occurred in the
intervertebral disc


* Results from Phase 3 trial of rexlemestrocel-L (REVASCOR(®)) in 537
patients with chronic heart failure (CHF) with reduced left ventricular
ejection fraction (HFrEF) showed that a single dose of rexlemestrocel-L
resulted in substantial reductions in heart attacks and strokes across the
entire evaluable study population of NYHA class II and III patients and in
significant and durable reduction in cardiac death in patients with New York
Heart Association (NYHA) class II disease


* The results indicate that treatment benefit in patients with chronic heart
failure may be greatest when inflammation is high and before irreversible
heart muscle loss and fibrosis has occurred


* Commencement of an investigator-led randomized, controlled study of
remestemcel-L delivered by an endoscope directly to the areas of inflammation
and tissue injury in up to 48 patients with medically refractory Crohn’s
disease or ulcerative colitis


* License and collaboration agreement with Novartis for the development,
manufacture, and commercialization of remestemcel-L, with an initial focus on
the development of the treatment of acute respiratory distress syndrome
(ARDS), including that associated with COVID-19. The agreement remains subject
to certain closing conditions, including time to analyze the results from the
COVID-19 ARDS trial
Key initiatives and upcoming milestones for the next two quarters:
* Mesoblast’s strengthened balance sheet will underpin the Company’s
operational preparedness and its ongoing discussions with potential strategic
partners to develop and commercialize rexlemestrocel-L and remestemcel-L for
the large market opportunities of chronic heart failure, chronic lower back
pain, and respiratory diseases 
 
* Mesoblast expects to meet with the United States Food and Drug
Administration (FDA) under a well-established regulatory process to discuss
the fastest pathway to licensure of remestemcel-L in the treatment of children
with steroid-refractory acute graft versus host disease


* Clinical results from remestemcel-L trials in COVID-19 ARDS and medically
refractory Crohn’s disease or ulcerative colitis


* Mesoblast intends to meet with FDA to discuss a potential pathway for
approval of rexlemestrocel-L in patients with chronic heart failure based on
the observed reduction in mortality and morbidity in the chronic heart failure
Phase 3 trial


* Mesoblast intends to meet with FDA to discuss a potential pathway for
approval of rexlemestrocel-L in patients with chronic discogenic lower back
pain based on the observed durable reduction in pain and opioid sparing
activity in the CLBP Phase 3 trial
About Mesoblast

Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular
medicines for the treatment of severe and life-threatening inflammatory
conditions. The Company has leveraged its proprietary mesenchymal lineage cell
therapy technology platform to establish a broad portfolio of late-stage
product candidates which respond to severe inflammation by releasing
anti-inflammatory factors that counter and modulate multiple effector arms of
the immune system, resulting in significant reduction of the damaging
inflammatory process.

Mesoblast has a strong and extensive global intellectual property portfolio
with protection extending through to at least 2040 in all major markets. The
Company’s proprietary manufacturing processes yield industrial-scale,
cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with
defined pharmaceutical release criteria, are planned to be readily available
to patients worldwide.

Mesoblast has completed Phase 3 trials of rexlemestrocel-L for advanced
chronic heart failure and chronic low back pain. Remestemcel-L is being
developed for inflammatory diseases in children and adults including steroid
refractory acute graft versus host disease and moderate to severe acute
respiratory distress syndrome. Two products have been commercialized in Japan
and Europe by Mesoblast’s licensees, and the Company has established
commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is
listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO).
For more information, please see www.mesoblast.com, LinkedIn: Mesoblast
Limited and Twitter: @Mesoblast

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 initiation, timing, progress and results of
Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and
development programs; Mesoblast’s ability to advance product candidates
into, enroll and successfully complete, clinical studies, including
multi-national clinical trials; Mesoblast’s ability to advance its
manufacturing capabilities; the timing or likelihood of regulatory filings and
approvals, manufacturing activities and product marketing activities, if any;
the commercialization of Mesoblast’s product candidates, if approved;
regulatory or public perceptions and market acceptance surrounding the use of
stem-cell based therapies; the potential for Mesoblast’s product candidates,
if any are approved, to be withdrawn from the market due to patient adverse
events or deaths; the potential benefits of strategic collaboration agreements
and Mesoblast’s ability to enter into and maintain established strategic
collaborations; Mesoblast’s ability to establish and maintain intellectual
property on its product candidates and Mesoblast’s ability to successfully
defend these in cases of alleged infringement; the scope of protection
Mesoblast is able to establish and maintain for intellectual property rights
covering its product candidates and technology; estimates of Mesoblast’s
expenses, future revenues, capital requirements and its needs for additional
financing; Mesoblast’s financial performance; developments relating to
Mesoblast’s competitors and industry; 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.

Release authorized by the Chief Executive.

For more information, please contact:

 Corporate Communications / Investors  Media                        
 Paul Hughes                           Kristen Bothwell             
 T: +61 3 9639 6036                    T: +1 917 613 5434           
 E: investors@mesoblast.com            E: kbothwell@rubenstein.com  


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