Chairman’s Address to the Mesoblast 2017 Annual General Meeting
November 16 2017 - 6:00AM
Welcome to the Mesoblast 2017 Annual General
Meeting.
It has been a significant year for
Mesoblast. Our proprietary and leading-edge cell therapy
technology platform has demonstrated consistent and durable
clinical outcomes across multiple difficult-to-treat diseases where
we believe our technology offers unique benefits and could achieve
commercial blockbuster potential. Our three most advanced
product candidates are fast approaching major Phase 3 outcomes,
bringing our goal of commercializing cellular medicines close to
fruition.
We look forward to reporting shortly on the Phase 3 results of
our cell therapy for the most devastating complication of bone
marrow transplants in children with blood cancers. This product
candidate is well poised to become the first industrially
manufactured allogeneic cellular medicine commercially available in
the United States, extending on the success of our technology
platform in Japan.
In parallel with our clinical progress, the
United States has recognized the tremendous potential of
regenerative medicine through the enactment of the
21st Century Cures Act that may facilitate earlier market
entry for our cellular therapies. We intend to take full
advantage of the convergence of this new regulatory framework for
cellular medicines with our strong clinical results in active
partnership discussions with companies that share our vision and
commercial objectives.
We could not have attained this strong progress
without the support of you, our shareholders. We would like to
thank our major institutional and retail shareholders for your
patience, financial backing and recognition of the key clinical
achievements that we have made this year. Your participation in the
retail and institutional entitlement offers, as well as the recent
absorption of the overhang in the marketplace, is deeply
appreciated.
The Board and the management team remain
steadfast in our commitment to deliver key milestones that have the
potential to drive shareholder value over the short, medium, and
longer term. At this important junction in the Company’s growth and
commercial plans, the Board is focused on complementing the
existing skill sets with additional international biopharmaceutical
and commercial expertise, as well as succession planning. We
expect to report on Board renewal in 2018. I would now like
to ask our Chief Executive Silviu Itescu to provide a detailed
insight into our corporate strategy and operational activities.
Thank you.
Brian
Jamieson
November 16, 2017
About MesoblastMesoblast Limited
(Nasdaq:MESO) (ASX:MSB) 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 StatementsThis 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. 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.
For further information, please
contact:
Julie MeldrumCorporate CommunicationsT: +61 3 9639
6036E: julie.meldrum@mesoblast.com
Schond GreenwayInvestor RelationsT: +1 212 880
2060E: schond.greenway@mesoblast.com
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