Mesoblast Enters Into US$50M Financing with Novaquest Capital for Commercial Readiness of Remestemcel-l in the Treatment of A...
02 July 2018 - 8:00PM
Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced a US$50
million financing from NovaQuest Capital Management, L.L.C.
(NovaQuest) for the continued development and
commercialization of its allogeneic product candidate remestemcel-L
(MSC-100-IV) for children with steroid refractory acute Graft
versus Host Disease (aGVHD). NovaQuest was formed in 2000 as a
strategic investment unit within Quintiles (now IQVIA), the world’s
largest clinical research organization, and became an independent
firm in 2010.
Mesoblast Chief Executive Dr Silviu Itescu stated: “We are
pleased to have NovaQuest’s support for our plans to bring
remestemcel-L to market. This transaction is underpinned by
the strength of our GVHD Phase 3 clinical trial results. This trial
is being managed in partnership with IQVIA, the clinical research
organization that provides trial oversight and global development
experience.”
NovaQuest partner Matthew Bullard said, “NovaQuest has been
providing novel solutions to the biopharmaceutical industry to fund
the development and commercialization of strategic assets for two
decades that reduce the cost of care, meet unmet medical needs,
improve efficacy and improve quality of life of patients.
Our extensive diligence leveraging our life science expertise
and network of industry experts gives us confidence in the ability
of Mesoblast to reach FDA approval and launch in the US for the
treatment of aGVHD. We believe Mesoblast’s disruptive technology
platform has the potential to be transformational in treatment of
severe and life-threatening diseases such as aGVHD.”
NovaQuest will provide a non-dilutive US$40 million, eight-year
term loan and purchase US$10 million of Mesoblast common shares.
The per share equity purchase price will represent a 5% premium to
the 10-day volume weighted average price at the time of execution
of the equity purchase agreement. Mesoblast will issue the shares
and draw the first tranche of the loan in the amount of US$30
million on closing, with an additional US$10 million to be drawn on
marketing approval of remestemcel-L by the United States Food and
Drug Administration (FDA).
Prior to maturity in July 2026, the loan is only repayable from
net sales of remestemcel-L in the treatment of pediatric patients
who have failed to respond to steroid treatment for acute GvHD, in
the United States and other geographies excluding Asia. Interest on
the loan will accrue at a rate of 15% per annum with the interest
only period lasting 4 years. Interest payments will be deferred
until after the first commercial sale. The financing will be
subordinated to the senior creditor, Hercules Capital, Inc..
Mesoblast’s open-label Phase 3 trial enrolled 55 children with
steroid-refractory aGVHD (aged between two months and 17 years) in
32 sites across the United States, with 89% of patients suffering
from the most severe form, grade C/D aGVHD. The trial was performed
under an United States Food and Drug Administration (FDA)
Investigational New Drug Application (NCT#02336230). This trial
previously met the primary endpoint of Day 28 overall response rate
(69% versus 45% historical control rate, p=0.0003). Top line Day
100 results demonstrated 87% survival rate for Day 28 responders to
remestemcel-L treatment (33/38), and an overall survival rate of
75% (41/55). The multi-infusion regimen of remestemcel-L was well
tolerated.
Based on interactions with the FDA, Mesoblast believes that
successful results from the completed Phase 3 trial, together with
Day 180 safety, survival and quality of life parameters in these
patients, may provide sufficient clinical evidence to file for
accelerated approval of remestemcel-L in the United States, where
there are currently no approved products for steroid-refractory
aGVHD.
Cantor Fitzgerald & Co. acted as exclusive arranger and
financial advisor to Mesoblast in this transaction.
About Mesoblast Mesoblast Limited (Nasdaq:MESO)
(ASX:MSB) is a global leader in developing innovative cell-based
medicines. Through a proprietary process, Mesoblast selects highly
purified 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.
The Company has leveraged its proprietary technology platform to
establish a broad portfolio of late-stage product candidates.
Mesoblast’s allogeneic, ‘off-the-shelf’ cell product candidates are
being evaluated in their ability to target advanced stages of
diseases with high, unmet medical needs including cardiovascular
conditions, orthopedic disorders, immunologic and inflammatory
disorders and oncologic/hematologic conditions.
About NovaQuestNovaQuest Capital Management is
a leading investor in life sciences and healthcare through its
BioPharma and Private Equity strategies. NovaQuest was formed in
2000 with the vision of building an investment platform to provide
strategic capital to life sciences and healthcare companies. Today,
NovaQuest Capital Management manages over $1.8 billion through its
BioPharma and Private Equity strategies. The investment team
consists of highly seasoned operational and investment
professionals with significant investment experience and deep life
science and healthcare expertise. Furthermore, NovaQuest benefits
from an extensive network of industry experts and relationships
that assist in identifying, analyzing and growing NovaQuest
portfolio companies and investments. For more information, please
visit www.novaquest.com.
Forward-Looking StatementsThis 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:
Mesoblast’s ability to meet the necessary conditions and milestones
to draw down on the facility; the timing, progress and results of
Mesoblast’s 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; the commercialization of Mesoblast’s product candidates,
if approved; 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: |
|
|
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Julie
Meldrum |
Schond Greenway |
Corporate
Communications |
Investor Relations |
T: +61 3 9639
6036 |
T: +1 212 880 2060 |
E: julie.meldrum@mesoblast.com |
E: schond.greenway@mesoblast.com |
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