Hercules Capital Provides US$15M From Existing Facility for Mesoblast to Accelerate Product Commercialization Programs
January 14 2019 - 10:46AM
Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today announced that it
has drawn down a further US$15 million from its US$75 million,
non-dilutive, four-year credit facility with Hercules Capital, Inc.
(NYSE:HTGC). The funds will be used primarily to ramp up
Mesoblast’s product commercialization programs including building
out a targeted sales force for its product candidate for acute
graft versus host disease (aGVHD).
The additional non-dilutive capital was made available after the
success of Mesoblast’s product candidate Revascor (MPC-150-IM) in
having significantly reduced hospitalization rates from major
gastrointestinal bleeding in patients with end-stage heart failure
and a left ventricular assist device (LVAD) compared with controls
in the 159-patient Phase 2 trial funded by the U.S. National
Institutes of Health.
Mesoblast plans to meet with the U.S. FDA during the first half
of 2019 to discuss a potential approval pathway for Revascor having
met this clinically meaningful outcome in LVAD patients.
Additionally, Mesoblast plans to submit a rolling Biologics
License Application with the FDA for use of remestemcel-L in
treating aGVHD in children in early 2019 and will execute on the
product candidate’s market access and commercialization strategy.
There are no FDA approved treatments for this disease with high
mortality.
Scott Bluestein, Chief Investment Officer of Hercules Capital,
said: “We are pleased with the continued clinical and corporate
progress of Mesoblast since the original funding of our credit
facility. We have made available a US$15 million second advance
following Mesoblast’s performance in 2018.
“This additional advance once again demonstrates Hercules’
unique ability to continue to finance our companies through
multiple value inflection points.”
An additional draw of US$25 million from the Hercules facility
may occur through Q4 2019 subject to certain conditions. There are
no warrants associated with this credit facility.
About Mesoblast Mesoblast Limited (ASX:MSB;
Nasdaq:MESO), world leader in the development and commercialization
of cellular medicines, has leveraged its proprietary technology
platform to establish a broad portfolio of late-stage allogeneic
(off-the-shelf) product candidates with three product candidates in
Phase 3 trials – acute graft versus host disease, chronic heart
failure and chronic low back pain due to degenerative disc disease.
Through a proprietary process, Mesoblast selects rare 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. Mesoblast
has facilities in Melbourne, New York, Singapore and Texas and is
listed on the Australian Securities Exchange (MSB) and on the
Nasdaq (MESO). www.mesoblast.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 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 GreenwayInvestor RelationsT: +1 212 880
2060E: schond.greenway@mesoblast.com
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