Appendix 4C Quarterly Activity Report
April 27 2023 - 9:00PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
provided an activity report for the third quarter ended March 31,
2023.
Financial Highlights
- Successful completion of a global
private placement primarily to Mesoblast’s existing major US, UK,
and Australian shareholders raising approximately US$40 million,
net of transaction costs.
- In addition to cash on hand at the end of the quarter of
US$48.8 million, pro-forma cash after proceeds raised in April is
US$88.8 million, with up to an additional US$40 million available
to be drawn down from existing financing facilities subject to
certain milestones.
- Net cash usage for
operating activities in the quarter was US$16.2 million; this
represented an increase of US$0.7 million, or 4%, on the
comparative quarter in FY2022, and a reduction of US$8.3 million,
or 34%, on the comparative quarter in FY2021.
- Revenue from
royalties on sales of TEMCELL® HS Inj.1 sold in Japan by our
licensee for the quarter were US$1.8 million. On a constant
currency basis, royalties on sales grew 4% quarter on quarter from
US$2.0 million2 for the quarter ended March 31, 2023, compared with
US$1.9 million for the quarter ended March 31, 2022.
Operational Highlights
Remestemcel-L
- Resubmitted to the U.S. Food and Drug
Administration (FDA) the Biologics License Application (BLA) for
approval of remestemcel-L in the treatment of children with
steroid-refractory acute graft versus host disease (SR-aGVHD).
- The resubmission contains new
information developed since the Complete Response Letter (CRL)
received in September 2020, including the generation of new data
and analyses which we believe provide substantial evidence of
remestemcel-L's effectiveness in pediatric SR-aGVHD.
- FDA accepted Mesoblast’s BLA
resubmission for remestemcel-L, considering the resubmission to be
a complete response and set a Prescription Drug User Fee Act
(PDUFA) goal date of August 2, 2023.
- As part of the ongoing review of the
BLA for remestemcel-L FDA scheduled a Pre-License Inspection (PLI)
of Mesoblast’s cell therapy manufacturing operations at Lonza
Bioscience in Singapore.
- Two studies on the remestemcel-L
development program for the treatment of children with SR-aGVHD
were selected by peer review and presented at the 2023 Tandem
Meetings of the American Society for Transplantation and Cellular
Therapy (ASTCT) and the Center for Blood and Marrow Transplant
Research (CIBMTR).
- The studies are titled “The
Immunomodulatory Activity of Remestemcel-L on T Cell Activation in
vitro is a Direct Measure of Product Potency and Correlates with
Clinical Outcomes in Pediatric Patients with Steroid-Refractory
Acute GVHD” and “Long-Term Survival in Children Treated with
Remestemcel-L for SR-aGVHD”. The data from both studies formed key
components of Mesoblast’s recent resubmission of its remestemcel-L
BLA to FDA for children with SR-aGVHD.
Rexlemestrocel-L
- FDA granted Regenerative Medicine
Advanced Therapy (RMAT) designation for rexlemestrocel-L in the
treatment of chronic low back pain (CLBP) associated with disc
degeneration, in combination with hyaluronic acid (HA) as delivery
agent for injection into the lumbar disc.
- FDA has confirmed that a 12-month
reduction in pain is an approvable indication and Mesoblast will
use this endpoint in its confirmatory Phase 3 trial under the RMAT
designation.
- Publication of the DREAM-HF Phase 3
trial results in the premier peer-reviewed journal for
cardiovascular medicine, the Journal of the American College of
Cardiology (JACC). The results of the randomized, double-blind,
controlled study in 537 patients showed that Mesoblast’s
mesenchymal precursor cell therapy (MPCs; rexlemestrocel-L)
strengthened heart function at 12 months, as measured by left
ventricular ejection fraction (LVEF) and decreased cardiovascular
death, myocardial infarction (MI) or stroke in patients with
chronic heart failure (CHF) due to reduced ejection fraction
(HFrEF) over a mean follow-up of 30 months.3
Other Salary payments to
full-time Executive Directors were US$330,756 and fees to
Non-Executive Directors were US$197,365, detailed in Item 6 of the
Appendix 4C cash flow report for the quarter.4
A copy of the Appendix 4C – Quarterly Cash Flow Report for the
third quarter FY2023 is available on the investor page of the
company’s website www.mesoblast.com.
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 2041 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 is developing product candidates for
distinct indications based on its remestemcel-L and
rexlemestrocel-L allogeneic stromal cell technology platforms.
Remestemcel-L is being developed for inflammatory diseases in
children and adults including steroid refractory acute graft versus
host disease, biologic-resistant inflammatory bowel disease, and
acute respiratory distress syndrome. Rexlemestrocel-L is in
development for advanced chronic heart failure and chronic low back
pain. 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
References / Footnotes
- TEMCELL® HS Inj. is a registered
trademark of JCR Pharmaceuticals Co. Ltd.
- TEMCELL sales by our Licensee are
recorded in Japanese Yen before being translated into USD for the
purposes of calculating the royalty paid to Mesoblast. Results have
been adjusted for the movement of the USD to Japanese Yen exchange
rate from 1USD:123.41 Yen for the 3 months ended March 31, 2022 to
1USD:134.54 Yen for the 3 months ended March 31, 2023.
- Perin EC. Et al. Randomized Trial of Targeted Transendocardial
Mesenchymal Precursor Cell Therapy in Patients With Heart Failure.
JACC Vol. 81, No. 9, 2023.
https://doi.org/10.1016/j.jacc.2022.11.061
- As required by ASX listing rule 4.7 and reported in Item 6 of
the Appendix 4C, reported are the aggregated total payments to
related parties being Executive Directors and Non-Executive
Directors
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.
Release authorized by the Chief Executive.
For more information, please contact:
Corporate Communications / Investors |
Media |
Paul Hughes |
BlueDot Media |
T: +61 3 9639 6036 |
Steve Dabkowski |
E: investors@mesoblast.com |
T: +61 419 880 486 |
|
E: steve@bluedot.net.au |
|
|
|
Rubenstein |
|
Tali Mackay |
|
E: tmackay@rubenstein.com |
|
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