Appendix 4C Quarterly Activity Report
January 31 2023 - 4:40AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
provided an activity report for the second quarter ended December
31, 2022.
Financial Highlights
- Revenue from royalties on sales of
TEMCELL® HS Inj.1 sold in Japan by our licensee for the quarter
increased 36% to US$1.9 million from US$1.4 million for the quarter
ended September 30, 2022.
- Net cash usage for operating
activities in the quarter was US$16.5 million; this represented a
reduction of US$1.7 million, or 9%, on the comparative quarter in
FY2022, and a reduction of US$14.1 million, or 46%, on the
comparative quarter in FY2021.2
- In December 2022 we announced that
funds managed by Oaktree Capital Management, L.P. (“Oaktree”)
extended to Mesoblast the availability of up to an additional US$30
million of its US$90 million five-year facility subject to
achieving certain milestones on or before September 30, 2023.
- Cash on hand at the end of the quarter was US$67.6 million,
with up to an additional US$40 million available to be drawn down
from existing financing facilities subject to certain
milestones.
Operational Highlights
- The Biologics License Application
(BLA) resubmission documents for remestemcel-L in the treatment of
children with steroid-refractory graft versus host disease
(SR-aGVHD) are complete and expected to be filed with FDA
shortly.
- Survival outcomes have not improved
over the past two decades for children or adults with the most
severe forms of SR-aGVHD.3-5 The lack of any approved treatments
for children under 12 means that there is an urgent need for a
therapy that improves the dismal survival outcomes in
children.
- Long-term survival results were
received for remestemcel-L from Mesoblast’s pivotal Phase 3
clinical trial (GVHD-001) in children with SR-aGVHD. The results
showed durable survival through 4 years of follow-up. These new
long-term survival data are a key component of the Company’s BLA
resubmission to the FDA.The study was performed by the Center for
International Blood and Marrow Transplant Research (CIBMTR) on 51
evaluable children with SR-aGVHD who were enrolled in the phase 3
trial across 20 centers in the US.Overall survival in the
remestemcel-L cohort was 63% at 1 year, 51% at 2 years, and 49% at
4 years, with median survival of 2 to 3 years. In recently
published studies of children or adults with SR-aGVHD who received
best available therapy (BAT) or the only FDA-approved agent for
adults, ruxolitinib, 1 year survival was 40-49% and 2 year survival
was 25%-38%.3,6-8
- Mesoblast has previously gained
alignment with the FDA on key metrics for a pivotal Phase 3 study
of rexlemestrocel-L in patients with chronic low back pain (CLBP)
with degenerative disc disease which seeks to replicate the
significant reduction in pain seen in the first Phase 3 trial.
- FDA has confirmed that 12-month
reduction in pain is an approvable indication, with key secondary
measures of improvement in function and reduction in opioid
usage.
- Preparation underway to commence the
pivotal Phase 3 clinical trial by mid-CY2023.
- Results from three randomized
controlled trials of rexlemestrocel-L in class II/III heart failure
with reduced ejection fraction (HFrEF) and in end-stage HFrEF with
left ventricular assist devices (LVADs) support the idea of a
common mechanism of action (MOA) by which rexlemestrocel-L reverses
inflammation-related endothelial dysfunction and reduces adverse
clinical outcomes across the spectrum of HFrEF patients.
- Improvement in left ventricular
ejection fraction (LVEF) at 12 months in patients with HFrEF may be
an appropriate early surrogate endpoint for long term reduction in
major adverse cardiovascular events (MACE).
- Mesoblast plans to meet with FDA
under its existing regenerative medicine advanced therapy (RMAT)
designation to discuss data and the evidence of a common MOA across
the broader HFrEF spectrum, including LVAD patients.
Other Salary payments to
full-time Executive Directors were US$324,678 and fees to
Non-Executive Directors were US$192,164, detailed in Item 6 of the
Appendix 4C cash flow report for the quarter.9
A copy of the Appendix 4C – Quarterly Cash Flow Report for the
second 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.
- The Appendix 4C for the quarter ended December 31, 2021
reported net cash usage for operating activities of US$19.8 million
which was subsequently revised to US$18.2 million, and the quarter
ended December 31, 2020 reported net cash usage for operating
activities of US$32.0 million which was subsequently revised to
US$30.6 million. These revisions were due to a change in accounting
policy adopted at December 31, 2021.
- Rashidi A et al. Outcomes and predictors of response in
steroid-refractory acute graft-versus-host disease:
single-center results from a cohort of 203 patients. Biol Blood
Bone Marrow Transplant 2019; 25(11):2297-2302.
- Berger M, Pessolano R, Carraro F, Saglio F, Vassallo E, Fagioli
F. Steroid-refractory acute graft-versus-host disease graded III-IV
in pediatric patients. A mono-institutional experience with a
long-term follow-up. Pediatric Transplantation. 2020;
24(7):e13806
- Biavasco F, Ihorst G, Wasch R, Wehr C, Bertz H, Finke J, Zeiser
R. Therapy response of glucocorticoid-refractory acute GVHD of the
lower intestinal tract. Bone Marrow Transplantation. 2022
- MacMillan ML et al. Pediatric acute GVHD: clinical phenotype
and response to upfront steroids. Bone Marrow Transplant 2020;
55(1): 165-171
- Zeiser R et al. Ruxolitinib for Glucocorticoid-Refractory Acute
Graft-versus-Host Disease. N Engl J Med 2020;382:1800-10.
- Jagasia M et al. Ruxolitinib for the treatment of
steroid-refractory acute GVHD (REACH1): a multicenter, open-label
phase 2 trial. Blood. 2020 May 14; 135(20): 1739–1749.
- 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 (including BLA resubmission), 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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