Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024
July 30 2024 - 9:13PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
provided highlights of its recent activities for the fourth quarter
ended June 30, 2024.
Mesoblast Chief Executive Silviu Itescu said:
“We are very pleased with the strong relationship we have built
with FDA across our product pipeline and the positive outcomes over
the past six months.”
“Our BLA resubmission for approval of Ryoncil®
(remestemcel-L) in the treatment of children with acute graft
versus host disease (SR-aGVHD) was accepted as a complete response,
we received feedback from FDA on the potential accelerated approval
pathway for Revascor® (rexlemestrocel-L) in end-stage heart failure
patients, and our confirmatory Phase 3 trial in inflammatory back
pain is actively enrolling with a primary endpoint of pain
reduction aligned with FDA.”
“We are executing on our go-to-market plan to
bring Ryoncil to the many children suffering with the devastating
disease of acute GVHD. I look forward to an activity update at our
full year financials and investor call on August 28th 6.30pm EDT
(August 29th 8.30am AEST).”
KEY HIGHLIGHTS
Graft versus Host Disease – Pending
Decision on FDA Approval
- FDA informed
Mesoblast at the end of March 2024 that, following additional
consideration, the available clinical data from the Phase 3 study
MSB-GVHD001 appears sufficient to support submission of the
proposed BLA for remestemcel-L (RYONCIL) for treatment of pediatric
patients with SR-aGVHD.
- Mesoblast
resubmitted its BLA for approval of RYONCIL on July 8, 2024,
addressing remaining CMC (Chemistry, Manufacturing, and Controls)
items in the August 2023 Complete Response Letter (CRL).
- FDA accepted the
BLA resubmission within two weeks, considering it to be a complete
response.
- Mesoblast
anticipates a decision prior to or on the FDA’s Prescription Drug
User Fee Act (PDUFA) goal date of January 7, 2025.
- FDA has already
conducted the Pre-License Inspection (PLI) of the manufacturing
process for RYONCIL in May 2023 and this did not result in the
issuance of any Form 483.
- RYONCIL is being
reviewed under Priority Review, a designation given to drugs that
treat a serious condition and provide a significant improvement in
safety or effectiveness over existing treatments.
Chronic Inflammatory Low Back Pain –
Phase 3 Program
- The confirmatory
Phase 3 trial of Mesoblast’s second generation allogeneic,
immunoselected, and industrially manufactured stromal cell product
rexlemestrocel-L in patients with chronic low back pain (CLBP) due
to inflammatory degenerative disc disease of less than five years
duration has commenced enrollment at multiple sites across the
United States.
- FDA has previously
confirmed alignment with Mesoblast on the design of the 300-patient
randomized, placebo-controlled trial and the 12-month primary
endpoint of pain reduction as an approvable indication. Key
secondary measures include improvement in quality of life,
function, and reduced opioid usage.
- FDA has designated
rexlemestrocel-L a Regenerative Medicine Advanced Therapy (RMAT)
for the treatment of chronic low back pain. RMAT designation
provides all the benefits of Breakthrough and Fast Track
designations, including rolling review and eligibility for priority
review on filing of a Biologics License Application (BLA).
Chronic Heart Failure with Reduced
Ejection Fraction (HFrEF) and Persistent Inflammation
- FDA informed
Mesoblast that it supports an accelerated approval pathway for its
second generation allogeneic, immunoselected, and industrially
manufactured stromal cell product rexlemestrocel-L (Revascor®), for
patients with end-stage ischemic heart failure with reduced
ejection fraction (HFrEF) and a left ventricular assist device
(LVAD).
- In these patients,
a single administration of REVASCOR reduced inflammation,
strengthened left ventricular function, reduced right ventricular
failure, and reduced hospitalizations.
- REVASCOR has also
reduced major adverse cardiac events (MACE) (cardiovascular death,
heart attacks and strokes) in a completed Phase 3 trial in ischemic
HFrEF patients with NYHA class II /III disease and
inflammation.
- Mesoblast has
received RMAT designation for rexlemestrocel-L in the treatment of
end-stage heart failure in LVAD patients and intends to meet with
FDA to discuss data presentation, timing and FDA expectations for
an accelerated approval filing in these patients.
FINANCIAL REPORT
We will take a measured approach to preparing
for the commercial launch of RYONCIL for treatment of children with
SR-aGVHD in anticipation of potential FDA BLA approval and ensure
prudent cash management. The successful implementation of the cost
containment plan from August 2023 and the re-prioritization of
projects has enabled us to reduce cash expenditure whilst still
making significant strides forward on key programs as outlined
above. We continue to work on corporate and strategic initiatives
to access commercial distribution channels and optimize our balance
sheet.
Fourth Quarter and Full Year
Results
- Cash balance at
June 30, 2024 is US$63.0 million, with additional US$10.0 million
available from an existing facility on FDA approval of
RYONCIL.
- Net operating cash spend of US$10.2
million for the fourth quarter FY2024.
- 37% (US$6.0
million) reduction in net operating cash spend for the fourth
quarter FY2024 versus the prior comparative quarter in FY2023.
- 23% (US$14.8
million) reduction in net operating cash spend in FY2024 compared
to FY2023.
Cost containment strategy
achieved
On completion of the FY2024 financial year we
are pleased to report the results of the successful cost
containment plan announced in August 2023 as follows:
Other Fees to Non-Executive
Directors were nil, consulting payments to Non-Executive Director
were US$102,783 and salary payments to full-time Executive
Directors were US$228,506, detailed in Item 6 of the Appendix 4C
cash flow report for the quarter.1 From 1 August 2023,
Non-Executive directors have voluntarily deferred 50% cash payment
of their director fees and agreed to receive the remaining 50% of
their fees in equity-based incentives and Executive Directors (our
Chief Executive and Chief Medical Officers) have voluntarily
reduced their base salaries for FY24 by 30% in lieu of accepting
equity-based incentives.
A copy of the Appendix 4C – Quarterly Cash Flow
Report for the fourth quarter FY2024 is available on the investor
page of the company’s website www.mesoblast.com.
About Mesoblast Mesoblast (the
Company) 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, and biologic-resistant inflammatory bowel disease.
Rexlemestrocel-L is being developed 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
- 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 |
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A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/ea78d212-3108-47c8-805d-fd80206fd7c4
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