23.05.2024 18:00:05 - dpa-AFX: GNW-Adhoc: Sequana Medical announces results of Annual and Extraordinary General Meetings of Shareholders
PRESS RELEASE
REGULATED INFORMATION
23 May 2024, 06:00 pm CEST
Ghent, Belgium - 23 May 2024 - Sequana Medical NV (Euronext Brussels: SEQUA)
(the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid
overload in liver disease, heart failure and cancer, today announces that all
proposed resolutions submitted to the Annual and Extraordinary General Meetings
of Shareholders were approved at the meetings held today at 09:00 am CEST.
The items on the agendas of the meetings included (among other) the approval of
a number of resolutions relating to the financial year ended 31 December 2023,
the approval of the revised remuneration policy, the reappointment of the
statutory auditor, certain approvals in accordance with Article 7:151 of the
Belgian Companies and Associations Code, the approval of the contribution in
kind of certain receivables pursuant to the unsecured and subordinated
convertible loan agreement entered into on 7 February 2024 between the Company
and Partners in Equity and Rosetta Capital in the principal amount of EUR
3,041,507.59, as well as the renewal of the authorization to the Board of
Directors to increase the share capital within the framework of the authorised
capital.
The minutes of the shareholders' meetings, as well as the revised versions of
the Company's articles of
association, can be accessed on the Company's website
(https://www.sequanamedical.com/investors/shareholder-information/).
For more information, please contact:
Sequana Medical
Ian Crosbie
Chief Executive Officer
E: IR@sequanamedical.com (mailto:IR@sequanamedical.com)
T: +44 7973 42 99 17
About Sequana Medical
Sequana Medical NV is a pioneer in treating fluid overload, a serious and
frequent clinical complication in patients with liver disease, heart failure and
cancer. This causes major medical issues including increased mortality, repeated
hospitalizations, severe pain, difficulty breathing and restricted mobility.
Although diuretics are standard of care, they become ineffective, intolerable or
exacerbate the problem in many patients. There are limited effective treatment
options, resulting in poor clinical outcomes, high costs and a major impact on
their quality of life. Sequana Medical is seeking to provide innovative
treatment options for this large and growing "diuretic-resistant" patient
population.
alfapump® and DSR® are Sequana Medical's proprietary platforms that work with
the body to treat diuretic-resistant fluid overload, delivering major clinical
and quality of life benefits for patients and reducing costs for healthcare
systems.
The Company's Premarket Approval (PMA) application for the alfapump was
submitted to the US FDA in December 2023 and accepted for substantive review in
January 2024, having reported positive primary and secondary endpoint data from
the North American pivotal POSEIDON study in recurrent or refractory ascites due
to liver cirrhosis. US market approval of the alfapump is anticipated before
the end of Q1 2025 with US commercial launch planned for H2 2025.
Results of the Company's RED DESERT and SAHARA proof-of-concept studies in heart
failure support DSR's mechanism of action as breaking the vicious cycle of
cardiorenal syndrome. All three patients from the non-randomized cohort of
MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have
been successfully treated with DSR, resulting in a dramatic improvement in
diuretic response and virtual elimination of loop diuretic requirements. The
independent Data Safety Monitoring Board approved the start of the randomized
MOJAVE cohort of up to a further 30 patients, which is planned after alfapump US
PMA approval.
Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker:
SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please
visit www.sequanamedical.com (http://www.sequanamedical.com).
Important Regulatory Disclaimers
The alfapump® system is currently not approved in the United States or Canada.
In the United States and Canada, the alfapump system is currently under clinical
investigation (POSEIDON Trial) and is being studied in adult patients with
refractory or recurrent ascites due to liver cirrhosis. DSR® therapy is still in
development and it should be noted that any statements regarding safety and
efficacy arise from ongoing pre-clinical and clinical investigations which have
yet to be completed. There is no link between DSR therapy and ongoing
investigations with the alfapump system in Europe, the United States or Canada.
Note: alfapump® and DSR® are registered trademarks.
Forward-looking statements
This press release may contain predictions, estimates or other information that
might be considered forward-looking statements. Such forward-looking statements
are not guarantees of future performance. These forward-looking statements
represent the current judgment of Sequana Medical on what the future holds, and
are subject to risks and uncertainties that could cause actual results to differ
materially. Sequana Medical expressly disclaims any obligation or undertaking to
release any updates or revisions to any forward-looking statements in this press
release, except if specifically required to do so by law or regulation. You
should not place undue reliance on forward-looking statements, which reflect the
opinions of Sequana Medical only as of the date of this press release.
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