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- Cash runway extended in H2 2021, allowing Sequana Medical to hit key turning points for value in the short term
- POSEIDON implants resumed and interim results expected in the first quarter of 2021 (North American registration study as of alfapump® in patients with relapsing or refractory ascites due to cirrhosis of the liver)
- RED DESERT – implants resumed and interim results expected in fourth quarter 2020 and top-line results expected in first quarter 2021 (repeated dose study of the alfaPump DSR in diuretic-resistant heart failure patients)
GENT, Belgium, July 28, 2020 (GLOBE NEWSWIRE) – Sequana Medical NV (Euronext Brussels: SEQUA) (the “society” or “Sequana Medical“), an innovator in the treatment of fluid overload in liver disease, malignant ascites and heart failure, today announced that it has secured € 7.3 million in debt financing through subordinate loan agreements, of which € 1.4 million is new Company shares.
The financing extends the cash runway into the second half of 2021 and enables the company to achieve key clinical milestones in its North American liver and global heart failure programs. A detailed financial update will be included in the half year results, which will be announced on September 3, 2020.
“We are pleased to have successfully secured this additional financing at attractive conditions, especially in view of the currently volatile financial markets“, called Kirsten Van Bockstaele, CFO at Sequana Medical. “With this financing, we are well positioned to continue implementing our strategy and to reach our next turning points in value, which are expected in the coming months. “
The company also announces an update on the timelines of its clinical development programs following the impact of the ongoing global health crisis of COVID-19.
the POSEIDON registration study in North America of alfapump in recurrent and refractory ascites due to cirrhosis of the liver has resumed recruiting activities in Canada. While the U.S. has travel restrictions and restrictions on unnecessary hospital visits and procedures, patients will continue to be screened for enrollment for the study. Subject to further developments in connection with the COVID-19 pandemic, patient recruitment in the US is expected to resume at the beginning of the fourth quarter of 2020 with interim results in the first quarter of 2021. until the end of 2021. The POSEIDON study aims to approve the alfaPump in the USA and Canada, FDA approval is expected in the first half of 2022.
Enrollment of the RED DESERT repeated dose feasibility study of alfaDSR (Direct Sodium Removal) pump for the treatment of diuretic-resistant heart failure patients has also resumed, and the company now expects to submit interim results in the fourth quarter of 2020 and top-line results in the first quarter of 2021, intending discussions with the U.S. FDA to assist in reaching agreement on plans for a US feasibility study alfaPump DSR in patients with volume overload due to heart failure, which is expected to be initiated in the 2nd half of 2021.
Ian Crosbie, Chief Executive Officer of Sequana Medical said: “With Sequana Medical resuming its operations swiftly after delays in starting clinical trials related to COVID-19, we are pleased to announce that patient and medical community interest in our innovative approaches to treatment remains high is. The quality of our team and our products, combined with this new funding, will allow us to continue the strong momentum of our development programs. We are very excited to bring these groundbreaking devices to patients as soon as possible and continue to deliver strong value to all of our stakeholders. “
Details on external financing in the amount of € 7.3 million
The company has subordinated loan agreements with several shareholders, including PMV / z-Leningen, for a total nominal amount of 7.3 million in future equity financing or the sale of the company.
The loans have a term of 36 months and are fully repayable at the end of the term. The loans bear interest at 6% pa, with the convertible portion of the loan bearing interest at 5% pa. The interest is only due after the loan term has expired. The price per share at which the convertible portion of the loan can be converted in the event of equity financing or a sale of the company is 75% of the price of the company’s shares reflected in the equity financing or sale.
The PMV / z-Leningen loan is part of the Flemish Region’s action plan to support businesses as a result of the COVID-19 crisis.
For more information, please contact:
Sequana Medical
Read Vanneste, Director Investor Relations
Tel: +32 498 05 35 79
E-mail: [email protected]
About the POSEIDON study
POSEIDON is a prospective, single-arm, open study that is expected to enroll up to 50 patients who will alfaPump in approximately 20 centers in the US and Canada for primary endpoint analysis. The primary efficacy outcome of the study will include the proportion of patients who have a 50% reduction in the average total incidence of paracentesis per month after implantation compared to pre-implantation. This endpoint will be evaluated nine months after inclusion. Patients will be followed up for up to two years after implantation for analysis of secondary outcome measurements. The first patients were enrolled in the study in the second half of 2019. Further information on the study can be found at Clinicaltrials.gov (NCT03973866).
About the RED DESERT study
RED DESERT is a prospective, single-arm, repeated-dose study that is expected to enroll up to 10 heart failure patients who receive high-dose diuretics and who are alfaPumping DSR in two centers in Belgium and Georgia. Primary safety endpoints include device, procedure, and / or therapy-related serious adverse events at two and six weeks. The secondary endpoints include the feasibility of alfaPump DSR to remove excess sodium and fluids from the body, eliminating the need for daily high-dose diuretics during the six-week treatment period. Additional exploratory endpoints measuring the potential effect of DSR therapy in restoring response to diuretics will be evaluated by week six. The first patients were enrolled in the study at the end of 2019. Further information on the study can be found at Clinicaltrials.gov (NCT04116034).
About Sequana Medical
Sequana Medical is a commercial-stage medical device company serving the alfaPump platform for treating fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a rapidly growing complication of advanced liver disease caused by NASH (non-alcoholic steatohepatitis) -related cirrhosis and a common complication of heart failure. The US market for the alfaThe pump is projected to exceed $ 3 billion annually for the next 10 to 20 years due to NASH-related cirrhosis. The heart failure market for the alfaPump DSR is estimated to be over 5 billion euros annually in the US and EU5 by 2026. Both indications use the advantages of Sequana Medical alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally expelled through urination.
In the USA, the company’s most important growth market, alfaPump has received the groundbreaking device designation from the FDA. The North American pivotal study (POSEIDON) in recurrent and refractory ascites due to cirrhosis of the liver is currently underway and is intended to be a commercial marketing application of the alfaPump in the US and Canada. In Europe it is alfaPump is CE marked for the treatment of refractory ascites due to cirrhosis of the liver and malignant ascites and is included in key clinical practice guidelines. Over 800 alfaPump systems have previously been implanted. Building on the tried and tested alfaSequana Medical develops the pump platform alfaPump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in an initial single-dose and repeated-dose DSR study in humans alfaPump DSR study (RED DESERT) in heart failure patients is ongoing.
Sequana Medical is headquartered in Ghent, Belgium. For more information please visit www.sequanamedical.com.
Important regulatory disclaimers
the alfaPump has not yet received regulatory approval in the United States and Canada. Any statement in this press release regarding the safety and effectiveness of the alfaPump does not apply to the United States and Canada as the device is currently undergoing clinical trials in these areas.
DSR therapy and the alfaPump DSR are still under development, and it should be noted that all statements in this press release regarding safety and efficacy are derived from preclinical studies and ongoing clinical trials that are yet to be completed. There is no association between DSR therapy, alfaPump DSR and ongoing investigations with the alfaPump system in Europe, the USA and Canada.
Forward-Looking Statements
This press release may contain predictions, estimates or other information that may be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent Sequana Medical’s current assessment of the future and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or obligation to post updates or revisions to any forward-looking statements in this press release, except as required by law or statute. You should not place undue reliance on any forward-looking statements, which represent only the opinions of Sequana Medical as of the date of this press release.
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