PRESS RELEASE
REGULATED INFORMATION – INSIDE INFORMATION
14 September 2023, 07:00 CEST

• alfapump® – sturdy pivotal POSEIDON knowledge offered at main worldwide liver congress / on observe to file Pre-Market Approval (PMA) utility to US FDA in This autumn 2023

• DSR® – security of single dose DSR 2.0 demonstrated / Phase 1/2a US MOJAVE examine in heart failure ongoing with preliminary knowledge anticipated in This autumn 2023

• Whole liquidity place of €17.1 million and money runway into Q1 2024

Convention name with reside webcast presentation at the moment at 03:00 pm CEST / 09:00 am EST

Ghent, Belgium – 14 September 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Firm” or “Sequana Medical“), a pioneer within the therapy of fluid overload in liver illness, coronary heart failure and most cancers, at the moment publicizes its enterprise highlights and monetary outcomes for the six-month interval ending 30 June 2023 and its outlook for the rest of the yr.

Ian Crosbie, Chief Government Officer at Sequana Medical, commented: “Through the first half of this yr, we made sturdy professionalgress in each our alfapump and DSR programs.

“Our alfapump liver program is advancing in direction of North American commercialization with submitting of the PMA with the FDA deliberate by yr finish. Data from our landmark POSEIDON examine was offered at the prestigious worldwide EASL liver congress and reaffirms alfapump’s sturdy scientific profile – just about eliminating the necessity for needle paracentesis and considerably improving sufferers’ high quality of life. Though not powered for survival, the examine’s one-year survival likelihood of 70% is encouraging in a affected person inhabitants the place 50% survival after one yr is typically reported. We’re happy to see the progress of TCET¹ within the US and applaud CMS² intent to assist affected person care and innovation by offering a brand new nationwide protection pathway for promising FDA-designated breakthrough units such because the alfapump.

“We’re excited to have the MOJAVE examine of our second-generation DSR product in diuretic-resistant coronary heart failure sufferers underway within the US, with first sufferers enrolled. On this Part 1/2a randomized managed examine, we’re searching for to construct upon the sturdy outcomes of our SAHARA examine the place we demonstrated DSR’s disease-modifying profile – secure, efficient and fast elimination of persistent congestion, vital enhancements in cardiovascular and renal well being, and the restoration of diuretic response of the kidney. We look ahead to reporting preliminary security and efficacy knowledge from the non-randomized cohort by yr finish, and are planning for enrollment of as much as 30 sufferers into the randomized cohort subsequent yr.

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“Regardless of difficult market circumstances, we have secured further financing, extending our money runway into the primary quarter of 2024. We’re delighted to welcome Ken Macleod to our Board, whose wealth of expertise in healthcare corporations and life science fund administration shall be invaluable to our journey.”

Highlights from yr 2023 thus far

North American alfapump liver program

• POSEIDON – knowledge offered by Principal Investigator Prof. Wong at EASL 2023 Congress from profitable pivotal examine in sufferers with recurrent or refractory ascites resulting from liver cirrhosis, helps sturdy scientific profile of alfapump

  • Efficient management of ascites, just about eliminating needle paracentesis

  • Security according to expectations

  • Clinically significant and statistically vital enchancment in sufferers’ high quality of life at six months post-implantation in comparison with baseline

  • One yr survival of 70% compares favorably to literature citing 50% on this affected person inhabitants³

• On observe to file PMA utility to the US FDA in This autumn 2023

DSR coronary heart failure program

• Profitable completion of IND⁴-enabling pre-clinical and Part 1 research of second-generation DSR product (DSR 2.0)

  • Information from GLP⁵ research in mice and sheep confirmed there was no distinction in systemic and native poisonous results in animals handled repeatedly with DSR 2.0 in comparison with animals within the management group, concluding that DSR 2.0 had constant security with the usual peritoneal dialysis resolution used within the management group.

  • Information from the Part 1 CHIHUAHUA examine in secure peritoneal dialysis sufferers demonstrated {that a} single dose of DSR 2.0 was secure and well-tolerated and indicated a compelling dosing profile.

• MOJAVE – US randomized managed Part 1/2a examine of DSR 2.0 for therapy of congestive coronary heart failure underway

  • First sufferers enrolled in non-randomized cohort of three sufferers. Progress to the randomized cohort of as much as 30 further sufferers deliberate for H1 2024, topic to approval from the unbiased Information and Security Monitoring Board following their evaluation of those first three sufferers.

• Extra DSR patents granted within the US and China

  • Extra US patents granted overlaying amongst different, the growth of the composition of matter and technique for Sequana Medical’s DSR remedy, together with further oncotic and osmotic brokers and using an implantable pump system.

  • A key composition of matter patent was granted in China.

Company

• Expanded Board of Administrators with the appointment of Dr. Kenneth Macleod as non-executive director. Dr. Macleod is a companion at Rosetta Capital and brings greater than 35 years’ expertise within the life science sector from his senior working roles in healthcare corporations and life science fund administration.

• Raised €15.8 million in gross proceeds by the use of an fairness placement by way of an accelerated guide constructing providing, extending the Firm’s money runway into Q1 2024.

• Whole liquidity place of €17.1 million on the finish of June 2023 in comparison with €18.9 million on the finish of December 2022.

Outlook for the rest of 2023

Monetary evaluation – Six months ended 30 June 2023

N.M.: Not Significant (proportion larger than 150%)
* Money place solely consists of extremely liquid money and money equivalents.

Condensed Consolidated Revenue Assertion

Income

Income decreased from €0.46 million in H1 2022 to €0.38 million in H1 2023 as a result of choice to reduce European industrial actions.

Value of products offered

Value of products offered decreased from €0.10 million in H1 2022 to €0.09 million in H1 2023 according to the lower in income.

Working bills

Whole working bills elevated from €13.87 million in H1 2022 to €15.92 million in H1 2023 primarily as a result of preparations of the submissions for advertising and marketing approval of the alfapump within the US and Canada.

Gross sales and Marketing bills remained secure at €1.15 million in H1 2022 and €1.10 million in H1 2023.

Medical bills decreased from €4.28 million in H1 2022 to €3.71 million in H1 2023 primarily on account of decrease prices associated to the North American pivotal POSEIDON examine of the alfapump and the SAHARA DSR proof-of-concept examine, partially compensated by pre-clinical and scientific improvement work required for the Firm’s IND submitting for its proprietary DSR product and graduation of the MOJAVE examine within the US.

High quality and Regulatory bills elevated from €1.66 million in H1 2022 to €3.19 million in H1 2023, primarily pushed by exterior recommendation solicited for the preparation of the submissions for advertising and marketing approval of the alfapump within the US and Canada.

Provide chain bills elevated from €1.48 million in H1 2022 to €2.37 million in H1 2023 largely pushed by further staffing and exterior recommendation for the preparation of the submissions for advertising and marketing approval of the alfapump within the US and Canada.

Engineering bills elevated from €1.76 million in H1 2022 to €2.10 million in H1 2023, largely pushed by check samples required for the preparation of the submissions for advertising and marketing approval of the alfapump within the US and Canada.

Common and Administration bills remained secure at €3.54 million in H1 2022 and €3.45 million in H1 2023.

Different revenue remained secure at €0.22 million in H1 2022 and €0.21 million in H1 2023 and consists of acknowledged revenue from Belgian Analysis & Growth (R&D) incentives with regard to incurred R&D bills.

EBIT

Because of the above, earnings earlier than curiosity and taxes (EBIT) advanced from a lack of €13.29 million in H1 2022 to a lack of €15.42 million in H1 2023.

Whole web finance price

Internet finance price decreased from €1.31 million in H1 2022 to €0.79 million in H1 2023, primarily ensuing from the affect of the valuation of the Bootstrap Warrants and Kreos Subscription Rights partially compensated by the preliminary valuation of the Investor Warrants (issued as a part of the April 2023 fairness placement). All of this stuff are non-cash gadgets.

Revenue tax expense

Revenue tax expense remained secure at €0.26 million in H1 2022 and H1 2023 and are a results of the actions in Switzerland.

Internet loss for the interval

Because of the above, the online loss elevated from €14.86 million in H1 2022 to €16.46 million in H1 2023.

Primary losses per share (LPS)

Primary losses per share decreased from €0.68 in H1 2022 to €0.65 in H1 2023.

Condensed Consolidated Assertion of Monetary Place

Internet debt

Internet debt⁸ at 30 June 2023 elevated by €1.80 million in comparison with 31 December 2022, primarily on account of barely decrease money place in comparison with 31 December 2022.

Working Capital

Working capital⁹ at 30 June 2023 remained secure at -€4.57 million in comparison with 31 December 2022.

Condensed Consolidated Assertion of Money Flows

Internet money outflow from working actions was €16.36 million in H1 2023 in comparison with €13.66 million in H1 2022. The upper outflow was primarily pushed by greater web lack of the interval.

Money movement from investing actions resulted in a web outflow of €0.08 million in H1 2023, in comparison with a web outflow of €0.44 million in H1 2022.

Money movement from financing actions resulted in a web influx of €14.72 million in H1 2023, primarily on account of the proceeds from the April 2023 fairness placement. In H1 2022, the online influx of €28.22 million was primarily a results of the March 2022 fairness placement.

The Firm ended H1 2023 with a complete liquidity place of €17.12 million (finish 2022: €18.87 million).

Convention Name and Webcast

Sequana Medical will host a convention name with reside webcast presentation at the moment at 15:00 CEST / 09:00 EST.

• Registration webcast: please click on right here

• Registration convention name (provided that you want to take part within the Q&A): please click on right here. As soon as registered, you’ll obtain dial-in numbers and a affirmation code.

The webcast and convention name shall be carried out in English and a replay shall be out there on Sequana Medical’s web site shortly after.

For extra data, please contact:

Sequana Medical

Lies Vanneste
Director Investor Relations
E: [email protected]
T: +32 (0)498 053579

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a severe and frequent scientific complication in sufferers with liver illness, coronary heart failure and most cancers. These sufferers can have as much as 15 liters of additional fluid of their our bodies, inflicting main medical points together with elevated mortality, repeated hospitalizations, extreme ache, problem respiratory and restricted mobility that severely impacts day by day life. Though diuretics are customary of care, the issue is that in lots of sufferers they’re now not efficient and / or tolerable. There are restricted efficient therapy choices for these sufferers, leading to poor scientific outcomes, excessive prices and a significant affect on their high quality of life. Sequana Medical is searching for to supply modern therapy choices for this huge and rising “diuretic-resistant” affected person inhabitants.

alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the physique to deal with diuretic-resistant fluid overload, delivering main scientific and high quality of life advantages for sufferers and lowering prices for healthcare programs. The Firm has reported optimistic major endpoint knowledge from the North American pivotal POSEIDON trial of the alfapump in recurrent or refractory ascites resulting from liver cirrhosis, enabling the submitting of a Pre-Market Approval (PMA) utility with the FDA, deliberate for This autumn 2023. Having delivered scientific proof-of-concept for DSR as a disease-modifying drug program for the therapy of coronary heart failure, the Firm has commenced MOJAVE, a US randomized managed multi-center Part 1/2a scientific trial of DSR 2.0, with preliminary knowledge anticipated in This autumn 2023.

Sequana Medical is listed on Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For additional data, please go to www.sequanamedical.com.

Necessary Regulatory Disclaimers

The alfapump® system is presently not accepted in america or Canada. In america and Canada, the alfapump system is presently beneath scientific investigation (POSEIDON Trial) and is being studied in grownup sufferers with refractory or recurrent ascites resulting from liver cirrhosis. DSR® remedy continues to be in improvement and it ought to be famous that any statements concerning security and efficacy come up from ongoing pre-clinical and scientific investigations which have but to be accomplished. There isn’t a hyperlink between DSR remedy and ongoing investigations with the alfapump system in Europe, america or Canada.

Observe: alfapump® and DSR® are registered trademarks.

Ahead-looking statements

This press launch might include predictions, estimates or different data that may be thought of forward-looking statements.
Such forward-looking statements are usually not ensures of future efficiency. These forward-looking statements signify the present judgment of Sequana Medical on what the longer term holds, and are topic to dangers and uncertainties that would trigger precise outcomes to vary materially. Sequana Medical expressly disclaims any obligation or endeavor to launch any updates or revisions to any forward-looking statements on this press launch, besides if particularly required to take action by regulation or regulation. You shouldn’t place undue reliance on forward-looking statements, which mirror the opinions of Sequana Medical solely as of the date of this press launch.

Monetary data

The condensed consolidated monetary statements have been ready in accordance with IAS 34, as adopted by the EU. The monetary data included within the press launch is an extract from the Condensed Consolidated Monetary Statements.

The Condensed Consolidated Monetary Statements for the six months ending 30 June 2023 can be found on the web site of Sequana Medical: https://www.sequanamedical.com/buyers/financial-information/

Condensed Consolidated Revenue Assertion

Condensed Consolidated Assertion of Complete Revenue

Condensed Consolidated Assertion of Monetary Place

Condensed Consolidated Assertion of Money Flows

Condensed Consolidated Assertion of Adjustments in Fairness

¹ TCET: Transitional Protection of Rising Applied sciences
² CMS: Heart for Medicare and Medicaid Providers
³ Biggins et al., Hepatology, Vol. 74, No. 2, 2021, AASLD Apply Steering; Moreau R et al., Liver Worldwide 2004: 24: 457-464; Bureau et al., Gastroenterology 2017
⁴ IND: Investigational New Drug
⁵ GLP: Good Laboratory Apply
⁶ NACSELD: North American Consortium for the Research of Finish-stage Liver Illness
⁷ EBIT is outlined as Income much less Value of products offered and Working Bills, plus Different revenue.
⁸ Internet debt is calculated by including short-term, long-term monetary and lease debt and deducting money and money equivalents.
⁹ The parts of working capital are inventories plus commerce receivables and different receivables minus commerce payables (together with contract liabilities) and different payables, and accrued liabilities.

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