ニュース

PRESS RELEASE

REGULATED INFORMATION – INSIDE INFORMATION

14 September 2023, 07:00 CEST

• alfapump® – strong pivotal POSEIDON data presented at leading international liver congress / on track to file Pre-Market Approval (PMA) application to US FDA in Q4 2023
• DSR® – safety of single dose DSR 2.0 demonstrated / Phase 1/2a US MOJAVE study in heart failure ongoing with initial data expected in Q4 2023
• Total liquidity position of €17.1 million and cash runway into Q1 2024

Conference call with live webcast presentation today at 03:00 pm CEST / 09:00 am EST

Ghent, Belgium – 14 September 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “SequanaMedical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces its business highlights and financial results for the six-month period ending 30 June 2023 and its outlook for the remainder of the year.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “During the first half of this year, we made strong progress in both our alfapump and DSR programs.

“Our alfapump liver program is advancing towards North American commercialization with filing of the PMA with the FDA planned by year end. Data from our landmark POSEIDON study was presented at the prestigious international EASL liver congress and reaffirms alfapump’s strong clinical profile – virtually eliminating the need for needle paracentesis and significantly improving patients’ quality of life. Although not powered for survival, the study’s one-year survival probability of 70% is encouraging in a patient population where 50% survival after one year is typically reported. We are pleased to see the progress of TCET[1] in the US and applaud CMS[2]intent to support patient care and innovation by providing a new national coverage pathway for promising FDA-designated breakthrough devices such as the alfapump.

“We are excited to have the MOJAVE study of our second-generation DSR product in diuretic-resistant heart failure patients underway in the US, with first patients enrolled. In this Phase 1/2a randomized controlled study, we are seeking to build upon the strong results of our SAHARA study where we demonstrated DSR’s disease-modifying profile – safe, effective and rapid elimination of persistent congestion, important improvements in cardiovascular and renal health, and the restoration of diuretic response of the kidney. We look forward to reporting initial safety and efficacy data from the non-randomized cohort by year end, and are planning for enrollment of up to 30 patients into the randomized cohort next year.

“Despite challenging market conditions, we’ve secured additional financing, extending our cash runway into the first quarter of 2024. We’re delighted to welcome Ken Macleod to our Board, whose wealth of experience in healthcare companies and life science fund management will be invaluable to our journey.”

Highlights from year 2023 to date

North American alfapump liver program

• POSEIDON – data presented by Principal Investigator Prof. Wong at EASL 2023 Congress from successful pivotal study in patients with recurrent or refractory ascites due to liver cirrhosis, supports strong clinical profile of alfapump
  • Effective control of ascites, virtually eliminating needle paracentesis
  • Safety in line with expectations
  • Clinically meaningful and statistically significant improvement in patients’ quality of life at six months post-implantation compared to baseline
  • One year survival of 70% compares favorably to literature citing 50% in this patient population[3]
• On track to file PMA application to the US FDA in Q4 2023

DSR heart failure program

• Successful completion of IND[4]-enabling pre-clinical and Phase 1 studies of second-generation DSR product (DSR 2.0)
  • Data from GLP[5] studies in mice and sheep showed there was no difference in systemic and local toxic effects in animals treated repeatedly with DSR 2.0 compared to animals in the control group, concluding that DSR 2.0 had consistent safety with the standard peritoneal dialysis solution used in the control group.
  • Data from the Phase 1 CHIHUAHUA study in stable peritoneal dialysis patients demonstrated that a single dose of DSR 2.0 was safe and well-tolerated and indicated a compelling dosing profile.
• MOJAVE – US randomized controlled Phase 1/2a study of DSR 2.0 for treatment of congestive heart failure underway
  • First patients enrolled in non-randomized cohort of three patients. Progress to the randomized cohort of up to 30 additional patients planned for H1 2024, subject to approval from the independent Data and Safety Monitoring Board following their review of these first three patients.
• Additional DSR patents granted in the US and China
  • Additional US patents granted covering among other, the expansion of the composition of matter and method for Sequana Medical’s DSR therapy, including additional oncotic and osmotic agents and the use of an implantable pump system.
  • A key composition of matter patent was granted in China.

Corporate

• Expanded Board of Directors with the appointment of Dr. Kenneth Macleod as non-executive director. Dr. Macleod is a partner at Rosetta Capital and brings more than 35 years’ experience in the life science sector from his senior operating roles in healthcare companies and life science fund management.
• Raised €15.8 million in gross proceeds by means of an equity placement via an accelerated book building offering, extending the Company’s cash runway into Q1 2024.
• Total liquidity position of €17.1 million at the end of June 2023 compared to €18.9 million at the end of December 2022.

Outlook for the remainder of 2023

• North American alfapump liver program – on track to file PMA application to the US FDA in Q4 2023
  • Top-line data from the US patient preference study expected in H2 2023
  • Data from propensity matched interim analysis of NACSELD[6] registry vs POSEIDON pivotal cohort expected in H2 2023

• DSR heart failure program – continue US Phase 1/2a randomized controlled MOJAVE study
  • Data from three patients in non-randomized cohort expected in Q4 2023

MORE INFO:

https://www.sequanamedical.com...