alfapump® – Positive results from second interim analysis of POSEIDON pivotal study; awaiting FDA approval on POSEIDON pivotal study expansion alfapump® – FDA regulatory submission now expected in mid-2023 due to worldwide supply shortage of electronic components; European commercial activities and clinical studies unaffected alfapump DSR® – Strong top-line results from RED DESERT; interim results of SAHARA DESERT study in heart failure patients with persistent congestion expected in Q4 2021 DSR® – Key patents granted in U.S. and Europe; expansion of DSR development programme with short-term DSR therapy; proprietary DSR Infusate 2.0 development ongoing Total liquidity position of €21.8 million provides cash runway into Q2 2022
Ghent, Belgium – 2 September 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces its business highlights and financial results for the six-month period ending 30 June 2021 and its outlook for the remainder of the year and beyond.
Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We have continued to deliver outstanding clinical results in H1 2021 with promising data from our POSEIDON and RED DESERT studies demonstrating the potential of our two technology platforms, alfapump and Direct Sodium Removal (DSR).
“We believe that the strong interim results from the POSEIDON Roll-In Cohort significantly de-risk our North American liver programme and demonstrate the potential of the alfapump to provide a safe and efficacious treatment that can dramatically improve the quality of life for patients with recurrent or refractory liver ascites. While we have made strong progress in POSEIDON patient recruitment, we continue to work with the FDA on expanding the number of patients to be enrolled and look forward to updating the market on timing. The delay in planned submission of the PMA due to subcomponent shortages is frustrating but reflects the growing issues facing many high-tech companies in sourcing complex electronic components and we are working tirelessly with our long-term suppliers to further minimise the delay on alfapump PMA submission in the U.S.
“RED DESERT demonstrated that alfapump DSR could not only replace high doses of loop diuretics but also improve the diuretic response and cardio-renal status in patients with diuretic-resistant heart failure. These results indicate the unique capabilities of DSR, which we are further evaluating in the SAHARA DESERT study in decompensated heart failure patients. We expect to report interim results from this trial before the end of the year.
“The continued growth of the NASH-related ascites and decompensated heart failure markets validates our focus on delivering innovative treatments for when diuretics are no longer an effective option in these patients.”
Outlook for the remainder of 2021 and for 2022
POSEIDON – The North American pivotal study of the alfapump in recurrent and refractory ascites due to liver cirrhosis is ongoing. As previously reported, the Company submitted a protocol amendment to the U.S. FDA to extend the patient enrolment due to the higher rate of attrition. Our discussions with the agency on the expansion of patient enrolment are ongoing and the Company will update the market once it has clarity from the FDA on study expansion and expected end of patient enrolment and subsequent primary endpoint read-out.
As a result of recent detailed planning involving discussions with the Company’s suppliers in connection with the verification and validation activities supporting the submission of the Pre-Market Approval (PMA) to the U.S. FDA, it has become clear that the worldwide shortage of electronic components will result in an expected six-months delay of the PMA submission.
SAHARA DESERT – The study of the alfapump DSR in diuretic-resistant heart failure patients with persistent congestion is ongoing and intends to enrol 20 patients. The study will evaluate the ability of alfapump DSR therapy to eliminate persistent congestion, restore correct fluid status (euvolemia) and improve cardio-renal condition for up to 22 weeks. Interim results are expected in Q4 2021 and top-line results in H2 2022.
European commercial production and activities resumed in August 2021. Assuming no further COVID-19 related restrictions, the Company expects to generate 2021 revenues, on a pro rata basis, in line with the periods before the reduced manufacturing supply.
The Company continues to monitor the impact of COVID-19 on its activities, particularly in respect to POSEIDON and its European commercial business. While the situation has improved dramatically over the past 12 months, the recent increase in infections due to the delta variant is a potential cause for concern and may impact the Company’s forecasts for milestones.
H1 2021 Operational Highlights
- POSEIDON – The ongoing North American pivotal study of the alfapumpin recurrent and refractory ascites due to liver cirrhosis reported the second positive interim analysis. Data from 26 patients in the Roll-In Cohort reconfirmed positive outcomes against all primary endpoints and demonstrated (i) over 90% reduction in mean frequency of therapeutic paracentesis (TP) versus baseline, (ii) all patients having at least a 50% reduction in mean frequency of TP per month versus baseline, (iii) clinically important improvement in quality of life maintained even up to 12 months post-implantation and (iv) safety profile in line with expectations. These data substantially exceed the primary endpoints as defined for the Pivotal Cohort in the POSEIDON study.
- RED DESERT – Positive clinical data were reported in this repeated dose proof-of-concept study of the alfapump DSR in diuretic-resistant heart failure patients. The study demonstrated that alfapump DSR (i) is highly effective at replacing high-dose loop diuretics, (ii) dramatically improved diuretic response and the benefit was maintained in long-term follow-up and (iii) significantly improved cardio-renal function. Results were presented as a late-breaker at European Society of Cardiology’s Heart Failure 2021 and selected as one of the congress highlights.
- SAHARA DESERT – Initiated the dose-ranging feasibility study in 20 decompensated heart failure patients with persistent congestion despite high-dose diuretics. Interim results are expected at the end of 2021 and top-line results in H2 2022.
- Key patents for the alfapump DSR granted in the U.S and European Union. The patents cover the alfapump DSR and its method of operation.
- Continued pre-clinical development of the proprietary DSR Infusate 2.0 intended to deliver a superior therapeutic profile as well as a high margin recurring revenue flow to accompany alfapump DSR sales.
- Expanded DSR development programme with Short-Term DSR to support faster adoption of the DSR therapy in the clinical community, support alfapump DSR market entry, expand potential market opportunity and target earlier entry into the U.S. market.
- Resolved the alfapump manufacturing yield issues and brought production volumes back to normal levels. Sequana Medical resumed commercial activity in Europe in August 2021. Due to the limited supply in H1 2021, the Company prioritised the supply of the alfapump to the POSEIDON and RED DESERT clinical studies. This together with the COVID-19 related restrictions on non-essential procedures and access to hospitals in Germany and France, limited the European alfapump sales in H1 2021.
H1 2021 Financial Highlights
- Raised €22.5 million in gross proceeds by means of a private placement via an accelerated bookbuild offering from existing investors and new experienced life sciences investors and industry experts, extending the Company’s cash runway into Q2 2022.
- Total liquidity position of €21.8 million at the end of June 2021 compared to €11.0 million at the end of December 2020.
Post Period Events
- Hosted a Key Opinion Leader webinar with two leading KOLs from the Mayo Clinic, Arizona, Dr. Vargas and Dr. Knuttinen, on “the impact of liver ascites on patients and healthcare systems and the potential of alfapump therapy in NASH-related ascites”.
- Appointed Jackie Fielding, a former Vice President of medical technology company Medtronic with more than 30 years of experience in the healthcare industry, as independent Non-Executive Director of the Company, effective as of 1 September 2021.
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