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Currency in EUR
Last close As at 30/03/2023
EUR4.90
▲ −0.14 (−2.78%)
Market capitalisation
EUR124m
Research: Healthcare
Sequana Medical provided an update following encouraging data from its Phase IIa SAHARA Direct Sodium Removal (DSR) study in patients with persistent congestion despite maximal loop diuretic therapy. The DSR approach continues to demonstrate its potential in reducing persistent congestion, an area of unmet need given that c 90% of the more than one million US hospitalisations for heart failure (HF) are due to fluid overload. All 10 evaluable SAHARA patients enrolled in the original cohort design met proof of concept, with a >30% mean reduction of NT-proBNP (indicating improved cardio-renal status), a mean 6kg weight loss and a significant reduction in their loop diuretic dosing (nine out of 10 had a reduction of more than 90%). Following further analysis showing treatment persistence (eg a reduced need for diuretics) for up to 11 months, Sequana believes that a focused three- to four-week session of DSR therapy using a peritoneal catheter (âshort-term DSRâ) could be sufficient to provide six to 12 months of therapeutic effect. As alfapump implantation may not be needed to reach a sustained treatment effect, Sequana is focusing future DSR development on this short-term DSR approach using its second-generation product (DSR 2.0).
Sequana Medical |
A step closer on DSR heart failure programme |
DSR programme update |
Pharma and biotech |
19 July 2022 |
Share price performance
Business description
Analyst
Sequana Medical is a research client of Edison Investment Research Limited |
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Sequana Medical provided an update following encouraging data from its Phase IIa SAHARA Direct Sodium Removal (DSR) study in patients with persistent congestion despite maximal loop diuretic therapy. The DSR approach continues to demonstrate its potential in reducing persistent congestion, an area of unmet need given that c 90% of the more than one million US hospitalisations for heart failure (HF) are due to fluid overload. All 10 evaluable SAHARA patients enrolled in the original cohort design met proof of concept, with a >30% mean reduction of NT-proBNP (indicating improved cardio-renal status), a mean 6kg weight loss and a significant reduction in their loop diuretic dosing (nine out of 10 had a reduction of more than 90%). Following further analysis showing treatment persistence (eg a reduced need for diuretics) for up to 11 months, Sequana believes that a focused three- to four-week session of DSR therapy using a peritoneal catheter (‘short-term DSR’) could be sufficient to provide six to 12 months of therapeutic effect. As alfapump implantation may not be needed to reach a sustained treatment effect, Sequana is focusing future DSR development on this short-term DSR approach using its second-generation product (DSR 2.0).
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
1.0 |
(19.0) |
(1.25) |
0.0 |
N/A |
N/A |
12/21 |
0.4 |
(24.4) |
(1.36) |
0.0 |
N/A |
N/A |
12/22e |
0.6 |
(23.3) |
(0.98) |
0.0 |
N/A |
N/A |
12/23e |
0.7 |
(22.8) |
(0.96) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
DSR 2.0, based on icodextrin and dextrose, is expected to have an improved therapeutic and favourable safety profile compared to first-generation infusate (DSR 1.0) studied in SAHARA and RED DESERT, as it is designed to provide a slower and longer dwelling time. Furthermore, the regulatory approval pathway for short-term DSR therapy with DSR 2.0 could be more straightforward than the alfapump DSR combination studied in SAHARA and RED DESERT, since DSR 2.0 would be regulated as a drug by the FDA, whereas the alfapump DSR combination would likely have needed to be regulated as a drug-device combination.
Sequana also plans to expand SAHARA to include a cohort of up to five patients who will use DSR 2.0 (instead of DSR 1.0), with results expected in Q422. The data are expected to support Sequana’s US IND filing for MOJAVE, a Phase Ib/IIa US trial assessing DSR 2.0 as short-term DSR therapy in chronic HF patients with persistent congestion. The MOJAVE IND is expected to be filed in Q422, with recruitment planned to start in early 2023 leading to the release of top-line data in H124. Sequana remains on track to report primary efficacy data from the POSEIDON alfapump North American pivotal study in Q422, and expects to file a US premarket application in H223, a slight delay to its prior estimate of mid-2023 given that the biocompatibility testing required to support the application has been extended by c three months. We await further details from the conference call planned today before revising our estimates.
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Research: Metals & Mining
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