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Research: Healthcare
Sequana Medical has announced interim results from all three patients comprising the non-randomised cohort of its MOJAVE US Phase I/IIa study evaluating its second-generation Direct Sodium Removal (DSR) product, DSR 2.0, in diuretic-resistant chronic heart failure (CHF) patients with persistent congestion. Consistent with data already reported in October from the cohort’s first two patients, the third patient has also shown beneficial treatment effects from the DSR therapy. To date, the results indicate DSR 2.0 is safe and well tolerated and all three patients restored and maintained euvolemia without the need of loop diuretics and showed improved cardiorenal status post-treatment, as demonstrated through different measures. All three patients are in their three-month safety follow-up period and, in early Q124, the study’s independent Data and Safety Monitoring Board (DSMB) is expected to review their data. As no clinically relevant changes in serum sodium levels, serious adverse events or hospitalisations have occurred, we are confident that the DMSB will permit the progression of MOJAVE to the randomised cohort phase, which is designed to recruit an additional 30 patients.
Sequana Medical |
Positive data in non-randomised MOJAVE cohort |
MOJAVE study update |
Pharma and biotech |
4 December 2023 |
Share price performance
Business description
Analyst
Sequana Medical is a research client of Edison Investment Research Limited |
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Sequana Medical has announced interim results from all three patients comprising the non-randomised cohort of its MOJAVE US Phase I/IIa study evaluating its second-generation Direct Sodium Removal (DSR) product, DSR 2.0, in diuretic-resistant chronic heart failure (CHF) patients with persistent congestion. Consistent with data already reported in October from the cohort’s first two patients, the third patient has also shown beneficial treatment effects from the DSR therapy. To date, the results indicate DSR 2.0 is safe and well tolerated and all three patients restored and maintained euvolemia without the need of loop diuretics and showed improved cardiorenal status post-treatment, as demonstrated through different measures. All three patients are in their three-month safety follow-up period and, in early Q124, the study’s independent Data and Safety Monitoring Board (DSMB) is expected to review their data. As no clinically relevant changes in serum sodium levels, serious adverse events or hospitalisations have occurred, we are confident that the DMSB will permit the progression of MOJAVE to the randomised cohort phase, which is designed to recruit an additional 30 patients.
Year |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/21 |
0.4 |
(24.4) |
(1.36) |
0.0 |
N/A |
N/A |
12/22 |
0.9 |
(30.9) |
(1.37) |
0.0 |
N/A |
N/A |
12/23e |
0.7 |
(31.8) |
(1.14) |
0.0 |
N/A |
N/A |
12/24e |
1.8 |
(33.1) |
(1.17) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As explained in our prior note, the MOJAVE study consists of two groups: an non-randomised cohort with three patients receiving DSR 2.0 alongside optimised usual care for up to four weeks and a randomised cohort, where 20 patients will receive DSR 2.0 on top of optimised usual care for CHF for up to four weeks, plus 10 patients randomised to receive intravenous loop diuretic treatment.
The company has now reported data on all three patients from the non-randomised cohort and they all show improvements in congestion management, diuretic response and cardiorenal status. Their diuretic response (as measured by six-hour excretion of sodium after IV administration of 40mg of furosemide diuretic) had nearly normalised, with a mean 324% increase in their six-hour urinary sodium excretion post-treatment versus baseline. Their kidney function also showed a strong improvement, with a mean improvement in estimated glomerular filtration rate of 47% and decrease of blood urea nitrogen of 57%. Importantly, following the completion of the four-week DSR treatment period, the need for loop diuretics was substantially reduced or eliminated, as assessed in their ongoing safety follow-up period (representing time periods between 1.4 and 11.4 weeks following the last administered DSR therapy). These indications of sustained restoration of euvolemia post-treatment are potentially indicative of the durability of the DSR treatment response, in our view. If the DMSB’s review of the non-randomised cohort is favourable, as we anticipate, the company plans to start the randomised cohort of the MOJAVE study and it expects to report interim data in H224, followed by top-line data in 2025.
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