reports
- Hilde Van Boxstael
- Jacob Mekhael
- Thomas Couvreur
- Wim Lewi
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Sharad Kumar S.P
- Thibault Leneeuw
- Thomas Vranken
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
Sequana Medical FIRST LOOK: FY23 update comes with 90-day FDA letter f...
Sequana reported FY23 results with a cash position of € 2.6m (YE22: € 18.9m), which together with the € 3m convertible loan in February 2024 and € 11.5m equity placement in March 2024, provides a cash runway to end of 3Q24. The company is evaluating the feedback received last night in the 90-day letter from the FDA. Given the short timeframe, management is unable to provide more details on the FDA comments, and will update the market in due course. The company has a day-100 meeting scheduled wit...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Thomas Couvreur
- Wim Lewi
- Jacob Mekhael
Sequana Medical FIRST LOOK: 3-month follow up maintains DSR 2.0 benefi...
Sequana reported positive 3-month follow up in 3 patients from the non-randomised cohort of the phase 1/2a (MOJAVE) study with DSR 2.0 for the treatment of diuretic-resistant heart failure showing continued benefit on diuretic response as well as kidney function. With DSMB approval already obtained, we look forward to the start of the randomised portion of the MOJAVE trial in 30 patients, expected after US market approval for the alfapump (end of 3Q24). We reiterate our BUY rating and € 6 TP.
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Thomas Vranken
- Wim Lewi
- Jacob Mekhael
Sequana Medical FIRST LOOK: Financing overhang lifted with € 11.5m ABB...
Sequana raised € 11.5m through a private placement via an accelerated bookbuild offering of approx. 7.7m new shares at a price of € 1.5 per share. This capital raise is an important achievement for the company, lifting the financing overhang and providing cash runway into PMA approval for the alfapump in the US, expected in 3Q24. We believe PMA approval will be a key trigger for the stock price, potentially attracting a new set of investors into the name. KBC Securities is acting as Sole Global ...
- Guy Sips
- Jacob Mekhael
- Thibault Leneeuw
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Laura Roba
Sequana Medical - Lack of financial visibility hinders investment case
Last week, Sequana announced a EUR 3m convertible bond, the imminent launch of a EUR 13m capital raise, the focus on its PMA approval and an agreement with lenders to postpone debt repayment.We have included these changes in our model and rolled forward our DCF one year. We increased our WACC to 22% to reflect the concerning financial situation of the company. We trim our TP to EUR 2.9 vs. EUR 10 previously.Although our belief in the investment case did not changed, the uncertainty surrounding i...
- Jacob Mekhael
Sequana Medical Update following recent convertible loan financing
We provide an update following Sequana's recent announcements of i) a € 3m convertible loan from existing shareholders, ii) an agreement to defer its debt service payments until after PMA approval, and iii) a re-allocation of resources delaying the start of the randomised portion of the MOJAVE trial until after PMA approval for the alfapump expected in 2H24. We now expect DSR 2.0 to enter the market in 2028 (previously 2027). While we acknowledge the financing risk, the convertible loan from exi...
- Laura Roba
Sequana Medical - EUR 3m convertible loan
Sequana Medical secured a EUR 3m convertible loan from existing shareholders and entered into a letter of intend with its lenders to postpone the repayment of its debt. The company will now focus on reaching PMA approval and will hence halt EU commercial activities and postpone the start of the randomized phase of the MOJAVE study in DSR. This will allow to reduce cash requirements by EUR 9m before the end of 2024.Cash runway is now extended until March 2024. The company is initiating the proces...
- Sean Conroy
Sequana Medical - Termination of coverage
Edison Investment Research is terminating coverage on Sequana Medical (SEQUA). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our website.
- Hilde Van Boxstael
- Jacob Mekhael
- Wim Lewi
- Jacob Mekhael
Sequana Medical FIRST LOOK: DSMB nod to continue phase 1/2 of DSR 2.0 ...
Sequana announced that an independent DSMB approved the start of the randomised cohort in the phase 1/2a (MOJAVE) study of DSR 2.0 (direct sodium removal, drug only approach) in the US for treatment of fluid overload in patients with diuretic-resistant heart failure. The first patient is expected in 1Q24, and data from the trial is guided for 2H24, which could trigger partnering discussions - though we note the company's cash runway is into 1Q24 and Sequana is actively working to secure addition...
- Jacob Mekhael
- Sharad Kumar S.P
- Laura Roba
Sequana Medical - Green light to go on with MOJAVE
Sequana Medical announced that following the review of the safety data from the 3-patients non-randomized cohort, the independent Data Safety Monitoring Board approved the enrollment of the entire 30-patients randomized cohort in the MOJAVE study (heart failure program). Interim results foreseen in H2.Follow-up data from the non-randomized cohort confirms the benefits of the DSR therapy with DSR 2.0.Given the good safety profile of DSR 2.0, we expected this approval. This is a positive news but ...
- Sean Conroy
Sequana Medical - New CPT III codes to support reimbursement
Sequana Medical announced that the American Medical Association has issued six new Category III Current Procedural Terminology (CPT III) codes for the alfapump system. The issue of these codes augments the existing ICD-10 procedure codes and is expected to assist healthcare professionals and insurers in identifying specific procedures related to the alfapump system for reimbursement. This may broaden and facilitate the future US utilisation and reimbursement for the alfapump for the treatment of...
- Sean Conroy
Sequana Medical - PMA application submitted to FDA for alfapump
Sequana Medical announced in late December that it has submitted a Premarket Approval (PMA) application to the US FDA regarding its alfapump device for use in patients with recurrent and refractory ascites (RRA), meeting its guidance for a submission in Q423. This marks a critical milestone for the company and we expect an FDA decision in H224. Given robust primary efficacy data from the POSEIDON North American pivotal study, as well as favourable safety and efficacy trends maintained at 12 mont...
- Hilde Van Boxstael
- Thomas Vranken
- Wim Lewi
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