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Sequana Medical reported positive top-line results from its SAHARA Phase IIa study of DSR 1.0, involving 10 evaluable patients with diuretic-resistant heart failure. Results from these patients, who had completed the 16-week follow-up period (the second phase of the study, see our recent outlook note for details on study phases and design) following intensive DSR therapy, were largely consistent with the interim data reported in July. These patients reported a mean 33% reduction in NT-proBNP at
Companies: Sequana Medical N.V
Positive results from POSEIDON, Sequana Medical’s North American pivotal study of its implantable alfapump device in patients with recurrent and refractory ascites (RRA), should pave the way for the company to file a US premarket approval application (PMA) with the FDA in H223. The study convincingly met the primary efficacy endpoints and, given that no unanticipated adverse device effects (UADE) were observed, we believe that these results should de-risk the likelihood of US market approval and
Sequana Medical reported that the POSEIDON North American pivotal study of its implantable alfapump device in patients with recurrent and refractory ascites (RRA) due to liver cirrhosis met the primary efficacy endpoint, and that safety results were in line with expectations. These positive results should pave the way for the company to file a US premarket approval application with the FDA in H223, in line with prior guidance, which we estimate can lead to US market launch in mid-2024. The alfap
Sequana Medical reported H122 financials with expenditure mildly above our forecasts and confirmed previous guidance for its cash runway to last into Q323, including €10m in potential proceeds from its Kreos loan facility. Most importantly, it maintained guidance for key upcoming catalysts, namely its expectation to report top-line data for its North American POSEIDON study of alfapump in recurrent and refractory ascites (RRA) in Q422 and to submit a US premarket approval (PMA) application in H2
Following sustained positive effects from the SAHARA I study in restoring diuretic response (DR) in heart failure (HF) patients with persistent congestion, Sequana will focus on advancing its Direct Sodium Removal (DSR) programme using its second-generation product (DSR 2.0) as applied through a peritoneal catheter (‘short-term DSR’). This should provide a more straightforward regulatory pathway than the alfapump DSR combination approach studied previously. The company continues to expect to rep
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
Sequana reported its FY21 results on 12 April and confirmed its operating guidance for the coming months. The company continues to expect to report top-line data for its North American POSEIDON study of alfapump in recurrent and refractory ascites (RRA) in Q422 and submit a US premarket approval (PMA) application in mid-2023. It plans to report top-line data for its SAHARA DESERT alfapump DSR study in patients with decompensated heart failure (HF) in H222. The company plans to begin its first hu
On 5 April, Sequana announced that it has completed all implantations required for the North American POSEIDON pivotal study assessing the alfapump device for the treatment of recurrent or refractory ascites (RRA) due to liver cirrhosis. Of the 71 patients enrolled in the study’s pivotal cohort, 40 have been implanted with the device. Top-line data are expected in Q422, and the company expects to submit a US pre-market approval (PMA) application in mid-2023, which we believe could lead to a US l
Sequana Medical recently announced positive interim data on six patients in its two-phase SAHARA DESERT study in decompensated heart failure (HF) patients with persistent congestion despite maximal diuretic therapy. While the sample size is small, alfapump DSR was shown to eliminate persistent congestion, restore normal bodily fluid volume and improve diuretic response. The market need for improved HF congestion control is significant, given that there are over one million hospitalisations in th
Meeting its recent Q421 guidance, Sequana has completed patient enrolment for the POSEIDON North American pivotal study assessing the alfapump system for the treatment of recurrent or refractory ascites (RRA) due to liver cirrhosis. 70 patients have been enrolled in the pivotal cohort, with Sequana expecting to implant 50 of these with the alfapump by the end of Q122. This should allow Sequana to meet its pre-defined target of having 40 evaluable patients for the primary efficacy analysis at six
Sequana Medical announced on 4 October that it had received approval from the US FDA to expand patient recruitment in the pivotal cohort of its POSEIDON pivotal study to 70 (an increase of 10 patients). This decision should allow Sequana to meet its pre-defined target of having 40 evaluable patients for the primary efficacy analysis, and thus provide it with the desired statistical power to potentially meet the primary endpoint. In our view, the positive FDA decision reduces a degree of uncertai
Sequana Medical indicated that due to a worldwide shortage of electronic components, it now anticipates its US premarket approval (PMA) application for the alfapump will now be submitted in mid-2023, compared to prior guidance of Q422. We have pushed back our potential North American alfapump launch estimate in recurrent and refractory ascites (RRA) to mid-2024 (from H223 previously), while our projections for the Direct Sodium Removal (DSR) programmes in heart failure are unchanged. We now obta
Sequana has reported positive data from the second interim analysis in roll-in cohort patients from the POSEIDON pivotal study. Results from 26 subjects confirmed the efficacy trends from the initial analysis in Q420 (which only reflected the first 13 patients in the cohort). As in that analysis, the subjects had a greater than 90% reduction in mean frequency of therapeutic paracentesis (TP) versus baseline, and all patients experienced at least 50% reduction in mean TP frequency per month versu
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Kistos Holdings plc, intends to join AIM. The Company was incorporated to act as a new holding company for the group companies 0f Kistos plc (KIST), a holding company with the objective of creating value for its investors through the acquisition and management of companies or businesses in the energy sector. Anticipated Market Cap £327m. Expected 22 Dec 2022.
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Interims are in line with expectations and should reassure, particularly given the strong mid-teens growth ex-China. Improved pork prices should be supportive of a recovery in China in H2 and management remains cautiously optimistic over the full year outlook. New product development activities continue to plan, and should start to contribute from FY25 onwards. Our forecasts, Buy recommendation and 246p Target Price (2.0x EV/Sales) are unchanged. After recent weakness, the shares now stand at a
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BWP REIT joins the Wholesale Segment of the International Property Securities Exchange (IPSX). BWP REIT is a newly formed single asset company and has raised £35m by issuing 35m new ordinary shares at 100 pence per share to acquire Bridgewater Place, an office-led mixed use property in central Leeds and valued at £63m. The property is one of the tallest buildings in Yorkshire, comprising 234,000 sq. ft of office space, and is close to 90% let to EY, as well as multinatio
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Inspiration Healthcare has provided an update on trading, noting that due to broad market uncertainty the company does not expect its FY23E revenues to ‘significantly exceed' FY22A revenues and as a result, H2/23E EBITDA is expected to be below H1/23A levels. We have updated our forecasts for FY23E and FY24E to reflect this update, removing revenue growth in the current year and shifting our previous revenue growth expectations out one year. We expect high-end, higher margin sales to have been p
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POLB announces that, further to its announcement in March 2022, the construction of the computational artificial intelligence (AI) influenza disease model has been completed by CytoReason Limited, indicating that it is on track to deliver outputs in Q2 2023. The model aims to unlock clinically meaningful insights into influenza infection and recovery through the analysis of POLB’s unique human challenge trial data. We view this rapid progress on the collaboration as positive and envisage that fu
Companies: Poolbeg Pharma Ltd.
Venture Life has announced the acquisition of HL Healthcare Ltd (HL) and its three Ear-Nose-Throat (ENT) brands, Earol, EarolSwim and Sterinase. Venture Life will pay £13m for the business which generated £4.5m of sales and £1.7m of EBITDA to the year-ending March 22, indicating trailing acquisition multiples of 2.9x and 7.6x, respectively. The portfolio is expected to grow in the year to March 2023 and we expect the acquisition to be accretive. The company has also announced additional distribu
Companies: Venture Life Group Plc
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Ithaca Energy (ITH.L) has joined the Premium Segment of the Main Market. Based on the offer price of 250 pence per ordinary share, the market capitalisation will be approximately £2.5bn. Ithaca Energy is one of the largest independent oil and gas companies in the UKCS. The Company will target a free float of at least 10% of its issued share capital and expects to be eligible for inclusion in the FTSE UK indices.
OTAQ plc, (OTAQ.L) has joined the Access Segment of the AQS
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Guanajuato Silver Company (AQSE: GSVR) has joined the AQSE Growth Market.
Leavers: Eastinco Mining and Exploration left the AQSE Growth Market and joined the Standard List of the Main Market (yesterday we incorrectly said it had joined AIM.)
Lamprell has left the Main Market.
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Ithaca Energy, a UK independent exploration and production company focused on the UK North Sea, intends to join the Premium Segment of the Main Market. Ithaca En
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Bowen Fintech (BWN.L), a special purpose acquisition company to acquire technology companies in the financial services sector has joined the Standard Segment of the Main Market. £2m raised.
Leavers: Vertu Capital has left the Main Market following a RTO. Vox Valor Capital (VOX.L), formerly Vertu Capital, has joined the Standard Segment of the Main Market.
What’s cooking in the IPO kitchen?**
Ithaca Energy, a UK independent exploration and production company focused on the UK North Sea,
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GSK’s Q3 beat was driven by a strong showing in vaccines – led by Shingrix and the HIV franchise – with healthy support from the other franchises. The 2022 outlook was again revised upwards. While recent (R&D) disappointments along with some past questionable decisions and Zantac uncertainties could again pile pressure on the management, we remain positive on the stock, supported by GSK’s meaningful presence in vaccines and the HIV markets, healthy momentum for the newer drugs and significant po
Companies: GSK plc
Alliance Pharma’s H1 interims are relatively robust, with trading conforming to recent commentary. Whilst there has been an impact in some areas of the business in H1 (Prescription Medicine) as expected per the trading update in July, the rest of the business particularly Kelo-cote, has proved very resilient and highlights the defensive nature of the business, and underlying adj. PBT (excl. amortisation and impairment charges) was solid in H1 2020 at £16.3m (+7% YoY). We anticipate some push and
Companies: Alliance Pharma plc
An update from CVS this morning covering conclusion of the CMA process, a further acquisition and update on trading. The CMA investigation into the acquisition of Quality Pet Care (QPC) is now complete, thereby bringing to an end a 9 month process. As part of the undertaking, CVS yesterday completed the sale of QPC for cash proceeds of c.£9m, implying a c.£12m impairment. Whilst the CMA episode has clearly been a setback, it does not seem to have fundamentally impaired ongoing M&A ambitions give
Companies: CVS Group plc