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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
Companies: Sequana Medical N.V
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
Sequana’s proprietary alfapump and Direct Sodium Removal (DSR) platforms are being advanced as long-term treatments for diuretic-resistant fluid overload related to liver disease, malignant ascites and heart failure (HF). The alfapump is commercialised in parts of Europe for liver disease and is undergoing a pivotal North American registration study (POSEIDON), with primary endpoint data expected in Q222. This device removes localised excess fluid build-up in the peritoneal cavity, and aims to p
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VLG has delivered a pleasing and reassuring H1 result against a challenging backdrop. The recent acquisitions are performing strongly and it has been able to mitigate a lot of the recent incremental cost/inflation headwinds. Trading so far in H2 is slightly ahead of plan and it has a very strong order book which will lead to increased H2 weighting. Confidence in EBITDA forecasts is therefore high. We have, however, reduced our PBT/EPS forecasts on the back of higher D&A (non-cash) than expected.
Companies: Venture Life Group Plc
Singer Capital Markets
Oncimmune has released results for the 12m period to May-22, ahead of its changed year and to August. These results reflect a period of investment into the commercial team for ImmunoINSIGHTS and increased penetration into the Top 15 global pharma customers, where a number of MSAs have been signed. These are expected to translate into faster contract wins and management reports a current weighted value pipeline of £11.0m across the business, providing increased revenue visibility. Cost savings in
Companies: Oncimmune Holdings Plc
Companies: Warpaint London PLC
Belluscura has made very significant progress in technology, manufacturing and sales in the year to date and remains strongly positioned to achieve considerable scale next year.
Companies: Belluscura PLC
Trading momentum has been sustained in early Q3, triggering a 3rd upgrade YTD. There is clear evidence the growth strategy is bearing fruit. Distribution gains are increasing brand reach both in the UK and overseas. This appears to be an ideal time for its on-trend value-for-money proposition to gain traction in its key channels, potentially with counter-cyclical characteristics as consumers start trading down. After a further pull-back (YTD now -29%), valuation is out of synch with its growth t
Companies: Medica Group Plc
OptiBiotix has launched its GoFigure weight management range in India through its commercial partner Apollo Hospitals (Apollo). Apollo owns and operates the largest pharmacy network across India and will initially stock the GoFigure range in key stores in major Indian cities, as well as online. Apollo is one of three large partners which entered commercial agreements with OptiBiotix in late-2021. The launch demonstrates OptiBiotix' strategic shift towards selling a greater proportion of finished
Companies: OptiBiotix Health PLC
OptiBiotix has issued its interim results for the six months ended 30 June 2022. In line with the company's August trading update, revenues have fallen to £0.12m as delays to customer restocking and new product launches impacted the top-line. Whilst the operating loss grew to £1.11m, as the company invested in key management personnel, OptiBiotix delivered over £10.2m in value to shareholders through a dividend in specie following the listing of ProBiotix Health (PBX) in March 2022. Post-period,
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Independent Living REIT plc, intends to float on the Premium Segment of the Main Market. The Company's investment objective is to address the shortage of high-quality supported housing, delivering capital growth and inflation-linked income returns for its investors whilst providing a fair deal for society through savings for the UK taxpayer, and improved outcomes for residents. Raising £150
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Following ReNeuron’s strategic review and change of management, the company has refocused on the exploitation of its exosome platform. We have likewise focussed our research on the potential for, and value of, ReNeuron’s exosomes. In this note, we do not dwell on the past but explore the potential for ReNeuron’s exosomes and why they may be the answer to pressing drug delivery questions. One of its previous products – now under the control of a partner – remains as an upside to our valuation.
Companies: ReNeuron Group plc
Venture Life has published its interim results for the 6-months to June 22, which show profits slightly ahead of the previous trading update. Revenues grew 36% in the period to £18.9m, while both gross and adjusted EBITDA margins improved strongly, 5.0 and 3.6 percentage points, respectively. Growth was driven by recent acquisitions, with new distribution deals and product launches through the period. Performance has continued into H2/22, with further deals signed and trading in-line with expect
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Synairgen reported interim results to end-June 2022 that reflected a lower R&D spend on COVID-19-related trials and lower expenses overall. With net cash of £18m at the end of the period augmented by the receipt of a £9.1m R&D tax credit in August, our forecast of net cash of £10m at end-2022 is raised to just under £16m. The Group notes that it has a cash runway until at least end-September 2023, which we view as conservative, and with the introduction of 2023E forecasts, we now estimate end-20
Companies: Synairgen plc
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Rockwood Strategic plc has transferred from AIM to the Main Market.
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TECC Capital plc, to be renamed EDX Medical Group, intends to join the AQSE Growth Market. EDX operates a molecular biology and diagnostics laboratory in Cambridge, UK, from which it performs research & development, provides Polymerase Chain Reaction (PCR) testing and genomic sequencing services, undertakes quality assurance and has establis
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