Last close As at 05/08/2026
SEK4.76
▲ −0.02 (−0.33%)
Market capitalisation
SEK1,484m
Research: Healthcare
Cereno Scientific has taken a step closer to advancing its second asset, CS014, a novel HDAC inhibitor with epigenetic effects, to the clinic with the submission of the clinical trial application (CTA) to the European Medicines Agency (EMA). The CTA is for the first-in-human Phase I trial for CS014, which Cereno is developing for thrombosis prevention, without increased risk of bleeding. We believe this has the potential to address the main limitation of current standard-of-care antithrombotic medicines and offers a sizeable opportunity for Cereno (backed by supportive preclinical data). Subject to clearance from the EMA, management plans to commence the Phase I study in Q224, consistent with prior guided timelines. Cereno’s lead asset is CS1, which is in a Phase II trial for pulmonary arterial hypertension (PAH). The results are expected in Q324, potentially representing the company’s next catalyst, in our view.
Written by
Cereno Scientific |
CS014 (thrombosis) progresses towards the clinic |
Regulatory update |
Pipeline update |
Pharma and biotech |
16 April 2024 |
Share price performance
Business description
Analysts
Cereno Scientific is a research client of Edison Investment Research Limited |
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Cereno Scientific has taken a step closer to advancing its second asset, CS014, a novel HDAC inhibitor with epigenetic effects, to the clinic with the submission of the clinical trial application (CTA) to the European Medicines Agency (EMA). The CTA is for the first-in-human Phase I trial for CS014, which Cereno is developing for thrombosis prevention, without increased risk of bleeding. We believe this has the potential to address the main limitation of current standard-of-care antithrombotic medicines and offers a sizeable opportunity for Cereno (backed by supportive preclinical data). Subject to clearance from the EMA, management plans to commence the Phase I study in Q224, consistent with prior guided timelines. Cereno’s lead asset is CS1, which is in a Phase II trial for pulmonary arterial hypertension (PAH). The results are expected in Q324, potentially representing the company’s next catalyst, in our view.
Year end |
Revenue (SEKm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
0.0 |
(27.6) |
(0.20) |
0.0 |
N/A |
N/A |
12/23 |
0.0 |
(48.2) |
(0.23) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(51.2) |
(0.19) |
0.0 |
N/A |
N/A |
12/25e |
0.0 |
(48.6) |
(0.17) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Cereno continues to make progress in its quest to develop innovative treatments for rare and common cardiovascular diseases, with the submission of the CTA for CS014, a novel histone deacetylase inhibitor (HDACi), for thrombosis prevention. As an epigenetic modulator, CS014 shows promise in regulating platelet activity, local fibrinolysis and clot stability, underpinned by preclinical research showing signs of thrombosis prevention without increased risk of bleeding in various animal models (see our initiation note for more detail). If cleared by the EMA, the Phase I trial will be an open-label study involving healthy volunteers, aiming to assess the safety and tolerability of CS014 at single and multiple ascending doses across one week; pharmacokinetics and pharmacodynamics will also be evaluated. With the global antithrombotic market valued at c $29bn in 2022 and projected to reach c $46bn by 2028, we believe there is a sizeable opportunity for Cereno.
Lead asset, CS1 (also an HDACi), is being developed for PAH, and is in a Phase II trial, leveraging Abbott’s CardioMEMS technology. An interim patient case study and data quality control review provided encouraging signs that CS1 could provide a clinically meaningful benefit for PAH patients. Further, the FDA has granted Expanded Access to CS1 for PAH, making it available to patients in an extension programme, indicating the perceived patient benefit, in our view, although we acknowledge that detailed conclusions cannot be drawn until the final analysis is conducted. This is expected in Q324, and may represent Cereno’s next catalyst.
Cereno has also strengthened its intellectual property position, having expanded patent protection for CS1 in Canada and in 25 European countries. It also announced extended patent protection in Europe for its third programme, CS585, for which we expect updates on preclinical progress throughout 2024. We also note that Cereno recently reported gross proceeds of c SEK76.7m from the exercise of series TO3 warrants, equating to a 99.6% subscription rate, extending Cereno’s cash runway into 2025, per our estimates.
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Research: Investment Companies
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