Cereno Scientific — Four-month EAP data support CS1 plans

Cereno Scientific (OMX: CRNO-B)

Last close As at 16/06/2025

SEK10.18

−0.07 (−0.68%)

Market capitalisation

SEK2,861m

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Research: Healthcare

Cereno Scientific — Four-month EAP data support CS1 plans

Cereno Scientific has announced encouraging four-month follow-up data from its Expanded Access Program (EAP) for CS1, a first-in-class HDAC inhibitor being developed to treat pulmonary arterial hypertension (PAH). While details have not been disclosed, management has noted that the data, collected from a 10-patient cohort who continued CS1 treatment following the successful Phase IIa trial, align closely with earlier results, reinforcing the drug’s safety and tolerability, as well as early efficacy signals. Top-line results from the full 12-month follow-up are expected in Q126, and we believe these, along with data from the Fluidda sub-study, will help build understanding of long-term usage of CS1 as the company prepares for the Phase IIb study, to commence in H126. Our estimates remain unchanged following this announcement, as we await the full 12-month results in Q126.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Director, healthcare

Healthcare

Clinical update

17 June 2025

Price SEK10.25
Market cap SEK2,877m

SEK9.7/US$

Net cash/(debt) at 31 March 2025

SEK(103.4)m

Shares in issue

281.0m
Free float 93.0%
Code CRNO B
Primary exchange NGM
Secondary exchange N/A
Price Performance

Business description

Cereno Scientific is a clinical-stage biotech based in Sweden, focused on the development of innovative, effective and safe treatments for indications with high unmet needs. Lead asset CS1 is an HDAC inhibitor that acts as an epigenetic modulator. Cereno reported positive top-line results from the Phase IIa study in pulmonary arterial hypertension in September 2024. Second asset CS014, a proprietary NCE and HDACi, is being developed for idiopathic pulmonary fibrosis, and preclinical asset CS585 is likely to target rare thrombosis-related indications.

Analysts

Jyoti Prakash, CFA
+44 (0)20 3077 5700
Arron Aatkar, PhD
+44 (0)20 3077 5700

Cereno Scientific is a research client of Edison Investment Research Limited

Note: PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

Year end Revenue (SEKm) PBT (SEKm) EPS (SEK) DPS (SEK) P/E (x) Yield (%)
12/23 0.0 (46.4) (0.20) 0.00 N/A N/A
12/24 0.0 (98.1) (0.35) 0.00 N/A N/A
12/25e 0.0 (94.8) (0.34) 0.00 N/A N/A
12/26e 0.0 (83.4) (0.30) 0.00 N/A N/A

While details of the observations from the four-month EAP readout have not been disclosed, management has reported that the data align with the results from the previous 12-week Phase IIa study, which demonstrated favourable safety and tolerability (a key consideration given the strong side effect profile for recently approved Winrevair (Merck), positioned as a disease-modifying treatment for PAH), as well as efficacy signals on exploratory efficacy measures, such as the REVEAL risk scores, mean pulmonary arterial pressure and functional class changes. Further incremental data following the completion of the clinical study report in Q125 showed the potential to reverse vascular remodelling, based on improvements in measures such as right-ventricular global longitudinal strain and pulmonary vascular resistance, supporting the disease-modifying positioning of the drug.

The EAP, which includes 10 eligible patients from the 21-patient Phase IIa study, is being conducted under an FDA-approved protocol and is designed to collect long-term safety and efficacy data over a 12-month period. We remind readers that the company received the go-ahead from the FDA for the EAP in January 2024, with the first patient dosed in August 2024, and all 10 patients enrolled by December 2024. The primary objective of the EAP is to establish the long-term safety and tolerability of CS1, as well as further evaluate exploratory efficacy. Note that the company is also undertaking a sub-study (with five to seven patients from the EAP) using Fluidda’s novel imaging technology to visualise the effect of CS1 on inducing long-term reverse remodelling. This, we believe, will support the company’s dialogue with both potential partners and regulators, and help refine dosing and potentially the study endpoints ahead of the randomised, placebo-controlled Phase IIb trial, expected to commence in H126.

Our estimates are unchanged, pending further details from the follow-up data from the EAP.

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