Cereno Scientific has reaffirmed its Q428 top-line guidance for the Phase IIb EPIMODE trial of CS1 in pulmonary arterial hypertension (PAH), despite a slower-than-anticipated start to patient randomisation. The company expects up to 15 clinical sites to be activated by end-2026, with more than 50% of the planned global network of c 68 sites operational by end-Q127, supporting its target to complete recruitment during 2027. EPIMODE remains Cereno's principal clinical value driver, with the potential to validate CS1's disease-modifying profile in a placebo-controlled setting amid an evolving PAH treatment landscape. With its average recruitment requirement of fewer than two patients per site (n=126), we consider the enrolment target manageable, provided site activation progresses as planned. We maintain our valuation at SEK21.5 per share.

Cereno Scientific has reported positive top-line results from the Phase I pharmacokinetic (PK) bridging study of CS014 (n=14), clearing an important development hurdle for its second clinical-stage HDAC inhibitor (HDACi). The results showed that CS014’s PK relationship with valproic acid (VPA) was consistent with the assumptions underpinning Cereno’s bridging strategy. This could enable Cereno to leverage the extensive clinical safety and PK experience with VPA to streamline CS014’s development pathway, potentially reducing development timelines and funding requirements. Cereno plans to file an Investigational New Drug (IND) application with the FDA in Q426 and, subject to regulatory acceptance, could progress directly into a placebo-controlled Phase IIb study in PH-ILD, bypassing Phase IIa and additional non-clinical safety studies. We expect planned Phase IIb initiation in Q327 to strengthen Cereno's broader investment case, with two HDACi assets in concurrent Phase IIb development.

Cereno’s Q226 results recapped an active period, with subsequent developments marking a tangible shift towards advanced clinical development. The post-period highlight was the August activation of the first site in the Phase IIb EPIMODE study of CS1, enabling patient screening and recruitment to commence. The focus is now on first-patient randomisation, site activation and recruitment progress. Encouragingly, management continues to guide to Q428 for the top-line data, despite the slight shift from the initial June target for study commencement. CS014 provides a near-term catalyst, with top-line data expected within September following completion of the PK bridging study. Supportive results could enable a direct move into Phase IIb in PH-ILD, now targeted for Q327 (from Q127). The SEK60m directed issue supports headroom into late Q426, although further funding and/or partnering will be required. We keep CS1’s PoS unchanged, with our valuation at SEK7.0bn or SEK21.5/share.