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.

Cereno Scientific has launched the global Phase IIb study for CS1 (EPIMODE) in pulmonary arterial hypertension (PAH) with the activation of the first clinical site. We view this as a meaningful execution milestone, clearing the path to patient recruitment (to commence mid-September) towards top-line results in Q428. The 56-week study will recruit c 126 patients across c 68 sites, providing the required controlled setting in which to evaluate CS1’s dose response, efficacy and proposed disease-modifying profile. EPIMODE is differentiated by its two-stage, re-randomisation design, optimised to assess dose response, efficacy and the durability of treatment effects across a broad patient cohort. The primary endpoint will be change in pulmonary vascular resistance (PVR) at nine months, a well-established objective haemodynamic measure in PAH. With clinical timelines broadly in line with our estimates, we leave our valuation unchanged ahead of upcoming Q226 results.