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The findings provide further long-term clinical experience with CS1 and add important context as the company prepares to initiate its global Phase IIb study, where CS1’s potential disease-modifying profile in PAH will be further evaluated in a controlled setting.

Pulmonary arterial hypertension (PAH) remains a serious and life-threatening disease despite significant advances in treatment over the past decades. As the field increasingly shifts its focus from symptom management toward disease modification, new therapeutic approaches targeting the underlying mechanisms of disease are gaining attention. In this interview, Professor Marc Humbert, one of the world's leading PAH experts and Chair of the Clinical Steering Committee for Cereno Scientific's CS1 program, shares his perspective on the current treatment landscape, key considerations in clinical development, and what may define the next generation of therapies for PAH.

Cereno Scientific recently confirmed that CS1 met its primary endpoint of safety and tolerability in the 12-month Expanded Access Program (EAP) with CS1 in pulmonary arterial hypertension (PAH), confirming that CS1 was well tolerated with a favorable safety profile . While based on a limited number of patients, the EAP represents an important step forward by adding longer-term clinical data to the CS1 program. The initial analysis of the EAP has been focused on the primary endpoint of safety and tolerability. Further analyses will be conducted on data from the EAP and Fluidda imaging sub-study evaluating changes in the pulmonary vessels during Q2 2026.

Cereno Scientific has presented initial insights from an Expanded Access Program (EAP), in which patients with pulmonary arterial hypertension (PAH) were treated with the drug candidate CS1 for 12 months. The results confirm a favorable safety and tolerability profile during long-term treatment and are consistent with previously reported findings from the Phase IIa study.

At the recent LSX World Congress Europe in Lisbon, Cereno Scientific CEO Sten R. Sörensen joined industry leaders for the panel “Rare Diseases vs. Broad Indications: Where to Focus Early Stage Innovation.”