Cereno Scientific announced an update on the progress of the Phase II study of CS1 in pulmonary arterial hypertension (PAH). Cereno has seen substantial interest in the FDA-approved Expanded Access Program ("compassionate use") for patients who have completed the Phase II study, with investigators indicating that a majority of patients would be interested in continued access to CS1 following study completion. The company reports considerable progress in the study.

Due to a longer start-up phase for the two new study sites than previously estimated, the study timeline has been negatively affected and top-line results are now expected in Third Quarter 2024. The Phase II study of CS1 In the rare disease PAH is actively running at 10 specialist clinics in the US, with one new clinic activated in late December and one new clinic currently in late-stage start-up process. To date, 25 patients have received the CardioMEMS HF System implantation, of which 23 patients have been randomized to CS1 drug therapy; and 19 patients have completed the study.

Investigators indicate that close to two-thirds of the patients, having completed the study or are currently on therapy, have been judged to be interested in continued access toCS1 following study completion. Currently site-specific and IRB approvals are being progressed. The EAP will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH.

The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which will help further inform the design of Phase IIb/III pivotal study with CS1. While the company reports notable progress in the study, a slower recruitment pace than estimated during the last months and a longer start-up phase For the new sites have affected the study timeline. The updated study timeline now expects study completion and top-line results during Third Quarter 2024.