Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that it will host an Investigator Meeting in Boston, USA, on December 2, 2026, bringing together all US investigators and study coordinators involved in the global Phase IIb EPIMODE trial of lead drug candidate CS1 in pulmonary arterial hypertension (PAH). The Company is encouraged by the strong interest and enthusiasm among participating sites, reflecting positive momentum as clinical sites progress through start-up activities.
The meeting brings together investigators and study coordinators from participating clinical sites to deepen their knowledge of CS1, align on the EPIMODE study protocol and prepare for effective trial execution. The US sites are currently at different stages of activation and operational readiness, and are encouraged to start identify eligible patients before activation to facilitate effective patient recruitment.
"We are encouraged by the strong enthusiasm and engagement among EPIMODE investigators and study coordinators. The upcoming meeting in Boston will strengthen alignment on CS1, the study protocol and its potential benefits for patients, supporting continued momentum in the trial," said Rahul Agrawal, Chief Medical Officer and Head of R&D at Cereno Scientific.
"EPIMODE is our most important clinical development program and a key driver of Cereno Scientific's long-term value creation. Seeing the trial advance alongside such positive engagement from the clinical community strengthens our confidence in the path ahead. We are excited about the progress being made and remain focused on advancing CS1 toward its next important development milestones, bringing us closer to realizing its potential for patients and shareholders," said Sten R. Sörensen, CEO of Cereno Scientific.
Supporting effective execution across the global EPIMODE trial
Investigator Meetings are an established part of clinical trial conduct, providing structured training and scientific and operational alignment for investigators and study teams. The December meeting in the US will focus on the scientific background and clinical rationale for CS1, key elements of the EPIMODE protocol, patient eligibility criteria, study procedures, and practical aspects of trial execution.
As individual sites progress through the start-up process at different stages, this alignment is intended to support consistent trial conduct and high quality execution.
In its latest EPIMODE update, Cereno Scientific communicated that up to 15 clinical sites are expected to be activated by year-end 2026, with more than 50% of the planned global sites expected to be activated by the end of Q1 2027. The Company continues to target completion of patient recruitment during 2027 and anticipates topline results in Q4 2028, subject to recruitment timelines.
For further information, please contact:
Tove Bergenholt, Head of IR & Communications
Email: tove.bergenholt@cerenoscientific.com
Phone: +46 73- 236 62 46
About the EPIMODE trial
EPIMODE is a global, randomized, double-blind, placebo-controlled, dose-finding Phase IIb trial designed to evaluate the efficacy of CS1 when added to standard of care and identify the optimal dose for continued development, alongside evaluating safety and tolerability and further assessing CS1's potential disease-modifying effects. The primary endpoint is pulmonary vascular resistance (PVR) measured after the first treatment period of nine months. PVR is a key measure of resistance in the blood vessels of the lungs and is a fundamental measure in PAH, where increased pulmonary resistance and pressure place strain on the right side of the heart. Other measures will also be evaluated including right-heart function, functional capacity, risk evaluation, biomarker changes, clinical worsening, patient-reported outcomes, and pharmacokinetics. A differentiated two-stage trial design is utilized that enables the assessment of how treatment effects develop following continued CS1 treatment or a switch between CS1 and placebo, providing additional insights into the potential durability of CS1's disease-modifying treatment profile. The trial is designed to enroll approximately 126 patients across approximately 68 investigational sites in 12 countries in North America, Europe and South America. The top-line results are anticipated in Q4 2028, subject to recruitment timelines. The Phase IIb trial has been named EPIMODE, reflecting the scientific foundation of the CS1 program and Cereno Scientific's focus on epigenetic modulation in cardiopulmonary diseases. More information is available on Clinicaltrials.gov: NCT07761572.
About Cereno Scientific AB
Cereno Scientific is pioneering treatments to enhance and extend life. The company's innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the fullest.
Lead candidate CS1 is an HDAC inhibitor that works through epigenetic modulation and represents a novel therapeutic approach by targeting the underlying mechanisms of pulmonary arterial hypertension (PAH). CS1 is a well-tolerated oral therapy with a favorable safety profile that has shown encouraging efficacy signals in a Phase IIa trial in patients with PAH, including improvements in right heart function, functional class, risk score and patient quality of life, with early signs consistent with reverse vascular remodeling. An Expanded Access Program confirmed CS1 to be well-tolerated with a favorable safety profile over 12 months of treatment and showed that a majority of patients completing treatment maintained or improved clinical status. CS1 is currently being evaluated in EPIMODE, a global, placebo-controlled Phase IIb trial in PAH. CS014 is a new chemical entity and HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of a range of cardiovascular and pulmonary diseases with high unmet needs. CS014 showed a favorable safety and tolerability profile in Phase I, and is being advanced through a streamlined, FDA-aligned pathway toward Phase IIb in pulmonary hypertension associated with interstitial lung disease (PH-ILD). Cereno Scientific is also advancing the preclinical program CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist shown to prevent thrombosis without increased bleeding risk, currently being evaluated in antiphospholipid syndrome (APS).
The Company is headquartered in GoCo Health Innovation City in Gothenburg, Sweden, and has a US subsidiary, Cereno Scientific Inc., located in Kendall Square, Boston. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company's Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com.
