Aankondiging • May 18
Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026 Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026, at 11:00 W. Europe Standard Time. Location: maqs advokatbytas premises, masthamnsgatan 13, gothenburg Sweden Aankondiging • Apr 02
Cereno Scientific Reports Favorable Safety and Tolerability After 12 Months of Cs1 Treatment in Pah from the Expanded Access Program Cereno Scientific announced initial learnings from the 12-month Expanded Access Program (EAP) with its lead drug candidate CS1 in pulmonary arterial hypertension (PAH). The data confirm a favorable safety and tolerability profile over long-term treatment, consistent with previous Phase IIa results, further strengthening the value proposition of CS1 as an oral, once-daily potentially disease-modifying therapy. The Expanded Access Program (EAP) enrolled ten patients who had completed the Phase IIa trial, enabling continued treatment with CS1 under physician supervision. Initial learnings from the completed 12-month treatment period show that CS1 was well tolerated, with no unexpected safety concerns observed. No deaths were reported, and no discontinuations were reported to be related to CS1. Six out of ten patients completed the full 12 months of continuous treatment with CS1. Of the remaining patients, two discontinued CS1 treatment following atrial fibrillation events, which was assessed as not related to CS1; one withdrew consent, and one was lost to follow-up. The EAP was conducted under a formal FDA protocol and initiated following requests from patients and physicians. It enabled the generation of additional long-term data beyond the three-month Phase IIa trial, which had demonstrated that CS1 had favorable safety and tolerability and showed encouraging efficacy signals, including improvements in right heart function, functional class and patient quality of life, with signs consistent with reverse vascular remodeling. Together, the Phase IIa trial and the EAP provide up to 15 months of treatment experience in patients, further strengthening the overall clinical understanding of CS1 in PAH. The EAP was initiated following positive results of the Phase IIa trial, which evaluated the safety, tolerability, pharmacokinetics, and exploratory efficacy of CS1 on top of standard therapy in patients with PAH. The Phase IIa trial was conducted at 10 US clinics over 3 months with a total of 25 patients of which 21 were evaluated for efficacy parameters. The trial successfully met its primary endpoint of safety and tolerability, with no drug-related serious adverse events. Encouraging efficacy signals were observed in the trial, including improvements in right heart function, functional class and patient quality of life, with early signs consistent with reverse vascular remodeling. Preparations for a larger, placebo-controlled global Phase IIb study of CS1 in PAH are ongoing, with first patient enrollment anticipated in June 2026. Further analyses from the EAP, including results from the exploratory imaging sub-study using Fluidda's technology, are planned to be communicated during Second Quarter 2026. CS1 is an orally administered histone deacetylase inhibitor (HDACi) in development as a well-tolerated, disease-modifying therapy for pulmonary arterial hypertension (PAH) with favorable safety profile. Acting through epigenetic modulation, CS1 targets key disease-driving mechanisms such as vascular remodeling, fibrosis and inflammation. CS1 has shown disease-modifying potential in early clinical evaluation and is being evaluated as an add-on (on top of standard-of-care) therapy with the potential to improve outcomes for patients with high unmet medical needs. It has been granted Orphan Drug Designation (ODD) in both the U.S. and the EU and received Fast Track designation from the U.S. FDA in August 2025, underscoring its potential to address a serious condition with high unmet medical need. CS1 has first-in-class potential and is currently in preparation for a global Phase IIb trial. Aankondiging • Mar 18
Cereno Scientific AB Receives Approval to Initiate Fda-Aligned Phase I Pharmacokinetic Study of Cs014 Supporting Phase Ii Development in Ph-Ild Cereno Scientific announced that the Swedish Medical Products Agency has approved the initiation of a Phase I pharmacokinetic study of CS014. The study is designed based on feedback received in a pre-IND meeting with the U.S. Food and Drug Administration (FDA) and is expected to remove the need for additional safety studies and a Phase IIa trial. This supports a streamlined and capital-efficient development pathway toward the planned Phase II trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the First Quarter 2027. The approved study is a Phase I, open-label, randomized, two-period crossover pharmacokinetic (PK) trial in 14 healthy adult volunteers. The study will evaluate steady-state pharmacokinetics following seven days of repeat oral dosing of CS014 compared to valproic acid (VPA), a well-established HDAC inhibitor. The primary objective is to characterize total and unbound plasma concentrations of CS014 at steady state compared to VPA. Following a constructive pre-IND meeting, the FDA indicated that comparative bioavailability data would be acceptable to support the initiation of a Phase IIb trial with CS014. The pharmacokinetic comparison allows Cereno Scientific to leverage the extensive clinical experience with VPA to strengthen the CS014's safety package. A successful trial is expected to remove the need for additional nonclinical safety studies and a clinical Phase IIa trial, allowing Cereno Scientific to progress directly toward Phase IIb preparations. CS014 is a precision deuterated HDAC inhibitor and proprietary new chemical entity within Cereno Scientific's differentiated HDAC inhibitor platform. Designed as a multi-modal epigenetic modulator, CS014 aims to optimize pharmacokinetics and metabolic stability while targeting underlying disease mechanisms such as fibrosis, vascular remodeling, inflammation and thrombosis, which are central drivers in several cardiopulmonary diseases. Aankondiging • Feb 05
Cereno Scientific Provides Update on Expanded Access Program for CS1 Cereno Scientific announced the last patient's last visit concluded the 12-month active study period of the CS1 Expanded Access Program (EAP) in pulmonary arterial hypertension (PAH). Initial learnings from the EAP expected to be available in the first quarter of 2026 and further analyses planned during second quarter of 2026, contributing to the ongoing CS1 development program and its overall value proposition. The Expanded Access Program (EAP) for CS1 was initiated following the completion of the Phase IIa study to enable eligible patients with pulmonary arterial hypertension (PAH) to continue treatment with CS1 under physician supervision. The Phase IIa trial, conducted over 3-months, demonstrated that CS1 was well-tolerated with a favorable safety profile, and showed promising efficacy signals, including improvements in right heart function, patient quality of life, and signals consistent with reverse vascular remodeling. The EAP program enrolled 10 patients who had completed the Phase IIa study, enabling the collection of longer-term information on safety and tolerability during extended use of CS1. Insights generated from the EAP, including the exploratory imaging sub-study of vascular changes in the lung, are intended to complement the Phase IIa results and support the ongoing clinical development of CS1. The EAP is now entering standard processes including database lock, quality assurance and subsequent analysis and interpretation. Initial learnings from the program are expected to be communicated in First Quarter 2026, with additional analyses and interpretation planned during Second Quarter 2026. In parallel, preparations for the global Phase IIb study of CS1 in PAH are progressing, including start-up activities in the United States and planned regulatory interactions in Europe and South America. First patient enrollment in the Phase IIb study is anticipated in the second quarter of 2026. Aankondiging • Feb 04
Cereno Scientific AB (publ) Broadens Development Focus for CS014 to Pulmonary Hypertension Associated with Interstitial Lung Disease Cereno Scientific announced that it is broadening the development focus of its HDAC inhibitor CS014 to pulmonary hypertension associated with interstitial lung disease (PH-ILD). The broadened focus is intended to support a more clinically relevant Phase II program, strengthen the development potential of CS014, and address a patient population with very. high unmet medical need. CS014 has been developed with idiopathic pulmonary fibrosis (IPF) as the intended initial indication. Secondary lung diseases (ILDs) comprise a group of fibrotic lung disorders, of which IPF is the most common and a key disease where CS014 remains highly relevant. A substantial proportion of patients with ILD, including many with IPF, go on to develop pulmonary hypertension, a complication associated with significantly worse prognosis. Broadening the development focus to PH-ILD reflects these disease characteristics and allows CS014 to be evaluated in patients where both fibrotic lung disease and pulmonary vascular pathology play a central role. The rare disease PH-ILD is a severe and life-limiting condition associated with markedly worse outcomes compared with fibrotic lung disease alone, including IPF without pulmonary hypertension. PH-ILD patients who develop pulmonary hypertension experience reduced exercise capacity, faster disease progression and high mortality, while treatment options remain very limited and largely focused on symptom management rather than disease modification. CS014 is a novel, orally administered HDAC inhibitor with potential to address underlying disease mechanisms in severe cardiopulmonary diseases. With a completed Phase I study and a broadened development focus on PH-ILD, Cereno Scientific is advancing preparations for a Phase II study planned to be initiated in first quarter 2027. Aankondiging • Jan 14
Cereno Scientific Announces First Peer-Reviewed Publication on HDAC Inhibitor CS014: Antithrombotic Efficacy Cereno Scientific announced the publication of the first peer-reviewed manuscript describing CS014, a new chemical entity (NCE) and HDAC inhibitor, in the Journal of Thrombosis and Haemostasis. The work reveals the chemical structure of the CS014 molecule, data on its potential mechanism of action and some of its important nonclinical pharmacology; highly efficacious antithrombotic effects at doses in animals that do not jeopardize hemostasis. This publication validates the underlying HDAC inhibition mechanism critical to CS014's therapeutic potential in cardiovascular and pulmonary diseases where thrombosis, vascular remodeling, and fibrosis play interconnected pathological roles. The manuscript, "Novel HDAC inhibitor, CS014, attenuates in vivo thrombosis while maintaining hemostasis," characterizes CS014 as a novel histone deacetylase (HDAC) inhibitor, engineered to improve upon valproic acid (VPA) through reduced hepatotoxicity risk while preserving the mechanistic benefits of HDAC inhibition. The work shows that CS014 maintains efficacious HDAC inhibitory activity, increases tPA mRNA expression and produces strong antithrombotic effects in small artery, large artery and large vein models. Notably, CS014 achieves these effects while preserving normal coagulation and bleeding time, and it produces substantially lower levels of the hepatotoxic 4-ene metabolite compared with VPA in, in vitro and in vivo systems. Access to the manuscript: Stanger, Livia et al. (2025) Novel histone deacetylase inhibitor, CS014, attenuate in vivo thrombosis While maintaining hemostasis. Journal of Thrombosis & Haemostasis. CS014 is being developed as a next-generation HDAC inhibitor and novel chemical entity designed to modulate epigenetic pathways that target the root cause of cardiovascular and pulmonary diseases. Non-clinical studies have demonstrated potent effects on pathways involved in vascular remodeling and fibrosis, which are key drivers of disease progression in several cardiovascular and pulmonary conditions and suggests disease-modifying potential. The recently completed Phase I study confirmed that CS014 has a favorable safety profile and is well tolerated at and above exposure levels that, based on non-clinical data, are predicted to support maximal effects on the reversal of pulmonary vascular remodeling and fibrosis. These findings support advancement of CS014 into Phase II clinical development with an initial focus on idiopathic pulmonary fibrosis (IPF). Cereno Scientific is advancing CS014 as a potential new treatment for patients with severe, progressive cardiovascular and pulmonary diseases that currently lack effective therapies. 
