14 slides from Cereno Scientific Ab Class B's technical presentation, Dec 17, 2025
Slide 1: Safety, tolerability, and pharmacokinetics of the novel HDAC inhibitor CS014: a first-in-human trial
Safety, tolerability, and pharmacokinetics of the novel HDAC inhibitor CS014: a first-in-human trial Tatiane Abreu Dall’Agnol1, Fredrik Frick1, Rahul Agrawal1, Björn Dahlöf1,2, Johan Nilsson3, Johan Bylund3, Erik Westrin3, Nicholas Oakes1 1Cereno Scientific, Gothenburg, Sweden; 2University of Gothen
Slide 2: CS014 is being developed for rare and severe cardiopulmonary diseases involving vascular remodeling and fibrosis
CS014 is being developed for rare and severe cardiopulmonary diseases involving vascular remodeling and fibrosis • Several rare diseases involving the remodeling of pulmonary vasculature, including pulmonary arterial hypertension (PAH) • Small pulmonary arteries: fibrosis, vasoconstriction, thickeni
Slide 3: CS014, a novel HDAC inhibitor with a molecular structure based upon valproic acid
CS014, a novel HDAC inhibitor with a molecular structure based upon valproic acid • Histone deacetylase inhibitors (HDACi), CS014 Structure including valproic acid (VPA), have been postulated to have beneficial effects in severe cardiopulmonary diseases, including PAH • CS014, a novel precision deut
Slide 4: Preclinical data in a PAH rat model – Dose-dependent reversal of pulmonary vascular remodeling
Preclinical data in a PAH rat model – Dose-dependent reversal of pulmonary vascular remodeling Reduced incidence of plexiform lesions in small pulmonary arteries (<100µm) (%) Cross sections of arteries (<100 µm) Sugen/hypoxia rat model Healthy Plexiform lesions CS014 also reduced small artery-associ
Slide 5: CS014-001 Phase I: First-in-human, single- and multiple-dose study (SAD/MAD) in healthy volunteers
CS014-001 Phase I: First-in-human, single- and multiple-dose study (SAD/MAD) in healthy volunteers Volunteers' characteristics: SAD: Part Gender Age (years) 30 participants, : n=26 5 cohorts SAD 34 – 64 : n=4 Primary endpoint: Secondary endpoints: MAD: Safety and PK properties : n=12 18 participants
Slide 6: MAD cohorts: CS014 treatment had few treatment-related adverse events, all mild and fully resolved
MAD cohorts: CS014 treatment had few treatment-related adverse events, all mild in nature and fully resolved CS014 600 mg CS014 900 mg CS014 1200 mg Total (N=6) (N=6) (N=6) (N=18) System organ class n (%) m n (%) m n (%) m n (%) m Preferred term Total 0 0 3 (50%) 9 3 (50%) 13 6 (33%) 22 Gastrointest
Slide 7: CS014 induced no clinically significant changes in objective safety measurements
CS014 induced no clinically significant changes in objective safety measurements • Physical examination • Vital signs • Safety ECGs (including no QT prolongation) • Safety laboratory (clinical chemistry, hematology, coagulation) All volunteers completed No serious adverse events All treatment-relate
Slide 8: CS014 first-in-human trial reveals well-defined pharmacokinetics
CS014 first-in-human trial reveals well-defined pharmacokinetics Total plasma concentrations • CS014-FA rapidly absorbed • Plasma accumulation upon repeated dosing and CS014-FA (µg/mL) increased exposure with increasing dose • Steady-state by Day 7 • Mean T1/2 at steady state increased with dose: ~1
Slide 9: CS014 plasma protein binding: non-linear and concentration-dependent
CS014 plasma protein binding: non-linear and concentration- dependent 100 Cb = Cbmax K Cu / (1 + K 90 • Plasma protein binding determined using a Bound Concentration (µg/mL) 80 rapid equilibrium device in selected 70 50% Binding plasma samples from all volunteers in 1400 60 Capacity mg SAD cohort 50
Slide 10: FIH doses were safe, well-tolerated, and exceeded exposure levels needed for reversal of pulmonary vascular remodeling
FIH doses were safe, well-tolerated, and exceeded exposure levels needed for reversal of pulmonary vascular remodeling 350 Steady-state unbound exposure Unbound AUC (hr.µg/mL) 300 estimates for the three MAD dose 250 groups, 600, 900, and 1200mg/day 200 (geometric mean values) 150 Steady-state unbo
Slide 11: Conclusion
Conclusion • In this Phase 1 trial, single and multiple oral doses of CS014 in healthy volunteers were safe and well tolerated, based on reported AEs, vital signs, ECG measurements, safety laboratory parameters, and physical examination findings • PK properties, including plasma protein binding, wer
Slide 12: Read CS014's first manuscript
Journal Pre-proof For more information: Read CS014’s first manuscript Journal of Thrombosis and Haemostasis December 2025 Access here > 12
Slide 13: Thank you for your attention!
Thank you for your attention! Questions? Contact details Email: tatiane.dallagnol@cerenoscientific.com
Slide 14: Cereno Scientific is pioneering treatments to enhance and extend life
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 full. The company is headquartered in GoCo Health Innovati