CS 014 / Cereno Scientific - LARVOL DELTA

Cereno Scientific announces positive topline results from Phase I trial of CS014 – a novel HDAC inhibitor – supporting advancement into Phase II - P1 | N=48 | "Summary of the topline results from the Phase I trial: CS014 demonstrated favorable safety and tolerability in healthy volunteers. All 48 healthy volunteers completed the study; no early withdrawals or deaths were reported. No serious adverse events (SAEs) occurred. All treatment-related adverse events (AEs) reported were mild, transient, and fully recovered. CS014 achieved levels in the blood stream at and above those projected, based on non-clinical data, to be required for achieving maximal effects on reversal of pulmonary vascular remodeling and fibrosis."

P1 data • Idiopathic Pulmonary Fibrosis

Cereno Scientific secures 100 MSEK through additional loan financing and conversion to advance HDAC inhibitors CS1 and CS014 in Phase II (Firstwordpharma Press Release) - "Cereno Scientific...announced entering loan financing agreements securing a total of 100 MSEK....The proceeds from the Addendum and the New Financing Agreement are primarily intended for: Advancing CS1 Phase IIb trial to initiation through preparation of regulatory documentation, obtaining approvals and conducting start-up activities; Initiating a Phase II program for CS014; Progressing the Expanded Access Program (EAP), including the Fluidda sub-study, to gain insights into the long-term use of CS1 in patients with pulmonary arterial hypertension (PAH); Continuing and expanding the company’s global partnering activities Continuing to strengthen footprint in the scientific community through publications and presentations."

Financing • Pulmonary Arterial Hypertension

Cereno Scientific reports that its Phase I trial of CS014 has been concluded and confirms that top-line results are anticipated in June 2025 (Cision) - "Cereno Scientific...today announced that the second and final part of the Phase I trial of drug candidate CS014 in healthy volunteers has been concluded with the last patient’s last visit. The Phase I trial intends to primarily evaluate the safety and tolerability profile of CS014 in humans and is divided into two parts – a single ascending dose part (SAD) and a multiple ascending dose part (MAD)...and the trial’s top-line results are expected to be announced in June 2025. The new chemical entity CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF)."

P1 data • Trial status • Cardiovascular • Idiopathic Pulmonary Fibrosis

Cereno Scientific’s HDACi CS014 has successfully completed part one of its Phase I trial evaluating the safety profile with a single ascending dose (SAD) study (Cision) - "Cereno Scientific...announced that drug candidate CS014 has completed the first part of two in its Phase I trial in healthy volunteers without any safety concerns...The Phase I trial intends to evaluate the safety profile of CS014 in humans and is divided into two parts – a single ascending dose part (SAD) and a multiple ascending dose part (MAD). Part two of the trial (MAD) is currently ongoing according to plan and the Phase I trial is expected to be completed in mid-2025. HDACi CS014 has the potential to transform the treatment landscape of IPF...Part one of the Phase I trial of CS014 conducted by our CRO partner CTC in Uppsala explored the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses (SAD) of CS014 in 30 patients. This first part of the trial has successfully been completed with results showing that CS014 exhibited an acceptable safety profile supporting its potential for further clinical development."

Trial completion date • Trial status • Cardiovascular • Idiopathic Pulmonary Fibrosis