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Cereno Scientific is a biotechnologyballgi clinical phase developing treatments for rare diseases. The company's portfolio includes three drug candidates – CS1, CS014 and CS585 – which are evaluated in separate and parallel development programs.
A milestone during the third the quarter was the announcement av topline-the results from phase IIa-study w/ CS1, the company's lead candidate for the treatment of the rare disease pulmonary arterial hypertension (PAH). CS1 is a histone deacetylase inhibitor (HDAC inhibitors) that act via epigenetic modulation. Study results showed that CS1 was safe and well tolerated, with no serious side effects associated with the treatment.
Convincing positive impact of exploratory clinical power parameters
Key exploratory efficacy outcomes were equally promising. Patients treated with CS1 in combination with standard of care showed improvements in clinical parameters such as REVEAL Risk Score and NYHA Functional Class, two important measures in the management of PAH. In addition, sustained reductions in mean pulmonary artery pressure were noted, indicating a positive effect on patients' physical capacity and other relevant aspects.
An in-depth analysis showed that 25 percent of patients were so-called “remarkable responders,” with significant reductions in pulmonary vascular resistance and increased right ventricular stroke volume. The results are in line with CS1's proposed mechanism of reversing pathological vascular changes, and reinforce Cereno's goal of developing a disease-modifying treatment that addresses the root cause of PAH.
During the quarter, the first patient within an Expanded Access Program (EAP) for CS1 in PAH was also dosed. The results from here will be important in dialogues with regulatory authorities and when planning future studies.
Cereno enters into partnership with Fluidda
In September, Cereno entered into a collaboration with Fluidda, a company specializing in respiratory imaging technology. The collaboration will provide increased understanding of how CS1 affects structural changes in the pulmonary vessels. The collaboration will use Fluidda's imaging technology to visualize how long-term use of CS1 affects structural changes in pulmonary arteries, and an investigator-initiated study with patients from the EAP program is currently being planned.
Ahead of the next development phase for CS1, Cereno is now preparing for a Phase IIb or pivotal Phase IIb/III study, with a planned start in 2026.
Market exclusivity for CS1 in the EU
CS1 ficker under quarter also Orphan Medicinal Product Designation (OMPD) for PAH from European Commissions, which implies tio years market exclusivity Inom EU after approval. This complements sju years exclusivity as granted i USA. Tillsammans w/ patent protection stronger of that atgärder CS1:s commercial potential globally.
IPF becomes indication for CS014
For the company's andra HDAC-inhibitor, CS014, announced Cereno to the initial target indication coming to early idiopathic pulmonary fibrosis (IPF). IPF lacks today efficient treatment options, and preclinical data for CS014 indicates potential to treat de underlying the disease processes. The drug candidate went noften in i dose escalation part i fas I, w/ results expected below the middle av 2025. The goal is to gå in i fas II in 2026.
Promising results with CS585
Results - for prostacyclin agonist CS585 was presented vid European Society of Cardiology and American Heart Association. Man lying downthus gives additional preclinical data to documentationone, as indicates that CS585 inhibits platelet activation and blood clot formation for up to 24 hours after administration.
Strengthened financial position
After Q3, Cereno secured financing of at least SEK 250 million, which means that the company's cash is now expected to last into 2026. The financing comes from Fenja Capital II A/S and US-based Arena Investors and consists of both cash loans and convertible loans. The capital injection provides Cereno with the resources to achieve key milestones, such as: advancing CS1 through regulatory approval from the FDA for a Phase IIb study or a pivotal Phase IIb/III study in PAH, completing the Phase I study for CS014, advancing the Expanded Access Program (EAP) investigating the long-term clinical use of CS1 in PAH. As well as obtaining regulatory approval for a Phase II study with CS014 in IPF, and continuing the preclinical development of CS585.
The funding also strengthens business development efforts, particularly discussions with potential partners and professional investors, to further support progress within the company's programs.
Cereno CEO Sten R. Sörensen commented:
– The financing gives us a stable foundation to reach important milestones and enables us to explore optimal strategic collaborations, both with financial players and with pharmaceutical companies.