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 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. Interstitial 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.
"Broadening the development focus for CS014 to PH-ILD is a natural and scientifically driven evolution," said Sten R. Sörensen, CEO of Cereno Scientific. "It enables us to target a severe condition with very limited treatment options and is expected to strengthen the clinical and strategic positioning of CS014 without changing its underlying scientific rationale or long-term development focus. The underlying rationale for this strategic focus is that we believe it will enable us to get CS014 faster to market at lower cost and with a higher probability of success."
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. 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 targets key pathophysiological processes that are shared across fibrotic lung disease and pulmonary vascular disease, including vascular remodeling, fibrosis, thrombosis and inflammation," said Rahul Agrawal, CMO and Head of R&D at Cereno Scientific. "By broadening the development focus to PH-ILD, we can design a Phase II study that better reflects real-world disease biology and for patients with worse prognosis."
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 Q1 2027.
For further information, please contact:
Tove Bergenholt, Head of IR & Communications
Email: tove.bergenholt@cerenoscientific.com
Phone: +46 73- 236 62 46
About CS014
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, fibrosis and thrombosis, which are key drivers of disease progression in several cardiovascular and pulmonary conditions and suggests disease-modifying potential (Stanger, L. et al (2025). 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. Cereno Scientific is advancing CS014 as a potential new treatment for patients with severe, progressive cardiovascular and pulmonary diseases that currently lack effective therapies.
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 root mechanisms of the 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 and patient quality of life, consistent with reverse vascular remodeling. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014, a new chemical entity with disease-modifying potential, showed favorable safety and tolerability profile in a Phase I trial. 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). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like thrombosis prevention without increased risk of bleeding.
The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. 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.
