Disease-modifying therapies in clinical development
Cereno Scientific develops innovative therapies for rare cardiovascular and pulmonary diseases where current treatment options remain limited. The company’s lead candidate, CS1, is preparing for a global Phase IIb study in pulmonary arterial hypertension (PAH) - a pivotal stage where its potential to influence the underlying disease process will be evaluated at a larger scale.
From symptom control to disease modification
Over the past two decades, the treatment of PAH has advanced significantly. Today’s therapies improve symptoms and prognosis, but have limited impact on the underlying biological mechanisms driving disease progression.
Cereno’s ambition is to contribute to the next stage of development: therapies that may halt, slow, or reverse disease progression — not merely alleviate its consequences.
This is where the company is strategically positioned.
Epigenetic platform with broad potential
Cereno’s clinical drug candidates are based on selective HDAC inhibition; an epigenetic approach targeting central disease-driving mechanisms such as inflammation, fibrosis, thrombosis, and pathological vascular remodeling.
These biological processes are central to the development of several cardiovascular and pulmonary diseases, giving the platform potential to expand into additional indications over time.
CS1 – Global Phase IIb as the next defining milestone
CS1 is the company’s most advanced drug candidate and is being developed for the rare disease pulmonary arterial hypertension (PAH). Over the past year, the development program has achieved several important milestones.
Following a successful Type C meeting with the FDA, the company received regulatory endorsement for the planned Phase IIb study. In the fourth quarter of 2025, green light was obtained to initiate the study in the US. A collaboration was established in mid-2025 with a leading global CRO to conduct the trial. CS1 has been granted Fast Track designation by the FDA as well as Orphan Drug Designation (ODD) in both the US and Europe.
Cereno plans to initiate a global, randomized, placebo-controlled Phase IIb study including approximately 125 patients across North America, Europe, and Latin America in the second quarter of 2026. The study is designed to further evaluate safety, tolerability, and efficacy, including the potential to effect underlying disease mechanisms.
It is in this study that CS1’s clinical and commercial potential will be evaluated at scale.
CS014 – Next-generation HDAC inhibitor
In parallel with CS1, Cereno is developing CS014, a next-generation HDAC inhibitor with improved selectivity and optimized pharmacological properties.
In 2025, positive topline results were presented from a Phase I study. The candidate demonstrated favorable safety and tolerability and achieved exposure levels that, based on preclinical data, are expected to influence disease-driving fibrosis and vascular remodeling.
CS014 is planned to advance into clinical development in pulmonary hypertension associated with interstitial lung disease (PH-ILD), an area with significant unmet medical need and limited treatment options.
The program broadens the pipeline and strengthens the long-term potential of Cereno’s epigenetic HDAC platform by demonstrating the biological mechanism across multiple indications.
Market dynamics and partnering
The global PAH market is projected to reach approximately USD 13.5 billion by 2032. Growth is driven by improved diagnostics, new therapeutic principles, and increasing focus on treatments that impact disease progression.
At the same time, several major pharmaceutical companies are facing significant patent expirations in the coming years, creating structural demand for new growth-driving assets. Historically, such market dynamics have led to increased partnering and M&A activity in areas where clinical differentiation and regulatory advantages can be demonstrated.
Cereno develops its programs with the objective of entering into partnerships for further development and commercialization following key clinical value-inflection milestones. Dialogues with potential partners are ongoing.
Intellectual property and regulatory advantages
The Company holds a growing patent portfolio related to its drug candidates. Together with Orphan Drug Designation in key regions, this provides the foundation for market exclusivity and long-term commercial value.
The combination of clinical development, regulatory support, and intellectual property protection is central to Cereno’s strategic position.
Investment Summary
Cereno is currently in a value-creating phase of development where multiple drivers converge:
- Global Phase IIb study with CS1
- Fast Track and Orphan Drug Designations
- Expanded clinical pipeline through CS014
- Epigenetic HDAC platform with expansion potential
- Active partnering strategy
The most significant near-term value driver is the Phase IIb data for CS1, where the Company’s scientific hypothesis and strategic positioning will be evaluated at scale.
Quick Facts
- Company: Cereno Scientific
- Listing: Nasdaq First North Growth Market (CRNO B)
- Focus: Rare cardiovascular and pulmonary diseases
- Lead program: CS1 in global Phase IIb for PAH
- Pipeline: Epigenetic HDAC platform
- Strategy: Clinical value validation followed by partnering
Our Development Programs
CS1 – Pulmonary Arterial Hypertension (PAH)
A potential new oral treatment designed to act on the root causes of PAH with encouraging early data suggesting improvement in lung vessel structure and right heart function. CS1 has received Fast Track designation from the the FDA, highlighting its potential to address this serious condition.
CS014 – Pulmonary Hypertension – Interstitial Lung Disease (PH-ILD)
A next-generation therapy candidate being developed for PH-ILD, a progressive lung disease. CS014 has shown favorable safety and tolerability in a Phase I trial and could represent a new way to slow or alter the disease process.
CS585 – Novel Prostacyclin Receptor Agonist
In early research, CS585 has shown potential to prevent blood clots without increasing bleeding risk, which could be valuable in rare thrombotic disorders.
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