Cereno Scientific broadens development focus for CS014 to pulmonary hypertension associated with interstitial lung disease

Rhea-AI Summary

Cereno Scientific (NASDAQ First North: B) is broadening the development focus of its orally administered HDAC inhibitor CS014 to pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company completed a Phase I study and plans a Phase II program aimed to start in Q1 2027. The shift intends to target a patient population with high unmet need and align CS014 with combined fibrotic and pulmonary vascular pathology to strengthen clinical and strategic positioning.

Positive

• Completed Phase I study for CS014
• Phase II planned to initiate in Q1 2027
• Broadened focus to PH-ILD targets a severe unmet-need population
• CS014 targets shared mechanisms (vascular remodeling, fibrosis, thrombosis, inflammation)

Negative

• No Phase II efficacy data yet; clinical proof in PH-ILD remains unreported
• Phase II not expected to start until Q1 2027, extending timeline to potential pivotal data

Key Figures

Phase I status: Phase I study completed Phase II timing: Phase II planned Q1 2027

2 metrics

Phase I status Phase I study completed CS014 safety and tolerability completed before Phase II planning

Phase II timing Phase II planned Q1 2027 Planned start for PH-ILD-focused Phase II study of CS014

Market Reality Check

Price: $47.53 Vol: Volume 23,761,859 vs 20-d...

normal vol

$47.53 Last Close

Volume Volume 23,761,859 vs 20-day avg 17,411,654 (relative volume 1.36) shows elevated interest ahead of this update. normal

Technical Price 47.53 is trading above 200-day MA at 32.5, reflecting a pre-existing upward trend.

Peers on Argus

While the stock is up 2.37%, key peers like WPM, FNV, AEM and KGC show same-day ...

While the stock is up 2.37%, key peers like WPM, FNV, AEM and KGC show same-day declines between about -0.75% and -2.83%, indicating this move is stock-specific rather than a gold-sector rotation.

Historical Context

5 past events · Latest: Jan 21 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 21	Operating structure change	Positive	+0.3%	Global operating structure consolidated into U.S. and International divisions.
Jan 14	Clinical publication	Positive	+0.5%	Peer-reviewed CS014 data with antithrombotic efficacy and Phase I safety.
Jan 13	Leadership changes	Positive	+1.4%	New president and leadership team to support growth and execution.
Jan 07	Earnings date notice	Neutral	-1.0%	Announcement of date and time for FY and Q4 2025 results release.
Jan 07	Strategic partnership	Positive	-1.0%	Collaboration with Microsoft to advance humanoid robotics applications.

Pattern Detected

Recent news events generally show modest positive alignment between operational or clinical updates and next-day price moves, with one notable divergence on a major partnership announcement.

Recent Company History

Over the past months, news tied to the broader corporate group has spanned operating restructurings, leadership changes, strategic partnerships, and CS014 clinical progress. A peer-reviewed CS014 publication with Phase I safety data was followed by a small positive reaction of 0.48%, while leadership and structural updates also saw mild gains. An earnings date notice and a robotics partnership both coincided with -0.98% moves. Against this backdrop, the new focus on PH-ILD fits an ongoing narrative of incremental strategic and development updates driving measured price responses.

Market Pulse Summary

This announcement broadens CS014’s development focus to PH-ILD, aiming for a more clinically relevan...

Analysis

This announcement broadens CS014’s development focus to PH-ILD, aiming for a more clinically relevant Phase II program and targeting a population with high unmet need. With a completed Phase I study and a Phase II trial planned for Q1 2027, it extends the existing CS014 trajectory highlighted in earlier clinical communications. Investors may track upcoming protocol details, regulatory interactions, and how this focus integrates with prior IPF plans to assess whether the strategy meaningfully enhances CS014’s long-term development potential.

Key Terms

pulmonary hypertension, interstitial lung disease, idiopathic pulmonary fibrosis, hdac inhibitor, +2 more

6 terms

pulmonary hypertension medical

"broadening the development focus of its HDAC inhibitor CS014 to pulmonary hypertension"

Pulmonary hypertension is a condition where the blood vessels in the lungs become narrowed or stiff, forcing the right side of the heart to work much harder to push blood through—imagine a pump trying to push water through narrower pipes. For investors, it matters because the condition drives demand for diagnostic tests, ongoing treatments, and new drugs; changes in clinical trial results, approvals, or treatment guidelines can meaningfully affect the commercial prospects and costs for companies focused on this disease.

interstitial lung disease medical

"pulmonary hypertension associated with interstitial lung disease (PH-ILD)"

A group of lung conditions that cause inflammation and scarring of the thin tissue between the air sacs, which makes it harder for oxygen to pass into the blood; imagine the lungs’ fine filters becoming stiff and less effective. Investors care because reports of interstitial lung disease can affect a drug’s safety profile, trigger regulatory warnings or label changes, and shift demand for treatments or create liability risks that influence a company’s valuation.

idiopathic pulmonary fibrosis medical

"CS014 has been developed with idiopathic pulmonary fibrosis (IPF) as the intended initial indication."

Idiopathic pulmonary fibrosis is a chronic lung disease in which the air‑carrying tissue becomes progressively thickened and scarred for no identifiable reason, making the lungs stiff and less able to move oxygen—similar to a sponge that hardens and loses its pores. It matters to investors because it is life‑limiting with limited effective treatments, so clinical trial outcomes, regulatory approvals, pricing and reimbursement decisions can strongly affect the commercial value of therapies and the financial prospects of companies developing treatments.

hdac inhibitor medical

"broadening the development focus of its HDAC inhibitor CS014 to pulmonary hypertension"

A HDAC inhibitor is a drug that blocks enzymes (histone deacetylases) which act like dimmer switches on genes, changing how tightly DNA is packaged and thereby turning certain genes up or down. For investors, these drugs matter because they can alter disease pathways—particularly in cancer and some neurological conditions—so clinical trial results, safety profiles, and regulatory decisions directly affect a company’s drug value and market potential.

phase ii medical

"support a more clinically relevant Phase II program, strengthen the development potential"

Phase II is the mid-stage clinical trial where a potential drug or medical treatment is tested in a larger group of patients to see if it works and to help determine the best dose and common side effects. For investors, Phase II results matter because they give the first meaningful evidence about effectiveness and safety—like a road test that shows whether a product has real promise before a much bigger, costly final trial and potential regulatory approval.

phase i medical

"With a completed Phase I study and a broadened development focus on PH-ILD"

A Phase I clinical trial is the first stage of testing a new drug or treatment in humans, focused mainly on safety and finding an appropriate dose by studying a small group of volunteers or patients. Investors watch Phase I results because they reveal early signs of safety, tolerability and how the body handles the treatment—information that helps gauge development risk and the likelihood and timing of later, larger trials that drive a drug’s value, much like a test drive reveals whether a prototype is worth further investment.

AI-generated analysis. Not financial advice.

GOTHENBURG, Sweden, Feb. 4, 2026 /PRNewswire/ -- 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.

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/cereno-scientific/r/cereno-scientific-broadens-development-focus-for-cs014-to-pulmonary-hypertension-associated-with-int,c4302330

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Press release

View original content:https://www.prnewswire.com/news-releases/cereno-scientific-broadens-development-focus-for-cs014-to-pulmonary-hypertension-associated-with-interstitial-lung-disease-302678755.html

SOURCE Cereno Scientific

FAQ

What change did Cereno Scientific (B) announce about CS014 on February 4, 2026?

Cereno Scientific announced a broadened development focus for CS014 to PH-ILD, expanding beyond IPF to include pulmonary hypertension associated with ILD. According to the company, this aims to strengthen clinical relevance and target patients with higher unmet medical need.

When does Cereno Scientific plan to start the Phase II study for CS014 (B)?

Cereno Scientific plans to initiate a Phase II study for CS014 in Q1 2027. According to the company, preparations are ongoing to design a study reflecting combined fibrotic and vascular disease biology in PH-ILD patients.

What is the scientific rationale for testing CS014 in PH-ILD for ticker B?

CS014 targets vascular remodeling, fibrosis, thrombosis and inflammation shared across fibrotic lung and pulmonary vascular disease. According to the company, this shared pathology supports evaluating CS014 in PH-ILD where both processes drive worse outcomes.

Does Cereno Scientific (B) have prior clinical data for CS014 before the Phase II plan?

Yes. Cereno Scientific completed a Phase I study for CS014, establishing early clinical development progress. According to the company, the Phase I is complete but no Phase II efficacy readouts have been reported yet.

How could the CS014 focus on PH-ILD affect patients and development strategy for Cereno Scientific (B)?

The focus aims to address a severe patient group with limited options and may strengthen CS014's positioning in development. According to the company, it expects a more clinically relevant Phase II and potential for faster, lower-cost development.