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 the Board of Directors and Chief Executive Officer of Cereno Scientific AB here presents the Year-end Report for 2025 (January 1 - December 31, 2025).
Financial overview
Cereno Scientific Group
Full year 2025
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -117 754 773 (-99 525 680)
- Earnings per share was SEK -0.38 (-0.35) before dilution and SEK -0.33 (-0.32) after dilution
- The equity/assets ratio was 62.7% (46.4%)
- Cash and bank balance was SEK 74 639 333 (127 557 645)
Fourth quarter 2025
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -44 709 850 (-40 262 214)
- Earnings per share was SEK -0.14 (-0.14) before dilution and SEK -0.12 (-0.13) after dilution
- The equity/assets ratio was 62.7% (46.4%)
- Cash and bank balance was SEK 74 593 709 (127 466 516)
Parent company
Full year 2025
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -117 676 391 (-99 442 612)
- Earnings per share was SEK -0.38 (-0.35) before dilution and SEK -0.33 (-0.32) after dilution
- The equity/assets ratio was 62.7% (46.4%)
- Cash and bank balance was SEK 74 593 709 (127 466 516)
Fourth quarter 2025
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -44 713 046 (-40 262 214)
- Earnings per share was SEK -0.14 (-0.14) before dilution and SEK -0.12 (-0.13) after dilution
- The equity/assets ratio was 62.7% (46.4%)
- Cash and bank balance was SEK 74 593 709 (127 466 516)
Significant events during the fourth quarter
- On November 11, Cereno Scientific receives SEK 4 million through exercise of 600,000 warrants by Arena Investors, LP. This was in connection with the financing agreement being entered into on November 11, 2024.
- On November 17, the company's CEO Sten R. Sörensen was recognized for being shortlisted at the 'CEO of the Year' award at the European Lifestars Awards 2026 held in London, UK.
- On November 28, it was announced that the company secured loan financing of up to SEK 350 million, and a directed issue of new Class B shares of SEK 100 million and warrants that can provide up to an additional SEK 100 million upon exercise, before issue costs. This includes convertible loans of SEK 175 million and a loan facility of SEK 175 million, with Fenja Capital II A/S and a company associated company to Fenja as lenders. This amounts to a total of approximately SEK 665 million upon full exercise of warrants and convertibles and extends the financial runway to Q4 2027. A new advisory relationship has been established with the investment bank Stifel. Major shareholders and new investors back the company's long-term strategy with equity investment at a premium through the directed share issue.
- On December 8, the FDA granted clearance to initiate the Phase IIb trial of lead drug candidate CS1 for the treatment PAH. The FDA's decision enables Cereno to advance toward first patient in (FPI) in Q2 2026, with top-line data anticipated around Q4 2028, subject to enrollment timelines. The clearance follows constructive regulatory interactions and builds on the favorable safety, tolerability and encouraging disease-modifying signals observed in the Phase IIa study. CS1 has also been granted Orphan Drug Designation and Fast Track designation in the US.
- On December 18, announced that all shareholding members of its board of directors and management have signed lock-up agreements for their shares and/or other securities in the company until and including June 30, 2026.
- Cereno Scientific participated at several key partnering and investor conferences during the period: Nordic Life Science Days 2025 on October 8-9, BIO-Europe Fall 2025 in Vienna on November 3-5, London Life Sciences Week 2025 on November 17-21. Any recordings of presentations are available on our website, https://cerenoscientific.com/events-presentations/.
- The company presented new data of CS014 at the scientific conference Pharmacology 2025 organized by the British Pharmacology Society on December 16-18 in Belfast, Northern Ireland. Visit our webpage for the presented data, https://cerenoscientific.com/pipeline/scientific-publications/.
Significant events after the period
- Cereno Scientific participated at JPM Healthcare Week 2026 in San Francisco on January 12-15, one of the most influential annual gatherings for the global life science and healthcare industry.
- On January 8, Cereno Scientific receives approximately SEK 5 million through exercise of 728,957 warrants by Arena Investors, LP. This was in connection with the financing agreement being entered into on November 11, 2024.
- The company presented data of CS014 and participated in panel at the scientific conference PVRI 2026 Dublin organized by the The Pulmonary Vascular Research Institute (PVRI) on January 28 - February 1, 2026, in Dublin, Ireland. Visit our webpage for the presented data, https://cerenoscientific.com/pipeline/scientific-publications/.
- On January 14, the company shared the publication of the first peer-reviewed manuscript describing CS014 in the Journal of Thrombosis and Haemostasis. This publication validates the underlying HDAC inhibition mechanism critical to CS014's therapeutic potential in cardiovascular and pulmonary diseases where thrombosis, vascular remodeling, and fibrosis play interconnected pathological roles. Visit our webpage for access to the manuscript, https://cerenoscientific.com/pipeline/scientific-publications/.
- On February 3, an update was communicated regarding the Expanded Access Program for CS1 in PAH since the last patient's last visit concluded the 12-month active study period. Initial learnings from the EAP are expected to be available in the first quarter of 2026 and further analyses are planned during second quarter of 2026, contributing to the ongoing CS1 development program and its overall value proposition.
- On February 4, the company announced that the Phase II development focus of HDAC inhibitor CS014 will be pulmonary hypertension associated with interstitial lung disease (PH-ILD). The sharpened 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.
Letter from the CEO
Entering global development phase
2025 marked a pivotal year for Cereno Scientific. We moved from encouraging Phase IIa data with CS1 to establishing a regulatorily aligned and operationally ready global Phase IIb program. At the same time, our second HDACi asset, CS014, delivered positive Phase I results and is progressing toward Phase II, reinforcing the depth and scalability of our HDAC inhibitor platform. As we enter 2026, our priority is clear: initiate the global Phase IIb trial with CS1, maintain close regulatory interaction and execute the trial with operational excellence.
CS1 - ready for global Phase IIb
During the year, the development of CS1 for pulmonary arterial hypertension (PAH) has reached central milestones. Following positive Phase IIa data and a successful Type C meeting with the FDA, we received the Agency's endorsement for the planned Phase IIb study and partnered with a leading global CRO to support its execution. In August, CS1 was granted FDA Fast Track designation, enabling closer regulatory interaction and the potential to accelerate development timelines. In the fourth quarter, we obtained regulatory clearance from the FDA allowing us to initiate the Phase IIb trial.
Overall, this means that the regulatory and operative risk ahead of the Phase IIb trial has been significantly reduced. The trial is designed on the back of positive Phase IIa data, to further evaluate safety, tolerability and efficacy, including the potential to impact underlying disease mechanisms, as well as determining optimal dose for Phase III. It is the first PAH Phase IIb trial with a design that includes a longer exploratory phase to evaluate signs of disease modification. The trial is planned to start during the second quarter of 2026.
Expanded Access Program - operational milestone and upcoming insights
The Expanded Access Program (EAP) for CS1, which allowed eligible patients who completed the Phase IIa trial to continue treatment under a formal protocol, reached an important operational milestone when the final patient completed their last visit in the 12-month active treatment period.
Initial learnings from the EAP are expected to be available in the first quarter of 2026, with further analyses planned during the second quarter of 2026. These insights are intended to complement the Phase IIa data with longer-term information on safety, tolerability and exploratory imaging sub-studies, which will contribute to the overall understanding of CS1's potential and its value proposition.
CS014 - next-generation HDAC inhibitor with sharpened development focus
During the year, positive topline data from the Phase I trial of CS014 was reported. The trial demonstrated a favorable safety and tolerability profile at achieved exposure levels predicted to impact disease-driving processes such as fibrosis and vascular remodeling. The Phase I results, together with previous non-clinical studies, support CS014 as a promising candidate for the treatment of cardiovascular and pulmonary diseases where vascular remodeling, fibrosis, and thrombosis play key roles.
CS014 received external scientific validation through the publication of its first peer-reviewed manuscript in the Journal of Thrombosis and Haemostasis (JTH), which is a key foundational element for scientific credibility as the asset advances in development. Presentations of data at international scientific conferences, including Pharmacology 2025, and most recently at PVRI 2026 in January, has further contributed to increased awareness and visibility of our pioneering epigenetic approach within the scientific community.
At the beginning of 2026, we announced that CS014 will be developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD) - a severe condition with high unmet need. This focus is intended to enhance the clinical relevance of the upcoming Phase II study and accelerate the pathway to relevant outcomes by targeting a patient population characterized by both fibrotic lung disease and pulmonary vascular involvement. A Phase II trial is planned to start early 2027.
CS014 represents the next generation within our epigenetic HDAC inhibitor platform. The platform addresses the central biological processes including fibrosis, inflammation, vascular remodeling and thrombosis - which are fundamental drivers across a broad range of cardiopulmonary diseases.
The clinical progress with CS014 not only advances the program but also reinforces the long-term potential of our HDAC inhibitor platform.
Scientific & Strategic positioning - ahead of the curve
In 2025, we strengthened our scientific and strategic profile through participation in international partnering and investor events, scientific presentations and peer-reviewed publications. Our Capital Markets Day in Stockholm, held on February 5, brought together clinical experts, a patient representative and investors and articulated the company's long-term direction: to lead a paradigm shift in PAH from symptomatic treatment to disease modification.
In a market where several major pharmaceutical companies are facing extensive patent expirations, demand is increasing for differentiated clinical-stage projects, particularly in orphan drug areas with regulatory support. Projects that combine clinical maturity, biological differentiation, and commercial rationale are often prioritized in partnering discussions. It is in this context that we position CS1, CS014 and our epigenetic HDACi platform.
Financial position & Capital structure
During the year, the remaining convertible loans of SEK 75 million from a financing agreement in November 2024 were converted into shares, further strengthening the balance sheet.
In November 2025, the company secured a financing package of approximately SEK 665 million upon full exercise of warrants and convertibles providing financial runway to Q4 2027. The financing comprised a directed share issue of SEK 100 million, completed at a premium to the market price, and a loan financing facility of up to SEK 350 million. Major shareholders and new investors participated in the transaction, demonstrating confidence in the Company's long-term strategy.
The company's financial position supports the execution of planned near-term development activities, including the global Phase IIb program for CS1 and continued advancement of CS014. As Cereno Scientific progresses into the next stage of clinical development, the company continuously evaluates its capital strategy to support ongoing operations and upcoming value-inflection milestones.
Looking forward - catalysts & market context
As we enter 2026, our priorities are clear:
- Initiate the global Phase IIb study with CS1
- Share initial learnings from the CS1 EAP in Q1-Q2 2026
- Drive forward the CS014 Phase II development in PH-ILD
- Continue to engage in business development (BD) activities toward partnering and deals to support our growth
The initiation of the Phase IIb program represents the most important operational milestone in the company's history to date and a pivotal step in the clinical development of our disease-modifying lead asset at scale.
Beyond clinical development, we believe the market environment remains favorable for differentiated rare disease projects. Capital allocation in the sector is increasingly directed toward programs with clear scientific differentiation, regulatory advantages and meaningful patient impact. This dynamic, combined with broader industry patent expirations and strategic portfolio needs, supports our positioning and ongoing partnering discussions.
As this report is published, Rare Disease Day on February 28 approaches. It is a reminder of why we pursue our work: for patients living with rare and serious diseases where disruptive therapies are needed with significant impact on disease progression, quality of life and prognosis.
I extend my sincere thanks to our shareholders, partners and patients for their continued trust and support. We enter 2026 with determination, strategic focus and confidence in the path ahead.
February 2026
Sten R. Sörensen, CEO
Financial calendar
Annual Report 2025……........……………………….May 11-15, 2026
Interim Report Q1 2026……....................................May 27, 2026
For further information, please contact:
Tove Bergenholt, Head of IR & Communications
Email: tove.bergenholt@cerenoscientific.com
Phone: +46 73- 236 62 46
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 is a new chemical entity and HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of a range of cardiovascular and pulmonary diseases with high unmet needs. CS014 showed favorable safety and tolerability profile in Phase I, development focus for Phase II is pulmonary hypertension associated with interstitial lung disease (PH-ILD). 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.
