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 Interim Report for Q3 2025 (July 1 - September 30, 2025).
Financial overview
Cereno Scientific Group - Q3
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -21 321 915 (-22 718 087)
- Earnings per share was SEK -0.07 (-0.08) before dilution and SEK -0.07 (-0.07) after dilution
- The equity/assets ratio was 49.5% (66.8%)
- Cash and bank balance was SEK 74 179 974 (73 841 665)
Parent company - Q3
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -22 323 425 (-22 718 087)
- Earnings per share was SEK -0.07 (-0.08) before dilution and SEK -0.07 (-0.07) after dilution
- The equity/assets ratio was 49.5% (66.8%)
- Cash and bank balance was SEK 74 096 722 (73 791 605)
Significant events during the third quarter
- On July 1, Cereno Scientific was added to Nasdaq's First?North?25 Index, reflecting its status as one of the most traded securities on the First?North Growth Market.
- On July 4, Cereno Scientific selected a top-tier global CRO to conduct the upcoming Phase IIb trial of CS1 in the rare disease pulmonary arterial hypertension.
- On July 15, Cereno Scientific announced positive topline results from the Phase I trial of CS014, in which the primary endpoint was met. CS014 was well tolerated with favorable safety and exposure profiles in healthy volunteers, providing data that support advancement into Phase II development.
- In August, a conversion of convertibles amounting to SEK 25 million was requested by Fenja Capital II A/S and Arena Investors, LP.
- On September 15, Cereno Scientific Announces Conversion of All Remaining Convertibles Following Request by Fenja Capital II A/S and Arena Investors, LP
- On September 3, CEO Sten R. Sörensen was announced a finalist for 'CEO of the Year' at the European Lifestars Awards 2025. The Awards celebrate the achievements from remarkable breakthroughs to transformational investments and deals of the exceptional individuals, teams, and organizations that have shaped the life science industry over the past 12 months. The 'CEO of the Year' category recognizes leaders who have demonstrated outstanding career achievements, created shareholder value, forged impactful partnerships, and influenced the wider life science industry.
- Cereno Scientific participates at several key partnering and investor conferences during the period: GoCo Investor Day on September 9 and Nordic Life Science Days 2025 on October 8-9. and Recordings of the presentations are available on our website, https://cerenoscientific.com/events-presentations/.
Significant events after the period
- Cereno Scientific participated at BIO-Europe Fall 2025 in Vienna on November 3-5, which is one of the main global biopharma partnering events of the year.
- 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 10, the submission of the clinical trial protocol for the planned global Phase IIb trial of lead drug candidate CS1 was sent to the U.S. Food and Drug Administration (FDA). The submission marks an important milestone, moving the company closer to advancing CS1 into its next clinical phase and toward bringing a novel therapeutic approach to patients living with pulmonary arterial hypertension (PAH). Cereno Scientific anticipates clearance to proceed with the trial following the FDA's standard 30-day review.
Letter from the CEO
Advancing toward the next phase
The third quarter of 2025 has been a very productive and defining period for Cereno Scientific. As we move through the final weeks of the year, we continue to build strong momentum across our clinical pipeline and strengthen our foundation for the next phase of growth. Our focus remains on advancing our pioneering HDAC inhibitor portfolio, increasing recognition of our scientific platform, and pursuing the next major milestones that will propel our growth journey.
CS1: Advancing toward Phase IIb with FDA alignment
Following the positive regulatory interactions earlier this year, we reached a major milestone in November with the submission of the clinical trial protocol for our planned global Phase IIb trial of CS1 to the U.S. Food and Drug Administration (FDA). This submission moves us closer to initiating the clinical Phase IIb trial in H1 2026, and we anticipate FDA's greenlight within the next few weeks. The protocol has been developed in alignment with the FDA's guidance from our Type C meeting, ensuring that the study design meets regulatory expectations and is positioned to support late-stage development.
The upcoming trial will build on the encouraging results from our successful Phase IIa study, which demonstrated that CS1 has a favorable safety and tolerability profile and showed promising efficacy signals, including improvements in right heart function and patient quality of life. We will further evaluate the safety, tolerability and efficacy of different doses of CS1, including the potential to reverse vascular remodeling, improve right heart function and patient quality of life. These findings, together with preclinical data indicating the potential to reverse pathological vascular remodeling, form a strong foundation for further evaluation in the Phase IIb study.
With FDA Fast Track designation in place and strong regulatory alignment, we are progressing with confidence as we work to advance CS1 as a novel, disease-modifying therapy for patients living with pulmonary arterial hypertension (PAH).
CS014: Positive Phase I data supports advancement to Phase II
In mid-July, we announced positive topline results from our first-in-human Phase I study of CS014. The trial met its primary endpoint, demonstrating a favorable safety and tolerability profile in healthy volunteers. Importantly, we saw that CS014 achieved blood concentrations expected, based on non-clinical data, to impact disease-driving fibrosis and vascular remodeling. Together with its strong preclinical data, these results form a solid foundation for advancing CS014 into Phase II development.
CS014 represents our second HDAC inhibitor program and holds potential not only in idiopathic pulmonary fibrosis (IPF), our initial target indication, but also in other fibrotic and vascular diseases where few effective treatment options exist. Building on the Phase I results, we see a broadening of CS014's clinical potential and are refining our development strategy to best leverage its therapeutic promise. This may include opportunities to expand our impact across rare disease with significant unmet needs.
The successful completion of this Phase I study marks another significant milestone for Cereno's HDACi platform and further strengthens our position at the forefront of innovation in cardiovascular and pulmonary medicine.
Strengthening the scientific platform for HDAC inhibition
Recent months have also seen a notable increase in scientific publications highlighting the potential of HDAC inhibition in cardiovascular and pulmonary disease. This growing body of external research combined with our own research emphasizes the importance of addressing disease-driving mechanisms such as fibrosis, inflammation and vascular remodeling, which aligns closely with our own development strategy. As the first clinical-stage company advancing HDAC inhibitors specifically for cardiovascular and pulmonary diseases, Cereno Scientific is well positioned within this rapidly evolving scientific landscape.
CS585: Continuing preclinical progress
Our third program, CS585, a selective prostacyclin (IP) receptor agonist, continues to progress in preclinical development through our collaboration with the University of Michigan. Data generated to date support its potential as a differentiated treatment approach for rare thrombotic diseases by preventing thrombosis without increasing bleeding risk, which is a key unmet need in cardiovascular medicine.
Expanding our scientific footprint
Our scientific visibility continues to grow, supported by several important activities across the global research community. After the end of the period, the first manuscript describing the structure and supportive non-clinical data for CS014 was accepted in the respected Journal of Thrombosis & Haemostasis. This peer-reviewed publication provides external validation of our scientific approach and strengthens the foundation for the continued development of our second HDAC inhibitor program.
Our CSO, Björn Dahlöf, will represent Cereno Scientific at the annual, invitation-only CVCT Forum in Washington, D.C., and participate in two panel discussion. This key event brings together leading experts from industry, academia and regulatory agencies to discuss advances in cardiovascular clinical trial design.
The team is also preparing for several upcoming scientific conferences. In mid-December, we will present the CS014 Phase I data to a scientific audience for the first time at Pharmacology 2025, hosted by the British Pharmacological Society. Further results will also be shared at the Pulmonary Vascular Research Institute (PVRI) annual congress in early 2026, providing important opportunities to engage with global leaders in pulmonary vascular disease.
Strengthening Cereno's position, visibility and growth
Cereno Scientific's visibility and reputation as a pioneering biotech company continued to grow during the quarter. In this context, I was honored to be named a finalist for "CEO of the Year" at the European Lifestars Awards 2025. This recognition reflects the importance of committed leadership in navigating the complexities of drug development, building strong relationships across the industry, and keeping a clear long-term vision centered on patient need.
Throughout the autumn, we have maintained a high level of activity across the investor and partnering landscape. This included participation at Nordic Life Science Days in Gothenburg and GoCo Investor Day during the quarter, followed by BIO-Europe Fall in Vienna and London Life Sciences Week 2025 after the period.* At BIO-Europe, our CMO and Head of R&D, Rahul Agrawal, was invited to speak on an engaging panel hosted by IQVIA Institute for Human Data Science focused on access to the US market for European biotechs. These engagements are important for broadening our network, supporting ongoing dialogue with investors and potential partners, and sharing updates on our clinical and corporate progress.
During the quarter, all remaining convertibles held by Fenja Capital II A/S and Arena Investors LP were converted into shares, completing the conversion of SEK 75 million convertible loan held by the debt providers. After the end of the period, Arena Investors also exercised 600,000 warrants, providing SEK 4 million in proceeds.
Looking ahead
As we approach year-end, our focus is on maintaining operational drive and pipeline momentum. With two HDAC inhibitor programs advancing and a promising preclinical candidate in CS585, we are well positioned for continued progress in 2026.
Every milestone, from clinical advancement to scientific recognition and growing industry visibility, brings us closer to our mission of developing pioneering treatments that enhance and extend life for patients living with rare cardiovascular and pulmonary diseases.
The growing awareness of Cereno's pioneering efforts during 2025 is also a testament to the dedication of our team, the value of our partnerships, and the trust of our shareholders.
Thank you for your continued support as we take the next steps toward this new stage for Cereno Scientific.
November 2025
Sten R. Sörensen, CEO
Financial calendar
Year-end Report, Q4 2025……...............................February 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 of reverse vascular remodeling and improvement of right heart function as observed in a Phase IIa trial in patients with PAH. 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 and Pulmonary Hypertension.
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.