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 2026 (July 1 - September 30, 2026).
Financial Overview
Cereno Scientific Group
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -27 369 580 (-21 321 915)
- Earnings per share was SEK -0.08 (-0.07) before dilution and SEK -0.07 (-0.07) after dilution
- The equity/assets ratio was 47.6% (49.5%)
- Cash and bank balance was SEK 40 238 566 (74 179 974)
Parent company
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -27 372 762 (-21 323 425)
- Earnings per share was SEK -0.08 (-0.07) before dilution and SEK -0.07 (-0.07) after dilution
- The equity/assets ratio was 47.6% (49.5%)
- Cash and bank balance was SEK 32 663 140 (74 096 722)
Significant events during the third quarter
- On July 2, Cereno Scientific announced that all members of the Board of Directors and Executive Management had entered into lock-up agreements covering their shares and/or other securities in the Company until December 31, 2026. The agreements restrict the disposal of these holdings during the period, subject to certain exceptions.
- On July 7, Cereno Scientific announced that all dosing and participant visits had been completed in the FDA-aligned Phase I pharmacokinetic (PK) bridging study of its drug candidate CS014. The study subsequently progressed to data processing, database lock, and analysis, with topline results expected in Q3 2026. The study is designed to support a more direct and capital-efficient development path toward Phase IIb in pulmonary hypertension associated with interstitial lung disease (PH-ILD).
- On July 8, Cereno Scientific announced that members of Executive Management, including the CEO, CSO, CMO, and Head of R&D, as well as the Chair of the Board, had acquired a total of 292,061 Class B shares in the Company for an aggregate value exceeding SEK 1.5 million.
- On August 13, Cereno Scientific announced the activation of the first clinical site in the global Phase IIb EPIMODE trial evaluating its drug candidate CS1 in pulmonary arterial hypertension (PAH). The site was operationally cleared to begin patient screening and recruitment, marking a step toward first patient randomization and dosing. Preparations to activate additional specialist PAH centers continued.
- On September 25, Cereno Scientific reported positive topline results from the Phase I pharmacokinetic (PK) bridging study of its HDAC inhibitor CS014. The results met the Company's predefined expectations and strengthened its planned regulatory strategy to advance CS014 directly toward Phase IIb in PH-ILD without a separate Phase IIa trial or additional nonclinical safety studies, subject to FDA review of the complete IND package. The Company plans to submit an Investigational New Drug (IND) application to the FDA in Q4 2026, with initiation of the Phase IIb trial planned for Q3 2027, subject to regulatory approval.
- During September, Cereno Scientific participated in Nordic Life Science Days (NLSDays) on September 8-9 in Stockholm and the H.C. Wainwright 28th Annual Global Investment Conference on September 14-16 in New York City. The conferences provided opportunities to engage with potential pharmaceutical partners, US and international investors, and other industry stakeholders to discuss the Company's clinical progress, upcoming milestones, and the strategic potential of its pipeline.
Significant events after the period
- On October 8, Cereno Scientific provided an update on the global Phase IIb EPIMODE trial evaluating CS1 in PAH. The Company expects up to 15 clinical sites to be activated by the end of 2026 and more than 50 percent of the planned global sites to be activated by the end of Q1 2027. Based on the current site activation and patient recruitment plan, the Company continues to target completion of patient recruitment during 2027 and the reporting of topline results in Q4 2028.
- On October 16, the Company announced that Sten R. Sörensen, CEO, and Rahul Agrawal, CMO and Head of R&D, will participate in BIO-Europe 2026, taking place November 9-11, 2026, in Cologne, Germany. Participation forms part of the ongoing global business development activities, focused on building relationships with potential pharmaceutical partners and evaluating strategic collaborations. Rahul will also speak in a fireside chat "Learning from Failures and Successes in Clinical Trials" on Wednesday, November 11.
- On October 28, an Extraordinary General Meeting was held to re-elect the Board of Directors Moi Brajanovic, Gunnar Olsson, Anders Svensson, Sten R. Sörensen, and Jeppe Øvlesen, and to elect Johan Eriksson as a new director, for the period until the end of the next Annual General Meeting.
- On November 2, Cereno Scientific announced strong investigator engagement in the ongoing Phase IIb EPIMODE trial of CS1 in PAH and an upcoming Investigator Meeting in Boston on December 2, bringing together US investigators and study coordinators. The meeting will strengthen scientific and operational alignment across participating sites, supporting effective trial execution and patient recruitment.
- On November 3, Cereno Scientific announced its participation at the Global PH Summit, November 4-7 in Barcelona, organized by PHA Europe & Global. The Company has been invited to present Cereno Scientific and EPIMODE alongside other key stakeholders in the field. The participation strengthens Cereno's presence in the international PH patient community and supports patient engagement and the foundations for effective recruitment in EPIMODE.
Letter from the CEO
Advancing our pipeline with purpose
The third quarter of 2026 and developments following the period have marked important progress for Cereno Scientific's clinical pipeline. Positive topline results from the Phase I pharmacokinetic (PK) bridging study of CS014 strengthened the support for the intended direct path toward Phase IIb in PH-ILD and the IND-submission. EPIMODE, our global Phase IIb trial of CS1 in PAH, continues to advance with patient screening ongoing across a growing number of activated clinical sites. Meanwhile, CS585 progresses in preclinical development targeting rare thrombotic diseases. These advances reflect the growing maturity of our pipeline, and across three differentiated programs, our focus is on measurable clinical, regulatory and preclinical milestones.
CS1: Building recruitment readiness and investigator engagement across EPIMODE
We continue to advance EPIMODE, our global Phase IIb trial of CS1 in pulmonary arterial hypertension (PAH). While first patient randomization and dosing have taken longer than initially anticipated, our team and contract research organization (CRO) have made substantial progress across the wider trial, preparing specialist PAH centers in North America, Europe and South America for activation and patient recruitment.
An important part of this work is ensuring that sites are ready to begin recruiting patients as soon as they become operational. Alongside regulatory, contractual and operational start-up activities, we are working closely with investigators to identify potentially eligible patients in advance, where permitted. This allows sites to move promptly into formal screening and recruitment once all necessary approvals are in place.
We are encouraged by the strong interest and engagement we are seeing from investigators and study teams as EPIMODE advances. On December 2, we will bring together US investigators and study coordinators for an Investigator Meeting in Boston, with similar meetings planned in other regions in 2027. These meetings will strengthen alignment across our expanding site network and build on the positive engagement we see as an important foundation for successful collaboration and patient recruitment.
Importantly, the extended start-up phase does not mean that we anticipate an equally extended recruitment period. Rather than a gradual build-up of enrollment as individual sites are activated over time, we now expect a larger number of centers to become operational within a more concentrated period. With preparations already progressing across the network, multiple sites should be able to screen and recruit patients in parallel, supporting a shorter, more intensive recruitment phase than originally envisaged.
First patient randomization and dosing remain an immediate priority. However, the progress made across the wider network gives us confidence in our current recruitment plan. Based on the planned site activations and recruitment activities, we continue to target completion of patient recruitment during 2027 and topline results in Q4 2028, subject to recruitment progress.
PAH remains a serious, progressive disease despite available treatments. The encouraging safety, tolerability and efficacy signals observed in CS1's completed Phase IIa trial, alongside supportive findings from the 12-month Expanded Access Program (EAP), provide the rationale for further clinical evaluation. EPIMODE will assess CS1's potential to address underlying disease mechanisms, including pathological vascular remodeling, with the aim to translate into meaningful clinical benefit in a larger, randomized and placebo-controlled trial.
CS014: Positive results strengthen the path toward Phase IIb
An important achievement during the quarter was the positive topline readout from the FDA-aligned Phase I PK bridging study of CS014. The results met our predefined expectations, addressing an important development question and providing further support for our proposed direct progression to Phase IIb in pulmonary hypertension associated with interstitial lung disease (PH-ILD). This pathway could eliminate the need for a separate Phase IIa trial and additional nonclinical safety studies, potentially reducing development time, cost and complexity.
PH-ILD combines interstitial lung disease with elevated pressure in the lungs' blood vessels, resulting in a serious, progressive condition with limited treatment options. There is currently only one approved drug substance specifically for PH-ILD in the US, while no treatments are approved specifically for this indication in Europe. CS014 is designed to influence underlying disease processes, including lung fibrosis and abnormal vascular remodeling, offering a potentially differentiated approach to this significant unmet medical need.
Our next milestone in the program is the planned submission of an Investigational New Drug (IND) application to the FDA in Q4 2026. It will combine the PK bridging results with existing clinical, nonclinical and chemistry, manufacturing and controls (CMC) documentation. Manufacturing preparations are progressing in parallel to support clinical trial supply. We continue to target initiation of the Phase IIb trial in Q3 2027, subject to regulatory approval and completion of the required preparations.
CS585: Advancing a differentiated preclinical approach to thrombosis
CS585 continues to progress in preclinical development through our longstanding research collaboration with the University of Michigan, with an initial focus on antiphospholipid syndrome (APS), a rare autoimmune disease associated with recurrent thrombosis and significant unmet medical need.
Our selective prostacyclin (IP) receptor agonist has demonstrated promising antithrombotic effects without an observed increase in bleeding risk in preclinical studies. This differentiated profile offers a potentially novel treatment approach in an area where balancing antithrombotic efficacy with bleeding risk remains a significant challenge.
Ongoing studies in APS disease models aim to further evaluate CS585's therapeutic potential and guide the next stages of development. We also plan to progress IND-enabling activities as we work toward future first-in-human clinical evaluation.
With its distinct mechanism of action and encouraging preclinical profile, CS585 represents an additional potential value driver within Cereno's pipeline, complementing our two clinical-stage HDAC inhibitor programs.
Strengthening international engagement and our presence in the PAH community
As our clinical programs advance and mature, we are deepening dialogue with specialist investors, institutions, family offices and potential pharmaceutical partners across the US, Europa and Asia. In September, we met with around 60 investors in Paris and Monaco, building on earlier meetings in Zurich and Geneva.
Our scientific presence has also expanded through participation in the European Society of Cardiology (ESC) Congress and the European Respiratory Society (ERS) Congress, where we connected with leading experts, clinicians and investigators, including those involved in EPIMODE. Nordic Life Science Days in Stockholm and the H.C. Wainwright Global Investment Conference in New York offered further opportunities for discussions with potential partners, international investors and analysts.
An increasingly important dimension of our engagement is building meaningful relationships within the PAH patient community. Following the collaboration we established earlier this year with PHA Europe & Global, we are taking another important step by participating in the organization's annual pulmonary hypertension conference this November. We have been invited to present Cereno Scientific and our EPIMODE trial alongside other established companies and key stakeholders active in the field.
For Cereno, this represents an important opportunity to establish a stronger presence and build long-term relationships within the patient community. People living with PAH continue to face substantial unmet medical needs, and their experiences and perspectives are essential to understanding what meaningful treatment advances should deliver. Engaging directly with patient representatives allows us to increase awareness of our research, listen to their needs and strengthen understanding of the potential role of clinical trials in advancing new treatment options.
We also see this engagement as an important foundation for recruitment excellence in EPIMODE. By building trust, increasing understanding of the study and incorporating patient perspectives into how we communicate about clinical research, we aim to support informed patient engagement and effective recruitment through our participating clinical centers. Together with the strong commitment we see from investigators, these relationships contribute to a more patient-centered approach to trial execution.
Our expanding network of relationships across the scientific, clinical, patient, investor and pharmaceutical communities supports our clinical programs, trial execution, future partnering activities and a broader international shareholder base.
We also recently welcomed Johan Eriksson to our Board of Directors. Johan brings extensive experience in executive leadership, business development and strategic transactions, as well as a strong commitment to Cereno as a long-term shareholder. His expertise will be a valuable addition as we advance our clinical and strategic priorities, and we look forward to working with him.
An active schedule lies ahead, including partnering discussions at BIO-Europe in Cologne in November, further international investor and scientific meetings, and planned patient community and investigator engagement in support of the EPIMODE trial execution and recruitment.
Priorities for the remainder of 2026
As we enter the final quarter of 2026, our priorities are clear: randomize and dose the first patient in EPIMODE and expand recruitment capability by activating up to 15 sites, prepare CS014's IND submission and progressing CS585 toward clinical development in APS. Beyond year-end, we are preparing for CS014 to enter Phase IIb in Q3 2027 and expanding the active EPIMODE trial sites globally to achieve recruitment completion during 2027. Each program has a distinct path forward, and these measurable milestones will show our progress.
Securing the additional capital required to execute our development plans at the intended pace also remains a priority. We continue to evaluate financing and strategic partnership against concrete needs to serve our programs and the long-term interests of our shareholders.
I am proud of what our team has accomplished and grateful to our investigators, clinical partners, collaborators and shareholders for their continued commitment and support.
We remain dedicated on generating the clinical evidence needed to turn our drug candidates into treatments that have the potential to enhance and extend life for people living with rare cardiovascular and pulmonary diseases.
November 2026
Sten R. Sörensen
CEO
Upcoming financial reports
Year-end Report (Q4) 2026 17 February 2027
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 underlying mechanisms of 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, functional class, risk score and patient quality of life, with early signs consistent with reverse vascular remodeling. An Expanded Access Program confirmed CS1 to be well-tolerated with a favorable safety profile over 12 months of treatment and showed that a majority of patients completing treatment maintained or improved clinical status. CS1 is currently being evaluated in EPIMODE, a global, placebo-controlled Phase IIb trial in PAH. 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 a favorable safety and tolerability profile in Phase I, and is being advanced through a streamlined, FDA-aligned pathway toward Phase IIb in pulmonary hypertension associated with interstitial lung disease (PH-ILD). Cereno Scientific is also advancing the preclinical program CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist shown to prevent thrombosis without increased bleeding risk, currently being evaluated in antiphospholipid syndrome (APS).
The Company is headquartered in GoCo Health Innovation City in Gothenburg, Sweden, and has a US subsidiary, Cereno Scientific Inc., located in Kendall Square, Boston. 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.
