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 Q1 2026 (January 1 - March 31, 2026).
Financial Overview
Cereno Scientific Group
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -28,601,713 (-25,009,234)
- Earnings per share was SEK -0.09 (-0.09) before dilution and SEK -0.08 (-0.08) after dilution
- The equity/assets ratio was 52.3% (44.2%)
- Cash and bank balance was SEK 70,929,664 (77,000,187)
Parent company
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -25,009,428 (-25,009,428)
- Earnings per share was SEK -0.08 (-0.09) before dilution and SEK -0.07 (-0.08) after dilution
- The equity/assets ratio was 53.0% (44.2%)
- Cash and bank balance was SEK 70,902,132 (76,983,871)
Significant events during the first quarter
- On January 8, Cereno Scientific receives approximately SEK 5 million through exercise of 728,957 warrants by Arena Investors, LP, connected to the financing agreement being entered into on November 11, 2024.
- 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.
- 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.
- 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.
- On March 17, the Swedish Medical Products Agency approved the initiation of a Phase I pharmacokinetic study of CS014. The study is designed based on feedback received in a pre-IND meeting with the U.S. Food and Drug Administration (FDA) and is expected to remove the need for additional safety studies and a Phase IIa trial. This supports a streamlined and capital-efficient development pathway toward a planned Phase IIb trial in PH-ILD starting in Q1 2027.
- On March 27, it was announced that the leading global investment bank Stifel initiated equity research coverage of the company with a Buy rating and a price target of SEK 20 per share. Coverage is led by healthcare analyst Oscar Haffen Lamm and introduces Cereno Scientific to a broader base of international investors and analysts.
- On March 31, Cereno reported that the primary endpoint of safety and tolerability of CS1 was met in the Expanded Access Program (EAP). Together, the accumulative 15-month safety and tolerability data strengthens the overall documentation of CS1 and support continued development toward the planned Phase IIb study, regulatory pathway and ongoing partnering discussions. Further analysis of the EAP will be communicated during the second quarter of 2026.
- Cereno Scientific participated at key conferences focused on partnering and investment discussions, including 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; and BIO-Europe Spring on March 25-26 in Lisbon, and LSX World Congress Europe 2026 on March 23-26 in Lisbon.
Significant events after the period
- On May 11, Cereno announced a collaboration with the patient organization PHA Europe & Global. The partnership aims to strengthen patient-centric drug development, increase disease awareness, and improve outcomes for individuals living with pulmonary arterial hypertension (PAH) and related pulmonary hypertension conditions.
- On May 21, Cereno Scientific announced plans to initiate preclinical disease model studies evaluating its drug candidate CS585 in antiphospholipid syndrome (APS), a rare autoimmune disease associated with recurrent blood clots and serious cardiovascular complications. This is an important next step in the development of CS585 toward rare thrombotic diseases with high unmet medical need, supporting future clinical development planning.
- On May 26, it was announced that the first healthy volunteer has been dosed in the Phase I pharmacokinetic (PK) bridging study of the company's novel HDAC inhibitor CS014. The FDA-aligned study is designed to support the continued clinical development of CS014 and a streamlined pathway toward a Phase IIb trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) starting in Q1 2027.
- Cereno Scientific participated at key conferences focused on partnering discussions, including Nordic Health Summit Japan, April 23-24 in Tokyo, Japan, and ChinaBio Partnering Forum, April 28-29 in Shanghai, China.
Letter from the CEO
Positioned for the next clinical leap
The first quarter of 2026 accelerated Cereno Scientific's transition into the next stage of clinical development. We advanced preparations for the global Phase IIb trial with CS1 in pulmonary arterial hypertension (PAH), progressed CS014 through a streamlined pathway toward Phase IIb, and continued strengthening our scientific and strategic position within rare cardiopulmonary diseases. As multiple near-term milestones approach, we are increasingly focused on execution, operational readiness and continued value creation across the pipeline.
CS1 - preparations for global Phase IIb start in June
Preparations for the global Phase IIb trial with CS1 in PAH continued to advance during the quarter ahead of planned study initiation in June 2026. The trial is designed to further evaluate CS1's disease-modifying potential, including its potential to reverse pathological vascular remodeling, and generate a robust clinical package to support continued development and future regulatory interactions.
We continue to work closely with leading PAH experts, clinical investigators and operational partners to support high-quality execution of the study. Entering Phase IIb represents an important value catalyst for both CS1 and Cereno Scientific as we continue advancing toward later-stage global clinical development.
During the quarter, we also communicated positive 12-month data from the Expanded Access Program (EAP) following the Phase IIa study of CS1. The data was in line with the expectations and confirmed the favorable safety and tolerability profile observed in the Phase IIa study, now extended to approximately 15 months of cumulative treatment exposure.
We are encouraged by these findings, particularly given the importance of long-term safety and tolerability as a critical differentiator in progressive diseases such as PAH where patients require lifelong treatment. Together with the efficacy signals reported from the Phase IIa, the EAP results continue to strengthen the overall clinical evidence package for CS1 and support ongoing regulatory and partnering discussions.
Further analyses from the EAP, including the Fluidda imaging sub-study evaluating pulmonary vascular changes, are expected during Q2 2026. These analyses may provide additional insights into CS1's potential disease-modifying effects and long-term therapeutic value.
CS014 - advancing through a streamlined and capital-efficient pathway
CS014 continued to progress during the quarter through a focused and streamlined development strategy designed to support efficient advancement toward Phase IIb.
We announced that the initial development focus for CS014 in Phase II is pulmonary hypertension associated with interstitial lung disease (PH-ILD). It is a severe, progressive disease where current treatments fail to adequately address the underlying disease progression, leaving patients with insufficient options and a significant unmet need. We believe this represents a scientifically and strategically attractive opportunity that will enable a more efficient development pathway while maintaining the broad underlying rationale of our HDAC inhibitor platform.
We also received approval from the Swedish Medical Products Agency to initiate the Phase I pharmacokinetic bridging study for CS014. The study was designed following feedback received from the U.S. Food and Drug Administration (FDA) and aims to support direct progression into Phase IIb without additional safety studies or a separate Phase IIa trial.
The first participant has now entered the study, and topline results are expected in mid-2026. We view this as an important operational and regulatory milestone that supports our ambition to bring innovative treatments to patients through capital-efficient and differentiated development pathways
Growing validation of our HDAC inhibitor platform
Scientific and clinical interest in epigenetic modulation through HDAC inhibition in cardiopulmonary diseases continues to increase, further supporting the long-term potential of our platform.
During the quarter, the first peer-reviewed publication on CS014 was published in the Journal of Thrombosis and Haemostasis (JTH), highlighting antithrombotic efficacy without increased bleeding risk and supporting the candidate's broad therapeutic potential in cardiopulmonary diseases.
We also continue to see encouraging developments within the broader regulatory environment for rare diseases, especially by the FDA. Increasing support for repurposing strategies, accelerated development pathways and regulatory flexibility in areas with high unmet medical need aligns well with Cereno Scientific's long-standing development philosophy.
For CS1, our Phase IIb study is designed to generate a differentiated and comprehensive dataset evaluating not only safety and efficacy, but also potential disease-modifying effects over time. Combined with extensive historical safety experience in humans, we believe this positions the program well for continued regulatory discussions and potentially accelerated approval pathways as development advances.
CS585 - continued progress in rare thrombotic diseases
Our third program, CS585, also continued to advance during the quarter. Preparations progressed in the preclinical development program and we recently shared that the next step is upcoming studies evaluating CS585 in antiphospholipid syndrome (APS), a rare autoimmune thrombotic disease characterized by recurrent thrombosis, limited treatment options and substantial unmet medical need.
Preclinical data generated to date continue to support the differentiated profile of CS585, including antithrombotic effects without increased bleeding risk and prolonged duration of effect. The upcoming APS-focused studies, conducted in collaboration with Professor Michael Holinstat at the University of Michigan, aim to further evaluate the therapeutic potential of CS585 in rare thrombotic diseases.
Patient centricity and global engagement
Patients remain central to our development approach. During the quarter, we strengthened our collaboration with the patient organization PHA Europe & Global to further integrate patient perspectives into our clinical development programs.
We believe patient engagement contributes to more relevant and patient-friendly clinical trials while supporting broader awareness of pulmonary hypertension and the significant unmet medical need that remains within these diseases.
At the same time, we continued expanding Cereno Scientific's active global visibility through participation at several international scientific, investor and partnering conferences across key global forums, including JPM Healthcare Week in San Francisco, BIO-Europe Spring and LSX World Congress Europe in Lisbon, Nordic Health Summit Japan in Tokyo, and ChinaBio Partnering Forum in Shanghai.
Beyond visibility, these activities serve as a clear and deliberate strategic purpose to support our active business development efforts and strengthen awareness and relationships with potential partners, investors, and key stakeholders globally.
Recognition and continued positioning
We also continue to see growing recognition of Cereno Scientific within the investment and biotech communities. The recently initiated analyst coverage by leading global investment bank Stifel represented an important milestone in expanding awareness of the Company among international institutional investors and reflects increasing interest in our pipeline and development strategy.
In parallel, members of our Management Team participated in several panel discussions and speaker engagements focused on clinical trial strategy, rare disease development, regulatory innovation and AI in drug development. These activities continue to strengthen Cereno Scientific's positioning within the epigenetic and HDAC inhibitor space and support broader recognition of our differentiated development approach.
2026 outlook - multiple value-driving milestones ahead
Looking ahead, we remain focused on executing across several important near-term milestones:
- CS1 - further analyses from the Expanded Access Program, including Fluidda imaging data, expected during Q2 2026
- CS1 - first patient expected to enter the global Phase IIb trial in June 2026
- CS014 - topline results from the PK bridging study expected in mid-2026
- CS014 - IND submission and approval expected during H2 2026
- CS585 - initiation of APS-focused preclinical studies expected during H1 2026
With preparations for the CS1 Phase IIb trial initiation nearing completion and multiple pipeline milestones approaching during 2026, Cereno Scientific continues to strengthen its position within rare cardiopulmonary diseases.
I would like to thank our shareholders, partners, investigators and patients for their continued trust and support as we advance toward the next clinical leap.
May 2026
Sten R. Sörensen, CEO
Upcoming financial reports
- Interim report Q2 2026….26 August 2026
- Interim report Q3 2026…..4 November 2026
- Interim report Q4 2026…..3 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 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, functional class 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 treatment. 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 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. 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.
