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 2025 (January 1 - March 31).
Financial overview
Cereno Scientific Group - Q1
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -25 009 234 (-15 437 724)
- Earnings per share was SEK -0.09 (-0.07) before dilution and SEK -0.08 (-0.05) after dilution
- The equity/assets ratio was 44.2% (74.5%)
- Cash and bank balance was SEK 77 000 187 (49 178 602)
Parent company - Q1
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -25 009 428 (-15 233 285)
- Earnings per share was SEK -0.09 (-0.07) before dilution and SEK -0.08 (-0.05) after dilution
- The equity/assets ratio was 44.2% (74.5%)
- Cash and bank balance was SEK 76 983 871 (49 110 483)
Significant events during the first quarter
- On February 11, it was shared that the first part of two in the Phase I trial of CS014 was completed with an acceptable safety profile. Part two, MAD part, is was ongoing according to plan. The top-line results are expected to be reported in June 2025.
- On February 19, a sub-study of the Extended Access Program (EAP) utilizing innovative imagng technology developed by Fluidda was initiated following approval by the local Institutional Review Board (IRB). The study is expected to provide a visualization of how long-term treatment of CS1 on top of standard therapy may impact disease characteristic structural changes in small pulmonary arteries, demonstrated by improvements in blood vessel volume in these arteries on the CT images.
- On February 20, a Type C meeting request was successfully submitted to align the next development steps of CS1 with the FDA's expectations. The meeting was held within 75 days in accordance with FDA's timelines.
- On February 25, additional data from the Phase IIa trial of CS1 was shared following Clinical Study Report completion. The additional data showed encouraging signs of reverse vascular remodeling effects of CS1, which are accompanied by measures of improved right-ventricular function of the heart, increasing impact over time on REVEAL 2.0 risk score and NYHA functional class as well as improved quality of life. The combined preclinical and clinical data supports that the epigenetic modulating HDAC-inhibitor CS1 has a strong potential to transform the lives of PAH patients as a well-tolerated oral therapy with favorable safety profile and disease-modifying effects.
- On March 12, it was announced that a Type C meeting has been scheduled on April 21, 2025, by the U.S. Food and Drug Administration (FDA). The intention is to seek advice from the FDA to reach alignment on multiple aspects of the planned development program of CS1 based on the encouraging signals suggesting reverse vascular remodeling effects of CS1 observed in the Phase IIa trial.
- On March 17, it was announced that a new patent has been granted in the US for drug candidate CS1's second patent family. Two patent applications have, additionally, been filed based on the encouraging efficacy signals observed in the recently completed Phase IIa trial of CS1 in the rare disease pulmonary arterial hypertension (PAH). These patent applications combined with the existing patent portfolio has the potential to extend the market exclusivity for CS1 in PAH to 2045.
- Cereno Scientific participated at the partnering conference BioEurope Spring in Milan, Italy, on March 17-19, 2025.
- Cereno Scientific presented at the 9th Annual Nordic-American Healthcare Conference (NAHC), organized by the DNB//Back Bay Healthcare Partnership, in collaboration with Nasdaq Nordic, in New York City on March 26-27, 2025.
Significant events after the period
- On April 16, it was reported that the Phase I trial of CS014 has been concluded. Data management, database lock, and analysis commenced after the last patient's last visit, and the trial's top-line results are expected to be announced in June 2025.
- On April 22, that the company has completed a Type C meeting with the FDA. The discussions during the meeting indicate alignment between the FDA and Cereno Scientific on the plans for the Phase IIb trial and further clinical development of CS1.
- Cereno Scientific participated at the ChinaBio Partnering Forum virtually on April 29-30, 2025.
- On May 7, the nomination committee proposed a new Board with particular expertise in M&A/partnering and business development (BD). The Nomination Committee's proposal means that Jeppe Øvlesen is proposed as the new Chairman of the Board, that Moi Brajanovic is proposed to be newly elected as a Board member and that Joakim Söderström is not proposed to be a member of the Board. The other Board members Anders Svensson, Gunnar Olsson and Sten R. Sörensen are proposed to be re-elected.
- On May 9, an oral presentation titled "Exploratory outcomes of CS1 in Pulmonary Arterial Hypertension: Phase 2A, Prospective, Randomized, Open-Label, Multicenter Trial" was presented at the 5th Baltic Pulmonary Hypertension Conference 2025 in Kaunas, Lithuania.
- Cereno Scientific presented at the ABGSC Investor Days on May 13-14, 2025.
- Cereno Scientific participated at the annual partnering conference LSX Nordics on May 20-21, 2025, in Bergen, Norway.
- Cereno Scientific will attend the partnering conference BIO International Convention 2025 - largest and most comprehensive event for biotechnology - on June 16-19, 2025, in Boston.
CEO comments
Strong start to pivotal year
The first quarter of 2025 has set a strong and focused tone for the year ahead. Our progress this period reflects the momentum we've built in advancing our clinical pipeline, strengthening our regulatory standing, and expanding our international position. Most importantly, the developments this quarter continue to support our mission: to enhance and extend the lives of patients living with rare cardiovascular and pulmonary diseases.
CS1: Additional data, regulatory progress, and expanded access
I am particularly pleased with our significant progress with the CS1 program. Following the successful completion of the exploratory Phase IIa trial in pulmonary arterial hypertension (PAH), we finalized the Clinical Study Report and shared additional data that further supports CS1's disease-modifying potential. These findings demonstrated sustained improvements in REVEAL 2.0 risk score, functional class, and patient-reported quality of life. These are early signals of therapeutic impact over time. In addition to these findings, additional analyses of the data also showed early signs of improvement of the right heart function. This is a key predictor of mortality in PAH so the ability to improve this function could be a game-changer in the treatment of the disease, extending life for patients with PAH.
In April, we held a successful Type C meeting with the U.S. Food and Drug Administration (FDA), aligning on the design of the upcoming placebo-controlled Phase IIb trial - an important step toward broader clinical validation. We also advanced our Expanded Access Program (EAP) and initiated a new sub-study in February using Fluidda's imaging technology to evaluate structural changes in pulmonary vessels during long-term CS1 treatment.
On May 9, Tatiane Abreu Dall'Agnol, medical director at Cereno Scientific, were in Kaunas, Lithuania, presenting the Phase IIa trial results at the 5th Baltic Pulmonary Hypertension Conference 2025. This was the first time Cereno presented the results to the scientific community in a formal meeting. There was a clear interest from the audience in the potential of an HDAC inhibitor that could go beyond symptom management and target the underlying mechanisms of disease as a novel therapy for PAH.
CS014: Clinical progress
I am very pleased that our second HDACi program, CS014, also reached a major milestone this year. The first-in-human Phase I trial concluded in April is now undergoing data analysis, with top-line results expected in June 2025. We are looking forward to these results enabling us to continue to next stage clinical development of CS014.
Business development and global exposure
To meet the increasing interest in our ground breaking development programs and further support our partnering strategy and global presence, we participated in several key investor and partnering events, including J.P. Morgan Healthcare Week in San Francisco, BioEurope Spring in Milan, the Nordic-American Healthcare Conference in New York, ChinaBio virtually and LSX Nordics. We continue to engage with potential partners and investors and look forward to further conversations including upcoming events such as BIO International Convention in Boston this summer and more activities during the year.
Outlook
We remain laser focused on delivering on our strategy and achieving key milestones across our pipeline. With two HDACi programs now in clinical development, a preclinical candidate advancing in its program, a growing IP portfolio, and strong scientific and regulatory momentum, Cereno Scientific is well-positioned to continue its trajectory toward becoming a leader in epigenetically modulating therapies for rare cardiovascular and pulmonary diseases.
Thank you for your continued support and confidence.
May 2025
Sten R. Sörensen, CEO
Financial calendar
Annual General Meeting 2025..............................June 10, 2025
Interim Report, Q2 2025.......................................August 27, 2025
Interim Report, Q3 2025……........………………..November 27, 2025
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. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full.
Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as an effective and disease modifying treatment with a favorable safety and tolerability profile for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1's safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 has a favorable safety profile, is well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014, in Phase I development, is a new chemical entity with disease-modifying potential. 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 Certified Adviser is Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com.
