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 the year 2024 (January 1 - December 31, 2024).
Financial overview
Group
Full-year 2024
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -99 525 680 SEK (-48 106 210)
- Earnings per share was SEK -0.35 (-0.21) before dilution and SEK -0.32 (-0.16) after dilution
- The equity/assets ratio was 46.4% (75.9%)
- Cash and bank balance was SEK 127 577 645 SEK (87 168 535)
Fourth quarter 2024
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -40 262 214 SEK (-21 933 596)
- Earnings per share was SEK -0.14 (-0.09) before dilution and SEK -0.13 (-0.07) after dilution
Parent company
Full-year 2024
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -99 442 612 SEK (-48 181 632)
- Earnings per share was SEK -0.35 (-0.21) before dilution and SEK -0.32 (-0.16) after dilution
- The equity/assets ratio was 46.4% (75.9%)
- Cash and bank balance was SEK 73 791 605 SEK (87 102 526)
Fourth quarter 2024
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -40 262 214 SEK (-21 936 821)
- Earnings per share was SEK -0.14 (-0.09) before dilution and SEK -0.13 (-0.07) after dilution
Significant events during the fourth quarter
- On October 2, Edison Investment Research increased their valuation of Cereno Scientific to 3.9 BSEK or SEK 13.9 SEK/share after positive topline data.
- On October 17, the Company announced a pivot to rare disease Idiopathic Pulmonary Fibrosis (IPF) as the initial target indication for novel HDAC inhibitor CS014, and a strengthening of the Company's focus on rare diseases.
- On October 17, Cereno Scientific hosted a Capital Markets Day in Stockholm, presenting the Company's strategic focus and pipeline to investors and shareholders. A recording of the event is available on the company website.
- On October 25, Edison Investment Research increased their valuation of Cereno Scientific to 4.05 BSEK or SEK 14.3 SEK/share after IPF selected as initial target indication for CS014.
- On November 11, Cereno Scientific secured minimum 250 MSEK loan financing to reach set milestones into 2026.
- On November 14, the Phase I trial of CS014 entered the Multiple Ascending Dose (MAD) part of the trial.
- On November 16, new preclinical data for CS585 was presented at the American Heart Association (AHA) Scientific Sessions 2024, indicating that drug candidate, a novel prostacyclin (IP) receptor agonist, inhibits platelet activation and clot formation up to 24 hours post-administration.
- New preclinical data for the company's drug candidate CS585 was presented at the ASH Annual Meeting and Exposition 2024 that took place in San Diego, December 7-10, 2024. The data indicates that drug candidate CS585, a novel prostacyclin (IP) receptor agonist is both highly selective for the IP receptor and provides sustained prevention of thrombus formation.
- On December 27, 9 additional patients had been enrolled in the Expanded Access Program (EAP) with CS1 in rare disease PAH. In total, the EAP now includes 10 patients. The additional data collected on the patients in the EAP will strengthen the long-term safety and efficacy documentation of CS1 and support regulatory interactions for future clinical trials.
Significant events after the period
- 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 currently ongoing according to plan. The full Phase I trial is expected to be completed in mid-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 has successfully been submitted to align the next development steps of CS1 with the FDA's expectations and is expected to be 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 safe, well-tolerated oral therapy with disease-modifying effects.
- Cereno Scientific will participate at the partnering conference BioEurope Spring in Milan, Italy, on March 17-19, 2025.
- Cereno Scientific will present 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.
CEO comments
Strengthened clinical foundation
The fourth quarter of 2024 was an intense culmination of several important activities for our business. From a highly anticipated capital markets day in October to a further strengthening of a rare disease focus and progress for our clinical programs. Numerous milestones over the years, both large and small, have contributed to our current position, where Cereno Scientific is dedicated to enabling individuals with rare diseases to live life to the fullest.
Keen market interest in our different treatment approach with epigenetic modulating HDACi portfolio for cardiovascular and pulmonary diseases
In early January, we were present at the J.P. Morgan Healthcare Week in San Francisco, the major biotech/pharma event of the year gathering 20 thousand key decisionmakers in our industry. Sharing our significant progress over the past year was a true highlight throughout the week. Most importantly were the appreciative responses received from potential pharma partners, investors and advisors when presenting our clinical stage epigenetic modulating HDAC inhibitor portfolio, CS1 and CS014, and discussing the connection between previously published preclinical data and our positive top-line data from the CS1 Phase IIa trial and the significant potential for disease-modifying capacity with our unique mode of action. The preclinical and clinical data supports the disease-modifying ability of our HDACi CS1 and demonstrates its potential to prevent and/or reverse the pathological remodeling which is driving disease progression in PAH. Our key takeaway from these interactions is that there is a void in the market for a pioneering treatment approach to rare and fatal cardiovascular and pulmonary diseases that our disease-modifying HDACi portfolio has the promise to fill.
We have experienced similar positive signals when presenting at Nordic investor-focused events, hosted by BIO-Europe Fall, DNB and ABGSC respectively, and engaging with the global equity analysts at Edison at the end of last year.
Phase IIa trial's positive results strengthen understanding of CS1's disease-modification potential
We now have two completed clinical studies supporting our epigenetic modulating HDACi CS1 as a safe and well-tolerated drug candidate after successfully meeting the primary endpoint in our Phase IIa trial. I am very excited to see that our understanding of CS1's reverse vascular remodeling effects through epigenetic modulation is further strengthened by clinical data as we recently shared. The new data reported, in addition to earlier reported top-line results, show compelling signs of disease-modifying effects of CS1 as accompanied by:
i) the improvement of right-ventricular function of the heart,
ii) the gradual improvement over time on the REVEAL 2.0 risk score and NYHA functional class, and,
iii) the positive impact on quality of life.
We are planning to present these new data in a webcast next week to provide a comprehensive presentation of the Phase IIa trial results. I hope you can tune in on March 4, more details to come.
CS1 now enroute to next key clinical step
There are several ongoing activities with our CS1 drug candidate in PAH, each which independently are driving crucial development advancement. About half the patients from the original Phase IIa trial are included in an ongoing FDA-approved expanded access program (EAP) where patients can continue treatment with CS1. These patients and their physicians experienced such a positive impact of CS1 treatment that they opted to partake in the EAP for continuation of CS1 treatment. Additionally, the data from the EAP will provide further insight into the long-term disease-modification effects of CS1.
We recently shared that a sub-study of the EAP was initiated utilizing an innovative imaging technology by Fluidda. This will help bridge the gap between preclinical models and clinical practice when looking at the reverse vascular remodeling effects of CS1 in patients. The study is conducted with three CT scans during a period of 12 months. The aim is to learn more about CS1's effect on the small pulmonary arteries over a longer treatment period in patients, aiming to shed more light on the reverse remodeling effects and disease-modifying potential of CS1 in PAH.
The Cereno Team is also well underway working toward the next key clinical development step for CS1. Activities include discussing regulatory strategies, exploring and engaging various service providers supporting us operationally, and working with the scientific community to further establish our company at key scientific meetings. We are further continuing preparations for an important interaction with the FDA in a Type C meeting this spring. I am looking forward to share more as the pieces fall more into place over time.
CS014's progressing well with favorable safety and tolerability profile in part one of Phase I
We recently shared that the first part of two in the Phase I trial in healthy volunteers has been completed without any safety concerns. In the first part, CS014 was administered as a single ascending oral dose (SAD) and, in the second part that is now currently ongoing CS014 is administered as multiple ascending oral doses (MAD). The full Phase I trial is expected to be reported by mid-2025.
I am very pleased to see favorable clinical data consistent with what we have previously expected from the CS014's safety and tolerability profile. Our HDACi CS014 is a new chemical entity that now has been tested for the first time in humans with initial positive results as a safe and well-tolerated drug candidate. This is a major milestone in clinical development, especially for a new chemical entity drug (NCE). These positive safety and tolerability data is a strong initial validation and support further clinical development. We believe that the novel CS014 has the potential to be a safe, well-tolerated oral drug with disease-modifying capacity in the significant unmet need and market of IPF treatments.
Strengthened focus on rare cardiovascular and pulmonary diseases
We have strengthened the Cereno commitment to rare diseases when selecting the target indication idiopathic pulmonary fibrosis (IPF) for our novel HDACi CS014. The rare disease shares several of the disease mechanisms with PAH, our target indication for our lead program CS1, and both diseases are characterized by high unmet clinical needs despite today's available treatments. Our safe, well-tolerated orally administered epigentic modulating HDACis, CS1 and CS014, hold promise to completely change the approach to how these rare diseases are treated with the ability to enhance and extend life for people affected.
New preclinical data of CS585 shared with the scientific community
We are excited that we have been invited to share new preclinical data on our promising novel prostacyclin (IP) receptor agonist CS585 at several international conferences in the fourth quarter of 2024. At the ASH Annual Meeting and Exposition 2024, in December in San Diego, new preclinical data showed that through prolonged anti-thrombotic efficacy and high selectivity for the IP receptor, CS585 offers a promising new approach to anti-platelet therapy for thrombotic disease without bleeding.
Additionally, preclinical data presented at the ESC congress 2024 in August showed that CS585 inhibits platelet activation and clot formation up to 24 hours post-administration. This data was later published in the esteemed medical journal European Heart Journal (follow link to read).
Strengthening the Cereno Scientific promise
We have a razor-sharp focus on continuing dialogues with potential pharmaceutical partners and investors this spring. There are two exciting events in March where we will be presenting on stage as and have stakeholder meetings; BioEurope Spring is the leading partnering conference in Europe and the Nordic-American Healthcare Conference is the premier Nordics event in the US for life science innovation, where we have been invited along with major players in the healthcare space. In parallel with the positive progress of our clinical programs, there have been several relevant news announcements in the competitor realm which we operate and related to clinical study terminations as well as safety committee pausing a later stage clinical trial. These developments further underscore the important aspect to develop new drugs that are safe and well-tolerated in this space. We believe we are well positioned to have a competitive advantage with our HDACi drugs in this regard in both PAH and in IPF.
When this report is published, we are just a few days from Rare Disease Day on February 28. I hope you join us in raising awareness of these diseases and the high unmet clinical needs. I, on behalf of the Cereno Scientific team, am grateful for the continued support you show us as we are working to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the fullest.
Thank you for your confidence.
Sten R. Sörensen, CEO
Financial calendar
Annual Report 2024..............................Week 20, 2025
Interim Report, Q1 2025........................22 May 2025
Interim Report, Q2 2025.......................27 August 2025
Interim Report, Q3 2025……........……27 November 2025
Year-end Report, Q4 2025……......27 February 2026
For further information, please contact:
Tove Bergenholt, Head of IR & Communications
Email: tove.bergenholt@cerenoscientific.com
Phone: +46 73- 236 62 46
Sten R. Sörensen, CEO
Email: sten.sorensen@cerenoscientific.com
Phone: +46 73-374 03 74
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 a safe, effective and disease modifying treatment 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 was safe, 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. HDACi CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 employs a multi-modal mechanism of action as an epigenetic modulator, targeting key unmet needs in patients with rare disease 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.
