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 Q2 2025 (April 1 - June 30, 2025).
Financial overview
Cereno Scientific Group - Q2
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -26 626 999 (-21 234 039)
- Earnings per share was SEK -0.09 (-0.08) before dilution and SEK -0.08 (-0.91) after dilution
- The equity/assets ratio was 46.4% (76.2%)
- Cash and bank balance was SEK 74 982 054 (85 596 493)
Parent company - Q2
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -26 630 492 (-21 229 026)
- Earnings per share was SEK -0.09 (-0.08) before dilution and SEK -0.08 (-0.91) after dilution
- The equity/assets ratio was 46.4% (76.2%)
- Cash and bank balance was SEK 74 901 892 (85 472 485)
Significant events during the second quarter
- On April 16, it was reported that the Phase I trial of CS014 had concluded. Data management, database lock, and analysis commenced after the last patient's last visit in preparation for the trial's topline results.
- 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.
- On May 23, Cereno Scientific received endorsement from the FDA on the plans for the Phase IIb trial and further clinical development of CS1 in PAH. The endorsement was the outcome of a Type C meeting held with the FDA on April 21.
- On May 27, the company shared that it is shortlisted for 'Company of the Year' in the European Mediscience Awards 2025. The prestigious Awards is the largest annual gathering showcasing achievement and success in the UK and European healthcare, biotech, pharmaceutical and life sciences sectors.
- On June 10, a new Board of Directors was elected with particular expertise in M&A/partnering and business development (BD) at the Annual General Meeting. The Board comprises Jeppe Øvlesen (new Chairman), Moi Brajanovic (newly elected), Gunnar Olsson (re-elected), Anders Svensson (re-elected) and Sten R. Sörensen (re-elected).
- On June 16, 4-month follow-up data from the Expanded Access Program (EAP) following the Phase IIa trial of CS1 was communicated confirming that data are in line with the safety, tolerability and signals of efficacy observed in the Phase IIa trial. The EAP will run to completion for 12 months with results anticipated in Q1 2026.
- On June 20, 100 MSEK was secured through additional loan financing and conversion. As a continuation of the strategic financing that was completed in November 2024, it allows Cereno Scientific to maintain flexibility while providing runway to reach key clinical and regulatory milestones for CS1 and CS014.
- Cereno Scientific presented at the ABGSC Investor Days on May 13-14, 2025. A recording is available on the company's website.
- Cereno Scientific participated at several key partnering conferences: ChinaBio Partnering Forum virtually on April 29-30, 2025; LSX Nordics on May 20-21, 2025, in Bergen, Norway; and BIO International Convention 2025 - the largest and most comprehensive event for biotechnology - on June 16-19, 2025, in Boston.
Significant events after the period
- 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 August 26, it was announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for CS1 in PAH. Fast Track designation is designed to accelerate the development and regulatory review of new therapies for serious conditions with high unmet medical need.
Letter from the CEO
Building momentum toward the next phase
The second quarter of 2025 has been an important period for Cereno Scientific, marked by strong clinical progress and strategic achievements that strengthen our position for continued growth. This quarter, the key focus has been to advance our pioneering efforts with our two HDAC inhibitor programs toward their next clinical trials in Phase II, while continuing to build Cereno's core foundations in science, partnerships, and market presence. This is what drives and solidifies our long-term success.
CS014: Positive Phase I results pave the way forward
In July, we announced positive topline results from our first-in-human Phase I trial of CS014 in healthy volunteers. The trial met its primary endpoint, showing a favorable safety and tolerability profile, with exposure levels consistent with those projected to impact pulmonary vascular remodeling and fibrosis based on non-clinical data. Combined with the strong preclinical data, these results give us confidence to advance CS014 into a Phase II trial.
While idiopathic pulmonary fibrosis (IPF) is our initial target indication, CS014's mechanism of action through HDAC inhibition and epigenetic modulation holds promise across a broader spectrum of rare diseases involving vascular remodeling and fibrosis. We believe this broad potential strengthens the strategic value of our HDACi portfolio and positions CS014 as an attractive candidate for both further internal development and future partnerships.
CS1: Laying the groundwork for Phase IIb
Our lead program CS1 took important steps forward toward a global, placebo-controlled Phase IIb trial in PAH. We achieved regulatory alignment with the FDA through a productive Type C meeting in April, securing their endorsement of our Phase IIb trial plans. This gives us confidence that our CS1 Phase IIb trial design is aligned with regulatory expectations and will be well positioned to support late-stage development and, ultimately the marketing approval process. In July, we selected a top-tier global contract research organization (CRO) to manage the trial from IND submission through to completion. This is a major milestone in preparing for trial initiation in H1 2026.
In May, our Medical Director, Dr. Tatiane Abreu Dall'Agnol, presented the Phase IIa results at the 5th Baltic Pulmonary Hypertension Conference, further enhancing our visibility and engagement within the global PAH scientific community.
CS1: Fast Track designation underscores potential
Importantly, in August, CS1 was granted Fast Track designation by the U.S. FDA for the treatment of PAH. This recognition underscores both the urgent need for safer, disease-modifying therapies in this devastating disease and the strength of our CS1 program. Fast Track designation is designed to accelerate the development and review of promising new therapies, providing us with closer dialogue with the FDA, the possibility of rolling submissions, and potential priority review. For patients, this can shorten the time to access new treatments, and for Cereno, it represents a significant milestone that enhances the value of CS1, strengthens our competitive position, and supports future partnering discussions.
Validating our approach - the growing scientific momentum for HDACi in cardiovascular disease
The potential of HDAC inhibitors in cardiovascular disease is increasingly being recognized in the scientific community. Several recent publications have highlighted their promise in targeting underlying disease mechanisms in several diseases. This is an area where Cereno is already taking a leading role with two HDACi programs in clinical development. This growing external validation supports our conviction that epigenetic modulation can transform treatments for cardiovascular and pulmonary diseases.
CS585: Continuing promising preclinical work
Our third program, CS585, a selective prostacyclin (IP) receptor agonist, continues to progress in preclinical development in collaboration with the University of Michigan. Data to date suggest it may offer novel approach to preventing thrombosis without increasing bleeding risk - a key differentiator in the cardiovascular space.
Strengthening the company for growth
Cereno Scientific's profile as an innovative biotech company continues to grow among investors, partners, and the broader life sciences community. This quarter, we were honored to be shortlisted for the prestigious European Mediscience Awards' "Company of the Year." This nomination is an important recognition of the progress Cereno Scientific has made in advancing truly innovative science in rare cardiovascular and pulmonary diseases with high unmet needs in patients suffering from these conditions.
Cereno Scientific's visibility among potential pharma partners, the investor community and scientific research communities was also reinforced by high-profile speaking invitations for our leadership team. In May, I was invited to participate at LSX Nordics in Bergen, Norway, on a panel on strategies for taking Nordic biotechs global, and in June, our CMO, Rahul Agrawal, joined a panel hosted by U.S.-based investment bank Jones Trading focused on new emerging treatment paradigms in PAH.
Alongside these achievements, we secured SEK 100 million in additional financing through a combination of loan funding and convertible note conversion. This transaction extends our financial runway to reach key milestones for CS1 and CS014. Since this transaction, an additional SEK 25 million has been converted to shares from the loan, which has lowered our loan burden with SEK 50 million effectively.
Notably, equity analyst firm Edison Group concluded an increased target share price of SEK 17 corresponding to a market cap of SEK 5 billion based on this period of positive development in the company.
Together with our inclusion in Nasdaq's First North 25 Index from July 1, these achieved key milestones and positive development underscore market confidence in our trajectory and our ability to maintain flexibility while driving our programs forward.
Looking ahead
We have entered the second half of the year with strong momentum with a line of sight to multiple value-driving milestones ahead. This fall, we will participate in several key investor and partnering events, including the Annual Biotech in Europe Forum and NLSDays in October, BioEurope Fall in November, and a Cereno Scientific Capital Markets Day (date to be announced) where we will present an update on pipeline and strategy.
We also intend to participate at leading scientific conferences, including European Respiratory Society (ERS) Congress in September, American Heart Association's (AHA) Scientific Sessions 2025 in November and the annual CVCT Forum in December. These activities will showcase our scientific progress, expand our network, and support partnering discussions.
With two HDAC inhibitor programs in clinical development, a preclinical prostacyclin receptor agonist candidate advancing, and a growing reputation in both the investor and scientific communities, Cereno Scientific has built a strong stance and momentum for future continued growth. Every step, from clinical progress to strategic partnerships and market recognition, brings us closer to our mission: to develop pioneering treatments to patients with rare cardiovascular and pulmonary diseases where unmet needs are greatest.
Thank you for your continued trust and support as we advance toward the next phase of our exciting journey.
August 2025
Sten R. Sörensen, CEO
Financial calendar
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. 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 full.
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.
