Cereno Scientific（CRNO.F）株式概要臨床段階のバイオテクノロジー企業であるセレノ・サイエンティフィックAB（publish）は、スウェーデン国内および国際的に、心血管系および肺疾患の治療薬を開発している。 詳細CRNO.F ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長0/6過去の実績0/6財務の健全性1/6配当金0/6リスク分析キャッシュランウェイが1年未満である 今後3年間の収益は年平均28%減少すると予測されている。 株式の流動性は非常に低い 現在は利益が出ておらず、今後3年間で利益が出る見込みはない すべてのリスクチェックを見るCRNO.F Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW480,107 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINRODA480,107 investors already sharing narrativesYour Fair ValueUS$Current PriceUS$0.63該当なし内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-121m76m2016201920222025202620282031Revenue -SEK 876.1kEarnings -SEK 157.4kAdvancedSet Fair ValueView all narrativesCereno Scientific AB (publ) 競合他社Camp4 TherapeuticsSymbol: NasdaqGM:CAMPMarket cap: US$161.5mArmata PharmaceuticalsSymbol: NYSEAM:ARMPMarket cap: US$192.4mAtrium TherapeuticsSymbol: NasdaqGS:RNAMarket cap: US$208.2mFortress BiotechSymbol: NasdaqCM:FBIOMarket cap: US$117.9m価格と性能株価の高値、安値、推移の概要Cereno Scientific過去の株価現在の株価SEK 0.6352週高値SEK 0.9952週安値SEK 0.63ベータ-0.371ヶ月の変化0%3ヶ月変化n/a1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化-36.42%最新ニュースお知らせ • May 18Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026, at 11:00 W. Europe Standard Time. Location: maqs advokatbytas premises, masthamnsgatan 13, gothenburg Swedenお知らせ • Apr 02Cereno Scientific Reports Favorable Safety and Tolerability After 12 Months of Cs1 Treatment in Pah from the Expanded Access ProgramCereno Scientific announced initial learnings from the 12-month Expanded Access Program (EAP) with its lead drug candidate CS1 in pulmonary arterial hypertension (PAH). The data confirm a favorable safety and tolerability profile over long-term treatment, consistent with previous Phase IIa results, further strengthening the value proposition of CS1 as an oral, once-daily potentially disease-modifying therapy. The Expanded Access Program (EAP) enrolled ten patients who had completed the Phase IIa trial, enabling continued treatment with CS1 under physician supervision. Initial learnings from the completed 12-month treatment period show that CS1 was well tolerated, with no unexpected safety concerns observed. No deaths were reported, and no discontinuations were reported to be related to CS1. Six out of ten patients completed the full 12 months of continuous treatment with CS1. Of the remaining patients, two discontinued CS1 treatment following atrial fibrillation events, which was assessed as not related to CS1; one withdrew consent, and one was lost to follow-up. The EAP was conducted under a formal FDA protocol and initiated following requests from patients and physicians. It enabled the generation of additional long-term data beyond the three-month Phase IIa trial, which had demonstrated that CS1 had favorable safety and tolerability and showed encouraging efficacy signals, including improvements in right heart function, functional class and patient quality of life, with signs consistent with reverse vascular remodeling. Together, the Phase IIa trial and the EAP provide up to 15 months of treatment experience in patients, further strengthening the overall clinical understanding of CS1 in PAH. The EAP was initiated following positive results of the Phase IIa trial, which evaluated the safety, tolerability, pharmacokinetics, and exploratory efficacy of CS1 on top of standard therapy in patients with PAH. The Phase IIa trial was conducted at 10 US clinics over 3 months with a total of 25 patients of which 21 were evaluated for efficacy parameters. The trial successfully met its primary endpoint of safety and tolerability, with no drug-related serious adverse events. Encouraging efficacy signals were observed in the trial, including improvements in right heart function, functional class and patient quality of life, with early signs consistent with reverse vascular remodeling. Preparations for a larger, placebo-controlled global Phase IIb study of CS1 in PAH are ongoing, with first patient enrollment anticipated in June 2026. Further analyses from the EAP, including results from the exploratory imaging sub-study using Fluidda's technology, are planned to be communicated during Second Quarter 2026. CS1 is an orally administered histone deacetylase inhibitor (HDACi) in development as a well-tolerated, disease-modifying therapy for pulmonary arterial hypertension (PAH) with favorable safety profile. Acting through epigenetic modulation, CS1 targets key disease-driving mechanisms such as vascular remodeling, fibrosis and inflammation. CS1 has shown disease-modifying potential in early clinical evaluation and is being evaluated as an add-on (on top of standard-of-care) therapy with the potential to improve outcomes for patients with high unmet medical needs. It has been granted Orphan Drug Designation (ODD) in both the U.S. and the EU and received Fast Track designation from the U.S. FDA in August 2025, underscoring its potential to address a serious condition with high unmet medical need. CS1 has first-in-class potential and is currently in preparation for a global Phase IIb trial.お知らせ • Mar 18Cereno Scientific AB Receives Approval to Initiate Fda-Aligned Phase I Pharmacokinetic Study of Cs014 Supporting Phase Ii Development in Ph-IldCereno Scientific announced that the Swedish Medical Products Agency has 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 the planned Phase II trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the First Quarter 2027. The approved study is a Phase I, open-label, randomized, two-period crossover pharmacokinetic (PK) trial in 14 healthy adult volunteers. The study will evaluate steady-state pharmacokinetics following seven days of repeat oral dosing of CS014 compared to valproic acid (VPA), a well-established HDAC inhibitor. The primary objective is to characterize total and unbound plasma concentrations of CS014 at steady state compared to VPA. Following a constructive pre-IND meeting, the FDA indicated that comparative bioavailability data would be acceptable to support the initiation of a Phase IIb trial with CS014. The pharmacokinetic comparison allows Cereno Scientific to leverage the extensive clinical experience with VPA to strengthen the CS014's safety package. A successful trial is expected to remove the need for additional nonclinical safety studies and a clinical Phase IIa trial, allowing Cereno Scientific to progress directly toward Phase IIb preparations. CS014 is a precision deuterated HDAC inhibitor and proprietary new chemical entity within Cereno Scientific's differentiated HDAC inhibitor platform. Designed as a multi-modal epigenetic modulator, CS014 aims to optimize pharmacokinetics and metabolic stability while targeting underlying disease mechanisms such as fibrosis, vascular remodeling, inflammation and thrombosis, which are central drivers in several cardiopulmonary diseases.お知らせ • Feb 05Cereno Scientific Provides Update on Expanded Access Program for CS1Cereno Scientific announced the last patient's last visit concluded the 12-month active study period of the CS1 Expanded Access Program (EAP) in pulmonary arterial hypertension (PAH). Initial learnings from the EAP expected to be available in the first quarter of 2026 and further analyses planned during second quarter of 2026, contributing to the ongoing CS1 development program and its overall value proposition. The Expanded Access Program (EAP) for CS1 was initiated following the completion of the Phase IIa study to enable eligible patients with pulmonary arterial hypertension (PAH) to continue treatment with CS1 under physician supervision. The Phase IIa trial, conducted over 3-months, demonstrated that CS1 was well-tolerated with a favorable safety profile, and showed promising efficacy signals, including improvements in right heart function, patient quality of life, and signals consistent with reverse vascular remodeling. The EAP program enrolled 10 patients who had completed the Phase IIa study, enabling the collection of longer-term information on safety and tolerability during extended use of CS1. Insights generated from the EAP, including the exploratory imaging sub-study of vascular changes in the lung, are intended to complement the Phase IIa results and support the ongoing clinical development of CS1. The EAP is now entering standard processes including database lock, quality assurance and subsequent analysis and interpretation. Initial learnings from the program are expected to be communicated in First Quarter 2026, with additional analyses and interpretation planned during Second Quarter 2026. In parallel, preparations for the global Phase IIb study of CS1 in PAH are progressing, including start-up activities in the United States and planned regulatory interactions in Europe and South America. First patient enrollment in the Phase IIb study is anticipated in the second quarter of 2026.お知らせ • Feb 04Cereno Scientific AB (publ) Broadens Development Focus for CS014 to Pulmonary Hypertension Associated with Interstitial Lung DiseaseCereno Scientific announced that it is broadening the development focus of its HDAC inhibitor CS014 to pulmonary hypertension associated with interstitial lung disease (PH-ILD). The broadened 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. CS014 has been developed with idiopathic pulmonary fibrosis (IPF) as the intended initial indication. Secondary lung diseases (ILDs) comprise a group of fibrotic lung disorders, of which IPF is the most common and a key disease where CS014 remains highly relevant. A substantial proportion of patients with ILD, including many with IPF, go on to develop pulmonary hypertension, a complication associated with significantly worse prognosis. Broadening the development focus to PH-ILD reflects these disease characteristics and allows CS014 to be evaluated in patients where both fibrotic lung disease and pulmonary vascular pathology play a central role. The rare disease PH-ILD is a severe and life-limiting condition associated with markedly worse outcomes compared with fibrotic lung disease alone, including IPF without pulmonary hypertension. PH-ILD patients who develop pulmonary hypertension experience reduced exercise capacity, faster disease progression and high mortality, while treatment options remain very limited and largely focused on symptom management rather than disease modification. CS014 is a novel, orally administered HDAC inhibitor with potential to address underlying disease mechanisms in severe cardiopulmonary diseases. With a completed Phase I study and a broadened development focus on PH-ILD, Cereno Scientific is advancing preparations for a Phase II study planned to be initiated in first quarter 2027.お知らせ • Jan 14Cereno Scientific Announces First Peer-Reviewed Publication on HDAC Inhibitor CS014: Antithrombotic EfficacyCereno Scientific announced the publication of the first peer-reviewed manuscript describing CS014, a new chemical entity (NCE) and HDAC inhibitor, in the Journal of Thrombosis and Haemostasis. The work reveals the chemical structure of the CS014 molecule, data on its potential mechanism of action and some of its important nonclinical pharmacology; highly efficacious antithrombotic effects at doses in animals that do not jeopardize hemostasis. 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. The manuscript, "Novel HDAC inhibitor, CS014, attenuates in vivo thrombosis while maintaining hemostasis," characterizes CS014 as a novel histone deacetylase (HDAC) inhibitor, engineered to improve upon valproic acid (VPA) through reduced hepatotoxicity risk while preserving the mechanistic benefits of HDAC inhibition. The work shows that CS014 maintains efficacious HDAC inhibitory activity, increases tPA mRNA expression and produces strong antithrombotic effects in small artery, large artery and large vein models. Notably, CS014 achieves these effects while preserving normal coagulation and bleeding time, and it produces substantially lower levels of the hepatotoxic 4-ene metabolite compared with VPA in, in vitro and in vivo systems. Access to the manuscript: Stanger, Livia et al. (2025) Novel histone deacetylase inhibitor, CS014, attenuate in vivo thrombosis While maintaining hemostasis. Journal of Thrombosis & Haemostasis. CS014 is being developed as a next-generation HDAC inhibitor and novel chemical entity designed to modulate epigenetic pathways that target the root cause of cardiovascular and pulmonary diseases. Non-clinical studies have demonstrated potent effects on pathways involved in vascular remodeling and fibrosis, which are key drivers of disease progression in several cardiovascular and pulmonary conditions and suggests disease-modifying potential. The recently completed Phase I study confirmed that CS014 has a favorable safety profile and is well tolerated at and above exposure levels that, based on non-clinical data, are predicted to support maximal effects on the reversal of pulmonary vascular remodeling and fibrosis. These findings support advancement of CS014 into Phase II clinical development with an initial focus on idiopathic pulmonary fibrosis (IPF). Cereno Scientific is advancing CS014 as a potential new treatment for patients with severe, progressive cardiovascular and pulmonary diseases that currently lack effective therapies.最新情報をもっと見るRecent updatesお知らせ • May 18Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026, at 11:00 W. Europe Standard Time. Location: maqs advokatbytas premises, masthamnsgatan 13, gothenburg Swedenお知らせ • Apr 02Cereno Scientific Reports Favorable Safety and Tolerability After 12 Months of Cs1 Treatment in Pah from the Expanded Access ProgramCereno Scientific announced initial learnings from the 12-month Expanded Access Program (EAP) with its lead drug candidate CS1 in pulmonary arterial hypertension (PAH). The data confirm a favorable safety and tolerability profile over long-term treatment, consistent with previous Phase IIa results, further strengthening the value proposition of CS1 as an oral, once-daily potentially disease-modifying therapy. The Expanded Access Program (EAP) enrolled ten patients who had completed the Phase IIa trial, enabling continued treatment with CS1 under physician supervision. Initial learnings from the completed 12-month treatment period show that CS1 was well tolerated, with no unexpected safety concerns observed. No deaths were reported, and no discontinuations were reported to be related to CS1. Six out of ten patients completed the full 12 months of continuous treatment with CS1. Of the remaining patients, two discontinued CS1 treatment following atrial fibrillation events, which was assessed as not related to CS1; one withdrew consent, and one was lost to follow-up. The EAP was conducted under a formal FDA protocol and initiated following requests from patients and physicians. It enabled the generation of additional long-term data beyond the three-month Phase IIa trial, which had demonstrated that CS1 had favorable safety and tolerability and showed encouraging efficacy signals, including improvements in right heart function, functional class and patient quality of life, with signs consistent with reverse vascular remodeling. Together, the Phase IIa trial and the EAP provide up to 15 months of treatment experience in patients, further strengthening the overall clinical understanding of CS1 in PAH. The EAP was initiated following positive results of the Phase IIa trial, which evaluated the safety, tolerability, pharmacokinetics, and exploratory efficacy of CS1 on top of standard therapy in patients with PAH. The Phase IIa trial was conducted at 10 US clinics over 3 months with a total of 25 patients of which 21 were evaluated for efficacy parameters. The trial successfully met its primary endpoint of safety and tolerability, with no drug-related serious adverse events. Encouraging efficacy signals were observed in the trial, including improvements in right heart function, functional class and patient quality of life, with early signs consistent with reverse vascular remodeling. Preparations for a larger, placebo-controlled global Phase IIb study of CS1 in PAH are ongoing, with first patient enrollment anticipated in June 2026. Further analyses from the EAP, including results from the exploratory imaging sub-study using Fluidda's technology, are planned to be communicated during Second Quarter 2026. CS1 is an orally administered histone deacetylase inhibitor (HDACi) in development as a well-tolerated, disease-modifying therapy for pulmonary arterial hypertension (PAH) with favorable safety profile. Acting through epigenetic modulation, CS1 targets key disease-driving mechanisms such as vascular remodeling, fibrosis and inflammation. CS1 has shown disease-modifying potential in early clinical evaluation and is being evaluated as an add-on (on top of standard-of-care) therapy with the potential to improve outcomes for patients with high unmet medical needs. It has been granted Orphan Drug Designation (ODD) in both the U.S. and the EU and received Fast Track designation from the U.S. FDA in August 2025, underscoring its potential to address a serious condition with high unmet medical need. CS1 has first-in-class potential and is currently in preparation for a global Phase IIb trial.お知らせ • Mar 18Cereno Scientific AB Receives Approval to Initiate Fda-Aligned Phase I Pharmacokinetic Study of Cs014 Supporting Phase Ii Development in Ph-IldCereno Scientific announced that the Swedish Medical Products Agency has 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 the planned Phase II trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the First Quarter 2027. The approved study is a Phase I, open-label, randomized, two-period crossover pharmacokinetic (PK) trial in 14 healthy adult volunteers. The study will evaluate steady-state pharmacokinetics following seven days of repeat oral dosing of CS014 compared to valproic acid (VPA), a well-established HDAC inhibitor. The primary objective is to characterize total and unbound plasma concentrations of CS014 at steady state compared to VPA. Following a constructive pre-IND meeting, the FDA indicated that comparative bioavailability data would be acceptable to support the initiation of a Phase IIb trial with CS014. The pharmacokinetic comparison allows Cereno Scientific to leverage the extensive clinical experience with VPA to strengthen the CS014's safety package. A successful trial is expected to remove the need for additional nonclinical safety studies and a clinical Phase IIa trial, allowing Cereno Scientific to progress directly toward Phase IIb preparations. CS014 is a precision deuterated HDAC inhibitor and proprietary new chemical entity within Cereno Scientific's differentiated HDAC inhibitor platform. Designed as a multi-modal epigenetic modulator, CS014 aims to optimize pharmacokinetics and metabolic stability while targeting underlying disease mechanisms such as fibrosis, vascular remodeling, inflammation and thrombosis, which are central drivers in several cardiopulmonary diseases.お知らせ • Feb 05Cereno Scientific Provides Update on Expanded Access Program for CS1Cereno Scientific announced the last patient's last visit concluded the 12-month active study period of the CS1 Expanded Access Program (EAP) in pulmonary arterial hypertension (PAH). Initial learnings from the EAP expected to be available in the first quarter of 2026 and further analyses planned during second quarter of 2026, contributing to the ongoing CS1 development program and its overall value proposition. The Expanded Access Program (EAP) for CS1 was initiated following the completion of the Phase IIa study to enable eligible patients with pulmonary arterial hypertension (PAH) to continue treatment with CS1 under physician supervision. The Phase IIa trial, conducted over 3-months, demonstrated that CS1 was well-tolerated with a favorable safety profile, and showed promising efficacy signals, including improvements in right heart function, patient quality of life, and signals consistent with reverse vascular remodeling. The EAP program enrolled 10 patients who had completed the Phase IIa study, enabling the collection of longer-term information on safety and tolerability during extended use of CS1. Insights generated from the EAP, including the exploratory imaging sub-study of vascular changes in the lung, are intended to complement the Phase IIa results and support the ongoing clinical development of CS1. The EAP is now entering standard processes including database lock, quality assurance and subsequent analysis and interpretation. Initial learnings from the program are expected to be communicated in First Quarter 2026, with additional analyses and interpretation planned during Second Quarter 2026. In parallel, preparations for the global Phase IIb study of CS1 in PAH are progressing, including start-up activities in the United States and planned regulatory interactions in Europe and South America. First patient enrollment in the Phase IIb study is anticipated in the second quarter of 2026.お知らせ • Feb 04Cereno Scientific AB (publ) Broadens Development Focus for CS014 to Pulmonary Hypertension Associated with Interstitial Lung DiseaseCereno Scientific announced that it is broadening the development focus of its HDAC inhibitor CS014 to pulmonary hypertension associated with interstitial lung disease (PH-ILD). The broadened 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. CS014 has been developed with idiopathic pulmonary fibrosis (IPF) as the intended initial indication. Secondary lung diseases (ILDs) comprise a group of fibrotic lung disorders, of which IPF is the most common and a key disease where CS014 remains highly relevant. A substantial proportion of patients with ILD, including many with IPF, go on to develop pulmonary hypertension, a complication associated with significantly worse prognosis. Broadening the development focus to PH-ILD reflects these disease characteristics and allows CS014 to be evaluated in patients where both fibrotic lung disease and pulmonary vascular pathology play a central role. The rare disease PH-ILD is a severe and life-limiting condition associated with markedly worse outcomes compared with fibrotic lung disease alone, including IPF without pulmonary hypertension. PH-ILD patients who develop pulmonary hypertension experience reduced exercise capacity, faster disease progression and high mortality, while treatment options remain very limited and largely focused on symptom management rather than disease modification. CS014 is a novel, orally administered HDAC inhibitor with potential to address underlying disease mechanisms in severe cardiopulmonary diseases. With a completed Phase I study and a broadened development focus on PH-ILD, Cereno Scientific is advancing preparations for a Phase II study planned to be initiated in first quarter 2027.お知らせ • Jan 14Cereno Scientific Announces First Peer-Reviewed Publication on HDAC Inhibitor CS014: Antithrombotic EfficacyCereno Scientific announced the publication of the first peer-reviewed manuscript describing CS014, a new chemical entity (NCE) and HDAC inhibitor, in the Journal of Thrombosis and Haemostasis. The work reveals the chemical structure of the CS014 molecule, data on its potential mechanism of action and some of its important nonclinical pharmacology; highly efficacious antithrombotic effects at doses in animals that do not jeopardize hemostasis. 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. The manuscript, "Novel HDAC inhibitor, CS014, attenuates in vivo thrombosis while maintaining hemostasis," characterizes CS014 as a novel histone deacetylase (HDAC) inhibitor, engineered to improve upon valproic acid (VPA) through reduced hepatotoxicity risk while preserving the mechanistic benefits of HDAC inhibition. The work shows that CS014 maintains efficacious HDAC inhibitory activity, increases tPA mRNA expression and produces strong antithrombotic effects in small artery, large artery and large vein models. Notably, CS014 achieves these effects while preserving normal coagulation and bleeding time, and it produces substantially lower levels of the hepatotoxic 4-ene metabolite compared with VPA in, in vitro and in vivo systems. Access to the manuscript: Stanger, Livia et al. (2025) Novel histone deacetylase inhibitor, CS014, attenuate in vivo thrombosis While maintaining hemostasis. Journal of Thrombosis & Haemostasis. CS014 is being developed as a next-generation HDAC inhibitor and novel chemical entity designed to modulate epigenetic pathways that target the root cause of cardiovascular and pulmonary diseases. Non-clinical studies have demonstrated potent effects on pathways involved in vascular remodeling and fibrosis, which are key drivers of disease progression in several cardiovascular and pulmonary conditions and suggests disease-modifying potential. The recently completed Phase I study confirmed that CS014 has a favorable safety profile and is well tolerated at and above exposure levels that, based on non-clinical data, are predicted to support maximal effects on the reversal of pulmonary vascular remodeling and fibrosis. These findings support advancement of CS014 into Phase II clinical development with an initial focus on idiopathic pulmonary fibrosis (IPF). Cereno Scientific is advancing CS014 as a potential new treatment for patients with severe, progressive cardiovascular and pulmonary diseases that currently lack effective therapies.お知らせ • Dec 31+ 4 more updatesCereno Scientific AB (publ) to Report Fiscal Year 2025 Final Results between Apr 13, 2026 and Apr 17, 2026Cereno Scientific AB (publ) announced that they will report fiscal year 2025 final results on between Apr 13, 2026 and Apr 17, 2026お知らせ • Dec 11Cereno Scientific AB Receives FDA Clearance to Initiate Global Phase IIb Trial of CS1 in Pulmonary Arterial Hypertension (PAH)Cereno Scientific AB announced that the U.S. Food and Drug Administration (FDA) has granted clearance to initiate the company's Phase IIb trial of its lead drug candidate CS1 for the treatment of pulmonary arterial hypertension (PAH). The FDA's decision enables Cereno to advance toward first patient in (FPI) in second quarter 2026, with top-line data anticipated around fourth quarter 2028, subject to enrollment timelines. The clearance follows constructive regulatory interactions and builds on the favorable safety, tolerability and encouraging disease-modifying signals observed in the Phase IIa study. CS1 has also been granted Orphan Drug Designation and Fast Track designation in the U.S. The Phase IIb trial is formally titled "A Phase 2b, Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study, to compare the Efficacy and Safety/Tolerability of CS1 Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH). It is a global, multicenter trial enrolling approximately 126 patients with PAH who are stable on background therapy. The study will evaluate the effect of CS1 on pulmonary vascular resistance (PVR) at Week 36 via right-heart catheterization, changes in 6-minute walk distance at Week 36, and a range of additional evaluations including measures of heart function, biomarker changes, clinical worsening, patient-reported outcomes, and pharmacokinetics. This dose-finding trial is expected to be conducted across 10-12 countries in the U.S., Europe and South America at approximately 65 investigative sites. Acting through epigenetic modulation, CS1 targets key disease-driving mechanisms such as vascular remodeling, fibrosis and inflammation. CS1 has shown disease-modifying potential in early clinical evaluation and is being evaluated as an add-on (on top of standard-of-care) therapy with the potential to improve outcomes for patients with high unmet medical needs. It has been granted Orphan Drug Designatedation (ODD) in both the U.S. and the EU and received Fast Trackdesignation from the U.S. FDA in August 2025, underscoring its potential to address a serious condition with high unmet medical need. CS1 has first-in-class potential and is currently in Phase II clinical development.お知らせ • Dec 05Cereno Scientific AB to Present New Data of CS014 at the Pharmacology 2025 on December 15-18Cereno Scientific AB announced that the company will present new data of CS014 at the scientific conference Pharmacology 2025 organized by the British Pharmacology Society on December 16-18 in Belfast, Northern Ireland. The findings relate to CS014's preclinical studies and Phase I trial, supporting advancement of the program into Phase II development. CS014 is being developed as a next-generation HDAC inhibitor and novel chemical entity designed to modulate epigenetic pathways that target the root cause of cardiovascular and pulmonary diseases. Non-clinical studies have demonstrated potent effects on pathways involved in vascular remodeling and fibrosis, which are key drivers of disease progression in several cardiovascular and pulmonary conditions. The recently completed Phase I study confirmed that CS014 has a favorable safety profile and is well tolerated at and above exposure levels that, based on non-clinical data, are predicted to support maximal effects on the reversal of pulmonary vascular remodeling and fibrosis. These findings support advancement of CS014 into Phase II clinical development with an initial focus on idiopathic pulmonary fibrosis.お知らせ • Nov 29Cereno Scientific AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 99.999942 million.Cereno Scientific AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 99.999942 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 14,285,706 Price\Range: SEK 7 Transaction Features: Subsequent Direct Listingお知らせ • Nov 10Cereno Scientific Submits Phase IIb Trial Protocol for CS1 in Pulmonary Arterial Hypertension to the U.S. FDACereno Scientific announced the submission of the clinical trial protocol for the planned global Phase IIb trial of its lead drug candidate CS1 to the U.S. Food and Drug Administration (FDA). The submission marks an important milestone, moving the company closer to advancing CS1 into its next clinical phase and toward bringing a novel therapeutic approach to patients living with pulmonary arterial hypertension (PAH). The planned Phase IIb trial is designed to further evaluate the safety, tolerability and efficacy of CS1, a histone deacetylase inhibitor (HDACi) in development as an oral treatment targeting the root mechanisms of PAH through epigenetic modulation. The Phase IIb trial will build on the results from the completed Phase IIa trial, where CS1 demonstrated a favorable safety and tolerability profile together with encouraging efficacy signals including reverse vascular remodeling, improved right heart function, and enhanced patient quality of life. The new global, multicenter, placebo-controlled trial will be conducted in collaboration with a leading international contract research organization (CRO). Regulatory interactions in other key regions will follow as part of the global start-up preparations.PA His a rare, progressive and life-threatening disease characterized by high blood pressure in the pulmonary arteries that leads to right heart failure and premature death. Current standard treatments mainly focus on managing symptoms, leaving a significant unmet need for disease-modifying therapies that can change the course of disease and improve long-term outcomes. Following the FDA's standard 30-day review, Cereno Scientific anticipates clearance to proceed with the trial. The Phase IIb trial is planned to begin during H1 2026 as part of the company's global development program for CS1.お知らせ • Aug 26Cereno Scientific Receives Fda Fast Track Designation for Cs1 in Rare Disease Pulmonary Arterial Hypertension (Pah)Cereno Scientific announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead program, CS1,for the treatment of pulmonary arterial hypertension (PAH). Fast Track designation is designed to accelerate the development and regulatory review of new therapies for serious conditions with high unmet medical need. The designation highlights CS1's potential as a differentiated treatment approach for PAH, a rare and progressive disease where safer, disease-modifying therapies are urgently needed. The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions with the potential to address unmet medical needs. Fast Track designation enables closer and more frequent interaction with the FDA, eligibility for rolling review, and potential priority review, with the goal of bringing promising treatments to patients more quickly. Drug candidate CS1 is an oral HDAC inhibitor (HDACi) with a unique mechanism of action through epigenetic modulation. In a Phase IIa trial in PAH, CS1 met its primary endpoint of safety and tolerability while showing encouraging efficacy signals in a Phase II a trial in PAH, including improvement of REVEAL risk score, functional class, quality of life, and early signs 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 modulation 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.株主還元CRNO.FUS BiotechsUS 市場7D0%-0.5%-2.0%1Yn/a29.7%15.1%株主還元を見る業界別リターン: CRNO.FがUS Biotechs業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: CRNO.F US市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is CRNO.F's price volatile compared to industry and market?CRNO.F volatilityCRNO.F Average Weekly Movementn/aBiotechs Industry Average Movement10.1%Market Average Movement7.1%10% most volatile stocks in US Market16.1%10% least volatile stocks in US Market3.2%安定した株価: CRNO.Fの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のCRNO.Fのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト201210Sten Sorensenwww.cerenoscientific.com臨床段階のバイオテクノロジー企業であるセレノサイエンティフィック社（Cereno Scientific AB）は、スウェーデン国内および国際的に、心血管系および肺疾患の治療薬を開発している。同社の主要医薬品候補は、希少疾患である肺動脈性肺高血圧症の治療薬として第II相臨床試験段階にあるCS1であり、また、血圧降下作用、リバースリモデリング作用、抗炎症作用、抗線維化作用、抗血栓作用を有するエピジェネティック・モジュレーターとして作用するヒストン脱アセチル化酵素（HDAC）阻害剤である。同社の医薬品ポートフォリオには、心血管疾患、肺疾患、特発性肺線維症の治療薬としてフェーズI段階にあるエピジェネティック・モジュレーターCS014や、抗リン脂質症候群などの希少血栓性疾患の治療薬として選択的プロスタサイクリン（IP）受容体作動薬CS585などの前臨床医薬品候補がある。同社はミシガン大学とCS585およびCS014の前臨床開発プログラムに関する共同研究契約を締結しており、CS014は心血管疾患の前臨床治療薬候補であり、アボット社とはCardioMEMS HF Systemの使用に関する共同研究契約を締結している。Cereno Scientific AB（publ）は2012年に設立され、スウェーデンのヨーテボリに本社を置いている。もっと見るCereno Scientific AB (publ) 基礎のまとめCereno Scientific の収益と売上を時価総額と比較するとどうか。CRNO.F 基礎統計学時価総額US$155.19m収益（TTM）-US$12.48m売上高(TTM)US$6.87m22.9xP/Sレシオ-12.6xPER（株価収益率CRNO.F は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計CRNO.F 損益計算書（TTM）収益SEK 66.82m売上原価SEK 0売上総利益SEK 66.82mその他の費用SEK 188.17m収益-SEK 121.35m直近の収益報告Mar 31, 2026次回決算日Aug 26, 2026一株当たり利益（EPS）-0.39グロス・マージン100.00%純利益率-181.61%有利子負債／自己資本比率76.4%CRNO.F の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/07/23 05:04終値2026/05/07 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社のGitHubページでご覧いただけます。また、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Cereno Scientific AB (publ) 2 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Jyoti PrakashEdison Investment ResearchOscar Haffen LammStifel, Equities Research
お知らせ • May 18Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026, at 11:00 W. Europe Standard Time. Location: maqs advokatbytas premises, masthamnsgatan 13, gothenburg Sweden
お知らせ • Apr 02Cereno Scientific Reports Favorable Safety and Tolerability After 12 Months of Cs1 Treatment in Pah from the Expanded Access ProgramCereno Scientific announced initial learnings from the 12-month Expanded Access Program (EAP) with its lead drug candidate CS1 in pulmonary arterial hypertension (PAH). The data confirm a favorable safety and tolerability profile over long-term treatment, consistent with previous Phase IIa results, further strengthening the value proposition of CS1 as an oral, once-daily potentially disease-modifying therapy. The Expanded Access Program (EAP) enrolled ten patients who had completed the Phase IIa trial, enabling continued treatment with CS1 under physician supervision. Initial learnings from the completed 12-month treatment period show that CS1 was well tolerated, with no unexpected safety concerns observed. No deaths were reported, and no discontinuations were reported to be related to CS1. Six out of ten patients completed the full 12 months of continuous treatment with CS1. Of the remaining patients, two discontinued CS1 treatment following atrial fibrillation events, which was assessed as not related to CS1; one withdrew consent, and one was lost to follow-up. The EAP was conducted under a formal FDA protocol and initiated following requests from patients and physicians. It enabled the generation of additional long-term data beyond the three-month Phase IIa trial, which had demonstrated that CS1 had favorable safety and tolerability and showed encouraging efficacy signals, including improvements in right heart function, functional class and patient quality of life, with signs consistent with reverse vascular remodeling. Together, the Phase IIa trial and the EAP provide up to 15 months of treatment experience in patients, further strengthening the overall clinical understanding of CS1 in PAH. The EAP was initiated following positive results of the Phase IIa trial, which evaluated the safety, tolerability, pharmacokinetics, and exploratory efficacy of CS1 on top of standard therapy in patients with PAH. The Phase IIa trial was conducted at 10 US clinics over 3 months with a total of 25 patients of which 21 were evaluated for efficacy parameters. The trial successfully met its primary endpoint of safety and tolerability, with no drug-related serious adverse events. Encouraging efficacy signals were observed in the trial, including improvements in right heart function, functional class and patient quality of life, with early signs consistent with reverse vascular remodeling. Preparations for a larger, placebo-controlled global Phase IIb study of CS1 in PAH are ongoing, with first patient enrollment anticipated in June 2026. Further analyses from the EAP, including results from the exploratory imaging sub-study using Fluidda's technology, are planned to be communicated during Second Quarter 2026. CS1 is an orally administered histone deacetylase inhibitor (HDACi) in development as a well-tolerated, disease-modifying therapy for pulmonary arterial hypertension (PAH) with favorable safety profile. Acting through epigenetic modulation, CS1 targets key disease-driving mechanisms such as vascular remodeling, fibrosis and inflammation. CS1 has shown disease-modifying potential in early clinical evaluation and is being evaluated as an add-on (on top of standard-of-care) therapy with the potential to improve outcomes for patients with high unmet medical needs. It has been granted Orphan Drug Designation (ODD) in both the U.S. and the EU and received Fast Track designation from the U.S. FDA in August 2025, underscoring its potential to address a serious condition with high unmet medical need. CS1 has first-in-class potential and is currently in preparation for a global Phase IIb trial.
お知らせ • Mar 18Cereno Scientific AB Receives Approval to Initiate Fda-Aligned Phase I Pharmacokinetic Study of Cs014 Supporting Phase Ii Development in Ph-IldCereno Scientific announced that the Swedish Medical Products Agency has 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 the planned Phase II trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the First Quarter 2027. The approved study is a Phase I, open-label, randomized, two-period crossover pharmacokinetic (PK) trial in 14 healthy adult volunteers. The study will evaluate steady-state pharmacokinetics following seven days of repeat oral dosing of CS014 compared to valproic acid (VPA), a well-established HDAC inhibitor. The primary objective is to characterize total and unbound plasma concentrations of CS014 at steady state compared to VPA. Following a constructive pre-IND meeting, the FDA indicated that comparative bioavailability data would be acceptable to support the initiation of a Phase IIb trial with CS014. The pharmacokinetic comparison allows Cereno Scientific to leverage the extensive clinical experience with VPA to strengthen the CS014's safety package. A successful trial is expected to remove the need for additional nonclinical safety studies and a clinical Phase IIa trial, allowing Cereno Scientific to progress directly toward Phase IIb preparations. CS014 is a precision deuterated HDAC inhibitor and proprietary new chemical entity within Cereno Scientific's differentiated HDAC inhibitor platform. Designed as a multi-modal epigenetic modulator, CS014 aims to optimize pharmacokinetics and metabolic stability while targeting underlying disease mechanisms such as fibrosis, vascular remodeling, inflammation and thrombosis, which are central drivers in several cardiopulmonary diseases.
お知らせ • Feb 05Cereno Scientific Provides Update on Expanded Access Program for CS1Cereno Scientific announced the last patient's last visit concluded the 12-month active study period of the CS1 Expanded Access Program (EAP) in pulmonary arterial hypertension (PAH). Initial learnings from the EAP expected to be available in the first quarter of 2026 and further analyses planned during second quarter of 2026, contributing to the ongoing CS1 development program and its overall value proposition. The Expanded Access Program (EAP) for CS1 was initiated following the completion of the Phase IIa study to enable eligible patients with pulmonary arterial hypertension (PAH) to continue treatment with CS1 under physician supervision. The Phase IIa trial, conducted over 3-months, demonstrated that CS1 was well-tolerated with a favorable safety profile, and showed promising efficacy signals, including improvements in right heart function, patient quality of life, and signals consistent with reverse vascular remodeling. The EAP program enrolled 10 patients who had completed the Phase IIa study, enabling the collection of longer-term information on safety and tolerability during extended use of CS1. Insights generated from the EAP, including the exploratory imaging sub-study of vascular changes in the lung, are intended to complement the Phase IIa results and support the ongoing clinical development of CS1. The EAP is now entering standard processes including database lock, quality assurance and subsequent analysis and interpretation. Initial learnings from the program are expected to be communicated in First Quarter 2026, with additional analyses and interpretation planned during Second Quarter 2026. In parallel, preparations for the global Phase IIb study of CS1 in PAH are progressing, including start-up activities in the United States and planned regulatory interactions in Europe and South America. First patient enrollment in the Phase IIb study is anticipated in the second quarter of 2026.
お知らせ • Feb 04Cereno Scientific AB (publ) Broadens Development Focus for CS014 to Pulmonary Hypertension Associated with Interstitial Lung DiseaseCereno Scientific announced that it is broadening the development focus of its HDAC inhibitor CS014 to pulmonary hypertension associated with interstitial lung disease (PH-ILD). The broadened 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. CS014 has been developed with idiopathic pulmonary fibrosis (IPF) as the intended initial indication. Secondary lung diseases (ILDs) comprise a group of fibrotic lung disorders, of which IPF is the most common and a key disease where CS014 remains highly relevant. A substantial proportion of patients with ILD, including many with IPF, go on to develop pulmonary hypertension, a complication associated with significantly worse prognosis. Broadening the development focus to PH-ILD reflects these disease characteristics and allows CS014 to be evaluated in patients where both fibrotic lung disease and pulmonary vascular pathology play a central role. The rare disease PH-ILD is a severe and life-limiting condition associated with markedly worse outcomes compared with fibrotic lung disease alone, including IPF without pulmonary hypertension. PH-ILD patients who develop pulmonary hypertension experience reduced exercise capacity, faster disease progression and high mortality, while treatment options remain very limited and largely focused on symptom management rather than disease modification. CS014 is a novel, orally administered HDAC inhibitor with potential to address underlying disease mechanisms in severe cardiopulmonary diseases. With a completed Phase I study and a broadened development focus on PH-ILD, Cereno Scientific is advancing preparations for a Phase II study planned to be initiated in first quarter 2027.
お知らせ • Jan 14Cereno Scientific Announces First Peer-Reviewed Publication on HDAC Inhibitor CS014: Antithrombotic EfficacyCereno Scientific announced the publication of the first peer-reviewed manuscript describing CS014, a new chemical entity (NCE) and HDAC inhibitor, in the Journal of Thrombosis and Haemostasis. The work reveals the chemical structure of the CS014 molecule, data on its potential mechanism of action and some of its important nonclinical pharmacology; highly efficacious antithrombotic effects at doses in animals that do not jeopardize hemostasis. 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. The manuscript, "Novel HDAC inhibitor, CS014, attenuates in vivo thrombosis while maintaining hemostasis," characterizes CS014 as a novel histone deacetylase (HDAC) inhibitor, engineered to improve upon valproic acid (VPA) through reduced hepatotoxicity risk while preserving the mechanistic benefits of HDAC inhibition. The work shows that CS014 maintains efficacious HDAC inhibitory activity, increases tPA mRNA expression and produces strong antithrombotic effects in small artery, large artery and large vein models. Notably, CS014 achieves these effects while preserving normal coagulation and bleeding time, and it produces substantially lower levels of the hepatotoxic 4-ene metabolite compared with VPA in, in vitro and in vivo systems. Access to the manuscript: Stanger, Livia et al. (2025) Novel histone deacetylase inhibitor, CS014, attenuate in vivo thrombosis While maintaining hemostasis. Journal of Thrombosis & Haemostasis. CS014 is being developed as a next-generation HDAC inhibitor and novel chemical entity designed to modulate epigenetic pathways that target the root cause of cardiovascular and pulmonary diseases. Non-clinical studies have demonstrated potent effects on pathways involved in vascular remodeling and fibrosis, which are key drivers of disease progression in several cardiovascular and pulmonary conditions and suggests disease-modifying potential. The recently completed Phase I study confirmed that CS014 has a favorable safety profile and is well tolerated at and above exposure levels that, based on non-clinical data, are predicted to support maximal effects on the reversal of pulmonary vascular remodeling and fibrosis. These findings support advancement of CS014 into Phase II clinical development with an initial focus on idiopathic pulmonary fibrosis (IPF). Cereno Scientific is advancing CS014 as a potential new treatment for patients with severe, progressive cardiovascular and pulmonary diseases that currently lack effective therapies.
お知らせ • May 18Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2026, at 11:00 W. Europe Standard Time. Location: maqs advokatbytas premises, masthamnsgatan 13, gothenburg Sweden
お知らせ • Apr 02Cereno Scientific Reports Favorable Safety and Tolerability After 12 Months of Cs1 Treatment in Pah from the Expanded Access ProgramCereno Scientific announced initial learnings from the 12-month Expanded Access Program (EAP) with its lead drug candidate CS1 in pulmonary arterial hypertension (PAH). The data confirm a favorable safety and tolerability profile over long-term treatment, consistent with previous Phase IIa results, further strengthening the value proposition of CS1 as an oral, once-daily potentially disease-modifying therapy. The Expanded Access Program (EAP) enrolled ten patients who had completed the Phase IIa trial, enabling continued treatment with CS1 under physician supervision. Initial learnings from the completed 12-month treatment period show that CS1 was well tolerated, with no unexpected safety concerns observed. No deaths were reported, and no discontinuations were reported to be related to CS1. Six out of ten patients completed the full 12 months of continuous treatment with CS1. Of the remaining patients, two discontinued CS1 treatment following atrial fibrillation events, which was assessed as not related to CS1; one withdrew consent, and one was lost to follow-up. The EAP was conducted under a formal FDA protocol and initiated following requests from patients and physicians. It enabled the generation of additional long-term data beyond the three-month Phase IIa trial, which had demonstrated that CS1 had favorable safety and tolerability and showed encouraging efficacy signals, including improvements in right heart function, functional class and patient quality of life, with signs consistent with reverse vascular remodeling. Together, the Phase IIa trial and the EAP provide up to 15 months of treatment experience in patients, further strengthening the overall clinical understanding of CS1 in PAH. The EAP was initiated following positive results of the Phase IIa trial, which evaluated the safety, tolerability, pharmacokinetics, and exploratory efficacy of CS1 on top of standard therapy in patients with PAH. The Phase IIa trial was conducted at 10 US clinics over 3 months with a total of 25 patients of which 21 were evaluated for efficacy parameters. The trial successfully met its primary endpoint of safety and tolerability, with no drug-related serious adverse events. Encouraging efficacy signals were observed in the trial, including improvements in right heart function, functional class and patient quality of life, with early signs consistent with reverse vascular remodeling. Preparations for a larger, placebo-controlled global Phase IIb study of CS1 in PAH are ongoing, with first patient enrollment anticipated in June 2026. Further analyses from the EAP, including results from the exploratory imaging sub-study using Fluidda's technology, are planned to be communicated during Second Quarter 2026. CS1 is an orally administered histone deacetylase inhibitor (HDACi) in development as a well-tolerated, disease-modifying therapy for pulmonary arterial hypertension (PAH) with favorable safety profile. Acting through epigenetic modulation, CS1 targets key disease-driving mechanisms such as vascular remodeling, fibrosis and inflammation. CS1 has shown disease-modifying potential in early clinical evaluation and is being evaluated as an add-on (on top of standard-of-care) therapy with the potential to improve outcomes for patients with high unmet medical needs. It has been granted Orphan Drug Designation (ODD) in both the U.S. and the EU and received Fast Track designation from the U.S. FDA in August 2025, underscoring its potential to address a serious condition with high unmet medical need. CS1 has first-in-class potential and is currently in preparation for a global Phase IIb trial.
お知らせ • Mar 18Cereno Scientific AB Receives Approval to Initiate Fda-Aligned Phase I Pharmacokinetic Study of Cs014 Supporting Phase Ii Development in Ph-IldCereno Scientific announced that the Swedish Medical Products Agency has 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 the planned Phase II trial in pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the First Quarter 2027. The approved study is a Phase I, open-label, randomized, two-period crossover pharmacokinetic (PK) trial in 14 healthy adult volunteers. The study will evaluate steady-state pharmacokinetics following seven days of repeat oral dosing of CS014 compared to valproic acid (VPA), a well-established HDAC inhibitor. The primary objective is to characterize total and unbound plasma concentrations of CS014 at steady state compared to VPA. Following a constructive pre-IND meeting, the FDA indicated that comparative bioavailability data would be acceptable to support the initiation of a Phase IIb trial with CS014. The pharmacokinetic comparison allows Cereno Scientific to leverage the extensive clinical experience with VPA to strengthen the CS014's safety package. A successful trial is expected to remove the need for additional nonclinical safety studies and a clinical Phase IIa trial, allowing Cereno Scientific to progress directly toward Phase IIb preparations. CS014 is a precision deuterated HDAC inhibitor and proprietary new chemical entity within Cereno Scientific's differentiated HDAC inhibitor platform. Designed as a multi-modal epigenetic modulator, CS014 aims to optimize pharmacokinetics and metabolic stability while targeting underlying disease mechanisms such as fibrosis, vascular remodeling, inflammation and thrombosis, which are central drivers in several cardiopulmonary diseases.
お知らせ • Feb 05Cereno Scientific Provides Update on Expanded Access Program for CS1Cereno Scientific announced the last patient's last visit concluded the 12-month active study period of the CS1 Expanded Access Program (EAP) in pulmonary arterial hypertension (PAH). Initial learnings from the EAP expected to be available in the first quarter of 2026 and further analyses planned during second quarter of 2026, contributing to the ongoing CS1 development program and its overall value proposition. The Expanded Access Program (EAP) for CS1 was initiated following the completion of the Phase IIa study to enable eligible patients with pulmonary arterial hypertension (PAH) to continue treatment with CS1 under physician supervision. The Phase IIa trial, conducted over 3-months, demonstrated that CS1 was well-tolerated with a favorable safety profile, and showed promising efficacy signals, including improvements in right heart function, patient quality of life, and signals consistent with reverse vascular remodeling. The EAP program enrolled 10 patients who had completed the Phase IIa study, enabling the collection of longer-term information on safety and tolerability during extended use of CS1. Insights generated from the EAP, including the exploratory imaging sub-study of vascular changes in the lung, are intended to complement the Phase IIa results and support the ongoing clinical development of CS1. The EAP is now entering standard processes including database lock, quality assurance and subsequent analysis and interpretation. Initial learnings from the program are expected to be communicated in First Quarter 2026, with additional analyses and interpretation planned during Second Quarter 2026. In parallel, preparations for the global Phase IIb study of CS1 in PAH are progressing, including start-up activities in the United States and planned regulatory interactions in Europe and South America. First patient enrollment in the Phase IIb study is anticipated in the second quarter of 2026.
お知らせ • Feb 04Cereno Scientific AB (publ) Broadens Development Focus for CS014 to Pulmonary Hypertension Associated with Interstitial Lung DiseaseCereno Scientific announced that it is broadening the development focus of its HDAC inhibitor CS014 to pulmonary hypertension associated with interstitial lung disease (PH-ILD). The broadened 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. CS014 has been developed with idiopathic pulmonary fibrosis (IPF) as the intended initial indication. Secondary lung diseases (ILDs) comprise a group of fibrotic lung disorders, of which IPF is the most common and a key disease where CS014 remains highly relevant. A substantial proportion of patients with ILD, including many with IPF, go on to develop pulmonary hypertension, a complication associated with significantly worse prognosis. Broadening the development focus to PH-ILD reflects these disease characteristics and allows CS014 to be evaluated in patients where both fibrotic lung disease and pulmonary vascular pathology play a central role. The rare disease PH-ILD is a severe and life-limiting condition associated with markedly worse outcomes compared with fibrotic lung disease alone, including IPF without pulmonary hypertension. PH-ILD patients who develop pulmonary hypertension experience reduced exercise capacity, faster disease progression and high mortality, while treatment options remain very limited and largely focused on symptom management rather than disease modification. CS014 is a novel, orally administered HDAC inhibitor with potential to address underlying disease mechanisms in severe cardiopulmonary diseases. With a completed Phase I study and a broadened development focus on PH-ILD, Cereno Scientific is advancing preparations for a Phase II study planned to be initiated in first quarter 2027.
お知らせ • Jan 14Cereno Scientific Announces First Peer-Reviewed Publication on HDAC Inhibitor CS014: Antithrombotic EfficacyCereno Scientific announced the publication of the first peer-reviewed manuscript describing CS014, a new chemical entity (NCE) and HDAC inhibitor, in the Journal of Thrombosis and Haemostasis. The work reveals the chemical structure of the CS014 molecule, data on its potential mechanism of action and some of its important nonclinical pharmacology; highly efficacious antithrombotic effects at doses in animals that do not jeopardize hemostasis. 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. The manuscript, "Novel HDAC inhibitor, CS014, attenuates in vivo thrombosis while maintaining hemostasis," characterizes CS014 as a novel histone deacetylase (HDAC) inhibitor, engineered to improve upon valproic acid (VPA) through reduced hepatotoxicity risk while preserving the mechanistic benefits of HDAC inhibition. The work shows that CS014 maintains efficacious HDAC inhibitory activity, increases tPA mRNA expression and produces strong antithrombotic effects in small artery, large artery and large vein models. Notably, CS014 achieves these effects while preserving normal coagulation and bleeding time, and it produces substantially lower levels of the hepatotoxic 4-ene metabolite compared with VPA in, in vitro and in vivo systems. Access to the manuscript: Stanger, Livia et al. (2025) Novel histone deacetylase inhibitor, CS014, attenuate in vivo thrombosis While maintaining hemostasis. Journal of Thrombosis & Haemostasis. CS014 is being developed as a next-generation HDAC inhibitor and novel chemical entity designed to modulate epigenetic pathways that target the root cause of cardiovascular and pulmonary diseases. Non-clinical studies have demonstrated potent effects on pathways involved in vascular remodeling and fibrosis, which are key drivers of disease progression in several cardiovascular and pulmonary conditions and suggests disease-modifying potential. The recently completed Phase I study confirmed that CS014 has a favorable safety profile and is well tolerated at and above exposure levels that, based on non-clinical data, are predicted to support maximal effects on the reversal of pulmonary vascular remodeling and fibrosis. These findings support advancement of CS014 into Phase II clinical development with an initial focus on idiopathic pulmonary fibrosis (IPF). Cereno Scientific is advancing CS014 as a potential new treatment for patients with severe, progressive cardiovascular and pulmonary diseases that currently lack effective therapies.
お知らせ • Dec 31+ 4 more updatesCereno Scientific AB (publ) to Report Fiscal Year 2025 Final Results between Apr 13, 2026 and Apr 17, 2026Cereno Scientific AB (publ) announced that they will report fiscal year 2025 final results on between Apr 13, 2026 and Apr 17, 2026
お知らせ • Dec 11Cereno Scientific AB Receives FDA Clearance to Initiate Global Phase IIb Trial of CS1 in Pulmonary Arterial Hypertension (PAH)Cereno Scientific AB announced that the U.S. Food and Drug Administration (FDA) has granted clearance to initiate the company's Phase IIb trial of its lead drug candidate CS1 for the treatment of pulmonary arterial hypertension (PAH). The FDA's decision enables Cereno to advance toward first patient in (FPI) in second quarter 2026, with top-line data anticipated around fourth quarter 2028, subject to enrollment timelines. The clearance follows constructive regulatory interactions and builds on the favorable safety, tolerability and encouraging disease-modifying signals observed in the Phase IIa study. CS1 has also been granted Orphan Drug Designation and Fast Track designation in the U.S. The Phase IIb trial is formally titled "A Phase 2b, Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study, to compare the Efficacy and Safety/Tolerability of CS1 Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH). It is a global, multicenter trial enrolling approximately 126 patients with PAH who are stable on background therapy. The study will evaluate the effect of CS1 on pulmonary vascular resistance (PVR) at Week 36 via right-heart catheterization, changes in 6-minute walk distance at Week 36, and a range of additional evaluations including measures of heart function, biomarker changes, clinical worsening, patient-reported outcomes, and pharmacokinetics. This dose-finding trial is expected to be conducted across 10-12 countries in the U.S., Europe and South America at approximately 65 investigative sites. Acting through epigenetic modulation, CS1 targets key disease-driving mechanisms such as vascular remodeling, fibrosis and inflammation. CS1 has shown disease-modifying potential in early clinical evaluation and is being evaluated as an add-on (on top of standard-of-care) therapy with the potential to improve outcomes for patients with high unmet medical needs. It has been granted Orphan Drug Designatedation (ODD) in both the U.S. and the EU and received Fast Trackdesignation from the U.S. FDA in August 2025, underscoring its potential to address a serious condition with high unmet medical need. CS1 has first-in-class potential and is currently in Phase II clinical development.
お知らせ • Dec 05Cereno Scientific AB to Present New Data of CS014 at the Pharmacology 2025 on December 15-18Cereno Scientific AB announced that the company will present new data of CS014 at the scientific conference Pharmacology 2025 organized by the British Pharmacology Society on December 16-18 in Belfast, Northern Ireland. The findings relate to CS014's preclinical studies and Phase I trial, supporting advancement of the program into Phase II development. CS014 is being developed as a next-generation HDAC inhibitor and novel chemical entity designed to modulate epigenetic pathways that target the root cause of cardiovascular and pulmonary diseases. Non-clinical studies have demonstrated potent effects on pathways involved in vascular remodeling and fibrosis, which are key drivers of disease progression in several cardiovascular and pulmonary conditions. The recently completed Phase I study confirmed that CS014 has a favorable safety profile and is well tolerated at and above exposure levels that, based on non-clinical data, are predicted to support maximal effects on the reversal of pulmonary vascular remodeling and fibrosis. These findings support advancement of CS014 into Phase II clinical development with an initial focus on idiopathic pulmonary fibrosis.
お知らせ • Nov 29Cereno Scientific AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 99.999942 million.Cereno Scientific AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 99.999942 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 14,285,706 Price\Range: SEK 7 Transaction Features: Subsequent Direct Listing
お知らせ • Nov 10Cereno Scientific Submits Phase IIb Trial Protocol for CS1 in Pulmonary Arterial Hypertension to the U.S. FDACereno Scientific announced the submission of the clinical trial protocol for the planned global Phase IIb trial of its lead drug candidate CS1 to the U.S. Food and Drug Administration (FDA). The submission marks an important milestone, moving the company closer to advancing CS1 into its next clinical phase and toward bringing a novel therapeutic approach to patients living with pulmonary arterial hypertension (PAH). The planned Phase IIb trial is designed to further evaluate the safety, tolerability and efficacy of CS1, a histone deacetylase inhibitor (HDACi) in development as an oral treatment targeting the root mechanisms of PAH through epigenetic modulation. The Phase IIb trial will build on the results from the completed Phase IIa trial, where CS1 demonstrated a favorable safety and tolerability profile together with encouraging efficacy signals including reverse vascular remodeling, improved right heart function, and enhanced patient quality of life. The new global, multicenter, placebo-controlled trial will be conducted in collaboration with a leading international contract research organization (CRO). Regulatory interactions in other key regions will follow as part of the global start-up preparations.PA His a rare, progressive and life-threatening disease characterized by high blood pressure in the pulmonary arteries that leads to right heart failure and premature death. Current standard treatments mainly focus on managing symptoms, leaving a significant unmet need for disease-modifying therapies that can change the course of disease and improve long-term outcomes. Following the FDA's standard 30-day review, Cereno Scientific anticipates clearance to proceed with the trial. The Phase IIb trial is planned to begin during H1 2026 as part of the company's global development program for CS1.
お知らせ • Aug 26Cereno Scientific Receives Fda Fast Track Designation for Cs1 in Rare Disease Pulmonary Arterial Hypertension (Pah)Cereno Scientific announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead program, CS1,for the treatment of pulmonary arterial hypertension (PAH). Fast Track designation is designed to accelerate the development and regulatory review of new therapies for serious conditions with high unmet medical need. The designation highlights CS1's potential as a differentiated treatment approach for PAH, a rare and progressive disease where safer, disease-modifying therapies are urgently needed. The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions with the potential to address unmet medical needs. Fast Track designation enables closer and more frequent interaction with the FDA, eligibility for rolling review, and potential priority review, with the goal of bringing promising treatments to patients more quickly. Drug candidate CS1 is an oral HDAC inhibitor (HDACi) with a unique mechanism of action through epigenetic modulation. In a Phase IIa trial in PAH, CS1 met its primary endpoint of safety and tolerability while showing encouraging efficacy signals in a Phase II a trial in PAH, including improvement of REVEAL risk score, functional class, quality of life, and early signs 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 modulation 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.
