Cereno Scientific（4A1）株式概要セレノサイエンティフィックAB（publish）は、臨床段階のバイオテクノロジー企業で、世界中の心血管疾患や希少疾患の治療薬を開発している。 詳細4A1 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。 German市場と比較して、過去 3 か月間の株価の変動が非常に大き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4A1 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 Value€Current Price€0.42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Heidelberg PharmaSymbol: XTRA:HPHAMarket cap: €122.6mGenetic AnalysisSymbol: DB:8V8Market cap: €46.2mFormyconSymbol: XTRA:FYBMarket cap: €335.8mDextech MedicalSymbol: DB:LQ0Market cap: €195.0m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 0.4252週高値SEK 0.9152週安値SEK 0.39ベータ-0.371ヶ月の変化-21.89%3ヶ月変化-21.89%1年変化-51.29%3年間の変化776.92%5年間の変化-3.59%IPOからの変化48.52%最新ニュースNew Risk • Jun 12New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr174m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr201m net loss in 2 years).Reported Earnings • May 27First quarter 2026 earnings releasedFirst quarter 2026 results: Revenue: kr39.0m (up 137% from 1Q 2025). Net loss: kr28.6m (loss widened 14% from 1Q 2025). Revenue is expected to decline by 142% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Europe are expected to grow by 15%.Board Change • May 20No independent directorsThere are 4 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 4 new directors. 6 experienced directors. No highly experienced directors. No independent directors (5 non-independent directors). Director Anders Svensson is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of experienced directors.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.最新情報をもっと見るRecent updatesNew Risk • Jun 12New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr174m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr201m net loss in 2 years).Reported Earnings • May 27First quarter 2026 earnings releasedFirst quarter 2026 results: Revenue: kr39.0m (up 137% from 1Q 2025). Net loss: kr28.6m (loss widened 14% from 1Q 2025). Revenue is expected to decline by 142% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Europe are expected to grow by 15%.Board Change • May 20No independent directorsThere are 4 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 4 new directors. 6 experienced directors. No highly experienced directors. No independent directors (5 non-independent directors). Director Anders Svensson is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of experienced directors.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.お知らせ • Jul 16Cereno Scientific AB Announces Positive Topline Results from Phase I Trial of CS014Cereno Scientific AB announced positive topline results from its Phase I trial of CS014, a novel HDAC inhibitor in development for idiopathic pulmonary fibrosis (IPF). The trial confirms a favorable safety and tolerability profile, and data support further clinical evaluation. Based on the findings, preparations are underway to initiate a Phase II trial. The Phase I trial evaluated safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The trial was conducted in two parts: part one explored safety, tolerability and PK of single ascending oral doses (SAD) of CS014; part two explored safety, tolerability, PK, and PD following multiple ascending doses (MAD) of CS014, dosed for seven days. In total, 48 subjects were included in the trial, 30 in the SAD and 18 in the MAD part. The trial was conducted by CTC in Uppsala, Sweden. Summary of the topline results from the Phase I trial: CS014 demonstrated favorable safety and tolerability in healthy volunteers. All 48 healthy volunteers completed the study; no early withdrawals or deaths were reported. No serious adverse events (SAEs) occurred. All treatment-related adverse events (AEs) reported were mild, transient, and fully recovered. CS014 achieved levels in the blood stream at and above those projected, based on non-clinical data, to be required for achieving maximal effects on reversal of pulmonary vascular remodeling and fibrosis. These findings, combined with non-clinical data demonstrating a favorable impact on plexiform lesions in the SAD/Hypoxia rat model, offer insights that support dose selection and support advancement into Phase II development. "CS014 is a novel HDAC inhibitor with a unique mechanism of action through epigenetic modulation that could represent a differentiated treatment approach for IPF. These positive Phase I results, combined with strong non-clinical data, give confidence as it advance into Phase II clinical development. CS014 is a cornerstone of broader HDAC inhibitor portfolio, which believe holds significant disease-modifying potential across a range of rare cardiovascular and pulmonary diseases. The company is advancing plans to prepare for a Phase II trial initiation in H1 2026. Full results from the Phase I trial will be submitted for publication in a peer-reviewed scientific journal.お知らせ • Jul 04Cereno Scientific Selects Top-Tier Global Contract Research Organization for Phase IIb Trial of CS1 in the Rare Disease Pul Arterial HypertensionCereno Scientific announced that the company has signed an agreement with a top-tier global contract research organization (CRO) relating to the Phase IIb trial of CS1. The selection of a CRO is an important step in the clinical development for CS1 and marks a significant milestone toward the initiation of the Phase IIb trial. CS1 has the potential to become an effective disease-modifying treatment to enhance and extend life for patients with pulmonary arterial hypertension (PAH). Partnering with a CRO that combines deep expertise in the disease area with a well-established network of seasoned investigators is essential to the successful execution of clinical trials. This CRO has a proven track record in PAH trials providing access to both highly experienced clinical teams and a broad, well-characterized patient population. Their extensive experience and robust infrastructure are important capacities as the lead candidate CS1's clinical program in the rare disease PAH. The Phase IIb trial of CS 1 is planned as a global, multi-center, placebo-controlled trial designed to further evaluate the encouraging efficacy signals observed in the Phase IIa trial, including reverse vascular remodeling and improvement of right heart function. In May 2025, the U.S. FDA provided an endorsement of the plans for the Phase IIb trial through a Type C meeting. Preparations for an IND submission are underway, with trial initiation targeted for H1 2026, pending regulatory approvals.お知らせ • Jun 30Cereno Scientific AB (publ) Announces Top-Line Results of the CS014 Phase I Trial to Be Announces Mid-July 2025Cereno Scientific announced that the top-line results of CS014's Phase I trial will be announced mid-July 2025. The previously communicated timeline was June 2025. The Phase I trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The trial was conducted in two parts: part one explored safety, tolerability and PK of single ascending oral doses (SAD) of CS014; part two explored safety, tolerability, PK, and PD following multiple ascending doses (MAD) of CS014, dosed for seven days. In total, 48 subjects were included in the trial, 30 in the SAD and 18 in the MAD part. The trial was conducted in Sweden.お知らせ • Jun 10Cereno Scientific AB (Publ) Announces Board ElectionsCereno Scientific AB (publ) announced that at its AGM held on June 10, 2025, shareholders approved the election of Moi Brajanovic as new board member. Jeppe Øvlesen was elected as chairman of the Board of Directors.お知らせ • May 23Cereno Scientific AB Receives Approval from FDA on Plans for Phase IIb Trial of CS1 in Rare Disease Pulmonary Arterial Hypertension (PAH)Cereno Scientific announced that the US Food & Drug Administration (FDA) provided endorsement of the plans for the Phase IIb trial of CS1 as noted by the official meeting minutes from the Type C-me meeting held on April 21. The next clinical development step of CS1 is a larger, placebo-controlled Phase IIb trial aiming to further evaluate the encouraging efficacy signs including reverse vascular remodeling and improvement of right heart function as observed in the Phase IIa trial. The plans for the Phase IIb trials are in alignment with the expectations of the FDA, meaning that the company have high confidence that the Phase IIb trial design will include the relevant criteria contributing to the development program's marketing approval process. Drug candidate CS1 is a well-tolerated oral therapy with a favorable safety profile and showed signals of disease-modifying effects as observed in a Phase IIa trial in patients with the rare disease pulmonary arterial hypertension (PAH). The aim for CS1 is to offer an effective disease-modifying treatment with the ability to enhance quality of life and extend life for PAH patients. Unlike standard therapy that focus on managing symptoms, CS1 represents a novel therapeutic approach by targeting the root mechanisms of PAH. Preparations are currently underway for a larger placebo-controlled Phase IIb trials to continue advancing CS1 toward regulatory approval and wider patient access. The Phase IIb trial is planned to be initiated in first half 2026.お知らせ • May 13Cereno Scientific AB Presents Cs1's Phase Iia Trial Results At the 5Th Baltic Pulmonary Hypertension Conference 2025Cereno Scientific AB announced that 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 on May 9, 2025, in Kaunas, Lithuania. The data presented in an abstract at the Baltic PH Conference highlighted key results from the Phase IIa trial of CS1 in PAH. The primary endpoint of safety and tolerability was met without any drug-related safety concerns. After 12 weeks, REVEAL Risk Score 2.0 was improved from baseline in 40.9% of patients and stable in a further 31.8% of patients. A total of 31.8% and 54.5% of patients improved or maintained their NYHA/WHO functional class, respectively. The majority of patients (71%) showed an improvement in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The abstract concludes that the findings from the Phase IIa trial suggest that treatment with CS1 in patients with pulmonary arterial hypertension (PAH) improve risk score, functional class and quality of life. The conclusion states that CS1 warrants further study. Atiane Abreu Dall'Agnol, Medical Director at Cereno Scientific, presented the abstract at the conference. A publication of the Phase IIa trial results of CS1 in PAH is in development with the aim be published during H2 2025. Abstract details: Benza, R., et al. (2025). Exploratory outcomes of CS 1 in pulmonary arterial hypertension: Phase 2A, prospective, randomized, open-label, multicenter trial Raymond [Abstract). Abstracts book of the 5th Baltic PulmonaryHypertension Conference 2025, Kaunas, Lithuania. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis. Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor receptor antagonist 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 Thrombic pulmonary fibrosis.お知らせ • Apr 22Cereno Scientific AB Completes Successful FDA Meeting Discussing Further Clinical Development of Drug Candidate CS1 in Rare Disease PAHCereno Scientific AB announced that the company has completed a Type C meeting with the U.S. Food and Drug Administration (FDA). The intention was to seek advice from the FDA to finalize the Phase IIb trial design and align on further clinical development steps for CS1 based on the encouraging signals suggesting reverse vascular remodeling effects observed in the Phase IIa trial. The discussions during the meeting indicate alignment between the FDA and Cereno Scientific on the plans. An update on the CS1 program will be shared following receipt of the official meeting minutes. The FDA Type C meeting that was held on April 21, 2025, focused on finalizing the design of the Phase IIb trial and aligning on further clinical development steps. Cereno Scientific plans to give an update on CS1's development program following receipt of the official Meeting minutes, which are expected approximately one month after the meeting. Drug candidate CS1 is an epigenetic modulating HDACi that aims to improve quality of life and extend life expectations for patients with the rare disease pulmonary arterial hypertension (PAH). A Phase IIa trial showed that CS1 has a favorable safety profile and is well-tolerated as a treatment for people with pulmonary arterial hypertension (PA H). The trial showed efficacy signals suggesting reverse vascular remodeling effect of CS1. This was accompanied by signals suggesting improved right ventricular function, functional class (NYHA) and quality of life (QoL) as well as improved REVEAL 2.0 risk score. These parameters indicate better patient outcomes, improvement and/or stabilization of disease progression, as well as improving patient function and proggnosis. Cereno Scientific intends to continue to explore the effects of CS1 on reverse vascular remodeling in further clinical development. A larger placebo-controlled Phase IIb trial is being planned to confirm and expand upon these effects.お知らせ • Apr 16Cereno Scientific Reports That Its Phase I Trial of CS014 Has Been Concludes and Confirms That Top-Line Results Are Anticipated in June 2025Cereno Scientific announced that the second and final part of the Phase I trial of drug candidate CS014 in healthy volunteers has been concluded with the last patient's last visit. The Phase I trial intends to primarily evaluate the safety and tolerability profile of CS014 in humans and is divided into two parts - a single ascending dose part (SAD) and a multiple ascending dose part (MAD). Data management, database lock, and analysis will now commence after the last patient's last visit, and the trial's top-line results are expected to be announced in June 2025. The new chemical entity 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). Drug candidate CS014 has shown strong vascular remodeling effects in preclinical studies, which indicates a disease-modifying potential. The Phase I trial of CS014 conducted by Cereno's CRO partner CTC in Uppsala evaluated safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending oral doses and multiple ascending oral doses of CS014 for seven days in 48 healthy volunteers. Completed in February 2025, part one of the trial indicated that CS014 has an acceptable safety and tolerability profile supporting its potential for further clinical development. Top-line results of the complete Phase I trial will be available in June 2025. The Phase I trial is an open-label, first-in-man trial designed to evaluate safety, tolerability, pharmacodynamics (PK), and pharmacodynamics ("PD) of single ascending oral dose of CS014 and multiple ascending oral doses ofCS014 for seven days in healthy volunteers. The Phase I trial ofCS014 involves 48 subjects. Top-line results of The study is anticipated in June 2025.お知らせ • Mar 17Cereno Scientific Extends Patent Protection for Drug Candidate CS1 in the US and Has Filed to Extend Market Exclusivity to 2045Cereno Scientific announced that a new patent has been granted in the US for drug candidate CS1's second patent family. Two patent applications have, additionally, been filed based on the encouraging efficacy signals observed in the recently completed Phase IIa trial of CS1 in the rare disease pulmonary arterial hypertension (PAH). These patent applications combined with the existing patent portfolio has the potential to extend the market exclusivity for CS1 in PAH to 2045. The granted patent in the US is the third approved patent for the second patent family, which broadens the protection already obtained in this key market for drug candidate CS1. The patent is titled "Valproic acid for the treatment or prevention of pathological conditions associated with excess fibrin deposition and/or thrombus formation" and has been given patent number 12,245,999 by the US Patent Office (USPTO). The two newly filed patent applications relate to the recently completed Phase IIa trial in PAH. The trial showed efficacy signals suggesting reverse vascular remodeling effects of CS1. This was accompanied by signals suggesting improved right ventricular function, functional class (NYHA) and quality of life (QoL) as well as improved REVEAL 2.0 risk score. These parameters indicate better patient outcomes, improvement and/or stabilization of disease progression, as well as improving patient function and prognosis. The trial also showed that CS1 has a good safety profile and is well-tolerated. An ongoing Extended Access Program (EAP) allowing patients to continue CS1 treatment will provide further insight into the long-term disease-modification effects of CS1. A sub-study of the EAP utilizes the non-invasive imaging technology Functional Respiratory Imaging (FRI) developed by Fluidda to visualize how long-term treatment of CS1 on top of standard therapy may impact changes in pulmonary arteries. Cereno Scientific intends to continue to explore the effects of CS1 on reverse vascular remodeling in further clinical development. A larger placebo-controlled Phase IIb trial is being planned to confirm and expand upon these effects.お知らせ • Mar 12Cereno Scientific Secures FDA Meeting to Advance Its Development of CS1 for the Treatment of Rare Disease PAHCereno Scientific announced that a Type C meeting has been scheduled on April 21, 2025, by the U.S. Food and Drug Administration (FDA). The intention is to seek advice from the FDA to reach alignment on multiple aspects of the planned development program of CS1 based on the encouraging signals suggesting reverse vascular remodeling effects of CS1 observed in the Phase IIa trial. An update on the results of the meeting with the FDA is planned to be shared upon receipt of the written meeting minutes. Drug candidate CS1 is an epigenetic modulating HDACi that aims to improve quality of life and expand life expectancy for patients with the rare disease pulmonary arterial hypertension (PAH). The FDA Type C meeting, scheduled for April 21, 2025, will focus on finalizing the design of the Phase IIb trial and aligning on further clinical development steps. Cereno Scientific plans to give an update on the results of the meeting following receipt of the written meeting minutes, which are expected approximately one month after the meeting. The Phase IIa trial in PAH showed that CS1 has a good safety profile and is well-tolerated. The trial showed efficacy signals suggesting reverse vascular remodeling effects of CS1. This was accompanied by signals suggesting improved right ventricular function, functional class (NYHA) and quality of life (QoL) as well as improved REVEAL 2.0 risk score. These parameters indicate better patient outcomes, improvement and/or stabilization of disease progression, as well as improving patient function and prognosis. Cereno Scientific intends to continue to explore the effects of CS1 on reverse vascular remodeling in further clinical development. A larger placebo-controlled Phase IIb trial is being planned to confirm and expand upon these effects.お知らせ • Feb 25Cereno Scientific Announces Additional Phase IIa Trial Data with Drug Candidate CS1 in Pulmonary Ar Arterial Hy Hypertension (PAH) Following the Clinical Study Report CompletionCereno Scientific announced additional Phase IIa trial data with drug candidate CS1 in pulmonary arterial hypertension (PAH) following the Clinical Study Report (CSR) completion. The company see 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. An ongoing Extended Access Program (EAP) allowing patients to continue CS1 treatment will provide further insight into the long-term disease-modification effects of CS1. A larger placebo-controlled trial is being planned to confirm and expand upon these compelling findings. 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. PAH is a progressive and fatal disease with pathological changes to the pulmonary vasculature and the right-heart. Despite the trial's short duration, CS1 showed improvement of right-ventricular function signaling a disease-modifying effect by halting disease progression or through the reversal of pathological vascular remodeling. Based on these encouraging findings and the completed Clinical Study Report, the company have now initiated a Type C meeting with the FDA to align the next development steps of CS1 and in parallel the publication of scientific data. The Phase IIa trial was conducted over 12 weeks 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.お知らせ • Feb 22Cereno Scientific to Evaluate CS1 with Advanced Imaging TechnologyCereno Scientific announced that a sub-study with CS1 within the ongoing Extended Access Program (EAP) now can commence following regulatory approvals. The study will utilise Fluidda's imaging technology to deepen the understanding of the drug candidate's potential to prevent and reverse pathological remodeling of blood vessels in the lung of patients with the rare disease pulmonary arterial hypertension (PAH). Moreover, company has requested a Type C meeting with the FDA to discuss the next development steps for CS1.お知らせ • Feb 20Cereno Scientific Submits Type C Meeting Request with FDA for Phase II Drug Candidate CS1 in Preparation for Further Clinical DevelopmentCereno Scientific announced that a Type C meeting request has successfully been submitted to the U.S. Food and Drug Administration (FDA). Based on the encouraging signals from the Phase IIa trial, Cereno Scientific wants to further explore the effects of CS1 on reverse remodeling in PAH. The meeting is intended to align the next development steps of CS1 with the FDA and is expected to be held within 75 days in accordance with FDA's timelines. Drug candidate CS1, an HDACi, is in development aiming to be an effective disease-modifying treatment with ability to improve quality of life and expand life expectancy for patients with the rare disease pulmonary arterial hypertension (PAH) as an oral, safe, and well-tolerated therapeutic option. In a Type C meeting, the role of FDA is to evaluate the risk benefit profile of a product for the indication and patient group it is intended to address. FDA can and will provide specific feedback about the sufficiency of the development plan provided in the briefing package to address any potential concerns. A Type C meeting will be scheduled within 75 calendar days from receipt of the meeting request according to FDA timelines.お知らせ • Feb 19Cereno Scientific AB Receives Approval to Initiate Sub- Study of the CS1 EAP Using Fluidda's Innovative Imaging Technology to Obtains Insights on the Long-Term Disease-Modifying Potential of CS1 in PAHCereno Scientific AB announced that a sub-study of the ongoing CS1 Expanded Access Program (EAP) will be initiated after obtaining all necessary regulatory approvals. The study will be using non-invasive imaging technology from innovative medtech company Fluidda to further assess CS1's disease-modifying potential to prevent or reverse pathological remodeling of blood vessels in the lung of patients with the rare disease pulmonary arterial hypertension (PAH). The local Institutional Review Board (IRB) has approved the sub-study design, enabling Cereno Scientific to immediately initiate the study. The study is intended to support the translation of the well-documented reverse vascular remodeling effects of CS1 in preclinical models to clinical practice. The lack of non-invasive methods available to demonstrate this effect in patients present a challenge. The innovative imaging technology Functional Respiratory Imaging (FRI), developed by Fluidda, has been explored as a potential non-invasive tool to solve this challenge by providing detailed, patient-specific insights into pulmonary vascular changes. The study, also referred to as the "Fluidda study", is designed to include three CT scans in certain patients enrolled in the EAP during a 12-month period. 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. The trial showed that CS1 is safe and well-tolerated and revealed compelling data supporting a disease-modifying capacity on top of standard therapy. The EAP comprising 10 patients was approved as an extension of the Phase IIa trial in PAH, allowing patients who have completed the Phase IIa trial to continue CS1 treatment. The EAP, an FDA-approved protocol, enables Cereno to obtain valuable long-term safety and efficacy data of CS1 in PAH patients supporting required regulatory interactions and planning future Phase IIb or pivotal Phase III trials.お知らせ • Feb 13Cereno Scientific's HDAC Inhibitor CS014 AdvancesCereno Scientific announced that the first part of the phase I study with the HDAC inhibitor CS014 has been completed without any safety issues. The study evaluates the safety profile of the drug candidate, which is being developed for the treatment of the rare disease idiopathic pulmonary fibrosis (IPF).お知らせ • Feb 11Cereno Scientific's HDACi CS014 Successfully Completed Part One of Its Phase I Trial Evaluating the Safety Profile with A Single Ascending Dose (Sad) StudyCereno Scientific announced that drug candidate CS014 has completed the first part of two in its Phase I trial in healthy volunteers without any safety concerns. CS014 is a novel histone deacetylase (HDAC) inhibitor with disease-modifying potential being developed for the rare disease idiopathic pulmonary fibrosis (IPF). The Phase I trial intends to evaluate the safety profile of CS014 in humans and is divided into two parts - a single ascending dose part (SAD) and a multiple ascending dose part (MAD). Part two of the trial (MAD) is currently ongoing according to plan and the Phase I trial is expected to be completed in mid-2025. HDACi CS014 has the potential to transform the treatment landscape of IPF. Drug candidate CS014 is a new chemical entity that acts through HDACi with strong vascular remodeling effects and disease-modifying potential as seen in preclinical studies. The potential of the HDACis has been demonstrated through preclinical studies including reversal of pathological remodeling of pulmonary vessels and anti-fibrotic effects in an animal model of PAH, as well as in vivo anti-thrombotic effects across a broad range of vasculature. These properties align with the key disease mechanisms of idiopathic pulmonary fibrosis (IPF) and addresses significant unmet medical needs. The HDACi CS014 has a safety and efficacy profile that is consistent with the significant medical needs remaining despite current IPF treatments. Part one of the Phase I trial of CS014 conducted by our CRO partner CTC in Uppsala explored the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses (SAD) of CS014 in 30 patients. This first part of the trial has successfully been completed with results showing that CS014 exhibited an acceptable safety profile supporting its potential for further clinical development. The Phase I trial is an open-label, first-in-man trial designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The Phase I trial of CS014 will involve approximately 48 subjects and is expected to be completed mid-2025 whereafter top-line results can be shared after data analysis has been conducted.お知らせ • Dec 27Cereno Scientific Enters 9 Additional Patients in its Expanded Access Program with CS1 Providing More Long-Term Safety and Efficacy Data in Rare Disease PAHCereno Scientific announced that 9 additional patients have entered its Expanded Access Program (EAP) with drug candidate CS1 in rare disease pulmonary arterial hypertension (PAH). In total, the EAP now includes 10 patients with the possibility of more patients being included in the coming months. 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. Drug candidate CS1 has been approved by the FDA for an Expanded Access Program as an extension of the Phase IIa trial in PAH. This program allows patients who have completed the Phase IIa trial to continue CS1 treatment if deemed suitable by physicians in the study. Through the recently entered collaboration with innovative medical company Fluidda, their non-invasive imaging technology called Functional Respiratory Imaging (FRI) will be used on certain patients enrolled in the EAP to visualize how long-term use of CS1 influences changes in pulmonary arteries. The EAP, an FDA-approved protocol, enables Cereno to obtain valuable long-term safety and efficacy data of CS1 in PAH patients supporting required regulatory interactions and planning future Phase IIb or pivotal Phase III trials.お知らせ • Nov 14Cereno Scientific Announces Initiation of Multiple Ascending Dose (MAD) Part of Phase I Trial of the Novel HDAC Inhibitor CS014Cereno Scientific announced that the Company has initiated the Multiple Ascending Dose (MAD) part of the first-in-man Phase I trial of novel HDACi CS014, after the Safety Monitoring Committee ensuring that the safety profile in the Single Ascending Dose (SAD) part is within acceptable limits. The CS014 development program is targeting rare disease Idiopathic Pulmonary Fibrosis (IPF). The MAD part (Part II) of the Phase I trial will explore safety, tolerability, pharmacokinetics (PK), and efficacy parameters following multiple ascending doses of CS014, dosed for seven days. The MAD was preceded by the SAD part (Part I) that is exploring safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of CS014. The trial is a Phase I, open-label, first-in-man trial designed to evaluate safety, tolerability, pharmacokinetics, and efficacy parameters of single and multiple ascending oral doses of CS014 in healthy volunteers. The Phase I trial of CS014 will involve approximately 48 subjects and is expected to conclude by mid-2025.お知らせ • Oct 23+ 2 more updatesCereno Scientific AB (publ) to Report Q2, 2025 Results on Aug 27, 2025Cereno Scientific AB (publ) announced that they will report Q2, 2025 results on Aug 27, 2025お知らせ • Oct 17Cereno Scientific AB (publ) Selects Rare Disease Idiopathic Pulmonary Fibrosis as the Initial Target Indication for Novel HDACi CS014Cereno Scientific announced that the Company has selected rare disease Idiopathic Pulmonary Fibrosis (IPF) as the initial target indication for novel HDACi CS014. This decision follows recent preclinical results showing significant reductions in pulmonary artery occlusion and fibrosis. With this move, Cereno strengthens its focus on rare diseases, reinforcing its commitment to addressing the significant needs of patients affected by these conditions. IPF initial target indication for CS014: Idiopathic Pulmonary Fibrosis (IPF) is a rare, progressive, and fatal disease characterized by irreversible scarring (fibrosis) of the lungs. Patients experience significant symptoms, including a persistent dry cough, fatigue, and exertional dyspnea. Over time, this fibrosis leads to a gradual loss of lung function, ultimately resulting in respiratory failure. Mortality rates in IPF are comparable to those of severe cancers. There is currently no cure for IPF, and current treatments have severe tolerability issues. There is an outspoken need for new therapies that can halt and reverse disease progression, extend lifespan and improve quality of life of patients suffering from this disease.Cereno's HDAC inhibitor CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator. The scientific rationale for evaluating CS014 for the treatment of IPF is supported by preclinical studies, which have demonstrated that HDAC inhibitors can effectively reverse fibrosis in models of IPF. The studies also show that HDAC inhibitors prevent the pathological remodeling of pulmonary vessels that ultimately leads to pulmonary hypertension in many IPF patients. The rationale is further strengthened by recently published preclinical data in an established model of PAH showing that CS014 has an effect on reversal of fibrosis and a dose-dependent beneficial effect on pathological vascular remodeling. Together, these findings indicate that CS014 has the potential to address the underlying pathophysiology behind the development of IPF. Patients with IPF have an increased risk of developing venous thromboembolism. CS014 regulates platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as demonstrated in preclinical studies. This adds to the favorable profile of CS014 in relation to the unmet needs of IPF patients. Cereno Scientific eyes pipeline focus on rare diseases: As a result of a chosen initial target indication for CS014, Cereno now advances a pipeline of three innovative drug candidates, two of which are being developed as disease-modifying treatments for rare diseases where high unmet needs persist.お知らせ • Sep 25Cereno Scientific AB (publ) Announces New Preclinical Data Demonstrates Dose Dependent Positive Impact on Reversal of Pulmonary Vascular RemodelingCereno Scientific AB (publ) announced new preclinical data that demonstrates dose dependent reversal of pulmonary vascular remodeling by Cereno's HDAC inhibitor CS014. CS014, having recently entered a Phase I trial in healthy volunteers in June 2024, is a novel histone deacetylase (HDAC) inhibitor being developed by Cereno. CS014 is, together with lead compound CS1 part of Cereno's HDACi program which capitalizes on the principle of epigenetic modulation. Studies of CS014 were conducted in a well-established preclinical model of Pulmonary Arterial Hypertension (PAH). This model exhibits many features in common with the clinical disease, including pulmonary vascular remodeling and fibrosis. Importantly, the model also exhibits so called ‘plexiform lesions’, a pathophysiological hallmark feature of PAH. The study demonstrated that CS014 induced a robust, dose dependent reversal of the pulmonary vascular remodeling in this preclinical PAH model. This included statistically significant reductions in small artery vessel occlusion, plexiform lesions and small vessel related fibrosis. Overall, these preclinical data provide the most compelling evidence to date that CS014 offers a disease modifying approach to PAH and related pulmonary vascular diseases by robustly reversing pulmonary pathological vascular remodeling and fibrosis. Further study details and results will be shared in a future scientific publication.お知らせ • Sep 19Cereno Scientific AB Announces Changes in the Nomination Committee's Composition for the Annual General Meeting 2025Cereno Scientific announced on May 2, 2024, that the Company's nomination committee for the annual general meeting 2025 had been appointed and that it consists of Cihan Punar, Joakim Söderström, and Björn Dahlöf. Cereno Scientific announces that Cihan Punar has informed that he resigns as a member of the Company's nomination committee and that Andreas Ejlegård has been appointed as new member of the nomination committee. Cereno Scientific announces that Cihan Punar has informed that he resigns as a member of the Company's nomination committee. According to the principles for the nomination committee, the nomination committee shall primarily appoint a new member nominated by the shareholder or the group of shareholders which nominated the resigning member, provided that the shareholder or group of shareholders is still the Company's largest shareholder or group of shareholders. Cereno Scientific announces that Andreas Ejlegård has been appointed as a new member of the Company's nomination committee in accordance with the principles and that he thereby replaces Cihan Punar. The Company's nomination committee for the annual general meeting 2025 thus consist of the following members: Andreas Ejlegård, representing the Company's largest group of shareholders per April 30, 2024; Joakim Söderström, convening member and chairman of the Board of Directors of Cereno Scientific; and Björn Dahlöf, CSO and Head of Clinical Development in Cereno Scientific. The nomination committee's term of office extends until a new nomination committee is appointed.Board Change • Sep 10No independent directorsThere are 4 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 4 new directors. 6 experienced directors. No highly experienced directors. No independent directors (5 non-independent directors). Director Anders Svensson is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of experienced directors.お知らせ • Sep 04Cereno Scientific AB Announces New Preclinical Data for Cereno Scientific's Novel IP Receptor Agonist CS585 Presented at ESC Congress 2024Cereno Scientific AB announced new preclinical data indicating that drug candidate CS585, a novel prostacyclin (IP) receptor agonist, inhibits platelet activation and clot formation up to 24 hours post-administration. The new data was presented at the ESC (European Society of Cardiology) Congress 2024, on August 30-September 2, 2024. CS585, was shown to inhibit platelet activation and clot formation in the blood up to 24 hours post administration. In both in vivo and ex vivo models, the sustained effects of CS585 were demonstrated. In contrast, currently FDA-approved IP receptor agonists were shown not to have sufficient duration of action to target the IP receptor for prevention of thrombus formation in blood. Therefore, CS585 represents a novel prostacyclin ("IP") receptor agonist for antiplatelet treatment of thrombotic diseases. The abstract was presented, by Dr. Michael Holinstat, Professor at the Department of Pharmacology, the Department of Internal Medicine (Division of Cardiovascular Medicine), and the Department of Vascular Surgery at the University of Michigan. Dr. Holinstat leads Cereno's preclinical work at the University of Michigan and is Director of Translational Research at Cereno. The purpose of the study was to assess the stability profile of CS585, an IV and orally bioavailable IP agonist, compared to FDA-approved IP agonists iloprost and selexipag, with regards to sustained activity in vivo in the blood in limiting platelet activation and thrombosis. Blood drawn from mice administered CS585 was observed to show a decrease in platelet adhesion and clot formation. The effects of iloprost and selexIPag are no longer observed at 24 hours post-administration; Administration of CS585 resulted in sustained inhibition of platelet accumulation and fibrin formation in the laser-induced cremaster arteriole thrombosis assay up to 18 hours post-administration. In mice administered iloprost, a decrease in thrombus formation was observed 10 minutes post-administration, but thrombus size returned to vehicle levels by 4 hours. Selexipag-dosed mice demonstrated inhibition of thrombus formation up to 4 hours, but effects were no longer observed at 18 hours. The current data in a preclinical model shows that IV administration of CS585 elicited full protection against thrombosis formation for the entire 18h window that was tested. The lead drug candidate, CS1, is an HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties. A Phase II trial is ongoing (patient recruitment closed on July 1st, 2024) to evaluate CS1's safety, tolerability, and exploratory efficacy in patients with the rare disease pulmonary arterial hypertension (PAH). The study will also provide insights for planning the subsequent trial of CS1 in PAH. A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the trial. Two initiatives performed during the Phase II trial have shown positive findings suggesting the potential clinical benefit of CS1 in PAH patients. These initial findings are, however, not a guarantee of the final trial results that are expected in third quarter 2024. Since January 2024, the company are delighted that the FDA's Expanded Access Program will enable patients with PAH, a serious life-threatening disease condition, to gain access to CS1 where no comparable alternative therapy options are available. Cereno's pipeline comprises two additional programs in development through research with the University of Michigan. Investigational drug CS1 is a novel prostacyclin receptor agonist for the prevention of thrombosis.お知らせ • Sep 03Cereno Scientific Receives Orphan Medicinal Product Designation in the Eu for Cs1 in Rare Disease Pulmonary Arterial HypertensionCereno Scientific announced that the European Commission has granted Orphan Medicinal Product Designation (OMPD) to the Company's lead drug candidate CS1 in the rare disease Pulmonary Arterial Hypertension (PAH). The European Commission is responsible for granting applications, reviewed by the European Medicines Agency (EMA) for OMPD in the EU. To qualify for orphan designation, a drug must meet a number of criteria: it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development; no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. Companies that obtain orphan designation benefit from protocol assistance, a type of scientific advice specific for designated orphan drugs, and market exclusivity once the drug is on the market. Fee reductions are also available depending on the status of the sponsor and the type of service required. About CS1 Drug candidate CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a treatment for the rare disease PAH. CS1 has the potential to be an effective, safe and disease-modifying drug. CS1’s unique efficacy profile fits well with the pathogenetic mechanisms of PAH and is believed to be able to address today’s major unmet need for better treatment alternatives. The aim of CS1’s development is to offer improved quality of life and prolonged life for patients with PAH. Cereno Scientific has over the last year reported encouraging findings from the ongoing Phase II study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH. Since January 30th, 2024, CS1 is approved by the FDA for Expanded Access, as an extension of the ongoing Phase II trial CS1-003 evaluating CS1 in PAH. The EAP gives patients that have completed the Phase II trial the opportunity to, after being judged suitable and to benefit from CS1 treatment by investigators, continue CS1 treatment of PAH when no comparable or satisfactory alternative therapy options are available. The EAP allows Cereno to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. As such, this initiative not only supports the treatment of PAH patients but also enables Cereno to gather additional CS1 usage documentation for regulatory discussions and Phase IIb/III pivotal study design planning. On August 30, 2024, the Company announced that the first patient had been dosed under the EAP. Patient recruitment to the Phase II trial CS1-003 was closed on July 1, 2024, based on a recommendation by the Study Clinical Steering Committee, which concluded that there is sufficient data for evaluating the next steps in development. Topline results will be shared in the third quarter of 2024.お知らせ • Aug 30+ 1 more updateCereno Scientific AB (publ), Annual General Meeting, Jun 17, 2025Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2025.お知らせ • Aug 16Cereno Scientific Expands Patent Protection for PAH Drug Candidate CS1's Third Patent Family in BrazilCereno Scientific announced that a new granted patent in CS1's third patent family has been issued in Brazil. Drug candidate CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a treatment for the rare disease PAH. CS1 has the potential to be an effective, safe and disease-modifying drug. CS1's unique efficacy profile fits well with the pathogenetic mechanisms of PAH and is believed to be able to address today's major unmet need for better treatment alternatives. The aim of CS1's development is to offer improved quality of life and prolonged life for patients with PAH. Cereno Scientific has over the last year reported encouraging findings from the ongoing Phase II study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH. Since January 30th, 2024, CS1 is approved by the FDA for Expanded Access, an extension of the ongoing Phase II trial evaluating CS1 in PAH. The Expanded Access Program (EAP) will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. This initiative not only supports the treatment of PAH patients but also enables Cereno to gather additional CS1 usage documentation for regulatory discussions and Phase IIb/III pivotal study design planning. Currently site-specific contracts and IRB approvals are being progressed. Patient recruitment to the Phase II trial CS1-003 was closed on July 1st, 2024, based on a recommendation by the Study Clinical Steering Committee, which concluded that there is sufficient data for evaluating the next steps in development. Topline results will be shared in Q3, 2024.お知らせ • Jun 28+ 1 more updateFirst Subject Dosed in Cereno Scientifics First-In-Human Phase I Trial of Novel Hdac Inhibitor Cs014Cereno Scientific announced that the first subject has been dosed in first-in-human, Phase I, trial of novel HDAC inhibitor CS014, being developed as an innovative therapy for thrombosis prevention. The Phase I trial CS014-001, titled "A First-in-human, Open-label Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CS014 in Healthy Volunteers After Single and Multiple Administration", is conducted in partnership with the contract research organization (CRO) Clinical Trial Consultants AB (CTC), in Uppsala, Sweden. The trial is a Phase I, open-label, FIH trial designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The trial will be conducted in two parts: A single ascending dose (SAD) part (Part I) will explore safety, tolerability and PK of single ascending oral doses of CS014. A multiple ascending dose (MAD) part (Part II) will explore safety, tolerability, PK, and PD following multiple ascending doses of CS014, dosed for seven days. The Phase I trial of CS014 will include around 48 subjects and results are expected in a year's time.お知らせ • Jun 18Cereno Scientific Receives Approval from, EMA to Initiate First-In-Human Phase I Trial with Novel Epigenetic HDAC Inhibitor, CS014Cereno Scientific announced that the Clinical Trial Application (CTA) for a first-in-human, Phase I trial of novel histone deacetylase inhibitor (HDACi) drug candidate CS014, has been approved by the European Medicines Agency. The aim of the planned first-in-human Phase I trial is to evaluate the safety and tolerability of CS014 in healthy volunteers. The design is a single-ascending- and multiple-ascending-dose trial for 1 week. The title of the study is "A first-in-human, open-label trial to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of CS014 in healthy volunteers after single and multiple administration". The investigational drug candidate CS014 belongs to Cereno's HDAC inhibitor program, capitalizing on the principle of epigenetic modulation. The innovative drug candidate represents a novel approach to antithrombotic treatment without the associated increased risk of bleeding. CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator - regulating platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as documented in preclinical studies. Given the potential for the disease-modifying properties seen with HDAC inhibition, additional cardiovascular benefits of CS014 may be expected, including amelioration of inflammation, fibrosis, vascular changes and elevated blood pressure. HDAC inhibition as thrombosis prevention could fundamentally change the thrombosis prevention landscape and meet a major unmet medical need. CS014 is being developed in collaboration with the University of Michigan.お知らせ • May 24Cereno Scientific AB (publ) to Report Q1, 2025 Results on May 22, 2025Cereno Scientific AB (publ) announced that they will report Q1, 2025 results on May 22, 2025お知らせ • May 03Cereno Scientific AB (Publ) Announces Nomination Committee Appointments Ahead of Annual General Meeting 2025Cereno Scientifi announced that the representatives of the nomination committee have been appointed ahead of the annual general meeting 2024. The nomination committee has been appointed in accordance with the principles for the nomination committee which were established by the annual general meeting on June 1, 2023. According to the principles for the nomination committee that were resolved at the annual general meeting on April 16, 2024, the nomination committee should be appointed as follows. The Company’s largest shareholder, or group of shareholders, as of 30 April 2024, shall have the right to appoint one member of the Nomination Committee. Furthermore, the Nomination Committee shall consist of the chairman of the Board of Directors, who shall also be the convener. In addition, Björn Dahlöf, CSO and Head of Clinical Development in the Company, shall be a member of the Nomination Committee. The Nomination Committee shall thus consist of three persons. The nomination committee ahead of the annual general meeting 2025 has thus been appointed and comprises: Cihan Punar, representing the company’s largest group of shareholders per April 30, 2024, Joakim Söderström, convening member and Chair of the Board of Cereno, and Björn Dahlöf, CSO and Head of Clinical Development in the Company. One of the members, but not the chairman of the Board of Directors, shall be appointed as chairman of the Nomination Committee. The Nomination Committee’s term of office extends until a new Nomination Committee is appointed.お知らせ • Apr 17Cereno Scientific AB (publ), Annual General Meeting, Apr 16, 2024Cereno Scientific AB (publ), Annual General Meeting, Apr 16, 2024. Location: Östra Hamngatan 24 in Gothenburg, Sweden Gothenburg Sweden Agenda: To consider Adoption of income statement and balance sheet for the company and the group; to Allocation of result; to Discharge from liability; to Determination of number of board members, deputy board members and the number of auditors and determination of fees to the board and auditors and auditor; to Election of directors, deputies, and auditors; and to consider other matters if any.お知らせ • Apr 16Cereno Scientific AB (Publ) Approves Election of New DirectorsCereno Scientific AB (publ) at its AGM held on April 16, 2024, approved that Gunnar Olsson and Sten R. Sörensen be elected as new board members.お知らせ • Apr 10Cereno Scientific AB Submits Clinical Trial Application (CTA) for First-In-Human Phase I Study with Novel Epigenetic HDACi Drug Candidate CS014Cereno Scientific AB announced the submission of a clinical trial application (CTA) to the European Medicines Agency (EMA) for a first-in-human, Phase I study of novel histone deacetylase inhibitor (HDACi) drug candidate CS014. The CTA was submitted for a first in human Phase I study to primarily evaluate the safety and tolerability of CS014 in healthy volunteers. The design is a traditional single ascending and multiple ascending dose study for 1 week. Title of the study is "A first-in-human, open-label trial to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of CS014 in healthy volunteers after single and multiple administration". The Phase I study is planned to be initiated during second quarter of 2024. The investigational drug candidate CS014 belongs to Cereno's HDAC inhibitor program, capitalizing on the principle of epigenetic modulation. The innovative drug candidate represents a novel approach to antithrombotic treatment without the associated increased risk of bleeding in humans. CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator - regulating platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as documented in preclinical studies. Given the potential for the disease-modifying properties seen with HDAC inhibition, additional cardiovascular benefits of CS014 may be expected, including amelioration of inflammation, fibrosis, vascular changes and elevated blood pressure. HDAC inhibition as thrombosis prevention has the opportunity to fundamentally change the thrombosis prevention landscape and meet a major unmet medical need. CS014 is being developed in collaboration with the University of Michigan.Reported Earnings • Mar 31Full year 2023 earnings released: kr0.21 loss per share (vs kr0.20 loss in FY 2022)Full year 2023 results: kr0.21 loss per share (further deteriorated from kr0.20 loss in FY 2022). Revenue: kr49.3m (down 14% from FY 2022). Net loss: kr48.1m (loss widened 74% from FY 2022). Products in clinical trials Phase II: 1 Revenue is expected to decline by 145% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 17%.お知らせ • Mar 22Cereno Scientific Announces A Study Protocol Presented for the FDA Approved Expanded Access Program for CS1 in PAHCereno Scientific announced that a study protocol synopsis for the Expanded Access Program (EAP) for its lead candidate drug, the HDAC inhibitor CS1, in the rare disease Pulmonary Arterial Hypertension (PAH), has been published. The EAP will support long-term documentation of safety and efficacy data of CS1 treatment in the Phase II study in PAH. The EAP study named CS-004, is an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1. The exploratory objectives are to evaluate clinical benefit by using CardioMEMS, echocardiography, cardiac magnetic resonance imaging, right heart catheterization, quality of life assessments, biomarkers and actigraphy to measure changes in clinical response with continued treatment with CS1 in patients with Pulmonary Arterial Hypertension (PAH). Safety and exploratory efficacy endpoints will be measured, using the same methods as in the parent study, at the start of the study and subsequently at 4, 8 and 12 months every year. As such, the EAP study will allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which will help in discussions with regulatory authorities and to design Phase IIb/III pivotal study with CS1. Up to 30 patients could participate in Study CS1-004, if they completed the parent study, tolerated CS1 treatment, and if, in the investigator's judgement, the benefits of continued treatment with CS1 outweigh the risk. Some patients will directly roll-over into Study CS1-004 with no disruption in CS1 treatment, while other patients that have already completed Study CS1-003, will need to be restarted on CS1. Patients will, initially, receive the same dose they received in the parent study CS1-003. All patients will later have the option to be titrated to the most efficacious and safe dose determined from the ongoing CS1-003 study, when completed. On a yearly basis, the principal investigator will determine if a patient continues the Expanded Access study for a subsequent year based on safety, tolerability, and clinical benefit of CS1. Continuation of the Expanded Access study will also be evaluated on a yearly basis by Cereno Scientific. As previously reported, investigators have shown substantial interest in the EAP with two-thirds of the patients, having completed the study or are currently on therapy, deemed by investigators to be eligible for continued access to CS1. Currently site-specific and Ethics Committee (IRB) approvals are underway and once these are in place the first patients can be dosed in the EAP.お知らせ • Mar 15Cereno Scientific Appoints Don De Bethizy as Board of DirectorsCereno Scientific announced that Don de Bethizy has been engaged as Senior Advisor to the Executive Management and Board of Directors of Cereno Scientific, to support the company in reaching its strategic growth objectives. J. Donald (Don) de Bethizy,PhD has more than 30 years of experience in managing and financing life science-related technologies and has played a key role in building and advising several life sciences companies. Don de Bethizy advised the CEO and board of NDA Group AB one of the world's leading private biotechnology regulatory consulting firms until its sale to SSI Strategy in 2023. In 2017, Don facilitated the management buyout of Albumedix Ltd. from Novozymes A/S and the subsequent sale of Albumedix Ltd. to Sartorius for 415 MGBP in late 2022. Currently, Don de Bethizy is Vice Chair of the board of argenx NV a global commercial immunology company headquartered in Gent, Belgium with 2023 sales of 1.2 BUSD of its first drug Vyvgart in the rare autoimmune disease myasthenia gravis. In 2014, in his role as Chief Executive Officer of the Danish biotech Santaris Pharma A/S, he led the sale of the company to Roche for 450 MUSD. He co-founded Targacept Inc. and served as its President and Chief Executive Officer for 15 years. Don de Bethizy led Targacept's private and US Nasdaq public financings totaling approximately 330 MUSD, including the Company's Initial Public Offering (IPO) in April 2006. Don de Bethizy holds a B.S. in Biology from the University of Maryland and an M.S. and PhD in Toxicology from Utah State University. He is currently President of White City Consulting ApS (Denmark), a Director at Lophora ApS (Denmark) and Proterris Inc. (USA). He is a U.S. citizen and resident of Denmark.お知らせ • Mar 06Cereno Scientific Publishes Update and Study Protocol for the FDA Approved Expanded Access Program for CS1 in PAHCereno Scientific AB announced the study protocol for the Expanded Access Program (EAP) for its lead candidate drug, the HDAC inhibitor CS1, in the rare disease Pulmonary Arterial Hypertension. The EAP will support long-term documentaMon of safety and efficacy data of CS1 treatment in the Phase II study in PAH. As previously reported, investigators have shown substantial interest in the EAP with two-thirds of the patients, having completed the study or are currently on therapy, deemed by investigators to be eligible for continued access to CS1. EAP study named CS-004, is a prolongation of the CS-003 Phase II study of CS1 in PAH, with the primary objective being to evaluate the long-term safety and tolerability of continued treatment with CS1 and exploratory efficacy as secondary objective with the same methods as in the parent study (timepoints being at start, 4, 8 and 12 months every year). Further details will be published on clinicaltrials.gov later. Currently site-specific and Ethics Committee (IRB) approvals are underway and once these are in place the first patients can be dosed in the EAP. The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which will help in discussions with regulatory authorities and to design Phase IIb/III pivotal study with CS1. The approval of the Expanded Access Program (EAP) comes on the heels of encouraging reports emerging from the Phase II study of CS1 in PAH, actively running at 10 specialist clinics in the US. In June, an investigator highlighted a notable case of patient improvement with CS1. Further, Cereno reported in October 2023 that a Data Quality Control Review (DQCR), of data obtained by the CardioMEMS HF System from the first sixteen patients, was concluded with positive findings. In November, another investigator urged Cereno to submit an Expanded Access request to the FDA, seeking permission to continue administering the investigational drug, CS1, to patients post the conclusion of the study treatment. Cereno promptly submitted the request on January 3rd, which was granted by the FDA on January 30 2024.お知らせ • Feb 29Cereno Scientific Reports One New Patient Enrolled, One Additional Patient Randomized, and One Additional Patient Completed in the Phase II Study of CS1 in PAHCereno Scientific announced that one new additional patient have been enrolled in the study, one additional patient has been randomized on CS1 drug and one additional patient has completed the study. This update serves as the latest progress update for the Phase II study of drug candidate CS1 in rare disease pulmonary arterial hypertension (PAH). The study is set to be completed by third quarter 2024. The Phase II study of CS1 in the rare disease PAH is actively running at 10 specialist clinics in the US, with the latest clinic activated in late December. One additional new clinic is currently in late-stage start-up process. Since the last phase II study progress update communicated on February 21, 2024, one new additional patient have now been enrolled in the study, one additional patient has now been randomized to CS1 drug in the study and one additional patient has now completed the study. Enrolled patients are scheduled to receive CardioMEMS HF System implantation within two weeks from enrollment and are, following successful implantation of CardioMEMS and up to 6 weeks baseline evaluation, randomized to CS1 drug therapy on their next scheduled visit. The next step for the recently enrolled patient is to undergo CardioMEMS implantation. 25 patients have already received CardioMEMS implantation, of which 24 patients have already been randomized to CS1 drug therapy and one is still in baseline period prior to randomization. To date 20 patients have completed the study. EAP approval follows positive findings from the PAH study with CS1 drug therapy reported since 2023: Cereno Scientific has during the last few months reported positive findings from the ongoing study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH. Study completion and top-line results are expected during third quarter of 2024. Remarkable Patient Case with CS1 reported June 2023: First, a patient case study performed on the first patient having completed the study at a specific clinic showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% reduction in pulmonary pressure and a 20% increase in cardiac output. The patient’s overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that the patient had next to normal functional physical capacity with CS1 added to stable conventional therapy. Data Quality Control Review reported October 13th 2023: In addition, Cereno reported in October 2023 that a Data Quality Control Review (DQCR), of data obtained by the CardioMEMS HF System from the first 16 patients, was concluded with positive findings. The data quality of the CardioMEMS measurements was found satisfactory with adherence to study protocol and with timely data transfers from the patient's home to the clinic. Efficacy findings showed a clinically meaningful reduction of pulmonary pressure in several patients, included in the data quality control, of a similar or greater magnitude as in the Patient Case. EAP for CS1 Approved Jan 30th 2024: Further, the Expanded Access Program (EAP) (“Compassionate Use”) approved by the FDA on 31st January 2024 is progressing according to plan, propelled by investigator and patient interest. Investigators indicate that close to two-thirds of the patients, having completed the study or are currently on therapy, have been judged to be interested in continued access to CS1 following study completion. Currently site-specific and IRB approvals are being progressed. The EAP will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which will help in discussions with regulatory authorities and to design Phase IIb/III pivotal study with CS1.Reported Earnings • Feb 22Full year 2023 earnings released: kr0.21 loss per share (vs kr0.20 loss in FY 2022)Full year 2023 results: kr0.21 loss per share (further deteriorated from kr0.20 loss in FY 2022). Revenue: kr49.3m (down 14% from FY 2022). Net loss: kr48.1m (loss widened 74% from FY 2022). Revenue is expected to decline by 139% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 13%.お知らせ • Feb 22Cereno Scientific Reports Progress of Expanded Access Program and Announces Timeline Adjustment in the Phase II Study of CS1 in PAHCereno Scientific announced an update on the progress of the Phase II study of CS1 in pulmonary arterial hypertension (PAH). Cereno has seen substantial interest in the FDA-approved Expanded Access Program ("compassionate use") for patients who have completed the Phase II study, with investigators indicating that a majority of patients would be interested in continued access to CS1 following study completion. The company reports considerable progress in the study. Due to a longer start-up phase for the two new study sites than previously estimated, the study timeline has been negatively affected and top-line results are now expected in Third Quarter 2024. The Phase II study of CS1 In the rare disease PAH is actively running at 10 specialist clinics in the US, with one new clinic activated in late December and one new clinic currently in late-stage start-up process. To date, 25 patients have received the CardioMEMS HF System implantation, of which 23 patients have been randomized to CS1 drug therapy; and 19 patients have completed the study. Investigators indicate that close to two-thirds of the patients, having completed the study or are currently on therapy, have been judged to be interested in continued access toCS1 following study completion. Currently site-specific and IRB approvals are being progressed. The EAP will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which will help further inform the design of Phase IIb/III pivotal study with CS1. While the company reports notable progress in the study, a slower recruitment pace than estimated during the last months and a longer start-up phase For the new sites have affected the study timeline. The updated study timeline now expects study completion and top-line results during Third Quarter 2024.New Risk • Feb 14New minor risk - Market cap sizeThe company's market capitalization is less than US$100m. Market cap: €92.6m (US$99.1m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr83m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Shareholders have been substantially diluted in the past year (70% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr37m net loss in 3 years). Revenue is less than US$5m (kr53m revenue, or US$5.0m). Market cap is less than US$100m (€92.6m market cap, or US$99.1m).お知らせ • Feb 13Cereno Scientific AB Appoints Rahul Agrawal as Chief Medical Officer and Head of R&DCereno Scientific AB (publ) announced that Dr. Rahul Agrawal has been appointed as Chief Medical Officer and Head of R&D. The recruitment follows an intense period in the clinical-stage biotech's growth journey. Dr. Rahul Agrawal is an experienced senior executive leader with a diverse background spanning Big Pharma and biotech. His expertise encompasses the entire value chain including R&D, Medical Affairs, commercial and strategy experience across various therapeutic areas such as cardiovascular, renal, respiratory, and rare/orphan drugs and he has launched seven drugs globally. Joining Cereno after having worked as a CMO at another gene therapy focused biotech Cardior, and prior to that as VP and Global Medicines Leader at AstraZeneca, Dr Agrawal brings extensive cardiovascular clinical trial leadership. Further, his experience in branding and marketing for the Pulmonary Hypertension portfolio as Global Director of Medical Affairs and Clinical Development at Bayer HealthCare, makes him a valuable addition to the Cereno Scientific team. Dr. Agrawal has an MD degree after having studied at the Free University of Berlin, Germany and Cornell University, New York, USA, and is board-certified in cardiology, internal medicine, and emergency medicine. Additionally, he holds an MBA from Buckinghamshire New University, UK. Dr. Agrawal will in his capacity be a member of the Executive Management Team and report to Sten R. Sörensen, CEO. Björn Dahlöf, in his capacity as CSO, will continue to report to Sten R. Sörensen, CEO.お知らせ • Feb 03Cereno Scientific AB (publ) Appoints Megha Ranjan as Project Director to Strengthen Business CapabilitiesCereno Scientific AB (publ) announced that Megha Ranjan has joined the company as Project Director. She will be part of the company’s business and operational team and report to Sten R. Sörensen, Chief Executive Officer (CEO). Megha Ranjan has nearly a decade of experience supporting small to large-sized global life sciences companies in defining their strategies using comprehensive market insights, intelligence, and valuations. She has previously gained experience from roles in commercial and scientific teams at large pharmaceutical companies including BD&L valuations, real-world evidence analysis, go-to-market strategies, medical affairs and medical information. Megha Ranjan holds a B.Sc. in Dental Surgery and an MBA in Healthcare Management from IIHMR University, India.お知らせ • Feb 02Cereno Scientific AB Appoints Julia Fransson as Director of Business DevelopmentCereno Scientific AB announced that Julia Fransson has joined the company as Director of Business Development. She joins the clinical stage biotech at an exciting point of the company's growth journey, in developing innovative treatments for common and rare cardiovascular disease, with lead candidate drug CS1 in phase II in orphan disease PAH which is to deliver top line study results by Second Quarter this year. Julia Fransson is an experienced business development professional in the life science industry. She is skilled in crafting strong and focused strategies, translating key scientific and market insights toward investors and partners as well as business modelling market analysis and biotech asset valuation. Previous roles include management positions within developing technology companies as well as, most recently, heading up a boutique life science strategy advisory firm. Julia holds a B.Sc. in Biotechnology and a M.Sc. in Business Design in life science companies from Chalmers University of Technology, Sweden.お知らせ • Jan 31Cereno Scientific Receives Expanded Access by the FDA to Drug Candidate CS1 for Rare Disease Pulmonary Arial HypertensionCereno Scientific announced that the company has been granted approval by the FDA for Expanded Access, sometimes called "compassionate use", to investigational drug CS1 for use in an extension of the ongoing Phase II trial evaluating CS1 in pulmonary arterial hypertension (PAH). Cereno's Expanded Access Program (EAP) to drug candidate CS1 will initially be limited to patients who have completed the Phase II study in PAH. The approval of the Expanded Access Program (EAP) comes on the heels of encouraging reports emerging from the phase II study. In July, an investigator highlighted a notable case of patient improvement with CS1. Subsequently, positive outcomes were observed during a midway study readout in October. In November, another investigator urged Cereno to submit an Expanded Access request to the FDA, seeking permission to continue administering the investigational drug, CS1, to patients post the conclusion of the study treatment. Cereno promptly submitted the request on January 3rd, and it has now been successfully granted by the FDA. The Expanded Access Program (E AP) with CS1 in PAH provides patients who have completed the Phase I study the option to continue with CS1 drug therapy, in consultation with the investigator and subject to approval by theethics committee at the local hospital. The Expanded Access Program will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which could provide valuable support to later potential applications to the FDA such as fast-track designation/breakthrough therapy as well as support to obtain the IND acceptance to start a Phase IIb/III pivotal study with CS1.お知らせ • Jan 12Cereno Scientific Strengthens R&D with Recruitment of Tatiane Abreu Dall'Agnol as Medical DirectorCereno Scientific announced that Tatiane Abreu Dall'Agnol has joined the company as Medical Director. She will be part of the company's R&D team and report to Björn Dahlöf, Chief Medical Officer (CMO). Tatiane Abreu Dall'Agnol is a medical doctor with nearly a decade of clinical experience. She has previously also worked as a life science consultant advising biotech companies on drug development strategy and analysis; and gained experience in business development and competitive intelligence at Pieris Pharmaceuticals. Tatiane has a medical degree from the Universidade Positivo, Curitiba, PR, Brazil, and an M.Sc. in Business Creation and Entrepreneurship in Biomedicine from the University of Gothenburg, Sweden.お知らせ • Dec 21Cereno Scientific AB Confirms New Clinic Activated in the Phase II Study of Drug Candidate CS1 in Rare Disease PAHCereno Scientific AB announced that a new clinic has been activated in the ongoing Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH). The clinic is located in Austin, Texas, and starts recruiting patients immediately. The Phase II study is now actively running at 10 specialist clinics in the US with yet another new clinic currently in the late-stage start-up process. The Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH) is now actively recruiting patients at 10 specialist clinics in the US, and one additional new clinic is in the process of opening. An investigator-initiated patient case study performed on the first patient having completed the study at the clinic where the investigator was based showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% pulmonary pressure reduction and a 20% increase in cardiac output. The patient's overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that she had next to normal functional physical capacity. A data quality control review (DQCR) initiative was performed confirming the utility of the CardioMEMS HF System (Abbott Inc.) and showed that CS1 has a clinically meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result. Currently, a request for expanded access to CS1 (also called "compassionate use") is being prepared upon inquiry from patients and investigators in the study. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be reported in second quarter of 2024.お知らせ • Dec 14+ 2 more updatesCereno Scientific AB (publ) to Report Q3, 2024 Results on Nov 21, 2024Cereno Scientific AB (publ) announced that they will report Q3, 2024 results on Nov 21, 2024お知らせ • Dec 13Cereno Scientific's Novel HDACi CS014 Has Potential to Become an Effective Antithrombotic Therapy in Patients with A High Risk of Thrombotic Events as Presented at the ASH MeetingCereno Scientific announced that new preclinical data suggests that CS014 has the potential to enrich the toolbox of anticoagulant therapies in patients with a high risk of thrombotic events without increasing the risk of bleeding. CS014 is a novel histone deacetylase (HDAC) inhibitor that acts as an epigenetic modulator and is in preclinical development as a treatment for thrombosis prevention. The new data was presented at the 65th ASH Annual Meeting & Exposition organized by the American Society of Hematology, in San Diego, US, on December 9-12, 2023. The study presented at the ASH Annual Meeting sought to determine if CS014, histone deacetylase (HDAC) inhibitor, either alone or in combination with the FXa inhibitor rivaroxaban, is able to effectively inhibit platelet and fibrin-rich thrombosis formation at the site of vascular injury without causing a significant increase in the bleeding risk in a mouse cremaster thrombosis model. The findings suggest that while CS014 and rivaroxaban are each effective antithrombotic agents, they work well together to minimize clot formation and CS014 in combination did not alter coagulation compared to rivaroxaban alone. Hence, CS014 has the potential to enrich the toolbox of antithrombotic therapies to prevent thrombosis without bleeding in patients with a high risk of thrombotic events. Drug candidate CS014 is a novel HDAC inhibitor in development as a treatment for arterial and venous thrombosis prevention. Preparations are currently ongoing towards a Phase I study and include completion of the preclinical development program, including a preclinical safety program that has already been completed, development and manufacturing of the investigational formulation used for oral dosing of the healthy volunteers and obtaining permission from the Swedish Medical Products Agency as well as the Ethics Committee to start the study. The Phase I study is estimated to be initiated in Sweden during the first half of 2024.お知らせ • Dec 12Cereno Scientific Announces New Preclinical Data Concludes That Drug Candidate CS585Cereno Scientific announced that new preclinical data conclude that drug candidate CS585 provides a new option of activating the IP receptor to decrease platelet reactivity and could represent the first viable option for targeting the IP receptor on platelets for primary inhibition of thrombosis with a reduced risk of bleeding. The data was presented at the 65th ASH Annual Meeting & Exposition organized by the American Society of Hematology, in San Diego, US, on December 9-12, 2023. For the first time, a head-to-head comparison of CS585, a novel IP receptor agonist, was conducted with the FDA-approved IP receptor agonists selexipag and iloprost. The compounds were assessed by direct comparison to elucidate potential differences in selectivity and sustained action. In contrast to the FDA-approved IP receptor agonists (iloprost and selexipag) which showed short-term protection from thrombosis in the laser induced cremaster thrombosis assay in mice, treatment with CS585 resulted in sustained inhibition of clot and fibrin formation in the same model up to 48 hours post-administration. The preclinical results with CS585 thus indicate a favorable profile for inhibiting platelet activation and clot formation and demonstrate a sustained duration of action in mice in the ability to inhibit platelet activation through multiple routes of administration. Importantly, CS585 does not affect coagulation parameters and previous studies demonstrated no potential for increased bleeding in mouse models. Overall, CS585 provides a new option of activating the IP receptor to decrease platelet reactivity and could represent the first viable option for targeting the IP-receptor on platelets for primary inhibition of thrombosis with a reduced risk of bleeding. CS585 was also shown to be more selective for the IP receptor than selexipag and iloprost as determined by platelet aggregation and VASP phosphorylation. The abstract presented at the 65th ASH Annual Meeting & Exposition is titled "CS585 Demonstrates Favorable Selectivity and Sustained In Vivo Action in Preventing Platelet Activation and Thrombosis Compared to Existing IP Receptor Agonists", and was authored by L. Stanger, P. Yalavarthi, S. Lambert, A. Rickenberg, K. Goerger and D. Gilmore at the Department of Pharmacology, University of Michigan Medical School, Ann Arbor, MI, US; B. Dahlöf and N. Bergh at the University of Gothenburg, Gothenburg, Sweden; and M. Holinstat at the Department of Pharmacology, University of Michigan Medical School, Ann Arbor, MI, US. There is a growing body of evidence around drug candidate CS585 supporting favorable tolerability and efficacy in preclinical studies. Recently, the drug candidate was published in the top-tier journal color:Blood showing that CS585 is a highly potent and selective compound given both orally and intravenously and prevents thrombosis for up to 48 hours as observed in preclinical studies.お知らせ • Dec 02Cereno Scientific Completes Preclinical Safety Program for Innovative Drug Candidate CS014 Targeting Thrombosis Prevention and Reaches A Major Preparatory Milestone Towards the Phase I StudyCereno Scientific announced that the preclinical safety program for drug candidate CS014 has successfully been completed. The safety documentation is a key component needed to apply for permission from regulatory authorities to start a first-in-human Phase I study. The Phase I study will be conducted in Sweden in partnership with the contract research organization (CRO) Clinical Trial Consultants (CTC) and is planned to start during the first half of 2024. Drug candidate CS014 is a histone deacetylase inhibitor (HDACi) in development as a treatment for arterial and venous thrombosis prevention. This innovative drug candidate represents an approach to antithrombotic treatment so far shown to be without the associated increased risk of bleeding. The preparations before a Phase I study can be initiated includes completion of the preclinical development program, including a preclinical safety program, development and manufacturing of the investigational formulation used for oral dosing of the healthy volunteers and obtaining permission from the Swedish Medical Products Agency as well as the Ethics Committee to start the study. The Phase I study is estimated to be initiated in the first half of 2024.お知らせ • Nov 29Cereno Scientific Obtains First Patent in India for Drug Candidate Cs1 Through Its Third Patent FamilyCereno Scientific announced that drug candidate CS1's third patent family has obtained a patent in India. This strengthens and broadens the intellectual property rights (IPR) for Cereno's Phase II drug candidate CS1, which is being developed for the treatment of rare disease pulmonary arterial hypertension (PAH). Drug candidate CS1 is currently being evaluated in a Phase II study in PAH. The study is actively recruiting patients at 9 specialist clinics in the US, and two additional new clinics are in the process of opening. An investigator-initiated patient case study performed on the first patient having completed the study at the clinic where the investigator was based showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% pulmonary pressure reduction and a 20% increase in cardiac output. The patient's overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that she had next to normal functional physical capacity. A data quality control review (DQCR) initiative was performed confirming the utility of the CardioMEMS HF System (Abbott Inc.) and showed that CS1 has a clinically meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result. Currently, a request for expanded access to CS1 (also called "compassionate use") is being prepared upon inquiry from patients and investigators in the study. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be reported in Second Quarter 2024.お知らせ • Nov 19Cereno Scientific AB (Publ) Move to Request “Compassionate Use” of CS1 for Treatment of Patients with Rare Disease PAHCereno Scientific announced that the company will submit a request for expanded access to investigational drug CS1 for use as a treatment outside of a clinical trial, sometimes called “compassionate use.” The initiative is prompted by a request from an investigator in the ongoing Phase II study of CS1. Cereno will submit a request to the FDA under the ‘Expanded Access to Investigational Drugs for Treatment Use’ requesting expanded access to CS1 which initially will be limited to patients who have completed the Phase II study in PAH. The Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. If Cereno’s request for expanded access to CS1 is authorized by the FDA and subsequently approved by the local hospital sites’ ethics committees, patients having completed the Phase II study will, in consultation with the investigator, have the option to continue with the CS1 drug therapy. The expanded access would provide Cereno with the ability to collect efficacy and safety data on extended long-term exposure to CS1 in patients with pulmonary arterial hypertension (PAH) under a formal FDA-approved protocol, which could provide support to later applications to the FDA such as fast-track designation/breakthrough therapy and to obtain the IND acceptance to start a Phase III study with CS1.Reported Earnings • Nov 19Third quarter 2023 earnings releasedThird quarter 2023 results: Revenue: kr5.80m (down 47% from 3Q 2022). Net loss: kr11.1m (loss widened 53% from 3Q 2022). Revenue is expected to decline by 94% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 12%.お知らせ • Nov 17Cereno Scientific Reports Significant Progress and A Time Time Adjustment in the Phase II Study of CS1 in Rare Disease PAHCereno Scientific announced an update on the progress of the Phase II study of CS1 in pulmonary arterial hypertension (PAH). The company reports significant progress in the study, however, a slower recruitment pace than estimated during the last months and a longer start-up phase for two new clinics have affected the study timeline. The updated study timeline now expects study completion and top-line results during second quarter 2024. The Phase II study of CS1 In the rare disease PAH is actively running at 9 specialist clinics in the US with two new clinics currently in late-stage start-up process. To date, 32 patients have been enrolled in the study; 8 of those did not, after consent, meet all study criteria to continue in the study; 20 patients have received the CardioMEMS HF System implantation; 19 patients have been randomized to drug therapy; and 16 patients have completed the study, one of which terminated early due to non-drug related issues. The company has earlier this year reported positive findings from the ongoing study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH. First, a patient case study performed on the first patient having completed the study at a specific clinic showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% reduction in pulmonary pressure and a 20% increase in cardiac output. The patient's overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that she had next to normal functional physical capacity with CS1. The Phase II study will continue to completion without any changes to the study protocol. The DQCR findings are not based on data from all patients participating in the Phase II study and some patients in this analysis have not completed the full study period. The final results of the study may differ from the findings in this DQCR and shall not in any way be seen as a guarantee regarding the outcome and conclusions of the upcoming final Phase II study results. The Phase II study ofCS1 in the rare disease pulmonary arterial hypertension (PA H) is actively recruiting patients at 9 specialist clinics in the U.S, and two new clinics are in the process of opening. An investigator-initiated patient case study performed on the First Quarter of the study performed on the first patients having completed the study at the clinic the investigator was based showed remarkable efficacy data. In12 weeks of treatment with CS1., the patient showed a 30% pulmonary pressure reduction and a 20% increase in cardiovascular output. A data quality control initiative was performed confirming the utility of the CardioMEM HF System (Abbott Inc.) and showed that CS1 has a clinical meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be estimated to be expected to be completed in the second quarter of 2024.お知らせ • Nov 08Cereno Scientific AB (publ) Appoints Jeppe Øvlesen as a New Board MemberCereno Scientific AB (publ) announced that at the extraordinary general meeting held on November 7, 2023 elected Jeppe Øvlesen as a new board member.お知らせ • Oct 14Cereno Scientific AB (Publ) Reports Positive Results from the Data Quality Control Review Initiative in the Phase II Study of CS1 in Rare Disease Pul Arterial Hypertension (PAH)Cereno Scientific announced that the initiative to control the data quality produced from the cutting-edge technology CardioMEMS HF System (Abbott Inc.) used in the Phase II study of CS1 in pulmonary arterial hypertension (PAH) has successfully been concluded with positive results. The Data Quality Control Review (DQCR) found the data quality of the CardioMEMS measurements satisfactory with adherence to study protocol and with timely data transfers from the patient's home to the clinic. Efficacy findings show a clinically meaningful reduction of pulmonary pressure in several patients included in the data quality control already after 3 weeks of treatment with CS1, in line with the results from the previously communicated Patient Case. Cereno emphasizes that these reported initial findings of the DQCR may differ from the Phase II study's final results. The top-line results of the completed Phase II study are expected in First Quarter 2024. As communicated on June 26, 2023, an investigator-initiated Patient Case review showed remarkable efficacy data in the first patient completing the Phase II study of CS1. The results from right heart catheterization showed that the patient's mean pulmonary arterial pressure (mPAP) was reduced from 33 mmHg at baseline to 23 mmHg at the end of the 12-week treatment period. Cardiac output was increased from 4.7 L/min at baseline to 5.6 L/min. Right ventricular (RV) stroke volume (SV) also increased when treated with the highest dose of CS1 over time, together with SV index and RV efficiency. These changes were accompanied by reductions in RV stroke work and total pulmonary resistance (TPR). With CardioMEMS HF System, there was a sustained reduction in mPAP over time measured as the Area Under the Curve (AUC) mmHg days. The patient required no changes to her PAH medication during the study, and her status was improved from NYHA/WHO functional class II to functional class I at the end of the 12-week treatment period. This month a Data Quality Control Review (DQCR) initiative was performed with the aim of correcting potential deviations from the set protocol or identifying issues around data transfer from the patient's home to the clinic to increase standardization of the data and also obtain an early indication of CS1's efficacy. The DQCR was performed on blinded data regarding the individual patient dosing. The review included data obtained by the CardioMEMS HF System from the first 16 patients enrolled in the Phase II study. Key findings from the DQCR: The DQCR concluded no concerning issues with digital data transfer and patient/physician protocol adherence. The DQCR shows several patients with a reduction in mPAP of similar or greater magnitude as the initial Patient Case as measured with CardioMEMS HF System over time (AUC mmHg days). This indicates a clinically meaningful efficacy potential with CS1 in reducing mPAP in patients with PAH on top of standard-of-care drug therapy. The DQCR shows that more than 60% of patients on CS1, all doses included, have a sustained reduction in mPAP evaluated as the AUC. Reductions of mPAP (AUC) as so far seen in several patients in this study are clinically meaningful for patients with PAH. The DQCR indicates an efficacy response compatible with a dose-response pattern. As the analysis was performed with dosages blinded, the final assessment of a dose-response relationship will need to await unblinding of the data at the end of the study. The DQCR indicates an early onset of action with drug therapy of CS1 as measured by the reduction of mPAP. This early onset was observed already after 3 weeks for several patients. The DQCR showed a sustained reduction of mPAP in the 2-week follow-up period after the 12-week period of therapy with CS1 was discontinued.お知らせ • Sep 13Cereno Scientific Announces Appointments to the Nomination Committee Ahead of the Annual General Meeting 2024Cereno Scientific announced that the representatives of the nomination committee have been appointed ahead of the annual general meeting 2024. The nomination committee has been appointed in accordance with the principles for the nomination committee which were established by the annual general meeting on June 1, 2023. According to the principles for the nomination committee that were resolved at the annual general meeting on June 1, 2023, the nomination committee should be appointed as follows. The company's largest shareholder, or group of shareholders, as of May 31, 2023, has the right to appoint one representative of the nomination committee. Furthermore, a group of shareholders that consists of the company's founders Sverker Jern and Niklas Bergh have the right to appoint one representative of the nomination committee. In addition, the nomination committee must include the Chair of the Board who must also be the convener. The nomination committee ahead of the annual general meeting 2024 has thus been appointed and comprises Cihan Punar, representing the company's largest group of shareholders per May 31, 2023. Sverker Jern, representing the Company's founders Sverker Jern och Niklas Bergh. Joakim Söderström, convening member and Chair of the Board of Cereno. One of the members, but not the Chair of the Board, must be appointed the Chair of the nomination committee. The nomination committee's term of office extends until a new nomination committee is appointed.New Risk • Sep 03New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 122% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (28% average weekly change). Shareholders have been substantially diluted in the past year (122% increase in shares outstanding). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr93m). Currently unprofitable and not forecast to become profitable over next 3 years (kr37m net loss in 3 years). Market cap is less than US$100m (€39.0m market cap, or US$42.1m).Reported Earnings • Aug 27Second quarter 2023 earnings releasedSecond quarter 2023 results: Revenue: kr10.6m (down 39% from 2Q 2022). Net loss: kr10.7m (loss widened 64% from 2Q 2022). Revenue is expected to decline by 98% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 16%.お知らせ • Aug 24Cereno Scientific to Open Two New Clinics to Complete Patient Recruitment in the Phase II Study of CS1 in PahCereno Scientific announced that further mitigation strategies have been activated for the Phase II study of CS1 in pulmonary arterial hypertension (PAH) due to slower patient recruitment than anticipated. Two new specialist clinics with large capacities are currently in the start-up phase to open to complete the recruitment of patients fulfilling the study criteria. Consequently, the timeline of the study estimates top-line results to be reported in first quarter 2024. The Phase II study of CS1 In the rare disease PAH is currently actively running at 9 specialist clinics in the US. The two new clinics to open have already identified suitable patients for screening before being activated. At existing clinics, there are potential patients due to be screened during September and October. To date, there are 25 patients enrolled in the study, 16 patients having received CardioMEMS HF System implantation, 16 patients randomized and in active treatment, and 3 patients having completed the study. The study is designed to include 30 randomized patients with the rare disease PAH.お知らせ • Aug 22Cereno Scientific AB (Publ) Appoints Eva Jagenheim as Chief Financial OfficerCereno Scientific announced that Eva Jagenheim is appointed Chief Financial Officer (CFO). Jagenheim has broad experience in finance and the Swedish biotech sector. She will join the company on August 28, 2023. Eva Jagenheim, born 1966, has an M.Sc. in Business and Economics from Växjö University and an MBA from Gothenburg Business School. She has a broad experience of various roles within finance. Previous experience includes working as an accountant at PWC, consultant at the accounting firm Arthur Andersen, and at companies of varying sizes across several different industries. She most recently work as CFO at RLS Global, a medtech company listed on Nasdaq First North Growth Market.お知らせ • Jun 30Cereno Scientific Reports Positive Data from Patient Case StudyCereno Scientific has reported positive data received from a patient case study from the ongoing phase II trial with lead candidate CS1 in pulmonary arterial hypertension.Recent Insider Transactions • Jun 29Chairperson recently bought €68k worth of stockOn the 27th of June, Joakim Soderstrom bought around 1m shares on-market at roughly €0.055 per share. This transaction increased Joakim's direct individual holding by 4x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Joakim's only on-market trade for the last 12 months.お知らせ • Jun 27Cereno Scientific Reports an Investigator-Initiated Patient Case Study from the Ongoing Phase II Study of CS1 in PAHCereno Scientific announced data received from a patient case study initiated by an investigator on the first patient having completed the Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH) at the site. The case study is based on one patient and was performed to control the utility of CardioMEMS™ HF System (Abbott Inc.), an innovative technology used to daily monitor pulmonary pressure and other cardiopulmonary function in patients in the study. Data indicates that drug candidate CS1 has a positive effect on pulmonary arterial pressure and cardiac function. It further indicates the utility of CardioMEMS in evaluating drug medication effectiveness in PAH. The patient in the case study was a 51-year-old female patient with symptomatic PAH for three years (NYHA/WHO functional class II) who was enrolled in the study. She had received maintenance treatment of tadalafil 40 mg, macitentan 10 mg, and treprostinil 32 µg dry powder inhaler. The CardioMEMS pulmonary artery (PA) Sensor was implanted in a distal branch of her PA following screening and she was randomized to the 1920 mg dose of CS1. The findings of the case study, carried out during a 12-week treatment period with CS1, show that the patient's mean pulmonal arterial (PA) pressure was reduced from 33 mmHg at baseline to 23 mmHg at the end of the period. Cardiac output was increased from 4.7 L/min at baseline to 5.6 L/min. Right ventricular (RV) stroke volume (SV) also increased when treated with CS1 over time, together with SV index and RV efficiency. These changes were accompanied by reductions in RV stroke work and total pulmonary resistance (TPR). The patient required no changes to her PAH medication during the study, and her status was improved from NYHA/WHO functional class II to functional class I at the end of the treatment period. There were no adverse events related to PA sensor implantation or the device itself and there were no serious adverse events reported on CS1. In addition to the data related to the effects of CS1 in the PAH patient, the case study indicates that using the CardioMEMS PA Sensor permits safe daily remote monitoring of PA pressure over time in patients with PAH, permitting assessment of medication effectiveness on an individual patient level. The Phase II study is currently actively recruiting patients. In mid-May, the company reported that 16 patients were enrolled in the study, 9 patients have received CardioMEMS HF System implantation, 5 patients were randomized and in active treatment, and 2 patients had completed the study. Recruitment of the 30 PAH patients to be included in the study is on track and top-line results are anticipated around year-end 2023.お知らせ • Jun 09+ 2 more updatesCereno Scientific AB (publ), Annual General Meeting, Jun 03, 2024Cereno Scientific AB (publ), Annual General Meeting, Jun 03, 2024.お知らせ • May 13Cereno Scientific Shares Progress Update in the Phase II Study with Drug Candidate CS1 in the Rare Disease PAHCereno Scientific announced an updated progress report of the Phase II study in pulmonary arterial hypertension (PAH) with drug candidate CS1. The study is proceeding well with currently 16 patients enrolled in the study, 9 patients having received CardioMEMS HF System implantation, 6 patients randomized and in active treatment, and 2 patients having completed the study. Recruitment of the 30 PAH patients to be included in the study is on track and top-line results are anticipated at year-end 2023. The Phase II study with CS1 is divided into several important steps from beginning to end to ensure high-quality data from the study. The patient recruitment begins with each clinic identifying and pre-screening patients using the clinic's patient registries and study physicians' knowledge about their patients. The patients that fulfill all inclusion criteria and none of the exclusion criteria are scheduled for a first visit where patients consent to participation in the study and all criteria are confirmed. If all checks out, the patient is considered to have started the study (i.e., been recruited into the study with a successful screening visit). Within two weeks after the first visit, the patient is subjected to right heart catheterization and implantation of the CardioMEMS HF System to monitor blood pressure in the pulmonary circulation and other cardio-pulmonary hemodynamics daily during the study. After four to six weeks of CardioMEMS HF measurements, a full baseline evaluation including, among others, a 6-minute walk test, echocardiography, biomarkers, validated risk scores, patient-reported outcomes, and MRI are measured. The 30 patients are randomized to one of three dose groups of CS1, and the active treatment period is 12 weeks. In addition to the daily CardioMEMS measurements, all measurements are repeated at the end of the 12-week treatment period with CS1 and compared to baseline measurements and between doses to enable evaluation of CS1's safety, tolerability, and exploratory efficacy. The study's total duration is a maximum of 22 weeks, including the follow-up visit two weeks after the treatment period.お知らせ • May 05Cereno Scientific's Phase II Study in the Rare Disease PAH Reports Two Patients Successfully Completed the Treatment Period with Drug Candidate CS1Cereno Scientific announced that two patients have successfully completed the treatment period in the study. The study is proceeding according to plan and top-line results are anticipated at year-end 2023. The Phase II study is divided into several important steps from beginning to end to ensure high-quality data from the study. The patient recruitment begins with each clinic identifying and pre-screening patients using the clinic's patient registries and study physicians' knowledge about their patients. The patients that fulfill all inclusion criteria and none of the exclusion criteria are scheduled for a first visit where patients consent to participation in the study and all criteria are confirmed. If all checks out, the patient is considered to have started the study (i.e., been recruited into the study with a successful screening visit). About two weeks post the first visit, the patient is subjected to right heart catheterization and implantation of the CardioMEMS HF System to monitor blood pressure in the pulmonary circulation and other cardio-pulmonary hemodynamics daily during the study. After further four to six weeks of CardioMEMS HF measurements, a full baseline evaluation including, among others, a 6-minute walk test, echocardiography, biomarkers, validated risk scores, patient-reported outcomes, and MRI are measured. The 30 patients are randomized to one of three dose groups of CS1, and the active treatment period is 12 weeks. To enable exploration of CS1's safety, tolerability, and efficacy, all measurements are repeated at the end of the 12-week treatment period with CS1 and compared to baseline measurements and between doses. The study's total duration is a maximum of 22 weeks, including the follow-up visit two weeks after the treatment period.Reported Earnings • Apr 11Full year 2022 earnings released: kr0.20 loss per share (vs kr0.15 loss in FY 2021)Full year 2022 results: kr0.20 loss per share (further deteriorated from kr0.15 loss in FY 2021). Revenue: kr57.5m (up 28% from FY 2021). Net loss: kr27.7m (loss widened 70% from FY 2021). Products in clinical trials Phase II: 1 Revenue is expected to decline by 150% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Germany are expected to grow by 22%.Reported Earnings • Feb 23Full year 2022 earnings released: kr0.26 loss per share (vs kr0.15 loss in FY 2021)Full year 2022 results: kr0.26 loss per share (further deteriorated from kr0.15 loss in FY 2021). Revenue: kr57.5m (up 28% from FY 2021). Net loss: kr27.7m (loss widened 70% from FY 2021). Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe.お知らせ • Feb 15Cereno Scientific AB (publ) Reports Progress with CS1 Phase II Study in Pulmonary Arterial HypertensionCereno Scientific AB (publ) announced that all clinical sites are activated and actively recruiting patients in the ongoing Phase II study in the rare disease pulmonary arterial hypertension (PAH) with thedrug candidate CS1. To date, three patients have been randomized and entered the treatment period. The study's top-line results are now expected by end of 2023. The Phase II study in the rare disease PAH with drug candidate CS1 has received much recognition for its innovative design. In March 2020, Cereno received the US FDA's orphan drug designation (ODD) for the clinical development program for CS1 in PAH. Through the granted ODD, the FDA has indicated that they believe CS1 has the potential to provide significant benefit to patients suffering from PAH. The patient recruitment starts with the patient undergoing a screening process. After right heart catheterization, implantation of the CardioMEMS HF System takes place to monitor blood pressure in the pulmonary circulation and other cardio-pulmonary hemodynamics daily during the study. After 4 to 6 weeks of CardioMEMS HF measurements, a full baseline evaluation including, among others, a 6-minute walk test, echocardiography, biomarkers, validated risk scores, patient-reported outcomes, and MRI are evaluated. To enable exploration of CS1's efficacy, measurements are repeated at the end of the 12-week treatment with CS1 and compared to baseline and between doses. In September 2021, the FDA accepted an investigational drug application (IND) to start the Phase II multi-center PAH study in the US. Since then, many activities and processes have been executed culminating in the recent activation of all clinical sites participating in the study and the acceptance by FDA of change in eligibility criteria.株主還元4A1DE BiotechsDE 市場7D6.1%0.4%-1.0%1Y-51.3%8.1%-2.2%株主還元を見る業界別リターン: 4A1過去 1 年間で8.1 % の収益を上げたGerman Biotechs業界を下回りました。リターン対市場: 4A1は、過去 1 年間で-2.2 % のリターンを上げたGerman市場を下回りました。価格変動Is 4A1's price volatile compared to industry and market?4A1 volatility4A1 Average Weekly Movement17.0%Biotechs Industry Average Movement7.6%Market Average Movement5.4%10% most volatile stocks in DE Market12.8%10% least volatile stocks in DE Market2.7%安定した株価: 4A1の株価は、 German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: 4A1の 週次ボラティリティ は、過去 1 年間で12%から17%に増加しました。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セレーノ・サイエンティフィック社（Cereno Scientific AB）は臨床段階のバイオテクノロジー企業であり、世界中の心血管疾患および希少疾患の治療薬を開発している。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と、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）阻害剤が同社のリード医薬品候補である。前臨床段階の新薬候補はCS585とCS014で、心血管系疾患の治療薬として前臨床段階にある。同社は、心血管疾患の前臨床治療薬候補であるCS585およびCS014の前臨床開発プログラムに関してミシガン大学と、CardioMEMS HFシステムの使用に関してアボット社と、また肺・血管研究所（PVRI）と共同研究契約を結んでいる。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。4A1 基礎統計学時価総額€137.90m収益（TTM）-€10.93m売上高(TTM)€6.02m22.9xP/Sレシオ-12.6xPER（株価収益率4A1 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4A1 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%4A1 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 03:52終値2026/07/23 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
New Risk • Jun 12New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr174m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr201m net loss in 2 years).
Reported Earnings • May 27First quarter 2026 earnings releasedFirst quarter 2026 results: Revenue: kr39.0m (up 137% from 1Q 2025). Net loss: kr28.6m (loss widened 14% from 1Q 2025). Revenue is expected to decline by 142% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Europe are expected to grow by 15%.
Board Change • May 20No independent directorsThere are 4 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 4 new directors. 6 experienced directors. No highly experienced directors. No independent directors (5 non-independent directors). Director Anders Svensson is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of experienced directors.
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.
New Risk • Jun 12New major risk - Share price stabilityThe company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr174m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr201m net loss in 2 years).
Reported Earnings • May 27First quarter 2026 earnings releasedFirst quarter 2026 results: Revenue: kr39.0m (up 137% from 1Q 2025). Net loss: kr28.6m (loss widened 14% from 1Q 2025). Revenue is expected to decline by 142% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Europe are expected to grow by 15%.
Board Change • May 20No independent directorsThere are 4 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 4 new directors. 6 experienced directors. No highly experienced directors. No independent directors (5 non-independent directors). Director Anders Svensson is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of experienced directors.
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.
お知らせ • Jul 16Cereno Scientific AB Announces Positive Topline Results from Phase I Trial of CS014Cereno Scientific AB announced positive topline results from its Phase I trial of CS014, a novel HDAC inhibitor in development for idiopathic pulmonary fibrosis (IPF). The trial confirms a favorable safety and tolerability profile, and data support further clinical evaluation. Based on the findings, preparations are underway to initiate a Phase II trial. The Phase I trial evaluated safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The trial was conducted in two parts: part one explored safety, tolerability and PK of single ascending oral doses (SAD) of CS014; part two explored safety, tolerability, PK, and PD following multiple ascending doses (MAD) of CS014, dosed for seven days. In total, 48 subjects were included in the trial, 30 in the SAD and 18 in the MAD part. The trial was conducted by CTC in Uppsala, Sweden. Summary of the topline results from the Phase I trial: CS014 demonstrated favorable safety and tolerability in healthy volunteers. All 48 healthy volunteers completed the study; no early withdrawals or deaths were reported. No serious adverse events (SAEs) occurred. All treatment-related adverse events (AEs) reported were mild, transient, and fully recovered. CS014 achieved levels in the blood stream at and above those projected, based on non-clinical data, to be required for achieving maximal effects on reversal of pulmonary vascular remodeling and fibrosis. These findings, combined with non-clinical data demonstrating a favorable impact on plexiform lesions in the SAD/Hypoxia rat model, offer insights that support dose selection and support advancement into Phase II development. "CS014 is a novel HDAC inhibitor with a unique mechanism of action through epigenetic modulation that could represent a differentiated treatment approach for IPF. These positive Phase I results, combined with strong non-clinical data, give confidence as it advance into Phase II clinical development. CS014 is a cornerstone of broader HDAC inhibitor portfolio, which believe holds significant disease-modifying potential across a range of rare cardiovascular and pulmonary diseases. The company is advancing plans to prepare for a Phase II trial initiation in H1 2026. Full results from the Phase I trial will be submitted for publication in a peer-reviewed scientific journal.
お知らせ • Jul 04Cereno Scientific Selects Top-Tier Global Contract Research Organization for Phase IIb Trial of CS1 in the Rare Disease Pul Arterial HypertensionCereno Scientific announced that the company has signed an agreement with a top-tier global contract research organization (CRO) relating to the Phase IIb trial of CS1. The selection of a CRO is an important step in the clinical development for CS1 and marks a significant milestone toward the initiation of the Phase IIb trial. CS1 has the potential to become an effective disease-modifying treatment to enhance and extend life for patients with pulmonary arterial hypertension (PAH). Partnering with a CRO that combines deep expertise in the disease area with a well-established network of seasoned investigators is essential to the successful execution of clinical trials. This CRO has a proven track record in PAH trials providing access to both highly experienced clinical teams and a broad, well-characterized patient population. Their extensive experience and robust infrastructure are important capacities as the lead candidate CS1's clinical program in the rare disease PAH. The Phase IIb trial of CS 1 is planned as a global, multi-center, placebo-controlled trial designed to further evaluate the encouraging efficacy signals observed in the Phase IIa trial, including reverse vascular remodeling and improvement of right heart function. In May 2025, the U.S. FDA provided an endorsement of the plans for the Phase IIb trial through a Type C meeting. Preparations for an IND submission are underway, with trial initiation targeted for H1 2026, pending regulatory approvals.
お知らせ • Jun 30Cereno Scientific AB (publ) Announces Top-Line Results of the CS014 Phase I Trial to Be Announces Mid-July 2025Cereno Scientific announced that the top-line results of CS014's Phase I trial will be announced mid-July 2025. The previously communicated timeline was June 2025. The Phase I trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The trial was conducted in two parts: part one explored safety, tolerability and PK of single ascending oral doses (SAD) of CS014; part two explored safety, tolerability, PK, and PD following multiple ascending doses (MAD) of CS014, dosed for seven days. In total, 48 subjects were included in the trial, 30 in the SAD and 18 in the MAD part. The trial was conducted in Sweden.
お知らせ • Jun 10Cereno Scientific AB (Publ) Announces Board ElectionsCereno Scientific AB (publ) announced that at its AGM held on June 10, 2025, shareholders approved the election of Moi Brajanovic as new board member. Jeppe Øvlesen was elected as chairman of the Board of Directors.
お知らせ • May 23Cereno Scientific AB Receives Approval from FDA on Plans for Phase IIb Trial of CS1 in Rare Disease Pulmonary Arterial Hypertension (PAH)Cereno Scientific announced that the US Food & Drug Administration (FDA) provided endorsement of the plans for the Phase IIb trial of CS1 as noted by the official meeting minutes from the Type C-me meeting held on April 21. The next clinical development step of CS1 is a larger, placebo-controlled Phase IIb trial aiming to further evaluate the encouraging efficacy signs including reverse vascular remodeling and improvement of right heart function as observed in the Phase IIa trial. The plans for the Phase IIb trials are in alignment with the expectations of the FDA, meaning that the company have high confidence that the Phase IIb trial design will include the relevant criteria contributing to the development program's marketing approval process. Drug candidate CS1 is a well-tolerated oral therapy with a favorable safety profile and showed signals of disease-modifying effects as observed in a Phase IIa trial in patients with the rare disease pulmonary arterial hypertension (PAH). The aim for CS1 is to offer an effective disease-modifying treatment with the ability to enhance quality of life and extend life for PAH patients. Unlike standard therapy that focus on managing symptoms, CS1 represents a novel therapeutic approach by targeting the root mechanisms of PAH. Preparations are currently underway for a larger placebo-controlled Phase IIb trials to continue advancing CS1 toward regulatory approval and wider patient access. The Phase IIb trial is planned to be initiated in first half 2026.
お知らせ • May 13Cereno Scientific AB Presents Cs1's Phase Iia Trial Results At the 5Th Baltic Pulmonary Hypertension Conference 2025Cereno Scientific AB announced that 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 on May 9, 2025, in Kaunas, Lithuania. The data presented in an abstract at the Baltic PH Conference highlighted key results from the Phase IIa trial of CS1 in PAH. The primary endpoint of safety and tolerability was met without any drug-related safety concerns. After 12 weeks, REVEAL Risk Score 2.0 was improved from baseline in 40.9% of patients and stable in a further 31.8% of patients. A total of 31.8% and 54.5% of patients improved or maintained their NYHA/WHO functional class, respectively. The majority of patients (71%) showed an improvement in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The abstract concludes that the findings from the Phase IIa trial suggest that treatment with CS1 in patients with pulmonary arterial hypertension (PAH) improve risk score, functional class and quality of life. The conclusion states that CS1 warrants further study. Atiane Abreu Dall'Agnol, Medical Director at Cereno Scientific, presented the abstract at the conference. A publication of the Phase IIa trial results of CS1 in PAH is in development with the aim be published during H2 2025. Abstract details: Benza, R., et al. (2025). Exploratory outcomes of CS 1 in pulmonary arterial hypertension: Phase 2A, prospective, randomized, open-label, multicenter trial Raymond [Abstract). Abstracts book of the 5th Baltic PulmonaryHypertension Conference 2025, Kaunas, Lithuania. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis. Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor receptor antagonist 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 Thrombic pulmonary fibrosis.
お知らせ • Apr 22Cereno Scientific AB Completes Successful FDA Meeting Discussing Further Clinical Development of Drug Candidate CS1 in Rare Disease PAHCereno Scientific AB announced that the company has completed a Type C meeting with the U.S. Food and Drug Administration (FDA). The intention was to seek advice from the FDA to finalize the Phase IIb trial design and align on further clinical development steps for CS1 based on the encouraging signals suggesting reverse vascular remodeling effects observed in the Phase IIa trial. The discussions during the meeting indicate alignment between the FDA and Cereno Scientific on the plans. An update on the CS1 program will be shared following receipt of the official meeting minutes. The FDA Type C meeting that was held on April 21, 2025, focused on finalizing the design of the Phase IIb trial and aligning on further clinical development steps. Cereno Scientific plans to give an update on CS1's development program following receipt of the official Meeting minutes, which are expected approximately one month after the meeting. Drug candidate CS1 is an epigenetic modulating HDACi that aims to improve quality of life and extend life expectations for patients with the rare disease pulmonary arterial hypertension (PAH). A Phase IIa trial showed that CS1 has a favorable safety profile and is well-tolerated as a treatment for people with pulmonary arterial hypertension (PA H). The trial showed efficacy signals suggesting reverse vascular remodeling effect of CS1. This was accompanied by signals suggesting improved right ventricular function, functional class (NYHA) and quality of life (QoL) as well as improved REVEAL 2.0 risk score. These parameters indicate better patient outcomes, improvement and/or stabilization of disease progression, as well as improving patient function and proggnosis. Cereno Scientific intends to continue to explore the effects of CS1 on reverse vascular remodeling in further clinical development. A larger placebo-controlled Phase IIb trial is being planned to confirm and expand upon these effects.
お知らせ • Apr 16Cereno Scientific Reports That Its Phase I Trial of CS014 Has Been Concludes and Confirms That Top-Line Results Are Anticipated in June 2025Cereno Scientific announced that the second and final part of the Phase I trial of drug candidate CS014 in healthy volunteers has been concluded with the last patient's last visit. The Phase I trial intends to primarily evaluate the safety and tolerability profile of CS014 in humans and is divided into two parts - a single ascending dose part (SAD) and a multiple ascending dose part (MAD). Data management, database lock, and analysis will now commence after the last patient's last visit, and the trial's top-line results are expected to be announced in June 2025. The new chemical entity 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). Drug candidate CS014 has shown strong vascular remodeling effects in preclinical studies, which indicates a disease-modifying potential. The Phase I trial of CS014 conducted by Cereno's CRO partner CTC in Uppsala evaluated safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending oral doses and multiple ascending oral doses of CS014 for seven days in 48 healthy volunteers. Completed in February 2025, part one of the trial indicated that CS014 has an acceptable safety and tolerability profile supporting its potential for further clinical development. Top-line results of the complete Phase I trial will be available in June 2025. The Phase I trial is an open-label, first-in-man trial designed to evaluate safety, tolerability, pharmacodynamics (PK), and pharmacodynamics ("PD) of single ascending oral dose of CS014 and multiple ascending oral doses ofCS014 for seven days in healthy volunteers. The Phase I trial ofCS014 involves 48 subjects. Top-line results of The study is anticipated in June 2025.
お知らせ • Mar 17Cereno Scientific Extends Patent Protection for Drug Candidate CS1 in the US and Has Filed to Extend Market Exclusivity to 2045Cereno Scientific announced that a new patent has been granted in the US for drug candidate CS1's second patent family. Two patent applications have, additionally, been filed based on the encouraging efficacy signals observed in the recently completed Phase IIa trial of CS1 in the rare disease pulmonary arterial hypertension (PAH). These patent applications combined with the existing patent portfolio has the potential to extend the market exclusivity for CS1 in PAH to 2045. The granted patent in the US is the third approved patent for the second patent family, which broadens the protection already obtained in this key market for drug candidate CS1. The patent is titled "Valproic acid for the treatment or prevention of pathological conditions associated with excess fibrin deposition and/or thrombus formation" and has been given patent number 12,245,999 by the US Patent Office (USPTO). The two newly filed patent applications relate to the recently completed Phase IIa trial in PAH. The trial showed efficacy signals suggesting reverse vascular remodeling effects of CS1. This was accompanied by signals suggesting improved right ventricular function, functional class (NYHA) and quality of life (QoL) as well as improved REVEAL 2.0 risk score. These parameters indicate better patient outcomes, improvement and/or stabilization of disease progression, as well as improving patient function and prognosis. The trial also showed that CS1 has a good safety profile and is well-tolerated. An ongoing Extended Access Program (EAP) allowing patients to continue CS1 treatment will provide further insight into the long-term disease-modification effects of CS1. A sub-study of the EAP utilizes the non-invasive imaging technology Functional Respiratory Imaging (FRI) developed by Fluidda to visualize how long-term treatment of CS1 on top of standard therapy may impact changes in pulmonary arteries. Cereno Scientific intends to continue to explore the effects of CS1 on reverse vascular remodeling in further clinical development. A larger placebo-controlled Phase IIb trial is being planned to confirm and expand upon these effects.
お知らせ • Mar 12Cereno Scientific Secures FDA Meeting to Advance Its Development of CS1 for the Treatment of Rare Disease PAHCereno Scientific announced that a Type C meeting has been scheduled on April 21, 2025, by the U.S. Food and Drug Administration (FDA). The intention is to seek advice from the FDA to reach alignment on multiple aspects of the planned development program of CS1 based on the encouraging signals suggesting reverse vascular remodeling effects of CS1 observed in the Phase IIa trial. An update on the results of the meeting with the FDA is planned to be shared upon receipt of the written meeting minutes. Drug candidate CS1 is an epigenetic modulating HDACi that aims to improve quality of life and expand life expectancy for patients with the rare disease pulmonary arterial hypertension (PAH). The FDA Type C meeting, scheduled for April 21, 2025, will focus on finalizing the design of the Phase IIb trial and aligning on further clinical development steps. Cereno Scientific plans to give an update on the results of the meeting following receipt of the written meeting minutes, which are expected approximately one month after the meeting. The Phase IIa trial in PAH showed that CS1 has a good safety profile and is well-tolerated. The trial showed efficacy signals suggesting reverse vascular remodeling effects of CS1. This was accompanied by signals suggesting improved right ventricular function, functional class (NYHA) and quality of life (QoL) as well as improved REVEAL 2.0 risk score. These parameters indicate better patient outcomes, improvement and/or stabilization of disease progression, as well as improving patient function and prognosis. Cereno Scientific intends to continue to explore the effects of CS1 on reverse vascular remodeling in further clinical development. A larger placebo-controlled Phase IIb trial is being planned to confirm and expand upon these effects.
お知らせ • Feb 25Cereno Scientific Announces Additional Phase IIa Trial Data with Drug Candidate CS1 in Pulmonary Ar Arterial Hy Hypertension (PAH) Following the Clinical Study Report CompletionCereno Scientific announced additional Phase IIa trial data with drug candidate CS1 in pulmonary arterial hypertension (PAH) following the Clinical Study Report (CSR) completion. The company see 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. An ongoing Extended Access Program (EAP) allowing patients to continue CS1 treatment will provide further insight into the long-term disease-modification effects of CS1. A larger placebo-controlled trial is being planned to confirm and expand upon these compelling findings. 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. PAH is a progressive and fatal disease with pathological changes to the pulmonary vasculature and the right-heart. Despite the trial's short duration, CS1 showed improvement of right-ventricular function signaling a disease-modifying effect by halting disease progression or through the reversal of pathological vascular remodeling. Based on these encouraging findings and the completed Clinical Study Report, the company have now initiated a Type C meeting with the FDA to align the next development steps of CS1 and in parallel the publication of scientific data. The Phase IIa trial was conducted over 12 weeks 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.
お知らせ • Feb 22Cereno Scientific to Evaluate CS1 with Advanced Imaging TechnologyCereno Scientific announced that a sub-study with CS1 within the ongoing Extended Access Program (EAP) now can commence following regulatory approvals. The study will utilise Fluidda's imaging technology to deepen the understanding of the drug candidate's potential to prevent and reverse pathological remodeling of blood vessels in the lung of patients with the rare disease pulmonary arterial hypertension (PAH). Moreover, company has requested a Type C meeting with the FDA to discuss the next development steps for CS1.
お知らせ • Feb 20Cereno Scientific Submits Type C Meeting Request with FDA for Phase II Drug Candidate CS1 in Preparation for Further Clinical DevelopmentCereno Scientific announced that a Type C meeting request has successfully been submitted to the U.S. Food and Drug Administration (FDA). Based on the encouraging signals from the Phase IIa trial, Cereno Scientific wants to further explore the effects of CS1 on reverse remodeling in PAH. The meeting is intended to align the next development steps of CS1 with the FDA and is expected to be held within 75 days in accordance with FDA's timelines. Drug candidate CS1, an HDACi, is in development aiming to be an effective disease-modifying treatment with ability to improve quality of life and expand life expectancy for patients with the rare disease pulmonary arterial hypertension (PAH) as an oral, safe, and well-tolerated therapeutic option. In a Type C meeting, the role of FDA is to evaluate the risk benefit profile of a product for the indication and patient group it is intended to address. FDA can and will provide specific feedback about the sufficiency of the development plan provided in the briefing package to address any potential concerns. A Type C meeting will be scheduled within 75 calendar days from receipt of the meeting request according to FDA timelines.
お知らせ • Feb 19Cereno Scientific AB Receives Approval to Initiate Sub- Study of the CS1 EAP Using Fluidda's Innovative Imaging Technology to Obtains Insights on the Long-Term Disease-Modifying Potential of CS1 in PAHCereno Scientific AB announced that a sub-study of the ongoing CS1 Expanded Access Program (EAP) will be initiated after obtaining all necessary regulatory approvals. The study will be using non-invasive imaging technology from innovative medtech company Fluidda to further assess CS1's disease-modifying potential to prevent or reverse pathological remodeling of blood vessels in the lung of patients with the rare disease pulmonary arterial hypertension (PAH). The local Institutional Review Board (IRB) has approved the sub-study design, enabling Cereno Scientific to immediately initiate the study. The study is intended to support the translation of the well-documented reverse vascular remodeling effects of CS1 in preclinical models to clinical practice. The lack of non-invasive methods available to demonstrate this effect in patients present a challenge. The innovative imaging technology Functional Respiratory Imaging (FRI), developed by Fluidda, has been explored as a potential non-invasive tool to solve this challenge by providing detailed, patient-specific insights into pulmonary vascular changes. The study, also referred to as the "Fluidda study", is designed to include three CT scans in certain patients enrolled in the EAP during a 12-month period. 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. The trial showed that CS1 is safe and well-tolerated and revealed compelling data supporting a disease-modifying capacity on top of standard therapy. The EAP comprising 10 patients was approved as an extension of the Phase IIa trial in PAH, allowing patients who have completed the Phase IIa trial to continue CS1 treatment. The EAP, an FDA-approved protocol, enables Cereno to obtain valuable long-term safety and efficacy data of CS1 in PAH patients supporting required regulatory interactions and planning future Phase IIb or pivotal Phase III trials.
お知らせ • Feb 13Cereno Scientific's HDAC Inhibitor CS014 AdvancesCereno Scientific announced that the first part of the phase I study with the HDAC inhibitor CS014 has been completed without any safety issues. The study evaluates the safety profile of the drug candidate, which is being developed for the treatment of the rare disease idiopathic pulmonary fibrosis (IPF).
お知らせ • Feb 11Cereno Scientific's HDACi CS014 Successfully Completed Part One of Its Phase I Trial Evaluating the Safety Profile with A Single Ascending Dose (Sad) StudyCereno Scientific announced that drug candidate CS014 has completed the first part of two in its Phase I trial in healthy volunteers without any safety concerns. CS014 is a novel histone deacetylase (HDAC) inhibitor with disease-modifying potential being developed for the rare disease idiopathic pulmonary fibrosis (IPF). The Phase I trial intends to evaluate the safety profile of CS014 in humans and is divided into two parts - a single ascending dose part (SAD) and a multiple ascending dose part (MAD). Part two of the trial (MAD) is currently ongoing according to plan and the Phase I trial is expected to be completed in mid-2025. HDACi CS014 has the potential to transform the treatment landscape of IPF. Drug candidate CS014 is a new chemical entity that acts through HDACi with strong vascular remodeling effects and disease-modifying potential as seen in preclinical studies. The potential of the HDACis has been demonstrated through preclinical studies including reversal of pathological remodeling of pulmonary vessels and anti-fibrotic effects in an animal model of PAH, as well as in vivo anti-thrombotic effects across a broad range of vasculature. These properties align with the key disease mechanisms of idiopathic pulmonary fibrosis (IPF) and addresses significant unmet medical needs. The HDACi CS014 has a safety and efficacy profile that is consistent with the significant medical needs remaining despite current IPF treatments. Part one of the Phase I trial of CS014 conducted by our CRO partner CTC in Uppsala explored the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses (SAD) of CS014 in 30 patients. This first part of the trial has successfully been completed with results showing that CS014 exhibited an acceptable safety profile supporting its potential for further clinical development. The Phase I trial is an open-label, first-in-man trial designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The Phase I trial of CS014 will involve approximately 48 subjects and is expected to be completed mid-2025 whereafter top-line results can be shared after data analysis has been conducted.
お知らせ • Dec 27Cereno Scientific Enters 9 Additional Patients in its Expanded Access Program with CS1 Providing More Long-Term Safety and Efficacy Data in Rare Disease PAHCereno Scientific announced that 9 additional patients have entered its Expanded Access Program (EAP) with drug candidate CS1 in rare disease pulmonary arterial hypertension (PAH). In total, the EAP now includes 10 patients with the possibility of more patients being included in the coming months. 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. Drug candidate CS1 has been approved by the FDA for an Expanded Access Program as an extension of the Phase IIa trial in PAH. This program allows patients who have completed the Phase IIa trial to continue CS1 treatment if deemed suitable by physicians in the study. Through the recently entered collaboration with innovative medical company Fluidda, their non-invasive imaging technology called Functional Respiratory Imaging (FRI) will be used on certain patients enrolled in the EAP to visualize how long-term use of CS1 influences changes in pulmonary arteries. The EAP, an FDA-approved protocol, enables Cereno to obtain valuable long-term safety and efficacy data of CS1 in PAH patients supporting required regulatory interactions and planning future Phase IIb or pivotal Phase III trials.
お知らせ • Nov 14Cereno Scientific Announces Initiation of Multiple Ascending Dose (MAD) Part of Phase I Trial of the Novel HDAC Inhibitor CS014Cereno Scientific announced that the Company has initiated the Multiple Ascending Dose (MAD) part of the first-in-man Phase I trial of novel HDACi CS014, after the Safety Monitoring Committee ensuring that the safety profile in the Single Ascending Dose (SAD) part is within acceptable limits. The CS014 development program is targeting rare disease Idiopathic Pulmonary Fibrosis (IPF). The MAD part (Part II) of the Phase I trial will explore safety, tolerability, pharmacokinetics (PK), and efficacy parameters following multiple ascending doses of CS014, dosed for seven days. The MAD was preceded by the SAD part (Part I) that is exploring safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of CS014. The trial is a Phase I, open-label, first-in-man trial designed to evaluate safety, tolerability, pharmacokinetics, and efficacy parameters of single and multiple ascending oral doses of CS014 in healthy volunteers. The Phase I trial of CS014 will involve approximately 48 subjects and is expected to conclude by mid-2025.
お知らせ • Oct 23+ 2 more updatesCereno Scientific AB (publ) to Report Q2, 2025 Results on Aug 27, 2025Cereno Scientific AB (publ) announced that they will report Q2, 2025 results on Aug 27, 2025
お知らせ • Oct 17Cereno Scientific AB (publ) Selects Rare Disease Idiopathic Pulmonary Fibrosis as the Initial Target Indication for Novel HDACi CS014Cereno Scientific announced that the Company has selected rare disease Idiopathic Pulmonary Fibrosis (IPF) as the initial target indication for novel HDACi CS014. This decision follows recent preclinical results showing significant reductions in pulmonary artery occlusion and fibrosis. With this move, Cereno strengthens its focus on rare diseases, reinforcing its commitment to addressing the significant needs of patients affected by these conditions. IPF initial target indication for CS014: Idiopathic Pulmonary Fibrosis (IPF) is a rare, progressive, and fatal disease characterized by irreversible scarring (fibrosis) of the lungs. Patients experience significant symptoms, including a persistent dry cough, fatigue, and exertional dyspnea. Over time, this fibrosis leads to a gradual loss of lung function, ultimately resulting in respiratory failure. Mortality rates in IPF are comparable to those of severe cancers. There is currently no cure for IPF, and current treatments have severe tolerability issues. There is an outspoken need for new therapies that can halt and reverse disease progression, extend lifespan and improve quality of life of patients suffering from this disease.Cereno's HDAC inhibitor CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator. The scientific rationale for evaluating CS014 for the treatment of IPF is supported by preclinical studies, which have demonstrated that HDAC inhibitors can effectively reverse fibrosis in models of IPF. The studies also show that HDAC inhibitors prevent the pathological remodeling of pulmonary vessels that ultimately leads to pulmonary hypertension in many IPF patients. The rationale is further strengthened by recently published preclinical data in an established model of PAH showing that CS014 has an effect on reversal of fibrosis and a dose-dependent beneficial effect on pathological vascular remodeling. Together, these findings indicate that CS014 has the potential to address the underlying pathophysiology behind the development of IPF. Patients with IPF have an increased risk of developing venous thromboembolism. CS014 regulates platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as demonstrated in preclinical studies. This adds to the favorable profile of CS014 in relation to the unmet needs of IPF patients. Cereno Scientific eyes pipeline focus on rare diseases: As a result of a chosen initial target indication for CS014, Cereno now advances a pipeline of three innovative drug candidates, two of which are being developed as disease-modifying treatments for rare diseases where high unmet needs persist.
お知らせ • Sep 25Cereno Scientific AB (publ) Announces New Preclinical Data Demonstrates Dose Dependent Positive Impact on Reversal of Pulmonary Vascular RemodelingCereno Scientific AB (publ) announced new preclinical data that demonstrates dose dependent reversal of pulmonary vascular remodeling by Cereno's HDAC inhibitor CS014. CS014, having recently entered a Phase I trial in healthy volunteers in June 2024, is a novel histone deacetylase (HDAC) inhibitor being developed by Cereno. CS014 is, together with lead compound CS1 part of Cereno's HDACi program which capitalizes on the principle of epigenetic modulation. Studies of CS014 were conducted in a well-established preclinical model of Pulmonary Arterial Hypertension (PAH). This model exhibits many features in common with the clinical disease, including pulmonary vascular remodeling and fibrosis. Importantly, the model also exhibits so called ‘plexiform lesions’, a pathophysiological hallmark feature of PAH. The study demonstrated that CS014 induced a robust, dose dependent reversal of the pulmonary vascular remodeling in this preclinical PAH model. This included statistically significant reductions in small artery vessel occlusion, plexiform lesions and small vessel related fibrosis. Overall, these preclinical data provide the most compelling evidence to date that CS014 offers a disease modifying approach to PAH and related pulmonary vascular diseases by robustly reversing pulmonary pathological vascular remodeling and fibrosis. Further study details and results will be shared in a future scientific publication.
お知らせ • Sep 19Cereno Scientific AB Announces Changes in the Nomination Committee's Composition for the Annual General Meeting 2025Cereno Scientific announced on May 2, 2024, that the Company's nomination committee for the annual general meeting 2025 had been appointed and that it consists of Cihan Punar, Joakim Söderström, and Björn Dahlöf. Cereno Scientific announces that Cihan Punar has informed that he resigns as a member of the Company's nomination committee and that Andreas Ejlegård has been appointed as new member of the nomination committee. Cereno Scientific announces that Cihan Punar has informed that he resigns as a member of the Company's nomination committee. According to the principles for the nomination committee, the nomination committee shall primarily appoint a new member nominated by the shareholder or the group of shareholders which nominated the resigning member, provided that the shareholder or group of shareholders is still the Company's largest shareholder or group of shareholders. Cereno Scientific announces that Andreas Ejlegård has been appointed as a new member of the Company's nomination committee in accordance with the principles and that he thereby replaces Cihan Punar. The Company's nomination committee for the annual general meeting 2025 thus consist of the following members: Andreas Ejlegård, representing the Company's largest group of shareholders per April 30, 2024; Joakim Söderström, convening member and chairman of the Board of Directors of Cereno Scientific; and Björn Dahlöf, CSO and Head of Clinical Development in Cereno Scientific. The nomination committee's term of office extends until a new nomination committee is appointed.
Board Change • Sep 10No independent directorsThere are 4 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 4 new directors. 6 experienced directors. No highly experienced directors. No independent directors (5 non-independent directors). Director Anders Svensson is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of experienced directors.
お知らせ • Sep 04Cereno Scientific AB Announces New Preclinical Data for Cereno Scientific's Novel IP Receptor Agonist CS585 Presented at ESC Congress 2024Cereno Scientific AB announced new preclinical data indicating that drug candidate CS585, a novel prostacyclin (IP) receptor agonist, inhibits platelet activation and clot formation up to 24 hours post-administration. The new data was presented at the ESC (European Society of Cardiology) Congress 2024, on August 30-September 2, 2024. CS585, was shown to inhibit platelet activation and clot formation in the blood up to 24 hours post administration. In both in vivo and ex vivo models, the sustained effects of CS585 were demonstrated. In contrast, currently FDA-approved IP receptor agonists were shown not to have sufficient duration of action to target the IP receptor for prevention of thrombus formation in blood. Therefore, CS585 represents a novel prostacyclin ("IP") receptor agonist for antiplatelet treatment of thrombotic diseases. The abstract was presented, by Dr. Michael Holinstat, Professor at the Department of Pharmacology, the Department of Internal Medicine (Division of Cardiovascular Medicine), and the Department of Vascular Surgery at the University of Michigan. Dr. Holinstat leads Cereno's preclinical work at the University of Michigan and is Director of Translational Research at Cereno. The purpose of the study was to assess the stability profile of CS585, an IV and orally bioavailable IP agonist, compared to FDA-approved IP agonists iloprost and selexipag, with regards to sustained activity in vivo in the blood in limiting platelet activation and thrombosis. Blood drawn from mice administered CS585 was observed to show a decrease in platelet adhesion and clot formation. The effects of iloprost and selexIPag are no longer observed at 24 hours post-administration; Administration of CS585 resulted in sustained inhibition of platelet accumulation and fibrin formation in the laser-induced cremaster arteriole thrombosis assay up to 18 hours post-administration. In mice administered iloprost, a decrease in thrombus formation was observed 10 minutes post-administration, but thrombus size returned to vehicle levels by 4 hours. Selexipag-dosed mice demonstrated inhibition of thrombus formation up to 4 hours, but effects were no longer observed at 18 hours. The current data in a preclinical model shows that IV administration of CS585 elicited full protection against thrombosis formation for the entire 18h window that was tested. The lead drug candidate, CS1, is an HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties. A Phase II trial is ongoing (patient recruitment closed on July 1st, 2024) to evaluate CS1's safety, tolerability, and exploratory efficacy in patients with the rare disease pulmonary arterial hypertension (PAH). The study will also provide insights for planning the subsequent trial of CS1 in PAH. A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the trial. Two initiatives performed during the Phase II trial have shown positive findings suggesting the potential clinical benefit of CS1 in PAH patients. These initial findings are, however, not a guarantee of the final trial results that are expected in third quarter 2024. Since January 2024, the company are delighted that the FDA's Expanded Access Program will enable patients with PAH, a serious life-threatening disease condition, to gain access to CS1 where no comparable alternative therapy options are available. Cereno's pipeline comprises two additional programs in development through research with the University of Michigan. Investigational drug CS1 is a novel prostacyclin receptor agonist for the prevention of thrombosis.
お知らせ • Sep 03Cereno Scientific Receives Orphan Medicinal Product Designation in the Eu for Cs1 in Rare Disease Pulmonary Arterial HypertensionCereno Scientific announced that the European Commission has granted Orphan Medicinal Product Designation (OMPD) to the Company's lead drug candidate CS1 in the rare disease Pulmonary Arterial Hypertension (PAH). The European Commission is responsible for granting applications, reviewed by the European Medicines Agency (EMA) for OMPD in the EU. To qualify for orphan designation, a drug must meet a number of criteria: it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development; no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. Companies that obtain orphan designation benefit from protocol assistance, a type of scientific advice specific for designated orphan drugs, and market exclusivity once the drug is on the market. Fee reductions are also available depending on the status of the sponsor and the type of service required. About CS1 Drug candidate CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a treatment for the rare disease PAH. CS1 has the potential to be an effective, safe and disease-modifying drug. CS1’s unique efficacy profile fits well with the pathogenetic mechanisms of PAH and is believed to be able to address today’s major unmet need for better treatment alternatives. The aim of CS1’s development is to offer improved quality of life and prolonged life for patients with PAH. Cereno Scientific has over the last year reported encouraging findings from the ongoing Phase II study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH. Since January 30th, 2024, CS1 is approved by the FDA for Expanded Access, as an extension of the ongoing Phase II trial CS1-003 evaluating CS1 in PAH. The EAP gives patients that have completed the Phase II trial the opportunity to, after being judged suitable and to benefit from CS1 treatment by investigators, continue CS1 treatment of PAH when no comparable or satisfactory alternative therapy options are available. The EAP allows Cereno to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. As such, this initiative not only supports the treatment of PAH patients but also enables Cereno to gather additional CS1 usage documentation for regulatory discussions and Phase IIb/III pivotal study design planning. On August 30, 2024, the Company announced that the first patient had been dosed under the EAP. Patient recruitment to the Phase II trial CS1-003 was closed on July 1, 2024, based on a recommendation by the Study Clinical Steering Committee, which concluded that there is sufficient data for evaluating the next steps in development. Topline results will be shared in the third quarter of 2024.
お知らせ • Aug 30+ 1 more updateCereno Scientific AB (publ), Annual General Meeting, Jun 17, 2025Cereno Scientific AB (publ), Annual General Meeting, Jun 17, 2025.
お知らせ • Aug 16Cereno Scientific Expands Patent Protection for PAH Drug Candidate CS1's Third Patent Family in BrazilCereno Scientific announced that a new granted patent in CS1's third patent family has been issued in Brazil. Drug candidate CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a treatment for the rare disease PAH. CS1 has the potential to be an effective, safe and disease-modifying drug. CS1's unique efficacy profile fits well with the pathogenetic mechanisms of PAH and is believed to be able to address today's major unmet need for better treatment alternatives. The aim of CS1's development is to offer improved quality of life and prolonged life for patients with PAH. Cereno Scientific has over the last year reported encouraging findings from the ongoing Phase II study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH. Since January 30th, 2024, CS1 is approved by the FDA for Expanded Access, an extension of the ongoing Phase II trial evaluating CS1 in PAH. The Expanded Access Program (EAP) will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. This initiative not only supports the treatment of PAH patients but also enables Cereno to gather additional CS1 usage documentation for regulatory discussions and Phase IIb/III pivotal study design planning. Currently site-specific contracts and IRB approvals are being progressed. Patient recruitment to the Phase II trial CS1-003 was closed on July 1st, 2024, based on a recommendation by the Study Clinical Steering Committee, which concluded that there is sufficient data for evaluating the next steps in development. Topline results will be shared in Q3, 2024.
お知らせ • Jun 28+ 1 more updateFirst Subject Dosed in Cereno Scientifics First-In-Human Phase I Trial of Novel Hdac Inhibitor Cs014Cereno Scientific announced that the first subject has been dosed in first-in-human, Phase I, trial of novel HDAC inhibitor CS014, being developed as an innovative therapy for thrombosis prevention. The Phase I trial CS014-001, titled "A First-in-human, Open-label Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CS014 in Healthy Volunteers After Single and Multiple Administration", is conducted in partnership with the contract research organization (CRO) Clinical Trial Consultants AB (CTC), in Uppsala, Sweden. The trial is a Phase I, open-label, FIH trial designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The trial will be conducted in two parts: A single ascending dose (SAD) part (Part I) will explore safety, tolerability and PK of single ascending oral doses of CS014. A multiple ascending dose (MAD) part (Part II) will explore safety, tolerability, PK, and PD following multiple ascending doses of CS014, dosed for seven days. The Phase I trial of CS014 will include around 48 subjects and results are expected in a year's time.
お知らせ • Jun 18Cereno Scientific Receives Approval from, EMA to Initiate First-In-Human Phase I Trial with Novel Epigenetic HDAC Inhibitor, CS014Cereno Scientific announced that the Clinical Trial Application (CTA) for a first-in-human, Phase I trial of novel histone deacetylase inhibitor (HDACi) drug candidate CS014, has been approved by the European Medicines Agency. The aim of the planned first-in-human Phase I trial is to evaluate the safety and tolerability of CS014 in healthy volunteers. The design is a single-ascending- and multiple-ascending-dose trial for 1 week. The title of the study is "A first-in-human, open-label trial to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of CS014 in healthy volunteers after single and multiple administration". The investigational drug candidate CS014 belongs to Cereno's HDAC inhibitor program, capitalizing on the principle of epigenetic modulation. The innovative drug candidate represents a novel approach to antithrombotic treatment without the associated increased risk of bleeding. CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator - regulating platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as documented in preclinical studies. Given the potential for the disease-modifying properties seen with HDAC inhibition, additional cardiovascular benefits of CS014 may be expected, including amelioration of inflammation, fibrosis, vascular changes and elevated blood pressure. HDAC inhibition as thrombosis prevention could fundamentally change the thrombosis prevention landscape and meet a major unmet medical need. CS014 is being developed in collaboration with the University of Michigan.
お知らせ • May 24Cereno Scientific AB (publ) to Report Q1, 2025 Results on May 22, 2025Cereno Scientific AB (publ) announced that they will report Q1, 2025 results on May 22, 2025
お知らせ • May 03Cereno Scientific AB (Publ) Announces Nomination Committee Appointments Ahead of Annual General Meeting 2025Cereno Scientifi announced that the representatives of the nomination committee have been appointed ahead of the annual general meeting 2024. The nomination committee has been appointed in accordance with the principles for the nomination committee which were established by the annual general meeting on June 1, 2023. According to the principles for the nomination committee that were resolved at the annual general meeting on April 16, 2024, the nomination committee should be appointed as follows. The Company’s largest shareholder, or group of shareholders, as of 30 April 2024, shall have the right to appoint one member of the Nomination Committee. Furthermore, the Nomination Committee shall consist of the chairman of the Board of Directors, who shall also be the convener. In addition, Björn Dahlöf, CSO and Head of Clinical Development in the Company, shall be a member of the Nomination Committee. The Nomination Committee shall thus consist of three persons. The nomination committee ahead of the annual general meeting 2025 has thus been appointed and comprises: Cihan Punar, representing the company’s largest group of shareholders per April 30, 2024, Joakim Söderström, convening member and Chair of the Board of Cereno, and Björn Dahlöf, CSO and Head of Clinical Development in the Company. One of the members, but not the chairman of the Board of Directors, shall be appointed as chairman of the Nomination Committee. The Nomination Committee’s term of office extends until a new Nomination Committee is appointed.
お知らせ • Apr 17Cereno Scientific AB (publ), Annual General Meeting, Apr 16, 2024Cereno Scientific AB (publ), Annual General Meeting, Apr 16, 2024. Location: Östra Hamngatan 24 in Gothenburg, Sweden Gothenburg Sweden Agenda: To consider Adoption of income statement and balance sheet for the company and the group; to Allocation of result; to Discharge from liability; to Determination of number of board members, deputy board members and the number of auditors and determination of fees to the board and auditors and auditor; to Election of directors, deputies, and auditors; and to consider other matters if any.
お知らせ • Apr 16Cereno Scientific AB (Publ) Approves Election of New DirectorsCereno Scientific AB (publ) at its AGM held on April 16, 2024, approved that Gunnar Olsson and Sten R. Sörensen be elected as new board members.
お知らせ • Apr 10Cereno Scientific AB Submits Clinical Trial Application (CTA) for First-In-Human Phase I Study with Novel Epigenetic HDACi Drug Candidate CS014Cereno Scientific AB announced the submission of a clinical trial application (CTA) to the European Medicines Agency (EMA) for a first-in-human, Phase I study of novel histone deacetylase inhibitor (HDACi) drug candidate CS014. The CTA was submitted for a first in human Phase I study to primarily evaluate the safety and tolerability of CS014 in healthy volunteers. The design is a traditional single ascending and multiple ascending dose study for 1 week. Title of the study is "A first-in-human, open-label trial to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of CS014 in healthy volunteers after single and multiple administration". The Phase I study is planned to be initiated during second quarter of 2024. The investigational drug candidate CS014 belongs to Cereno's HDAC inhibitor program, capitalizing on the principle of epigenetic modulation. The innovative drug candidate represents a novel approach to antithrombotic treatment without the associated increased risk of bleeding in humans. CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator - regulating platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as documented in preclinical studies. Given the potential for the disease-modifying properties seen with HDAC inhibition, additional cardiovascular benefits of CS014 may be expected, including amelioration of inflammation, fibrosis, vascular changes and elevated blood pressure. HDAC inhibition as thrombosis prevention has the opportunity to fundamentally change the thrombosis prevention landscape and meet a major unmet medical need. CS014 is being developed in collaboration with the University of Michigan.
Reported Earnings • Mar 31Full year 2023 earnings released: kr0.21 loss per share (vs kr0.20 loss in FY 2022)Full year 2023 results: kr0.21 loss per share (further deteriorated from kr0.20 loss in FY 2022). Revenue: kr49.3m (down 14% from FY 2022). Net loss: kr48.1m (loss widened 74% from FY 2022). Products in clinical trials Phase II: 1 Revenue is expected to decline by 145% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 17%.
お知らせ • Mar 22Cereno Scientific Announces A Study Protocol Presented for the FDA Approved Expanded Access Program for CS1 in PAHCereno Scientific announced that a study protocol synopsis for the Expanded Access Program (EAP) for its lead candidate drug, the HDAC inhibitor CS1, in the rare disease Pulmonary Arterial Hypertension (PAH), has been published. The EAP will support long-term documentation of safety and efficacy data of CS1 treatment in the Phase II study in PAH. The EAP study named CS-004, is an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1. The exploratory objectives are to evaluate clinical benefit by using CardioMEMS, echocardiography, cardiac magnetic resonance imaging, right heart catheterization, quality of life assessments, biomarkers and actigraphy to measure changes in clinical response with continued treatment with CS1 in patients with Pulmonary Arterial Hypertension (PAH). Safety and exploratory efficacy endpoints will be measured, using the same methods as in the parent study, at the start of the study and subsequently at 4, 8 and 12 months every year. As such, the EAP study will allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which will help in discussions with regulatory authorities and to design Phase IIb/III pivotal study with CS1. Up to 30 patients could participate in Study CS1-004, if they completed the parent study, tolerated CS1 treatment, and if, in the investigator's judgement, the benefits of continued treatment with CS1 outweigh the risk. Some patients will directly roll-over into Study CS1-004 with no disruption in CS1 treatment, while other patients that have already completed Study CS1-003, will need to be restarted on CS1. Patients will, initially, receive the same dose they received in the parent study CS1-003. All patients will later have the option to be titrated to the most efficacious and safe dose determined from the ongoing CS1-003 study, when completed. On a yearly basis, the principal investigator will determine if a patient continues the Expanded Access study for a subsequent year based on safety, tolerability, and clinical benefit of CS1. Continuation of the Expanded Access study will also be evaluated on a yearly basis by Cereno Scientific. As previously reported, investigators have shown substantial interest in the EAP with two-thirds of the patients, having completed the study or are currently on therapy, deemed by investigators to be eligible for continued access to CS1. Currently site-specific and Ethics Committee (IRB) approvals are underway and once these are in place the first patients can be dosed in the EAP.
お知らせ • Mar 15Cereno Scientific Appoints Don De Bethizy as Board of DirectorsCereno Scientific announced that Don de Bethizy has been engaged as Senior Advisor to the Executive Management and Board of Directors of Cereno Scientific, to support the company in reaching its strategic growth objectives. J. Donald (Don) de Bethizy,PhD has more than 30 years of experience in managing and financing life science-related technologies and has played a key role in building and advising several life sciences companies. Don de Bethizy advised the CEO and board of NDA Group AB one of the world's leading private biotechnology regulatory consulting firms until its sale to SSI Strategy in 2023. In 2017, Don facilitated the management buyout of Albumedix Ltd. from Novozymes A/S and the subsequent sale of Albumedix Ltd. to Sartorius for 415 MGBP in late 2022. Currently, Don de Bethizy is Vice Chair of the board of argenx NV a global commercial immunology company headquartered in Gent, Belgium with 2023 sales of 1.2 BUSD of its first drug Vyvgart in the rare autoimmune disease myasthenia gravis. In 2014, in his role as Chief Executive Officer of the Danish biotech Santaris Pharma A/S, he led the sale of the company to Roche for 450 MUSD. He co-founded Targacept Inc. and served as its President and Chief Executive Officer for 15 years. Don de Bethizy led Targacept's private and US Nasdaq public financings totaling approximately 330 MUSD, including the Company's Initial Public Offering (IPO) in April 2006. Don de Bethizy holds a B.S. in Biology from the University of Maryland and an M.S. and PhD in Toxicology from Utah State University. He is currently President of White City Consulting ApS (Denmark), a Director at Lophora ApS (Denmark) and Proterris Inc. (USA). He is a U.S. citizen and resident of Denmark.
お知らせ • Mar 06Cereno Scientific Publishes Update and Study Protocol for the FDA Approved Expanded Access Program for CS1 in PAHCereno Scientific AB announced the study protocol for the Expanded Access Program (EAP) for its lead candidate drug, the HDAC inhibitor CS1, in the rare disease Pulmonary Arterial Hypertension. The EAP will support long-term documentaMon of safety and efficacy data of CS1 treatment in the Phase II study in PAH. As previously reported, investigators have shown substantial interest in the EAP with two-thirds of the patients, having completed the study or are currently on therapy, deemed by investigators to be eligible for continued access to CS1. EAP study named CS-004, is a prolongation of the CS-003 Phase II study of CS1 in PAH, with the primary objective being to evaluate the long-term safety and tolerability of continued treatment with CS1 and exploratory efficacy as secondary objective with the same methods as in the parent study (timepoints being at start, 4, 8 and 12 months every year). Further details will be published on clinicaltrials.gov later. Currently site-specific and Ethics Committee (IRB) approvals are underway and once these are in place the first patients can be dosed in the EAP. The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which will help in discussions with regulatory authorities and to design Phase IIb/III pivotal study with CS1. The approval of the Expanded Access Program (EAP) comes on the heels of encouraging reports emerging from the Phase II study of CS1 in PAH, actively running at 10 specialist clinics in the US. In June, an investigator highlighted a notable case of patient improvement with CS1. Further, Cereno reported in October 2023 that a Data Quality Control Review (DQCR), of data obtained by the CardioMEMS HF System from the first sixteen patients, was concluded with positive findings. In November, another investigator urged Cereno to submit an Expanded Access request to the FDA, seeking permission to continue administering the investigational drug, CS1, to patients post the conclusion of the study treatment. Cereno promptly submitted the request on January 3rd, which was granted by the FDA on January 30 2024.
お知らせ • Feb 29Cereno Scientific Reports One New Patient Enrolled, One Additional Patient Randomized, and One Additional Patient Completed in the Phase II Study of CS1 in PAHCereno Scientific announced that one new additional patient have been enrolled in the study, one additional patient has been randomized on CS1 drug and one additional patient has completed the study. This update serves as the latest progress update for the Phase II study of drug candidate CS1 in rare disease pulmonary arterial hypertension (PAH). The study is set to be completed by third quarter 2024. The Phase II study of CS1 in the rare disease PAH is actively running at 10 specialist clinics in the US, with the latest clinic activated in late December. One additional new clinic is currently in late-stage start-up process. Since the last phase II study progress update communicated on February 21, 2024, one new additional patient have now been enrolled in the study, one additional patient has now been randomized to CS1 drug in the study and one additional patient has now completed the study. Enrolled patients are scheduled to receive CardioMEMS HF System implantation within two weeks from enrollment and are, following successful implantation of CardioMEMS and up to 6 weeks baseline evaluation, randomized to CS1 drug therapy on their next scheduled visit. The next step for the recently enrolled patient is to undergo CardioMEMS implantation. 25 patients have already received CardioMEMS implantation, of which 24 patients have already been randomized to CS1 drug therapy and one is still in baseline period prior to randomization. To date 20 patients have completed the study. EAP approval follows positive findings from the PAH study with CS1 drug therapy reported since 2023: Cereno Scientific has during the last few months reported positive findings from the ongoing study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH. Study completion and top-line results are expected during third quarter of 2024. Remarkable Patient Case with CS1 reported June 2023: First, a patient case study performed on the first patient having completed the study at a specific clinic showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% reduction in pulmonary pressure and a 20% increase in cardiac output. The patient’s overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that the patient had next to normal functional physical capacity with CS1 added to stable conventional therapy. Data Quality Control Review reported October 13th 2023: In addition, Cereno reported in October 2023 that a Data Quality Control Review (DQCR), of data obtained by the CardioMEMS HF System from the first 16 patients, was concluded with positive findings. The data quality of the CardioMEMS measurements was found satisfactory with adherence to study protocol and with timely data transfers from the patient's home to the clinic. Efficacy findings showed a clinically meaningful reduction of pulmonary pressure in several patients, included in the data quality control, of a similar or greater magnitude as in the Patient Case. EAP for CS1 Approved Jan 30th 2024: Further, the Expanded Access Program (EAP) (“Compassionate Use”) approved by the FDA on 31st January 2024 is progressing according to plan, propelled by investigator and patient interest. Investigators indicate that close to two-thirds of the patients, having completed the study or are currently on therapy, have been judged to be interested in continued access to CS1 following study completion. Currently site-specific and IRB approvals are being progressed. The EAP will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which will help in discussions with regulatory authorities and to design Phase IIb/III pivotal study with CS1.
Reported Earnings • Feb 22Full year 2023 earnings released: kr0.21 loss per share (vs kr0.20 loss in FY 2022)Full year 2023 results: kr0.21 loss per share (further deteriorated from kr0.20 loss in FY 2022). Revenue: kr49.3m (down 14% from FY 2022). Net loss: kr48.1m (loss widened 74% from FY 2022). Revenue is expected to decline by 139% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 13%.
お知らせ • Feb 22Cereno Scientific Reports Progress of Expanded Access Program and Announces Timeline Adjustment in the Phase II Study of CS1 in PAHCereno Scientific announced an update on the progress of the Phase II study of CS1 in pulmonary arterial hypertension (PAH). Cereno has seen substantial interest in the FDA-approved Expanded Access Program ("compassionate use") for patients who have completed the Phase II study, with investigators indicating that a majority of patients would be interested in continued access to CS1 following study completion. The company reports considerable progress in the study. Due to a longer start-up phase for the two new study sites than previously estimated, the study timeline has been negatively affected and top-line results are now expected in Third Quarter 2024. The Phase II study of CS1 In the rare disease PAH is actively running at 10 specialist clinics in the US, with one new clinic activated in late December and one new clinic currently in late-stage start-up process. To date, 25 patients have received the CardioMEMS HF System implantation, of which 23 patients have been randomized to CS1 drug therapy; and 19 patients have completed the study. Investigators indicate that close to two-thirds of the patients, having completed the study or are currently on therapy, have been judged to be interested in continued access toCS1 following study completion. Currently site-specific and IRB approvals are being progressed. The EAP will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which will help further inform the design of Phase IIb/III pivotal study with CS1. While the company reports notable progress in the study, a slower recruitment pace than estimated during the last months and a longer start-up phase For the new sites have affected the study timeline. The updated study timeline now expects study completion and top-line results during Third Quarter 2024.
New Risk • Feb 14New minor risk - Market cap sizeThe company's market capitalization is less than US$100m. Market cap: €92.6m (US$99.1m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr83m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Shareholders have been substantially diluted in the past year (70% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr37m net loss in 3 years). Revenue is less than US$5m (kr53m revenue, or US$5.0m). Market cap is less than US$100m (€92.6m market cap, or US$99.1m).
お知らせ • Feb 13Cereno Scientific AB Appoints Rahul Agrawal as Chief Medical Officer and Head of R&DCereno Scientific AB (publ) announced that Dr. Rahul Agrawal has been appointed as Chief Medical Officer and Head of R&D. The recruitment follows an intense period in the clinical-stage biotech's growth journey. Dr. Rahul Agrawal is an experienced senior executive leader with a diverse background spanning Big Pharma and biotech. His expertise encompasses the entire value chain including R&D, Medical Affairs, commercial and strategy experience across various therapeutic areas such as cardiovascular, renal, respiratory, and rare/orphan drugs and he has launched seven drugs globally. Joining Cereno after having worked as a CMO at another gene therapy focused biotech Cardior, and prior to that as VP and Global Medicines Leader at AstraZeneca, Dr Agrawal brings extensive cardiovascular clinical trial leadership. Further, his experience in branding and marketing for the Pulmonary Hypertension portfolio as Global Director of Medical Affairs and Clinical Development at Bayer HealthCare, makes him a valuable addition to the Cereno Scientific team. Dr. Agrawal has an MD degree after having studied at the Free University of Berlin, Germany and Cornell University, New York, USA, and is board-certified in cardiology, internal medicine, and emergency medicine. Additionally, he holds an MBA from Buckinghamshire New University, UK. Dr. Agrawal will in his capacity be a member of the Executive Management Team and report to Sten R. Sörensen, CEO. Björn Dahlöf, in his capacity as CSO, will continue to report to Sten R. Sörensen, CEO.
お知らせ • Feb 03Cereno Scientific AB (publ) Appoints Megha Ranjan as Project Director to Strengthen Business CapabilitiesCereno Scientific AB (publ) announced that Megha Ranjan has joined the company as Project Director. She will be part of the company’s business and operational team and report to Sten R. Sörensen, Chief Executive Officer (CEO). Megha Ranjan has nearly a decade of experience supporting small to large-sized global life sciences companies in defining their strategies using comprehensive market insights, intelligence, and valuations. She has previously gained experience from roles in commercial and scientific teams at large pharmaceutical companies including BD&L valuations, real-world evidence analysis, go-to-market strategies, medical affairs and medical information. Megha Ranjan holds a B.Sc. in Dental Surgery and an MBA in Healthcare Management from IIHMR University, India.
お知らせ • Feb 02Cereno Scientific AB Appoints Julia Fransson as Director of Business DevelopmentCereno Scientific AB announced that Julia Fransson has joined the company as Director of Business Development. She joins the clinical stage biotech at an exciting point of the company's growth journey, in developing innovative treatments for common and rare cardiovascular disease, with lead candidate drug CS1 in phase II in orphan disease PAH which is to deliver top line study results by Second Quarter this year. Julia Fransson is an experienced business development professional in the life science industry. She is skilled in crafting strong and focused strategies, translating key scientific and market insights toward investors and partners as well as business modelling market analysis and biotech asset valuation. Previous roles include management positions within developing technology companies as well as, most recently, heading up a boutique life science strategy advisory firm. Julia holds a B.Sc. in Biotechnology and a M.Sc. in Business Design in life science companies from Chalmers University of Technology, Sweden.
お知らせ • Jan 31Cereno Scientific Receives Expanded Access by the FDA to Drug Candidate CS1 for Rare Disease Pulmonary Arial HypertensionCereno Scientific announced that the company has been granted approval by the FDA for Expanded Access, sometimes called "compassionate use", to investigational drug CS1 for use in an extension of the ongoing Phase II trial evaluating CS1 in pulmonary arterial hypertension (PAH). Cereno's Expanded Access Program (EAP) to drug candidate CS1 will initially be limited to patients who have completed the Phase II study in PAH. The approval of the Expanded Access Program (EAP) comes on the heels of encouraging reports emerging from the phase II study. In July, an investigator highlighted a notable case of patient improvement with CS1. Subsequently, positive outcomes were observed during a midway study readout in October. In November, another investigator urged Cereno to submit an Expanded Access request to the FDA, seeking permission to continue administering the investigational drug, CS1, to patients post the conclusion of the study treatment. Cereno promptly submitted the request on January 3rd, and it has now been successfully granted by the FDA. The Expanded Access Program (E AP) with CS1 in PAH provides patients who have completed the Phase I study the option to continue with CS1 drug therapy, in consultation with the investigator and subject to approval by theethics committee at the local hospital. The Expanded Access Program will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. The EAP will thus allow Cereno to gather further documentation of CS1 use in patients suffering from PAH, which could provide valuable support to later potential applications to the FDA such as fast-track designation/breakthrough therapy as well as support to obtain the IND acceptance to start a Phase IIb/III pivotal study with CS1.
お知らせ • Jan 12Cereno Scientific Strengthens R&D with Recruitment of Tatiane Abreu Dall'Agnol as Medical DirectorCereno Scientific announced that Tatiane Abreu Dall'Agnol has joined the company as Medical Director. She will be part of the company's R&D team and report to Björn Dahlöf, Chief Medical Officer (CMO). Tatiane Abreu Dall'Agnol is a medical doctor with nearly a decade of clinical experience. She has previously also worked as a life science consultant advising biotech companies on drug development strategy and analysis; and gained experience in business development and competitive intelligence at Pieris Pharmaceuticals. Tatiane has a medical degree from the Universidade Positivo, Curitiba, PR, Brazil, and an M.Sc. in Business Creation and Entrepreneurship in Biomedicine from the University of Gothenburg, Sweden.
お知らせ • Dec 21Cereno Scientific AB Confirms New Clinic Activated in the Phase II Study of Drug Candidate CS1 in Rare Disease PAHCereno Scientific AB announced that a new clinic has been activated in the ongoing Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH). The clinic is located in Austin, Texas, and starts recruiting patients immediately. The Phase II study is now actively running at 10 specialist clinics in the US with yet another new clinic currently in the late-stage start-up process. The Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH) is now actively recruiting patients at 10 specialist clinics in the US, and one additional new clinic is in the process of opening. An investigator-initiated patient case study performed on the first patient having completed the study at the clinic where the investigator was based showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% pulmonary pressure reduction and a 20% increase in cardiac output. The patient's overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that she had next to normal functional physical capacity. A data quality control review (DQCR) initiative was performed confirming the utility of the CardioMEMS HF System (Abbott Inc.) and showed that CS1 has a clinically meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result. Currently, a request for expanded access to CS1 (also called "compassionate use") is being prepared upon inquiry from patients and investigators in the study. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be reported in second quarter of 2024.
お知らせ • Dec 14+ 2 more updatesCereno Scientific AB (publ) to Report Q3, 2024 Results on Nov 21, 2024Cereno Scientific AB (publ) announced that they will report Q3, 2024 results on Nov 21, 2024
お知らせ • Dec 13Cereno Scientific's Novel HDACi CS014 Has Potential to Become an Effective Antithrombotic Therapy in Patients with A High Risk of Thrombotic Events as Presented at the ASH MeetingCereno Scientific announced that new preclinical data suggests that CS014 has the potential to enrich the toolbox of anticoagulant therapies in patients with a high risk of thrombotic events without increasing the risk of bleeding. CS014 is a novel histone deacetylase (HDAC) inhibitor that acts as an epigenetic modulator and is in preclinical development as a treatment for thrombosis prevention. The new data was presented at the 65th ASH Annual Meeting & Exposition organized by the American Society of Hematology, in San Diego, US, on December 9-12, 2023. The study presented at the ASH Annual Meeting sought to determine if CS014, histone deacetylase (HDAC) inhibitor, either alone or in combination with the FXa inhibitor rivaroxaban, is able to effectively inhibit platelet and fibrin-rich thrombosis formation at the site of vascular injury without causing a significant increase in the bleeding risk in a mouse cremaster thrombosis model. The findings suggest that while CS014 and rivaroxaban are each effective antithrombotic agents, they work well together to minimize clot formation and CS014 in combination did not alter coagulation compared to rivaroxaban alone. Hence, CS014 has the potential to enrich the toolbox of antithrombotic therapies to prevent thrombosis without bleeding in patients with a high risk of thrombotic events. Drug candidate CS014 is a novel HDAC inhibitor in development as a treatment for arterial and venous thrombosis prevention. Preparations are currently ongoing towards a Phase I study and include completion of the preclinical development program, including a preclinical safety program that has already been completed, development and manufacturing of the investigational formulation used for oral dosing of the healthy volunteers and obtaining permission from the Swedish Medical Products Agency as well as the Ethics Committee to start the study. The Phase I study is estimated to be initiated in Sweden during the first half of 2024.
お知らせ • Dec 12Cereno Scientific Announces New Preclinical Data Concludes That Drug Candidate CS585Cereno Scientific announced that new preclinical data conclude that drug candidate CS585 provides a new option of activating the IP receptor to decrease platelet reactivity and could represent the first viable option for targeting the IP receptor on platelets for primary inhibition of thrombosis with a reduced risk of bleeding. The data was presented at the 65th ASH Annual Meeting & Exposition organized by the American Society of Hematology, in San Diego, US, on December 9-12, 2023. For the first time, a head-to-head comparison of CS585, a novel IP receptor agonist, was conducted with the FDA-approved IP receptor agonists selexipag and iloprost. The compounds were assessed by direct comparison to elucidate potential differences in selectivity and sustained action. In contrast to the FDA-approved IP receptor agonists (iloprost and selexipag) which showed short-term protection from thrombosis in the laser induced cremaster thrombosis assay in mice, treatment with CS585 resulted in sustained inhibition of clot and fibrin formation in the same model up to 48 hours post-administration. The preclinical results with CS585 thus indicate a favorable profile for inhibiting platelet activation and clot formation and demonstrate a sustained duration of action in mice in the ability to inhibit platelet activation through multiple routes of administration. Importantly, CS585 does not affect coagulation parameters and previous studies demonstrated no potential for increased bleeding in mouse models. Overall, CS585 provides a new option of activating the IP receptor to decrease platelet reactivity and could represent the first viable option for targeting the IP-receptor on platelets for primary inhibition of thrombosis with a reduced risk of bleeding. CS585 was also shown to be more selective for the IP receptor than selexipag and iloprost as determined by platelet aggregation and VASP phosphorylation. The abstract presented at the 65th ASH Annual Meeting & Exposition is titled "CS585 Demonstrates Favorable Selectivity and Sustained In Vivo Action in Preventing Platelet Activation and Thrombosis Compared to Existing IP Receptor Agonists", and was authored by L. Stanger, P. Yalavarthi, S. Lambert, A. Rickenberg, K. Goerger and D. Gilmore at the Department of Pharmacology, University of Michigan Medical School, Ann Arbor, MI, US; B. Dahlöf and N. Bergh at the University of Gothenburg, Gothenburg, Sweden; and M. Holinstat at the Department of Pharmacology, University of Michigan Medical School, Ann Arbor, MI, US. There is a growing body of evidence around drug candidate CS585 supporting favorable tolerability and efficacy in preclinical studies. Recently, the drug candidate was published in the top-tier journal color:Blood showing that CS585 is a highly potent and selective compound given both orally and intravenously and prevents thrombosis for up to 48 hours as observed in preclinical studies.
お知らせ • Dec 02Cereno Scientific Completes Preclinical Safety Program for Innovative Drug Candidate CS014 Targeting Thrombosis Prevention and Reaches A Major Preparatory Milestone Towards the Phase I StudyCereno Scientific announced that the preclinical safety program for drug candidate CS014 has successfully been completed. The safety documentation is a key component needed to apply for permission from regulatory authorities to start a first-in-human Phase I study. The Phase I study will be conducted in Sweden in partnership with the contract research organization (CRO) Clinical Trial Consultants (CTC) and is planned to start during the first half of 2024. Drug candidate CS014 is a histone deacetylase inhibitor (HDACi) in development as a treatment for arterial and venous thrombosis prevention. This innovative drug candidate represents an approach to antithrombotic treatment so far shown to be without the associated increased risk of bleeding. The preparations before a Phase I study can be initiated includes completion of the preclinical development program, including a preclinical safety program, development and manufacturing of the investigational formulation used for oral dosing of the healthy volunteers and obtaining permission from the Swedish Medical Products Agency as well as the Ethics Committee to start the study. The Phase I study is estimated to be initiated in the first half of 2024.
お知らせ • Nov 29Cereno Scientific Obtains First Patent in India for Drug Candidate Cs1 Through Its Third Patent FamilyCereno Scientific announced that drug candidate CS1's third patent family has obtained a patent in India. This strengthens and broadens the intellectual property rights (IPR) for Cereno's Phase II drug candidate CS1, which is being developed for the treatment of rare disease pulmonary arterial hypertension (PAH). Drug candidate CS1 is currently being evaluated in a Phase II study in PAH. The study is actively recruiting patients at 9 specialist clinics in the US, and two additional new clinics are in the process of opening. An investigator-initiated patient case study performed on the first patient having completed the study at the clinic where the investigator was based showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% pulmonary pressure reduction and a 20% increase in cardiac output. The patient's overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that she had next to normal functional physical capacity. A data quality control review (DQCR) initiative was performed confirming the utility of the CardioMEMS HF System (Abbott Inc.) and showed that CS1 has a clinically meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result. Currently, a request for expanded access to CS1 (also called "compassionate use") is being prepared upon inquiry from patients and investigators in the study. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be reported in Second Quarter 2024.
お知らせ • Nov 19Cereno Scientific AB (Publ) Move to Request “Compassionate Use” of CS1 for Treatment of Patients with Rare Disease PAHCereno Scientific announced that the company will submit a request for expanded access to investigational drug CS1 for use as a treatment outside of a clinical trial, sometimes called “compassionate use.” The initiative is prompted by a request from an investigator in the ongoing Phase II study of CS1. Cereno will submit a request to the FDA under the ‘Expanded Access to Investigational Drugs for Treatment Use’ requesting expanded access to CS1 which initially will be limited to patients who have completed the Phase II study in PAH. The Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. If Cereno’s request for expanded access to CS1 is authorized by the FDA and subsequently approved by the local hospital sites’ ethics committees, patients having completed the Phase II study will, in consultation with the investigator, have the option to continue with the CS1 drug therapy. The expanded access would provide Cereno with the ability to collect efficacy and safety data on extended long-term exposure to CS1 in patients with pulmonary arterial hypertension (PAH) under a formal FDA-approved protocol, which could provide support to later applications to the FDA such as fast-track designation/breakthrough therapy and to obtain the IND acceptance to start a Phase III study with CS1.
Reported Earnings • Nov 19Third quarter 2023 earnings releasedThird quarter 2023 results: Revenue: kr5.80m (down 47% from 3Q 2022). Net loss: kr11.1m (loss widened 53% from 3Q 2022). Revenue is expected to decline by 94% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 12%.
お知らせ • Nov 17Cereno Scientific Reports Significant Progress and A Time Time Adjustment in the Phase II Study of CS1 in Rare Disease PAHCereno Scientific announced an update on the progress of the Phase II study of CS1 in pulmonary arterial hypertension (PAH). The company reports significant progress in the study, however, a slower recruitment pace than estimated during the last months and a longer start-up phase for two new clinics have affected the study timeline. The updated study timeline now expects study completion and top-line results during second quarter 2024. The Phase II study of CS1 In the rare disease PAH is actively running at 9 specialist clinics in the US with two new clinics currently in late-stage start-up process. To date, 32 patients have been enrolled in the study; 8 of those did not, after consent, meet all study criteria to continue in the study; 20 patients have received the CardioMEMS HF System implantation; 19 patients have been randomized to drug therapy; and 16 patients have completed the study, one of which terminated early due to non-drug related issues. The company has earlier this year reported positive findings from the ongoing study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH. First, a patient case study performed on the first patient having completed the study at a specific clinic showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% reduction in pulmonary pressure and a 20% increase in cardiac output. The patient's overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that she had next to normal functional physical capacity with CS1. The Phase II study will continue to completion without any changes to the study protocol. The DQCR findings are not based on data from all patients participating in the Phase II study and some patients in this analysis have not completed the full study period. The final results of the study may differ from the findings in this DQCR and shall not in any way be seen as a guarantee regarding the outcome and conclusions of the upcoming final Phase II study results. The Phase II study ofCS1 in the rare disease pulmonary arterial hypertension (PA H) is actively recruiting patients at 9 specialist clinics in the U.S, and two new clinics are in the process of opening. An investigator-initiated patient case study performed on the First Quarter of the study performed on the first patients having completed the study at the clinic the investigator was based showed remarkable efficacy data. In12 weeks of treatment with CS1., the patient showed a 30% pulmonary pressure reduction and a 20% increase in cardiovascular output. A data quality control initiative was performed confirming the utility of the CardioMEM HF System (Abbott Inc.) and showed that CS1 has a clinical meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be estimated to be expected to be completed in the second quarter of 2024.
お知らせ • Nov 08Cereno Scientific AB (publ) Appoints Jeppe Øvlesen as a New Board MemberCereno Scientific AB (publ) announced that at the extraordinary general meeting held on November 7, 2023 elected Jeppe Øvlesen as a new board member.
お知らせ • Oct 14Cereno Scientific AB (Publ) Reports Positive Results from the Data Quality Control Review Initiative in the Phase II Study of CS1 in Rare Disease Pul Arterial Hypertension (PAH)Cereno Scientific announced that the initiative to control the data quality produced from the cutting-edge technology CardioMEMS HF System (Abbott Inc.) used in the Phase II study of CS1 in pulmonary arterial hypertension (PAH) has successfully been concluded with positive results. The Data Quality Control Review (DQCR) found the data quality of the CardioMEMS measurements satisfactory with adherence to study protocol and with timely data transfers from the patient's home to the clinic. Efficacy findings show a clinically meaningful reduction of pulmonary pressure in several patients included in the data quality control already after 3 weeks of treatment with CS1, in line with the results from the previously communicated Patient Case. Cereno emphasizes that these reported initial findings of the DQCR may differ from the Phase II study's final results. The top-line results of the completed Phase II study are expected in First Quarter 2024. As communicated on June 26, 2023, an investigator-initiated Patient Case review showed remarkable efficacy data in the first patient completing the Phase II study of CS1. The results from right heart catheterization showed that the patient's mean pulmonary arterial pressure (mPAP) was reduced from 33 mmHg at baseline to 23 mmHg at the end of the 12-week treatment period. Cardiac output was increased from 4.7 L/min at baseline to 5.6 L/min. Right ventricular (RV) stroke volume (SV) also increased when treated with the highest dose of CS1 over time, together with SV index and RV efficiency. These changes were accompanied by reductions in RV stroke work and total pulmonary resistance (TPR). With CardioMEMS HF System, there was a sustained reduction in mPAP over time measured as the Area Under the Curve (AUC) mmHg days. The patient required no changes to her PAH medication during the study, and her status was improved from NYHA/WHO functional class II to functional class I at the end of the 12-week treatment period. This month a Data Quality Control Review (DQCR) initiative was performed with the aim of correcting potential deviations from the set protocol or identifying issues around data transfer from the patient's home to the clinic to increase standardization of the data and also obtain an early indication of CS1's efficacy. The DQCR was performed on blinded data regarding the individual patient dosing. The review included data obtained by the CardioMEMS HF System from the first 16 patients enrolled in the Phase II study. Key findings from the DQCR: The DQCR concluded no concerning issues with digital data transfer and patient/physician protocol adherence. The DQCR shows several patients with a reduction in mPAP of similar or greater magnitude as the initial Patient Case as measured with CardioMEMS HF System over time (AUC mmHg days). This indicates a clinically meaningful efficacy potential with CS1 in reducing mPAP in patients with PAH on top of standard-of-care drug therapy. The DQCR shows that more than 60% of patients on CS1, all doses included, have a sustained reduction in mPAP evaluated as the AUC. Reductions of mPAP (AUC) as so far seen in several patients in this study are clinically meaningful for patients with PAH. The DQCR indicates an efficacy response compatible with a dose-response pattern. As the analysis was performed with dosages blinded, the final assessment of a dose-response relationship will need to await unblinding of the data at the end of the study. The DQCR indicates an early onset of action with drug therapy of CS1 as measured by the reduction of mPAP. This early onset was observed already after 3 weeks for several patients. The DQCR showed a sustained reduction of mPAP in the 2-week follow-up period after the 12-week period of therapy with CS1 was discontinued.
お知らせ • Sep 13Cereno Scientific Announces Appointments to the Nomination Committee Ahead of the Annual General Meeting 2024Cereno Scientific announced that the representatives of the nomination committee have been appointed ahead of the annual general meeting 2024. The nomination committee has been appointed in accordance with the principles for the nomination committee which were established by the annual general meeting on June 1, 2023. According to the principles for the nomination committee that were resolved at the annual general meeting on June 1, 2023, the nomination committee should be appointed as follows. The company's largest shareholder, or group of shareholders, as of May 31, 2023, has the right to appoint one representative of the nomination committee. Furthermore, a group of shareholders that consists of the company's founders Sverker Jern and Niklas Bergh have the right to appoint one representative of the nomination committee. In addition, the nomination committee must include the Chair of the Board who must also be the convener. The nomination committee ahead of the annual general meeting 2024 has thus been appointed and comprises Cihan Punar, representing the company's largest group of shareholders per May 31, 2023. Sverker Jern, representing the Company's founders Sverker Jern och Niklas Bergh. Joakim Söderström, convening member and Chair of the Board of Cereno. One of the members, but not the Chair of the Board, must be appointed the Chair of the nomination committee. The nomination committee's term of office extends until a new nomination committee is appointed.
New Risk • Sep 03New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 122% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (28% average weekly change). Shareholders have been substantially diluted in the past year (122% increase in shares outstanding). Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr93m). Currently unprofitable and not forecast to become profitable over next 3 years (kr37m net loss in 3 years). Market cap is less than US$100m (€39.0m market cap, or US$42.1m).
Reported Earnings • Aug 27Second quarter 2023 earnings releasedSecond quarter 2023 results: Revenue: kr10.6m (down 39% from 2Q 2022). Net loss: kr10.7m (loss widened 64% from 2Q 2022). Revenue is expected to decline by 98% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 16%.
お知らせ • Aug 24Cereno Scientific to Open Two New Clinics to Complete Patient Recruitment in the Phase II Study of CS1 in PahCereno Scientific announced that further mitigation strategies have been activated for the Phase II study of CS1 in pulmonary arterial hypertension (PAH) due to slower patient recruitment than anticipated. Two new specialist clinics with large capacities are currently in the start-up phase to open to complete the recruitment of patients fulfilling the study criteria. Consequently, the timeline of the study estimates top-line results to be reported in first quarter 2024. The Phase II study of CS1 In the rare disease PAH is currently actively running at 9 specialist clinics in the US. The two new clinics to open have already identified suitable patients for screening before being activated. At existing clinics, there are potential patients due to be screened during September and October. To date, there are 25 patients enrolled in the study, 16 patients having received CardioMEMS HF System implantation, 16 patients randomized and in active treatment, and 3 patients having completed the study. The study is designed to include 30 randomized patients with the rare disease PAH.
お知らせ • Aug 22Cereno Scientific AB (Publ) Appoints Eva Jagenheim as Chief Financial OfficerCereno Scientific announced that Eva Jagenheim is appointed Chief Financial Officer (CFO). Jagenheim has broad experience in finance and the Swedish biotech sector. She will join the company on August 28, 2023. Eva Jagenheim, born 1966, has an M.Sc. in Business and Economics from Växjö University and an MBA from Gothenburg Business School. She has a broad experience of various roles within finance. Previous experience includes working as an accountant at PWC, consultant at the accounting firm Arthur Andersen, and at companies of varying sizes across several different industries. She most recently work as CFO at RLS Global, a medtech company listed on Nasdaq First North Growth Market.
お知らせ • Jun 30Cereno Scientific Reports Positive Data from Patient Case StudyCereno Scientific has reported positive data received from a patient case study from the ongoing phase II trial with lead candidate CS1 in pulmonary arterial hypertension.
Recent Insider Transactions • Jun 29Chairperson recently bought €68k worth of stockOn the 27th of June, Joakim Soderstrom bought around 1m shares on-market at roughly €0.055 per share. This transaction increased Joakim's direct individual holding by 4x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Joakim's only on-market trade for the last 12 months.
お知らせ • Jun 27Cereno Scientific Reports an Investigator-Initiated Patient Case Study from the Ongoing Phase II Study of CS1 in PAHCereno Scientific announced data received from a patient case study initiated by an investigator on the first patient having completed the Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH) at the site. The case study is based on one patient and was performed to control the utility of CardioMEMS™ HF System (Abbott Inc.), an innovative technology used to daily monitor pulmonary pressure and other cardiopulmonary function in patients in the study. Data indicates that drug candidate CS1 has a positive effect on pulmonary arterial pressure and cardiac function. It further indicates the utility of CardioMEMS in evaluating drug medication effectiveness in PAH. The patient in the case study was a 51-year-old female patient with symptomatic PAH for three years (NYHA/WHO functional class II) who was enrolled in the study. She had received maintenance treatment of tadalafil 40 mg, macitentan 10 mg, and treprostinil 32 µg dry powder inhaler. The CardioMEMS pulmonary artery (PA) Sensor was implanted in a distal branch of her PA following screening and she was randomized to the 1920 mg dose of CS1. The findings of the case study, carried out during a 12-week treatment period with CS1, show that the patient's mean pulmonal arterial (PA) pressure was reduced from 33 mmHg at baseline to 23 mmHg at the end of the period. Cardiac output was increased from 4.7 L/min at baseline to 5.6 L/min. Right ventricular (RV) stroke volume (SV) also increased when treated with CS1 over time, together with SV index and RV efficiency. These changes were accompanied by reductions in RV stroke work and total pulmonary resistance (TPR). The patient required no changes to her PAH medication during the study, and her status was improved from NYHA/WHO functional class II to functional class I at the end of the treatment period. There were no adverse events related to PA sensor implantation or the device itself and there were no serious adverse events reported on CS1. In addition to the data related to the effects of CS1 in the PAH patient, the case study indicates that using the CardioMEMS PA Sensor permits safe daily remote monitoring of PA pressure over time in patients with PAH, permitting assessment of medication effectiveness on an individual patient level. The Phase II study is currently actively recruiting patients. In mid-May, the company reported that 16 patients were enrolled in the study, 9 patients have received CardioMEMS HF System implantation, 5 patients were randomized and in active treatment, and 2 patients had completed the study. Recruitment of the 30 PAH patients to be included in the study is on track and top-line results are anticipated around year-end 2023.
お知らせ • Jun 09+ 2 more updatesCereno Scientific AB (publ), Annual General Meeting, Jun 03, 2024Cereno Scientific AB (publ), Annual General Meeting, Jun 03, 2024.
お知らせ • May 13Cereno Scientific Shares Progress Update in the Phase II Study with Drug Candidate CS1 in the Rare Disease PAHCereno Scientific announced an updated progress report of the Phase II study in pulmonary arterial hypertension (PAH) with drug candidate CS1. The study is proceeding well with currently 16 patients enrolled in the study, 9 patients having received CardioMEMS HF System implantation, 6 patients randomized and in active treatment, and 2 patients having completed the study. Recruitment of the 30 PAH patients to be included in the study is on track and top-line results are anticipated at year-end 2023. The Phase II study with CS1 is divided into several important steps from beginning to end to ensure high-quality data from the study. The patient recruitment begins with each clinic identifying and pre-screening patients using the clinic's patient registries and study physicians' knowledge about their patients. The patients that fulfill all inclusion criteria and none of the exclusion criteria are scheduled for a first visit where patients consent to participation in the study and all criteria are confirmed. If all checks out, the patient is considered to have started the study (i.e., been recruited into the study with a successful screening visit). Within two weeks after the first visit, the patient is subjected to right heart catheterization and implantation of the CardioMEMS HF System to monitor blood pressure in the pulmonary circulation and other cardio-pulmonary hemodynamics daily during the study. After four to six weeks of CardioMEMS HF measurements, a full baseline evaluation including, among others, a 6-minute walk test, echocardiography, biomarkers, validated risk scores, patient-reported outcomes, and MRI are measured. The 30 patients are randomized to one of three dose groups of CS1, and the active treatment period is 12 weeks. In addition to the daily CardioMEMS measurements, all measurements are repeated at the end of the 12-week treatment period with CS1 and compared to baseline measurements and between doses to enable evaluation of CS1's safety, tolerability, and exploratory efficacy. The study's total duration is a maximum of 22 weeks, including the follow-up visit two weeks after the treatment period.
お知らせ • May 05Cereno Scientific's Phase II Study in the Rare Disease PAH Reports Two Patients Successfully Completed the Treatment Period with Drug Candidate CS1Cereno Scientific announced that two patients have successfully completed the treatment period in the study. The study is proceeding according to plan and top-line results are anticipated at year-end 2023. The Phase II study is divided into several important steps from beginning to end to ensure high-quality data from the study. The patient recruitment begins with each clinic identifying and pre-screening patients using the clinic's patient registries and study physicians' knowledge about their patients. The patients that fulfill all inclusion criteria and none of the exclusion criteria are scheduled for a first visit where patients consent to participation in the study and all criteria are confirmed. If all checks out, the patient is considered to have started the study (i.e., been recruited into the study with a successful screening visit). About two weeks post the first visit, the patient is subjected to right heart catheterization and implantation of the CardioMEMS HF System to monitor blood pressure in the pulmonary circulation and other cardio-pulmonary hemodynamics daily during the study. After further four to six weeks of CardioMEMS HF measurements, a full baseline evaluation including, among others, a 6-minute walk test, echocardiography, biomarkers, validated risk scores, patient-reported outcomes, and MRI are measured. The 30 patients are randomized to one of three dose groups of CS1, and the active treatment period is 12 weeks. To enable exploration of CS1's safety, tolerability, and efficacy, all measurements are repeated at the end of the 12-week treatment period with CS1 and compared to baseline measurements and between doses. The study's total duration is a maximum of 22 weeks, including the follow-up visit two weeks after the treatment period.
Reported Earnings • Apr 11Full year 2022 earnings released: kr0.20 loss per share (vs kr0.15 loss in FY 2021)Full year 2022 results: kr0.20 loss per share (further deteriorated from kr0.15 loss in FY 2021). Revenue: kr57.5m (up 28% from FY 2021). Net loss: kr27.7m (loss widened 70% from FY 2021). Products in clinical trials Phase II: 1 Revenue is expected to decline by 150% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Germany are expected to grow by 22%.
Reported Earnings • Feb 23Full year 2022 earnings released: kr0.26 loss per share (vs kr0.15 loss in FY 2021)Full year 2022 results: kr0.26 loss per share (further deteriorated from kr0.15 loss in FY 2021). Revenue: kr57.5m (up 28% from FY 2021). Net loss: kr27.7m (loss widened 70% from FY 2021). Revenue is forecast to grow 29% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe.
お知らせ • Feb 15Cereno Scientific AB (publ) Reports Progress with CS1 Phase II Study in Pulmonary Arterial HypertensionCereno Scientific AB (publ) announced that all clinical sites are activated and actively recruiting patients in the ongoing Phase II study in the rare disease pulmonary arterial hypertension (PAH) with thedrug candidate CS1. To date, three patients have been randomized and entered the treatment period. The study's top-line results are now expected by end of 2023. The Phase II study in the rare disease PAH with drug candidate CS1 has received much recognition for its innovative design. In March 2020, Cereno received the US FDA's orphan drug designation (ODD) for the clinical development program for CS1 in PAH. Through the granted ODD, the FDA has indicated that they believe CS1 has the potential to provide significant benefit to patients suffering from PAH. The patient recruitment starts with the patient undergoing a screening process. After right heart catheterization, implantation of the CardioMEMS HF System takes place to monitor blood pressure in the pulmonary circulation and other cardio-pulmonary hemodynamics daily during the study. After 4 to 6 weeks of CardioMEMS HF measurements, a full baseline evaluation including, among others, a 6-minute walk test, echocardiography, biomarkers, validated risk scores, patient-reported outcomes, and MRI are evaluated. To enable exploration of CS1's efficacy, measurements are repeated at the end of the 12-week treatment with CS1 and compared to baseline and between doses. In September 2021, the FDA accepted an investigational drug application (IND) to start the Phase II multi-center PAH study in the US. Since then, many activities and processes have been executed culminating in the recent activation of all clinical sites participating in the study and the acceptance by FDA of change in eligibility criteria.
