RegulationOrphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Special Review Project (China)

Structure/Sequence

Molecular FormulaC22H19FN4O2

InChIKeySZMJVTADHFNAIS-BJMVGYQFSA-N

CAS Registry1616493-44-7

330

Clinical Trials associated with Chidamide

NCT07545967

/ Not yet recruitingPhase 1IIT

A Prospective, Single-arm Clinical Study on Re-irradiation Combined With Chidamide in the Treatment of Patients With Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy

To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.

Start Date01 Jul 2026

Sponsor / Collaborator

West China Hospital

NCT07542912

/ Not yet recruitingNot ApplicableIIT

A Single-Arm, Multicenter, Phase II Study of Sintilimab Combined With Chidamide and Azacitidine in Patients With Treatment-Naïve Stage I-II Extranodal Natural Killer/T-Cell Lymphoma (SCENT-3)

This is an open-label, single-arm, multi-center Phase II clinical trial evaluating the efficacy and safety of a novel sequential regimen as first-line therapy for treatment-naïve patients with Extranodal NK/T-cell Lymphoma (ENKTL). The study consists of a Screening Phase, a Safety Lead-in Phase, and a Treatment Phase. During the Safety Lead-in Phase, 6 patients will be enrolled to receive a fixed dose of Sintilimab and Chidamide combined with Azacitidine to verify the dose (testing 100mg/d on days 1-3 versus days 1-5). Following the lead-in, all subjects will undergo a 2-cycle Immunotherapy Induction Phase with the SCA regimen (Sintilimab, Chidamide, and Azacitidine). Subsequently, treatment will be stratified based on response: patients achieving Complete Response (CR) or Partial Response (PR) will receive 4 additional cycles of SCA consolidation, while those with Stable Disease (SD) or Progressive Disease (PD) will switch to 4 cycles of P-GemOx chemotherapy. Upon completion of systemic therapy, all patients will undergo consolidative involved-field radiotherapy (≥50Gy).

Start Date01 Jun 2026

Sponsor / Collaborator

Sun Yat-Sen University

NCT07493109

/ RecruitingPhase 3IIT

Evaluation of the Efficacy and Safety of Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP: A Prospective, Multicenter, Open-label Phase III Clinical Trial

To evaluate the efficacy and safety of chidamide monotherapy as maintenance treatment in patients with diffuse large B-cell lymphoma (DLBCL) and HBV infection following initial response to R-CHOP therapy, and to provide evidence for the clinical application of chidamide.

Start Date30 May 2026

Sponsor / Collaborator

The First Hospital of Jilin University

100 Clinical Results associated with Chidamide

100 Translational Medicine associated with Chidamide

100 Patents (Medical) associated with Chidamide

2,283

Literatures (Medical) associated with Chidamide

01 May 2026·INTERNATIONAL JOURNAL OF CANCER

The efficacy and survival impact of chidamide on angioimmunoblastic T‐cell lymphoma based on Epstein‐Barr virus stratification in the real world: A multicenter study

Article

Author: Wang, Xiaodong ; Xue, Xinyu ; Yang, Jiao ; Xing, Hongyun ; Yang, Wanxi ; Xu, Caigang ; Wang, Xuemei

Abstract:

Epstein–Barr virus (EBV) infection is frequently observed in angioimmunoblastic T‐cell lymphoma (AITL), yet its prognostic and therapeutic implications remain unclear. This multicenter real‐world study analyzed 155 newly diagnosed AITL patients (117 EBV‐encoded RNA‐positive [EBER+] and 38 EBER‐negative [EBER−]) from Chinese institutions between 2012 and 2022. EBER+ cases demonstrated significantly higher Ki67 proliferation indices and CD30 expression compared to EBER− cases ( p = .013 and p = .045, respectively). While no survival difference was observed between EBER+ and EBER− groups (overall survival [OS] p = .16; progression‐free survival [PFS] p = .43), chidamide‐combined chemotherapy significantly improved outcomes exclusively in EBER+ patients (OS p = .014; PFS p = .0018) with no benefit seen in EBER− cases (OS p = .98; PFS p = .83). Multivariate analysis identified distinct risk factors by EBV status. Older age (≥60), thrombocytopenia (<150 × 10 9 /L) and nasopharyngeal involvement independently predicted poor prognosis in EBER+ patients, whereas B symptoms were prognostic in EBER− cases. These findings suggest that EBER+ and EBER− AITL may represent distinct disease entities. EBV infection appears to influence disease progression and prognosis in EBER‐positive patients, whereas EBER‐negative cases more closely align with the disease characteristics observed in other peripheral T‐cell lymphomas. The results suggest that stratifying patients by EBV status is crucial for optimizing AITL clinical management.

01 May 2026·COLLOIDS AND SURFACES B-BIOINTERFACES

Esterase-activatable dimeric HDAC inhibitor nanotherapeutics for enhanced lymphoma epigenetic therapy

Article

Author: Li, Tongyu ; Qian, Wenbin ; Yi, Ping ; Fan, Shufang ; Zhuang, Wanchuan ; Ouyang, Guifang

BACKGROUND:

Despite advances in lymphoma therapy, significant challenges persist including R-CHOP resistance and CAR-T toxicity. Hydroxamate-based histone deacetylase inhibitors (HDACi) like vorinostat (SAHA) offer epigenetic therapeutic potential but are limited by poor bioavailability and rapid clearance.

METHODS:

To overcome these barriers, we rationally designed an esterase- activatable dimeric prodrug by conjugating two SAHA molecules via a glutaric acid linker (SAHA-cc-SAHA). This prodrug co-assembled with DSPE-PEG₂₀₀₀ into nanoparticles (cc-diSAHA NPs). The system was characterized (DLS/TEM), and its drug release profile was assessed with/without porcine liver esterase (PLE). Antitumor activity was evaluated in EL4/A20 lymphoma cells (apoptosis/cycle assays, etc) and EL4 allograft. Transcriptomic mechanisms were deciphered by RNA-seq.

RESULTS:

The cc-diSAHA NPs were uniform spheres (∼74 nm, PDI = 0.187) with excellent colloidal stability and minimal drug leakage (<4 % in 7 days), while enabling rapid drug release upon esterase stimulation (92.4 % within 7 h with PLE). In vitro, they demonstrated broad-spectrum anti-lymphoma activity, inducing G₀/G₁ arrest and apoptosis, albeit with delayed kinetics versus free formulations, consistent with a sustained-release profile. Transcriptomics revealed multifaceted mechanisms, including potent activation of interferon-mediated immunogenic stress and hematopoietic differentiation, alongside enriched adhesion and redox metabolism pathways. In vivo, intravenous cc-diSAHA NPs suppressed EL4 tumor growth significantly more than oral SAHA (819.36 vs 1594.40 mm³; p < 0.01), without inducing systemic toxicity or organ damage.

CONCLUSION:

This nanoplatform overcomes HDACi delivery barriers by reconciling the stability-activation paradox, providing a therapeutically viable option for lymphoma patients ineligible for standard intensive therapies.

01 Mar 2026·Biochemistry and Biophysics Reports

Chidamide and Anlotinib act synergistically in Jurkat cells by inhibiting the Hippo signaling pathway

Article

Author: Wei, Gang ; Yang, Shuting ; Ma, Tao ; Yu, Yuan ; Chen, Yan ; Zuo, Xiuqin ; Xiao, Qiong

Background:

T-cell Acute Lymphoblastic Leukemia (T-ALL) is an aggressive hematologic malignancy characterized by drug resistance, relapse and poor prognosis. Chidamide, a histone deacetylase inhibitor, has shown epigenetic therapeutic potential in T-ALL, but its efficacy is limited and acquired drug resistance exists. To overcome these limitations, we systematically evaluated the synergistic Combination effects of three drug candidates, OTX-015 (BET inhibitor), Metformin (metabolic regulator), and Anlotinib (multitargeted tyrosine kinase inhibitor), with Chidamide.

Methods:

We chose Jurkat cells, a cell line for T-ALL, for our experiments. With the CCK-8 trial, we chose the most efficacious Combination of Anlotinib and Chidamide, for the follow-up trial. The antitumor activity of Chidamide and Anlotinib alone or in Combination on Jurkat cells was detected by cell proliferation, apoptosis and cell cycle assay. Transcriptome sequencing and Western blotting were used to identify the key signaling pathways.

Results:

Jurkat cells treated with Anlotinib showed significant inhibition of cell viability, G2/M arrest and apoptosis. Combination therapy with Chidamide synergistically potentiates these effects. Mechanistically, the Combination treatment inhibited the components of the Hippo pathway (CCN2 and YAP), suppressed the PI3K-Akt signaling pathway, and remodeled the expression of extracellular matrix (ECM) -related genes. Transcriptomic analysis further highlighted the enrichment of ECM organization and PI3K-Akt pathway.

Conclusions:

Chidamide and Anlotinib synergistically inhibit Hippo signaling pathway, which reveals a novel "dual epigenetic kinase targeting" strategy for the treatment of T-ALL. Future studies should validate these findings in vivo and investigate the impact of the metabolic microenvironment on therapeutic efficacy.

News (Medical) associated with Chidamide

05 Mar 2026

·www.prnewswire.com

GNTbm's self-developed anti-cancer new drug GNTbm-38 has obtained IND approval from the U.S. FDA for Phase I clinical trials

TAIPEI, March 5, 2026 /PRNewswire/ -- Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm) (stock code: 7427) announced that its independently developed novel epigenetic immunoactivator GNTbm-38, with global rights for cancer immunotherapy, has received approval from the U.S. FDA for its IND application and will proceed with patient enrollment for a Phase I clinical trial in the United States. Clinical Trial Title: A Phase 1a/1b, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GNTbm‑38 in Adult Patients with Advanced Solid Tumors and Relapsed/Refractory Peripheral T-Cell Lymphoma. GNTbm independently developed the epigenetic immune-activating new drug GNTbm-38, which has global development rights. After five years of development, it completed preclinical studies that meet U.S. regulatory requirements. On January 30, 2026 (U.S. time), it completed the IND application for Phase I clinical trials with the U.S. FDA. After review and response to the review comments, it was approved on February 28, 2026 (U.S. time) to conduct Phase I clinical trials. GNTbm-38 is the achievement of years of research by the GNTbm R&D team in the fields of epigenetics and cancer immunotherapy. Over 10,000 pages of research reports have been accumulated, and it has successfully obtained IND approval from the U.S. FDA. This marks another highly valuable and significant milestone for GNTbm, following the successful development and domestic launch in Taiwan of the anticancer new drug "Kepida®". The R&D team of GNTbm, guided by the belief of 'Taiwanese innovative R&D to benefit late-stage cancer patients worldwide', continually strives for excellence in innovating new drug and has developed the 'next-generation epigenetic immune-activating dual-function drug'—GNTbm-38. GNTbm-38 has been filed for global patent applications in multiple countries around the world and has already been granted in 40 countries. GNTbm-38 possesses exceptionally superior anti-tumor activity, mainly due to its unique epigenetic regulatory mechanism, which can significantly activate the immune system and achieve highly effective anti-tumor immune activity. In 2025, GNTbm-38's research findings were presented at ASCO; in the same year, it was recognized with the 22nd Taiwan National Innovation Award, and currently also received IND approval from the U.S. FDA, providing tremendous encouragement to GNTbm's R&D team. GNTbm will collaborate with internationally experienced CRO companies to advance GNTbm-38 into multi-national, multi-center clinical trials primarily in the United States, China, and Taiwan, aiming to offer new treatment options for late-stage cancer patients. Dr. Chia-Nan Chen, Chairman of GNTbm, stated: "GNTbm-38 is a new generation anti-cancer immunotherapy drug independently developed by the GNTbm R&D team after years of experiences on developing new drug Kepida®." GNTbm-38 is a brand new orally administered new chemical entity drug independently developed in Taiwan. GNTbm-38 has excellent epigenetic regulation and immune activation mechanisms, which can control the on-off switches of genes and further impact the expression of genes and proteins at a deeper level. The R&D team of GNTbm has already planned a clinical development strategy for multiple indications for GNTbm-38, prioritizing the development of relapsed or refractory peripheral T-cell lymphoma to obtain orphan drug designation; subsequently, new indications will be expanded. GNTbm-38 is a broad-spectrum, oral, anti-cancer new drug with immense development potential. It can be used in combination with drugs of different mechanisms, including unique multi-kinase inhibitors, immune checkpoint inhibitors, or anti-PD-1/VEGF bispecific antibodies, generating stronger synergistic anti-cancer effects and providing patients with better treatment benefits. About GNTbm-38 GNTbm-38 is the key drug of a new generation of cancer immunotherapy independently developed by GNTbm and has obtained IND approval from the U.S. FDA to enter Phase I clinical trials. It is an anticancer candidate drug selected through a tumor-loaded animal testing platform with an intact immune system and has been confirmed through multiple preclinical studies to possess excellent anticancer activity in tumor immunity. GNTbm-38 is an oral drug with dual unique activities of epigenetic regulation to control gene expression and immune activation, which is significantly different from the mechanism of previously developed epigenetic drugs and focuses mainly on a distinctive immunoactivating pharmacological mechanism. GNTbm-38 can substantially remodel the tumor microenvironment (TME) through a unique epigenetic regulatory mechanism, primarily affecting the cellular composition and gene expression of the TME, turning originally "cold tumors" into "hot tumors," thereby attracting more CTL infiltration into the TME. At the same time, it can also reduce the recruitment of immunosuppressive cells (such as TAMs, Tregs, and MDSCs) to the TME to achieve TME remodeling, which is more favorable for the anticancer therapeutic effect of cancer immunotherapy. GNTbm-38 monotherapy can be used to treat hematological tumors, while GNTbm-38 combination therapy can be used in combination with unique multi-kinase inhibitors, immune checkpoint inhibitors and anti-PD-1/VEGF bispecific antibodies to treat various solid tumors, primarily achieving superior anticancer therapeutic goals through a unique cancer immunotherapy mechanism. About GNTbm GNTbm's stock code in Taiwan is 7427. It is a company that independently develops new chemical entity drugs and has already launched a new drug, Kepida®, which has been launched in Taiwan market for the treatment of HR+/Her-2- advanced breast cancer, and whose National Health Insurance reimbursement became effective on December 1, 2025. Recently, GNTbm's independently developed epigenetic immune-activating new drug GNTbm-38 has obtained IND approval from the U.S. FDA and will enter phase I clinical trials. GNTbm's R&D team has the capability to independently develop new drugs and lay out the global patent applications, aiming to address unmet clinical needs of patients. GNTbm focuses mainly on developing new drugs with innovative mechanisms, conducting clinical validation for next-generation cancer immunotherapy, with the hope of successfully developing innovative cancer immunotherapies that can be used for multiple indications. These new drugs are expected to provide more effective and safer innovative treatments to meet the treatment needs of advanced cancer patients globally, improve patients' quality of life, and help patients and their families regain precious moments together. Press Spokesperson of GNTbm Senior Vice President: Dr. Ye-Su Chao E mail: [email protected] SOURCE Great Novel Therapeutics Biotech & Medicals Corporation 21% more press release views with Request a Demo

INDImmunotherapyOrphan DrugPhase 1

27 Feb 2026

·cerenoscientific.com

Cereno Scientific Publishes Year-end Report for 2025 (January 1 – December 31, 2025)

27 Feb 2026 06:45Regulatory Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the Board of Directors and Chief Executive Officer of Cereno Scientific AB here presents the Year-end Report for 2025 (January 1 – December 31, 2025). Financial overview Cereno Scientific Group Full year 2025 Net Sales were SEK 0 (0) Result after financial items was SEK -117 754 773 (-99 525 680) Earnings per share was SEK -0.38 (-0.35) before dilution and SEK -0.33 (-0.32) after dilution The equity/assets ratio was 62.7% (46.4%) Cash and bank balance was SEK 74 639 333 (127 557 645) Fourth quarter 2025 Net Sales were SEK 0 (0) Result after financial items was SEK -44 709 850 (-40 262 214) Earnings per share was SEK -0.14 (-0.14) before dilution and SEK -0.12 (-0.13) after dilution The equity/assets ratio was 62.7% (46.4%) Cash and bank balance was SEK 74 593 709 (127 466 516) Parent company Full year 2025 Net Sales were SEK 0 (0) Result after financial items was SEK -117 676 391 (-99 442 612) Earnings per share was SEK -0.38 (-0.35) before dilution and SEK -0.33 (-0.32) after dilution The equity/assets ratio was 62.7% (46.4%) Cash and bank balance was SEK 74 593 709 (127 466 516) Fourth quarter 2025 Net Sales were SEK 0 (0) Result after financial items was SEK -44 713 046 (-40 262 214) Earnings per share was SEK -0.14 (-0.14) before dilution and SEK -0.12 (-0.13) after dilution The equity/assets ratio was 62.7% (46.4%) Cash and bank balance was SEK 74 593 709 (127 466 516) Significant events during the fourth quarter On November 11, Cereno Scientific receives SEK 4 million through exercise of 600,000 warrants by Arena Investors, LP. This was in connection with the financing agreement being entered into on November 11, 2024. On November 17, the company's CEO Sten R. Sörensen was recognized for being shortlisted at the 'CEO of the Year' award at the European Lifestars Awards 2026 held in London, UK. On November 28, it was announced that the company secured loan financing of up to SEK 350 million, and a directed issue of new Class B shares of SEK 100 million and warrants that can provide up to an additional SEK 100 million upon exercise, before issue costs. This includes convertible loans of SEK 175 million and a loan facility of SEK 175 million, with Fenja Capital II A/S and a company associated company to Fenja as lenders. This amounts to a total of approximately SEK 665 million upon full exercise of warrants and convertibles and extends the financial runway to Q4 2027. A new advisory relationship has been established with the investment bank Stifel. Major shareholders and new investors back the company’s long-term strategy with equity investment at a premium through the directed share issue. On December 8, the FDA granted clearance to initiate the Phase IIb trial of lead drug candidate CS1 for the treatment PAH. The FDA’s decision enables Cereno to advance toward first patient in (FPI) in Q2 2026, with top-line data anticipated around Q4 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 US. On December 18, announced that all shareholding members of its board of directors and management have signed lock-up agreements for their shares and/or other securities in the company until and including June 30, 2026. Cereno Scientific participated at several key partnering and investor conferences during the period: Nordic Life Science Days 2025 on October 8-9, BIO-Europe Fall 2025 in Vienna on November 3-5, London Life Sciences Week 2025 on November 17-21. Any recordings of presentations are available on our website, https://cerenoscientific.com/events-presentations/. The company presented new data of CS014 at the scientific conference Pharmacology 2025 organized by the British Pharmacology Society on December 16-18 in Belfast, Northern Ireland. Visit our webpage for the presented data, https://cerenoscientific.com/pipeline/scientific-publications/. Significant events after the period Cereno Scientific participated at JPM Healthcare Week 2026 in San Francisco on January 12-15, one of the most influential annual gatherings for the global life science and healthcare industry. On January 8, Cereno Scientific receives approximately SEK 5 million through exercise of 728,957 warrants by Arena Investors, LP. This was in connection with the financing agreement being entered into on November 11, 2024. The company presented data of CS014 and participated in panel at the scientific conference PVRI 2026 Dublin organized by the The Pulmonary Vascular Research Institute (PVRI) on January 28 – February 1, 2026, in Dublin, Ireland. Visit our webpage for the presented data, https://cerenoscientific.com/pipeline/scientific-publications/. On January 14, the company shared the publication of the first peer-reviewed manuscript describing CS014 in the Journal of Thrombosis and Haemostasis. 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. Visit our webpage for access to the manuscript, https://cerenoscientific.com/pipeline/scientific-publications/. On February 3, an update was communicated regarding the Expanded Access Program for CS1 in PAH since the last patient’s last visit concluded the 12-month active study period. Initial learnings from the EAP are expected to be available in the first quarter of 2026 and further analyses are planned during second quarter of 2026, contributing to the ongoing CS1 development program and its overall value proposition. On February 4, the company announced that the Phase II development focus of HDAC inhibitor CS014 will be pulmonary hypertension associated with interstitial lung disease (PH-ILD). The sharpened 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. Letter from the CEO Entering global development phase 2025 marked a pivotal year for Cereno Scientific. We moved from encouraging Phase IIa data with CS1 to establishing a regulatorily aligned and operationally ready global Phase IIb program. At the same time, our second HDACi asset, CS014, delivered positive Phase I results and is progressing toward Phase II, reinforcing the depth and scalability of our HDAC inhibitor platform. As we enter 2026, our priority is clear: initiate the global Phase IIb trial with CS1, maintain close regulatory interaction and execute the trial with operational excellence. CS1 — ready for global Phase IIb During the year, the development of CS1 for pulmonary arterial hypertension (PAH) has reached central milestones. Following positive Phase IIa data and a successful Type C meeting with the FDA, we received the Agency’s endorsement for the planned Phase IIb study and partnered with a leading global CRO to support its execution. In August, CS1 was granted FDA Fast Track designation, enabling closer regulatory interaction and the potential to accelerate development timelines. In the fourth quarter, we obtained regulatory clearance from the FDA allowing us to initiate the Phase IIb trial. Overall, this means that the regulatory and operative risk ahead of the Phase IIb trial has been significantly reduced. The trial is designed on the back of positive Phase IIa data, to further evaluate safety, tolerability and efficacy, including the potential to impact underlying disease mechanisms, as well as determining optimal dose for Phase III. It is the first PAH Phase IIb trial with a design that includes a longer exploratory phase to evaluate signs of disease modification. The trial is planned to start during the second quarter of 2026. Expanded Access Program — operational milestone and upcoming insights The Expanded Access Program (EAP) for CS1, which allowed eligible patients who completed the Phase IIa trial to continue treatment under a formal protocol, reached an important operational milestone when the final patient completed their last visit in the 12-month active treatment period. Initial learnings from the EAP are expected to be available in the first quarter of 2026, with further analyses planned during the second quarter of 2026. These insights are intended to complement the Phase IIa data with longer-term information on safety, tolerability and exploratory imaging sub-studies, which will contribute to the overall understanding of CS1’s potential and its value proposition. CS014 — next-generation HDAC inhibitor with sharpened development focus During the year, positive topline data from the Phase I trial of CS014 was reported. The trial demonstrated a favorable safety and tolerability profile at achieved exposure levels predicted to impact disease-driving processes such as fibrosis and vascular remodeling. The Phase I results, together with previous non-clinical studies, support CS014 as a promising candidate for the treatment of cardiovascular and pulmonary diseases where vascular remodeling, fibrosis, and thrombosis play key roles. CS014 received external scientific validation through the publication of its first peer-reviewed manuscript in the Journal of Thrombosis and Haemostasis (JTH), which is a key foundational element for scientific credibility as the asset advances in development. Presentations of data at international scientific conferences, including Pharmacology 2025, and most recently at PVRI 2026 in January, has further contributed to increased awareness and visibility of our pioneering epigenetic approach within the scientific community. At the beginning of 2026, we announced that CS014 will be developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD) — a severe condition with high unmet need. This focus is intended to enhance the clinical relevance of the upcoming Phase II study and accelerate the pathway to relevant outcomes by targeting a patient population characterized by both fibrotic lung disease and pulmonary vascular involvement. A Phase II trial is planned to start early 2027. CS014 represents the next generation within our epigenetic HDAC inhibitor platform. The platform addresses the central biological processes including fibrosis, inflammation, vascular remodeling and thrombosis – which are fundamental drivers across a broad range of cardiopulmonary diseases. The clinical progress with CS014 not only advances the program but also reinforces the long-term potential of our HDAC inhibitor platform. Scientific & Strategic positioning — ahead of the curve In 2025, we strengthened our scientific and strategic profile through participation in international partnering and investor events, scientific presentations and peer-reviewed publications. Our Capital Markets Day in Stockholm, held on February 5, brought together clinical experts, a patient representative and investors and articulated the company’s long-term direction: to lead a paradigm shift in PAH from symptomatic treatment to disease modification. In a market where several major pharmaceutical companies are facing extensive patent expirations, demand is increasing for differentiated clinical-stage projects, particularly in orphan drug areas with regulatory support. Projects that combine clinical maturity, biological differentiation, and commercial rationale are often prioritized in partnering discussions. It is in this context that we position CS1, CS014 and our epigenetic HDACi platform. Financial position & Capital structure During the year, the remaining convertible loans of SEK 75 million from a financing agreement in November 2024 were converted into shares, further strengthening the balance sheet. In November 2025, the company secured a financing package of approximately SEK 665 million upon full exercise of warrants and convertibles providing financial runway to Q4 2027. The financing comprised a directed share issue of SEK 100 million, completed at a premium to the market price, and a loan financing facility of up to SEK 350 million. Major shareholders and new investors participated in the transaction, demonstrating confidence in the Company’s long-term strategy. The company’s financial position supports the execution of planned near-term development activities, including the global Phase IIb program for CS1 and continued advancement of CS014. As Cereno Scientific progresses into the next stage of clinical development, the company continuously evaluates its capital strategy to support ongoing operations and upcoming value-inflection milestones. Looking forward — catalysts & market context As we enter 2026, our priorities are clear: Initiate the global Phase IIb study with CS1 Share initial learnings from the CS1 EAP in Q1–Q2 2026 Drive forward the CS014 Phase II development in PH-ILD Continue to engage in business development (BD) activities toward partnering and deals to support our growth The initiation of the Phase IIb program represents the most important operational milestone in the company’s history to date and a pivotal step in the clinical development of our disease-modifying lead asset at scale. Beyond clinical development, we believe the market environment remains favorable for differentiated rare disease projects. Capital allocation in the sector is increasingly directed toward programs with clear scientific differentiation, regulatory advantages and meaningful patient impact. This dynamic, combined with broader industry patent expirations and strategic portfolio needs, supports our positioning and ongoing partnering discussions. As this report is published, Rare Disease Day on February 28 approaches. It is a reminder of why we pursue our work: for patients living with rare and serious diseases where disruptive therapies are needed with significant impact on disease progression, quality of life and prognosis. I extend my sincere thanks to our shareholders, partners and patients for their continued trust and support. We enter 2026 with determination, strategic focus and confidence in the path ahead. February 2026 Sten R. Sörensen, CEO Financial calendar Annual Report 2025……........……………………….May 11-15, 2026 Interim Report Q1 2026……....................................May 27, 2026 For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 73- 236 62 46 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. The company’s innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the fullest. Lead candidate CS1 is an HDAC inhibitor that works through epigenetic modulation and represents a novel therapeutic approach by targeting the root mechanisms of the pulmonary arterial hypertension (PAH). CS1 is a well-tolerated oral therapy with a favorable safety profile that has shown encouraging efficacy signals in a Phase IIa trial in patients with PAH, including improvements in right heart function and patient quality of life, consistent with reverse vascular remodeling. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014 is a new chemical entity and HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of a range of cardiovascular and pulmonary diseases with high unmet needs. CS014 showed favorable safety and tolerability profile in Phase I, development focus for Phase II is pulmonary hypertension associated with interstitial lung disease (PH-ILD). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like thrombosis prevention without increased risk of bleeding. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company’s Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Read PDF Share

Phase 1Phase 2Fast TrackClinical ResultOrphan Drug

27 Nov 2025

·cerenoscientific.com

Cereno Scientific Publishes Interim Report for Q3 2025 (July 1 – September 30, 2025)

Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the Board of Directors and Chief Executive Officer of Cereno Scientific AB here presents the Interim Report for Q3 2025 (July 1 – September 30, 2025). Financial overview Cereno Scientific Group – Q3 Net Sales were SEK 0 (0) Result after financial items was SEK -21 321 915 (-22 718 087) Earnings per share was SEK -0.07 (-0.08) before dilution and SEK -0.07 (-0.07) after dilution The equity/assets ratio was 49.5% (66.8%) Cash and bank balance was SEK 74 179 974 (73 841 665) Parent company – Q3 Net Sales were SEK 0 (0) Result after financial items was SEK -22 323 425 (-22 718 087) Earnings per share was SEK -0.07 (-0.08) before dilution and SEK -0.07 (-0.07) after dilution The equity/assets ratio was 49.5% (66.8%) Cash and bank balance was SEK 74 096 722 (73 791 605) Significant events during the third quarter On July 1, Cereno Scientific was added to Nasdaq’s First North 25™ Index, reflecting its status as one of the most traded securities on the First North Growth Market. On July 4, Cereno Scientific selected a top-tier global CRO to conduct the upcoming Phase IIb trial of CS1 in the rare disease pulmonary arterial hypertension. On July 15, Cereno Scientific announced positive topline results from the Phase I trial of CS014, in which the primary endpoint was met. CS014 was well tolerated with favorable safety and exposure profiles in healthy volunteers, providing data that support advancement into Phase II development. In August, a conversion of convertibles amounting to SEK 25 million was requested by Fenja Capital II A/S and Arena Investors, LP. On September 15, Cereno Scientific Announces Conversion of All Remaining Convertibles Following Request by Fenja Capital II A/S and Arena Investors, LP On September 3, CEO Sten R. Sörensen was announced a finalist for ‘CEO of the Year’ at the European Lifestars Awards 2025. The Awards celebrate the achievements from remarkable breakthroughs to transformational investments and deals of the exceptional individuals, teams, and organizations that have shaped the life science industry over the past 12 months. The ‘CEO of the Year’ category recognizes leaders who have demonstrated outstanding career achievements, created shareholder value, forged impactful partnerships, and influenced the wider life science industry. Cereno Scientific participates at several key partnering and investor conferences during the period: GoCo Investor Day on September 9 and Nordic Life Science Days 2025 on October 8-9. and Recordings of the presentations are available on our website, https://cerenoscientific.com/events-presentations/. Significant events after the period Cereno Scientific participated at BIO-Europe Fall 2025 in Vienna on November 3-5, which is one of the main global biopharma partnering events of the year. On November 11, Cereno Scientific receives SEK 4 million through exercise of 600,000 warrants by Arena Investors, LP. This was in connection with the financing agreement being entered into on November 11, 2024. On November 10, the submission of the clinical trial protocol for the planned global Phase IIb trial of lead drug candidate CS1 was sent 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). Cereno Scientific anticipates clearance to proceed with the trial following the FDA’s standard 30-day review. Letter from the CEO Advancing toward the next phase The third quarter of 2025 has been a very productive and defining period for Cereno Scientific. As we move through the final weeks of the year, we continue to build strong momentum across our clinical pipeline and strengthen our foundation for the next phase of growth. Our focus remains on advancing our pioneering HDAC inhibitor portfolio, increasing recognition of our scientific platform, and pursuing the next major milestones that will propel our growth journey. CS1: Advancing toward Phase IIb with FDA alignment Following the positive regulatory interactions earlier this year, we reached a major milestone in November with the submission of the clinical trial protocol for our planned global Phase IIb trial of CS1 to the U.S. Food and Drug Administration (FDA). This submission moves us closer to initiating the clinical Phase IIb trial in H1 2026, and we anticipate FDA's greenlight within the next few weeks. The protocol has been developed in alignment with the FDA’s guidance from our Type C meeting, ensuring that the study design meets regulatory expectations and is positioned to support late-stage development. The upcoming trial will build on the encouraging results from our successful Phase IIa study, which demonstrated that CS1 has a favorable safety and tolerability profile and showed promising efficacy signals, including improvements in right heart function and patient quality of life. We will further evaluate the safety, tolerability and efficacy of different doses of CS1, including the potential to reverse vascular remodeling, improve right heart function and patient quality of life. These findings, together with preclinical data indicating the potential to reverse pathological vascular remodeling, form a strong foundation for further evaluation in the Phase IIb study. With FDA Fast Track designation in place and strong regulatory alignment, we are progressing with confidence as we work to advance CS1 as a novel, disease-modifying therapy for patients living with pulmonary arterial hypertension (PAH). CS014: Positive Phase I data supports advancement to Phase II In mid-July, we announced positive topline results from our first-in-human Phase I study of CS014. The trial met its primary endpoint, demonstrating a favorable safety and tolerability profile in healthy volunteers. Importantly, we saw that CS014 achieved blood concentrations expected, based on non-clinical data, to impact disease-driving fibrosis and vascular remodeling. Together with its strong preclinical data, these results form a solid foundation for advancing CS014 into Phase II development. CS014 represents our second HDAC inhibitor program and holds potential not only in idiopathic pulmonary fibrosis (IPF), our initial target indication, but also in other fibrotic and vascular diseases where few effective treatment options exist. Building on the Phase I results, we see a broadening of CS014’s clinical potential and are refining our development strategy to best leverage its therapeutic promise. This may include opportunities to expand our impact across rare disease with significant unmet needs. The successful completion of this Phase I study marks another significant milestone for Cereno’s HDACi platform and further strengthens our position at the forefront of innovation in cardiovascular and pulmonary medicine. Strengthening the scientific platform for HDAC inhibition Recent months have also seen a notable increase in scientific publications highlighting the potential of HDAC inhibition in cardiovascular and pulmonary disease. This growing body of external research combined with our own research emphasizes the importance of addressing disease-driving mechanisms such as fibrosis, inflammation and vascular remodeling, which aligns closely with our own development strategy. As the first clinical-stage company advancing HDAC inhibitors specifically for cardiovascular and pulmonary diseases, Cereno Scientific is well positioned within this rapidly evolving scientific landscape. CS585: Continuing preclinical progress Our third program, CS585, a selective prostacyclin (IP) receptor agonist, continues to progress in preclinical development through our collaboration with the University of Michigan. Data generated to date support its potential as a differentiated treatment approach for rare thrombotic diseases by preventing thrombosis without increasing bleeding risk, which is a key unmet need in cardiovascular medicine. Expanding our scientific footprint Our scientific visibility continues to grow, supported by several important activities across the global research community. After the end of the period, the first manuscript describing the structure and supportive non-clinical data for CS014 was accepted in the respected Journal of Thrombosis & Haemostasis. This peer-reviewed publication provides external validation of our scientific approach and strengthens the foundation for the continued development of our second HDAC inhibitor program. Our CSO, Björn Dahlöf, will represent Cereno Scientific at the annual, invitation-only CVCT Forum in Washington, D.C., and participate in two panel discussion. This key event brings together leading experts from industry, academia and regulatory agencies to discuss advances in cardiovascular clinical trial design. The team is also preparing for several upcoming scientific conferences. In mid-December, we will present the CS014 Phase I data to a scientific audience for the first time at Pharmacology 2025, hosted by the British Pharmacological Society. Further results will also be shared at the Pulmonary Vascular Research Institute (PVRI) annual congress in early 2026, providing important opportunities to engage with global leaders in pulmonary vascular disease. Strengthening Cereno’s position, visibility and growth Cereno Scientific’s visibility and reputation as a pioneering biotech company continued to grow during the quarter. In this context, I was honored to be named a finalist for “CEO of the Year” at the European Lifestars Awards 2025. This recognition reflects the importance of committed leadership in navigating the complexities of drug development, building strong relationships across the industry, and keeping a clear long-term vision centered on patient need. Throughout the autumn, we have maintained a high level of activity across the investor and partnering landscape. This included participation at Nordic Life Science Days in Gothenburg and GoCo Investor Day during the quarter, followed by BIO-Europe Fall in Vienna and London Life Sciences Week 2025 after the period.* At BIO-Europe, our CMO and Head of R&D, Rahul Agrawal, was invited to speak on an engaging panel hosted by IQVIA Institute for Human Data Science focused on access to the US market for European biotechs. These engagements are important for broadening our network, supporting ongoing dialogue with investors and potential partners, and sharing updates on our clinical and corporate progress. During the quarter, all remaining convertibles held by Fenja Capital II A/S and Arena Investors LP were converted into shares, completing the conversion of SEK 75 million convertible loan held by the debt providers. After the end of the period, Arena Investors also exercised 600,000 warrants, providing SEK 4 million in proceeds. Looking ahead As we approach year-end, our focus is on maintaining operational drive and pipeline momentum. With two HDAC inhibitor programs advancing and a promising preclinical candidate in CS585, we are well positioned for continued progress in 2026. Every milestone, from clinical advancement to scientific recognition and growing industry visibility, brings us closer to our mission of developing pioneering treatments that enhance and extend life for patients living with rare cardiovascular and pulmonary diseases. The growing awareness of Cereno's pioneering efforts during 2025 is also a testament to the dedication of our team, the value of our partnerships, and the trust of our shareholders. Thank you for your continued support as we take the next steps toward this new stage for Cereno Scientific. November 2025 Sten R. Sörensen, CEO Financial calendar Year-end Report, Q4 2025……...............................February 27, 2026 For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 73- 236 62 46 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. The company’s innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the fullest. Lead candidate CS1 is an HDAC inhibitor that works through epigenetic modulation and represents a novel therapeutic approach by targeting the root mechanisms of the pulmonary arterial hypertension (PAH). CS1 is a well-tolerated oral therapy with a favorable safety profile that has shown encouraging efficacy signals of reverse vascular remodeling and improvement of right heart function as observed in a Phase IIa trial in patients with PAH. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1 CS014, a new chemical entity with disease-modifying potential, showed favorable safety and tolerability profile in a Phase I trial. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company’s Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Read PDF Share

Phase 1Phase 2Clinical Result

100 Deals associated with Chidamide

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KEGG	Wiki	ATC	Drug Bank
-	Chidamide	L01XX	DB06334

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	China	Shenzhen Chipscreen Biosciences Co., Ltd.	24 Apr 2024
Adult T-Cell Leukemia-Lymphoma	Japan	Meiji Seika Pharma Co., Ltd.	23 Jun 2021
Hormone receptor positive HER2 negative breast cancer	China	Shenzhen Chipscreen Biosciences Co., Ltd.	20 Nov 2019
Peripheral T-Cell Lymphoma	China	Shenzhen Chipscreen Biosciences Co., Ltd.	23 Dec 2014

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
pMMR/MSS Locally Advanced Colon Cancer	Phase 3	China	Shenzhen Chipscreen Biosciences Co., Ltd.	06 Dec 2024
Unresectable Colorectal Carcinoma	Phase 3	China	Shenzhen Chipscreen Biosciences Co., Ltd.	06 Dec 2024
Metastatic Microsatellite Stable Colorectal Carcinoma	Phase 3	China	Sun Yat-Sen University	01 Mar 2023
Microsatellite Stable Colorectal Carcinoma	Phase 3	China	Sun Yat-Sen University	01 Mar 2023
Brain metastases	Phase 3	United States	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Japan	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Australia	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Austria	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Belgium	Huyabio International LLC	12 Aug 2021
Brain metastases	Phase 3	Brazil	Huyabio International LLC	12 Aug 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05141357 (HBI-8000, CTgov)	Phase 2	Non-Small Cell Lung Cancer	5	HBI-8000+pembrolizumab	dmwzczzizf = jgedgamgud tbpmbwrxig (rrdwqokqhf, gfdtrqrmcg - jclgyxeczc) View more	-	24 Dec 2025
SABCS2025	Phase 2	HR-positive \| HER2-negative	30	Chidamide + Fulvestrant	ofwgauikhe(vychctdwvb) = jukqkzdiur jmlfqjjnaq (jexxvdykxh )	Positive	10 Dec 2025
ASH2025	Phase 2	-	100	Venetoclax-Azacitidine-Chidamide Plus CAG (CACAG-VEN)	uynvvggwtp(eionoaknka) = vjofxqaijy ggzctzehny (hxxzhomfht ) View more	Positive	06 Dec 2025
				“3+7” regimen	uynvvggwtp(eionoaknka) = ynslkbssta ggzctzehny (hxxzhomfht ) View more
NCT05367856 (ASH2025)	Phase 2	Peripheral T-Cell Lymphoma	23	Chidamide+BEAM+ASCT	oukgfpxent(frvlnvygme) = wqvslhkvwk wtcgomezmt (ednovzkopn, 72.9 - 99.4) View more	Positive	06 Dec 2025
NCT03838354 (ASH2025)	Phase 1/2	Purpura, Thrombocytopenic, Idiopathic	61	Chidamide 2.5 mg	srkbhxspgl(yeykbdqvna) = yiruparatn fbpauwtlde (ewrfuwmmqn ) View more	Positive	06 Dec 2025
				Chidamide 5 mg	srkbhxspgl(yeykbdqvna) = ohflyapobl fbpauwtlde (ewrfuwmmqn ) View more
ASH2025	Not Applicable	Acute Myeloid Leukemia	51	The ABC-14 regimen (Azacitidine, Venetoclax, and Chidamide)	cdtejubmmz(qfkjpwvqmd) = Rates of 100-day and overall CMV/EBV infection were similar between the groups urcnxrepgy (nrzdzjkepx ) View more	Positive	06 Dec 2025
				Intensive chemotherapy (IC)
NCT05991973 (ASH2025)	Phase 2	Precursor T-Cell Lymphoblastic Leukemia-Lymphoma \| Lymphoma Maintenance	44	Chidamide 10 mg	svobbovudh(cmpbxfolha) = vlmuvpxkpy lbpucfojdi (bwezoggsjm, 75.8 - 97.1) View more	Positive	06 Dec 2025
NCT06068621 (ASH2025)	Phase 3	Acute Myeloid Leukemia First line	170	Venetoclax-azacitidine in combination with chidamide and CAG (cytarabine, aclarubicin, granulocyte colony-stimulating factor)	tbsdsmbfvk(vhpqqhvoor) = zqpitcefyv ztgwuujgld (locstazozu ) View more	Positive	06 Dec 2025
				daunorubicin and cytarabine	tbsdsmbfvk(vhpqqhvoor) = evvgarjqdx ztgwuujgld (locstazozu ) View more
NCT04231448 (DEB, ASH2025)	Phase 3	Diffuse Large B-Cell Lymphoma MYC \| BCL2	423	Tucidinostat plus R-CHOP	dvoquztslg(ecmotkaviv) = dyrhehcnla aozodsqdub (ysbrbuzwkf ) View more	Positive	06 Dec 2025
				Placebo plus R-CHOP	dvoquztslg(ecmotkaviv) = zkaycqypjp aozodsqdub (ysbrbuzwkf ) View more
NCT05976997 (ASH2025)	Phase 2	Immunoblastic Lymphadenopathy First line	12	Duvelisib + Chidamide + CHOP chemotherapy	gffdozduut(paifchlmme) = mainly hematological toxicity, including leucopenia (41.7%)and neutropenia (41.7%), as well as infections including lung infections 33.3% xsyigsqbuo (kmtlamapnu ) View more	Positive	06 Dec 2025

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