Chidamide

Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that the Board of Directors and Chief Executive Officer of Cereno Scientific AB here presents the Interim Report for Q2 2025 (April 1 – June 30, 2025). Financial overview Cereno Scientific Group – Q2 Net Sales were SEK 0 (0) Result after financial items was SEK -26 626 999 (-21 234 039) Earnings per share was SEK -0.09 (-0.08) before dilution and SEK -0.08 (-0.91) after dilution The equity/assets ratio was 46.4% (76.2%) Cash and bank balance was SEK 74 982 054 (85 596 493) Parent company – Q2 Net Sales were SEK 0 (0) Result after financial items was SEK -26 630 492 (-21 229 026) Earnings per share was SEK -0.09 (-0.08) before dilution and SEK -0.08 (-0.91) after dilution The equity/assets ratio was 46.4% (76.2%) Cash and bank balance was SEK 74 901 892 (85 472 485) Significant events during the second quarter On April 16, it was reported that the Phase I trial of CS014 had concluded. Data management, database lock, and analysis commenced after the last patient’s last visit in preparation for the trial’s topline results. On May 9, an oral presentation titled “Exploratory outcomes of CS1 in Pulmonary Arterial Hypertension: Phase 2A, Prospective, Randomized, Open-Label, Multicenter Trial” was presented at the 5th Baltic Pulmonary Hypertension Conference 2025 in Kaunas, Lithuania. On May 23, Cereno Scientific received endorsement from the FDA on the plans for the Phase IIb trial and further clinical development of CS1 in PAH. The endorsement was the outcome of a Type C meeting held with the FDA on April 21. On May 27, the company shared that it is shortlisted for ‘Company of the Year’ in the European Mediscience Awards 2025. The prestigious Awards is the largest annual gathering showcasing achievement and success in the UK and European healthcare, biotech, pharmaceutical and life sciences sectors. On June 10, a new Board of Directors was elected with particular expertise in M&A/partnering and business development (BD) at the Annual General Meeting. The Board comprises Jeppe Øvlesen (new Chairman), Moi Brajanovic (newly elected), Gunnar Olsson (re-elected), Anders Svensson (re-elected) and Sten R. Sörensen (re-elected). On June 16, 4-month follow-up data from the Expanded Access Program (EAP) following the Phase IIa trial of CS1 was communicated confirming that data are in line with the safety, tolerability and signals of efficacy observed in the Phase IIa trial. The EAP will run to completion for 12 months with results anticipated in Q1 2026. On June 20, 100 MSEK was secured through additional loan financing and conversion. As a continuation of the strategic financing that was completed in November 2024, it allows Cereno Scientific to maintain flexibility while providing runway to reach key clinical and regulatory milestones for CS1 and CS014. Cereno Scientific presented at the ABGSC Investor Days on May 13-14, 2025. A recording is available on the company’s website. Cereno Scientific participated at several key partnering conferences: ChinaBio Partnering Forum virtually on April 29-30, 2025; LSX Nordics on May 20-21, 2025, in Bergen, Norway; and BIO International Convention 2025 – the largest and most comprehensive event for biotechnology – on June 16-19, 2025, in Boston. Significant events after the period On July 1, Cereno Scientific was added to Nasdaq’s First North 25™ Index, reflecting its status as one of the most traded securities on the First North Growth Market. On July 4, Cereno Scientific selected a top-tier global CRO to conduct the upcoming Phase IIb trial of CS1 in the rare disease pulmonary arterial hypertension. On July 15, Cereno Scientific announced positive topline results from the Phase I trial of CS014, in which the primary endpoint was met. CS014 was well tolerated with favorable safety and exposure profiles in healthy volunteers, providing data that support advancement into Phase II development. In August, a conversion of convertibles amounting to SEK 25 million was requested by Fenja Capital II A/S and Arena Investors, LP. On August 26, it was announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for CS1 in PAH. Fast Track designation is designed to accelerate the development and regulatory review of new therapies for serious conditions with high unmet medical need. Letter from the CEO Building momentum toward the next phase The second quarter of 2025 has been an important period for Cereno Scientific, marked by strong clinical progress and strategic achievements that strengthen our position for continued growth. This quarter, the key focus has been to advance our pioneering efforts with our two HDAC inhibitor programs toward their next clinical trials in Phase II, while continuing to build Cereno's core foundations in science, partnerships, and market presence. This is what drives and solidifies our long-term success. CS014: Positive Phase I results pave the way forward In July, we announced positive topline results from our first-in-human Phase I trial of CS014 in healthy volunteers. The trial met its primary endpoint, showing a favorable safety and tolerability profile, with exposure levels consistent with those projected to impact pulmonary vascular remodeling and fibrosis based on non-clinical data. Combined with the strong preclinical data, these results give us confidence to advance CS014 into a Phase II trial. While idiopathic pulmonary fibrosis (IPF) is our initial target indication, CS014’s mechanism of action through HDAC inhibition and epigenetic modulation holds promise across a broader spectrum of rare diseases involving vascular remodeling and fibrosis. We believe this broad potential strengthens the strategic value of our HDACi portfolio and positions CS014 as an attractive candidate for both further internal development and future partnerships. CS1: Laying the groundwork for Phase IIb Our lead program CS1 took important steps forward toward a global, placebo-controlled Phase IIb trial in PAH. We achieved regulatory alignment with the FDA through a productive Type C meeting in April, securing their endorsement of our Phase IIb trial plans. This gives us confidence that our CS1 Phase IIb trial design is aligned with regulatory expectations and will be well positioned to support late-stage development and, ultimately the marketing approval process. In July, we selected a top-tier global contract research organization (CRO) to manage the trial from IND submission through to completion. This is a major milestone in preparing for trial initiation in H1 2026. In May, our Medical Director, Dr. Tatiane Abreu Dall’Agnol, presented the Phase IIa results at the 5th Baltic Pulmonary Hypertension Conference, further enhancing our visibility and engagement within the global PAH scientific community. CS1: Fast Track designation underscores potential Importantly, in August, CS1 was granted Fast Track designation by the U.S. FDA for the treatment of PAH. This recognition underscores both the urgent need for safer, disease-modifying therapies in this devastating disease and the strength of our CS1 program. Fast Track designation is designed to accelerate the development and review of promising new therapies, providing us with closer dialogue with the FDA, the possibility of rolling submissions, and potential priority review. For patients, this can shorten the time to access new treatments, and for Cereno, it represents a significant milestone that enhances the value of CS1, strengthens our competitive position, and supports future partnering discussions. Validating our approach – the growing scientific momentum for HDACi in cardiovascular disease The potential of HDAC inhibitors in cardiovascular disease is increasingly being recognized in the scientific community. Several recent publications have highlighted their promise in targeting underlying disease mechanisms in several diseases. This is an area where Cereno is already taking a leading role with two HDACi programs in clinical development. This growing external validation supports our conviction that epigenetic modulation can transform treatments for cardiovascular and pulmonary diseases. CS585: Continuing promising preclinical work Our third program, CS585, a selective prostacyclin (IP) receptor agonist, continues to progress in preclinical development in collaboration with the University of Michigan. Data to date suggest it may offer novel approach to preventing thrombosis without increasing bleeding risk — a key differentiator in the cardiovascular space. Strengthening the company for growth Cereno Scientific's profile as an innovative biotech company continues to grow among investors, partners, and the broader life sciences community. This quarter, we were honored to be shortlisted for the prestigious European Mediscience Awards’ “Company of the Year.” This nomination is an important recognition of the progress Cereno Scientific has made in advancing truly innovative science in rare cardiovascular and pulmonary diseases with high unmet needs in patients suffering from these conditions. Cereno Scientific’s visibility among potential pharma partners, the investor community and scientific research communities was also reinforced by high-profile speaking invitations for our leadership team. In May, I was invited to participate at LSX Nordics in Bergen, Norway, on a panel on strategies for taking Nordic biotechs global, and in June, our CMO, Rahul Agrawal, joined a panel hosted by U.S.-based investment bank Jones Trading focused on new emerging treatment paradigms in PAH. Alongside these achievements, we secured SEK 100 million in additional financing through a combination of loan funding and convertible note conversion. This transaction extends our financial runway to reach key milestones for CS1 and CS014. Since this transaction, an additional SEK 25 million has been converted to shares from the loan, which has lowered our loan burden with SEK 50 million effectively. Notably, equity analyst firm Edison Group concluded an increased target share price of SEK 17 corresponding to a market cap of SEK 5 billion based on this period of positive development in the company. Together with our inclusion in Nasdaq’s First North 25™ Index from July 1, these achieved key milestones and positive development underscore market confidence in our trajectory and our ability to maintain flexibility while driving our programs forward. Looking ahead We have entered the second half of the year with strong momentum with a line of sight to multiple value-driving milestones ahead. This fall, we will participate in several key investor and partnering events, including the Annual Biotech in Europe Forum and NLSDays in October, BioEurope Fall in November, and a Cereno Scientific Capital Markets Day (date to be announced) where we will present an update on pipeline and strategy. We also intend to participate at leading scientific conferences, including European Respiratory Society (ERS) Congress in September, American Heart Association's (AHA) Scientific Sessions 2025 in November and the annual CVCT Forum in December. These activities will showcase our scientific progress, expand our network, and support partnering discussions. With two HDAC inhibitor programs in clinical development, a preclinical prostacyclin receptor agonist candidate advancing, and a growing reputation in both the investor and scientific communities, Cereno Scientific has built a strong stance and momentum for future continued growth. Every step, from clinical progress to strategic partnerships and market recognition, brings us closer to our mission: to develop pioneering treatments to patients with rare cardiovascular and pulmonary diseases where unmet needs are greatest. Thank you for your continued trust and support as we advance toward the next phase of our exciting journey. August 2025 Sten R. Sörensen, CEO Financial calendar Interim Report, Q3 2025……........……………………….November 27, 2025 Year-end Report, Q4 2025……...............................February 27, 2026 For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 73- 236 62 46 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. The company’s innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full. Lead candidate CS1 is an HDAC inhibitor that works through epigenetic modulation and represents a novel therapeutic approach by targeting the root mechanisms of the pulmonary arterial hypertension (PAH). CS1 is a well-tolerated oral therapy with a favorable safety profile that has shown encouraging efficacy signals of reverse vascular remodeling and improvement of right heart function as observed in a Phase IIa trial in patients with PAH. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1 CS014, a new chemical entity with disease-modifying potential, showed favorable safety and tolerability profile in a Phase I trial. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company’s Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Read PDF Share

The HDAC inhibitor pipeline remains active, with several next-generation agents advancing in clinical trials. Abexinostat (Xynomic Pharmaceuticals) is in Phase III development for renal cell carcinoma, representing a potential expansion into solid tumors. Quisinostat (Viriom) is in Phase II for uveal melanoma, and Entinostat, partnered between EOC Pharma and Syndax, is being explored in Hodgkin lymphoma. LAS VEGAS, Aug. 20, 2025 /PRNewswire/ -- DelveInsight's HDAC Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging HDAC inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the HDAC Inhibitors Market Report As per DelveInsight's analysis, the total market size of HDAC inhibitors in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as Multiple Myeloma, Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL), Amyotrophic Lateral Sclerosis (ALS), and others. Leading HDAC inhibitor companies, such as Xynomic Pharmaceuticals, Viriom, EOC Pharma, Syndax Pharmaceuticals, Jubilant Therapeutics, and others, are developing novel HDAC inhibitors that can be available in the HDAC inhibitors market in the coming years. Some of the key HDAC inhibitors in the pipeline include Abexinostat, Quisinostat, Entinostat, JBI-802, and others. Discover which indication is expected to grab the major HDAC inhibitors market share @ HDAC Inhibitors Market Report HDAC Inhibitors Overview Histone deacetylases (HDACs) remove acetyl groups from both histone and non-histone proteins. Because acetylation of histones is linked to an open chromatin structure and active gene transcription, HDAC activity leads to histone deacetylation and epigenetic suppression of gene expression. Since HDACs influence many pathways involved in cancer development, HDAC inhibitors (HDACis) show clinical effects through several mechanisms, including changes in gene expression of cell cycle and apoptotic proteins, acetylation of other proteins involved in cell growth and survival, effects on angiogenesis, aggresome formation, and DNA repair. There are 18 known HDACs, divided into two major groups and four classes based on their cellular location, homology, enzyme mechanism, sequence of discovery, and histone substrate specificity. The first group includes zinc-dependent HDACs, which all share a similar catalytic core for deacetylating acetyl-lysine residues. These comprise Class I (HDAC1, -2, -3, -8), Class II (IIa: HDAC4, -5, -7, -9; IIb: HDAC6, -10), and Class IV (HDAC11). The second group includes Class III HDACs (sirtuins, SIRT1–7), which rely on NAD+ for their enzymatic activity. HDAC Inhibitors Epidemiology Segmentation The HDAC inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indications for HDAC Inhibitor Total Eligible Patient Pool of Selected Indications for HDAC Inhibitor Total Treated Cases of Selected Indications for HDAC Inhibitor HDAC Inhibitors Treatment Market Several HDAC inhibitors are currently available on the market. Recent entrants include DUVYZAT (givinostat), while earlier approved drugs include BELEODAQ (belinostat), HIYASTA (tucidinostat), among others. DUVYZAT is a histone deacetylase inhibitor approved for treating Duchenne muscular dystrophy (DMD) in patients aged 6 and above. While it is categorized as an HDAC inhibitor, its exact mechanism of action in DMD is not fully understood. In April 2025, Italfarmaco announced that the CHMP of the European Medicines Agency (EMA) issued a positive opinion on DUVYZAT. The drug is also being evaluated in other indications: Phase III trial in Becker muscular dystrophy (BMD) and Phase II trial in polycythemia vera. HIYASTA (HBI-8000) is an epigenetic immunomodulator approved for several indications, including use as monotherapy for certain subtypes of relapsed or refractory T-cell non-Hodgkin's lymphoma, specifically adult T-cell leukemia-lymphoma (ATLL) and peripheral T-cell lymphoma (PTCL) in Japan. HUYABIO International is conducting a multinational Phase III trial evaluating HIYASTA in combination with nivolumab for previously untreated metastatic or unresectable malignant melanoma. HIYASTA is an oral HDAC Class I inhibitor that induces cell cycle arrest and apoptosis in tumor cells, which underlies its efficacy in lymphoma. In September 2020, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted orphan drug designation (ODD) to HIYASTA for relapsed/refractory ATL, and in December 2015 for PTCL. In June 2021, HUYABIO also received regulatory approval in Japan for HBI-8000 as monotherapy for relapsed/refractory ATL. Key Emerging HDAC Inhibitors and Companies Xynomic Pharmaceuticals (Abexinostat), Viriom (Quisinostat), EOC Pharma/Syndax Pharmaceuticals (Entinostat), Jubilant Therapeutics (JBI-802), and several other companies are currently engaged in the development and production of HDAC inhibitors, which have the potential to significantly impact and enhance the HDAC inhibitors market. Abexinostat, an oral, broad-spectrum HDAC inhibitor originally developed by Pharmacyclics and later licensed by Xynomic Pharmaceuticals in 2017, has demonstrated encouraging activity in both blood cancers and solid tumors. The drug is currently being studied in several Phase I to III clinical trials worldwide. In September 2019, Xynomic announced that the FDA had granted Fast Track Designation (FTD) to abexinostat as a monotherapy for fourth-line treatment of relapsed or refractory follicular lymphoma. The FDA had previously granted FTD for abexinostat in combination with pazopanib for first- or second-line therapy in renal cell carcinoma. Additional Phase II trials are underway in indications such as Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma. Quisinostat is another potent, selective oral pan-HDAC inhibitor, initially developed by Janssen Pharmaceuticals. HDAC inhibitors work by inducing cell cycle arrest, promoting differentiation, and triggering apoptosis in various human cancer cell lines. By inhibiting histone deacetylase, they increase acetylation of histone proteins, resulting in a more transcriptionally active chromatin state and altered gene expression involved in proliferation, apoptosis, and differentiation. Multiple preclinical studies and Phase I/II trials have evaluated quisinostat's safety and effectiveness, showing promising anti-tumor effects in several advanced and treatment-resistant cancers — including platinum-resistant ovarian cancer (in combination with paclitaxel and carboplatin), uveal melanoma, and synovial sarcoma. The anticipated launch of these emerging therapies are poised to transform the HDAC inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HDAC inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about HDAC inhibitors clinical trials, visit @ HDAC Inhibitors Treatment Recent Developments in the HDAC Inhibitors Space In May 2025, Amylyx Pharmaceuticals announced positive Week 48 data from the Phase II open-label HELIOS clinical trial of AMX0035 in adults living with Wolfram syndrome. In May 2025, the University of Miami, in collaboration with Viriom, initiated a Phase II clinical trial in the US (NCT06932757) to evaluate an oral therapy for patients with uveal melanoma who have undergone at least one prior line of treatment. In April 2025, Xynomic Pharmaceuticals concluded a Phase I/II clinical trial in the United States (NCT03939182), evaluating a combination oral therapy for patients with Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma who had received at least one prior line of treatment. Discover more about HDAC inhibitors in development @ HDAC Inhibitors Clinical Trials HDAC Inhibitors Market Dynamics HDAC inhibitors are a class of epigenetic drugs that modify gene expression by altering chromatin structure. Initially developed as anticancer agents, they have shown significant therapeutic potential in various malignancies, especially hematologic cancers like T-cell lymphoma and multiple myeloma. The market initially gained traction with FDA approvals of drugs such as Vorinostat, Romidepsin, and Panobinostat. Their unique mechanism of action targeting epigenetic regulation drew interest as precision medicine and oncology research grew, driving pharmaceutical investment in this segment. The HDAC inhibitors market continues to expand largely due to the rising prevalence of cancer worldwide and the need for more targeted therapies with better safety profiles. Additionally, ongoing clinical trials are exploring HDAC inhibitors in combination with other therapies, such as immune checkpoint inhibitors, proteasome inhibitors, and traditional chemotherapeutics. These combination approaches aim to overcome resistance and enhance efficacy, creating more opportunities for market growth. As more data emerges demonstrating synergistic benefits, partnerships between biotech startups and large pharmaceutical firms are accelerating further development. Despite this positive outlook, the market faces several challenges. Many HDAC inhibitors are associated with toxicity issues such as fatigue, gastrointestinal disturbances, and thrombocytopenia, which limit broader adoption. Competition from newer targeted therapies and immuno-oncology drugs also puts pressure on the HDAC inhibitor segment. Moreover, several compounds failed in late-stage trials due to a lack of efficacy, leading to cautious investor sentiment and prioritization of combination rather than monotherapy approaches. Looking ahead, the market dynamics are expected to be shaped increasingly by precision oncology trends and biomarker-driven patient selection, allowing more effective targeting of responders. If safety profiles can be improved and combination regimens continue to show strong results, HDAC inhibitors will retain a meaningful role in the evolving oncology landscape. Novel formulations, selective HDAC isoform inhibitors, and expansion into non-oncology indications such as neurodegenerative or inflammatory diseases may further diversify the market and drive its next phase of growth. Learn more about the HDAC inhibitors @ HDAC Inhibitors Analysis Scope of the HDAC Inhibitors Market Report HDAC Inhibitors Therapeutic Assessment: HDAC Inhibitors' current marketed and emerging therapies HDAC Inhibitors Market Dynamics: Conjoint Analysis of Emerging HDAC Inhibitor Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, HDAC Inhibitors Market Access and Reimbursement Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Sanofi, Karyopharm Therapeutics, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. 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