This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study.
To be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.

Start Date04 Dec 2025

Sponsor / Collaborator

Ryvu Therapeutics SA

NCT06397313

/ RecruitingPhase 2

An Open-Label Clinical Trial of RVU120 as Monotherapy and in Combination With Ruxolitinib in Patients With Intermediate or High-Risk, Primary or Secondary Myelofibrosis (POTAMI-61)

The objective of this clinical trial is to evaluate the efficacy (how well the drug works), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the study drug, RVU120, in treating adult patients with intermediate or high-risk, primary or secondary myelofibrosis. RVU120 will be given as a single agent or in combination with ruxolitinib.

Start Date19 Sep 2024

Sponsor / Collaborator

Ryvu Therapeutics SA

NCT06243458

/ RecruitingPhase 2

A Phase II, Open-label, Multicenter Study of Orally Administered RVU120 for the Treatment of Anemia in Patients With Lower-risk Myelodysplastic Neoplasms (MDS)

This study will evaluate orally administered RVU120, a novel small molecule Cyclin-dependent Kinase (CDK) 8/19 inhibitor, in terms of erythroid hematologic improvement (HI-E) and safety in participants with lower-risk myelodysplastic syndrome (MDS). Responding patients are eligible to continue treatment until loss of response/disease progression.

Start Date10 Sep 2024

Sponsor / Collaborator

GCP Service International Ltd & Co KG

[+6]

100 Clinical Results associated with SEL-120

100 Translational Medicine associated with SEL-120

100 Patents (Medical) associated with SEL-120

Literatures (Medical) associated with SEL-120

01 Jul 2025·BIOCHEMICAL PHARMACOLOGY

Identification of pyrazole scaffold inhibitors targeting cyclin-dependent kinase 8 for potential use in pulmonary fibrosis

Article

Author: Yen, Shih-Chung ; Sung, Tzu-Ying ; Yang, Chia-Ron ; Chang, Yu-Wei ; Hsu, Jui-Yi ; Tsai, En-Yun ; Wu, Yi-Wen ; Hsu, Kai-Cheng ; Huang, Wei-Jan ; Pan, Shiow-Lin ; Hsieh, Jui-Hua ; Chou, Ching-Hsuan ; Lin, Tony Eight

Idiopathic Pulmonary Fibrosis (IPF) is a disease that includes inflammation and scarring of the lung tissues. Cyclin-dependent kinase 8 (CDK8) is a target of interest due to its role in inflammatory pathways. CDK8 can also modulate the TGF-β/Smad signaling associated with IPF. Herein, a structure-based virtual screening (SBVS) campaign led to the identification of three CDK8 inhibitors. Testing of candidate inhibitors in protein and cellular assays confirmed CDK8 inhibition, with the most potent inhibitor producing an IC₅₀ value of 398.8 nM. Computational analysis identified pharmacological interactions that lead to CDK8 inhibition. No significant cytotoxicity was observed when the inhibitor was treated in vitro. Further results showed that the inhibitor can disrupt proteins associated with the epithelial-mesenchymal transition (EMT) and reduce cell migration. Additionally, the inhibitor can disrupt the TGF- β1/Smad signaling axis in the nucleus, potentially impacting the transcription of IPF related protein expression, when treated in cells at 5 µM. Comparisons to structures of known CDK8 inhibitors showed the identified inhibitor to be structurally novel. When tested against a panel of kinases at 1 µM, the most potent inhibitor demonstrated a favorable CDK8 selectivity profile. The identification of the CDK8 inhibitors in this study can be used in future drug design studies and as CDK8 probes to explore alternative therapeutics for IPF.

01 Jun 2024·PROTEIN SCIENCE

An ensemble machine learning model generates a focused screening library for the identification of CDK8 inhibitors

Article

Author: Hsu, Kai‐Cheng ; Yang, Chia‐Ron ; Huang, Wei‐Jan ; Yen, Shih‐Chung ; Pan, Shiow‐Lin ; Wu, Yi‐Wen ; Sung, Tzu‐Ying ; Yen, Dyan ; Hsieh, Jui‐Hua ; Hsu, Jui‐Yi ; HuangFu, Wei‐Chun ; Lin, Tony Eight

Abstract:

The identification of an effective inhibitor is an important starting step in drug development. Unfortunately, many issues such as the characterization of protein binding sites, the screening library, materials for assays, etc., make drug screening a difficult proposition. As the size of screening libraries increases, more resources will be inefficiently consumed. Thus, new strategies are needed to preprocess and focus a screening library towards a targeted protein. Herein, we report an ensemble machine learning (ML) model to generate a CDK8‐focused screening library. The ensemble model consists of six different algorithms optimized for CDK8 inhibitor classification. The models were trained using a CDK8‐specific fragment library along with molecules containing CDK8 activity. The optimized ensemble model processed a commercial library containing 1.6 million molecules. This resulted in a CDK8‐focused screening library containing 1,672 molecules, a reduction of more than 99.90%. The CDK8‐focused library was then subjected to molecular docking, and 25 candidate compounds were selected. Enzymatic assays confirmed six CDK8 inhibitors, with one compound producing an IC50 value of ≤100 nM. Analysis of the ensemble ML model reveals the role of the CDK8 fragment library during training. Structural analysis of molecules reveals the hit compounds to be structurally novel CDK8 inhibitors. Together, the results highlight a pipeline for curating a focused library for a specific protein target, such as CDK8.

11 Nov 2021·ACS medicinal chemistry lettersQ3 · MEDICINE

Development of Highly Potent and Selective Pyrazolopyridine Inhibitor of CDK8/19

Q3 · MEDICINE

Article

Author: Gray, Nathanael S. ; Wang, Eric ; Jiang, Jie ; Vatsan, Prasanna S. ; Hatcher, John M.

CDK8 and its paralog CDK19 are cyclin-dependent kinases that are core components of the so-called Mediator complex that has essential roles as a positive and negative regulator of gene expression. Several efforts to develop inhibitors have yielded natural and synthetic ATP-competitive compounds including cortistatin A, Sel120, BCD-115, CCT251921 (1), and MSC2530818 (2). Here, we used a hybridization approach starting from CCT251921 and MSC2530818 to derive new inhibitors with the aim of developing highly potent and selective inhibitors of CDK8/19. Initial compounds suffered from rapid aldehyde oxidase-mediated metabolism. This liability was overcome by utilizing a pyrazolopyridine hinge binder with a chlorine at the C-3 position. These efforts resulted in JH-XVI-178 (compound 15), a highly potent and selective inhibitor of CDK8/19 that displays low clearance and moderate oral pharmacokinetic properties.

News (Medical) associated with SEL-120

11 Jun 2026

·ryvu.com

Ryvu Therapeutics presents clinical data and program update on romaciclib at the European Hematology Association Congress 2026

Romaciclib in acute myeloid leukemia (AML): In the RIVER-81 Phase II study, romaciclib combined with venetoclax (VEN) shows encouraging anti-leukemic activity, including durable responses, in patients with relapsed/refractory AML (r/r AML) after VEN-based therapy failure. These results support further clinical development at the selected dose. On May 28, 2026, the Food and Drug Administration (FDA) reactivated the IND, enabling the initiation of the expansion cohort at the recommended dose of 150 mg once daily (QD). Romaciclib in myelofibrosis (MF): In the POTAMI-61 Phase II study, romaciclib demonstrates a favorable safety profile and clinical activity in myelofibrosis (MF), both as monotherapy and in combination with ruxolitinib (RUX). The observed spleen volume reductions and hematologic tolerability support continued clinical evaluation. Eight patients from POTAMI-61 will continue treatment in the ROVER-01 study, reflecting ongoing clinical benefit in a subset of patients. Krakow, Poland – June 11, 2026 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, presents romaciclib (RVU120) data at the European Hematology Association Congress (EHA), June 11-14, 2026, in Stockholm, Sweden. Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics said: We are pleased to share updated clinical data at EHA that reinforce the potential of romaciclib across hematologic malignancies. The poster presentations highlight consistent clinical activity and a manageable safety profile, both as a single agent and in rational combinations, including in difficult-to-treat patient populations. Importantly, the FDA review of the program and the recent reactivation of the RIVER-81 IND in the US as well as the continued treatment of patients from POTAMI-61 in the ROVER-01 study, are meaningful signals reflecting both regulatory progress and continued patient benefit. These milestones strengthen our confidence in romaciclib’s differentiated mechanism of action and support its continued clinical advancement. Program updates: In the RIVER-81 trial of patients with r/r AML, Ryvu is initiating an expansion cohort of approximately 30 patients to confirm the positive efficacy demonstrated in the dose cohort of 150 mg QD romaciclib combined with 400 mg QD venetoclax. Following completion of the required regulatory steps, including an updated study protocol and submission of documentation under the existing IND, the FDA reactivated the IND for RIVER-81 study on May 28, 2026. In the POTAMI-61 study investigating romaciclib’s efficacy in MF, eight patients will be transferred into the ROVER-01 study rollover protocol, underscoring that a subset of patients continue to derive meaningful clinical benefit from romaciclib treatment. These patients will continue to receive treatment with romaciclib as long as they benefit in ROVER-01. EHA poster presentations: Poster (PF529):  Updated findings from the Phase 2 RIVER-81 study of romaciclib (RVU120) combined with venetoclax in acute myeloid leukemia after first-line venetoclax and hypomethylating agent failure Poster session date and time: Friday, June 12 (6:45 – 7:45 PM CEST) Venetoclax (VEN) combined with hypomethylating agents is the standard first-line treatment for patients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy, yet ~70% experience relapsed/refractory disease with a median survival of under three months. Romaciclib, a first-in-class CDK8/CDK19 inhibitor, has shown single-agent activity in AML and preclinical synergy with VEN through enhanced apoptotic signaling and attenuation of resistance pathways. In the ongoing Phase 2 RIVER-81 trial, romaciclib in combination with VEN demonstrates anti-leukemic activity in patients with poor prognostic AML. While responses have been observed across dose levels, the most consistent responses were seen at romaciclib 150 mg QD + VEN 400 mg QD, including two complete remissions with (CR) and one without (CRi) full hematologic recovery, resulting in a CR/CRi rate of 43% (3/7). The mean duration of response (DoR) of the CRs was 156 days, reported with a cut-off date of 12 May 2026. Based on safety, PK, and preliminary efficacy findings, this regimen was selected as the recommended dose for expansion. Poster (PS2008):   Romaciclib (RVU120), a selective CDK8/19 inhibitor, as monotherapy or in combination with ruxolitinib in patients with myelofibrosis: Updated results from the phase II POTAMI-61 study Poster session date and time: Saturday, June 13 (6:45 – 7:45 PM CEST) Myelofibrosis (MF) is driven by dysregulated JAK/STAT signaling, and while JAK inhibition with ruxolitinib (RUX) improves splenomegaly and symptoms, cytopenias and suboptimal responses remain clinical challenges. Romaciclib is a first-in-class, oral CDK8/19 inhibitor that modulates STAT-dependent transcription and shows synergy with RUX in preclinical MF models. In the ongoing Phase II POTAMI-61 study, romaciclib administered as monotherapy or combined with RUX demonstrates a manageable safety profile in patients with MF without significant treatment-related cytopenias. Prolonged exposure, spleen volume reductions, including in patients with high-molecular-risk mutations, and favorable hematologic tolerability support continued clinical development. The posters are available online and can be accessed via the conference website:  https://ehaweb.org/ and Ryvu’s website: https://ryvu.com/ The project entitled “The conduct of a phase II, multicentre, open-label clinical trial (RIVER-81) evaluating the safety and efficacy of RVU120 in combination with venetoclax in patients with relapsed/refractory acute myeloid leukemia who have failed prior therapy with venetoclax and a hypomethylating agent.”, carried out by Ryvu Therapeutics S.A., is co-financed by the Medical Research Agency from the state budget under the “Development of targeted or personalised medicine based on medicinal products involving nucleic acids and small-molecule compounds” call (ABM/2022/6). Total Project value: PLN 132,471,740.70 Total funding: PLN 62,268,848.90 RYVU Therapeutics Leona Henryka Sternbacha 2 30-394 Kraków, Poland

Phase 2Clinical ResultASHIND

21 May 2026

·ryvu.com

Ryvu Therapeutics reports first quarter 2026 financial results and provides corporate update

Following an analysis of Company resources and positive data in r/r AML, a population of high unmet medical need, Ryvu is prioritizing rapid development of romaciclib in AML. Updated clinical data from the Phase II RIVER-81 and POTAMI-61 studies will be presented at EHA 2026 (June 11-14, Stockholm). The Company signed the PERO grant agreement with the National Centre for Research and Development (NCBR), securing PLN 20.0 million in non-dilutive funding for an innovative oncology target validation platform. Total operating revenues in Q1 2026 amounted to €5.1 million, compared to €5.0 million for the same period in 2025. EBITDA loss was €2.4 million, compared to €8.4 million in the previous year. As of May 15, 2026, Ryvu’s cash position was €17.6 million. The Company has also secured approximately €20.6 million in non-dilutive grant funding. Krakow, Poland – May 21, 2026 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, today reported financial results for the first quarter, ended March 31, 2026. Pawel Przewiezlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said: Clinical results in RIVER-81 and POTAMI-61 Phase II studies support romaciclib’s further development both in acute myeloid leukemia and myelofibrosis. Based on resources and clinical data generated so far, we decided to prioritize the AML development path by enrolling approximately 30 additional patients in RIVER-81. Alongside romaciclib clinical development, we have demonstrated good results in our early-stage programs, including RVU305, our potentially best-in-class MTA-cooperative PRMT5 inhibitor and ONCO Prime platform. Projects developed in cooperation with our partners are progressing, with potentially important milestones ahead. Q1 2026 SUMMARY AND RECENT CORPORATE EVENTS Romaciclib (RVU120) clinical development plan progress Ryvu continues to advance the clinical development of romaciclib, a first-in-class selective CDK8/CDK19 inhibitor, across hematologic malignancies. Current data support continued development of romaciclib in acute myeloid leukemia (AML) and myelofibrosis (MF). With the particularly strong data in relapsed/refractory (r/r) AML, near-term priorities will focus on development in AML, where the high unmet medical need could lead to an accelerated approval path. Ryvu generated further clinical insights and will present updated clinical data from the RIVER-81 and POTAMI-61 studies at the European Hematology Association (EHA) Congress 2026 (June 11-14, Stockholm, Sweden). Based on available abstracts: RIVER-81: Romaciclib combined with venetoclax (VEN) shows encouraging anti-leukemic activity, including durable responses, in patients with r/r AML after VEN-based therapy failure. These results support further clinical development at the selected dose. POTAMI-61: Romaciclib demonstrates a favorable safety profile and clinical activity in MF, both as monotherapy and in combination with ruxolitinib. The observed spleen volume reductions and hematologic tolerability support continued clinical evaluation. On May 20, following the analysis of resources and clinical data generated so far, Ryvu decided to prioritize RIVER-81 study by enrolling approximately 30 additional patients. As part of resource prioritization, the Company decided to close the POTAMI-61 study (ongoing patients will continue to receive treatment in a new roll-over study ROVER-01). Ryvu retains the option to resume a modified MF development program. This approach is intended to preserve strategic optionality for romaciclib while, in the short term, focusing resources on the clinical dataset that is expected to be most relevant for potential development partners. New preclinical data for the ONCO Prime platform were presented at the AACR Annual Meeting 2026. Ryvu’s integrated precision oncology discovery platform leveraging patient-driven models, engineered systems, and high-throughput CRISPR/omics analytics, enables the identification of novel synthetic lethal vulnerabilities in genetically stratified colorectal cancer models, including proof-of-concept validation using a clinically approved drug. This establishes a scalable platform for drug discovery programs and strategic partnerships built on ONCO Prime’s ability to bridge functional genomics with therapeutic development. Extension of the research collaboration with BioNTech: on March 16, 2026, Ryvu reported that it amended its research collaboration and exclusive license option agreement with BioNTech, originally disclosed in November 2022. Under the amendment, the parties agreed to extend their research collaboration by an additional period of one year until November 2028. Grant funding for the PERO project: on March 11, 2026, the Company signed a grant agreement with the National Centre for Research and Development (in Polish: Narodowe Centrum Badań i Rozwoju; NCBR) for the PERO (“Predictive Engineering for Rational Oncology”) project. The objective of PERO is to establish an innovative technological platform for the functional validation of structural protein pockets of potential therapeutic targets in oncology. The project addresses a significant technological gap by enabling an in-depth, currently unavailable level of functional target validation based on integrated genomic, structural, and pharmacological data. The funding, PLN 20.0 million of a PLN 32.4 million project, will significantly fund the development of an innovative platform for functional target validation in oncology. Ryvu continues to advance partnerships with Menarini Group, BioNTech, and Exelixis, under which the Company is fully reimbursed for its expenses and has the potential to receive multiple financial milestones. KEY UPCOMING INDUSTRY AND INVESTOR EVENTS Ryvu will host partnering and investor meetings at the following conferences: ASCO Annual Meeting (Chicago, IL), May 29 to June 2 EHA Annual Congress (Stockholm, Sweden), June 12-15 BIO International Convention (San Diego, CA), June 22-25 Q1 2026 FINANCIAL UPDATE Cash Position – On May 15, 2026, Ryvu Therapeutics held €17.6 million in cash, cash equivalents and investment funds. In addition, the Company has secured approximately €20.6 million in non-dilutive grant funding. Operating Revenues – In Q1 2026, Ryvu recognized total operating revenues (including grants) of €5.1 million, compared with €5.0 million in Q1 2025. Operating costs, related primarily to research and development expenditures, excluding the valuation of NodThera shares and non-cash cost of valuation of the Incentive Program for Q1 2026, amounted to €8.0 million, compared to €11.4 million in Q1 2025. EBITDA result – EBITDA loss in Q1 2026 was €2.4 million, compared to €8.4 million in the previous year. Net Loss Attributable to Common Shareholders – In Q1 2026, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €2.9 million, compared to €5.8 million in the same period of the previous year. RYVU Therapeutics Leona Henryka Sternbacha 2 30-394 Kraków, Poland

License out/inPhase 2Financial StatementASHAACR

19 Mar 2026

·ryvu.com

Ryvu Therapeutics Reports 2025 Fiscal Year Financial Results and Provides Corporate Update

Results presented at the American Society of Hematology (ASH) Annual Meeting in December 2025 confirmed the clinical activity of romaciclib (RVU120) in patients with relapsed/refractory acute myeloid leukemia (r/r AML), who have historically poor outcomes following venetoclax-based therapy. In the Phase II RIVER-81 study, complete and incomplete remission rates reached 43% in the 150 mg once-daily cohort, with a favorable safety profile. Romaciclib Phase II POTAMI-61 study in myelofibrosis (MF), which included patients previously exposed or refractory to JAK inhibitors, brought early signals of spleen volume reduction (SVR) and symptom improvement (total symptom score; TSS) without significant myelosuppression. SVR rate of at least 25% (SVR25) was met by 4 out of 14 evaluable patients (29%). At the same time SVR10 was achieved by 7 patients (50%). The Company is progressing research and clinical collaborations with BioNTech, Exelixis, and Menarini Group, as well as strengthening its long-term value drivers with progress in fully owned early pipeline projects. Total operating revenues for the full year 2025 were €20.7 million, compared to €23.7 million for the same period in 2024. EBITDA loss was reduced to €23.2 million, compared to €25.9 million in the previous year. For Q4 alone, those figures were €3.5 million and €8.8 million, respectively. As of March 9, 2026, Ryvu’s cash position was €20.7 million. In addition, Ryvu has secured approximately €20.9 million in non-dilutive grant funding. Krakow, Poland – March 19, 2026 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, reports its financials for the 2025 fiscal year and provides a corporate update. Pawel Przewiezlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said: – In 2025, we continued to focus on disciplined execution across our clinical programs while maintaining strict cost control. Our priority remains the efficient advancement of romaciclib (RVU120), for which we presented positive Phase II clinical data demonstrating efficacy in difficult-to-treat hematologic malignancies, including acute myeloid leukemia and myelofibrosis. At the same time, we continued to prepare RVU305 for clinical development and to advance multiple early pipeline programs. Thanks to ongoing partnerships and strategic reorganization implemented in Q1 2025, we are generating stable revenue streams and have significantly reduced operating costs. Importantly, we entered 2026 with new grant funding to support our preclinical discovery and research. Krzysztof Brzozka, Ph.D., Executive Vice President and Chief Scientific Officer, said: – Our discovery and research strategy continues to generate promising opportunities in precision oncology. The ONCO Prime platform remains a key engine of innovation, enabling the identification of novel precision oncology targets, including synthetic lethal approaches, in genetically defined cancers. In parallel, we continue to explore next-generation ADC payloads leveraging both synthetically lethal and immunocytotoxic mechanisms. Together with new projects – such as our PERO project (Predictive Engineering for Rational Oncology), which secured significant grant funding in March 2026 – these initiatives are designed to drive the development of future oncology therapies that address high unmet medical needs. 2025 SUMMARY AND RECENT CORPORATE EVENTS Romaciclib (RVU120) clinical development plan progress Ryvu continued to advance the clinical development of romaciclib (RVU120), a first-in-class selective CDK8/CDK19 inhibitor, across multiple hematologic malignancies. Current data support continued development of romaciclib in AML and MF, including further exploration of combination strategies. Throughout 2025, three Phase II studies continued as planned: RIVER-81 (combination with venetoclax in r/r AML), POTAMI-61 (monotherapy and combination with ruxolitinib in MF), and REMARK (monotherapy in LR-MDS; investigator-initiated trial). Ryvu generated further clinical insights and presented updated clinical data from the RIVER-81 and POTAMI-61 studies at the American Society of Hematology (ASH) Annual Meeting. RIVER-81 The Phase II RIVER-81 study evaluates the combination of romaciclib (RVU120), a selective CDK8/CDK19 inhibitor, with venetoclax (VEN) in unfit patients with r/r AML following frontline VEN plus hypomethylating agent (HMA) therapy, a patient population of high unmet need with no approved therapies. In the cohort testing romaciclib dose of 150 mg QD (once daily) and VEN 400 mg , 3 of 7 treated patients (43%) achieved CR/CRi (CRx) and 2 of 7 patients (28%) achieved CR. Overall, the mean duration of response at 150 mg QD was 141 days.   These data support expansion of the RIVER-81 study and present opportunities for investigation in additional AML settings, including the frontline setting. In January 2026, the U.S. Food and Drug Administration (FDA) held the Type C meeting requested by Ryvu. The FDA raised no objections to opening the expansion cohort in the United States with romaciclib at 150 mg QD in combination with VEN. POTAMI-61 The Phase II POTAMI-61 study evaluates romaciclib as monotherapy and in combination with ruxolitinib (RUX) in patients with MF who have failed or shown suboptimal response to JAK inhibitor therapy. Of the 14 patients evaluable for spleen volume evaluation at 12 weeks or more, 9 achieved spleen volume reduction, with 7 (50%) achieving at least SVR10 and 4 (29%) achieving SVR25 or better. One patient achieved a 59% reduction in spleen volume at week 36. Patients with a high-risk mutation in ASXL1 derived clinical benefit from romaciclib.  Significant and durable TSS improvement was achieved in patients in both cohorts.  These early data indicate that romaciclib is well tolerated and shows initial clinical activity, supporting continued evaluation of romaciclib as a potential therapeutic option for patients with MF. In September 2025, Ryvu announced the initiation of a collaboration with the Children’s Memorial Health Institute as part of the MEDWAY project, an investigator-initiated Phase I clinical study evaluating romaciclib in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma. FPFV (First Patient, First Visit) is expected in Q2 2026. Dapolsertib (MEN1703, SEL24): The JASPIS-01 Phase II study evaluates dapolsertib in patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) as a monotherapy and in combination with glofitamab. The first patient was dosed in March 2025. JASPIS-01 is fully funded by the Menarini Group and operationally executed by Ryvu. RVU305: Ryvu continues development of RVU305, its potentially best-in-class brain-permeable, MTA-cooperative PRMT5 inhibitor, which is completing IND/CTA-enabling studies in preparation for clinical development. In October 2025, the Company presented preclinical data on RVU305 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, highlighting its brain-permeable profile and potential in MTAP-deleted cancers. Ryvu continues to advance its dual-pronged preclinical discovery and research strategy, focused on the ONCO Prime platform (novel small-molecule precision medicine, including synthetic lethality targets) and ADCs (antibody-drug conjugates) with novel payloads. Grant funding for the ADCraft project: on April 23, 2025, Ryvu announced signing a grant agreement with the Medical Research Agency (in Polish: Agencja Badań Medycznych, “MRA”) for the “ADCraft – next-generation small-molecule payloads for antibody-drug conjugates in oncology” project. The aim of the Project is to develop methods for discovering and testing a new generation of ADC payloads along with a portfolio of R&D activities focused on new therapeutic modalities used in oncology. The Company expects to receive PLN 9.9 million to support the project of a total net value of PLN 13.2 million. Grant funding for the PERO project: on March 11, 2026, the Company signed the grant agreement with the National Centre for Research and Development (in Polish: Narodowe Centrum Badan I Rozwoju; NCBR) for the PERO (“Predictive Engineering for Rational Oncology”) project. The objective of PERO is to establish an innovative technological platform for the functional validation of structural protein pockets of potential therapeutic targets in oncology. The project addresses a significant technological gap by enabling an in-depth, currently unavailable level of functional target validation based on integrated genomic, structural, and pharmacological data. The funding, PLN 20.0 million of a PLN 32.4 million project, will significantly fund the development of an innovative platform for functional target validation in oncology. Ryvu continues to advance partnerships with Menarini Group, BioNTech, and Exelixis, under which the Company is fully reimbursed for its expenses and has the potential to receive multiple financial milestones. Clinical collaboration with BioNTech: on September 2, 2025, Ryvu announced an expansion of its collaboration with BioNTech. Based on the new agreement, Ryvu supports BioNTech in accelerating site activation and patient enrollment for several of BioNTech’s priority oncology clinical programs in Poland, including indications such as lung, breast, and colorectal cancers. Extension of the research collaboration with BioNTech: on March 16, 2026, Ryvu informed about amending its research collaboration option exclusive license agreement with BioNTech, originally disclosed in November 2022. Under the amendment, the parties agreed to extend its research collaboration by an additional period of one year – until November 2028. KEY UPCOMING INDUSTRY AND INVESTOR EVENTS Ryvu will host partnering and investor meetings at all of the below conferences, with scientific presentations where noted: BIO-Europe Spring (Lisbon, Portugal), March 23-25 LSX World Congress (Lisbon, Portugal), March 24-25 AACR Annual Congress (San Diego, CA), April 17-22: Data to be presented on the ONCO Prime platform BIO Equity Europe (Prague, Czech Republic), May 4-6 ASCO Annual Meeting (Chicago, IL), May 29 to June 2 EHA Annual Congress (Stockholm, Sweden), June 12-15 BIO International Convention (San Diego, CA), June 22-25 2025 FISCAL YEAR FINANCIAL UPDATE Cash Position – On December 31, 2025, Ryvu Therapeutics held €25.5 million in cash, cash equivalents, and investment funds, compared to €52.7 million at the end of 2024. On March 9, 2026, the Company held €20.7 million in cash, cash equivalents and investment funds. In addition, Ryvu has secured approximately €20.9 million in non-dilutive grant funding. Operating Revenues – In 2025, Ryvu recognized total operating revenues (including grants) of €20.7 million, compared to €23.7 million in 2024. Operating costs, related primarily to research and development expenditures, excluding the valuation of NodThera shares and the non-cash cost of valuation of the Incentive Program for 2025, amounted to €43.0 million, compared to €51.1 million in 2024. EBITDA result – EBITDA loss for full-year 2025 was reduced to €23.2 million, compared to €25.9 million in the previous year. EBITDA loss in Q4 2025 was €3.5 million, compared to €8.8 million in the previous year. Net Loss Attributable to Common Shareholders – In 2025, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €23.2 million, compared to €24.9 million in the previous year. RYVU Therapeutics Leona Henryka Sternbacha 2 30-394 Kraków, Poland

Phase 2Clinical ResultLicense out/inASHPhase 1

100 Deals associated with SEL-120

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	Poland	Ryvu Therapeutics SA	04 Dec 2025
Advanced Malignant Solid Neoplasm	Phase 2	Spain	Ryvu Therapeutics SA	04 Dec 2025
Myelofibrosis	Phase 2	Italy	Ryvu Therapeutics SA	19 Sep 2024
Myelofibrosis	Phase 2	Poland	Ryvu Therapeutics SA	19 Sep 2024
Chromosome 5q Deletion Syndrome	Phase 2	France	Ryvu Therapeutics SA	10 Sep 2024
Chromosome 5q Deletion Syndrome	Phase 2	Germany	Ryvu Therapeutics SA	10 Sep 2024
Chromosome 5q Deletion Syndrome	Phase 2	Italy	Ryvu Therapeutics SA	10 Sep 2024
Chromosome 5q Deletion Syndrome	Phase 2	Poland	Ryvu Therapeutics SA	10 Sep 2024
Chromosome 5q Deletion Syndrome	Phase 2	Spain	Ryvu Therapeutics SA	10 Sep 2024
Monosomy 7 of Bone Marrow	Phase 2	France	Ryvu Therapeutics SA	10 Sep 2024

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06397313 (POTAMI-61, ASH2025)	Phase 1/2	Myelofibrosis	23	Romaciclib	lqsxcbzcls(xyrbzsoqyf) = xnefzeguuf kjjqsqinza (spngsvxhzd ) View more	Positive	06 Dec 2025
NCT06397313 (POTAMI-61, ASH2025)	Phase 1/2	Myelofibrosis	23	Romaciclib + Ruxolitinib	lqsxcbzcls(xyrbzsoqyf) = gwfniisgvl kjjqsqinza (spngsvxhzd ) View more	Positive	06 Dec 2025
NCT06191263 (REMARK, ASH2025)	Phase 2	Anemia \| Myelodysplastic-Myeloproliferative Diseases SF3B1 mutation	42	Romaciclib 150 mg q.o.d.	yvevdnscjl(alvexqojwl) = jeatncbgsh pggkkgaudi (ohsbuxivoe ) View more	Positive	06 Dec 2025
NCT06191263 (RIVER-81, EHA2025)	Phase 2	Acute Myeloid Leukemia First line ASXL1 \| TP53 \| NRAS	36	RVU120+VEN	emueqlqbhr(tvtrhtncbf) = 41% of the treated patients qssidjqbzc (cycikkiklg ) View more	Positive	14 May 2025
NCT06191263 (RIVER-81, EHA2025)	Phase 2	Acute Myeloid Leukemia First line ASXL1 \| TP53 \| NRAS	36	Placebo		Positive	14 May 2025
NCT04021368 (RIVER-52, EHA2025)	Phase 1	Acute Myeloid Leukemia \| Refractory High Risk Myelodysplastic Syndrome NPM1 mutation	39	RVU120 250 mg	pohmlqlaja(aylgigheiw) = Infectious complications were among the most frequent events fvrofyralm (bjtsvgncte ) View more	Negative	14 May 2025
NCT04021368 \| NCT06268574 (CLI120-001, EHA 12024 \| EHA 22024) Manual	Phase 1/2	High Risk Myelodysplastic Syndrome \| Refractory acute myeloid leukemia	39	RVU120	ytcrnpomcr(fvsusjnbtj) = In CLI120-001, Nausea and vomiting (mostly G1-2) were the most frequent treatment-emergent adverse events. In RIVER-52 did not experience any drug-related adverse events in the first cycle xrcgsyhtaa (tllddgesua ) View more	Positive	14 May 2024
NCT06191263 (RIVER-81, EHA 12024 \| EHA 22024) Manual	Phase 2	Acute Myeloid Leukemia Second line	3	RVU120+venetoclax	cmjsbdldmg(indlovkbme) = None ersyywduaf (ybyvtecavr ) View more	Positive	14 May 2024
NCT04021368 \| NCT06268574 (EHA2024)	Not Applicable	Myelodysplastic-Myeloproliferative Diseases Second line	39	RVU120	gobeicaenk(lrfqgxydvd) = pnsbempaxo ykamjbkgox (esxziitrun )	Positive	14 May 2024
NCT04021368 (CLI120-001, Biospace) Manual	Phase 1	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	38	RVU120 250 mg	xygbvvslcb(wyoovbtday) = ewjyrhmwst xugvyilpse (ennwgwjxke ) View more	Positive	11 Dec 2023
NCT05052255 (ESMO 12023 \| ESMO 22023) Manual	Phase 1/2	Solid tumor	30	RVU120	xnzudgyrnp(irmypeahtl) = garxwjseun dsoucjkfdz (anbkkvmnea ) View more	Positive	23 Oct 2023
NCT04021368 (CLI120-001, EHA2023)	Phase 1	High Risk Myelodysplastic Syndrome \| Refractory acute myeloid leukemia	22	RVU120	kqfesqpyzq(ldwufxsabh) = in a patient treated at 100 mg xdfqdsbqbw (vxjkmvdisc ) View more	-	08 Jun 2023

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