- 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 €6 million. The Company has also secured approximately €20.6 million in non-dilutive grant funding.
KRAKOW, Poland, May 21, 2026 / Biotech Newswire / -- 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.
Semantic keywords: Financial results; PERO grant; Congresses as Topic; Clinical Trials, Phase II as Topic; Ryvu Therapeutics; romaciclib; RVU120; CDK8/CDK19 inhibitor; acute myeloid leukemia; AML; relapsed/refractory acute myeloid leukemia; r/r AML; venetoclax; VEN; RIVER-81; myelofibrosis; MF; ruxolitinib; POTAMI-61; hematologic malignancies; anti-leukemic activity; favorable safety profile; EHA 2026; European Hematology Association Congress; ONCO Prime; precision oncology discovery platform; BioNTech; research collaboration; RVU305; MTA-cooperative PRMT5 inhibitor; partnerships
About Ryvu Therapeutics
Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel oncology therapies that address emerging targets in oncology. Internally discovered pipeline candidates at Ryvu use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules and antibody-drug conjugates directed at kinases, synthetic lethality, and immuno-oncology targets.
Ryvu’s most advanced program is romaciclib (RVU120, SEL120), a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors. Romaciclib is currently in Phase II development (i) in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study, (ii) as a monotherapy and in combination with ruxolitinib for the treatment of patients with myelofibrosis (MF) –the POTAMI-61 study. Dapolsertib (MEN1703, SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group that is currently being investigated in a Phase II study in diffuse large B-cell lymphoma (DLBCL) – the JASPIS-01 study. RVU305, a potentially best-in-class, brain-permeable PRMT5 inhibitor aiming to treat multiple solid tumors, has completed IND/CTA-enabling studies. Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis.
Ryvu was founded in 2007 and is headquartered in Kraków, Poland. It is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index.
Contact
Ryvu Therapeutics
Anna Wilk
+48 532 698 425
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Source: Biotech Newswire