- Three romaciclib (RVU120) abstracts and one dapolsertib (MEN1703) abstract were accepted for poster presentation at the 2025 American Society of Hematology (ASH) Annual Meeting in December.
- Romaciclib continues to demonstrate meaningful activity in the Phase II study across multiple hematologic malignancies, including AML and myelofibrosis, while dapolsertib offers an innovative approach to address treatment resistance in aggressive lymphomas.
- Ryvu presented new preclinical data on RVU305 (brain-penetrant, MTA-cooperative PRMT5 inhibitor) and the ONCO Prime novel target discovery platform at the 2025 AACR-NCI-EORTC Conference in October.
- As of November 11, 2025, Ryvu’s cash position was €28.2 million. In addition, Ryvu has secured approximately €18.5 million in non-dilutive grant funding.
KRAKOW, Poland, November 20, 2025 / 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 third quarter ended September 30, 2025, and provided a corporate update.
Pawel Przewięźlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said: "We are excited to present Phase II clinical data at the ASH conference in December, with three abstracts on romaciclib and one on dapolsertib. Romaciclib continues to show meaningful activity across multiple hematologic malignancies, and dapolsertib is being tested as an innovative option for aggressive lymphomas."
Q3 2025 SUMMARY AND RECENT CORPORATE EVENTS
Romaciclib (RVU120):
- In the third quarter of 2025, Ryvu advanced romaciclib, its selective CDK8/CDK19 inhibitor, across three Phase II clinical studies in hematologic malignancies. Three abstracts were accepted for presentation at the 2025 American Society of Hematology (ASH) Annual Meeting (December 6-9), highlighting continued progress and clinical activity across AML, myelofibrosis, and lower-risk MDS.
- Acute myeloid leukemia (AML): Data from the Phase II RIVER-81 trial suggest that romaciclib restores sensitivity to venetoclax in resistant AML, inducing complete remissions with a favorable safety profile.
- Myelofibrosis (MF): Interim results from the Phase II POTAMI-61 study indicate clinically meaningful spleen volume and symptom reductions, supporting romaciclib’s potential role in the post-JAK inhibitor setting.
- Lower-risk myelodysplastic syndrome (LR-MDS): In the Phase II REMARK study, one heavily pretreated patient achieved a major erythroid response.
- New IIT Phase I study: on September 9, Ryvu announced the initiation of a collaboration with the Children’s Memorial Health Institute as part of the MEDWAY project – a new, investigator-initiated Phase I clinical study aimed to evaluate romaciclib in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma.
Dapolsertib: a dapolsertib abstract was accepted for presentation at the 2025 ASH Annual Meeting, reflecting growing clinical experience with the program. The ongoing Phase II JASPIS-01 study is evaluating dapolsertib in aggressive B-cell lymphomas, both as a single agent and in combination with glofitamab.
RVU305: In October 2025, Ryvu presented preclinical data on RVU305, a brain-permeable MTA-cooperative PRMT5 inhibitor, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, showcasing a potentially best-in-class profile in MTAP-deleted cancers. IND/CTA-enabling studies are planned to be completed in H2 2025.
ONCO Prime platform: At the same event (AACR-NCI-EORTC), Ryvu also presented data from ONCO Prime, its proprietary, integrated synthetic lethality discovery platform leveraging patient-driven models, engineered systems, and high-throughput CRISPR/omics analytics – uncovers the identification of novel targets across various cancer types, including colorectal cancer (CRC) in genetically defined patient populations. Ryvu continues to advance its dual-pronged preclinical discovery strategy built around the ONCO Prime platform, focused on novel small-molecule precision medicine, including synthetic lethality targets and ADCs (antibody-drug conjugates) with novel payloads.
New strategic agreement with BioNTech: on September 2, Ryvu announced an expansion of its collaboration with BioNTech. Based on the new agreement, Ryvu will support 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.
Ryvu is progressing R&D partnerships with BioNTech, Exelixis, and Menarini. Ryvu is fully reimbursed for its expenses in these collaborations and has the potential to achieve multiple financial milestones.
UPCOMING INDUSTRY AND INVESTOR EVENTS
- Life Science Open Space (Krakow, Poland), November 27-28: Paweł Przewięźlikowski, CEO of Ryvu, will deliver a presentation entitled: “From Ryvu labs in Krakow to AML patients worldwide – the story of romaciclib”.
- 2025 American Society of Hematology Annual Meeting (Orlando, US), December 6-9: Ryvu will present four abstracts on romaciclib and dapolsertib and host scientific and partnering meetings.
- DM BOŚ Investor Conference – Business Outlook for 2026 (online), January 8, 10:00 AM CET: Ryvu will host investor presentation.
- 11th Oncology Innovation Forum (San Francisco, US), January 10: Ryvu will host partnering and investor meetings.
- Biotech Showcase (San Francisco, US), January 12-14: Ryvu will host partnering and investor meetings.
- BIO Partnering at JPM (San Francisco, US), January 12-15: Ryvu will host partnering and investor meetings.
Q1-Q3 2025 FINANCIAL UPDATE
Cash Position – On September 30, 2025, Ryvu Therapeutics held €32 million in cash, cash equivalents, and investment funds, compared to €52.7 million on December 31, 2024. On November 11, 2025, the Company held €28.2 million in cash, cash equivalents, and investment funds. In addition, Ryvu has secured approximately €18.5 million in non-dilutive grant funding.
Operating Revenues – In the first three quarters of 2025, Ryvu recognized total operating revenues (including grants) of €14.6 million, compared to €17.1 million in the corresponding period of 2024.
Operating costs, primarily related to research and development expenditures, excluding the valuation of NodThera shares and non-cash cost of valuation of the Incentive Program for the first three quarters of 2025, amounted to €33 million, compared to €35.1 million for the same period last year. Thanks to the cost discipline and strategic reorganization announced in February 2025 Ryvu reduced its operating loss in Q3 2025 by €0.2 million (3%) yoy.
Net Loss Attributable to Common Shareholders – In the first three quarters of 2025, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €19.1 million, compared to €17.1 million in the same period of the previous year.
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. RVU120 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 for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) –the REMARK study, (iii) 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, is currently in 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