- Ryvu presented one oral presentation and four posters from the RVU120 program at EHA 2025. The following data update is expected in Q4 2025.
- On September 9, the Company announced the initiation of a collaboration with the Children’s Memorial Health Institute (PL. Instytut „Pomnik – Centrum Zdrowia Dziecka”) to explore RVU120 in combination with everolimus in a new, investigator-initiated Phase I study to treat pediatric medulloblastoma patients.
- On September 2, Ryvu announced a strategic agreement to support clinical trials for BioNTech’s investigational cancer immunotherapies by supporting trial site activation and patient recruitment for multiple investigational immunotherapies of BioNTech’s oncology pipeline in Poland.
- The total operating revenues in H1 2025 amounted to €10.1 million, compared to €11.3 million for the same period in 2024.
- Thanks to the cost optimization and strategic reorganization announced in February 2025, Ryvu reduced its operating loss in Q2 2025 by €1.1 million (15%) compared to the corresponding period in 2024.
- As of September 8, 2025, Ryvu’s cash position was €30.9 million.
KRAKOW, Poland, September 18, 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 half year ended June 30, 2025.
Pawel Przewięźlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said: "The months ahead will be pivotal for Ryvu. In Q4, we anticipate key results from Phase II clinical trials of RVU120 in three blood cancers. We have successfully completed patient enrollment across all ongoing studies, and by year-end, we expect to have data that will guide the next steps in the program’s development. At the same time, we are working to extend our cash runway from H2 2026 through non-dilutive financing. Alongside the recently secured grants, our new strategic agreement with BioNTech – both a key partner and Ryvu’s shareholder – will play an important role."
H1 2025 SUMMARY AND RECENT CORPORATE EVENTS
RVU120:
- 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, non-commercial, investigator-initiated Phase I clinical study aimed at evaluating RVU120 in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma.
- The Phase II development plan continues with a focus on three studies:
- the RIVER-81 study in patients with relapsed or refractory acute myeloid leukemia (r/r AML) in combination with venetoclax (VEN),
- the POTAMI-61 study in patients with myelofibrosis (MF) as a monotherapy and in combination with ruxolitinib (RUX),
- the REMARK study in patients with lower-risk myelodysplastic syndrome (LR-MDS).
- EHA: Ryvu presented five posters (including one oral presentation) with clinical and preclinical data from RVU120 at the 2025 European Hematology Association Congress. Data highlighted RVU120 in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myelofibrosis (MF).
- The next RVU120 data update is planned in Q4.
RVU305:
- In April 2025, Ryvu presented preclinical data on RVU305, a brain-permeable MTA-cooperative PRMT5 inhibitor, at the 2025 AACR Annual Meeting, showcasing a potentially best-in-class profile in MTAP-deleted cancers.
- IND/CTA-enabling studies are planned to be completed in H2 2025.
Dapolsertib:
- In March 2025, the first patient was dosed with dapolsertib (MEN1703, SEL24) in the Phase II JASPIS-01 study, treating patients with relapsed/refractory Diffuse Large B-cell Lymphoma (r/r DLBCL) as a monotherapy and in combination with glofitamab. JASPIS-01 is fully funded by the Menarini Group and operationally executed by Ryvu.
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.
New strategic agreement with BioNTech: on September 2, Ryvu announced the expansion of its relationship with one of its key shareholders, BioNTech. Based on the new, strategic agreement, Ryvu will support BioNTech in the acceleration of site activation and patient enrollment for several of BioNTech’s priority oncology clinical programs in Poland, in 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 and has the potential to achieve multiple financial milestones.
UPCOMING INDUSTRY AND INVESTOR EVENTS
- Discovery On Target Conference (Boston, US), September 24-25: Ryvu will present its latest developments on the ONCO Prime platform.
- 25th Annual Biotech in Europe Forum (Basel, CH), October 8-9, Ryvu will host partnering and investor meetings
- ESMO Congress 2025 (Berlin, GER), October 17-21: Ryvu will host scientific and partnering meetings.
- 1st Polish Corporate Day (Frankfurt, GER), Oct. 20: Ryvu will host investor meetings.
- 2025 AACR-NCI-EORTC Conference (Boston, US), October 22-26: Ryvu will present two scientific posters and host dedicated scientific meetings.
- Polish Society of Haematology and Transfusion Medicine (Gdansk, POL), October 23-25: Ryvu will showcase its scientific achievements at its booth.
- 2025 LSBC Central European Life Science Investment Conference (Krakow, POL), October 30-31: Ryvu will host scientific and partnering meetings.
- BIO Europe Fall (Vienna, AUS), November 3-5: Ryvu will host scientific and partnering meetings.
- World ADC (San Diego, US), November 3-6: Ryvu will host scientific and partnering meetings.
H1 2025 FINANCIAL UPDATE
Cash Position – On June 30, 2025, Ryvu Therapeutics held €36.6 million in cash, cash equivalents, bonds, and investment funds, compared to €52.7 million on December 31, 2024. As of September 8, 2025, the Company held €30.9 million in cash, cash equivalents, bonds, and investment funds. In addition, Ryvu has secured approximately €18.8 million in non-dilutive grant funding.
Operating Revenues – In H1 2025, Ryvu recognized total operating revenues (including grants) of €10.1 million, compared to €11.3 million in H1 2024.
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 H1 2025, amounted to €22.6 million, compared to €23.6 million in H1 2024. Thanks to the cost discipline and strategic reorganization announced in February 2025, Ryvu reduced its operating loss in Q2 2025 by €1.1 million (15%) compared to the corresponding period in 2024.
Net Loss Attributable to Common Shareholders – In H1 2025, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €13.5 million, compared to €11.0 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 RVU120, 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