- One oral presentation and four posters from the RVU120 program to be presented at EHA 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).
- RVU305, a potentially best-in-class brain penetrant MTA-cooperative PRMT5 inhibitor, is progressing through IND/CTA-enabling studies.
- Total operating revenues in Q1 2025 amounted to €5.0 million, compared to €5.9 million for the same period in 2024.
- As of May 19, 2025, Ryvu’s cash position was €37.6 million. The strategic reorganization implemented in February 2025 and additional secured funding sources extended the company’s financial runway to H2 2026.
Krakow, Poland – May 22, 2025 – 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, 2025.
Pawel Przewięźlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said:
- RVU120 Phase II clinical program is progressing well, and we look forward to our oral presentation and four posters at the EHA congress next month. We are also rapidly advancing RVU305, our potentially best-in-class, brain-permeable MTA-cooperative PRMT5 inhibitor, and plan to complete IND/CTA-enabling studies in H2 2025. We are executing all projects at full speed and in line with our planned budget.
Q1 2025 SUMMARY AND RECENT CORPORATE EVENTS
- RVU120:
- 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), and the REMARK study in patients with lower-risk myelodysplastic syndrome (LR-MDS).
- EHA: Ryvu announced that it will have one oral presentation and four posters with clinical and preclinical data from RVU120 at the 2025 EHA Congress (June 12-15, Milan, IT). Abstracts are available at https://ehaweb.org/congress/eha2025-congress/
- 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.
- 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.
- Ryvu continues to advance its dual-pronged preclinical discovery and research strategy:
- ONCO Prime – novel small-molecule precision medicine: as part of its proprietary ONCO Prime platform, Ryvu continues to advance several novel precision oncology targets, including synthetic lethality targets. ONCO Prime combines data from patient-derived cells and isogenic cell lines to discover first-in-class oncology targets in defined patient populations. A poster highlighting novel targets in KRAS/APC-mutated colorectal cancer was presented at the AACR conference in April. Colorectal cancer represents one of the many tumor types being explored with the ONCO Prime platform.
- ADCs (antibody-drug conjugates) with novel payloads: Ryvu continues to develop ADCs with next-generation novel payloads, including synthetically lethal and immuno-mechanisms. Ryvu works on novel ADCs internally and through the existing collaboration with Exelixis (STING-based ADCs).
Ryvu continues to advance 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
- ASCO Conference (Chicago, US), May 30-June 3: Ryvu will hold partnering and investor meetings.
- EHA Annual Congress (Milan, IT), June 12-15: Ryvu will present RVU120 clinical and preclinical data, including one oral presentation and four posters.
- BIO International Convention (Boston, US), June 16-19: Ryvu will hold partnering meetings.
Q1 2025 FINANCIAL UPDATE
Cash Position – On March 31, 2025, Ryvu Therapeutics held €43.4 million in cash, cash equivalents, bonds and investment funds, compared to €52.7 million on December 31, 2024. On May 19, 2025, Ryvu Therapeutics held €37.6 million in cash, cash equivalents, bonds and investment funds. In addition, the Company has secured approximately €19.8 million in non-dilutive grant funding.
Operating Revenues – In Q1 2025, Ryvu recognized total operating revenues (including grants) of €5.0 million, compared to €5.9 million in Q1 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 Q1 2025, amounted to €14.0 million, compared to €11.1 million in Q1 2024.
Net Loss Attributable to Common Shareholders – In Q1 2025, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €5.8 million, compared to €4.2 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 e.g. 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.
For more information, please visit www.ryvu.com
Contact:
Anna Wilk
Ryvu Therapeutics
+48 532 698 425