- Total operating revenues for 2024 were €23.7 million, compared to €15 million for the same period in 2023.
- As of March 9, 2025, Ryvu’s cash position was €43.7 million. The strategic reorganization implemented in February 2025 and additional secured funding sources extended the company's financial runway from Q1 to H2 2026.
KRAKOW, Poland, March 13, 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, reports its financials for the 2024 fiscal year.
Pawel Przewięźlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said: "In the past year, we have made significant progress in our clinical and preclinical pipeline. We launched all of the planned Phase II clinical trials of RVU120, our first-in-class CDK8/19 inhibitor. By the end of 2024, we had enrolled almost 100 patients and activated more than 110 clinical sites in Europe and North America. We look forward to essential readouts in mid-2025. We also expect to complete IND/CTA-enabling studies of RVU305, our potentially best-in-class PRMT5 MTA-cooperative inhibitor, in H2 2025."
Krzysztof Brzózka, Ph.D., Executive Vice President, and Chief Scientific Officer, said: "At the beginning of 2025 we announced our dual-pronged preclinical strategy, which has potential to generate multiple oncology medicines. We continue to develop our proprietary ONCO Prime platform, which includes synthetic lethal targets; the platform has already identified several novel targets for KRAS-driven tumors. We are also leveraging our expertise in cancer biology to develop novel ADCs with next-generation payloads, both targeting synthetically lethal and immunocytotoxic mechanisms."
2024 SUMMARY AND RECENT CORPORATE EVENTS
RVU120 clinical development plan progress
- Ryvu successfully launched all four RVU120 Phase II clinical studies planned for 2024: RIVER-52 (monotherapy in AML and HR-MDS), RIVER-81 (combination with venetoclax in AML), POTAMI-61 (monotherapy/combination with ruxolitinib in myelofibrosis) and REMARK (monotherapy in LR-MDS).
- As of February 2025, approximately 120 patients have been dosed across all RVU120 Phase II studies. Over 110 clinical sites have been activated.
- Based on the analysis of RIVER-81 and RIVER-52 data, as well as feedback from advisory boards in February 2025, the Company decided to optimize RVU120 clinical program. RIVER-81 will continue as planned, while enrollment in RIVER-52 has been suspended to focus investment on the other RVU120 development paths.
- Three Phase II RVU120 studies are progressing as planned: RIVER-81, POTAMI-61, and REMARK.
- Ryvu emphasizes rapid RVU120 study enrollment and quality data generation in 2025. The next data update is planned in Q2 2025.
Status of other programs
- The JASPIS-01 study was initiated in Q4 2024, currently awaiting enrollment of the first patient, which is still expected in Q1 2025. The study will commence at clinical sites in Poland with ongoing efforts to expand to additional EU and non-EU countries.
- In September 2024, Ryvu decided to advance RVU305, its potentially best-in-class PRMT5 inhibitor, to IND/CTA-enabling studies, which 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.
- 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 Menarini, BioNTech and Exelixis. Ryvu is fully reimbursed for its expenses and has the potential to achieve multiple financial milestones.
UPCOMING INDUSTRY AND INVESTOR EVENTS
- BIO EU (Milan, IT), March 17-19: Ryvu will hold partnering and investor meetings.
- Tumor Models Summit Nordic (Stockholm, SE), April 9-10 – Ryvu will deliver a presentation and host scientific and partnering meetings.
- AACR Annual Congress (Chicago, IL), April 25-30: Ryvu will present a scientific update and host scientific and partnering meetings.
- ADC Payload Summit (Boston, MA), May 6-8: Ryvu will deliver a presentation on ADC payloads and host scientific and partnering meetings.
- EHA Annual Congress (Milan, IT), June 12-15: Ryvu will present clinical data updates.
2024 FISCAL YEAR FINANCIAL UPDATE
Cash Position – On December 31, 2024, Ryvu Therapeutics held €52.7 million in cash, cash equivalents, bonds and investment funds, compared to €57.6 million at the end of 2023. On March 9, 2025, Ryvu Therapeutics held €43.7 million in cash, cash equivalents, bonds and investment funds. In addition, the Company has secured approximately €21.8 million in non-dilutive grant funding.
Operating Revenues – In 2024, Ryvu recognized total operating revenues (including grants) of €23.7 million, compared to €15 million in 2023.
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 2024, amounted to €51.1 million, compared to €34.7 million in 2023.
Net Loss Attributable to Common Shareholders – In 2024, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €24.9 million, compared to €18.5 million in 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 and solid tumors. RVU120 is currently in Phase II development (i) as a monotherapy for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS) – the RIVER-52 study, (ii) in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study, (iii) as a monotherapy for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) – the REMARK study, (iv) 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 expected to start a Phase II study in diffuse large B-cell lymphoma (DLBCL) – the JASPIS-01 study in 1Q25. RVU305, a potentially best-in-class 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.
The company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the mWIG40 index.
Contact
Ryvu Therapeutics
Anna Wilk
+48 532 698 425
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Keywords: Ryvu Therapeutics; 2024 fiscal year; Financials; Cash position; Strategic reorganization; Drug discovery; Development; Oncology; Pawel Przewięźlikowski; Clinical pipeline; Preclinical pipeline; Phase II clinical trials; RVU120; CDK8/19 inhibitor; IND/CTA-enabling studies; RVU305; PRMT5 MTA-cooperative inhibitor; Krzysztof Brzózka; Preclinical strategy; Oncology medicines; ONCO Prime platform; Synthetic lethal targets; KRAS-driven tumors; Antibody-drug conjugates (ADCs); Next-generation payloads; Immunocytotoxic mechanisms; Poland; Hematological malignancies; Solid tumors; Acute myeloid leukemia (AML); Myelodysplastic syndromes (MDS); High-risk myelodysplastic syndromes (HR-MDS); Lower-risk myelodysplastic syndromes (LR-MDS); Myelofibrosis (MF); Dapolsertib (MEN1703, SEL24); PIM/FLT3 kinase inhibitor; Diffuse large B-cell lymphoma (DLBCL); Warsaw Stock Exchange
Source: Biotech Newswire