Ryvu Therapeutics Releases 2024 Mid-Year Financials and Corporate Update

Ryvu Therapeutics, a clinical-stage company focused on novel small molecule therapies in oncology, reported its financial results for the first half of 2024 and provided a corporate update.

In the first half of 2024, total operating revenues for Ryvu amounted to USD 12.1 million, reflecting an increase of USD 4.2 million from the same period in 2023. As of September 5, 2024, the company's cash position stood at USD 65.3 million, ensuring a financial runway through the first quarter of 2026. Additionally, Ryvu received the final EUR 6 million tranche of financing from the European Investment Bank on September 5, 2024, further bolstering their financial resources.

The company announced significant progress in its RVU120 clinical development plan. Two Phase II studies for RVU120, RIVER-52 and RIVER-81, were launched in early 2024. The RIVER-52 study is focused on RVU120 as a monotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (HR-MDS), while RIVER-81 investigates RVU120 in combination with venetoclax for patients with AML. By the end of August, 16 sites in Poland and Italy had been activated for the RIVER-52 study, with additional sites planned in Spain, France, and Canada. For the RIVER-81 study, 27 sites were activated across Poland, Italy, Spain, and France, with a target of 34 sites by the year's end.

Enrollment for the POTAMI-61 Phase II study, evaluating RVU120 in myelofibrosis (MF) patients, is expected to begin soon, initially in Poland and Italy. Another Phase II study, REMARK, targeting low-risk myelodysplastic syndromes (LR-MDS), will enroll patients across five countries and will be conducted through the EMSCO network.

At the 2024 European Hematology Association (EHA) Congress in Madrid, Ryvu presented both clinical and preclinical data for RVU120. Preliminary data from the RIVER-52 study showed early signs of clinical benefit. The RIVER-81 study demonstrated the safety of combining RVU120 with venetoclax, indicating potential synergy and the ability of RVU120 to overcome resistance to venetoclax in AML patients. Further translational data highlighted RVU120's potential in myeloproliferative neoplasms (MPNs), including its beneficial effects when combined with JAK inhibitors and the BET inhibitor pelabresib.

In the preclinical pipeline, Ryvu's PRMT5 inhibitor, RVU305, was advanced to further preclinical development steps, including toxicology and manufacturing processes, with an IND/CTA filing target in the second half of 2025. RVU305 has shown strong antiproliferative effects on MTAP-deleted cell lines and a favorable safety profile.

The WRN inhibitor program also made strides, demonstrating target engagement and potent synthetic lethal effects, with promising tumor growth inhibition in preclinical studies. Ryvu aims to select a preclinical candidate in the coming quarters.

From March to September 2024, Ryvu secured all three tranches of financing from the EIB, amounting to EUR 22 million. In June 2024, a funding agreement with the Polish Agency for Enterprise Development was concluded, securing approximately USD 6.6 million in grant funding over five years to support the ONCO Prime discovery platform. Ryvu also became an Associate Partner in the IPCEI Med4Cure program with its PANACEA-NOVO project, which seeks to discover new therapeutic targets for rare cancers.

Ryvu achieved a milestone under a license agreement with Exelixis in February 2024, receiving a USD 2.0 million payment.

Financially, as of June 30, 2024, Ryvu held USD 63.9 million in cash and equivalents. Operating costs for the first half of 2024 were USD 25.4 million, primarily attributed to R&D expenditures. The net loss for common shareholders, excluding non-cash costs, was USD 11.9 million.

Founded in 2007 and headquartered in Kraków, Poland, Ryvu Therapeutics continues to focus on developing novel small-molecule therapies in oncology, with its advanced programs targeting various hematological malignancies and solid tumors.