Ryvu Therapeutics Q1 2024 Financial Results and Corporate Update

In the first quarter of 2024, Ryvu Therapeutics reported significant progress in its clinical and financial performance. Total operating revenues reached $6.4 million, up from $4.3 million in the same period last year. As of May 9, 2024, the company held a cash position of $59.0 million, which includes the first tranche of €8 million in venture debt from the European Investment Bank (EIB) obtained in March. This financial standing ensures operational funding through the first quarter of 2026.

One of Ryvu’s major advancements is the initiation of two Phase II studies for their drug candidate RVU120. These studies target patients with relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS). Updated clinical data from these trials will be presented at the upcoming 2024 European Hematology Association (EHA) Congress. In addition, a webinar focusing on RVU120's potential in treating myelofibrosis (MF) is scheduled for May 17.

In February 2024, Ryvu achieved the second milestone under its license agreement with Exelixis, earning $2.0 million. Following that, in March, the company announced it would receive approximately $6.6 million in grant funding over the next five years from the Polish Agency for Enterprise Development (PARP) to support its ONCO Prime discovery platform.

CEO Pawel Przewiezlikowski highlighted Ryvu's rapid progress in both clinical and preclinical programs. RVU120, now in Phase II, is a notable achievement, and the company plans to enroll approximately 100 patients across all Phase II studies by the end of 2024. Ryvu is well-prepared for future milestones with secured funding and potential non-dilutive capital sources.

In early 2024, Ryvu launched two Phase II studies with RVU120: the RIVER-52 study, which investigates RVU120 as a monotherapy in patients with r/r AML or HR-MDS, and the RIVER-81 study, which looks at RVU120 in combination with venetoclax for AML patients. Additionally, the POTAMI-61 Phase II study, evaluating RVU120 in patients with myelofibrosis (MF), is set to begin in the third quarter of 2024. The REMARK study, focusing on low-risk myelodysplastic syndromes (LR-MDS), is expected to start in mid-2024.

At the 2024 American Association for Cancer Research (AACR) Annual Meeting, Ryvu presented preclinical data demonstrating the efficacy of its PRMT5 inhibitors, which show a strong antiproliferative effect on MTAP-deleted cell lines. The WRN inhibitor program also showed promising results, providing a new targeted oncological therapy. RVU120 has shown effectiveness both as a monotherapy and in combination with ruxolitinib in preclinical models of myeloproliferative neoplasms (MPN), including myelofibrosis (MF) and polycythemia vera.

Ryvu plans to present more data at various industry events in the coming months, including the 10th Annual Oncology Innovation Forum in Chicago, the Pekao I Technology & Consumer Conference in Warsaw, and the Erste | CEE Consumer & Technology Conference in Warsaw. The company will also showcase its findings at the EHA Congress in Madrid, where it will present updated data from the Phase Ib trial of RVU120, preclinical data on its combination with venetoclax, and in vivo data supporting CDK8 inhibition as a therapeutic strategy for myeloproliferative neoplasms.

Financially, Ryvu ended Q1 2024 with $62.7 million in cash, cash equivalents, and bonds, down slightly from $63.7 million at the end of 2023. Operating costs, mainly related to research and development, were $11.7 million, compared to $7.5 million in the previous year. The net loss attributable to common shareholders was $4.6 million, up from $3.3 million in Q1 2023.

Ryvu Therapeutics, founded in 2007 and headquartered in Kraków, Poland, is dedicated to developing novel small-molecule therapies targeting cancer. The company’s leading programs include RVU120, a selective CDK8/CDK19 kinase inhibitor, and SEL24 (MEN1703), a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group. Ryvu has established multiple partnerships with global companies, including BioNTech and Exelixis, and is listed on the Warsaw Stock Exchange as part of the mWIG40 index.