Ryvu Therapeutics Announces Q3 2024 Financials and Corporate Update

Ryvu Therapeutics, a clinical-stage drug discovery and development company in Krakow, Poland, recently shared its financial outcomes for the third quarter of 2024 and provided updates on their ongoing projects, particularly focusing on RVU120, a selective CDK8/CDK19 kinase inhibitor.

In the initial nine months of 2024, Ryvu reported total operating revenues, including grants, of USD 18.6 million. This marks a notable increase from their USD 11.9 million revenue in the same period of 2023. The company has also accelerated patient enrollment for its Phase II clinical studies of RVU120, mainly due to an increase in the number of active clinical sites. By October 31, 2024, Ryvu had activated 33 sites across several countries for the RIVER-52 study and another set of 33 sites for the RIVER-81 study.

Pawel Przewiezlikowski, CEO of Ryvu Therapeutics, acknowledged the significant progress in the RVU120 Phase II studies. He highlighted that the activation of multiple new sites in the RIVER-52 and RIVER-81 studies for patients with relapsed or refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS), along with the launch of the REMARK study for low-risk myelodysplastic syndromes (LR-MDS), has led to accelerated enrollment. The company is also preparing to launch a fourth study, POTAMI-61, targeting myelofibrosis patients.

The REMARK study, initiated in September, focuses on assessing the efficacy of RVU120 as a monotherapy for LR-MDS patients. This study is being conducted across five countries and aims to activate approximately 25 clinical sites. Similarly, the POTAMI-61 study, another Phase II investigation of RVU120, will explore both monotherapy and combination therapy for myelofibrosis, with plans to activate 18 sites in Poland and Italy by the end of 2024.

In October 2024, Ryvu presented clinical and preclinical data at the EORTC-NCI-AACR Symposium in Barcelona. This included advancements in their RVU305 program, an MTA-cooperative PRMT5 inhibitor, and progress in their ONCO Prime discovery platform aimed at identifying novel synthetic lethal inhibitors. Additionally, Ryvu is developing WRN helicase inhibitors, showing significant potential in treating tumors with high microsatellite instability (MSI-H).

Financially, Ryvu's cash position was USD 58.1 million as of November 4, 2024, providing a financial runway through the first quarter of 2026. Over the first three quarters of 2024, the company's operating costs, largely driven by research and development expenditures, amounted to USD 38.2 million, up from USD 27.4 million during the same period in 2023. The net loss attributable to common shareholders for this period was USD 18.5 million, compared to USD 13.5 million in the previous year.

The company has also engaged in various business activities, including a collaboration with nCage Therapeutics to develop a next-generation antibody-drug conjugate platform and an operational agreement for the MEN1703 (SEL24) Phase II clinical trial in diffuse large B-cell lymphoma (DLBCL), known as the JASPIS-01 study. Ryvu fulfilled conditions for the disbursement of all three tranches of financing from the European Investment Bank (EIB), totaling EUR 22 million. Furthermore, Ryvu secured a funding agreement with the Polish Agency for Enterprise Development (PARP) for approximately USD 6.6 million in grant funding over five years.

In conclusion, Ryvu Therapeutics continues to advance its pipeline with significant progress in its RVU120 Phase II studies and other research initiatives. The company remains focused on developing innovative therapies to address unmet needs in oncology, supported by its strong financial position and strategic collaborations.