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Ryvu Therapeutics Accelerates RVU120 Clinical Trials and Reports Q3 2024 Financial Results

• Ryvu Therapeutics reported USD 18.6 million in operating revenues for Q1-Q3 2024, compared to USD 11.9 million in the same period last year, driven by pipeline advancements. • Enrollment in RVU120 Phase II studies (RIVER-52, RIVER-81, REMARK) has accelerated due to increased clinical site activation, with 66 sites active as of October 31. • The company plans to present RVU120 Phase II data at an investor event on December 12 and is preparing to launch a Phase II study of MEN1703 (SEL24) in DLBCL. • Ryvu's cash position stands at USD 58.1 million as of November 4, providing a financial runway through Q1 2026, supported by secured funding sources.

Ryvu Therapeutics (WSE: RVU) announced its Q3 2024 financial results and provided a corporate update, highlighting significant progress in its RVU120 clinical trials and advancements in its broader oncology pipeline. The company is focused on developing novel small molecule therapies targeting emerging oncology targets.

RVU120 Clinical Trial Updates

Patient enrollment in the RVU120 Phase II clinical studies, including RIVER-81 and RIVER-52, has accelerated, attributed to a substantial increase in activated clinical sites. As of October 31, 66 sites were active, and further growth is anticipated by year-end. These studies are evaluating RVU120 in patients with relapsed or refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS).
"We have significantly accelerated enrollment in RVU120 Phase II studies since September thanks to the activation of numerous new sites in the RIVER-52 and RIVER-81 studies for patients with r/r AML and HR-MDS and the launch of the REMARK study for patients with LR-MDS," said Pawel Przewiezlikowski, CEO of Ryvu Therapeutics. The company is also preparing to launch the POTAMI-61 study, a Phase II trial focusing on patients with myelofibrosis.

Pipeline Advancements

Ryvu is advancing its pipeline with several key developments:
  • RIVER-52 and RIVER-81 Studies: These Phase II studies are investigating RVU120 as a monotherapy and in combination with venetoclax for r/r AML and HR-MDS. RIVER-52 has expanded to sites in Spain, France, and Canada.
  • REMARK Study: This Phase II study is evaluating RVU120 as a monotherapy for low-risk myelodysplastic syndromes (LR-MDS) and has commenced enrollment across multiple European countries.
  • POTAMI-61 Study: This Phase II study will investigate RVU120 as a monotherapy and in combination therapy for myelofibrosis (MF).
  • RVU305 (PRMT5 inhibitor): Ryvu is advancing its potentially best-in-class MTA-cooperative PRMT5 inhibitor, RVU305, towards IND/CTA filing in H2 2025.

Financial Highlights

Ryvu reported total operating revenues of USD 18.6 million for Q1-Q3 2024, compared to USD 11.9 million for the same period in 2023. As of November 4, 2024, the company's cash position was USD 58.1 million, providing a runway through Q1 2026.

Upcoming Events

Ryvu will host an investor event on December 12 to discuss the progress and data update of the RVU120 Phase II studies. The company is also preparing to launch JASPIS-01, a Phase II study of MEN1703 (SEL24) in patients with diffuse large B-cell lymphoma (DLBCL).
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[1]
Ryvu Therapeutics Reports 2024 Q3 Financial Results and Provides Corporate Update
markets.ft.com · Nov 7, 2024

Ryvu Therapeutics reports Q1-Q3 2024 operating revenues of USD 18.6 million, with accelerated RVU120 Phase II study enro...

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