Ryvu Therapeutics (RVU) Corporate presentation summary

Strategic focus and pipeline overview

• Advancing first-in-class oncology therapeutics, with romaciclib (CDK8/19 inhibitor) as the lead asset targeting high unmet needs in AML and myelofibrosis, and a robust pipeline including RVU305 (PRMT5 inhibitor) and novel ADC payloads.

• End-to-end R&D capabilities in a state-of-the-art Krakow facility, with global clinical reach and collaborations with leading institutions and pharma partners.

• Multiple programs in clinical and preclinical stages, addressing emerging oncology targets and leveraging precision medicine and immune modulation strategies.

Romaciclib clinical progress and data

• Demonstrated efficacy in post-venetoclax AML, with dose expansion data expected in 2026 to support accelerated development and potential fast-track approval.

• RIVER-81 Phase II study in VEN-refractory AML showed up to 43% CR/CRi rate in dose optimization cohort, with favorable safety and limited cytopenias.

• FDA Type C meeting in January 2026 provided guidance for US expansion, with updated IND submission and patient enrollment planned.

• In myelofibrosis, romaciclib showed clinically meaningful spleen volume reductions and symptom improvements, especially in patients with ASXL1/CALR mutations.

Pipeline innovation and discovery platforms

• RVU305, a best-in-class PRMT5 inhibitor, demonstrated strong preclinical efficacy, brain penetration, and selectivity for MTAP-deleted cancers.

• ONCO Prime platform enables discovery of novel precision oncology and synthetic lethal targets, with initial data in colorectal cancer and broad applicability.

• Novel ADC payloads, including immunomodulatory and immunocytotoxic classes, are being developed to improve efficacy, safety, and combinability.

• STING-activating ADCs in collaboration with Exelixis show robust in vitro and in vivo activity, aiming for localized immune response and improved tolerability.