Ryvu Therapeutics (RVU) Corporate presentation summary

Pipeline and clinical development

• Lead asset romaciclib (RVU120), a first-in-class oral CDK8/19 inhibitor, is in Phase II for AML and myelofibrosis, showing promising efficacy and safety, including a 43% CR/CRi rate in VEN-refractory AML and spleen volume reductions in MF.

• RVU305, a best-in-class, brain-penetrant PRMT5 inhibitor, is advancing toward IND-enabling studies, demonstrating superior preclinical efficacy in MTAP-deleted cancers.

• Dapolsertib, a dual PIM/FLT3 inhibitor, is in Phase II for DLBCL in partnership with Menarini, with ongoing translational work for other hematologic indications.

• ONCO Prime platform is generating novel precision oncology targets, including synthetic lethal targets, with initial data in colorectal cancer.

• ADC programs focus on novel payloads, including immunocytotoxic and STING-activating ADCs, with collaborations with Exelixis and BioNTech.

Clinical results and regulatory progress

• Romaciclib demonstrated the ability to overcome VEN resistance in AML, with a favorable safety profile and no significant exacerbation of cytopenias.

• In MF, romaciclib showed clinically meaningful spleen volume reductions and symptom improvements, especially in patients with high-risk mutations.

• FDA Type C meeting in January 2026 provided guidance for U.S. expansion of romaciclib trials; pivotal studies in AML and MF are planned for 2026.

• Medulloblastoma Phase I study in children is set to start in 2026, fully funded by a Polish grant.

Market opportunity and financials

• High unmet need in AML and MF, with global AML and MF markets projected to reach $6.6B and $2.9B by 2031, respectively.

• Romaciclib could set a new standard of care in post-VEN AML and post-JAKI MF, with potential for accelerated approval.

• 2025 revenues were €20.7M, with a cash position of €20.7M as of March 2026 and €20.9M in non-dilutive grant funding.

• Key partnerships with BioNTech, Exelixis, and Menarini provide significant milestone and royalty potential.