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 43% CR/CRi in VEN-refractory AML and spleen volume reduction in MF.

• RVU305, a best-in-class, brain-penetrant PRMT5 inhibitor, is in IND-enabling studies targeting MTAP-deleted tumors, with strong preclinical efficacy and brain penetration.

• Dapolsertib, a dual PIM/FLT3 inhibitor, is in Phase II for DLBCL in partnership with Menarini, with orphan drug designation and manageable safety profile.

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

• Multiple collaborations with Exelixis and BioNTech validate the discovery platforms and provide significant milestone and royalty potential.

Clinical results and regulatory progress

• Romaciclib demonstrated promising efficacy in VEN-refractory AML, with a 43% CR/CRi rate in a dose optimization cohort and a favorable safety profile with limited cytopenias.

• FDA Type C meeting in January 2026 provided guidance for U.S. expansion at 150 mg QD, with protocol updates and IND submission planned.

• Next pivotal studies for romaciclib in AML and MF are set to initiate in 2026, aiming for potential approval as early as 2028.

• Phase I study of romaciclib in pediatric medulloblastoma is set to start in 2026, fully funded by a €8.1M grant.

Market opportunity and financials

• AML and MF represent high unmet needs, with global AML market projected to grow from $3.2B in 2022 to $6.6B in 2031, and MF from $2.3B to $2.9B.

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

• Q1 2026 revenues were €5.1M, with a cash position of €17.6M as of May 2026 and €20.6M in non-dilutive grant funding secured.

• Key partnerships with BioNTech and Menarini contributed to partnering revenues and future milestone opportunities.