Ryvu Therapeutics (RVU) Corporate Presentation summary

Company overview

• Ryvu Therapeutics develops small molecule therapies targeting high-value, emerging pathways in oncology, with a focus on first-in-class clinical candidates and a fully integrated R&D organization.

• The company is listed on the Warsaw Stock Exchange (WSE: RVU), employs over 320 people (including ~100 PhDs), and operates a state-of-the-art 108,000 sq ft facility.

• Leadership team and supervisory board have a strong track record in clinical development and value creation, with experience from leading biotech and pharma companies.

Clinical pipeline and programs

• RVU120, a wholly owned oral CDK8/19 inhibitor, is in multiple Phase II studies for AML, HR-MDS, LR-MDS, and myelofibrosis, with potential for three accelerated approvals by 2026-2027.

• MEN1703 (SEL24), a dual PIM/FLT3 inhibitor partnered with Menarini, is in Phase II for hematologic malignancies, with a new study in DLBCL to start in Q4 2024.

• Discovery and preclinical pipeline includes RVU305 (PRMT5 inhibitor) advancing to IND in H2 2025, a WRN inhibitor program, and novel synthetic lethality targets.

• Immuno-oncology collaborations include a multi-target partnership and STING agonist license with BioNTech, and a STING ADC collaboration with Exelixis.

RVU120 clinical development highlights

• RVU120 shows clinical benefit in heavily pretreated AML and HR-MDS patients, especially those with NPM1 and DNMT3A mutations; favorable safety profile at 250 mg dose.

• Phase II studies (RIVER-52, RIVER-81, POTAMI-61, REMARK) are ongoing globally, targeting AML, HR-MDS, LR-MDS, and MF, with interim data expected throughout 2024 and 2025.

• RIVER-81 combines RVU120 with venetoclax in relapsed/refractory AML, supported by €13.3M Polish grant; initial safety confirmed, with preclinical synergy demonstrated.

• RVU120 also being evaluated in myelofibrosis (POTAMI-61) and low-risk MDS (REMARK), with preclinical data supporting efficacy and safety in these indications.