Ryvu Therapeutics Sa · GPW:RVU
Ryvu Therapeutics Sa — Investor Presentation (June 2025)
49 slides from Ryvu Therapeutics Sa's investor presentation, June 2025
Slide 1: Corporate Presentation June 2025
Developing therapeutics at the forefront of oncology Corporate Presentation June 2025
Slide 2: Note on the presentation and forward-looking statements
Note on the presentation and forward-looking statements This document does not constitute a public offering in the meaning of the Regulation (EU) 2017/1129 of the European Parliament and of the Council, or any other offer or invitation to acquire any Company's securities, nor the incentive to subm
Slide 3: Ryvu is developing novel therapies to address high-value emerging targets in oncology
Ryvu is developing novel therapies to address high-value emerging targets in oncology Clinical and Prelinical Candidate Pipeline Novel Multi-Target Discovery RVU120 • First-in-class, oral CDK8/19 inhibitor • Phase II studies are ongoing in AML, MF, and LR- ONCO Prime Platform • Multiple novel prec
Slide 4: Team with a strong track record of clinical development and shareholder value creation
Team with a strong track record of clinical development and shareholder value creation Pawel Przewięźlikowski, MSc, MBA Krzysztof Brzózka, PhD, MBA Hendrik Nogai, MD Kamil Sitarz, PhD, MBA CEO and Founder CSO CMO COO Vatnak Vat-Ho, MBA Jakub Janowski, MSc Justyna Żółtek, MSc Bartłomiej Konicki, MSc
Slide 5: Broad pipeline addressing emerging targets in oncology
Broad pipeline addressing emerging targets in oncology EXPECTED PROGRAM INDICATION DISCOVERY PRECLINICAL PHASE I PHASE II PARTNER MILESTONES R/R AML Updated Ph II data RIVER-81 (combo with venetoclax) in 2Q25 Q R/R AML/HR-MDS RIVER-52 Updated Ph II data (monotherapy) (enrollment suspended) in 2Q25 R
Slide 6: RVU120: First-in-Class CDK8/19 Inhibitor in Hematologic Malignancies
RVU120: First-in-Class CDK8/19 Inhibitor in Hematologic Malignancies
Slide 7: RVU120 is a clinical-stage, first-in-class, small molecule CDK8/19 kinase inhibitor
RVU120 is a clinical-stage, first-in-class, small molecule CDK8/19 kinase inhibitor developed and fully-owned by Ryvu high selectivity 1 low risk of DDI (esp antifungals) easy to formulate orally bioavailable favorable safety profile RVU120 is an innovative dual CDK8/19 inhibitor designed to target
Slide 8: RVU120: opportunities across a broad range of cancers
RVU120: opportunities across a broad range of cancers Blood Cancers & Disorders Solid Tumors Medulloblastoma AML Low-risk MDS ACC Myelofibrosis (MF) Breast High-risk MDS MDS/MPN overlap syndrome Sarcoma NHL Diamond-Blackfan Anemia • Signs of clinical activity in AML ▪ Translational evidence in multi
Slide 9: RVU120 Diversified clinical development plan with high commercial potential
RVU120 Diversified clinical development plan with high commercial potential 2025 2026 2027 2028 Beyond 2028 I II III IV I II III IV I II III IV I II III IV Phase II studies in hematologic malignancies • RIVER-81: AML, combination with venetoclax Exploratory part Confirmatory part Phase III (potentia
Slide 10: RIVER-81 in VEN-refractory patients with AML
Phase II study testing RVU120 in combination with venetoclax RIVER-81 in VEN-refractory patients with AML STUDY DESIGN • Primary endpoints: ― Rate of CR, CRi, CRh, with and without MRD, and DoR RVU120 + • Secondary endpoints: Transfusion independence, PFS, RFS, OS RIVER-81 is supported venetoclax •
Slide 11: RIVER-81 providing rationale for a Phase II study in venetoclax refractory patients
Strong nonclinical evidence for synergy between RVU120 and venetoclax RIVER-81 providing rationale for a Phase II study in venetoclax refractory patients RVU120+VEN significantly decreases the proportion RVU120+VEN suppresses pathways of leukemia-initiating cells (LICs) while showing previously iden
Slide 12: RIVER-81: 7 of 27 evaluable patients with CR/CRi across cohorts
RIVER-81 7 of 27 evaluable patients with CR/CRi across cohorts Data Cut-off: May 14, 2025 Preliminary data All responders progressed on prior VEN+HMA therapy, which makes activity of VEN alone very unlikely. Therefore, the observed benefit must be attributed to the combination of RVU120 + VEN. 3/13
Slide 13: RIVER-81 and longer durability of responses
RVU120 administered QD associated with higher CR/CRi rate RIVER-81 and longer durability of responses Data Cut-off: May 14, 2025 Preliminary data Part 1 Part 1 Part 1 Part 2 Part 1 Part 1 Cohort 1 Cohort 2 Cohort 3 Stage 1 Cohort 4 Cohort 6 Treatment schedule RVU120 125mg QOD RVU120 250mg QOD RVU120
Slide 14: RIVER-81 Favorable safety profile confirmed
RIVER-81 Favorable safety profile confirmed Data Cut-off: May 14, 2025 Preliminary data TEAEs N (%) All grades Grade 1 & 2 Grade 3 & 4 Nausea 23 (53%) 19 (44%) 4 (9%) RVU120 in combination with VEN is safe and tolerated in patients with VEN-failed AML Vomiting 19 (44%) 18 (42%) 1 (2%) • No DLTs and
Slide 15: POTAMI-61 Phase II study of RVU120 in myelofibrosis as mono and combo
POTAMI-61 Phase II study of RVU120 in myelofibrosis (MF) as mono and combo – enrollment in exploratory part completed in May 2025 STUDY DESIGN • Population: • Primary or secondary MF; intermediate or high-risk MF per DIPSS; Cohort 1) previously treated with or ineligible for JAK inhibitor and Cohort
Slide 16: POTAMI-61 RVU120 validated preclinically as a drug candidate in MF
POTAMI-61 RVU120 validated preclinically as a drug candidate in MF Mechanism of RVU120 RVU120 reduces Opportunity in myelofibrosis in MF splenomegaly RVU120 as a monotherapy and in combination • Growing market with many patients undiagnosed or not treated with ruxolitinib reduces splenomegaly due to
Slide 17: POTAMI-61 Phase II study of RVU120 in myelofibrosis (MF)
POTAMI-61 Phase II study of RVU120 in myelofibrosis (MF) Data Cut-off: May 14, 2025 First data shows early signs of clinical activity at 12 weeks Evaluation time for primary endpoint: 24 weeks Median time on treatment: 10 weeks Early readout at 12 weeks Some patients showed signs of RVU120 clinical
Slide 18: REMARK RVU120 in LR-MDS: enrollment in the study has been completed
REMARK RVU120 in LR-MDS: enrollment in the study has been completed STUDY DESIGN PHASE II • Population: • Patients with relapsed/refractory LR-MDS EXPLORATORY • Primary endpoint: • Erythroid response (HI-E) according to IWG 2018 criteria RVU120 AS A SINGLE AGENT after 8 cycles of treatment Patients
Slide 19: REMARK RVU120 validated preclinically as a drug candidate in LR-MDS
REMARK RVU120 validated preclinically as a drug candidate in LR-MDS Opportunity in LR-MDS Mechanism of RVU120 in LR-MDS • Unmet medical need remains in low-risk MDS (LR-MDS) after failure of available therapies • Transfusion burden remains high, resulting a poor quality of life Rationale for RVU120
Slide 20: RIVER-52 Phase II study with RVU120 as a single agent in AML/HR-MDS
RIVER-52 Phase II study with RVU120 as a single agent in AML/HR-MDS STUDY DESIGN • Primary endpoints: ― Rate of CR, CRh, CRi, with and without MRD, and DoR RVU120 • Secondary endpoints: ― Transfusion independence, Progression-free survival, Relapse-free survival (RFS), Overall survival monotherapy •
Slide 21: RVU120 Market potential in hematological malignancies
RVU120 Market potential in hematological malignancies AML (Acute Myeloid Leukemia) MF (Myelofibrosis) MDS (Myelodysplastic Syndrome) • The most common, highly aggressive type • MF is a bone marrow disease characterized • Disease leading to bone marrow damage, of acute leukemia occurring in adults; b
Slide 22: RVU120 Phase II clinical development with a global footprint
RVU120 Phase II clinical development with a global footprint Global site locations and patient population Global CROs and clinical vendors Planned locations for RVU120 Ph II studies: Part 1: exploratory data Regulatory authorities Part 2: expansion worldwide Expected status by June 30, 2025 Number o
Slide 23: RVU120 program on track with next efficacy readouts in Q4 2025
RVU120 program on track with next efficacy readouts in Q4 2025 RVU120 After more than 150 patients have been dosed across all Phase II studies, data are now maturing RVU120 program summary RIVER-81 Next data in Q4 2025 • Enrollment in Phase II exploratory parts mostly completed • Safety profile conf
Slide 24: Dapolsertib (MEN1703, SEL24) First-in-Class PIM/FLT3 Inhibitor
Dapolsertib (MEN1703, SEL24) First-in-Class PIM/FLT3 Inhibitor
Slide 25: Dapolsertib JASPIS-01 Phase II clinical study in DLBCL
Dapolsertib (MEN1703, SEL24) JASPIS-01 Phase II clinical study in DLBCL DLBCL PARTNERSHIP AGREEMENT PROVEN SAFETY WITH MENARINI GROUP AND CLINICAL ACTIVITY • Development continues with the initiation of a new Phase II study in relapsed/refractory diffuse large B-cell (2017) lymphoma (DLBCL) Future O
Slide 26: Phase II in DLBCL
Phase II in DLBCL DAPOLSERTIB PROFILE • First-in-class dual PIM/FLT3 inhibitor with a unique mechanism of action • Differentiated activity in cellular models compared to selective PIM inhibitors (broader activity profile) CLINICAL STUDIES TO DATE • H1 2017- H1 2021 Phase I dose escalation and cohort
Slide 27: RVU305: MTA-cooperative PRMT5 inhibitor
RVU305: MTA-cooperative PRMT5 inhibitor • Best-in-class potency and selectivity • Brain-penetrant
Slide 28: RVU305: Best-in-class PRMT5 MTA-cooperative inhibitor in IND-enabling studies
RVU305: Best-in-class PRMT5 MTA-cooperative inhibitor in IND-enabling studies RVU305/PRMT5i RVU305 has best-in-class potential based on robust multiparameter optimization PRMT5 MTA-cooperative inhibitors • Antiproliferative activity: demonstrated in MTAP- KEY RATIONALE exert synthetic lethal phenot
Slide 29: RVU305 shows superiority in multiple cell lines
RVU305 shows superiority in multiple cell lines Analysis of pancreatic, lung and bladder cancer origin cell lines shows RVU305 superiority over MRTX1719 • Panel of MTAP-deleted and MTAP-wt cells was profiled with RVU305 in a 5-day CellTiter-Glo assay • A differential response to Ryvu PRMT5 MTA-coope
Slide 30: RVU305 shows significant antitumor efficacy in vivo
RVU305 shows significant antitumor efficacy in vivo Strong antitumor efficacy Complete responses demonstrated in vivo: favorable vs. MRTX1719 DoHH2 MTAP-deleted model (DLBCL) Tumor volume Tumor volume Tumor volume 4096 Individual tumor volume [mm3] 4096 RVU305, 150 mg/kg PO QD Individual tumor volum
Slide 31: RVU305 is CNS-penetrant PRMT5 inhibitor with predicted efficacious exposure in the brain
RVU305 is CNS-penetrant PRMT5 inhibitor with predicted efficacious exposure in the brain RVU305 shows optimal systemic target coverage and RVU305 exhibits high potency and efficacy excellent brain penetration against CNS cell lines Predicted free RVU305 exposure in projected human escalation phases
Slide 32: RVU305 has a potentially best-in-class profile
RVU305 has a potentially best-in-class profile • RVU305 is brain-penetrant and shows better target coverage in brain compared to AMG193 MRTX1719/ TNG462 TNG456 AMG193 RVU305 BMS-986504 • RVU305 has better selectivity Potency* +++ +++ ++ ++ +++ in MTAP-deleted vs WT cells compared to MRTX1719/ Brain
Slide 33: Early pipeline Dual-pronged strategy with potential to generate multiple oncology medicines
Early pipeline Dual-pronged strategy with potential to generate multiple oncology medicines Novel precision oncology Next-generation ONCO Prime ADCs drug discovery platform novel ADC payloads Broad potential to discover novel precision oncology targets, Potential to improve efficacy, safety and comb
Slide 34: ONCO Prime: Novel Precision Oncology
ONCO Prime: Novel Precision Oncology Multi-asset platform generating first-in-class therapeutics
Slide 35: Driving novel precision oncology drug discovery with Ryvu's ONCO Prime platform
Driving novel precision oncology drug discovery with Ryvu’s ONCO Prime platform Discovering Novel Precision Oncology Ryvu’s CRISPR-based target Discovery Platform Targets, including Synthetic Lethal Targets Engineered Model Patient-Derived Cells (PDCs) Synthetic Common Engineered Lethal APC KRAS TP5
Slide 36: Initial ONCO Prime data presented in CRC; broad applicability across oncology
Initial ONCO Prime data presented in CRC; broad applicability across oncology • The third most prevalent cancer worldwide • Estimated number of colorectal cancers in the US for 2024 are 153,000 new cases1 CRC • Diagnosed usually at an advanced stage. Mortality still remains high. Five-year survival
Slide 37: ONCO Prime is accelerating the development of novel precision medicine targets
ONCO Prime is accelerating the development of novel precision medicine targets, including synthetic lethal targets Modeling cancer progression High Throughput Screenings Novel Targets & Treatments APC KRAS TP53 SMAD4 Patient-derived material Ryvu’s OncoPrime platform has broad potential to discover
Slide 38: ADCs with Novel Payloads
ADCs with Novel Payloads Generating multiple first-in-class therapeutics
Slide 39: Novel payloads have the potential to improve efficacy and safety in next generation ADCs
Novel payloads have the potential to improve efficacy and safety in next generation ADCs Approved ADCs use three main types of payloads Novel payloads have the potential to improve on… Efficacy: overcome resistance to existing payloads and potentially improve on potency Safety: expand the safety win
Slide 40: ADCs Ryvu's payload strategy is focused on novel and potent mechanisms
ADCs Ryvu’s payload strategy is focused on novel and potent mechanisms PAYLOAD CLASSES IMMUNOMODULATORY SYNTHETICALLY LETHAL/ IMMUNOCYTOTOXIC POTENT CYTOTOXINS PAYLOADS PRECISION PAYLOADS PAYLOADS Traditional approach A newer approach Innovative approach Innovative approach Established cytotoxics •
Slide 41: Ryvu has shortlisted several immunocytotoxic payloads to advance
Ryvu has shortlisted several immunocytotoxic payloads to advance Based on initial screens at Ryvu, several targets have been selected as promising immunocytotoxic payloads. Some blinded examples are presented below. Low nM PoC as Single agent Pantoxic IO combo Target Drug name inhibitors ADC Type of
Slide 42: STING agonists licensed to Exelixis for ADCs
Ryvu has already developed a portfolio of immunostimulatory payloads: STING agonists licensed to Exelixis for ADCs 1 Building STING-based antibody drug conjugates (ADCs) 2 Leveraging Ryvu’s STING agonist portfolio and Exelixis’s ADC technology Partnership Key Financial Terms • Exclusive license agre
Slide 43: STING activating Antibody-Drug Conjugates
STING activating Antibody-Drug Conjugates STING activating Antibody-Drug Conjugates • Proprietary STING agonist chemotype • ADC development expertise • Localised immune response after systemic • Small-molecule, non-CDN structures • Antibodies against cancer-relevant administration antigens STING • I
Slide 44: BioNTech and Ryvu: global collaboration to develop immune modulation small molecules
BioNTech and Ryvu: global collaboration to develop and commercialize immune modulation small molecule candidates Largest-ever Ryvu deal: November 2022 Partnership Key Financial Terms • Multi-target research collaboration: Ryvu is conducting discovery • Ryvu received €40 million from BioNTech, and re
Slide 45: Corporate Progress
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Slide 46: Financial Results: Q1 YTD 2025
Financial Results: Q1 YTD 2025 Q1 YTD Q1 YTD € million 2024* 2024* 2025* Cash position as of May 19, 2025 Revenues 23.7 5.9 5.0 Partnering Grants 18.1 5.6 5.0 0.9 4.0 1.0 €37.6M (PLN 161.1M) In addition, the company has secured approximately Total Costs** 51.0 10.8 11.4 €19.8M (PLN 84.8M) in non-dil
Slide 47: Ryvu's Vision remains unchanged: key goals 2025
Ryvu’s Vision remains unchanged: from 2026, Ryvu will improve the lives of cancer patients worldwide 2025 / KEY GOALS AND FINANCING RVU120 PROGRESS SUMMARY • RVU120 broad development • Enrollment in Phase II exploratory parts mostly completed (including potential fast-to-market strategy in AML/LR-MD
Slide 48: Ryvu equity summary
Ryvu equity summary Top Holders3 IPO on WSE Nov 2014 1 Paweł Przewięźlikowski 17.2% Corporate Split: Selvita and Ryvu Oct 2019 2 OFE Allianz Polska 9.2% 3 BioNTech SE 8.3% Ticker: WSE RVU 4 OFE Nationale Nederlanden 6.0% 52-Week Range1 PLN 17.62 – 55.20 5.9% 5 Tadeusz Wesołowski z Augebit FIZ Averag
Slide 49: Thank you
Thank you CONTACT DATA: Ryvu Therapeutics S.A. www.ryvu.com ryvu@ryvu.com ir@ryvu.com
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