IDEAYA Biosciences, Inc. · NASDAQ:IDYA
IDEAYA Biosciences — Investor Presentation (February 2025)
38 slides from IDEAYA Biosciences's investor presentation, Feb 18, 2025
Slide 1: IDEAYA Biosciences
February 2025 NASDAQ: IDYA IDEAYA Biosciences Improving Lives Through Transformative Precision Medicines
Slide 2: Safe Harbor Statement
Safe Harbor Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future financial performance of IDEAYA Biosciences, Inc. (the “Company”) and involve known and unknown risks, uncertainti
Slide 3: IDEAYA Biosciences Highlights
IDEAYA Biosciences Highlights Leading Precision Medicine Oncology Biotechnology Company Advancing Potential First-in-Class Therapies Target Milestone Guidance on Broad Pipeline of 6 Clinical & 3 Preclinical (IND-enabling) Programs: PHASE 2/3 PHASE 1/2 PRECLINICAL DAROVASERTIB (PKC) IDE397 (MAT2A) ID
Slide 4: IDEAYA Precision Medicine Oncology Platform
IDEAYA Precision Medicine Oncology Platform Fully-Integrated Target, Biomarker, Drug Discovery and Translational Capabilities Translational Research and Opportunity Expansion Drug Discovery and Genomics – DNA and RNA Analysis Pharmacological Validation Proteomics – Protein Expression Profiling Targe
Slide 5: IDEAYA Precision Oncology Drug Discovery Platform & IND Engine
IDEAYA Precision Oncology Drug Discovery Platform & IND Engine AI/ML & Structure Based Drug Design to Deliver Potential First-in-Class Development Candidates Structural Biology & Structure Based Drug Design AI/ML Enabled Computational Drug Discovery1 Full suite of capabilities in structural biology,
Slide 6: IDEAYA's Potential First-in-Class Precision Medicine Oncology Pipeline
IDEAYA’s Potential First-in-Class Precision Medicine Oncology Pipeline Potential Commercial Modality/Indication Biomarker Pre-clinical IND Enabling Phase 1 Phase 2 Program Goals / Achievements Collaborations Registrational (IDEAYA) +cMET1 Combination Ph 2 (AA) / Ph 3 registrational trial1 – targetin
Slide 7: Darovasertib: Potential to Broadly Impact Uveal Melanoma (UM)
Darovasertib Darovasertib: Potential to Broadly Impact Uveal Melanoma (UM) * Potential First-in-Class and Best-in-Class in (Neo)adjuvant UM and Metastatic UM (MUM) Mutations in GNAQ / GNA11 activate PKC Signaling, a genetic driver of Uveal Melanoma Darovasertib is an oral, potent and selective PKC i
Slide 8: Daro + Crizo Phase 2 Efficacy: First-Line MUM and Any-Line MUM Best Tumor Response
Daro + Crizo Phase 2 Efficacy: First-Line MUM and Any-Line MUM Oral Presentation Compelling Overall Response Rate (ORR) by RECIST 1.1 Observed 60% Darovasertib + Crizotinib Phase 2 Confirmed 45% ORR and 90% DCR 50% Response by RECIST 1.1 Evaluable First-Line MUM (n=20) Best Tumor Response (%) 40% Fi
Slide 9: Median PFS in First-Line, Any-Line and Hepatic-Only MUM
Median PFS in First-Line, Any-Line and Hepatic-Only MUM Oral Presentation Observed Compelling Median Progression Free Survival with Encouraging Trend MUM Swimlane Plot Darovasertib + Crizotinib Phase 2 Median Progression Free Survival • First-Line (n=20): 7.1 months • Any-Line (n=63): 6.8 months • H
Slide 10: 2-Year PFS Kaplan Meier Curve: Daro + Crizo in Any-Line MUM
2-Year PFS Kaplan Meier (KM) Curve: Daro + Crizo in Any-Line MUM1 Daro + Crizo Combo Observes a Promising 2-Year PFS KM Curve and a “Long Tail” Effect 2-Year PFS Kaplan Meier Curves in MUM Daro + Crizo Any-Line MUM1 • N=63 Tebentafusp 1L MUM (registrational trial)2 • N=252 Tebentafusp Control Arm 1L
Slide 11: Darovasertib + Crizotinib Combination Clinical Summary in MUM
Darovasertib + Crizotinib Combination Clinical Summary in MUM Highly Differentiated Clinical Efficacy & AE Profile Observed1, 2 Cabozantinib Mono / Darovasertib + Crizotinib Selumetinib + DTIC Ipi + Nivo Tebentafusp Crizotinib Mono Target / Mechanism PKC + cMET cMET MEK + Chemotherapy CTLA4 + PD-1 H
Slide 12: Accelerated Approval Trial Design in First-Line HLA-A2 Negative MUM
Accelerated Approval Trial Design in First-Line HLA-A2 Negative MUM FDA Guided Design: Open Label Ph2/3 Evaluation of Daro + Crizo vs. Investigator's Choice1 FDA Project FrontRunner: Target First-Line approval strategy to enhance patient benefit in MUM FDA Accelerated Approval: Address unmet need in
Slide 13: Darovasertib Neoadjuvant Therapy: Ph2 Company Sponsored & Ph2 IST UM Trials
Darovasertib Neoadjuvant Therapy: Ph2 Company Sponsored & Ph2 IST UM Trials 61% (19 of 31) Observed Eye Preservation and 49% (24 of 49) with >30% Tumor Reduction* 60.0 ~59% (29 of 49) observed >20% Tumor Reduction Clinical Efficacy (n=49) ~49% (24 of 49) observed ≥ 30% Tumor Reduction Evaluable Pati
Slide 14: Preliminary Darovasertib Neoadjuvant UM Phase 3 Trial Design
Preliminary Darovasertib Neoadjuvant UM Phase 3 Trial Design1 Paradigm Shifting Opportunity to Save the Eye and Protect Vision Primary Endpoints2 • Cohort 1: Time to Vision Loss • Cohort 2: Eye Preservation Primary Local Therapy (e.g. enucleation, plaque) Secondary Endpoints • Cohort 1 and 2: No det
Slide 15: Darovasertib and Uveal Melanoma Patient Journey
Darovasertib and Uveal Melanoma Patient Journey High Unmet Need and Multiple First-Line Opportunities in UM and MUM1 +95% of UM patients harbor GNAQ/GNA11 mutation Uveal Melanoma Patient Journey Neoadjuvant UM Adjuvant UM MUM Daro + Crizo No FDA Approved No FDA Approved Therapies1 No FDA Approved Th
Slide 16: MAT2A Inhibition is Synthetic Lethal with MTAP-Deletion
MAT2A Inhibition is Synthetic Lethal with MTAP-Deletion MAT2A Strategies to address MTAP-/- Prevalence in ~15% of all Solid Tumors MTAP-MAT2A Synthetic Lethality Biology Robust monotherapy activity in lung, urothelial and gastric PDX MTAP-/- Gastric MTAP-/- Urothelial Mean Tumor Volume (mm3) ± S.E.M
Slide 17: IDE397: Phase 2 Potential First-in-Class MAT2A Inhibitor
IDE397: Phase 2 Potential First-in-Class MAT2A Inhibitor ~48k U.S. Annual Incidence in MTAP-Deletion NSCLC and Urothelial Cancer High Unmet Need: No FDA-Approved Therapies for MTAP-Deletion Solid Tumors U.S. Annual Incidence in Priority Tumor Types U.S. Annual Incidence in Potential Expansion Tumor
Slide 18: IDE397 Phase 1 Clinical Efficacy in MTAP-Deletion NSCLC & UC
IDE397 Phase 1 Clinical Efficacy in MTAP-Deletion NSCLC & UC Best Response by RECIST 1.1 at 30mg QD Phase 2 expansion dose1 Efficacy by RECIST 1.11 ~ 33% ORR by RECIST 1.1 = 9 PR or CR out of 27 Evaluable Pts 27 9 of 9 responses have been confirmed Best Response, n (%) Best Response by RECIST (% cha
Slide 19: IDE397 Phase 1 Clinical Efficacy in MTAP-Deletion NSCLC & UC
IDE397 Phase 1 Clinical Efficacy in MTAP-Deletion NSCLC & UC Time on treatment at 30mg QD Ph2 Expansion Dose NSCLC & Urothelial Cancer Efficacy Evaluable Patients Treated at 30 mg (n=27)1 Urothelial Cancer Adeno NSCLC Squamous NSCLC Complete Response Partial Response Stable Disease Progressive Disea
Slide 20: IDE397 Confirmed CR by RECIST 1.1 in UC Patient With MTAP-Deletion
IDE397 Confirmed CR by RECIST 1.1 in UC Patient With MTAP-Deletion Case Report and CT-Scan Images Baseline Characteristics: Urothelial Carcinoma with MTAP-Deletion: Maintained CR at Week 18 60+ years old male urothelial Baseline Week 18 carcinoma Treatment History: • Neo-adjuvant cisplatin/gemcitabi
Slide 21: IDE397 + Sacituzumab Govitecan Confirmed PR in Urothelial with MTAP-Deletion
IDE397 + Sacituzumab Govitecan Confirmed PR by RECIST 1.1 in Urothelial with MTAP-Deletion and FGFR3-TACC3 Fusion Case Report and CT-Scan Images Baseline Characteristics: Urothelial Cancer MTAP-Deletion Patient: PR at Week 12 CT-Scan 60+ years old male with Baseline Week 12 Urothelial Cancer and MTA
Slide 22: IDE892 DC: Potential Best-in-Class MTA-Cooperative PRMT5 Inhibitor
PRMT5 IDE892 DC: Potential Best-in-Class MTA-Cooperative PRMT5 Inhibitor Target to Enable Wholly-Owned Clinical Combo with IDE397/MAT2A in H2 20251 MTA-templated target binding Potent biochemical inhibition Exceptional IDE397 combination benefit (MTAP-/- CDX) E435 Mean Tumor Volume (mm3) ± S.E.M. 10
Slide 23: TRODELVY + IDE397 Combination in MTAP-Deletion Urothelial Cancer
TRODELVY® + IDE397 Combination in MTAP-Deletion Urothelial Cancer Disordered methionine metabolism underpins IDE397 combination opportunity with TOP1i-based ADC IDE397 perturbs both nucleotide pools and mRNA splicing in MTAP-/- cells Metabolic perturbation by IDE397 IDE397 provokes DDR selectively i
Slide 24: IDE397 Phase 1/2 Clinical Development Plan in MTAP-Deletion Solid Tumors
IDE397 Phase 1/2 Clinical Development Plan in MTAP-Deletion Solid Tumors Clinical Strategic Focus on High Conviction Rational Combinations IDE397 is strategically well positioned to evaluate both monotherapy and clinical IDE397 – Clinical Profile combinations in MTAP-deletion solid tumors Exposure-D
Slide 25: IDE849 (SHR-4849): Phase 1 DLL3 TOP1i ADC
DLL3 IDE849 (SHR-4849): Phase 1 DLL3 TOP1i ADC First-in-Class Potential and Targeting Lineage Survival Oncogene Activity Significant unmet need in Small Cell Lung Cancer (SCLC) IDE849 (SHR-4849) potential first-in-class/best-in-class Annual SCLC Patients1 (2025) 5 Year Survival The SCLC lineage surv
Slide 26: IDE849 (SHR-4849): Well-tolerated Robust Antitumor Activity in DLL3+ SCLC
IDE849 (SHR-4849): Well-tolerated Robust Antitumor Activity in DLL3+ SCLC DLL3-Specific Tumor Cell binding, Internalization and Payload Release SHR-4849 displays DLL3-specific tumor cell binding, Deep regressions in DLL3+ CDX/PDX with exceptional internalization and payload release linker/payload st
Slide 27: IDE849 (SHR-4849): Potential First-in-Class with Preliminary Ph1 Clinical PoC
IDE849 (SHR-4849): Potential First-in-Class with Preliminary Ph1 Clinical PoC Phase 1 FIH Study of DLL3 Topo-1-Payload ADC in Pre-Treated SCLC Patients Tumor Reductions and Responses seen in most evaluable subjects Phase 1 Dose Escalation in China in Pre-Treated SCLC Patients1 after IDE849 Treatment
Slide 28: IDE849 (SHR-4849): Pre-Treated SCLC Patient Case Study and Development Plan
IDE849 (SHR-4849): Potential First-in-Class with Preliminary Ph1 Clinical PoC Pre-Treated SCLC Patient Case Study and Preliminary IDEAYA Clinical Development Plan Case Example in Phase 1 FIH Dose Escalation IDE849 Phase 1/2 Clinical Development Plan • IDE849 Monotherapy Dose Escalation and Expansion
Slide 29: IDE275 (GSK959): Potential First-in-Class Ph1 Werner Helicase Inhibitor
Werner IDE275 (GSK959): Potential First-in-Class Ph1 Werner Helicase Inhibitor WRN Helicase Activity is Specifically Essential for Survival of MSI-high/dMMR Cancer Cells WRNi: tumor-intrinsic DNA damage Anti-tumor response is specific for MSI-H 1 WRN resolves TA repeat 2° structures to 1 2500 Vehicl
Slide 30: IDE275 (GSK959) Werner Helicase Inhibitor Demonstrates Robust Anti-Tumor Activity
IDE275 (GSK959) Werner Helicase Inhibitor Demonstrates Robust Anti- Tumor Activity in MSI-H and Heavily Pre-Treated Tumors Supports Clinical Strategy to Expand beyond MSI-H Colorectal Cancers Endometrial CDX Endometrial PDX Treatment-relapsed CRC PDX 2000 1200 Vehicle PO, QD Vehicle PO, QD WRNi PO,
Slide 31: IDE275 (GSK959): Phase 1 Werner Helicase Inhibitor Clinical Development Plan
IDE275 (GSK959): Phase 1 Werner Helicase Inhibitor Clinical Development Plan IDE275 (GSK959) Werner Helicase Werner Clinical Development Plan Inhibitor PART 1: Monotherapy PART 3: Combination • IDE275 (GSK959) has demonstrated Dose Escalation Dose Escalation robust and selective synthetic lethality
Slide 32: IDE161: Potential First-in-Class Phase 1 PARG Inhibitor
PARG IDE161: Potential First-in-Class Phase 1 PARG Inhibitor PARG Inhibition is synthetic-lethal with replication stress IDE161 disrupts DNA replication fork fidelity 1 1 IDE161 induces fork progression defects IDE161 induces transcription- PARG inhibition promotes PARP1 leading to pan-nuclear D
Slide 33: IDE161 Combination Strategies with PD-1 and TOP1i-ADCs
IDE161 Combination Strategies with PD-1 and TOP1i-ADCs High Conviction Mechanistic Rationale with Potentially Broad Development Opportunity STING activation by IDE161 enhances antitumor immunity IDE161/TOP1i DDR interaction enhances ADC efficacy blank combination benefit associated with enhanced imm
Slide 34: IDE161 Phase 1/2 Clinical Development Plan in Solid Tumors
IDE161 Phase 1/2 Clinical Development Plan in Solid Tumors Clinical Strategic Focus on Rational Combinations with TOP1i-ADCs and PD-1 IDE161 Phase 1/2 – Monotherapy and Combination Clinical Development Plan IDE161 Monotherapy Dose Escalation and Expansion in HRD Solid Tumors1 IDE161 monotherapy expa
Slide 35: IDE705 (GSK101): Potential First-in-Class Ph1 Pol Theta Helicase Inhibitor
Pol Theta IDE705 (GSK101): Potential First-in-Class Ph1 Pol Theta Helicase Inhibitor Phase 1 in Combination with Niraparib (PARPi) Pol Theta Helicase In Vivo Activity BRCA 1/2 Clinical Reversions Clinical Development Strategy IDE705(GSK101) + PARPi Pol Theta Helicase PARP BRCA Reversions Mediated by
Slide 36: IDE034 DC: Potential First-in-Class B7H3/PTK7 TOP1i Bi-Specific ADC
B7H3/PTK7 IDE034 DC: Potential First-in-Class B7H3/PTK7 TOP1i Bi-Specific ADC1 Dual Tumor-Associated Antigen Targeting for Potential Enhanced Therapeutic Window IDE034: B7H3/PTK7 Bispecific Ab-TOP1i ADC1 B7H3+/PTK7+ Expression PDX Model Mean Tumor Volume (mm3) ± S.E.M. Anti-B7-H3 Anti-PTK7 3000 2500
Slide 37: IDE251 DC: Dual KAT6/7 Inhibitor with High Selectivity vs KAT Family
KAT6/7 IDE251 DC: Dual KAT6/7 Inhibitor with High Selectivity vs KAT Family1 Potent Pathway Modulation Delivers Robust Biomarker-Specific Single-Agent Activity IDE251 solves considerable Wide biochemical selectivity window Durable anti-tumor activity design challenge IDE251 KAT-family in vitro PDX S
Slide 38: Building a Fully-Integrated Biotech in Precision Medicine Oncology
Building a Fully-Integrated Biotech in Precision Medicine Oncology Foundational Potential First-in-Class Clinical Pipeline and Drug Discovery Platform CLINICAL PROGRAMS DEVELOPMENT CANDIDATES PRECLINICAL PROGRAMS Ph 2/3 – Darovasertib (PKC) 1 Ph 2 – IDE397 (MAT2A) 1 IDE892 (PRMT5) – Targeting IND Mi
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