Ideaya Biosciences, Inc. · NASDAQ:IDYA
Ideaya Biosciences — Investor Presentation (May 2024)
38 slides from Ideaya Biosciences's investor presentation, May 7, 2024
Slide 1: IDEAYA Biosciences
May 2024 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 Broad Pipeline of 4 Clinical Programs with Multiple 2024 Target Milestones and Catalysts PHASE 2/3 PHASE 1/2 PHASE 1 IND-ENABLING PRECLINICAL DAROVASERTIB (PKC) IDE397
Slide 4: Leading Functional Genomics and Synthetic Lethality Platform
Leading Functional Genomics and Synthetic Lethality Platform The Next Frontier in Precision Medicine Oncology Functional Genomics and Synthetic Lethality provides a powerful approach to discover novel precision medicine therapies with patient biomarkers, including MTAP-deletion (~15% of solid tumors
Slide 5: 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 6: IDEAYA Functional Genomics and Synthetic Lethality Platform
IDEAYA Functional Genomics and Synthetic Lethality Platform Novel Target and Biomarker Discovery and Validation Target and Biomarker Discovery & Validation Platform IDEAYA Functional Genomics Platform integrates proprietary and public data sets with orthogonal and complementary content Bioinformatic
Slide 7: IDEAYA Precision Oncology Drug Discovery Platform & IND Engine
IDEAYA Precision Oncology Drug Discovery Platform & IND Engine AI/ML & Structure Based Drug Design to Deliver First-in-Class Development Candidates Structural Biology & Structure Based Drug Design AI/ML Enabled Computational Drug Discovery* Full suite of capabilities in structural biology, MAT2A Mak
Slide 8: 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 Phase 2 (AA) / Phase 3 GNAQ/11 1L HLA-A2(-) MUM r
Slide 9: Darovasertib – Potential to Broadly Impact Uveal Melanoma
Darovasertib Darovasertib – Potential to Broadly Impact Uveal Melanoma * Potential First-in-Class and Best-in-Class in (Neo)adjuvant UM and Metastatic UM Mutations in GNAQ / GNA11 activate PKC Signaling, a genetic driver of Uveal Melanoma Darovasertib is an oral, potent and selective PKC inhibitor G
Slide 10: Phase 2 Clinical Trial - Comparatively High-Risk, Poor Prognosis Population
Phase 2 Clinical Trial - Comparatively High-Risk, Poor Prognosis Population Disease Burden Significantly Higher in Both Any-Line and First-Line MUM Population+ IDE196-001 Phase 2* Tebentasfusp First-Line Phase 3# Darovasertib + Crizotinib Baseline Characteristics Tebe Arm Control Arm^ Any-Line n=63
Slide 11: Daro + Crizo Phase 2 Efficacy: First-Line MUM and Any-Line MUM
Daro + Crizo Phase 2 Efficacy: First-Line MUM and Any-Line MUM 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% First-Line MUM (N=2
Slide 12: Daro + Crizo Phase 2 Efficacy: HLA-A2-Negative and HLA-A2-Positive MUM
Daro + Crizo Phase 2 Efficacy: HLA-A2-Negative and HLA-A2-Positive MUM Clinical Combination Observes Clinical Efficacy Irrespective of HLA-A2 Status HLA-A2 Negative (n=31) HLA-A2 Positive (n=19) * First-Line: 42% ORR; 100% DCR * First-Line: 60% ORR; 100% DCR Any-Line: 29% ORR; 94% DCR Any-Line: 32%
Slide 13: Observed 94% ctDNA Molecular Response Rate with Deep & Sustained MRs
Observed 94% ctDNA Molecular Response Rate with Deep & Sustained MRs* Any-Line MUM Patients Treated with the Darovasertib + Crizotinib Combination Molecular Response Regardless of BAP1 Mutation Molecular Response Correlates with RECIST Response ^ * * Normalized ctDNA (log AUC / Total Time) + Confirm
Slide 14: Median PFS in First-Line, Any-Line and Hepatic-Only MUM
Median PFS in First-Line, Any-Line and Hepatic-Only MUM Observed Compelling Median Progression Free Survival with Encouraging Trend Any-Line 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 • Hepatic-On
Slide 15: 2-Year PFS Kaplan Meier Curve: Daro + Crizo in Any-Line MUM
2-Year PFS Kaplan Meier (KM) Curve: Daro + Crizo in Any-Line MUM* 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 MUM* • N=63 Tebentafusp 1L MUM (registrational trial)** • N=252 Tebentafusp Control Arm 1
Slide 16: Darovasertib + Crizotinib Combination Clinical Summary in MUM
Darovasertib + Crizotinib Combination Clinical Summary in MUM Highly Differentiated Clinical Efficacy & AE Profile Observed+, ++ Cabozantinib Mono / Darovasertib + Crizotinib Selumetinib + DTIC Ipi + Nivo Tebentafusp Crizotinib Mono Target / Mechanism PKC + cMET cMET MEK + Chemotherapy CTLA4 + PD1 H
Slide 17: 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 Choice ^ FDA Project FrontRunner: Target First-Line approval strategy to enhance patient benefit in MUM FDA Accelerated Approval: Address unmet need i
Slide 18: Darovasertib Monotherapy in (Neo)adjuvant Primary Uveal Melanoma
Darovasertib Monotherapy in (Neo)adjuvant Primary Uveal Melanoma 3 of 6 evaluable (50%) UM Patients Observed Eye Preservation in Enucleation Cohort^ IDEAYA Phase 2 and IST ongoing to evaluate Darovasertib Evaluable UM Patients Treated to Maximal Benefit φ+ Current Treatment Approach following diagno
Slide 19: (Neo)Adjuvant Darovasertib in Primary Uveal Melanoma (UM)
(Neo)Adjuvant Darovasertib in Primary Uveal Melanoma (UM) Paradigm Shifting Opportunity to Save the Eye, Protect Vision and Save Lives Phase 2 Study of Darovasertib Monotherapy as Neoadjuvant Therapy followed by Adjuvant Therapy ^ Primary Local Therapy Neoadjuvant Adjuvant Primary Endpoints • Safety
Slide 20: GNAQ/11 Cutaneous Melanoma Patients Treated With Darovasertib
GNAQ/11 Cutaneous Melanoma Patients Treated With Darovasertib 2 of 4 (50%) Observed Durable Partial Responses by RECIST 1.1 with Daro Combination Cutaneous Melanoma Patients Treated with Daro Mono (n=7) Cutaneous Melanoma Patients Treated with Daro Combo (n=4) 40 40 Best Tumor Response (%) Best Tumo
Slide 21: Darovasertib Clinical & Commercial Strategy in Uveal Melanoma and CM
Darovasertib Clinical & Commercial Strategy in Uveal Melanoma and CM High Unmet Need and Multiple First-Line Opportunities Uveal Melanoma Patient Journey Neoadjuvant UM Adjuvant UM MUM Metastatic CM No FDA Approved Daro No FDA Approved Therapies* No FDA Approved Therapies* Daro Daro + Crizo Therapie
Slide 22: MAT2A Inhibition is Synthetic Lethal with MTAP-Deletion
MAT2A MAT2A Inhibition is Synthetic Lethal with MTAP-Deletion Strategies to address MTAP-/- Prevalence in ~15% of all Solid Tumors MTAP-MAT2A Synthetic Lethality Biology Endogenous Suppression in MTAP-/- PDX Models Methionine Methylation Pathway Suppression in MTAP(-/-) Squamous Lung (LUSC) MTAP SDM
Slide 23: IDE397 Demonstrates Broad Efficacy across MTAP-Deletion PDX Models
IDE397 Demonstrates Broad Efficacy across MTAP-Deletion PDX Models Deep Regressions observed in NSCLC-squamous (LUSC), Esophageal and Bladder Cancers IDE397 Efficacy: 47 MTAP-/- PDX Models IDE397 In Vivo Efficacy in LUSC PDX Models TGI with IDE397 (30mpk) in MTAP-/- PDX Panel Blank blank Observed Tu
Slide 24: IDE397 Clinical Combination Strategy in MTAP-Deletion NSCLC
IDE397 Clinical Combination Strategy in MTAP-Deletion NSCLC Phase 1 Study of IDE397 + AMG 193 (Amgen PRMT5) Clinical Combination Enrolling IDE397 + MTA-Cooperative PRMT5i Alternative mRNA Splicing Analysis Preclinical Efficacy IDE397 + MTA-Cooperative PRMT5 Inhibitor Blank Combination IXCH Highly Pe
Slide 25: IDE397 Phase 2 Monotherapy Expansion in MTAP-Deletion Squamous NSCLC
IDE397 Phase 2 Monotherapy Expansion in MTAP-Deletion Squamous NSCLC Robust Tumor Shrinkage and ctDNA Molecular Responses Observed Best Response from Baseline among subjects with Squamous NSCLC with 33% shrinkage by PET/CT and decreased hypermetabolism noted in evaluable ctDNA samples* the mediastin
Slide 26: 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 27: IDE397 Phase 2 Monotherapy Expansion in MTAP-Deletion Urothelial Cancer
IDE397 Phase 2 Monotherapy Expansion in MTAP-Deletion Urothelial Cancer Robust Tumor Shrinkage and ctDNA Molecular Responses Observed Best Overall Response by RECIST 1.1 in Urothelial / Bladder Cancer ctDNA: Best Response From Baseline in Urothelial / Bladder Cancer* 50 Preliminary IDE397 Mono Effic
Slide 28: IDE397 Phase 1/2 Clinical Development Plan in MTAP-Deletion Solid Tumors
IDE397 Phase 1/2 Clinical Development Plan in MTAP-Deletion Solid Tumors Strategic Focus in Select Monotherapy Indications and High Conviction Clinical Combinations IDE397 is strategically well positioned to evaluate both monotherapy and clinical IDE397 – Clinical Profile combinations in MTAP-deleti
Slide 29: PARG Inhibition is Synthetic Lethal with HRD
PARG PARG Inhibition is Synthetic Lethal with HRD Novel, Mechanistically-Differentiated Target in a Clinically Validated Pathway PARG Activity is required to resolve DNA Repair PARG Inhibition is Mechanistically Distinct from PARPi Replication Stress Mechanisms of Tolerance PARGi PARPi ↓ ↓ Fork Reve
Slide 30: IDE161: Potential First-in-Class Phase 1 PARG Inhibitor
IDE161: Potential First-in-Class Phase 1 PARG Inhibitor IDE161 Profile: Potent, Selective with Favorable Properties IDE161 Sensitivity Profile in Cell Panel IDE161-induced Cellular IDE161-induced DNA Damage Response Blank Cellular response profiles reveal mechanistic PAR Accumulation associations wi
Slide 31: IDE161 is Active and Well-Tolerated in HRD ER+ Her2- Breast Cancer Models
IDE161 is Active and Well-Tolerated in HRD ER+ Her2- Breast Cancer Models Observed PARG inhibitor Activity is Distinct from PARP Inhibition IDE161 Selective Sensitivity vs PARPi Regression in BRCA-altered Breast Cancer PDX Models * HRD cell lines are selectively sensitive * ER+ / Her2- Breast Cancer
Slide 32: Preliminary IDE161 Clinical Efficacy at Phase 1 Expansion Dose
Preliminary IDE161 Clinical Efficacy at Phase 1 Expansion Dose 2 PRs by RECIST 1.1 and 100% DCR in Priority Solid Tumor Types with HRD Initial tumor scans support favorable efficacy of IDE161 in HRD solid tumors: Subjects with Priority Tumor Types at Phase 1 Expansion Dose 40 • 100% DCR (5 of 5): 4
Slide 33: IDE161 Phase 1/2 Clinical Development Plan in HRD Solid Tumors
IDE161 Phase 1/2 Clinical Development Plan in HRD Solid Tumors Strategic Focus in Endometrial, Colorectal, Prostate, Breast & Other Solid Tumor Types IDE161 Phase 1/2 – Monotherapy and Combination Clinical Development Plan Preliminary IDE161 monotherapy clinical efficacy observed, including RECIST I
Slide 34: GSK101 (IDE705): Potential First-in-Class Pol Theta Helicase Inhibitor
Pol Theta GSK101 (IDE705): Potential First-in-Class 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 GSK101 + PARPi BRCA Reversions Mediated by MMEJ Pol Theta Helicase PARP Inhibi
Slide 35: IDEAYA's AI/ML Enabled Drug Discovery Platform and IND-Engine
IDEAYA’s AI/ML Enabled Drug Discovery Platform and IND-Engine IND-Filing and Multiple Potential First-in-Class Development Candidates (DCs) Targeted in H2 2024 WRN Helicase Multi-Pronged Strategy in MTAP-/- AI/ML-Enabled IND-Engine blank k k Target Discovery Nominated Werner Helicase Next Generation
Slide 36: Werner Helicase is Synthetic Lethal with Microsatellite Instability
Werner Werner Helicase is Synthetic Lethal with Microsatellite Instability Targeting IND Submission in H2 2024 Werner Helicase Synthetic Lethal with High-MSI Werner Helicase Inhibitors Phenocopy Genetic SL in MSI-High Cancers Nanomolar Potency, Biochemical and Cellular Activity, and Selectivity over
Slide 37: IDEAYA Pipeline: MTAP-Deletion New Target Opportunity
IDEAYA Pipeline: MTAP-Deletion New Target Opportunity Mechanism-based activity distinct from PRMT5 pathway Mean Tumor Volume in NCI-H838 8 of 10 Complete Responses Minimal Body Weight Change blank vehicle Vehicle vehicle Vehicle test IDC-0020980 100 mg/kg BID + IDC-0020232 100 mg/kg BID test IDC-002
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 Ph 2/3 – Darovasertib 1 Ph 2 – IDE397 (MAT2A) 1 Werner DC – Targeting Targeting Multiple DC Nomi
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