Ideaya Biosciences, Inc. · NASDAQ:IDYA
Ideaya Biosciences — Investor Presentation (July 2024)
43 slides from Ideaya Biosciences's investor presentation, Jul 8, 2024
Slide 1: IDEAYA Biosciences
July 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 Potential First-in-Class Development Candidates Structural Biology & Structure Based Drug Design AI/ML Enabled Computational Drug Discovery* Full suite of capabilities in structural biology,
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 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% F
Slide 12: Daro + Crizo Phase 2 Efficacy: HLA-A2-Negative and HLA-A2-Positive MUM
Oral Presentation 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%
Slide 13: Observed 94% ctDNA Molecular Response Rate
Oral Presentation 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 / Tot
Slide 14: 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 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 m
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: Phase 2 Darovasertib Neoadjuvant UM Company-Sponsored Study
IDEAYA Phase 2 Darovasertib Neoadjuvant UM Company-Sponsored Study Enucleation & Plaque Eligible Patients who Received >4 Months Treatment (n=8) Preliminary data on 8 patients % Best Response for All Patients Treated w/Daro ≥ 4 Months By Tumor Volume^ (n=8) treated with neoadjuvant darovasertib for
Slide 19: Neoadjuvant UM Case Study Examples in Enucleation and Plaque Eligible Patients
IDEAYA Phase 2 Darovasertib Neoadjuvant UM Company-Sponsored Study Case Study Examples in Enucleation and Plaque Eligible UM Patient Plaque Patient: Maximal Change in Tumor Size Enucleation Patient: Maximal Change in Tumor Size • 50+ year old plaque eligible UM patient who received at • 60+ year old
Slide 20: Phase 2 Darovasertib Neoadjuvant UM IST Results in Enucleation Patients
Phase 2 Darovasertib Neoadjuvant UM IST Results in Enucleation Patients Oral Presentation 75% (9/12) of Eyes Preserved with Darovasertib Neoadjuvant Treatment up to 6 months % Change in Tumor Volume^ Over Time For Each Patient Best Response in Tumor Volume Post Darovasertib (n=15#) Treatment (n=12)
Slide 21: Neoadjuvant UM IST: Pre & Post Darovasertib Treatment
Phase 2 Darovasertib Neoadjuvant UM IST Results in Enucleation Patients Oral Presentation Pre & Post Darovasertib Treatment Radiation Plaque Planning and Vision Implications Reduced Radiation to Critical Structures & Baseline & Post Baseline Measurements Plaque Treatment Plan Potential Improvement i
Slide 22: (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 23: 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 24: 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 25: 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 26: 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 27: IDE397 Human Pharmacokinetics (PK) and Pharmacodynamics (PD)
IDE397 Human Pharmacokinetics (PK) and Pharmacodynamics (PD) 30mg QD Expansion Dose Delivers Target Drug Coverage and Robust Plasma SAM PD Human PK at 30 mg Expansion Dose (n=2) Steady-State Plasma SAM PD at 30 mg Dose (n=4) a Individual Patients Plasma SAM 30 mg IDE397 Plasma Conc. at 30mg QD C1D15
Slide 28: Preliminary IDE397 Adverse Event Profile of 30mg QD Ph2 Expansion Dose
Preliminary IDE397 Adverse Event Profile of 30mg QD Ph2 Expansion Dose MTAP-Deletion Solid Tumor Patients • Favorable adverse event (AE) Drug-Related Adverse Event Profile (>5%), n=18 profile demonstrated for the 30 mg Phase 2 expansion dose (n=18) Drug Related AE Drug Related Serious AE • ~5.6% of
Slide 29: 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 30: Preliminary IDE397 Efficacy Evaluation of 30 mg Phase 2 Expansion Dose
Preliminary IDE397 Efficacy Evaluation of 30 mg Phase 2 Expansion Dose ORR by RECIST 1.1: 18 Evaluable NSCLC & Urothelial Cancer MTAP-Deletion Patients* 60 IDE397 Efficacy by RECIST 1.1* ~39% ORR = 6ORR ~39% PRs=(11 CR awaiting + 6 PRs confirmation) + 1 CR outout (2 awaiting confirmation) ofof 1818
Slide 31: IDE397 Efficacy Evaluation: Swimlane
Preliminary IDE397 Efficacy Evaluation of 30 mg Phase 2 Expansion Dose Swimlane: 18 Evaluable NSCLC and Urothelial Cancer MTAP-Deletion Patients* Swimlane in NSCLC & Urothelial Cancer (n=18) Durability in Heavily Pre-Treated Patients Median Prior Lines of Therapy = 2 [1 to 7] 11 of 18 Patients Still
Slide 32: IDE397 ctDNA Molecular Response Rate
Preliminary IDE397 Efficacy Evaluation of 30 mg Phase 2 Expansion Dose ~81% ctDNA Molecular Response Rate in 16 NSCLC & Urothelial MTAP-Deletion Patients* • Molecular Response (MR) ctDNA Molecular Response (MR) Analysis (n=16) analysis of 16 MTAP- 1 deletion patients (3 adeno NSCLC, 7 urothelial, an
Slide 33: IDE397 Confirmed PR by RECIST 1.1 in NSCLC at 30mg Expansion Dose
IDE397 Confirmed PR by RECIST 1.1 in NSCLC at 30mg Expansion Dose Case Report and CT-Scan Images Baseline Characteristics: NSCLC MTAP-Deletion Patient: Partial Response at Week 6 CT-Scan 60+ year old male with squamous Baseline Week 6 NSCLC Treatment History: 2 prior lines of therapy: • Necitumumab
Slide 34: IDE397 Confirmed CR by RECIST 1.1 in Urothelial at 30mg Expansion Dose
IDE397 Confirmed CR by RECIST 1.1 in Urothelial at 30mg Expansion Dose Case Report and CT-Scan Images Baseline Characteristics: Urothelial MTAP-Deletion Patient: Complete Response at Week 18 CT-Scan 60+ year old male with high grade Baseline Week 18 urothelial carcinoma of the renal pelvis Treatment
Slide 35: 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 IXCHHighly Per
Slide 36: 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 37: 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 38: 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 HRD/replication stress PARG Inhibition is Mechanistically Distinct from PARPi IDE161 is a potent and selective PARG inhibitor Induction of DNA damage, persistent replication stress and checkpoint ac
Slide 39: 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 40: 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 41: 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 42: 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 43: 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 DCs in
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