Relay Therapeutics, Inc. · NASDAQ:RLAY
Relay Therapeutics — J.P. Morgan Healthcare Conference 2025
29 slides from Relay Therapeutics's conference presentation, Jan 13, 2025
Slide 1: J.P. Morgan Conference Presentation January 2025
J.P. Morgan Conference Presentation January 2025 Exhibit 99.1
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the progress and timing of the clinical development of the programs across
Slide 3: Clear Path to Address Large, Near-Term Commercial Opportunities
Relay Tx – Clear Path to Address Large, Near-Term Commercial Opportunities Anticipated 2025 Corporate Milestones Productive Platform & Strong Balance Sheet 8 DCs & 4 INDs 2 clinical POC datasets Breast Cancer RLY-2608 Pivotal trial start – 2025 Full Ph1-2 data – 2025 Vascular Malformations RLY-2608
Slide 4: RLY-2608 Unlocks Large Breast Cancer Market
RLY-2608 Unlocks Large Breast Cancer Market Robust RLY-2608 Clinical Data 9.2mo mPFS 11.4mo mPFS 9.2mo mPFS 2L only 2L+ 5.5mo mPFS for capivasertib + fulv in pt with prior CDK4/63 13 countries worldwide ~100 clinical sites 800+ patients dosed across trials ~$840M cash as of end 3Q 2024 Expected pivo
Slide 5: Relay Tx – 2025 Priorities
Relay Tx – 2025 Priorities BREAST CANCER PI3Kα-Driven Breast Cancer PI3Kα-Driven Vascular Malformations 1st mutant-selective PI3Kα inhibitor 1st mutant-selective PI3Kα inhibitor Fabry Disease 1st non-inhibitory αGal chaperone GENETIC DISEASE GENETIC DISEASE NRAS-Driven Solid tumors 1st NRAS-selectiv
Slide 6: PI3Kα Mutations Represent a Large Commercial Opportunity
PI3Kα Mutations Represent a Large Commercial Opportunity PI3Kα mutations represent a large commercial opportunity Non-selective PI3Kα targeting has significant limitations Relay Tx’s Dynamo®️ Platform created mutant selective molecule Breast Cancer Vascular Malformations Non-Breast Cancer Solid Tumo
Slide 7: Breast Cancer – Large Market for Mutant-Selective PI3Kα Targeted Therapies
Breast Cancer – Large Market for Mutant-Selective PI3Kα Targeted Therapies CDK4/6 + AI (abema / ribo / palbo) 1L Endocrine Sensitive 10,000 pt CDK4/6 + fulvestrant Inavolisib + palbo + fulv Capivasertib + fulvestrant or Alpelisib + fulvestrant or Everolimus + AI Current PI3Kα Pathway Total Addressab
Slide 8: RLY-2608 – Mutant-Selective PI3Kα Additive to Many Potential Combinations
RLY-2608 – Mutant-Selective PI3Kα Additive to Many Potential Combinations PI3Kα Backbone Current Standard of Care Non-Mutant Selective Inhibitors (capivasertib, alpelisib, inavolisib) Emerging Options for Future Standard of Care RLY-2608 PIK3CAmut HR+/HER2- Breast Cancer Treatment Paradigm + Cell Cy
Slide 9: RLY-2608 – ReDiscover Trial Overview
RLY-2608 – ReDiscover Trial Overview 1. Excludes PIK3CAmut clear cell OvCA, HNSCC, Cervical cancer, and colorectal patients; 2. Double mutation defined as one major PIK3CA mutation (E542X, E545X, H1047X) + ≥1 additional PIK3CA mutation per local assessment; CCOC = clear cell ovarian cancer Part 2 –
Slide 10: Doublet Combination Regimens Data Benchmark
1. SABCS 2021 #P5-17-05 (n=60); 2. SABCS 2021 #PD-13-05; 3. Turner N Engl J Med 2023; 388:2058-2070 (n=355); 4. 5.5mo mPFS reported in CDK4/6-experienced patient sub-population of CAPItello-291; 5. Prior SERD includes fulvestrant and next-generation SERDs; 6. FDA Prescribing Information. Note: These
Slide 11: RLY-2608 – Efficacy: 11.4 Month Median PFS in 2L & Kinase Patients
RLY-2608 – Efficacy: 11.4 Month Median PFS in 2L & Kinase Patients ReDiscover preliminary data as of 11/04/2024 Note: Follow-up estimated based on reversed KM. PFS estimates based on KM methods. Time Since First Dose (months) RLY-2608 600 mg BID (RP2D) + Fulvestrant Post-CDK4/6 Patients, excluding P
Slide 12: PI3Kα Inhibitors – Tolerability Profiles
PI3Kα Inhibitors – Tolerability Profiles 1. SABCS 2021 #P5-17-05; 2. Rugo 2021 Lancet Oncol 22:489; 3. FDA Prescribing Information; 4. CAPItello-291: Turner N Engl J Med 2023; 388:2058-2070. Note: These data are derived from different clinical trials at different points in time, with differences in
Slide 13: RLY-2608 – Interim Clinical Data Continue to Show Clinically Meaningful PFS
RLY-2608 – Interim Clinical Data Continue to Show Clinically Meaningful PFS 1. CAPItello-291: Turner N Engl J Med 2023; 388:2058-2070; 2. In CAPItello-291, CBR and ORR not reported for CDK4/6-experienced patient population; ORR = objective response rate, mPFS = median progression free survival, LoT
Slide 14: RLY-2608 – Initial Pivotal Trial Planned for Post-CDK4/6 Patients in 2025
RLY-2608 – Initial Pivotal Trial Planned for Post-CDK4/6 Patients in 2025* Eligibility Criteria: PIK3CAmut HR+, HER2- advanced / met BC 1 prior line CDK4/6 inhibitor Broad metabolic inclusion criteria No known PTEN or AKT mutation RLY-2608 (600 mg BID, RP2D) + fulvestrant Capivasertib (400 mg BID 4
Slide 15: Large Unmet Need in Metastatic Breast Cancer
Large Unmet Need in Metastatic Breast Cancer 13,000 patients 2L PIK3CAmut, HR+/HER2- mBC1 6,000 patients 1L Endocrine Resistant 10,000 patients 1L Endocrine Sensitive Notes: 1. Prevalent US patient population with a PIK3CA mutation in each line of therapy, excluding PTEN co-mutations (Global Data HR
Slide 16: RLY-2608 – On Track to Realize 1L Potential with Triplet Combinations
RLY-2608 – On Track to Realize 1L Potential with Triplet Combinations Phase 1 Aim for Triplets: Demonstrate safety, tolerability and preliminary efficacy with both current generation CDK4/6 and next-gen CDK4 to enable pivotal development potential in both Atirmociclib triplet has initiated Currently
Slide 17: Relay Tx – 2025 Priorities
Relay Tx – 2025 Priorities BREAST CANCER PI3Kα-Driven Breast Cancer PI3Kα-Driven Vascular Malformations 1st mutant-selective PI3Kα inhibitor 1st mutant-selective PI3Kα inhibitor Fabry Disease 1st non-inhibitory αGal chaperone GENETIC DISEASE GENETIC DISEASE NRAS-Driven Solid tumors 1st NRAS-selectiv
Slide 18: Vascular Malformations – Over 170,000 US Patients
Vascular Malformations – Over 170,000 US Patients US Patients % PIK3CAmut Approved Therapies Lymphatic Malformation (LM) Venous Malformation (VM) Cerebral Cavernous Malformation (CCM) PIK3CA-Related Overgrowth Spectrum (PROS) ~80k 80% ~65k pt ~100k ~20-25% ~20-25k pt ~120k 40-55% ~50-65k pt ~5-15k 1
Slide 19: PI3Kα-Driven Vascular Malformations – Patient Treatment Journey
PI3Kα-Driven Vascular Malformations – Patient Treatment Journey Current unmet need for selective, systemic therapy for Vascular Malformations Surgeon, Int. Radiologist, Dermatologist, Heme-Onc Geneticist, “Vascular Anomalist” PCP, Dermatologist, Surgeon, ENT, etc. Referral Pathway Symptom presentati
Slide 20: Relay Tx – 2025 Priorities
Relay Tx – 2025 Priorities BREAST CANCER PI3Kα-Driven Breast Cancer PI3Kα-Driven Vascular Malformations 1st mutant-selective PI3Kα inhibitor 1st mutant-selective PI3Kα inhibitor Fabry Disease 1st non-inhibitory αGal chaperone GENETIC DISEASE GENETIC DISEASE NRAS-Driven Solid tumors 1st NRAS-selectiv
Slide 21: NRAS – Large Validated Market With Significant Unmet Need
NRAS – Large Validated Market With Significant Unmet Need NRAS mutations observed in broad range of tumor types NRAS mutations are a key driver of solid tumors, though no NRAS-selective agent exists Head and Neck NSCLC Melanoma2 X ~0.6k ~2.2k ~4.0k ~0.4k ~6.4k ~1.1k Pancreatic Cancer Colorectal (CRC
Slide 22: Limited Therapeutic Window of Current Agents
Limited Therapeutic Window of Current Agents – Pan-RAF/RAS & MEK Inhibitors based Limited Efficacy Limited Tolerability Limited Target Inhibition MEK + RAFi 62 – 100% Dose Modifications Pan-RAS (PDAC) 42% Regimen (2L NRASmut melanoma) ORR PFS (mo) Naporafenib (RAFi) + trametinib (MEKi) 13 – 47% 4.2
Slide 23: Deep Regressions in PDXs Across Histologies & NRAS Genotypes
Deep Regressions in PDXs Across Histologies & NRAS Genotypes Vehicle RTX-6 25 mg/kg QD RTX-6 100 mg/kg QD Binimetinib+ Exarafenib 3+10 mg/kg BID RTX-6 20 mg/kg QD Relay Tx compounds well tolerated in exploratory animal toxicology studies at exposures >10X above the predicted efficacious exposure lev
Slide 24: Relay Tx – 2025 Priorities
Relay Tx – 2025 Priorities BREAST CANCER PI3Kα-Driven Breast Cancer PI3Kα-Driven Vascular Malformations 1st mutant-selective PI3Kα inhibitor 1st mutant-selective PI3Kα inhibitor Fabry Disease 1st non-inhibitory αGal chaperone GENETIC DISEASE GENETIC DISEASE NRAS-Driven Solid tumors 1st NRAS-selectiv
Slide 25: Fabry Disease – Large Validated Market With Significant Unmet Need
~$1.6B peak sales1 Fabry Disease – Large Validated Market With Significant Unmet Need Over 1,000 different GLA gene mutations Reduces αGal protein levels Leads to accumulation of toxic Gb3 substrate Broad clinical manifestations; Life threatening cardiac & renal disfunction Fabry disease is a lysoso
Slide 26: Fabry Disease – Potential Benefits of Non-Inhibitory Chaperone Approach
Fabry Disease – Potential Benefits of Non-Inhibitory Chaperone Approach Notes: 1. R301Q mut αGal (2hr post compound washout, expressed in GLA KO HEK293 cells); In vitro αGal activity assay (4MU) across multiple GLA mutations expressed in HEK293 GLA KO cells (assessed at 1uM); 3. GLA KO mouse model,
Slide 27: Relay Tx – 2025 Priorities
BREAST CANCER Relay Tx – 2025 Priorities PI3Kα-Driven Vascular Malformations ~140,000 pts1 ~170,000 pts2 (chronic treatment) 1st mutant-selective PI3Kα inhibitor 1st mutant-selective PI3Kα inhibitor 1. Prevalent US patient population with a PIK3CA mutation (excluding PTEN co-mutations) in adjuvant,
Slide 28: RLY-2608 Unlocks Large Breast Cancer Market
RLY-2608 Unlocks Large Breast Cancer Market Robust RLY-2608 Clinical Data 9.2mo mPFS 11.4mo mPFS 9.2mo mPFS 2L only 2L+ 5.5mo mPFS for capivasertib + fulv in pt with prior CDK4/63 13 countries worldwide ~100 clinical sites 800+ patients dosed across trials ~$840M cash as of end 3Q 2024 Expected pivo
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