Relay Therapeutics, Inc. · NASDAQ:RLAY
Relay Therapeutics — Corporate Update (September 2024)
34 slides from Relay Therapeutics's corporate update, Sep 9, 2024
Slide 1: RLY-2608 Data
RLY-2608 Data September 9, 2024 Exhibit 99.2
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 Relay Therapeutics' strategy, business plans and focus; the progress and ti
Slide 3: Today's Update
Today’s Update RLY-2608 abstract submitted to San Antonio Breast Cancer Symposium RLY-2608 – Next steps 2 ReDiscover Trial Update – RLY-2608 + Fulvestrant Doublet Data 1
Slide 4: Interim Clinical Data Show Clinically Meaningful PFS
RLY-2608 – Interim Clinical Data Show Clinically Meaningful PFS 1. CAPItello-291: Turner N Engl J Med 2023; 388:2058-2070; 2. ORR includes 2 ongoing unconfirmed partial response as of the data cut-off. After the data cut-off, one uPR patient has confirmed and the other uPR patient remains on treatme
Slide 5: 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 6: Interim Clinical Data Show Clinically Meaningful PFS
RLY-2608 – Interim Clinical Data Show Clinically Meaningful PFS Interim RLY-2608 safety and efficacy data supportive of pivotal trial in 2L Breast Cancer against capivasertib ReDiscover preliminary data as of 08/12/2024 Favorable Tolerability More Heavily Pre-Treated Patients 42% Gr3 TRAE Capivasert
Slide 7: Initial Pivotal Trial Planned for 2L Doublet in 2025
RLY-2608 – Initial Pivotal Trial Planned for 2L Doublet 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 days on, 3
Slide 8: PI3Kα Franchise - Opportunity for Multiple Value-Creating Datasets Over Next 2 Yrs
PI3Kα Franchise - Opportunity for Multiple Value-Creating Datasets Over Next 2 Yrs Team and Capital to Execute Ribociclib triplet ongoing; CDK4 triplet start Monotherapy dose expansions start Clinical start 2L doublet pivotal start Vascular Malformations Solid Tumors Meaningful Efficacy Data Expecte
Slide 9: Relay Tx – Broad Precision Medicine Pipeline
Relay Tx – Broad Precision Medicine Pipeline Target Program Preclinical Early Clinical Late Clinical BREAST CANCER PI3Kα RLY-2608 (PI3KαPAN) Endocrine Tx (ET) doublet Ribociclib + ET triplet CDK4i + ET triplet Other Novel Combinations CDK2 RLY-2139 ERα RLY-1013 (Degrader) GENETIC DISEASE Fabry Disea
Slide 10: 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 11: ReDiscover Trial Enrollment
RLY-2608 – ReDiscover Trial Enrollment Part 2 – Dose Expansion RLY-2608 + Fulvestrant Doublet 200 mg BID – N=3 100 mg BID – N=3 800 mg BID – N=16 1000 mg BID – N=1 600 mg BID – N=17 600 mg BID – N=47 Study Arm Part 1 – Dose Escalation 64 patients total across dose escalation and expansion at 600 mg
Slide 12: ReDiscover Trial Baseline Demographics
RLY-2608 – ReDiscover Trial Baseline Demographics ReDiscover preliminary data as of 08/12/2024 RLY-2608 + Fulvestrant All Patients (N=118) 600 mg BID (RP2D, N=64) Age, Median (Range), Years 59.0 (34, 85) 59.0 (34, 80) ECOG, 0 / 1, n (%) 69 (58.5) / 49 (41.5) 38 (59.4) / 26 (40.6) Local PIK3CA Baseli
Slide 13: Efficacy: Median PFS 9.2 Months
RLY-2608 – Efficacy: Median PFS 9.2 Months ReDiscover preliminary data as of 08/12/2024 Note: Follow-up estimated based on reversed KM. PFS estimates based on KM methods. Progression-Free Survival (%) Time Since First Dose (months) 6-month PFS: 64.1% 9-month PFS: 60.1% CBR: 57.1% (20/35 pt) Median f
Slide 14: RLY-2608 – Efficacy: ORR 33%
ReDiscover preliminary data as of 08/12/2024 RLY-2608 600 mg BID (RP2D) + Fulvestrant Excluding PTEN / AKT Co-Mutations – Measurable Disease (N=30) ORR: 33.3% (10/30)1 Tumor Reduction: 73.3% (22/30) 1. ORR includes 2 ongoing unconfirmed partial response as of the data cut-off. After the data cut-off
Slide 15: RLY-2608 – Efficacy: ctDNA Clearance
RLY-2608 (All Doses) + Fulvestrant (N=69) RLY-2608 – Efficacy: ctDNA Clearance PIK3CA ctDNA Variant Allele Frequency (%) Kinase Non-Kinase RLY-2608 (600 mg BID) + Fulvestrant (N=35) At 600 mg BID1 (RP2D): 34 (97.1%) patients had decline in PIK3CA ctDNA 19 (54.3%) patients completely cleared PIK3CA c
Slide 16: Efficacy: Kinase Mutations mPFS 10.3 Months, ORR 53%
RLY-2608 – Efficacy: Kinase Mutations mPFS 10.3 Months, ORR 53% ReDiscover preliminary data as of 08/12/2024 RLY-2608 600 mg BID (RP2D) + Fulvestrant PIK3CA Kinase mutations, excluding PTEN / AKT co-mutations (N=29) 10.3mo mPFS (95% CI: 5.8, NR) Progression-Free Survival (%) Time Since First Dose (m
Slide 17: Tolerability: Limited Observed Impact on Glucose Homeostasis
RLY-2608 – Tolerability: Limited Observed Impact on Glucose Homeostasis ReDiscover preliminary data as of 08/12/2024 Alpelisib Label Criteria* 100 mg BID (N=3) 200 mg BID (N=3) 400 mg BID (N=31) 600 mg BID (N=64) 800 mg BID (N=16) 1000 mg BID (N=1) Glucose (mg/dL) RLY-2608 + Fulvestrant Grade 3 (250
Slide 18: Tolerability: TRAEs
RLY-2608 – Tolerability: TRAEs ReDiscover preliminary data as of 08/12/2024 No Gr4-5 TRAEs 1: Hyperglycemia includes the MedDRA v26.0 Preferred Terms (PTs): Hyperglycemia, Blood Glucose Increased, Glucose Tolerance Impaired; Fatigue includes the PTs: Fatigue and Asthenia; Hypokalemia includes the PT
Slide 19: RLY-2608 – Tolerability: Dose Intensity and Modifications
Note: * Fatigue includes the Preferred Terms: Fatigue and Asthenia; TRAEs leading to Dose Reduction in more than 2 patients within 600 mg BID are presented. RLY-2608 – Tolerability: Dose Intensity and Modifications Maintained 95% dose intensity with very low TRAE discontinuations at 600mg BID All Pa
Slide 20: Initial Pivotal Trial Planned for 2L Doublet in 2025
RLY-2608 – Initial Pivotal Trial Planned for 2L Doublet 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 days on, 3
Slide 21: 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 Dose Escalation On track for end of year ini
Slide 22: Breast Cancer – Large Market in Current and Emerging Standards of Care
Breast Cancer – Large Market in Current and Emerging Standards of Care Endocrine Sensitive CDK4 + next gen oral ET Oral SERD monoTx Inavolisib + palbo + fulv Inavolisib + fulvestrant ADCs 11,000 pts Endocrine Resistant Capivasertib + fulvestrant or Alpelisib + fulvestrant or Everolimus + AI Elacestr
Slide 23: PI3Kα Inhibitors – Tolerability Profiles
1. SABCS 2021 #P5-17-05; 2. Rugo 2021 Lancet Oncol 22:489; 3. FDA Prescribing Information Document; 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 molecule composition, trial desi
Slide 24: PI3Kα Inhibitors – Tolerability Profiles
1. SABCS 2021 #P5-17-05; 2. Rugo 2021 Lancet Oncol 22:489; 3. FDA Prescribing Information Document; 4. per CAPItello-291 enrollment criteria; 5. Rash for capivasertib references Cutaneous Adverse Reactions grouped term includes a number of preferred terms listed in FDA prescribing information Note:
Slide 25: PI3Kα Inhibitors – Efficacy Profiles
PI3Kα Inhibitors – Efficacy Profiles Data below are not from head-to-head studies. Cross-trial data interpretation should be considered with caution as it is limited by differences in study population, design and many other factors. 1. SABCS 2021 #P5-17-05 (n=60); 2. SABCS 2021 #PD-13-05; 3. Turner
Slide 26: Relay Tx's PI3Kα Franchise – Large Opportunities Across Pillars
Relay Tx’s PI3Kα Franchise – Large Opportunities Across 3 Pillars PIK3CA mutant HR+/HER2- Breast Cancer PIK3CA mutant Vascular Malformations PIK3CA mutant Other Solid Tumors 1. Prevalent US patient population with a PIK3CA mutation in each line of therapy (Global Data HR+/HER2- Breast Cancer Global
Slide 27: Relay Tx's Dynamo – Productive Computationally Enabled Platform
2024 Dynamo® Platform Relay Tx’s Dynamo® – Productive Computationally Enabled Platform Free energy calculations Digitally encoded libraries Long time-scale MD Differential dynamics Automated Chemical Design Generative design Active learning ADME/PK models ML-DEL + AI models for DEL Giga-scale virtua
Slide 28: Relay Tx – Additional Near-Term Clinical Programs
Relay Tx – Additional Near-Term Clinical Programs 1. Prevalence of Fabry patients (National Fabry Disease Foundation, Jan 2024); 2. Newly diagnosed (incident) solid tumors with an NRAS mutation, excluding melanoma stages 0-II (SEER, 3rd party source for alteration rate, Jan 2024); 3. Fabry disease f
Slide 29: Lirafugratinib (RLY-4008) – Updated Data and Next Steps
Lirafugratinib (RLY-4008) – Updated Data and Next Steps Next Step: Seek global commercialization partner for lirafugratinib Updated Tumor Agnostic data ORR 37% mDoR 7.3mo Data to be presented at ENA 2024 Tumor Agnostic FGFR2 Fusions (non-CCA) N=47; preliminary data as of 06/26/24 Regulatory Feedback
Slide 30: Relay Tx – Broad Precision Medicine Pipeline
Relay Tx – Broad Precision Medicine Pipeline Target Program Preclinical Early Clinical Late Clinical BREAST CANCER PI3Kα RLY-2608 (PI3KαPAN) Endocrine Tx (ET) doublet Ribociclib + ET triplet CDK4i + ET triplet Other Novel Combinations CDK2 RLY-2139 ERα RLY-1013 (Degrader) GENETIC DISEASE Fabry Disea
Slide 31: Relay Tx – Anticipated Milestones 2024-25
Relay Tx – Anticipated Milestones 2024-25 Breast Cancer Portfolio Milestones PI3Kα RLY-2608 Genetic Disease Portfolio milestones Solid Tumors portfolio milestones Clinical start – 2H 2025 ~$688M cash as of end 2Q 2024 Expected to fund current operating plan into 2H 2026 Dynamo®️ Platform 5+ unnamed
Slide 32: PI3Kα Franchise - Opportunity for Multiple Value-Creating Datasets Over Next 2 Yrs
PI3Kα Franchise - Opportunity for Multiple Value-Creating Datasets Over Next 2 Yrs Team and Capital to Execute Ribociclib triplet ongoing; CDK4 triplet start Monotherapy dose expansions start Clinical start 2L doublet pivotal start Vascular Malformations Solid Tumors Meaningful Efficacy Data Expecte
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Slide 34: Efficacy: 57.1% CBR
RLY-2608 – Efficacy: 57.1% CBR RLY-2608 600 mg BID (RP2D) + Fulvestrant Excluding PTEN / AKT Co-Mutations (N=52) CBR: 20/35 (57.1%) ReDiscover preliminary data as of 08/12/2024 CBR: Clinical Benefit defined as all patients with confirmed complete response or partial response or stable disease ≥24 we
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