Relay Therapeutics, Inc. · NASDAQ:RLAY
Relay Therapeutics — ESMO Congress 2022
27 slides from Relay Therapeutics's conference presentation, Sep 12, 2022
Slide 1: ESMO Disclosure Call Materials September 2022
ESMO Disclosure Call Materials September 2022 Exhibit 99.2
Slide 2: Disclaimer
Disclaimer This presentation contains forward-looking statements and information about our current and future prospects and our operations and financial results, which are based on currently available information. All statements other than statements of historical facts contained in this presentatio
Slide 3: Relay Tx – New Breed of Biotech
Relay Tx – New Breed of Biotech Chemical biology insights Deep structural understanding Physics-based simulations AI / ML PEOPLE EXPERIMENTATION COMPUTATION
Slide 4: Relay Tx – Extensive Precision Medicine Focused Pipeline
Relay Tx – Extensive Precision Medicine Focused Pipeline Breast Cancer1 PI3Kα franchise PI3KαPAN RLY-26082 RLY-2608 Pan-mutant allosteric inhibitor ~8-51K ~50-156K all solid tumors RLY-58362 PI3KαSPECIFIC H1047R-specific RLY-1047R H1047R allosteric inhibitor ~4-25K ~15-48K all solid tumors PI3KαOTHE
Slide 5: Relay Tx – Anticipated Milestones
Relay Tx – Anticipated Milestones RLY-4008 (Selective FGFR2) Clinical start in 4Q 2023 or 1Q 2024 Selective CDK2 GDC-1971 (RLY-1971, SHP2) Atezolizumab combo trial initiated RLY-2608 (PI3KαPAN) Development candidate nomination in 2023 ERα Degrader Tumor Agnostic Breast Cancer Franchise Additional da
Slide 6: FGFR2 – Validated Target Present in Several Tumor Types
FGFR2 – Validated Target Present in Several Tumor Types Fusions Amplifications Mutations FGFR2 Annual Cases (US, comprehensive) FGFR2-altered cancers remain a high unmet medical need Pancreatic Breast Endometrial Skin Melanoma Stomach Lung Bladder CUP Ovarian ~5K-15K patients in the US per year1 ~3K
Slide 7: FGFR2 – Selective Inhibitor Required to Address Large Unmet Medical Need
FGFR2 – Selective Inhibitor Required to Address Large Unmet Medical Need A selective inhibitor of FGFR2 with broad activity against acquired resistance mutations is necessary to address significant unmet need in patients with FGFR2-altered tumors Compound Company Stage FGFR2 Selective Response Rate
Slide 8: A Highly Selective and Irreversible FGFR2 Inhibitor
RLY-4008 – A Highly Selective and Irreversible FGFR2 Inhibitor Pan-FGFR Inhibitors RLY-4008 AZD4547 Erdafitinib Pemigatinib Futibatinib FGFR2 Note: Single experiment that tested each compound run at 500nM against 468 targets in the absence of ATP and without preincubation Source: KINOMEscanTM by Eur
Slide 9: Summary of Sept 2022 Interim Data Disclosure at ESMO
RLY-4008 – Summary of Sept 2022 Interim Data Disclosure at ESMO Favorable Interim Safety Profile Potential Outside of CCA Favorable Tolerability & Safety profile across 195 patients Highly Selective with no clinically significant off-target tox Early signs of activity in non-CCA patients, including
Slide 10: ReFocus Trial Design
RLY-4008 – ReFocus Trial Design RLY-4008 – ReFocus Trial Design Part 1: Dose Escalation Unresectable or metastatic solid tumors FGFR2 alterations per local assessment Both FGFRi-naïve & FGFRi-treated allowed RLY-4008 RP2D: 70 mg QD Part 2: Dose Expansion Non-CCA advanced, solid tumors with FGFR2 alt
Slide 11: Continued Robust Activity Observed in FGFRi-Naïve CCA Patients
RLY-4008 – Continued Robust Activity Observed in FGFRi-Naïve CCA Patients Unresectable or metastatic solid tumors FGFR2 alterations per local assessment Both FGFRi-naïve & FGFRi-treated allowed RLY-4008 RP2D: 70 mg QD RLY-4008 – Continued Robust Activity Observed in FGFRi-Naïve CCA Patients Part 1:
Slide 12: Patient Characteristics
RLY-4008 – Patient Characteristics Fusion+ CCA FGFRi-Naïve1 Total (N=195)2 Parameter 70 mg QD (N=17) All doses (N=38) Age (years), median (range) 57 (36-81) 58 (33-81) 59 (23-87) Female, % 59% 58% 62% Race, % White / Asian / Black / Unknown 41% / 24% / 0% / 35% 58% / 21% / 3% / 18% 63% / 15% / 4% /
Slide 13: Interim Response Data at Pivotal Dose (70 mg QD)
Approved Pan-FGFR Inhibitors Demonstrate 23-36% ORR in This Population3 RLY-4008 – Interim Response Data FGFRi-Naïve Fusion+ CCA Patients at Pivotal Dose (70 mg QD) Best RECIST Change (%) from Baseline Based on Investigator Evaluated Response for Fusion+ CCA FGFRi-Naïve Patients at 70 mg QD (N=17) 1
Slide 14: Interim Response Data FGFRi-Naïve Fusion+ CCA Patients Across All Doses
RLY-4008 – Interim Response Data FGFRi-Naïve Fusion+ CCA Patients Across All Doses 92% of Patients With Tumor Reduction Across All Dose Levels, Majority of Patients With Partial Response per RECIST 1.1 Best RECIST Change (%) from Baseline Based on Investigator Evaluated Response for Fusion+ CCA FGFR
Slide 15: Time on Treatment for Fusion+ CCA FGFRi-Naïve Patients (All Doses)
RLY-4008 – Time on Treatment for Fusion+ CCA FGFRi-Naïve Patients (All Doses) Complete tumor resection: R0 resection performed in curative intent, patient remains no evidence of disease as of 31 May 2022 Data cut-off: August 01, 2022; efficacy analysis includes patients with measurable disease who h
Slide 16: Patient Treated at 70 mg QD Resulted in 68% Tumor Regression
RLY-4008 – Patient Treated at 70 mg QD Resulted in 68% Tumor Regression Baseline Cycle 5 Liver lesions Liver lesions Bone lesion Hepatic dome lesions not detected Deep liver tumor regression Ossification 56-year-old Female With FGFR2-PLETHA4 Rearrangement ICC. Refractory to Gemcitabine/Cisplatin; Tr
Slide 17: Interim Safety Data from ESMO Disclosure Includes 195 Patients
RLY-4008 – Interim Safety Data from ESMO Disclosure Includes 195 Patients Data from 2022 ESMO Congress (September 2022) RLY-4008 – Interim Safety Data from ESMO Disclosure Includes 195 Patients Part 1: Dose Escalation Part 2: Dose Expansion Non-CCA advanced, solid tumors with FGFR2 alterations 3 Coh
Slide 18: Treatment-Related Adverse Events (TRAEs) Interim Profile
RLY-4008 – Treatment-Related Adverse Events (TRAEs) Interim Profile TRAEs > 15% TRAE Dose Modification RP2D, 70 mg QD (N=89) All Doses (N=195) Dose interruption (%) 42% 47% Dose reduction (%) 27% 33% Dose discontinuation (%) 1% 1%* Clinically Insignificant Off-Target Hyperphosphatemia (12%, all Gr 1
Slide 19: Additional Disclosures Expected in 2023
RLY-4008 – Additional Disclosures Expected in 2023 Data from 2022 ESMO Congress (September 2022) Unresectable or metastatic solid tumors FGFR2 alterations per local assessment Both FGFRi-naïve & FGFRi-treated allowed RLY-4008 RP2D: 70 mg QD Entire dose escalation to be disclosed in 1H23 Last full up
Slide 20: Observations from October 2021 Initial Clinical Data Disclosure
RLY-4008 – Observations from October 2021 Initial Clinical Data Disclosure Data from 2021 Triple Meeting (October 2021, N=49 patients) Tumor regression also observed across FGFR2 mutations (N=7) and amplifications (N=3) Mutations (N=7) Amplifications (N=3) BC BC BC BC Demonstrated activity against r
Slide 21: Summary of ESMO Disclosure and Anticipated Milestones
RLY-4008 – Summary of ESMO Disclosure and Anticipated Milestones Data from 2022 ESMO Congress (September 2022) Favorable Interim Safety Profile Potential Outside of CCA Favorable Tolerability & Safety profile across 195 patients Highly Selective with no clinically significant off-target tox Initial
Slide 22: Relay Tx’s Emerging Breast Cancer Franchise Addresses Large Opportunity
Relay Tx’s Emerging Breast Cancer Franchise Addresses Large Opportunity Relay Tx’s PI3Kα Franchise PI3KαPAN PI3KαSPECIFIC PI3KαOTHER RLY-2608* Pan-mutant selective allosteric inhibitor H1047R-specific allosteric inhibitor Other mutant-selective mechanisms Additional chemically distinct programs Rela
Slide 23: PI3Kα – RLY-2608 Trial Design
PI3Kα – RLY-2608 Trial Design Part 1: Dose Escalation a. Excludes PIK3CAmut clear cell OvCA, HNSCC, and Cervical cancer patients; b. Double mutation defined as one major PIK3CA mutation (E542X, E545X, H1047X) + ≥1 additional PI3KCA mutation per local assessment; c. Intolerance to PI3K alpha inhibito
Slide 24: SHP2 – Genentech Global Collaboration for GDC-1971
SHP2 – Genentech Global Collaboration for GDC-1971 (Formerly RLY-1971) GDC-1971 + Atezolizumab (PD-L1 Ab) initiated August 2022 Collaboration Provides Meaningful Economics to Relay Tx* * As of June 30, 2022: $95 million in upfront & milestone payments received, plus an opt-in option for 50/50 profit
Slide 25: Relay Tx – Extensive Precision Medicine Focused Pipeline
Relay Tx – Extensive Precision Medicine Focused Pipeline Breast Cancer1 PI3Kα franchise PI3KαPAN RLY-26082 RLY-2608 Pan-mutant allosteric inhibitor ~8-51K ~50-156K all solid tumors RLY-58362 PI3KαSPECIFIC H1047R-specific RLY-1047R H1047R allosteric inhibitor ~4-25K ~15-48K all solid tumors PI3KαOTHE
Slide 26: Relay Tx – Capital, Team & Execution Focus to Deliver on Anticipated Milestones
GDC-1971 (RLY-1971, SHP2) Relay Tx – Capital, Team & Execution Focus to Deliver on Anticipated Milestones RLY-4008 (Selective FGFR2) Clinical start in 4Q 2023 or 1Q 2024 Selective CDK2 Atezolizumab combo trial initiated RLY-2608 (PI3KαPAN) $838M Cash, cash equivalents and investments as of the end o
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