Slide 1: RLY-4008 (lirafugratinib) in FGFR2-Altered Solid Tumors
RLY-4008 (lirafugratinib) in FGFR2-Altered Solid Tumors October 2023 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 the progress and timing of the clinical development of the programs across
Slide 3: RLY-4008 – Embodies The Power of Our R&D Engine
RLY-4008 – Embodies The Power of Our R&D Engine Motion Based Drug Design… ...Created First Known Selective FGFR2 FGFR2 First Patient Dosed Sep 2020 Oct 2023 Pivotal Cohort Fully Enrolled RP2D selected, demonstrated PoC, escalation cohorts initiated Down Down Up Up Down Down Down Relay Approach Stand
Slide 4: RLY-4008 – Initial Clinical Efficacy Observed Across Tumor Types
RLY-4008 (lirafugratinib) – Initial Clinical Efficacy Observed Across Tumor Types cORR = Confirmed Objective Response Rate; ORR = Objective Response Rate Sources: ACS; SEER; Globocan; World Bank; 3rd party sources; 1. ORR includes 2 unconfirmed partial responses that confirmed post data cut off; 2.
Slide 5: Relay Tx – Patient-Driven
Relay Tx – Patient-Driven Cash, cash equivalents and investments as of the end of 2Q 2023 Current cash, cash equivalents and investments are expected to be sufficient to fund current operating plan into 2H 2026 ~$872M …Focusing Investment… …To Create Long Term Value Productive In-House R&D Engine… E
Slide 6: FGFR2 – Tumor Agnostic Opportunity
FGFR2 – Tumor Agnostic Opportunity Current data suggests potentially large global opportunity All Solid Tumors: FGFR2 Amplifications All Solid Tumors: FGFR2 Fusions Global patients per year1 US patients per year ~7k Up to ~34k ~13k Up to ~43k ~2k ~1k Up to ~6k Up to ~67k ~9k Up to ~28k Gastric Cance
Slide 7: PI3Kα Represents a Major Market Opportunity
PI3Kα mutants PI3Kα Represents a Major Market Opportunity Kinase Helical Other Total 14% EGFR ERBB2 BRAF ALK 6% 6% 6% 1% % of all solid tumors with alteration E542X E545X H1047X ~$7B Total 2022 Global Revenue ~$9B ~$2B ~$3B PI3Kα is the most frequently mutated kinase in solid tumors HR+/HER2- Breast
Slide 8: PI3Kα Franchise Moving Rapidly to Triplet Combinations
PI3Kα Franchise Moving Rapidly to Triplet Combinations Monotherapy Doublet (combo with fulvestrant) Triplet (combo with fulvestrant and CDK4/6i) Part 1: Dose Escalation PIK3CAmut adv solid tumors PIK3CAmut, HR+/HER2- advanced / metastatic Breast Cancer PIK3CAmut, HR+/HER2- advanced / metastatic Brea
Slide 9: Relay Tx's Execution & Capital Focus on Highest Value Opportunities
Relay Tx’s Execution & Capital Focus on Highest Value Opportunities Target Program Annual US Patient # PI3Kα franchise RLY-2608 PI3KαPAN Monotherapy ~10-68K breast cancer ~76-238K all solid tumors Endocrine Tx (ET) doublet CDK4/6i + ET triplet RLY-5836 PI3KαPAN Monotherapy Endocrine Tx (ET) doublet
Slide 10: Relay Tx – Capital, Team & Execution Focus to Deliver on Key Milestones
Initial RLY-2608 data in 1H 2023 RLY-5836 clinical start in 2Q 2023 RLY-2608 expansion cohorts initiated 2H 2023 RLY-2608 Triplet Dose Escalation initiated by YE 2023 Additional data update in 2024 Relay Tx – Capital, Team & Execution Focus to Deliver on Key Milestones Undisclosed RLY-4008 (lirafugr
Slide 11: FGFR2 – Limitations of Current CCA and Non-CCA Treatment Options
FGFR2 – Limitations of Current CCA and Non-CCA Treatment Options 1. Sources: Pemigatinib – prescribing information; futibatinib – prescribing Information; erdafitinib – prescribing information; (note: AEs are reflective of respective label indications); 2. From pemigatinib NDA review documents: "Pem
Slide 12: RLY-4008 (lirafugratinib) – ReFocus Trial Design
RLY-4008 (lirafugratinib) – 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 Today’s Disclosure
Slide 13: Baseline Characteristics – Heavily Pre-Treated Patients Across 18 Tumor Types
Baseline Characteristics – Heavily Pre-Treated Patients Across 18 Tumor Types Parameter Efficacy Population (N=84) Sex, n (%) Female 51 (61) Age (years), median (range) 62 (33, 84) Race, n (%) White 46 (55%) Asian 12 (14%) Other/Unknown 26 (31%) ECOG PS, n (%) 0 31 (37%) 1 52 (62%) 2 1 (1%) Prior li
Slide 14: Tumor Responses Observed Across Multiple FGFR2-Fusion Solid Tumors
Tumor Responses Observed Across Multiple FGFR2-Fusion Solid Tumors ORR: 35% (9/26) DCR: 69% (18/26) 6 patients ongoing: 3 responders 3 stable disease Note: Waterfall includes patients with post-baseline scans. ORR calculation includes 26 efficacy evaluable patients; ORR = Objective Response Rate; DC
Slide 15: Durable Responses Observed Across FGFR2-Fusion Solid Tumors
Durable Responses Observed Across FGFR2-Fusion Solid Tumors Range DoR (mon): 2+, 12 % pt with DoR ≥6mo: 63% Preliminary data as of 23 Aug 2023 SD uPR PR Stable Disease Unconfirmed Partial Response Confirmed Partial Response Progressive Disease PD BOR = Best Overall Response: * * Response confirmed p
Slide 16: Early Signal in FGFR2-Amplifications Driven by Key Tumor Types
Early Signal in FGFR2-Amplifications Driven by Key Tumor Types ORR: 24% (8/34) DCR: 62% (21/34) 6 patients ongoing: 4 responders 1 stable disease 1 treated beyond PD Encouraging gastric cancer signal where current approved last line of treatment yields 4% ORR, <4mo mPFS1 Indication PR SD N ORR DCR A
Slide 17: Durable Responses Observed Across FGFR2-Amplification Solid Tumors
Durable Responses Observed Across FGFR2-Amplification Solid Tumors Range DoR (mon): 3+, 13+ % pt with DoR ≥6mo: 43% Preliminary data as of 23 Aug 2023 3/3 breast pts with DOR >6mo and ongoing SD uPR PR Stable Disease Unconfirmed Partial Response Confirmed Partial Response Progressive Disease PD BOR
Slide 18: Strong Signal in HR+/HER2- Breast Cancer
Strong Signal in HR+/HER2- Breast Cancer ORR: 40% (4/10) DCR: 70% (7/10) 3 responders ongoing Subtype HR+/HER2- HR+/HER2- HR+/HER2- HR+/HER2- HR+/HER2- HR+/HER2- HR+/HER2-* HR+/HER2- ^ HR+/HER2- ^^ HR+/HER2- Prior LoT Prior ET? Prior CDK4/6? ESR1 status 10 9 6 5 3 7 6 8 11 - Y Y Y Y Y Y Y Y Y Y Y Y
Slide 19: Multiple Long-Term Responses Observed in Heavily Pre-Treated HR+/HER2- Breast Cancer
Multiple Long-Term Responses Observed in Heavily Pre-Treated HR+/HER2- Breast Cancer Range DoR (mon): 6+, 13+ % pt with DoR ≥6mo: 100% 5 10 9 3 6 Y - Y Y Y Y Y Y Y Y Prior LoT Prior ET? Prior CDK4/6? ESR1 status + - + + - HR+/ HER2- HR+/ HER2- HR+/ HER2- HR+/ HER2- HR+/ HER2- Subtype HR+/ HER2- HR+/
Slide 20: Durable cPR in Heavily Pre-Treated FGFR2-Amplified HR+ Breast Cancer
Durable cPR in Heavily Pre-Treated FGFR2-Amplified HR+ Breast Cancer Baseline Cycle 9 Courtesy Dr Tai, NCC Singapore ctDNA cleared at C2 Initial PR at Cycle 5, Max 46% tumor regression Patient ongoing treatment at Cycle 19 Generally tolerable safety profile with dose mods Maintained cPR on 20mg QD T
Slide 21: ORR & DCR by FGFR2 Alteration Types
ORR & DCR by FGFR2 Alteration Types Efficacy Parameter Fusion N=26 Amplification N=34 Mutation N=24 Best Overall Response, n (%) Partial response, n (%)* 9 (35%) 8 (24%) 3 (13%) Stable disease, n (%) 9 (35%) 13 (38%) 7 (29%) Progressive disease, n (%) 6 (23%) 9 (26%) 12 (50%) Not evaluable, n (%)**
Slide 22: Encouraging ORR Across FGFR2 Fusions and Amplifications in Key Tumor Types
Encouraging ORR Across FGFR2 Fusions and Amplifications in Key Tumor Types Efficacy Evaluable Fusions and Amplifications (N=60) ORR = Objective Response Rate; DCR = Disease Control Rate Note: ORR includes PR + 1 ongoing uPR in ovarian cancer patient with FGFR2 fusion confirmed after data extraction,
Slide 23: Current Limitations of Late Line Standard of Care for FGFR2 Non-CCA Tumors
Current Limitations of Late Line Standard of Care for FGFR2 Non-CCA Tumors Tumor Regimen(s) Med Prior LoT ORR HR+ Breast Cancer1,2 Endocrine Tx1, chemo2 1-3+ 2-16% Gastric Cancer3 Chemotherapy 2 4% Pancreatic Cancer4-6 Chemotherapy 1-2 0-6%* NSCLC7,8 Chemotherapy 2 6-7% Ovarian9,10 Chemotherapy 1-2^
Slide 24: RLY-4008 (lirafugratinib) – Safety Profile Consistent with Previous Data
RLY-4008 (lirafugratinib) – Safety Profile Consistent with Previous Data Treatment ongoing: N=38 (31%) Discontinued from study treatment N=86 (69%): Due to progressive disease N=73 (59%) Due to adverse event N=3 (2.4%; 2 unrelated) No treatment-related Grade 4/5 AEs Interruption, n (%) 59 (48%)
Slide 25: RLY-4008 (lirafugratinib) – Regulatory Strategy to Address More Patients
RLY-4008 (lirafugratinib) – Regulatory Strategy to Address More Patients Up to ~6k patients CCA Fusions Up to ~43k patients Tumor Agnostic Fusions Up to ~34k patients Tumor Agnostic Amplifications Up to ~28k patients Breast Cancer (all alts) Revised regulatory strategy: Initial NDA focused on broade
Slide 26: Relay Tx's Execution & Capital Focus on Highest Value Opportunities
Relay Tx’s Execution & Capital Focus on Highest Value Opportunities Target Program Annual US Patient # PI3Kα franchise RLY-2608 PI3KαPAN Monotherapy ~10-68K breast cancer ~76-238K all solid tumors Endocrine Tx (ET) doublet CDK4/6i + ET triplet RLY-5836 PI3KαPAN Monotherapy Endocrine Tx (ET) doublet
Slide 27: Relay Tx – Capital, Team & Execution Focus to Deliver on Key Milestones
Initial RLY-2608 data in 1H 2023 RLY-5836 clinical start in 2Q 2023 RLY-2608 expansion cohorts initiated 2H 2023 RLY-2608 Triplet Dose Escalation initiated by YE 2023 Additional data update in 2024 Relay Tx – Capital, Team & Execution Focus to Deliver on Key Milestones Undisclosed RLY-4008 (lirafugr
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Slide 29: RLY-4008 – Non-CCA Mutations
RLY-4008 – Non-CCA Mutations Note: ORR calculation includes 24 efficacy evaluable patients; mutations per local assessment ORR: 13% (3/24) DCR: 42% (10/24) 4 pt total ongoing: 2 responders 2 stable disease Add'l deep response (67% tumor reduction) in salivary gland cancer in pt previously treated wi
Slide 30: RLY-4008 – Non-CCA Mutations
RLY-4008 – Non-CCA Mutations Range DoR (mon): 9, 15 % pt with DoR ≥6mo: 100% Preliminary data as of 23 Aug 2023 C382R L763Hfs K659M C382R P253R N549K P253R R678G P253R L618F P253R P253R N549K C382R N549K S252W V564L N549K L550R S252W N549K C382R S252W N549K Mutation