Spyre Therapeutics, Inc. · NASDAQ:SYRE
Spyre Therapeutics — Aeglea BioTherapeutics — Investor Presentation (December 2018)
13 slides from Spyre Therapeutics's investor presentation, Dec 11, 2018
Slide 1: Investor Presentation
INVESTOR PRESENTATION | PUBLIC
Slide 2: Forward Looking Statements
Forward Looking Statements entation and the accompanying oral presentation contain “forwarcl-Jooking' statements that are hased on our manaviem ent's beliefs and assumptions and on inform vailable to manayem ent. Forwarcl-Jooking statem ents include all statem ents other than statem ents of historic
Slide 3: Clinical-Stage Biotechnology Company Designing Human Enzyme Therapeutics
Clinical-Stage Biotechnology Company that Designs & Develops Innovative Human Enzy: aeglea Therapeutics for Patients with Rare Genetic SICTIERAPELTICS Diseases and Cancer A Thi Lead Investigational Program Ss Pegzilarginase — Phase 3 ARG1-D Employees. Pipeline: 59 Homocystinuria Cystinuria “Non-GAAP
Slide 4: Introduction to PEACE: Pegzilarginase Effect on Arginase Deficiency Clinical Endpoints
\troduction to PEACE zilarginase Effect on Arginase Deficiency Clinical Endpoints ise 3 Pivotal Ti 2 BioThetapeutis ARG1-D: a severe disease impacting children w progressively worsening complications leading t severe disabilities and early death Single, global pivotal trial to support registration a
Slide 5: Pivotal Phase 3: Trial Design
E Pivotal Phase 3: Trial Design 24 weeks a: Pegzilarginase (N=20) Open Label Extension 1 Randomization Pegzilarginase study pattvipants remain on current jsease Mranatiernentfor the duration of the trial Endpoints 1. Primary — plasma arginine reduction 2. Secondary — measures of mobility, adaptive b
Slide 6: Pivotal Phase 3: Key Design Elements
E Pivotal Phase 3: Key Design Elements Eligibility Criteria ma arginine greater than 250M (mean) ars or older cit in mobility or adaptive behavior )mg/kg adjustments in the double-blind treatment period can be made to optimize plasma arginine control for levels outside the range of 50-1 Jed, weekly
Slide 7: Pivotal Phase 3: Primary Endpoint of Arginine Reduction
SE Pivotal Phase 3: Primary Endpoint Of Arginine Reduction Phase 1/2 Part 2 and Open-Label Extension (OLE) 9 9 9 5 Part 28. PreDoseWk25 __PreDoseWk6SandFiY OLE Pre-Dose Baseline; Wk=eok: FIUSFolonup Treatment Guidance 2 Bio Therapeutic Insights From Phase 1/2 Trial + Current disease management fails
Slide 8: Pivotal Phase 3: Secondary Endpoints
E Pivotal Phase 3: Secondary Endpoints lical outcomes measured utilizing validated assessments obility [ZMWT, FMA (comprised of FMS and GFAQ)] laptive behavior (Vineland) sponse rate for each individual clinical assessments al number of mobility and adaptive behavior responses per patient portion of
Slide 9: Elements for Successful Execution of Pivotal Trial for Pegzilarginase in ARG1-D
‘nts For Successful Execution of Pivotal Trial for Pegzilarginase in ARG1 Understanding of ARG1-D and Effects of Pegzilarginase Phase 1/2: ivotal Trial Readiness Community Engagement Patient Finding Moment slobal CRO engaged and Growing enthusiasm Increased number of drug supply complete among patie
Slide 10: Growing Confidence in Aeglea's Patient Finding Efforts
ng Confidence in Aeglea’s Patient Finding Efforts 170+ Patients 140+ Patients 100+ Patients April September December 2018 2018 2018 2 BioTherapeutcs United States 50+ Patients Rest of World Europe 100- Patients
Slide 11: PEACE: Summary and Next Steps
E: Summary and Next Steps CE is a single, global pivotal trial CE is aligned with collaborative it from FDA and EMA se 1/2 data demonstrates clinical ent finding momentum and trial ation underway Primary endpoint: arginine reduction Secondary endpoints: clinical outcomes, safety and 30 patients, ran
Slide 12: Pipeline Building Using a Unique Drug Hunting Approach
ne Building Using A Unique Drug Hunting Approach rginase nine Arginase 1 Deficiency Cystinuria Homocystinuria Undisclosed Cutaneous Melanoma, Uveal Melanoma, SCLC - Single rginase Agent Expansion ine SCLC ~ Combination with Checkpoint Inhibitor 3103 Tejuine Can02" Metabolism 2108 Cancer Metabolism c
Slide 13: Slide 13
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