Synlogic Inc · OTC:SYBX
Synlogic — Technical Presentation (December 2022)
26 slides from Synlogic's technical presentation, Dec 15, 2022
Slide 1: Proof of Concept for SYNB8802 for Enteric Hyperoxaluria
Exhibit 99.2 Transforming Medicine Through Synthetic Biology Proof of Concept for SYNB8802 for Enteric Hyperoxaluria Top-Line Results from Phase 1b Study December 15, 2022 © © 2 20 02 22 2 SY SYN NLO LOG GIIC C.. P PR RO OO OF F O OF F C CO ON NC CE EP PT T F FO OR R SY SYN NB B8 88 80 02 2 IIN N E
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in t
Slide 3: Speakers
Speakers Aoife Brennan, MB ChB Kyle Wood, MD Caroline Kurtz, PhD Dave Hava, PhD President & CEO Associate Professor, Urology, Chief Development Officer Chief Scientific Officer University of Alabama at Birmingham © 2022 SYNLOGIC. PROOF OF CONCEPT FOR SYNB8802 IN EH. ALL RIGHTS RESERVED.
Slide 4: Opening Remarks
Opening Remarks Dr. Aoife Brennan President & CEO © © 2 20 02 22 2 SY SYN NLO LOG GIIC C.. P PR RO OO OF F O OF F C CO ON NC CE EP PT T F FO OR R SY SYN NB B8 88 80 02 2 IIN N E EH H.. A ALL R LL RIIG GH HT TS R S RE ESE SER RV VE ED D..
Slide 5: SYNB8802: Enteric POC Achieved with Potential for Hyperoxaluria
SYNB8802: Enteric POC Achieved with Potential for Hyperoxaluria & Urinary Oxalate First Approved the Burden of Lowering from Treatment for Recurrent Phase 1b Study Enteric Kidney Stones Hyperoxaluria © 2022 SYNLOGIC. PROOF OF CONCEPT FOR SYNB8802 IN EH. ALL RIGHTS RESERVED.
Slide 6: Enteric Hyperoxaluria & Recurrent Kidney Stones: An Overview
Enteric Hyperoxaluria & Recurrent Kidney Stones: An Overview Dr. Kyle Wood Associate Professor, Urology University of Alabama at Birmingham © 2020 SYNLOGIC. QU ARTE R LY R ES U LT S.A LLRIG H TS RESERVED .| 3 © 2022 SYNLOGIC. PROOF OF CONCEPT FOR SYNB8802 IN EH. ALL RIGHTS RESERVED. © 201 9 SY NLO G
Slide 7: Enteric Hyperoxaluria (EH) & Recurrent Kidney Stones
`` `` Enteric Hyperoxaluria (EH) & Recurrent Kidney Stones • Oxalate crystals damage kidneys, impair renal Excruciating function Pain • Can lead to CKD, ESRD, Dietary Oxalate*: nephrocalcinosis, plant-derived; in systemic oxalosis excess, absorbed Circulating from GI tract into oxalate results in ci
Slide 8: Urinary Oxalate Levels: Recognized Predictor of Recurrent Stones
Urinary Oxalate Levels: Recognized Predictor of Recurrent Stones Higher urinary oxalate (UOx) levels predict stone events in EH patients, with ~20% decrease in UOx associated with ~25% reduction in annual 1 stone event risk 1. D’Costa, et al. Nephrol Dial Transplant (2020) © 2022 SYNLOGIC. PROOF OF
Slide 9: Urinary Oxalate Levels and GI Malabsorption Increase Risk for CKD
Urinary Oxalate Levels – and GI Malabsorption - Also Increase Risk for CKD Incident CKD Risk vs. Baseline Methodology • Largest population-based study on the Urinary Oxalate & GI Malabsorption relationship of urinary oxalate levels and incident All Subjects CKD to date 3.0 Malabsorption Condition •
Slide 10: Hyperoxaluria May Have Genetic or Enteric Etiology
Hyperoxaluria May Have Genetic or Enteric Etiology Primary Hyperoxaluria (PH) Enteric Hyperoxaluria (EH) Pathology Rare genetic condition Dietary oxalate hyperabsorption Onset Pediatric Adult Underlying insult to bowel: including IBD, Etiology Genetic liver enzyme deficiency bariatric surgery, other
Slide 11: Clinical Path: Differential Diagnosis to Enteric Hyperoxaluria
Clinical Path: Differential Diagnosis to Enteric Hyperoxaluria Etiology of Oxalate Clinical Presentation Stone Composition Malabsorption Source of GI Injury Other Genetic High Risk of Recurrent Kidney Calcium Oxalate Stones Surgery Idiopathic 1 Stones (“annual stone 1 formers”) 2 Enteric IBD/Crohn’s
Slide 12: Today, Treatment for EH is Limited to Dietary Restrictions
Today, Treatment for EH is Limited to Dietary Restrictions Stone Etiology Current Management Strategy Low Volume Increase fluid intake Ø Modest efficacy Hypocitraturia Citrate supplements Ø Avoids healthy foods (e.g. green vegetables) Low oxalate diet, calcium supplements, Hyperoxaluria Ø Calcium su
Slide 13: Proof of Concept Data for SYNB8802
Proof of Concept Data for SYNB8802 Caroline Kurtz, PhD. Chief Development Officer © 2022 SYNLOGIC. PROOF OF CONCEPT FOR SYNB8802 IN EH. ALL RIGHTS RESERVED.
Slide 14: SYNB8802: Consuming Oxalate in the GI Tract to Prevent Absorption
SYNB8802: Consuming Oxalate in the GI Tract to Prevent Absorption Our Approach Precision Engineering of Probiotic Oral therapy Consume oxalate in the GI tract Gut lumen Intestinal epithelium Reduce oxalate in the urine Consumes Oxalate Throughout GI Tract © 2022 SYNLOGIC. PROOF OF CONCEPT FOR SYNB88
Slide 15: SYNB8802 Differentiation: Targeting Oxalate Throughout the GI Tract
SYNB8802 Differentiation: Targeting Oxalate Throughout the GI Tract Oxalate Absorption ABSORPTION SITES OF ACTION Dietary Oxalate Healthy Disease State State Stomach • SYNB8802 consumes oxalate throughout Small Intestine the GI tract • Extends duration of action, increasing Colon oxalate-lowering ef
Slide 16: SYNB8802-CP-002 Phase 1b Study Design
SYNB8802-CP-002 Phase 1b Study Design Phase 1b Study Design Randomized, placebo-controlled Day -3 -2 -1 1 2 3 4 5 6 7 8 9 10 11 12 parallel arm, in-patient study Treatment Treatment Primary endpoint: safety and tolerability 11 11 3 x 10 1 x 10 Placebo Treatment Controlled diet: Standardized dietary
Slide 17: Urinary Oxalate Levels Show Dose-Related Change with SYNB8802
Urinary Oxalate Levels Show Dose-Related Change with SYNB8802 Urinary Oxalate Values During Dosing Period* Phase 1b SYNB8802-CP-002 Study 40 • Urinary oxalate levels at screening were consistent with 30 diet and patient population (at ~30), and generally remained consistent with baseline values duri
Slide 18: POC Achieved by Lowering of Urinary Oxalate
POC Achieved by Lowering of Urinary Oxalate SYNB8802 Urinary Oxalate Lowering vs. Baseline Compared to Placebo* Phase 1b SYNB8802-CP-002 Study 0% • Findings demonstrate that by consuming oxalate in the GI tract to prevent its absorption, SYNB8802 resulted in changes -20% in urinary oxalate in gastri
Slide 19: Safety and Tolerability Findings
Safety and Tolerability Findings SYNB8802 – Proof of Concept from 002 Study Top-Line Results • SYNB8802 was well tolerated, with no serious adverse events • The most common adverse events were GI-related, mild, and transient • The GI-related AEs occurred at a similar frequency in active and placebo
Slide 20: SYNB8802: Proof of Concept Achieved, Focused Path Forward
SYNB8802: Proof of Concept Achieved, Focused Path Forward • EH: Well-recognized burden of recurrent stones, with no FDA approved specific medical treatment options • SYNB8802: POC data shows potential for a powerfully differentiated treatment • Dose related lowering of UOx established in patients wi
Slide 21: Cross-Platform Implications
Cross-Platform Implications Dave Hava, PhD Chief Scientific Officer © 2020 SYNLOGIC. QU ARTE R LY R ES U LT S.A LLRIG H TS RESERVED .| 3 © 201 9 SY NLO G IC. ALL RI G HTS RESERVE D. | 3 © 2022 SYNLOGIC. PROOF OF CONCEPT FOR SYNB8802 IN EH. ALL RIGHTS RESERVED.
Slide 22: SYNB8802 POC: A Milestone for Synthetic Biotic Platform
SYNB8802 POC: A Milestone for Synthetic Biotic Platform rd ü 3 positive data readout in 4Q 2022, following proof of concept in PKU, and proof of mechanism in HCU ü 2nd disease state with POC achieved ü Platform experience accelerates learnings, for dosing, tolerability © 2022 SYNLOGIC. PROOF OF CONC
Slide 23: Concluding Remarks
Concluding Remarks Dr. Aoife Brennan President & CEO © © 2 20 02 22 2 SY SYN NLO LOG GIIC C.. P PR RO OO OF F O OF F C CO ON NC CE EP PT T F FO OR R SY SYN NB B8 88 80 02 2 IIN N E EH H.. A ALL R LL RIIG GH HT TS R S RE ESE SER RV VE ED D..
Slide 24: Advancing a New Class of Biotherapeutics
Advancing a New Class of Biotherapeutics IND- Exploratory Preclinical Enabling Phase 1 Phase 2 Phase 3 Studies Phenylketonuria (PKU) FT SYNB1934* ODD (US) ODD SYNB1353 FT ODD Homocystinuria (HCU) SYNB8802 (US) Metabolic SYNB8802 Enteric Hyperoxaluria ODD Gout SYNB2081 Inflammatory Bowel Disease (IBD
Slide 25: Available For Questions
Available For Questions Aoife Brennan, MB ChB Caroline Kurtz, PhD Dave Hava, PhD Kyle Wood, MD President & CEO Chief Development Officer Chief Scientific Officer Associate Professor, Urology, University of Alabama at Birmingham Michael Jensen Molly Harper Antoine Awad Chief Financial Officer Chief B
Slide 26: Thank You
Thank You © 2022 SYNLOGIC. PROOF OF CONCEPT FOR SYNB8802 IN EH. ALL RIGHTS RESERVED. © 2022 SYNLOGIC. PROOF OF CONCEPT FOR SYNB8802 IN EH. ALL RIGHTS RESERVED.