Synlogic Inc · OTC:SYBX

Synlogic — Technical Presentation (October 2022)

24 slides from Synlogic's technical presentation, Oct 18, 2022

  1. Slide 1: Synpheny-1 Phase 2 Top-Line Results

    Synpheny-1 Phase 2 Top-Line Results Transforming Medicine Through Synthetic Biology October 18, 2022 Exhibit 99.2

  2. Slide 2: Forward Looking Statements

    Forward Looking Statements This press release 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 i

  3. Slide 3: Speakers

    Speakers Molly Harper Chief Business Officer Aoife Brennan, MB ChB President & CEO Caroline Kurtz, PhD. Chief Development Officer

  4. Slide 4: Opening Remarks

    Opening Remarks Dr. Aoife Brennan President & CEO © 2022 SYNLOGIC. SYNPHENY-1 PHASE 2 TOP-LINE RESULTS. ALL RIGHTS RESERVED. |

  5. Slide 5: PKU remains a profound burden

    PKU remains a profound burden Phase 2 top-line data confirm transformative potential of SYNB1934 Expect to initiate Phase 3 with SYNB1934 in H1 2023

  6. Slide 6: The Opportunity & Positioning for PKU

    © 2020 SYNLOGIC. QU©AR2T0E1R9LYSYRNELSOUGLTICS.. AALLLL RRIIGGHHTTSS RREESSEERRVVEEDD.. || 33 The Opportunity & Positioning for PKU Molly Harper Chief Business Officer © 2022 SYNLOGIC. SYNPHENY-1 PHASE 2 TOP-LINE RESULTS. ALL RIGHTS RESERVED. |

  7. Slide 7: PKU: Universally Diagnosed, Underserved

    PKU: Universally Diagnosed, Underserved OPPORTUNITY ~75% remain untreated1 pegvaliase (Palynziq®) sapropterin (Kuvan®) -20% Per clinician, KOL input4 Regulatory precedent for response target5 17,000 in the US;1 >150,000 globally2 Kuvan® achieved $500mm/yr with ~15% share3 Palynziq®: $300mm for 2022

  8. Slide 8: Designed to Fit with PKU Patients

    Designed to Fit with PKU Patients 2 Potential clinical positioning: as both monotherapy and adjunctive* treatment options Lack of systemic absorption Convenient, oral administration * to sapropterin (Kuvan®) Patient Presentation, SYNB1618 & SYNB1934

  9. Slide 9: Synpheny-1 Phase 2 Top-Line Results

    Synpheny-1 Phase 2 Top-Line Results Caroline Kurtz, PhD. Chief Development Officer © 2022 SYNLOGIC. SYNPHENY-1 PHASE 2 TOP-LINE RESULTS. ALL RIGHTS RESERVED. |

  10. Slide 10: Disposition & Demographics: Study Design

    Disposition & Demographics Study Design Phase 2 Synpheny-1 in Patients with PKU D5-Phe Tracer Study Fasting Plasma Phe Diet Run-In Dose Ramp1 Enrolled 20 adults with PKU (SYNB1618 =11, SYNB1934 = 9) All had Phe > 600 μM at screening, despite diet and/or sapropterin (Kuvan®), with mean of 1,041 μM an

  11. Slide 11: Robust Mean Reductions in Plasma Phe (All Comers)

    SYNB1934 SYNB1618 Data are LS mean +/- 95% CI SYNB1618 n=10; SYNB1934 n=5 * Defined as those that completed dosing Plasma Phe Change vs. Baseline (Day 14) Robust Mean Reductions in Plasma Phe (“All Comers”*) Note: The 95% confidence interval did not cross zero for either strain

  12. Slide 12: Robust Mean Reductions in Plasma Phe vs Kuvan benchmark

    SYNB1934 SYNB1618 Data are LS mean +/- 95% CI SYNB1618 n=10; SYNB1934 n=5 * Defined as those that completed dosing Plasma Phe Change vs. Baseline (Day 14) Robust Mean Reductions in Plasma Phe (“All Comers”*) Note: The 95% confidence interval did not cross zero for either strain Kuvan® pivotal study

  13. Slide 13: Responder Data Show Clinical Significance of Phe Lowering

    SYNB1934 6/10 achieved at least 20% Phe lowering1 Range among responders2 -20% to -61% Range among responders2 -29% to -80% 3/5 achieved at least 20% Phe lowering1 SYNB1618 Responder Data Show Clinical Significance of Phe Lowering Responder definition: >20% reduction vs. baseline in plasma Phe level

  14. Slide 14: Results Across All Participants Support Strength of Profile

    Data Based on Integrated Analysis with Arms 1 & 2 (n=15) Response 60% (9/15) achieved at least 20% Phe lowering* 42% mean Phe lowering in responders (n=9 responders) Responders Threshold Lowering 7/9 of the responders achieved Phe levels ≤600 µM 600 µM Results Across All Participants Support Strengt

  15. Slide 15: Data Confirm Potential as Adjunctive Treatment Option

    Data Confirm Potential as Adjunctive Treatment Option ADJUNCTIVE OPPORTUNITY ~75% remain untreated1 sapropterin (Kuvan®) Data included patients who received study drugs as an adjunct to ongoing treatment with sapropterin (Kuvan®) Adjunctive data for patients for both strains were consistent with bro

  16. Slide 16: Biomarkers Confirm Phe Metabolism in GI Tract by Both Strains

    Biomarkers Confirm Phe Metabolism in GI Tract by Both Strains Plasma D5-Phe* Data are LS mean +/- 95% CI; SYNB1618 n=10; SYNB1934 n=5 Inhibition of Phe Absorption Biomarkers of Strain Activity in GI Tract Plasma D5-TCA Urinary D5-HA SYNB1934 SYNB1618 * Primary Endpoint TCA = trans-cinnamic acid; HA

  17. Slide 17: Safety & Tolerability – Summary of Top-Line Findings

    Adverse events were all mild to moderate, predominantly GI in nature, and similar across SYNB1618 and SYNB1934. Across both arms, 3 patients discontinued due to GI-related AEs. One patient withdrew consent at the baseline visit and one reported facial flushing which was attributed to a potential all

  18. Slide 18: Phase 2 Top-Line Results Support Potential to Transform PKU

    Phase 2 Top-Line Results Support Potential to Transform PKU The vast majority of PKU patients need a medical treatment to lower Phe, with 75% untreated Clinically meaningful Phe reduction: SYNB1934 “All-comers” mean Phe reduction of -34% Strong response: 60% achieved clinical response across both st

  19. Slide 19: Conclusions

    Conclusions Dr. Aoife Brennan President & CEO © 2022 SYNLOGIC. SYNPHENY-1 PHASE 2 TOP-LINE RESULTS. ALL RIGHTS RESERVED. |

  20. Slide 20: PKU Program Has Clear Path to Phase 3

    SYNB1618: POC established SYNB1934: Greater potency confirmed in Phase 1 Committed to Ph. 3 based on strength of POC SYNB1618: Completed Ph. 2 SYNB1934: Generated data in PKU patients Monotherapy and adjunctive potential positioning confirmed Ph. 3 initiation with SYNB1934 Single, registrational stu

  21. Slide 21: PKU remains a profound burden

    PKU remains a profound burden Phase 2 top-line data confirm transformative potential of SYNB1934 Expect to initiate Phase 3 with SYNB1934 in H1 2023

  22. Slide 22: Advancing a New Class of Biotherapeutics

    Phenylketonuria (PKU) Inflammatory Bowel Disease (IBD) Enteric Hyperoxaluria SYNB8802 Homocystinuria (HCU) Gout Proof of Concept H2 2022 Combo study late ‘21 Metabolic Immunology SYNB1934 IBD Program - Single Target Exploratory Preclinical IND-Enabling Studies Phase 1 Phase 2 Phase 3 Ph 1 HV Data H2

  23. Slide 23: Available For Questions

    Available For Questions Dave Hava, PhD Chief Scientific Officer Michael Jensen Chief Financial Officer Antoine Awad Chief Operating Officer Molly Harper Chief Business Officer Aoife Brennan, MB ChB President & CEO

  24. Slide 24: Thank You

    Thank You © 2022 SYNLOGIC. SYNPHENY-1 PHASE 2 TOP-LINE RESULTS. ALL RIGHTS RESERVED. |

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