Pursuant to Section 13 or 15(d) of the
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Date of Report (Date of earliest event reported): August 13, 2019
(Exact name of registrant as specified in its charter)
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301 Binney St., Suite 402
Cambridge, MA
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Registrant’s telephone number, including area code: (617) 401-9975
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Securities registered pursuant to Section 12(b) of the Act: 
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging Growth Company
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Item 7.01.    Regulation FD Disclosure.

On August 13, 2019, Synlogic, Inc. (the “Company”) updated its investor presentation (the “Investor Presentation”), which the Company expects to use in connection with general corporate presentations and will be made available on the Company’s website or distributed by the Company in hardcopy or electronic form.

A copy of the Company’s updated Investor Presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.  The Investor Presentation is current as of August 13, 2019, and the Company disclaims any obligation to update the Investor Presentation after such date.

In accordance with General Instruction B.2 on Form 8-K, the information set forth in this Item 7.01 and the Investor Presentation attached to this report as Exhibit 99.1 is “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended.

Item 9.01.    Financial Statements and Exhibits.

(d)            Exhibits

99.1            Investor Presentation of Synlogic, Inc., dated August 13, 2019

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date:  August 13, 2019
/s/ Todd Shegog  
Todd Shegog  
Chief Financial Officer  

Exhibit 99.1

   Synlogic   DESIGNED FOR LIFE  2019 Wedbush PacGrow Healthcare ConferenceScott Plevy, MD, Chief Scientific OfficerAugust 13, 2019 

 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 this presentation regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this presentation, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the approach we are taking to discover and develop novel therapeutics using synthetic biology; statements regarding the potential of our platform to develop therapeutics to address a wide range of diseases, including: inborn errors of metabolism, liver disease, inflammatory and immune disorders, and cancer; the future clinical development of Synthetic Biotic medicines; the potential of our technology to treat hyperammonemia and phenylketonuria; the expected timing of our anticipated clinical trial initiations; the benefit of orphan drug and fast track status; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials; the results of our collaborations; and the difficulty in predicting the time and cost of development of our product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the uncertainties inherent in the preclinical development process; our ability to protect our intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading “Risk Factors” in our filings with the SEC. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in our Annual Report on Form 10-Q filed with the SEC on August 8, 2019. The forward-looking statements contained in this presentation reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof. 

 Harnessing nature and technology to create LIVING medicines designed to significantly improve patients’ LIVES   Synthetic BioticTM Medicines Designed For Life 

   v              Synthetic BioticTM Medicines A Novel Class of Engineered Living Medicines  Designed genetic circuits to execute biological functionsDegradation of disease-causing metabolitesProduction of therapeutic molecules  Bacterial chassisNon-pathogenicAmenable to genetic manipulation  PATHWAYS, COMBINATIONS, BIOMARKERS  PROGRAMMABLE POTENCY AND CONTROL  LOCAL ACTIVITY, REDUCED SYSTEMIC TOXICITY              BIOTIC  SYNTHETIC 

   Synthetic Biotic Portfolio: Breadth and Potential  Initial Applications Designed to Target Different Sites of Action in Metabolic and Immunomodulatory Diseases  Oral Administration  IMMUNOMODULATION  METABOLIC DISEASES  Immuno-Oncology  Inflammatory and Autoimmune  Small or Large Intestine  “Cold” Solid Tumors  Small or Large Intestine  Rare MetabolicDisease  BroadMetabolicDisease 

   Investing in Development of a Robust Pipeline for a Range of Diseases          Hyperammonemia – Urea Cycle Disorder  Research  IND-Enabling Studies  Phase 1  Phase 2  Phenylketonuria  Additional Rare Metabolic Diseases  Hyperammonemia – Hepatic Encephalopathy (HE)  Inflammatory Bowel Disease  Immuno-Oncology Solid Tumors  Additional Oncology Applications  SYNB1020    SYNB1618        SYNB1020        SYNB1891        Rare Metabolic DiseasesBroad Metabolic DiseaseImmunomodulation   

 © 2019 SYNLOGIC. ALL RIGHTS RESERVED. | 7      Metabolic Disease Pipeline 

 UREA CYCLE DISORDERS (UCD)  SYNB1020 for Hyperammonemia Indications  Characterized by Systemic Ammonia Accumulation  Neuropsychiatric complication in patients with end-stage liver disease (cirrhosis)Liver dysfunction leads to ammonia accumulationToxic to brain, leading to HE crisis & hospitalizationPatients: 165,000 diagnosed overt patients in USUp to 70% of patients with cirrhosis characterized as covert (subclinical)Treatment: Lactulose: laxative with significant side effectsRifaximin: reduction in overt HE recurrence  Genetic defects in Urea CycleDeficiency in one of the six enzymes Nitrogen accumulates as toxic ammonia leading to metabolic crisisPatients: ~2,000 diagnosed in US; similar in EUTreatment: Ammonia scavengers: Buphenyl® (sodium phenylbutyrate), Ravicti® (glycerol phenylbuterate)Low protein diet with amino acid supplements  Target Profile to Address Unmet Need:Reduce episodes of hospitalizationImprove cognitive outcomes, Quality of Life  HEPATIC ENCEPHALOPATHY (HE)  Target Profile to Address Unmet Need:Maintain blood ammonia in normal range, avoid crisisProtein liberalization: 50-100% more per dayOral administration 

   Arginine  Urea  SYNB1020 Mechanism of Action:  Dose-responsive ammonia lowering in multiple preclinical models   Conversion of Toxic Ammonia into Beneficial Arginine for the Treatment of UCD and HE  Ammonia/NH4Cl  UreaCycle      Converts ammonia to Arginine  Can re-enter the Urea Cycle  Ammonia metabolism blocked in disease 

   SYNB1020 Clinical Data in Healthy Volunteers  Dose-dependent Exposure, Clearance on Cessation of Dosing and Strain Activity  DOSE-DEPENDENT INCREASE IN FECES  PLASMA NITRATE  URINARY NITRATE  CLEARANCE 

   SYNB1020 Clinical Development  Hepatic Encephalopathy Phase 1b/2a in Patients with Cirrhosis and Elevated Ammonia  Hepatic Encephalopathy Clinical TrialRandomized, double-blind placebo-controlled study ongoing at multiple sites in the US Primary outcome: establish safety/tolerability in patients with cirrhosis and elevated ammoniaSecondary outcome: reduction of ammonia  2018  2019  Q1  Q2  Q3  Q4  Q1  Q2  Q3  Q4  Phase 1b / 2a  PROGRAM  Hepatic Encephalopathy    Mild Cirrhosis Patients, MELD1<12, Open label, TID for 6 days  Sentinel cohort for safetyN = 6  Cirrhosis Patients: MELD < 20 & Elevated Ammonia; RCT, TID for 6 days  Proof of MechanismN up to 40    Safety Evaluation  Part 1  Part 2  1. MELD score: scoring system model for end-stage liver disease  Urea Cycle Disorders(Plans to continue development in UCD dependent on data from Ph 1b/2a HE study) 

   PKU is a rare inherited amino acid metabolism disorder Causes build up of amino acid phenylalanine (Phe) in the bodyToday, less than half of adults are at or below target Phe levels of 120-360 mmol / LIf left untreated, symptoms include cognitive impairment, convulsions, behavioral problems, skin rashPatients:16,500 diagnosed in US, similar in EU5Treatment: Phenylalanine is found in all proteins therefore low protein diet is followed (no meat, dairy, nuts, eggs)KUVAN® (sapropterin dihydrochloride): PAH cofactor. 20-40% of patients are respondersPalynziqTM (pegvaliase-pqpz): injectable, pegylated, bacterial enzyme (phenylalanine ammonia-lyase or PAL) for treatment of adult patients  SYNB1618 for Phenylketonuria (PKU)  Target Profile to Address Unmet Need:Manage Phe below target levels to prevent irreversible cognitive damageIncrease natural protein intake: classic PKU patients’ natural protein intake is typically less than 10g Oral dosing without systemic toxicity  Goal: Managing Plasma Phe Levels 

   SYNB1618 Potential to Address Unmet Need Across Patient Groups  360 mmol /L  Uncontrolled Adults  Partially Controlled Adults(Adults on Kuvanand/or low-Phe Diet)  Pediatric Patients (controlled / partially controlled) (Pediatric patients on Kuvan and / or low-Phe diet           Phe  Natural protein  Phe      Phe    Initial Focus 

 SYNB1618 Mechanism of Action  Amino acids from dietary proteins (absorption and recirculation)                  Phe  PKU  Healthy  Phenylalanine Hydroxylase (PAH) converts Phe into Tyrosine          Tyrosine  Accumulation of Phe to toxic levels  Impaired PAH                    SYNB1618      Manage Phe levels      SYNB1618 provides an alternative mechanismPAL3: produces TCA which is converted to HA in the liver and is excreted in urineLAAD: produces phenylpyruvate (PP)  IN VIVO EFFICACY IN (PKU) PAHenu2/enu2 MOUSE  Nat. Biotechnol. 2018 Oct;36(9):857-864 

 SYNB1618 Phase 1/2a Study Design  Single Ascending Dose (SAD)6 cohorts, N = 24  Multiple Ascending Dose (MAD)- TID x 7 days4 cohorts, N = 32    Dose ID  Single Dose (SD)N = 4  Multiple Dose (MD)TID x 7 daysN =10    Dose Confirm    MTD  Part 1: Healthy Volunteers  Part 2: PKU Patients  PKU Clinical Trial DesignRandomized, double-blind placebo-controlled study at multiple sites in the US Primary outcome: establish safety/tolerability following single and multiple doses in HV and PKU patients Secondary outcome: SYNB1618 kinetics in fecesExploratory: change from baseline in plasma and urinary biomarkers of Phe metabolism  Presented in September 2018  New Data 

 SYNB1618 in the Clinic: Safety  No treatment-related SAEs, no systemic toxicity or infections Mild or moderate severity treatment-related AEs. Most GI-relatedSingle dose MTD in healthy volunteers 2x1011 CFU Evaluated dose of 7x1010 CFU TID over seven days in PKU patients. Well tolerated - no discontinuations.All subjects cleared SYNB1618 (one PKU patient in follow-up). No evidence of colonization  Phase 1/2a SAD/MAD Study Demonstrates Safety and Clearance in Healthy Volunteers and PKU Patients  56 healthy volunteers, 14 PKU patients  Received at least one dose of SYNB1618 or placebo  AdultsAge range: 18-62 yrs old 

     SYNB1618 in the Clinic: Activity  Statistically Significant and Equivalent Activity of SYNB1618 in Healthy Volunteers and Patients  SYNB1618 or placebo  Protein shake / meal   D5-Phe         Measure over 6hrs:Plasma:Phe/D5-PheTCA/D5-TCAUrine: HA/D5-HA  Key: HA: Hippurate, D5-HA: labeled HA, CFB: change from baseline, CFP: change from placebo    MD URINARY HA AND D5-HA    

 Modeling: Potential For Phe Reduction in PKU Patients   % Blood Phe lowering  7x1010 1x1011 3x1011 5x1011  125100755025          TPP >30%  SYNB1618 Dose (CFU)  8-18%  11-26%  34-79%  57-131%  Ranges representLow: PAL mechanism only (conservative) High: PAL + LAAD activity (estimates maximum with both pathways) 

 Development of Lyophilized SYNB1618  Improved fermentation process enables production of a solid formulation of SYNB1618 with: Minimal impact on cell viability and activitySimilar activity to frozen liquid as measured by Phe consumption and biomarker productionImproved quality attributesPatient and commercialization-friendly presentationStability profile at 2-8 ◦C and room temperatureProcess is robust and reproducible at 30 L production scaleGMP cleanroom build-out has been completed, and lyophilized SYNB1618 material has been manufactured and released for clinical use 

 SYNB1618 Milestones  Established new solid formulation and manufacturing process Completed EPO1 interactions with FDA to align on program plans (clinical, manufacturing, toxicology) Completed Phase 1/2a study (healthy volunteers and PKU patients)Initiated bridging study with solid formulation Q3 2019Initiate efficacy study in PKU patients to assess Phe lowering 1H 2020           


       CHECKPOINT INHIBITORS HAVE TREATMENT FAILURES  Synlogic Vision for Immuno-Oncology  Expand the Benefits of Immunotherapy Broadly Across Tumor Types  Other tumors, where CPIs are not indicated, show little-to-no response to checkpoint inhibitors  Failure Rates for Select FDA Approved CPI Monotherapy      55%  NSCL 1st line      60%  Melanoma 1st line      71%  Bladder 1st line      87%  Cervical / Gastric 2nd line    Non-responders  For indications where immune checkpoint inhibitors are indicated, 55-87% of patients fail to respond  Nature often gives us hints to her profoundest secrets, and it is possible that she has given us a hint in which, if we will but follow, may lead us on to the solution of this difficult problem.  “    ”  Bacteria Recognized as Earliest Immunotherapy  DR. WILLIAM B. COLEYIMMUNO-ONCOLOGY PIONEER  Enable broad response and remission through engagement of multiple immunomodulatory pathways to enhance tumor inflammation and promote robust T cell responses 

 Dual Innate Immune Activator:  Synthetic biology applied to confer activities for efficacy and control for safetyDesigned as a dual innate immune activator: combined benefit of bacterial chassis and STING agonistThe dacA gene is integrated into genome under the control of inducible promoter (Pfnr) to produce c-di-AMP (CDA)Dual biosafety feature via auxotrophies – no proliferation in tumor, systemic circulation or environmentLearnings inform future combinations  ANAEROBIC ENVIRONMENT            dacA      Pfnr  ATP +ATP  Cyclic-di-AMP(STING Agonist)    02  AuxotrophiesDiaminopimelic acid (DAP)Thymidine  Synthetic Biotic Medicine Producing STING Agonist (SYNB1891) 

 Dual Innate Immune Activator SYNB1891  Designed to Locally Inflame the TME and Systemically Drive Tumor Antigen-Specific Immunity  Tumor Colonization without LeakageEnhanced Activity vs. Naked STING AgonistIntracellular Activation of STING and Bacterial-Induced Immune Pathways Within APCsDose-dependent Anti-tumor ActivityImmunological MemoryAtezolizumab supply agreement in placeIND Cleared by FDAPhase 1 monotherapy data expected in 2020  STING Agonism in Target Cells that Drive EfficacySparing Cells Where STING Agonism is DetrimentalActivation of Multiple Innate Immune PathwaysLow Systemic Risk  PROMISE OVER OTHER APPROACHES  PROGRESS TOWARDS THE CLINIC 

     Broad Ambitions in Immuno-Oncology      SYNB1891  DISCOVERY PORTFOLIO  INTRATUMORAL  Vision: Expand and Exceed the Effect of Cancer Immunotherapies  COMBINATIONS  HARNESS THE MICROBIOME  ORAL                     

   Builds off validated pilot program initiated in 2017  Provides access to Ginkgo’s industrial scale, high-throughput strain optimization and screeningEnables screening and identification of higher quality optimized candidates, increasing potential for success Delivers novel tools for increased candidate potencyIncluded equity investment at a premium, extending runway through multiple milestones   Platform Collaboration to Accelerate Development of Synlogic’s Synthetic Biotic Medicines    

   2019 Progress and Milestones  SYNB1618 in PKUCompleted Phase 1/2a study in healthy volunteers and patients, top-line data presentedFull data presentation Sept. 2019 (SSIEM)Bridging study initiatedSYNB1020 in HyperammonemiaPreclin. and HV clin. data published in Sci. Transl. Med.Complete ongoing study in patients with cirrhosisData expected 3Q2019 (safety, tolerability and ammonia-lowering)With ammonia-lowering data define development planSYNB1891 in Immuno-OncologyIND Cleared by FDAClinical trial material manufactured and CPI agreement in placeAdvance AbbVie collaboration establish Ginkgo collaborationAdvance preclinical pipeline 

   Harnessing nature and technology to create LIVING medicines designed to significantly improve patients’ LIVES   Synthetic BioticTM Medicines Designed For Life