UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
_________________________________________________________________________________
 
 
FORM 8-K
 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): August 20, 2019
 
SYNLOGIC, INC.
 
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-37566
 
26-1824804
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)

301 Binney St., Suite 402
Cambridge, MA
 
 
02142
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (617) 401-9975
 
 Not applicable
(Former Name or Former Address, if Changed Since Last Report)
 
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):
 
☐  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock
SYBX
The Nasdaq Capital Market
 
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 ☒
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
 

 
Item 7.01. Regulation FD Disclosure.

On August 20, 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 20, 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 8.01. Other Events.

On August 20, 2019, Synlogic issued a press release announcing the discontinuation of its SYNB2010 program being evaluated in patients with cirrhosis and elevated blood ammonia for the treatment of hyperammonemia.

The full text of Synlogic’s press release regarding the announcement is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01.                          Financial Statements and Exhibits.

(d)              Exhibits

99.1            Investor Presentation of Synlogic, Inc. dated August 20, 2019
99.2            Press release dated August 20, 2019



SIGNATURES
 
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.
 
 
  SYNLOGIC, INC.
     
Date:  August 20, 2019 
By:
/s/ Todd Shegog
  Name:
Todd Shegog
  Title:
Chief Financial Officer
 

Exhibit 99.1

   Synlogic   DESIGNED FOR LIFE   August 2019Corporate Presentation 
 

 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, inflammatory and immune disorders, and cancer; the future clinical development of Synthetic Biotic medicines; the potential of our technology to treat 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, and in any subsequent filings we make with the SEC. 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        Research  IND-Enabling Studies  Phase 1  Phase 2  Phenylketonuria  Additional Rare Metabolic Diseases  Inflammatory Bowel Disease  Immuno-Oncology Solid Tumors  Additional Oncology Applications  SYNB1618            SYNB1891        Rare Metabolic DiseasesImmunomodulation   
 

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

   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 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      When Phe is not efficiently metabolized (PKU) SYNB1618 provides an alternative mechanismPAL3: produces TCA which is converted to HA in the liver and is excreted in urineLAAD: produces phenylpyruvate (PP)  Phenylalanine (Phe)  Hippuric Acid (HA)    Engineered Probiotic Bacteria: E. coli NissleComponents of Synthetic Genetic Circuit  trans-Cinnamic Acid (TCA)      PheP: High-Affinity Uptake    trans-Cinnamic Acid (TCA)  pheP  PAL3  Metabolic Conversions  FNR  FNR  FNR  FNR  Phenylalanine        LAAD  AraC  AraC  Phenylalanine (Phe)      Phenylpyruvate (PP)     
 

   SYNB1618 Preclinical Characterization  Biomarkers Demonstrate Activity of SYNB1618 in Mouse Model of PKU and Healthy NHPs  IN VIVO EFFICACY IN (PKU) PAHenu2/enu2 MOUSE  DOSE RESPONSE IN HEALTHY NHPs  Nat. Biotechnol. 2018 Oct;36(9):857-864  Development of synthetic live bacterial therapeutic for the human metabolic disease phenylketonuriaVincent M Isabella et al, Synlogic, Inc. 
 

 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 (HV)  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  There were no treatment-related serious adverse events, no systemic toxicity or infections Treatment-emergent adverse events were either mild or moderate in severity, and reversible. Most adverse events were GI-relatedSingle dose MTD in healthy volunteers was defined as 2x1011 CFU. Doses above this level were associated with dose-limiting GI adverse eventsBased on pharmacodynamic data and tolerability profile, a dose of 7x1010 CFU was identified for the second part of the study in PKU patientsDose of 7x1010 CFU TID over seven days was well-tolerated in PKU patients. There were no discontinuations.All subjects cleared the bacteria (one PKU patient in follow-up). There was no evidence of colonization, and no subject required antibiotics  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) 
 

   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 
 

 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 
 

 Batch to Batch Consistency of SYNB1618 Solid Formulation        Viability   Activity in WT mice  
 

 Stability of SYNB1618 Solid Formulation  
 

 Upcoming Milestones and Path Forward  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)Initiate bridging study with solid formulation in Q3 2019Phase 2 study in PKU patients to assess Phe lowering to start in 1H 2020                   
 

 © 2019 SYNLOGIC. ALL RIGHTS RESERVED. | 20    Immuno-Oncology Pipeline  © 2019 SYNLOGIC. ALL RIGHTS RESERVED. CONFIDENTIAL | 20 
 

       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 Biotic Medicine Producing STING Agonist (SYNB1891)  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 
 

 SYNB1891 In Vitro Characterization  Interferon Production Across Multiple Human STING Alleles – Activity Greater than Naked STING Agonist   HUMAN PRIMARY DENDRITIC CELLS  REPORTER HUMAN MONOCYTIC LINE  Human STING Alleles  STING Knockout 
 

 SYNB1891 In Vivo Characterization  d1  107, 5x107 or 108 CFU, i.t. (SYNB1891-PT1)  A20 tumors ~100 mm3, randomize groups  d7  d4  d18    Dose-dependent Anti-tumor Activity of SYNB1891 Prototype Strain (PT1) as a Single Agent  Control  Control  SYNB1891-PT1 (1 x 107)  SYNB1891-PT1 (5 x 107)  SYNB1891-PT1 (1 x 108)          = Dose 
 

   SYNB1891 In Vivo Characterization  SYNB1891 Prototype Strain (PT1) Leads to Systemic Anti-tumor Immunity      SYNB1891-PT1 dose    Re-challenge        d1  108 CFU, i.t. (Bacteria)  A20 tumors ~80-100 mm3, randomize groups  d7  d4  d35  d63  Rechallenge (2e5 A20 cells)  d1 
 

 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 
 

   A Tumor Can Evade Multiple Critical Aspects of the Cancer-Immunity Cycle    Killing  Recognition  Infiltration  Antigen release  Presentation  Priming and activation  T cell trafficking      Insufficientactivity/proliferation  Immuno-suppression  Insufficient trafficking  Insufficient priming  Recognized Need to Combine Mechanisms to Broaden the Benefit of Immunotherapy  Adapted from Chen, Melman; Immunity 2013  MONOTHERAPIES OFTEN FAIL TO OVERCOME TUMOR EVASION MECHANISMS  Rationally Designed for Combinatorial EffectLocally Inflame the tumor microenvironment (TME)Systemically Drive Tumor-Antigen Specific Immunity In Situ Vaccination: Neo-antigen Priming and Sustained Immune Response  ENGINEER LIVING SOLUTIONS: SYNTHETIC BIOTIC MEDICINES 
 

 Additional Synthetic Biotic Effectors  VISION: Rational Design to Locally Inflame the TME AND Systemically Drive Tumor-Antigen Specific Immunity  Chassis effectCXCL10Hyaluronidase  Kyn ConsumptionAde ConsumptionαPD-1 scFv  Chassis effect5FC5FUSTINGαCD40 scFv/CD40L  TNFαIFNγαCD47 ScFv / SirpαGM-CSF      TUMOR  LYMPH NODE  Systemic Tumor-Antigen Specific Immunity           Locally Inflame the TME   IL-15; IL-12Arg Production4-1BBLOX40L    RELIEVE IMMUNOSUPRESSION  PROMOTE AND SUSTAIN IMMUNE ACTIVATION  PRIME FOR TUMOR-ANTIGEN-SPECIFIC VACCINATION  PROMOTE TRAFFICKING 
 

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

   Synlogic Internal GMP Manufacturing Capabilities  In-house Process Development and Clinical Manufacturing for Early & Mid-Stage Trials      Biotherapeutic Manufacturing  Candidate Selection & Process Dev.          Testing (in vitro and in vivo)  Strain Engineering  OptimizedProcess  Scale-up    Process development and lab scale production    MicrobioreactorsHigh throughput strain screening & process development  Fermentation  DownstreamHarvest/Formulation  Lyophilization, milling, & capsule fill  Discovery  Lead Optimization  Pre-IND  Phase 1  Mid-Stage Trials      Analytical Methods Development and Validation   
 

   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 potencyIncludes 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.Completed Phase 1b/2a study in patients with cirrhosis (program discontinued)SYNB1891 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 
 

     301 BINNEY ST., #402, CAMBRIDGE, MA 02142TEL: 617-401-9975WEB: WWW.SYNLOGICTX.COM | EMAIL: INFO@SYNLOGICTX.COM© SYNLOGIC. CONFIDENTIAL. ALL RIGHTS RESERVED. 
 

Exhibit 99.2


Synlogic Discontinues Development of SYNB1020 to Treat Hyperammonemia

SYNB1020 well tolerated in Phase 1b/2a study, but did not lower blood ammonia in patients with cirrhosis –

Company will focus resources on advancement of SYNB1618, SYNB1891 and new early development programs –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--August 20, 2019--Synlogic, Inc., (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, today announced that it is discontinuing development of SYNB1020, an early stage clinical product candidate for the treatment of hyperammonemia. The decision to discontinue the program was based on top-line data from an interim analysis of a randomized, double-blind, placebo-controlled Phase 1b/2a study of the Synthetic Biotic medicine in 23 patients with cirrhosis and elevated blood ammonia. The study was designed to evaluate the safety and tolerability of SYNB1020 treatment, as well as changes in blood ammonia levels and several exploratory endpoints associated with early stage hepatic encephalopathy (HE). SYNB1020 was well tolerated in patients with cirrhosis. Plasma and urinary nitrate increased in subjects treated with SYNB1020, indicating that the strain was active, but there was no evidence of blood ammonia lowering or changes in other exploratory endpoints relative to placebo.

“We are disappointed that results from our Phase 1b/2a study of SYNB1020 did not demonstrate an activity profile in ammonia lowering that warranted continued development of the program. We would like to thank the patients and investigators who participated in the clinical trial and contributed to this research,” said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer. “Moving forward, we will focus our resources on advancement of SYNB1618 for the treatment of phenylketonuria, SYNB1891 for the treatment of solid tumors and several new programs in early development.”

Detailed results of the Phase 1b/2a study are expected to be presented at a future scientific or medical conference.

About Synlogic’s Phase 1b/2a Trial of SYNB1020 in Patients with Cirrhosis

The study had two parts. First, an initial sentinel open-label cohort of six subjects with cirrhosis and a Model for End-Stage Liver Disease (MELD) score < 12 received orally administered SYNB1020 (5 x 1011 CFU TID) for six days. Subjects were admitted to an inpatient facility for a run-in diet, baseline assessments, safety monitoring, and collection of blood, urine, and fecal samples for the evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of treatment. The safety data were reviewed by a safety data monitoring committee and the second part of the trial was opened for enrollment.

The second part of the trial comprised a randomized, double-blinded, placebo-controlled study in patients with cirrhosis and hyperammonemia. Eligible subjects were admitted to an inpatient facility for a run-in diet period of five days and 24-hour ammonia profile (AUC), and those subjects with elevated plasma ammonia levels were randomized and received either placebo or orally administered SYNB1020 (5 x 1011 CFU TID) for six days. A total of 17 subjects entered Part 2 of the trial of which, eight subjects received placebo. The primary endpoint of the study was safety and tolerability. In addition, the study evaluated the effect of SYNB1020 administration on plasma ammonia levels as well as other exploratory endpoints, including levels of inflammatory markers IL-6, TNF-alpha, and endotoxin, and psychometric hepatic encephalopathy score (PHES).


About Synlogic
Synlogic is pioneering the development of a novel class of living medicines, Synthetic Biotic medicines, based on its proprietary drug development platform. Synlogic leverages the tools and principles of synthetic biology to genetically engineer probiotic microbes to perform or deliver critical functions missing or damaged due to disease. The company’s lead program, SYNB1618, targets phenylketonuria (PKU). When delivered orally, Synthetic Biotic medicines can act from the gut to compensate for the dysfunctional metabolic pathway and have a systemic effect, with the potential to significantly improve symptoms of disease for affected patients. In addition, the company is developing SYNB1891 as an immunostimulatory approach for the treatment of advanced solid tumors. Further, the company is leveraging the broad potential of its platform to create Synthetic Biotic medicines for the treatment of other more common diseases, including inflammatory and immune disorders. Synlogic is collaborating with AbbVie to develop Synthetic Biotic-based treatments for inflammatory bowel disease (IBD). For more information, please visit www.synlogictx.com.

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, including statements regarding Synlogic’s plans and expectations for the development of SYNB1020 and its other product candidates. All statements, other than statements of historical facts, included in this press release 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 press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Synlogic may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential of Synlogic’s platform to develop therapeutics to address a wide range of diseases including: cancer, inborn errors of metabolism and inflammatory and immune disorders; the future clinical development of Synthetic Biotic medicines; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic’s clinical trials and availability of clinical trial data. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including: the uncertainties inherent in the preclinical development process; the ability of Synlogic to protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading “Risk Factors” in Synlogic’s filings with the SEC. The forward-looking statements contained in this press release reflect Synlogic’s current views with respect to future events. Synlogic anticipates that subsequent events and developments will cause its views to change. However, while Synlogic may elect to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Synlogic’s view as of any date subsequent to the date hereof.

Contacts

MEDIA CONTACT:
Caroline Rufo, Ph.D.
MacDougall
Phone: 781-235-3060
Email: crufo@macbiocom.com

INVESTOR CONTACT:
Elizabeth Wolffe, Ph.D.
Synlogic, Inc.
Phone: 617-207-5509
Email: liz@synlogictx.com