Synlogic Reports First Quarter 2020 Financial Results and Provides Business Update

CAMBRIDGE, Mass., May 8, 2020 /PRNewswire/ -- Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, today reported its financial results for the first quarter ended March 31, 2020.

"In the first quarter, we continued to advance our programs and enhance our Synthetic Biotic platform capabilities in synthetic biology, manufacturing and development. While the coronavirus pandemic necessitated we update a number of our development plans, I am very grateful to our dedicated employees who have enabled us to continue to execute on our strategy under challenging circumstances," said Aoife Brennan, M.B., Ch.B., Synlogic's president and chief executive officer. "We look forward to showcasing our deep platform capabilities and expanding program portfolio at our upcoming virtual R&D event on May 27(th), which will include more details on one of our newest and rapidly advancing programs in enteric hyperoxaluria."

2020 Priorities

Pipeline

    --  Initiation of a Phase 2 clinical trial to evaluate a solid formulation
        of SYNB1618 in patients with phenylketonuria (PKU). SYNB1618 is an
        orally administered Synthetic Biotic medicine that is being developed as
        a treatment for PKU.
        --  Synlogic intends to continue to work with sites to complete
            preparatory work, however as a result of the coronavirus pandemic it
            does not expect to be able to enroll subjects into its Phase 2
            clinical trial of SYNB1618 until it is safe for patients to enter
            clinical trial sites.
        --  The Phase 2 trial is designed to evaluate safety and tolerability of
            a solid formulation of SYNB1618 as well as its potential to lower
            blood phenylalanine levels in PKU patients. In addition, the study
            is expected to provide valuable information to validate predictive
            pharmacodynamic and preclinical modeling.
    --  Evaluation of data from the monotherapy arm of the Phase 1 clinical
        study of SYNB1891 in patients with advanced solid tumors or lymphoma. 
        SYNB1891 is an intra-tumorally administered Synthetic Biotic medicine
        engineered to produce cyclic di-AMP, an agonist of the STING pathway,
        that is designed to serve as a dual innate activator of the immune
        system as a potential treatment for solid tumors or lymphoma. SYNB1891
        is being evaluated as a monotherapy in an ongoing Phase 1 open-label,
        multicenter, dose escalation clinical trial (NCT04167137) in patients
        with advanced solid tumors or lymphoma.
        --  While this clinical trial and most clinical sites have remained open
            and enrolled patients have continued on study, Synlogic expects
            slower enrollment of new patients as a result of the coronavirus
            pandemic, which has the potential to impact the availability of data
            in 2020.
    --  Continued development of patient and commercialization-appropriate drug
        presentations of SYNB1618.
        --  Synlogic has developed and manufactured a solid formulation of its
            Synthetic Biotic SYNB1618 that it plans to use in future clinical
            trials and continues to evaluate and develop different drug
            presentations (e.g. capsule, pressed pill, sachet) for eventual
            commercialization.
    --  Advancement of new Synthetic Biotic programs in metabolic diseases with
        high unmet medical need.
        --  Synlogic is conducting preclinical studies of Synthetic Biotic
            medicines to treat enteric hyperoxaluria, an acquired metabolic
            disorder in which patients develop recurrent kidney stones due to
            elevated urinary oxalate levels and are at an increased risk of
            kidney failure. Synlogic expects to move a clinical candidate in its
            enteric hyperoxaluria program, into IND-enabling studies in 2020.
        --  In addition, Synlogic is also developing Synthetic Biotic medicines
            for the treatment of other metabolic diseases, including maple syrup
            urine disease (MSUD), a rare inherited metabolic disease caused by
            defective enzymes that metabolize branched chain amino acids (BCAAs)
            which are components of protein.
    --  Publication and presentation of data demonstrating the breadth and
        potential of its Synthetic Biotic platform.
        --  On March 8(th), Nature Communications published a Perspective
            authored by Synlogic scientists entitled, "Developing a new class of
            engineered live bacterial therapeutics to treat human diseases." 
            The paper, which highlights the considerations for the design and
            development of engineered live bacteria, including Synthetic Biotic
            medicines, is available on the Synlogic website on the Presentations
            and Publications page of the Investors and Media section.
    --  On May 27(th), 2020 Synlogic will host its first virtual R&D event
        --  The webcast event will highlight the Company's progress in
            developing its platform capabilities and pipeline of rare metabolic
            disease programs for internal prosecution and programs in
            immunomodulation for potential partnering. Dr. David Goldfarb,
            Professor of Medicine and Physiology at NYU School of Medicine,
            Clinical Chief of the Nephrology Division at NYU Langone Health, and
            Chief of the Nephrology Section and Director of the Hemodialysis
            Unit at the New York VA Medical Center in Manhattan will also
            present an overview of enteric hyperoxaluria. A link to the live
            webcast will be available on Synlogic's website on the News & Events
            page of the Investors and Media section.

First Quarter 2020 Financial Results
As of March 31, 2020, Synlogic had cash, cash equivalents, and short-term investments of $114.2 million.

For the three months ended March 31, 2020, Synlogic reported a consolidated net loss of $15.8 million, or $0.46 per share, compared to a net loss of $12.9 million, or $0.51 per share, for the corresponding period in 2019.

Research and development expenses were $12.7 million for the three months ended March 31, 2020 compared to $10.4 million for the corresponding period in 2019. The increase in expenses was primarily due to use of synthetic biology services provided under Synlogic's collaboration with Ginkgo and increased clinical activities associated with the SYNB1618 bridging study and the SYNB1891 Phase 1 clinical trial.

General and administrative expenses for the three months ended March 31, 2020 were $3.8 million compared to $3.7 million for the corresponding period in 2019.

Revenue was $0.1 million for the three months ended March 31, 2020 compared to $0.3 million for the three months ended March 31, 2019. Revenue is associated with services performed under the Synlogic's collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of IBD.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 8:00 a.m. ET today, Friday, May 8, 2020. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 6869043. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

About Synlogic
Synlogic is pioneering the development of a novel class of living medicines, Synthetic Biotic(TM) medicines, based on its proprietary drug development platform. Synlogic leverages the tools and principles of synthetic biology to genetically engineer beneficial microbes to perform or deliver critical functions missing or damaged due to disease. When delivered orally, Synthetic Biotic medicines are designed to function in 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. The Company's lead program in this area, SYNB1618, targets PKU. In addition, the Company is leveraging the broad potential of its platform to create Synthetic Biotic medicines for the treatment of more common diseases, including inflammatory and immune disorders, and cancer. Synlogic's first immuno-oncology program, SYNB1891, is in clinical development for the treatment of solid tumors and lymphoma. 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. 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, rare metabolic diseases, liver disease, and inflammatory and immune disorders; the initiation, enrollment, timing, progress, release of data from and results of our planned and ongoing clinical trials; the future clinical development of Synthetic Biotic medicines; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; the potential of Synlogic's technology to treat various diseases; Synlogic's ability to develop and manufacture Synthetic Biotic formulations; Synlogic's goals with respect to the development and potential use, if approved, of each of its product candidates; and statements regarding the impact of coronavirus on Synlogic's product candidates, clinical trials, development and business operations. 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 and clinical 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.


                                                                                     
            
              Synlogic, Inc.


                                                                    
            
              Condensed Consolidated Statements of Operations


                                                                                            
            (unaudited)



            (in thousands except share and per share data)                                                                                                       For the three months ended



                                                                                     
            
              March 31, 2020                                          
            
              March 31, 2019






            Revenue                                                                                                                         $100                                                $338





            Operating expenses


                                                             
     Research and development                                                                 12,677                                              10,384


                                                             
     General and administrative                                                                3,821                                               3,651



            Total operating expenses                                                                                                                 16,498                                              14,035



            Loss from operations                                                                                                                   (16,398)                                           (13,697)



            Other income, net                                                                                                                           570                                                 751



            Net loss                                                                                                                   $(15,828)                                          $(12,946)






            Net loss per share - basic and diluted                                                                                       $(0.46)                                            $(0.51)




            Weighted-average common shares used in                                                                                               34,233,688                                          25,293,791
    computing net loss per share - basic and diluted









                                                                                     
            
              Synlogic, Inc.


                                                                         
            
              Condensed Consolidated Balance Sheets


                                                                                            
            (unaudited)



            (in thousands, except share data)


                                                                                     
            
              March 31, 2020                                        
            
              December 31, 2019




            
              Assets


                                                             
     Cash, cash equivalents, and short and long-term investments                            $114,249                                            $127,073


                                                             
     Fixed assets                                                                            $12,661                                              13,021


                                                             
     Other assets                                                                            $44,225                                              48,480




            Total assets                                                                                                                $171,135                                            $188,574






            
              Liabilities and stockholders' equity


                                                             
     Current liabilities                                                                      $6,819                                              $8,863


                                                             
     Long-term liabilities                                                                   $22,199                                              22,806


                                                             
     Total liabilities                                                                        29,018                                              31,669



                                                             
     Total stockholders' equity                                                             $142,117                                             156,905



            Total liabilities and stockholders' equity                                                                                  $171,135                                            $188,574






            Common stock and common stock equivalents


                                                             
     Common stock                                                                         32,459,394                                          32,266,814


                                                             
     Common stock warrants (pre-funded)                                                    2,548,117                                           2,548,117



            Total common stock                                                                                                                   35,007,511                                          34,814,931

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SOURCE Synlogic, Inc.