SYBX Synlogic Inc.

3.52
-0.05  -1%
Previous Close 3.57
Open 3.53
52 Week Low 1.78
52 Week High 5.11
Market Cap $184,354,055
Shares 52,373,311
Float 37,099,321
Enterprise Value $100,877,983
Volume 293,948
Av. Daily Volume 407,346
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Upcoming Catalysts

Drug Stage Catalyst Date
SYNB1891 and TECENTRIQ (atezolizumab)
Solid tumors
Phase 1
Phase 1
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SYNB8802
Enteric Hyperoxaluria
Phase 1
Phase 1
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SYNB1934
Phenylketonuria (PKU)
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
SYNB1618 (SynPheny-1)
Phenylketonuria (PKU)
Phase 2
Phase 2
Phase 2 interim analysis demonstrated clinically meaningful reductions of phenylalanine (Phe) at several dose levels, across multiple time points, September 20, 2021.
SYNB1020
Cirrhotic patients with elevated ammonia
Phase 1/2
Phase 1/2
Development to be discontinued due to lack of efficacy.

Latest News

  1. CAMBRIDGE, Mass., Sept. 20, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced positive data from clinical studies evaluating both SYNB1618 and SYNB1934, investigational Synthetic Biotic™ medicines for the treatment of phenylketonuria (PKU).

    SYNB1618 demonstrated clinically meaningful reductions of phenylalanine (Phe) at several dose levels, across multiple time points, in an interim analysis of the Phase 2 SynPheny-1 study. SYNB1934, an optimized strain evolved from SYNB1618, demonstrated two-fold higher activity than SYNB1618 in a head-to-head Phase 1 study in healthy volunteers, as measured by biomarkers of Phe metabolism.

    Synlogic…

    CAMBRIDGE, Mass., Sept. 20, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced positive data from clinical studies evaluating both SYNB1618 and SYNB1934, investigational Synthetic Biotic™ medicines for the treatment of phenylketonuria (PKU).

    SYNB1618 demonstrated clinically meaningful reductions of phenylalanine (Phe) at several dose levels, across multiple time points, in an interim analysis of the Phase 2 SynPheny-1 study. SYNB1934, an optimized strain evolved from SYNB1618, demonstrated two-fold higher activity than SYNB1618 in a head-to-head Phase 1 study in healthy volunteers, as measured by biomarkers of Phe metabolism.

    Synlogic intends to incorporate SYNB1934 into an arm of the Phase 2 SynPheny-1 trial with final results expected in the first half of 2022. Based on the favorable clinical data from the SYNB1618 and SYNB1934 programs available to date, the Company intends to initiate planning for a pivotal Phase 3 study for the most promising strain. 

    "The PKU program demonstrated clear proof of concept in this analysis, with SYNB1618 achieving a clinically meaningful reduction of phenylalanine in patients across multiple endpoints and time points," said Aoife Brennan, M.B. Ch.B., Synlogic's President and Chief Executive Officer. "Additionally, our second PKU candidate SYNB1934 provides greater potency, which will allow us to optimize the clinical profile to address the profound needs of patients with PKU."

    "Together, these data provide strong support for the ability of Synthetic Biotic medicines to make a meaningful difference to patients. These events mark a major milestone for Synlogic's Synthetic Biotic platform. We look forward to completing our Phase 2 SynPheny-1 study and  advancing the PKU program into a pivotal study," continued Dr. Brennan.

    "In addition to our strong clinical results, we're highly encouraged by the predictive validity of our prospective biomarker driven modeling of therapeutic effect," said David Hava, Ph.D., Chief Scientific Officer. "Patient clinical data observed to date was consistent with our preclinical predictions of Phe metabolism by the strains. The ability to translationally model clinical activity enables rapid and effective strain optimization, which we have applied both to PKU and other inherited and acquired metabolic disorders."

    Interim SYNB1618 Synpheny-1 Phase 2 Results

    Synpheny-1 (NCT04534842) is an open-label, single arm Phase 2 study in patients with PKU. The study evaluated a dose-ramp regimen consisting of four dose levels of SYNB1618 over 15 days of treatment. The primary endpoint was reduction of the area under the curve (AUC) for plasma D5-phenylalanine (D5-Phe) after a meal challenge. Secondary endpoints include changes from baseline in fasting levels of plasma Phe at multiple timepoints, and incidence of treatment-emergent adverse events (TEAEs). Dietary intake of Phe was carefully managed during the study through individualized diet management plans.

    The interim analysis included 8 patients. Clinical results demonstrated meaningful reductions of Phe, consistent with prospective biomarker-driven modeling. These results included:

    • 20% reduction in fasting plasma Phe after 14 days of dosing, at a dose of 1e12 live cells;
      • Fasting plasma Phe level began to trend down after seven days of dose titration, at a dose up to 3e11 live cells, and was statistically significant at the 1e12 dose at day 14
    • 40% reduction in labeled plasma D5-Phe after meal challenge at day 15, at a dose of 2e12 live cells; and
    • Rebound of plasma Phe levels following cessation of dosing, confirming therapeutic effect

    Safety and tolerability were consistent with prior studies, with no serious adverse events or systemic events of any kind. AEs were primarily GI related and mild to moderate in nature. There were no treatment drug related discontinuations.

    SYNB1934 Phase 1 Results

    SYNB1934 was evolved from SYNB1618 to potentially provide increased Phe lowering activity for patients living with PKU. Clinical studies of SYNB1934 were initiated following preclinical in vivo and in vitro studies demonstrating an approximately two-fold improvement in the ability of SYNB1934 to break down Phe compared to SYNB1618.

    The Phase 1 multiple ascending dose study of SYNB1934 (NCT04984525) evaluated the safety, tolerability and Phe consumption activity of SYNB1934, including a head-to-head comparison with SYNB1618 in healthy volunteers using biomarkers of Phe consumption such as trans-cinnamic acid (TCA). Results included:

    • Dose dependent increase in plasma TCA area under the curve;
    • Two-fold higher activity level than SYNB1618 in a head-to-head comparison based on biomarkers of Phe consumption
    • Safety and tolerability in cohorts 1 – 3 were similar to other Synthetic Biotic medicines, including SYNB1618, at equivalent doses. The most common adverse events were GI-related, mild to moderate in severity, and some events led to discontinuation of dosing
    • Dosing continues in the dose escalation portion of the study and the maximum tolerated dose has not been reached

    SYNB1934 clinical results were consistent with preclinical data and previously presented prospective biomarker driven modeling. The Company believes that the increased activity of SYNB1934, relative to SYNB1618, could provide the opportunity to optimize the clinical profile based on individual patient needs.

    Next Steps

    Synlogic intends to complete the SynPheny-1 study with a cohort of patients receiving SYNB1934 and anticipates final SynPheny-1 results in the first half of 2022.

    Based on the clinical data from the SYNB1618 and SYNB1934 programs available to date, the Company intends to initiate planning for a pivotal Phase 3 study of the most promising strain.

    Synlogic continues to evaluate Synthetic Biotic medicines for other metabolic diseases such as Enteric Hyperoxaluria, including development of predictive efficacy models. Preclinical and Phase 1A data suggest SYNB8802 has the potential to consume clinically meaningful levels of dietary oxalate in patients with disease. The Company is continuing to enroll Part B of the Phase 1 study of SYNB8802 and due to ongoing challenges presented by the COVID-19 pandemic, anticipates study data will be available in the first half of 2022.

    Synlogic continues to advance preclinical programs targeting additional inherited and acquired metabolic indications. The company expects to file an IND for an additional metabolic indication in 2022.

    Patients can learn more about the SynPheny-1 study (NCT04534842) by visiting https://pkuresearchstudy.com. More information about Synlogic's programs and pipeline can be found at https://www.synlogictx.com.

    Conference Call & Webcast Information

    Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, Monday, September 20, 2021. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. 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 1154745. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.

    About Phenylketonuria

    Phenylketonuria (PKU) is an inherited metabolic disease that manifests at birth and is marked by an inability to break down Phe, an amino acid commonly found in many foods. Left untreated, high levels of Phe become toxic and can lead to serious neurological and neuropsychological problems affecting the way a person thinks, feels, and acts. Due to the seriousness of these symptoms, infants are screened at birth in many countries to ensure early diagnosis and treatment to avoid intellectual disability and other complications.

    About Synlogic

    Synlogic™ is bringing the transformative potential of synthetic biology to medicine. With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways. Synlogic's proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including Phenylketonuria (PKU) and Enteric Hyperoxaluria. The company is also building a portfolio of partner-able assets in immunology and oncology.

    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, clinical development plans, 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, metabolic diseases, 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; 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 clinical and 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 Securities and Exchange Commission. 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 could 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.

     

     

    Cision View original content:https://www.prnewswire.com/news-releases/synlogic-announces-positive-phase-2-data-demonstrating-reduction-in-plasma-phenylalanine-levels-in-patients-with-phenylketonuria-301380078.html

    SOURCE Synlogic, Inc.

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  2. CAMBRIDGE, Mass., Sept. 10, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced that it will present data on SYNB8802, an investigational Synthetic Biotic medicine for the treatment of Enteric Hyperoxaluria (HOX), during the American Urological Association (AUA) Annual Meeting, being held virtually September 10 – 13th.

    Title: Safety and Tolerability of an Oxalate-Consuming Synthetic Biotic Medicine: SYNB8802 in Healthy Volunteers with Induced Dietary Hyperoxaluria
    Abstract Number: 21-6087

    Synlogic will share previously communicated results of the SYNB8802 Phase 1A study including:

    • SYNB8802 was generally well tolerated in healthy volunteers…

    CAMBRIDGE, Mass., Sept. 10, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced that it will present data on SYNB8802, an investigational Synthetic Biotic medicine for the treatment of Enteric Hyperoxaluria (HOX), during the American Urological Association (AUA) Annual Meeting, being held virtually September 10 – 13th.

    Title: Safety and Tolerability of an Oxalate-Consuming Synthetic Biotic Medicine: SYNB8802 in Healthy Volunteers with Induced Dietary Hyperoxaluria

    Abstract Number: 21-6087

    Synlogic will share previously communicated results of the SYNB8802 Phase 1A study including:

    • SYNB8802 was generally well tolerated in healthy volunteers. There were no serious or systemic adverse events. The most frequent adverse events were mild or moderate, transient, and GI-related.
    • Dietary Hyperoxaluria was successfully induced in healthy volunteers.
    • Dose-responsive changes in urinary oxalate levels were observed with a significant reduction in urinary oxalate relative to placebo across three dose levels.
    • A dose of 3e11 live cells administered three times daily with meals was selected as the dose for Part B of the study.
      • This dose was well-tolerated and resulted in a 28.6% (90% CI: -42.4 to -11.6) reduction from baseline urinary oxalate levels compared to placebo.
    • At the end of dosing, the mean 24-hour urinary oxalate level was 40.1 mg for subjects treated with SYNB8802 3e11 live cells, compared to 58.1 mg for placebo subjects.
      • Upper limit of normal urinary oxalate levels are 45 mg per 24 hours.

    Learn more about Synlogic's programs and pipeline by visiting https://www.synlogictx.com/.

    About Enteric Hyperoxaluria

    Enteric hyperoxaluria (HOX) is an acquired metabolic disorder caused by increased absorption of dietary oxalate, which is present in many common foods including leafy greens, nuts, and chocolate. Enteric hyperoxaluria often occurs as a result of a primary insult to the bowel, such as inflammatory bowel disease, Crohn's disease, short bowel syndrome, or as a result of surgical procedures such as Roux-en-Y bariatric weight-loss surgery.

    Enteric hyperoxaluria results in dangerously high levels of urinary oxalate, which causes progressive kidney damage, kidney stone formation, and nephrocalcinosis. There are an estimated 250,000 patients with enteric hyperoxaluria in the United States. Enteric hyperoxaluria has no approved treatment options. 

    About SYNB8802

    SYNB8802 is an engineered non-pathogenic strain of E. coli (Nissle), using Synlogic's Synthetic Biotic platform, designed to consume oxalate in the GI tract and lower urinary oxalate levels, potentially reducing kidney damage due to enteric hyperoxaluria. SYNB8802 is administered orally. SYNB8802 is currently undergoing Phase 1 studies in healthy volunteers and patients with enteric hyperoxaluria.

    About Synlogic

    Synlogic™ is bringing the transformative potential of synthetic biology to medicine. With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways. Synlogic's proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including Phenylketonuria (PKU) and Enteric Hyperoxaluria (HOX). The company is also building a portfolio of partner-able assets in immunology and oncology.

    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, clinical development plans, 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 clinical and 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.

     

    Media Contact:

    Investor Contact:

    Daniel Rosan

    Synlogic, Inc.

    Phone: 617-207-5509

    Email: dan.rosan@synlogictx.com

    Daniel Rosan

    Synlogic, Inc.

    Phone: 617-207-5509

    Email: dan.rosan@synlogictx.com

    Cision View original content:https://www.prnewswire.com/news-releases/synlogic-presents-data-on-synb8802-for-enteric-hyperoxaluria-at-american-urological-association-aua-annual-meeting-301373400.html

    SOURCE Synlogic, Inc.

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  3. CAMBRIDGE, Mass., Sept. 10, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today presented on the development of investigational Synthetic Biotic medicines for the treatment of Phenylketonuria (PKU) at the Global PKU Patient Meeting, being held virtually September 10-11th, 2021.

    The presentation, "Synthetic Biotic Medicines for the Treatment of PKU," was delivered by Dr. Marja Puurunen, M.D., Ph.D., Synlogic's Senior Medical Director and Head of Metabolic Programs, and included an overview of the SYNB1618 development program.

    In addition, Synlogic presented findings from a survey of adult PKU patients and the caregivers of pediatric PKU patients…

    CAMBRIDGE, Mass., Sept. 10, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today presented on the development of investigational Synthetic Biotic medicines for the treatment of Phenylketonuria (PKU) at the Global PKU Patient Meeting, being held virtually September 10-11th, 2021.

    The presentation, "Synthetic Biotic Medicines for the Treatment of PKU," was delivered by Dr. Marja Puurunen, M.D., Ph.D., Synlogic's Senior Medical Director and Head of Metabolic Programs, and included an overview of the SYNB1618 development program.

    In addition, Synlogic presented findings from a survey of adult PKU patients and the caregivers of pediatric PKU patients on their experience with the low phenylalanine diet which remains the primary treatment for PKU. Findings from the survey include:

    • Two-thirds of adult and one-third of pediatric PKU patients do not have Phe levels within the target range, despite a restrictive low phenylalanine diet and treatment with currently available therapies.
    • Greater than 90% of patients and 95% of pediatric caregivers would like to increase the amount of natural protein in their diet.
    • More than 50% of adult respondents and more than 80% of pediatric caregiver respondents found 2-3 grams of additional natural protein per day "meaningful."
      • One slice of bread or one medium sized potato contains 2-3 grams of natural protein.

    The survey was conducted through partnerships with the National PKU Alliance (NPKUA) of the U.S. and the Canadian PKU and Allied Disorders Inc (CanPKU). Complete survey results will be presented at a future medical meeting or in publication.

    Patients can learn more about the SynPheny-1 study by visiting https://pkuresearchstudy.com. More information about Synlogic's programs and pipeline can be found at https://www.synlogictx.com.

    About PKU

    Phenylketonuria (PKU) is an inherited metabolic disease that manifests at birth and is marked by an inability to break down phenylalanine (Phe), an amino acid that is commonly found in many foods. Left untreated, high levels of Phe become toxic and can lead to serious neurological and neuropsychological problems affecting the way a person thinks, feels, and acts. Due to the seriousness of these symptoms, infants are screened at birth in many countries to ensure early diagnosis and treatment to avoid intellectual disability and other complications.

    About SYNB1618

    SYNB1618 is an investigational oral drug for the treatment of Phenylketonuria (PKU) composed of an engineered Synthetic Biotic designed to lower plasma phenylalanine (Phe) levels by consuming Phe in the GI tract. A solid oral lyophilized formulation of SYNB1618 was found to be safe and well-tolerated, and consumes Phe in the GI tract of healthy volunteers. Synlogic has initiated a Phase 2 study in PKU patients (NCT04534842).

    About Synlogic

    Synlogic™ is bringing the transformative potential of synthetic biology to medicine. With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways. Synlogic's proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including Phenylketonuria (PKU) and Enteric Hyperoxaluria. The company is also building a portfolio of partner-able assets in immunology and oncology.

    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, clinical development plans, 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; our expectations about sufficiency of our existing cash balance; 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 of SYNB1618 and availability of clinical trial data including Phase 2 data of SYNB1618 for the treatment of PKU. 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 clinical and 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.

    Media Contact:

    Investor Contact:

    Daniel Rosan

    Synlogic, Inc.

    Phone: 617-401-9152

    Email: dan.rosan@synlogictx.com

    Daniel Rosan

    Synlogic, Inc.

    Phone: 617-401-9152

    Email: dan.rosan@synlogictx.com

    Cision View original content:https://www.prnewswire.com/news-releases/synlogic-presents-at-global-pku-patient-meeting-301373398.html

    SOURCE Synlogic, Inc.

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  4. CAMBRIDGE, Mass., Aug. 12, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today reported financial results for the second quarter ended June 30, 2021, and provided an update on its clinical and preclinical programs.

    "We are executing across our co-lead metabolic programs and advancing towards proof of concept readouts of our Synthetic Biotic™ medicines for the treatment of Phenylketonuria and Enteric Hyperoxaluria," said Aoife Brennan, M.B. Ch.B., Synlogic's President and Chief Executive Officer. "With a next-generation strain in a Phase 1 study for the treatment of Phenylketonuria, a strategic collaboration in place to expand our IBD pipeline and…

    CAMBRIDGE, Mass., Aug. 12, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today reported financial results for the second quarter ended June 30, 2021, and provided an update on its clinical and preclinical programs.

    "We are executing across our co-lead metabolic programs and advancing towards proof of concept readouts of our Synthetic Biotic™ medicines for the treatment of Phenylketonuria and Enteric Hyperoxaluria," said Aoife Brennan, M.B. Ch.B., Synlogic's President and Chief Executive Officer. "With a next-generation strain in a Phase 1 study for the treatment of Phenylketonuria, a strategic collaboration in place to expand our IBD pipeline and an advancing pre-clinical pipeline of metabolic disease programs, we have a robust set of potential therapies that could provide meaningful benefit to patients. We look forward to communicating results and next steps over the coming months."  

    Quarter Highlights

    The Metabolic Portfolio:

    Proof of concept data of SYNB1618 for the treatment of Phenylketonuria (PKU) anticipated in second half of 2021, Phase 1 study of SYNB1934 initiated.

    • The SynPheny-1 Phase 2 trial of SYNB1618 continues to progress.
      • SynPheny-1 is designed to evaluate plasma phenylalanine (Phe) lowering of a solid oral formulation of SYNB1618 in adult PKU patients who do not benefit from, or do not tolerate, existing therapies.
    • In July, the Company initiated a Phase 1 study of SYNB1934, a next-generation strain designed for the treatment of PKU, to evaluate safety, tolerability and head-to-head comparison of Phe-consumption biomarkers between SYNB1934 and SYNB1618.
      • SYNB1934, an evolved strain of SYNB1618 in the PKU portfolio, has the potential to provide increased benefit to patients living with PKU.
      • Preclinical in vivo and in vitro studies demonstrated a greater than 2-fold improvement in the ability of SYNB1934 to consume and break down Phe compared to SYNB1618.
    • Papers published in the journals Nature Metabolism and Communications Biology detail findings from a first-in-human study of SYNB1618 and the development of a mechanistic model to predict the function of Synthetic Biotic medicines in healthy volunteers and PKU patients.
      • Data from the first-in-human study of SYNB1618 showed dose-responsive, non-saturated increases in gastrointestinal consumption of Phe by SYNB1618.
      • These data add to the growing body of scientific research demonstrating the therapeutic potential of Synthetic Biotic medicines for the treatment of PKU.

    SYNB1618 and SYNB1934 are orally administered Synthetic Biotic medicines being developed as potential treatments for PKU. They are intended to address the needs of patients of all age groups through the consumption of Phe in the gastrointestinal (GI) tract, which has the potential to lower blood Phe levels and enable the consumption of more natural protein in the diet.

    Proof of concept data of SYNB8802 for the treatment of Enteric Hyperoxaluria anticipated in second half of 2021.

    • SYNB8802 demonstrated proof of mechanism in Part A of an ongoing Phase 1 trial, with evidence of urinary oxalate lowering in a Dietary Hyperoxaluria model in healthy volunteers given a high oxalate diet.
      • Urinary oxalate lowering by SYNB8802 was robust and dose-dependent.
      • The 3e11 dose is undergoing evaluation in Part B of the study in patients with Enteric Hyperoxaluria.
      • This dose was well-tolerated and resulted in a 28.6% (90% CI: -42.4 to -11.6) reduction in urinary oxalate as measured by a change from baseline compared to placebo.
    • Part B of the study is continuing with the evaluation of SYNB8802 in patients with Enteric Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery.
    • Data on the development of SYNB8802 was presented at the Synthetic Biology: Engineering, Evolution & Design (SEED) conference in June 2021.

    SYNB8802 is an orally administered Synthetic Biotic medicine being developed as a potential treatment for Enteric Hyperoxaluria. SYNB8802 is designed to consume oxalate in the GI tract to prevent the increased absorption of oxalate in Enteric Hyperoxaluria patients.

    Enteric Hyperoxaluria results in dangerously high urinary oxalate levels causing progressive kidney damage, kidney stone formation, and nephrocalcinosis. Enteric Hyperoxaluria has no approved treatment options. Approximately 100,000 patients in the US suffer from chronic and recurrent kidney stones as a result of severe Enteric Hyperoxaluria.

    The Immunomodulation Portfolio:

    Progression of SYNB1891 in combination arm dosing with PD-L1 checkpoint inhibitor in Phase 1 study in patients with advanced solid tumors or lymphoma. 

    • SYNB1891 is currently being evaluated in a Phase 1 study that has two parts: Part A is a monotherapy arm that has enrolled six dose cohorts to date. Part B is a combination arm with SYNB1891 and the PD-L1 checkpoint inhibitor atezolizumab that has enrolled two dose cohorts to date.
      • The study is ongoing. Mature combination therapy data is expected by the end of the year.

    SYNB1891 is an investigational drug for the intra-tumoral treatment of solid tumors and lymphoma, composed of an engineered Synthetic Biotic strain of E. coli Nissle that produces cyclic di-AMP (CDA), a stimulator of the STING (STimulator of INterferon Genes) pathway.

    Advancement of preclinical programs in Inflammatory Bowel Disease.

    • In June, Synlogic and Roche entered into a research collaboration agreement for the discovery of a novel Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD). Under the terms of the agreement, Synlogic and Roche will collaborate to develop a Synthetic Biotic medicine addressing an undisclosed novel target in IBD.
    • Data on novel Synthetic Biotic approaches for the treatment of IBD was presented at Digestive Disease Week (DDW) in May 2021.

    Corporate Update:

    Synlogic strengthens Balance Sheet and advances synthetic biology capabilities.

    • In April, Synlogic completed an underwritten public offering of 11.5 million shares, resulting in net proceeds to Synlogic of approximately $32.6 million.
    • Synlogic and Ginkgo Bioworks continue to advance their long-term strategic platform collaboration that provides expanded synthetic biology capabilities to Synlogic with multiple undisclosed metabolic programs now in preclinical stages of development. Additional information on these programs will be provided over the course of the year.

    Second Quarter 2021 Financial Results

    As of June 30, 2021, Synlogic had cash, cash equivalents, and short-term investments of $115.5 million.

    For the three months ended June 30, 2021, Synlogic reported a consolidated net loss of $14.5 million, or $0.28 per share, compared to a consolidated net loss of $15.5 million, or $0.44 per share, for the corresponding period in 2020.

    Research and development expenses were $10.7 million for the three months ended June 30, 2021 compared to $12.9 million for the corresponding period in 2020.

    General and administrative expenses for the three months ended June 30, 2021 were $4.1 million compared to $3.5 million for the corresponding period in 2020. 

    Revenue was $0.2 million for the three months ended June 30, 2021, compared to $0.4 million for the corresponding period in 2020. Revenue for the three months ended June 30, 2021 was due to the collaboration with Roche, for the discovery of a novel Synthetic Biotic medicine for treatment of inflammatory bowel disease (IBD). Under the terms of the agreement, Synlogic and Roche will collaborate to develop a Synthetic Biotic medicine addressing an undisclosed novel target in IBD. Revenue for the three months ended June 30, 2020 was due to the prior collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of inflammatory bowel disease, which was terminated in May 2020.

    Financial Outlook

    Based upon its current operating plan and balance sheet as of June 30, 2021 Synlogic expects to have sufficient cash to be able to fund the base operating plan into the second half of 2023.

    Conference Call & Webcast Information

    Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, Thursday, August 12, 2021. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. 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 7586239. A replay will be available for 30 days on the Investors and Media section of the Synlogic website. 

    About Synlogic

    Synlogic™ is bringing the transformative potential of synthetic biology to medicine. With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways. Synlogic's proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including Phenylketonuria (PKU) and Enteric Hyperoxaluria. The company is also building a portfolio of partner-able assets in immunology and oncology. More information about Synlogic's programs and pipeline can be found at https://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, clinical development plans, 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, metabolic diseases, and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; 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 clinical and 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.



    Synlogic, Inc.











    Condensed Consolidated Statements of Operations











    (unaudited)









    (in thousands,except share and per share data)

    For the three months ended



    For the six months ended





    June 30, 2021



    June 30, 2020



    June 30, 2021



    June 30, 2020



















    Revenue

    $                   246



    $                      445



    $             246



    $              545



















    Operating expenses

















    Research and development

    10,719



    12,909



    21,899



    25,586



    General and administrative

    4,061



    3,473



    7,912



    7,294

    Total operating expenses

    14,780



    16,382



    29,811



    32,880

    Loss from operations

    (14,534)



    (15,937)



    (29,565)



    (32,335)

    Other income, net

    49



    402



    109



    972

    Net loss

    $             (14,485)



    $                 (15,535)



    $        (29,456)



    $        (31,363)



















    Net loss per share - basic and diluted

    $                 (0.28)



    $                    (0.44)



    $           (0.63)



    $            (0.91)

    Weighted-average common shares used in computing

    net loss per share - basic and diluted

    52,049,424



    34,967,761



    46,876,216



    34,604,738

     



    Synlogic, Inc.



    Condensed Consolidated Balance Sheets



    (unaudited)

    (in thousands, except share data)











    June 30, 2021



    December 31, 2020

    Assets









    Cash, cash equivalents, and short-term investments

    $            115,462



    $                100,444



    Fixed assets

    $                9,928



    10,776



    Other assets

    $              31,494



    32,620

    Total assets

    $            156,884



    $                143,840











    Liabilities and stockholders' equity









    Current liabilities

    $                9,633



    $                    8,301



    Long-term liabilities

    $              19,173



    20,404



    Total liabilities

    28,806



    28,705



    Total stockholders' equity

    $            128,078



    115,135

    Total liabilities and stockholders' equity

    $            156,884



    $                143,840











    Common stock and common stock equivalents









    Common stock

    52,375,344



    38,183,273



    Common stock warrants (pre-funded)

    2,548,117



    2,548,117

    Total common stock 

    54,923,461



    40,731,390











     

    Cision View original content:https://www.prnewswire.com/news-releases/synlogic-reports-second-quarter-financial-results-and-provides-business-update-301353948.html

    SOURCE Synlogic, Inc.

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  5. CAMBRIDGE, Mass., Aug. 5, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced the Company will release its second quarter 2021 financial results before the market opens on Thursday, August 12, 2021. The press release will be followed by a conference call at 8:30 am ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

    The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 7586239. Participants may access the live…

    CAMBRIDGE, Mass., Aug. 5, 2021 /PRNewswire/ -- Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced the Company will release its second quarter 2021 financial results before the market opens on Thursday, August 12, 2021. The press release will be followed by a conference call at 8:30 am ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

    The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 7586239. Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company's website.

    Additionally, Aoife Brennan, M.B. Ch.B., Synlogic's President and Chief Executive Officer, will present at the following virtual banking and industry conference:

    • BTIG Virtual Biotechnology Conference: Dr. Brennan will participate in a Fireside Chat at 9:30 am ET on Tuesday, August 10, 2021.

    This is a virtual event. To listen to the live event, please contact the event organizers.

    About Synlogic

    Synlogic™ is bringing the transformative potential of synthetic biology to medicine. With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic therapeutics that target validated underlying biology to treat disease in new ways. Synlogic's proprietary pipeline includes Synthetic Biotics for the treatment of metabolic disorders including Phenylketonuria (PKU) and Enteric Hyperoxaluria (HOX). The company is also building a portfolio of partner-able assets in immunology and oncology.

    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, clinical development plans, 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, metabolic diseases, and inflammatory and immune disorders; our expectations about sufficiency of our existing cash balance; the future clinical development of Synthetic Biotic medicines; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; 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 clinical and 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.

     

    Cision View original content:https://www.prnewswire.com/news-releases/synlogic-announces-second-quarter-2021-conference-call--participation-in-upcoming-banking-conference-301349222.html

    SOURCE Synlogic, Inc.

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