SYN Synthetic Biologics Inc.

0.58
-0.01  -1%
Previous Close 0.59
Open 0.57
52 Week Low 0.2522
52 Week High 0.75
Market Cap $11,275,401
Shares 19,440,346
Float 19,375,239
Enterprise Value $18,687,483
Volume 274,185
Av. Daily Volume 683,391
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Upcoming Catalysts

Drug Stage Catalyst Date
SYN-010
Constipation-Predominant Irritable Bowel Syndrome (C-IBS)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
SYN-020
Healthy volunteers
Phase 1
Phase 1
Phase 1 trial planned.
SYN-004
Allogeneic hematopoietic cell transplantation (HCT)
Phase 1/2
Phase 1/2
Phase 1b/2 initiation under evaluation.
SYN-004 (ribaxamase)
C. difficile Infection
Phase 2b
Phase 2b
Phase 3 trial being considered.
Trimesta
Relapsing-remitting MS in women
Phase 2
Phase 2
License terminated following lack of efficacy shown February 2016

Latest News

  1. ROCKVILLE, Md., Aug. 6, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, today provided a clinical programs update and reported financial results for the quarter ended June 30, 2020.

    www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)" alt="Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)">

    "During the second quarter, we remained diligently focused on advancing our portfolio of GI and microbiome-focused clinical development programs while continuing to navigate the unprecedented global health and economic crisis sparked by the COVID-19 global pandemic," said Steven A. Shallcross, Chief Executive and Financial Officer of Synthetic Biologics. "We made significant progress positioning SYN-020, our orally delivered recombinant version of bovine intestinal alkaline phosphatase (IAP), for its first clinical trial. We were pleased to report the FDA responded to our Investigational New Drug application (IND) with a study-may-proceed letter to conduct a Phase 1 single ascending dose study of SYN-020 in healthy volunteers. Additionally, we expanded our collaboration with Massachusetts General Hospital (MGH) in the form of an exclusive option agreement to license intellectual property and technology to commercially develop SYN-020 for the treatment and prevention of metabolic and inflammatory diseases associated with aging. The Phase 1 clinical trial is intended to support the clinical development of SYN-020 in multiple indications, including an initial indication for the treatment of radiation enteropathy secondary to pelvic cancer therapy and indications that may be developed under the MGH license agreement."

    Mr. Shallcross continued, "Enrollment in the Phase 2b investigator-sponsored clinical trial of SYN-010, intended to treat irritable bowel syndrome-constipation (IBS-C) and being conducted out of Cedars-Sinai Medical Center (CSMC), has recommenced following a temporary postponement during the first and second quarter due to the impact of the COVID-19 global pandemic. A data readout in the form of an interim futility analysis is expected during the third quarter and topline data is anticipated during the first quarter of 2021, subject to potential COVID-19 complications." Mr. Shallcross concluded, "We remain in close contact with Washington University as we continue to evaluate opportunities to initiate the planned Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients in the face of the ongoing COVID-19 pandemic. We continue to closely monitor the crisis caused by the spread of the COVID-19 and look forward to sharing important updates and progress for this and all our GI and microbiome-focused clinical programs."

    Clinical Development and Operational Update 

    • Submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for SYN-020, the Company's recombinant version of bovine intestinal alkaline phosphatase (IAP) supporting an initial indication to mitigate the intestinal damage caused by radiation therapy routinely used to treat pelvic cancers (Q2 2020)
      • Received study-may-proceed letter from FDA to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters (Q3 2020),
      • The Phase 1 clinical program is intended to support the clinical development of SYN-020 in multiple indications, including an initial indication for the treatment and prevention of radiation enteropathy secondary to cancer therapy;
    • Entered into an agreement with Massachusetts General Hospital (MGH) granting the Company an option for an exclusive license to intellectual property and technology related to the use of IAP to maintain GI and microbiome health, diminish systemic inflammation, and treat age-related diseases (Q2 2020)
      • Under the terms of the agreement, Synthetic Biologics is granted exclusive rights to negotiate a worldwide license with MGH to commercially develop SYN-020 to treat and prevent metabolic and inflammatory diseases associated with aging,
      • If executed, the Company plans to use this license in the advancement of an expanded clinical development program for SYN-020;
    • Enrollment in the investigator-sponsored Phase 2b clinical trial of SYN-010, intended to treat IBS-C, has recommenced following a temporary halt in Q1 and Q2 2020 due to the COVID-19 global pandemic; however, the ability to continue to recruit new patients into this clinical trial remains at the discretion of CSMC and contingent upon the impact of the COVID-19 global pandemic
      • A data readout in the form of an interim futility analysis is expected during the third quarter of 2020 and topline data is anticipated during the first quarter of 2021, subject to the impact of COVID-19,
      • CSMC and Synthetic Biologics are co-funding the study. The patent rights covering the use of SYN-010 are owned by CSMC and are exclusively licensed by CSMC to Synthetic Biologics;
    • Received written notification from the FDA informing the Company that the FDA determined the Phase 1b/2a clinical program in adult allogeneic hematopoietic cell transplant (HCT) recipients may proceed per the submitted clinical program protocol (Q3 2020)
      • Due to the unique challenges posed by the global COVID-19 pandemic, Washington University continues to evaluate non-essential activities, which may have a direct impact on planned and ongoing clinical trials, including the SYN-004 (ribaxamase) Phase 1b/2a clinical program in allogeneic HCT recipients,
      • At this time, the Company has determined that postponing the initiation of the planned Phase 1b/2a clinical trial in allogeneic HCT recipients until at least the first quarter of 2021 remains the appropriate course of action due to continued uncertainty surrounding the ongoing global COVID-19 pandemic;
    • On July 30, 2020, the Company received written communication from NYSE American LLC (the "Exchange"), the Company's current listing exchange, stating that in addition to Section 1003(iii), it is now also not in compliance with both Section 1003(i) and Section 1003(ii) of the NYSE American Company Guide since it reported a stockholders' deficit of ($4.0) million as of March 31, 2020 and losses from continuing operations and/or net losses in its five most recent fiscal years ended December 31, 2019
      • The Company has previously submitted a plan of compliance which was accepted by the Exchange addressing how it intends to regain compliance with the Exchange continued listing standards by November 25, 2020, the end of the current compliance plan period,
      • The NYSE American notification does not affect the Company's business operations or the listing of the Company's shares on the Exchange, and does not represent any change or amendment to the Company's consolidated financial statements or to its quarterly reports for the quarter ended March 30, 2020 or to its annual report on Form 10-K for the year ended December 31, 2019.

    Quarter Ended June 30, 2020 Financial Results

    General and administrative expenses increased by 23% to $1.3 million for the three months ended June 30, 2020, from $1.0 million for the three months ended June 30, 2019. This increase is primarily due to increased legal costs related to business development, patent execution and employee contract matters, vacation expense, and insurance costs. The charge related to stock-based compensation expense was $67,000 for the three months ended June 30, 2020, compared to $59,000 the three months ended June 30, 2019.

    Research and development expenses decreased by 38% to $1.6 million for the three months ended June 30, 2020, from $2.6 million for the three months ended June 30, 2019. This decrease is primarily the result of the response to the global COVID-19 pandemic by our clinical development partners which led to the postponement of the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and a temporary halt during the second quarter in new enrollment in the Phase 2b investigator sponsored clinical trial of SYN-010. The charge related to stock-based compensation expense was $19,000 for the three months ended June 30, 2020, compared to $31,000 for the three months ended June 30, 2019.

    Other income was $6,000 for the three months ended June 30, 2020, compared to other income of $80,000 for the three months ended June 30, 2019. Other income for the three months ended June 30, 2020 and 2019 is primarily comprised of interest income.

    Cash and cash equivalents as of June 30, 2020 totaled $8.1 million, a decrease of $7.0 million from December 31, 2019.

    Conference Call

    Synthetic Biologics will hold a conference call today, Thursday, August 6, 2020, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at https://www.webcaster4.com/Webcast/Page/1096/35797. An archive of the call will be available for replay at the same URL, https://www.webcaster4.com/Webcast/Page/1096/35797, for 90 days after the call.

    About Synthetic Biologics, Inc.

    Synthetic Biologics, Inc. (NYSE:SYN) is a clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company's lead clinical candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, C. difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-010, which is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company is also advancing SYN-020, an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.     

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding the Phase 1 clinical trial of SYN-020 supporting the clinical development of SYN-020 in multiple indications, a data readout  in the investigator-sponsored Phase 2b clinical trial of SYN-010 in the form of an interim futility analysis during the third quarter and topline data during the first quarter of 2021, subject to potential COVID-19 complications, and use of the license with MGH in the advancement of an expanded clinical development program for SYN-020. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, a failure of Synthetic Biologics' clinical trials, and those conducted by investigators, for SYN-004, SYN-010 and SYN-020 to be commenced or completed on time or to achieve desired results and benefits, especially in light of COVID-19, a failure of Synthetic Biologics' clinical trials to continue enrollment as expected or receive anticipated funding, a failure of Synthetic Biologics to successfully develop, market or sell its products, Synthetic Biologics' inability to maintain its material licensing agreements, a failure to maintain our listing on the NYSE American, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31, 2019 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    - Financial Tables Follow -

    Synthetic Biologics, Inc. and Subsidiaries

    (in thousands, except share and per share amounts)



    Consolidated Balance Sheets







    June 30, 2020



    December 31, 2019

    Assets







       Cash and cash equivalents

    $         8,059



    $         15,045

       Prepaid expenses and other current assets

    897



    1,381

       Property and equipment, net

    251



    367

       Right of Use Asset

    352



    419

       Deposits and other assets

    23



    23

    Total Assets

    $         9,582



    $         17,235

    Liabilities and Stockholder's Deficit







       Total liabilities

    $          3,763



    $          5,748

       Series A Convertible Preferred Stock

    12,669



    12,544

    Synthetic Biologics, Inc. and Subsidiaries Equity (Deficit)

    (3,966)



    1,821

    Non-controlling interest

    (2,884)



    (2,878)

    Total Liabilities and Stockholders' Deficit

    $         9,582



    $         17,235









     

    Condensed Consolidated Statements of Operations

    (In thousands except share and per share amounts)





    For the three months ended

    June 30,



    For the six months ended

    June 30,



    (Unaudited)



    (Unaudited)



    2020



    2019



    2020



    2019

    Operating Costs and Expenses















       General and administrative

    $             1,286



    $               1,044



    $             2,679



    $             2,199

       Research and development

    1,603



    2,594



    3,238



    5,012

    Total Operating Costs and Expenses

    2,889



    3,638



    5,917



    7,211

    Loss from Operations

    (2,889)



    (3,638)



    (5,917)



    (7,211)

    Other Income















       Interest income

    6



    80



    44



    125

    Total Other Income, net

    6



    80



    44



    125

    Net Loss

    (2,883)



    (3,558)



    (5,873)



    (7,086)

    Net Loss Attributable to Non-controlling Interest

    (16)



    (27)



    (42)



    (43)

    Net Loss Attributable to Synthetic Biologics, Inc. and Subsidiaries

    $           (2,867)



    $           (3,531)



    $         (5,831)



    $         (7,043)

      Series A Preferred Dividends

    (63)



    (61)



    (125)



    (122)

      Series B Preferred Dividends

    (392)



    (117)



    (796)



    (515)

    Net Loss Attributable to Common Stockholders

    $            (3,322)



    $               (3,709)



    $             (6,752)



    $             (7,680)

    Net Loss Per Share – Basic and Dilutive

    $             (0.18)



    $               (0.23)



    $             (0.38)



    $             (0.48)

    Weighted average number of common shares outstanding - Basic and Diluted

    18,405,884



    16,465,314



    17,748,688



    16,063,283

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/synthetic-biologics-reports-2020-second-quarter-operational-highlights-and-financial-results-301108002.html

    SOURCE Synthetic Biologics, Inc.

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  2. ROCKVILLE, Md., July 30, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, today announced that it has received a study-may-proceed letter from the U.S. Food and Drug Administration (FDA) for the first clinical study of SYN-020, an oral formulation of recombinant intestinal alkaline phosphatase.

    ROCKVILLE, Md., July 30, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, today announced that it has received a study-may-proceed letter from the U.S. Food and Drug Administration (FDA) for the first clinical study of SYN-020, an oral formulation of recombinant intestinal alkaline phosphatase.

    www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)" alt="Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)">

    Synthetic Biologics intends to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters, during the first quarter of 2021. The Phase 1 clinical program is intended to support the clinical development of SYN-020 in multiple indications, including for the treatment of radiation enteropathy secondary to pelvic cancer therapy.

    "Receipt of the study-may-proceed letter from the FDA is a significant milestone for our SYN-020 program, which we believe will demonstrate an important role in regulating and maintaining GI and microbiome health," said Steven A. Shallcross, Chief Executive and Financial Officer. "We are excited to begin a clinical development program with an initial indication intended to evaluate SYN-020's ability to mitigate the intestinal damage caused by radiation therapy routinely used to treat pelvic cancers. Looking ahead, we will continue to explore additional indications where the use of orally administered IAP may have a profound impact on treating and preventing age-related metabolic and inflammatory diseases."

    Synthetic Biologics previously announced an agreement with Massachusetts General Hospital (MGH) granting the Company an option for an exclusive worldwide license to intellectual property and technology related to the use of IAP to maintain GI and microbiome health, diminish systemic inflammation, and treat age-related diseases. If executed, the Company plans to use this license in the advancement of an expanded clinical development program for SYN-020.

    About SYN-020 Intestinal Alkaline Phosphatase (IAP)

    SYN-020 is a purified recombinant bovine IAP formulated for oral delivery to the intestines. The published literature indicates that IAP functions to diminish intestinal inflammation, tighten the gut barrier to diminish "leaky gut," and promote a healthy microbiome. Despite its broad therapeutic potential, a key hurdle to commercialization has been the high cost of IAP manufacture. Synthetic Biologics has overcome this hurdle and has been able to produce SYN-020 at a scale and cost viable for clinical and commercial development. Synthetic Biologics is currently developing SYN-020 to reduce acute intestinal side effects associated with radiation therapy in patients with pelvic cancers.

    About Synthetic Biologics, Inc.

    Synthetic Biologics, Inc. (NYSE:SYN) is a clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company's lead clinical candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, C. difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-010, which is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company is also advancing SYN-020, an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.     

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding conducting  a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters, SYN-020 demonstrating an important role in regulating and maintaining gastrointestinal and microbiome health,  SYN-020's potential to mitigate the intestinal damage caused by radiation therapy routinely used to treat pelvic cancers, the use of orally administered IAP having a profound impact on treating and preventing age-related metabolic and inflammatory diseases and plans to use the license in the advancement of an expanded clinical development program for SYN-020. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, ability to obtain FDA clearance of the IND for the SYN-020 program, a failure of additional pre-clinical studies of SYN-020 to achieve similar results to those previously achieved or to provide support for exercise of the option, the ability to enter into a license to advance an expanded clinical development program for SYN-020, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, a failure of Synthetic Biologics' clinical trials, and those conducted by investigators, for SYN-004 and SYN-010 to be commenced or completed on time or to achieve desired results and benefits, especially in light of COVID-19, a failure of Synthetic Biologics' clinical trials to continue enrollment as expected or receive anticipated funding, a failure of Synthetic Biologics to successfully develop, market or sell its products, Synthetic Biologics' inability to maintain its material licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31, 2019 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

     

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    SOURCE Synthetic Biologics, Inc.

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  3. ROCKVILLE, Md., July 29, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, announced today that the Company intends to release its operational highlights and financial results for the quarter ended June 30, 2020 on Thursday, August 6, 2020, and to host a conference call the same day at 4:30 p.m. ET. The dial-in information for the call is as follows:

    ROCKVILLE, Md., July 29, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, announced today that the Company intends to release its operational highlights and financial results for the quarter ended June 30, 2020 on Thursday, August 6, 2020, and to host a conference call the same day at 4:30 p.m. ET. The dial-in information for the call is as follows:

    www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)" alt="Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)">

    U.S. (toll free): 1-888-347-5280

    International: +1-412-902-4280

    Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at https://www.webcaster4.com/Webcast/Page/1096/35797An archived replay of the call will be available for approximately ninety (90) days at the same URL, https://www.webcaster4.com/Webcast/Page/1096/35797 beginning approximately one hour after the call's conclusion.

    About Synthetic Biologics, Inc.

    Synthetic Biologics, Inc. (NYSE:SYN) is a clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company's lead clinical candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, C. difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-010, which is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company is also advancing SYN-020, an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/synthetic-biologics-to-report-2020-second-quarter-operational-highlights-and-financial-results-on-august-6-2020-301102511.html

    SOURCE Synthetic Biologics, Inc.

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  4. ROCKVILLE, Md., June 30, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal ("GI") diseases in areas of high unmet need, today announced that it submitted an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its SYN-020 Intestinal Alkaline Phosphatase ("IAP") program. The IND application supports an initial indication of SYN-020 for the treatment of radiation enteropathy secondary to pelvic cancer therapy. Under the IND application, the Company intends to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for…

    ROCKVILLE, Md., June 30, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal ("GI") diseases in areas of high unmet need, today announced that it submitted an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its SYN-020 Intestinal Alkaline Phosphatase ("IAP") program. The IND application supports an initial indication of SYN-020 for the treatment of radiation enteropathy secondary to pelvic cancer therapy. Under the IND application, the Company intends to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters.

    www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)" alt="Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)">

    "This IND submission is a key milestone in the clinical development program of SYN-020, which we believe can play an important role in regulating and maintaining gastrointestinal ("GI") and microbiome health," said Steven A. Shallcross, Chief Executive and Financial Officer. "We are excited about SYN-020's potential to mitigate the intestinal damage caused by radiation therapy routinely used to treat pelvic cancers, and look forward to exploring additional indications where the use of orally administered IAP may have a profound impact on treating and preventing age-related metabolic and inflammatory diseases."

    Synthetic Biologics previously announced an agreement with Massachusetts General Hospital ("MGH") granting the Company an option for an exclusive worldwide license to intellectual property and technology related to the use of IAP to maintain GI and microbiome health, diminish systemic inflammation, and treat age-related diseases. If executed, the Company plans to use this license in the advancement of an expanded clinical development program for SYN-020.

    About SYN-020 Intestinal Alkaline Phosphatase (IAP)

    SYN-020 is a purified recombinant bovine IAP formulated for oral delivery to the intestines. The published literature indicates that IAP functions to diminish intestinal inflammation, tighten the gut barrier to diminish "leaky gut," and promote a healthy microbiome. Despite its broad therapeutic potential, a key hurdle to commercialization has been the high cost of IAP manufacture. Synthetic Biologics has overcome this hurdle and has the ability to produce SYN-020 at a scale and cost viable for clinical and commercial development. Synthetic Biologics is currently developing SYN-020 to reduce acute intestinal side effects associated with radiation therapy in patients with pelvic cancers. The Company has completed the IND-enabling nonclinical studies and early GMP manufacturing and has filed an IND application for this program.

    About Synthetic Biologics, Inc.

    Synthetic Biologics, Inc. (NYSE:SYN) is a clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company's lead clinical candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, C. difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-010, which is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company is also advancing SYN-020, an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.     

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding conducting  a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters, SYN-020 playing an important role in regulating and maintaining gastrointestinal and microbiome health,  SYN-020's potential to mitigate the intestinal damage caused by radiation therapy routinely used to treat pelvic cancers, the use of orally administered IAP having a profound impact on treating and preventing age-related metabolic and inflammatory diseases and plans to use the license in the advancement of an expanded clinical development program for SYN-020. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, ability to obtain FDA clearance of the IND for the SYN-020 program, a failure of additional pre-clinical studies of SYN-020 to achieve similar results to those previously achieved or to provide support for exercise of the option, the ability to enter into a license to advance an expanded clinical development program for SYN-020, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, a failure of Synthetic Biologics' clinical trials, and those conducted by investigators, for SYN-004 and SYN-010 to be commenced or completed on time or to achieve desired results and benefits, especially in light of COVID-19, a failure of Synthetic Biologics' clinical trials to continue enrollment as expected or receive anticipated funding, a failure of Synthetic Biologics to successfully develop, market or sell its products, Synthetic Biologics' inability to maintain its material licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31, 2019 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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  5. ROCKVILLE, Md., May 5, 2020 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, today provided a clinical programs update and reported financial results for the quarter ended March 31, 2020.


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    "During the first quarter of 2020, we remained sharply focused on executing our strategy to advance our portfolio of GI and microbiome-focused clinical development programs while responding to the unprecedented global health and economic crisis sparked by the COVID-19 pandemic," said Steven A. Shallcross, Chief Executive and Financial Officer of Synthetic Biologics. "Recommendations by local governments, hospitals and healthcare organizations to concentrate resources towards COVID-19 care are having a material impact on ongoing and planned clinical trials. This includes our ongoing Phase 2b investigator-sponsored clinical trial of SYN-010, intended to treat irritable bowel syndrome with constipation (IBS-C), being conducted out of Cedars-Sinai Medical Center (CSMC), as well as our planned Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients, which will be conducted by the Washington University School of Medicine in St. Louis (Washington University). Although we have experienced additional delays in enrollment and site visits for our planned and ongoing clinical trials, we believe we have implemented an operational framework which will allow us to navigate this crisis and ultimately deliver on the tangible results and goals we have established for our company."

    Mr. Shallcross continued, "During the first quarter, we continued to make significant progress towards the completion of Investigational New Drug (IND)-enabling toxicology studies and assay development that are expected to support the filing of an IND for our SYN-020 intestinal alkaline phosphatase (IAP) program during the second quarter of 2020." Mr. Shallcross concluded, "In response to the efforts undertaken by our clinical development partners to conserve resources for combatting COVID-19, we have been able to reduce our burn rate and further extend our cash runway through at least the first quarter of 2021. We are monitoring the crisis caused by the spread of the COVID-19 closely and remain dedicated to protecting the health and safety of our employees, our clinical development partners and our patients."

    Clinical Development and Operational Update 

    • Received official meeting minutes from the U.S. Food & Drug Administration (FDA) in Q1 2020 following a Type-C meeting held at the Company's request to discuss the development of a Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients
      • The goal of this study is to evaluate the safety, tolerability and potential absorption into the systemic circulation (if any) of 150 mg oral SYN-004 (ribaxamase) administered to allogeneic HCT recipients four times per day who receive an IV beta-lactam antibiotic to treat fever,
      • Study participants will be enrolled into three sequential cohorts administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 (ribaxamase) and four will receive placebo,
      • Due to the unique challenges posed by the global COVID-19 pandemic, Washington University has temporarily limited all non-essential activities, which directly impacts planned clinical trials. As a result, commencement of the planned Phase 1b/2a clinical trial in allogeneic HCT recipients is postponed until the first quarter of 2021, subject to the impact of COVID-19,
      • Initiation of the clinical trial remains contingent upon approval of the clinical trial protocol by the Washington University School of Medicine's Institutional Review Board (IRB) and determination that the study is safe-to-proceed by the FDA;
    • Enrollment in the Phase 2b investigator-sponsored clinical study of SYN-010 for the treatment of IBS-C continued through most of the first quarter of 2020. However, due to the unique challenges posed by the global COVID-19 pandemic, CSMC has temporarily limited all non-essential activities, which directly impacts ongoing clinical trials
      • As a result, additional enrollment in the Phase 2b investigator-sponsored clinical trial is temporarily suspended until a time when the safety of the Company's employees, the employees of its clinical development partners, and study participants can be assured,
      • Active study participants who did not complete the study prior to the decision to halt all non-essential activities may elect to complete the study as CSMC has taken steps to ensure proper data collection from this group of patients,
      • A data readout is anticipated during the third quarter of 2020, subject to the impact of COVID-19,
      • Cedars-Sinai Medical Center and Synthetic Biologics are co-funding the study. The patent rights covering the use of SYN-010 are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai Medical Center to Synthetic Biologics;
    • Made additional progress towards the completion of IND-enabling toxicology studies and assay development that are expected to support the advancement of SYN-020 (intestinal alkaline phosphatase) into clinical trials targeting areas of significant unmet medical need, including enterocolitis associated with radiation therapy for cancer
      • Anticipate filing a U.S. IND in Q2 2020;
    • The Company has further extended its cash runway since its clinical development partners (CSMC, Washington University) have reduced their operating capacity to include only essential activities directed towards combatting COVID-19, which excludes all planned and ongoing clinical trials for the time being;
    • As previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the Securities and Exchange Commission on February 20, 2020, the Company's audited financial statements contained a going concern explanatory paragraph in the audit opinion from its independent registered public accounting firm. This announcement does not represent any change or amendment to the Company's financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2019.

    Quarter Ended March 31, 2020 Financial Results

    General and administrative expenses increased by 21% to $1.4 million for the three months ended March 31, 2020, from $1.1 million for the three months ended March 31, 2019. This increase is primarily due to increased insurance costs, registration fees, and legal costs. The charge related to stock-based compensation expense was $65,000 for the three months ended March 31, 2020, compared to $65,000 the three months ended March 31, 2019.

    Research and development expenses decreased by 32% to $1.6 million for the three months ended March 31, 2020, from $2.4 million for the three months ended March 31, 2019. This decrease is primarily the result of lower indirect program costs for the three months ended March 31, 2020, including salary and related expense reductions resulting from the 2019 headcount reductions and a decrease in manufacturing costs for SYN-020. The research and development costs incurred during the quarter were primarily related to the investigator-sponsored Phase 2b clinical study of SYN-010. We anticipate research and development expense to decrease as a result of the response to the global COVID-19 pandemic by our clinical development partners which has led to the postponement of the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and a temporary halt in new enrollment in the Phase 2b investigator sponsored clinical trial of SYN-010.   The charge related to stock-based compensation expense was $18,000 for the three months ended March 31, 2020, compared to no charge related to stock-based compensation expense for the three months ended March 31, 2019 resulting from the 2018 restructuring.

    Other income was $38,000 for the three months ended March 31, 2020, compared to other income of $44,000 for the three months ended March 31, 2019. Other income for the three months ended March 31, 2020 and 2019 is primarily comprised of interest income. 

    Cash and cash equivalents as of March 31, 2020 totaled $10.1 million, a decrease of $5.0 million from December 31, 2019.

    Conference Call

    Synthetic Biologics will hold a conference call today, Tuesday, May 5, 2020, at 4:30 p.m. (EDT). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at https://www.webcaster4.com/Webcast/Page/1096/34417. An archive of the call will be available for replay at the same URL, https://www.webcaster4.com/Webcast/Page/1096/34417, for 90 days after the call.

    About Synthetic Biologics, Inc.

    Synthetic Biologics, Inc. (NYSE:SYN) is a clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need. The Company's lead clinical candidates are: (1) SYN-004 (ribaxamase) which is designed to degrade certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, C. difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (2) SYN-010, which is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company is also advancing SYN-020, an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com.     

    This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding commencement of the planned Phase 1b/2a investigator-sponsored clinical study in allogeneic HCT patients in the first quarter of 2021, anticipated data readout for the investigator-sponsored Phase 2b clinical study for SYN-010 during the third quarter of 2020, anticipated IND filing for SYN-020 in the second quarter of 2020, SYN-004's degrading certain commonly used intravenous (IV) beta-lactam antibiotics within the gastrointestinal tract to prevent microbiome damage, C. difficile infection, overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease in allogeneic hematopoietic cell transplant (HCT) recipients, and SYN-010 reducing the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics' therapeutics, a failure of Synthetic Biologics' clinical trials, and those conducted by investigators, for SYN-004 and SYN-010 to be commenced or completed on time or to achieve desired results and benefits, especially in light of COVID-19, a failure of Synthetic Biologics' clinical trials to continue enrollment as expected or receive anticipated funding, a failure of Synthetic Biologics to successfully develop, market or sell its products, Synthetic Biologics' inability to maintain its material licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31, 2019 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

    - Financial Tables Follow -

     

    Synthetic Biologics, Inc. and Subsidiaries

    (in thousands, except share and per share amounts)


    Consolidated Balance Sheets


    For the three months ends 

    March 31,


    2020


    2019

    Assets




       Cash and cash equivalents

    $         10,085


    $         15,045

       Prepaid expenses and other current assets

    1,084


    1,381

       Property and equipment, net

    309


    367

       Right of Use Asset

    386


    419

       Deposits and other assets

    23


    23

    Total Assets

    $         11,887


    $         17,235

    Liabilities and Stockholder's Deficit




       Total liabilities

    $          3,281


    $          5,748

       Series A Convertible Preferred Stock

    12,606


    12,544

    Synthetic Biologics, Inc. and Subsidiaries Equity (Deficit)

    (1,122)


    1,821

    Non-controlling interest

    (2,878)


    (2,878)

    Total Liabilities and Stockholders' Equity (Deficit)

    $         11,887


    $         17,235








     

     

    Condensed Consolidated Statements of Operations





    For the three months ended
    March 31,



    2020


    2019

    Operating Costs and Expenses





       General and administrative


    $             1,393


    $             1,154

       Research and development


    1,635


    2,418

    Total Operating Costs and Expenses


    3,028


    3,572

    Loss from Operations


    (3,028)


    (3,572)

    Other Income





       Interest income


    38


    44

    Total Other Income


    38


    44

     

    Net Loss


    (2,990)


    (3,528)

    Net Loss Attributable to Non-controlling Interest


    (26)


    (16)

    Net Loss Attributable to Synthetic Biologics, Inc.

    and Subsidiaries


    $         (2,964)


    $         (3,512)

    Series A Preferred Stock Dividends


    (62)


    (61)

    Series B Preferred Stock Dividends


    (404)


    (398)

    Net Loss Attributable to Common Stockholders


    (3,430)


    (3,971)

    Net Loss Per Share - Basic and Dilutive


    $              (0.20)


    $              (0.25)

    Weighted average number of common shares outstanding -
    Basic and Dilutive


    17,093,920


    15,656,784

     

     

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