AZRX AzurRx BioPharma Inc.

0.72
-0.01  -2%
Previous Close 0.73
Open 0.74
52 Week Low 0.370868
52 Week High 1.9383
Market Cap $20,576,207
Shares 28,502,850
Float 27,515,384
Enterprise Value $25,120,029
Volume 195,572
Av. Daily Volume 470,127
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Upcoming Catalysts

Drug Stage Catalyst Date
MS1819 - OPTION 2
Cystic fibrosis
Phase 2b
Phase 2b
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MS1819 Combination
Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency
Phase 2
Phase 2
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Latest News

  1. Abstracts to Focus on:

    Results from Phase 2, Open-Label, Multicenter, 2x2 Cross-Over Trial to Assess Safety and Efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

    &

    Best Enteric Capsule for Targeted Duodenal Delivery of Non-Porcine MS1819 Lipase Enzyme

    NEW YORK, Sept. 15, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that two abstracts have been accepted for presentation at the North American Cystic Fibrosis Conference (NACFC) to be held virtually October 7 – October 23, 2020. The abstracts will be showcased in the NACFC…

    Abstracts to Focus on:

    Results from Phase 2, Open-Label, Multicenter, 2x2 Cross-Over Trial to Assess Safety and Efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

    &

    Best Enteric Capsule for Targeted Duodenal Delivery of Non-Porcine MS1819 Lipase Enzyme

    NEW YORK, Sept. 15, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that two abstracts have been accepted for presentation at the North American Cystic Fibrosis Conference (NACFC) to be held virtually October 7 – October 23, 2020. The abstracts will be showcased in the NACFC virtual poster gallery and electronically published as a supplement to Pediatric Pulmonology.

    "We are pleased to present the results from the Phase 2 OPTION clinical trial demonstrating that the non-porcine MS1819 lipase is well-tolerated with no clinically significant safety signals at the 2g daily dose," said James Sapirstein, President & CEO of AzurRx. "Furthermore, we have evaluated four different enteric capsules and identified the best suitable formulation for MS1819 that provides gastroprotection of enzyme content and delayed release into the duodenum. Our clinical program continues to advance, and we are determined to develop MS1819 as a safer alternative to porcine pancreatic enzyme replacement therapy (PERT), significantly reducing the pill burden of cystic fibrosis patients."

    Presentation Poster Details Below:

    Title:"Results From a Phase 2, Open-Label, Multicenter, 2X2 Cross-Over Trial to Assess the Safety and Efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis"
    Poster #:228
    Presenter:Michael Konstan, MD – Case Western Reserve University
    Time:Available virtually to registered attendees starting on October 7, 2020



    Title:"Evaluation and Selection of An Enteric Capsule for Targeting Duodenal Delivery of Non-Porcine MS1819 Lipase Enzyme"
    Poster #:243
    Presenter:Mathieu Schué, PhD – Head of Laboratory, AzurRx BioPharma, Inc.
    Time:Available virtually to registered attendees starting on October 7, 2020

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

    Forward-Looking Statements

    This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    760 Parkside Avenue, Suite 304

    Brooklyn, NY 11226

    Phone: (646)-699-7855

    Investor Relations contact:

    LifeSci Advisors, LLC.

    Hans Vitzthum, Managing Director

    1 International Place, Suite 1480

    Boston, MA 02110

    Phone: 617-430-7578

    Primary Logo

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  2. NEW YORK, Aug. 31, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it will be making company presentations at two upcoming investor conferences: the 2020 H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14th at 4:30 p.m. Eastern Time and the 2020 LD 500 Virtual Conference on Friday, September 4th at 11:40 a.m. Eastern Time.

    AzurRx CEO and President James Sapirstein will be presenting to a live virtual audience and will be participating in one-on-one meetings with investors who are registered to attend the two conferences.

    About AzurRx

    NEW YORK, Aug. 31, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it will be making company presentations at two upcoming investor conferences: the 2020 H.C. Wainwright 22nd Annual Global Investment Conference on Monday, September 14th at 4:30 p.m. Eastern Time and the 2020 LD 500 Virtual Conference on Friday, September 4th at 11:40 a.m. Eastern Time.

    AzurRx CEO and President James Sapirstein will be presenting to a live virtual audience and will be participating in one-on-one meetings with investors who are registered to attend the two conferences.

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

    Forward-Looking Statements

    This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    760 Parkside Avenue, Suite 304

    Brooklyn, NY 11226

    Phone: (646)-699-7855

    Investor Relations contact:

    LifeSci Advisors, LLC. 

    Hans Vitzthum, Managing Director 

    1 International Place, Suite 1480 

    Boston, MA 02110 

    Phone: 617-430-7578 

    Primary Logo

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    • Three clinical trial sites activated in Poland, with patient screening initiated
    • Follows activation of six clinical sites in the U.S. and dosing of first three patients
    • Topline data expected in Q1 2021

    NEW YORK, Aug. 17, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced its initial European trial sites are active and screening patients for its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). A total of nine of the expected fifteen sites globally are now active and recruiting patients. Top line…

    • Three clinical trial sites activated in Poland, with patient screening initiated

    • Follows activation of six clinical sites in the U.S. and dosing of first three patients
    • Topline data expected in Q1 2021

    NEW YORK, Aug. 17, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced its initial European trial sites are active and screening patients for its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). A total of nine of the expected fifteen sites globally are now active and recruiting patients. Top line data from the study are anticipated in Q1 2021.

    "We are moving forward swiftly with our OPTION 2 clinical trial and are pleased to have activated the first three European clinical trials sites in Poland," said Dr. James Pennington, Chief Medical Officer of AzurRx. "We now have nine clinical sites activated globally, six of which are in the U.S., and are optimistic that all fifteen clinical trial sites will be screening patients in September.  With our first three patients dosed already, we anticipate having top line data from this trial in Q1 2021 as expected."

    James Sapirstein, Chief Executive Officer of AzurRx, added, "Our team is successfully advancing both of our MS1819 clinical programs and actively initiating new clinical trial sites and screening and enrolling patients. We look forward to the successful completion of the OPTION 2 monotherapy trial and the Combination therapy trial in 2021."

    Phase 2b OPTION 2 Trial Design

    The Phase 2b OPTION 2 multi-center trial is designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills. The primary efficacy endpoint is the coefficient of fat absorption (CFA).

    It will be an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older will be enrolled.  

    MS1819 will be administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum. Patients will first be randomized into two cohorts: to either the MS1819 arm, where they receive a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they receive their pre-study dose of PERT pills for three weeks. After three weeks, stools will be collected for analysis of coefficient of fat absorption. Patients will then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools will again be collected for analysis of CFA. A parallel group of patients will be randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819. All patients will be followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients will be assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.

    About MS1819

    MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

    About Exocrine Pancreatic Insufficiency

    EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient's inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

    There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819.  AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care.  The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

    Forward-Looking Statements

    This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    760 Parkside Avenue, Suite 304

    Brooklyn, NY 11226

    Phone: (646)-699-7855

    Investor Relations contact:

    LifeSci Advisors, LLC. 

    Hans Vitzthum, Managing Director 

    1 International Place, Suite 1480 

    Boston, MA 02110 

    Phone: 617-430-7578 

    Primary Logo

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    • First three patients enrolled in dose escalation trial using delayed-release enteric capsules
    • Topline data expected in 1H 2021

    NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) --  AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that is has enrolled the first three patients in its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The trial will enroll approximately 30 CF patients with top line data from the study anticipated in 1H 2021.

    The Phase 2b multi-center study is designed to investigate the safety, tolerability, and…

    • First three patients enrolled in dose escalation trial using delayed-release enteric capsules
    • Topline data expected in 1H 2021

    NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) --  AzurRx BioPharma, Inc. (NASDAQ:AZRX) ("AzurRx" or the "Company"), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that is has enrolled the first three patients in its Phase 2b OPTION 2 clinical trial to investigate MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The trial will enroll approximately 30 CF patients with top line data from the study anticipated in 1H 2021.

    The Phase 2b multi-center study is designed to investigate the safety, tolerability, and efficacy of MS1819 (2.2 gram and 4.4 gram doses in enteric capsules) in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care.  The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA).

    "Enrolling the first patient in our Phase 2b OPTION 2 trial is an important milestone and we appreciate the support from our clinical trial specialists and centers. We are optimistic that our delayed-release delivery of MS1819 will achieve our primary and secondary efficacy endpoints in this study," said Dr. James Pennington, Chief Medical Officer of AzurRx. "We anticipate data from this trial will inform the optimal dose for our pivotal Phase 3 study, and look forward to top line results in the first quarter of next year."

    James Sapirstein, Chief Executive Officer of AzurRx, added, "We are very pleased to announce that patient dosing in the OPTION 2 trial has begun in the U.S. This represents an important milestone in the clinical development of MS1819 as an EPI monotherapy for patients with cystic fibrosis. Despite the challenges posed by the COVID-19 pandemic, the AzurRx team has been able to successfully activate new clinical trial sites and work with investigators to safely admit patients into the trial."

    Phase 2 OPTION 2 Trial Design

    The Phase 2b OPTION 2 multi-center trial is designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills. The OPTION 2 trial will be an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older will be enrolled.  MS1819 will be administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum.  Patients will first be randomized into two cohorts: to either the MS1819 arm, where they receive a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they receive their pre-study dose of PERT pills for three weeks. After three weeks, stools will be collected for analysis of coefficient of fat absorption. Patients will then be crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools will again be collected for analysis of CFA. A parallel group of patients will be randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819.  All patients will be followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients will be assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety.

    About MS1819

    MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

    About Exocrine Pancreatic Insufficiency

    EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient's inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

    There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills.

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819.  AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care.  The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

    Forward-Looking Statements

    This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    760 Parkside Avenue, Suite 304

    Brooklyn, NY 11226

    Phone: (646)-699-7855

    Investor Relations contact:

    LifeSci Advisors, LLC. 

    Hans Vitzthum, Managing Director 

    1 International Place, Suite 1480 

    Boston, MA 02110 

    Phone: 617-430-7578 

    Primary Logo

    View Full Article Hide Full Article
  3. NEW YORK, Aug. 12, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today issued the following letter to its shareholders and the investment community from James Sapirstein, President and Chief Executive Officer.

    Dear AzurRx Shareholders,

    I am writing to provide clarification on yesterday's press release and conference call where we discussed the positive interim data from the first patient cohort of our combination therapy trial.  We have also received a number of questions from investors regarding the study, our clinical trial timelines, our financing needs and recent changes to our proposed…

    NEW YORK, Aug. 12, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. ("AzurRx" or the "Company") (NASDAQ:AZRX), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today issued the following letter to its shareholders and the investment community from James Sapirstein, President and Chief Executive Officer.

    Dear AzurRx Shareholders,

    I am writing to provide clarification on yesterday's press release and conference call where we discussed the positive interim data from the first patient cohort of our combination therapy trial.  We have also received a number of questions from investors regarding the study, our clinical trial timelines, our financing needs and recent changes to our proposed 2020 equity incentive plan and I would like to take this opportunity to clarify any misunderstandings and update you on recent developments.

    Clinical Trials

    Combination Therapy Trial

    As reported yesterday, we believe that the interim data from the first cohort of five patients in the trial (of daily dose of PERT with MS1819 in patients with cystic fibrosis with severe exocrine pancreatic insufficiency) is positive and clinically meaningful.  Our data and analysis shows that MS1819 is clearly responsible for the change in the Coefficient of Fat Absorption (CFA) and the improvements in the primary and secondary efficacy endpoints were consistent for all patients, across all visits.  By way of summary:

    • The Primary Efficacy Endpoint was met
      • CFA > 80% for all patients, across all visits

         
    • The Secondary Efficacy Endpoints all showed positive changes
      • Stool Weight decreased
      • The number of Stools/Day decreased
      • Steatorrhea improved
      • Body Weight increased



    • Safety – MS1819 is safe, with no serious adverse events

    Option 2 Trial

    On July 22nd, we announced the initiation of the Phase 2b OPTION 2 clinical trial of MS1819 in patients with cystic fibrosis, with the first patient screened and the first three clinical trial sites activated.  The trial is proceeding according to schedule and we will be providing updates in due course.

    Clinical Trial Timelines

    Prior to COVID-19 we anticipated top-line results from both Phase 2 clinical trials by the end of Q4 2020. Subsequently, we have revised this to the release of topline data for OPTION 2 in Q1 2021 and the release of topline data for the combination therapy trial in Q2 2021 (1H 2021), barring any major disruptions from a second wave of COVID-19. Based on communication with our clinical trials sites in the U.S. and Europe we do not anticipate delays to these new timelines.  As discussed on yesterday's call, European sites are re-opening and being initiated for the Combination Therapy trial and the OPTION 2 clinical trials sites in the U.S. are being activated and patients are currently been screened for enrollment.

    Financing and Capitalization

    On July 16th, we completed a private placement (the "Series B Private Placement") of Series B Preferred Stock and warrants that resulted in gross cash proceeds of approximately $15.2 million and net cash proceeds of $13.5 million, and we additionally exchanged approximately $6.9 million principal amount plus accrued interest of senior convertible promissory notes into the Series B Private Placement.

    As a result of the Series B Private Placement, the Company is in a secure financial position with a debt-free balance sheet and sufficient cash on hand to fund our operations for over a one-year period (currently expected through Q3 2021) that will enable us to complete our two Phase 2 clinical trials and initiate preparations for a pivotal Phase 3 clinical trial of MS1819.

    As such, I want to reiterate that we are not looking to raise any additional capital to fund the Phase 2 MS1819 clinical programs. 

    Following the Series B Preferred Stock transactions, we currently have a total of approximately 87.5 million shares of common stock or reserved for issuance upon exercise or conversion of currently outstanding Series B Preferred Stock, warrants and stock options.

    Equity Incentive Plan

    I want to clarify a few things regarding the amended and restated 2020 Omnibus Equity Incentive Plan (the "2020 Plan"), which has been designed with an expected life of ten years.

    Firstly, we are very mindful of the potential dilution resulting from the 2020 Plan and other capital raises. We have proposed an initial 10,000,000 shares, which is approximately 11-12% of the current fully diluted outstanding.

    Secondly, the 2020 Plan aims to initially authorize 10,000,000 shares with potential increases to maintain availability of up to a maximum of 10% of the fully diluted share outstanding, on an as converted basis (not including shares issued and reserved under the 2020 Plan). This is consistent with the increases that have to date been automatically made under the current 2014 Omnibus Equity Incentive Plan (the "2014 Plan"). However, the proposed 2020 Plan increases are only effected on an annual basis every January 1st, rather than on a rolling basis, as per the current 2014 Plan. The proposed 2020 Plan also gives our board of directors discretion not to have such increases take effect, whereas under the 2014 Plan such increases were automatic.  Both are key differences, which impose greater limitations on potentially dilutive increases under the 2020 Plan, as compared to what the 2014 Plan allows.

    Lastly, the number of permitted to be issued as "incentive stock options" ("ISOs") under the 2020 Plan has been reduced, in our amended and restated proxy statement just refiled earlier this morning, to 15,000,000 from 100,000,000. I want to be very clear that this number in no way means that these shares have been authorized to be issued, but rather establishes a permanent maximum limit for reasonable capital expansion over the expected ten-year life of the 2020 Plan.

    Looking Ahead

    We are committed to delivering on our milestones and focused on executing our plan to have topline data for the Phase 2b OPTION 2 monotherapy trial in Q1 2021 and the Phase 2 combination therapy trial in Q2 2021. We have raised sufficient capital to fully fund both trials and to begin preparations for a pivotal Phase 3 trial by the end of 2021. Our interim data from the combination therapy trial is positive and demonstrates that MS1819 has efficacy and is safe.  The OPTION 2 monotherapy trial is actively recruiting patients.

    I believe that we are on track and will be successful in meeting our objectives and increasing shareholder value.

    Once again, I want to extend my personal thanks to all of you for your support of AzurRx and my personal wish that you and your loved ones stay healthy and safe.

    Best regards,

    James Sapirstein

    President & CEO

    AzurRx BioPharma, Inc.

    About AzurRx BioPharma, Inc.

    AzurRx BioPharma, Inc. (NASDAQ:AZRX) is a biopharmaceutical company engaged in the development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. The Company is headquartered in New York, NY, with scientific operations based in Langlade, France and clinical operations in Hayward, California.  Additional information on the Company can be found at www.azurrx.com.

    Important Information about the 2020 Annual Meeting

    The Company has filed with the Securities and Exchange Commission (the "SEC") a definitive proxy statement in connection with the matters to be considered at the 2020 Annual Meeting of Stockholders (the "2020 Annual Meeting"), which it anticipates to mail its stockholders on or about August 11, 2020.  The definitive proxy statement contains important information about the Company and the matters to be considered at the 2020 Annual Meeting. Stockholders are urged to read the proxy statement carefully. Stockholders are able to obtain free copies of the proxy statement and other documents filed with the SEC by the Company through the SEC's website at www.sec.report. In addition, Stockholders are able to obtain free copies of the proxy statement from the Company by contacting the Chief Financial Officer at (646) 699-7855.

    The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies with respect to the matters to be considered at the 2020 Annual Meeting. Additional information regarding interests of such participants is included in the Company's definitive proxy statement, which was initially filed with the SEC on August 7, 2020, as amended and restated on August 11, 2020.

    Forward-Looking Statements

    This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company's financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company's operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2019 under the heading "Risk Factors," as well as the Company's subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

    For more information:

    AzurRx BioPharma, Inc.

    760 Parkside Avenue, Suite 304

    Brooklyn, NY 11226

    Phone: (646)-699-7855

    Investor Relations contact:

    LifeSci Advisors, LLC. 

    Hans Vitzthum, Managing Director 

    1 International Place, Suite 1480 

    Boston, MA 02110 

    Phone: 617-430-7578 

     

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