AXLA Axcella Health Inc.

1.61
-0.17  -10%
Previous Close 1.78
Open 1.78
52 Week Low 1.77
52 Week High 6.84
Market Cap $58,679,464
Shares 36,446,872
Float 16,261,517
Enterprise Value $21,530,677
Volume 144,184
Av. Daily Volume 71,464
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Upcoming Catalysts

Drug Stage Catalyst Date
AXA1125 - (EMMPACT)
Non-alcoholic steatohepatitis (NASH) / non-alcoholic fatty liver disease (NAFLD)
Phase 2b
Phase 2b
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AXA1125
Long COVID-19
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
AXA1665 - (EMMPOWER)
Hepatic encephalopathy
Phase 2
Phase 2
Phase 2 trial initiation announced June 30, 2021. Data presented in a poster at the Liver Meeting November 12-15, 2021. Enrollment update due in 2022.

Latest News

    • Long COVID Phase 2a top-line data anticipated in mid-2022
    • EMMPACT℠ Phase 2b interim data in nonalcoholic steatohepatitis (NASH) anticipated in mid-2022

    Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today outlined key clinical and operational milestones that are expected for the company in 2022.

    "The year 2021 was a foundational time for Axcella Therapeutics that was highlighted by the clearance of our first investigational new drug (IND) filings and the initiation of three Phase 2 clinical trials," said Axcella President and Chief Executive Officer Bill Hinshaw. "These accomplishments…

    • Long COVID Phase 2a top-line data anticipated in mid-2022
    • EMMPACT℠ Phase 2b interim data in nonalcoholic steatohepatitis (NASH) anticipated in mid-2022

    Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today outlined key clinical and operational milestones that are expected for the company in 2022.

    "The year 2021 was a foundational time for Axcella Therapeutics that was highlighted by the clearance of our first investigational new drug (IND) filings and the initiation of three Phase 2 clinical trials," said Axcella President and Chief Executive Officer Bill Hinshaw. "These accomplishments set the stage for what we expect to be an exciting and transformative 2022 as we continue to enhance our platform, build on our science and leverage important new clinical insights for additional potential applications. With patient screening well underway in our Long COVID Phase 2a trial, we remain at the forefront of the therapeutic development landscape for this debilitating condition and are on track for a top-line data readout mid-year. Shortly thereafter, we plan to conduct an interim analysis from our EMMPACT Phase 2b clinical trial that will provide the most robust data to date about AXA1125's potential in NASH."

    AXA1125 for Long COVID

    AXA1125, a multi-targeted oral EMM composition that has shown the potential to improve mitochondrial energetics and reduce inflammation, is being investigated in a Phase 2a clinical trial enrolling approximately 40 patients with Long COVID. In 2022, Axcella expects to:

    • Complete enrollment in the Phase 2a trial (first half of 2022);
    • Report top-line data (mid-2022);
    • Assuming positive data, engage with regulatory authorities to discuss the potential for a registrational clinical trial of AXA1125 in Long COVID; and
    • Assuming positive data, consider AXA1125's potential to address mitochondrial dysfunction in conditions other than Long COVID.

    AXA1125 for NASH

    In past clinical studies, AXA1125 has demonstrated its potential to reduce well-established markers of liver fat, inflammation and fibrosis. This candidate is currently being investigated in the EMMPACT Phase 2b clinical trial enrolling approximately 270 patients with biopsy-confirmed F2/F3 NASH. In 2022, Axcella expects to:

    • Report interim data (mid-2022); and
    • Complete patient enrollment in EMMPACT.

    AXA1665 for OHE

    AXA1665 is a multi-targeted oral EMM composition that has shown the potential to improve amino acid balance, ammonia metabolism, muscle function and neurocognition in past clinical studies. This candidate is currently being investigated in the EMMPOWER℠ Phase 2 clinical trial enrolling approximately 150 patients with a history of overt hepatic encephalopathy (OHE). In 2022, Axcella expects to:

    • Provide an enrollment update for EMMPOWER.

    About Axcella Therapeutics (NASDAQ:AXLA)

    Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). The company's unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing of development plan disclosures, regulatory interactions, enrollment updates and clinical trial readouts. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the potential impact of COVID-19 on the company's ability to conduct and complete its ongoing or planned clinical studies and clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the company is able to collect in its clinical trials of AXA1665 and AXA1125, other potential impacts on the company's business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the company's clinical trial plans and timing, clinical trial design and target indications for AXA1665 and AXA1125, the clinical development and safety profile of AXA1665 and AXA1125 and their therapeutic potential, whether and when, if at all, the company's product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the company's target indications, and other risks identified in the company's SEC filings, including Axcella's Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the company's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The company explicitly disclaims any obligation to update any forward-looking statements.

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  1. Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that President and Chief Executive Officer Bill Hinshaw will be presenting at the H.C. Wainwright BioConnect Conference.

    A webcast of this presentation will be available on the "Investors & News" section of the company's website, www.axcellatx.com, at 7:00 a.m. ET on January 10, 2022. A replay will be accessible on Axcella's website for 90 days following the event.

    Internet Posting of Information
    Axcella uses its website, www.axcellahealth.com, as a means of disclosing material nonpublic information and for complying with its disclosure…

    Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that President and Chief Executive Officer Bill Hinshaw will be presenting at the H.C. Wainwright BioConnect Conference.

    A webcast of this presentation will be available on the "Investors & News" section of the company's website, www.axcellatx.com, at 7:00 a.m. ET on January 10, 2022. A replay will be accessible on Axcella's website for 90 days following the event.

    Internet Posting of Information

    Axcella uses its website, www.axcellahealth.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the company's website in the "Investors & News" section. Accordingly, investors should monitor this portion of the company's website, in addition to its press releases, SEC filings and public conference calls and webcasts.

    About Axcella Therapeutics (NASDAQ:AXLA)

    Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). The company's unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

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    • Patient screening underway in the United Kingdom in trial to assess oral product candidate's potential to address Long COVID fatigue and muscle weakness
    • Top-line data readout anticipated by mid-2022

    Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, and researchers at the Oxford University Radcliffe Department of Medicine today announced that patient screening is now underway in a Phase 2a trial that is investigating AXA1125, an oral product candidate, as a potential treatment for Long COVID, also known as Post COVID-19 Condition and post-acute sequelae of SARS-COV-2 infection (PASC).

    "There…

    • Patient screening underway in the United Kingdom in trial to assess oral product candidate's potential to address Long COVID fatigue and muscle weakness
    • Top-line data readout anticipated by mid-2022

    Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, and researchers at the Oxford University Radcliffe Department of Medicine today announced that patient screening is now underway in a Phase 2a trial that is investigating AXA1125, an oral product candidate, as a potential treatment for Long COVID, also known as Post COVID-19 Condition and post-acute sequelae of SARS-COV-2 infection (PASC).

    "There already has been a tremendous amount of interest in participating in this trial among patients suffering from Long Covid fatigue," said lead researcher Dr. Betty Raman, British Heart Foundation Oxford Centre of Research Excellence Clinical Transition Intermediate Fellow. "This is not surprising given the sheer number of patients impacted by this syndrome, the life-changing symptoms that they are experiencing and the complete absence of treatment options today. We are keen to evaluate AXA1125's impact on the mitochondria and muscle function and its potential to improve functional outcomes for patients who are in desperate need."

    The Phase 2a is a randomized, double-blind, placebo-controlled trial that is evaluating the efficacy and safety of AXA1125 in patients with exertional fatigue related to Long COVID. Approximately 40 patients in the United Kingdom will be enrolled and randomized evenly to receive either 67.8 grams per day of AXA1125 or a matched placebo in two divided doses for 28 days, with a one-week safety follow-up period.

    "There is mounting evidence suggesting that infection with the COVID-19 virus can impair the mitochondria's ability to act as the ‘powerhouse of the cell,' manifesting in Long COVID fatigue and muscle weakness," said Dr. Alison Schecter, President of R&D at Axcella. "Our preclinical and clinical findings to date demonstrate that AXA1125 holds the potential to improve multiple aspects of mitochondrial biology, including increasing energetics and reducing inflammation. This provides us with hope that we can make a real difference for tens of millions of patients suffering from this debilitating condition."

    The primary endpoint in this Phase 2a trial is the change from baseline to Day 28 in phosphocreatine (PCr) recovery time as measured by 31-phosphorus magnetic resonance spectroscopy (pMRS). In past clinical trials, this highly sensitive and well-established measure of mitochondrial function has been correlated with the six-minute walk test, which has been a registrational endpoint in other conditions involving fatigue, such primary pulmonary hypertension and exertional angina. Key secondary endpoints in the Phase 2a trial include lactate levels (a serum marker of mitochondrial dysfunction), six-minute walk test, fatigue scores, and safety and tolerability.

    Top-line data are expected to be reported from the Phase 2a trial in mid-2022.

    More than 270 million cases of COVID-19 have been reported worldwide to date, and a recent study estimates that nearly a quarter of Americans who contract COVID-19 experience Long COVID symptoms. Research indicates that fatigue is the most common of these symptoms, impacting a majority of Long COVID patients.

    About AXA1125

    AXA1125 is a proprietary multi-targeted EMM composition consisting of five amino acids and an amino acid derivative that works via multiple biological pathways. Preclinical and clinical data have shown this oral product candidate's potential to increase fatty acid oxidation, ATP production, ketogenesis and mitochondrial bioenergetics, contributing to meaningful reductions in key markets of liver fat, insulin resistance, inflammation, and fibrosis. AXA1125 is currently being investigated in the EMMPACT Phase 2b clinical trial in nonalcoholic steatohepatitis (NASH) (NCT04880187) and a Phase 2a clinical trial in Long COVID (NCT05152849).

    About the University of Oxford and The Radcliffe Department of Medicine

    Oxford University has been placed number 1 in the Times Higher Education (THE) World University Rankings for the sixth year running, and at the heart of this success is the University's ground-breaking research and innovation. Oxford is world-famous for research excellence and home to some of the most talented people from across the globe. The University's work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research sparks imaginative and inventive insights and solutions. Through its research commercialization arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years.

    The Radcliffe Department of Medicine (RDM) is one of the two main departments of medicine at the University of Oxford and aims to tackle some of the world's biggest health challenges by integrating innovative basic biology with cutting edge clinical research. The RDM has internationally renowned programs in a range of areas including cardiovascular sciences, diabetes and endocrinology, immunology, hematology and pathology. https://www.rdm.ox.ac.uk/.

    About Axcella Therapeutics (NASDAQ:AXLA)

    Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). The company's unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the characteristics, competitive position and development potential of AXA1125, the potential for it to address patients' unmet needs, and the timing of the company's clinical trial readouts. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the potential impact of COVID-19 on the company's ability to conduct and complete its ongoing or planned clinical studies and clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the company is able to collect in its clinical trials of AXA1665 and AXA1125, other potential impacts on the company's business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the company's clinical trial plans and timing, clinical trial design and target indications for AXA1665 and AXA1125, the clinical development and safety profile of AXA1665 and AXA1125 and their therapeutic potential, whether and when, if at all, the company's product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the company's target indications, and other risks identified in the company's SEC filings, including Axcella's Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the company's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The company explicitly disclaims any obligation to update any forward-looking statements.

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  2. Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that Margaret Koziel, M.D., has been promoted to the role of Chief Medical Officer and added as a member of the company's executive team. Dr. Koziel, who previously served as Vice President, Clinical Development, joined Axcella in 2019, bringing a wealth of leadership experience within both biopharma and academia.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211206005091/en/

    Margaret Koziel, M.D., Axcella Therapeutics Chief Medical Officer (Photo: Business Wire)

    Margaret Koziel, M.D., Axcella Therapeutics Chief Medical Officer (Photo: Business Wire)

    "Margaret…

    Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that Margaret Koziel, M.D., has been promoted to the role of Chief Medical Officer and added as a member of the company's executive team. Dr. Koziel, who previously served as Vice President, Clinical Development, joined Axcella in 2019, bringing a wealth of leadership experience within both biopharma and academia.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211206005091/en/

    Margaret Koziel, M.D., Axcella Therapeutics Chief Medical Officer (Photo: Business Wire)

    Margaret Koziel, M.D., Axcella Therapeutics Chief Medical Officer (Photo: Business Wire)

    "Margaret joined Axcella at a pivotal stage in the company's evolution and has been a key contributor and leader since Day 1, helping to bring multiple clinical studies to a successful conclusion, contributing to our multi-national regulatory engagements and rapidly advancing our lead candidates into later-stage development," said Bill Hinshaw, President and Chief Executive Officer of Axcella. "We look forward to benefitting from her continued wisdom and guidance as we advance AXA1125 and AXA1665 in three Phase 2 trials with the ultimate aim of treating patients with a range of complex diseases and conditions."

    As Chief Medical Officer, Dr. Koziel will lead Axcella's clinical development and regulatory affairs efforts. Before joining the company, she held positions of increasing responsibility at Kaleido Biosciences, Vertex Pharmaceuticals, and the Novartis Institute for Biomedical Sciences, working across the full spectrum of clinical development, from target selection through Phase 4 trials. Dr. Koziel has also served as a Professor and Assistant Vice Provost for Clinical Research at the University of Massachusetts Medical School, staff physician at the Beth Israel Deaconess Medical Center and Associate Professor of Medicine at Harvard Medical School. Dr. Koziel has published nearly 90 papers in journals such as the New England Journal of Medicine and The Journal of Clinical Investigation. She obtained her B.A. and M.D. from Dartmouth and her postgraduate medical training at New England Deaconess Hospital and Massachusetts General Hospital, affiliates of Harvard Medical School.

    "I am honored and excited by the opportunity to continue working alongside our strong team at Axcella as we seek to bring forward much-needed treatments for conditions like Long COVID, non-alcoholic steatohepatitis (NASH) and overt hepatic encephalopathy (OHE)," said Dr. Koziel. "With compelling data to date, a therapeutic approach that resonates with physicians, and a platform that can be rapidly applied to a number of additional areas, we have a strong foundation in place."

    About Axcella Therapeutics (NASDAQ:AXLA)

    Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). The company's unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the company's ability to apply its platform to additional areas and treat patients with a range of complex diseases and conditions. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the potential impact of COVID-19 on the company's ability to conduct and complete its ongoing or planned clinical studies and clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the company is able to collect in its clinical trials of AXA1665 and AXA1125, other potential impacts on the company's business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the company's clinical trial plans and timing, clinical trial design and target indications for AXA1665 and AXA1125, the clinical development and safety profile of AXA1665 and AXA1125 and their therapeutic potential, whether and when, if at all, the company's product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the company's target indications, and other risks identified in the company's SEC filings, including Axcella's Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the company's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The company explicitly disclaims any obligation to update any forward-looking statements.

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  3. Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that management will be participating in the Piper Sandler 33rd Annual Healthcare Conference.

    A fireside chat from the conference will be made available beginning Monday, November 22 at 10 a.m. ET on the "Investors & News" section of the company's website, www.axcellatx.com, and will be archived for approximately 90 days.

    Internet Posting of Information

    Axcella uses its website, www.axcellatx.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such…

    Axcella Therapeutics (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that management will be participating in the Piper Sandler 33rd Annual Healthcare Conference.

    A fireside chat from the conference will be made available beginning Monday, November 22 at 10 a.m. ET on the "Investors & News" section of the company's website, www.axcellatx.com, and will be archived for approximately 90 days.

    Internet Posting of Information

    Axcella uses its website, www.axcellatx.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the company's website in the "Investors & News" section. Accordingly, investors should monitor this portion of the company's website, in addition to its press releases, SEC filings and public conference calls and webcasts.

    About Axcella Therapeutics (NASDAQ:AXLA)

    Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella's pipeline includes lead therapeutic candidates in Phase 2 development for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence, the treatment of Long COVID, and the treatment of non-alcoholic steatohepatitis (NASH). The company's unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

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