AXLA Axcella Health Inc.

3.67
-0.04  -1%
Previous Close 3.71
Open 3.75
52 Week Low 3.53
52 Week High 7.73
Market Cap $133,760,020
Shares 36,446,872
Float 10,895,805
Enterprise Value $2,200,099
Volume 66,400
Av. Daily Volume 81,299
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Drug Pipeline

Drug Stage Notes
AXA1125
Non-alcoholic steatohepatitis (NASH) / non-alcoholic fatty liver disease (NAFLD)
Phase 2b
Phase 2b
Phase 2b trial planned for 2Q 2021.
AXA1665
Hepatic encephalopathy
Phase 2
Phase 2
Phase 2 trial to be initiated 2Q 2021.

Latest News

    • AXA1665 IND application cleared by FDA for the reduction in risk of recurrent OHE
    • AXA1125 IND application cleared by FDA for the treatment of NASH
    • Initiation of AXA1665 Phase 2 and AXA1125 Phase 2b clinical trials expected shortly
    • Company to host conference call at 8:30 a.m. ET today

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced financial results for the first quarter ended March 31, 2021 and provided a business update.

    "Already in 2021, we have made tremendous progress in advancing our EMM platform and our mission to bring new multi-targeted therapies to patients with complex…

    • AXA1665 IND application cleared by FDA for the reduction in risk of recurrent OHE
    • AXA1125 IND application cleared by FDA for the treatment of NASH
    • Initiation of AXA1665 Phase 2 and AXA1125 Phase 2b clinical trials expected shortly
    • Company to host conference call at 8:30 a.m. ET today

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced financial results for the first quarter ended March 31, 2021 and provided a business update.

    "Already in 2021, we have made tremendous progress in advancing our EMM platform and our mission to bring new multi-targeted therapies to patients with complex diseases and conditions," said Bill Hinshaw, President and Chief Executive Officer of Axcella. "The recent clearance of our first two investigational new drug (IND) applications has extended our strong track record of execution. Additionally, these milestones validate how we can efficiently compile a significant amount of clinical data and then rapidly progress into later-stage development. We expect to continue our momentum as we get our later-stage clinical trials in overt hepatic encephalopathy (OHE) and nonalcoholic steatohepatitis (NASH) underway this quarter, ramp up enrollment leveraging a physician network that is excited by our approach and modality, and expand Axcella's pipeline of EMM compositions."

    Recent Accomplishments and Next Steps

    AXA1665 for the Reduction in Risk of Recurrent OHE

    • Cleared IND: In January 2021, Axcella's IND application was cleared by the U.S. Food and Drug Administration (FDA) for AXA1665, the company's oral product candidate for OHE.
    • Readied for Phase 2 Clinical Trial: During the first quarter of 2021, Axcella finalized plans for a 24-week Phase 2 clinical trial of AXA1665 that will enroll patients with a history of OHE. Initiation of this trial is expected in the near future.
    • Accepted for DDW 2021 Oral Presentation: Data from Axcella's AXA1665-002 clinical study were accepted for an oral presentation at the Digestive Disease Week (DDW) 2021 Annual Meeting, which will be held virtually from May 21 to 23, 2021.

    AXA1125 for the Treatment of NASH

    • Cleared IND: In April 2021, Axcella's investigational new drug (IND) application was cleared by the FDA for AXA1125, the company's oral product candidate for NASH.
    • Readied for Phase 2b Clinical Trial: During the first quarter of 2021, Axcella finalized plans for a 48-week Phase 2b serial biopsy clinical trial of AXA1125 that will enroll adult patients with NASH, with primary and secondary endpoints based on liver histology. Initiation of this trial is expected in the near future.
    • Presented Data at NASH-TAG 2021: In March 2021, multiple presentations regarding AXA1125 were included in NASH-TAG 2021, an event bringing clinicians and researchers together to focus on the diagnosis and treatment of NASH and liver fibrosis. Among them was a poster presentation providing novel insights regarding AXA1125's multi-targeted mechanism of action and a AXA1125-003 clinical study data presentation that was recognized with a Distinguished Abstract and Poster Award.

    Management Team

    • Added Dr. Alison Schecter as President of R&D: In March 2021, Axcella announced the appointment of Alison D. Schecter, M.D., as the company's President of Research and Development. In this role, Dr. Schecter oversees all of the company's research, product candidate design, clinical and regulatory efforts. She brings more than 20 years of research, clinical and regulatory experience to Axcella at companies such as Sanofi-Genzyme, Johnson & Johnson, Selecta Biosciences, and Novartis.

    Financial Results

    Cash Position: As of March 31, 2021, cash, cash equivalents, and marketable securities totaled $93.0 million, compared to $107.3 million at December 31, 2020. Axcella expects that its cash balance will be sufficient to meet the company's operating needs into the third quarter of 2022.

    R&D Expenses: Research and development expenses were $10.2 million and $10.3 million for the quarters ended March 31, 2021 and 2020, respectively.

    G&A Expenses: General and administrative expenses were $4.3 million and $4.1 million for the quarters ended March 31, 2021 and 2020, respectively.

    Net Loss: Net loss for the quarter ended March 31, 2021 was $15.2 million, or $0.40 per basic and diluted share. This compares with a net loss of $15.0 million, or $0.65 per basic and diluted share, for the quarter ended March 31, 2020.

    Conference Call Reminder

    Axcella will host a conference call today at 8:30 a.m. ET to discuss the company's financial results and other recent business updates. The conference call webcast will be accessible in the Investors & News section on the company's website at www.axcellahealth.com. To access the call via telephone, please dial (844) 808-7139 (U.S. toll free) or (412) 902-0127 (international) five minutes prior to the start time. For those unable to listen in live, a webcast archive will be available on the company's website for 90 days following the call.

    About Endogenous Metabolic Modulators (EMMs)

    EMMs are a broad family of naturally occurring molecules, including amino acids, that regulate human metabolism. Axcella is developing a range of novel product candidates that are comprised of multiple EMMs engineered in distinct combinations and ratios to simultaneously impact multiple metabolic pathways to modify the underlying causes of various complex diseases and improve health.

    About Axcella's Clinical Studies

    Each of the company's clinical studies to date are or have been conducted as non-investigational new drug application (IND) clinical studies under U.S. Food and Drug Administration regulations and guidance supporting research with food. These studies evaluate product candidates for safety, tolerability and effects on the normal structures and functions in humans, including in individuals with disease. They were not designed or intended to evaluate a product candidate's ability to diagnose, cure, mitigate, treat or prevent a disease. INDs were recently cleared for Axcella's lead product candidates, AXA1665 and AXA1125, allowing for the investigation of efficacy, safety and tolerability in subsequent clinical trials.

    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 and News" section. Accordingly, investors should monitor this portion of the company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    About Axcella

    Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and their derivatives that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. Axcella's pipeline includes lead therapeutic candidates for non-alcoholic steatohepatitis (NASH) and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. For more information, please visit www.axcellahealth.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 AXA1665, AXA1125 and potential future EMM compositions, the potential for our product candidates to improve the quality of life for patients with complex diseases, the status and timing of the company's planned Phase 2 clinical trial of AXA1665 and planned Phase 2b clinical trial of AXA1125, and the company's expected cash runway into the third quarter of 2022. 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 of COVID-19 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.

    Axcella Health Inc.

    Unaudited Condensed Consolidated Balance Sheets

    (in thousands)

     

     

     

     

     

     

     

    March 31,

     

    December 31,

     

     

    2021

     

    2020

    Assets:

     

     

     

     

    Cash and cash equivalents

     

    $

    43,049

     

     

    $

    71,590

     

    Marketable securities

     

    49,909

     

     

    35,739

     

    Other assets

     

    1,522

     

     

    2,263

     

    Total assets

     

    $

    94,480

     

     

    $

    109,592

     

    Liabilities and stockholders' equity:

     

     

     

     

    Liabilities

     

    $

    32,822

     

     

    $

    34,211

     

    Stockholders' equity

     

    61,658

     

     

    75,381

     

    Total liabilities and stockholders' equity

     

    $

    94,480

     

     

    $

    109,592

     

     

    Axcella Health Inc.

    Unaudited Condensed Consolidated Statements of Operations

    (in thousands, except share and per share data)

     

     

     

     

     

    Three Months Ended

    March 31,

     

     

    2021

     

    2020

    Operating expenses:

     

     

     

     

    Research and development

     

    $

    10,240

     

     

    $

    10,335

     

    General and administrative

     

    4,256

     

     

    4,125

     

    Total operating expenses

     

    14,496

     

     

    14,460

     

    Loss from operations

     

    (14,496

    )

     

    (14,460

    )

    Other income (expense):

     

     

     

     

    Interest income (expense) and other income (expense), net

     

    (693

    )

     

    (549

    )

    Total other income (expense), net

     

    (693

    )

     

    (549

    )

    Net loss

     

    $

    (15,189

    )

     

    $

    (15,009

    )

    Net loss per share, basic and diluted

     

    $

    (0.40

    )

     

    $

    (0.65

    )

    Weighted average common shares outstanding, basic and diluted

     

    37,652,158

     

     

    23,188,816

     

     

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  1. Conference call to take place at 8:30 a.m. ET

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it plans to report its first quarter 2021 financial results and other business updates on May 6, 2021. The company will host a conference call at 8:30 a.m. ET that morning.

    The conference call webcast will be available in the Investors & News section on the company's website at www.axcellahealth.com. To access the call via telephone, please dial (844) 808-7139 (U.S. toll free) or (412) 902-0127 (international) five minutes prior to the start time. For those unable to listen in live, a webcast…

    Conference call to take place at 8:30 a.m. ET

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it plans to report its first quarter 2021 financial results and other business updates on May 6, 2021. The company will host a conference call at 8:30 a.m. ET that morning.

    The conference call webcast will be available in the Investors & News section on the company's website at www.axcellahealth.com. To access the call via telephone, please dial (844) 808-7139 (U.S. toll free) or (412) 902-0127 (international) five minutes prior to the start time. For those unable to listen in live, a webcast archive will be available on the company's website for 90 days following the call.

    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 and News" section. Accordingly, investors should monitor this portion of the company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    About Axcella

    Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and their derivatives that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. Axcella's pipeline includes lead therapeutic candidates for non-alcoholic steatohepatitis (NASH) and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. For more information, please visit www.axcellahealth.com.

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  2. Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced the following upcoming oral presentation at the DDW 2021 regarding AXA1665, the company's product candidate for the reduction in risk of recurrent overt hepatic encephalopathy (OHE):

    • Title: A Novel, Precision-Engineered Amino Acid Composition, AXA1665, is Safe, Well-Tolerated and Improves Neurocognition and Physical Function in Child-Pugh A and B Subjects
      Abstract Number: 848
      Presenter: Dr. Arun Sanyal, Professor in the Virginia Commonwealth University (VCU) Department of Internal Medicine and Education Core Director in the VCU Center for…

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced the following upcoming oral presentation at the DDW 2021 regarding AXA1665, the company's product candidate for the reduction in risk of recurrent overt hepatic encephalopathy (OHE):

    • Title: A Novel, Precision-Engineered Amino Acid Composition, AXA1665, is Safe, Well-Tolerated and Improves Neurocognition and Physical Function in Child-Pugh A and B Subjects

      Abstract Number: 848

      Presenter: Dr. Arun Sanyal, Professor in the Virginia Commonwealth University (VCU) Department of Internal Medicine and Education Core Director in the VCU Center for Clinical and Translational Research

      Session: #4450 Portal Hypertension

      Date/Time: Sunday, May 23rd from 5:45-6:00 p.m. ET

    DDW 2021 is being held virtually from May 21 to 23, 2021. Abstracts are expected to appear on DDW's website in late April and in the May online supplement to Gastroenterology. ePosters and ePapers will be made available on this website during the congress. DDW is the world's leading educational forum for clinicians, researchers, students and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery and related fields.

    About Endogenous Metabolic Modulators (EMMs)

    EMMs are a broad family of naturally occurring molecules, including amino acids, that regulate human metabolism. Axcella is developing a range of novel product candidates that are comprised of multiple EMMs engineered in distinct combinations and ratios to simultaneously impact multiple metabolic pathways to modify the underlying causes of various complex diseases and improve health.

    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 and News" section. Accordingly, investors should monitor this portion of the company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    About Axcella

    Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and their derivatives that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. Axcella's pipeline includes lead therapeutic candidates for non-alcoholic steatohepatitis (NASH) and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. For more information, please visit www.axcellahealth.com.

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    • Multi-targeted oral candidate with the potential to be a first-line treatment option for adult and pediatric patients with NASH
    • Phase 2b clinical trial in adults expected to begin in Q2

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it has achieved a key milestone with U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for AXA1125, enabling the company to proceed directly into a Phase 2b clinical trial. AXA1125 is Axcella's multi-targeted oral product candidate for nonalcoholic steatohepatitis (NASH), a chronic and progressive liver…

    • Multi-targeted oral candidate with the potential to be a first-line treatment option for adult and pediatric patients with NASH
    • Phase 2b clinical trial in adults expected to begin in Q2

    Axcella (NASDAQ:AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions, today announced that it has achieved a key milestone with U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for AXA1125, enabling the company to proceed directly into a Phase 2b clinical trial. AXA1125 is Axcella's multi-targeted oral product candidate for nonalcoholic steatohepatitis (NASH), a chronic and progressive liver disease impacting up to 40 million people in the U.S. alone.

    "This IND follows close on the heels of AXA1665's IND clearance earlier this year, ushering in an exciting new era for Axcella as we seek to tackle a variety of complex diseases and address important unmet needs for patients utilizing multi-targeted EMM compositions," said Bill Hinshaw, President and Chief Executive Officer of Axcella. "I am pleased by our team's strong execution in completing two robust FDA submissions and readying us for the start of our highly efficient, later-stage clinical trials."

    Axcella expects to initiate its Phase 2b clinical trial in the second quarter of 2021. This randomized, double-blind, placebo-controlled, multi-center trial will evaluate the efficacy, safety and tolerability of AXA1125 in adult patients with biopsy-confirmed F2/F3 NASH. Approximately 270 patients will be enrolled and randomized 1:1:1 to receive either 45.2 or 67.8 grams per day of AXA1125 or a matched placebo in two divided doses for 48 weeks, with a four-week safety follow-up period. Patients will be stratified based on the presence or absence of type 2 diabetes.

    The trial will be conducted globally across more than 70 clinical sites with a primary endpoint assessing the proportion of patients with a biopsy-confirmed ≥2 point improvement in NAFLD Activity Score (NAS) after the 48-week treatment period. Secondary endpoints will include the proportion of patients achieving biopsy-confirmed resolution of NASH without worsening of fibrosis and the proportion of patients achieving a ≥1 stage improvement in fibrosis without worsening of NASH. A range of non-invasive biomarkers, including MRI-PDFF and Fibroscan, will be utilized for additional endpoints and an interim analysis in the trial.

    "AXA1125 leverages a mechanism that engages multiple pathophysiologic pathways involved in the development of NASH using a modality with well-precedented safety, which is particularly important given the many comorbidities associated with this chronic disease," said Alison Schecter, M.D., President of R&D at Axcella. "In past clinical studies, compelling activity has been seen with AXA1125 across a range of non-invasive biomarkers, with enhanced effects in type 2 diabetics. Our goal in the Phase 2b is to affirm AXA1125's impact via histology and further strengthen its profile as a compelling candidate for first-line treatment in NASH."

    The upcoming Phase 2b clinical trial follows two earlier non-IND clinical studies in which reductions were seen with AXA1125 in key measures of hepatic fat, insulin resistance, inflammation and fibrosis with a safe and well tolerated profile. Presentations containing those findings can be found by visiting https://axcellahealth.com/publications/.

    About AXA1125 and Nonalcoholic Steatohepatitis (NASH)

    NASH is the most severe form of non-alcoholic fatty liver disease (NAFLD). This chronic, complex disease is associated with significant morbidity and mortality globally, and it is estimated to impact up to 40 million Americans, including up to 10% of American children. Despite its severity and increasing prevalence, there are currently no approved therapies for NASH in the United States.

    AXA1125, Axcella's NASH product candidate, is a composition of six amino acids and derivatives that is designed to target multiple metabolic pathways involved in NASH's progression from metabolism to inflammation to fibrosis. In prior clinical studies, this oral product candidate has been safe and well tolerated and has demonstrated clinically meaningful reductions in a range of well-accepted, non-invasive NASH biomarkers, with the most pronounced activity noted in subjects with type 2 diabetes. AXA1125 is now entering Phase 2b development in adults with NASH. Axcella also plans to investigate AXA1125 in pediatric NASH.

    About Endogenous Metabolic Modulators (EMMs)

    EMMs are a broad family of naturally occurring molecules, including amino acids, that regulate human metabolism. Axcella is developing a range of novel product candidates that are comprised of multiple EMMs engineered in distinct combinations and ratios to simultaneously impact multiple metabolic pathways to modify the underlying causes of various complex diseases and improve health.

    About Axcella's Clinical Studies

    Each of the company's clinical studies to date are or have been conducted as non-investigational new drug application (IND) clinical studies under U.S. Food and Drug Administration regulations and guidance supporting research with food. These studies evaluate product candidates for safety, tolerability and effects on the normal structures and functions in humans, including in individuals with disease. They were not designed or intended to evaluate a product candidate's ability to diagnose, cure, mitigate, treat or prevent a disease. INDs were recently cleared for Axcella's lead product candidates, AXA1665 and AXA1125, allowing for the investigation of these candidates' efficacy, safety and tolerability in subsequent clinical trials.

    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 and News" section. Accordingly, investors should monitor this portion of the company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    About Axcella

    Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases and improve health using endogenous metabolic modulator (EMM) compositions. The company's product candidates are comprised of EMMs and their derivatives that are engineered in distinct combinations and ratios to simultaneously impact multiple biological pathways. Axcella's pipeline includes lead therapeutic candidates for non-alcoholic steatohepatitis (NASH) and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. For more information, please visit www.axcellahealth.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 design, status and timing of the company's planned Phase 2b clinical trial of AXA1125, and the company's ability to address other complex diseases utilizing EMM compositions. 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 IND-enabled 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 planned clinical trial of AXA1125, other potential impacts of COVID-19 on the company's our business and financial results, including with respect to the company's 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 initiation plans and timing, clinical trial design and target indications for AXA1125, the clinical development and safety profile of AXA1125 and its 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. David Davidson, M.D. to Serve as Chief Medical and Development Officer; Hari Pujar, Ph.D. to Serve as Chief Operating Officer and Lin Guey, Ph.D. to Serve as Senior Vice President of Rare Diseases Program Strategy and Operations

    Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations. The senior appointments come just two months after the company announced over $230 million in Series B fundraising in January and will be key to advancing the company's Gene Writing platform and accelerating development…

    David Davidson, M.D. to Serve as Chief Medical and Development Officer; Hari Pujar, Ph.D. to Serve as Chief Operating Officer and Lin Guey, Ph.D. to Serve as Senior Vice President of Rare Diseases Program Strategy and Operations

    Tessera Therapeutics, a biotech company pioneering Gene Writing, announced today the appointment of David Davidson, M.D. as Chief Medical and Development Officer, Hari Pujar, Ph.D. as Chief Operating Officer, and Lin Guey, Ph.D. as Senior Vice President of Rare Diseases Program Strategy and Operations. The senior appointments come just two months after the company announced over $230 million in Series B fundraising in January and will be key to advancing the company's Gene Writing platform and accelerating development of multiple therapeutic programs.

    "David, Hari and Lin all bring a wealth of strategic leadership and deep expertise to Tessera at an exciting time in our growth," said Dr. Geoffrey von Maltzahn, CEO and Co-Founder of Tessera. "Together and alongside our current senior leadership team, they will be instrumental in advancing Tessera's mission to bring forth innovative and curative medicines that go beyond the limitations of current technologies."

    Dr. Davidson brings over 20 years of expertise in clinical drug development focused on rare diseases and gene therapy to his new role as Tessera's Chief Medical and Development Officer. For nearly a decade, Dr. Davidson served as Chief Medical Officer of bluebird bio, where he played a critical role in advancing a broad genetic medicine pipeline across blood disorders, rare diseases and oncology, successfully leading numerous genetic medicine programs into the clinic and delivering multiple first-in-class approvals for genetic medicines in the U.S. and Europe. Prior to bluebird, Dr. Davidson led clinical research for a wide range of therapeutic programs at Genzyme and GelTex, spanning biologics, polymers, and gene therapy. He completed a fellowship in infectious diseases at the Harvard Longwood Combined ID Program, his residency training in internal medicine, and an endocrinology research fellowship at the University of Chicago Hospitals. Dr. Davidson received his M.D. from New York University and B.A. from Columbia University.

    "I have been privileged to lead the clinical development of gene therapy programs from inception through approval to deliver these transformative medicines to patients with life-threatening diseases. I am excited to join the team at Tessera Therapeutics to bring innovative Gene Writing therapies into the clinic," said Dr. David Davidson. "By harnessing the power of mobile genetic elements, Tessera's Gene Writing platform is poised to realize the full potential of genetic medicine and make an unprecedented impact on human health. I am honored to help move this vision forward."

    Dr. Pujar, an Operating Partner at Flagship Pioneering since October 2020, will also serve as Tessera's Chief Operating Officer. Dr. Pujar brings more than 20 years of drug development, manufacturing and commercialization experience spanning AAV gene therapy, mRNA vaccines and therapeutics, and traditional vaccines and biologics. Most recently, Dr. Pujar served as Chief Technology Officer at Spark Therapeutics, a pioneer in AAV gene therapy, and Head of Technical Development and Manufacturing at Moderna, where he led mRNA and lipid nanoparticle development and manufacturing. Previously, Dr. Pujar spent 18 years at Merck & Co., developing and commercializing vaccines and biologics. Dr. Pujar received his Ph.D. in Chemical Engineering from the University of Delaware and his M.B.A. from the University of Pennsylvania.

    "As medicine continues to move up the central dogma of molecular biology from proteins to mRNA to DNA, the opportunity to cure diseases will continue to expand. I'm excited to help shape Tessera Therapeutics, whose Gene Writing technology has the potential to address many of the limitations of current genetic medicine technologies," said Dr. Hari Pujar.

    Dr. Guey, Tessera's Senior Vice President of Rare Diseases Program Strategy and Operations, will oversee the execution of Tessera's genetic medicine programs in Rare Diseases. Dr. Guey brings over 13 years of drug development experience in program leadership, research and nonclinical development, pharmacogenomics and epidemiology. Prior to joining Tessera, Dr. Guey served in senior leadership roles for Moderna, Xilio Therapeutics, Shire, and Pfizer. Dr. Guey received her Ph.D. in Statistics and B.S. in Mathematics from Stony Brook University.

    "With its pioneering and versatile Gene Writing technology, Tessera Therapeutics is at the very forefront of genetic medicine," said Dr. Lin Guey. "I look forward to working with the Tessera team to find new ways to cure rare genetic diseases at their source."

    For more information on Tessera, including how Gene Writing works, partnership opportunities, and job openings, visit www.tesseratherapeutics.com.

    About Tessera Therapeutics

    Tessera Therapeutics is a life sciences company pioneering Gene Writing, a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

    About Flagship Pioneering

    Flagship Pioneering conceives, creates, resources, and develops first-in-category life science platform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in over $80 billion in aggregate value. To date, Flagship has deployed over $2.3 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies, including Axcella Health (NASDAQ:AXLA), Codiak BioSciences (NASDAQ:CDAK) Denali Therapeutics (NASDAQ:DNLI), Evelo Biosciences (NASDAQ:EVLO), Foghorn Therapeutics (NASDAQ:FHTX), Indigo Ag, Kaleido Biosciences (NASDAQ:KLDO), Moderna (NASDAQ:MRNA), Rubius Therapeutics (NASDAQ:RUBY), Sana Biotechnology (NASDAQ:SANA), Seres Therapeutics (NASDAQ:MCRB), and Sigilon Therapeutics (NASDAQ:SGTX).

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