Tag: AXLA

Research News and Market Data on AXLA

January 23, 2023 at 4:15 PM EST

MHRA guidance aligns on key measurements for a registration trial, including primary endpoint and trial design elements

IND for phase 2b/3 trial submitted to the FDA

Axcella to host a conference call Tuesday, January 24 at 8:00 a.m. ET; To register, click here

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jan. 23, 2023– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering novel approaches to treating complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, announced a regulatory path to registration of AXA1125 in the treatment of Long COVID Fatigue. The company reported that it had received regulatory guidance from The Medicines and Healthcare products Regulatory Agency (MHRA), the U.K.’s regulatory agency, supporting a single trial that could serve as the registration trial for patients with Long COVID fatigue, and aligning on key measurements, including primary endpoint and trial design. Axcella will be meeting with the MHRA in the near term to discuss the Innovative Licensing and Access Pathway (ILAP) application. The company further reported submission of an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for a Phase 2b/3 trial.

These efforts follow submission of materials to both regulatory agencies including results from the Phase 2a randomized, double-blind, placebo-controlled investigation to evaluate the efficacy and safety of AXA1125 in patients with fatigue related to Long COVID. Notably, in this study subjects who received AXA1125 experienced clinically and statistically significant improvement in mental (p=0.0097) and physical (p=0.0097) fatigue scores compared to placebo subjects.

Long COVID is a persistent and growing long-term part of the pandemic, affecting an estimated one hundred million patients worldwide, with fatigue as the most commonly reported symptom. Recent estimates indicate that 15-20% of Americans with COVID have persisting health issues,ⁱ up to four million Americans are out of work due to Long COVID symptoms, and that Long COVID has contributed to approximately $1 trillion in lost earnings and $544 billion in increased medical spending.ⁱⁱ

“At Axcella, we are gratified and validated that there is a clear path to advance the Long COVID program into a potential registration trial with a leading regulator,” said Bill Hinshaw, CEO of Axcella. “This treatment could help millions of people around the world and there are no other agents that have demonstrated impact on the level of fatigue in a controlled trial. Many stakeholders have been eagerly anticipating a regulatory path in this new, important, and widespread disease and it is exciting to have this milestone achieved. With additional resources or collaboration, this program has the potential to advance and quickly reach patients in need.”

“We were pleased to have such constructive engagement with the MHRA, who have consistently recognized the urgent needs of patients and the healthcare system in the U.K. and have taken a rigorous and engaged, forward-looking approach to addressing Long COVID,” said Margaret Koziel, M.D., Chief Medical Officer of Axcella. “The tenor of the MHRA response and the results of our trial informed our recently completed FDA IND submission for our phase 2b/3 Long COVID trial. AXA1125 is the most advanced clinical-stage program for this devastating disease and we look forward to the opportunity to conduct a global trial that has the potential to rapidly enroll and submit for approval as the leading program in the field.”

“The statistically significant improvement in reported mental and physical fatigue among study participants receiving AXA1125 is a very encouraging finding for Long COVID patients, who often experience extreme and constant fatigue throughout their days,” added Betty Raman, M.D., Associate Professor of Cardiovascular Medicine at the Radcliffe Department of Medicine, University of Oxford, who led the phase 2a study.

“Given the devastating health and economic impact that Long COVID is having on millions of patients and their families, there is an urgent need for new treatments developed specifically for this population,” said Oved Amitay, Chief Executive Officer of Solve M.E., a non-profit organization that serves as a catalyst for critical research into diagnostics, treatments, and cures for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), Long COVID and other post-infection diseases. “We are encouraged by data from Axcella’s phase 2 study in Long COVID chronic fatigue patients and the hope that AXA1125 provides to these patients, and by the opportunity to advance the program to a pivotal clinical trial.” Amitay, who also is the co-founder of the Long COVID Alliance, a network of patient-advocates, scientists, disease experts, and drug developers focused on educating policy makers and accelerating research into post-viral illnesses, added, “I urge the US government to use all the available mechanisms, including the RECOVER study infrastructure, to advance a clinical study of Axcella’s investigational drug in the U.S. as rapidly as possible. Patients are waiting.”

Investor Conference Call Information

Axcella will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, January 24, 2023. To access the live conference call, please dial 844-808-7139 (domestic) or 412-902-0127 (international) and refer to “Axcella Health.” A webcast of the call will also be available under “Events and Presentations” in the Investors section of the Axcella Health website at https://ir.axcellatx.com/. The archived webcast will be available on Axcella’s website approximately two hours after the conference call and will be available for 90 days following the call.

About Axcella Therapeutics (Nasdaq: AXLA)

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates for the treatment of Long COVID, NASH, and the reduction in risk of OHE recurrence. 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 potential utility of AXA1125 as a treatment of Long COVID and the Company’s anticipated regulatory pathway for AXA1125 and the timing and potential success thereof. 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 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 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.

ⁱ Bull-Otterson L, Baca S, Saydah S, et al. Post–COVID Conditions Among Adult COVID-19 Survivors Aged 18–64 and ≥65 Years — United States, March 2020–November 2021. MMWR Morb Mortal Wkly Rep 2022;71:713–717. DOI: http://dx.doi.org/10.15585/mmwr.mm7121e1external icon
ⁱⁱ Bach K. New data shows long Covid is keeping as many as 4 million people out of work. Brookings Institute. August 24, 2022. https://www.brookings.edu/research/new-data-shows-long-covid-is-keeping-as-many-as-4-million-people-out-of-work/#footnote-3

View source version on businesswire.com: https://www.businesswire.com/news/home/20230123005745/en/

ir@axcellatx.com

Source: Axcella Therapeutics

Research, News, and Market Data on AXLA

November 1, 2022 at 7:00 AM EDT

• Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVID
• Positive Interim Data from Phase 2b EMMPACT Study of AXA1125 in Nonalcoholic Steatohepatitis (NASH)
• $34.2 Million Registered Direct Offering of Common Stock Priced At The Market
• Appointment of Two New Board Members

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 1, 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 announced financial results for the third quarter ended September 30, 2022 and provided a business update.

“This has been an extremely exciting period for Axcella,” said Bill Hinshaw President and Chief Executive Officer of Axcella. “Through the third quarter, we made important progress in our clinical development of AXA1125 and strengthened our balance sheet with a new financing. Specifically, we reported positive data from both our Phase 2 study of Long COVID and our Phase 2b EMMPACT study in non-alcoholic steatohepatitis (NASH). In addition, we completed a financing worth $34.2 million that will allow us to advance the Long COVID program and our EMMPACT Phase 2b clinical trial in NASH.”

Mr. Hinshaw continued, “As the company advances toward late-stage clinical trials, we are pleased to have the additions of Mr. Rosiello and Mr. Straight Nissen to our Board, whose extensive leadership experience will help guide Axcella as we focus on taking steps toward delivering these treatments to patients.”

Clinical Results in the Quarter:

The quarter saw progress in the clinical development of AXA1125, an orally delivered potent and safe compound addressing two very large markets: Long-COVID and NASH. This included the release of top-line results in Long COVID and an interim analysis of the Phase 2b EMMPACT trial in NASH.

Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated one hundred million patients worldwide, with fatigue as the most common symptom. In a release of top-line results, subjects who received AXA1125 had improvements in measures of mental and physical fatigue that were both highly statistically significant and clinically relevant compared to those who received placebo. Mean changes in total, physical and mental scores in the CFQ-11 versus placebo were -4.30 (p=0.0039), -2.94 (p=0.0097) and -1.32 (p=0.0097), respectively.

NASH affects an estimated 40 million people in the U.S., including approximately 10% of U.S. children. The complex pathogenesis of NASH includes dysregulation of metabolism, inflammation and fibrosis. In this interim analysis, at 24-weeks there were statistically significant improvements in the liver stiffness measurement (LSM) using vibration-controlled transient elastography compared to placebo in the high dose arm for all subjects. Absolute changes in LSM were 0.13, -2.01, and -4.07 kilopascals (kPa) in the placebo, low dose and high dose arms, respectively (p= 0.0992 and 0.0096 for the low and high dose, respectively, compared to placebo). These results were supported by statistically significant improvements in other non-invasive measures of liver fibrosis: ELF and FIB-4. Statistically significant improvements in alanine aminotransferase (ALT) were seen at both weeks 12 and 24 in all subjects (placebo-adjusted difference of -28.61% (p=0.0183) and -36.3% (p=0.0017) for the low and high doses, respectively). All subjects experienced significantly greater changes from baseline in MRI-PDFF at 12-weeks compared to the change from baseline in the placebo group (placebo adjusted difference of -18.98% (p=0.0082) and -21.24% (p=0.0014) for the low and high doses, respectively).

Financing and Board:

In September 2022, the Company received $6.0 million from the issuance of convertible notes to funds associated with Flagship Pioneering. In October 2022, the Company secured an additional $28.2 million in gross proceeds through a registered direct offering of common stock, which also resulted in the conversion of the convertible notes into common stock. In total, the Company sold 20,847,888 shares of common stock at a purchase price of $1.64 per share. Since this offering was made without an underwriter or a placement agent, Axcella did not pay any underwriting or placement agent commissions. Simultaneous with the financing, the company appointed Robert Rosiello and Torben Straight Nissen to its Board of Directors, and Mr. Rosiello also became Chairman of the Board. After five years of service, David Epstein stepped off the Board, and will continue to support the Company as a consultant.

Financial Results:

Cash Position: As of September 30, 2022, cash, cash equivalents, and marketable securities totaled $25.4 million, compared to $55.0 million as of December 31, 2021. In September 2022, the Company received $6.0 million from the issuance of convertible notes to funds associated with Flagship Pioneering and, in October 2022, the Company secured an additional $28.2 million in gross proceeds through a registered direct offering of common stock. As part of the registered direct offering, the $6.0 million convertible notes automatically converted into the Company’s common stock. Axcella expects that its current cash balance will be sufficient to meet its operating needs into the second quarter of 2023, provided that, if the Company is unable to satisfy the cash covenants contained in its loan and security agreement with SLR Investment Corp., and SLR Investment Corp. seeks immediate repayment of the loan in full, the Company believes that its cash and cash equivalents will be sufficient to fund its operations into the late first quarter of 2023.

R&D Expenses: Research and development expenses for the quarter and nine months ended September 30, 2022 were $13.3 million and $43.7 million, respectively. Research and development expenses for the same periods ended September 30, 2021 were $10.1 million and $30.7 million, respectively. These increases are the result of the Company’s EMMPACT and Long COVID Phase 2 clinical trials, as well as closure costs for its EMMPOWER Phase 2 clinical trial.

G&A Expenses: General and administrative expenses for the quarter and nine months ended September 30, 2022 were $3.8 million and $12.3 million, respectively. General and administrative expenses for the same periods ended September 30, 2021 were $4.8 million and $14.0 million. These decreases are primarily the result of lower non-cash stock-based compensation expenses.

Net Loss: Net loss for the quarter and nine months ended September 30, 2022 was $17.8 million, or $0.34 per basic and diluted share, and $58.2 million, or $1.19 per basic and diluted share, respectively. This compares with a net loss of $15.6 million, or $0.41 per basic and diluted share, and $46.7 million, or $1.23 per basic and diluted share, for the quarter and nine months ended September 30, 2021.

Internet Posting of Information

Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

About Axcella Therapeutics (Nasdaq: AXLA)

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). 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 biological pathways, improve cellular energetics and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, and 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 the company’s clinical trial data readouts, its expected cash runway and the expected benefits of Mr. Rosiello’s and Mr. Straight Nissen’s service on the Board of Directors of Axcella. 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 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221101005428/en/

Company
Ashley Robinson
arr@lifesciadvisors.com
(617) 430-7577

Source: Axcella Therapeutics

Research, News, and Market Data on AXLA

October 13, 2022 at 8:00 AM EDT

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 13, 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 announced that it has entered into a securities purchase agreement with investors in a registered direct offering of 20,847,888 shares of common stock (the “Shares”) at a purchase price of $1.64 per share, resulting in gross proceeds of $34.2 million, including $6.0 million received as the cancellation of indebtedness upon the conversion of unsecured subordinated convertible promissory notes held by Flagship Pioneering.

The offering closed on October 13, 2022. Since this offering was made without an underwriter or a placement agent, Axcella did not pay any underwriting discounts in connection with the transaction. Axcella intends to use the net proceeds from the offering together with existing cash and cash equivalents to advance the Long COVID program, including regulatory engagement and preparation for further clinical development; advance and complete enrollment of its EMMPACT Phase 2b clinical trial in non-alcoholic steatohepatitis (NASH); and for working capital and other general corporate purposes.

The Shares were offered pursuant to a shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on June 12, 2020. A final prospectus supplement, which contains additional information relating to the offering, has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor shall there be any sale of the Shares in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

“We believe investors were attracted by results from our Phase 2a Placebo Controlled Clinical Trial for Long COVID and positive interim data from our Phase 2b study of NASH. In addition to strong support from our largest current investors, this round of financing also included five investors who are new to Axcella as well as certain Directors and members of management of the company,” said Bill Hinshaw, CEO of Axcella.

Simultaneous with the financing, the company is appointing Robert Rosiello and Torben Straight Nissen to its Board of Directors, and Mr. Rosiello also will become Chairman of the Board. Mr. Rosiello is an Executive Partner of Flagship Pioneering, where he focuses on building capability to originate, manage, and grow new Flagship companies, and helps drive Flagship’s strategy, institution building, and growth initiatives. He came to Flagship after a thirty-year career at McKinsey advising CEOs and Boards of leading healthcare, technology and consumer companies. He also has experience managing through periods of change in a public company as CFO, and he has start-up Board experience through his previous service on the board of Flagship company Inari. Mr. Straight Nissen is a Senior Partner at Flagship Pioneering, where he is responsible for company creation in one of Flagship’s newest growth vectors, Preemptive Health and Medicine. He has provided executive and R&D leadership to biotech and pharmaceutical companies for more than twenty years. Prior to joining Flagship, Mr. Straight Nissen headed up Strategic Portfolio Management for Pfizer’s worldwide R&D organization where he oversaw Pfizer’s portfolio spanning discovery to Phase 2b across all major therapeutic areas.

“Axcella’s emerging leadership in therapeutics for Long COVID and NASH make it an exciting time for the company, and I look forward to working with the Axcella management team and Board as we advance the platform and continue to build value in the company,” said Mr. Rosiello.

“Axcella has generated impressive clinical data that demonstrate the potential to harness the power of EMMs to tackle prevalent chronic conditions and I believe the company is now well positioned to provide safe and convenient orally delivered 1^st line treatments for diseases with large unmet medical needs, such as NASH and Long COVID,” said Mr. Straight Nissen. “I look forward to working with Bill and his team to bring these important products to patients and their families.”

With Mr. Rosiello and Mr. Straight Nissen joining the Board, David Epstein will step down as Chairman and from the Board. Mr. Epstein has been with the Company for five years and has seen the Company through important milestones with multiple phase 2 programs reporting positive data in large and unserved diseases and now wishes to focus on personal priorities. Mr. Epstein remains highly supportive of the Company and will continue as a consultant to the Company.

Internet Posting of Information

Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

About Axcella Therapeutics (Nasdaq: AXLA)

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and 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, the anticipated closing date of the offering and use of proceeds from the offering, investor motivation to participate in the offering, the expected benefits of Mr. Rosiello’s and Mr. Straight Nissen’s service on the Board of Directors of Axcella and the potential for AXA1125 to serve as a first-line treatment option. 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 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 AXA1125, the clinical development and safety profile of 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221013005438/en/

Company
Ashley Robinson
arr@lifesciadvisors.com
(617) 430-7577

Source: Axcella Therapeutics

Friday, September 30, 2022

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). 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 treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. 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.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Axcella Announced Positive Interim NASH Results.  An interim analysis from the Phase 2b EMMPACT Study of AXA1125 in non-alcoholic steatohepatitis (NASH) showed improvements in measures of liver fibrosis and liver fat. The data presented was from patients who had been treated for 12 and 24 weeks of the 48-week treatment period. The study is continuing as planned, and we believe the interim data raise the probability of success for the trial.

Study Design and Analysis. The EMMPACT study was designed to test two doses of AXA1125 against placebo.  Patients receive either placebo, low dose (45.2g/day), or high dose (67.8g/day) twice daily for 48 weeks. It has a target enrollment of 270 patients with biopsy-confirmed Stage 2 or Stage 3 NASH, divided into three arms with 90 patients each. The interim analysis used non-invasive tests to evaluate reduction in liver fibrosis and inflammation.

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