Axcella Announces Patent Issuances Covering AXA1665

Axcella (Nasdaq: AXLA), a clinical-stage biotechnology company focused on leveraging endogenous metabolic modulators (EMMs) to pioneer a new approach for treating complex diseases and improving health, today announced the issuance of two new patents: U.S. Patent 10,682,325 and U.S. Patent 10,660,870. These are the first patents related to Axcella’s family of applications for AXA1665, the company’s product candidate for the reduction in risk of overt hepatic encephalopathy recurrence.

U.S. Patent 10,682,325 covers the composition of AXA1665 as well as other related EMM compositions. U.S. Patent 10,660,870 focuses on methods of use for these EMM compositions in treating a liver disease or disorder involving hyperammonemia and/or muscle wasting.

"Axcella’s goal is to build the world’s leading portfolio of EMM compositions, backed by strong intellectual property,” said Bill Hinshaw, President and Chief Executive Officer of Axcella. "Over the course of the past 18 months, we have grown our number of patent families to 19, covering both our product candidates as well as our platform. We also have more than tripled our number of patent applications to nearly 200 and received our first six patent issuances covering AXA1665, AXA1125, AXA4010 and AXA2678. These accomplishments position us well as we approach potential advanced clinical trials for our lead candidates, AXA1665 and AXA1125.”

About Endogenous Metabolic Modulators (EMMs)

EMMs are a broad family of 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 root causes of various complex diseases and improve health.

About Axcella’s Clinical Studies

Each of the company’s clinical studies to date, including AXA1125-003, 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 are not designed or intended to evaluate a product candidate’s ability to diagnose, cure, mitigate, treat or prevent a disease. If Axcella decides to further develop a product candidate as a potential therapeutic, as is the case with AXA1665 and AXA1125, any subsequent clinical studies will be conducted under an IND.

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 such portions 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 focused on leveraging endogenous metabolic modulators (EMMs) to pioneer a new approach for treating complex diseases and improving health. 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. Additional muscle- and blood-related programs are in earlier-stage development. 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 the company’s EMM product candidates and its platform, the coverage that the company’s expanded patent portfolio provides to its product candidates and platform and the potential to approach advanced clinical trials for AXA1665 and AXA1125. 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 any future challenges to the company’s patents, the scope of and ability to maintain patent protection, the ability of the patent portfolio to protect the company’s product candidates and platform, the potential impacts of COVID-19 on our business and financial results, whether data readouts and/or U.S. Food and Drug Administration feedback support our plans and timing for IND filings, clinical trial design and target indications for AXA1665 and AXA1125, the clinical development and safety profile of the company’s product candidates and their health or therapeutic potential, 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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