AXA1125

Claims cover methods of treating a subject presenting with fatigue from post-acute sequelae of COVID-19 (PASC), a/k/a Long COVID, with Candidate AXA1125 CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company focused on pioneering a new approach to address the biology of complex diseases using compositions of endogenous metabolic modulators (EMMs), today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 11,737,999 with claims covering methods of use of Candidate AXA1125, for treating a subject having post-acute sequelae of COVID-19 (PASC), a/k/a Long COVID, particularly fatigue. The patent was issued on August 29, 2023, with anticipated expiration in 2042. “Today’s issuance expands our global patent portfolio and Axcella’s protection of its lead candidate, AXA1125,” said Paul F. Fehlner, J.D., Ph.D., Senior Vice President, Chief Legal Officer of Axcella. “These patents and our entire portfolio are fully owned by Axcella.” AXA1125 is a novel composition of EMMs designed to simultaneously support metabolic, inflammatory and fibrotic pathways associated with fatigue. Axcella was previously granted patents related to AXA1125 with claims covering methods of use and compositions. In particular, Patents Nos. 10,201,513, 10,471,034, 11,129,804, and 11,602,511 cover the AXA1125 compositions, including pharmaceuticals and nutritional supplements. These previously granted patents have an anticipated expiration date in 2037. “In addition to further strengthening Axcella’s global intellectual property position regarding its proprietary composition of amino acids in AXA1125, today’s patent issuance further validates AXA1125’s formulation and its tie to treating PASC or Long COVID, explicitly symptoms of fatigue,” said Bill Hinshaw, President and Chief Executive Officer of Axcella. “We are pleased to have this additional designation as we pursue options to bring our investigational product forward for the benefit of the millions of people who continue to suffer from Long COVID Fatigue. The understanding of the disease continues to advance and show the importance of mitochondrial function and how a mitochondrial activator like AXA1125 has the potential to impact the issues these patients face.” About Endogenous Metabolic Modulators Endogenous metabolic modulators, or EMMs, are a broad family of molecules, including amino acids, which fundamentally impact and regulate human metabolism. Our AXA candidates are anchored by EMMs that have a history of safe use as food. We believe that, unlike conventional targeted interventions currently used to address dysregulated metabolism, EMM compositions have the potential to directly and simultaneously support and modulate multiple metabolic pathways implicated both in complex diseases and overall health. Internet Posting of Information Axcella uses the “Investors and News” section of its website, , 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 focused on pioneering a new approach to address the biology of complex diseases using compositions of endogenous metabolic modulators (EMMs). 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 . 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 pro 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.

AXA1125 remains the most advanced product to help patients experiencing fatigue post acute COVID-19 The Company continues to pursue a strategic alternative for stakeholders CAMBRIDGE, Mass.--(BUSINESS WIRE)--Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company focused on pioneering a new approach to address the biology of complex diseases using compositions of endogenous metabolic modulators (EMMs), today announced financial results for the second quarter ended June 30, 2023 and provided a business update. “Patients are seeking relief from Long COVID fatigue. Axcella’s proprietary composition of amino acids in AXA1125 in Long COVID fatigue is potentially an important step to help people maintain health after recovering from acute COVID-19,” said Bill Hinshaw, President and Chief Executive Officer of Axcella. “Axcella remains committed to helping people suffering from fatigue after acute viral infection, such as with SARS-CoV-2.” The Company has continued its efforts to progress its development program of AXA1125 and achieve a strategic alternative to maximize stakeholder value. With respect to the Company’s plans, no assurances can be made as to whether a strategic transaction will be recommended by the Board of Directors, and the Company does not intend to discuss developments with respect to the evaluation process unless a transaction is approved or disclosure otherwise becomes appropriate. If a strategic process is unsuccessful, the Company may be unable to continue operations at planned levels and be forced to further reduce or terminate operations. Financial Results Cash Position: As of June 30, 2023, cash and cash equivalents totaled $8.9 million, compared to $17.1 million as of December 31, 2022. R&D Expenses: Research and development expenses for the quarter and six months ended June 30, 2023 were $1.2 million and $2.7 million, respectively. Research and development expenses for the same periods ended June 30, 2022 were $16.9 million and $30.4 million, respectively. These decreases are the result of the Company’s decision to lay off 85% of its employees and terminate all research and development activity effective December 15, 2022. G&A Expenses: General and administrative expenses for the quarter and six months ended June 30, 2023 were $2.3 million and $5.1 million, respectively. General and administrative expenses for the same periods ended June 30, 2022 were $3.8 million and $8.5 million, respectively. These decreases are due to the reduction in force on December 15, 2022. Other (expense) income: Other income for the quarter and six months ended June 30, 2023 was $0.1 million and $0.3 million, respectively, and consisted of interest income on our cash balances. Other expense for the same periods ended June 30, 2022 were $0.7 million and $1.4 million, respectively, and consisted of interest expense on the loan and security agreement with SLR Investment Corp. We repaid the loan in full in December 2022. Net Loss: Net loss for the quarter and six months ended June 30, 2023 was $3.4 million, or $0.05 per basic and diluted share, and $7.4 million, or $0.10 per basic and diluted share. This compares with a net loss of $21.3 million, or $0.40 per basic and diluted share, and $40.3 million, or $0.86 per basic and diluted share for the quarter and six months ended June 30, 2022. Internet Posting of Information Axcella uses the “Investors and News” section of its website, , 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 focused on pioneering a new approach to address the biology of complex diseases using compositions of endogenous metabolic modulators (EMMs). 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 . 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, the outcome of strategic alternatives, restructuring the company to advance AXA1125 in Long COVID Fatigue and its financial condition and expected cash runway into the third quarter of 2023. 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 pro 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. Axcella Therapeutics Unaudited Condensed Consolidated Balance Sheets (in thousands) June 30, December 31, 2023 2022 Assets: Cash and cash equivalents $ 8,884 $ 17,147 Other assets 398 1,780 Total assets $ 9,282 $ 18,927 Liabilities and stockholders' equity: Accounts payable $ 8,395 $ 4,707 Accrued expenses and other current liabilities 1,754 7,849 Current portion of operating lease liability 1,391 1,592 Total current liabilities 11,540 14,148 Operating lease liability — 569 Other non-current liabilities — 46 Total liabilities 11,540 14,763 Stockholders' equity (deficit) (2,258 ) 4,164 Total liabilities and stockholders' equity $ 9,282 $ 18,927 Axcella Therapeutics Unaudited Condensed Consolidated Statements of Operations (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Operating expenses: Research and development $ 1,224 $ 16,866 $ 2,657 $ 30,410 General and administrative 2,319 3,753 5,069 8,539 Total operating expenses 3,543 20,619 7,726 38,949 Loss from operations (3,543 ) (20,619 ) (7,726 ) (38,949 ) Other income (expense): Interest income (expense) and other income (expense), net 130 (687 ) 337 (1,396 ) Total other income (expense), net 130 (687 ) 337 (1,396 ) Net loss $ (3,413 ) $ (21,306 ) $ (7,389 ) $ (40,345 ) Net loss per share, basic and diluted $ (0.05 ) $ (0.40 ) $ (0.10 ) $ (0.86 ) Weighted average common shares outstanding, basic and diluted 73,688,558 52,616,279 73,678,881 47,052,105