Friday, March 31, 2023
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.
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4Q22 Reported. Axcella Health reported a 4Q22 loss of $23.0 million or $(0.33) per share and a FY2022 loss of $81.2 million or $(1.49) per share. The 4Q loss included restructuring and impairment charges of $4.2 million. Since the restructuring, Axcella has made significant progress transforming AXA1125 from Phase 2a data into an approved IND for a Phase 2b/3 clinical trial. The company ended FY2023 with $17.1 million in cash.
Long COVID Trial Is “Phase 2b/3 Ready”. In February 2023, Axcella announced the FDA accepted its IND for a Phase 2b/3 pivotal study testing AXA1125 in Long COVID. The design of the study was based on the results of its Phase 2a placebo-controlled trial in Long COVID announced in August 2022. The Phase 2a data showed statistically significant results in mental and physical fatigue scores. Although an experimental biomarker endpoint in muscle recovery was not met, the FDA accepted the IND for a Phase 2b/3 trial.
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