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akЄro Akero Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update May 13 , 2021 SOUTH SAN FRANCISCO , Calif . , May 13 , 2021 ( GLOBE NEWSWIRE ) -- Akero Therapeutics , Inc. ( Nasdaq : AKRO ) , a cardio - metabolic biotechnology company developing transformational treatments for non - alcoholic steatohepatitis ( NASH ) , today reported first quarter financial results for the period ending March 31 , 2021 . " We continued to build on the strong foundation provided by last year's reports from the Phase 2a BALANCED main study , with new data showing signs of reversing fibrosis in biopsy - confirmed F4 NASH patients with compensated cirrhosis after only 16 weeks of treatment , " said Andrew Cheng , M.D. , Ph.D. , president and chief executive officer of Akero . " Our histology results , as well as non - invasive markers of fibrosis , indicate that efruxifermin ( EFX ) acts both directly and indirectly to rapidly reverse fibrosis . Consistent data across three placebo - controlled clinical trials increase our confidence that EFX will be efficacious as a treatment for all stages of NASH . This confidence is reflected in our initiation of two parallel , separate Phase 2b clinical trials in F2 - F3 and F4 NASH this year , for which we expect to begin reporting data in the third quarter of 2022. " First Quarter Business Highlights & Company Updates • During the first quarter , Akero reported positive , topline , preliminary results for its 16 - week evaluation of EFX in the treatment of adult NASH patients with compensated cirrhosis ( F4 ) , Child - Pugh Class A ( BALANCED study , Cohort C ) . • Among 12 EFX - treated patients who volunteered to have end - of - treatment biopsies , 7 of 12 ( 58 % ) achieved either a one - stage improvement in fibrosis without worsening of NASH or NASH resolution , compared with 0 of 5 ( 0 % ) for the placebo group . o 4 of 12 ( 33 % ) EFX - treated patients achieved a one - stage improvement of fibrosis without worsening of NASH , compared to 0 % for placebo , indicating rapid reversal of fibrosis among cirrhotic NASH patients after only 16 weeks of treatment . o 3 of 12 ( 25 % ) EFX - treated patients achieved NASH resolution compared to 0 % for placebo . o Improvements in histology were supported by improvements in noninvasive serum - based and imaging markers of fibrosis . • EFX - treated patients also experienced improvements in ALT , serum lipids and glycemic control , with a trend toward weight loss , consistent with the results previously observed for patients with F1 - F3 fibrosis . • During the first quarter , Akero initiated its HARMONY study , a Phase 2b , multicenter , randomized , double - blind , placebo- controlled , clinical trial in biopsy - confirmed NASH patients with fibrosis stage 2 or 3 , with the first patient randomized in March . Multiple Milestones Anticipated for 2021 and 2022 • Akero plans to report additional data from the BALANCED main study at the upcoming meeting of the European Association for the Study of the Liver ( EASL ) on June 23-26 , 2021 . • EASL Abstract No. 1314 : “ The role of reduction in liver fat content ( MRI - PDFF ) and ALT in predicting treatment response in NASH : A secondary analysis of the randomized , controlled BALANCED trial , " presented by Rohit Loomba , M.D. • EASL Abstract No. 1762 : " Correlation between changes in liver fat content and improvements in serum markers of liver injury , fibrosis , metabolism , and in histologic parameters following treatment with efruxifermin , " presented by Stephen Harrison , M.D. • Akero plans to present new data at the upcoming meeting of the American Diabetes Association on June 25-29 , 2021 , for which two abstracts have been accepted for presentation . • Akero expects to initiate its planned SYMMETRY study , a Phase 2b , multicenter , randomized , double - blind , placebo- controlled , clinical trial in biopsy - confirmed NASH patients with compensated cirrhosis ( F4 ) , Child - Pugh Class A , in the second half of 2021 . • Akero expects to report topline , preliminary results for the HARMONY study in the third quarter of 2022 , based on the primary histology endpoint after 24 weeks of treatment . • Akero expects to complete manufacturing of its planned Phase 3 combination drug / device product in 2022 , with release for clinical trials in the first half of 2023 . First Quarter 2021 Financial Results • Akero's cash , cash equivalents and short - term marketable securities for the period ended March 31 , 2021 were $ 250.0 million .