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ak = ro Akero Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update August 13 , 2021 SOUTH SAN FRANCISCO , Calif . , Aug. 13 , 2021 ( GLOBE NEWSWIRE ) -- Akero Therapeutics , Inc. ( Nasdaq : AKRO ) , a cardio - metabolic biotechnology company developing transformational treatments for non - alcoholic steatohepatitis ( NASH ) , today reported second quarter financial results for the period ending June 30 , 2021 . " Our clinical and manufacturing momentum is a testament to our confidence in efruxifermin ( EFX ) , which has the potential to be among the first investigational NASH therapies approved for treatment of both pre - cirrhotic ( F2 / F3 ) and cirrhotic ( F4 ) NASH , " said Andrew Cheng , M.D. , Ph.D. , president and chief executive officer of Akero . " We are excited to initiate our second Phase 2b clinical trial in patients with late - stage cirrhotic NASH ( F4 ) , who are at increased risk of liver failure and thus have the highest unmet medical need . " Second Quarter Business Highlights & Company Updates • During the second quarter , Akero continued to enroll patients in the HARMONY study , a Phase 2b multicenter , randomized , double - blind , placebo - controlled , clinical trial in biopsy - confirmed pre - cirrhotic NASH patients ( fibrosis stages F2 and F3 ) . • During the second quarter , Akero successfully initiated GMP manufacture of drug substance ( API ) to be used for Phase 3 evaluation of EFX . • In July , Nature Medicine published full results of the main portion of Akero's Phase 2a BALANCED trial in biopsy - confirmed NASH patients with F1 - F3 fibrosis . • Published analysis showed that pre - cirrhotic NASH patients treated for 16 weeks with EFX achieved substantial reductions in liver fat , associated with decreases in markers of liver injury and inflammation , and reversal of fibrosis . • The first published clinical evidence of fibrosis regression with an FGF21 analog . • In July , Akero initiated its 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. • Follows Akero's first quarter announcement of topline results from a 30 - patient expansion cohort of the Phase 2a BALANCED study of EFX in late - stage ( F4 ) cirrhotic NASH , which showed substantial improvements in fibrosis after 16 weeks of treatment among patients with end - of - treatment biopsies . Second Quarter 2021 Financial Results • Akero's cash , cash equivalents and short - term marketable securities for the period ended June 30 , 2021 were $ 230.0 million . • Akero believes that its cash , cash equivalents and marketable securities will be sufficient to fund its current operating plan into the third quarter of 2023 . • Research and development expenses for the three - month period ended June 30 , 2021 were $ 24.0 million , compared to $ 13.0 million for the comparable period in 2020. These increases are attributable to higher costs related to Akero's EFX program , including third - party contract manufacturing , contract research organization costs associated with the BALANCED and HARMONY studies and internal personnel costs . • General and administrative expenses for the three - month period ended June 30 , 2021 were $ 5.0 million , compared to $ 3.4 million for the comparable period in 2020. These increases are attributable to higher expenses for personnel , including non - cash stock - based compensation , and professional services and other costs associated with operating as a public company . • Total operating expenses were $ 29.0 million for the three - month period ended June 30 , 2021 , compared to $ 16.5 million for the comparable period in 2020 . About Akero Therapeutics Akero Therapeutics is a clinical - stage cardio - metabolic company developing transformational treatments for non - alcoholic steatohepatitis ( NASH ) , a disease without any approved therapies . Akero's investigational drug product candidate , efruxifermin ( EFX ) is a differentiated Fc - FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21 , an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body . EFX is designed to offer convenient once - weekly subcutaneous dosing . The consistency and magnitude of effects observed in clinical studies position EFX to be a potentially best - in - class medicine , if approved , for treatment of NASH . EFX is currently being evaluated in two Phase 2b clinical trials : the HARMONY study in pre - cirrhotic patients with F2 / F3 fibrosis and the SYMMETRY study in cirrhotic ( F4 ) patients . Akero is headquartered in South San Francisco . Visit www.akerotx.com for more information . Forward - Looking Statements Statements contained in this press release regarding matters that are not historical facts are " forward - looking statements " within the meaning of the