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89bio 89bio Reports Third Quarter 2021 Financial Results and Provides Corporate Update November 11 , 2021 SAN FRANCISCO , Nov. 11 , 2021 ( GLOBE NEWSWIRE ) -- 89bio , Inc. ( Nasdaq : ETNB ) , a clinical - stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio - metabolic diseases , today reported its financial results for the quarter ended September 30 , 2021 . " In the third quarter of 2021 , we took important steps to advance our ongoing clinical development program for BIO89-100 : a highly differentiated FGF21 analog with a validated and potentially transformational profile for patients suffering from NASH and SHTG , " said Rohan Palekar , Chief Executive Officer of 89bio . " With multiple ongoing studies in these indications , we look forward to reporting data from our open - label histology cohort in NASH patients in early to mid - January 2022 and our proof - of - concept study in SHTG in the first half of 2022. Additionally , we continue to make progress on the ENLIVEN Phase 2b study in NASH patients with F2 and F3 fibrosis . " Recent Highlights and Anticipated Milestones Report topline data from the open - label histology cohort in biopsy - confirmed fibrosis stage F2 F3 NASH patients in early to mid - January 2022. The paired - biopsy , open - label histology cohort is an expansion of the Phase 1b / 2a trial of BIO89-100 in NASH . In this cohort , biopsy - confirmed NASH patients are treated for 20 weeks with 27 mg of BIO89-100 once weekly . This cohort is intended to support both the clinical utility of BIO89-100 and our overall clinical development strategy in NASH . Report topline data from the Phase 2 ENTRIGUE trial of BIO89-100 in severe hypertriglyceridemia patients in the first half of 2022. Recently presented data at the National Lipid Association ( NLA ) meeting in September showed patients with SHTG also had high levels of liver fat by MRI - PDFF ( mean = 20 % ; n = 14 in this sub - analysis ) underscoring the potential of BIO89-100 to address the broader metabolic dysregulation seen in this patient population . Present new analyses from the Phase 1b / 2a NASH trial of BIO89-100 showing beneficial effects on spleen volume in an oral presentation at AASLD's The Liver Meeting 2021. Data from a sub - analysis looking at the correlation of liver fat and spleen volume suggests BIO89-100 can reduce spleen volume ( abstract # 139 ) . A poster with new data on population pharmacokinetics and pharmacodynamics of BIO89-100 that helped inform the dose selection for ENLIVEN will also be presented ( abstract # 1931 ) . Continue to enroll patients in the ENLIVEN Phase 2b trial of BIO89-100 for the treatment of NASH . ENLIVEN is a multi - center , randomized , double - blind , placebo - controlled Phase 2b trial designed to evaluate the safety and efficacy of BIO89-100 for the treatment of patients with fibrosis stage F2 F3 NASH . Third Quarter 2021 Financial Results Cash Position . As of September 30 , 2021 , 89bio had cash , cash equivalents , and short - term investments of $ 157.4 million . Research and Development ( R & D ) Expenses . R & D expenses were $ 23.6 million and $ 49.4 million for the three and nine months ended September 30 , 2021 , respectively , compared to $ 11.2 million and $ 27.4 million for the comparable periods in 2020 , respectively . The increase in R & D expenses was primarily driven by increases in clinical development , contract manufacturing , and personnel expenses . General and Administrative ( G & A ) Expenses . G & A expenses were $ 4.6 million and $ 14.2 million for the three and nine months ended September 30 , 2021 , respectively , compared to $ 3.2 million and $ 9.4 million for the comparable periods in 2020 , respectively . The increase in G & A expenses was primarily due to an increase in costs related to personnel expenses , insurance - related expenses , and expenses for professional services . Net Loss . 89bio reported a net loss of $ 28.3 million and $ 63.8 million for the three and nine months ended September 30 , 2021 , respectively , compared to a net loss of $ 14.6 million and $ 36.9 million for the comparable periods in 2020 , respectively . The increase in net loss is primarily attributable to increased R & D expenses for our programs and increased G & A expenses associated with our growth and operating as a public company . About 89bio 89bio is a clinical - stage biopharmaceutical company dedicated to the development of best - in - class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options . The company is focused on rapidly advancing its lead candidate , BIO89-100 , through clinical development for the treatment of non - alcoholic steatohepatitis ( NASH ) and severe hypertriglyceridemia ( SHTG ) . BIO89-100 is a specifically engineered , potentially best - in - class fibroblast growth factor 21 ( FGF21 ) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half - life . The company is headquartered in San Francisco with operations in Herzliya , Israel . For more information , visit www.89bio.com or follow the company on LinkedIn . Forward - looking Statements Certain statements in this press release may constitute " forward - looking statements " within the meaning of the federal securities laws , including , but not limited to , the therapeutic potential and clinical benefits of BIO89-100 , clinical development plans and timing for BIO89-100 , including the Phase 2b ENLIVEN trial and Phase 2 ENTRIGUE trial , the expected trial design for the ENLIVEN trial and the ENTRIGUE trial , including patient enrollment , dosing schedules and trial endpoints , and the timing for topline data for the open - label histology cohort and the Phase 2 ENTRIGUE trial . Words such as " may , " " might , " " will , " " objective , " " intend , " " should , " " could , " " can , " " would , " " expect , " " believe , " " design , " " estimate , " " predict , " " potential , "