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89bio 89bio Reports First Quarter 2021 Financial Results and Provides Corporate Update May 12 , 2021 ENLIVEN Phase 2b trial in NASH expected to be initiated in 2Q21 SAN FRANCISCO , May 12 , 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 March 31 , 2021 . " We are pleased to have received written guidance from the U.S. Food and Drug Administration ( FDA ) on our planned Phase 2b ENLIVEN trial design in non - alcoholic steatohepatitis ( NASH ) , " said Rohan Palekar , Chief Executive Officer of 89bio . " We have a well - defined work plan ahead of us and are well - funded to reach multiple clinical and regulatory milestones , which we expect will continue to validate BIO89-100's potential in both NASH and severe hypertriglyceridemia ( SHTG ) . " Recent Highlights and Anticipated Milestones • Received written guidance from the FDA on the Phase 2b ENLIVEN trial design , planned to initiate in 2Q21 : 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 2 or 3 NASH and will utilize a liquid formulation . A total of approximately 200 patients will receive either one of two different weekly doses or a every two - week dose of BIO89-100 or placebo for 24 weeks followed by a blinded extension phase of an additional 24 weeks for a total treatment period of 48 weeks . The primary efficacy outcome measures at Week 24 will include the two key histology - based endpoints of NASH resolution without worsening of fibrosis and the improvement of fibrosis ≥ 1 stage without worsening of NASH . • Report topline data from the paired - biopsy , open - label histology cohort in NASH patients by year - end 2021 : This cohort is enrolling patients with biopsy - confirmed NASH and is expected to provide an early opportunity to demonstrate the benefits of BIO89-100 on histology endpoints . • Report topline data from the Phase 2 ENTRIGUE trial of BIO89-100 in severe hypertriglyceridemia patients in 2H21 : ENTRIGUE is a multi - center , randomized , double - blind , placebo - controlled trial designed to evaluate safety and efficacy in patients who will receive BIO89-100 administered weekly ( 9mg , 18mg or 27 mg ) , every two weeks ( 36mg ) or placebo . ENTRIGUE was expanded recently with an additional cohort of patients on background fibrates . While the recent COVID - 19 surge in Europe has resulted in enrollment challenges in certain geographies , we are working closely with our CRO and remain optimistic that enrollment will pick up in the trial . First Quarter 2021 Financial Results Cash Position . As of March 31 , 2021 , 89bio had cash , cash equivalents , and short - term investments of $ 189.6 million . Research and Development ( R & D ) Expenses . R & D expenses were $ 10.1 million for the three months ended March 31 , 2021 , compared to $ 7.8 million for the three months ended March 31 , 2020. The increase in R & D expenses was primarily driven by increases in contract manufacturing and personnel expenses . General and Administrative ( G & A ) Expenses . G & A expenses were $ 4.6 million for the three months ended March 31 , 2021 , compared to $ 2.9 million for the three months ended March 31 , 2020. 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 $ 14.8 million for the three months ended March 31 , 2021 , compared to a net loss of $ 10.5 million for the three months ended March 31 , 2020. The increase in net loss is primarily attributable to increased R & D expenses for our programs and increased G & A expenses associated with operating as a public company . About 89bio 89bio is a clinical - stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio - metabolic diseases . The company's lead product candidate , BIO89-100 , is a specifically engineered glycoPEGylated analog of FGF21 . BIO89-100 is being developed for the treatment of nonalcoholic steatohepatitis ( NASH ) and severe hypertriglyceridemia ( SHTG ) . 89bio is headquartered in San Francisco with operations in Herzliya , Israel . 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 , the safety and tolerability of BIO89-100 , clinical development plans and