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89bio 89bio Reports Second Quarter 2021 Financial Results and Provides Corporate Update August 12 , 2021 - Initiated Phase 2b ENLIVEN trial in NASH patients - - Completed enrollment in NASH histology cohort with topline data expected by year - end 2021 SAN FRANCISCO , Aug. 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 June 30 , 2021 . " In the second quarter of 2021 , we continued to execute on our goals and took important steps in advancing BIO89-100 as a new treatment option for patients suffering from NASH , " said Rohan Palekar , Chief Executive Officer of 89bio . " We initiated our Phase 2b ENLIVEN trial in NASH and successfully completed target enrollment in the open - label histology cohort in biopsy - confirmed NASH patients . Leveraging this momentum , this quarter we are planning to initiate a pharmacokinetic study of BIO89-100 in NASH patients with compensated cirrhosis ( fibrosis stage F4 ) . As we build on the success of our clinical initiatives , we continue to add talent and depth to our leadership team to guide us through this exciting next phase of strategic growth . " Recent Highlights and Anticipated Milestones Initiated 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 . A total of approximately 216 patients will receive either one of two different weekly doses ( 15mg or 30mg ) , or an every two - week dose ( 44mg ) 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 . Completed target enrollment of 20 patients in open - label histology cohort in biopsy - confirmed fibrosis stage F2 - F3 NASH patients . These patients will be treated for approximately 20 weeks with 27 mg of BIO89-100 once weekly . The trial will provide an early opportunity to demonstrate BIO89-100's potential benefits on histology endpoints . Initiate Pharmacokinetic ( PK ) study in NASH patients with compensated cirrhosis ( fibrosis stage F4 ) in 3Q21 . The trial is designed to evaluate the PK , safety and tolerability of BIO89-100 administered as a single 30 mg dose to these NASH patients . Report topline data from the Phase 2 ENTRIGUE trial of BIO89-100 in severe hypertriglyceridemia patients in the first half of 2022 . 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 . Corporate Update . The company has further strengthened its leadership team in 2021 with key hires across different functions including manufacturing , clinical development , and human resources . Second Quarter 2021 Financial Results Cash Position . As of June 30 , 2021 , 89bio had cash , cash equivalents , and short - term investments of $ 171.0 million . Research and Development ( R & D ) Expenses . R & D expenses were $ 15.6 million and $ 25.8 million for the three and six months ended June 30 , 2021 , respectively , compared to $ 8.4 million and $ 16.2 million for the comparable periods in 2020. 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 $ 4.9 million and $ 9.5 million for the three and six months ended June 30 , 2021 , respectively , compared to $ 3.2 million and $ 6.2 million for the comparable periods in 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 $ 20.7 million and $ 35.5 million for the three and six months ended June 30 , 2021 , respectively , compared to a net loss of $ 11.8 million and $ 22.3 million for the comparable periods in 2020. 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 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 , efficacy , and tolerability 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