Research and Development (R&D) Expenses. R&D expenses were $7.2 million and $21.4 million for the three months and year ended December 31, 2019, respectively, compared to $3.7 million and $13.7 million for the three months and year ended December 31, 2018, respectively. The increase for the year ended December 31, 2019 was primarily driven by increases in clinical development, contract manufacturing,pre-clinical, and personnel expenses.
General and Administrative (G&A) Expenses. G&A expenses were $2.4 million and $5.3 million for the three months and year ended December 31, 2019, respectively, compared to $0.7 million and $1.5 million for the three months and year ended December 31, 2018, respectively. The increase for the year ended December 31, 2019 was primarily due to costs incurred in preparation to be a public company and personnel related costs.
AboutBIO89-100
BIO89-100 is a glycoPEGylated analog of FGF21 being developed for the treatment of NASH and a trial is planned for evaluating its role in the treatment of severe hypertriglyceridemia (SHTG). 89bio has specifically engineeredBIO89-100 using a proprietary glycoPEGylation technology designed to prolong the biological activity of native FGF21. In preclinical studies,BIO89-100 demonstrated consistent beneficial effects across a range of endpoints, including hepatic steatosis, injury, and fibrosis. In 89bio’s Phase 1a clinical trial in healthy volunteers,BIO89-100 demonstrated a favorable tolerability profile and dose-proportional pharmacokinetics.BIO89-100 also demonstrated statistically significant improvements in key lipid parameters for two weeks after a single dose, which combined with results from the company’s animal studies supports the potential for weekly or once every two weeks dosing. A proof of concept Phase 1a/2b clinical trial evaluatingBIO89-100 in patients with NASH or NAFLD and a high risk of NASH is currently underway.
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 being developed for the treatment of NASH. The company also intends to developBIO89-100 for the treatment of SHTG.BIO89-100 is a specifically engineered glycoPEGylated analog of FGF21 that is currently in a proof of concept Phase 1b/2a clinical trial in patients with NASH or NAFLD and a high risk of NASH. 89bio is headquartered in San Francisco with operations in Herzliya, Israel. Visit 89bio.com for more information.
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, 89bio’s expectations regarding plans for its clinical programs and clinical studies. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond 89bio’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the enrollment, completion and outcome of 89bio’s proof of concept Phase 1b/2a clinical trial evaluatingBIO89-100 in patients with NASH or patients with NAFLD and a high risk of NASH; expectations regarding
