Third Quarter 2019 Financial Results
Cash Position.Cash, cash equivalents and marketable securities were $16.2 million as of September 30, 2019, compared to $11.3 million as of December 31, 2018. Subsequent to September 30, 2019, 89bio raised gross proceeds of $97.6 million from its IPO before deducting underwriting discounts and commissions and other offering expenses.
Research and Development (R&D) Expenses. R&D expenses were $6.7 million and $14.2 million for the three and nine months ended September 30, 2019, respectively, compared to $3.3 million and $10.0 million for the same periods in 2018, respectively. The increase in R&D expenses was mainly driven by increases in contract manufacturing, clinical development and personnel related expenses.
General and Administrative (G&A) Expenses. G&A expenses were $1.5 million and $2.9 million for the three and nine months ended September 30, 2019, respectively, compared to $0.5 million and $0.8 million for the same periods in 2018, respectively. The increase in G&A expenses was primarily due to professional services and other costs associated with preparation to become a public company and personnel related expenses
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
