89bio(US:ETNB)2021-11-11 16:00Financial Performance - The company reported a net loss of $28.3 million for the three months ended September 30, 2021, compared to a net loss of $14.6 million for the same period in 2020, representing an increase of $13.7 million or 94%[91]. - The company has an accumulated deficit of $186.9 million as of September 30, 2021, indicating ongoing financial challenges[79]. - The company incurred a net loss of $63.8 million during the nine months ended September 30, 2021[114]. Operating Expenses - Total operating expenses for the three months ended September 30, 2021, were $28.2 million, up from $14.4 million in the same period in 2020, reflecting an increase of $13.8 million or 95%[91]. - Research and development expenses increased by $12.4 million, or 110%, to $23.6 million for the three months ended September 30, 2021, primarily due to a $7.6 million increase in contract manufacturing costs and a $3.8 million increase in clinical development costs[92]. - General and administrative expenses rose by $1.4 million, or 43%, to $4.6 million for the three months ended September 30, 2021, driven by higher personnel-related costs[93]. - Research and development expenses increased by $21.9 million, or 80%, to $49.4 million for the nine months ended September 30, 2021, compared to $27.4 million for the same period in 2020[97]. - General and administrative expenses rose by $4.8 million, or 51%, to $14.2 million for the nine months ended September 30, 2021, from $9.4 million for the same period in 2020[98]. Cash Position - As of September 30, 2021, the company had cash and cash equivalents totaling $157.3 million, which is expected to meet anticipated cash requirements for at least one year[78]. - The company expects existing cash and cash equivalents, along with proceeds from its term loan facility and ATM Facility, to fund operations for at least one year from the filing date of the report[107]. - Net cash used in operating activities was $48.5 million for the nine months ended September 30, 2021, compared to $32.2 million for the same period in 2020[114]. - Net cash used in investing activities was $11.9 million for the nine months ended September 30, 2021, compared to $77.8 million for the same period in 2020[116]. - Net cash provided by financing activities was $2.0 million for the nine months ended September 30, 2021, significantly lower than $158.2 million for the same period in 2020[119]. Research and Development - The company initiated a Phase 2 trial (ENTRIGUE) in patients with severe hypertriglyceridemia (SHTG) in Q3 2020, with topline data expected in the first half of 2022[75]. - The company completed target enrollment of 20 biopsy-confirmed NASH patients in a Phase 1b/2a trial and anticipates reporting topline data in early to mid-January 2022[75]. - The company expects research and development expenses to increase substantially as it advances BIO89-100 through clinical trials and seeks regulatory approval[87]. - The company plans to increase research and development expenses substantially for the foreseeable future as it continues clinical development of its product candidates[106]. - The increase in research and development expenses was primarily due to a $12.3 million increase in contract manufacturing costs and a $7.1 million increase in clinical costs related to ongoing clinical trials[97]. Other Expenses - Other expenses, net decreased by $29,000 to $117,000 for the three months ended September 30, 2021, primarily due to additional interest income[95].