Severe Hypertriglyceridemia (SHTG)
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Enrollment continues to progress in ENTRUST, the Phase 3 trial evaluating the efficacy, safety and tolerability
of pegozafermin in patients with SHTG. Topline results from this trial are expected in 2025. |
Third Quarter 2023 Financial Results
Cash Position. As of September 30, 2023, 89bio had cash, cash equivalents and short-term available-for-sale securities totaling $448.3 million.
Research and Development (R&D) Expenses.
R&D expenses were $31.4 million for the three months ended September 30, 2023, compared to $22.2 million for the three months ended September 30, 2022. The increase in R&D expenses was primarily driven by increases in
contract manufacturing costs and personnel expenses, offset by a decrease in clinical development costs.
General and Administrative (G&A)
Expenses. G&A expenses were $7.9 million for the three months ended September 30, 2023, compared to $4.8 million for the three months ended September 30, 2022. The increase in G&A expenses was primarily due to an
increase in personnel costs, stock-based compensation, and expenses related to professional services.
Net Loss. 89bio reported a net loss of
$34.7 million for the three months ended September 30, 2023, compared to a net loss of $26.8 million for the three months ended September 30, 2022. 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 dedicated to the development of
best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead
candidate, pegozafermin, through clinical development for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. Pegozafermin has been granted Breakthrough
Therapy Designation for the treatment of NASH with fibrosis from U.S. Food and Drug Administration (FDA). The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn.
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, statements regarding the therapeutic potential and utility, efficacy and clinical benefits of
pegozafermin, the safety and tolerability profile of pegozafermin, trial designs, clinical development plans and timing for pegozafermin, including the SHTG Phase 3 program, the ENTRUST Phase 3 trial in SHTG and the NASH Phase 3 trial, the
timing for meeting with regulatory authorities, the use of the SHTG Phase 3 program to support safety database requirements and expectations regarding the time period over which 89bios capital resources will be sufficient to fund its
anticipated operations. Words such as may, might, will, objective, intend, should, could, can, would, expect,
believe, design, estimate,