Company Overview

89bio is a clinical-stage biopharmaceutical company focused on developing innovative therapies for liver and cardio-metabolic diseases. The company’s lead product candidate, pegozafermin, is being developed to treat metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).

In 2023 and 2024, 89bio reported positive data from Phase 1 and 2 trials of pegozafermin in MASH patients, leading to the initiation of the Phase 3 ENLIGHTEN program in 2024. The company also reported positive Phase 2 data for pegozafermin in SHTG patients in 2022 and initiated the Phase 3 ENTRUST trial in 2023.

Financial Highlights

• 89bio has incurred significant losses since its inception, with net losses of $51.6 million and $28.8 million for the first quarter of 2024 and 2023, respectively. The increased loss in 2024 was primarily driven by higher research and development costs.

• As of March 31, 2024, 89bio had $562.3 million in cash, cash equivalents and marketable securities. The company expects this will fund operations for at least the next 12 months based on current operating plans.

• Cash resources have been boosted by $88-297 million in net proceeds from public offerings of common stock in 2022 and 2023 as well as $25 million in debt financing in 2023. An additional $21 million was raised in 2024 via an at-the-market (ATM) equity offering program.

Research and Development

• R&D expenses rose from $22.3 million in Q1 2023 to $47.4 million in Q1 2024. The increase was driven primarily by manufacturing scale-up activities, initiation of a Phase 3 trial, and higher personnel costs.

• 89bio expects R&D expenses to continue rising as it advances late-stage trials of pegozafermin and expands its pipeline. The timing and costs of development are difficult to predict.

General and Administrative

• General and administrative costs increased from $6.2 million in Q1 2023 to $9.8 million in Q1 2024, reflecting higher professional fees and personnel expenses.

• These costs are expected to increase to support organizational growth and public company infrastructure.

Liquidity and Capital Resources

• Based on current operating plans, 89bio believes its existing cash resources will fund operations for at least the next 12 months. Additional funding will be needed to complete development and commercialization of pegozafermin.

• Future capital requirements will depend on clinical trial progress, regulatory approvals, manufacturing costs, pipeline expansion efforts and other variables. Additional financing may not be available on favorable terms.

In summary, 89bio continues to report increased R&D spending and net losses as it advances pegozafermin through late-stage trials. With over $560 million in cash resources, the company appears to be sufficiently funded for at least the next year. Further progress with the pegozafermin development program and pipeline expansion efforts will require additional capital.