89bio Announces Q3 2024 Financial Results and Corporate Updates

89bio, Inc., a clinical-stage biopharmaceutical company specializing in innovative therapies for liver and cardiometabolic diseases, announced its financial outcomes for the third quarter ending September 30, 2024. The company is actively progressing three pivotal Phase 3 trials for its lead candidate, pegozafermin, which targets metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).

The Phase 3 ENLIGHTEN program for MASH involves two trials: ENLIGHTEN-Fibrosis for non-cirrhotic patients (F2-F3) with fibrosis, and ENLIGHTEN-Cirrhosis for compensated cirrhotic patients (F4). Both trials are crucial as their histology endpoints might support accelerated approval in the U.S. and conditional approval in Europe. These trials began earlier this year and continue to recruit patients. Additionally, new data from the Phase 2b ENLIVEN trial will be showcased at the 75th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2024.

For SHTG, the ENTRUST Phase 3 trial is evaluating pegozafermin’s efficacy, safety, and tolerability, with topline data expected in 2025.

Corporate developments include key additions to the leadership team: Charles McWherter, Ph.D., joined the Board of Directors; Francis Sarena was appointed Chief Operating Officer; and Teresa Perney, Ph.D., assumed the role of Chief Regulatory and Quality Officer. These appointments bring substantial industry expertise to 89bio as the company continues to advance its clinical programs.

Financially, 89bio strengthened its position with an amended credit facility from K2 HealthVentures, a healthcare-focused specialty finance company. This facility allows for borrowing up to $150 million, of which $35 million was drawn at closing, partially used to refinance an existing $25 million loan. Additional funds are available through 2025, contingent on certain milestones or approvals.

For the third quarter of 2024, 89bio reported cash, cash equivalents, and marketable securities totaling $423.8 million. Research and development expenses rose significantly to $141.4 million, driven by milestone payments to BiBo Biopharma Engineering Co., Ltd., increased clinical development costs, and higher personnel-related expenses due to an expanded team. General and administrative expenses also increased to $10.5 million, largely due to higher headcount and related costs.

The company experienced a net loss of $149.1 million for the quarter, up from $34.7 million in the same period the previous year, primarily due to the increased R&D and administrative expenses necessary to support its expanding operations.

89bio remains dedicated to developing best-in-class therapies for patients lacking optimal treatment options for liver and cardiometabolic diseases. Pegozafermin, their lead candidate, is a fibroblast growth factor 21 (FGF21) analog designed with unique glycoPEGylated technology to enhance biological activity and prolong half-life, showing promise in ongoing Phase 3 studies.

The company is headquartered in San Francisco and continues to focus on advancing its clinical trials and corporate objectives, bolstered by its robust financial backing and experienced leadership team.