89bio Announces Q1 2024 Financial Results and Corporate Update

SAN FRANCISCO, May 09, 2024 – 89bio, Inc., a clinical-stage biopharmaceutical company listed on Nasdaq as ETNB, has announced its financial results for the first quarter ending March 31, 2024. The firm focuses on developing and commercializing innovative treatments for liver and cardiometabolic diseases.

CEO Rohan Palekar expressed enthusiasm over the commencement of ENLIGHTEN-Fibrosis, the company's pivotal Phase 3 trial targeting metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis stages F2-F3. The trial aims to evaluate the efficacy and safety of pegozafermin in non-cirrhotic patients. Palekar also confirmed that the ENLIGHTEN-Cirrhosis trial, aimed at MASH patients with compensated cirrhosis (F4), will begin in the second quarter.

The ENLIGHTEN-Fibrosis trial features co-primary endpoints: a one-point or greater improvement in fibrosis without worsening MASH, and MASH resolution without worsening fibrosis. These endpoints will be assessed at Week 52 for a subset of patients to support accelerated approval filings in the U.S. and conditional approval in Europe. Patients will continue treatment beyond Week 52, aiming to enroll approximately 1,000 participants to secure full approval. This phase will also include patients on background GLP-1 therapies, where pegozafermin has shown additional benefits.

The European Medicines Agency (EMA) granted Priority Medicines (PRIME) status to pegozafermin for treating MASH with fibrosis and compensated cirrhosis, backed by positive data from the ENLIVEN Phase 2b trial. Further data from the 48-week extension phase of the ENLIVEN trial will be showcased at the European Association for the Study of the Liver Congress (EASL).

Pegozafermin is also being evaluated for severe hypertriglyceridemia (SHTG) in the ENTRUST Phase 3 trial, with enrollment progressing well and topline results expected in 2025.

89bio has struck a collaboration deal with BiBo Biopharma Engineering Co., Ltd. to build a production facility in China for pegozafermin, contingent on commercial approval. Additionally, Martin Babler has joined the Board of Directors, contributing over 30 years of experience in pharmaceuticals and biotech. The company will host a webinar on May 16, 2024, focusing on pegozafermin’s potential in the MASH landscape, featuring Arun J. Sanyal, MBBS, M.D.

Financial highlights for the first quarter of 2024 include:

- Cash Position: As of March 31, 2024, the company held approximately $562.3 million in cash, cash equivalents, and marketable securities.
- Research and Development (R&D) Expenses: These expenses rose to $47.4 million, up from $22.3 million compared to the same period in 2023. The increase was driven by higher contract manufacturing, clinical development, and personnel-related expenses, including stock-based compensation due to increased headcount.
- General and Administrative (G&A) Expenses: G&A expenses increased to $9.8 million, compared to $6.2 million for the same period in 2023, mainly due to higher professional fees and personnel-related costs.
- Net Loss: The net loss for the period was $51.7 million, up from $28.8 million in the previous year, attributed to higher R&D and G&A expenses.

89bio remains committed to advancing pegozafermin through clinical trials for MASH and SHTG. The company's lead candidate, pegozafermin, is a fibroblast growth factor 21 (FGF21) analog engineered with glycoPEGylated technology to enhance biological activity by extending its half-life. The company is headquartered in San Francisco.

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