89bio Q2 2024 Financial Results and Corporate Updates

89bio, Inc., a biopharmaceutical company based in San Francisco, has disclosed its financial results for the second quarter ending June 30, 2024. The company is actively engaged in developing treatments for liver and cardiometabolic diseases and has recently embarked on several significant clinical trials.

The company launched two critical Phase 3 trials focusing on metabolic dysfunction-associated steatohepatitis (MASH): the ENLIGHTEN-Fibrosis trial for non-cirrhotic patients and the ENLIGHTEN-Cirrhosis trial for patients with compensated cirrhosis (F4). Both trials could potentially secure accelerated approval based on histology. CEO Rohan Palekar emphasized the importance of these trials and the company's readiness for the potential commercialization of pegozafermin, a key drug candidate. Pegozafermin targets advanced fibrosis and cirrhosis in MASH patients and addresses severe hypertriglyceridemia (SHTG).

The ENLIGHTEN-Cirrhosis Phase 3 trial, initiated in the second quarter, is a global, randomized, double-blind, placebo-controlled study. It aims to enroll approximately 760 patients, who will be administered 30mg of pegozafermin weekly or a placebo. A subset of these patients will be evaluated at 24 months to assess fibrosis regression, supporting an accelerated approval filing in the U.S. and conditional approval in Europe. The primary goal of the trial is to improve fibrosis from stage F4 to an earlier stage, with final clinical outcome data providing the basis for confirmatory approval.

Parallel to the ENLIGHTEN trials, 89bio is also conducting the ENTRUST Phase 3 trial to test pegozafermin's efficacy, safety, and tolerability in patients with severe hypertriglyceridemia (SHTG). Enrollment for this trial is ongoing, and topline results are anticipated in 2025.

A notable corporate development in the second quarter was the appointment of Dr. Charles McWherter to 89bio's Board of Directors. Dr. McWherter has a robust background, having previously served as Chief Scientific Officer and President of Research and Development at CymaBay Therapeutics before its acquisition by Gilead Sciences in March 2024.

Financially, 89bio reported having $531.4 million in cash, cash equivalents, and marketable securities as of June 30, 2024. This figure excludes proceeds from the exercise of common stock warrants after the reporting period. Research and development (R&D) expenses for the quarter were $44.9 million, up from $34.9 million in the same period the previous year, driven mainly by increased clinical development and personnel-related expenses. General and administrative (G&A) expenses also rose to $8.6 million, compared to $7.2 million in the prior year, primarily due to higher professional fees and personnel costs.

The company reported a net loss of $48.0 million for the quarter, compared to $38.4 million for the same period in 2023. The increased net loss was mainly due to higher R&D and G&A expenses. However, this was partially offset by an increase in net interest income and other revenues, which rose to $6.5 million from $4.6 million, influenced by changes in interest rates and higher average invested balances.

89bio continues to focus on the development of pegozafermin, a fibroblast growth factor 21 (FGF21) analog designed to optimize biological activity through glycoPEGylation, which extends its half-life. The company believes pegozafermin holds significant promise for MASH and SHTG patients who do not respond to current standard treatments.

In summary, 89bio is advancing its clinical programs, expanding its executive team, and maintaining a strong financial position as it progresses towards potential commercialization of its lead drug candidate, pegozafermin. The company remains dedicated to developing effective therapies for liver and cardiometabolic diseases, addressing unmet medical needs in these areas.