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Jun 30, 2024
89Bio Q2 2024 Earnings Report
Reported financial results for the second quarter ended June 30, 2024.
Key Takeaways
89bio reported a net loss of $48.0 million for the second quarter ended June 30, 2024. The increase in net loss was primarily attributable to increased R&D expenses to advance the company’s Phase 3 clinical trials, increased G&A expenses associated with higher headcount, and expenses to support the Company’s expanded operations.
Initiated two pivotal Phase 3 trials addressing non-cirrhotic MASH and MASH with compensated cirrhosis.
Continued to take important steps forward that will strategically enhance preparedness for potential commercialization of pegozafermin including commercial manufacturing readiness.
Enrollment is ongoing in ENTRUST, the Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with SHTG.
Dr. Charles McWherter joined the Board of Directors, effective July 30, 2024.
89Bio
89Bio
Forward Guidance
The company is focused on advancing its Phase 3 clinical trials for pegozafermin in MASH and SHTG, and preparing for potential commercialization.
Positive Outlook
- Advancing Phase 3 trials for pegozafermin in MASH and SHTG.
- Preparing for potential commercialization of pegozafermin.
- Pegozafermin has the potential for accelerated approval using histology in both trials.
- Phase 3 ENTRUST trial for patients with severe hypertriglyceridemia (SHTG) continues to enroll patients.
- Topline data from the ENTRUST trial is expected in 2025.
Challenges Ahead
- The company reported a net loss of $48.0 million for the quarter.
- Increased R&D expenses are impacting profitability.
- Increased G&A expenses are also impacting profitability.
- Clinical trial outcomes are uncertain.
- Competition from competing products.