Thu, Feb 27, 10:25 PM (59 days ago)
In its 10-K filing for the fiscal year ended December 31, 2024, 89bio, Inc. (ETNB) reported significant financial developments and a strategic focus on its lead product candidate, pegozafermin, aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). The company incurred a net loss of $367.1 million on total operating expenses of $384.7 million, significantly up from $151.2 million in the previous year. R&D expenses surged to $345 million, primarily due to increased contract manufacturing costs and ongoing clinical trials. Pegozafermin received Breakthrough Therapy designation from the FDA and PRIME designation from the EMA, facilitating its advancement into Phase 3 trials. The company anticipates topline data from these trials in 2027 and 2028. 89bio's liquidity remains robust with $440 million in cash and marketable securities, bolstered by $269.9 million from a recent equity offering. Key risks include reliance on third-party manufacturers, the potential for regulatory setbacks, and intense competition in the biopharmaceutical sector. Overall, while 89bio is positioned for growth, its future hinges on successful clinical outcomes and regulatory approvals.