SAN FRANCISCO - 89bio, Inc. (NASDAQ:ETNB), a clinical-stage biopharmaceutical company, has announced new findings from the Phase 2b ENLIVEN trial of pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH) and advanced fibrosis. The data, presented at The American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in San Diego, California, suggest that pegozafermin may be effective in reversing fibrosis and preventing progression to cirrhosis in patients with advanced MASH.
The ENLIVEN trial, which included 192 patients, was designed to evaluate the safety and efficacy of pegozafermin, a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). The primary outcomes measured at week 24 included the resolution of MASH without worsening of fibrosis and a decrease in fibrosis stage with no worsening of MASH. Secondary measures assessed changes from baseline in liver fat, liver enzymes, noninvasive markers of liver fibrosis, glycemic control, lipoproteins, and body weight.
The trial achieved high statistical significance on primary histology endpoints with two dosing regimens of pegozafermin. Post-hoc analyses presented at the meeting demonstrated that pegozafermin improved patients' FAST scores, which are noninvasive tests correlating to histological endpoints, and achieved both MASH resolution and fibrosis improvement.
These findings have bolstered confidence in the design of Phase 3 trials for both cirrhotic and non-cirrhotic MASH. Pegozafermin has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and Priority Medicines status from the European Medicines Agency (EMA) for the treatment of MASH with fibrosis.
MASH, often underdiagnosed and undertreated, can lead to severe complications including cirrhosis and the need for liver transplantation. The new analyses suggest the potential of noninvasive tests like FAST and AGILE3+ to identify high-risk patients more conveniently and potentially reduce the need for liver biopsy.
The company is advancing pegozafermin through clinical development, with ongoing Phase 3 trials in MASH and severe hypertriglyceridemia (SHTG). The information reported is based on a press release statement from 89bio.
In other recent news, 89bio, Inc. has announced a significant public offering and the issuance of pre-funded warrants in partnership with Goldman Sachs (NYSE:GS) & Co. LLC, Leerink Partners LLC, and Evercore Group L.L.C. The company has agreed to sell over 11 million shares of common stock and issue pre-funded warrants for more than 3 million shares. The net proceeds from this offering are expected to be approximately $118.4 million.
In addition, 89bio has appointed Francis Sarena as Chief Operating Officer and Dr. Charles McWherter to its Board of Directors, marking recent developments in the company's leadership.
On the analyst front, UBS has maintained a Buy rating on 89bio, while Evercore ISI and others adjusted their price targets due to projected expenses.
These developments come as 89bio advances its lead candidate, pegozafermin, currently in advanced clinical trials, with results anticipated in 2025.
InvestingPro Insights
As 89bio (NASDAQ:ETNB) continues to make strides in its clinical trials for pegozafermin, investors should consider some key financial metrics and insights provided by InvestingPro. The company's market capitalization stands at $928.61 million, reflecting the market's current valuation of its potential in the MASH treatment space.
InvestingPro data shows that 89bio's stock has experienced a 14.98% price total return over the past year, indicating some investor optimism about the company's prospects. However, it's worth noting that the stock has taken a significant hit over the last week, with a -16.27% price total return, possibly due to market volatility or specific company news.
Two relevant InvestingPro Tips highlight important aspects of 89bio's financial situation. Firstly, the company "holds more cash than debt on its balance sheet," which is a positive sign for a clinical-stage biopharmaceutical company as it provides financial flexibility to continue its research and development efforts. Secondly, 89bio is "quickly burning through cash," which is not uncommon for companies in the clinical trial phase but emphasizes the importance of successful trial outcomes for the company's future.
It's important to note that 89bio is not currently profitable, with a negative EBITDA of -$303.81 million for the last twelve months as of Q3 2023. This aligns with another InvestingPro Tip stating that "analysts do not anticipate the company will be profitable this year." These financial metrics underscore the importance of the pegozafermin trials for 89bio's future prospects.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights, with 8 more tips available for 89bio on the platform.
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