Welcome to our dedicated page for 89Bio news (Ticker: ETNB), a resource for investors and traders seeking the latest updates and insights on 89Bio stock.
About 89bio, Inc.
89bio, Inc. (Nasdaq: ETNB) is a clinical-stage biopharmaceutical company headquartered in San Francisco, California, dedicated to the development and commercialization of innovative therapies for liver and cardiometabolic diseases. The company’s mission is to address unmet medical needs in these areas by advancing its lead product candidate, pegozafermin, a glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin is specifically engineered to optimize biological activity through an extended half-life, making it a promising therapeutic option for complex conditions such as metabolic dysfunction-associated steatohepatitis (MASH)—formerly known as nonalcoholic steatohepatitis (NASH)—and severe hypertriglyceridemia (SHTG).
Core Focus and Product Pipeline
The company’s primary focus is on developing pegozafermin for the treatment of MASH, a chronic and progressive liver disease characterized by fat accumulation, inflammation, and fibrosis, which can lead to cirrhosis, liver failure, or hepatocellular carcinoma. Pegozafermin is also being developed for SHTG, a condition marked by dangerously high triglyceride levels that increase the risk of pancreatitis and cardiovascular disease. Both indications represent significant unmet medical needs, with limited treatment options available.
Pegozafermin has demonstrated encouraging results in clinical trials, showing potential anti-fibrotic, anti-inflammatory, and metabolic benefits. The company is currently advancing pegozafermin through multiple Phase 3 clinical trials under its ENLIGHTEN and ENTRUST programs. These trials aim to evaluate the efficacy and safety of pegozafermin in both non-cirrhotic and cirrhotic MASH patients, as well as in individuals with SHTG. The company’s clinical strategy is bolstered by regulatory designations such as Breakthrough Therapy status from the U.S. FDA and PRIME designation from the European Medicines Agency (EMA), which underscore the potential of pegozafermin to address critical unmet needs.
Competitive Positioning
89bio operates in a competitive biopharmaceutical landscape, with other companies also pursuing therapies for NASH/MASH and SHTG. However, the company differentiates itself through its proprietary glycoPEGylation technology, which enhances the pharmacokinetics and therapeutic potential of pegozafermin. Clinical data from the Phase 2b ENLIVEN trial demonstrated statistically significant improvements in liver histology, non-invasive biomarkers, and metabolic parameters, positioning pegozafermin as a potentially best-in-class FGF21 analog.
Challenges and Opportunities
Like other clinical-stage biopharmaceutical companies, 89bio faces challenges such as clinical trial risks, regulatory approval processes, and the need for substantial capital to fund its development programs. The competitive landscape for MASH and SHTG therapies also necessitates differentiation through clinical efficacy, safety, and patient convenience. Nonetheless, the company’s robust clinical pipeline, strategic focus on high-need indications, and strong regulatory support provide a solid foundation for potential success.
Conclusion
89bio, Inc. is at the forefront of developing transformative therapies for liver and cardiometabolic diseases. By leveraging its expertise in FGF21 biology and glycoPEGylation technology, the company aims to deliver innovative solutions for patients with MASH and SHTG, addressing significant gaps in current treatment paradigms. With its lead candidate pegozafermin progressing through late-stage clinical trials, 89bio is well-positioned to make a meaningful impact in the biopharmaceutical industry.
89bio (ETNB) reported financial results for Q4 and full year 2024, highlighting progress in its clinical trials. The company's Phase 3 ENLIGHTEN trials for MASH patients continue advancing, with topline histology data expected in 1H 2027 for non-cirrhotic patients and 2028 for cirrhotic patients. The Phase 3 ENTRUST trial in severe hypertriglyceridemia completed enrollment with 369 patients, with topline data now expected in Q1 2026.
Financial highlights include cash position of $440.0 million as of December 31, 2024, with additional gross proceeds of $287.5 million from a follow-on offering in Q1 2025. R&D expenses increased to $345.0 million for 2024, up from $122.2 million in 2023. The company reported a net loss of $367.1 million for 2024, compared to $142.2 million in 2023.
89bio (Nasdaq: ETNB) announced the approval of inducement grants by its Board's Compensation Committee. The grants consist of non-qualified stock options to purchase 163,650 shares of common stock, awarded to seven new employees on January 31, 2025. The exercise price equals the closing price of 89bio's stock on the grant date. These options will vest over four years, with 25% vesting after one year and the remaining portion vesting in 12 equal quarterly installments, contingent on continued employment. The grants were made under the company's 2023 Inducement Plan and align with Nasdaq Listing Rule 5635(c)(4).
89bio (Nasdaq: ETNB) has successfully closed its previously announced public offering, raising approximately $287.5 million in gross proceeds. The offering included 25,957,142 shares of common stock at $8.75 per share, with underwriters fully exercising their option to purchase an additional 4,285,714 shares. Additionally, the company offered pre-funded warrants for up to 6,900,000 shares at $8.749 per warrant.
The offering was managed by Goldman Sachs & Co. , Leerink Partners, and BofA Securities as lead book-running managers, with Cantor acting as book-running manager. The securities were offered through an automatically effective shelf registration statement filed with the SEC on May 23, 2023.
89bio (Nasdaq: ETNB) has announced the pricing of its upsized public offering, consisting of 21,671,428 shares of common stock at $8.75 per share and pre-funded warrants to purchase up to 6,900,000 shares at $8.749 per share. The warrants have an exercise price of $0.001 and are immediately exercisable.
The company expects to raise approximately $250.0 million in gross proceeds before deducting underwriting discounts and expenses. The underwriters have a 30-day option to purchase up to an additional 4,285,714 shares. The offering is expected to close around January 30, 2025.
Goldman Sachs & Co. , Leerink Partners, and BofA Securities are serving as lead book-running managers, with Cantor as book-running manager for the offering.
89bio (Nasdaq: ETNB) has announced a proposed underwritten public offering of $250.0 million of common stock and pre-funded warrants. The company will grant underwriters a 30-day option to purchase up to an additional $37.5 million of shares. The proceeds will fund ongoing clinical activities and development of pegozafermin, manufacturing costs, and general corporate purposes.
The offering is being led by Goldman Sachs & Co. , Leerink Partners, and BofA Securities, with Cantor acting as book-running manager. The securities will be offered through an automatically effective shelf registration statement filed with the SEC on May 23, 2023.
89bio (ETNB) provided a corporate update and business outlook for 2025, highlighting key developments in their clinical programs. The company completed enrollment in the Phase 3 ENTRUST trial for severe hypertriglyceridemia (SHTG), with topline 26-week data expected in H2 2025. The Phase 3 ENLIGHTEN program for MASH (metabolic dysfunction-associated steatohepatitis) continues patient enrollment across both trials.
The company strengthened its financial position with $440 million in cash and equivalents as of December 31, 2024, bolstered by a $143.8 million equity offering and a credit facility up to $150 million with K2 HealthVentures. 89bio received regulatory feedback from FDA and EMA regarding pegozafermin's marketing requirements and enhanced its leadership team with four industry veterans in key positions.
89bio (Nasdaq: ETNB) announced that its Compensation Committee approved an inducement grant of non-qualified stock options to one new employee. The grant, made under the company's 2023 Inducement Plan, allows for the purchase of 48,000 shares of common stock at an exercise price equal to the closing price on December 13, 2024. The options will vest over four years, with 25% vesting after one year and the remaining portion vesting in 12 equal quarterly installments, contingent on continued employment.
89bio announced the approval of non-qualified stock options to purchase 49,800 shares of common stock granted to four new employees on November 25, 2024. These Inducement Grants, made under the company's 2023 Inducement Plan, were approved by the Compensation Committee and align with Nasdaq Listing Rule 5635(c)(4). The options' exercise price equals the closing price on the grant date and will vest over four years, with 25% vesting after one year and the remainder vesting in 12 quarterly installments, contingent on continued employment.
89bio (Nasdaq: ETNB) has announced its participation in the 7th Annual Evercore HealthCONx Conference. The company's management will engage in a fireside chat on Tuesday, December 3, 2024, at 8:20 AM ET, along with one-on-one investor meetings. The event will be accessible via webcast through 89bio's investor website section, with replay available for approximately 30 days post-conference. 89bio is a clinical-stage biopharmaceutical company developing innovative therapies for liver and cardiometabolic diseases.
89bio presented new analyses from the Phase 2b ENLIVEN trial evaluating pegozafermin in MASH patients with advanced fibrosis at The Liver Meeting® 2024. The post-hoc analyses demonstrate pegozafermin's potential anti-fibrotic effects and the utility of non-invasive tests (NITs) in correlating with histological endpoints. The data, presented in four poster sessions, showed that pegozafermin improved FAST scores and achieved both MASH resolution and fibrosis improvement, suggesting its effectiveness in preventing progression to cirrhosis in advanced MASH patients. The findings support the design of upcoming Phase 3 trials for both cirrhotic and non-cirrhotic MASH.
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