subslover
1年前
89bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Updates
– Plan to initiate the Phase 3 ENLIGHTEN NASH program for non-cirrhotic (F2-F3) and cirrhotic (F4) patients in the first and second quarters of 2024, respectively –
– Long-term data from Phase 2b ENLIVEN trial demonstrated sustained benefits of pegozafermin at week 48 in patients with advanced NASH, which was consistent across patient sub-groups –
– Data from Phase 2b ENLIVEN trial in patients with cirrhotic NASH were featured in an oral presentation during American Association for the Study of Liver Diseases The Liver Meeting® (AASLD) –
– Completed follow-on offering in the fourth quarter 2023 for $172.5 million in gross proceeds; cash, cash equivalents and marketable securities totaled $578.9 million as of December 31, 2023 –
SAN FRANCISCO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today reported its financial results for the fourth quarter and full year ended December 31, 2023, and provided corporate updates.
“In 2023, we advanced our late-stage clinical development programs and demonstrated the anti-fibrotic and metabolic benefits of pegozafermin, aligned our Phase 3 NASH program with regulatory agencies in the United States and Europe, initiated our Phase 3 trial for SHTG, and strengthened our financial position,” said Rohan Palekar, Chief Executive Officer of 89bio. “We are highly encouraged by the Phase 2b ENLIVEN data and the long-term efficacy and tolerability data, which demonstrated positive, sustained benefits over a 48-week period, which together, positions pegozafermin as a potential best-in-class FGF21. As we continue to pursue a new therapeutic option and standard of care for patients through the promise of pegozafermin, our team is focused on the execution of our planned Phase 3 trials in NASH and the ongoing Phase 3 trial in SHTG.”
Recent Highlights and Anticipated Milestones
Nonalcoholic Steatohepatitis (NASH), or Metabolic dysfunction-associated steatohepatitis (MASH)
Successful end-of-Phase 2 meetings (EOP2) with the U.S. Food & Drug Administration (FDA), and initial scientific advice received from the European Medicines Agency (EMA) supports the advancement of pegozafermin into Phase 3 in NASH. The ENLIGHTEN program is expected to include two Phase 3 trials evaluating patients with NASH. ENLIGHTEN-Fibrosis is expected to enroll non-cirrhotic patients with fibrosis stage F2-F3 and ENLIGHTEN-Cirrhosis is expected to enroll NASH patients with compensated cirrhosis (F4).ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis are expected to initiate in the first and second quarter of 2024, respectively.
Long-term data from the ENLIVEN Phase 2b trial demonstrated statistically significant improvements across key markers of fibrosis and liver health and at week 48 in NASH patients. Pegozafermin continued to demonstrate a favorable safety and tolerability profile consistent with previously reported data.
Data from the Phase 2b ENLIVEN trial of NASH patients with compensated cirrhosis (F4) were featured in an oral presentation during AASLD, showing clinically meaningful reductions in key non-invasive tests (NITs) of liver inflammation and fibrosis.
Severe Hypertriglyceridemia (SHTG)
Enrollment continues to progress well in ENTRUST, the Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with SHTG. Topline results from this trial are expected in 2025.
Corporate Updates
Completed follow-on offering in the fourth quarter of 2023 for $172.5 million in gross proceeds.
Fourth Quarter 2023 Financial Results
Cash Position. As of December 31, 2023, 89bio had cash, cash equivalents and marketable securities totaling $578.9 million, as compared to $188.2 million as of December 31, 2022.
Research and Development (R&D) Expenses. R&D expenses were $33.6 million and $122.2 million for the three months and year ended December 31, 2023, respectively, compared to $19.1 million and $80.8 million for the three months and year ended December 31, 2022, respectively. The increase in R&D expenses for the year was primarily driven by increases in contract manufacturing costs and personnel-related expenses.
General and Administrative (G&A) Expenses. G&A expenses were $7.6 million and $29.0 million for the three months and year ended December 31, 2023, respectively, compared to $6.3 million and $21.5 million for the three months and year ended December 31, 2022, respectively. The increase in G&A expenses for the year ended December 31, 2023, was primarily due to an increase in personnel-related expenses, employee headcount, including stock-based compensation expense, and increased consultant and professional service fees, partially offset by a decrease in insurance-related costs.
Net Loss. 89bio reported a net loss of $40.2 million and $142.2 million for the three months and year ended December 31, 2023, respectively, compared to a net loss of $24.6 million and $102.0 million for the three months and year ended December 31, 2022, respectively. The increase in net loss is primarily attributable to increased R&D expenses to advance the company’s programs, increased G&A expenses associated with additions in headcount, and expenses in support of the company’s expanded operations, offset by an increase in interest income.
The foregoing financial information is unaudited and subject to change, and actual results may vary from the foregoing.
About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. Pegozafermin has been granted Breakthrough Therapy Designation for the treatment of NASH with fibrosis from U.S. Food and Drug Administration (FDA). The company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the company on LinkedIn.
Forward-looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, statements regarding the therapeutic potential and utility, efficacy and clinical benefits of pegozafermin, the safety and tolerability profile of pegozafermin, trial designs, clinical development plans and timing for pegozafermin, including the initiation of the Phase 3 ENLIGHTEN-Fibrosis trial and Phase 3 ENLIGHTEN-Cirrhosis trial in NASH and the topline results from the ENTRUST Phase 3 trial in SHTG, and enrollment in clinical trials. Words
subslover
2年前
89bio Announces Publication of Results of Phase 1b/2a Study of Pegozafermin for the Treatment of NASH in The Lancet Gastroenterology & Hepatology
December 12 2022 - 06:30PM
GlobeNewswire Inc.
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89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases, today announced that data from cohorts 1-6 in the the Phase 1b/2a proof-of-concept study evaluating pegozafermin for the treatment of nonalcoholic steatohepatitis (NASH) was published online in The Lancet Gastroenterology & Hepatology. Study results showed statistically significant absolute reductions in hepatic fat fraction at week 13 with pegozafermin administered every week or every two weeks compared to placebo. Up to 88% of patients had at least a 30% reduction in hepatic fat fraction, which has been shown to correlate with reduced fibrosis progression.1,2 Furthermore, improvements in liver transaminases (measures of liver injury), measures of fibrosis and lipids were observed with pegozafermin compared to placebo. In this study, pegozafermin was well tolerated with no treatment-related serious adverse events observed.
“Patients with NASH, a complex disease, are in urgent need of disease-modifying treatments that are effective in improving their overall liver health and address key underlying metabolic issues and cardiovascular disease risk factors,” said Rohit Loomba MD, MHSc, Director, NAFLD Research Center, University of California San Diego, primary investigator of the Phase 1b/2a study and lead author of The Lancet Gastroenterology & Hepatology paper. “I am very encouraged by the published study results showing pegozafermin was highly potent in reducing liver fat and was associated with clinically meaningful changes in liver health and beneficial effects on lipids and cardiovascular markers. The benefits of pegozafermin were observed across all doses and most prominently at the highest tested doses.”
NASH is a key risk factor for cirrhosis, hepatocellular carcinoma and cardiovascular events and is a leading cause of liver transplantation. In the United States, the prevalence of NASH is expected to increase to 27 million in 2030.3 Management of this chronic disease is based primarily on lifestyle modification as no FDA-approved disease-modifying therapies are available.
“Based on the published proof-of-concept study, we are encouraged by the potential of pegozafermin to become a new treatment option for people living with NASH and potentially transform the treatment paradigm for this chronic, progressive fatty liver disease,” said Hank Mansbach, Chief Medical Officer of 89bio. “As part of our commitment to address the high medical need in NASH and bring patients a tolerable and highly effective treatment option, we are continuing to advance the clinical development of pegozafermin in our Phase 2b ENLIVEN trial, with topline results expected in the first quarter of next year.”
In the Phase 1b/2a study, participants were randomized to 12 weeks of placebo or one of two subcutaneously administered pegozafermin dosing regimens: 3, 9, 18 or 27 mg weekly or 18 or 36 mg every two weeks.
About the Phase 1b/2a Study
The multicenter, randomized, double-blind, placebo-controlled Phase 1b/2a multiple ascending dose study assessed the safety, tolerability, pharmacokinetic and pharmacodynamic effects of pegozafermin in patients with biopsy-confirmed NASH with fibrosis or at high risk of NASH (phenotypic NASH (PNASH), defined as obesity with either Type 2 diabetes or evidence of liver injury). The study also assessed change in liver fat measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) and key biomarker assessments. A total of 81 adults, age 21 to 75 years, were randomized to subcutaneously administered pegozafermin (3, 9, 18 or 27 mg weekly or 18 or 36 mg every two weeks) or placebo for up to 12 weeks. Overall, baseline characteristics were similar among the placebo and pegozafermin groups. The study was conducted at 12 clinical sites in the United States.
About Pegozafermin
Pegozafermin is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21) being developed for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). FGF21 is an endogenous hormone that modulates important drivers of lipid metabolism and NASH including triglyceride reduction, glycemic control, steatosis, inflammation and fibrosis. Pegozafermin was specifically engineered using a unique glycoPEGylated technology to extend the half-life while maintaining potency.
About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco with operations in Herzliya, Israel. For more information, visit www.89bio.com or follow the company on LinkedIn.
Forward-looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, the therapeutic potential and clinical benefits of pegozafermin, the clinical benefit, safety and tolerability profile of pegozafermin and clinical development plans and timing for pegozafermin. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “anticipate,” “goal,” “opportunity,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio’s filings with the SEC), many of which are beyond 89bio’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the timing and outcome of the Phase 2b ENLIVEN trial in NASH; expectations regarding the timing of topline data; 89bio’s ability to execute on its strategy; positive results from a clinical study may not neces
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