– 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
“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
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 theEuropean 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
Research and Development (R&D) Expenses. R&D expenses were
General and Administrative (G&A) Expenses. G&A expenses were
Net Loss. 89bio reported a net loss of
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
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 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
Condensed Consolidated Statement of Operations Data (Unaudited) (In thousands, except share and per share amounts) | |||||||||||||||
Three Months Ended | Year Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 33,592 | $ | 19,064 | $ | 122,230 | $ | 80,796 | |||||||
General and administrative | 7,614 | 6,298 | 28,974 | 21,453 | |||||||||||
Total operating expenses | 41,206 | 25,362 | 151,204 | 102,249 | |||||||||||
Loss from operations | (41,206 | ) | (25,362 | ) | (151,204 | ) | (102,249 | ) | |||||||
Interest expense | (866 | ) | (545 | ) | (4,794 | ) | (1,922 | ) | |||||||
Interest income and other, net | 5,704 | 1,321 | 17,676 | 2,164 | |||||||||||
Net loss before income tax | (36,368 | ) | (24,586 | ) | (138,322 | ) | (102,007 | ) | |||||||
Income tax expense | (3,867 | ) | (16 | ) | (3,867 | ) | (19 | ) | |||||||
Net loss | $ | (40,235 | ) | $ | (24,602 | ) | $ | (142,189 | ) | $ | (102,026 | ) | |||
Comprehensive loss | $ | (39,498 | ) | $ | (24,512 | ) | $ | (141,649 | ) | $ | (102,312 | ) | |||
Net loss per share, basic and diluted | $ | (0.50 | ) | $ | (0.48 | ) | $ | (2.00 | ) | $ | (2.93 | ) | |||
Weighted-average shares used to compute net loss per share, basic and diluted | 80,696,621 | 50,809,279 | 71,172,870 | 34,806,349 |
Condensed Consolidated Balance Sheet Data (Unaudited) (In thousands) | |||||||
2023 | 2022 | ||||||
Cash, cash equivalents and marketable securities | $ | 578,870 | $ | 188,160 | |||
Total assets | 596,269 | 196,824 | |||||
Total current liabilities | 29,611 | 24,614 | |||||
Non-current liabilities | 30,352 | 20,378 | |||||
Total stockholders’ equity | 536,306 | 151,832 | |||||
Total liabilities and stockholders' equity | $ | 596,269 | $ | 196,824 | |||
Investor Contact:
annie.chang@89bio.com
PJ Kelleher
+1-617-430-7579
pkelleher@lifesciadvisors.com
Media Contact:
Real Chemistry
sseapy@realchemistry.com
![](https://ml.globenewswire.com/media/MTdkMjlmZjEtMzA3NC00YjY1LThlNjgtZGNiOTE1MmZlZjYzLTEyMDE1OTM=/tiny/89bio-Inc-.png)
2024 GlobeNewswire, Inc., source