89bio Reports Second Quarter 2022 Financial Results and Provides Corporate Update
- Reported positive topline results from ENTRIGUE Phase 2 trial of pegozafermin in severe hypertriglyceridemia patients; initiation of Phase 3 trial expected in the first half of 2023 -
- ENTRIGUE data to be presented as a late-breaker at
- ENLIVEN Phase 2b NASH trial enrollment completion expected in the third quarter of 2022 followed by topline data in the first quarter of 2023 -
- Completed underwritten offering, raising approximately
“In the second quarter we reported positive topline results from the ENTRIGUE Phase 2 trial of pegozafermin in patients with severe hypertriglyceridemia (SHTG) and further strengthened our financial resources, which we believe will carry us through key value-driving milestones as we transition into a late-stage company,” said
Recent Highlights and Anticipated Milestones
Data from the Phase 2 ENTRIGUE trial of pegozafermin to be presented as a late-breaker at
- Data to be presented by
Deepak L. Bhatt, MD, MPH, Brigham and Women’s Hospital and Harvard Medical Schoolduring the Late-Breaking Science-Innovation in Drug Treatment session on Friday, August 26th at 6 a.m. ET/ 3 a.m. PT/ 12 p.m. CEST.
Reported positive topline data for the Phase 2 ENTRIGUE trial of pegozafermin in SHTG patients; initiation of Phase 3 trial expected in the first half of 2023.
- Treatment with pegozafermin resulted in clinically meaningful and statistically significant reductions in triglycerides (TG) from baseline across all doses (with a 63% reduction in the highest dosing group; p<0.001), statistically significant improvements in key markers of cardiovascular risk (non-HDL-C and apo B), reductions in liver fat, and improvements in glycemic control markers.
- Results were consistent in patients not on background therapy or on background therapy (consistent results on statins or statin combos, prescription fish oils, and fibrates) and across various subgroups, including those with the greatest disease burden, such as patients with type 2 diabetes and those with baseline TG levels ≥750 mg/dL.
- Consistent with prior studies, pegozafermin was generally well tolerated with a favorable safety profile across doses. The most commonly reported treatment-related adverse events were nausea, diarrhea, and injection site reactions, all which were classified as mild or moderate. No tremors or transaminase elevation adverse events were observed. There were no drug-related serious adverse events and two Grade 2 treatment-related discontinuations.
Expect to complete enrollment in the third quarter of 2022 with over 200 patients in the ENLIVEN Phase 2b trial; topline data expected in the first quarter of 2023.
- ENLIVEN is a Phase 2b trial designed to evaluate the safety and efficacy of weekly or every two-week pegozafermin for the treatment of patients with fibrosis stage F2 - F3 NASH and NAS ≥ 4.
Presented additional pegozafermin data at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022.
- Three poster presentations were showcased:
- Results from an open-label expansion cohort in the Phase 1b/2a proof-of-concept study evaluating pegozafermin for the treatment of NASH demonstrated clinically meaningful improvements on HbA1c, adiponectin, and lipid parameters with notable body weight reduction and favorable safety and tolerability observed.
- Treatment with pegozafermin in advanced fibrosis patients, 85% of which had type 2 diabetes and were on background therapy for diabetes, hyperlipidemia or both, demonstrated significant metabolic benefits in addition to robust beneficial effects on the liver, with favorable safety and tolerability. Together, these data suggest that pegozafermin has the potential to address broader cardiometabolic risks in addition to liver related outcomes.
- Treatment with pegozafermin demonstrated a robust pharmacokinetic/pharmacodynamic effect independent of NASH fibrosis stage, with a favorable safety and tolerability profile observed following a single 30-mg dose. These findings highlight the feasibility of assessing treatment response in F4 patients with compensated hepatic function without requiring a dose adjustment.
- Completed underwritten public offering of common stock, warrants to purchase shares of common stock and pre-funded warrants to purchase shares of common stock, raising approximately
$94.5 millionin gross proceeds.
Second Quarter 2022 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
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
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 safety and tolerability profile of pegozafermin, clinical development plans and timing for pegozafermin, including the Phase 2b ENLIVEN trial, the expected trial design for the ENLIVEN trial, including patient enrollment, dosing schedules and trial endpoints, the timing for topline data for the ENLIVEN trial, the timing for the initiation of the Phase 3 trial in SHTG and expectations regarding the time period over which 89bio’s capital resources will be sufficient to fund its anticipated operations. 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
(In thousands, except share and per share amounts)
|Three Months Ended||Six Months Ended|
|Research and development||$||19,686||$||15,630||$||39,535||$||25,761|
|General and administrative||5,052||4,921||10,311||9,529|
|Total operating expenses||24,738||20,551||49,846||35,290|
|Loss from operations||24,738||20,551||49,846||35,290|
|Other expenses, net||316||172||772||215|
|Net loss before tax||25,054||20,723||50,618||35,505|
|Income tax expense||—||—||1||—|
|Net loss per share, basic and diluted||$||1.23||$||1.03||$||2.49||$||1.77|
|Weighted-average shares used to compute net loss per share, basic and diluted||20,351,560||20,060,061||20,345,521||20,017,677|
Condensed Consolidated Balance Sheet Data
|Cash, cash equivalents and short-term investments||$||139,350||$||150,745|
|Total current liabilities||26,899||19,537|
|Non current liabilities||40,511||16,928|
|Total stockholders’ equity||80,185||125,957|
|Total liabilities and stockholders' equity||$||147,595||$||162,422|
Chief Financial Officer
Source: 89bio, Inc.