– Positive topline results from ENLIVEN Phase 2b trial of pegozafermin in NASH demonstrated high statistical significance on both primary histology endpoints supporting advancement to Phase 3; discussions with regulatory agencies planned for the second half of 2023 –
– SHTG Phase 3 trial expected to be initiated in the second quarter of 2023 –
– Completed underwritten public offering with $316.2 million in gross proceeds; cash balance of $480.9 million as of March 31, 2023 –
SAN FRANCISCO, May 04, 2023 (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 cardio-metabolic diseases, today reported its financial results for the first quarter ended March 31, 2023.
“In the first quarter we reported highly statistically significant topline results from the ENLIVEN Phase 2b NASH trial of pegozafermin, which we believe further de-risks our late-stage clinical development program and supports advancement to Phase 3,” said Rohan Palekar, Chief Executive Officer of 89bio. “We look forward to discussing next steps with the regulatory agencies in the second half of 2023. We intend to evaluate pegozafermin in F2/3 patients as well as in compensated cirrhosis (F4) patients, who have the most severe subset of the disease and highest unmet need.”
Mr. Palekar continued, “Additionally, we plan to advance pegozafermin in SHTG with initiation of the first of two recommended Phase 3 trials in the second quarter of this year. Following the recent public offering we are well positioned to execute on key priorities in both NASH and SHTG, bringing us one step closer to delivering a potentially transformational and highly differentiated treatment option to patients.”
Recent Highlights and Anticipated Milestones
Nonalcoholic Steatohepatitis (NASH)
Severe Hypertriglyceridemia (SHTG)
First Quarter 2023 Financial Results
Cash Position. As of March 31, 2023, 89bio had cash, cash equivalents, and short-term investments totaling $480.9 million.
Research and Development (R&D) Expenses. R&D expenses were $22.3 million for the three months ended March 31, 2023, compared to $19.8 million for the three months ended March 31, 2022. The increase in R&D expenses was primarily driven by increases in contract manufacturing and personnel expenses offset by decreases in clinical development costs.
General and Administrative (G&A) Expenses. G&A expenses were $6.2 million for the three months ended March 31, 2023, compared to $5.3 million for the three months ended March 31, 2022. The increase in G&A expenses was primarily due to an increase in costs related to professional services and stock-based compensation.
Net Loss. 89bio reported a net loss of $28.8 million for the three months ended March 31, 2023, compared to a net loss of $25.6 million for the three months ended March 31, 2022. The increase in net loss is primarily attributable to increased R&D expenses for our programs and increased G&A expenses associated with operating as a public company.
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. For more information, visit www.89bio.com or follow the company on LinkedIn.
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, efficacy and clinical benefits of pegozafermin, the safety and tolerability profile of pegozafermin, clinical development plans and timing for pegozafermin, including the Phase 3 trial in SHTG and commencement of a Phase 3 trial based on results from the Phase 2b ENLIVEN trial, the timing for meeting with regulatory authorities 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 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 initiation of the Phase 3 trial in SHTG and NASH; 89bio's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; 89bio's substantial dependence on the success of it lead product candidate; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of 89bio's capital resources and its ability to raise additional capital; and other risks and uncertainties identified in 89bio's Annual Report on Form 10-K for the year ended December 31, 2022 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Condensed Consolidated Statement of Operations Data
(In thousands, except share and per share amounts)
|Research and development||$||22,306||$||19,849|
|General and administrative||6,218||5,259|
|Total operating expenses||28,524||25,108|
|Loss from operations||28,524||25,108|
|Interest income and other, net||(1,763||)||48|
|Net loss before tax||28,836||25,564|
|Income tax expense||—||1|
|Net loss per share, basic and diluted||$||0.54||$||1.26|
|Weighted-average shares used to compute net loss per share, basic and diluted||53,171,370||20,339,416|
Condensed Consolidated Balance Sheet Data
|March 31,||December 31,
|Cash, cash equivalents and short-term investments||$||480,883||$||188,160|
|Total current liabilities||24,015||24,614|
|Non current liabilities||24,474||20,378|
|Total stockholders’ equity (deficit)||445,830||151,832|
|Total liabilities and stockholders' equity||$||494,319||$||196,824|
Chief Financial Officer
LifeSci Advisors, LLC