SAN FRANCISCO, Aug. 09, 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 cardiometabolic diseases, today reported its financial results for the second quarter ended June 30, 2023.
“Progress in our late-stage clinical development programs in both NASH and SHTG further position pegozafermin as a potentially leading FGF21 analog treatment option,” said Rohan Palekar, Chief Executive Officer of 89bio. “The importance of the Phase 2b ENLIVEN trial data in NASH was further validated with the recent New England Journal of Medicine (NEJM) publication. Specifically, the histology data and positive results seen across markers of total liver health in the overall trial population and in patients on background GLP-1 therapies continue to support the therapeutic utility of pegozafermin and highlight the potential opportunity for a combination approach in patients with comorbidities. As we continue to advance towards Phase 3 development, we look forward to discussions with regulatory agencies planned in the second half of 2023.”
Mr. Palekar continued, “In the second quarter of 2023, we initiated ENTRUST, the Phase 3 trial of pegozafermin in patients with SHTG, signifying entry of the first FGF21 analog into Phase 3 development. Results from our previous trials in SHTG, including the recently published Phase 2 ENTRIGUE data in Nature Medicine, highlight the therapeutic potential of pegozafermin to offer a highly differentiated treatment option that is supportive of adoption and compliance.”
Recent Highlights and Anticipated Milestones
Nonalcoholic Steatohepatitis (NASH)
Severe Hypertriglyceridemia (SHTG)
Second Quarter 2023 Financial Results
Cash Position. As of June 30, 2023, 89bio had cash, cash equivalents and short-term available-for-sale securities totaling $478.0 million.
Research and Development (R&D) Expenses. R&D expenses were $34.9 million for the three months ended June 30, 2023, compared to $19.7 million for the three months ended June 30, 2022. The increase in R&D expenses was primarily driven by increases in contract manufacturing costs, personnel expenses, and clinical development costs.
General and Administrative (G&A) Expenses. G&A expenses were $7.2 million for the three months ended June 30, 2023, compared to $5.1 million for the three months ended June 30, 2022. The increase in G&A expenses was primarily due to an increase in costs related to professional services and stock-based compensation, offset in part by a decrease in insurance-related costs.
Net Loss. 89bio reported a net loss of $38.4 million for the three months ended June 30, 2023, compared to a net loss of $25.1 million for the three months ended June 30, 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.
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 therapeutic candidate, pegozafermin, through clinical development for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 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 SHTG Phase 3 program, the ENTRUST Phase 3 trial in SHTG and the NASH Phase 3 trial, the timing for meeting with regulatory authorities, the use of the SHTG Phase 3 program to support safety database requirements 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 Securities and Exchange Commission (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 NASH; expectations regarding the timing and outcome of the ENTRUST Phase 3 trial in SHTG; 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.
89bio, Inc. | ||||||||||||||||
Condensed Consolidated Statement of Operations Data | ||||||||||||||||
(Unaudited) | ||||||||||||||||
(In thousands, except share and per share amounts) | ||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 34,915 | $ | 19,686 | $ | 57,221 | $ | 39,535 | ||||||||
General and administrative | 7,214 | 5,052 | 13,432 | 10,311 | ||||||||||||
Total operating expenses | 42,129 | 24,738 | 70,653 | 49,846 | ||||||||||||
Loss from operations | (42,129 | ) | (24,738 | ) | (70,653 | ) | (49,846 | ) | ||||||||
Interest expense | (894 | ) | (434 | ) | (2,969 | ) | (842 | ) | ||||||||
Interest income and other, net | 4,630 | 118 | 6,393 | 70 | ||||||||||||
Net loss before income tax | (38,393 | ) | (25,054 | ) | (67,229 | ) | (50,618 | ) | ||||||||
Income tax expense | — | — | — | (1 | ) | |||||||||||
Net loss | $ | (38,393 | ) | $ | (25,054 | ) | $ | (67,229 | ) | $ | (50,619 | ) | ||||
Comprehensive loss | $ | (38,747 | ) | $ | (25,116 | ) | $ | (67,473 | ) | $ | (50,873 | ) | ||||
Net loss per share, basic and diluted | $ | (0.52 | ) | $ | (1.23 | ) | $ | (1.06 | ) | $ | (2.49 | ) | ||||
Weighted-average shares used to compute net loss per share, basic and diluted | 74,126,569 | 20,351,560 | 63,706,856 | 20,345,521 |
89bio, Inc. | ||||||||
Condensed Consolidated Balance Sheet Data | ||||||||
(Unaudited) | ||||||||
(In thousands) | ||||||||
June 30, 2023 | December 31, 2022 | |||||||
Cash and cash equivalents and short-term investments | $ | 477,995 | $ | 188,160 | ||||
Total assets | 492,511 | 196,824 | ||||||
Total current liabilities | 25,944 | 24,614 | ||||||
Non current liabilities | 24,581 | 20,378 | ||||||
Total stockholders' equity | 441,986 | 151,832 | ||||||
Total liabilities and stockholders' equity | $ | 492,511 | $ | 196,824 | ||||
Investor Contact:
Ryan Martins
Chief Financial Officer
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PJ Kelleher
LifeSci Advisors, LLC
+1-617-430-7579
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Media Contact:
Sheryl Seapy
Real Chemistry
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Last Trade: | US$9.14 |
Daily Change: | 0.24 2.70 |
Daily Volume: | 341,784 |
Market Cap: | US$968.020M |
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