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AKERO THERAPEUTICS REPORTS RECENT HIGHLIGHTS AND THIRD QUARTER 2019 FINANCIAL RESULTS
SAN FRANCISCO, Calif., November 12, 2019 Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today reported third quarter 2019 financial results for the period ending September 30, 2019.
The third quarter of 2019 was a period of continued clinical and manufacturing progress for Akero, said Andrew Cheng, M.D., Ph.D., President and Chief Executive Officer. We remain on track to report results of the BALANCED studys primary endpoint in the first quarter of 2020 and full study results in the second quarter of 2020. We have successfully completed laboratory-scale transfer of AKR-001 drug substance manufacturing to Boehringer Ingelheim with yield and biological activity comparable to the drug substance originally manufactured by Amgen. We expect to release drug product produced in compliance with current good manufacturing practice requirements and to complete all nonclinical toxicology studies required to support a Phase 2b trial by the fourth quarter of 2020. These actions and our $147.8 million cash position provide a strong foundation for the continued development of AKR-001, which we believe has the potential to become a cornerstone of NASH treatment.
Third Quarter 2019 Financial Results
· Akeros cash and cash equivalents at September 30, 2019 were $147.8 million.
· Research and development expenses for the three-month and nine-month periods ended September 30, 2019 were $13.9 million and $23.9 million, respectively, compared to $1.2 million and $9.9 million for the comparable periods in 2018. These increases are attributable to higher costs related to Akeros AKR-001 program, including third-party contract manufacturing, contract research organization costs associated with the BALANCED study and internal personnel costs.
· General and administrative expenses for the three-month and nine-month periods ended September 30, 2019 were $2.4 million and $5.5 million, respectively, compared to $0.5 million and $0.9 million for the comparable periods in 2018. These increases are attributable to higher expenses for personnel, including non-cash stock-based compensation, and professional services and other costs associated with becoming a public company.
· Total operating expenses were $16.3 million and $29.4 million for the three-month and nine-month periods ended September 30, 2019, respectively, compared to $1.7 million and $10.8 million for the comparable periods in 2018.
NASH is a leading cause of liver failure around the world, driven by the growing global epidemic of obesity. NASH is a severe form of non-alcoholic fatty liver disease (NAFLD) characterized by liver cell (hepatocyte) damage, liver inflammation, and fibrosis that can progress to cirrhosis, liver failure, cancer and death.
The following information was filed by Akero Therapeutics, Inc. (AKRO) on Tuesday, November 12, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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