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Akero Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results
SAN FRANCISCO, Calif., March 16, 2020 -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) Company developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients, today reported fourth quarter and full year financial results for the period ending December 31, 2019.
“We saw in 2019 a period of continued clinical and manufacturing progress for Akero, driven by precision execution by our team,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “Our rapid progress combined with a strong cash position provide the foundation for the continued development of AKR-001, which we believe has the potential to become a cornerstone of NASH treatment.”
Fourth Quarter Business Highlights
|·||Enrollment was completed in the Phase 2a BALANCED study in NASH patients. The Company remains on track to report results of the BALANCED study’s primary endpoint in the first quarter of 2020. Top-line results related to secondary endpoints, including safety and tolerability as well as paired biopsies for patients who achieve at least 30% relative reduction in liver fat at week 12, will be reported in the second quarter of 2020.|
|·||The Company has successfully manufactured AKR-001 drug substance at commercial scale as an engineering run at Boehringer Ingelheim. Yield was comparable to the Good Manufacturing Practice (GMP) drug substance originally manufactured by Amgen. Analysis of the drug substance produced by Boehringer Ingelheim confirmed it met the same release specification as previously used for Amgen GMP drug substance. The Company expects to release drug product produced in compliance with current GMP requirements by the fourth quarter of 2020.|
Full Year and Fourth Quarter 2019 Financial Results
|·||Akero’s cash, cash equivalents and short-term marketable securities at December 31, 2019 were $136.4 million.|
|·||Research and development expenses for the three-month and twelve-month periods ended December 31, 2019 were $13.1 million and $37.0 million, respectively, compared to $2.0 million and $11.9 million for the comparable periods in 2018. These increases are attributable to higher costs related to Akero's 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 twelve-month periods ended December 31, 2019 were $3.1 million and $8.6 million, respectively, compared to $1.0 million and $1.9 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.|
The following information was filed by Akero Therapeutics, Inc. (AKRO) on Monday, March 16, 2020 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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