Akero Therapeutics Launches $92 Million IPO to Advance Innovative Therapy for Non-Alcoholic Fatty Liver Disease

VCBeat (WeChat ID: vcbeat) has learned that Akero Therapeutics, a clinical-stage biotechnology company, recently announced its listing on the Nasdaq Stock Market under the ticker symbol AKRO. The company offered 57.5 million shares of common stock in its initial public offering at a price of $16 per share. The proceeds from this financing will be primarily used for research and development, including exploring potential applications of AKR-001 in other diseases.

The offering is expected to close on June 24. In addition, Akero has granted the underwriters a 30-day option to purchase up to 860,000 shares of common stock at the public offering price. J.P. Morgan Securities LLC, Jefferies LLC, and Evercore Group L.L.C. are serving as joint book-running managers for the offering. Roth Capital Partners is acting as lead manager for the offering.

Akero Therapeutics, headquartered in South San Francisco, is a clinical-stage biotechnology company focused on developing and commercializing transformative therapies for patients with serious metabolic diseases and high unmet medical needs by restoring the body’s metabolic balance. The company is conducting a Phase 2a clinical trial of AKR-001 for the treatment of NASH.

NASH is a severe form of non-alcoholic fatty liver disease (NAFLD), characterized by excessive fat accumulation in the liver, leading to hepatocyte injury, hepatic inflammation, and fibrosis. It can progress to cirrhosis, liver failure, and cancer, ultimately resulting in patient mortality. NASH is closely associated with the epidemics of obesity and diabetes and is rapidly becoming the leading cause of liver failure worldwide. In 2016, 17.3 million people in the United States had NASH, and this number is projected to increase to 27 million by 2030.

AKR-001 is an Fc-FGF21 fusion protein engineered to mimic the biological activity profile of native FGF21. Native FGF21 is an endogenous hormone that regulates lipid and energy metabolism and is secreted systemically to mitigate cellular stress responses. Clinical trial observations of AKR-001 and other FGF analogs indicate that AKR-001 has the potential to reduce hepatic steatosis in patients with non-alcoholic steatohepatitis (NASH), alleviate cellular stress, inflammation, and fibrosis, and improve risk factors contributing to the development of cardiovascular disease.

The Phase 2a clinical trial is designed to evaluate the safety, tolerability, and efficacy of AKR-001. This multicenter, randomized, double-blind, placebo-controlled, dose-ranging study will enroll up to 80 patients with biopsy-confirmed NASH, who will be randomly assigned to receive once-weekly subcutaneous injections of AKR-001 or placebo.

Notably, on May 24, 2019, Akero Therapeutics’ lead candidate, AKR-001, received FDA approval for its New Drug Application.

“The Phase 2a clinical trial is a significant milestone for Akero,” said Andrew Cheng, President and Chief Executive Officer of Akero Therapeutics. “We believe that AKR-001 has the potential to become a cornerstone therapy for the treatment of NASH, thereby reducing mortality in this patient population.”

(Compiled by Li Chengping)