Akero Therapeutics Reports SECOND Quarter 2020 Financial Results

Therapeutics Reports SECOND Quarter 2020 Financial Results

SOUTH SAN FRANCISCO, Calif., August 12, 2020 -- Akero

Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering

medicines designed to restore metabolic balance and improve the overall health of NASH patients, today reported second quarter

financial results for the period ending June 30, 2020.

"During the second quarter of 2020, we reported the first

histological results for our FGF21 analog, efruxifermin (EFX), formerly AKR-001. We observed improvements in histological parameters

of NASH after only 16 weeks of treatment, the magnitude of which is among the highest observed to date across the NASH field, despite

other compounds having been evaluated for 24 to 78 weeks. These results have increased our confidence in EFX's potential

to become a foundational NASH monotherapy," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero.

"We believe positive histological data in biopsy-confirmed NASH patients could be a prerequisite for the FDA to define a

registrational development path for any investigational NASH compound. We look forward to discussing our development path with

the FDA and advancing a potentially promising therapy for patients, if our development plan is approved."

Clinically meaningful improvements in glycemic control, weight

loss and lipoproteins were also observed in the main BALANCED study. "The significant reductions in HbA1c and body weight

we observed in biopsy-confirmed NASH patients following EFX treatment were firsts for an FGF21 analogue," said Tim Rolph,

D.Phil., chief scientific officer of Akero. "Although various preclinical models have shown FGF21 improves glycemic control

and weight loss, these improvements have not translated to humans with prior FGF21 analogs. We believe the clinical results observed

for EFX can be attributed to EFX's unique engineering, based on pioneering discoveries that enabled the pharmacology of human

FGF21 to be reproduced in a long acting FGF21 analog."

Second Quarter Business Highlights

These results build on the significant 12-14% absolute

reductions (corresponding to 63-72% relative reductions) in liver fat, in each case compared with 0% for placebo. Reductions of

24-32 U/L were observed for ALT, a validated marker of liver damage, compared with 6 U/L for placebo.

Manufacturing Update

Financial Highlights

NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD

(non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and

diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress

and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually

death. The progressive damage to the liver associated with NASH resembles the pathology associated with excessive alcohol consumption

or viral infections. As a result, NASH has become a leading cause of liver transplants in the US and Europe.

Efruxifermin (EFX), formerly AKR-001, is Akero's lead

product candidate for NASH. Efruxifermin was designed to increase insulin sensitivity, improve lipoproteins, reduce liver fat and

inflammation, and reverse fibrosis. This holistic approach offers the potential to address the complex, multi-organ/tissue pathogenesis

of NASH, including improvements in risk factors linked to cardiovascular disease - the leading cause of death in NASH patients. Engineered

to mimic the biological activity profile of native human FGF21, efruxifermin offers convenient once-weekly dosing.

Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering

medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product

candidate, efruxifermin, has been evaluated in a 16-week Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered

in South San Francisco, CA. For more information, please visit www.akerotx.com.

Forward-Looking Statements

contained in this press release regarding matters that are not historical facts are "forward-looking statements" within

the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties,

actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited

to, statements regarding the Company's business plans and objectives, including future plans or expectations for EFX, upcoming

milestones, and therapeutic effects of EFX; Akero's Phase 2a BALANCED study, including its results and expected timing to

report the analysis of efficacy and safety data; expectations regarding the design, implementation, timing, and success

of its current and planned clinical trials for EFX; expectations regarding successful scale-up of drug substance manufacturing

and release of new drug product for use in clinical trials; expectations regarding the Company's use of capital, expenses

and other future financial results; statements regarding the timing of the FDA's review of the registrational development

plan; the Company's planned efforts to prepare for commercialization of EFX, if approved and the potential impact of COVID-19

on strategy, future operations, enrollment and clinical trials. Any forward-looking statements in this press release are

based on management's current expectations of future events and are subject to a number of risks and uncertainties that could

cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks

that contribute to the uncertain nature of the forward-looking statements include: risks related to the impact of COVID-19 on

the Company's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties,

manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing

of the Company's product candidate development activities and planned clinical trials; the Company'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; regulatory developments in the United States and foreign countries; the Company's ability to fund operations;

as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's Annual

Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 10-Q, as filed

with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important

factors in Akero's other filings and reports with the SEC. All forward-looking statements contained in this press

release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect

events that occur or circumstances that exist after the date on which they were made.

Canale Communications

Stern Investor Relations

Akero Therapeutics, Inc.

Condensed Consolidated Balance Sheets

Akero Therapeutics, Inc.

Condensed Consolidated Statements of

Operations and Comprehensive Loss

(In thousands, except share and per share