Full Press Release Details
Therapeutics Reports first Quarter 2020 Financial Results
SOUTH SAN FRANCISCO, Calif., May
13, 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 first quarter financial results for the period ending March 31, 2020.
"During the first quarter of 2020
we reported results for the primary endpoint and several secondary efficacy endpoints in our ongoing Phase 2a clinical trial, the
BALANCED study, and continued to make important progress toward advancing AKR-001 as a potential cornerstone treatment for NASH,"
said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "The reductions in liver fat and ALT observed
with AKR-001 are among the largest reductions reported for NASH clinical studies to date - not only in the FGF21 class, but
across all mechanisms in development. We are pleased with our progress and look forward to reporting efficacy and safety data,
including biopsy results, toward the end of this quarter when we expect the BALANCED study analysis to be completed. We remain
on schedule to initiate our Phase 2b clinical trial in NASH patients in the first half of 2021."
First Quarter Business Highlights
COVID-19 and BALANCED Study 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 closely resembles damage caused by excessive alcohol consumption
or viral infections, and the disorder is a leading cause of liver transplants in the US and Europe.
AKR-001 is Akero's lead product candidate for NASH. AKR-001
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-system disease state of NASH, including improvements in physiological
parameters linked to cardiovascular disease - the leading cause of death in NASH patients. Engineered to mimic the biological
activity profile of native FGF21, AKR-001 offers convenient once-weekly dosing.
About Akero Therapeutics
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, AKR-001, is
currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco,
CA. For more information, please visit www.akerotx.com.
Forward-Looking Statements
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 AKR-001, upcoming milestones, and therapeutic effects
of AKR-001; 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 AKR-001; expectations for successful completion of nonclinical studies; 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; 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
| March 31, 2020 | December 31, 2019 | |||||||
| Assets | ||||||||
| Cash, cash equivalents and short-term marketable securities | $ | 125,285 | $ | 136,400 | ||||
| Other current assets | 933 | 1,649 | ||||||
| Non-current assets | 403 | 69 | ||||||
| Total assets | $ | 126,621 | $ | 138,118 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | $ | 8,286 | $ | 9,369 | ||||
| Non-current liabilities | 12 | 23 | ||||||
| Stockholders' equity | 118,323 | 128,726 | ||||||
| Total liabilities and stockholders' equity | $ | 126,621 | $ | 138,118 |
Akero Therapeutics, Inc.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per share
| Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 8,791 | $ | 4,063 | ||||
| General and administrative | 3,588 | 1,449 | ||||||
| Total operating expenses | 12,379 | 5,512 | ||||||
| Loss from operations | (12,379 | ) | (5,512 | ) | ||||
| Other income, net | 493 | 150 | ||||||
| Net loss | $ | (11,886 | ) | $ | (5,362 | ) | ||
| Comprehensive loss | $ | (11,835 | ) | $ | (5,362 | ) | ||
| Net loss per common share - basic and diluted | $ | (0.42 | ) | $ | (31.90 | ) | ||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted | 28,499,475 | 168,071 |