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Akero Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results

Key Takeaway: 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 metabo

Full Press Release Details

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
Full Year and Fourth Quarter 2019 Financial
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, currently being evaluated in the ongoing Phase 2a BALANCED study. AKR-001 is 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 and has been well-tolerated in clinical studies to date.
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 San Francisco, CA. For more information, please visit
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 and the BALANCED study, upcoming milestones,
and therapeutic effects of AKR-001; 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 plans related to development of the Company's current and
future product candidates. 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: 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 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
December 31,
2019 2018
Assets
Cash, cash equivalents and short-term marketable securities $ 136,400 $ 75,975
Other current assets 1,649 1,156
Non-current assets 69 20
Total assets $ 138,118 $ 77,151
Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)
Current liabilities $ 9,369 $ 2,342
Non-current liabilities 23 -
Redeemable convertible preferred stock - 124,728
Stockholders' equity (deficit) 128,726 (49,919 )
Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) $ 138,118 $ 77,151
Akero Therapeutics, Inc.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per share
Three Months Ended December 31, Twelve Months Ended December 31,
2019 2018 2019 2018
Operating expenses:
Research and development $ 13,138 $ 1,983 $ 37,046 $ 11,882
General and administrative 3,083 985 8,605 1,896
Total operating expenses 16,221 2,968 45,651 13,778
Loss from operations (16,221 ) (2,968 ) (45,651 ) (13,778 )
Other income (expense), net 610 (58,504 ) 1,896 (67,936 )
Net loss $ (15,611 ) $ (61,472 ) $ (43,755 ) $ (81,714 )
Comprehensive loss $ (15,617 ) $ (61,472 ) $ (43,761 ) $ (81,714 )
Net loss attributable to common stockholders $ (15,611 ) $ (61,671 ) $ (43,755 ) $ (82,234 )
Net loss per share attributable to common stockholders - basic and diluted $ (0.55 ) $ (449.52 ) $ (2.90 ) $ (795.28 )
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 28,335,405 137,194 15,070,728 103,403
Last updated: Mar 16, 2020