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Akero Therapeutics Reports THIRD Quarter 2020 Financial Results

Key Takeaway: Therapeutics Reports THIRD Quarter 2020 Financial Results SOUTH SAN FRANCISCO, Calif., November 12, 2020 -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic ba

Full Press Release Details

Therapeutics Reports THIRD Quarter 2020 Financial Results
SOUTH SAN FRANCISCO, Calif., November 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 third quarter
financial results for the period ending September 30, 2020.
"On the heels of reporting strongly positive histological
data from our FGF21 analog, efruxifermin (EFX), we executed a number of important objectives in the third quarter that position
us for continued success," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "In addition
to raising more than $216 million to enable continued development of EFX, we received feedback from the FDA that enables us to
continue to pursue EFX development with our proposed adaptive Phase 2b/3 clinical trial design. EFX also received PRIME designation
from EMA for development as a NASH therapy. Each of these milestones represents a large step forward in the development of EFX,
which we believe has the potential to be a foundational monotherapy for NASH."
Third Quarter Business Highlights
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. 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. EFX has been shown to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation,
and reverse fibrosis. The breadth of desirable metabolic effects offers potential to address the complex, multi-organ/tissue pathogenesis
of NASH, including 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, EFX 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, 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
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, as well as the dosing, safety and tolerability of EFX; the potential benefits resulting from the PRIME designation of EFX;
Akero's Phase 2a BALANCED study and Phase 2b/3 study including results and expected timing to complete Cohort C; 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, including new
product formulations; expectations regarding the Company's use of capital, expenses and other future financial results;
statements regarding the timing of Company's efforts regarding the IND amendments; 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
September 30, 2020 December 31, 2019
Assets
Cash and cash equivalents and short-term marketable securities $ 291,870 $ 136,400
Other current assets 6,163 1,649
Non-current assets 2,003 69
Total assets $ 300,036 $ 138,118
Liabilities and Stockholders' Equity
Current liabilities $ 12,014 $ 9,369
Non-current liabilities 1,564 23
Stockholders' equity 286,458 128,726
Total liabilities and stockholders' equity $ 300,036 $ 138,118
Akero Therapeutics, Inc.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share and per
Three Months Ended September 30, Nine Months Ended September 30,
2020 2019 2020 2019
Operating expenses:
Research and development $ 17,379 $ 13,885 $ 39,207 $ 23,908
General and administrative 4,159 2,424 11,164 5,522
Total operating expenses 21,538 16,309 50,371 29,430
Loss from operations (21,538 ) (16,309 ) (50,371 ) (29,430 )
Other income 135 755 875 1,286
Net loss $ (21,403 ) $ (15,554 ) $ (49,496 ) $ (28,144 )
Comprehensive loss $ (21,477 ) $ (15,554 ) $ (49,474 ) $ (28,144 )
Net loss per common share, basic and diluted $ (0.63 ) $ (0.56 ) $ (1.63 ) $ (2.66 )
Weighted-average number of shares used in computing net loss per common share, basic and diluted 34,002,769 28,024,779 30,381,671 10,589,119
Last updated: Nov 12, 2020