Akero Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update
November 12 2021 - 7:00AM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic
biotechnology company developing transformational treatments for
non-alcoholic steatohepatitis (NASH), today reported third quarter
financial results for the period ending September 30, 2021.
“Our team remains focused on successfully completing two Phase
2b clinical trials, and diligently working with regulators to bring
efruxifermin (EFX) to market, potentially as a treatment for
patients with more advanced NASH who have the highest medical
need,” said Andrew Cheng, M.D., Ph.D., president and chief
executive officer of Akero. “We are pleased to have received a
Fast Track designation from the FDA, which we believe is a
testament to the strength of results we observed in our Phase 2a
BALANCED study.”
Third Quarter Business Highlights & Company
Updates
- In October, Akero announced that the U.S. Food and Drug
Administration (FDA) granted Fast Track designation to its lead
program investigating efruxifermin (EFX) for the treatment of
non-alcoholic steatohepatitis (NASH). This designation enables more
frequent interactions with the FDA and potential eligibility for
priority review if clinical data support it.
- During the third quarter, Akero continued to progress its Phase
2b program comprised of parallel clinical trials in pre-cirrhotic
patients with F2/F3 fibrosis (the HARMONY study) and cirrhotic
(compensated, F4) NASH (the SYMMETRY study). Akero also continued
to make progress towards a successful manufacture of drug product
for its Phase 3 program.
Third Quarter 2021 Financial Results
- Akero's cash, cash equivalents and short-term marketable
securities for the period ended September 30,
2021 were $215.1 million.
- Akero believes that its cash, cash equivalents and marketable
securities will be sufficient to fund its current operating plan
into the third quarter of 2023.
- Research and development expenses for the three-month period
ended September 30, 2021 were $19.5 million,
compared to $17.4 million for the comparable period in
2020. These increases are attributable to higher costs related to
Akero's EFX program, including third-party contract manufacturing
and process development costs, contract research organization costs
associated with the HARMONY and SYMMETRY studies and internal
personnel costs.
- General and administrative expense for the three-month period
ended September 30, 2021 were $4.9 million, compared
to $4.2 million for the comparable period in 2020. This
increase is attributable to higher expenses for personnel,
including non-cash stock-based compensation, and professional
services and other costs associated with operating as a public
company.
- Total operating expenses were $24.4 million for the
three-month period ended September 30, 2021, compared
to $21.5 million for the corresponding period in 2020.
About Akero Therapeutics
Akero Therapeutics is a clinical-stage cardio-metabolic company
developing transformational treatments for non-alcoholic
steatohepatitis (NASH), a disease without any approved therapies.
Akero's lead product candidate, efruxifermin (EFX) is a
differentiated Fc-FGF21 fusion protein that has been engineered to
mimic the balanced biological activity profile of native FGF21, an
endogenous hormone that alleviates cellular stress and regulates
metabolism throughout the body. EFX is designed to offer convenient
once-weekly subcutaneous dosing. The consistency and magnitude of
observed effects position EFX to be a potentially best-in-class
medicine, if approved, for treatment of NASH. EFX is currently
being evaluated in two Phase 2b clinical trials: the HARMONY study
in NASH patients with F2/F3 advanced fibrosis and the SYMMETRY
study in cirrhotic (compensated, F4) NASH patients. Akero is
headquartered in South San Francisco. Visit us at www.akerotx.com
for more information.
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 Akero'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; Akero’s Phase 2b HARMONY
and Phase 2b SYMMETRY clinical trials; the potential benefits
resulting from the Fast Track designation of EFX and related
implications; expectations regarding Akero’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 Akero'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
Akero's product candidate development activities and planned
clinical trials; Akero'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;
Akero'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 recent Annual Report on Form 10-K, as filed with
the Securities and Exchange Commission (SEC) and quarterly reports
on Form 10-Q filed with the 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.
Investor Contact:Christina TartagliaStern
Investor Relations,
Inc.212.362.1200christina.tartaglia@sternir.com
Media Contact:650.487.6488media@akerotx.com
Akero Therapeutics, Inc. |
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Condensed Consolidated Balance Sheets |
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(Unaudited) |
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(In thousands) |
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September 30, 2021 |
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December 31, 2020 |
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Assets |
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Cash, cash equivalents and short-term marketable securities |
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$ |
215,081 |
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$ |
268,387 |
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Other current assets |
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6,726 |
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2,958 |
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Non-current assets |
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1,726 |
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1,994 |
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Total assets |
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$ |
223,533 |
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$ |
273,339 |
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Liabilities and Stockholders’
Equity |
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Current liabilities |
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$ |
23,540 |
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$ |
13,111 |
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Non-current liabilities |
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1,365 |
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1,516 |
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Stockholders’ equity |
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198,628 |
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258,712 |
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Total liabilities and stockholders’ equity |
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$ |
223,533 |
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$ |
273,339 |
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Akero Therapeutics, Inc. |
Condensed Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
(In thousands, except share and per share amounts) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2021 |
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2020 |
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2021 |
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2020 |
Operating expenses: |
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Research and development |
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$ |
19,470 |
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$ |
17,379 |
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$ |
54,048 |
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$ |
39,207 |
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General and administrative |
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4,883 |
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$ |
4,159 |
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14,399 |
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11,164 |
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Total operating expenses |
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24,353 |
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21,538 |
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68,447 |
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50,371 |
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Loss from operations |
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(24,353 |
) |
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(21,538 |
) |
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(68,447 |
) |
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(50,371 |
) |
Other income |
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23 |
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135 |
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94 |
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875 |
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Net loss |
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$ |
(24,330 |
) |
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$ |
(21,403 |
) |
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$ |
(68,353 |
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$ |
(49,496 |
) |
Comprehensive loss |
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$ |
(24,338 |
) |
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$ |
(21,477 |
) |
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$ |
(68,367 |
) |
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$ |
(49,474 |
) |
Net loss per common share,
basic and diluted |
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$ |
(0.70 |
) |
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$ |
(0.63 |
) |
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$ |
(1.96 |
) |
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$ |
(1.63 |
) |
Weighted-average number of
shares used in computing net loss per common share, basic and
diluted |
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34,862,116 |
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34,002,769 |
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34,807,439 |
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30,381,671 |
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