Akero Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
29 Fevereiro 2024 - 9:00AM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company
developing transformational treatments for patients with serious
metabolic diseases marked by high unmet medical need, today
reported fourth quarter and full year financial results for the
period ending December 31, 2023.
“We concluded 2023 by dosing the first patients in our two Phase
3 SYNCHRONY studies evaluating EFX in the treatment of patients
with pre-cirrhotic MASH,” said Andrew Cheng, M.D., Ph.D., president
and chief executive officer of Akero. “In the first half of 2024,
we look forward to reporting results from the second on-treatment
biopsy in our 96-week Phase 2b HARMONY study in patients with
pre-cirrhotic MASH and initiating our third Phase 3 SYNCHRONY study
in patients with cirrhosis due to MASH.”
Phase 3 SYNCHRONY Program Update
- In December 2023 the
first patients were enrolled in two of three planned clinical
trials comprising the Phase 3 SYNCHRONY program.
- SYNCHRONY Histology
is evaluating the safety and efficacy of 28 and 50mg doses of
efruxifermin (EFX) in patients with biopsy confirmed pre-cirrhotic
MASH (F2-F3). The primary endpoint, ≥1-stage fibrosis improvement
and resolution of MASH after 52 weeks, is designed to support an
application for accelerated approval for pre-cirrhotic MASH.
Additional patients will be enrolled and followed for long-term
clinical outcomes to support an application for full marketing
approval.
- SYNCHRONY Real-World
is assessing the safety and tolerability of EFX in patients with
non-invasively diagnosed MASH or metabolic dysfunction-associated
steatotic liver disease (MASLD). Results will support evaluation of
safety for inclusion in an application for accelerated
approval.
- SYNCHRONY Outcomes,
which is expected to be initiated in the first half of 2024, will
evaluate the safety and efficacy of EFX in patients with
compensated cirrhosis (F4) due to MASH. Consistent with feedback
from the FDA in a recent Type B meeting, the trial is likely to
include two primary endpoints: (1) evaluation of histology from a
cohort of patients who will be biopsied after 96 weeks of treatment
to assess the extent of regression of hepatic fibrosis and (2)
assessment of clinical outcomes to support an application for full
marketing approval.
- In all EFX Phase 3
studies, patients will self-administer EFX using the LyoJect 3S
dual chamber syringe, a pre-filled device intended for commercial
use in the event EFX is approved for marketing. This optimized
formulation delivers blood levels of EFX comparable to those of the
liquid formulation used in prior clinical studies.
Phase 2b SYMMETRY Week 36 Results and Study
Update
- In the fourth
quarter of 2023, Akero reported results for the week 36 analysis of
the Phase 2b SYMMETRY study in patients with cirrhosis due to MASH.
- A trend, which was
not statistically significant, was observed for the primary
endpoint, with 22% and 24% of the 28mg and 50mg EFX-treated groups,
respectively, experiencing at least a one-stage improvement in
liver fibrosis and no worsening of MASH, compared with 14% for
placebo.
- Statistically
significant rates of MASH resolution in 67% and 60% of patients at
week 36 were observed for the 28mg and 50mg EFX-treated groups,
respectively, compared with 26% for placebo.
- Statistically
significant improvements were also observed for both EFX groups in
non-invasive markers of liver injury and fibrosis, insulin
sensitization and lipoproteins.
- EFX was reported to
be generally well-tolerated. Overall, the most frequent adverse
events were transient, gastrointestinal grade 1 or 2 events.
- Preliminary, topline
results for histopathology and noninvasive measurements after 96
weeks of treatment in the SYMMETRY study are expected to be
reported in the first quarter of 2025.
Full Year and Fourth Quarter 2023 Financial
Results
- Akero's cash, cash equivalents, short-term and long-term
marketable securities for the year ended December 31, 2023 were
$569.3 million.
- Akero believes that its cash, cash equivalents, short-term and
long-term marketable securities will be sufficient to fund its
current operating plan into 2026.
- Research and development expenses for the three-month and
twelve-month periods ended December 31, 2023 were $53.4 million and
$141.8 million, respectively, compared to $18.3 million and $85.3
million for the comparable periods in 2022. These increases are
attributable to higher expenses associated with the ongoing Phase
2b HARMONY and SYMMETRY studies, initiation of the Phase 3
SYNCHRONY Histology and SYNCHRONY Real-World studies, manufacturing
required to support Phase 3 and potential marketing applications,
as well as higher expenses for personnel.
- General and administrative expenses for the three-month and
twelve-month periods ended December 31, 2023 were $8.5 million and
$31.1 million, respectively, compared to $7.1 million and $29.9
million for the comparable periods in 2022. These increases are
attributable to higher expenses for personnel, and professional
services and other costs associated with operating as a public
company.
- Total operating expenses were $61.9 million and $172.9 million
for the three-month and twelve-month periods ended December 31,
2023, respectively, compared to $25.4 million and $115.2 million
for the comparable periods in 2022.
About EfruxiferminEfruxifermin (EFX), Akero’s
lead product candidate for MASH, 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 reduce liver fat and inflammation,
reverse fibrosis, increase insulin sensitivity and improve lipids.
This holistic approach offers the potential to address the complex,
multi-system disease state of MASH, including improvements in
lipoprotein risk factors linked to cardiovascular disease – the
leading cause of death in MASH patients. EFX is designed to offer
convenient once-weekly dosing and has been generally well tolerated
in clinical trials to date.
About MASHMASH is a serious form of MASLD that
is projected to affect over 25 million Americans by 2030. MASH 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. Approximately 20% of patients with
MASH will progress to cirrhosis, which has a higher risk of
mortality. There are no approved treatments for the condition and
MASH is the fastest growing cause of liver transplants and liver
cancer in the US and Europe.
About Akero TherapeuticsAkero Therapeutics
is a clinical-stage company developing transformational treatments
for patients with serious metabolic diseases marked by high unmet
medical need, including MASH, a disease without any approved
therapies. Akero's lead product candidate, EFX, is currently being
evaluated in two ongoing Phase 3 clinical trials, the SYNCHRONY
Histology study in patients with pre-cirrhotic MASH (F2-F3
fibrosis) and the SYNCHRONY Real-World study in patients with MASH
or MASLD. A third clinical trial, the SYNCHRONY Outcomes study in
patients with cirrhosis due to MASH, is expected to be initiated in
the first half of 2024. The Phase 3 SYNCHRONY program builds on the
results of two Phase 2b clinical trials, the HARMONY study in
patients with pre-cirrhotic MASH and the SYMMETRY study in patients
with cirrhosis due to MASH. Akero is headquartered in South San
Francisco. Visit us at akerotx.com and follow us on LinkedIn and
Twitter 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 upcoming milestones, including the
expected timing to report the week 96 results of Akero’s Phase 2b
HARMONY and SYMMETRY studies; Akero’s business plans and
objectives; the potential therapeutic effects of EFX, as well as
the dosing, safety and tolerability of EFX; the SYNCHRONY Phase 3
program, including the design and enrollment of the SYNCHRONY
Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes studies;
and plans related to use of a new formulation designed for
self-administration in Phase 3 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: 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 any of its clinical studies
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;
Akero’s ability to fully enroll patients in its SYNCHRONY Phase 3
studies including the SYNCHRONY Histology, SYNCHRONY Real-World,
and SYNCHRONY Outcomes studies; 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 and
Quarterly Report on Form 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.
Investor Contact:Christina
Tartaglia212.362.1200IR@akerotx.com
Media Contact:Sarah
O’Connell732.456.0092sarah.oconnell@vergescientific.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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December 31, 2023 |
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December 31, 2022 |
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Assets |
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Cash, cash equivalents and short-term marketable securities |
|
$ |
550,010 |
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$ |
351,449 |
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Other current assets |
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9,952 |
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3,724 |
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Non-current assets |
|
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20,309 |
|
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|
1,397 |
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Total assets |
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$ |
580,271 |
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$ |
356,570 |
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Liabilities
and Stockholders’ Equity |
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Current liabilities |
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$ |
19,128 |
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$ |
19,083 |
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Non-current liabilities |
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25,837 |
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10,925 |
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Stockholders’ equity |
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535,306 |
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326,562 |
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Total liabilities and stockholders’ equity |
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$ |
580,271 |
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$ |
356,570 |
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Akero Therapeutics,
Inc. |
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Condensed
Consolidated Statements of Operations and Comprehensive Loss |
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(Unaudited) |
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(In thousands,
except share and per share amounts) |
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Three Months Ended December 31, |
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Year Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating
expenses: |
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Research and development |
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$ |
53,392 |
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$ |
18,320 |
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$ |
141,798 |
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$ |
85,284 |
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General and administrative |
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8,481 |
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7,100 |
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31,072 |
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29,872 |
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Total operating expenses |
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61,873 |
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25,420 |
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172,870 |
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115,156 |
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Loss from
operations |
|
|
(61,873 |
) |
|
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(25,420 |
) |
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(172,870 |
) |
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(115,156 |
) |
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Interest
expense |
|
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(897 |
) |
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(362 |
) |
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(3,099 |
) |
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(739 |
) |
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Other
income, net |
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7,584 |
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2,723 |
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24,210 |
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3,862 |
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Net
loss |
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$ |
(55,186 |
) |
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$ |
(23,059 |
) |
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$ |
(151,759 |
) |
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$ |
(112,033 |
) |
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Comprehensive loss |
|
$ |
(54,410 |
) |
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$ |
(23,022 |
) |
|
$ |
(151,526 |
) |
|
$ |
(111,969 |
) |
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Net loss per
common share, basic and diluted |
|
$ |
(0.99 |
) |
|
$ |
(0.49 |
) |
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$ |
(2.89 |
) |
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$ |
(2.87 |
) |
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Weighted-average number of shares used in computing net loss per
common share, basic and diluted |
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55,717,726 |
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46,760,783 |
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52,568,159 |
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38,984,772 |
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Akero Therapeutics (NASDAQ:AKRO)
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