Akero Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update
11 Agosto 2023 - 7:00AM
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 second quarter financial results for the period ending
June 30, 2023 and provided business updates.
“We achieved important
progress in the clinical development of EFX during the second
quarter of this year, including attaining strong and consistent
results across our Phase 2 studies to date as reinforced by the
Phase 2b SYMMETRY Cohort D study results,” said Andrew Cheng, M.D.,
Ph.D., president and chief executive officer of Akero. “These
results add to the growing body of evidence supporting the ongoing
clinical development of EFX and its potential as a transformative
NASH therapy. Bolstered by $334.8 million in net proceeds raised in
the second quarter, we look forward to initiating our Phase 3
SYNCHRONY Histology and SYNCHRONY Real-World studies later this
year to further our goal of developing meaningful therapies for
patients living with NASH.”
Phase 3 SYNCHRONY
Program
- SYNCHRONY Histology and SYNCHRONY
Real-World studies remain on track to begin enrollment by the end
of this year.
- SYNCHRONY Histology will evaluate the
efficacy of 28mg and 50mg doses of EFX in patients with biopsy
confirmed pre-cirrhotic NASH, fibrosis stage 2 or 3 (F2-F3). The
primary endpoint will be ≥ 1-stage fibrosis improvement AND
resolution of NASH.
- SYNCHRONY Real-World will assess
safety and tolerability of EFX in patients with non-invasively
diagnosed NASH or NAFLD. Key secondary endpoints will include
changes in biomarkers of liver fibrosis as well as measures of
glycemic control and lipids.
Phase 2b SYMMETRY
Study Update
- Akero reported topline data from an
expansion cohort (N=31) of the Phase 2b SYMMETRY study known as
Cohort D.
- The primary aim of the 12-week study
was to assess safety and tolerability of EFX compared to placebo
when added to an existing GLP-1 receptor agonist (GLP-1) in
patients with Type 2 diabetes and F1-F3 liver fibrosis due to
NASH.
- Results of the Cohort D study showed
safety and tolerability endpoints were met. The study also showed
that adding EFX to GLP-1 therapy significantly improved
non-invasive markers of NASH-related disease, including a 65%
relative reduction in liver fat for the EFX-treated group compared
with a 10% reduction for the placebo group treated only with GLP-1.
In addition, 88% of EFX-treated patients normalized their liver fat
to 5% or less, compared with 10% for the placebo group.
- Akero remains on track to report Week
36 results of the Phase 2b SYMMETRY main study in adult patients
with cirrhotic NASH (F4, compensated) in the fourth quarter of
2023.
Second Quarter
2023 Financial Results
- The company raised $334.8 million in
net proceeds through an At-the-Market facility (ATM) and
underwritten registered direct offering, enhancing the company’s
cash position in the second half of 2023 as it nears initiation of
the Phase 3 SYNCHRONY Histology and SYNCHRONY Real-World studies of
Efruxifermin (EFX) in NASH.
- Akero's cash, cash equivalents and
short-term and long-term marketable securities for the period ended
June 30, 2023 were $658.9 million.
- Akero believes that its current 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 period ended June 30, 2023 were $28.0 million,
compared to $21.4 million for the comparable period in 2022. Direct
EFX program costs increased $5.4 million related to CRO and CMO
expenses for our ongoing HARMONY and SYMMETRY studies and personnel
and other R&D expenses increased $1.2 million.
- General and administrative expenses
for the three-month period ended June 30, 2023 were $7.6 million,
compared to $6.2 million for the comparable period in 2022. The
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 $35.6
million for the three-month period ended June 30, 2023, compared to
$27.6 million for the comparable period in 2022.
About NASHNASH is a serious form of NAFLD
(non-alcoholic fatty liver disease) that is estimated to affect 17
million Americans. 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.
There are no approved treatments for the condition and NASH is the
fastest growing cause of liver transplants and liver cancer in the
US and Europe.
About EfruxiferminEfruxifermin (EFX), formerly
known as AKR-001, is Akero’s lead product candidate for NASH,
currently being evaluated in the ongoing Phase 2b HARMONY and
SYMMETRY studies. 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 NASH, including
improvements in lipoprotein risk factors linked to cardiovascular
disease – the leading cause of death in NASH patients. Engineered
to mimic the biological activity profile of native FGF21, EFX is
designed to offer convenient once-weekly dosing and has been
generally well-tolerated in clinical trials to date.
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 NASH, a disease without any approved
therapies. Akero's lead product candidate, 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 patients with pre-cirrhotic NASH (F2-F3 fibrosis), and the
SYMMETRY study in patients with cirrhotic NASH (F4 fibrosis,
compensated). EFX has also been evaluated in an expansion cohort of
the SYMMETRY study, Cohort D, comparing the safety and tolerability
of EFX to placebo when added to an existing GLP-1 receptor agonist
in patients with pre-cirrhotic NASH (F1-F3 fibrosis) and Type 2
diabetes, for which topline results were reported on June 5, 2023.
Akero is headquartered in South San Francisco. Visit us at
akerotx.com and follow us on LinkedIn and Twitter for more
information.
Forward Looking StatementsStatements 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, the therapeutic
effects of EFX, as well as the dosing, safety and tolerability of
EFX, including in combination with GLP-1 therapies; and upcoming
milestones, including the results, and expected timing to report
such results of Akero’s Phase 2b SYMMETRY study, the SYNCHRONY
Phase 3 program, including the SYNCHRONY Histology and SYNCHRONY
Real-World studies and design of trials and expected timing
thereof; and Akero’s growth as a company and expectations regarding
its uses of capital, expenses, and financial results. 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 a clinical study, including Cohort D, 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 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:Austin
Murtagh212.698.8696IR@akerotx.com
Media Contact:Sarah
O’Connell732.456.0092soconnell@vergescientific.com
Akero Therapeutics, Inc. |
Condensed Consolidated Balance Sheets |
(Unaudited) |
(In thousands) |
|
|
|
|
|
|
|
|
|
June 30, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
|
|
|
Cash, cash equivalents and short-term marketable securities |
|
$ |
639,444 |
|
$ |
351,449 |
Other current assets |
|
|
3,759 |
|
|
3,724 |
Long-term marketable securities |
|
|
19,451 |
|
|
— |
Non-current assets |
|
|
1,152 |
|
|
1,397 |
Total assets |
|
$ |
663,806 |
|
$ |
356,570 |
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities |
|
$ |
21,602 |
|
$ |
19,083 |
Non-current liabilities |
|
|
25,767 |
|
|
10,925 |
Stockholders’ equity |
|
|
616,437 |
|
|
326,562 |
Total liabilities and stockholders’ equity |
|
$ |
663,806 |
|
$ |
356,570 |
|
|
|
|
|
|
|
Akero Therapeutics, Inc. |
Condensed Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
(In thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
27,985 |
|
|
$ |
21,363 |
|
|
$ |
49,772 |
|
|
$ |
41,877 |
|
General and administrative |
|
|
7,644 |
|
|
|
6,231 |
|
|
|
14,610 |
|
|
|
11,768 |
|
Total operating expenses |
|
|
35,629 |
|
|
|
27,594 |
|
|
|
64,382 |
|
|
|
53,645 |
|
Loss from operations |
|
|
(35,629 |
) |
|
|
(27,594 |
) |
|
|
(64,382 |
) |
|
|
(53,645 |
) |
Interest expense |
|
|
(857 |
) |
|
|
(53 |
) |
|
|
(1,314 |
) |
|
|
(53 |
) |
Other income, net |
|
|
5,403 |
|
|
|
244 |
|
|
|
8,782 |
|
|
|
266 |
|
Net loss |
|
$ |
(31,083 |
) |
|
$ |
(27,403 |
) |
|
$ |
(56,914 |
) |
|
$ |
(53,432 |
) |
Comprehensive loss |
|
$ |
(31,355 |
) |
|
$ |
(27,376 |
) |
|
$ |
(57,202 |
) |
|
$ |
(53,408 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.60 |
) |
|
$ |
(0.77 |
) |
|
$ |
(1.15 |
) |
|
$ |
(1.52 |
) |
Weighted-average number of shares used in computing net loss per
common share, basic and diluted |
|
|
51,867,854 |
|
|
|
35,383,685 |
|
|
|
49,419,558 |
|
|
|
35,195,638 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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