Akero Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update
May 10 2024 - 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 first quarter financial results for the period ending
March 31, 2024 and provided business updates.
"We continued to make significant advancements in the clinical
development of EFX during the first quarter of this year," said
Andrew Cheng, M.D., Ph.D., president and chief executive officer of
Akero. "The increased improvements in fibrosis stage observed from
weeks 24 to 96 in the Phase 2b HARMONY study in patients with
pre-cirrhotic MASH (F2-F3) showed EFX's potential to result in
higher rates of fibrosis improvement after longer treatment. With
over $900 million in cash, cash equivalents, and short term
marketable securities following a March 2024 equity offering, we
are well-positioned to progress our Phase 3 SYNCHRONY program
through primary endpoint readout for our two studies in patients
with pre-cirrhotic MASH and fund Akero’s current operating plan
into the second half of 2027."
Phase 2b HARMONY Study Week 96
Analysis
- In March 2024, Akero reported Week 96 results from HARMONY, a
Phase 2b study evaluating the efficacy and safety of efruxifermin
(EFX) in patients with pre-cirrhotic metabolic
dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or
3 (F2-F3).
- The study previously met its primary endpoint of ≥1 stage
improvement in fibrosis with no worsening of MASH after 24 weeks of
treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose
groups, compared to 20% for the placebo arm.
- At week 96, the response rates on this endpoint increased to
75% (p<0.001) for 50mg EFX and 46% (p=0.07) for 28mg EFX,
compared to 24% for placebo.
- The study also demonstrated additional improvements on
histology endpoints at week 96, including:
- 36% (p<0.01) and 31% (p<0.01) of patients treated with
50mg EFX and 28mg EFX experienced a 2-stage improvement in fibrosis
without worsening of MASH—more than 10-fold the placebo rate of
3%.
- 68% (p<0.001) and 27% (p=0.053) of patients with F3 fibrosis
at baseline in the 50mg EFX and 28mg EFX groups experienced ≥1
stage improvement in fibrosis without worsening of MASH, compared
with 14% for placebo.
- Statistically significant effects were also observed for
multiple secondary endpoints in both dose groups, including
improvements in liver enzymes, non-invasive fibrosis markers,
glycemic control, and lipoproteins.
- Treatment with EFX was generally well-tolerated, with a
tolerability profile comparable to that observed at week 24 in the
HARMONY study. A total of three patients treated with EFX were
discontinued due to adverse events between week 24 and week 96 (two
in the 28mg group and one in the 50mg group), compared with none
for placebo.
Phase 2b SYMMETRY Study
- The ongoing Phase 2b SYMMETRY study, which is evaluating the
efficacy and safety of EFX in patients with compensated cirrhosis
due to MASH (F4), remains on track to report week 96 results in the
first quarter of 2025.
Phase 3 SYNCHRONY Program
- Akero’s Phase 3 SYNCHRONY clinical trial program consists of
three trials, two of which started enrolling patients in December
2023 and the third of which remains on track to be initiated in the
second quarter of 2024.
- SYNCHRONY Histology is evaluating the efficacy and safety of
EFX in patients with biopsy-confirmed pre-cirrhotic MASH (F2-F3)
and is currently expected to enroll approximately 1,000 patients to
receive weekly injections of EFX 28mg, EFX 50mg, or placebo. The
primary endpoint, designed to support an application for
accelerated approval, is the proportion of patients experiencing ≥
1-stage fibrosis improvement AND resolution of MASH after 52 weeks
of treatment. After 52 weeks, patients will continue treatment as
randomized in SYNCHRONY Histology to be followed for long-term
clinical outcomes, such as progression to cirrhosis.
- SYNCHRONY Real-World is currently expected to enroll
approximately 700 patients with MASH or metabolic
dysfunction-associated steatotic liver disease (MASLD) diagnosed by
either histology or non-invasive tests to receive weekly injections
of EFX 50mg or placebo, including up to 100 patients rolled over
from Phase 2b studies of EFX. The primary endpoint of safety and
tolerability will be assessed after 52 weeks of treatment.
- SYNCHRONY Outcomes, which remains on track to be initiated in
the second quarter of 2024, will evaluate the safety and efficacy
of EFX in patients with compensated cirrhosis due to MASH
(F4).
- In all EFX Phase 3 studies, patients will use the LyoJect 3S
dual chamber syringe, a pre-filled device designed for patient
self-administration. This optimized formulation delivers blood
levels of EFX comparable to those of the liquid formulation used in
prior clinical studies.
Public Offering of Common Stock
- In March 2024, Akero announced the closing of its upsized,
underwritten public offering of 12,650,000 shares of its common
stock at a public offering price of $29.00 per share, which
included the exercise in full by the underwriters of their option
to purchase up to an additional 1,650,000 shares of common stock in
this offering.
- Gross proceeds from the offering, before deducting underwriting
discounts and commissions and estimated offering expenses, were
approximately $366.9 million.
First Quarter 2024 Financial Results
- Akero's cash, cash equivalents and short-term marketable
securities as of March 31, 2024, were $903.7 million.
- Akero believes that its current cash, cash equivalents, and
short-term marketable securities will be sufficient to fund its
Phase 3 SYNCHRONY Histology and Real-World studies through their
respective primary endpoints and Akero’s current operating plan
into the second half of 2027.
- Research and development expenses for the three-month period
ended March 31, 2024 were $50.7 million, compared to $21.8 million
for the comparable period in 2023. These increases are attributable
to higher expenses associated with the completion of the Phase 2b
HARMONY study, the ongoing SYMMETRY study, 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 period
ended March 31, 2024 were $9.3 million, compared to $7.0 million
for the comparable period in 2023. 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 $60.0 million for the three-month
period ended March 31, 2024, compared to $28.8 million for the
comparable period in 2023.
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 appears 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 estimated to affect more than 17 million Americans. 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. 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. Akero's lead product candidate, EFX,
is currently being evaluated in the ongoing SYMMETRY study, a
96-week Phase 2b clinical trial in patients with compensated
cirrhosis due to MASH (F4 fibrosis), as well as 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 (F1-F3 fibrosis) or MASLD. A third
clinical trial, the SYNCHRONY Outcomes study in patients with
compensated cirrhosis due to MASH (F4 fibrosis), is expected to be
initiated in the second quarter 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 (F2-F3) and the
SYMMETRY study in patients with compensated cirrhosis due to MASH
(F4). Akero is headquartered in South San Francisco. Visit us
at akerotx.com and follow us on LinkedIn and X 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 and clinical trial
design; the therapeutic effects of EFX; the timing and initiation
of Akero’s Phase 3 SYNCHRONY program; upcoming milestones,
including week 96 results of the Phase 2b SYMMETRY study; the
anticipated benefits and optimization of the LyoJect 3S dual
chamber syringe; and Akero’s growth as a company and expectations
regarding its uses of capital, expenses, and financial results,
including the expected cash runway. 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 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:Christina
Tartaglia212.362.1200IR@akerotx.com
Media Contact:Sarah
O’Connell732.456.0092soconnell@vergescientific.com
Akero Therapeutics, Inc. |
Condensed Consolidated Balance Sheets |
(Unaudited) |
(In thousands) |
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
December 31, 2023 |
Assets |
|
|
|
|
|
|
Cash, cash equivalents and short-term marketable securities |
|
$ |
903,665 |
|
|
$ |
550,010 |
|
Other current assets |
|
|
7,615 |
|
|
|
9,952 |
|
Non-current assets |
|
|
963 |
|
|
|
20,309 |
|
Total assets |
|
$ |
912,243 |
|
|
$ |
580,271 |
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities |
|
$ |
30,259 |
|
|
$ |
19,128 |
|
Non-current liabilities |
|
|
35,731 |
|
|
|
25,837 |
|
Stockholders’ equity |
|
|
846,253 |
|
|
|
535,306 |
|
Total liabilities and stockholders’ equity |
|
$ |
912,243 |
|
|
$ |
580,271 |
|
|
|
|
|
|
|
|
Akero Therapeutics, Inc. |
Condensed Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
(In thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended March31, |
|
|
2024 |
|
2023 |
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
50,650 |
|
|
$ |
21,787 |
|
General and administrative |
|
|
9,304 |
|
|
|
6,966 |
|
Total operating expenses |
|
|
59,954 |
|
|
|
28,753 |
|
Loss from operations |
|
|
(59,954 |
) |
|
|
(28,753 |
) |
Interest expense |
|
|
(991 |
) |
|
|
(457 |
) |
Interest and other income, net |
|
|
7,601 |
|
|
|
3,379 |
|
Net loss |
|
$ |
(53,344 |
) |
|
$ |
(25,831 |
) |
Comprehensive loss |
|
$ |
(53,693 |
) |
|
$ |
(25,847 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.90 |
) |
|
$ |
(0.55 |
) |
Weighted-average number of shares used in computing net loss per
common share, basic and diluted |
|
|
59,307,759 |
|
|
|
46,944,059 |
|
|
|
|
|
|
|
|
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