Akero Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
November 13 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 third quarter financial results for the period ending
September 30, 2023 and provided business updates.
“We continue to be encouraged by the totality of evidence
supporting clinical development of EFX for both pre-cirrhotic and
cirrhotic NASH,” said Andrew Cheng, M.D., Ph.D., president and
chief executive officer of Akero. “We look forward to enrolling the
first patients in our Phase 3 SYNCHRONY Histology and SYNCHRONY
Real-World studies later this year.”
Phase 3 SYNCHRONY Program
- The SYNCHRONY Histology and SYNCHRONY Real-World studies began
screening in September 2023 and remain on track to begin enrollment
by the end of this year.
- SYNCHRONY Histology will evaluate the efficacy of 28mg and 50mg
doses of efruxifermin (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.
- A Type B, End-of-Phase-2 meeting request to review the design
of the planned SYNCHRONY Outcomes study in light of the Week 36
Phase 2b SYMMETRY data was submitted to FDA in October. As
currently planned, SYNCHRONY Outcomes will evaluate EFX in the
treatment of patients with compensated cirrhosis (F4) due to
NASH.
Phase 2b SYMMETRY Study Week 36
Analysis
- In October 2023, Akero reported Week 36 results from SYMMETRY,
a 96-week Phase 2b study evaluating the efficacy and safety of its
lead product candidate EFX in patients with compensated cirrhosis
(F4) due to NASH.
- Although the primary endpoint of at least a one-stage
improvement in liver fibrosis with no worsening of NASH at week 36
was not met, statistically significant results for NASH resolution,
as well as non-invasive markers of liver injury and fibrosis,
insulin sensitization and lipoproteins were observed, including:
- 22% (28mg EFX) and 24% (50mg EFX) of patients experienced at
least a one-stage improvement in liver fibrosis with no worsening
of NASH, compared to 14% for placebo (not statistically
significant);
- 4% of patients in each EFX dose group experienced a three- or
two-stage reversal of fibrosis with no worsening of NASH, compared
to 0% for placebo; and
- 63% (28mg EFX) and 60% (50mg EFX) of patients experienced
statistically significant resolution of NASH, compared to 26% for
placebo—the first known public report of a clinical trial showing
statistically significant NASH resolution, in patients with
cirrhosis irrespective of development stage, treatment duration or
mechanism of action.
- Across EFX groups, the most frequent adverse events were
gastrointestinal, and mainly of mild to moderate severity.
Phase 2b HARMONY Study Week 96
Analysis
- Week 96 results from HARMONY, a 96-week Phase 2b HARMONY study
evaluating the efficacy and safety of EFX in biopsy-confirmed
patients with F2-F3 NASH, remain on track to be reported in the
first quarter of
2024.
Third Quarter 2023 Financial Results
- Akero's cash, cash equivalents and short-term and long-term
marketable securities for the period ended September 30, 2023 were
$613.0 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 September 30, 2023 were $38.6 million, compared to $25.1
million for the comparable period in 2022. Direct EFX program costs
increased $14.1 million related to CRO and CMO expenses for our
ongoing HARMONY and SYMMETRY studies as well as the initiation of
the Phase 3 SYNCHRONY program and personnel and other R&D
expenses decreased $0.5 million.
- General and administrative expenses for the three-month period
ended September 30, 2023 were $8.0 million, compared to $11.0
million for the comparable period in 2022. The decrease is
attributable primarily to lower non-cash stock-based compensation
expense, offset by an increase in expenses for personnel and
professional services.
- Total operating expenses were $46.6 million for the three-month
period ended September 30, 2023, compared to $36.1 million for the
comparable period in 2022.
About NASHNASH is a serious form of
non-alcoholic fatty liver disease (NAFLD) 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.
Approximately 20% of patients with NASH will progress to cirrhosis,
which has a higher risk of mortality. 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 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. 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). 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 the availability of sufficient cash to fund Akero’s
operating plan into 2026; the potential therapeutic effects of EFX,
as well as the dosing, safety and tolerability of EFX; the
SYNCHRONY Phase 3 program, including the SYNCHRONY Histology and
SYNCHRONY Real-World studies and design of trials, the expectation
to begin enrollment of Akero’s Phase 3 SYNCHRONY program by end of
2023 and expectations regarding potential communications with the
FDA; and upcoming milestones, including the results, and expected
timing to report the long-term follow-up week 96 results of Akero’s
Phase 2b HARMONY and SYMMETRY studies; 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 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; 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. |
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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, 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 |
|
$ |
554,732 |
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$ |
351,449 |
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Prepaid expenses and other current assets |
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21,247 |
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3,724 |
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Non-current assets |
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59,352 |
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1,397 |
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Total assets |
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$ |
635,331 |
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$ |
356,570 |
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Liabilities and Stockholders’ Equity |
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Current liabilities |
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$ |
28,447 |
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$ |
19,083 |
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Non-current liabilities |
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23,749 |
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10,925 |
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Stockholders’ equity |
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583,135 |
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326,562 |
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Total liabilities and stockholders’ equity |
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$ |
635,331 |
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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 September 30, |
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Nine Months Ended September 30, |
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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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$ |
38,634 |
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$ |
25,087 |
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$ |
88,406 |
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$ |
66,964 |
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General and administrative |
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7,981 |
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11,004 |
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22,591 |
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22,772 |
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Total operating expenses |
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46,615 |
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36,091 |
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110,997 |
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89,736 |
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Loss from operations |
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(46,615 |
) |
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(36,091 |
) |
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(110,997 |
) |
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(89,736 |
) |
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Interest expense |
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(888 |
) |
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(324 |
) |
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(2,202 |
) |
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(377 |
) |
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Other income, net |
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7,844 |
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873 |
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16,626 |
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1,139 |
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Net loss |
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$ |
(39,659 |
) |
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$ |
(35,542 |
) |
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$ |
(96,573 |
) |
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$ |
(88,974 |
) |
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Comprehensive loss |
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$ |
(39,914 |
) |
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$ |
(35,539 |
) |
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$ |
(97,116 |
) |
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$ |
(88,947 |
) |
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Net loss per common share, basic and diluted |
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$ |
(0.71 |
) |
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$ |
(0.92 |
) |
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$ |
(1.87 |
) |
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$ |
(2.45 |
) |
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Weighted-average number of shares used in computing net loss per
common share, basic and diluted |
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55,613,120 |
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38,663,469 |
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51,506,766 |
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36,364,284 |
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