Blog: AKERO THERAPEUTICS, INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) –

Item 7.01. Regulation FD Disclosure.

On September 13, 2022, Akero Therapeutics, Inc. (the “Company”) issued a press
release titled “In Akero Therapeutics’ Phase 2b HARMONY Study, Both the 50mg and
28mg EFX Doses Achieved Statistical Significance on Primary and Secondary
Histology Endpoints after 24 Weeks.” A copy of the press release is furnished as
Exhibit 99.1 to this Current Report on Form 8-K.

The information under this Item 7.01, including Exhibit 99.1 hereto, is being
furnished herewith and shall not be deemed “filed” for the purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, nor shall such
information be deemed incorporated by reference into any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except as expressly set
forth by specific reference in such filing.

Item 8.01. Other Events.

The Company from time to time presents and/or distributes to the investment
community slide presentations to provide updates and summaries of its business.
A copy of its HARMONY Study slide presentation is being filed herewith as
Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by
reference. The Company undertakes no obligation to update, supplement or amend
the materials attached hereto as Exhibit 99.2.

On September 13, 2022, the Company released topline data from HARMONY, a 24-week
Phase 2b study evaluating the efficacy and safety of its lead product candidate
efruxifermin (“EFX”) in patients with pre-cirrhotic nonalcoholic steatohepatitis
(“NASH”), fibrosis stage 2 or 3 (“F2-F3”). The study met its primary endpoint
for both the 50mg and 28mg efruxifermin (“EFX”) dose groups, with 41% and 39% of
EFX-treated patients, respectively, experiencing at least a one-stage
improvement in liver fibrosis with no worsening of NASH by week 24, compared
with 20% for the placebo arm. The study also met a key secondary endpoint with
76% and 47% of patients treated with 50mg and 28mg, respectively, achieving NASH
resolution without worsening of fibrosis, compared with 15% for placebo. In
addition, 41% and 29% of patients treated with 50mg and 28mg, respectively,
achieved both endpoints (NASH resolution and fibrosis improvement ?1 stage),
compared with 5% for placebo.

Patients in the HARMONY study exhibited characteristics of patients at high risk
of disease progression. The mean body weight across dose groups was
approximately 105 kilograms. Roughly 70% of patients across dose groups had Type
2 diabetes as well as NASH. Approximately twice as many patients in the HARMONY
study had fibrosis stage 3 (66%) as fibrosis stage 2 (34%). Despite these
indicators of more advanced disease, the study also demonstrated statistically
significant effects in multiple secondary endpoints in both dose groups,
including improvements in liver fat, liver enzymes, non-invasive fibrosis
markers, HbA1c, lipoproteins, and body weight. Treatment with EFX was generally
well-tolerated, with a tolerability profile comparable to that observed in the
Company’s Phase 2a BALANCED study.


EFX was reported to be generally well tolerated. Across both dose groups, the
most frequent adverse events (“AEs”) were grade 1 or 2 gastrointestinal events
(diarrhea, nausea, increased appetite, and frequent bowel movements), which were
transient in nature. A total of five patients treated with EFX were discontinued
due to AEs (two in the 28mg group and three in the 50mg group, one of which was
reported to be unrelated to study drug), compared with none for placebo. A
single drug-related serious adverse event (“SAE”) of esophagitis was experienced
by a patient in the 50mg group who had a history of gastroesophageal reflux
disease. Three other SAEs were reported as unrelated to study drug.

In July of 2021, the Company initiated the SYMMETRY study, a Phase 2b trial in
biopsy-confirmed NASH patients with compensated cirrhosis, Child-Pugh class A.
Based on enrollment to date, Akero expects to report results from the ongoing
Phase 2b SYMMETRY study in the second half of 2023. Results from a 12-week
expansion cohort of the SYMMETRY study, evaluating treatment of EFX on top of
GLP-1 therapy in patients with F1-F3 fibrosis, are expected in the first half of

Forward-Looking Statements

This Current Report on Form 8-K and certain materials furnished or filed
herewith contain forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including, without
limitation, implied and express statements regarding: the Company’s business
plans and objectives, including future plans or expectations for efruxifermin
(EFX), the therapeutic effects and clinical benefits of EFX, as well as the
dosing, safety and tolerability of EFX; and upcoming milestones, including the
results, and expected timing to report such results of the Company’s Phase 2b
SYMMETRY study; and the Company’s preparations for commercialization of EFX, if

Any forward-looking statements 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 public health epidemics affecting countries or regions in which we
have operations or do business, such as COVID-19, which has been labelled a
pandemic by the World Health Organization, including potential negative impacts
on the Company’s employees, manufacturers, supply chain and production as well
as on global economies and financial markets; the company’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 risks related to the competitive
landscape. For a discussion of these and other risks and uncertainties, and
other important factors, any of which could cause the Company’s actual results
to differ from those contained in the forward-looking statements, see the
section entitled “Risk Factors” in the Company’s annual report on Form 10-K
filed, with the United States 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 the Company’s
other filings with the SEC. All forward-looking statements contained in this
presentation speak only as of the date on which they were made. The Company
undertakes no obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were made.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

  No.       Description

99.1          Press Release issued by Akero Therapeutics, Inc. on September 13, 2022

99.2          Slide presentation of Akero Therapeutics, Inc.

104         Cover Page Interactive Data File (embedded within Inline XBRL document)


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