Item 7.01. Regulation FD Disclosure.
On November 12, 2021, Akero Therapeutics, Inc. (the "Company") issued a press
release titled "Akero Presents New Analysis of Phase 2a BALANCED Study Data
Showing Additional Qualitative Evidence of Histological Improvement in
EFX-treated NASH Patients after 16 Weeks of Treatment." 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 today presented additional post-hoc analysis of data from the
Company's Phase 2a BALANCED study in a poster at The Liver Meeting of the
American Association for the Study of Liver Diseases. The analysis evaluated
pre- and post-treatment biopsies in 40 EFX-treated patients from the BALANCED
study. These post-treatment biopsies showed improvements in histological
features of steatohepatitis in 87% (35 of 40) and fibrosis in 80% (32 of 40) of
EFX-treated patients after 16 weeks of treatment. Patterns of disease regression
were evident in many patients who did not meet the categorical thresholds for
either NASH resolution without worsening of fibrosis or at least a one-stage
improvement in fibrosis without worsening of NASH. Moreover, two target
populations at elevated risk of NASH progression-carriers of the PNPLA3 risk
allele (I148M) and/or those with Type 2 diabetes-showed comparable qualitative
and/or quantitative histological improvements to the rest of the patients in the
BALANCED study.
Forward-Looking Statements
Statements contained under this Item 8.01 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, upcoming milestones, and
therapeutic effects of EFX, as well as the dosing, safety and tolerability of
EFX; Akero's Phase 2a BALANCED study, including results and post-hoc analysis of
its data; and the potential impact of COVID-19 on strategy, future operations,
enrollment and clinical trials.
Any forward-looking statements in this Current Report on Form 8-K 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 COVID-19 on Akero's ongoing
and future operations, including potential negative impacts on Akero's
employees, third-parties, manufacturers, supply chain and production as well as
on global economies and financial markets; 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, as filed with the 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 Akero's other filings and reports with the SEC. All forward-looking
statements contained in this Current Report on Form 8-K 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit Description
No.
99.1 Press release issued by Akero Therapeutics, Inc. on November 12,
2021
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document)
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