ENGLEWOOD, Colo., May 16, 2022
/PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American:
AMPE) ("Ampio" or the "Company") today announced that an
independent special committee of the Ampio Board of Directors (the
"Committee"), with the assistance of independent legal counsel, is
in the process of conducting an internal investigation that relates
to, among other matters, Ampio's AP-013 clinical trial and other
clinical trials.
FDA has communicated to the Company that it does not consider
data from AP-013 to be sufficient to demonstrate efficacy as a
second pivotal trial for Ampion. Further analysis subsequent to
that communication from FDA suggests that data from AP-013 will not
be sufficient to support regulatory approval in the US or other
countries. Management's recent analyses also indicate no clinically
meaningful treatment effect signals from the Company's three
COVID-19 clinical trials, AP-017, AP-018, or AP-019.
The Ampio Board of Directors also has begun a process to
consider strategic alternatives for Ampio and Ampion, which may
include the continued development and advancement of Ampion,
capital raising, licensing and other partnering opportunities,
positioning the Company for a strategic transaction or other
alternative(s).
The Committee also is overseeing a review of unauthorized use of
Ampion by individuals not participating in clinical trials.
Ampion is an investigational drug not approved by FDA. Ampio
instituted safeguards to cease this practice and engaged
independent outside counsel to conduct a thorough review, which is
ongoing. The Company is currently in the process of working to
ensure that the issue has been resolved, that appropriate
mitigation measures have been implemented, and that this
information is provided to FDA.
The Company does not intend to make further public comment on
the Committee's work during the pendency of the investigation. The
Committee cannot predict the duration or outcome of the
investigation.
About Ampio Pharmaceuticals, Inc.
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company
primarily focused on the advancement of immunology-based therapies
for the potential treatment of multiple inflammatory conditions
(e.g., osteoarthritis of the knee (OAK) and other joints).
Ampio's lead drug is Ampion™.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Any statements contained
in this press release that are not statements of historical fact
may be deemed to be forward-looking statements. Without limiting
the foregoing, words such as "may," "will," "expect," "believe,"
"anticipate," or "estimate" or comparable terminology are intended
to identify forward-looking statements. Forward-looking statements
are subject to various risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
in such statements.
Such forward-looking statements include, for example, statements
about: the expected scope of the internal investigation and the
initiatives that may be pursued as part of a consideration of
strategic alternatives. The risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied in these forward-looking statements include the risk
factors described in the Ampio's Annual Report on Form 10-K for the
year ended December 31, 2021, and
other factors set forth in Ampio's filings with the Securities and
Exchange Commission, as well as (a) our cash resources available to
continue our operations and implement one or more strategic
alternatives, including our ability to raise capital through an
equity or debt financing; (b) the expenses and costs we will incur
in connection with the internal investigation, any related
litigation and compliance with FDA and SEC requirements; and (c)
the actual and perceived effectiveness of Ampion, and how Ampion
compares to competitive products.
The forward-looking statements in this press release speak only
as of the date of this press release. Except as required by law,
Ampio assumes no obligation to update or revise these
forward-looking statements for any reason, except as required by
law.
Investor and Media Contacts:
Tony Russo or Nic
Johnson
Russo Partners
info@ampiopharma.com
tony.russo@russopartnersllc.com
nic.johnson@russopartnersllc.com
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SOURCE Ampio Pharmaceuticals, Inc.