Ampio Pharmaceuticals’
Chairman of the Board Kevin Buchi and CEO Mike Martino Issues
Letter to Stockholders
ENGLEWOOD, Colo., August 3, 2022 — Ampio Pharmaceuticals, Inc.
(NYSE American: AMPE), today released the following letter to
stockholders from its Chairman, Kevin Buchi and Chief Executive
Officer, Mike Martino.
Dear Fellow Stockholders,
On
behalf of the Board and management team, we are writing to provide
an update on the previously announced internal investigations, the
clinical development of Ampion and how this impacts our strategic
alternatives process, and near-term strategic business
alternatives. Finally, we would like to take this opportunity to
address the importance of your vote at the 2022 Annual Meeting of
Stockholders to be held on Wednesday, August 10, 2022, at 11 am
MT.
As we announced on May 16, 2022, an independent special committee
of the Ampio Board of Directors (the “Special Committee”) has been
conducting internal investigations focused primarily on (1) the statistical
analysis of Ampio’s AP-013 clinical trial and (2) unauthorized provision of
Ampion, an investigational drug that is not approved by the Food
and Drug Administration (“FDA”), for use by individuals not
participating in clinical trials (“unauthorized use”). These
investigations are now completed and the investigations are
summarized below.
Through outside counsel, the Special Committee has engaged in
extensive fact finding, including interviewing numerous individuals
and reviewing documents and emails relating to the AP-013 clinical
trial. In connection with the unauthorized use investigation, the
Special Committee also reviewed documents, conducted interviews,
and reviewed other information regarding the provision and
unauthorized use of Ampion. The Special Committee committed
significant resources to these endeavors and did not impose
material limitations on the investigations’ scope, timing, or
access to information.
As it relates to the AP-013
clinical trial, the Special Committee’s primary findings include
that certain of Ampio’s former executive officers and senior staff
were aware, at the time of the per-protocol interim analysis in
March 2020, that the AP-013 trial did not demonstrate efficacy for
Ampion on its co-primary endpoints of pain and function; and that
these persons did not fully report the results of the AP-013 trial
and the timing of unblinding of data from the AP-013 trial. The
Special Committee has determined that the Company’s current
executive officers were not made aware of the unblinding events in
March 2020. Through counsel, the Company and the Special Committee
have informed the Securities and Exchange Commission of the
investigations. The Company and the Special Committee also have
contacted the FDA regarding this investigation.
As it relates to the unauthorized use of Ampion, the Special
Committee’s primary finding is that certain Ampio personnel,
including a former executive officer and certain former directors,
facilitated the provision of Ampion for unauthorized use. Ampio has worked to
resolve this issue, including through the conduct of safety
surveillance activities relating to the provision of Ampion for
unauthorized use, implementation of appropriate mitigation measures
(described below), and self-reporting to FDA. The results of the
safety surveillance activities have not changed the Company’s view
of the safety profile of Ampion. The Special Committee has
determined that the