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