Ampio Pharma (AMPE) Announces Independent Committee to Conduct Investigation

May 16, 2022 4:11 PM EDT

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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.

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