Ampio Pharmaceuticals, Inc.

Investigation
08/03/2022

Initial Lawsuit
08/17/2022

Lawsuit Progression
10/17/2022

Investigation

Continous Holding
December 29, 2020 to August 3, 2022
Proposed Claim
Securities Violation

Did Ampio Pharmaceuticals, Inc. (AMPE) mislead investors regarding the known inefficacy of Ampio AP-013 trial on its co-primary endpoints of pain and function? Were executives facilitating the provision of Ampion for unauthorized use?

This post is open for investors to gather facts, and findings and track their exposure to related lawsuits. We invite investors and shareholders to contribute to this investigation for their own benefit, add events to the factual timeline below and vote on events’ pertinence.

A lawsuit was subsequently filed. We update this post regularly.

Main Event

Unauto

08/03/2022

Company Statement

Ampio discloses the findings of its internal investigation:

“. . . certain former Ampio 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 former Ampio executive officers and senior staff did not fully report the results of the AP-013 trial and the timing of unblinding of data from the AP-013 trial. . . .

. . . certain Ampio personnel, including a former executive officer and certain former directors, facilitated the provision of Ampion for unauthorized use.”

The company also announced the termination of two executive offices, a restructuring of the board, separation of the role of chairman and CEO, additional disclosure committees & company policies, and that it contacted the FDA about its findings.

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close	Previous close	Price variation	Percentage variation
$0.1	$0.16	$-0.06	-37.5%

See more on Factual Timeline

Initial Lawsuit

First Complaint - 08/17/2022

An Ampio Pharmaceuticals, Inc. (AMPE) investor filed a securities class action lawsuit on behalf of all persons or entities that purchased or otherwise acquired Ampio common stock between December 29, 2020, and August 3, 2022, inclusive.

Filing Date
08/17/2022
Class Period
12/29/2020 to 08/03/2022
Transgression
Securities Violation
Filing Firms
Robbins LLP
Case Title
Kain v. Ampio Pharmaceuticals, Inc. et al
Docket Number
1:22-cv-02105
Court
Colorado District Court
Free File
Complaint

Allegations

According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors that:

(i) inflated the company’s true ability to successfully file a BLA for Ampion;
(ii) inflated the results of the AP-013 study and the timing of unblinding the data from the AP-013 study; and
(iii) that, as a result, of the foregoing, the defendants’ statements about the company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Excerpt

“Through various filings with the SEC, Ampio claims to have developed Ampion®, its lead product with “unique immunomodulatory action and anti-inflammatory effects” used to treat individuals with inflammatory conditions including, but not limited to, severe osteoarthritis of the knee (“OAK”). The Company further asserts that “Ampion is currently in development as an intra-articular injection treatment for severe OAK, an intravenous and inhaled treatment for hospitalized severe and/or critical COVID-19 patients, and an at-home inhalation treatment for patients with prolonged respiratory symptoms due to COVID-19, commonly referred to as “LongCOVID.”

Beginning in 2010 and lasting through approximately March 2022, Ampio conducted numerous clinical trials and analyses to determine Ampion’s efficacy. Despite confidently advertising on numerous occasions that Ampion demonstrated a statistically significant decrease in pain associated in symptomatic moderate-severe OAK, the Company failed to bring Ampion to market.

After months of delay and analyst speculation of the effectiveness of Ampion, on May 16, 2022, the Company announced that it had formed a special committee of the Ampio Board of Directors (the “Board”) was conducting internal investigations focusing specifically on the statistical analysis of Ampio’s AP-013 clinical trial and unauthorized provision of Ampion which had not yet been approved by the U.S. Food and Drug Administration (“FDA”).

Then, in premarket hours on August 3, 2022, Ampio issued a press release containing a letter to stockholders revealing that the Individual Defendants (as defined herein) “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.” On this news, the Company’s share price dropped $0.06, or 35.38%, from the previous day’s close, on greater than usual trading volume.”