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Ampio Pharmaceuticals, Inc. (AMPE) SEC Filing 10-Q Quarterly Report for the period ending Thursday, June 30, 2022

Ampio Pharmaceuticals, Inc.

CIK: 1411906 Ticker: AMPE

Exhibit 99.1

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Description automatically generated

Ampio Independent Committee to Conduct Investigation

Englewood, CO – May 16, 2022

– 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


The following information was filed by Ampio Pharmaceuticals, Inc. (AMPE) on Monday, May 16, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Ampio Pharmaceuticals, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Balance Sheets
Condensed Balance Sheets (Parenthetical)
Condensed Statements Of Cash Flows
Condensed Statements Of Operations
Condensed Statements Of Stockholders' Equity
Accounts Payable And Accrued Expenses
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Accounts Payable And Accrued Expenses (Tables)
Accounts Payable And Accrued Expenses - Commercial Insurance Premium Financing Agreement (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Employment Agreements (Detail)
Commitments And Contingencies - Lease Expense (Detail)
Commitments And Contingencies - Summary Of Reconciliation Of Company's Undiscounted Payments For Facility Lease And Carrying Amount Of Lease Liability (Detail)
Common Stock
Common Stock (Tables)
Common Stock - Common Stock Issued For Services (Detail)
Common Stock - Sales Agreement (Detail)
Common Stock - Summarizes The Company's Remaining Authorized Shares Available (Detail)
Earnings Per Share
Earnings Per Share (Detail)
Earnings Per Share (Tables)
Earnings Per Share - Anti-Dilutive (Detail)
Equity
Equity (Tables)
Equity - Activity Of Plan (Detail)
Equity - Assumptions Used In Computing Fair Value Of All Options Granted (Detail)
Equity - Restricted Stock Awards (Details)
Equity - Stock Option Activity (Detail)
Equity - Summary Of Stock Options Outstanding And Exercisable (Detail)
Equity - Summary Of Stock-Based Compensation Expense (Detail)
Fair Value Considerations
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Fair Value Considerations - Financial Assets And Liabilities (Detail)
Fair Value Considerations - Sets Forth A Reconciliation Of Changes (Detail)
Fixed Assets
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Fixed Assets (Tables)
Fixed Assets - Depreciation Expenses (Detail)
Prepaid Expenses And Other
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The Company And Summary Of Significant Accounting Policies
The Company And Summary Of Significant Accounting Policies (Policies)
The Company And Summary Of Significant Accounting Policies - Liquidity And Going Concern (Detail)
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Warrants - Narrative (Detail)
Warrants - Warrants Activity (Detail)
Warrants - Warrants Activity Classified As Equity And Liability (Detail)

Material Contracts, Statements, Certifications & more

Ampio Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits

Ticker: AMPE
CIK: 1411906
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-22-012937
Submitted to the SEC: Tue Aug 09 2022 5:26:07 PM EST
Accepted by the SEC: Tue Aug 09 2022
Period: Thursday, June 30, 2022
Industry: Pharmaceutical Preparations

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