Ampio Pharmaceuticals, Inc. (AMPE) SEC Filing 10-Q Quarterly report for the period ending Monday, September 30, 2019

Ampio Pharmaceuticals, Inc.

CIK: 1819175 Ticker: AMPE

Exhibit 99.1

Picture 1

Ampio Pharmaceuticals Provides Regulatory Update

ENGLEWOOD, Colo., April 29, 2019, /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that it has received comments from the U.S. Food and Drug Administration (FDA) regarding their Special Protocol Assessment (SPA). The FDA recommended the Company not start their confirmatory trial without obtaining FDA concurrence on the trial design. The Company agreed with the comments they received from the FDA and immediately sent a revised SPA to the FDA for review.

“While we will not officially start the trial until the SPA is approved,” said CEO Michael Macaluso, “extensive preparatory work is already underway. We hope to start the trial in May.”

About Osteoarthritis
Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.

About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company focused on the development of Ampion to treat prevalent inflammatory conditions for which there are limited treatment options.

Forward-Looking Statements
Ampio’s statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA decisions such as the SPA, whether the FDA will approve the same and the timing thereof, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements for any of its products, including Ampion and Optina, clinical trials and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact
Phone: (720) 437-6500

The following information was filed by Ampio Pharmaceuticals, Inc. (AMPE) on Tuesday, April 30, 2019 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
Balance Sheets
Balance Sheets (Parenthetical)
Statements Of Cash Flows
Statements Of Operations
Statements Of Stockholders' Equity (Deficit)
Statements Of Stockholders' Equity (Deficit) (Parenthetical)
Accounts Payable And Accrued Expenses
Accounts Payable And Accrued Expenses (Details)
Accounts Payable And Accrued Expenses (Tables)
Basis Of Presentation
Basis Of Presentation (Policies)
Basis Of Presentation - Additional Information (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Employment Agreements (Detail)
Commitments And Contingencies - Rent Expense (Detail)
Commitments And Contingencies - Summary Of Commitments And Contingencies (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 (Common Stock Issued For Services) (Details)
Common Stock (Controlled Equity Offering) (Details)
Common Stock (Public Offering Narrative) (Details)
Common Stock (Shelf Registration Narrative) (Details)
Common Stock (Summary Of Company???S Sales Under The Equity Distribution Agreement) (Details)
Common Stock (Tables)
Earnings Per Share
Earnings Per Share (Details)
Earnings Per Share (Tables)
Earnings Per Share - Narrative (Details)
Equity (Tables)
Equity - Activity Of Plan (Details)
Equity - Assumptions Used In Computing Fair Value Of All Options Granted (Detail)
Equity - Options, Additional Information (Detail)
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
Fair Value Considerations (Tables)
Fair Value Considerations - Financial Assets And Liabilities (Detail)
Fair Value Considerations - Sets Forth A Reconciliation Of Changes (Detail)
Fixed Assets
Fixed Assets (Detail)
Fixed Assets (Tables)
Fixed Assets - Depreciation And Amortization Expense (Detail)
Going Concern
Going Concern - Additional Information (Detail)
Prepaid Expense And Other
Prepaid Expense And Other (Details)
Prepaid Expense And Other (Tables)
Subsequent Events
Subsequent Events - (Details)
Warrants (Tables)
Warrants - (Detail)
Warrants - Assumptions For Warrants Issued (Detail)
Warrants - Warrants Issued In Conjunction With Its Senior Convertible Debentures (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: 0001558370-19-010403
Submitted to the SEC: Thu Nov 07 2019 11:32:23 AM EST
Accepted by the SEC: Thu Nov 07 2019
Period: Monday, September 30, 2019
Industry: Pharmaceutical Preparations

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