UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported): June 19, 2020

AMPIO PHARMACEUTICALS, INC.

(Exact name of registrant as specified in Charter)

Delaware

001-35182

26-0179592

(State or other jurisdiction of

incorporation or organization)

(Commission

File No.)

(IRS Employer

Identification No.)

373 Inverness Parkway, Suite 200

Englewood, Colorado 80112

(Address of principal executive offices, including zip code)

(720) 437-6500

(Registrant’s telephone number, including area code)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common	AMPE	NYSE American

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

◻Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

◻Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

◻Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

◻Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Item 8.01 Other Events.

On June 19, 2020, Ampio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration completed its review of the Company’s Investigative New Drug application for intravenous Ampion treatment for COVID-19 affected patients and has cleared the Company to proceed with human trials.

A copy of the press release is provided as Exhibit 99.1 to this Current Report.

Item 9.01 Financial Statements and Exhibits.


Exhibit Number		Description

99.1		Press Release dated June 19, 2020

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	AMPIO PHARMACEUTICALS, INC.

	By:	/s/ Michael Macaluso
		Michael Macaluso
		Chief Executive Officer

June 19, 2020

Exhibit 99.1

Ampio to Start First Clinical Trial in COVID-19 Program

ENGLEWOOD, Colo., June 19, 2020, /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) (the “Company”), is a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions. As part of this program, the Company is developing therapies for patients infected with the SARS-CoV-2 virus (“COVID-19”).

The U.S. Food and Drug Administration (“FDA”) completed its review of the Company’s Investigative New Drug (“IND”) application for intravenous (“IV”) Ampion^TM treatment for COVID-19 affected patients and has cleared the company to proceed with human trials.

The Company will begin a Phase 1 clinical trial to evaluate IV Ampion as a treatment for COVID-19 patients on supplemental oxygen. The need for supplemental oxygen in COVID-19 patients is indicative of an inflammatory process in the lungs. As an immunomodulatory anti-inflammatory agent, Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome of patients.

Years of extensive in-vitro studies on cell cultures have confirmed that the mechanism of action (“MOA”) of Ampion may be suitable for the treatment of inflammatory conditions, such as acute respiratory distress syndrome (“ARDS”) and the cytokine storm, associated with COVID-19. Many of these research related findings have been published in peer reviewed, scientific journals, which can be found on our website.

About Ampio Pharmaceuticals

Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio’s lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (“BPCIA”).

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,” “may,” “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, the Biological License Application (“BLA”), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, the timing and outcome of clinical trials, and that Ampion may be used to treat ARDS induced by COVID-19, 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