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): November 5, 2020

AMPIO PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)


Delaware	001-35182	26-0179592
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

373 Inverness Parkway, Suite 200

Englewood, Colorado 80112

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (720) 437-6500

Not Applicable

(Former name or former address, if changed since last report)

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:


☐	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))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock	AMPE	NYSE American

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 2.02 Results of Operations and Financial Condition.

On November 5, 2020, Ampio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing operating and financial highlights for the quarter ended September 30, 2020. The Company will also host a business and financial update webinar on Thursday, November 5, 2020 at 4:30 pm EST. A copy of the Company’s press release is furnished as Exhibit 99.1 on this Current Report on Form 8-K.

The information in this Form 8-K is furnished under “Item 2.02 Results of Operations and Financial Condition” and Exhibit 99.1, attached hereto, and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may be incorporated by reference in a filing under the Exchange Act or the Securities Act of 1933, as amended, only if such subsequent filing specifically references such disclosure in this Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

99.1	Press release, dated November 5, 2020.
104	The cover page from this Current Report on Form 8-K, formatted in Inline XBRL.

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.

Date: November 5, 2020	By:	/s/ Daniel G. Stokely
	Name:	Daniel G. Stokely
	Title:	Chief Financial Officer and Secretary

Exhibit 99.1

Ampio Pharmaceuticals, Inc. Provides Business Update and Reports Third Quarter 2020 Financial Results

ENGLEWOOD, CO, November 5, 2020 – Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, today, at 4:30pm EST, will provide an update and overview of its clinical development pipeline / activities and its financial results for the third quarter ended September 30, 2020.

Attending the webinar from Ampio will be, Mr. Michael Macaluso (President and CEO), Dr. David Bar-Or (Director and Founder), Ms. Laura Goldberg (Vice President) and Mr. Daniel Stokely (CFO). The key areas of focus will be as follows:

COVID-19 Platform / Pipeline Overview and Update

AP-014 (inhaled) and AP-016 (intravenous) clinical trial update

Possibility of obtaining an Emergency Use Authorization (EUA) from the FDA for inhaled Ampion

Discussion of the differences between Ampion vs. other therapeutic options for COVID-19

OAK Clinical Trial 2020 Timeline / Update

Ampio’s Osteoarthritis of the Knee (OAK) Phase III trial being conducted under a Special Protocol Assessment (SPA) with the FDA has been paused as a result of COVID-19

FDA released “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” in April 2020

FDA released “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency” in June 2020

Ampio harmonizes steps for OAK Phase III trial with the FDA guidance and submitted an SPA amendment to the FDA

Page 1 of 3

Financial Update

As of September 30, 2020, Ampio had $9.4 million of cash and cash equivalents, as compared to cash and cash equivalents of $6.5 million as of December 31, 2019.

For the third quarter of 2020, research and development costs were $1.7 million, down 52% from $3.4 million for the same period in 2019. This decrease was primarily attributable to a decrease in clinical trial and sponsored research costs. Ampio expects clinical trial and sponsored research costs to increase during the fourth quarter of fiscal 2020 due to the AP-014 inhaled Ampion study.

Operations / manufacturing expenses increased $190,000 in the current quarter, when compared to the same period in 2019.

General and administrative costs decreased $98,000, or 5.6%, from $1.7 million for the same period in 2019.

Ampio reported a net loss for the third quarter of $3.4 million compared to a net loss of $7.2 million for the same period in 2019.

To access the webinar, please log in to https://www.webcaster4.com/Webcast/Page/2569/38512 approximately 10 minutes prior to the start of the call. To ask a question, please dial in to 888-632-3385 (U.S.) or 785-424-1673 (International) and use the Participant Entry Code: 47668. Please note that you can also ask a question through the webinar platform.

A replay of this presentation will be available two hours after the end of the call by dialing 877-481-4010 (U.S.) or 919-882-2331 (International). Replay Passcode: 38512

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 United States Private Securities Litigation Reform Act of 1995, as amended to date. Forward-looking statements can be identified by the use of words such as “believe,”

Page 2 of 3

“expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to the safety and efficacy of Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biologics License Application (BLA), the ability of Ampio to enter into partnering or licensing arrangements, current or future clinical trials, changes in business conditions and similar events (including currently unforeseen risks associated with COVID-19), the possibility that Ampion may be used to treat ARDS induced by COVID-19, Ampio’s ability to continue as a going concern and its ability to continue to raise funds using its “at-the-market” equity offering or otherwise, 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, in Ampio’s Annual Report on Form 10-K for the period ended December 31, 2019, and in subsequent reports on Forms 10-Q and 8-K and other filings made by Ampio with the Securities and Exchange Commission. Accordingly, you should not place undue reliance on these forward-looking statements. 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

Investor Relations

Joe Hassett

joeh@gregoryfca.com

484-686-6600

Page 3 of 3

Document and Entity Information	Nov. 05, 2020
Document and Entity Information [Abstract]
Document Type	8-K
Document Period End Date	Nov. 05, 2020
Entity File Number	001-35182
Entity Registrant Name	AMPIO PHARMACEUTICALS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-0179592
Entity Address, Address Line One	373 Inverness Parkway, Suite 200
Entity Address, City or Town	Englewood
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80112
City Area Code	720
Local Phone Number	437-6500
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	AMPE
Security Exchange Name	NYSE
Entity Emerging Growth Company	false
Entity Central Index Key	0001411906
Amendment Flag	false