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 14, 2019
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)
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))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class: | | Trading Symbol | | Name of each exchange on which registered: |
| Common | | 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 or Rule 12b-2 of the Securities Exchange Act of 1934.
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 14, 2019, the Ampio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the Company received U.S. Food and Drug Administration (“FDA”) approval of the Company’s special protocol assessment (“SPA”) of a clinical protocol titled, “A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee.” The press release also indicates that FDA informed the Company that the design and planned analysis of the Company’s SPA adequately addresses the objectives necessary to support a regulatory submission, but final determinations for marketing application approval are made after a complete review of the marketing application and are based on the entire data in the application. A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
SIGNATURE
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 |
Dated: June 14, 2019
