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): October 10, 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) |
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◻ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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◻ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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◻ | 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 October 10, 2019, Ampio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing an update on the AP-013 Phase III clinical trial and the Ampion manufacturing facility. The AP-013 Phase III clinical trial is now enrolling patients at 23 of the 25 clinical sites authorized by the FDA and, as of October 8, 2019, 510 of the 1,034 patients to be enrolled had been injected and an additional 63 are currently in the screening. All required FDA CMC manufacturing pilot lots have been completed and documented and approximately 200,000 Ampion vials have been filled without contamination. Additionally, independent audit results of the manufacturing facility reflected no serious negative findings and concluded that the facility was ready for an FDA audit. A copy of the press release is provided as Exhibit 99.1 to this Current Report.
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: October 10, 2019
