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): April 20, 2015
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)) |
Item 7.01 Regulation FD Disclosure
On April 20, 2015, Ampio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the results of the multiple injection STRIDE study of AmpionTM in patients with osteoarthritis of the knee. A copy of the press release is furnished hereto as Exhibit 99.1.
The information contained in this Item 7.01 and Exhibit 99.1 to this report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filings made by Ampio under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as may be expressly set forth by specific reference in such filing.
Item 8.01 Other Events
On April 20, 2015, the Company announced that the multiple injection STRIDE study AP008 of AmpionTM in patients with osteoarthritis of the knee did not reach its primary endpoint against the saline control even though there was a statistically significant reduction in pain compared to baseline for patients receiving AmpionTM. This pain reduction with AmpionTM was consistent across all sites and with the Company’s previously reported SPRING and STRUT studies. The Company launched the Phase III program for AmpionTM to treat pain due to osteoarthritis of the knee. Each patient received three 4ml intra-articular injections of AmpionTM or the saline placebo, one at baseline, the second at two weeks and the third at four weeks. In the STRIDE study the saline control arm varied out of a normal range, when compared to previous AmpionTM studies and from the published results for other osteoarthritis drugs. The Company is analyzing the demographic differences between the patient populations in the STRIDE study compared to the SPRING and STRUT studies and expects to meet with the FDA to discuss the Company’s full clinical findings as soon as practical.
Item 9.01 Financial Statements and Exhibits.
| Exhibit Number | Description | |
| 99.1 | Press Release dated April 20, 2015 | |
This Current Report on Form 8-K and Exhibit 99.1 contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements typically are identified by use of terms such as “may,” “project,” “should,” “plan,” “expect,” “anticipate” “believe,” “estimate” and similar words, although some forward-looking statements are expressed differently. Forward-looking statements represent our management’s judgment regarding future events. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company can give no assurance that such expectations will prove to be correct. All statements other than statements of historical fact included in this Current Report on Form 8-K and in Exhibit 99.1 are forward-looking statements. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The Company cannot guarantee the accuracy of the forward-looking statements, and you should be aware that the Company’s actual results could differ materially from those contained in forward-looking statements due to a number of factors, including the statements under “Risk Factors” found in the Company’s Annual Reports on Form 10-K’s and its Quarterly Reports on Form 10-Q’s on file with the Securities and Exchange Commission.
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/ Gregory A. Gould | |
| Gregory A. Gould | ||
| Chief Financial Officer | ||
Dated: April 21, 2015
EXHIBIT INDEX
| Exhibit Number | Description | |
| 99.1 | Press Release dated April 20, 2015 | |