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): May 21, 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 May 21, 2015, Ampio Pharmaceuticals, Inc. (the “Company”) issued a press release announcing results of the OptimEyes trial of OptinaTM for the treatment of Diabetic Macular Edema. 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 May 21, 2015, the Company announced results of the OptimEyes trial of OptinaTM for the treatment of Diabetic Macular Edema. The OptimEyes trial was a multiple site, randomized, placebo controlled, parallel, double masked study to evaluate the safety and efficacy of two doses of oral OptinaTM (adjusted to body mass index) in adult patients with Diabetic Macular Edema. There were no drug related serious adverse events and no differences in side effect rates between placebo and the OptinaTM arms. The Company also identified a subgroup of patients based on body mass index in which treatment with the optimal OptinaTM dose resulted in significant improvements in both vision and retinal swelling.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit Number | Description | |
| 99.1 | Press Release dated May 21, 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: May 26, 2015
EXHIBIT INDEX
| Exhibit Number | Description | |
| 99.1 | Press Release dated May 21, 2015 | |