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): December 2, 2013
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 Employee Identification No.) |
5445 DTC Parkway, Suite 925
Greenwood Village, Colorado 80111
(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 December 2, 2013, Ampio Pharmaceuticals, Inc. (“Ampio” or the “Company”) issued a press release announcing receipt of Food and Drug Administration correspondence confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion™ for the treatment of osteoarthritis of the knee, a copy of which press release is furnished as Exhibit 99.1 to this report.
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 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
The following exhibit is furnished with this report:
| 99.1 | Press Release dated December 2, 2013 |
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 Report on Form 10-K filed with the Securities and Exchange Commission on March 6, 2013, and its Form 10-Qs on file with the SEC.
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/ Mark D. McGregor | |
| Mark D. McGregor | ||
| Chief Financial Officer | ||
Dated: December 5, 2013
AMPIO PHARMACEUTICALS, INC.
FORM 8-K
Exhibit Index
| Exhibit No. |
Description |
Method of Filing | ||
| 99.1 | Press Release issued by Ampio Pharmaceuticals, Inc. on December 2, 2013 | Furnished | ||
Exhibit 99.1
Ampio Receives FDA Confirmation that The Spring Study is Pivotal and Will Initiate the Final Pivotal Trial for Ampion™ Biological License Application (BLA).
GREENWOOD VILLAGE, Colo., November 14, 2012 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced receipt of FDA correspondence confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion™ for the treatment of osteoarthritis of the knee (OAK).
Dr. Vaughan Clift, Ampio’s Chief Regulatory Officer, noted the letter summarized the FDA’s conclusions after reviewing the complete clinical data set provided by Ampio following their October 29th pre-BLA meeting. The FDA letter includes the following statements:
| • | “Upon review of the dataset received on November 5, 2013, FDA concludes that study AP-003-A can be considered as one of two “pivotal trials” required in support of a BLA.” |
| • | “This recommendation is based on the fact that study AP-003-A was adequate (n=329) and well controlled (normal saline), the trial conduct was acceptable and the study met its primary endpoint (change in WOMAC score at 12 weeks).” |
| • | “The strength of the evidence is robust” |
| • | “FDA recommends that Ampio conduct an adequately powered study to confirm the effect size of AP-003-A and design the study to obtain information on the duration of action and repeat dosing.” |
| • | “The study to evaluate safety and efficacy of repeat dosing may be conducted post market approval.” |
Dr. Clift continued, “Our interactions with the FDA have been helpful at every step of this process and we are very grateful for their guidance. The final pivotal trial will confirm the efficacy and safety of the 4 ml injection in approximately five hundred (500) patients with a follow-up of no less than twenty (20) weeks in order to better understand the duration of action. This trial is planned to begin in early January 2014 with an additional six (6) clinical sites added to the nine (9) sites utilized in the SPRING study. Submission of the BLA, the documents used for approval, could then occur in the 3rd quarter of 2014.”
Michael Macaluso, Chairman and CEO of Ampio commented “We are all very proud of the excellent work of our clinical team, led by Dr. David Bar-Or, our Chief Science Officer, and the inventor of Ampion™, and Dr. Clift, that culminated in this encouraging FDA guidance.”
“Most important, greater improvement in pain relief was reported in patients with the most severe disease (Grades III and IV), which means we are now closer to the day when we may be able to significantly reduce the suffering and improve the quality of life for the millions of patients so greatly afflicted.”
Mr. Macaluso concluded “In response to the BLA timeline estimated by Dr. Clift, the company is accelerating the building of a manufacturing facility in Colorado that will produce commercial amounts of Ampion™ to satisfy demand for this and future indications as we plan to initiate new studies with Ampion™ for the treatment of such diseases as COPD and Crohn’s disease.”
About Osteoarthritis
Osteoarthritis is the most common form of arthritis, affecting over 27 million people in the United States. It is a progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. The incidence of developing osteoarthritis of the knee or hip over a lifetime is approximately 46% and 25%, respectively. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. Osteoarthritis is caused by inflammation of the soft tissue and bony structures of the joint, which worsens over time and leads to progressive thinning of articular cartilage. Other symptoms include narrowing of the joint space, synovial membrane thickening, osteophyte formation and increased density of subchondral bone.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
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 Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. 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, under Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.
Contact: Rick Giles, Director of Investor Relations, Ampio Pharmaceuticals, Inc. Direct: (720) 437-6530, Email: rgiles@ampiopharma.com