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.

 

Exhibit Number Description
   
99.1 Ampio Pharmaceuticals, Inc., press release, dated June 14, 2019

 

 

 

 

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

 

 

 

 

Exhibit 99.1

 

 

 

Ampio Regulatory and Clinical Update

 

ENGLEWOOD, Colo., June 14, 2019, /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced today that it received FDA approval of the Co mpany’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 FDA response noted “We have completed our review, and based on the information submitted, agree that the design and planned analysis of your study adequately address the objectives necessary to support a regulatory submission.”

 

The FDA continued, “ However, final determinations for marketing application approval are made after a complete review of the marking application and are based on the entire data in the application .”

 

According to Michael Macaluso, Ampio CEO, “The Company has identified and engaged 15 clinical sites for the trial (AP-013) and patient identification is underway. This pivotal trial seeks to enroll approximately 1,000 patients, with an interim look, to allow sample size adjustments, if required. This trial will assess co-primary endpoints of pain and function. More details of the study will be made available on clinicaltrials.gov.”

 

About Special Protocol Assessment (SPA)

A SPA is a process in which sponsors may ask to meet with the FDA to reach agreement on the design and size of certain clinical trials to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval. A SPA agreement would indicate concurrence by the FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study intended to support a future Biologic License Application (BLA). The elements of the study agreed upon in the SPA agreement are critical to ensuring that the trial conducted under the protocol can be considered an adequate and well-controlled study that can support marketing licensure of Ampion. However, a SPA agreement will not indicate FDA concurrence on every protocol detail, and the FDA may still require us to conduct additional clinical trials in the future to support a BLA for Ampion.

 

About Osteoarthritis
Osteoarthritis (OA) is an incurable and progressive disorder of the joints involving degradation of the intra-articular cartilage, joint lining, ligaments, and bone. Certain risk factors in conjunction with natural wear and tear lead to the breakdown of cartilage. OA 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, Inc.
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of Ampion, our product candidate, to treat prevalent inflammatory conditions for which there are limited treatment options.

 

 

 

 

 

 

Forward-Looking Statements
Ampio Pharmaceutical’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 the use of words such as “believe,” “expect,” “plan,” “predict,” “anticipate,” “will,” and similar expressions. These forward-looking statements include statements regarding Ampio’s expectations with respect to Ampion™ and its classification, as well as those associated with regulatory approvals and other FDA responses and decisions including the timing thereof, the SPA, the BLA, the ability of Ampio to enter into partnering arrangements, to initiate, conduct and report the results of clinical trials, and decisions and changes in business conditions and similar events, all of which are inherently subject to various risks and uncertainties. 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, quarterly reports of Form 10-Q, periodic reports on Form 8-K, and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events, or otherwise.

 

Company Contact

Phone: (720) 437-6500
info@ampiopharma.com