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): July 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)

 

 

◻

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))

 

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.

 

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 4.01 Changes in Registrant's Certifying Accountant

 

Engagement of Moss Adams

 

The Audit Committee (the “Audit Committee”) of the Board of Directors of Ampio Pharmaceuticals, Inc. (the “Company”) conducted a comprehensive process to determine the Company’s independent registered public accounting firm for the Company’s fiscal year ending December 31, 2019. On July 10, 2019, the Audit Committee approved the engagement of Moss Adams LLP (“Moss Adams”) as the Company’s independent registered public accounting firm for the Company’s fiscal year ending December 31, 2019.

 

During the fiscal years ended December 31, 2018, and 2017, and the subsequent interim periods through July 10, 2019, neither the Company nor anyone on its behalf has consulted with Moss Adams regarding: (i) the application of accounting principles to a specific transaction, either completed or proposed, or the type of audit opinion that might be rendered on the Company’s financial statements, and neither a written report or oral advice was provided to the Company that Moss Adams concluded was an important factor considered by the Company in reaching a decision as to any accounting, auditing, or financial reporting issue, (ii) any matter that was the subject of a disagreement within the meaning of Item 304(a)(1)(iv) of Regulation S-K, or (iii) any reportable event within the meaning of Item 304(a)(1)(v) of Regulation S-K.

 

The press release announcing the engagement of Moss Adams as the Company’s independent registered public accounting firm is attached hereto as Exhibit 99.1.

 

Resignation of Plante Moran

 

In conjunction with the appointment of Moss Adams as described herein, on July 10, 2019, Plante & Moran PLLC (“Plante Moran”) notified the Company of its resignation as the Company’s independent registered public accounting firm effective July 10, 2019.

 

As previously reported, on October 1, 2018, EKS&H LLLP (“EKS&H”), the Company’s prior independent registered public accounting firm, resigned in connection with EKS&H’s combination with Plant Moran. Plante Moran had served as the Company’s  registered public accounting firm since this time.

 

The audit report of Plante Moran on the Company’s consolidated financial statements for the fiscal year ended December 31, 2018 did not contain an adverse opinion or disclaimer of opinion and was not qualified or modified as to uncertainty, audit scope or accounting principles except the audit report of Plante Moran on the Company’s financial statements for the year ended December 31, 2018 contained an explanatory paragraph indicating that there was substantial doubt about the ability of the Company to continue as a going concern.  EKS&H’s audit report on the Company’s financial statements for the year ended December 31, 2017 contained a similar explanatory paragraph regarding the ability of the Company to continue as a going concern.

 

During the Company’s two most recent fiscal years and through date hereof, there have been no disagreements within the meaning of Item 304(a)(1)(iv) of Regulation S-K with Plante Moran (or its predecessor EKS&H) on any matters of accounting principles or practices, financial statement disclosure or auditing scope and procedure which, if not resolved to the satisfaction of Plante Moran (or EKS&H), would have caused Plante Moran (or EKS&H) to make reference to the subject matter in connection with its reports, and there were no reportable events as defined in Item 304(a)(1)(v) of Regulation S-K.

 

The Company provided a copy of the foregoing disclosures to Plante Moran and requested that Plante Moran furnish it with a letter addressed to the Securities and Exchange Commission stating whether Plante Moran agrees with the above statements. A copy of Plante Moran’s letter, dated July 10, 2019 is filed as Exhibit 16.1 to this Form 8-K.

 

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: July 11, 2019

 

 

 

Exhibit 16.1

 

IMAGE1.JPEG

 

 

July 11, 2019

 

Richard Giles

Audit Committee Chair

Ampio Pharmaceuticals, Inc.

373 Inverness Parkway, Suite 200

Englewood, Colorado 80112

 

Dear Mr. Giles:

 

We have read item 4.01 to be included in the Form 8-K of Ampio Pharmaceuticals, Inc. to be filed with the Securities and Exchange Commission regarding its change in auditors. We are in agreement with the statements made regarding our firm. We have no basis to agree or disagree with other statements made under item 4.01.

 

 

Very truly yours,

IMAGE2.PNG

Plante & Moran, PLLC

Exhibit 99.2

PICTURE 6

 

Ampio Appoints Moss Adams LLP as the Company’s new Independent Auditor

ENGLEWOOD, Colo., July 11, 2019, /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a development stage biopharmaceutical company focused on the discovery and development of a  novel therapy aimed at treating common inflammatory conditions for which there are limited treatment options, today announced that its Audit Committee and Board of Directors appointed Moss Adams LLP as the Company’s new independent auditor.

Moss Adams has served for over 100 years  as a fully integrated professional services firm with over 3,200 professionals across more than 25 locations in the western United States. Their Life Sciences Practice provides a variety of audit, tax and consulting services to over 550 clients of all sizes, with nearly 100 clients in the pharmaceuticals sector.

Michael Macaluso, Ampio CEO, noted “As Ampio moves forward with our pivotal trial of Ampion in adults with pain due to severe osteoarthritis of the knee, in which we are already dosing patients, we sought an accounting firm highly experienced in working with clients with products at a similar stage of development.  Moss Adams perfectly fits this requirement and is well known for their top quality, independent audit services for companies of our size and development stage in the life sciences market. We look forward to working with the Moss Adams’s experienced professional services team.”

Moss Adams will replace Plante Moran, PLLC who, through their predecessor EKS&H LLLP, had served as the Company’s independent auditor since 2010. The decision to change auditors was not caused by any disagreement between the Company and Plante Moran on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedure.

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 Moss Adams LLP

Moss Adams is a fully integrated professional services firm dedicated to assisting clients with growing, managing, and protecting prosperity.  With over 3,200 professionals and staff across more than 25 locations in the West and beyond, Moss Adams works with many of the world’s most innovative companies and leaders. Their strength in the middle market enables them to advise clients at all intervals of development—from start-up, to rapid growth and expansion, to transition.

About Ampio Pharmaceuticals

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.

 

PICTURE 5

 

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 the use of words such as "believe," "expect," "plan," "anticipate," 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 decisions,  the Biological License Application (BLA) , the ability of Ampio to enter into partnering arrangements, 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 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