FORM 8-K

0001193125-13-251851.txt : 20130607 0001193125-13-251851.hdr.sgml : 20130607 20130607170112 ACCESSION NUMBER: 0001193125-13-251851 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20130603 ITEM INFORMATION: Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130607 DATE AS OF CHANGE: 20130607 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Ampio Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001411906 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 260179592 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35182 FILM NUMBER: 13901318 BUSINESS ADDRESS: STREET 1: 5445 DTC PARKWAY STREET 2: SUITE 925 CITY: GREENWOOD VILLAGE STATE: CO ZIP: 80111 BUSINESS PHONE: 720-437-6500 MAIL ADDRESS: STREET 1: 5445 DTC PARKWAY STREET 2: SUITE 925 CITY: GREENWOOD VILLAGE STATE: CO ZIP: 80111 FORMER COMPANY: FORMER CONFORMED NAME: Chay Enterprises, Inc. DATE OF NAME CHANGE: 20070910 8-K 1 d550330d8k.htm FORM 8-K FORM 8-K

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 3, 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 3.01

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

(d) On June 6, 2013, Ampio Pharmaceuticals, Inc. (the “Company”) provided notice to the NASDAQ Capital Market (“NASDAQ”) that the Company intends to voluntarily transfer the listing of its common stock, par value $0.0001 per share (the “Common Stock”) from NASDAQ to the New York Stock Exchange (“NYSE”). The Common Stock has been approved for listing on the NYSE, and the Company expects that the Common Stock will begin trading on the NYSE on June 17, 2013. The Common Stock will continue to trade under the ticker symbol “AMPE.” Until the transfer of the listing to the NYSE is completed, the Common Stock will continue to be traded on NASDAQ.

Item 7.01

Regulation FD Disclosure.

On June 3, 2013, the Company issued a press release providing a progress report on the Company’s clinical programs, a copy of which press release is furnished as Exhibit 99.1 to this report.

On June 6, 2013, the Company issued a press release announcing that it plans to transfer the listing of its Common Stock from NASDAQ to the NYSE as detailed in Item 3.01 above. A copy of the press release is furnished as Exhibit 99.2 to this report.

The information contained in this Item 7.01 and Exhibits 99.1 and 99.2 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 the Company 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 exhibits are furnished with this report:

99.1	Press Release dated June 3, 2013

99.2	Press Release dated June 6, 2013

This Current Report on Form 8-K and Exhibits 99.1 and 99.2 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 Exhibits 99.1 and 99.2 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: June 7, 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 June 3, 2013	Furnished

99.2	Press Release issued by Ampio Pharmaceuticals, Inc. on June 6, 2013	Furnished

EX-99.1 2 d550330dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

Ampio Pharmaceuticals Provides Clinical Updates

GREENWOOD VILLAGE, Colo., June 3, 2013 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (AMPE), today announced an update on its clinical progress for Ampion™, Optina™, the sexual dysfunction portfolio, and Luoxis Diagnostics, Inc.

Ampion

In the SPRING trial, Ampion is being evaluated for its effect on reducing pain in osteoarthritis of the knee, measured by the WOMAC scale, as a single intra-articular injection into the knee in 4 milliliter (mL) and 10 milliliter (mL) volumes as compared to placebo at twelve weeks. The study treated in excess of the targeted 320 patient goal in less than four weeks. This was designed as a run-in to a Phase III pivotal trial, which Ampio will initiate once the optimal volume is determined and the proposed pivotal trial is properly powered to achieve its scientific objectives. By June 7^th, all patients in the SPRING trial will have received the three follow-up phone calls and the six (6) week exam that followed the baseline exam at time of dosing. Clinical results from the completed trial, which includes additional follow-up calls and a final exam, will be made available in the third quarter of 2013. These results will be the basis for corporate strategy and business negotiations going forward.

Optina

Optina (danazol) is being tested in a 505(b)(2) trial to treat diabetic macular edema (DME). This may become the pivotal trial as a portion of 505(b)(2) drugs receive FDA registration based on a single clinical trial.

The randomized, placebo-controlled, double-masked, multicenter United States trial is expected to enroll approximately 450 patients. The primary endpoint is improvement in best-corrected visual acuity (BCVA) compared to placebo. Secondary endpoints are 1) categorical changes in visual acuity (VA) in treated patients compared to placebo; 2) reduction in central macular thickness (CMT) in treated patients compared to placebo; and, 3) safety and tolerability of the two Optina™ doses. Interim four week masked data of approximately 360 patients will be announced in the fourth quarter of 2013. Full twelve week top-line preliminary data will be announced in the first quarter of 2014.

Sexual Dysfunction Portfolio

Ampio is in late-stage negotiations to license Zertane, for treatment of premature ejaculation, and Zertane-ED, for treatment of concomitant premature ejaculation and erectile dysfunction.

Ampio has also submitted the application to the Therapeutic Goods Administration (TGA) for approval of Zertane in Australia. The Company expects to receive marketing authorization (approval) in the first half of 2014. An approval in Australia will open up numerous markets worldwide including South Korea and Brazil where Ampio has licensing agreements. This could also be important for additional business negotiations and revenue for Ampio.

Luoxis Diagnostics, Inc.

Luoxis Diagnostics recently completed a private placement financing to initially fund the carve-out of Ampio Pharmaceuticals. Under terms of the private placement, which raised $4.7 million in gross proceeds, Ampio will retain approximately 80% ownership of the newly formed in-vitro diagnostics company focused on the commercialization of the Oxidation Reduction Potential (“ORP”) technology platform. Luoxis, under a newly appointed management team, is now fully funded to pursue FDA and CE Mark clearance for its proprietary point-of-care diagnostic system. In support of these regulatory submissions, and subsequent commercialization of the ORP product, will be data demonstrating the diagnostic capability of the product to detect serious medical conditions within more than 5,000 patients. This data will be available in 3^rd quarter 2013.

About Ampion^TM

Ampion is a non-steroidal anti-inflammatory biologic that has the potential to be used in a broad array of inflammatory conditions and autoimmune diseases. The active ingredient is aspartyl-alanyl diketopiperazine, referred to as DA-DKP, which is derived from two amino acids from human albumin and appears to have a significant role in the homeostasis of inflammation. Ampion is protected by composition of matter, use, and synthetic form patents. Ampio has published a number of studies and articles on the anti-inflammatory activity of DA-DKP.

About Optina^TM

Optina is a drug based on a low dose of the weak androgen, low-molecular-weight, very lipophilic steroid danazol. Oral administration of low dose danazol to patients with DME is safe with no evidence of serious adverse events. Ampio’s in vitro data suggest that danazol has a biphasic effect on endothelial cells: At low doses, danazol decreases vascular leakage, while at higher concentrations an increase in vascular permeability is observed. This biphasic effect was supported by the efficacy of danazol in vivo at various BMIs. From Ampio’s previously announced results, Optina appears to reduce DME in a BMI dosage-adjusted manner and appears to trend toward improved visual acuity and seems to be safe with few, if any, side effects.^{1, 2}

About The Sexual Dysfunction Portfolio

Zertane is a repurposed, on-demand, orally dissolving tablet to treat premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners. The active ingredient, tramadol, has multiple mechanisms of actions that can delay ejaculation. This drug also has an excellent safety record established during 30 years of human use for other medical indications. Zertane-ED, a patented combination of Zertane and any PDE-5 inhibitor, can be used to treat premature ejaculation and erectile dysfunction. It is estimated that 41% of men with erectile dysfunction are comorbid for premature ejaculation.

About Luoxis Diagnostics, Inc.

Luoxis Diagnostics is an in-vitro diagnostics company focused on the development and global commercialization of a “point of care” hand held device and disposable strips that measures, from a single drop of blood, the presence of oxidative stress and anti-oxidant reserves in a patient. ORP is an important measure in the detection of both critical and chronic illnesses, and is a novel marker of patient morbidity across a wide range of diseases and conditions. There are numerous clinical indications for this homeostatic parameter for which there is no currently available test.

About Ampio Pharmaceuticals

Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company focused on the rapid development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibition of specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level or (ii) activation of a specific phosphatase or depletion of the available phosphate needed for the inflammation process.

Forward Looking Statement

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 Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

References

1. Bar-Or D, Thomas GW, Salottolo K, et al. Oral Danazol for DME. Retina Today. 2012; Vol. 7, No. 7: 68-70. Available at: http://bmctoday.net/retinatoday/2012/10/article.asp?f=oral-danazol-for-dme

2. Thomas GW, Rael LT, Bar-Or R, et al. Biphasic effect of danazol on human vascular endothelial cell permeability and f-actin cytoskeleton dynamics. Biochem Biophys Res Commun. 2012;421:707-712. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22542943

Investor Contact:

Rick Giles

Director of Investor Relations

Ampio Pharmaceuticals, Inc.

Direct: (720) 437-6530

Email: rgiles@ampiopharma.com

EX-99.2 3 d550330dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

Ampio Pharmaceuticals to List on the NYSE MKT

GREENWOOD VILLAGE, Colo., June 6, 2013 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) announced today that it has received authorization from the NYSE Euronext (NYSE MKT) to transfer the listing from the NASDAQ Capital Market (NASDAQ).

The Company expects its common stock to begin trading on the NYSE MKT on Monday, June 17, under its current ticker symbol, AMPE, and it will celebrate the transfer of its listing by ringing the opening bell at the New York Stock Exchange that morning. The company expects to continue to trade on NASDAQ until the transfer is complete.

Michael Macaluso, Chairman and CEO of Ampio, commented “We are very pleased to join other strong and growing life science companies on the NYSE community. We feel that transferring the listing of our common stock to NYSE MKT will result in better visibility to the financial and medical community, while improving our liquidity and decreasing our volatility.”