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Ampio Pharmaceuticals, Inc. (AMPE) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, March 31, 2021

Ampio Pharmaceuticals, Inc.

CIK: 1411906 Ticker: AMPE

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Ampio Pharmaceuticals, Inc. Reports First Quarter 2021 Financial Results and Provides Business Update

Progress achieved across therapeutic platform, including in the AP-013 Phase III trial of Ampion™ in Osteoarthritis of the Knee (OAK)

Initiated two Phase II trials utilizing Ampion in COVID-19; in an inhaled form for lung inflammation and intravenously; could lead to application for Emergency Use Authorization

New Study in COVID-19 “Long Haulers” Initiated

Further details to be discussed in this afternoon’s conference call

ENGLEWOOD, CO, May 5, 2021

Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions for which there are limited treatment options, today reported quarterly financial results for the first quarter period ended March 31, 2021, and provided a corporate overview and business update.

Mr. Michael Macaluso, President and Chief Executive Officer, commented, “This has been an important quarter for Ampio, with noted progress across our therapeutic platform. For example, the FDA has recently responded to our plans for the AP-013 Phase III trial for the intra-articular injection of Ampion for patients suffering from severe osteoarthritis of the knee (OAK). The response not only provides us with flexibility for maintaining the Special Protocol Assessment (SPA) but, in addition, allows us to consider several alternative paths forward to an optimal solution that may include strategic discussions with potential partners for the commercialization, and expansion of osteoarthritis indications, of Ampion.”

“We were also encouraged with the results of the AP-014 Phase I clinical trial of inhaled Ampion for COVID-19 patients. The study met its primary endpoint of safety and tolerability, and a 78% reduction in all-cause mortality was observed for patients treated with Ampion compared to Standard of Care (SOC). Approximately 24% of the patients receiving SOC alone died during the study, compared with 5% treated with Ampion.”

“Our results from the AP-014 trial are strong and compelling,” continued Macaluso, “and we look forward to promptly enrolling patients in a set of double-blind, placebo-controlled Phase II trials utilizing Ampion in COVID-19 patients with inhalation and intravenous routes of drug delivery. We will be looking for confirmation of the efficacy results seen in our Phase I trial in order to move quickly in applying for Emergency Use Authorization.”

Mr. Michael Macaluso, President and Chief Executive Officer, Dr. David Bar-Or, Director and Founder, Ms. Holli Cherevka, Chief Operating Officer and Mr. Daniel Stokely, Chief Financial Officer will be hosting a Conference Call for the Investment Community this afternoon beginning at 4:30 PM ET (see details below).


The following information was filed by Ampio Pharmaceuticals, Inc. (AMPE) on Wednesday, May 5, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Ampio Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:

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Inside Ampio Pharmaceuticals, Inc.'s 10-Q Quarterly Report:

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Inside this 10-Q Quarterly Report

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Ampio Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits

Ticker: AMPE
CIK: 1411906
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-21-005918
Submitted to the SEC: Wed May 05 2021 4:10:46 PM EST
Accepted by the SEC: Wed May 05 2021
Period: Wednesday, March 31, 2021
Industry: Pharmaceutical Preparations

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