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

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

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

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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

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New Study in COVID-19 “Long Haulers” Initiated

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

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ENGLEWOOD, CO, May 5, 2021

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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.”

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“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.”

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“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.”

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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).

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