Ampio Pharmaceuticals Ongoing Phase I Clinical Trial for Inhalation Treatment of COVID-19 with Ampion is 55% Enrolled

ENGLEWOOD, Colo., January 14, 2021–Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced its ongoing U.S. Phase I clinical trial for inhalation treatment of COVID-19 with Ampion (AP-014) is 55% enrolled.

The Phase I clinical trial is ongoing, with the primary focus to evaluate the impact of inhaled Ampion treatment in patients with respiratory distress due to COVID-19. Inhaled Ampion specifically targets inflammation in the lung and is currently being investigated to determine whether its use will improve the clinical outcome for patients with respiratory distress due to COVID-19.

“We’ve received amazing feedback from healthcare providers about the improvement seen in patients receiving inhaled Ampion,” said Mike Macaluso, CEO of Ampio Pharmaceuticals. “We continue to remain very optimistic at the early, anecdotal evidence regarding the clinical effectiveness of inhaled Ampion in COVID-19 patients, and eagerly await the full results of this trial.”

“Our experience using inhaled Ampion to treat patients with COVID-19 continues to trend positively showing no serious drug-related adverse effects,” said Chief of Medical Staff for Penrose-St. Francis Health Services Michael Roshon, MD, PhD. “We look forward to seeing the full results of the study as therapeutics for COVID-19 continue to be in high demand.”

More than 22 million people in the United States have been diagnosed with COVID-19, making up nearly a quarter of the cases worldwide. Despite the growing availability of vaccines, therapeutics are and will continue to be necessary to treat patients suffering from some of the virus’ most challenging and damaging effects, including, but not limited to, systemic inflammation in the lungs.

Currently, the study of inhaled Ampion in COVID-19 patients has exhibited no drug-related serious adverse events (SAE). Feedback from the Safety Monitoring Committee (SMC), analyzing any safety concerns related to inhaled Ampion, is expected later this month.

In vitro, Ampion interrupts the hyper-active immune response, known as the cytokine storm, which is directly associated with the more serious symptoms of COVID-19. The benefit of this effect from Ampion is currently being studied in multiple human clinical trials. In addition to the U.S. based trial of inhaled Ampion, Ampio Pharmaceuticals has initiated a global study commencing in Israel and the U.S. for patients with moderate to severe COVID-19, assessing the safety and efficacy of intravenous Ampion treatment in both a hospital setting and as a therapy for out-patient care.

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. Ampio’s lead drug, Ampion, is backed by an extensive patent portfolio with intellectual property protection extending through 2032, and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA).

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, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, 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.

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