Ampio Pharmaceuticals (NYSE: AMPE) reports in line Q4 2020 Earnings

Credit Youtube


Ampio Pharmaceuticals (NYSE: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today reported annual financial results for the year ended December 31, 2020 and provided a corporate overview / business update.


  • Cash and cash equivalents totaled $17.3 million at December 31, 2020, compared to $6.5 million at December 31, 2019.


Mr. Michael Macaluso, President and CEO, noted, “The FDA has recently responded to our requests to expand our IV and Inhalation Covid-19 studies, utilizing Ampion, by recommending we conduct a randomized, double-blinded, placebo-controlled Phase II trial in each. They also indicated that their recommended trial design for both will allow for an effective and efficient review of data results, determine the safety and statistical significance and effectiveness of Ampion in comparison to Standard of Care, all of which are necessary for the FDA to objectively determine that the known and potential benefits of Ampion outweigh the known and potential risks and, consequently, Ampion may be considered for emergency use authorization (EUA).


In addition, we have provided a detailed proposal to the FDA in response to their recent guidance regarding the status of our Osteoarthritis of the Knee (OAK) Phase III clinical trial, which is paused as a result of the COVID pandemic. In summary, our response proposes analysis of the existing data in a reduced level of patients who had completed the 12-week study regimen for submission. It is important to note that this response is part of an ongoing active dialog with the FDA and until the FDA renders a final decision, this trial data will continue to remain paused and blinded to ensure clinical trial integrity.


Ampion is a platform biologic and, as such, is agnostic to whether it is treating a COVID patient or an osteoarthritis autoimmune condition. Simplified, Ampion directly and effectively addresses inflammation. Consequently, our ongoing and continued research and clinical trials may be applicable to a significant number of additional disease complications, not just COVID.”


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 2035 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the Biologics Price Competition and Innovation Act of 2009 (BPCIA).






Follow us on Google news for more updates and News


This content is being provided to you for informational purposes only. The content has been prepared by third parties not affiliated with CWEB Inc, a business. This content and any information contained therein, does not constitute a recommendation by CWEB to buy, sell or hold any security, financial product or instrument referenced in the content. This information neither is, nor should be construed as an offer, or a solicitation of an offer, to buy or sell securities by CWEB Inc. CWEB Inc. does not offer or provide any opinion regarding the nature, potential, value, suitability or profitability of any particular investment or investment strategy, and you shall be fully responsible for any investment decisions you make, and such decisions will be based solely on your evaluation of your financial circumstances, investment objectives, risk tolerance, and liquidity needs.

Unless stated otherwise, the web content provided by the CWEB family of companies is for educational purposes only. The information and tools provided neither are, nor should be construed, as an offer, or a solicitation of an offer, to buy or sell securities by CWEB Inc. or its affiliates. Unless stated otherwise, no information presented constitutes a recommendation by CWEB Inc. or its affiliates to buy, sell or hold any security, financial product or instrument discussed therein or to engage in any specific investment strategy.

Full Disclaimer

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.