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Sunday, November 27, 2022

Ampio Pharmaceuticals Inc (OTCMKTS: AMPE) Biotech Hits the OTC with a Thud but There’s a Silver Lining

Ampio Pharmaceuticals Inc (OTCMKTS: AMPE) has hit the OTC with a thud closing out its first day of trading on the exchange down another 62% and a new 52 week low of $0.016. On October 4 AMPE asked shareholders to vote “FOR” the proposal to authorize a reverse stock-split in advance of the Ampio Special Stockholder meeting on October 13, 2022. Management stated: “As many of you are aware, the NYSE Regulation has determined that the Company is no longer suitable for listing on the NYSE American Exchange (“Exchange”) due to the abnormally low trading price of its common stock 

Currently trading at a $4 million market valuation AMPE had $22.9 million in cash in the treasury, less than $8 million in liabilities and had 4 clinical trials in progress as of December 31, 2021, the period covered in their most recent 10k. According to management the move to the OTC comes at a time when “we are making substantial progress on previously outlined strategic objectives that we believe will maximize the future value returned to stockholders. Specifically, we are diligently evaluating a list of core strategic opportunities which include a strategic product/pipeline and/or merger and acquisition opportunities with a company that has a strategic development candidate and/or pipeline.” 


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Ampio Pharmaceuticals Inc (OTCMKTS: AMPE) is a biopharmaceutical company focused on developing novel therapies for prevalent inflammatory conditions for which limited treatment options exist. We are advancing immunology-based therapies to provide safe and effective treatments for patients suffering from these diseases. The Company’s lead product, Ampion™, is a biologic drug that uses the power of the immune response to address the underlying causes of inflammatory disease. Ampion is designed to provide anti-inflammatory relief to safely treat persistent inflammation and improve the lives of people with debilitating diseases, like osteoarthritis, respiratory illness, and other inflammatory conditions. Ampion is manufactured in the Company’s modern, state of the art facility, which has been designed to meet international regulatory standards with the capacity to supply global demand. 

Ampion is currently in development as an intra-articular injection treatment for severe OAK, an intravenous (“IV”) and inhaled treatment for hospitalized severe and/or critical COVID-19 patients, and an at-home inhalation treatment for patients with prolonged respiratory symptoms due to COVID-19, commonly referred to as “Long-COVID.” Clinical development of Ampion is advancing through several clinical trials in the United States and abroad. Ampion is conducting and involved in the ongoing management of four discrete clinical trials; all of which are at various stages of completion. The clinical trials in progress as of December 31, 2021 are as follows: 

  • AP-013 – A Randomized, Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee 
  • AP-017 – A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Intravenous Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation 
  • AP-019 – A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults with Respiratory Distress Due to COVID-19 
  • AP-018 – A Randomized, Double-Blinded, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Efficacy of Ampion in Patients with Prolonged Respiratory Symptoms due to COVID-19 (Long-COVID) 

In addition, Ampion continues its research and discovery efforts for additional Ampion applications. Laboratory results suggest that Ampion may have the potential to treat a wide variety of inflammatory and autoimmune diseases. Pre-clinical and discovery work is also underway for additional applications and indications for Ampion. 

Ampion’s therapeutic product pipeline is the result of more than two decades of research at leading hospital-based research centers. Significant discoveries in both scientific and clinical research have been published in peer-reviewed journals, highlighting the depth of research supporting Ampion’s therapeutic capabilities. Ampion is backed by an extensive and robust United States and global patent portfolio with intellectual property protection extending through 2037 for OAK and 2041 for use of Ampion to treat viral respiratory conditions, including COVID-19. In addition, we believe that if approved as a novel biologic, Ampion may be eligible for 12-year FDA market exclusivity under the Biologics Price Competition and Innovation Act of 2009. 

Ampion has developed a novel biologic drug, Ampion, which contains active ingredients that target multiple pathways in the innate immune response characteristic of inflammatory disease. In vitro studies in human cellular models have shown that Ampion represses the transcription of proteins responsible for inflammation, while activating anti-inflammatory proteins responsible for signaling tissue growth and healing. Ampion achieves its biological effect by targeting the elevated inflammatory cytokines, which is common in multiple inflammatory diseases like osteoarthritis and respiratory disease, and other infectious and inflammatory conditions. Ampion has been shown to uniquely reduce inflammation along multiple pathways, unlike other anti-inflammatory therapies that target only one mechanism. 

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AMPE

On October 4 AMPE asked shareholders to vote”FOR” the proposal to authorize a reverse stock-split in advance of the Ampio Special Stockholder meeting on October 13, 2022. Management stated: “As many of you are aware, the NYSE Regulation has determined that the Company is no longer suitable for listing on the NYSE American Exchange (“Exchange”) due to the abnormally low trading price of its common stock. As a result, the exchange has suspended trading of Ampio Pharmaceuticals common stock and has commenced proceedings to delist the Company from the Exchange. We are currently evaluating all of our options, including an appeal process given the close proximity of this decision to the upcoming stockholder meeting on October 13, 2022. 

Independent of evaluating the appeals process, our stock will begin trading on the OTC Markets Group Inc. Pink Sheets (“OTC”), effective October 4, 2022, under the same symbol, AMPE. We expect that the move to the OTC will have a significant impact on the Company’s business operations including, but limited to, the ease of trading and value of existing securities, the ability to source and secure future liquidity needs and the ability to execute on strategic alternatives; all of which would benefit existing stockholders. 

This notice comes at a time when we are making substantial progress on previously outlined strategic objectives that we believe will maximize the future value returned to stockholders. Specifically, we are diligently evaluating a list of core strategic opportunities which include a strategic product/pipeline and/or merger and acquisition opportunities with a company that has a strategic development candidate and/or pipeline. The pending de-listing could potentially jeopardize these opportunities. 

The delisting of our common stock from the Exchange emphasizes the need to vote FOR the proposal to authorize a reverse stock-split that will put us in a stronger position to appeal the NYSE decision and gives us the best near term opportunity to regain our listing on the Exchange. Without approval on this proposal, we lose the ability to remedy the delisting and severely limit our ability to execute on the outlined strategic alternatives which we believe will provide the maximum shareholder value. 

The support for this proposal has been strong. The Ampio Board of Directors has unanimously recommended a vote for the proposal and Institutional Shareholder Services Inc. (“ISS”), the leading corporate proxy advisory firm that provides proxy voting recommendations to pension funds, investment managers, mutual funds, and other institutional shareholders, has recommended that Ampio stockholders vote FOR the proposal. 

Most importantly, the vast majority of stockholders that have voted to date support the authorization of a reverse stock-split. However, approval is needed from 50.1% of Ampio’s total outstanding shares to meet the threshold of minimum acceptable votes from shareholders to validate the vote, and we are still just shy of the outstanding shares voted.  So, in short, every vote counts. 

A proxy, including voting instructions, will be sent out this week. Stockholders with voting procedural questions can call Ampio’s proxy solicitor, Alliance Advisors, at (877) 728-5010, for assistance. 

Every stockholder’s vote is important, regardless of the number of shares held. We urge Ampio stockholders to vote their proxy and approve the Proposal. 

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Currently trading at a $4.6 million market valuation AMPE has 226,286,867 shares outstanding a small float. This is an exciting story in small caps: AMPE had $22.9 million in cash in the treasury, less than $8 million in liabilities and had 4 clinical trials in progress as of December 31, 2021, the period covered in their most recent 10k. According to management the move to the OTC comes at a time when “we are making substantial progress on previously outlined strategic objectives that we believe will maximize the future value returned to stockholders. Specifically, we are diligently evaluating a list of core strategic opportunities which include a strategic product/pipeline and/or merger and acquisition opportunities with a company that has a strategic development candidate and/or pipeline.   We will be updating on AMPE when more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in AMPE either long or short and we have not been compensated for this article.

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