Adamis Pharmaceuticals Announces 2020 Financial Results and Business Update - Seite 2

Recently, the U.S. Patent and Trademark Office allowed one of Adamis’ patent applications relating to ZIMHI. The claims allowed describe a naloxone composition at a dose greater than or equal to five milligrams configured for administration as an injection.

Tempol

• In June 2020, Adamis entered into an exclusive worldwide license for a novel patented compound, Tempol, for the treatment of all respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19. Additionally, the license also includes the use of Tempol for reducing radiation dermatitis in patients undergoing treatment for cancer.
  
  
• In February 2021, the company announced results from a study in collaboration with Stanford University demonstrated that Tempol inhibited the release of multiple cytokines from activated immune cells of COVID-19 patients, which may be a unique mechanism of action for the agent. In-vivo preclinical data from a hamster virus challenge model has shown an attenuation of the lung pathology and more rapid healing in animals treated with Tempol. This animal model has been used successfully to test vaccines and monoclonal antibodies against COVID-19. These results further support the clinical program of testing Tempol in early COVID.
  
  
• The company’s IND relating to a protocol for a clinical trial of Tempol in COVID-19 patients received FDA clearance in January 2021. Adamis expects to begin the Phase 2/3 trial during the second quarter of 2021 to examine the effects of Tempol on preventing hospitalization in subjects with COVID-19 infection.
  

Drug Outsourcing Facility

• In January, the company announced that it had entered into a non-binding letter of intent with a potential buyer for the sale of substantially all of the assets of its US Compounding, Inc. (USC) registered outsourcing facility subsidiary. Under the terms of the LOI, the buyer would acquire substantially all of the assets of USC, in exchange for a total gross consideration that could range from approximately $10-$20 million, before transaction fees and expenses and other potential post-closing adjustments. Any definitive agreement would be subject to approval by the respective parties, including approval by the board of directors of Adamis, and would likely include customary provisions, including representations and warranties of Adamis and USC, restrictive covenants and indemnification provisions.