Claritas Pharmaceuticals, Inc. outlined the Company's plans for developing R-107, the Company's nitric oxide-releasing compound, for multiple clinical indications. Phase 1 Study in First Quarter 2022: The first step is completion of their Phase 1 clinical study to demonstrate that R-107 is safe in humans. They expect to complete this study during First Quarter this year.

Multiple Phase 2 Studies in 2H 2022: Following completion of the Phase 1 study, they will initiate several Phase 2 clinical studies across multiple clinical indications, as follows: COVID-Related Sepsis: Sepsis is the leading cause of death among COVID-19 patients, and, as they previously announced, a peer-reviewed article was recently published in Scientific Reports disclosing that R-107 effectively preserved multi-organ function in a sheep model of sepsis. These results suggest that R-107 could be a potentially revolutionary new treatment for sepsis. Based on these results, Claritas will initiate a Phase 2 clinical study to evaluate R-107 as a treatment for COVID-related sepsis and will apply for U.S. governmental grant funding to cover the costs of this study.

The costs of the preclinical development of R-107 were covered by approximately USD $20 million of grant funding previously provided through the U.S. Department of Health and Human Services, and Claritas will again seek such funding for the costs of this Phase 2 study as well as the potential follow-on Phase 3 study. The worldwide market for treatment of sepsis was valued at more than USD $600 million in 2020 and is projected to grow to USD $1.6 billion by 2031. COVID-Related ARDS: Acute respiratory distress syndrome ("ARDS") is one of thecommon clinical manifestations of severe COVID-19.

As they previously announced, a published study led by clinicians at Royal Brompton & Harefield NHS Foundation Trust 2 reported that inhaled nitric oxide significantly improved oxygen levels in patients with severe COVID-related ARDS. They believe that these data validate the potential of R-107 as a therapy for COVID-related ARDS, and, in Q3-Q4 2022, they will initiate a Phase 2 clinical study to evaluate R-107 as a treatment for COVID-related ARDS. They will apply for U.S. governmental grant funding to cover the costs of this study, as well as the potential follow-on Phase 3 study.

According to an analysis by Reports and Data, the global ARDS market was valued at USD 583.8 million in 2018 and is expected to reach USD 934.8 million by the year 2026. PAH: Pulmonary arterial hypertension ("PAH") is a lethal condition, with no cure, resulting from high blood pressure in the lungs. The worldwide market for treatment of PAH exceeds $6 billion per year and is projected to grow to $9.8 billion by 20273.

As they previously announced, R-107 is the first and only drug to demonstrate a durable reversal of established disease in a validated animal model of PAH. The data from this study are unprecedented in the scientific literature and suggest that R-107 is a potentially revolutionary new treatment for PAH. Claritas will initiate a Phase 2a clinical study of R-107 in hospitalized patients with PAH by mid-2022, which they expect to complete during Fourth Quarter 2022.