Board Change • Jul 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Independent Director Salvatore Cuzzocrea was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Apr 06
Claritas Pharmaceuticals, Inc. Announces Approval from Australian Ethics Committee to Begin Phase 1 Trial of R-107 Claritas Pharmaceuticals, Inc. announced that the Australian Human Research Ethics Committee has approved the Company’s submission for the Phase 1 clinical study of R-107 to be conducted at Scientia Clinical Research in Sydney, Australia. Claritas will now immediately begin enrollment in the study. R-107 is a liquid, nitric oxide-releasing compound with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia and South Korea. R-107 will Transform the Field of Nitric Oxide Therapy: Nitric oxide exists as a gas and must be delivered by inhalation therapy requiring use of a CPAP-like device and administration by trained respiratory therapists. For these reasons, use of nitric oxide gas is expensive and cumbersome, and therefore its application has been limited. R-107 is a breakthrough compound designed to overcome the limitations of nitric oxide inhalation therapy. Unlike gaseous nitric oxide, R-107 is a liquid that can be administered by mouth (in a capsule), by nasal spray, by nebulizer, by injection, by suppository (vaginally or rectally) or topically (in an ointment). R-107, holds the key to unlocking the full potential of nitric oxide, and it believe it is the only drug in development capable of doing this. Phase 1 Study Overview: The Phase 1 study will be a double-blind, single-center, single ascending dose escalation study that will evaluate the tolerability, safety, and pharmacokinetics of R-107 intramuscular injection. The study will enroll a total of 40 subjects, with 8 subjects in each of 5 cohorts. Potential of R-107 in the Treatment of PAH: Following completion of the Phase 1 study, Claritas will initiate a Phase 2a clinical study of R-107 in the treatment of in pulmonary arterial hypertension, which is a USD 6 billion commercial opportunity with the currently approved drugs, and which is projected to grow to USD 9.8 billion by 2027. Announcement • Feb 24
Claritas Pharmaceuticals, Inc. Announces Receipt of Comments from Australian Ethics Committee Regarding its Phase 1 Clinical Study of R-107 and Closing of Financing Claritas Pharmaceuticals, Inc. announced that it has received comments from the Australian Human Research Ethics Committee (the “HREC”) regarding the company’s Phase 1 clinical study of R-107, and is providing an update regarding the company’s previously announced financing with Alumina Partners (Ontario) Ltd. Claritas will respond to the HREC’s comments later this week and expects to receive approval for the Phase 1 study shortly thereafter. HREC approval is the final regulatory step prior to initiation of the study. The Phase 1 study will be a double-blind, single-center, single ascending dose escalation study that will evaluate the tolerability, safety, and pharmacokinetics of R-107 intramuscular injection. The study will enroll a total of 40 subjects, with 8 subjects in each of 5 cohorts. The study is being conducted at Scientia Clinical Research in Sydney, Australia. Following completion of the Phase 1 study, Claritas will initiate several Phase 2 clinical studies across multiple clinical indications, including pulmonary arterial hypertension (“PAH”); persistent pulmonary hypertension of the newborn (“PPHN”); and COVID-related sepsis and COVID-related ARDS. As the Company previously announced, R-107 has been evaluated in validated animal model studies of PAH and sepsis. The costs of these studies were funded through grants provided by the U.S. Department of Health and Human Services. The data from these studies in both PAH and sepsis are unprecedented in the scientific literature and suggest that R-107 is a potentially revolutionary new treatment for each of these diseases. In the animal model study of PAH, R-107 was demonstrated to be the first and only drug to produce a durable reversal, or potential cure, of this lethal disease. PAH is a lethal condition, with no cure, resulting from high blood pressure in the lungs. R-107 is a proprietary drug with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia, and South Korea. 
