ORCA-1 was initiated in October 2018 and evaluated 254 smokers in the United States. The fourth arm trended to significance (p= 0.052). Cytisinicline was well-tolerated with no serious AEs reported. Compliance with study treatment was greater than 94% across all arms. The FDA agreed that the 3 mg TID dosing schedule was acceptable. 7 ORCA-1 was initiated in October 2018 and evaluated 254 smokers in the United States. We, through our partner Sopharma, provided the study drug used in this trial. Global sales of Chantix® were $919 million in 2020. Under the Sopharma License Agreement, we agreed to pay a nonrefundable license fee. In 2012, new pharmacovigilance legislation came into force in the EU. There is no certainty that an adequacy decision will be granted. The seed pods are harvested from the shrubs and dried. Of those sales, $716 million, approximately 78%, were attributable to the U.S. market. We do not anticipate generating revenue from product sales for the foreseeable future. Claims could also be asserted under state consumer protection acts. The development and commercialization of new products is highly competitive. We are currently developing cytisinicline for smoking cessation. General Risk Factors We are at risk of securities class action litigation.
