Announcement • Jul 15
Cabbacis Releases Its Clinical Trial Results Demonstrating That the Company's Patented Iblend™? Cigarettes Cabbacis released its clinical trial results demonstrating that the Company's patented iBlend™? cigarettes were highly rated for satisfaction on the standardized mCEQ questionnaire and significantly reduced cravings for usual brand cigarettes. Cabbacis contracted the Rose Research Center to carry out a pilot clinical trial on 16 smokers exclusively using four types of reduced-nicotine tobacco cigarettes made by Cabbacis during 3-hour ad libitum use sessions, which followed overnight abstinence from their usual brand cigarette. The nicotine content of all types was reduced by approximately 95%, as compared to the average of mainstream American brands. Three iBlend™? cigarette types contained reduced-nicotine tobacco and each type had a different level of hemp (5%, 10% and 20%), and the fourth cigarette type contained reduced-nicotine tobacco without any hemp. All cigarettes exclusively contained patent-pending tobacco licensed by Cabbacis and grown by its contracted farmers. The study measured the effects of the four cigarette types on smokers' perceptions and smoking behavior. Although other measures in the study were evaluated, the most relevant measures were craving relief and those related to product acceptability. For, Did it immediately reduce craving for cigarettes, participants across all four cigarette types reported a significant reduction in craving for their usual brand of cigarettes which was sustained over the 3-hours of ad libitum use of the study cigarettes. All four Cabbacis cigarette types were rated higher for satisfaction on the standardized m CEQ questionnaire than has been previously reported in the literature with other 95% reduced-nicotine cigarettes. An unexpected positive result of the study was that the use of the three iBlend™? hemp-containing cigarettes (5%,10% and 20%) resulted in lower exhaled carbon monoxide (CO) levels, as compared to CO levels measured after use of the 0-% hemp cigarettes, with the reduction in the 20-% hemp iBlend™? cigarette being statistically significant at the 95% confidence level. In January 2025, the FDA issued a proposed rule that, if finalized, would make all cigarettes sold in the United States minimally or nonaddictive by limiting the level of nicotine in cigarettes (reduction of approximately 95%). Upon Cabbacis filing, and FDA issuing a PMTA, commercialization of the reduced-nicotine iBlend™? products would give smokers beneficial product choices with differentiated taste and sensory characteristics to expand the market for reduced-nicotine cigarettes. The FDA has already issued a PMTA and authorized modified-risk product claims on a reduced-nicotine cigarette brand, VLN®? (unrelated to Cabbacis), including "Helps you smoke less®?." In parallel to the FDA process for the U.S. market, the Company is planning to market its products internationally. 
