Slide 1: ORCA-2 Phase 3 Topline Data
ORCA-2 Phase 3 Topline Data NASDAQ: ACHV | April 27, 2022 EXHIBIT 99.2
Slide 2: Forward-looking statements
This presentation contains forward-looking statements, including, but not limited to, statements regarding the timing of planned clinical development activities of cytisinicline; the projected path toward potential regulatory approval; the safety, efficacy and commercial potential of cytisinicline;
Slide 3: ORCA-2: Phase 3 Study Design (N=810)
Arm C Arm B Arm A Placebo 6 weeks Cytisinicline 6 weeks Cytisinicline 6 weeks Placebo 6 weeks Placebo 6 weeks Cytisinicline 6 weeks Monthly Follow-Up CYT: 6 weeks CYT: 6 weeks n=270 CYT: 6 weeks Placebo: 6 weeks n=269 Placebo: 12 weeks n=271 Objective: Evaluate safety and efficacy of 3.0 mg of cytis
Slide 4: ORCA-2: Demographics and Baseline Characteristics
4 ORCA-2: Demographics and Baseline Characteristics
Slide 5: 12-week Cytisinicline Treatment: 6.3x increased likelihood of cessation at end of treatment
12-week Cytisinicline Treatment: 6.3x increased likelihood of cessation at end of treatment Quit Rates for 3 mg TID vs Placebo 5 Primary Endpoint: Weeks 9-12 Odds Ratio 6.3 (p<0.0001) Secondary Endpoint: Weeks 9-24 Odds Ratio 5.3 (p<0.0001)
Slide 6: 6-week Cytisinicline Treatment: 8x increased likelihood of cessation at end of treatment
6-week Cytisinicline Treatment: 8x increased likelihood of cessation at end of treatment Quit Rates for 3 mg TID vs Placebo 6 Primary Endpoint: Weeks 3-6 Odds Ratio Secondary Endpoint: Weeks 3-24 Odds Ratio 8.0 (p<0.0001) 3.7 (p=0.0016)
Slide 7: Low rates of AEs compares favorably to currently approved smoking cessation products
Low rates of AEs compares favorably to currently approved smoking cessation products 7 Safety Profile: -Well-tolerated with single digit rates of adverse events -No treatment-related serious adverse events reported Most commonly reported AE’s (>5% Overall)
Slide 8: Strong Relative Efficacy Compared to Current Treatments
8 Strong Relative Efficacy Compared to Current Treatments Odds Ratio (OR) expresses the drug effect in proportion to placebo OR is the preferred outcome measure in smoking cessation trials in the literature [-------Cochrane Database Review-------] *Varenicline = Chantix Cahill K et al; The Cochrane
Slide 9: ORCA-3: Phase 3 Study Design
Arm C Arm B Arm A Placebo 6 weeks Cytisinicline 6 weeks Cytisinicline 6 weeks Placebo 6 weeks Placebo 6 weeks Cytisinicline 6 weeks Monthly Follow-Up CYT: 6 weeks CYT: 6 weeks N=~250 CYT: 6 weeks Placebo: 6 weeks N=~250 Placebo: 12 weeks N=~250 Objective: Evaluate safety and efficacy of 3.0 mg of cy
Slide 10: 34M Adult Smokers in the U.S.
34M Adult Smokers in the U.S.3 11M Adult e-cigarette users in the U.S.3 4.8M Youth Tobacco users in the U.S.4 World Health Organization (WHO). WHO Report on the Global Tobacco Epidemic, 2019. U.S. Department of Health and Human Services, The Health Consequences of Smoking, 50 Years of Progress: A Re
Slide 11: Cytisinicline Near-term Development Milestones
Cytisinicline Near-term Development Milestones Indication Phase 1 Phase 2 Phase 3 Anticipated Milestones Smoking Cessation E-cigarette Cessation Completed In Progress Planned Statistically significant quit rates vs placebo (p<0.005) Statistically significant quit rates vs placebo (p<0.0001) Study In