Slide 1: ORCA-3 Phase 3 Topline Data
ORCA-3 Phase 3 Topline Data NASDAQ: ACHV | May 23, 2023 Exhibit 99.2
Slide 2: Forward Looking Statements
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 p
Slide 3: Cytisinicline ORCA Development Program
Cytisinicline ORCA Development Program Indication Phase 1 Phase 2 Phase 3 Completed Milestones Smoking Cessation E-cigarette Cessation Completed Clinical Trials Statistically significant quit rates vs placebo (p<0.005) Statistically significant quit rates vs placebo (p<0.0001) Statistically signific
Slide 4: Large Market Opportunity: Treating Nicotine Addiction
Annualized healthcare costs associated with smoking costs in the U.S.2 $300B 1.1B Global Smokers1 ~480K Deaths in the U.S. annually2 Tobacco use is the leading cause of preventable death1 Large Market Opportunity: Treating Nicotine Addiction 28M Adult Smokers in the U.S.3 11M Adult e-cigarette users
Slide 5: ORCA-3: Phase 3 Topline Results May 2023
Forward Looking Statements ORCA-3: Phase 3 Topline Results May 2023
Slide 6: 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=264 CYT: 6 weeks Placebo: 6 weeks N=263 Placebo: 12 weeks N=265 Objective: Evaluate safety and efficacy of 3.0 mg of cytis
Slide 7: ORCA-3 Demographics and Baseline Characteristics
ORCA-3 Demographics and Baseline Characteristics Characteristic Randomized (N=792) Sex Female Male 439 (55%) 353 (45%) Race White Black or African American Other 631 (80%) 139 (18%) 21 (2%) Age (yrs) Median 53 Average # Daily Cigarettes in last 30 days Median 20 Dura
Slide 8: 12-week Cytisinicline Treatment: 4x Increased Likelihood of Cessation
12-week Cytisinicline Treatment: 4x increased likelihood of smoking cessation at end of treatment & ~6x more likely at 24 weeks Quit Rates for 3 mg TID vs Placebo Primary Endpoint: Weeks 9-12 Odds Ratio 4.40 (p<0.0001) Secondary Endpoint: Weeks 9-24 Odds Ratio 5.79 (p<0.0001) (3 months) (1 month)
Slide 9: 6-week Cytisinicline Treatment: ~3x Increased Likelihood of Cessation
(4.5 months) (1 month) 6-week Cytisinicline Treatment: ~3x increased likelihood of smoking cessation at end of treatment & 6x more likely at 24 weeks Quit Rates for 3 mg TID vs Placebo Primary Endpoint: Weeks 3-6 Odds Ratio 2.85 (p=0.0008) Secondary Endpoint: Weeks 3-24 Odds Ratio 6.25 (p=0.0006)
Slide 10: Safety Profile: Well-tolerated with Low Rates of Adverse Events
No treatment-related serious adverse events reported Safety Profile: Well-tolerated with low rates of adverse events reported Most commonly reported AE’s (>5% Overall) 164 (62.6%) 170 (64.6%) 168 (64.5%) 20 (7.6%) 29 (11.0%) 31 (11.9%) Adverse Event (AE) Placebo (N=262) 6-week CYT (N=263) 12-week CY
Slide 11: Strong Relative Efficacy Compared to Current Treatments
3.7 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 Li
Slide 12: Cytisinicline is Well Positioned
Cytisinicline is Well Positioned... To Meet the Cessation Needs of Smokers and Patients Battling Nicotine Addiction Dual-acting, differentiated, and highly selective MOA provides minimal adverse events (AEs) and excellent compliance rates Safe & Well-Tolerated Efficacious Robust efficacy demonstrate
Slide 13: Appendix
Forward Looking Statements APPENDIX
Slide 14: ORCA-2: Phase 3 Study Results April 2022
Forward Looking Statements ORCA-2: Phase 3 Study Results April 2022
Slide 15: ORCA-2: 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=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 16: ORCA-2: Demographics and Baseline Characteristics
ORCA-2: Demographics and Baseline Characteristics Characteristic Randomized (N=810) Sex Female Male 442 (55%) 368 (45%) Race White Black or African American Other 659 (81%) 130 (16%) 21 (3%) Age (yrs) Median 54 Average # Daily Cigarettes in last 30 days Median 20 Dur
Slide 17: 12-week Cytisinicline Treatment: 6.3x Increased Likelihood of Cessation
12-week Cytisinicline Treatment: 6.3x increased likelihood of cessation at end of treatment Quit Rates for 3 mg TID vs Placebo Primary Endpoint: Weeks 9-12 Odds Ratio 6.3 (p<0.0001) Secondary Endpoint: Weeks 9-24 Odds Ratio 5.3 (p<0.0001) (3 months) (1 month)
Slide 18: 6-week Cytisinicline Treatment: 8x Increased Likelihood of Cessation
(4.5 months) (1 month) 6-week Cytisinicline Treatment: 8x increased likelihood of cessation at end of treatment Quit Rates for 3 mg TID vs Placebo Primary Endpoint: Weeks 3-6 Odds Ratio 8.0 (p<0.0001) Secondary Endpoint: Weeks 3-24 Odds Ratio 3.7 (p=0.0016)
Slide 19: Safety Profile: Well-tolerated with Single Digit Rates of Adverse Events
No treatment-related serious adverse events reported Safety Profile: Well-tolerated with single digit rates of adverse events Most commonly reported AE’s (>5% Overall) 166 (61.5%) 172 (63.9%) 184 (68.1%) 13 (4.8%) 23 (8.6%) 26 (9.6%) Adverse Event (AE) Placebo (N=270) 6-week CYT (N=269) 12-week CYT
Slide 20: ORCA-2 & ORCA-3 Combined Results
Forward Looking Statements ORCA-2 & ORCA-3 Combined Results
Slide 21: ORCA-2 and ORCA-3 Demographics and Baseline Characteristics
ORCA-2 and ORCA-3 Demographics and Baseline Characteristics Characteristic ORCA-2 Randomized (N=810) ORCA-3 Randomized (N=792) Sex Female Male 442 (55%) 368 (45%) 439 (55%) 353 (45%) Race White Black or African American Other 659 (81%) 130 (16%) 21 (3%) 631 (80%) 139 (1
Slide 22: 12-week Cytisinicline Treatment: ORCA-2 and ORCA-3
Cytisinicline Placebo 12-week Cytisinicline Treatment: ORCA-2 (N=810) and ORCA-3 (N=792) Secondary Endpoint (Weeks 9-24) Primary Endpoint (Weeks 9-12) Odds Ratio: 5.79 (p<0.0001) Odds Ratio: 5.3 (p<0.0001) Odds Ratio: 4.40 (p<0.0001) Odds Ratio: 6.3 (p<0.0001)
Slide 23: 6-week Cytisinicline Treatment: ORCA-2 and ORCA-3
Cytisinicline Placebo 6-week Cytisinicline Treatment: ORCA-2 and ORCA-3 Secondary Endpoint (Weeks 3-24) Primary Endpoint (Weeks 3-6) Odds Ratio: 6.25 (p=0.0006) Odds Ratio: 3.7 (p=0.0016) Odds Ratio: 2.85 (p=0.0008) Odds Ratio: 8.0 (p<0.0001)
Slide 24: Safety Profile: Well-tolerated with Low Rates of Adverse Events
No treatment-related serious adverse events reported Safety Profile: Well-tolerated with low rates of adverse events reported Most commonly reported AE’s (>5% Overall) 166 (61.5%) 172 (63.9%) 184 (68.1%) 13 (4.8%) 23 (8.6%) 26 (9.6%) Adverse Event (AE) Placebo 6-week CYT 12-week CYT At least 1 TEAE