Achieve Life Sciences, Inc. · NASDAQ:ACHV
Achieve Life Sciences — Investor Presentation (July 2026)
25 slides from Achieve Life Sciences's investor presentation, July 2026
Slide 1: Achieve Life Sciences
Achieve Life Sciences NASDAQ: ACHV July 2026
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval; data results and commercialization strategy and activities; the potent
Slide 3: Cytisinicline
Cytisinicline After two decades without meaningful innovation in U.S. smoking cessation, cytisinicline demonstrated potential best-in- class efficacy and an excellent safety profile — even in the hardest-to-treat patients.
Slide 4: Driving toward regulatory approval and launch
Driving toward regulatory approval and launch Anticipated timeline and key milestones Today ORCA-OL 52-week Smoking safety data4 May 2026 Potential FDA Cessation ORCA-2 Phase 3 ORCA-3 Phase 3 US manufacturing approval & Continuing topline data1 topline data2 FDA accepts NDA transition NDA resubmissi
Slide 5: Recent developments: well-capitalized with a proven launch team
Recent developments: well-capitalized with a proven launch team New financing, the Ohtuvayre commercial team, and three new independent directors WELL-CAPITALIZED Apr 2026 COMMERCIAL EXPERIENCE May 2026 STRENGTHENED BOARD Jun 2026 Up to Reunites the team behind the Ohtuvayre® Two new independent dir
Slide 6: A large, underserved U.S. nicotine-dependence market
The Market A large, underserved U.S. nicotine-dependence market A large nicotine-dependent population 1 1 1 1 ~48M ~38M 25M ~18M U.S. tobacco / nicotine users Smokers and/or vapers Adult cigarette smokers E-cigarette (vape) users Most try to quit, and most fail 4 4 3 ~15M ~14M 10.5M Attempt to quit
Slide 7: Nicotine dependence is a costly and growing medical problem
Nicotine dependence is a costly and growing medical problem Smoking's toll on the U.S. $600B 1 480,000+ 2 Annual U.S. economic cost of smoking (~$240B of it in direct health U.S. deaths each year, the #1 cause of preventable death care) Vaping: a rising public health crisis 3 4,5 ~90% ~1 in 7 growth
Slide 8: Best-in-class odds of quitting smoking across Phase 3 trials
Across multiple Phase 3 trials, 12 weeks of cytisinicline 1,2 demonstrated best-in-class odds of quitting smoking P U B L I SH E D I N Primary Cytisinicline 12 weeks pooled Secondary Cytisinicline 12 weeks pooled endpoint (continuous abstinence, weeks 9-12) endpoint (continuous abstinence, weeks 9-2
Slide 9: Cytisinicline for Smoking Cessation: A Randomized Clinical Trial
From: Cytisinicline for Smoking Cessation: A Randomized Clinical Trial JAMA. 2023;330(2):152-160. doi:10.1001/jama.2023.10042 Copyright 2023 American Medical Association. All Rights Reserved.
Slide 10: Efficacy regardless of number of prior quit attempts
Cytisinicline demonstrated efficacy regardless of 1 number of prior quit attempts Primary Continuous abstinencea, weeks 9-12 endpoint Cytisinicline Patients achieving continuous abstinenceb (%) 60 Placebo OR: 5.9 OR: 4.6 50 p<0.0001c p<0.0001c 33.8% 40 Nearly 29.8% 30 ~4 to 6-fold 20 10.2% higher od
Slide 11: Efficacy regardless of prior varenicline use
Cytisinicline demonstrated efficacy regardless of 1 prior varenicline use Primary Continuous abstinencea, weeks 9-12 endpoint Cytisinicline Patients achieving continuous abstinenceb (%) 60 Placebo OR: 4.1 OR: 7.8 50 p<0.0001c p<0.0001c 33.6% 40 Approximately 29.8% 30 8-fold 20 9.6% higher odds of ce
Slide 12: Potential efficacy in hard-to-treat populations, such as COPD
Potential efficacy in hard-to-treat populations, such 1 as experienced smokers with COPD Primary Continuous abstinencea, weeks 9-12 endpoint Cytisinicline Patients achieving continuous abstinenceb (%) 60 Placebo OR: 5.2 OR: 5.3 OVER 50 p<0.0001 c p=0.04 c 40 32.6% 5-fold 19.1% higher odds of cessati
Slide 13: Cytisinicline Efficacy in Hard-to-Treat Populations, History of Cancer
EFFICACY RESULTS Cytisinicline Efficacy in Hard- 6-WEEK TREATMENT (Wks 3–6) 12-WEEK TREATMENT (Wks 9–12) to-Treat Populations, 24.4% 32.4% Participants with a Baseline cytisinicline (11/45) vs 10.5% placebo (4/38) OR 2.75 (95% CI 0.81–10.74) cytisinicline (12/37) vs 15.8% placebo (6/38) OR 2.56 (95%
Slide 14: Smoking cessation associated with reduced mortality risk among cancer patients
Smoking cessation is associated with reduced mortality risk among cancer patients, even when initiated after diagnosis or in patients with advanced-stage disease Tohmasi S, Baker TB, Heiden BT, et al. Smoking Cessation and Mortality Risk in Cancer Survivorship: Real-World Data From a National Cancer
Slide 15: Dosing is a short, fixed course of 6 or 12 weeks
Dosing is a short, fixed course of 6 or 12 weeks Pooled point-prevalence abstinence is sustained through Week 24, with the 12-week course outperforming 6 weeks End of End of 6-week course 12-week course 0.5 Placebo (536) Cytisinicline 6 wk (532) Cytisinicline 12 wk (534) Both courses keep abstinence
Slide 16: FDA recognized cytisinicline as a national priority treatment for vaping cessation
For two consecutive years, the FDA recognized cytisinicline as a national priority treatment for vaping cessation 2024 2025 FDA RECOGNITION FDA RECOGNITION 1 2 Breakthrough Therapy Designation Commissioner's National Priority Voucher Reserved for therapies showing the potential for substantial New p
Slide 17: Continuous e-cigarette abstinence (ORCA-V1)
40% Primary Outcome 31.8% Continuous e-cigarette abstinence (%) End of treatment (Weeks 9-12) 30% OR 2.64 20% 95% CI 1.06-7.10 P=0.035 15.1% 10% 0% Cytisinicline Placebo n=107 n=53 Rigotti NA, Benowitz NL, Prochaska JJ, et al. Cytisinicline for vaping cessation in adults using nicotine e-cigarettes:
Slide 18: Current FDA-approved options present significant tolerability and adherence challenges
Current FDA-approved options present significant tolerability and adherence challenges Varenicline Bupropion NRT (Chantix) (Zyban) Nicotine replacement therapy TOLERABILITY & LABEL WARNINGS LIMITED EFFICACY DOSING & ADHERENCE 4.4× the odds of nausea vs placebo; Less effective for quitting than Frequ
Slide 19: Cytisinicline generally well tolerated with low discontinuation due to TEAEs
Cytisinicline was generally well tolerated with low incidence of discontinuation due to treatment-emergent adverse events (TEAEs) <5% of patients on cytisinicline discontinued due to adverse events Low incidence of TEAEs observed, most of Overall Placebo Overall Cytisinicline which were mild or mode
Slide 20: Near-complete α4β2 binding with no meaningful 5-HT3 binding
▪ Unlike varenicline, cytisinicline shows near-complete binding at the α4β2 nicotinic receptor (99% displacement) but no meaningful binding at the 5-HT3 receptor (−8%) - the receptor implicated in nausea ▪ This selective receptor profile provides a pharmacologic rationale for cytisinicline's lower n
Slide 21: Minimal off-target activity may support a favorable safety profile
Minimal off-target activity may support a favorable safety profile 5-HT3 is a receptor commonly associated with nausea and vomiting Receptor Selectivity of Cytisinicline: Minimal 5-HT3 Binding May Explain Lower Incidence of Nausea in Smoking Cessation Therapy Mark L. Rubinstein, MD; Cindy Jacobs, Ph
Slide 22: 52-week continuous therapy shows persistent tolerability and favorable safety
52-week continuous therapy shows persistent tolerability and a favorable safety profile
Slide 23: Matching-adjusted indirect comparison: cytisinicline vs varenicline
Matching-adjusted indirect comparison: cytisinicline vs varenicline Higher odds of quitting vs varenicline at the secondary (weeks 9-24) endpoint; Lower odds of nausea vs varenicline A matching-adjusted indirect treatment comparison (MAIC) was conducted to estimate relative efficacy and tolerability
Slide 24: Multiple value drivers designed to de-risk potential approval
Multiple value drivers designed to de-risk potential approval 01 02 03 04 05 Large, underserved Strong efficacy Favorable safety Clear regulatory path Resourced for launch market profile ~38M U.S. smokers, vapers Up to 5-6x higher odds of Minimal 5-HT3 receptor NDA accepted and backed by Up to $354M
Slide 25: Achieve Life Sciences
Achieve Life Sciences NASDAQ: ACHV July 2026
Achieve Life Sciences — Investor Presentation (July 2026) on 6ix