Achieve Life Sciences : Corporate Presentation April 2026 (ACHV Corporate Deck April)

Published: 2026-05-03 15:39:04 ET ACHV

Published on 05/03/2026 at 03:39 pm EDT

Corporate Presentation

April 2026

Transforming public health and delivering shareholder value

Cytisinicline, as a first potential new nicotine dependent treatment in 20 years, gives Achieve Life Sciences a unique opportunity to treat an addressable market of up to 50 million Americans who use tobacco1

Addressing nicotine dependence, an underserved public health crisis costing billions of dollars and impacting lives.

Cytisinicline PDUFA for treatment of nicotine dependence for smoking cessation is June 20, 2026. U.S. launch expected in 1H 2027.

Vaping cessation indication, awarded Commissioner's National

3 Priority Voucher (CNPV) and under FDA Breakthrough Therapy

Designation.

Competitive advantage with a highly differentiated and well-tolerated product profile and favorable payor environment with Affordable Care Act coverage.

Focused launch strategy leveraging innovative, data-driven solutions to drive adoption and future growth.

1. Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults-United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475-483. DOI: http://dx.doi.org/10.15585/mmwr.mm7218a1.

First potential new FDA-approved treatment 20 years

Limited competition in market or development

Strong demand anticipated from dissatisfied HCPs & patients

High Unmet Need

Differentiated Product Profile

Highly selective MOA

Excellent efficacy & tolerability in 6-or 12-week treatment durations

Effective in treatment-resistant smokers

Relapse prevention

cytisinicline

Once-daily oral dosing

Alternate admin routes (patch, spray, lozenge)

Expanded indications: long-term maintenance/relapse prevention, cutting down to quit

Synthetic cytisinicline manufacture

Lifecycle Expansion Opportunities

Targeted Launch Strategy

Large and clearly defined customer segments

Scalable for market share and/or

market growth strategies

Ideal for leveraging AI & omnichannel communications

Anticipated timeline and key milestones

Smoking Cessation

NDA

Acceptance

FDA Review Period

Product Launch

Expected Cytisinicline

Milestones

2H'25 1H'26

1H'26

PDUFA

1H'27

E-cigarette Cessation (CNPV)*

Phase 3 Trial Initiation**

Phase 3 Completion

Timeline are estimates based on management current expectations that have no guarantee and may vary.

* Commissioner's National Priority Voucher.

** E-cigarette cessation program timeline is finance dependent.

Nicotine dependency is a medical issue,

requiring a medical solution

25M U.S. smokers with few treatment options2

Cardio-metabolic disease Hypertension, heart attack, stroke & obesity

of deaths from lung cancer & COPD from smoking3

increased risk of CVD from smoking3

increased risk of Type 2 Diabetes from smoking3

increased risk of stroke from heavy smoking4

Immune system

diseases Infections, autoimmune

diseases

Neurodegenerative

disease

Dementia

Type-2 Diabetes

Respiratory disease

COPD and asthma

Cancer

Lung and multiple other cancers

VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation - United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633-641

National Center for Health Statistics. National Health Interview Survey, 2023 and 2024. 2026 (https://www.cdc.gov/nchs/nhis.htm).

USDHHS-The Health Consequences of Smoking-2014; 4. Bhat VM,-2008.

Profound co-morbidity health harms from smoking

Smoking cessation with cytisinicline can be positioned as a high-ROI upstream cardiometabolic intervention

STRATEGIC THESIS

Smoking cessation, when combined with cardiometabolic therapies including GLP-1 receptor agonists, SGLT2 inhibitors, and PCSK9 inhibitors, is associated with greater absolute cardiovascular risk reduction than treating individual risk factors alone.1, 2

COMMERCIAL LOGIC

Can expand the target prescriber audience by expanding outreach to include cardiology, endocrinology, and pulmonology.

FINANCIAL LOGIC

Potential for attractive cost-effectiveness, outcomes-based contracting potential, and near-term revenue to balance long CV-outcome-trial portfolios.

PUBLIC HEALTH PRIORITY

Directly advances prevention priorities and strengthens alignment with public health and ESG objectives.

Cardiovascular Effects of Smoking and Smoking Cessation: A 2024 Update. https://globalheartjournal.com/articles/10.5334/gh.1399

Virani SS, Newby LK, Arnold SV, et al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA guideline for the management of patients with chronic coronary disease. J Am Coll Cardiol. 2023;82:833-955.

Majority of people who vape are 18-24 and have never smoked3,4

Instead of harm reduction, this is possible

harm creation for this group

Many popular vapes used by young adults contain the nicotine equivalent of 13 packs of cigarettes5

The cumulative exposure to vape aerosols over time in these young vapers could lead to severe nicotine dependence and the emergence of previously unknown lung diseases

~18M U.S. adults reported use of e-cigarettes2

Source: National Center for Health Statistics, National Health Survey6

Palmer AM, Smith TT, Nahhas GJ, et al. Interest in quitting e-cigarettes among adult e-cigarette users with and without cigarette smoking history. JAMA Netw Open. 2021;4(4):e214146.

National Center for Health Statistics. National Health Interview Survey, 2023 and 2024. 2026 (https://www.cdc.gov/nchs/nhis.htm).Cornelius ME, Loretan CG, Jamal A, Davis Lynn BC, Mayer M, Alcantara IC, Neff L. Tobacco Product Use Among Adults - United States, 2021. MMWR Morb Mortal Wkly Rep. 2023 May 5;72(18):475-483.

Centers for Disease Control and Prevention.QuickStats: Percentage distribution of cigarette smoking status among current adult e-cigarette users, by age group-National Health Interview Survey, United States, 2021. MMWR Morb Mortal Wkly Rep. 2023;72:270.

Leigh, N. J., Page, M. K., Jamil, H., & Goniewicz, M. L. (2024). Characteristics and ingredients of disposable 'Elfbar'e-cigarettes sold in the United States and the United Kingdom. Addiction.

National Center for Health Statistics. Percentage of current electronic cigarette use for adults aged 18 and over, United States, 2019-2024. National Health Interview Survey. Generated interactively:

Jul 18 2025 from https://wwwn.cdc.gov/NHISDataQueryTool/SHS_adult/index.html 8

Confidential - Not for Public Consumption or Distribution

Cessation helps restore it

Dual-acting mechanism of action

NICOTINE DEPENDENCE TREATMENT NICOTINE CESSATION

Cytisinicline blocks some of the receptors so that nicotine can't get in

Cytisinicline is designed to provide just enough reinforcement to reduce craving

Dysregulated Dopamine Signaling Dopamine Signaling Normalization

Nicotine dependence is characterized by a cycle of craving and withdrawal mediated by nicotinic receptor signaling

Sources: 1. Perry D-1999; 2. Picciotto M-1998; 3. Coe, J.W.-2005; 4. Radchenko, E. V.-2015 10

ORCA-2 and ORCA-3: Efficacy, tolerability, craving reduction, broad patient response

30.0%

25.0%

Quit Rates

20.0%

15.0%

10.0%

5.0%

0.0%

6-week Cytisinicline Treatment Primary Endpoint (Weeks 3-6)

25.3%

4.4%

14.8%

6.0%

35.0%

30.0%

Quit Rates

25.0%

20.0%

15.0%

10.0%

5.0%

0.0%

12-week Cytisinicline Treatment Primary Endpoint (Weeks 9-12)

32.6%

7.0%

30.3%

9.4%

Odds Ratio: 8.0

(p<0.0001)

Odds Ratio: 2.85

(p=0.0008)

Odds Ratio: 6.3

(p<0.0001)

Odds Ratio: 4.4

(p<0.0001)

Source: ORCA-2: Rigotti NA, Benowitz NL, Prochaska JJ, et al. Cytisinicline for Smoking Cessation: A Randomized Clinical Trial. JAMA. 2023;330(2):152-160. ORCA-3: Rigotti NA, Benowitz NL, Prochaska JJ, et al. Cytisinicline for Smoking Cessation: The ORCA Phase 3 Replication Randomized Clinical Trial. JAMA Intern Med. Published online April 21, 2025. doi:10.1001/jamainternmed.2025.0628

Cytisinicline

Placebo

Cytisinicline demonstrates higher abstinence rates vs placebo

Point prevalence abstinence rates by week for placebo vs 6-weeks or 12-weeks cytisinicline

6-week Cytisinicline Treatment 12-week Cytisinicline Treatment

Abstinence by self-report of not smoking and verified by carbon monoxide < 10ppm

Source: ORCA-2 and ORCA-3 Pooled Phase 3 Results - Data on File; Achieve Life Sciences, Inc. 12

Adverse event profile compared to Chantix®

Comparative Analysis of Safety Events* Selective Receptor Targeting3

Treatment Time

Adverse Events

Nausea Insomnia

Abnormal Dreams Headache

Cytisinicline1 Varenicline (Chantix®)2

30%

18%

13%

15%

6.2%

10.8%

7.7%

8.1%

12 weeks 12 weeks

Cytisinicline3 Varenicline (Chantix®)2 Adverse Events

5-HT3

Nausea

α7

Sleep Disturbances

Headache, GI Upset

α4β2

Cytisinicline is >2000 fold less potent at 5-HT3 receptor4

α4β2

Chantix® is a registered trademark of Pfizer, Inc.

Data on file; Achieve Life Sciences ORCA-2 & ORCA-3 pooled data.

Chantix Prescribing Information, 6/2018 Pfizer, Inc.

Coe J et al. J. Med. Chem. 2005, 48:3474-3477; Papke RL et al. JPET. 2011, 337:367-379;

Slater YE et al. Neuropharm. 2003, 44:503-515; Lummis SCR et al. JPET. 2011, 339:125-131.

Lummis, SCR, Price,KL, Clarke A, SRNT-E 2020.

*Not a head-to-head comparison trial evaluation. 13

Efficacy and tolerability extend to heavier, more treatment-experienced smokers

32.6%

35.0%

Primary Endpoint (Weeks 3-6)

Primary Endpoint (Weeks 9-12)

Smoking cessation is the most impactful intervention for people living with COPD, and cytisinicline is being evaluated as a potential tool to support quitting.

5.5%

Aligns with Achieve's broader strategy to expand indications to vaping cessation and beyond

30.0%

25.0%

Quit Rates

20.0%

15.0%

10.0%

5.0%

6.3

5.3

Cytisinicline Pla5ce.8bo

0.0%

19.3%

8.6%

No-COPD

17.3%

2.1%

COPD

No-COPD

19.1%

4.3%

COPD

Odds Ratio: 4.1 Odds Ratio: 9.7 Odds Ratio: 5.2 Odds Ratio: 5.3

Prochaska, J., Rubinstein, M., Perdok, R., Blumenstein, B., & Jacobs, C. (2025). Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trials. Thorax.

Efficacy, tolerability, compliance, Phase 3 warranted

Phase 2 ORCA-V1 trial design

Key insights from vaping cessation trial

(N=160)

Arm A (N=53)

Randomize

Placebo TID 12 weeks + Behavioral support

Arm B (N=107)

3.0 mg Cytisinicline TID 12 weeks +

Behavioral support

Robust efficacy

Nicotine E-Cigarette Cessation Trial

Statistically significant quit rates despite small sample size

showing 2.6x (p=0.035) increased likelihood of quitting

Excellent tolerability

Follow- up

Favorable adverse event profile demonstrated, no serious adverse events reported

High-level compliance

Greater compliance observed in cytisinicline-treated arm compared to placebo

Phase 3 warranted

Strong evidence supporting use of cytisinicline for vaping cessation to be further evaluated in Phase 3 ORCA-V2 trial

Source: Rigotti NA, Benowitz NL, Prochaska JJ, et al. Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial. JAMA Intern Med. 2024;184(8):922-930.

Cytisinicline one of first nine treatments awarded CNPV

CNPV program accelerates the review of products that align with national priorities

Selected products must address large emerging public health needs such as crises, provide innovative cures, address unmet medical needs or enhance national security through drug development and manufacturing to advance the health interests of the U.S.

Rapid approval expected in 1-2 months compared to standard 10-12 months

Enhanced communication with FDA reviewers to streamline development and approval processes

Non-transferable designation

Clearly defined customer segments with high unmet need

Well-established therapeutic category

Ease of market entry

and prescribing

Quiet promotional landscape

Limited treatment options with nothing new since 2006 -most have tried and failed

Harms of smoking are

known - education to focus on optimal patient selection

ACA coverage expected

Favorable tolerability profile reduces HCP burden

No branded products to battle for share of voice and customer headspace - nothing new on the horizon

Lack of options for people who want to quit & for HCPs

~53% attempt to quit smoking annually2

~50% who saw an HCP received advice about quitting5

<10% successfully quit2

No new FDA-approved options in 20 years

CDC estimates 36% of people who smoke utilize Rx and OTC cessation treatments annually5

National Center for Health Statistics. National Health Interview Survey, 2023 and 2024. 2026 (https://www.cdc.gov/nchs/nhis.htm).

VanFrank B, Malarcher A, Cornelius ME, et al. Adult Smoking Cessation United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633-641

Estimate of $500/mo. Chantix pricing - 1 mo.. Rx/patient

Palmer AM, Smith TT, Nahhas GJ, et al. Interest in quitting e-cigarettes among adult e-cigarette users with and without cigarette smoking history. JAMA Netw Open. 2021;4(4):e214146.

Centers for Disease Control Smoking Cessation Fast Facts, accessed 2/8/25.

~25M1

adult smokers

~15.4M adults who smoke

attempt to quit annually2

$11 Billion

Estimated Rx

Opportunity3

~18M1

adult vape users

Estimated 60% want to quit4

Changing the Narrative about Nicotine Dependence

Medical Issue vs. Moral Issue

Drive Awareness & Education of Cytisinicline

First New Treatment in 20 Years

Focus at Launch on Audiences Most Likely to Take Action:

High-Volume Prescribers & Engaged Quitters

Cessation Rx Enthusiasts Highly Motivated Quitters

High prescribing volume of varenicline

Sizeable smoking population in practice

Actively initiates in cessation discussions and follows up

Prefers Rx to natural treatments

Favorable impression of cytisinicline

Heavy, long-term smoker embarrassed of habit and concerned about its health impact

Consider quitting a top priority

Confident in healthcare system and utilize it regularly

Proactively pursue Rx from doctor

Willing to take oral medication for 6-12 weeks

Source: ACHV Data on File; HCP & Patient Segmentation, Symphony Nicotine Dependence Claims Analysis 2023

Disclaimer

Achieve Life Sciences Inc. published this content on May 03, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 03, 2026 at 19:38 UTC.