Achieve Life Sciences, Inc. · NASDAQ:ACHV
Achieve Life Sciences — IPO Roadshow (December 2019)
39 slides from Achieve Life Sciences's IPO roadshow presentation, Dec 2, 2019
Slide 1: Corporate Presentation December 2019
Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333-234530 December 2, 2019 ACHIEVE Life Sciences NASDAQ:ACHV Corporate Presentation December 2019 1
Slide 2: Forward Looking Statements
Forward Looking Statements ACHIEVE Life Sciences 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, eff
Slide 3: Free Writing Prospectus
Free Writing Prospectus ACHIEVE Life Sciences This presentation highlights basic information about us and the offering. Because it is a summary that has been prepared solely for informational purposes, it does not contain all of the information that you should consider before investing in our compan
Slide 4: Corporate Overview
Corporate Overview 4
Slide 5: Cytisinicline: A Potential New Treatment for Millions of Smokers
Cytisinicline: A Potential New Treatment for Millions of Smokers ACHIEVE Life Sciences Achieve acquired the global rights* to cytisinicline from Sopharma AD Exclusively focused on the development and commercialization of cytisinicline for smoking cessation & nicotine addiction Robust Historical Data
Slide 6: Cytisinicline – Strong Value Proposition
Cytisinicline – Strong Value Proposition ACHIEVE Life Sciences Well-differentiated Product Profile Solid Foundation of Clinical Evidence Significant Market & Growth Potential Addresses Global Public Health Epidemic Single & short course of treatment Dual-acting, highly selective MOA – improved toler
Slide 7: Significant Opportunity to Expand Smoking Cessation Treatment Utilization with Cytisinicline
Significant Opportunity to Expand Smoking Cessation Treatment Utilization with Cytisinicline ACHIEVE Life Sciences Why so low market penetration of current treatment options? Favorable reimbursement for all smoking cessation medications ACA mandates coverage for smoking cessation medications includi
Slide 8: Vaping epidemic leading to new population of nicotine addicts
Vaping epidemic leading to new population of nicotine addicts ACHIEVE Life Sciences 10.8M American Adults Use E-Cigarettes1 In 2018, 4.8M youth used tobacco products2 E-Cigarettes most commonly used by youth2 As of Nov. 2019, over 2,000 cases of vaping related lung injury have been reported and 47 d
Slide 9: FDA Failed Crackdown on Nicotine
FDA Failed Crackdown on Nicotine ACHIEVE Life Sciences In July 2017, the FDA announced plans to cut the level of nicotine allowed in cigarettes¹ In November 2019, the FDA abandoned the plan to slash cigarette nicotine levels More people in the U.S. are addicted to nicotine than to any other drug² Th
Slide 10: Cytisinicline Planned Development Program & Milestones
Cytisinicline Planned Development Program & Milestones ACHIEVE Life Sciences Activity Anticipated Timing ORCA-1 Phase 2b Top Line Data Results Q2 2019 MTD Study Top Line Results Q3 2019 Type C FDA Meeting Q4 2019 ORCA-1 Additional Phase 2b Results Presented Q1 2020 ORCA-2 Phase 3 Trial Initiation 1H
Slide 11: Proven Leadership Team
Proven Leadership Team ACHIEVE Life Sciences Achieve founders Richard Stewart, Chairman & CEO, and Anthony Clarke, President, CSO and Director, have a proven track record of value creation for shareholders. Mr. Stewart: CEO Dr. Clarke: CSO Huxley Pharmaceuticals Mr. Stewart: CEO Dr. Clarke: CSO Amar
Slide 12: The Cytisinicline Difference
The Cytisinicline Difference Dual-Acting, Highly-Targeted MOA Single & Short Treatment Very Well-Tolerated 12
Slide 13: Dual-Acting MOA Specifically Targets α4β2 Nicotine Receptors
Dual-Acting MOA Specifically Targets α 4 β 2 Nicotine Receptors ACHIEVE Life Sciences Activity 1: Partial Agonist Cytisinicline binds to the receptor partially stimulating dopamine release Reduces nicotine cravings Reduces the severity of withdrawal symptoms Activity 2: Partial Antagonist Cytisinicl
Slide 14: Cytisinicline vs. Chantix® MOA
Cytisinicline vs. Chantix® MOA ACHIEVE Life Sciences Cytisinicline1 Varenicline (Chantix®)2 More selective Less selective Selective Receptor Targeting* α4β2 α4β2 α7 5-HT3 Cytisinicline has high affinity & selective binding to α4β2 receptors in brain Varenicline’s activity at “off-target” receptors c
Slide 15: Cytisinicline’s Relative Efficacy Profile
Cytisinicline’s Relative Efficacy Profile ACHIEVE Life Sciences Cytisinicline vs Varenicline Pooled RR based on 2 published studies N=937 RR (CI95%) longest follow-up 3.98 (2.01-7.87) Pooled RR based on 27 published studies N=12,625 RR (CI95%) longest follow-up 2.24 (2.06-2.43) Relative “Risk” (RR)
Slide 16: Cytisinicline vs. Chantix® Adverse Event Profile
Cytisinicline vs. Chantix® Adverse Event Profile ACHIEVE Life Sciences Cytisinicline1 Varenicline (Chantix®)2 Treatment Time 25 days 12 weeks 2018 U.S. Sales -$838 million3 Adverse Events (95% CI) Nausea/Vomiting 4.4% 27.8% Sleep Disorder/Abnormal Dreams 3.3% 12.5% Insomnia 1.3% 14.2% Headache 2.0%
Slide 17: Cytisinicline vs. Chantix® - RAUORA Study
Cytisinicline vs. Chantix® - RAUORA Study ACHIEVE Life Sciences The RAUORA Study is a single investigator led study in New Zealand comparing Tabex (contains cytisine) and Champix® 2,140 patient randomized study Primary outcome is CO verified continuous abstinence at 6 months post-quite date 12 week
Slide 18: Cytisinicline Clinical Development
Cytisinicline Clinical Development 18
Slide 19: Cytisinicline Clinical Profile
Cytisinicline Clinical Profile Solid Foundation of Clinical Evidence ACHIEVE Life Sciences Two, investigator-led Phase 3 clinical trials conducted in more than 2,000 patients published in NEJM* Phase 3 TASC* trial – cytisinicline versus placebo (n=740)Phase 3 CASCAID** trial— cytisinicline versus NR
Slide 20: Investigator-Led Phase 3 Trials of Cytisinicline
Investigator-Led Phase 3 Trials of Cytisinicline ACHIEVE Life Sciences Design Comparator Key Endpoints Results TASC N=740 Aged 18 or over; randomized 1:1 Double-blind, placebo-controlled Minimal behavioral support Placebo 25-day cytisinicline dosing regimen or matched placebo 6 & 12-month quit rates
Slide 21: ORCA-1 Phase 2b Dose Selection Study (N=254)
ORCA-1 Phase 2b Dose Selection Study (N=254) ACHIEVE Life Sciences Objective: To optimize Phase 3 trial planning for dosing, scheduling, compliance and efficacy rates in U.S. Evaluate safety and efficacy of 1.5mg and 3mg of cytisinicline vs placebo administered over 25 days All subjects to receive s
Slide 22: ORCA-1 Dose Selection Study Results: Baseline Subject Demographics
ORCA-1 Dose Selection Study Results: Baseline Subject Demographics TID Downward Titration 1.5 mg (n=52) 3.0 mg (n=50) 1.5 mg (n=51) 3.0 mg (n=50) Pooled Placebo (n=51) ALL (n=254) Smoking duration (mean years) 30.9 30.0 33.3 33.2 33.0 32.1 Daily smoking (median cigarettes) 20 18 20 20 20 20 Prev. qu
Slide 23: ORCA-1 Results: Statistically Significant Efficacy Observed for 3.0 mg TID
ORCA-1 Dose Selection Study Results: Statistically Significant Efficacy Observed for 3.0 mg TID ACHIEVE Life Sciences Characteristic 3.0 mg CYT (N=50) Placebo (N=51) P Value Reduction in expired CO 1 80% 38% p = 0.003 4 Week Abstinence 2 54% 16% p < 0.001 Continuous Abstinence (Weeks 5-8) 3 30% 8% p
Slide 24: ORCA-1 Results: Biochemically Confirmed Reduction in Cigarette Consumption
ORCA-1 Dose Selection Study Results: Biochemically Confirmed Reduction in Cigarette Consumption ACHIEVE Life Sciences Subjects on cytisinicline experienced a 74-80% median reduction in cigarettes smoked, compared to a 62% reduction for placebo Expired CO levels declined by a median of 71-80% in the
Slide 25: ORCA-1 Results: Significant Increase in Quit Rates Across All Cytisinicline Arms
ORCA-1 Dose Selection Study Results: Significant Increase in Quit Rates Across All Cytisinicline Arms ACHIEVE Life Sciences All cytisinicline arms demonstrated statistically significant end of treatment quit rates (>= 50%; p<0.001) TID administration outperformed the downward titration groups at bot
Slide 26: ORCA-1 Results: Confirmation of Safety & Tolerability
ORCA-1 Dose Selection Study Results: Confirmation of Safety & Tolerability ACHIEVE Life Sciences Most commonly reported (>5%) side effects from ORCA-1: Adverse Event 3.0 mg TID (n=50) Pooled Cytisinicline (n=203) Placebo (n=51) At least 1 AE 42% 46% 47% Upper Respiratory Tract Infections 6% 6% 14% N
Slide 27: Next Steps for Cytisinicline Development: Phase 3 Plans
Next Steps for Cytisinicline Development: Phase 3 Plans ACHIEVE Life Sciences 3.0 mg TID dosing selected for P3 development Best safety & efficacy demonstrated in ORCA-1 Extend dosing period from 25 days to 42 days (6 weeks) Potential to increase quit rates seen in ORCA-1 Evaluate abstinence rates d
Slide 28: Pivotal Phase 3 Study Design
Pivotal Phase 3 Study Design ACHIEVE Life Sciences Primary Endpoint: Biochemically verified continuous abstinence during the last 4 weeks of treatment Arm B: Weeks 3-6 Arm C: Weeks 9-12 Secondary Endpoint: Continuous abstinence from end of treatment through week 24 Objective: Evaluate safety and eff
Slide 29: U.S. NDA-Supportive Trials: Completed and Planned
U.S. NDA-Supportive Trials: Completed and Planned ACHIEVE Life Sciences Study Completed / Status Food Effect PK Clinical Study ✓ Repeat Dose PK/PD Clinical Study ✓ Reproductive Toxicology One study ongoing and two completed in Q4 2017 (NCI supported) Drug to Drug Interaction ✓ Chronic Toxicology 6 m
Slide 30: Market Opportunity
Market Opportunity 30
Slide 31: Why Smoking Cessation?
Why Smoking Cessation? ACHIEVE Life Sciences Tobacco use causes more than 8 million deaths per year, globally 1 Nearly 480,000 deaths in the U.S. annually or 1,300 per day 2 Nearly 35M U.S. adults still smoke cigarettes 3 and 4.8M youth use tobacco products 4 Each year in the U.S., nearly $300B spen
Slide 32: So, Quit Already!
So, Quit Already! ACHIEVE LIFE SCIENCES Treatment options are limited with nothing new in over a decade Chantix (varenicline) and ZYBAN® (bupropion hydrochloride) Both are oral drugs given on average for 12 weeks Safety has been a concern with both treatments including historic black box warnings Ni
Slide 33: Broad Product Protection
Broad Product Protection ACHIEVE LIFE SCIENCES PATENT APPLICATIONS REGULATORY EXCLUSIVITY API SUPEXCLUSIVEPLY SECOND GENERATION CYTISINICLINE • Several patent families pursued globally including formulation, method of use, extraction • Issued patents – new cytisinicline salt formulation • Ongoing di
Slide 34: Capitalization
Capitalization 34
Slide 35: Capitalization
Capitalization ACHIEVE LIFE SCIENCES ▪ C a s h , c a s h e q u i v a l e n t s a n d i n v e s t m e n t s o f ~ $ 7 . 4 M a s S e p t e m b e r 3 0 , 2 0 1 9 ▪ N o d e b t ▪ C a p i t a l i z a t i o n ( a s o f N o v . 6 , 2 0 1 9 ) : C o m m o n S h a r e s O u t s t a n d i n g 8,352,764 Warrant
Slide 36: Investment Highlights
Investment Highlights ACHIEVE LIFE SCIENCES Cytisinicline well-positioned to address global tobacco public health epidemic ▪ A d d r e s s e s t o b a c c o & n i c o t i n e a d d i c t i o n , l e a d i n g c a u s e o f c a n c e r a n d c a r d i o v a s c u l a r d i s e a s e - r e l a t e d d
Slide 37: Thank You!
ACHIEVE LIFE SCIENCES Thank You! 37
Slide 38: Achieve Management Team
Achieve Management Team ACHIEVE LIFE SCIENCES Rick Stewart, Chairman & Chief Executive Officer John Bencich, MBA, EVP, Chief Financial & Operations Officer Anthony Clarke, PhD; Chief Scientific Officer Cindy Jacobs, PhD, MD; EVP, Chief Medical Officer Jaime Xinos, EVP, Commercial Nearly 25 years of
Slide 39: Achieve Board of Directors
Achieve Board of Directors Rick Stewart, Chairman & Chief Executive Officer Anthony Clarke, PhD; Chief Scientific Officer Donald Joseph, Lead Independent Director Jay Moyes, Audit Chair Dr. Martin Mattingly, Compensation Committee Chair Stewart Parker, Nominating & Corporate Governance Chair Scott C