Achieve Life Sciences, Inc. · NASDAQ:ACHV
Achieve Life Sciences — IPO Roadshow (June 2018)
36 slides from Achieve Life Sciences's IPO roadshow presentation, Jun 6, 2018
Slide 1: Corporate Presentation June 2018
Nasdaq: “ACHV” Corporate Presentation June 2018 Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333-224840 June 6, 2018
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 cytisine; the projected path toward potential regulatory approval; the safety, efficacy and commercial potent
Slide 3: Free Writing Prospectus
Free Writing Prospectus This presentation highlights basic information about us and the contemplated 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 company. Except
Slide 4: Focused on preventing smoking-related diseases rather than treating them
Focused on preventing smoking-related diseases rather than treating them Cytisine for the treatment of nicotine addiction Completed NIH-sponsored non-clinical update Completed Phase 1 fed-fasted study Completed Phase 1/2 repeat-dose PK/PD study Preparing for Phase 2b trial Phase 3 trials and NDA pla
Slide 5: Proven Leadership Team
Proven Leadership Team Achieve founders Richard Stewart, Chairman & CEO, and Anthony Clarke, President, CSO and Director, have a proven track record of value creation Brabant Pharma sold to Zogenix, Inc. (NASDAQ:ZGNX) in 2014 $130M in upfront & milestone payments, NDA submission 2018 Huxley Pharma s
Slide 6: Achieve At a Glance
Achieve At a Glance Exclusively focused on development and commercialization of cytisine Founded in 2015 by Rick Stewart and Dr. Anthony Clarke Acquired global* rights to cytisine from Sopharma AD Sopharma is a leading generics company in Europe - has manufactured and marketed cytisine for over 20 y
Slide 7: Recent Milestones
Recent Milestones Completion of NIH-sponsored non-clinical update March 2017 FDA acceptance of cytisine IND July 2017 Completion of Phase 1 fed-fasted study November 2017 Expansion of partnership with University of Bristol for next generation cytisine therapies January 2018 Completion of Phase 1/2 r
Slide 8: Cytisine – Strong Value Proposition
Favorable safety & efficacy from 2 prior Phase 3 trials in >2,000 patients More than 20M patients treated to date Solid Foundation of Clinical Evidence 1.1B smokers worldwide – more than 36M in U.S. 1 Smoking cessation market ~ $13B in 20163 Most prescribed Rx (CHANTIX® - varenicline) sales of $997M
Slide 9: The Cytisine Difference
The Cytisine Difference Dual-Acting, Highly-Targeted MOA Single & Short Treatment Anti-Addiction Dosing Schedule
Slide 10: Dual-Acting MOA Specifically Targets α4β2 Nicotine Receptors
Activity 1: Partial Agonist Cytisine binds to the receptor partially stimulating dopamine release Reduces nicotine cravings Reduces the severity of withdrawal symptoms Activity 2: Partial Antagonist Cytisine binding to the receptor prevents the binding of nicotine Removes the “nicotine-induced” rewa
Slide 11: Dual-acting MOA Specifically Targets α4β2 Nicotine Receptors
Dual-acting MOA Specifically Targets α4β2 Nicotine Receptors Current Smoker Increased nicotine receptors Increase sensitivity of receptors Treatment Completion Receptors normalized Nicotine receptors Nicotine Increased dopamine release Rapid burst firing Cytisine Treatment Initiation Receptors parti
Slide 12: Advantages Over Current Treatments
Less selective receptor targeting High uptake into brain combined with activity at “off-target” receptors could be responsible for varenicline’s adverse event profile Advantages Over Current Treatments More selective receptor targeting High affinity selective binding to α4β2 receptors in brain Low a
Slide 13: Compelling Safety & Tolerability
Compelling Safety & Tolerability Most commonly reported side effects: Adverse Event (95% CI) Cytisine* Varenicline** Nausea/Vomiting 4.1% (3.0% – 5.4%) 27.8% (26.8% - 28.8%) Sleep Disorder/Abnormal Dreams 2.5% (1.7% - 3.6%) 12.5% (11.8% - 13.3%) Insomnia 0.2% (0.03% – 0.68%) 14.2% (15.6% - 14.9%) He
Slide 14: Cytisine’s Relative Efficacy Profile
Cytisine’s Relative Efficacy Profile Cochrane Group independent meta analysis of nicotine receptor partial agonists* Relative risk versus placebo for both cytisine and varenicline were in the same order of magnitude A head-to-head between cytisine and varenicline has not been performed Cytisine trea
Slide 15: Classic anti-addiction dosing schedule
Classic anti-addiction dosing schedule Cytisine titrates from 9mg/day to 1.5mg in typical anti-addiction approach Unlike varenicline, steady-state dosing Cytisine dose reductions during course of therapy reflect decreased nicotine dependence Differentiated dosing schedule has distinct competitive ad
Slide 16: Cytisine Clinical Profile & Development Plan
Cytisine Clinical Profile & Development Plan
Slide 17: Cytisine Clinical Profile
Cytisine Clinical Profile Solid Foundation of Clinical Evidence Two, investigator-led Phase 3 clinical trials conducted in more than 2,000 patients published in NEJM* Phase 3 TASC* trial – cytisine versus placebo (n=740) Phase 3 CASCAID** trial— cytisine versus NRT (n=1,310) In both trials, cytisine
Slide 18: TASC and CASCAID Phase 3 Trials
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 cytisine dosing regimen or matched placebo 6 & 12-month quit rates biochemically confirmed Cytisine 3.4 times more likely to result in smoking
Slide 19: NIH-Sponsored IND-Enabling Studies Completed
Study GLP Status Single dose range finding toxicity study in Sprague Dawley rats Non-GLP 7-day repeat-dose range finding toxicity study in Sprague Dawley rats Non-GLP 28-day repeat-dose toxicity study in Sprague Dawley rats GLP Respiratory safety pharmacology assessment in Sprague Dawley rats GLP CN
Slide 20: Repeat Dose PK/PD Preliminary Study Results
Abstinence Rates (Biochemically verified) on Day 26 Cytisine 1.5 mg 50% (6/12) Cytisine 3.0 mg 67% (8/12) Overall 58% (14/24) Repeat Dose PK/PD Preliminary Study Results: Significant Efficacy Signals Observed Average Cigarettes Smoked Per Day Note: Preliminary results from subjects in the age 18 to
Slide 21: Planned Phase 2b Optimization Study
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 cytisine vs placebo administered over 25 days All subjects to receive standardized behavioral support and will be followed up out to 8 weeks Pop
Slide 22: Cytisine Planned Development Program & Milestones
Cytisine Planned Development Program & Milestones Q3 Phase 2b Enrollment Period Enrollment start Enrollment complete LPLV Data results Q4 Activity Anticipated Timing Drug to drug interaction study results Q2 2018 Fed/fasted study results with new formulation Q3 2018 First patient enrolled P2b Q4 201
Slide 23: Study Status
Study Status Food Effect PK Clinical Study Initiated in Q2 2018 Repeat Dose PK/PD Clinical Study Completed – Preliminary results announced in Q1 2018 Reproductive Toxicology Completed in Q4 2017 (NCI supported) Drug to Drug Interaction Completed in Q2 2018 (Standard DDI studies ) Chronic Toxicology
Slide 24: Commercial Overview
Commercial Overview
Slide 25: Cytisine Profile Enables Differentiated Positioning
3-months of treatment required High number of drop offs reported after 1-month of treatment Less selective receptor targeting High uptake into brain combined with activity at “off-target” receptors could be responsible for varenicline’s adverse event profile Unfavorable side effect profile and histo
Slide 26: Quitting is Hard
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 Nicotine replacement ineffective and creat
Slide 27: High Unmet Need for New Treatments
Chantix dominates U.S. market (83% share) due to high pricing and favorable reimbursement environment 74% of global Chantix sales attributed to U.S. market ($742M) From a patient share perspective, Chantix only captures ~30% of overall treated market ~2.7M U.S. Chantix prescriptions written annually
Slide 28: U.S. Provides Large Market Opportunity
U.S. Provides Large Market Opportunity Plan to commercialize cytisine with efficient launch plan and sales effort Highly targeted customer segmentation to aid feasibility and early adoption ~20% of prescribers write ~60% of all Chantix scripts in the U.S. Innovation through digital channels, both di
Slide 29: Broad Product Protection
Several Patent Families pursued globally including formulation, method of use, extraction Issued patents – New cytisine salt formulation Ongoing discovery and other development work in providing additional IP opportunities PATENT APPLICATIONS Hatch-Waxman – 5 years for NCE Europe – Up to 10 years in
Slide 30: Manufacturing & Supply Chain
Manufacturing & Supply Chain API & solid dosage manufacturer Exclusive supply agreement for 100% of Achieve’s cytisine requirement Supply for clinical trials and commercial use Competitive cost of goods EU-GMP compliant state-of-the-art pharmaceutical manufacturing Opened November 2013 Capacity 4 bi
Slide 31: Corporate Profile
Corporate Profile
Slide 32: Corporate Overview
Corporate Overview Achieve Life Sciences (Nasdaq: ACHV) listed August 2017 13 full-time employees Offices in Vancouver, BC and Seattle, WA Cash, cash equivalents and investments of ~$4.4M as March 31, 2018 No debt Capitalization (as of March 31, 2018*): Common Shares Outstanding 1,274,793 Options (W
Slide 33: Investment Highlights
*PFE Q4 & 2017 YE Results Investment Highlights Novel MOA positions Achieve to significantly impact the global public health epidemic of tobacco addiction Addresses tobacco addiction, a major driver of both cancer and cardiovascular disease deaths MOA differentiation from leading approved products,
Slide 34: Achieve Management Team
Achieve Management Team Rick Stewart, Chairman and Chief Executive Officer John Bencich , MBA, CPA; EVP, Chief Financial and Operations Officer Over 22 years of experience in the pharmaceutical industry having founded and served as CEO for private and public companies Ricanto , Renown Pharma , Braba
Slide 35: Achieve Board of Directors
Achieve Board of Directors Rick Stewart, Chairman and Chief Executive Officer Anthony Clarke, PhD; Chief Scientific Officer Jay Moyes , Audit Chair Donald Joseph, Lead Independent Director Over 20 years of biopharmaceutical industry experience with senior management positions in global health non-pr
Slide 36: Achieve Life Sciences
ACHIEVE | LIFE SCIENCES