Achieve Life Sciences, Inc. · NASDAQ:ACHV
Achieve Life Sciences — Oncogenex Pharmaceuticals — Merger or Acquisition (June 2017)
33 slides from Achieve Life Sciences's merger presentation, Jun 13, 2017
Slide 1: Rule 425 filing legend
Filed by OncoGenex Pharmaceuticals, Inc. Pursuant to Rule 425 under the Securities Act of 1933 Deemed filed pursuant to Rule 14a-12 of the Securities Exchange Act of 1934 Subject Company: OncoGenex Pharmaceuticals, Inc. Commission File No.: 033-80623 Achieve Life Science, Inc. plans to present the f
Slide 2: Achieve Life Sciences June 2017
ACHIEVE LIFE SCIENCES June 2017
Slide 3: Forward-looking statements
Thiseconomic expected Inc. regulatory objectives, Life intentions number Achieve transaction and process forward-looking (OncoGenex) Science, presentation of or ownership or developing, approval; risks, expectations may OncoGenex meet Inc. conditions; not uncertainties statements contains (Achieve)
Slide 4: Additional information about the proposed merger
This communication Pharmaceuticals, contains proxy OncoGenex, STATEMENT/PROSPECTUS/INFORMATION SUPPLEMENTS) INFORMATION statement/prospectus/information information Creek statement/prospectus/information Parkway, a preliminary about Achieve, Suite Inc. THAT OncoGenex, ANDisand 201, the proxy being S
Slide 5: Participants in the solicitation
This the jurisdiction with Participants OncoGenex merger. proxy Achieve stockholder becomes communication statement Achieve proposed may available. in vote in and have which Solicitation on its and onmerger in executive Schedule matters its shall such theofficers transaction shall offer, not relatin
Slide 6: Achieve Life Sciences: specialty pharmaceutical company advancing cytisine
Achieve Life Sciences is a specialty pharmaceutical company committed to advancing cytisine as a smoking cessation aid to overcome the global tobacco addiction epidemic
Slide 7: Merger strengthens Achieve and provides access to public markets
Builtclinical Founded Skyepharma, One Strategic Transition Strengthens Delivers Provides Key *Excluding ofaround the capital in access merger from largest 2015 Eastern clinical/regulatory/financial development cytisine—a Amarin, privately towith by generic continue public Europe, Rick OncoGenex Huxl
Slide 8: Cytisine highlights and regulatory path
Cytisine Safety Both Marketed Rapid FDA Pivotal Clear Single ® Registered published meeting differentiation path and 25 Phase isday inefficacy well toCentral trademark regulatory 3clarified short-course in trial positioned NEJM supported in and of regulatory the cytisine of Eastern approval U.S. for
Slide 9: Large global market and unmet need in smoking cessation
Large Global Addresses An The 36.5 Significant Despite 70% 40% Up It Economic *Smoking-related **Coherent isCenters estimated to estimated NIH million of60% attempted and smoking current existing and expanding cost afor of unmet Market global people WHO 1quitters that Disease of smokers to billion c
Slide 10: Current smoking cessation treatment landscape
Current The Available Generally There Both Safety Favorable Strong Up Coverage All ® Registered to branded most are 2are has U.S. quit smoking oral common two both includes shown reimbursement been commercial smoking attempts drugs trademark prescriptions OTC a cessation to concern counseling treatm
Slide 11: Chantix, NRT and Zyban market position
On track Chantix NRT Zyban Primarily IMS Health, market monthly usage leads faces for due$1 QuintilesIMS, is lags limited to the unit highly billion poor other U.S. volume resistance safety fragmented prescription in therapies global isMay profile ~2/3 with sales 2017 but ofmarket including current
Slide 12: Cytisine mechanism and profile
MOA Characterized Well 4nicotinic Cytisine Strong In-Market Two Over Anticipated IND Pathway Pivotal Expected Short Profile Competitive Excellent *Comparable 2 nicotinic Cahill Phase enabling 10,000 21 15 course Phase Phase Kmillion is interrupts acetylcholine IND NDA safety Data et a3Regulatory eff
Slide 13: Cytisine development milestones
Mid17 Cytisine 1H 2017 Initiate 2018 NDA/MAA Phase Q3 2019 Completion Q2 EU 2H Food Potential 2018/2019 NDA 202018 19 regulatory 17 effects submission 3phase completion IND to file of enabling (fed/fasted) 3pathway non-clinical merger study decentralized MAA study with discussions submission study w
Slide 14: Cytisine Clinical Profile & Development Plan
Cytisine Clinical Profile & Development Plan
Slide 15: Extensive clinical experience with cytisine
Extensive More Two Phase Anti-addiction Dosage *Cytisine ** West Walker large, than 3etstarts TASC* dose al; clinical et 10,000 Phase N al; high reductions dosing Engl trial N3and participants Engl and clinical J–cytisine Med; schedule in-market isJduring reduced Med; trials 365:13 versus in371:25 c
Slide 16: Phase 3 trial in moderate-to-heavy smokers (N=740)
Moderate-to-Heavy N=740 Aged Randomized 25-day 6Key Double-blind, Design Conducted Cytisine Results cytisine West & 12-month Endpoints et 18cytisine al; group vs. 3.4 orNin over; Placebo times 1:1 Engl Poland randomized, quit No dosing serious more Jrates smokers Med; with regimen likely biochemical
Slide 17: Phase 3 trial versus NRT (N=1,310)
Heavy N=1,310 25-day (patch Key 1, Randomized, Design Conducted Cytisine Results published related Walker 2, Endpoints &&/or smokers adverse cytisine 6-month et1.43 vs. al; inby gum NRT The Nopen-label, times University events Engl dosing Aged quit or Lancet lozenge) more Jrates 18 with Med; regimen
Slide 18: NDA/MAA enabling studies and pivotal Phase 3 plan
Impact N=24; Crossover NDA/MAA Repeat Phase 3Pivotal -N=2,100 Patients Primary: Secondary: arms31single –of dose registration will standard food trial—fasted Biochemically enabling PK be Abstinence dose on provided study dose cytisine trial study studies Renal cytisine, subjects rate behavioral veri
Slide 19: Cytisine Competitive Advantage
Cytisine Competitive Advantage
Slide 20: Differentiated dosing schedule
-Classic 6Cytisine 242.5 Day Differentiated Shorter Applicability Unlike tablets hrs 1-3: 4-12: 13-16: 17-20: 21-24: 25:2.5 anti-addiction time 1varenicline titrates dose 9mg 6mg 3mg 2tablet 5hrs 3tablets 64-5 on hrs in reductions dosing 2.5 2hrs medication urgent from 1.5mg hrs 63hrs hrs 4-5 7.5mg
Slide 21: Cytisine partial agonist mechanism
Cytisine Partial -This *Rollema Cytisine Reduces dual agonistic specifically action H partially nicotine theetpleasurable severity al.activity TIPS. cravings stimulates blocks targets of2007, at nicotine sensation receptors, 4b2 the receptors, 28 that 4 2(7):316-325. withdrawal nicotinic binds of bl
Slide 22: Cytisine versus varenicline receptor selectivity
Low Varenicline High Site 75Brain Periphery *Coe Cytisine -HT3 Receptor affinity affinity uptake J4et 2has al. 3 has 4into aJ. binding selective Cytisine more Med. a brain lessselective Chem. to selective binding Varenicline combined 7 & 2005, 5-HT3 receptor to receptor with 448:3474-3477; 2inrecept
Slide 23: Most commonly reported adverse events
Most Cytisine(*) Adverse Nausea/Vomiting (3.0% 3Sleep — (1.7% .6%) (0.03% commonly Insomnia 2Headache (0.9% .3%)on Data Cahill –(12.0% Event –5.4%) Varenicline(**) 0.2% et (95% 0.68%) 1.4% file; al; (26.8% reported 4.1% Disorder/Abnormal K(11.8% — 14.2% Achieve CI)27.8% 13.3%) (15.6% 12.7% 13.5%) Co
Slide 24: Cytisine and varenicline pooled efficacy comparison
Cytisine Pooled Varenicline Cochrane Relative days *Cahill vs.RR Kvarenicline “Risk” risk Group etbased al; versus Cochrane (RR) independent onplacebo for 2defined 27published 12 published Database orfor more meta asboth the studies studies analysis weeks of likelihood cytisine Systematic N=937 N=12
Slide 25: Commercial Overview
Commercial Overview
Slide 26: Commercial strategy and lifecycle opportunities
Sales Direct Strategic China/Japan/Rest U.S., Out Lifecycle Rx Expanded New Evaluate Multiple Partnership tolicense formulation/ EU & OTC commercialization Marketing indication potential Partnering hospital Primary &label Switch with Pipeline and University of & Care administration OTC Focus opportu
Slide 27: Regulatory exclusivity and intellectual property
Regulatory U.S.—5 5-6 Ability Filed Dosage Method Exclusive Nextyear generation and to form of API years planned synthesize API license manufacturing/extraction exclusivity lead Formulation under supply highly agreement time patent Hatch-Waxman cytisine from Single targeted estate Method Sopharma wi
Slide 28: Sopharma API exclusive supply agreement
Sopharma API Exclusive EU-GMP Opened & solid November compliant supply ADdosage agreement 2013 manufacturer state-of-the-art Capacity for 100% 4 pharmaceutical billion of Achieve’s tablets cytisine manufacturing requirement Supply for clinical trials and commercial use Competitive cost of goods
Slide 29: Corporate Profile
Corporate Profile
Slide 30: Pro forma combined company
Upon Clinical -Achieve Pro Achieve OGXI forma completion shareholders development, Life will will (combined retain Science, explore ofapatorsen, the are company) regulatory Inc. strategic merger, expected andaOncoGenex solutions drug Achieve cash, and to receive designed finance cash shareholders fo
Slide 31: Management team
RickClinical Chairman CEO Founder John CFO Cindy CMO Anthony CSO VP Stewart Bencich, CFO CSO of CMO Jacobs, Allozyne Trubion Amarin Huxley &Clarke, & of CBO Development, and of CEO Chairman Integrated Brabant PhD, MBA, Corixa Pharma Corp Regulatory, Pharmaceuticals PhD ofof CEO SkyePharma MD Huxley
Slide 32: Investment highlights summary
Large21 Substantial High formulations De-risked Over Safety Clear Single Distinct probability product market and short MOA million clinical efficacy global course opportunity differentiation with patients ofdevelopment commercial of shown clinical compelling treatment already with insuccess 2 opport
Slide 33: Achieve Life Sciences
Lo ACHIEVE LIFE SCIENCES
Oncogenex Pharmaceuticals — Merger or Acquisition (June 2017) on 6ix