SANIONA COMPANY PRESENTATION JANUARY, 2015 January 2015 1 AGENDA Understanding the values of Saniona Our research and product portfolio Financial position and new issue of shares January 2015 2 RISK AND REWARDS January 2015 3 BENCHMARK ACQUISITION Convergence Pharmaceuticals Ion channel products Lead program in Phase 2 for neuropathic pain Biogen Idec acquired Convergence for a total of up to $675 million on Jan 11 $200 million in upfront $475 million in milestones Saniona is currently raising SEK 24M at a premoney valuation of SEK 97M with the aim of taking AN363 through Phase 1 clinical development for neuropathic pain This project is one of 16 programs of which five are active today. January 2015 4 WHAT HAVE WE ACHIEVED THE LAST YEAR February 2014 Pfizer agreement March Biogen and Atlas Ventures invest up to USD 17 million into Saniona’s ataxia program April Saniona raises SEK 17 million in IPO and are listed on AktieTorget in April July Saniona selects AN363 development candidate and initiate preclinical development with the aim of initiating Phase 1 in Q4 2015 August Janssen and Saniona extend research collaboration with 12 months September Ataxion and Saniona extend research collaboration with 12 months October Tesofensine acquired – unique phase 2 obesity/diabetes asset November Risk sharing agreement for development of AN363 November Pain data on AN363 presented December Biogen/Atlas research milestone January 2015 New rights issue of 24 mill SEK January 2015 Pfizer research milestone January 2015 5 2015 MILESTONE TRIGGERS (12-15 MONTHS) Partnerships Milestone in research collaboration with Pfizer Selection of clinical candidate with a partner Potential additional partnerships based on ongoing and future discussions Internal pipeline AN363 GMP manufacture and tox studies IND/CTA regulatory filing and approval Initiation of phase 1 Positioning of tesofensine for partnering and further clinical studies Progression of at least one of the current clinical asset together with partners Selection of 2nd preclinical candidate January 2015 6 UNDERSTANDING THE VALUES OF SANIONA Products 5 active programs and >10 other opportunities • more than euro 250 mill invested in assets Pipeline Three big pharma partnerships • Pfizer, Johnson&Johnson, Biogen/Atlas • Full financing of drug discovery • Major upside potential Partnerships World class ion channel team Platform January 2015 7 SANIONA STRATEGY Saniona follows three main strategies Research collaborations with partners Saniona projects Two ongoing collaborations: – Pfizer and Janssen Own development Partners Own early phase development Janssen Alliance Pfizer Alliance AN346 AN363 CNS Neurology IBD Chronic pain Outlicensing planned in clinical phase Potassium channel modulator Spin out Financed by venture/Pharma partner: Biogen/Atlas and Ataxion is an example Ataxia Biogen/Atlas Ataxion January 2015 8 CURRENT PARTNERSHIPS Collaboration based on Saniona ion channel program for neurological indications Pfizer has exclusive commercialisation rights Up to 52M USD in milestone payments plus royalties on product sales Financed by Pfizer Collaboration based on Saniona ion channel program for treatment of diseases of the central nervous system (CNS) Janssen has an option to obtain exclusive commercialisation rights Up to 75M € in milestone payments plus royalties on product sales Financed by Janssen Ataxion is a spin-out (USA) from Saniona Biogen has an option to acquire company following Phase 1 Up to 14% of acquisition price plus royalties on product sales Financed by Biogen Idec and Atlas Venture (US$ 17 million) January 2015 9 OUR PIPELINE Product or program Indication Preclinical research Active and currently supported program s AN363 Neuropathic pain AN346 Inflammation, IBD Janssen program CNS Ataxion program Ataxia Pfizer program Neurological disease Other internal programs CNS Program s subject to partnering or spinouts Tesofensine monotherapy Obesity Tesofensine combination therapy Obesity AN788 Depression AN761 Cognitive impairment January 2015 10 Preclinical Clinical developm ent Phase 1 Clinical Phase 2 AN363 FOR NEUROPATHIC PAIN Class GABA Modulator Status Preclinical development Phase 1 to be initiated in Q4 2015 Indication Neuropathic pain Prevalence + 10 mill globally Market + USD 6 billion Medical need Efficacy and less adverse effect MoA Selective GABAa2/3 PAM restores the endogenous pain control system in spinal cord Goal Development of a • first in class • effective • well tolerated product for first line treatment of neuropathic pain Patent Until 2029 January 2015 11 AN363 MODE OF ACTION IN NEUROPATHIC PAIN AN363 Cl- α2/3 GABA Na+ January 2015 12 AN363 EFFECTIVE IN NEUROPATHIC PAIN MODEL Mechanical allodynia rat CCI model Paw withdrawal threshold g (n=7-21) 20 Other paw Vehicle (5%DMSO+0.5%HPMC) AN363- 1mg/kg/10ml PO AN363- 3mg/kg/10ml PO AN363- 10mg/kg/10ml PO AN363- 30mg/kg/10ml PO **** 15 **** **** **** 10 ** 5 0 0 30 90 60 120 Post treatment (min) ** P<0.01, ****P<0.0001 vs vehicle, 2way ANOVA Bonferroni multiple comparisons January 2015 13 morphine AN346 FOR INFLAMMATORY BOWEL DISEASE Class Ion Channel Blocker Status Candidate selection Indication Inflammatory Bowel Disease: Cronhs and Colitis Prevalence ~ 400/100.000 (~1.4 mill in USA) Market ~ 4 billion € Treatment Maintenance: 5-ASA Induction and remission: Steroids, biologics and surgery Medical need Efficacy and less adverse effect 30 – 40% of all Colitis patients and almost all Cronhs patients require surgery at least once in their lifetime MoA Block of IK channel in immune cells Goal Development of a unique • first in class • effective • well tolerated product for first line treatment and maintenance of IBD IP protection 2032 January 2015 14 AN346 MODE OF ACTION IN INFLAMMATORY BOWEL DISEASE AN346 K+ + K + K + K + K Ca++ Ca++ ++ Ca Ca++Ca++ January 2015 15 AN346 NORMALISES COLON HISTOLOGY Induced IBD (+ DNDS) Control Sulfazalasine (5-ASA) January 2015 AN346 16 TESOFENSINE FOR OBESITY/DIABETES Class Triple monoamine reuptake inhibitor (MRI) Status Phase 2 completed (Monotherapy) Indication Obesity / type II diabetes Prevalence 2.1 billion overweight WW in 2013 ~ 38% (Lancet) Market + USD 750 million (2019 estimate: 2.6 billion) Medical need Efficacy and safety MoA Triple MRIs regulate appetite, metabolic drive and craving for sweet and fat (“food addiction”) Goal Development of a • Highly efficacious • well tolerated product for first line treatment of obesity and type II diabetes Patents January 2015 Composition of matter until 2017; additional patents and patent applications covering use, combinations, production and formulation extending until 2034. 17 18.0-21.9% 22.0-25.9% >26.0% TESOFENSINE MECHANISM OF ACTION Tesofensine blocks uptake of dopamine, serotonin and noradrenaline Regulates appetite craving for sweet and fat (“food addiction”) metabolic drive January 2015 18 TESOFENSINE A UNIQUE TREATMENT OPPORTUNITY IN OBESITY Weight reduction Unique weight loss 14-15% at 48 weeks (Placebo ~ 2%) 10.0% Potentially competitive to surgery (1520%) 9.0% Potential prevention and treatment of Type 2 diabetes 7.0% 8.0% 6.6% 6.0% 6.0% Full and clean tox package 5.0% Well tolerated in obese and elderly (+1200 individuals) 4.0% 5.2% 3.1% 3.0% Adverse Effects similar to placebo 2.0% Increase in heart rate 1.0% 2.4% 0.0% Novel patent application on combination product January 2015 9.2% Xenical, Belvig, Contrave, 3x120mg, 4 2x10mg, 1 2x360/32mg, years year 56 weeks 19 Victoza, 3mg, 56 weeks Qsymnia, Tesofensine, 7.5/46mg, 0,50mg, 24 56 weeks weeks FINANCIAL POSITION AND RIGHTS ISSUE January 2015 20 FINANCIAL POSITION 2014-01-30 2014-01-01 2014-01-01 2013-01-01 2014-09-30 2014-01-29 2014-09-30 2013-12-31 8 mån 1 mån 9 mån 12 mån Koncernen / Koncernen Saniona ApS Saniona ApS Saniona ApS Resultaträkning Nettoomsättning Rörelsens kostnader Rörelseresultat 14 459 -18 488 -4 029 3 539 -1 526 2 013 17 998 -20 014 -2 016 13 323 -14 983 -1 660 Balansräkning Likvida medel Balansomslutning * 14 170 20 607 11 309 15 071 14 170 20 607 914 3 975 -12 404 8 490 -3 914 -2 143 2 886 10 395 13 281 -6 238 Kassaflödesanalys Löpande verksamheten Periodens kassaflöde * Ingen immateriella anläggningstillgångar registrerat Booket värde af utrustning 1,2 MSEK (nyprisvärde cirka 30 MSEK) January 2015 21 SÅ HÄR ANVÄNDER VI EMISSIONSLIKVIDEN Emissionslikviden på 24,3 MSEK ska accelerera tillväxten i bolaget och användas till: Preklinisk och FAS1-utveckling av AN363 till neuropatisk smärta Positionering av tesofensine för partnerskap och ytterligare kliniska studier Val av ytterligare preklinisk kandidat Förädling av andra projekt för partnerskap Bolaget har med emissionslikviden tillräcklig finansiering för att ta AN363 genom FAS1-utveckling och hade i november 2014 en kassa på ca 10 MSEK January 2015 22 NEW FINANCE ROUND IPO in April 2014 at 5 SEK per share Share price at present is around 9 SEK Share price for new issue is SEK 7 per share equal to a pre money valuation of SEK 97M Share Index SEK January 2015 23 Market Cap MSEK MUSD Offering 7,0 100 97 12 Current share price 9,0 129 125 15 Autumn 11,0 157 153 19 Redeye valuation 19,5 279 271 33 BENCHMARK ACQUISITION Convergence Pharmaceuticals Ion channel products Lead program in Phase 2 for neuropathic pain Biogen Idec acquired Convergence for a total of up to $675 million on Jan 11 $200 million in upfront $475 million in milestones Saniona is currently raising SEK 24M at a premoney valuation of SEK 97M with the aim of taking AN363 through Phase 1 clinical development for neuropathic pain This project is one of 16 programs of which five are active today. January 2015 24 ERBJUDANDET I SAMMANDRAG (FÖRETRÄDESEMISSION) Teckningstid: 22 januari – 5 februari 2015 Företrädesrätt: För varje befintlig aktie erhålls en (1) teckningsrätt Innehav av 4 teckningsrätter berättigar till teckning av 1 nya aktie Handel med teckningsrätter: 22 januari – 3 februari 2015 Teckningskurs: 7,00 SEK per aktie Emissionsvolym: Högst 3 470 550 aktier, motsvarande 24 293 850 SEK Antal aktier före nyemission: 13 882 200 aktier Pre-money värdering: 97,2 MSEK Teckningsförbindelser: 15,3 MSEK ~ 63% av emissionsvolymen Marknadsplats: AktieTorget January 2015 25 BOARD AND MANAGEMENT Leif Andersson, board member Ex-partner Sund Kommunikation Claus Braestrup, Chairman Ex-CEO Lundbeck Thomas Feldthus CFO and board member January 2015 Anker Lundemose, Board member CEO Mission Therapeutics Jørgen Drejer CEO and board member 26 SUMMARY Low burn and high ambitions World class research team Range of validated discovery and development stage programs Proven track record for partnering with 3 major collaborations in 2 years Significant milestones achieved since April 2014 Transforming into a clinical stage company First compound planned for the clinic this year Acquired a unique phase 2 asset January 2015 27 Saniona AB Baltorpvej 154 DK-2750 Ballerup Denmark Tel: +45 70705225 Web: saniona.com January 2015 28
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