UNDERSTANDING THE VALUES OF SANIONA

Transcription

1 UNDERSTANDING THE VALUES OF SANIONA JUNE 2014 June

2 OM SANIONA Biotech-bolag med låg burn rate höga ambitioner Partnerskap med 3 av de största läkemedelsbolagen i världen Pfizer: forskningssamarbete Johnson&Johnson: forskningssamarbete Biogen + Atlas Venture: USA spin-out (Ataxion) Forskarteam i världsklass inom sin nisch jonkanaler Stark pipeline med forskning och utveckling program utköpt från NeuroSearch Framgångsrik emission avslutad 18e mars och listning på AktieTorget 22a april 2014 Starkt forskningsteam, avancerad forskningssite, partnerskap, projekt och forskningssubstanser av hög internationell klass samt finansiering på plats June

3 SANIONA STRATEGY Saniona follows three main strategies Drug discovery collaborations with partners Two ongoing collaborations Pfizer and Janssen. Own early phase development Outlicensing planned in clinical phase Janssen Alliance Partners Saniona projects Pfizer Alliance Own development IK-blockers IBD GABAa2/3 PAM Chronic pain Spin out Joint ventures Saniona collaborates with venture companies in founding new companies for common development of projects. Biogen/Atlas and Ataxion is an example. Potassium channel modulator Ataxia Biogen/Atlas Ataxion Listing on stockmarked Spin out with biotech/pharma Public Listing of spin out Spin out with other biotech/pharma June

4 FINANSIELLT 2013 NYCKELTAL FÖR DOTTERBOLAGET ANIONA APS KSEK Total Resultaträkning Omsättning Rörelsens kostnader Periodens resultat Kassaflödesanalys Löpande verksamheten Årets kassaflöde Balansräkning Likvida medel Balansomslutning * *Ingen goodwill registrarat Booket värde af utrustning 1,2 MSEK (nyprisvärde cirka 30 MSEK) June

5 IPO AND LISTING ON AKTIETORGET IN APRIL 2014 Saniona raised 17 MSEK before subscription costs in an IPO in March 2014 Offering subscribed at MSEK equivalent to a subscription rate of about 667.5% The company received 770 new shareholders Net proceeds of 15.9MSEK will be used to accelerate company growth Preclinical evaluation of AN346 and AN363 6,0 MSEK Maturing other early stage programs for partnering 4,0 MSEK Working capital and reserves 5,9 MSEK Saniona expect to raise addition capital upon selection of first program for internal development Share price has increased with 10% since listing on April 21 IPO: 5.00 SEK ~ 69.1MSEK market cap June 6: 5.45 SEK ~ 75.7MSEK market cap June

6 UNDERSTANDING THE VALUES OF SANIONA Major Market opportunities 5 active programs and >10 other opportunities more than 2 bill SEK invested in assets Three big pharma partnerships Pfizer, Johnson&Johnson, Biogen/Atlas Full financing of drug discovery Major upside potential Products Pipeline Partnerships World class ion channel team Platform June

7 PLATFORM = PEOPLE + PREMISES + POWDERS + PATENTS Right people at the right time in the right place is the basis for any successful business Saniona has a research team of world class in place within its niche ion channels A team with more than 25 years of joint experience who developed the assets in Saniona s pipeline A team with Phama experience from more than 20 Pharma collaborations 3 ongoing in Saniona A state of the art research site with a value of at least 30 MSEK A compound library of more than proprietary substances to chose from A patent portfolio of 18 active patent families Pipeline Partnerships Platform June

8 HEADQUARTERS IN BALLERUP, DENMARK June

9 BOARD AND MANAGEMENT Chairman of the board: Claus Braestrup, founder, Ex-CEO Lundbeck Member of the board: Anker Lundemose, founder, CEO BioNor Member of the board: Leif Andersson, Ex-partner Sund Kommunikation (Grayling) CEO, member of the board: Jørgen Drejer, PhD, founder, co-founder of NeuroSearch CFO, member of the board: Thomas Feldthus, founder, co-founder of Symphogen CSO: Palle Christophersen, founder, Ex-NeuroSearch VP June

10 PARTNERSHIPS Partnerships serves as a validation of Saniona and our platform Partnerships represents a low risk opportunity where costs and risks are covered by the partners of Saniona Partnerships is a faster, more secure and less costly route to reach the objectives a successful product launch Saniona has three key partnerships with some of the biggest and most professional Pharma companies in the world Pfizer, Johnson&Johnson and Biogen/Atlas The management team of Saniona has a more than 25 year long experience of creating partnerships with big pharma Partnerships are one of the fundamental reasons why Saniona is a biotech company with low capital burn Pipeline Partnerships Platform June

11 CURRENT PARTNERSHIPS Financed collaboration focusing on ion channel targets for neurological indications Initiated early 2014 Up to 52 mio USD in milestone payments and financed drug discovery as well as royalties Financed collaboration focused on ion channel targets for treatment of diseases of the central nerveous system (CNS) Acquired by Saniona in 2012, prolonged in 2013 Up to 45 mio in milestone payments for drug discovery and development + further commercial milestones up to 30 mio as well as royalties of sales Ataxion: A Saniona spin-out (USA) Established in June 2013, drug discovery collaboration ongoing 17 mill USD committed by Biogen/Atlas Venture Saniona ownership in Ataxion is 14% with an anti-dilution clause up to a total investment in the company of 18 mio USD as well as royalties on sales. June

12 PIPELINE Many biotech companies suffer from a very short or even one stringed pipeline Saniona has at the moment a pipeline consisting of no less than 15 projects Of these five are active at the moment and work is in progress to partner at least two more Saniona is constantly seeking for ways of developing more projects. Both through internal work and acquisitions Pipeline Partnerships Platform June

13 25 YEARS EXPERIENCE OF BIG PHARMA PARTNERSHIPS billion SEK accumulated investment billion SEK billion SEK June

14 SANIONA PRECLINICAL PROGRAMS Program Indication Phase Hit to lead Lead opt Preclin test Nica7 agonist Cognitive deficits Phase I ready Nica4b2 PAM Cognitive deficits Lead Nica7 PAM Pain Hit Nica6 PAM Parkinsons Lead IK blockers Inflammation Lead K openers Ataxia Lead Kv7 2/3 opener Epilepsy, Pain Lead TREK opener Pain Hit to lead TREK blocker Depression Hit to lead BK opener Non-CNS Hit to lead GABAa2/3 PAM Pain Lead GABAa4d PAM Sleep, Stress Hit to lead GABAa4g PAM Epilepsy Hit to lead GABAa5 PAM Autism Lead Monoamine RI Pain Lead Not including Pfizer and Janssen collaboration programs (confidential targets) June

15 OUR PIPELINE Indication Differentiation Status Financed by partner J&J-program Confidential First in class Drug discovery phase Ataxion-program Ataxia First in class Drug discovery phase Pfizer-program Confidential First in class Drug discovery phase Financed by Saniona AN346 IBD (inflammatory bowel disease) First in class Qualified lead identified AN363 Neuropatic pain First in class Qualified lead identified Spin out/outlicencing/co-development AN761 Cognitive diseases Best in class Ready for phase 1 AN788 Depression First in class Phase 1 concluded June

16 AN363 FOR NEUROPATHIC PAIN Indication Prevalence Class Neuropathic Pain + 10 mill globally Small molecule MoA Goal Market Status IP protection 2029 Selective GABAa2/3 PAM restores the endogenous pain control system in spinal cord Development of a first in class effective well tolerated product for first line treatment of neuropathic pain + $4 billion Preclinical a 4 b x d a 2b 1 g 1 q a 1 a 6 bg 2 a 4 b x g 2 a 6 b x d a 6 b x g 2 a 5 b 3 g 2 a 2 b 1 g 1 a x b x e a xb x g 3a 1 a 3 b x g 2 a 1 b 3 g 2 Next milestone Start of preclinical development end 2014/early 2015 a 3 b 3 g 2 a 2 b 3 g 2 June

17 NEUROPATHIC PAIN Pathophysiology Caused by a lesion or dysfunction of the central or peripheral nervous system following diseases such as diabetes, varicella zoster, cancer and HIV or mechanical lesion and trauma or the use of drugs such as chemotherapy Neuropathic pain is often chronic, irreversible and notorious difficult to manage Key neuropathic pain population in the Major Markets Decision resources 2008 Million patients Prevalence Treated Chronic low-back pain 32,0 15,4 Painfull Diabetic Neuropathy 7,3 1,6 Postherpetic neuralgia 0,6 0,5 Neuropathic cancer pain 0,5 0,2 HIV/AIDS related neuropathic pain 0,8 0,2 Total 41,2 17,9 Current treatments generates $4 billion in sales Various drug classes which have been approved for other indications including anticonvulsants (epilepsy), antidepressants and narcotic analgesics Significant medical need Improved efficacy: 50% of patients archive a partial relief only. The balance do not receive any relief Fewer side effects: Existing drugs have severe and dose limiting side effects such as drowsiness, dizziness and somnolence Broad pipeline with room for improvement AN363 Competitive market with more than 50 programs in clinical development: However, majority not particular novel and unlikely to address real medical need e.g. new sustained release formulation and topical administration of existing drugs A novel first in class concept which may prove to be efficacious without severe side effects Developed specifically for neuropathic pain May either be used as stand alone or in combination with existing therapies June

18 NEW CONCEPT OF GABA PAIN TREATMENT The GABA pain control center in spinal cord dampens pain input before it is transmittet to the brain This is a selective action on GABAa2,3 receptors In neuropathic pain this control center works suboptimal Pain control restored by AN363 which selectively activate GABAa2,3 Spinal cord Pain control center GABA 2,3 June

19 GABA Α 2,3 SUFFICIENT FOR ANALGESIC EFFECT June

20 AN346 FOR INFLAMMATORY BOWEL DISEASE Indication Prevalence Class MoA Goal Inflammatory Bowel Disease: Cronhs and Colitis ~ 400/ (~1.4 mill in USA) Small molecule Block of IK channel in immune cells Development of a unique product for first treatment of remission and maintenance in IBD Market ~ 4 billion Status Preclinical IP position 2032 Next milestone Start of preclinical development end 2014/early 2015 June

21 CURRENT IBD TREATMENTS Induction of remission Steroids (side-effects, tolerance development) Biologics (non-responders, infections, expense) Maintenance of remission 5-ASAs (sub-optimal efficacy, poor compliance) Thiopurines (toxicity) IK blocker Rescue therapy Cyclosporine (toxicity, failure rates) Surgery 30 40% of all UC patients and almost all CD patients require surgery at least once in their lifetime June

22 THE IK CHANNEL AND ITS FUNCTION IN IMMUNE CELLS The target: Ca 2+ -activated K + channel, K Ca 3.1 (gene: KCNN4) Localisation: Immune cells but absent from neurons and muscles Function: Essential for expression of immune activity Safety: Knock-out animals are healthy IK channel K + Ca 2+ Ca channel Cytokine production + Calcineurine Strong activation Cell division and migration June

23 AN346 NORMALISES COLON HISTOLOGY Control + DNDS + Sulfazalasine +AN346 June

24 PRODUCTS Creating products for the market is the final and ground breaking step for any biotech company. Most fail on the route. Those who succeed makes fortunes. Saniona has all of the vital parameters in place for success People, Patents, Partnerships and Pipeline. In order to keep risks as low as possible Saniona is working on a model of low capital burn involving partnerships, license model and IPO s or divestments. PRODUCTS Pipeline Partnerships Platform June

25 SUMMERING Saniona är ett forsknings- och utvecklingsbolag med låg burn rate och höga ambitioner På plats finns redan ett forskningsteam av världsklass, en forskningssite av hög internationell standard och 15 läkemedelsprojekt Tre samarbeten är etablerade för tre av läkemedelsprojekten: Pfizer, Johnson&Johnson och Biogen/Atlas Venture. Väletablerade nätverk, uppbyggda under 25 år, finns för att kunna få ytterligare samarbeten på plats Finansieringen från dessa samarbeten kan driva bolaget framåt. Sanionas lyckade emission og listning på AktieTorget skall nu ytterligare accelerera tillväxten och driva fram två projekt för att välja minst en läkemedelskandidat till klinisk fas I utveckling på egen hand June

26 Saniona AB Baltorpvej 154 DK-2750 Ballerup Denmark Tel: Web: saniona.com June