SANIONA COMPANY PRESENTATION

Transcription

1 SANIONA COMPANY PRESENTATION MARCH, 2016 March

2 THE SANIONA WAY Low burn rate without compromising on high ambitions Top class science World-class research team focused on ion channels CNS, pain, metabolic diseases and autoimmune diseases Strong pipeline Nine active discovery and clinical stage programs Five partnerships Lots of partnerships Platform and additional discovery and clinical assets Revenues and value March

3 BOARD AND MANAGEMENT Carl Johan Sundberg, board member Professor, Karolinska Institute Leif Andersson, board member Ex-partner Sund Kommunikation Thomas Feldthus CFO and board member Claus Braestrup, Chairman Ex-CEO Lundbeck Jørgen Drejer CEO and board member Anker Lundemose, Board member CEO Mission Therapeutics March

4 SANIONA STRATEGY Research collaborations with partners Pharmaceutical companies finance programs and Saniona receives upfront, milestones and royalties Grants Internal early clinical phase development Pre-clinical, Phase 1 and Phase 2 Out-licensing planned in clinical phase Spin-outs Financed by venture/pharma partner Independent listing March

5 OUR PIPELINE Product or program Indication Preclinical research Preclinical development Clinical Phase 1 Clinical Phase 2 Clinical Phase 3 Tesofensine monotherapy Obesity Tesomet Type 2 diabetes NS2359 Cocaine addiction AN363 Neuropathic pain AN346 Inflammation, IBD AN470 Schizophrenia Ataxion program Ataxia Upsher-Smith program Neuological disorders Nic-a6 Parkinsons In addition to the active pipeline shown above, Saniona has a range of validated drug discovery assets as well as clinical stage assets (e.g. AN788 and AN761) positioned for partnering or spin-out. March

6 NEW PARTNERSHIPS Upsher-Smith collaboration for neurological indications Based on Saniona discovery ion channel program Upsher-Smith has exclusive commercialization rights Up to 30M USD in milestones plus royalties on product sales Financed by Upsher-Smith Medix collaboration for obesity Development of tesofensine and Tesomet for obesity Medix to finance and conduct Phase 3 trial for tesofensine and Phase 2 and 3 trials for Tesomet for obesity Medix has exclusive rights in Mexico and Argentina Saniona retains all other rights including exclusive rights to clinical data from collaboration in rest of world Regulatory milestone payments and double digit royalties March

7 EXISTING PARTNERSHIPS Ataxion spin-out (USA) for ataia Based on Saniona s ataxia program Financed by Biogen Idec and Atlas Venture (US$ 17 million) Research performed at Saniona under fee for service contract Biogen has an option to acquire Ataxion following Phase 1 Saniona has 14% ownership and receives 14% of acquisition price plus royalties on product sales Penn University for cocaine addiction Penn performs Phase 2 studies based on public funding Saniona retains all commercial rights to NS2359 Saniona has supplied drug product and funded minor CMC costs March

8 COMMERCIAL RIGHTS VERSUS FINANCING Saniona commercial rights AN363 AN346 Nic α6 NS2359 AN470 Saniona finance Saniona investments Risk sharing Tesomet T2D Tesomet obesity Ataxion Saniona retains commercial rights Saniona receives Milestones Royalties tesofensine obesity 3 rd party finance Upsher- Smith 3 rd party commercial rights March

9 TESOMET FOR TYPE 2 DIABETES Tesomet Fixed dose combination of tesofensine and metoprolol Status Phase 2a in H Indication Type 2 diabetes Prevalence and costs 53 million patients in 7 MM in 2014 Total cost for society in the US: 174B USD Huge growing market From USD 23B in 2014 to USD 42B in 2023 Weight reducing products to drive growth TD2 is probably the biggest medical challenge in modern history March

10 REVERSAL OF T2D THROUGH WEIGHT LOSS Some T2D patients escape the disease through weight loss by diet and exercise Type 2 diabetes disappear in societies during famine and reduction in food supply (Japan, 2 nd WW) T2D cancer patients often recover from T2D when they loose weight because of cancer Pories et al (Am J Clin Nutr, 1992) Bariatric surgical for obesity in T2D patients 90% of patients remained free of T2D 10 years after surgery Dixon et al, (JAMA, 2008) A randomized controlled trial where T2D patients were subscribed to adjustable gastric banding and conventional therapy for T2D Remission was related to weight loss and achieved in 73% of the surgical group and 13% of the medical group because surgery was more effective in achieving weight loss Lim et al (Diabetologia, 2011), Plasma glucose, insulin secretion and first phase insulin respond are normalized in T2D patients during a 8 week very-low-calorie diet March

11 TESOMET PHASE 2A STUDY - HIGH LEVEL DEVELOPMENT PLAN 60 type 2 diabetes patients with 2 arms (placebo versus Tesomet) 3 months treatment Primary endpoint: Demonstrate that Metoprolol can blunt BP and HR effects of tesofensine Secondary endpoints: Effect on glycaemic endpoints 6.2 * Prediabetics defined as initial HbA1c between 5.7 and 6.4 Placebo Tesofensine 0.5 mg 6.4 Sustained efficacy of Tesomet on weight loss Effect on liver fat % 5.6 * post week *p<0.05 vs placebo, unpaired 't ' test, n= March

12 NS2359 PHASE 2A STUDY - HIGH LEVEL DEVELOPMENT PLAN Potential first drug for treatment of cocaine addiction cocaine addicts with 2 arms (placebo versus NS2359) Drug withdrawal symptoms Drug craving 8 weeks treatment The euphoria associated with cocaine Phase 1 data in 24 psychostimulant cocaine users "Amount you would pay" "Like to use" "Feeling stimulated" "Desire" "Drug liking" "Feeling high" Heart rate 0% 20% 40% 60% 80% 100% Cocaine NS cocaine Primary endpoint: Abstinence from cocaine during the last 2 weeks of treatment Secondary endpoints: Reduce craving for cocaine and withdraw symptoms Reduce amount of alcohol consumption Reduce smoking Improved cognitive ability March

13 AN363 FOR NEUROPATHIC PAIN Class Status Indication Prevalence Market Medical need MoA GABA Modulator Preclinical development with NOAEL of 10mg/kg Additional studies warranted Phase 1 to be initiated in 2016 Neuropathic pain + 10 mill globally + USD 6 billion despite products are not effective and developed for other indications: Antiepileptic Antidepressants Efficacy and less adverse effect Designed specifically for neuropathic pain Patent Until 2029 Selective GABAa2/3 PAM restores the endogenous pain control system in spinal cord March

14 MICHAEL J FOX RESEARCH PROGRAM NICOTINIC Α6 PAMS PROMOTE DOPAMINE FUNCTION IN PARKINSON S Parkinson s disease develops when dopamine producing neurons degenerate in substantia nigra Dopamine neurons in this centre relay messages that control body movements When dopamine neurons die in Parkinson s disease control of muscle tension and movement is lost Smokers have less risk of developing Parkinson s Nicotine protects the dopamine neurons Nicotine increases release of dopamine Nicotinic α6 receptors are believed to be the action point for nicotine in dopamine neurons Saniona s specific nicotinic α6 subtype compounds are expected to provide Protection of dopamine neurons (disease modifying) Symptomatic treatment of Parkinson s March

15 FINANCIAL POSITION KSEK Profit & loss Net sales 13,989 21,718 13,323 Operating expenses -41,705-29,977-14,983 Operating profit -28,075-8,258-1,660 Balance sheet Cash 47,004 9, Equity 52,943 8,780-2,901 Total balance * 57,673 15,461 3,974 Cash flow Operating activities -13,989-8,478-2,143 Financing activities 44,090 17,553 0 Net cash flow 34,066 8,739-6,238 March

16 NEWS FLOW AND INFLECTIONS POINTS Dec 2015 Saniona increase share holder base with more than 50% (+3,000 today) Release of Tesomet drug substance and manufacturing of tablets for Phase 2a TRC to initiate Phase 2 in H following grant from Dana Foundation Jan 2016 Upsher-Smith collaboration for Neurological Disorders Feb Medix collaboration for tesofensine and Tesomet in Mexico and Argentina Medix plans to initiate Phase 3 studies with tesofensine in 2016 Michael J Fox Foundation grant for Parkinson s diseases 2016 Inflection points Initiation of Phase 2a for Tesomet in type 2 diabetes Initiation of Phase 2 for NS2359 in cocaine addiction Initiation of Phase 3 for tesofensine in obesity Progress on other ongoing programs including AN363 New collaborations Update on NASDAQ Smallcap Listing March

17 SUMMARY Transforming into a clinical stage company Tesomet to enter Phase 2a for T2D NS2359 to enter Phase 2 for cocaine addiction based on public funding Medix plans Phase 3 for tesofensine in obesity AN363 in late stage preclinical development World class research team and several programs for partnering Strong news flow in start of 2016 with 3 new partnerships Many future potential inflection points Moving towards Nasdaq Stockholm Small Cap in 2016 March

18 Saniona AB Baltorpvej 154 DK-2750 Ballerup Denmark Tel: Web: saniona.com March