Company presentation June 2017 1 |
Clinical stage company focusing on drugs for diseases of the central nervous system, autoimmune diseases and metabolic diseases 3 clinical stage candidates for obesity, metabolic diseases and cocaine addiction Several partnerships with top names in the field World-class research team focused on ion channels with over 25 years of experience Selected partners 2 | 2 |
1. Introduction 2. Portfolio I. Clinical stage programs II. Pre-clinical programs 3. Financials and outlook 3 | 3 |
Pipeline Preclinical Preclinical Product or Target Indication Clinical Phase 1 Clinical Phase 2 Clinical Phase 3 research development Tesofensine monotherapy Obesity Tesomet Type 2 diabetes Tesomet Prader-Willis syndrome NS2359 Cocaine addiction GABA-A α2/α3 Neuropathic pain Boehringer Ingelheim program Schizophrenia IK Inflammation, IBD Luc Therapeutics program Ataxia Proximagen program Neurological disorders Nicotinic α6 program Parkinson's disease 4 | 4 |
Corporate milestones Recent pipeline milestones 06/2016 – U Penn (TRC) initiates Phase 2a study for NS2359 in cocaine addiction 09/2012 – Saniona 2012 operational 08/2016 – Saniona signs partnership with Boehringer Ingelheim for Schizophrenia 10/2016 – Saniona and Proximagen research 04/2014 - Heavily 2014 collaboration oversubscribed IPO 01/2017 – Saniona reports positive top line results from the Tesomet Phase 2a study in type 2 diabetes 05/2016 - Saniona moves to 2016 Nasdaq First North Premier 04/2017 – Saniona initiates Phase 2a study for Tesomet in Prader-Willi syndrome 04/2017 – Saniona obtains research milestone from The Michael J. Fox Foundation for Parkinson's Research 2017 06/2017 - Saniona moves to 2017 Nasdaq Stockholm Small Cap 04/2017 – Medix receives approval to initiate Phase 3 study in obesity 5 | 5 |
1. Introduction 2. Portfolio I. Clinical stage programs II. Pre-clinical programs 3. Financials and outlook 6 | 6 |
Tesofensine treats Obesity as a CNS disorder Saniona is collaborating with Medix on tesofensine for obesity in Mexico Triple mode of action for unique weight loss DESCRIPTION Tesofensine is a triple monoamine inhibitor which targets dopamine, serotonin and noradrenaline to Tesofensine is a triple monoamine reuptake stimulate weight loss in obese patients inhibitor DOPAMINE PLEASURE REWARD CENTER - Humans feel pleasure by eating as it stimulates dopamine INDICATION (TARGET GEOGRAPHY) Food cravings - Obese patients crave food and suger due to under stimulation Obesity (Mexico) 1 - Tesofensine reduces the craving for food by stimulating the - Prevalence in Mexico: 28.1% reward center SEROTONIN SATIETY CENTER MARKET SIZE - Humans achieve satiety by eating as it stimulates this center The prescription medicine market for obesity in Appetite Mexico is around USD 250 million 2 - Obese patients have continuous hunger due to under stimulation - Tesofensine normalizes appetite by stimulating the satiety center STAGE OF DEVELOPMENT NORADRENALINE PATHWAYS Regulatory approval to start Phase III in 2017 - Humans respond to stress by mobilizing energy from fat and increasing the heart rate, both functions are controlled by Fat burn noradrenaline - Obese patients accumulate fat due to reduced fat burn PARTNER - Tesofensine increases fat burn, but also heart rate 7 | (1) World Health Organisation estimate of prevalence for both sexes in 2014. (2) Medix estimate.
Tesofensine could double weight loss compared to competitors Results at 48 weeks suggest tesofensine could be used as an alternative to surgery Phase 2b study methodology Reduction in bodyweight compared to baseline Randomised, double-blind, placebo controlled trial in five Danish obesity management centers 203 patients were enrolled: - 52 received placebo - 52 assigned to 0.25mg tesofensine group - 50 assigned to 0.50mg tesofensine group - 49 assigned to 1.00mg tesofensine group Energy restricted diet with a daily energy deficit of 300kcal in addition to physical activity of 30-60 minutes Primary endpoint: percentage change in bodyweight compared to baseline at 24 weeks Phase 2b trial results Placebo 2.0% average reduction 0.25mg tesofensine 6.5% average reduction 0.50mg tesofensine 11.2% average reduction 1.00mg tesofensine 12.6% average reduction Adverse effects similar to placebo with an increase in heart rate compared to baseline Follow up results An open label study was conducted to follow patients for a further 24 weeks after the Phase 2b trial. At 48 weeks patients had lost 14- 15% in bodyweight compared to baseline. The results at 48 weeks suggest tesofensine could be competitive to surgery which usually result in 15-20% reduction in bodyweight 8 | *Results from competing drugs taken from their respective studies and have been adjusted for their respective placebo results. Results from competing trials are not directly comparable.
Tesofensine could double weight loss compared to competitors Results at 48 weeks suggest tesofensine could be used as an alternative to surgery Phase 2b study methodology Reduction in bodyweight versus competing drugs * Randomised, double-blind, placebo controlled trial in five Danish obesity management centers Tesofensine 0.5 mg, 48 weeks open label: 14-15% compared to baseline 203 patients were enrolled: - 52 received placebo - 52 assigned to 0.25mg tesofensine group - 50 assigned to 0.50mg tesofensine group - 49 assigned to 1.00mg tesofensine group Energy restricted diet with a daily energy deficit of 300kcal in addition to physical activity of 30-60 minutes 10,0% Primary endpoint: percentage change in bodyweight compared to baseline at 24 weeks 9,0% 9.2% 8,0% Placebo controlled weight loss Phase 2b trial results 6.6% 7,0% Placebo 2.0% average reduction 6.0% 0.25mg tesofensine 6.5% average reduction 6,0% 5.2% 0.50mg tesofensine 11.2% average reduction 5,0% 1.00mg tesofensine 12.6% average reduction Adverse effects similar to placebo with an increase in heart rate 4,0% compared to baseline 3.1% 3,0% 2.4% Follow up results 2,0% An open label study was conducted to follow patients for a further 24 weeks after the Phase 2b trial. At 48 weeks patients had lost 14- 1,0% 15% in bodyweight compared to baseline. 0,0% The results at 48 weeks suggest tesofensine could be competitive Xenical, Belvig, Contrave, Victoza, 3mg, Qsymnia, Tesofensine, to surgery which usually result in 15-20% reduction in bodyweight 3x120mg, 4 2x10mg, 1 2x360/32mg, 56 weeks 7.5/46mg, 56 0,50mg, 24 years year 56 weeks weeks weeks 9 | *Results from competing drugs taken from their respective studies and have been adjusted for their respective placebo results. Results from competing trials are not directly comparable.
Medix Phase 3 study Medix to initiate Phase 3 in 2017 and could potentially be on the market before 2020 Randomised, double-blind, placebo controlled trial in Mexican population 372 patients to be enrolled: 124 will receive placebo 124 will receive 0.25mg tesofensine 124 will receive 0.50mg tesofensine All patients are prescribed an energy restricted diet with a daily energy of 1,500-2,000 kcal in addition to a physical activity of 20-40 minutes Primary endpoint: percentage change in bodyweight compared to baseline at 24 weeks Secondary endpoints include: proportions of patients achieving a weight loss of more than 5 and 10 percent respectively, metabolic including glycaemic endpoints, quality of life. 10 |
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