Company Presentation February 2019 1 |
FORWARD LOOKING STATMENTS This presentation contains forward- looking statements that provide Saniona’s expectations or forecasts of future events such as new product developments, regulatory approvals and financial performance. Such forward looking statements are subject to risks, uncertainties and may be impacted by inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of Saniona’s forward -looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, breaches or terminations of contracts, government-mandated or market driven price decreases, introduction of competing products, exposure to product liability claims and other lawsuits, changes in reimbursement rules, changes of laws regulations or interpretation thereof, and unexpected cost increases. Saniona undertakes no obligation to update forward looking statements. 2 | 2 |
Investment Highlights Go-2-Market opportunity with Tesomet in orphan indications 1 - Tesomet may be Phase 3-ready in 2020, with potential market approval in 2022 - Phase 2a Prader Willi Syndrome (PWS) results - Phase 2a for Hypothalamic Obesity initiation Additional value driver from late stage partnership with Medix 2 - Tesofensine in Phase 3 for obesity – developed by Medix in Mexico - Medix owns rights for Mexico and Argentina - Saniona eligible for low double-digit royalties - Validating for Tesomet - Significant interest from RoW markets - Tesofensine is an off-patent compound that has been clinically tested in multiple indications Unique platform fuels early stage pipeline and generates cash for the company 3 - SAN711 in preclinical development for Neuropathic pain & Itching - CAD-1883 in Phase 2 for tremor and Phase 1 for ataxia – Cadent partnership - Boehringer Ingelheim program in preclinical development for Schizophrenia 3 | 3 |
Tesomet: Go-2-Market opportunity in orphan indications Potential for market entry within 4 years – Total investment of $30-40M - >$4B opportunity Prader Willi Syndrome Hypothalamic Obesity Positive Phase 2a in PWS adults Phase 2 study preparations Phase 2a in adolescent patients ongoing Life-threatening hyperphagia and obesity Life-threatening hyperphagia and obesity Prevalence: 1/(50.000-100,000) Prevalence: 1/40.000 Estimated market size: >1B USD Estimated market size: ~3B USD 2018 2019 2020 2021 2022 Prader Willi FDA Phase 2a Dose finding Phase 3 filing Syndrome Hypothalamic FDA Phase 2a Phase 3 filing obesity 4 | 4 |
Proprietary Pipeline Near term news flow and value generation Product Indication Preclinical Phase 1 Phase 2 Milestone Tesomet Prader Willi Ph2a data Q1 19 tesofensine + Syndrome Ph2b/3 start 2019/20 metoprolol Hypothalamic (monoamine reuptake Ph2a start Q1 19 inhibitor + beta blocker) obesity Neuropathic pain SAN711 Ph1 start Itching ( GABA α3 PAM) Candidate selection IK Program Inflammation, IBD 5 | 5 | 5 |
Partnered pipeline Near term news flow and non-dilutive cash Product Indication Preclinical Phase 1 Phase 2 Phase 3 Tesofensine Obesity Essential tremor Spinout Minority stake CAD-1883 Royalties Ataxia Upfront: 5M € Not Schizophrenia Milestones: 85M € disclosed Royalties NS2359 off patent; NS2359 Cocaine Addiction financed by US grants 6 | 6 | 6 |
Tesomet – packs all benefits of tesofensine & controls for heart rate 7 |
Tesomet: tesofensine + metoprolol Tesofensine, in preclinical models and clinical trials, has shown efficacy and safety • Reduction in food intake • Weight loss efficacy • Effects on glycemic parameters relevant for type 2 diabetes • Excellent safety and tolerability COMPOSITION TESOFENSINE METOPROLOL Beta blocker to control slight increase in heart rate Effective weight loss drug Tesomet = tesofensine + beta blocker (metroprolol) • Neutralizes slight heart rate increase observed with tesofensine • Allows for strong intellectual property protection through 2036 8 |
Tesomet: Potential Orphan Drug with Blockbuster Potential MoA creates multiple opportunities within metabolic diseases and eating disorders Potential “best -in- class” profile for weight related metabolic diseases via unmatched weight loss and benign side effect profile 9 |
Tesomet/tesofensine development strategy: Geographies EU & US: Rest of the world: PWS and HO Metabolic disease 10 |
Tesomet: Go-2-Market opportunity in orphan indications Potential for market entry within 4 years – Total investment of $30-40M - >$4B opportunity Prader Willi Syndrome Hypothalamic Obesity Positive Phase 2a in PWS adults Phase 2 study preparations Phase 2a in adolescent patients ongoing Life-threatening hyperphagia and obesity Life-threatening hyperphagia and obesity Prevalence: 1/(50.000-100,000) Prevalence: 1/40.000 Estimated market size: >1B USD Estimated market size: ~3B USD 2018 2019 2020 2021 2022 Prader Willi FDA Phase 2a Dose finding Phase 3 filing Syndrome Hypothalamic FDA Phase 2a Phase 3 filing obesity 11 | 11 |
Tesomet - lead indication: Prader-Willi syndrome Genetic disease caused by mutations/deletion of genes on chromosome 15 Chronic feeling of extreme hunger (hyperphagia) no matter how much the patient eats Other symptoms and characteristics Mental retardation and behavioural problems Low metabolic rate (50% of normal) Sensitive to some medicines (½ dose prescribed) Medical need } Acute life-threating hyperphagia (choking, bowel rupture) Short life expectation (average in 30s) Life-threatening obesity No effective treatment available today Economic and social costs Quality of life for patients and families Family stress and loss of income Care and medical costs (USD 100-300K per year) 12 |
Tesomet: Phase 2a Study in PWS adults Study set up Phase 2a study initiated in April 2017 Exploratory randomized, Positive effect on key PK and Safety double-blind, placebo- efficacy endpoints controlled 12 weeks study - No SAE in 9 patients - Reduced craving for - AE mainly CNS related food - Half-life longer than - Tesomet 6 - Weight loss expected in PWS patients - Placebo 3 13 |
Tesomet: Phase 2a Study in PWS adults Results PWS hyperphagia score (data show mean and SD) 20 PWS weight loss 15 Week 8 Week 13 Hyperphagia score Tesomet 5.00 % (n=5) 6.75 % (n=2) 10 Placebo 0.46 % (n=2) 0.75 % (n=2) Second part of PWS study 5 in adolescents ongoing 0 0 20 40 60 80 100 days of treatment placebo treatment 14 |
PWS opportunity has blockbuster potential Accessible market value equals 3 Billion USD (Analyst estimates) Premium pricing potential Orphan drug status will ensure premium pricing Majority of drugs with less that 10,000 patients in the US tend to be priced above 200K USD per year Large commercial opportunity No drugs approved for treating hyperphagia Low investment Clear endpoint with short studies (Phase 3: 100 patients / 6 months) Straightforward commercialization (most patients are managed by specialists in central centers) 15 |
Tesomet/tesofensine development strategy: Geographies EU & US: Rest of the world: PWS and HO Metabolic disease 16 |
Medix partnership With ~50% market share, Medix is market leader in the $250M Rx Obesity Market in Mexico Regional deal structure Medix holds the rights to tesofensine & Tesomet in Mexico & Argentina Medix finances clinical studies and commercialization Saniona receives double digit royalties Saniona retains rights to rest of the world including exclusive rights to Medix’ clinical data Medix could be on the market in Mexico in 2020 and in Argentina one year later 2018 2019 2020 2021 2022 Cofepris Mexico Commercialization Phase 3 review Argentina Argentina Commercialization NDA 17 | 17 |
Tesofensine: Successful Phase 3 Study in Mexico by Partner Medix Medix to file for registration in Mexico and Argentina Phase 3 Study Design All endpoints met: Randomized, double-blind, placebo controlled trial in Mexico Primary endpoint: percent change in bodyweight compared to baseline at 372 patients enrolled: 24 weeks - N=124: placebo - N=124: 0.25mg tesofensine Secondary endpoints include: - N=124: 0.50mg tesofensine - Proportions of patients achieving a weight loss of >5 and 10 percent, - 24 weeks treatment period and 12 respectively week follow up - Metabolic including glycemic - All patients prescribed an energy endpoints restricted diet of 1,500-2,000 kcal - Quality of life and physical activity of 20-40 minutes 18 | 18 |
Tesofensine: Phase 2 Study Study methodology & results Methodology Results Randomized, double-blind, placebo At 24 weeks patients had lost 11.2 controlled trial in five Danish % in bodyweight at 0.5 mg per day obesity management centers compared to 2.0% for placebo Enrolled 203 patients Tesofensine well tolerated Energy restricted diet with a daily Adverse effects similar to placebo energy deficit of 300kcal in addition with an increase in heart rate to physical activity of 30-60 minutes compared to baseline Primary endpoint: percentage change in bodyweight compared to baseline at 24 weeks 19 |
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