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Company Presentation March 2019 1 | FORWARD LOOKING STATMENTS This - PowerPoint PPT Presentation

Company Presentation March 2019 1 | FORWARD LOOKING STATMENTS This presentation contains forward- looking statements that provide Sanionas expectations or forecasts of future events such as new product developments, regulatory approvals and


  1. Company Presentation March 2019 1 |

  2. 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 |

  3. Investment highlights “Saniona has two drugs that work!” Experienced management team with a globally recognized track record of developing product candidates for CNS related disorders and conditions An advanced-stage pipeline in the drug tesofensine Tesofensine is progressing toward regulatory approval in the $250M obesity market in Mexico. Other markets are being evaluated Tesomet (a combination of tesofensine and metoprolol) has demonstrated dramatic reductions in craving for food and weight in the rare genetic eating disorder Prader Willi Syndrome and will be progressed to Phase 2b targeting a billion dollar market Tesomet is also being studied in patients with Hypothalamic Obesity, another rare eating disorder with limited treatment options representing a billion dollar market opportunity Discovered and is advancing four first in class ion channel modulators through early clinical and late preclinical development Two internally addressing large market segments as well as rare diseases with high medical need Two with partners for treatment of schizophrenia and ataxia respectively Continue to look for strategic partners where shareholder value can be accelerated 3 | 3 |

  4. 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 Conclusion from Phase 2a study in PWS Tesomet a promising highly effective treatment option for control of hyperphagia and weight in PWS patients The optimal dose is expected to be between 0.25 mg and 0.5 mg per day 2018 2019 2020 2021 2022 Prader Willi Open FDA Phase 2a Phase 3 Phase 2b filing Syndrome label Hypothalamic FDA Phase 2a Phase 3 filing obesity 4 | 4 |

  5. 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 ready Itching ( GABA α3 PAM) Candidate selection IK Program Inflammation, IBD H1 19 5 | 5 | 5 |

  6. 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 |

  7. Tesomet – packs all benefits of tesofensine & controls for heart rate 7 |

  8. 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 8 | 8 |

  9. 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 9 | 9 |

  10. 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 10 |

  11. Tesofensine strong efficacy in bodyweight and appetite Phase 2b study comprising 200 obese subjects in Denmark Reduction in bodyweight Reduction in appetite/craving for food compared to baseline Change from baseline (total score) 0.25 mg 0.5 mg 1.0 mg Placebo 4 ng/ml 9 ng/ml 18 ng/ml 20 0 2.0% reduction -20 6.5% reduction -40 11.2% reduction -60 Appetite reduction 12.6% reduction Reduction in craving for sweet and fat -80 11 |

  12. Tesofensine could double weight loss compared to competitors Results at 48 weeks suggest tesofensine could be used as an alternative to surgery “Apples to oranges” comparison of reduction in bodyweight versus competing drugs * ̴ 14% 48 weeks open label 10.0% 9.0% 9.2% 8.0% Weight loss treated vs placbo 6.6% 7.0% 6.0% 6.0% 5.2% 5.0% 4.0% 3.1% 3.0% 2.4% 2.0% 1.0% 0.0% Tesofensine Xenical, Belvig, Contrave, Victoza, 3mg, Qsymnia, Tesofensine, 0,50 mg, 48 weeks 3x120mg, 4 2x10mg, 1 2x360/32mg, 56 weeks 7.5/46mg, 56 0,50mg, 24 open label extension years year 56 weeks weeks weeks 12 | *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.

  13. Dramatic weight loss directly related to tesofensine blood concentrations Additional weight loss in open label extension up to 48 weeks with drug holiday of 10 weeks TIPO-1 TIPO-4 (open label extension) 0 Placebo 0.5 mg tesofensine -5 Weight loss in kg vs baseline -10 0.5 mg tesofensine -15 Drug holiday 0.5 mg tesofensine 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 Time (weeks) 9 13 |

  14. Tesofensine and Tesomet are supported by a large safety database Tesofensine, the key active ingredient in Tesomet, is well studied and has been safe and well tolerated More than 1700 subjects treated to date. One Phase 3 study, N= 372 (248 tesofensine) Eight Phase 2 studies, Two Phase 2 studies* N = 1310 (one ongoing), N=78 (1000 tesofensine) Eighteen Phase 1 studies, Three Phase 1 studies* N = 391 (325 tesofensine) (one ongoing), N=105 14 | *Indications include Type 2 diabetes and Prader Willi syndrome

  15. 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 15 |

  16. Tesomet: Pipeline in a drug blockcbuster 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 16 |

  17. Tesomet/tesofensine development strategy: Geographies EU & US: Rest of the world: PWS and HO Metabolic disease 17 |

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