Saniona AB · OMXSTO:SANION
Saniona AB — Investor Presentation (March 2019)
25 slides from Saniona AB's investor presentation, Mar 19, 2019
Slide 1: Company Presentation March 2019
Company Presentation March 2019 1|
Slide 2: Forward Looking Statements
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
Slide 3: Investment highlights
Investment highlights “Saniona has two drugs that work!” 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 demonst
Slide 4: Proprietary Pipeline
Proprietary Pipeline Near term news flow and value generation Product Indication Preclinical Phase 1 Phase 2 Milestone Tesomet Prader Willi Ph2b/3 start 2019/20 tesofensine + Syndrome metoprolol (monoamine reuptake Hypothalamic inhibitor + beta blocker) Ph2a readout Q1 20 obesity SAN711 Neuropathic
Slide 5: Partnered pipeline
Partnered pipeline Near term news flow and non-dilutive cash Product Indication Preclinical Phase 1 Phase 2 Phase 3 Tesofensine Obesity Essential tremor Spinout CAD-1883 Minority stake Royalties Ataxia Upfront: 5M € Not Schizophrenia Milestones: 85M € disclosed Royalties NS2359 off patent; NS2359 Co
Slide 6: Tesofensine – How does it work?
Tesofensine – How does it work? 6|
Slide 7: Tesomet = Tesofensine + "betablocker"
Tesomet = Tesofensine + “betablocker” 7|
Slide 8: Tesofensine: Medix partnership
Tesofensine: 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 roy
Slide 9: Tesofensine: Successful Phase 3 Study in Mexico by Partner Medix
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 pati
Slide 10: Tesofensine and Tesomet are supported by a large safety database
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 1800 subjects treated to date. 1 Phase 3 study, N= 372 (248 tesofensine) 8 Phase 2 studies, 2 Phase 2 studies* N = 1310 (
Slide 11: Tesomet: tesofensine + metoprolol
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 METOPROL
Slide 12: Tesomet: Go-2-Market opportunity in orphan indications
Tesomet: Go-2-Market opportunity in orphan indications Potential for market entry within 4 years >$4B opportunity Prader Willi Syndrome Hypothalamic Obesity Positive Phase 2a in PWS adults Phase 2 study initiated in March 2019 Phase 2a in adolescent patients ongoing Proof of principle from previous
Slide 13: Tesomet - lead indication: Prader-Willi syndrome
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 rat
Slide 14: Causes of death among individuals with PWS
Causes of death among 312 individuals with PWS Source: HHS Public Access, Merlin G. Butler et al Merlin G. Butler et al: “individuals with PWS show high rates of choking, accidents and GI-perforation presumably related to uncontrolled hyperphagia and food seeking behaviors contributing to about one
Slide 15: Tesomet: Phase 2a Study in PWS adults
Tesomet: Phase 2a Study in PWS adults Study set up Results from Phase 2a study in February 2018 (0.5 mg per day) 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 C
Slide 16: Tesomet: Phase 2a Study in PWS adults – hyperphagia score
Tesomet: Phase 2a Study in PWS adults Strong effect on hyperphagia and weight (0.5 mg per day) 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) 5 0 0 20 40 60 80 100 days of tre
Slide 17: PWS opportunity has blockbuster potential
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 op
Slide 18: Tesomet: Phase 2a Study in PWS adolescents
Tesomet: Phase 2a Study in PWS adolescents Study set up Second part of Phase 2a study conducted at quarter of dose (0.125 mg per day) Exploratory randomized, Reduction in hyperphagia PK and Safety double-blind, placebo- in both treatment and controlled 12 weeks study placebo group - Well tolerated i
Slide 19: Key learnings from PWS studies
Key learnings from PWS studies Tesomet provides strong reduction in both hyperphagia and weight at 0.5 mg per day, but dose may be too high in some patients Tesofensine’s long half-life in PWS patients leads to very high plasma level when given at 0.5 mg per day (optimal dose for obese patients) Ear
Slide 20: Hypothalamic Obesity (HO)
Hypothalamic Obesity (HO) HO: Acquired rare disease as a consequence of damage to “appetite center” (hypothalamus) Craniopharyngioma Cause: Benign tumor formation on the pituitary and hypothalamus Diagnosis: Histological examination of a surgical specimen CHOP Pituitary Brain Tumor Day Prevalence: 1
Slide 21: Ion channel platform is rapidly fuelling early stage pipeline
Ion channel platform is rapidly fuelling early stage pipeline Leverage research platform through partnerships and develop at least one candidate to Phase 2 internally Preclinical Preclinical Product/Target Indication Phase 1 Phase 2 Research Development CAD-1883 Essential tremor Ataxia Neuropathic p
Slide 22: Financial statements - million SEK
Financial statements - million SEK 2018, 2017 and accumulated since the company became operations in 2012 Income statement MSEK 2018 2017 2012 - 2018 Net sales 54.9 20.7 207.1 Operating expenses -109.1 -77.9 -354.6 Operating profit/loss -54.2 -57.2 -147.5 Financial items 5.9 0.9 6.9 Tax on net profi
Slide 23: Major milestones 2018/Q1 2019 – all achieved
Major milestones 2018/Q1 2019 – all achieved NEWS/activity STATUS March 2019 MILESTONE Dec 2017 SAN711: selection of new candidate Preclinical devl. complete - Ph1 ready √ Dec 2017 Scandion spin out IPO completed Nov 2018 √ PWS Ph2 initiated Part 1 successfully reported √ Apr 2018 PWS Ph2 second par
Slide 24: Near term value inflection points
Near term value inflection points Go-2-Market opportunity with Tesomet in orphan indications 1 Data from open label extension studies of Phase 2a in adolescents with PWS Initiate Phase 2b/3 PWS study Results from Phase 2a in hypothalamic obesity Additional value drivers from Medix tesofensine collab
Slide 25: Saniona AB contact details
Saniona AB Baltorpvej 154 DK-2750 Ballerup Denmark Tel: +45 70705225 Web: saniona.com 25 |