Bio Europe Munich. November 4, 2015 TSX-V: SBM
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1 Bio Europe Munich November 4, 2015 TM
2 Sirona s Fluorination Chemistry Technology The Solution to Unstable Carbohydrate Molecules Carbohydrate molecules are unstable by nature Our technology stabilizes carbohydrate molecules Resulting in improved bioavailability and selectivity that translates into better safety and efficacy
3 Current Collaborations & Pipeline Cosmetic Products Therapeutic Area Compound Partnering Status Skin lightening SBM-TFC-849 Valeant Skin lightening SBM-TFC-1067 In partnering discussions Cell Preservation SBM-TFC-837 In partnering discussions Pharmaceutical Products Therapeutic Area Compound Partnering Status Diabetes SBM-TFC-039 Fosun in China Ready for licensing in ROW Regenerative Medicine SBM-TFC-1165 In partnering discussions Inflammatory Disease In development JV with Bloom Burton & Co
4 Global Skin Lightening Market 25.0 $ billions Japan Asia-Pacific US, EU, ROW
5 Skin Lightening Agent SBM-TFC-1067 TM
6 Safety of SBM-TFC-1067 In vitro stability: percentage of hydroquinone released Hydroquinone Released (%) Water RT 14 days Bis Tris buffer RT 14 days PBS RT 14 days Ringer solution at ph 6.8 at RT 14 days 80 Ringer solution at ph 5.5 at 70 C 24H Ringer solution at ph 8.5 at 70 C 24H 60 Fibroblasts RT 48H 40 Keratinocytes RT 48H Human skin extract RT 48H Synthetic perspiration RT 48H Deoxyarbutin SBM-TFC-1067 SBM-TFC-1067 is stable and extremely safe, with zero hydroquinone released in all tested conditions (chemical, biological)
7 Efficacy of SBM-TFC-1067 Inhibition of Human Tyrosinase (300U/ml) mm IC50 (mm) mm 0 SBM-TFC-1067 Deoxyarbutin SBM-TFC-1067 has 8 times the efficacy of deoxyarbutin
8 Safety and Efficacy Summary Safety Superior safety profile over deoxyarbutin with zero hydroquinone released No genotoxicity (0-0.25%) Very minor ocular irritation at 0.14% No ocular irritation at 0.01% No skin irritation at 0.05% No sensitization No phototoxicity Efficacy 8 times the efficacy of deoxyarbutin High flux capacity to the site of action in the epidermis Antioxidant properties
9 Glycoprotein Program Anti-Aging and Regenerative Medicine TM
10 Natural Anti-Freeze Glycoproteins (AFGPs) enable survival under freezing temperatures
11 Efficacy of SBM-TFC-837 Viability of fibroblasts under stressed conditions of serum deprivation Cell viability (%) Stress control Stress + TFC-837 at 5mg/ml 20 0 D0 D1 D2 D3 D4 D5 D6 D7 D10 D12 At the conclusion of a 12 day study, 100% of the unprotected cells were dead whereas 75% of the glycoprotein-protected cells were fully viable. SBM-TFC-837 protects fibroblasts from the stressed condition of serum deprivation
12 Efficacy of New Glycoproteins Under Starvation Conditions Viability of fibroblasts under the stressed condition of serum deprivation TFC-1165: 1 sugar-3 AA TFC-1288: 1 sugar-2 AA TFC-1287: 1 sugar-1 AA Fibroblasts Viability (%) D D4 20 D7 0 Positive control (10% FBS) Stress control (no FBS) Stress + TFC-1165 (17mM) Stress + TFC-1288 (17mM) Stress + TFC-1287 (17mM) Similar efficacy of SBM-TFC-1165, 1288 and 1287, despite the differing number of amino acids
13 Efficacy of New Glycoproteins: UVA stress Viability of fibroblasts under the stressed condition of UV irradiation (11J/cm2) TFC-1165: 1 sugar-3 AA Fibroblasts Viability (%) H 60 3H 40 24H 20 0 no irradiation irradiation control irradiation + TFC-1165 (8.5mM) irradiation + TFC-1165 (17mM) irradiation + TFC-1165 (25.5mM) SBM-TFC-1165 protects fibroblasts from UV irradiation in a dose dependent manner
14 Efficacy of SBM-TFC-1165 Neutral red uptake method Viability of human fibroblasts in culture for 24h after adding H Cell viability (%) h 60 24h Positive control (no stress) Stress Control 100µM H202 Stress + TFC-1165 (5 mg/ml) Stress + TFC-1165 (10 mg/ml) Stress + TFC-1165 (15 mg/ml) SBM-TFC-1165 protects fibroblasts from oxidative stress
15 Sirona s Glycoprotein program: Biomimicry The potential opportunities are enormous Sirona s Glycoprotein program Adjuvants for biological material preservation Cosmetic Active Ingredients Anti-aging Cells Organs Transplant Protection & Regeneration Stem cells Islet cells Skin explants, RHE, Healing, Wound care, Platelets Cornea Hypothermic protection, Red blood cells Sunscreen Post-sunburn/ radiotherapy Tissues Adipocytes Renal Reperfusion Living organisms Vaccines
16 SGLT2 Inhibitor Program Type 2 diabetes TM
17 SBM-TFC-039 Ongoing Development Milestone Status Upfront payment Complete Preclinical Studies (first line tests) Urinary Glucose Excretion (UGE) Oral glucose tolerance test (OGTT) Pharmacokinetic study in rats Batch production of 80g of compound 14 day toxicology study with repeated administration in Sprague Dawley (SD) rats Complete (06/2014) Complete (06/2014) Complete (07/2014) Complete (12/2014) Complete (02/2015) Milestone payment for completion of toxicology study Expected in March 2016 Preclinical studies (second line tests) Investigational New Drug (IND)
18 Head-to-Head trial Six hours after administration, SBM-TFC-039 reduced blood glucose by 44% compared to 26% for Canagliflozin [Blood Glucose] (mmol/l) SBM-TFC-039 (1 mg/kg) proved to be more efficacious than Canagliflozin Control Diabetic 15 Canagliflozin 1 mg/kg 10 SBM-TFC mg/kg 5 Control Lean Hrs 6 8
19 Results of the 14 Day Toxicology Study mg/kg/day Maximum Tolerated Dose SBM-TFC-039 Canagliflozin Efficacy study dosing: 3 mg/kg/day Pharmacokinetics study dosing: 10mg/kg/day PO and 1 mg/kg/ day IV
20 Summary Sirona Biochem is a discovery and development stage biotechnology company that is the leader in commercializing carbohydrate chemistry There are opportunities to: o o o License our newest skin lightener Collaborate / License our glycoprotein for antiaging and regenerative medicine License our SGLT2 inhibitor for type 2 diabetes
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