Sirona Biochem Corp. General Overview TSX-V: SBM

Transcription

1 Sirona Biochem Corp. General Overview TM

2 Forward Looking Statements There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words believes, may, plans, will, estimate, continue, anticipates, intends, expects, and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, Sirona Biochem s stage of development, lack of product revenues, additional capital requirements, risks associated with the completion of clinical trials and obtaining regulatory approval to market Sirona Biochem s products, the ability to protect its intellectual property, and dependence on collaborative partners. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forwardlooking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forwardlooking statements contained herein to reflect future results, events or developments.

3 Proprietary Chemistry Technology The Solution to Unstable Carbohydrate Molecules Enhanced molecules with improved stability, bioavailability, selectivity and efficacy. Preclinical proof of concept to facilitate pharma partnership. Unstable carbohydrate molecule SBM chemistry stabilizes molecule

4 Sirona Biochem s Development Portfolio Priority programs o SGLT inhibitor o Skin lightener (funded by French government) Secondary programs o Inducer o Glycoprotein anti-aging, cell preservation Exploratory therapeutic programs o Morphine analogues o Selectin inhibitors o Chemotherapeutic agents

5 Pipeline of Carbohydrate Compounds Quick to market

6 SGLT Inhibitors New Class of Diabetes Drugs

7 SGLT2 Inhibitors in Development Name Lead company Phase Forxiga (Dapagliflozin) Bristol-Myers Squibb EU approval Nov Complete response received by FDA. Canagliflozin 1,2 Johnson & Johnson NDA (US) & MAA (EU) submitted Empagliflozin (BI 10773) Boehringer Ingelheim III Tofogliflozin (CSG452) Chugai Pharmaceutical III Ipragliflozin (ASP1941) Astellas Pharma III LX Lexicon Pharmaceuticals IIb Ertugliflozin (PF ) Pfizer II Luseogliflozin (TS-071) Taisho Pharmaceutical II SBM-TFC-039 Sirona Biochem Preclinical EGT1442 Theracos Preclinical 1 NDA filed May 31, 2012, MAA (EU) filed June 26, Daiichi Sankyo & Mitsubishi Tanabe Pharma Establish Joint Sales Alliance for canagliflozin 3 Lexicon receives funding for Phase 2 trial of SGLT inhibitor on Type 1 diabetes

8 SBM s SGLT Inhibitor Eliminated Glucose in Dose Dependent Manner UGE (mg/24hr/100g body weight) Control 1mg/kg 3mg/kg 10mg/kg Glucose excreted in urine over 24 hrs per 100 g body weight by Sirona Biochem s SGLT Inhibitor

9 [Glucose] (mmol/l) AUC SBM-TFC-039 Reduced Blood Glucose Excursions 12 9 Control 1mg/kg Time (min) 0 Control 1mg/kg Sirona Biochem s SGLT Inhibitor reduces blood glucose excursions following a glucose challenge

10 [Blood Glucose] (mmol/l) [Blood Glucose] (mmol/l) Blood Glucose Reduced in Obese Diabetic Rats Acute Dosing Chronic Dosing Control ZDF 1 mg/kg ZDF Control Fa/ Control Fa/+ Control ZDF 1 mg/kg ZDF Time (hr) 0 J0 J7 J14 J21 J28 Time (days) Sirona Biochem s SGLT Inhibitor reduced the blood glucose level in obese ZDF (Zucker diabetic fatty) rats to the level of lean rats within 6 hours. In a 28-day chronic dosing study, SBM-TFC-039 normalized diabetes. Compound well-tolerated

11 SBM-TFC-039 timeline

12 Sirona Biochem s SGLT Inhibitor SBM-TFC-039 Performs Better Than Johnson and Johnson s SGLT Inhibitor in Preclinical Study Well tolerated and orally bioavailable Triggers glycosuria in a dose-dependent manner Glycosuria lasted up to 24 hours Reduces blood glucose levels following glucose challenge Reduces blood glucose level in obese diabetic rats and normalized diabetes in a 28-day chronic study

13 Skin Lighteners: A Fast Growing Market $7.5B Market 15% of Worldwide Market Invests in Skin Lighteners 5.5% Annual Growth Rate Major market in Asia - North America & Europe Emerging Markets Current Products Ineffective or Toxic Used in creams by major cosmetic companies

14 Skin Lighteners: Demand for Effective but Safer Products Hydroquinone Product Highly toxic to skin and linked to cancer Unstable Disadvantages Banned in several countries Major adverse events Monobenzyl ether of hydroquinone or Monobenzone (MBEH) Nearly irreversible depigmentation Mild irritation Depigmentation at sites distant to application Azelaic acid Weak inhibitor of tyrosinase in vitro. Major adverse effects. Alpha hydroxyl acids (AHAs) Lactic acid, glycolic acid Not effective for inhibiting melanin production Irritant ph dependant Kojic acid Unstable Oxidizes in air and loses function. Mild irritation Allergen Kojic Dipalmitate No research showing to be as effective as Not oxidized in air kojic acid Mequinol (4-hydroxyanisole) 2% did not produce significant hypopigmentation Ascorbic Acid Chemical Instability Low penetration Irritant Weak activity Retinoïd, Tretinoin Adverse effects Irritant Weak activity Niacinamide, Nicotinamide, (Vitamin B3) Mild irritant Weak activity Licorice extract/ glycyrrhetinic acid Mild irritant No control trials α-arbutin Expensive compounds Can still decompose and release hydroquinone

15 Skin Lightener: Arbutin is our target Natural product Extracted from bearberry plant High potential as depigmenting agent Non-irritating to skin Spots and freckles, sunburn marks, melanogenesis. Prevents melanin formation through tyrosinase inhibition Sirona chemistry technology highly applicable Aim to develop potent and safe skin lightener

16 Skin Lightener: Tyrosinase inhibition Tyrosine Dopa Dopaquinone Dopachrome Melanin Vial A Pigmentation Appears Tyrosinase on Tyrosine substrate A B Vial B Tyrosinase Inhibition with TFC-723 Tyrosinase in solution containing Tyrosine and TFC- 723

17 Skin Lightener Funded Through French Grant $1.9M grant by French government Sufficient to commercial-ready stage Patents filed Consortium assembled to advance agent

18 TFC-723 and TFC-849 Safety and Efficacy Evaluation Skin explants culture, melanin dosage Stability in different conditions Safety tests

19 Skin Lightener Program Status

20 IPGMim A stable inducer for recombinant protein expression in ecoli IPTG Requires special on-site storage conditions (ideally stored at -20 C) Cannot maintain induction for long periods Minimum concentration required IPGMim Stored at room temperature Maintains induction for at least 56 hours Induces expression at a much lower concentration than IPTG Higher stability

21 Quantity (ng) IPGMim Produces More Protein than IPTG IPTG (0.1mM) TFC-358 (0.1mM) Post induction time (hours) IPGMim induced more protein than IPTG at the same concentration of 0.1 mm. Total production was 1.7X and 2.9X that of IPTG at 24 and 56 hours respectively.

22 TFChem A subsidiary of Sirona Biochem Located in Val de Reuil, France, northwest of Paris 5,400 square foot state-of-the-art laboratory Located in France s Cosmetic Valley, where the world s leading cosmetic companies conduct their R&D Part of a pharma park, surrounded by pharmaceutical companies like Janssen Cilag and Sanofi Pasteur Award-winning synthetic chemists; experts in fluorinated building blocks, addressing limitations of carbohydrate-based molecules

23 Complementary Experience on Management Team Howard J. Verrico, MD Founder, CEO Neil Belenkie Chief Executive Officer Geraldine Deliencourt- Godefroy, PhD Chief Scientific Officer Nigel Terrett Strategic Advisor Christopher Hopton, CGA Chief Financial Officer MD, Emergency Physician Venture capital & public markets experience Top 40 Under 40 Winner Founder, GrowthPoint Group Leadership roles at OrthoBiotech & Hoffman LaRoche Founder of TFChem Red Medal Award - French Senate, French Ministry of Research, Francinov Prize of Research & Innovation Chemistry patents, top ranked publications Former Chairman at Excelleris Former Chief Strategic Officer, LifeLabs Former Chief Information Officer at MDS Diagnostics Investment & finance consultant for private & public cos. Financial Planning, Policy, Business process improvement Central Resources Corp., Canadian Airlines, 360networks

24 TM