Big Digital Energy, Inc. · NASDAQ:BGDE
Big Digital Energy — Wize Pharma — J.P. Morgan Healthcare Conference 2019
33 slides from Big Digital Energy's conference presentation, Jan 4, 2019
Slide 1: J.P. Morgan Healthcare Conference January 2019 Corporate Presentation
Wize Pharma INC All Rights Reserved J.P. Morgan Healthcare Conference January 2019 Corporate Presentation
Slide 2: Forward-Looking Information
Forward - Looking Information This presentation contains forward - looking statements about our expectations, beliefs or intentions regarding, among other thing s, our product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time t
Slide 3: Welcome to Wize Pharma: The Company
Welcome to Wize Pharma The Company
Slide 4: Corporate Overview
Corporate Overview Wize Pharma , Inc. (OTCQB: WIZP) is focused on the treatment of ophthalmic disorders, including dry eye syndrome, a $ 3.7 billion global market. Wize’s eye drop formula, LO 2 A, is proven safe and effective in certain countries in Europe for the treatment of dry eye syndrome. The
Slide 5: Wize Pharma: At-A-Glance
Wize Pharma: At - A - Glance Ticker symbol: OTCQB (WIZP) Main shareholders: • Ridge Valley Corp: ~ 16 % • Other large investors: ~ 29 % HQ: Israel Founded: 2015 Market Cap: ~$ 8 M as of 12 / 26 / 1 8 Manufacturing facilities: Pharma Stulln, Fareva All Rights Reserved
Slide 6: The Product: LO2A Eye Drops
The Product: LO 2 A Eye Drops All Rights Reserved Wize has licensed certain rights to develop, purchase, market, sell and distribute LO 2 A for ophthalmic disorders in the United States, Israel, Ukraine and China. Wize has certain rights to add additional territories. Wize has the option to purchase
Slide 7: The Product: LO2A Eye Drops
The Product : LO 2 A Eye Drops Established sales history in Europe * Approved to treat DES in four European countries * Switzerland, Germany, Hungary and the Netherlands Anti - Irritant Anti - irritant properties Compatible Suitable for use with contact lenses Preservative - Free Removes potential f
Slide 8: LO2A: The Opportunity
LO 2 A: The Opportunity Proven eye drops formulation Developed by the licensor, Prof. Dikstein, for treatment of dry eye syndrome (DES), sold exclusively in Europe (*) with lubricant and anti - irritant properties Completed and ongoing clinical trials, results for FDA pre - IND submission Finished P
Slide 9: Competitive Landscape: The Market
Competitive Landscape The Market
Slide 10: European Sales Territory
European Sales Territory Manufactured in Distributor Packages sold in 2017 Hungary Pharma Stulln (Germany) PannonPharma 8,000 Germany Pharma Stulln (Germany) Pharma Stulln 265,000 The Netherlands Pharma Stulln (Germany) Tramedico 158,000 Switzerland Fareva (France) Thea Pharmaceuticals Ltd 1,100,000
Slide 11: LO2A Vs. Competition
+ + + Dry Eye Most common, instillation site irritation and decrease in visual acuity ( 5 - 25 % of patients). Blurred vision, eye irritation, conjunctival redness, pruritus (occur in 1 - 5 % of patients) 2 Most common, ocular burning ( 17 %). Conjunctival redness, tearing, blurred vision, eye pain,
Slide 12: Multiple Indications: Sjögren's Syndrome
Multiple Indications: Sjögren’s Syndrome Affects about 0.2 % - 4 % of the adult population 9,10 Wide range, in part, reflects the lack of uniform diagnostic criteria Male/female ratio of 1:9 9 https://emedicine.medscape.com/article/332125 - overview#a6 10 https://www.ncbi.nlm.nih.gov/pubmed/20012976
Slide 13: Multiple Indications: CCh
Multiple Indications: CCh Refers to redundant folds of loose conjunctiva Increases dramatically with age 12 Current treatment for severe cases is surgical procedure 11 http://journals.plos.org/plosone/article?id= 10.1371 /journal.pone. 0132656 12 https://www.ncbi.nlm.nih.gov/pubmed/ 23036571 Present
Slide 14: Multiple Indications: Dry Eye Syndrome
Multiple Indications: Dry Eye Syndrome More than 16 M adults in the US have DES 7 Approx. 19 M prescriptions were filled in the US in 2013 for anti - inflammatory drugs administered by eye drops for ocular diseases and conditions, resulting in sales of approximately $ 2.2 billion (Source: IMS Health
Slide 15: Clinical Trials & Intellectual Property
Clinical Trials & Intellectual Property
Slide 16: Prior Clinical Trials: Dry Eye Syndrome
Dry Eye Syndrome • Several clinical trials in Europe involving more than 200 patients with Dry Eye • Documented beneficial effect of LO 2 A eye drops by both the investigators and the patient DES & Sjögren’s Syndrome See Appendix • Investigator - initiated study • Performed in Hungary • 21 patients
Slide 17: DES and CCh Phase II: Overview
DES and CCh Phase II: Overview DES & CCh Phase II Trial • Multi - center, double - masked, placebo - controlled study in Israel • Completed patient enrollment and treatment of all 62 patients • Evaluate safety and efficacy of LO 2 A for patients with moderate to severe CCh • Randomized using a 1:1 a
Slide 18: DES and CCh Phase II: Initial Results
DES and CCh Phase II: Initial Results DES & CCh Phase II Trial • Phase II trial successful met primary objective of lowering lissamine green conjunctival staining (LGCS) score from baseline at 3 months • Based on analysis of 49 fully evaluable patients, out of the 62 originally enrolled, using a mix
Slide 19: Ongoing Clinical Trial: DES & Sjögren's Syndrome
Ongoing Clinical Trial: DES & Sjögren’s Syndrome Phase IV Confirmatory Trial • Multi - center, double - masked study design in up to 60 patients in Israel • Currently enrolling patients • Evaluate safety and efficacy of LO 2 A for symptomatic improvement of dry eye in patients with Sjögren’s Syndrom
Slide 20: Anticipated Timeline
Anticipated Timeline All Rights Reserved Q 1 / 2020 Q 4 / 2019 Q 3 / 2019 Q 2 / 2019 Q 1 / 2019 Q 4 / 2018 మ Phase II Trial CCh - results మ Phase IV Trial DES Sjögren’s Syndrome – complete recruitment మ Phase IV Trial DES Sjögren’s Syndrome – results మ FDA – pre IND
Slide 21: Intellectual Property
Intellectual Property Territory Manufactured in Distributor International Patent Application Publ. No. WO 2012150583 filed on April 5 , 2012 , assigned to Resdevco, Corresponding members include US Patent No. 8,912,166 , Israeli Patent No. 212725 , Japanese Patent No. 5957517 and pending European Pa
Slide 22: Summary
Summary vip...
Slide 23: Financial Information
• ~$ 8 M market cap as of 12 / 26 / 2018 on OTCQB • Average monthly burn rate: ~$ 200,000 Financial Information All Rights Reserved FINANCING ROUNDS TO DATE $ 1.2 M Private Placement $519K Convertible Loan $827K Convertible Loan $1M Private Placement 2017 2015 2016 2016 $ 1.15 M Warrants & Investmen
Slide 24: Capital Structure 2018
Capital Structure All Rights Reserved 2018 As of 11 / 13 / 2018 Weighted Average Exercise Price (WAEP) Common Stock 8,462,550 Convertible Loans 1,366,803 WAEP: $ 1.054 (Conversion Price) Investment Rights 890,138 WAEP: $ 1.321 Options 259,896 WAEP: $ 3.68 Warrants 10,015,871 WAEP: $ 1.119 Preferred
Slide 25: Introducing Management Team
Introducing Management Team Or Eisenberg CFO, ACTING CEO Joined March 2015 Formerly controller of Katzir Fund Group Formerly external controller/CFO of multiple TASE companies Formerly accountant at Ernst & Young BA in Economics & Accounting (from Haifa University) CPA in Israel OE Noam Danenberg Ch
Slide 26: Introducing Scientific Advisory Board
Introducing Scientific Advisory Board Prof. Janos Nemeth Ophthalmologic surgeon and Board Member of the Drug Discovery and Safety Center at Semmelweis University in Budapest, Hungary Performed clinical trial with LO2A in the treatment of CCh JN All Rights Reserved Dr. Penny Asbell KOL in the treatme
Slide 27: LO2A: The Opportunity
LO 2 A: The Opportunity Proven eye drops formulation Developed by the licensor, Prof. Disktein, for treatment of DES, sold exclusively in Europe (*) with lubricant and anti - irritant properties Completed and ongoing clinical trials, results for FDA pre - IND submission Finished Phase II study to ev
Slide 28: Thank You
24 Hanagar St. Hod Hasharon, Israel Tel: + 972 72 2600536 Cell: + 972 54 4318380 Fax: + 972 72 2600537 Thank You Visit wizepharma.com or email info@wizepharma.com
Slide 29: Appendix
Appendix vip.
Slide 30: Clinical Results: Hungarian CCh Study
Clinical Results: Hungarian CCh Study * Month 0 Month 1 Month 3 Comparison Month 3 vs Month 0 Comparison Month 3 vs Month 1 Mean ± SD Mean ± SD Mean ± SD Shift parameter and 95% Cl P value Shift parameter and 95% Cl P value Right Left Right Left Right Left Right Left Right Left Right Left Right Left
Slide 31: Clinical Results: Hungarian CCh Study
Clinical Results: Hungarian CCh Study * 1 2 3 0 1 2 3 Conjunctivochalasis (LIPCOF degree) Time (months) Right eyes 0 1 2 3 0 1 2 3 Conjunctivochalasis (LIPCOF degree) Time (months) Left eyes 0 The graph demonstrates a statistically significant improvement in treating patients with CCh according to L
Slide 32: Clinical Results: Hungarian CCh Study
Clinical Results: Hungarian CCh Study * 0 2 2 0 15 22 6 17 15 34 6 1 BASELINE 1 MONTH 3 MONTH Number of Eyes Study Visit LIPCOF Grade following 1 and 3 month treatment with Conheal Grade 0 Grade 1 Grade 2 Grade 3 Bar chart demonstrating the improvement in CCh per eye, measured by LIPCOF Grade, after
Slide 33: Clinical Results: Hungarian Sjögren's Study
Clinical Results: Hungarian Sjögren ’ s Study * Figure 1 : The artificial tears with high glycerine content ceased the corneal staining almost completely in the patients with Sjögren’s Sy ndrome by the end of the three - month treatment. In the patients the initial ocular sin face staining was devel