Big Digital Energy, Inc. · NASDAQ:BGDE
Big Digital Energy — Wize Pharma — Investor Presentation (May 2018)
30 slides from Big Digital Energy's investor presentation, May 7, 2018
Slide 1: Wize Pharma Investor Presentation May 2018
Wize Pharma INC Date: May 2018 Investor Presentation All Rights Reserved
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 Company Overview
Welcome to Wize Pharma Company Overview
Slide 4: Wize Pharma At-A-Glance
WizePharma – At - A - Glance Ticker symbol: OTCQB (WIZP) Main shareholders: • Ridge Valley Corp: ~22% • Main private Investors: ~31% HQ: Israel Founded: 2015 Market Cap: ~$ 29 M as of 05 / 03 / 1 8 Manufacturing facilities: Pharma Stullen, Fareva All Rights Reserved
Slide 5: LO2A Opportunity
LO2A Opportunity Proven eye drops formulation Developed by the licensor, Prof. Disktein , for treatment of dry eye syndrome (DES), sold exclusively in Europe (*) with lubricant and anti irritant properties Ongoing clinical trials, results for pre - IND submission Ongoing Phase II study to evaluate s
Slide 6: LO2A Eye Drops
LO2A Eye Drops Established sales history in Europe (*) Compatible Used with any contact lenses Anti - Irritant Anti - irritant properties Well - established safety profile No material side effects reported Preservative - Free Removes potential for irritation and sensitization which can damage the oc
Slide 7: Previous Clinical Trials
Dry Eye Syndrome (DES) See Appendix • 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 Hun
Slide 8: Competitive Landscape Market Overview
Competitive Landscape Market Overview
Slide 9: LO2A Eye Drops License
All Rights Reserved LO 2 A Eye Drops Wize has licensed certain rights to develop, purchase, market, sell and distribute LO2A 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 licensor's agr
Slide 10: European Sales
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: 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: Prevalence of DES
Prevalence of DES More than 16 M adults in the US have dry eye syndrome 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) Econom
Slide 13: Prevalence of Sjögren's Syndrome
Prevalence of 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 A chronic
Slide 14: Prevalence of CCh
Prevalence of CCh Refers to redundant folds of loose conjunctiva Increases dramatically with age 12 11 http://journals.plos.org/plosone/article?id= 10.1371 /journal.pone. 0132656 12 https://www.ncbi.nlm.nih.gov/pubmed/ 23036571 Present in up to a third of dry eye patients 11 (approx. 7 million peopl
Slide 15: Clinical Trials & Intellectual Property
Clinical Trials & Intellectual Property
Slide 16: Ongoing Clinical Trials
Ongoing Clinical Trials DES & Sjogren’s syndrome (Phase IV trial) (*) • Currently enrolling patients • Evaluate safety and efficacy of LO 2 A for symptomatic Improvement of Dry Eye in Patients with Sjögren’s Syndrome • Randomized, double - masked study design in up to 60 patients • Study treatment w
Slide 17: Timeline
Timeline Q4/2017 Q1/2018 Q 2 / 2018 Q 3 / 2018 Q 4 / 2018 Q 1 / 2019 Phase IV Trial DES Sjögren’s Syndrome (IRB approval) Phase IV Trial DES Sjögren’s Syndrome (start - 1st patient) Phase II Trial CCh (completion) Phase IV Trial DES Sjögren’s Syndrome (completion) Recruiting Key Option Leaders (KOL)
Slide 18: Patents
Patents Territory Manufactured in Distributor International Patent Application Publ. No. WO2012150583 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 Pat. Appl. 2704747 G
Slide 19: Summary
Summary VIP...
Slide 20: Financial Information
• ~$29 M market cap as of 05/03/2018 on OTCQB • Monthly burn rate: ~$150 K • ~ 5 M shares outstanding • ~ 8.3 M shares on a fully diluted basis • Average exercise price of convertible securities $ 1.44 (proceeds of ~$5M to the company) Financial Information FINANCING ROUNDS TO DATE $ 1.2 M Private P
Slide 21: LO2A Opportunity
LO2A Opportunity Proven eye drops formulation Developed by the licensor, Prof. Disktein , for treatment of dry eye syndrome (DES), sold exclusively in Europe (*) with lubricant and anti irritant properties Ongoing clinical trials, results for pre - IND submission Ongoing Phase II study to evaluate s
Slide 22: Management Team
Introducing. Management Team Or Eisenberg CFO, ACTING CEO Joined in March 2015 Formerly controller of Katzir Fund Group Formerly external controller/CFO of TASE co’s Accountant at Ernst & Young BA in Economics & Accounting (Haifa U.) CPA in Israel. OE Noam Danenberg COO Strategic advisor to Wize sin
Slide 23: Scientific Advisory Board
Introducing. Scientific Advisory Board Dr. Gideon Stein Medical Advisor More than 15 years experience in drug development, marketing and business development in the biotech industry in public and private companies. A graduate of the Faculty of Medicine at Tel Aviv University, with a specialization i
Slide 24: Thanks
Thanks 24 Hanagar St. Hod Hasharon , Israel Tel: + 972 72 2600536 Cell: + 972 54 4318380 Fax: + 972 72 2600537 Visit wizepharma.com or email info@wizepharma.com
Slide 25: Appendix
Appendix VP...
Slide 26: Dry Eye – Clinical Trial Results (CCh)
Dry Eye – Clinical Trial Results (CCh) 1.9 2.4 2.6 2.8 0 1 week p=0.19 p<0.0001 Rose Bengal Score Eyecon Control "Rose Bengal Staining is the Clinical Gold Standard for the Diagnosis of Dry Eye" Dr. E.Knight , FDA, 1994 • Cellulose derivatives • PVP+hydroxyethylcellulose Improvement in Rose Bengal S
Slide 27: Clinical Results – Hungarian Study (CCh)
Clinical Results – Hungarian Study (CCh) Month 3* Comparison Month 3 vs Month 0 Comparison Month 3 vs Month 1 MeanlSD Shift parameter** and 95% Cl P value*** Shift parameter** and 95% Cl P value*** Right Left Right Left Right Left Right Left Right Left LIPCOF 1.4 1.4 - 2.0( - 2.0 - 1.0 ( - 2.0 <0.00
Slide 28: Clinical Results – Hungarian Study (CCh)
Clinical Results – Hungarian Study (CCh) 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
Slide 29: Clinical Results – Hungarian Study (CCh)
Clinical Results – Hungarian Study (CCh) Bar chart demonstrating the improvement in CCh per eye, measured by LIPCOF Grade, after one and three months treatment with Conheal® All Rights Reserved
Slide 30: Clinical Results – Hungarian Study (Sjögren's)
Clinical Results – Hungarian Study (Sjögren ’ s) Figure 1 : The artificial tears with high glycerine content ceased the corneal staining almost completely in the patients with Sjogren s ynd rome by the end of the three - month treatment. In the patients the initial ocular sin face staining was devel