ZAPP WorldwideAll-‐in-‐one product with disruptive breakthrough anti-‐microbial technology
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TM
• ZAPP-‐ a breakthrough productwith a rangeof effects
• This platform technology will be adapted to regulatoryrequirementsworldwide
• Under development for over 20 years with dramatic effects onpatients tested
What is ZAPP: A Platform Technology
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Overview – Rx Formats
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Rx Topical Cream
US, Canada, Ja
pan
RxMouthwash
US, Canada, Ja
pan
RxWound Irrigation
Worldwide
RxNasal Spray
Worldwide
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*Excluding Japan
Overview – OTC Formats
OTC Mouthwash
Europe, A
sia, Latin Am.*
OTC Topical Cream (Small Tube)
Europe, A
sia, Latin Am.*
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Competitive Advantage
Patent applications for worldwide coverage have been filed and additional applications are under development
IP
Collectively, the executive team brings over 100 years ofexperience in medicine, entrepreneurship, and executiveleadership in the biopharmaceutical industry
Team
Overview - Advantages
The combined ingredients work in a synergy to create a unique effectThis unique antimicrobial has a broad spectrum effect killing bacteria, viruses and fungi
ProblemFinding a One-Stop solution that does-it-all
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They need a single solution that will kill all microbes,and disinfect wounds.Patients
Physicians/Surgeons need a simple and safe solutionto control infectionsPhysicians
Consumers need an everyday broad-‐spectrum productthat controls infection
Consumers
üKills BacteriaüKills VirusesüKills Fungi
üEffective on resistant bugs i.e. MRSA
The Solution: ZAPPA multi-benefit, broad spectrum, one-stop breakthrough product with predictable results
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ZAPP ointment can be used onsurgical wounds, burns, acne,animal bites and insect bites
ZAPP antimicrobial rinse or irrigationdisinfects surgical wounds, mouthand lip sores and nasal/sinusinfections in both humans andanimals
ZAPP does not cause bacteria todevelop resistance-‐ a commonproblem with antibiotics
Product Formats5 formats to satisfy all end-users: Patients, Physicians, Surgeons and Consumers
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Mouth Rinse Gargle Anti-viral, anti-bacterial and anti-fungal mouth rinse for colds, flu, mouth infections, allergies, lesions and ulcerations, post surgical flush/rinse
Nasal SprayAnti-viral, anti-bacterial and anti-fungal nasal & sinus spray for colds, flu and post surgical flush/rinse
Rx/OTC Large & Small Topical Antimicrobial TubesAnti-viral, anti-bacterial and anti-fungal topical cream for medical, surgical, infected and skin wounds, burns, acne and animal bites
Surgical/Topical Wound Irrigating SolutionAnti-viral, anti-bacterial and anti-fungal wound disinfectant for all surgical procedures with a few exceptions
MARKET SIZES AND CLINICAL TRIAL COSTS
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526$
679$
90$52$
801$838$
0"
100"
200"
300"
400"
500"
600"
700"
800"
900"
US+Canada" Europe" Asia"Pacific" La@n"America"
Comparison"of"Global"Markets"
Market$Size$2013$$M$ Market$Size$2018$$M$
Nasal Spray Market is Forecast to GrowThe Nasal Spray market is predicted to grow over the next 5 years in US+Canadaand Europe*
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* Growth data for AsiaPac. and Lat Am not available
The Nasal Spray Market is valued at $1.3 B in
2013 and is likely to cross $1.8 B by 2018
Rx Nasal Spray
1289%
720%
1889%
41%
1523%
839%
2265%
52%
0"
500"
1000"
1500"
2000"
2500"
US+Canada" Europe"(Big"5)" Asia"Pacific" La>n"America"
Comparison"of"Markets"and"Growth"to"2018"
Market%Size%2013%$M% Market%Size%2018%$M%
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The mouth rinse market is valued at $3.9 B in
2013 and will increase to $4.7 B by 2018
Mouth Rinse Market is Forecast to Grow
OTC Mouth RinseRx Mouth Rinse
Market Sizes in 2018US + Canada: $5.2 BEurope 5 + PL: $7 B
ZAPP Prescription Topical Market is Forecast to GrowThe prescription dermatological market is predicted to grow over the next 5 years
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Total Prescription Dermatological Market (US+Canada+Europe) is valued at $15.7.8 B in 2013 and will reach $21
B in 2018
Effective CAGRsUS + Canada: 6.14%Europe 5 + PL: 6.2%
RX Large Tube
Geographical Comparison of Rx Surgical/Topical Wound Irrigation
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975$867$
296$
28$0"
200"
400"
600"
800"
1000"
1200"
US+Canada" Europe"Big5+1" Asia"Pacific" La?n"America"
Market"Size"Across"Geographies"$M" The number of surgical procedures appear to remain fairly constant over the years, hence change in market size could not be calculated
Total Market Size is Estimated at: $2.1 B
Rx Wound Irrigation
4300$
1600$
5100$
1600$
5540$
2062$
6571$
2062$
0"
1000"
2000"
3000"
4000"
5000"
6000"
7000"
Western"Europe" C&E"Europe" Asia"Pacific" La=n"America"
Market"Size"Comparison:"2013"vs"2018"
2013"Market"Size"$M" 2018"Market"Size"$M"
OTC Antimicrobial Market is Forecast to GrowThe market is set to grow across all geographies over the next 4 years
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The combined market size was $12.6 B in 2013 and will reach $16.2 B by
2018
OTC Small Tube
ZAPP’s Advantages Over Competitors
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ü All-‐in-‐1 anti-‐microbial
ü Kills bacteria, viruses and fungi
Intellectual Property
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PCT Patent Application
• Already filed and intends to file further patent applications for worldwide IP protection
• Protection for formulations, formats, and uses (as topical antimicrobial, mouth rinse, Rx Surgical/Topical Wound Irrigation and nasal spray)
History to Date
• Proprietary regional formulations have been established
• Proof-‐of-‐concept studies have been undertaken
• Overall, the founder and team have spent twenty years developing this unique product concept
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Business Model and Development PlanThe company has devised an organized approach to reach market
Business Model
Development Plan
• ZAPP will be available in 5 formats and sold to medical practitioners or directly to consumers either as prescription or OTC product
• Payment:• Cash payments from patients/consumers• Building the product cost into the cost of the procedure
• Payment from third party insurers
• Antimicrobial application is the most advanced and will be quickest to market
• Pre-‐clinical toxicology and animal testing for tissue tolerance
• Microbial, Viral, fungal panel testing and surrogate models
• Clinical testing in humans
• CMC and stability studies will be undertaken
Estimated Costs for Clinical Studies
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PHASE 1, PHASE 2, PHASE 3 CLINICAL STUDIES Cost-‐‑Low ($) Cost-‐‑High ($) Clinical Studies for the following @ $8,000/subject: A. Topical (Cream/Ointment/Gel/Spray) B. Mouth Rinse C. Nasal Rinse D. Surgical-‐‑Topical Irrigation Solution
$9.0M
$14.0M
Insurance: Clinical site; IRB; Recruitment costs; CRO
$4.0M
$5.0M
CMC: Chemistry, Formulation, Manufacturing, Stability
$4.0M
$5.0M
Panels and Surrogate Markers/Endpoints: Costs (all products-‐‑A, B, C, D)
$2.5M
$2.5M
Regulatory/Safety Reports: Regulatory, e-‐‑subs, Safety Reports
$5.0M
$7.0M
Pre-‐‑Clinical: Costs:
$1.25M
$1.25M
FDA and Other: FDA Meetings, Clinical Investigator Meetings & Audits, Pre-‐‑FDA Audits; Internal Operations
$5.0M
$6.0M Rx Products: A, B, C, D: (Rx costs only)
Sub-‐‑Total:
$30.75M
$40.75M OTC Costs: Costs: labeling, EU Regs, etc.
$1.0M
$1.0M
Sub-‐‑Total: $31.75 $41.75
Total: $31.75M $41.75M
Executive Team
Glenn Abrahmsohn, LDS, RCS (Eng), Chief Executive Officer & Founder• 39 years experience in dentistry• 20 years working with antimicrobial solutions• Extensive publications in peer-‐reviewed journals
Mark Kirn-‐Slaboszewicz, MA, Chief Advisor• 32 years executive leadership in biopharmaceutical industry• Former President, Schering-‐Plough Healthcare Products• Additional leadership roles at Sterling Drug and American Cyanamid
Benjamin Lewis, PhD, RPh, RAC, Regulatory Affairs Executive and Scientist• 30 years experience at FDA: Director, Regulatory Operations• Developed and successfully submitted multiple INDs and 8 NDAs • Head Regulatory Affairs, N. America at Mitsubishi; VP Regulatory Affairs at Prestwick
Dean Rodwell, MS, Research & Development Executive• 40 years experience in toxicology, GLP, and drug development• Executive experience in roles such as VP (IIT Research Institute), President (Huntingdon
Life Sciences), and COO (BioDuro)
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IP Counsel and Advisors 1/2
Doug Nordlinger, JD, Corporate Advisor• 30 years experience in joint ventures, M&A, and project financing • Partner at Skadden, Arps, Slate, Meagher & Flom• Additional experience with regulatory agencies
Richard Dulik, JD, Intellectual Property Counsel• 18 years experience in IP law• Expertise in patent prosecution, counseling biotechnology and internet start-‐ups, technology
exports, and licensing• Adjunct Professor of Law at Georgetown University
Gary Connell, J.D., Intellectual Property Attorney – Sheridan Ross PC• B.S., Biology, 1982; J.D., 1986• 25+ years patent prosecution experience in biotechnology and pharmaceuticals • Former In-‐house Patent Attorney, PPG Industries, Inc.• Co-‐President, Sheridan Ross PC
Richard Stern, Ph.D., Patent Agent – Sheridan Ross PC• 14 years experience in IP law; patent agent since 2002• Former Manager of Intellectual Property at Heska Corporation• Research background in molecular genetics, infectious diseases and immunology
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IP Counsel and Advisors 2/2
Robert Traver, Ph.D., J.D., Intellectual Property Attorney – Sheridan Ross PC• B.S., Pharmacy, 1988; Ph.D., Pharmaceutical Science, 1997; J.D., 2000• 12 years working experience as a hospital and retail pharmacist• 15 years patent prosecution experience in pharmaceutical formulation and pharmacology • Teaches patent law in the Bioinnovation and Entrepreneurship Program at the University of
Colorado, DenverFaith Charles, JD, Corporate Transactions and Securities
• 25 years of corporate transactional experience• Partner at Thompson Hine• Leads Thompson Hine’s Life Sciences group
Matthew Vaughan, JD, Corporate Transactions and Securities• Focus on early stage and emerging companies at Thompson Hine• Experience in private equity and venture capital transactions• 5 years experience in litigation
Yuxin Zhang, PhD, Statistician• 15 years in statistics for the pharmaceutical industry• 12 years Former Head of Biometrics & Data Management at Shire Ltd• Outstanding track record of NDA approvals
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Contact
Glenn Abrahmsohn, L.D.S., R.C.S., (Eng.)Founder & CEO
The Dental Connection260 Crandon BoulevardKey Biscayne, FL 33149.(305) 361-0778
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IMPORTANT CLARIFICATIONS:
THIS BUSINESS OVERVIEW CONTAINS PROJECTIONS OF, AND ASSUMPTIONS REGARDING, FUTURE EVENTS REFLECTING THE BELIEFS AND EXPECTATIONS OF THE COMPANY. SUCH EVENTS MAY OR MAY NOT OCCUR. CONSEQUENTLY, THESE PROJECTIONS AND ASSUMPTIONS MUST NOT BE RELIED ON TO INDICATE, OR GUARANTEE, ANY ACTUAL RESULTS.
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