Disruptive Animal VaccinesJenny Filbey, Ph.D.
CEO
Summer 2020
Ø Value Proposition
Ø Mazen’s Oral Vaccine Technology / Customer Need
Ø Market
Ø Team
Ø Financing
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Revolutionizing Animal Disease Prevention is our Mission:• We believe all animals should be protected from preventable disease
• Mazen can turn that belief into reality
• Mazen will develop, manufacture, and commercialize orally delivered vaccines for farm and companion animals
• Our initial focus is swine with plans to expand into companion animal, poultry, fish and other species
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Mazen’s Oral Vaccines have Competitive AdvantagesOur Compelling Value Proposition for Producers
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More cost effectiveRemoving today’s threshold decision to
vaccinate
Improved safety for animals & workers
Eliminating contact
Greater efficacyWith dual protection (systemic and mucosal)
against disease
Greater stabilityRemoving the need for cold chain and
improving supply reliability
Traditional injectable vaccination has many challenges…
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Vet• Veterinarian orders vaccine
Vaccine Delivery
• Expensive cold storage required (2°-7°C )• Multiple chances for mishandling and deactivation
Vaccine Crew
• Costly crews not always available when needed• Can carry contamination from other sites
Inject pigs
• Vaccination process causes disruption to feeding• Risk of broken needles in pigs and missed
vaccinations
… that the Mazen oral vaccination platform addresses
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Oral Vaccination
Improved biosecurity
Continuous feed
Improved worker safety
Needle free
Consistent potency
Revolutionizing Animal Disease PreventionFirst in Class Solid Oral-dosed Vaccines
Feed–Through VaccinesFor Farm Animals
Treat-based VaccinesFor Companion Animals
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Revolutionizing Animal Disease PreventionMaize is an optimum production platform for vaccines
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High expression levels of antigen enable commercial dosingDosing fits well into current feed mill and producer systemsCorn matrix provides bioencapsulation and protection of the antigenHeat stable allows processing into feed and room temperature transportCorn production facilitates low cost of goods
Production from Concept to Commercial
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Antigen Transformation
Greenhouse Development Scale-up
ProcessingFinal Use Product Feedmill Animals
Design Gene
Innovative Platform TechnologyOral vaccination has been demonstrated
• Oral vaccination has demonstrated protection in multiple species –monogastric and polygastric mammals, birds and fish enabling broad product portfolio opportunities
Multiple Species
• Oral vaccination has addressed both enteric and non-enteric diseases allowing for multiple applications in each speciesVaried disease types
• Efficacy has been shown comparable to commercially available injectable modified live vaccines, reducing barriers to switchComparable to injectable
• Oral administration enables both a systemic response (IgG) as well as a mucosal response (IgA), not exhibited with injectable creating a more efficacious solution
Mucosal immunity
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Oral Vaccination WorksDemonstrated antibody production and protection against a challenge in multiple species and diseases
• Protection against a challenge
• IgA in colostrum
TGEV*
• Equivalent antibody titers
• Protection against a challenge
NDV*
• Equivalent antibody titers
• Protection against a challenge
Rabies*
Improved efficacy over injectable
IPNV*
• Reduction in fungal burden
• Biomarker for protection
Valley fever
Serum neutralizing antibodies after challenge
PEDV
11 *Literature work
Mazen’s Initial Focus is on Swine
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Proof of concept• Porcine Epidemic
Diarrhea Virus (PEDV)
• Transmissible Gastroenteritis Virus (TGEV)
Compelling value proposition• Swine producer to
test PEDV vaccine
Additional swine vaccines identified• Porcine circovirus
(PCV2)• Rotavirus
Portfolio diversification• After initial swine
product commercialization
Oral Vaccination WorksMazen’s Proof of Concept Data
Serum neutralizing antibodies after challenge comparable to injectable
PEDV
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Initial pig study showed neutralizing antibodies after oral delivery
2000 lb vaccine candidate ready for testing
Next study is sow study with challenge to newborn pigs to select dose
Once dose selected, send vaccine candidate to producer collaborator for testing in
experimental barns
Implementation of candidate at producer in parallel to regulatory development
Conf
iden
tial
Inject/Inject Oral/Oral Control0
20
40
80160
320
640
1280
Mazen’s PEDV Vaccine Indicates ProtectionPorcine Epidemic Diarrhea Virus causes 100% mortality in newborn pigs and endemic infections slow weight gain in older pigs. A cost-effective, efficacious vaccine targets 6M sows and 115M pigs in the US annually.
Objective: Demonstrate that a maize-produced antigen when orally delivered to pigs can elicit neutralizing antibodies.Basic Design: 4 pigs per arm, ~ 1 month old at startDosing at Days 0, 28Challenge at Day 42SNA measured at Day 57Results:Pigs administered orally delivered antigens or injected vaccine showed a clear significant increase in sera neutralizing antibodies, indicative of protection after viral challenge.
Oral prime and oral boost elicit serum neutralizing antibodies providing proof of concept for product candidate and technology platform14
* Treatment groups statistically different from control using the Tukey HSD method P values < 0.05
• Over 15 issued and pending patents• Process• Use• Enhanced immunogenicity• Promoters• Ex: 9,944,937
• Patents pending for PEDV and Valley fever
• Strong IP estate in the U.S.
• Patents pending related to antigens from USDA-ARS
Clear Defensible & Competitive Advantages
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Current Global Situation in Disease Prevention
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Problem:• Growing world population is putting
pressure on the world’s ability to generate protein, causing an increase in production density
• Increasing pressure from regulatory and public groups to decrease or eliminate antibiotic use in production animals
• Effective and practical disease prevention is required to enable producers to meet the global protein needs
Current Solution:• Disease prevention is managed through
biosecurity and in some cases, vaccination
• Current global vaccine market is ~$10B, represented primarily by injectable vaccines
• Producers are not happy with the effectiveness of many of these vaccines and often make the economic decision not to vaccinate
Mazen Opportunity:• Vaccines dosed with feed, to cost effectively remove the threshold decision of whether
or not to vaccinate, increasing vaccination rate, improving safety and decreasing antibiotic use
Our Future Customers Want Oral Vaccines
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“Injectable to gilts is a pain, so interested in gilts.”
“I’d love it if it works. No one likes to inject pigs. Expect high adoption if it works.”
“We still deal with broken needles in the meat”
“Likelihood of [vaccine] usage comes down to how easy it is to administer.”
“Vaccine crews carry disease from one barn to another”
Confidential
Mazen’s Commercial StrategyProduction Animal Vaccines
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Accelerate Commercial Adoption
Target Global Accounts
Confidential
Producer Collaboration Strategy
Together with producers, we collaborate to speed adoption
• Early access to Mazen’s technology• Create a mutual competitive advantage• Access to capabilities and facilities to aid in
development• Collaborate with target producers to implement
Mazen’s vaccines into their systems• Align pipeline to Top Producers’ unmet needs
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Confidential
Value Proposition Provides Competitive AdvantagesMazen will Commercialize into a $10+B Animal Vaccine Market
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Compelling Value Proposition for Producers
• More cost effective • Improved animal and worker safety• Greater efficacy• Greater stability
PEDV Oral Vaccine Advantages
• Potential for significant price differential• Eliminates PEDV introduction from the
system
Launching Products into a $10B Global Vaccine MarketGlobal Product Revenue Projected to Exceed $30M in 2025
• Attractive sales growth with strong EBITA• >90% margin on cogs• Plan to sell swine
vaccines and out-license Valley fever• Future portfolio growth
beyond 2025 anticipated to produce over $250M in revenue annually• Plan for global portfolio
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$-
$5,000,000
$10,000,000
$15,000,000
$20,000,000
$25,000,000
$30,000,000
$35,000,000
$40,000,000
2020 2021 2022 2023 2024
Feline - Panleuk, Calic, RhinoFeline - Rabies
Canine - Parvo, Dist, HepCanine - Rabies
PCV-2 - Swine/PigletPiglet - PEDV
Sow - PEDVCanine - Valley Fever
2021 2022 2023 2024 2025
Experienced Leadership Team that DeliversAnimal Health, Technical & Commercial Expertise
TEAM
Jenny Filbey, PhDFounder, CEO
Tom Overbay, DVMDevelopment
• Entrepreneur focused on commercialization of new technologies
• President of NPI
• Nektar, Nobex, Hoechst
• Regulatory, business development, tech operations
• Expedite Animal Health
• Animal health, feed ingredients & production animal marketing
• Elanco
• Bayer
Candidate Identified
Kerryann KocherCommercial
Advisor
John Howard, PhDFounder, CSO
• World leader in protein expression in maize grain
• CEO of ABI
• 20 years of oral sub-unit vaccine experience
• Finance & corporate development
• Public & private company experience
• Healthcare, SaaS software/eCommerce, Professional Services and Logistics industries
• McKesson,
Key Additions at Financing: R&D Head, Production Head, Veterinarian, Regulatory
Ronan Molloy, JDExec Board Member
• President, Innovation Stockyard
• Zoetis, Synbiotics, Primus
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David Morrison, MBAHead of Finance
Experienced BoardAnimal Health, Technical & Commercial Expertise
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Kelly Lechtenberg,
DVM
Terry Speizer, MBA
Ronan Molloy, JD
• President, Innovation Stockyard
• Zoetis, Synbiotics, Primus
• President of Midwest Veterinary Services & the Veterinary and Biomedical Research Center
• Infectious Disease Model Specialist
• Food Animal Production Consultant
• Serial entrepreneur
• Morro View Winery
• Domaine Alfred Winery
• Electec, Flextec
Jenny Filbey, Ph.D.
John Howard, Ph.D.
• Entrepreneur focused on commercialization of new technologies
• President of NPI• Nektar, Nobex, Hoechst
• World leader in protein expression in maize grain
• CEO of ABI
• 20 years of oral sub-unit vaccine experience
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Mazen’s Team has Set Stage for Success
2424
2017 2018 2019 2020 2021
$670k $340k $272k
• Initial PEDV scale-up• PEDV PoC Study• Valley fever added to
portfolio• Cal Poly Grant
awarded
• PEDV scale-up• VF scale-up• SBIR for cocci in
poultry• SBIR for pancreas
disease in salmon• Swine producer
collaboration• Animal health co.
collaboration• 2nd animal health co.
collaboration• Raising $1,000,000-
$2,000,000 for dose ranging sow study to demonstrate lactogenic immunity & advance product development
• Raise $7-9M• Product scale-up• Team build out• Producer trials• USDA registration
studies• Expansion of
portfolio
• PEDV Selected• PEDV gene to
greenhouse• Positive regulatory
meeting with USDA
Mazen’s Financing Strategy
• Mazen has raised $1.28M in convertible notes bolstered by $0.4M in grants
• Raising current round for animal testing and lead product development
• Mazen’s producer collaborator can move forward with studies required for implementation
• Next financing round will be raised in parallel to producer study
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Convertible Notes
($1.28M)
USDA SBIR Grants
($0.2M)
Cal Poly Grant ($0.2M)
$1M - $2M
Series A:$7-9M Raise
Demonstrated Near Term Value with Opportunity for GrowthØ Experienced Team that Delivers Results
Ø Robust and real customer value proposition
Ø Product approval will drive value and create exit opportunities
Ø Speed to market with a Platform technology
Ø Global Multi-Species Portfolio
Ø World-class manufacturing cost, producing room temperature stable product
Global Disruptive Animal Disease Prevention
Potential exits:• Traditional animal health
companies• Related industry
companies (e.g. feed/nutrition, producers)
• IPO
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