Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs •...

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Disruptive Animal Vaccines Jenny Filbey, Ph.D. CEO Summer 2020

Transcript of Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs •...

Page 1: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

Disruptive Animal VaccinesJenny Filbey, Ph.D.

CEO

Summer 2020

Page 2: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

Ø Value Proposition

Ø Mazen’s Oral Vaccine Technology / Customer Need

Ø Market

Ø Team

Ø Financing

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Page 3: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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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Page 4: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 5: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 6: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

… that the Mazen oral vaccination platform addresses

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Oral Vaccination

Improved biosecurity

Continuous feed

Improved worker safety

Needle free

Consistent potency

Page 7: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

Revolutionizing Animal Disease PreventionFirst in Class Solid Oral-dosed Vaccines

Feed–Through VaccinesFor Farm Animals

Treat-based VaccinesFor Companion Animals

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Page 8: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 9: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

Production from Concept to Commercial

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Antigen Transformation

Greenhouse Development Scale-up

ProcessingFinal Use Product Feedmill Animals

Design Gene

Page 10: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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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Page 11: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 12: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 13: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 14: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 15: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

• 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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Page 16: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 17: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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”

Page 18: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

Confidential

Mazen’s Commercial StrategyProduction Animal Vaccines

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Accelerate Commercial Adoption

Target Global Accounts

Page 19: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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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Page 20: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 21: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 22: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 23: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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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Page 24: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

Mazen’s Team has Set Stage for Success

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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

Page 25: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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

Page 26: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

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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Page 27: Disruptive Animal Vaccines · Jenny Filbey, Ph.D. CEO Summer 2020. ... • >90% margin on cogs • Plan to sell swine vaccines and out-license Valley fever • Future portfolio growth

Jennifer Filbey, Ph.D.CEO

[email protected]+1-256-417-8568

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www.mazenanimalhealth.com