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Disruptive Animal Vaccines Jenny Filbey, Ph.D. CEO 1

Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

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Page 1: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

Disruptive Animal VaccinesJenny Filbey, Ph.D.

CEO

1

Page 2: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

22

• Producers want to prevent disease, but…• Economic threshold to accomplish disease prevention

• Mazen offers a cost effective way to prevent disease

• Safer, more effective vaccination method

Page 3: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

First in Class Solid Oral-dosed Vaccines

Revolutionizing Animal Disease Prevention

Feed–Through Vaccines

For Farm Animals

Treat-based Vaccines

For Companion Animals3

Page 4: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

4

Mazen’s Competitive Advantage

4

Meaningful Customer Value Proposition

• More cost effective

• Improved animal and worker safety

• Greater efficacy

• Greater stability

Best in Class Manufacturing

• Lower recombinant vaccine cost

• Limited CapEx for facilities

• Flexible supply chain

Page 5: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

5

Oral Vaccination Works

•Protection against a challenge

• IgA in colostrum

TGEV*

•Equivalent antibody titers

•Protection against a challenge

NCD*

•Equivalent antibody titers

•Protection against a challenge

Rabies*

Improved efficacy over injectable

IPNV*

Serum neutralizing antibodies after challenge

PEDV

•Reduction in fungal burden

•Biomarker for protection

Valley fever

5 *Literature work

Page 6: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

6

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.

0

50

100

150

200

250

300

350

400

Inject/Inject Oral S1/Oral S1 Oral Control/Oral Control

Ave

rage

Tit

er

Serum Neutralizing AntibodiesObjective: Demonstrate that a maize-produced antigen when orally delivered to pigs can elicit neutralizing antibodies.

Basic Design: 4 pigs per arm, ~ 1month old at startDosing at Days 0, 28Challenge at Day 42SNA measured at Day 57

Results: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 platform

6

Co

nfi

de

nti

al

* Treatment

groups statistically

different from

control using the

Tukey HSD method

P values < 0.05

*

*

Page 7: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

7

Mazen’s Valley fever vaccine first to indicate protection against a fungal disease

Fungal infection impacting mammals cause severe lung, spleen and bone infection, often leading to death. Approximately 12M

dogs are candidates for the vaccine in the Southwest U.S. There is no vaccine for Valley fever today – Mazen has a solution.

0

20

40

60

80

100

120

GCP B GCP M GCP B+ Mwafer

Ctrl

CFU in Lungs

CF

U X

10

7

All Ag2 antigen treatments showed a significant reduction in fungal burden in the lung as measured by Colony Forming Units (CFU)

78.0

80.0

82.0

84.0

86.0

88.0

90.0

92.0

GCP B GCP M GCP +Wafer

Ctrl

Weight Loss

Pe

r ce

nt

of

we

igh

t p

ost

ch

alle

nge

Only the combination of oral + injectable gave statistically significant improvement in weight loss

GCP B – Bacterial produced Ag2 antigen on glycan chitosan particles (inj)

Treatments: GCP M – Maize produced Ag2 antigen on glycan chitosan particles (inj)GCP B + M Wafer - Combination of GCP B with orally delivered maize produced Ag2Control – No Ag27

Co

nfi

de

nti

al

Page 8: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

8

Mazen’s Platform Well-Suited for Aquaculture

Vaccines can be dosed with feed with no

risk of replication

Low cost of goods for vaccine

production

Vaccines can be integrated

into fish producers systems

Proof of concept

demonstrated with IPNV

High need vaccine

candidates identified for development

8

Page 9: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

9

Demonstration Platform Technology - Summary

▪ Oral vaccination has demonstrated protection in multiple species – monogastric

and polygastric mammals as well as birds and fish

▪ Oral vaccination has addressed multiple diseases – both enteric and non-enteric

▪ Efficacy shown comparable to commercially available vaccines, injectables,

modified live

▪ Oral administration enables both a systemic response (IgG) as well as a mucosal

response (IgA). Antibody responses also observed in fish.

9

Co

nfi

de

nti

al

Page 10: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

10

Oral Vaccination has Attractive Margins• Expression, Dose and Yield drive acreage requirements and cost of goods

• Current acreage for For Further Manufacturing (FFM) meets the projected

demand through 2022 allowing 3.5 years for planned growth to meet the future

forecasts

• Vaccine supply has flexibility to fit into customers’ current systems so that vaccine can be dosed with feed

• Excellent margins can be realized with all products

1010

88% 90% 89% 95%

Page 11: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

Mazen’s Business Model

ManufacturingProduct

Development &

Registration

Phase 1 --- CORE Business Build

Commercial

Operations

Phase 2 --- BuildPhase 3 -- Partnership

Antigen

Discovery

Page 12: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

Collaborations Serve to Add Value to the Business Model In

vest

me

nt • ROI

• Disruptive Technology enabling global distribution

• Fast to MarketP

art

ne

rsh

ip • Antigen Discovery and Development

• Target Product development and registration

• Final Use Product Manufacturing

• Commercial Partnership

Syn

erg

ies • Global Customers

• Diagnostics

• Regulatory

• Technical Expertise

Co

nfi

de

nti

al

Page 13: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

13

Product Portfolio Expands to Cover Multiple Species

• PEDV• PCV• Rotavirus• FMD

Swine

• VF• Rabies• Canine Core• Feline Core

Companion

• Coccidiosis• New Castle

Disease• Necrotic enteritis

Poultry

• Nodavirus• Salmonid

Rickettsial Septicaemia

Fish

• Rabies• BVD• IBR• FMD

Cattle

Gray vaccines not in current financial projections

Mazen’s product portfolio initiates with swine and

companion animal vaccines. Coccidiosis for

poultry is the next identified unmet need

addressed with Mazen’s vaccine production

platform. The platform can then be expanded to

address cattle, aquaculture and small

ruminants.

13

Page 14: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

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Mazen Global Product Revenue Projected to Exceed $300M

by 2026

First products to market address Porcine Epidemic Diarrhea Virus and Canine Valley Fever

Product portfolio designed to self-fund future product development with a $20M investment

$(50,000,000)

$-

$50,000,000

$100,000,000

$150,000,000

$200,000,000

$250,000,000

$300,000,000

$350,000,000

2020 2021 2022 2023 2024 2025 2026

Feline - Rabies

Canine -

Rabies

Fish Vaccine -

Trout

Feline -

Panleuk, Calic,

RhinoCanine - Parvo,

Dist, Hep

Fish Vaccine -

Salmon

Poultry -

Coccidiosis

PCV-2 -

Swine/Piglet

PEDV -

Swine/Piglet

Valley Fever -

Canine

14

Page 15: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

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Experienced Leadership TeamAnimal Health, Technical & Commercial Expertise

TEAM

Jenny Filbey, PhD

Founder, 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 Kocher

Commercial

Strategy & Ops

John Howard, PhD

Founder, 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 Hires at Financing: R&D, Veterinarian, Manufacturing, CFO

Ronan Molloy, JD

Exec Board Member

• President, Innovation

Stockyard

• Zoetis, Synbiotics, Primus

15

David Morrison, MBA

Head of Finance

Page 16: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

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Experienced BoardAnimal Health, Technical & Commercial Expertise

TEAM

Kelly

Lechtenberg,

DVM

Terry Speizer,

MBARonan 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

1616

Page 17: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

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➢ Robust and real customer value

proposition

➢ 2 Product candidates in development with

robust product portfolio

➢ Experienced Team

➢ Speed to market with a Platform

technology

➢ Global Multi-Species Portfolio

➢ World-class manufacturing cost

Demonstrated Near Term Value with Opportunity for Growth

Global Disruptive

Animal Disease

Prevention

17

Page 18: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

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Page 19: Disruptive Animal Vaccines...•Rabies •BVD •IBR •FMD Cattle Gray vaccines not in current financial projections Mazen’s product portfolio initiates with swine and companion

19 19

Jennifer Filbey, Ph.D.CEO

[email protected]+1-256-417-8568

19

Kerryann KocherCommercial Strategy & [email protected]

+1-317-997-7385

www.mazenanimalhealth.com