Disruptive Animal VaccinesJenny Filbey, Ph.D.

CEO

January 2020

Revolutionizing Animal Disease Prevention is our Mission:•We believe all animals should be protected from preventable disease; Mazen can turn

that belief into a reality

•Mazen will develop, manufacture, and commercialize orally delivered vaccines for farm and companion animals

•We will disrupt the traditional animal vaccine market in four distinct ways:• More cost effective – deliver vaccines that remove today’s economic threshold to vaccination• Improved safety – develop vaccines with a safer method of administration for animals and

workers• Greater efficacy – produce vaccines with dual protection (systemic and mucosal) against disease• Greater stability– removing the need for a cold chain supply chain and improving supply reliability

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Revolutionizing Animal Disease PreventionFirst in Class Solid Oral-dosed Vaccines

Feed–Through VaccinesFor Farm Animals

Treat-based VaccinesFor Companion Animals

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Production from Concept to Commercial

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Antigen Transformation

Greenhouse Development Scale-up

ProcessingFinal Use Product Feedmill Animals

Design Gene

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Demonstrated Platform Technology

§ 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.

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Initial focus on swine vaccines

Traditional vaccination has many challenges…Vet approval

Order vaccine crew (not necessarily available when

needed)

Vaccine deliveryCold storage 2°-7°C

expensive

Vaccinate pigsFarm-to-farm contamination

Feed disruption = slower growthUnvaccinated pigs

Broken needles in pigs6

… that the Mazen vaccination platform addresses

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Vet approval

Order feed premixed with vaccineImproved biosecurity

No human interaction to disrupt feedingAutomated feed delivery

Needle-free

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Mazen’s Competitive AdvantagesOur Unique Solution

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Compelling Producer Value Proposition• More cost effective• Improved animal and worker safety• Greater efficacy• Greater stability

Meaningful Companion Animal Value Proposition• Elimination of injection site issues• Improved veterinarian visit experience• Flexibility in access to vaccines

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Oral Vaccination WorksMazen’s proof of concept data

Serum neutralizing antibodies after challenge

PEDV

• Reduction in fungal burden

• Biomarker for protection

Valley fever

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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.

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

Aver

age

Tite

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Serum Neutralizing Antibodies

Oral prime and oral boost elicit serum neutralizing antibodies providing proof of concept for product candidate and technology platform

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* Treatment groups statistically different from control using the Tukey HSD method P values < 0.05

*

*

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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.

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GCP B GCP M GCP B+ Mwafer

Ctrl

CFU in Lungs

CFU

X 10

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All antigen treatments showed a significant reduction in fungal burden

78.0

80.0

82.0

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GCP B GCP M GCP +Wafer

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Weight Loss

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ost c

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The combination of oral + injectable resulted in dramatic reduction in weight loss

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* Treatment groups statistically

different from control using the Mann-Whitney U

test

* **

* GCP+wafer statistically

different from control using the

Student T test

*

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Oral Vaccination has Attractive Margins• Manufacturing platform is established

• Expression system is fully operational• High yield production platform is at multi-ton level in field-based production

• Expression, dose and yield drive acreage requirements and cost of goods

• 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

1295% 90%

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• 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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Animal Testing

Commercial Focus

Scale-up

Regulatory Confirmation

Antigen Production

Mazen Team Delivered Angel Round Milestones

Expressed antigen and developed production lines for two vaccine candidates. 2 USDA SBIRs – Cocci, PD

Confirmed Mazen’s platform approach to product development with USDA Center for Veterinary Biologics

Tested two vaccine candidates, both with results indicating protection

Current production has yielded 2,000 lbs of seed for PEDV and 100 lbs of seed for VF

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Agreement with major swine producer to commercially test Mazen’s PEDV vaccine; Agreement with major AH company to develop a product

Conf

iden

tial

PEDV Product Development Status

• Vaccine Supply• Harvest from field crop completed

• ~2,000 lbs of grain• Material for Mazen sow study, producer sow study, 2 piglet studies • Material available for Quality Management System• Master seed identified

• Winter nursery• Initiated back-cross program with Master Seed

• Production plan focused on CVB material for sales - ready end of 2021• Small quantities of non-CVB grain - available in 2021 for sale

• Animal Studies• Proof of concept in pig challenge study demonstrated immune response

comparable to injectable vaccine • Next step – dose ranging passive immunity study in sows

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Next Steps in PEDV Product Development Plan• Mazen dose ranging passive immunity study in sows

• Material available for study• Protocol draft developed with SOPs – refinement in process• Site selection initiated (one site already vetted)

• Producer study in experimental barn followed by implementation at producer location (agreement in place)

• CVB-related studies• Characterization and stability studies of final product and key intermediates

• Developmental of production lines and grain

• Development of QMS

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Bridge Round funds sow study

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Bridge Financing of $500,000-$1,000,000 will enable sow studies to demonstrate lactogenic immunity/piglet protectionBudget Estimates Through Mazen Dose Ranging Sow Study

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tial

Winter nursery $ 70,000 Mazen Sow Study $ 250,000 Producer Collaboration $ 50,000 Cal Poly Study $ 50,000 G&A $ 50,000 Travel $ 30,000 TOTAL $ 500,000

To achieve

• Back-cross• Sow study illustrating lactogenic

immunity in newborn pigs• Dose determined for producer

study• Material supplied to producer for

experimental barn study• Additional constructs and dosing

regimens evaluated in pigs

PEDV Regulatory Development PlanRegulatory Timelines for PEDV

• Agreement on Working Cell Stock and Master Seed (1H-2020)• Purity and identity

• Agreement on CVB efficacy protocol (2H-2020)• Based upon results from sow passive immunity study• At least 6 late gestation, PEDV-negative gilts & sows dosed and boosted• Challenge at day 3 of offspring

• Early safety evaluation with APHIS• Submission of efficacy data (2H-2021)• Agreement on safety protocol (1H-2021)

• Typically 300 swine at each of 3 locations – at least 50 late gestation gilts & sows plus their pigs

• 2 pre-licensing serials, dosed at each location to half the test group each• 21 days observation

• Submission of safety data (2H-2021)

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Q1-20 Q2-20 Q3-20 Q4-20 Q1-21 Q2-21 Q3-21 Q4-21

Summary Timeline for PEDV Vaccine DevelopmentFor Producer Utilization & CVB Approval

Producer utilization

Quality Management System

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Mazen Sow study Producer Sow study

Producer implementation studies

Field production

FFM & FUP Process Dev

PEDV

CVB Efficacy Study

Winter nurseryBack-cross

Pre-lic Serials Safety studies

Producer process stability

Field productionWinter nursery

Master & WorkingCell stock

CVB efficacy/safety protocol dev & prep

Submission toCVB

Submission toCVB

Revenue from producer

$

Conf

iden

tial

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Planning for a Series A round of $7M-$9M$1.28M Angel Round Bolstered by $0.4M in Grants

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Convertible Notes

($1.28M)

USDA SBIR Grants

($0.2M)

Cal Poly Grant ($0.2M)

Bridge Round

Series A:$7-9M Raise

• Bridge round will provide efficacy data demonstrating lactogenic immunity and protection against a challenge in newborn pigs

• With dose determined during bridge round, Mazen’s producer collaborator can move forward with studies required for implementation

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Mazen’s Growing Team will Continue to Deliver on Key Milestones to be Achieved in next 18 Months

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Demonstrate PoC in sows at producer with PEDV and establish product implementation

Complete preliminary efficacy studies; Initiate efficacy & safety studies for CVB approval

Complete efficacy studies; Advance safety studies for CVB approval

Produce antigen for Cocci testing (grant funded)

Produce antigen for PD testing (grant funded)

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Mazen’s Growing Team will Continue to Deliver on Key Milestones Series A Round - $7M-$9M – Use of Funds

• Focus on Swine• As first demonstration of platform

technology, Mazen will focus on development and commercialization of swine vaccines• PEDV – Scale-up; sow studies; producer

testing• PCV – Initiate program upon funding

• Relationships with producers will enable early testing, implementation and sales• One producer agreement already in

place• Other discussions on-going

• CVB approval anticipated in 202222

• VF development to approval and out-license• Valuable asset can provide revenue for

production animal vaccine development• CVB approval anticipated in 2021

• Upside potential supported with non-dilutive funding• USDA SBIR Grants for Coccidiosis in

chicken & Pancreas Disease in Salmon

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Launching Products into a $7+B Global Vaccine MarketGlobal Product Revenue Projected to Exceed $30M in 2024

Series A ($7M) will enable:

• 2 near market-ready products

• 3 products ready for PoC testing

• Initial product sales

• Significant value increase

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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

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Ø 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

Demonstrated Near Term Value with Opportunity for Growth

Global Disruptive Animal Disease Prevention

Potential exits:• Traditional animal health

companies(Elanco, Ceva, Virbac, ...)

• Related industry companies (e.g. feed/nutrition, producers)(Mars, Purina, Cargill, Kemin …)

• IPO

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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

Strategy & Ops

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

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Experienced BoardAnimal Health, Technical & Commercial Expertise

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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Jennifer Filbey, Ph.D.CEO

jfilbey@mazenanimalhealth.com+1-256-417-8568

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Kerryann KocherCommercial Strategy & Operationskkocher@mazenanimalhealth.com

+1-317-997-7385

www.mazenanimalhealth.com