Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
Disruptive Animal VaccinesJenny Filbey, Ph.D.
CEO
1
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
First in Class Solid Oral-dosed Vaccines
Revolutionizing Animal Disease Prevention
Feed–Through Vaccines
For Farm Animals
Treat-based Vaccines
For Companion Animals3
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
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
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
*
*
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
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
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
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%
Mazen’s Business Model
ManufacturingProduct
Development &
Registration
Phase 1 --- CORE Business Build
Commercial
Operations
Phase 2 --- BuildPhase 3 -- Partnership
Antigen
Discovery
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
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
14
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
15
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
16
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
17
➢ 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
18 1818
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