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www.enesipharma.com Summary Presentation October 2019 Non-Confidential

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Page 1: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

www.enesipharma.com

Summary Presentation

October 2019

Non-Confidential

Page 2: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

• Enesi Pharma is an innovative pharmaceutical company developing a range

of novel injectable solid dose vaccine products, enabled by our proprietary

ImplaVax® formulation and device technologies.

• Data suggests that such products have potential to transform the performance

and delivery of vaccines, facilitating increased uptake, coverage and make a

material impact on global health and healthcare economics.

• Significant potential benefits for all population groups, health-care professionals,

and payers across the global vaccine ecosystem.

• Proven Management Team and International Scientific Advisory Board.

• Based Oxfordshire, UK.

Enesi Overview‘Vaccination Saves Lives’

Enesi are building a UK-based world leading company of exceptional potential value

and will make a material positive impact on global health

2

Page 3: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

ImplaVax® Solid Dose Vaccine TechnologyMaking a Material Impact on Global Health

Distribute

With Ease

Administer

To All

Thermally

Stable

Easy & Rapid

Administration

Enhanced

Immune Response

Highly

Cost Effective

Strong Subject

Preference

Design

For Purpose

Produce

On Demand

Needle Free

By Design

Reduced

Cold Chain

Eliminates

‘Mix & Shoot’Error Free

Unit Dosing

Stockpile

Optimisation

3

2

1

3 Reusable Actuator (1,000x)2 Single Use Disposable Cassette1 Unit Solid Dose Vaccine3

Page 4: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

ImplaVax® Solid Dose Vaccine TechnologyCombination of unique formulation and device technology

Single-Use, Unit Dose Cassette

• Contains solid vaccine implant (UVI)

• Needle-free by design

• Viewing window confirms delivery

• Lock-out mechanism prevents re-use

• Eliminates cross-contamination

• Reduces error and wastage

• Saves time

Robust IP position and significant know-how with protection through 2039

2

Multi-Use Actuator

• Spring loaded

• Activated by downward pressure on skin

• Audible click confirms delivery

• Re-useable up to 1,000 times, if required

3

1

Universal Vaccine Implant (UVI)

• Unit solid dose

• Enhances immune response and immunogenicity

• Dosing and regimen sparing demonstrated

• Made using proprietary formulation technology

• Eliminates need for point-of care reconstitution with diluent

• Eliminates needle-stick-injury and sharps disposal challenge

• Unit dose delivery assured each time, and every time

• Enhanced thermal stability with reduced / negated cold chain

1

4

1

Page 5: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

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Enesi Business Strategy3 reinforcing complimentary activities driving serial value

Licensing

Select partnerships,and co-developments1

e.g. Bigger Pharma, Specialty Players, Niche Opportunities,

Government LaboratoriesUniversities

Global Public Interest Projects

Grants & Philanthropic Funds

e.g. BARDA, CEPI, CARB-X,PATH, BMGF, Innovate UK

WHO, Gavi

1 Licensing• Near term Revenues

• Target and Term Specific Collaborations

• Staged Access Fee & Milestones

• Product Sales & Royalties

3 Future Product Sales• Own-funded new product development

targeting areas of unmet need

• Commercial rights retained in full

2 Global Public Interest Projects• Co-funded targeted product development

leveraging non-dilutive Government and

philanthropic capital and NGOs

• Commercial rights retained in developed

world markets

Supported by Key Clients, Collaborators and 3rd Party Manufacturing Partners

Future ProductSales

Targeting Unmet Need

e.g. AMR, Allergy,Emergent Threats,Priority Pathogens

Page 6: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

Enesi Pipeline and ReachRobust IP protection through 2039

Traditional

Products

DNA/RNA

Lower

Higher

Re

lati

ve

va

lue

ad

d

Relative Complexity

Allergy

‘Disease X’

Lower Higher

Cancer

Emerging

Pathogens Biodefence

Breadth of Enesi client pipeline1

6

Page 7: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

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Selected ImplaVax® PartnershipsNon-exhaustive list of collaborators; many more not disclosed

Page 8: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

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Comparison to Other PlatformsImplaVax® enabled products can be market leading

Va

ccin

e D

eli

ve

ry S

yst

em

Sta

tus

Ne

ed

le F

ree

Dil

ue

nt

Fre

e

Co

ld C

ha

in N

ee

d

Un

it D

ose

Ass

ure

d

Ad

juv

an

t F

ree

Cro

ss C

on

tam

ina

tio

n R

isk

Wa

sta

ge

Ra

te

Do

se /

Re

gim

en

Sp

ari

ng

Sh

ow

n

Ad

min

istr

ati

on

Ch

all

en

ge

To

tal

Tim

e t

o A

dm

inis

ter

Inje

ct S

ite

Iss

ue

s

To

tal

Co

st p

er

De

liv

ere

d

Do

se

Needle & Syringe Commercial No Sometimes High Yes Sometimes High High No Med-High 30 sec Frequent Low-Med

Microneedle Add on Development No Sometimes High Yes Sometimes High High Yes Med-High 45 sec Frequent Low-Med

Hydrodynamic Injectors Semi-Commercial Yes Sometimes High Yes Sometimes Low Medium Possibly Med-High 60 sec Frequent Med

Microneedle Patch Development No Yes Med No Unknown High Low Possibly Med-HighUp to 30

minsFrequent Med

Laser Poration Semi-Commercial Yes Sometimes High Unknown Unknown Low Medium Possibly High Minutes Unknown High

ImplaVax® Development Yes Yes Low Yes Yes Zero Zero Yes Low< 20

SecsNone

Potentially

Least

• ImplaVax® has potential to be the world’s leading and default vaccine platform

Page 9: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

• All vaccines delivered subcutaneously

• Solid implant (#2) better than standard vaccine delivered by needle and syringe (#1) achieving

comparable performance after only 1 boost

• Reconstituted solid dose formulation control (#3) is comparable to standard vaccine

• Suggests solid dose implant may have its own beneficial effect

(#1)

(#2)

(#3)

Solid Implants Improve Immune Response #1Diphtheria - Guinea Pig Immunogenicity Study

9

Page 10: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

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Solid Implants Improve Immune Response #2(i) Haemophilus Influenzae Type B (Hib) - Immunogenicity Studies

(ii) Follow Up Pooled Serum Rat Challenge

• Enesi implant better than standard vaccine delivered by needle and syringe

• Immune response from 1st boost dose better than standard post 2nd boost

• 100% protection rate achieved in follow on rat challenge study

Page 11: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

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Solid Implants Improve Immune Response #3Influenza H3N2 Immunogenicity Studies1 – Ferret Model

• Seroprotection achieved with single dose delivered by SC2 solid implant

• Viral shedding significantly reduced with SC solid implant as compared to

either IM deliveries and control group

• Peak viral shedding delayed by 1 day

Control Implant

IM

Implant Recon

IM

Implant

SC

Me

an

Ma

xim

um

Vir

us

Tit

re

1 Primed intranasally Day -49 with Influenza A/New Caledonia/20/99 (H1N1), immunised with test vaccines or control at Day -28 and Day -7,challenge at Day 0 with Influenza A/Wisconsin/67/2005 (H3N2)

2 Subcutaneous

Page 12: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

• Enesi formulations (FXX-10-SC Blue Lines) tested at various antigen1 loadings; SC2 delivery,

no adjuvant. 2 Dose Regimen with dosing at Day 0 and Day 28

• Significantly higher antibody levels observed for all Enesi formulations (#1), compared to

commercially available standard delivered intramuscularly (IM) used as active control

• Suggests antibody levels with a single dose of Enesi formulations are sufficient to

rapidly achieve target response level at day 12 (#2), evidencing regimen sparing and

potentially transforming protocol

Solid Implants Improve Immune Response #4Rabbit Immunogenicity Studies

1 rPA targeting specific Biothreat2 Subcutaneous

(#2)

(#1)

12

Page 13: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

• Antigen formulated into solid dose implants

• 3 different test methods confirm retained potential potency of antigen

• Exemplar stability with potency retained after 15 months storage at 40˚C,75% RH

13

Solid Implants Enhance StabilityPotency and mechanical performance maintained

Re

cove

ry

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• No significant effects or SAE’s were observed during the trial

• No oedema, bleeding, ‘blebbing’, or serum leakage using the solid dose

• After the trial, only 10% of patients mentioned the red mark at all

Pre Dose Post Dose

1hr Post Dose 12hr Post Dose

Administration Site ObservationsStudy utilising therapeutic peptide delivered in solid dose form

Page 15: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

Final Product Assembly OverviewManufacturing Process

• Lyophilization /

Spray drying

• Extrusion /Micro tableting

• Drying

• Cutting

Assembly

Cassette

IPC

Pouching

LabellingIPC

Foil Pouch

Release Testing

4m

m

0.85 mm

Unit Solid Dose

Implant

Implant Manufacture

+

FinalProduct

IPC

NB: Not to scale

Parenteral Excipients

Bulk Vaccine(Liquid or Powder)

15

Page 16: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

Device ManufacturingLeveraging leading medical device manufacturing partner

• Long term relationship

• World scale capable

• All IP and design rights owned by Enesi

• Working to relevant industrial standards and guidance from appropriate

international regulatory bodies

• Independent industry leading analysis confirms ImplaVax® competitiveness

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Page 17: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

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Human Factor StudiesResults from recent Formative Study

Would you prefer an injection with ImplaVax® or needle and syringe (N&S)?

ImplaVax® Don’t mind

N&S

High Income Country Nurses

Parents of Infants < 18m

Parents of Children 2 -12 yr

Recently Vaccinated Adults

Aid Workers

HCP was retiring 1 week post study

HCP would prefer ImplaVax® to N&S if ImplaVax® device was approved

HCP provided suggestions for improvement which have now been implemented

Page 18: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

• How do you feel about this

device being used to give

your child a vaccination?

Positively

Negatively

Parents of Infants

< 18 months

Parents of Children

2 -12 years

• Would you prefer your

child to have an injection

with ImplaVax or needle

and syringe?

ImplaVax

Needle

• How acceptable would

you find it to have your

child vaccinated with

this device?

Very acceptable

Very unacceptable

Acceptable

Unacceptable

Neither

Human Factor StudiesStrong Subject Preference Evident January 2018

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Page 19: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

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Strong Subject Preference EvidentHuman Factor Study Feedback

“When the child sees a needle that's when they freak out… this doesn't even look like you're giving a vaccination”“It would save a lot of trouble for us regarding refrigeration”“Standardises everything”; “ After half an hour of using it, you'd be using it in seconds”“It's all in one; no mixing, no drawing up ... Just quick clean and easy”Nurses

“The storage conditions - I love it”; “Ideal for developing countries”“It's easy - less exposure to needle”“Doesn't need specialist training - we have a lot of trainee and junior doctors”

Aid Workers

Parents of

Infants & Children

“Less daunting than a needle”“Whole lot cleaner” “No risk of infection” “Really good!”“My 3 year old daughter has sensory issues; She probably won't even realise she is having an injection.”

Adults

“Less threatening, less trepidation, less scary”“Really quick and easy and I didn't feel a thing”“I would probably seek this out, when booking, if there was an option”

Page 20: Summary Presentation October 2019 - Enesi Pharma...Summary Presentation October 2019 Non-Confidential • Enesi Pharma is an innovative pharmaceutical company developing a range of

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ImplaVax® Summary

Better Products

Target AgnosticEnhanced Immunogenicity

Prophylactic and Therapeutic

Enhanced Stability

Reduces Cold Chain ChallengeExtends Shelf Life

Reduces stockpiling

Ultimate Convenience

Quick, Easy, Intuitive to UseNeedle free by design

No diluent or ‘mix and shoot’Clear subject and HCP preference

High Value Adding

Dose and Regimen SparingCost Effective

ImplaVax®

www.enesipharma.com