Valneva Company Presentation · J.P. Morgan 34th Annual Healthcare Conference January 2016 . Disclaimer This presentation does not contain or constitute an offer of, or the solicitation

Valneva Company Presentation

J.P. Morgan 34th Annual Healthcare Conference

January 2016

Disclaimer

This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva

shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. The

Valneva shares may not be offered or sold in the USA. The offer and sale of the Valneva shares has not been and will

not be registered under the US Securities Act.

Valneva is a European company. Information distributed is subject to European disclosure requirements that are

different from those of the United States. Financial statements and information may be prepared according to

accounting standards which may not be comparable to those used generally by companies in the United States.

This presentation includes only summary information and does not purport to be comprehensive. Any information in this

presentation is purely indicative and subject to modification at any time. Valneva does not warrant the completeness,

accuracy or correctness of the information or opinions contained in this presentation. None of Valneva, or any of their

affiliates, directors, officers, advisors and employees shall bear any liability for any loss arising from any use of this

presentation.

Certain information and statements included in this presentation are not historical facts but are forward-looking

statements. The forward-looking statements (a) are based on current beliefs, expectations and assumptions, including,

without limitation, assumptions regarding present and future business strategies and the environment in which Valneva

operates, and involve known and unknown risk, uncertainties and other factors, which may cause actual results,

performance or achievements to be materially different from those expressed or implied by these forward-looking

statements, (b) speak only as of the date this presentation is released, and (c) are for illustrative purposes only.

Investors are cautioned that forward-looking information and statements are not guarantees of future performances and

are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of

Valneva.

January 2016 Valneva - Company Presentation - JPM 2

Valneva, a leading pure play and independent vaccine Company


Offering commercial Products, R&D Portfolio and Platforms

Products

Portfolio

Platforms

2 commercial products

+ Valneva expects a sharp increase in revenues

+ and an improvement in profitability

2 late-stage clinical products

+ Positive Phase II results for C. diff candidate in 2015

+ Phase II/III results for Pseudo expected in Q2 2016

2 vaccine platforms

+ Valneva expects additional royalties on its EB66®

vaccine production cell line in 2016

€90-100m revenues

in 2016

Partnering and licensing

strategies offer potential

upsides

EB66® transitioning into

a commercial product

Valneva SE corporate profile


+ Created in May 2013 through the merger of Vivalis

SA and Intercell AG;

+ Expanded its business by acquiring a commercial

product from Crucell/Janssen in February 2015

+ Incorporated in Lyon, France

+ Approximately 400 employees

+ Principal sites in:

› Vienna, Austria (R&D, G&A, QA/QC)

› Nantes, France (R&D, G&A)

› Solna, Sweden (Manufacturing)

› Livingston, Scotland (Manufacturing)

+ Own commercial presence in:

› US

› Canada

› UK

› Sweden, Norway, Finland

1 Excluding 17.8m preferred shares which convert into approximately 9.4m ordinary shares following approval of the Pseudomonas vaccine candidate

+ Listed on NYSE Euronext Paris and Vienna Stock

Exchange

+ Number of ordinary shares1: 74,698,099

+ Market cap: ~ €270m (Jan 1, 2016)

+ ISIN: FR0004056851

+ Shareholder structure:

Stock information

Corporate profile

A leading pure play vaccines company

Free Float*

Bpifrance Participations

Groupe Grimaud

Management & employees

1.0%

16.2% 70.8%

10.0%

2.0%

* Free float includes all shareholders with up to 5%

Other registered

shareholders

Valneva’s management team


Dedicated and committed to the future growth of Valneva

Thomas Lingelbach

President & CEO Président du Directoire

+ CEO of Intercell since 2011

+ Managing Director for Novartis

Vaccines & Diagnostics Germany

+ Vice President Global Industrial

Operations Chiron Vaccines

+ More than 20 years in Vaccines

industry

Franck Grimaud

Deputy CEO Directeur Général

+ CEO and co-founder of Vivalis since 1999

+ Formerly responsible for Groupe

Grimaud’s development in China,

Malaysia and Thailand

+ More than 20 years in Business

Development and Life Sciences

Reinhard Kandera

CFO Directeur financier

+ CFO of Intercell since 2009

+ Formerly at Deutsche Bank

+ More than 20 years in Financial

Management and Life Sciences

Valneva’s unique business model dedicated to Vaccines


1 As per Q3 outlook and transition impact from termination of Marketing & Distribution Agreement for Ixiaro® with GSK; 2 from acquired business as of Feb 10th 2015;

* Net sales revenues to Valneva (differ from in-market sales)

R&D and Technologies Products/Commercial*

Marketed products, R&D portfolio and technology platforms

Japanese encephalitis Vaccine

~ €25-28m (2015)1

Cholera and ETEC Diarrhea Vaccine

~ €21-23m (2015)²

Marketing & Distribution

~ €4-8m (2015)²

Ph I / II Research &

pre-clinical Ph II / III

Pseudomonas aeruginosa

Clostridium difficile

Lyme borreliosis

Cell-based platform EB66®

IC31® adjuvant / Other laboratory services

* viral / travel New targets*

Third Party

http://patentdocs.typepad.com/.a/6a00d83451ca1469e2013486203300970c-pi

http://www.farvet.com/

http://patentdocs.typepad.com/.a/6a00d83451ca1469e2013486203300970c-pi

http://www.farvet.com/

http://altimmune.com/

Japanese encephalitis and cholera


Japanese encephalitis

+ The leading cause of viral neurological disease

& disability in Asia1

+ A rare disease, but associated with high

individual morbidity and mortality rate2

› Estimated 68,000 symptomatic cases in Asia

each year3

› Between 0.1% and 4% of infections lead to

clinical disease4

› Fatal in 20-30% of symptomatic cases1

› Half of the survivors are left with neurological

sequelae1

Cholera and ETEC

+ Cholera is the most severe form of diarrhea

› Estimated 3 – 5 million cases and 100,000 to

120,000 deaths per year5

+ ETEC is the most frequent form of traveler’s

diarrhea

› Estimated 5 – 18 million reported cases per year6

+ Cholera and ETEC transmission through

ingestion of contaminated food or water

1 Solomon T et al. J. Neurol. Neurosurg. Psychiatry 2000;68:405-415; 2 CDC. MMWR 2010;59:1-27; 3 WHO. Bull World Health Organ 2011; 89:766–774E; 4 van den Hurk AF et al.

Annu Rev Entomol 2009;54:17-35; 5 WHO cholera factsheet February 2014; 6 Lundkvist J, Steffen R, Jonsson B. Cost-benefit of WC/rBS oral cholera vaccine for vaccination against

ETEC-caused travellers' diarrhea. J Travel Med 2009; 16(1):28-34;

Two life-threatening diseases

Leading commercial product: Japanese encephalitis vaccine


+ Designed to protect travelers, military and populations in endemic regions

against Japanese encephalitis

+ Indicated for active immunization against JE in adults, adolescents,

children and infants aged two months and older1

+ 248 million travelers to Asia in 20132

› Travelers to Asia expected to grow by 4.4% per year2

+ Global JE vaccines market valued at ~ €150m – €200m3

› Traveler 65%, Military 15%, Endemic 20%3

+ Currently, no effective treatment for the disease4

+ Valneva’s vaccine is the only approved vaccine available

for US and EU travelers ≥ 2 month of age3

› Exclusive supplier agreement in place with US Military

+ Asian manufacturers mainly serve local public markets

1 Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which

this vaccine is licensed. The currently available presentation for IXIARO® can be used in children from 3 years of age. Prior to availability of the new presentation, no attempt should be

made to adjust the syringe volume or to administer a 0.25mL/3µg dose in children less than 3 years of age; 2 UNWTO Tourism Highlights 2014; 3 Nomura Code estimates (October

2012) and Valneva Management estimates; 4 CDC. MMWR 2010;59:1-27

Market potential

Commercial position

Protecting travelers from the most common encephalitis in Asia1

Japanese encephalitis

Leading commercial product: Japanese encephalitis vaccine

January 2016 VALNEVA - Company Presentation 9

Annual sales development

Split of product net sales revenues (€ m)

Strong growth through new commercial channels and continued

improved usage

30.2 %

30.6 %

30.1 %

9.0 %

Total: €28.1m

U.S. military

U.S. private

Europe

Other

2014

Upside from Asian endemic partnerships

Valneva receives royalties

JEEV®

+ India, Indian subcontinent

+ Produced locally based on

Valneva’s technology

Valneva receives revenues

from transfer prices

Local trade name (tbd)

+ Taiwan

+ Produced locally based

on Valneva’s bulk supply

Biological E. LimitedBiological E. Limited

+ Direct Marketing & Distribution US Military, Canada, UK,

Nordics (100% revenue recognition)

+ Enhanced marketing focus with new distribution

partners

+ Improved recommendations

+ Increased usage through rapid-immunization-schedule

Key drivers 2016

1 Transition impact (Valneva PR, June 22, 2015: Valneva takes direct control over Marketing & Distribution of IXIARO® to increase margin and profitability);

2 2015 expected / 2016 Management estimate

589

465

601

0

100

200

300

400

500

600

700

VOL kds

28.1 25-28

~50

0

10

20

30

40

50

60

€m

2014

20151,2 exp.

20162 est.

2nd commercial product: cholera/ (ETEC)1 vaccine


+ For the prevention of Diarrhea caused by Vibrio cholera (Cholera) and/or

heat-labile toxin producing Enterotoxigenic Escherichia coli (ETEC)1

+ In some countries indicated to protect against Cholera only

+ Designed to protect adults and children from 2 years of age who will be

visiting endemic areas

+ 331 million travelers to Asia/South America/Africa in 20132

+ Revenue 2014: €25.6m3

› Canada, Sweden, Australia account for ~75% of sales

+ Growth driven by ongoing travel to risk regions, improved

awareness and updating travel recommendations

› Significant growth potential in key markets

(penetration rate <1%)3

+ Only approved cholera/ETEC2 vaccine available for

European, Canadian and Australian travelers

› WHO pre-qualification widely used in other countries

› Asian manufacturers predominantly serve local markets

and primarily for cholera only

+ US based PaxVax vaccine candidate in Phase III (US only),

for cholera indication only

1 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing,

safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium. 2 UNWTO Tourism Highlights 2014; 3 Johnson & Johnson pro

forma management reporting, unaudited figures; Source picture: http://goingawesomeplaces.com

Market potential Commercial position

Established vaccine in the field of diarrhea

Cholera

2nd commercial product: cholera/ (ETEC)1 vaccine


1 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing,

safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium; 2 Expected 2015 sales, including sales achieved by the previous

owner between Jan 1 and Feb 9, 2015; 3 Management estimate; 4 Johnson & Johnson pro forma management reporting, unaudited figures; 5 Label impact – PR Dec 23rd 2015

Geographic sales breakdown

DUKORAL® – Analysis of sales and growth potential

Canada 54%

Sweden 13%

Australia 5%

Norway 7%

UK 6%

Other countries

15%

Total: €25.6m4

2014

Annual sales development

1505

1417

1291

1150

1200

1250

1300

1350

1400

1450

1500

1550

VOL kds

25.6 282

235

0

5

10

15

20

25

30

€m

2014

20152 exp.

20163 est.

Potential upside from product expansion

+ Impact of label change in Canada5

+ Direct control over Marketing & Distribution in

Canada, UK, Nordics

+ Reinforced Key Opinion Leader (KOL) management

+ Develop different marketing channels

Key revenue drivers 2016

+ Extend product into new territories

+ Support label harmonization across all key

countries

+ Explore further product life cycle possibilities

EB66® platform for efficient large scale vaccine production


Revenue generating platform

+ Fully characterized cell-line

(avian embryonic stem cell

derived) with low production

costs

+ Over 35 agreements with the

world’s largest pharma cos

+ ~ 7 new licenses per year

+ €34m in upfront, milestones &

research fees received to date

+ Exclusive license to:

› GSK for EB66® -based pandemic

and seasonal flu vaccines

› Jianshun Biosciences to

commercialize EB66® in China

10 new agreements signed in

2015

Approved EB66® vaccines &

competition

Approved human vaccines (2)

+ Prototype influenza vaccine and

H5N1 pandemic vaccine, Japan –

Kaketsuken

Approved veterinary vaccines (3)

+ Duck Parvovirus (MDPV),

Europe – Merial

+ Inclusion body hepatitis (IBH),

Latin America – Farvet

+ Egg drop Syndrome,

Japan – Kaketsuken

Many competing cell lines have:

+ no vaccine on the market

(PER.C6®, AGE1.CR®, CAP Cell® )

+ or high production costs: VeroCell

adherent cell line (free access)

Potential additional milestones of up to €80m and royalty payments

from existing licenses

2 1

5

5 5

5 7

6

10

Research Commercial

Pre-commercial product: Pseudomonas aeruginosa vaccine


Picture from www.rtmagazine.com; 1 Pseudomonas Infection, Selina SP Chen, Russell W Steele, MD – Chapter on Epidemiology www.emedicine.medscape.com; 2 Vincent JP et al,

JAMA, 1995; p639-644; 3 McConville, M.D., John P. Kress, M.D. Weaning Patients from the Ventilator, N Engl J Med 2012; 367:2233-2239; 4 Vincent et al, JAMA 1995; 274:639-644

Targeting hospital-acquired pneumonia, with a market potential

of $1bn

+ Causes ~20% of all hospital-acquired infections 1,2

+ Target population: patients in intensive care units on

mechanical ventilation

› Up to 1 million in the US and Europe per year3

› All-cause mortality rate of 20% to 40% in this target

population4

+ Phase II/III enrolment completed (800 patients)

(co-financed by GSK)5

+ Reduction in mortality as primary endpoint

+ Interim analysis after 400 patients confirmed clinically

meaningful effect but less pronounced

+ Addition of a secondary endpoint for a subgroup of

patients following Phase II post -hoc analysis

+ Valneva awaits full analysis of the ongoing efficacy trial,

including day 180 follow-up time-points, before

releasing data

+ Valneva considers that ≥5% absolute difference in

mortality should support the ongoing development of a

licensable product

Current development status VLA 43

Phase II/III data release expected in Q2 2016


+ Only clinical program, no

vaccine on the market

+ Recombinant OprF/I fusion

produced in E.coli

+ No preservatives

+ 2 injections- days 0 & 7

Valneva’s vaccine candidate

Pre-commercial product: Clostridium difficile vaccine

Valneva - Company Presentation - JPM 14

Source picture: www.123rf.com; 1 Magill S, Edwards J R, Bamberg W et al. Multistate Point-Prevalence Survey of Health Care–Associated Infections. New England Journal of Medicine

2014;370:1198-208; 2 Lessa et al, Burden of Clostridium difficile Infection in the United States. N Engl J Med 2015;372:825-34. 3 Clostridium difficile infection in Europe. A CDI Europe Report.;

4 Leffler et al, Clostridium difficile infection. N Engl J Med 2015;372:1539-48; 5 If Phase II successful under pre-defined terms, under SAA with GSK: Intercell Annual report 2012, p. 39,45

Vaccine targeting healthcare-associated diarrhea, an increasing

threat to elderly

+ Single most common pathogen of acute healthcare-

associated infections in the US1 (~ 450,000 cases of

annually and ~ 30,000 deaths2)

+ ~ 172,000 cases in EU member states per year3

+ Targeting primary prevention of C. difficile

› Current antibiotic treatments have significant limitations

with recurrence in ~20% of cases4

Clostridium difficile (C. diff)

+ Recombinant fusion protein of

relevant parts of toxins A and

B, not adjuvanted

+ Liquid formulation 3

injections on days 0, 7 and 28

+ Potential competitive

advantage on cost efficiency


+ Positive Phase II results announced in Nov. 2015

+ Vaccine dose confirmed in older adults and elderly

+ Highly immunogenic in all age groups tested (strong

immune responses to both C. diff toxins A & B)

+ Good safety and tolerability profile confirmed

+ Next steps to be announced after final study close-out

and consultations with regulators and partner

+ One of three clinical programs

+ Expected to enter market as number two

+ GSK opt-in rights5

Current development status VLA84

Final Phase II data to be announced in Q2 2016

January 2016


+ Pre-clinical testing completed

› Data showed that the vaccine has the potential to provide

protection against the majority of Borrelia species

pathogenic for humans

+ IND submission initiated

+ Priority in EU markets where high awareness on tick

transmitted diseases exists

+ Expected penetration rates of up to 10% in high-

incidence territories given likely reimbursement status

+ GSK opt-in rights4

Source picture: PHIL – Public Health Photo Library; 1 Stanek et al. 2012, The Lancet 379:461–473;2 Estimated from available national data. However, this number is largely underestimated as

case reporting is highly inconsistent in Europe and many LB infections go undiagnosed, based on WHO Europe Lyme Report; ECDC tick-borne-diseases-meeting-report; 3 Latest data from

the CDC (PR on Aug 19, 2013); 4 If Phase II successful under pre-defined terms, under SAA with GSK: Intercell Annual report 2012, p. 39,45; 5 Estimate of Valneva, concentrated in private

markets

Current development status VLA15 (Pre-clinical)

Clinical entry planned in H2 2016

+ Transmitted by Ixodes ticks1, causing Lyme

+ Most common vector borne illness in the Northern

Hemisphere (~300,000 cases per year in US3 and ~85,000

cases per year in Europe2)

+ Delayed or inadequate treatment can lead to disabling

sequels

Lyme Borreliosis

+ Only active clinical program,

no vaccine on the market

+ Multivalent, protein subunit-

based vaccine

+ Targets the outer surface

protein A (OspA) of Borrelia


Pre-commercial product: Lyme borreliosis vaccine

Targeting Lyme borreliosis, with market potential of above €500m5

09/30/15

All cash*** 37,258

Shareholders’ equity 145,208 Borrowings (excluding finance lease) 44,085 Finance lease obligations (net of cash deposit****) 18,112

Valneva Financials


9M 2015

*unaudited; ** calculated as operating loss deducting amortization, depreciation & impairment; *** consisted of €35.6 million in cash and cash equivalents, €0.6 million in restricted cash,

and €1.0 million in short-term deposits; **** €11.3 million cash deposit included in other non-current assets;

Summarized Income Statements* (€ in thousands) 9M 2014 9M 2015

Product sales 19,282 44,169

Revenues from collaborations and licensing, grants 10,034 16,513

Revenues and grants 29,316 60,682

Cost of goods and services (10,150) (37,711)

R&D expenses (15,220) (18,730)

S,G&A expenses (10,225) (16,169)

Other income and expenses, net (241) 309

Amortization and impairment (7,446) (5,689)

OPERATING LOSS (13,966) (17,308)

Finance, investment and income tax expenses / income (786) (2,529)

LOSS FOR THE PERIOD (14,752) (19,838)

EBITDA** (3,610) (8,012)

Summarized Balance Sheet* (€ in thousands)

Financial outlook


FY 2015 revenues and grants are expected to be

above EUR 75m

+ Growth driven by acquired Crucell Sweden and

DUKORAL® business

+ Negative short-term transition impact from taking

direct control of IXIARO®’s marketing and

distribution

+ Significant improvement in revenues and profitability

of the JE vaccine expected from 2016 onwards

FY 2015 net loss: no improvement expected in this

transitional year, but Company is setting the base

for moving towards break-even

+ Integration of DUKORAL® and Nordics trade, cost

improvements and decreasing impact of acquisition

accounting effects

+ Development of marketing and distribution of the

Company’s key value generator IXIARO® to improve

product margin and profitability

2015 marked by integration of Crucell Sweden/DUKORAL® and

temporary IXIARO® transition impact

Valneva highlights


Combining industrial execution skills with biotech innovation and

entrepreneurship

Fully integrated public

vaccines company

Revenues (~ €100m)

& innovative R&D

R&D, manufacturing and

global commercialization

Promising portfolio of

R&D candidates

Financially sustainable –

towards break-even

Strategy on revenue growth +

biotech value creation

International presence and

independent

Leveraging the space between

Biotech and Big Pharma

Marketed products, R&D portfolio

and technology platforms

Focus on product sales

and R&D investments (~30m€)

Partnerships with leading

Pharma and Biotech companies

Platform for further

strategic growth

Back up slides

Primary endpoint not met, but study

confirms vaccines effect in different

target setting, phase III study with

different endpoints required.

Primary endpoint not met, but study

confirms a clinically meaningful

vaccines effect, phase III study

required for product licensure.

If primary endpoint is met,

study outcome supports product

licensure.

+ Phase II/III, double-blind, randomized, multi-center, placebo-

controlled pivotal efficacy study*

+ Participating countries: Austria, Belgium, Hungary, Germany,

Spain, Czech Republic

Pre-commercial product: Pseudomonas aeruginosa vaccine

VLA43-202 – a confirmatory efficacy study with pivotal character

January 2016 Valneva - Company Presentation - JPM

*Based on EMA scientific advice obtained in October 2011

IC43 100 mcg w/o, 400 patients

Placebo, 400 patients

Day 0

Day 7

Day 14

Day 28

Survival

P.a infection

+ SOFA

Immuno-

genicity

Safety

X

X

X

X

X

X

X

X

X

X

R

Day 56

X

X

Day 90

Primary study endpoint: day 28-mortality

Sponsor considers ≥ 5% difference (absolute) licensable product

X

X

Day 180

Possible positive outcomes of

phase II/III study:

20


Key findings in Phase II: reduction of mortality in all Pseudomonas vaccine

groups vs. placebo


Survival Rates IC43-201 Phase II trial*

Day 28

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Emerging

immune

response

Days

% alive

100 mcg w/o Alum (n = 100)

100 mcg with Alum (n = 100)

200 mcg with Alum (n = 100)

Placebo (n = 100)

Statistically significant reduction

of mortality for group vaccinated

with 100 mcg w/o Alum

(p = 0.0196 at day 28, compared to

placebo)

Day 14

10 20 30 40 50 60 70 80 90

Selected for ongoing

Phase II/III study

= day of injection

January 2016

* IC43-201 Clinical Study Report 1.0 Fig 22, page 206

Pseudomonas aeruginosa:

Additional supportive Phase II analysis1, 2


Primary endpoint on immunogenicity

met

3,000

2,500

2,000

1,500

1,000

500

0

Day 0 Day 7 Day 14 Day 28

p = <0.0001*

Strong immunogenicity after second vaccination

Vaccination:

days 0 and 7

+ Significant prognostic value of OprF/I titers on survival

+ Reduced mortality in vaccinated patients with infections

Mortality in patients without infection

% alive

90 70 50 30 10

100

80

60

40

20 Time (days)

GMT

* Group vs. placebo

** All vaccine groups pooled

*** Any investigator confirmed infection

Primary

endpoint

100 mcg

with Alum

100 mcg

w/o Alum

200 mcg

with Alum

Placebo

Vaccine**

no infection

n = 108

Placebo

no infection

n = 40

Mortality in patients with infection

% alive

90 70 50 30 10

100

80

60

40

20 Time (days)

Δ ~15%

Vaccine**

with infection***

n = 195

Placebo

with infection***

n = 58

1 IC43-201 Clinical Study Report 1.0 Tab 11, Fig 2; pp 103-104; 2 IC43-201 Statistical Report Post Hoc II_17 Dec2013 Fig 3.2.47, pp 7 - 11

Pre-commercial product: Clostridium difficile vaccine

Ongoing Phase 2 Trial VLA84-201 – Study Design

+ Randomized, observer-blind, placebo-controlled multi-center dose-confirmation immunogenicity and

safety study

+ Design cleared with FDA in pre-IND meeting July 2014: interim study results will enable EoP2

+ Population: 500 healthy adults aged 50 years and older

› 1:1 stratified from age groups 50-64 years, 65 years and older

› Study Locations: Germany (3 sites) and US (7 sites)

+ 3 VLA84 dose groups: 75 mcg w/o Alum, 200 mcg w/o Alum, 200 mcg w Alum

+ Primary Endpoint: Seroconversion Rate* against both Toxin A and Toxin B at Day 56

January 2016

* Defined as ≥4-fold increase in IgG titers over baseline

Visit 1 2 3 4 5 6 7 8

Placebo N=50

TREATMENT

VLA84 200 µg w Alum N=150

VLA84 75 µg w/o Alum N=150

VLA84 200 µg w/o Alum N=150

FOLLOW-UP

Day 0 7 14 28 35 56 120 210 / Month 7

Healthy Adults

50-64 yrs, N=250

65+ yrs, N=250

Primary Endpoint

Dose Confirmation

Interim Analysis Q4 2015

Interim analysis on all SAEs


VLA84 Induced Toxin A and Toxin B-specific IgG Antibodies at

Similar Levels in Elderly and Adults in Phase I

Valneva - Company Presentation - JPM

Adults

To

xin

A G

MT

(EL

ISA

)

[EU

/mL

]

January 2016

1

10

100

1000

10000

D0 D7 D14 D28 D56 D84 D236

75 µg +

75 µg -

200 µg +

200 µg -

Elderly

1

10

100

1000

10000

D0 D7 D14 D28 D56 D84 D236

75 µg +

75 µg -

200 µg +

200 µg -

10

100

1000

10000

D0 D7 D14 D21 D28 D113 D201

20 µg +

75 µg +

75 µg -

200 µg +

200 µg -

10

100

1000

10000

D0 D7 D14 D21 D28 D113 D201

20 µg +

75 µg +

75 µg -

200 µg +

200 µg -

To

xin

B G

MT

(EL

ISA

)

[EU

/mL

]

24

0

20

40

60

80

100

0 28 56 84

Day

0

20

40

60

80

100

0 28 56 84

100%

VLA84 Induced Seroconversion Against Both Toxins

in up to 100%* of Subjects in Phase I

January 2016 Valneva - Company Presentation - JPM

Elderly Adults

Day

100%

Part A: 18 - <65 yrs; median age = 30 Part B: ≥65 yrs; median age = 69

Sero

co

nvers

ion

rate

(%)

Sero

co

nvers

ion

rate

(%)

* Depending on Dose / Formulation Tested

** Defined as ≥4-fold increase in titers over baseline

IgG Seroconversion** Rates against Both Toxins, Example 75 µg w/o Alum Group

25

Thank you

Merci

Danke

Tack

Documents

Valneva Company Presentation · J.P. Morgan 34th Annual Healthcare Conference January 2016 . Disclaimer This presentation does not contain or constitute an offer of, or the solicitation