Investor presentation November 2017 · • symptom and drug intake reduction statistically...

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Investor presentation November 2017

Transcript of Investor presentation November 2017 · • symptom and drug intake reduction statistically...

Page 1: Investor presentation November 2017 · • symptom and drug intake reduction statistically significant -15.5% during the peak and -17.9% over the pollen season (p

Investor presentation November 2017

Page 2: Investor presentation November 2017 · • symptom and drug intake reduction statistically significant -15.5% during the peak and -17.9% over the pollen season (p

Disclaimer

• THIS DOCUMENT AND ANY MATERIALS DISTRIBUTED IN CONNECTION WITH THIS DOCUMENT ARE NOT DIRECTED TO, OR INTENDED FOR DISTRIBUTION TO OR USE BY,ANY PERSON OR ENTITY THAT IS A CITIZEN OR RESIDENT OR LOCATED IN ANY LOCALITY, STATE, COUNTRY OR OTHER JURISDICTION WHERE SUCH DISTRIBUTION,PUBLICATION, AVAILABILITY OR USE WOULD BE CONTRARY TO LAW OR REGULATION OR WHICH WOULD REQUIRE ANY REGISTRATION OR LICENSING WITHIN SUCHJURISDICTION. THE DISTRIBUTION OF THIS DOCUMENT IN CERTAIN JURISDICTIONS MAY BE RESTRICTED BY LAW AND PERSONS INTO WHOSE POSSESSION THISDOCUMENT COMES SHOULD INFORM THEMSELVES ABOUT, AND OBSERVE ANY SUCH RESTRICTIONS.

• This presentation has been prepared by the management of ASIT biotech SA (the Company). It does not constitute or form part of, and should not be construed as,an offer, solicitation or invitation to subscribe for, underwrite or otherwise acquire, any securities of the Company nor should it or any part of it form the basis of, or berelied on in connection with, any contract to purchase or subscribe for any securities of the Company, nor shall it or any part of it form the basis of or be relied on inconnection with any contract or commitment whatsoever.

• This presentation is not a prospectus and recipients should not purchase, subscribe for or otherwise acquire any securities of the Company except on the basis ofinformation in a prospectus or in the annual report approved by the FSMA. Copies of the prospectus and annual report issued are available on the website of theCompany www.asitbiotech.com or at the Company’s registered office.

• The information included in this presentation has been provided to you solely for your information and background and is subject to updating, completion, revision andamendment and such information may change materially. No person is under any obligation to update or keep current the information contained in this presentationand any opinions expressed in relation thereto are subject to change without notice. No representation or warranty, express or implied, is made as to the fairness,accuracy, reasonableness or completeness of the information contained herein. Neither the Company nor any other person accepts any liability for any losshowsoever arising, directly or indirectly, from this presentation or its contents.

• This presentation includes forward-looking statements that reflect the Company's intentions, beliefs or current expectations concerning, among other things, theCompany’s results, condition, performance, prospects, growth, strategies and the industry in which the Company operates. These forward-looking statements aresubject to risks, uncertainties and assumptions and other factors that could cause the Company's actual results, condition, performance, prospects, growth oropportunities, as well as those of the markets it serves or intends to serve, to differ materially from those expressed in, or suggested by, these forward-lookingstatements. The Company cautions you that forward-looking statements are not guarantees of future performance and that its actual results and condition and thedevelopment of the industry in which the Company operates may differ materially from those made in or suggested by the forward-looking statements contained in thispresentation. In addition, even if the Company's results, condition, and growth and the development of the industry in which the Company operates are consistent withthe forward-looking statements contained in this presentation, those results or developments may not be indicative of results or developments in future periods. TheCompany and each of its directors, officers and employees expressly disclaim any obligation or undertaking to review, update or release any update of or revisions toany forward-looking statements in this presentation or any change in the Company's expectations or any change in events, conditions or circumstances on whichthese forward-looking statements are based, except as required by applicable law or regulation.

• In this presentation, references are made to the Company’s product candidates, for which marketing authorisation has not yet been obtained. These productcandidates are designated throughout this presentation by their internal project names at the Company. The names used are not meant to refer to these products (ifand when they will be approved), as it is yet uncertain if and under what names these product candidates would be marketed in the future. Nothing in this presentationshould be construed as endorsing or advertising such product candidates.

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➢ ASIT biotech pitch

➢ Market opportunity in allergy

➢ ASIT+™ Technology

➢ ASIT+™ Clinical Development

➢ Investment opportunity

We aim to restore quality of life of

millions of allergicpeople!

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ASIT biotech pitch

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Thierry Legon,

Co-Founder & CEOEngineer in Agronomy, MBA

Everard van der Straten,

CFO- Master’s degree, Solvay Business School

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Clinical stage biopharmaceutical company focusedon the development and future commercialization of a rangeof breakthrough drug products for the most allergic patients

looking for new treatments.

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About ASIT biotech

• ASIT biotech has dual market listing in Brussels (Belgium) and Paris (France) since May 2016.

• Raised €59.1 million since inception and €23.4 million by IPO.

• Secured €7.2 million non-dilutive financing granted by the Walloon Region.

• Partnership with internationally renowned institutions.

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• Our primary focus is to deliver on unmet medical need of > 20 millions allergic patients looking for new treatments.

• We have built-up a unique technology platform, ASIT+TM, generating novel active ingredientsfor the treatment of the most prevalent allergies i.e. pollen & mite rhinitis and food allergies

• These novel active ingredients allow for short-course allergy immunotherapy treatments(AIT)

• Proof Of Concept (PoC) supported by positive clinical Phase III results in grass pollen rhinitis

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Market opportunity in allergy

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Allergy – a mistaken of the immune system

HEALTHY IMMUNE RESPONSE‒ protection against pathogens

(bacteria, virus, moulds, parasites) and foreign substances

‒ induction of specific antibodies‒ specific antibodies mark foreign

substances for destruction

IMMUNE SYSTEMPATHOGENS &

FOREIGN SUBSTANCES

ANTIBODIES ANTIBODIES & FOREIGNSUBSTANCE COMPLEXES

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Allergy – a mistaken of the immune system

ALLERGIC IMMUNE RESPONSE TO SOME FOREIGN SUBSTANCES

- different class of specific antibodiesreferred as specific IgE

- IgE naturally binding to sentry cell surface (mast cell and basophil)

- each times foreign substances bind to specific IgE loaded on sentry cell surface

quick histamine release

allergic symptoms

IgE ANTIBODIES

HistamineRelease

IMMUNE SYSTEMALLERGENS

(food, pollen, dust, venom)

IgE - ALLERGEN COMPLEXES ON MAST CELLS

AllergicSymptoms

+

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Allergy leads to symptomsimpairing quality of life

Reduced work productivity

Eye symptoms

Nasalsymptoms

Sleep deprivation

Reducedschool performance

Anaphylactic reaction

AngiodemaAsthma

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Allergic Rhinitis:up to 400 million people worldwide

Bauchau V & Durham SR Eur Respir J 2004; 24: 758-764 Katelaris, C.H. et al., 2012. Clinical and experimental allergy 42(2), pp.186–207C.F., M. & Tong Janice S.C. Lin, 2015. European Academy of Allergy and Clinical Immunology, pp. 62–63.

Pollen

Animals Mold

Dust

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Food allergy:more than 200 millions people worldwide

• 15 million of American, 17 million of Europeanssuffer from food allergy1

• Increasing prevalence in both developed and developing countries2

• Peanut, cow’s milk and egg white concern>74% children3

• Total annual food allergy management costestimate/child in the US: $ 4,1844

1. Commins et al. 2016 and World Allergy Organization2. Prescott et al. 20133. Scott et al. 20114. Gupta et al 2013

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IgE ANTIBODIES

IMMUNE SYSTEM ALLERGENS

Current drugs block the symptoms with no impact on the root cause of the disease

Allergic rhinitis & asthma

• $20 billion/year• daily intake required during allergen

exposure (seasonal/perennial)• no long-term effect• limited effectiveness due to low

compliance

• >90% of the market

Food allergy

• no drugs available• excepted epinephrine injection

NonspecificimmunosuppressorsIntranasal steroids

Inhaled steriodsLeukotriene modifiers

IgE-specificblockers (mAb)

Omalizumab(Novartis/Genentech)

AntihistaminesZyrtec, Xyzal, Allegra, Claritin

IgE - ALLERGEN COMPLEXES ON MAST CELLS

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IMMUNE SYSTEM

IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLS

REGULATORYCELLS

Allergy immunotherapy (AIT) is the only treatmenttargeting the root cause of the disease

Injection of high dose of allergens

regulatory cells

down regulation• allergic immune system

(Th2 cells)• IgE synthesis• histamine release

synthesis of IgG4 & IgA

BEST AVAILABLE TREATMENTBlockingANTIBODIES

ALLERGENS

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AIT market< 10% of the allergy drug market

WHY SUCH A LOW MARKET SHARE?

Sources: Global Data “Allergic Rhinitis Immunotherapy Market 2018” (Sep-2014)ALK-Abelló, Stallergènes and Allergy Therapeutics annual reports

Country Sales % Market Share

Europe

€700 millions

78%Germany - €275 millions (39%) ALK - Abelló (33%)France - €215 millions (31%) Stallergènes (31%)

Italy / Spain = 50 millions each Allergy Therapeutics (7%)

USA € 90 millions 10%

ALK - Abelló

Hollister - Stier

Stallergènes / Greer

Japan € 5 millions

ROW €105 millions 12%

TOTAL € 900 millions 100%ALK - Abelló (33%)Stallergènes (28%)

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Current allergy immunotherapyis long and cumbersome

Year 1 Year 2 Year 3

SCIT 40-60Doctor visits

Daily administration

180 to 360 days/year

COMPLIANCE

< 25%

< 12.5%

Only ¼ patient looking for a new treatment start immunotherapy in Europe

SCITSubcutaneous

immunotherapy

SLITSublingual

immunotherapy

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ASIT™ technology

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Active ingredients make the difference

IgE ANTIBODIES

IMMUNE SYSTEM

IgE - ALLERGEN COMPLEXES ON MAST CELLS

CURRENT ALLERGENS

REGULATORYCELLS

BlockingANTIBODIES

Current allergens activateallergic reaction beforeallergy regulation

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Active ingredients make the difference

IgE - ALLERGEN COMPLEXES ON MAST CELLSIgE ANTIBODIES

IMMUNE SYSTEM ASIT+TM ALLERGENS

REGULATORYCELLS

BlockingANTIBODIES

ASIT+TM induces directlyand immediately the adequate allergyregulation

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A straight mechanism of actionshorten the treatment

ASIT Biotech’sproposal

4 doctor visits in 3 weeks before each pollen season

Year 1 Year 2 Year 3

ASIT biotech makes the best available allergy treatmentreally attractive

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ASIT+™ Clinical Development

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ASIT biotech pipeline: achieved milestones

Pre-clinical Phase I Phase II Phase III

Grass pollen

Q1 2017 - Positive phase III

gp-ASIT+™

hdm-ASIT+™

Q2 2017 - Positive Phase I/II

House dust mite

Launch of preclinical development program

food-ASIT+™

FoodPeanut - Egg white - Cow’s milk

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gp-ASIT+™first Phase III clinical study (BTT009): positive results

Feedback of the PEI

• symptom and drug intake reduction statistically significant -15.5% during the peak and -17.9% over the pollen season (p<0.05).

• all the results pointed to symptom improvement

• robust immunological results supporting the clinical efficacy data

• Phase III results missed the predefined 20% reduction of symptoms and drug intake

• PEI considers BTT009 study as supportive and ask for a second Phase III clinical study

• intended improvement to the next Phase III • more selective inclusion criteria -> more allergic patient -> improved homogeneity of the population• higher number of clinical center -> limited number of patient/clinical center -> improved coherence of the results

• use of e-DIARY -> improved reliability of the raw data -> improved quality of the study• one CRO supervised by M-E Pinelli M.D. responsible for the development of Zyrtec & Xyzal (UCB)

‒ 2:1 (active : placebo)‒ 93% retention rate: 512

patients attended the last visit

‒ Clinical efficacy during pollen season based on reduction in the combined symptom-medication score (CSMS)

‒ Double-blind‒ Placebo controlled‒ 67 centers in Europe

TRIAL # PATIENTS PRIMARY OBJECTIVE DESIGN

Phase III

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hdm-ASIT+™ first in man clinical study: safety of ASIT+TM confirmed

• 27 patients treated with hdm-ASIT+™ - 9 placebo.

• safety and tolerability of hdm-ASIT+™ confirmed

• slight positive immunological and clinical impact in a limited number of treated patients

• no complementary effect after 8 months of natural allergen challenge

• 3 new product prototypes in testing by Prof. M. Shamji at ICL to select the best active ingredient before Phase II clinicalstudy

‒ 36 patients randomized‒ Assessment of the maximum tolerated

dose ‒ Safety and clinical tolerability‒ Immunogenicity ‒ Impact on reactivity to a challenge test

‒ Q2 2017

TRIAL # PATIENTS AIM COMPLETED

Phase I/IIa

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‒ Selection of product candidatepeanut, cow’s milk & egg white

‒ ex vivo safety and tolerability‒ ex vivo immunogenicity

‒ Q2 2018

PRE-CLINICAL DEVELOPMENT AIM COMPLETED

Product prototype ex

vivo screening

food-ASIT+™product prototypes screening on-going

• non-dilutive funding from the Walloon Region to co-finance 55% 1

• collaboration with Prof. M. Shamji (ICL), and Dr. S. Till (King’s)

• first-in-man Phase I/II trial in peanut allergy expected to be conducted from H1 2018 to end-2019

1 a recoverable cash advance granted in January 2017

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ASIT biotech pipeline: next milestones

Pre-clinical Phase I Phase II Phase III

Grass pollen

gp-ASIT+™ FDA feedback - Q4 2017Second Phase III Q4 2018 - Q4 2019

hdm-ASIT+™House dust mite

Selection of a new ASIT+TM active ingredient - Q1 2018Second Phase I/II clinical trial with improved prototype – Q1 2019

FoodPeanut - Egg white - Cow’s milk

food-ASIT+™Selection of ASIT+TM active ingredient for each allergen - Q2 2018

First Phase I/II clinical trial in food - H2 2018

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Investment opportunity

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Addressing the unmet Patients’ need!

Patient4 doctor visits

Time & Money saving

Reduction of symptoms and rescue medication in the real life

Improved quality of life

Healthcare systemsDocumented safety and efficacy

Improved acceptance

Improved compliance

Improved real-life efficacy

Reduced direct & indirect costs

AllergistsNew therapeutic option

More patient accepting AIT

Patients more compliant

Fast onset of action

Better patient follow-up

Higher patient satisfaction

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Investment opportunity

Focus on moderate to severe allergic patients (respiratory & food)

Focus on improving allergy immunotherapy, the best available allergy treatment

A dedicated team supported by internationally renowned experts and institutions

A unique technology platform, ASIT+TM

• novel active ingredients • improved safety/efficacy ratio• applicable to pollens, mites and food (peanut, milk and egg white)

Short course treatment thanks to novel active ingredients• improving patients acceptance and compliance• proof of concept supported by positive Phase 3 results in grass pollen rhinitis• straight and optimal down-regulation of the allergic reactions1

Further developments• preparation of a second Phase 3 in grass pollen rhinitis on-going• Selection of new product prototypes for house dust mite and food allergy

1. Shamji et al, EAACI, 2017 Oral presentation

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Board of Directors

Gerd Zettlmeissl,Chairman of the Board

Working in the biopharma & vaccine industry since 1985 : e.g. former CEO of the Austrian-based biotech Valneva SE (formerly Intercell AG), chairman of the

Board of GlycoVaxyn 2013-2015, member of the Board of Aeras

Thierry Legon,CEO

Everard van der Straten, Director and CFO

François Meurgey,Director

Jean Duchateau,Director & Co-founder

Allergist. One of the inventor of the 1st patents on toleranceinduction to allergy and graft

rejection, new LED tests, ownedby ASIT biotech

RE Finance Consulting SA, Independent Director

(represented by Yves Désiront)

Bruservices SA (represented by Henri De Meyer)

Meusinvest SA (representedby Marc Foidart)

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Shareholder structure post-IPO

Float54%

EPIMEDE6%

Management4%

MEUSINVEST3%

Mr de Spoelberch9%

S.F.P.I.11%

S.R.I.B.7%

S.R.I.W. 6%

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ASIT biotech on the stock market

Market data• Market: Euronext Brussels and Paris

• IPO price: €7.00 (11/05/2016)

• Current price: €4.049 (16/11/2017)

• Highest: €8.399

• Lowest: €3.150

• Number of shares (fully diluted) : 13,056,600

• Average volume: 10,760 shares / day (sinceIPO)

Stock market codes • Name: ASIT

• Ticker: ASIT

• ISIN code: BE0974289218

Change in stock price since the IPO

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Contacts

ASIT Biotech

Thierry Legon – CEOTel.: +32 2 264 03 90

[email protected]

NewCap

Investor Relations & Strategic CommunicationsPierre Laurent / Dusan Oresansky

Tel.: +33 1 44 71 94 [email protected]

www.newcap.eu