Investor presentation November 2017

Transcription

1 Investor presentation November 2017

2 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 SUCH JURISDICTION. THE DISTRIBUTION OF THIS DOCUMENT IN CERTAIN JURISDICTIONS MAY BE RESTRICTED BY LAW AND PERSONS INTO WHOSE POSSESSION THIS DOCUMENT 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 be relied 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 in connection 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 of information 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 the Company 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 and amendment and such information may change materially. No person is under any obligation to update or keep current the information contained in this presentation and 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 loss howsoever 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, the Company s results, condition, performance, prospects, growth, strategies and the industry in which the Company operates. These forward-looking statements are subject to risks, uncertainties and assumptions and other factors that could cause the Company's actual results, condition, performance, prospects, growth or opportunities, 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-looking statements. The Company cautions you that forward-looking statements are not guarantees of future performance and that its actual results and condition and the development of the industry in which the Company operates may differ materially from those made in or suggested by the forward-looking statements contained in this presentation. In addition, even if the Company's results, condition, and growth and the development of the industry in which the Company operates are consistent with the forward-looking statements contained in this presentation, those results or developments may not be indicative of results or developments in future periods. The Company and each of its directors, officers and employees expressly disclaim any obligation or undertaking to review, update or release any update of or revisions to any forward-looking statements in this presentation or any change in the Company's expectations or any change in events, conditions or circumstances on which these 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 product candidates are designated throughout this presentation by their internal project names at the Company. The names used are not meant to refer to these products (if and 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 presentation should be construed as endorsing or advertising such product candidates.

3 We aim to restore quality of life of millions of allergic people! ASIT biotech pitch Market opportunity in allergy ASIT+ Technology ASIT+ Clinical Development Investment opportunity

4 ASIT biotech pitch

5 Thierry Legon, Co-Founder & CEO Engineer in Agronomy, MBA Everard van der Straten, CFO- Master s degree, Solvay Business School

6 Clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough drug products for the most allergic patients looking for new treatments.

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

8 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 ingredients for 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

9 Market opportunity in allergy

10 Allergy a mistaken of the immune system IMMUNE SYSTEM PATHOGENS & FOREIGN SUBSTANCES HEALTHY IMMUNE RESPONSE protection against pathogens (bacteria, virus, moulds, parasites) and foreign substances induction of specific antibodies specific antibodies mark foreign substances for destruction ANTIBODIES ANTIBODIES & FOREIGN SUBSTANCE COMPLEXES

11 Allergy a mistaken of the immune system IMMUNE SYSTEM + ALLERGENS (food, pollen, dust, venom) ALLERGIC IMMUNE RESPONSE TO SOME FOREIGN SUBSTANCES - different class of specific antibodies referred 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 Histamine Release Allergic Symptoms IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLS

12 Allergy leads to symptoms impairing quality of life Reduced work productivity Eye symptoms Nasal symptoms Asthma Sleep deprivation Angiodema Reduced school performance Anaphylactic reaction

13 Allergic Rhinitis: up to 400 million people worldwide Pollen Dust Animals Mold Bauchau V & Durham SR Eur Respir J 2004; 24: Katelaris, C.H. et al., Clinical and experimental allergy 42(2), pp C.F., M. & Tong Janice S.C. Lin, European Academy of Allergy and Clinical Immunology, pp

14 Food allergy: more than 200 millions people worldwide 15 million of American, 17 million of Europeans suffer from food allergy 1 Increasing prevalence in both developed and developing countries 2 Peanut, cow s milk and egg white concern >74% children 3 Total annualfood allergy management cost estimate/child in the US: $ 4, Commins et al and World Allergy Organization 2. Prescott et al Scott et al Gupta et al 2013

15 Current drugs block the symptoms with no impact on the root cause of the disease Nonspecific immunosuppressors Intranasal steroids Inhaled steriods Leukotriene modifiers IMMUNE SYSTEM ALLERGENS 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 IgE-specific blockers (mab) Omalizumab (Novartis/Genentech) Antihistamines Zyrtec, Xyzal, Allegra, Claritin IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLS

16 Allergy immunotherapy (AIT) is the only treatment targeting the root cause of the disease IMMUNE SYSTEM ALLERGENS Injection of high dose of allergens regulatory cells down regulation allergic immune system (Th2 cells) IgE synthesis histamine release REGULATORY CELLS synthesis of IgG4 & IgA Blocking ANTIBODIES BEST AVAILABLE TREATMENT IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLS

17 AIT market < 10% of the allergy drug market Country Sales % Market Share 700 millions Europe Germany millions (39%) ALK - Abelló (33%) 78% France millions (31%) Stallergènes (31%) Italy / Spain = 50 millions each Allergy Therapeutics (7%) USA 90 millions 10% ALK - Abelló Hollister - Stier WHY SUCH A LOW MARKET SHARE? Stallergènes / Greer Japan 5 millions ROW 105 millions 12% TOTAL 900 millions 100% ALK - Abelló (33%) Stallergènes (28%) Sources: Global Data Allergic Rhinitis Immunotherapy Market 2018 (Sep-2014) ALK-Abelló, Stallergènes and Allergy Therapeutics annual reports

18 Current allergy immunotherapy is long and cumbersome Year 1 Year 2 Year 3 COMPLIANCE SCIT Subcutaneous immunotherapy SLIT Sublingual immunotherapy SCIT Doctor visits Daily administration 180 to 360 days/year < 25% < 12.5% Only ¼ patient looking for a new treatment start immunotherapy in Europe

19 ASIT technology

20 Active ingredients make the difference IMMUNE SYSTEM CURRENT ALLERGENS Current allergens activate allergic reaction before allergy regulation REGULATORY CELLS Blocking ANTIBODIES IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLS

21 Active ingredients make the difference IMMUNE SYSTEM ASIT+ TM ALLERGENS ASIT+ TM induces directly and immediately the adequate allergy regulation REGULATORY CELLS Blocking ANTIBODIES IgE ANTIBODIES IgE - ALLERGEN COMPLEXES ON MAST CELLS

22 A straight mechanism of action shorten the treatment 4 doctor visits in 3 weeks before each pollen season Year 1 Year 2 Year 3 ASIT Biotech s proposal ASIT biotech makes the best available allergy treatment really attractive

23 ASIT+ Clinical Development

24 ASIT biotech pipeline: achieved milestones Pre-clinical Phase I Phase II Phase III Grass pollen gp-asit+ Q Positive phase III House dust mite hdm-asit+ Q Positive Phase I/II Food Peanut - Egg white - Cow s milk Launch of preclinical development program food-asit+

25 gp-asit+ first Phase III clinical study (BTT009): positive results TRIAL # PATIENTS PRIMARY OBJECTIVE DESIGN Phase III 2:1 (active : placebo) 93% retention rate: 512 patients attended the last visit Clinical efficacy during pollen season based on reduction in the combined symptommedication score (CSMS) Double-blind Placebo controlled 67 centers in Europe 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)

26 hdm-asit+ first in man clinical study: safety of ASIT+ TM confirmed TRIAL # PATIENTS AIM COMPLETED Phase I/IIa 36 patients randomized Assessment of the maximum tolerated dose Safety and clinical tolerability Immunogenicity Impact on reactivity to a challenge test Q 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 clinical study

27 food-asit+ product prototypes screening on-going PRE-CLINICAL DEVELOPMENT AIM COMPLETED Product prototype ex vivo screening Selection of product candidate peanut, cow s milk & egg white ex vivo safety and tolerability ex vivo immunogenicity Q 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 H to end a recoverable cash advance granted in January 2017

28 ASIT biotech pipeline: next milestones Pre-clinical Phase I Phase II Phase III Grass pollen gp-asit+ FDA feedback - Q Second Phase III Q Q House dust mite hdm-asit+ Selection of a new ASIT+ TM active ingredient - Q Second Phase I/II clinical trial with improved prototype Q Food Peanut - Egg white - Cow s milk food-asit+ Selection of ASIT+ TM active ingredient for each allergen - Q First Phase I/II clinical trial in food - H2 2018

29 Investment opportunity

30 Addressing the unmet Patients need! Patient 4 doctor visits Time & Money saving Reduction of symptoms and rescue medication in the real life Improved quality of life Healthcare systems Documented safety and efficacy Improved acceptance Improved compliance Improved real-life efficacy Reduced direct & indirect costs Allergists New therapeutic option More patient accepting AIT Patients more compliant Fast onset of action Better patient follow-up Higher patient satisfaction

31 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 reactions 1 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

32 Board of Directors Gerd Zettlmeissl, Chairman of the Board Thierry Legon, CEO Everard van der Straten, Director and CFO François Meurgey, Director Jean Duchateau, Director & Co-founder 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 , member of the Board of Aeras Allergist. One of the inventor of the 1st patents on tolerance induction to allergy and graft rejection, new LED tests, owned by ASIT biotech RE Finance Consulting SA, Independent Director (represented by Yves Désiront) Bruservices SA (represented by Henri De Meyer) Meusinvest SA (represented by Marc Foidart)

33 Shareholder structure post-ipo S.R.I.B. 7% S.R.I.W. 6% S.F.P.I. 11% Mr de Spoelberch 9% Float 54% MEUSINVEST 3% Management 4% EPIMEDE 6%

34 ASIT biotech on the stock market Market data Market: Euronext Brussels and Paris IPO price: 7.00 (11/05/2016) Current price: (16/11/2017) Highest: Lowest: Number of shares (fully diluted) : 13,056,600 Average volume: 10,760 shares / day (since IPO) Change in stock price since the IPO Stock market codes Name: ASIT Ticker: ASIT ISIN code: BE

35 Contacts ASIT Biotech Thierry Legon CEO Tel.: investors@asitbiotech.com NewCap Investor Relations & Strategic Communications Pierre Laurent / Dusan Oresansky Tel.: asitbiotech@newcap.eu