Neovacs Sa · EURONEXT:ALNEV
Neovacs Sa — Investor Presentation (April 2017)
29 slides from Neovacs Sa's investor presentation, April 2017
Slide 1: Next Generation Immunotherapies - Neovacs
NEXT GENERATION IMMUNOTHERAPIES NEOVACS April 2017 1
Slide 2: Disclaimer
Disclaimer This presentation and the information contained herein does not constitute or form part of, and should not be construed as, an offer or invitation to sell or subscribe for, or a solicitation of any offer or invitation to acquire, dispose of or subscribe for, securities of Neovacs S.A. (th
Slide 3: Presentation Outline
Presentation Outline AN INNOVATIVE AND REVOLUTIONARY APPROACH TO MODERN IMMUNOTHERAPY 1) Company Listed on Alternext Paris since April 2010 (ALNEV, ISIN: FR0004032746) Kinoids®, revolutionary anti-cytokine therapeutic vaccines, IP protected until 2032 2) Technology The vaccine uses the patients’ own
Slide 4: Company Background
1) Company Background Shareholders structure as of December 31, 2016 23,9% Key Financial Data as of March 31, 2017 Institutional Investors Neovacs SA Ticker: ALNEV FP Market Cap (EUR): 40M Stock Price (EUR): 0.90 52W H/L (EUR): 1.56/0.66 8,6% Historical shareholders Shares Outstanding: 45m (Novartis
Slide 5: Milestones
3) Applicable Therapeutic Markets Milestones FINAL RESULTS OF PHASE IIB STUDY WITH IFNα KINOID IN LUPUS 2018 END OF RECRUITMENT FOR THE PHASE IIB STUDY IN LUPUS WITH IFNα KINOID PRECLINICAL POC RESULTS IN NEOVACS REPORTS TYPE 1 FIRST POSITIVE DIABETES With IFNα Kinoid IMMUNOGENICITY RESULTS NEOVACS
Slide 6: An experienced management team
1) An experienced management team MIGUEL SIELER THERESE CROUGHS Chief Executive Officer Chief Medical Officer • 32 years of an international career for Bayer. Former CEO of Bayer • She joined Neovacs in 2015. Formerly, CMO at Cytheris for over 6 Korea, former CEO of Bayer Pharma France , then Chairm
Slide 7: Kinoid Technology Platform: Vaccine-Like Approach to Treating Chronic Diseases
2) Kinoid® Technology Platform Vaccine-Like Approach to Treating Chronic Diseases Intramuscular Induces self-pAb Injection production T cells generated by the carrier protein (KLH) bypass B cell tolerance to induce self polyclonal anti-cytokine antibodies: Target multiple epitopes : Broad and sust
Slide 8: Superiority of Neovacs' Polyclonal Approach
2) Kinoid® Technology Platform Superiority of Neovacs’ Polyclonal Approach Current treatments Neovacs treatment Monoclonal antibodies: Polyclonal antibodies: – Injection of non-self Abs – Self Abs generated by the patient’s immune system – Abs bind to one specific epitope of the cytokine – Abs bind
Slide 9: Competitive Positioning vs. Monoclonal Antibodies
2) The Kinoid® Technology: Competitive Positioning vs. Monoclonal Antibodies Kinoid® induces Natural Kinoid® induces binding to polyclonal antibodies : multiple epitopes no risk of anti-drug antibody vs. single epitopes (Mabs) (ADA) 5 injections i.m. the first year, ~ 1mg of protein/year vs. once ev
Slide 10: Transforming the Traditional Market Size into an Untapped Revenue Pool
2) Kinoid® Technology Platform Transforming the Traditional “Market Size” into an Untapped Revenue Pool Neovacs’ vaccine-like approach will significantly reduces a patient’s lifetime expense. Majority of modern treatment of chronic diseases require regular dosage over the course of the disease, in c
Slide 11: Progress of Product Development
3) Applicable Therapeutic Markets Progress of Product Development Preclinical Phase I Phase II Phase III Marketing IFNα-Kinoid in SLE – Europe, Latin Phase IIb America, Asia, USA Ongoing Phase IIa IFNα-Kinoid in DM – EU Ongoing IFNα-Kinoid in Diabetes Type-1 VEGF-Kinoid in AMD VEGF-Kinoid in solid t
Slide 12: An Extendable Technology
2) Kinoid® Technology Platform An Extendable Technology Kinoid Technology Pre-Clinical Kinoid Derived Products IFN-Kinoid VEGF-Kinoid IL-4/IL-13-Kinoid Age-Related Lupus Dermatomyositis Type-1 Solid tumor Allergies Target Macular Indications Diabetes Degeneration Current Clinical Phase IIb Phase I/I
Slide 13: IFN-Kinoid for Systemic Lupus Erythematosus (SLE) or Lupus
Applicable Therapeutic Markets 3A) IFN-Kinoid for Systemic Lupus Erythematosus (SLE) or Lupus A chronic auto-immune disease: –Auto-antibodies –Fluctuating disease course: relapses-remissions –Can affect all organs (skin, kidneys, liver, heart) –Accumulations of manifestations over time –Increased mo
Slide 14: Lupus Market Overview
Applicable Therapeutic Markets 3A) Lupus Market Overview Significant market Market for lupus therapies 2010 vs. 2019 –US$ 3.5 billion estimate (2010) Million dollars –18% CAGR potential by 2019 –GSK $3.6 bn takeover of HGS (Benlysta) An unmet medical need –Benlysta (GSK), first new drug in 50 years
Slide 15: IFNα-Kinoid Phase I/IIa in SLE: study design and population
Applicable Therapeutic Markets 3A) IFNα-Kinoid Phase I/IIa in SLE : study design and population •Population Population: Design – 18- 50 years of age – Double-blind, placebo controlled, 3:1 (IFN- – SLE ACR 4/11, K/Placebo) – SLEDAI 4-10 – 28 patients, 7 countries, 12 centers – ANA and/or anti-dsDNA p
Slide 16: Phase I/IIa in SLE: 100% of patients developed anti-IFN antibodies
Applicable Therapeutic Markets 3A) Phase I/IIa in SLE: 100% of SLE patients developed anti-IFN antibodies in IFN-K group 3 doses 4 doses Anti-IFNa antibody GMT 100000 100000 30 mcg IFN-K 120 mcg IFN-K 60 mcg IFN-K 240 mcg IFN-K Placebo 100% of SLE patients developed 10000 10000 anti-IFN antibodies
Slide 17: Polyclonal Antibody Response Neutralizes all IFNα subtypes
Applicable Therapeutic Markets 3A) Phase I/IIa in SLE: Polyclonal Antibody Response Neutralizes all IFNα subtypes 9F3 Polyclonal antibodies Monoclonal IFNα of an IFN-K immunized Antibody Sub-type Patient (D964) anti-IFNα 10 U/mL (Dilution) (concentration Since probably all IFNα ng/mL) subtypes are i
Slide 18: Lupus – Results from Clinical Trial Phase I/IIa
Applicable Therapeutic Markets 3A) Lupus – Results from Clinical Trial Phase I/IIa Extended follow-up data from phase I/IIa trial confirms potent biological activity 4 years after end of trial1: Neutralizing Abs still present 4 years after the first immunization ; They continue to maintain norma
Slide 19: Lupus - Clinical Trial Phase IIb (Ongoing)
Applicable Therapeutic Markets 3A) Lupus - Clinical Trial Phase IIb (Ongoing) Clinical Trial Phase IIb began in September 2015, and currently ongoing Population Design 18- 65 years Double-blind, placebo controlled, 1:1 SLE ACR 4/11 (IFN-K/Placebo) SLEDAI ≥ 6 178 pts, >20countries, >120 cen
Slide 20: Phase IIb Global Clinical Studies
Applicable Therapeutic Markets 3A) Lupus - Clinical Trial Phase IIb Global Clinical Studies USA 100/100.000 ASIA population EUROPE 50/100.00 population 50/100.00 population AFRICA 100/100.000 population LATAM 80/100.000 population 20
Slide 21: Lupus – IFN-Kinoid Development Timeline
Applicable Therapeutic Markets 3A) Lupus – IFN-Kinoid Development Timeline 2016 2017 2018 2019 2020 2021 2022 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Subm MAA Launch in South Sth Korea (ODD) Korea , , South Korea – Around 1,000 Patients Treated Ph IIb - IF
Slide 22: IFN-K & Dermatomyositis
IFN-K & Dermatomyositis Severe autoimmune inflammatory disease, potentially life-threathening and chronically debilitating characterized by muscle weakness and skin rash Pulmonary involvment Risk of relapse (flare) Orphan Disease in EU1 & US2 Heliotrope rash Gottrons papules Shawl sign Incid
Slide 23: Phase IIa in DM: population and study design
Applicable Therapeutic Markets 3B) Phase IIa in DM: population and study design Rationale to support a Proof of Concept in Humans No single animal model fully reproduced human disease, no toxicity observed in Cynomolgus monkeys IFN gene signature pathway documented (Greenberg et al, 2012, Alle
Slide 24: DM – IFN-Kinoid Development Timeline
Applicable Therapeutic Markets 3B) DM – IFN-Kinoid Development Timeline 2016 2017 2018 2019 2020 2021 2022 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 IFN-K-002 Phase III SLE INTERIM RESULTS 250 pts - M12 Cohort 1 Cohort 1&2 IMPD M4 M12 M6 IFN signature IFN-K-
Slide 25: Overview of Partnerships
Overview of Partnerships PARTNERSHIP TYPE COMPANY PRODUCTS COMMERCIAL CKD PHARMA - SOUTH KOREA IFN KINOID - LUPUS & OUT-LICENSING BIOSENSE GLOBAL LLC- CHINA STELLAR BIOTECHNOLOGIES - USA ALL TYPES OF KINOIDS INDUSTRIAL 3P BIOPHARMACEUTICALS – IFN KINOID SPAIN PARIS HOSPITAL COCHIN- F
Slide 26: Scientific Advisory Board
Scientific Advisory Board Pr. BETTY DIAMOND, MD Pr. JACQUES BANCHEREAU, PhD •Investigator & Head, Center for Autoimmune and Président du SAB Musculoskeletal Diseases, The Feinstein Institute for •Director of immunological sciences The Jackson Laboratory Medical Research for Genomics Medicine, At the
Slide 27: Lupus – Clinical Advisory Board
Lupus – Clinical Advisory Board Pr. FRÉDÉRIC HOUSSIAU, MD Pr. JOAN MERRILL, MD • Chief of Rheumatology Unit, SSS/IREC/RUMA, •Professor of Medicine, Adjunct Professor, Oklahoma Cliniques Universitaires Saint Luc & Université Medical Research Foundation; School of Pharmacy Catholique de Louvain, Bruss
Slide 28: Thank you & Contact
Thank you & Contact Do not hesitate to contact us NEOVACS NEOVACS Miguel Sieler Charlène Masson CEO Corporate Communication 3/5 impasse Reille Manager 75014 Paris Tel: +33-153-109-314 Tel: +33-153-109-300 cmasson@neovacs.com msieler@neovacs.com 28
Slide 29: Kinoid Technology Platform: A Patent-Protected Approach
2) Kinoid Technology Platform A Patent-Protected Approach Granted Patents Patent Expiration Date (excluding SPCs) Pat.# Nature of Patent Country Exp. Date WO/2000/064937 Composition of matter EP, US 2020 WO/2004/024189 Composition of matter EP, US, CN,CA, ZA, AU, JP, BR, IN, 2023 NZ WO/2005/028513 C