Ose Immunotherapeutics Sa · EURONEXT:OSE
Ose Immunotherapeutics Sa — Investor Presentation (May 2021)
40 slides from Ose Immunotherapeutics Sa's investor presentation, May 27, 2021
Slide 1: Immuno-Oncology And Autoimmune Diseases
Immuno-Oncology And Autoimmune Diseases We Are Armed to Fight
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial project
Slide 3: OSE Immunotherapeutics: Leaders in Immunology
OSE Immunotherapeutics: Leaders in Immunology IMMUNO-ONCOLOGY INFLAMMATION OSE z VACCINES 3
Slide 4: OSE Immunotherapeutics: Delivering from Target to Clinic
OSE Immunotherapeutics Delivering from Target to Clinic KEY FACTS 2012 - 2015 5 clinical assets in 2021 €42m raised €67m generated Creation to IPO EuroNext ~70 FTEs through equity through partnerships (OSE) Phase 3 asset: Tedopi® • Phase 3 Step-1 Primary endpoint met 1 Positive Step-1 results in NSC
Slide 5: Complementary Platforms and Balanced Pipeline
Complementary Platforms and Balanced Pipeline ASSET TARGET INDICATION PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 NEXT INFLECTION POINT Potential regulatory filing: end of Tedopi® Neoepitopes NSCLC post CKI failure 2021 in pre-specified population Advanced pancreatic cancer in combination with Chemo Phase
Slide 6: Transforming OSE Immunotherapeutics for the Next Decade
Transforming OSE Immunotherapeutics for the Next Decade Immunology Moving to a expertise validated fully-fledged by strong clinical data biotech model and partnerships Clear goals and First post-IPO objectives Laser-focused capital injection to capture more in- to deliver prioritization of R&D resou
Slide 7: An Executive Team with Complementary Expertise and Proven Track Record
An Executive Team with Complementary Expertise and Proven Track Record Leading organizational Clinical Competencies Immunology Partnerships Fund raising growth development Alexis Peyroles Chief Executive Officer Previously HMR • 10 products registered Dominique Costantini Head of Development includi
Slide 8: 130k patient opportunity in advanced NSCLC post-Immune Checkpoint Inhibitors
130k patient opportunity in advanced NSCLC post-Immune Checkpoint Inhibitors
Slide 9: Tedopi
Tedopi® NEOEPITOPES / HLA / TCR binding*: • Mandatory to activate cytotoxic T-cell response • Neoepitopes: Small peptides deriving from tumor specific antigens expressed in various cancers • 1st T-lymphocyte activation signal Proprietary combination Restores immuno-surveillance Induces early T cell
Slide 10: Identifying Epitopes to Trigger Optimal Immunogenicity
Identifying Epitopes to Trigger Optimal Immunogenicity Based on 10 Years of R&D HLA-A2 1 Epitope prediction In silico motif analysis Tumor cell 2 Affinity determination In vitro capture assays 3 Immunogenicity In vivo T cell activation 10
Slide 11: Tedopi Demonstrated Overall Survival Benefit in NSCLC post-CKI in Phase 3 Step-1
Tedopi® Demonstrated Overall Survival Benefit in NSCLC post-CKI in Phase 3 Step-1 Overall Survival Benefit Clinically Meaningful Post Progression Survival ITT Population In the Targeted Per Protocol Population Benefit of Tedopi® Continued Beyond Progression Median OS Median Post Progression Tedopi®
Slide 12: Tedopi Proved Safe and Provided Enduring Quality of Life
Tedopi® Proved Safe and Provided Enduring Quality of Life Positive Benefit/Risk vs Standard of Care Significant Increase in Time to ECOG deterioration Significantly Safer than Standard of Care Tedopi® Standard of Care (SoC) (n=63) (n=37) All grades Severe* G3-4 All grades Severe* G3-4 Median Time to
Slide 13: Tedopi Market Opportunity
Tedopi® Market Opportunity For Non-Small Cell Lung Cancer (NSCLC) after Checkpoint Inhibitor Failure 250,000 New lung cancer New lung cancer 470,000 cases per year cases per year 212k NSCLC 400k NSCLC 89k CKI 168k CKI non-responders non-responders 44k 84k HLA- HLA- A2+ A2+ Source: WHO International
Slide 14: Tedopi Commercial Strategy – Maximizing Return to Shareholders
Tedopi® Commercial Strategy – Maximizing Return to Shareholders OSE Flexible Approach to Commercialization Next Regulatory Steps in NSCLC Post-CKI Option 1 - PARTNER Q1/Q2 • Collection of data on additional 100 NSCLC patients from Tedopi® Phase 3 (Step-2 interrupted due to COVID-19) 2021 • Maximizin
Slide 15: CoVepiT, 2nd generation COVID-19 vaccine
CoVepiT, 2nd generation COVID-19 vaccine Multi-Target T cell responses against COVID-19 (provides long immune memory, anticipates viral mutation)
Slide 16: CoVepiT to Add T Cell Memory to B Cell Response for COVID-19
CoVepiT to Add T Cell Memory to B Cell Response for COVID-19 Viral clearance requires T cell stimulation B Cell – Humoral Response T Cell – Cellular Response PROS PROS • Validated concept • Fast and potent immune response • Large global manufacturing capacity • Stimulates direct T cell attack agains
Slide 17: CoVepiT: Second Generation Multi-Epitope CD8+ T Cell Vaccine Against COVID-19 variants
CoVepiT : Second Generation Multi-Epitope CD8+ T Cell Vaccine Against COVID-19 variants Booster strategy against multi-variants Confirmed In vivo and Human Ex vivo Results Broad and diversified targeting of most conserved epitopes (12 epitopes CD8+ T cells against 11 conserved viral proteins and one
Slide 18: BI 765063 (OSE-172) SIRPα-CD47 in Solid Tumors
BI 765063 (OSE-172) SIRP⍺-CD47 in Solid Tumors in collaboration with
Slide 19: BI 765063 (OSE-172) Controlling the Don't-Eat-Me Signal
BI 765063 (OSE-172) Controlling the “Don’t-Eat-Me” Signal Without CD47 Antagonists Potential Drawbacks CD47- SIRPa interaction blocks immune cell activation BI 765063 : stops the “Don’t Eat Me” mechanism by which leading to tumor cell growth tumors evade immune detection and allows T lymphocytes to
Slide 20: BI 765063 Strong Rational for Improved Safety and Synergy with Anti-PD-1
BI 765063 (OSE-172) Strong Rational for Improved Safety and Synergy with Anti-PD-1 Phase 1 : Monotherapy and combination with anti-PD-1 on-going Pre-clinical evidence differentiates SIRPa blockade and CD47 blockade Anti-SIRPa Anti-CD47 Comment BI 765063 Restricted to cells of the Broad/restricted ex
Slide 21: BI 765063 Potential Best-in-Class Asset in Blockbuster Market
BI 765063 (OSE-172) Potential Best-in-Class Asset in Blockbuster Market Boehringer Ingelheim Deal Structure Market events raise expectations and valuations for the CD47 pathway Up to €1.1bn in milestones $3.0bn Market Cap €30m received Received Additional potential $4.9bn Acquisition by Gilead + Hig
Slide 22: OSE-127 in Ulcerative Colitis and Sjögren's Syndrome
OSE-127 in Ulcerative Colitis and Sjögren’s Syndrome in collaboration with
Slide 23: OSE-127 - Differentiated MoA as Full IL-7 Receptor Antagonist
OSE-127 - Differentiated MoA as Full IL-7 Receptor Antagonist License Option to Servier after Phase 2 Activated Proliferating Inactivated A collaborative deal underpinning differentiated science T cell T cell IL-7 : specific T-cell growth factor Up to €272m in milestones €20m received Received Expec
Slide 24: OSE-127 – Ulcerative Colitis
OSE-127 – Ulcerative Colitis License Option to SERVIER after Phase 2 Current standard of care largely calls on two main Ulcerative Colitis developed by OSE therapeutics classes with a total market of $6.3 billions1 • UC affects 3.3 million patients in US, Europe and Japan • ~50% UC patients “moderat
Slide 25: OSE-127 – Sjögren's Syndrome
OSE-127 – Sjögren’s Syndrome License Option to SERVIER after Phase 2 Sjögren’s syndrome developed by SERVIER • 3rd most common autoimmune disease affecting the • Well identified patient population; over 75% of Sjögren’s body's moisture-producing glands, lungs, kidney and syndrome patients are treate
Slide 26: Proprietary Early-Stage Assets: Creating Significant Value
Proprietary Early-Stage Assets : Creating Significant Value Over the Next Three Years and Beyond OSE-230 CLEC-1 BiCKI® FR104 Bi-Functional Platform Blocking myeloid CD28 antagonist in Innovative bifunctional Anti-ChemR23 agonist immune checkpoint autoimmune diseases anti-PD1 antibody Resolution of i
Slide 27: Better, Faster and Safer R&D Strategy – Partnering with MAbSilico
Better, Faster and Safer Research and Development Strategy – Partnering with MAbSilico Leverage artificial intelligence Build a unique drug design (AI) and deep learning to powerhouse with an in-silico AI- accelerate drug discovery and driven De Novo antibody optimization generation and design platf
Slide 28: FR104 - CD28 Antagonist in Autoimmune Diseases & Transplantation
FR104 - CD28 Antagonist in Autoimmune Diseases & Transplantation Phase 1 results: Selective CD28 antagonist FR104 persistently reduces antibody responses CD28 antagonist (FR104) • Good safety - demonstrated o Absence of clinical or biological events o No change in total lymphocyte counts o No cytoki
Slide 29: FR104 – Ambitious Development Plan in 2021 through Partnership with Veloxis
FR104 – Ambitious Development Plan in 2021 through our Partnership in Transplantation with Veloxis and our focus in Auto-Immune diseases Global license agreement with Veloxis in transplantation • Global partnership agreement with Veloxis, a leading transplantation company ▪ To develop, manufacture a
Slide 30: OSE-230 – Resolving Inflammation is an Active Immune Process
OSE-230 – Resolving Inflammation is an Active Immune Process During chronic inflammation With ChemR23 agonistic mAbs Restoration of homeostasis Dying neutrophils send out inflammatory OSE-230-mediated activation of resident macrophages signals that are important in maintaining induces efferocytosis
Slide 31: OSE-230 – Pre-Clinical Data Demonstrate Strong Effect on Neutrophils and Leucocytes
OSE-230 – Pre-Clinical Data Demonstrate Strong Effect on Neutrophils and Leucocytes Higher ChemR23 expression in anti-TNFα OSE-230 significantly reduces neutrophils and leucocytes refractory patients in inflammatory models in monkeys Ulcerative colitis U lcerativ e C ro h n Ulcerative c o8litis Croh
Slide 32: CLEC-1
CLEC-1 Blocking myeloid immune checkpoint from delivering another “Don’t-eat-me” signal Tumor homeostasis CLEC-1 mAbs disrupt tumor homeostasis Anti-CLEC-1 mAbs increase DON’T EAT-ME DON’T EAT-ME killing efficacy of myeloid signal signal cells & T cell responses SIRPa CD47 Eat-Me Eat-Me Eat-Me signa
Slide 33: CLEC-1 - Pre-Clinical Data Demonstrate Strong Rational for CLEC-1 Inhibition
CLEC-1 - Pre-Clinical Data Demonstrate Strong Rational for CLEC-1 Inhibition in Combination to Chemotherapy CLEC-1 antagonist mAbs increase tumor CLEC-1L surges on tumor cells CLEC-1 deficiency impairs tumor cells ADCP by human macrophages after chemotherapy growth in combination with (shown) and tu
Slide 34: BiCKI Bi-Functional Platform in Oncology
BiCKI® Bi-Functional Platform in Oncology OSE-279: Humanized Anti-PD1 mAb blocking binding of PD-L1 and PD-L2 Anti PD-1 Backbone • Blocks PD-1 inhibitory signal Increases TCR signaling Fc fusion + • Delivers drug to tumor microenvironment (TME) on flexible linker PD-1-expressing T cells Is o ty p e
Slide 35: BiCKI OSE-279/IL-7 Show Strong Synergistic Effect in Multiple Solid Tumor Types
BiCKI® OSE-279/IL-7 Show Strong Synergistic Effect in Multiple Solid Tumor Types BiCKI®IL-7 promotes human TILs IFNg secretion in ex vivo organoid model 35 Poster #910 SITC 2020 – “A novel bifunctional anti-PD-1 / IL-7 fusion protein potentiates effector function of exhausted T cell and disarms Treg
Slide 36: BiCKI OSE-279/IL-7 demonstrates high preclinical efficacy
BiCKI® OSE-279/IL-7 demonstrates high preclinical efficacy Superior efficacy in PD-1 resistant models In vivo preclinical efficacy in Ex vivo reactivation of PD-1 resistant mouse model anti PD1 resistant human TILs HCC orthotopic model hPD1 humanized mice Resected tumor Ex vivo 100 STIM IFNg secreti
Slide 37: Summary
Summary Jan OSE tis
Slide 38: Transitioning from World-Class Science to Commercial Readiness
Transitioning from World-Class Science to Commercial Readiness Adjusting strategy to prepare for proprietary pipeline acceleration and next phase of growth World leading research capabilities having delivered 3 platforms with mid-late stage assets Tedopi® in NSCLC post-CKI showed strong clinical ben
Slide 39: Financial Visibility and Capital Structure
Financial Visibility and Capital Structure Shareholding structure Financial visibility and share price Number of outstanding shares : 17,983,038 Founders, Management, Share price April 23rd 2021 : 11.12 Euros Board and Employees 38% Latest fund raising (Nov 2020) : 18.6 million Euros BEI agreement f
Slide 40: Immuno-Oncology And Autoimmune Diseases
Immuno-Oncology And Autoimmune Diseases CONTACTS Alexis Peyroles, CEO alexis.peyroles@ose-immuno.com +33 6 11 51 19 77 Head Office Paris Office 22, boulevard Bénoni Goullin 100, avenue de Suffren Dominique Costantini, Chair, Director of Development 44200 Nantes, France 75015 Paris, France dominique.
OSE Immunotherapeutics — Investor Presentation (May 2021) on 6ix