OSE Immunotherapeutics SA · EURONEXT:OSE
OSE Immunotherapeutics SA — Investor Presentation (October 2021)
37 slides from OSE Immunotherapeutics SA's investor presentation, Oct 12, 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 €80m generated Creation to IPO EuroNext ~70 FTEs through equity through partnerships (OSE) Phase 3 asset: Tedopi® in NSCLC • Final positive Atalante results presented at ESMO 2021 1 po
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 Final results of Atalante trial Tedopi® Neoepitopes NSCLC post ICI failure presented at ESMO 2021 Advanced pancreatic cancer in combination with Chemo Tedopi® Neoepitopes
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: Strong Financial Foundation With Our Notable Strategic Partners
Strong Financial Foundation With Our Notable Strategic Partners Over €1.6 billion in potential milestones & royalties; €80m already received1 Up to €272m in milestones Up to €315m in milestones Up to €1.1bn in milestones €25m received €7m received €38m received + Low teens royalties + Tiered royalti
Slide 8: BI 765063 (OSE-172) SIRPα-CD47 in Solid Tumors
BI 765063 (OSE-172) SIRP⍺-CD47 in Solid Tumors in collaboration with
Slide 9: BI 765063: Controlling the Don't-Eat-Me Signal Without CD47 Antagonists Drawbacks
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 10: BI 765063: Strong Rationale 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 11: BI 765063 Phase 1 Monotherapy Data Shows Preliminary Efficacy and Good Safety
BI 765063 - Phase 1 Monotherapy data shows preliminary efficacy and good safety profile Monotherapy (n=50) Study design • A two-step, open-label, multicenter Phase 1 study in V1/V1 homozygous and V1/V2 heterozygous patients (n=50) with advanced solid tumors who progressed or were not eligible for st
Slide 12: Clinical Efficacy Demonstrated in Monotherapy
Clinical Efficacy Demonstrated in Monotherapy Monotherapy (n=50) Spider plot of percentage change in sum CT scans of a patient with Hepatocellular of target lesions from baseline carcinoma with a durable PR Before After A) B) 160 140 Lung 120 V1/V1 V1/V2 100 % change sum 80 60 40 C) D) 20 0 Liver -2
Slide 13: BI 765063 Continues to Demonstrate Exceptional Tolerability Profile In Combo
BI 765063 Continues to Demonstrate Exceptional Tolerability Profile In Combo Dual Combination (n=18) • Two dose levels of BI765063 at 18 and 24 mg/kg by intravenous (iv) Q3W were tested in combination with ezabenlimab 240 mg iv Q3W • The RP2D of BI 765063 was determined as 24 mg/kg Q3W with full RO
Slide 14: BI765063 Preliminary Activity in Combo
BI765063 Preliminary Activity in Combo Dual Combination (n=18) CT scans of two patients (endometrial and Spider plot of percentage change in sum of HCC) with a durable PR target lesions from baseline (cut off 04Aug21) Liver (HCC) Endometrium Colorectal Endometrium • In 16 patients evaluable for effi
Slide 15: 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 Signed in 2018 at Pre-Clinical stage valuations for the CD47 pathway Up to €1.1bn $2.3bn in milestones Acquisition by Pfizer €38m received Received Additio
Slide 16: 130,000 patient market opportunity in advanced NSCLC post-ICI
130 000 patient market opportunity in advanced NSCLC post-Immune Checkpoint Inhibitors
Slide 17: 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 18: Secondary Resistance to ICI Identified as Population of Interest
Secondary Resistance to ICI Identified as Population of Interest All patients Step 2 – Secondary Inclusion: Feb-16 to Apr-20 resistant to ICI Inclusion: Feb-16 to Apr-20 Intent To Treat 219 pts with prior ICI failure 118 pts with 2d resistance in 9 patients with major protocol Population (1rst and 2
Slide 19: Tedopi Demonstrated Overall Survival Benefit in NSCLC post-ICI in Phase 3
Tedopi® Demonstrated Overall Survival Benefit in NSCLC post-ICI in Phase 3 in Patients Secondary Resistant to ICI Overall Survival Benefit Clinically Meaningful Post Progression Survival In patients secondary resistant to ICI Benefit of Tedopi® Continued Beyond Progression Median OS Median Post Prog
Slide 20: 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 in Patients Secondary Resistant to ICI Significant Increase in Time to ECOG deterioration Significantly Safer than Standard of Care Tedopi® Standard of Care (SoC) (n=79) (n=37) All grades Severe* G3-4
Slide 21: Positioning Tedopi as a new standard of care in NSCLC after Checkpoint failure
Positioning Tedopi® as a new standard of care in NSCLC after Checkpoint failure OSE Flexible Approach to Market Next Steps in NSCLC after Immune Checkpoint Failure Option 1 - PARTNER Final positive results of Atalante-1 study in NSCLC secondary resistant patients after Immune Checkpoint failure Maxi
Slide 22: Tedopi: Expanding Targeted Markets In Additional Settings
Tedopi® - Expanding Targeted Markets In 3 Additional Settings Combining Tedopi® with leading IO treatments 2nd line post ICI Maintenance setting post standard of care Combi-TED - NSCLC TEDOVA - Ovarian Cancer TEDOPaM - Pancreatic Cancer In Combination with nivolumab In Combination with pembrolizumab
Slide 23: 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 24: 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 25: 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 26: OSE-127 in Ulcerative Colitis and Sjögren's Syndrome
OSE-127 in Ulcerative Colitis and Sjögren’s Syndrome in collaboration with
Slide 27: 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 €25m received Received Upon
Slide 28: 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 29: 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 30: 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 31: Proprietary Early-Stage Assets: Creating Significant Value Over the Next Three Years
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 32: 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 33: 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 34: Summary
Summary Jaen OSE ts
Slide 35: 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-ICI showed strong clinical ben
Slide 36: Financial Visibility and Capital Structure
Financial Visibility and Capital Structure Shareholding structure Financial visibility and share price Founders, Number of outstanding shares : 17,983,038 Management, Board and Employees 38% Share price October 12th 2021 : 10.66 Euros Institutional Investors and Retail Financial visibility until Q3
Slide 37: Immuno-Oncology And Autoimmune Diseases: Contacts
Immuno-Oncology And Autoimmune Diseases CONTACTS Alexis Peyroles, CEO alexis.peyroles@ose-immuno.com +33 6 75 83 77 58 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.
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