Ose Immunotherapeutics Sa · EURONEXT:OSE
Ose Immunotherapeutics Sa — Investor Presentation (October 2025)
46 slides from Ose Immunotherapeutics Sa's investor presentation, October 2025
Slide 1: Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies
Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies October 2025
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains express or implied information and statements that might be deemed This presentation does not constitute an offer to sell the shares or soliciting an offer to purchase any of forward-looking information and statements in respect of OSE Immunothera
Slide 3: Investment highlights
Investment highlights Tedopi®, is a potential first-to-market oncology vaccine, currently in pivotal Phase 3 study Compelling portfolio of late- Lusvertikimab, an anti-IL7R antibody, represents a first-in-class and best-in-class program across a range of I&I stage, OSE-owned programs indications inc
Slide 4: An experienced executive leadership team
COMPANY OVERVIEW An experienced executive leadership team Marc Le Bozec Nicolas Poirier, PhD Thomas Gidoin Sonya Montgomery, ND Silvia Comis, MD Jean-Jacques Mention, PhD Fiona Olivier Aurore Morello, PhD Interim Chief Executive Officer Chief Scientific Officer Chief Financial Officer Chief Developm
Slide 5: Clinical Pipeline
Clinical Pipeline Combining a clinical portfolio of first-in-class immunotherapies and diversified assets in IO and I&I Product candidate Target Indication Research IND-enabling Phase Ia/Ib Phase II Phase III Upcoming Milestones OSE-127 Complete data Anti-IL-7R Ulcerative Colitis Positive Results St
Slide 6: Research platforms
Research platforms Extra(not) Ordinary Research PowerHouse Myeloid Checkpoint Cis-targeted Cytokine Pro-Resolutive mAb RNA Therapeutics Anti-SIRPα Anti-PD1/cytokine Anti-ChemR23 IL-35 mRNA Anti-CLEC-1 mAbs Cis-Demasking technology Undisclosed new Undisclosed programs pro-resolutive GPCRs Partnered A
Slide 7: Strategic partners provide industry-leading clinical support & strong financial foundations
Strategic partners provide industry-leading clinical support & strong financial foundations Immuno-Oncology Potential Over €2.1bn in potential milestones; €219m* already received Immuno-Inflammation Received BI 770371 ABBV-230 Pegrizeprument + anti-PD1/cytokine Chronic (FR104) Solid tumors & Metabol
Slide 8: Key potential catalysts
Key potential catalysts* Readouts • Tedopi® Phase 3 results in NSCLC 2L Phase 2 combination results • Lusvertikimab New study results • BI 770371 (partnered) Progress Readouts Phase 1b onco + Phase 2 MASH results • Lusvertikimab • Tedopi® • Pegrizeprument (FR104) (partnered) Full data set Phase 2 in
Slide 9: Proprietary clinical programs
Proprietary clinical programs
Slide 10: Lusvertikimab
Lusvertikimab Most advanced anti-IL-7R mAb Strong biological rational in refractory IBD patients
Slide 11: IL-7 fuels chronic inflammation in tissues
Lusvertikimab IL-7 fuels chronic inflammation in tissues Upstream mechanism of resistance in hyper-inflammation Upstream Recent evidence suggests the presence of highly pro-inflammatory — or ‘angry’ — cells in the intestinal mucosa in inflammatory bowel disease (IBD) that drive molecular resistance
Slide 12: Lusvertikimab / OSE-127
Lusvertikimab Lusvertikimab / OSE-127 Pure IL-7 receptor antagonist mAb Tackling the fuel of memory T-lymphocytes while sparing Tregs A differentiated IL7R antagonist with positive Phase 2 data in hand • IL-7 produced by inflamed tissues sustains T-cell survival and chronicity, drives Th1 and Th17 T
Slide 13: Preclinical & translational research of IL-7 in IBD
Lusvertikimab Preclinical & translational research of IL-7 in IBD High preclinical efficacy in-vivo and ex-vivo + high target expression in diseased tissues Mucosal IL7R pathway over-expression in IBD High preclinical efficacy in different models High correlation with SOC unresponsiveness Colon Skin
Slide 14: Anti-IL-7R + IL-12/23 combination preclinical & translational rationale
Lusvertikimab Anti-IL-7R + IL-12/23 combination preclinical & translational rationale IL-7R and IL-23 cytokine mucosal IL-7R + IL-12/23 blockade synergizes to induce complete IL-7 drives IL-23 antagonist resistance over-expression in Ustekinumab UC patients mucosal healing in chronic colitis UC colo
Slide 15: CoTikiS phase 2 randomized study of Lusvertikimab
Lusvertikimab CoTikiS phase 2 randomized study of Lusvertikimab Moderate-to-severe ulcerative colitis W0 W10 W34 Open Label Extension Full analysis set (FAS): 134 patients Screening Induction OLE 50 pts group 850mg Lusvertikimab 35 pts group 450mg Lusvertikimab Lusvertikimab 85 pts pooled group (450
Slide 16: IBD clinical Advisory Board, and what they say
Lusvertikimab IBD clinical Advisory Board, and what they say "We have a new mode of action in UC with a strong safety profile. These full Phase 2 clinical “These data suggest that “The trial was well-conducted, with robust data induction results provide strong efficacy data Lusvertikimab has the pot
Slide 17: CoTikiS - demographics and disease characteristics
Lusvertikimab CoTikiS - demographics and disease characteristics 850 mg group slightly more severe disease than 450 mg and/or placebo groups Placebo (n=49) 450 mg (n=35) 850 mg (n=50) Total (n=134) Age: mean (SD) 42.7 (15.9) 38.8 (10.5) 42.5 (15.1) 41.6 (14.4) Sex: male 28 (57.1%) 22 (62.9%) 27 (54.
Slide 18: Clinical induction results at week 10
Lusvertikimab Clinical induction results at week 10 Clinically and statistically meaningful outcomes in the Lusvertikimab-treated groups Primary Endpoint: Modified Mayo Score Clinical Remission at W10 Improvement (MMS)*µ at W10 Δ 11.8%; p=0.066 Placebo 450 850 450/850 30 (n=49) (n=35) (n=50) (n=85)
Slide 19: Endoscopic improvement and remission at week 10
Lusvertikimab Clinical induction results at week 10 Clinically meaningful and significant endoscopic improvement and remission Endoscopic Improvement* Endoscopic Remission** UC Endoscopic Index of Severity UCEIS*** at W10 at W10 change from baseline at W10 Δ 19.3%; p=0.027 Δ 11.7% Δ 31.9%; p=0.004 Δ
Slide 20: Histological and histo-endoscopic mucosal improvement
Lusvertikimab Clinical induction results at week 10 Clinically meaningful and significant histological and histo-endoscopic mucosal improvement Histological Improvement Histo-Endoscopic Mucosal Histological Geboes index at W10* Improvement (HEMI) at W10** change from baseline at W10 Δ 27.0%; p<0.01
Slide 21: Subgroup analysis: bio-naïve, baseline endoscopic score = 3
Lusvertikimab Subgroup analysis: bio-naïve, baseline endoscopic score = 3 Clinical Remission at W10 Endoscopic Improvement at W10 Histological Improvement at W10 30 40 50 % of Patients with Endoscopic Improvement % of Patients with Clinical Remisssion 43% 42% 25% 33% 42% Histological Improvement NHI
Slide 22: Subgroup analysis: high disease activity & biologics-experienced
Lusvertikimab Subgroup analysis: clinical induction at week 10 Lusvertikimab induced clinical and endoscopic remission in high disease activity & biologics-experienced populations Patients with high baseline FCP Patients with previous exposure (Fecal Calprotectin >250µg/g) to biologics Δ 16.9% 35 Δ
Slide 23: PRO2 results in the open label extension (OLE)
Lusvertikimab PRO2 results in the open label extension (OLE) Symptomatic remission rates improved for all groups, with 850 mg induction dose group plateauing earlier in the OLE Symptomatic remission Treatment during induction phase % of Patients with Symptomatic Remisssion 100 Placebo 450 mg 850 mg
Slide 24: Safety in induction phase
Lusvertikimab Safety in induction phase Placebo 450 mg 850 mg Total (N=49) (N=36) (N=51) (N=136) N(%) [E] N(%) [E] N(%) [E] N(%) [E] At least one TEAE 16 (32.7) [29] 17 (47.2) [33] 20 (39.2) [42] 53 (39.0) [104] At least one TEAE related to study treatment 1 (2.0) [1] 3 (8.3) [4] 4 (7.8) [14] 8 (5.9
Slide 25: CoTikiS Phase 2 study of Lusvertikimab highlights
Lusvertikimab CoTikiS Phase 2 study of Lusvertikimab highlights • Lusvertikimab demonstrated high clinical, endoscopic, and histological efficacy vs placebo at week 10 at both 450 and 850mg doses in moderate to severe UC patients • 89% of the CoTikiS patients entered the open label extension phase a
Slide 26: Market opportunity for UC supports multiple players
Lusvertikimab Market opportunity for UC supports multiple players Background, epidemiology & market opportunity Unmet need & positioning in the UC market • Despite new agents targeting inflammatory pathways (e.g. anti-TL1-As), only ~20-30% • Chronic disabling bowel disease characterised by inflammat
Slide 27: Potential for highly sensitive and specific prediction of clinical remission
Lusvertikimab Potential for highly sensitive and specific prediction* of clinical remission Biomarker-positive population represents ~30% of CoTikiS cohort 70 Δ 46.5% AI-powered precision medicine % of Patients with Clinical Remisssion 60 59% Clinical data 50 (body scale) Histology slides 40 (tissue
Slide 28: Lusvertikimab clinical remission vs. approved UC therapies (placebo-adjusted)
Lu sv er tik Clinical Remission (%) 0 10 20 30 40 50 60 70 28 Lu ima sv b- -4 45 5 0 +18 Lu 0+8 sv 50 +12 Ad b al mk im + +47 G um ol im ab u Lusvertikimab In ma Ve lix b f +9 +11 do im l a +20 Et izu b ro ma O liz b +11 nt um a U ma ab st +12 e lim R kim ab iz +14 an um k a Biomarker+ G izu b +12 u
Slide 29: TEDOPI
TEDOPI® Most Advanced Therapeutic Cancer Vaccine Bringing new hope to patients in the fight against ICI resistant NSCLC
Slide 30: Personalized vs Off-the-Shelf cancer vaccines
Tedopi® Personalized vs Off-the-Shelf cancer vaccines Neoepitope cancer vaccine Neoantigen cancer vaccine = Precision Medicine = Personalized Medicine -> Off-the-Shelf -> Custom TEDOPI® “Ready-to-Use” emulsion CDx-based selection (blood sample) Cons: Tumor biopsy, Cost, Time Homogeneous HLA-A2+ popu
Slide 31: An immunotherapy activating specific T-cells to revive anti-tumor response
Tedopi® An immunotherapy activating specific T-cells to revive anti-tumor response Most advanced Cancer Vaccine in clinical development • Unique combination of neoepitopes: small peptides deriving from tumor specific antigens* expressed in various cancers • Strong binding to HLA-A2 receptor (45% pop
Slide 32: Tedopi is a novel cancer vaccine with a strong biological rational in post-ICI secondary resistance
Tedopi® Tedopi® is a novel cancer vaccine with a strong biological rational in post-ICI secondary resistance Shifting paradigms with cancer vaccine immunotherapy Primary (intrinsic) resistance No T-cell Patients who do not respond to ICIs refractory with a rapid disease progression tumors → Immune r
Slide 33: Clinically meaningful benefit of Tedopi in 3rd line NSCLC
Tedopi® Clinically meaningful benefit of Tedopi® in 3rd line NSCLC Randomized Phase 3 with positive results vs. standard of care (SOC) OS rate at 12 months Overall Survival 44% Significantly safer than Chemo. secondary resistance post anti-PD(L)1 in Tedopi® vs. 11% vs 35% grade 3-5 AEs 27.5% in SoC
Slide 34: Tedopi in NSCLC: ARTEMIA study
Tedopi® Tedopi® in NSCLC : ARTEMIA study ARM A Tedopi® (n=242) PRIMARY ENDPOINT: KEY ELIGIBILITY CRITERIA Q3W for 6 subcut. inj., Overall Survival* then Q8W until end Year 1, - HLA-A2+ then Q12W up to end Year 2 SECONDARY ENDPOINTS: - Metastatic squamous & non-squamous NSCLC Until loss of clinical b
Slide 35: Tedopi answers to real medical need in NSCLC
Tedopi® Tedopi® answers to real medical need in NSCLC Tedopi® has the potential to become the new standard for recurrent patients in 2L NSCLC presenting HLA-A2 phenotype LUNG CANCER : Incidence of High prevalence, mortality and unmet need - worldwide advanced NSCLC • Highest mortality among 36 cance
Slide 36: Tedopi delivers important clinical benefits vs competition
Tedopi® Tedopi® delivers important clinical benefits vs competition Better Safety profile and QoL in current landscape of late-stage drug development post CT-IO Company Checkpoint Inhibitors ADCs Target Multi-epitopes vaccine TKIs (anti-angiogenic) TIM-3 CTLA-4 TROP2 TROP2 CEACAM5 c-MET Current Stud
Slide 37: Further additional potential clinical value in combination NSCLC, PDAC and OC
Tedopi® Further additional potential clinical value in combination NSCLC, PDAC and OC Phase 2 ISS trials in combination with immunotherapy or chemotherapy treatments 2nd line post 1st line chemo IO Maintenance setting post standard of care CombiTED - NSCLC TEDOVA - Ovarian Cancer TEDOPaM - Pancreati
Slide 38: OSE-279: Proprietary anti-PD1 mAb
OSE-279 OSE-279: Proprietary anti-PD1 mAb High affinity PD-1 antibody, recent patent granted in US, Europe, China, Japan Clinical Responses in registered anti-PD1 early Phase 1 studies OSE-279 P1 ❖ Potential of combo with 40% All subjects 10mg/kg or >500mg 36% internal asset 35% 33% 30% Subjects (%)
Slide 39: Partnered clinical programs
Partnered clinical programs
Slide 40: ABBV-230 - Resolving inflammation is an active immune process
ABBV-230 ABBV-230 - Resolving inflammation is an active immune process Restoration of homeostasis During chronic With ChemR23 inflammation agonistic mAbs Dying neutrophils send out ABBV-230 limits recruitment, inflammatory signals (e.g. survival & NETosis of NETosis) that are important in inflammato
Slide 41: SIRPα inhibition may have a synergistic antitumour effect when combined with ICIs
SIRPα program SIRPα inhibition may have a synergistic antitumour effect when combined with ICIs • Infiltrating myeloid cells promotes immune evasion, and this has generated interest in The use of SIRPα myeloid-immune targets1,2 antagonists to enhance o The CD47–SIRPα interaction transduces inhibitor
Slide 42: Pegrizeprument (FR104) CD28 antagonist in organ transplantation
Pegrizeprument (FR104) Pegrizeprument (FR104) CD28 antagonist in organ transplantation Selective CD28 antagonist mAb Ambitious Partnership & Development Plan in Kidney Transplantation with Veloxis CD28 antagonist (FR104) o Veloxis is a global leader in transplantation with leading product Envarsus X
Slide 43: Governance
Governance
Slide 44: A Board of Directors combining international expertise in medicines development, industry & finance
Corporate Highlights A Board of Directors combining international expertise in medicines development, industry & finance, and experience in listed biotech companies Markus Cappel Pascale Briand Jonathan Cool Marc Le Bozec Chairman Independent Director Independent Director Independent Director • Head
Slide 45: International research Scientific Advisory Board (research SAB)
Corporate Highlights International research Scientific Advisory Board (research SAB) - renowned experts in IO and I&I Wolf-Hervé Fridman, MD Myriam Merad, MD, PhD Charles N. Serhan, PhD, DSc Jennifer Wargo, MD, M.M.Sc Bernard Malissen, PhD Sophie Brouard, PhD Chairman of the SAB, Professor Director
Slide 46: Breaking through the therapeutic ceiling with first-in-class immunotherapies
Breaking through the therapeutic ceiling with first-in-class immunotherapies Immuno-Oncology & Immuno-Inflammation Head Office Paris Office 22, boulevard Bénoni Goullin 10, Place de Catalogne 44200 Nantes, France 75014 Paris, France Company Information: http://ose-immuno.com/en/
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