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OSE Immunotherapeutics SA — Investor Presentation (July 2025)
50 slides from OSE Immunotherapeutics SA's investor presentation, July 2025
Slide 1: Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies
Breaking Through the Therapeutic Ceiling with First-In-Class Immunotherapies July 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 Phase 3 oncology asset Tedopi® Late-stage compelling products Promising Phase 2 clinical data from the I&I asset Lusvertikimab (UC) Focus on multi-billion $ markets Large market opportunities • I&I: IBD (Ulcerative Colitis), Cardiovascular-Renal-Metabolic diseases (MASH), Kidne
Slide 4: An experienced executive leadership team
An experienced executive leadership team Nicolas Poirier, PhD Sonya Montgomery, ND Silvia Comis, MD Jean-Jacques Mention, PhD Fiona Olivier Aurore Morello, PhD Chief Executive Officer Chief Development Officer Chief Clinical Research Chief Business Officer Chief Corporate Affairs & Head of Research
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 Readouts • Lusvertikimab Progress • BI 770371 (partnered) Full data set Phase 2 induction UC results • Lusvertikimab Phase 1b onco + Phase 2 MASH results UC phase 2 s
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: clinical remission
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: Clinical induction results: endoscopic improvement and remission
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: Clinical induction results: histological 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: fecal calprotectin decrease and normalization
Lusvertikimab Subgroup analysis: clinical induction at week 10 Significant fecal calprotectin decrease and normalization Fecal calprotectin (FCP) changes FCP normalization at W10 in patients from baseline at W10 with high baseline FCP (>250µg/g) Δ 24%, p=0.02 Δ 27%, p=0.02 250 189 50 % of Patients w
Slide 22: Subgroup analysis: high disease activity & biologics-experienced populations
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: Patient reported outcomes in the open label extension
Lusvertikimab Patient reported outcomes in the open label extension Deepening of efficacy response from end of induction at week 10 through week 14 of the OLE 2.0 Mean baseline ❑ 87% of patients who entered the OLE completed W34 Rectal bleeding subscore 1.5 All patients received 850 mg every 4 weeks
Slide 25: PRO2 results in the OLE for week 10 responders
Lusvertikimab PRO2 results in the OLE for week 10 responders* Patients in symptomatic remission at end of induction & through the OLE Symptomatic remission in week 10 responders Treatment during induction phase *Responders defined as patients with PRO2 ≦ 1 (stool frequency subscore = 0 or 1) and RB
Slide 26: PRO2 results in the OLE for week 10 non-responders
Lusvertikimab PRO2 results in the OLE for week 10 non-responders* Patients who were non-responders at end of induction who achieved symptomatic remission in the OLE Symptomatic remission in week 10 non-responders Treatment during induction phase Placebo 450 mg 850 mg Pooled 450/850 mg *Responders de
Slide 27: 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 28: Safety in OLE phase AESI (>1%)
Lusvertikimab Safety in OLE phase AESI (>1%) All patients received 850 mg every 4 weeks in the OLE from week 10 through 34 Placebo 450 mg 850 mg Total Induction phase dose group: (N=49) (N=36) (N=51) (N=136) N(%) N(%) N(%) N(%) At least one AESI 10 (23.8%) 9 (29.0%) 16 (34.0%) 35 (29.2%) Covid-19 3
Slide 29: 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 30: 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 31: 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 32: TEDOPI
TEDOPI® Most Advanced Therapeutic Cancer Vaccine Bringing new hope to patients in the fight against ICI resistant NSCLC
Slide 33: 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 34: 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 35: 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 36: 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 37: 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 38: 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 39: 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 40: 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 41: 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 42: Partnered clinical programs
Partnered clinical programs
Slide 43: 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 44: 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 45: 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 46: Pegrizeprument (FR104) - Transforming kidney transplant management
Pegrizeprument (FR104) Pegrizeprument (FR104) - Transforming kidney transplant management Positive results of the FIRsT Phase 1/2 clinical evaluation Kidney Transplant Market: in kidney transplantation1 A multi-billion-dollar commercial opportunity • 45k+ new kidney transplant annually for an estima
Slide 47: Governance
1a) Cc a Ov > O UO
Slide 48: 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 Didier Hoch, MD Maryvonne Hiance Nicolas Poirier, PhD Marc Dechamps Chairman Vice Chairwoman Director, CEO Independant & Chief Scientif
Slide 49: 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 50: 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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