Nanobiotix Sa · EURONEXT:NANO
Nanobiotix Sa — Investor Presentation (January 2025)
43 slides from Nanobiotix Sa's investor presentation, January 2025
Slide 1: Corporate Presentation
CORPORATE PRESENTATION January 2025 Developing disruptive physics-based nanotherapeutics to transform outcomes for millions of patients 1
Slide 2: Important notice regarding forward-looking statements
Important notice regarding forward-looking statements IMPORTANT: You must read the following before continuing. References herein to this presentation (the “Presentation”) shall mean and include this document, the oral presentation accompanying this document provided by Nanobiotix SA (the "Company"
Slide 3: Pathway to Sustainability and Growth
Pathway to Sustainability and Growth 2-3 year path to reach financial sustainability and growth Addressing one of the Largest Untapped Markets in Oncology Beyond NBTXR3 : Developing new With Janssen1 First in Class Products With Curadigm First in Class Radioenhancer NBTXR3 (JNJ-1900) Platform $2.7B+
Slide 4: Develop First-in-Class Nanophysics-Based Drugs to Benefit Millions
Develop First-in-Class Nanophysics-Based Drugs to Benefit Millions Three platforms leading to multiple products, from Phase 3 to preclinical stage NBTXR3 Curadigm OOcuity Nano-radioenhancer to help Nanoprimers to redefine the way Nanoswitches to rewire the brain millions of patients receiving Radiot
Slide 5: Addressing one of the Largest Untapped Markets in Oncology With Johnson & Johnson
Addressing one of the Largest Untapped Markets in Oncology With Johnson & Johnson Potential First-in-Class Radioenhancer NBTXR3 5
Slide 6: Interventional Oncology's Solution Could Be one of the Largest Untapped Oncology Markets
Interventional Oncology’s Solution Could Be one of the Largest Untapped Oncology Markets Millions of cancer patients share an unmet medical need for local treatment, whereas most drug development is focused on highly segmented, later-stages of disease – incidence data US and EU5 Breast Prostate Lung
Slide 7: Radiotherapy is one of the Largest Market Opportunities in Oncology
Radiotherapy is one of the Largest Market Opportunities in Oncology We seek to help many more patients by leveraging radiotherapy 1 % PATIENTS RECEIVING RT3 # PATIENTS RECEIVING RT 1,3 20M 87% Breast cancer 2.00M new patients diagnosed with cancer 77% Lung cancer 1.91M worldwide per year Up to 74% H
Slide 8: Radiotherapy is one of the Largest Market Opportunities in Oncology
Radiotherapy is one of the Largest Market Opportunities in Oncology We seek to help many more patients by leveraging radiotherapy, not the more limited reach of targeted therapy, e.g., anti-PD-1 1 % PATIENTS RECEIVING RT3 # PATIENTS RECEIVING RT 1,3 20M 87% Breast cancer 2.00M new patients diagnosed
Slide 9: Delivery of Efficient Radiation Dose is Limited by Damage to Healthy Tissue
Delivery of Efficient Radiation Dose is Limited by Damage to Healthy Tissue Increasing the dose to the tumor without increasing the dose to healthy tissue is not achievable with current technology Beam of radiation passes through healthy tissue to reach tumor, damaging both tissues Dosing is limited
Slide 10: NBTXR3 Causes Much Higher Energy Absorption Only in the Tumor
NBTXR3 Causes Much Higher Energy Absorption Only in the Tumor 01 Aqueous suspension of inorganic crystalline hafnium oxide (HfO2) nanoparticles NEGATIVELY charged coating 02 providing highly efficient energy absorption High electron density (Atomic Number Z=72) material 03 Activated by ionizing radi
Slide 11: Hyper-Focused Delivery of Enhanced Radiation Into Cancer Cells
Hyper-Focused Delivery of Enhanced Radiation Into Cancer Cells 9x dose enhancement* of radiotherapy for selective and robust tumor killing X-Rays RADIOTHERAPY ALONE electrons X-rays interact with H2O Free electrons generated ROS Triggers cell death or damage Cell Death X-Rays RADIOTHERAPY + NBTXR3 R
Slide 12: NBTXR3 is Designed to Create Local and Systemic Effects
NBTXR3 is Designed to Create Local and Systemic Effects Local and systemic benefits through cell death and immune activation against tumor antigens PHYSICAL DESTRUCTION OF CANCER CELLS TO PROVIDE BETTER LOCAL CONTROL Lesion Size Direct Cell Death Decrease (apoptosis, necrosis) AndNBTXR3 triggers sys
Slide 13: NBTXR3: Key Value Drivers of Clinical Differentiation
NBTXR3: Key Value Drivers of Clinical Differentiation Designed to disrupt outcomes without disrupting clinical practice One-time intratumoral administration in a course of radiotherapy Single Treatment Maximizing the dose in the tumor, minimizing the systemic exposure Easily Integrated into Does not
Slide 14: Proof-of-Concept Established in Randomized Phase 2/3
Proof-of-Concept Established in Randomized Phase 2/3 In tough to treat soft tissue sarcoma population Doubling of Pathological Complete Response Results Pathological Complete Response Rate - ITT Full Analysis Set Achieved its primary endpoint of pathological CRR 20 Achieved its secondary endpoint in
Slide 15: Pan-Solid Tumor Potential, Beginning in Head and Neck and Lung Cancers
Pan-Solid Tumor Potential, Beginning in Head and Neck and Lung Cancers Patients (Current Study) N Phase 1 Phase 2 Phase 3 Operational Sponsor Head & Neck Elderly Cisplatin-ineligible (NANORAY-312, RT-NBTXR3 ± cetuximab 500 Janssen vs RT ± cetuximab) R/M IO Naïve (Study 1100, RT-NBTXR3 fb anti-PD-1)
Slide 16: Nanobiotix and Janssen Advance NBTXR3 Together
Nanobiotix and Janssen* Advance NBTXR3 Together License agreement and LianBio rights assignment consolidates global rights with Janssen Potential for approximately $2.7B^ milestones and royalties from low 10s to low 20s Development, regulatory and sales milestones** Up to $1.8 billion Additional reg
Slide 17: Establishing a Foothold Through Treatment of Head and Neck Cancers
Addressing one of the Largest Untapped Markets in Oncology With Johnson & Johnson Establishing a Foothold Through Treatment of Head and Neck Cancers 17
Slide 18: RT-Activated NBTXR3 Could Benefit Most Patients With LA-HNSCC
RT-Activated NBTXR3 Could Benefit Most Patients With LA-HNSCC LA-HNSCC biggest unmet need is in front line local treatment; PD-1 treatment is mainly after local treatment fails Local or locally-advanced at diagnosis 90% (~135,000) Metastatic at diagnosis 10% (~15,000) Cisplatin ineligible Surgery ad
Slide 19: NBTXR3 for Treatment of Locally-Advanced HNSCC In Cis Ineligible Patients
NBTXR3 for Treatment of Locally-Advanced HNSCC In Cis Ineligible Patients Post IT injection Post radiotherapy 7 months after RT CT scan presented at MHNCS 2020 – Ph1 Study 102 19
Slide 20: Study 102 Design
Study 102 Design Phase 1 dose escalation and dose expansion evaluated RT-NBTXR3 in locally-advanced head and neck cancers Diagnosed with Locally Advanced Head and Neck Squamous Cell Carcinoma Cetuximab Ineligible Key Inclusion Criteria >70 years of age or >65 but <70 and cisplatin ineligible or Cisp
Slide 21: RT-Activated NBTXR3 Associated With Locoregional Control 81.8% ORR Including 63.6% CR
RT-Activated NBTXR3 Associated With Locoregional Control 81.8% ORR Including 63.6% CR Best Overall Response Based on Investigator Assessment Study 102 data cut-off date: Jan 20, 2023. Evaluable patients for Objective Tumor Response: Underwent at least one post-treatment assessment and received at le
Slide 22: Median PFS of 16.9 Months in Evaluable Patients
Median PFS of 16.9 Months in Evaluable Patients By Independent Central Review All Treated Population N=56 Evaluable Population* N=44 Among the 12 patients who were non-evaluable for objective tumor response, 9 had severe comorbidities (ACCI≥4) ~30% of HNSCC patients > 70 years old and have poor outc
Slide 23: Median Overall Survival 23.1 Months in Evaluable Patients
Median Overall Survival 23.1 Months in Evaluable Patients All Treated Population N=56 Evaluable Population* N=44 Among the 12 patients who were non-evaluable for objective tumor response, 9 had severe comorbidities (ACCI≥4) ~30% of HNSCC patients > 70 years old and have poor outcomes (PFS ~9 months3
Slide 24: Potential Benefit in Survival Compared to Historical Control
Potential Benefit in Survival Compared to Historical Control With patients having better prognosis including less comorbidity (67% in Study 102 vs ~20% in historical controls) Median OS: 23.1 months Median OS: ~ 12 months Study 102, Evaluable Population, n=44 Historical control* Cut-off date: Jan 20
Slide 25: NANORAY-312 Trial Design
NANORAY-312 Trial Design Ongoing global Phase 3 registration trial locally-advanced HNSCC Designed to provide robust evidence for survival superiority Age ≥65 years: Eligible for definitive RT, at least one measurable and IT injectable tumor Key Inclusion Criteria Ineligible for platinum-based chemo
Slide 26: Study 1100 Potential IO Combination
Study 1100 Potential IO Combination Phase 1 evaluation of NBTXR3-RT ± immune checkpoint inhibitors for recurrent and/or metastatic HNSCC Expansion Cohorts 1 and 2: Inoperable LRR or R/M HNSCC (anti-PD-1 resistant and anti-PD-1 Naïve, respectively) with at least one lesion that is amenable to irradia
Slide 27: NBTXR3 for the Treatment of Recurrent or Metastatic Head and Neck Cancer
NBTXR3 for the Treatment of Recurrent or Metastatic Head and Neck Cancer SITC 2022: Anti-PD-1 resistant patient case study Target Lesion PR in injected and irradiated tumor Non-Target Lesion CR in non-injected and non-irradiated distal lesion suggesting systemic response PET Baseline PET Follow-Up V
Slide 28: Study 1100: First Line Recurrent and/or Metastatic HNSCC in Combination With Anti-PD-1
Study 1100: First Line Recurrent and/or Metastatic HNSCC in Combination With Anti-PD-1 TREATMENT Number of lesions ICI Naive (N=33) Anti-PD-1 naïve patients Missing 4 RT-activated NBTXR3 in combination with anti-PD-1 n 29 ENDPOINTS 1 10 (34.5) Evaluate the safety, feasibility, and anti-tumor respons
Slide 29: Best Change in Diameter Sum From Baseline and RECIST Response
Best Change in Diameter Sum From Baseline and RECIST Response ASCO 2024: ICI naïve, evaluable patients (N=25) Systemic Control in anti-PD-1 naïve patients with high disease burden (24% of patients have 4+ lesions; 66% have 2+ lesions) Cut-off date: April 17, 2024 29
Slide 30: Progression Free Survival (PFS) and Overall Survival (OS)
Progression Free Survival (PFS) and Overall Survival (OS) ASCO 2024: All treated R/M HNSCC ICI naïve patients PFS from NBTXR3 injection OS from NBTXR3 injection All treated population (N=33) All treated population (N=32*) Overall Survival (OS) from NBTXR3 injection Progression Free Survival (PFS) fr
Slide 31: Study 1100: Second Line Treatment in Recurrent and/or Metastatic HNSCC Refractory to Anti-PD-1
Study 1100: Second Line Treatment in Recurrent and/or Metastatic HNSCC Refractory to Anti-PD-1 TREATMENT Number of lesions ICI Resistant (N=35) Anti-PD-1 resistant patients Missing 1 RT-activated NBTXR3 in combination with anti-PD-1 34 n 1 7 (20.6) ENDPOINTS Evaluate the safety, feasibility, and ant
Slide 32: Best Change in Diameter Sum From Baseline and Study Duration
Best Change in Diameter Sum From Baseline and Study Duration ASCO 2024: ICI resistant, evaluable patients (N=25) • 83% of ICI resistant patients entered Study 1100 after having been recorded in progression in their last treatment line • 17% have unknown status before entering the study, but supposed
Slide 33: Progression Free Survival (PFS), Overall Survival (OS) and OS2
Progression Free Survival (PFS), Overall Survival (OS) and OS2 ASCO 2024: All treated R/M HNSCC resistant patients PFS from NBTXR3 injection OS from NBTXR3 injection All treated population (N=35) All treated population (N=35) Progression Free Survival (PFS) from NBTXR3 injection Overall Survival (OS
Slide 34: Moving to Broad Adoption Through Treatment of Lung Cancers
Addressing one of the Largest Untapped Markets in Oncology With Johnson & Johnson Moving to Broad Adoption Through Treatment of Lung Cancers 34
Slide 35: NBTXR3 Could Benefit Unresectable LA-NSCLC Patients in the Near Term
NBTXR3 Could Benefit Unresectable LA-NSCLC Patients in the Near Term And could potentially reach a significant proportion of NSCLC in the long term based on its agnostic MoA Local or locally advanced at diagnosis: 40% (~200,000) EU5 & US Metastatic at diagnosis: 60% (~290,000) EU5 & US Early stage o
Slide 36: Leading the Market Through Expansion Across Solid Tumor Indications
Addressing one of the Largest Untapped Markets in Oncology With Johnson & Johnson Leading the Market Through Expansion Across Solid Tumor Indications
Slide 37: RT-NBTXR3 Offers Multi-Billion $ Potential
RT-NBTXR3 Offers Multi-Billion $ Potential First two indications alone offer potential path to registration and address over 100,000 patients, and much more in ROW Average pricing for innovative oncology drugs ranges from $100,000-$200,000* NBTXR3: Addressable Patient Stage North America EU5 ROW Pop
Slide 38: Multiple Potential Value Inflection Points with NBTXR3 and Janssen in the Next 2-3 Years
Multiple Potential Value Inflection Points with NBTXR3 and Janssen* in the Next 2-3 Years** For Financial Sustainability and Long-Term Growth First indication to market • LPI and • FDA regulatory Locally advanced H&N interim • EU regulatory • Sales readout • Asia regulatory Expansion into lung cance
Slide 39: Multiple Potential Value Inflection Points Expected Within 12-24 Months
Multiple Potential Value Inflection Points Expected Within 12-24 Months* NBTXR3 (license agreement with Janssen**) Addressing one of the Largest Untapped Markets in Oncology Locally advanced head and neck squamous cell carcinoma H&N LA ineligible to Cis, Phase 3 (Jansen Sponsored trial/transfer in p
Slide 40: Financial Summary
Financial Summary (Amounts in thousands of euros, except per share numbers) • Cash* as of September 30, 2024: €53.2M For the half-year period ended June 30, 2024 • Cash runway extends into Q4 2025 2024 2023 • November 2023 equity raise gross proceeds €55.5M ($58.7M) Revenue and other income • Princi
Slide 41: Pathway to Sustainability and Growth
Pathway to Sustainability and Growth 2-3 year path to reach financial sustainability and growth Addressing one of the Largest Untapped Markets in Oncology Beyond NBTXR3 : Developing new With Janssen1 First in Class Products With Curadigm First in Class Radioenhancer NBTXR3 (JNJ-1900) Platform $2.7B+
Slide 42: Abbreviations
Abbreviations NANOBIOTIX
Slide 43: Principal abbreviations used in the presentation
Principal abbreviations used in the presentation ACCI: Age-adjusted Charlson Comorbidity Index CNS: Central nervous sytem CRR: Complete response rate CT: Chemotherapy HNSCC (also abbreviated H&N): head and neck squamous cell carcinoma ICI: Immune checkpoint inhibitor IO: Immuno-oncology (therapy) IT