Nanobiotix Sa · EURONEXT:NANO
Nanobiotix Sa — Investor Presentation (June 2023)
36 slides from Nanobiotix Sa's investor presentation, Jun 9, 2023
Slide 1: Corporate Presentation
CORPORATE PRESENTATION June 2023 Developing disruptive physics-based nanotherapeutics to treat locally advanced and metastatic cancers
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: Applying universal properties of physics to develop nanotherapeutics
NANOBIOTIX: Applying universal properties of physics to develop nanotherapeutics targeting the biological complexities of disease NBTXR3 is a first-in-class radioenhancer with paradigm breaking potential and proven MOA in randomized Ph 3 trial Focused and Differentiated Pipeline Physics-based mechan
Slide 4: Evaluating tumor agnostic, combination agnostic potential of NBTXR3 in solid tumors
Evaluating tumor agnostic, combination agnostic potential of NBTXR3 in solid tumors with an initial focus in HNSCC Pipeline-in-a-product strategy Expected Indication Trial Name Approach Phase 1 Phase 2 Phase 3 Milestones Interim Ph 3 data NANORAY-312 NBTXR3-RT* ± cetuximab 2H 2024 Head and Neck Loca
Slide 5: NBTXR3: The universal radioenhancer for solid tumors
NBTXR3: The universal radioenhancer for solid tumors Suspension of metabolically inert nano-sized particles for intratumoral injection Hafnium oxide CORE NEGATIVELY charged coating Negative surface charge for High atomic number (72) Nanometer scale stability at neutral pH in and high e- density to f
Slide 6: 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 7: Local cell destruction induced by NBTXR3 activates immune priming
Local cell destruction induced by NBTXR3 activates immune priming Local and systemic benefits through cell death and immune activation against tumor antigens LOCAL TUMOR CONTROL: PHYSICAL DESTRUCTION OF CANCER CELLS Lesion Size Direct Cell Death Decrease (apoptosis, necrosis) AndNBTXR3 triggers syst
Slide 8: NBTXR3: Key value drivers of clinical differentiation
NBTXR3: Key value drivers of clinical differentiation Designed to disrupt outcomes without disrupting clinical practice Single One-time intratumoral administration Treatment Significantly enhances therapeutic index of radiotherapy Easily Activated by any form of radiotherapy using standard equipment
Slide 9: Proprietary commercial manufacturing capability and robust IP
Proprietary commercial manufacturing capability and robust IP Composition, quality, and performance are highly dependent on the manufacturing processes In-house, GMP compliant, scalable drug substance manufacturing established in 2017 Built to scale, validated process with ability to accommodate com
Slide 10: Focusing on late-stage development opportunities in head and neck cancer
Focusing on late-stage development opportunities in head and neck cancer Based on Phase 1 proof-of-concept studies NBTRXR3-RT is well-positioned for two Phase 3 registrational opportunities Phase 3 Registrational Pathway Phase 1 Advanced Locally NANORAY-312 Study 102 Dose Escalation RP2D Dose Expans
Slide 11: Potential $4.5B HNSCC market despite significant disease-related limitations
Potential $4.5B HNSCC market1 despite significant disease-related limitations Among the deadliest malignant tumors, with ~700,000 new patients diagnosed per year and a 5-year survival rate of roughly 50%2 Radiation therapy ± Erbitux pembrolizumab and nivolumab chemotherapy (cetuximab) generally used
Slide 12: Study 102
Study 102: Phase 1 dose escalation and dose expansion evaluation of NBTXR3-RT* in locally advanced head and neck cancers Key Inclusion Criteria Endpoints Diagnosed with Locally Advanced Head and Neck Primary for Dose Escalation: Squamous Cell Carcinoma • Incidence of DLTs Cetuximab Ineligible • Dete
Slide 13: 85% of patients achieved a response to NBTXR3-RT
85% of patients achieved a response to NBTXR3-RT* as per Investigator Assessment Median follow up of 9.5 months 63% achieved a Complete Response** Dose expansion N= 41 evaluable patients *NBTXR3-RT: NBTXR3 activated by radiotherapy **Study 102 ASTRO 2021; Data cut-off date: September 2021 13
Slide 14: High response rate correlates with improved OS and PFS
High response rate correlates with improved OS and PFS ASTRO 21 update, September 2021 Data Cut-off Median OS: 18.1 months Median PFS: 10.6 months Evaluable population (n=41) Evaluable population (n=41) v v t rs Ce n s o re All patients treated (n=54) at 14.1 months All patients treated (n=54) at 9.
Slide 15: Continued increase in mOS
Continued increase in mOS Cut-off date 22 Feb 2022 Median OS: 23.0 months Median OS: 17.9 months Evaluable Population, n=44 All Patients Treated, n=56 Product-Limit Survival Estimate Product-Limit Survival Estimate With Number of Subjects at Risk With Number of Subjects at Risk 1.00 Censored 1.00 Ce
Slide 16: NBTXR3 demonstrated curative potential
NBTXR3 demonstrated curative potential Provides strong clinical rationale for pursuing registration Complete Response and >55 months survival after treatment with NBTXR3 + RT Post IT injection Post radiotherapy 7 months after RT CT scan presented at MHNCS 2020 16
Slide 17: Moving from successful Phase 1 to Phase 3 registration trial
Moving from successful Phase 1 to Phase 3 registration trial Study 102 supports global randomized NANORAY-312 Phase 3 trial Study 102: Cetuximab Ineligible NANORAY-312: Cetuximab Eligible Phase 1 escalation and expansion Global randomized Phase 3 (75 patients): (~500 patients): • Feasible • Target p
Slide 18: NANORAY-312: Global Phase 3 registration trial locally advanced HNSCC
NANORAY-312: Global Phase 3 registration trial locally advanced HNSCC Designed to provide robust evidence for survival superiority NBTXR3 dosed at 33% of the Key Inclusion Criteria Gross Tumor Volume A A ≥65 Statistics Endpoints N=500, NBTXR3 + RT Expected mPFS in control arm: Eligible for definitiv
Slide 19: The promise and limitations of immuno-oncology agents
The promise and limitations of immuno-oncology agents IO has been practice changing and life ...but continues to leave many patients out in c w c c … “c d” KEYNOTE-177 in mMSI-H/dMMR CRC1 KEYNOTE-048 in R/M HNSCC2 Pembrolizumab Chemotherapy HR 0.6, 95% CI, 0.45-0.80), P=0.0002 Pembrolizumab alone Ce
Slide 20: Study 1100: Dose escalation
Study 1100: Dose escalation Phase 1 evaluation of NBTXR3-RT* ± immune checkpoint inhibitors for recurrent and/or metastatic HNSCC Key Inclusion Criteria Anti-PD-1 Naïve; or LRR or R/M HNSCC 35Gy will be delivered in 5 Endpoints Anti-PD-1 Resistant: fractions of 7Gy Dose escalation cohorts: Primary:
Slide 21: Assessing change in target & non-target lesions
Assessing change in target & non-target lesions SITC 2022: Anti-PD-1 resistant patient case study Target Lesion PR in injected and irradiated tumor Patient progressing at enrollment after ~ 1-year anti-PD-1 treatment Local control (PR) achieved in target lesion in anti-PD-1 resistant patient Distant
Slide 22: Lesion/s reduction observed in naive and anti-PD-1 patients
Lesion/s reduction observed in naïve and anti-PD-1 patients SITC 2022: All target lesions Objective reduction in target lesion/s from baseline was observed in: • 71.43 % of evaluable patients (15/21) • 67.00 % of anti-PD-1 resistant (10/15) • 83.00 % of anti-PD-1 naïve (5/6) 22
Slide 23: Objective reductions with long-term control in both naive & resistant patients
Objective reductions with long-term control in both anti-PD-1 naïve & resistant patients SITC 2022: All target lesions Objective reduction in target lesion/s resulted in long term control in both naive and resistant lesions- regardless of site of injection 8 patients with > 6 months disease control
Slide 24: % Change from baseline over time: injected lesion vs all target lesions
% Change from baseline over time: injected lesion vs all target lesion/s SITC 2022: All target lesions Local control in injected lesions occurred in all patients and remained in all patients except 1 In 8/21 patients this resulted in disease control of 6 months or longer 24
Slide 25: Study 1100: Dose expansion
Study 1100: Dose expansion Phase 1 evaluation of NBTXR3-RT* ± immune checkpoint inhibitors for recurrent and/or metastatic HNSCC Key Inclusion Criteria Anti-PD-1 Resistant Endpoints #1 LRR or R/M HNSCC with lesion H/N area or in lung or liver, LRR or R/M HNSCC (35 pts) Primary: Further assess the sa
Slide 26: Study 1100 POC forms basis for 2nd potential HNSCC registration study
Study 1100 POC forms basis for 2nd potential HNSCC registration study NBTXR3-RT* + anti-PD-1 inhibitor for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) Study 1100: Anti-PD-1 naïve & refractory Planned registration pathway: in advanced solid tumors Anti-PD-1 refractor
Slide 27: Leveraging strategic collaborations to advance and expand NBTXR3 opportunity
Leveraging strategic collaborations to advance and expand NBTXR3 opportunity with optimal efficiency Develop and commercialize NBTXR3 across tumor types and therapeutic combinations in Greater China, South Korea, Singapore and Thailand • Development commitment includes 5 registration studies Advance
Slide 28: Financial Summary and Key Message Points
Financial Summary and Key Message Points (Amounts in thousands of euros, except per share numbers) For the full-year period ended Dec 31, 2022 • Cash* as of Dec , : €41.4M 2022 2021 • Equity line financing line provides flexible access to capital Revenue and other income • Accessible capital resourc
Slide 29: Multiple Potential Value Inflection Points Expected in the Next 12-24 Months
Multiple Potential Value Inflection Points Expected in the Next 12-24 Months 2023 2024 Indication Trial Name Approach 1H 2H 1H 2H NANORAY-312 Head and Futility analysis Interim Ph 3 data NBTXR3-RT* ± cetuximab Neck Locally Study 102 Advanced Final Ph 1 data NBTXR3-RT* TBD FDA Head and protocol Neck
Slide 30: Developing first-in-class nanotherapeutic with potential to become integral part of cancer therapy
Developing first-in-class nanotherapeutic with the potential to become integral part of cancer therapy Opportunity to improve outcomes for patients with locally advanced & recurrent/metastatic disease Robust preclinical and clinical datasets supporting consistent clinical effect of NBTXR3 to Strong
Slide 31: Appendix
Appendix 31
Slide 32: Proof-of-concept established in randomized PII/III and CE mark in soft tissue sarcoma
Proof-of-concept established in randomized PII/III, and European marketing authorization (CE mark) secured in tough to treat soft tissue sarcoma population Doubling of Pathological Complete Response in Phase II/III Results Pathological Complete Response Rate • Achieved its primary endpoint of pathol
Slide 33: Study 102: High response rates evidence of improved local control
Study 102: High response rates evidence of improved local control in elderly, tough to treat LA-HNSCC Overall Objective Response Rate of 63.4% NBTXR3 85.4%** 22% All Evaluable Patients (n=41) 14.6% Elderly patients (70) ineligible for cisplatin, 66.7% NBTXR3 33.3% intolerant to OPSCC HPV- (n=12) cet
Slide 34: Local and systemic response regardless of prior anti-PD-1 exposure
Local and systemic response regardless of prior anti-PD-1 exposure SITC 2022 % of NBTXR3 Treated Patients Who Experienced Tumor Reductions All (n=21) 95%(20/21) Anti-PD-1 + RT 43% (9/21) + NBTXR3 100% (6/6) Anti-PD-1 Naïve (n=6) 67%(4/6) 93%(14/15) Anti-PD-1 Non-Responders (n=15) 33% (5/15) Anti-PD-
Slide 35: Objective reduction target lesion/s in previously progressing patients
Objective reduction target lesion/s in previously progressing patients SITC 2022: All target lesions Out of the 15 evaluable anti-PD-1 resistant patients, 87% (13) had progressive disease when entering the study: • 31% (4/13) had a measurable reduction of at least 30% or more • 15% (2/13) experience
Slide 36: Focusing on HNSCC: 16 of 21 evaluable patients with primary HNSCC
Focusing on HNSCC: 16 of 21 evaluable patients with primary HNSCC SITC 2022: All target lesions Objective reduction from baseline in target lesion was observed in • 75% patients with primary HNSCC: • 70% patients with primary HNSCC resistant to anti-PD-1 • 83.33% patients with primary HNSCC naïve to