Nanobiotix SA · EURONEXT:NANO
Nanobiotix SA — Investor Presentation (May 2020)
49 slides from Nanobiotix SA's investor presentation, May 2020
Slide 1: Corporate Presentation May 2020
CORPORATE PRESENTATION May 20
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND DISCLAIMER IMPORTANT: You must read the following before continuing. In accessing this document, you agree to be bound by the following terms and conditions. References herein to this presentation (this “Presentation”) shall mean and include this document, the oral presentation
Slide 3: Our vision: bringing nanophysics to the heart of the cell
Our vision is to change the face of treatment for millions of patients by bringing nanophysics to the heart of the cell CORPORATE PRESENTATION May 20
Slide 4: Nanobiotix at a Glance
NANOBIOTIX AT A GLANCE NBTXR3 is a radioenhancer with the potential to improve outcomes for millions of oncology patients Disruptive technology with universal, physical MoA 15 clinical trials (H&N, lung, liver, pancreas, prostate, etc.) Clinical proof of concept established in a randomized PIII tria
Slide 5: Millions of patients receive radiotherapy but still have unmet needs
THE UNMET NEED Millions of patients receive radiotherapy each year but still have significant unmet medical needs CORPORATE PRESENTATION THE UNMET NEED May 20
Slide 6: Radiotherapy is the most common treatment: 18M new patients per year
THE UNMET NEED Is the most Common treatment… RECEIVING RTx NUMBER OF PATIENTS W/ RTX 87% Breast cancer 1,800,000 77% Lung cancer 1,600,000 60% 74% H&N 700,000 18M RTx 58% Prostate 60% Rectum 740,000 420,000 new patients per year 49% Pancreas 225,000 80% CNS 237,000 CORPORATE PRESENTATION THE UNMET N
Slide 7: But radiotherapy still presents significant unmet needs
THE UNMET NEED ...But still presents significant Inadequate local control (Local invasion or systemic expansion) 60% Inadequate systemic control (metastatic patients) 18M RTx new patients Unfavorable safety profile per year (dose de-escalation/re-irradiation) CORPORATE PRESENTATION THE UNMET NEED Ma
Slide 8: NBTXR3: first-in-class radioenhancer
FIRST-IN-CLASS RADIOENHANCER NBTXR3 is a first-in-class, universal solution to transform radiotherapy into nanoradiotherapy CORPORATE PRESENTATION FIRST-IN-CLASS RADIOENHANCER NBTXR3 May 20
Slide 9: First-in-class radioenhancer
FIRST-IN-CLASS RADIOENHANCER First-in-class radioenhancer Aqueous suspension of inorganic crystalline hafnium oxide (HfO2) nanoparticles Nanosized to enter the cell and designed to strongly absorb ionizing radiation Universal mode of action targeting all solid tumors Demonstrated clinical benefit in
Slide 10: Hyper-focused dose delivery in the heart of the cell
FIRST-IN-CLASS RADIOENHANCER Creates Hyper-focused dose Delivery in the heart of the cell Dose Dose Usual dose Dose* around delivered in the cell nanoparticles Radiotherapy Radiotherapy with NBTXR3 Usual dose delivered in the cell Clusters of XRay XRay Nanoparticles Local absorption 2 µm of energy *
Slide 11: NBTXR3's physical, universal mode of action
FIRST-IN-CLASS RADIOENHANCER NBTXR3’s PHYSICAL, UNIVERSAL MOA triggers cellular destruction along with adaptative immune response Physical damage inducing Direct Cell Death Structural Damage (Apoptosis, Necrosis, …) DNA damage Stress Immunogenic Cell Death Cell Killing by Sting pathway activation CD
Slide 12: Global Development Strategy
GLOBAL DEVELOPMENT STRATEGY Nanobiotix will develop NBTXR3 across tumor indications with radiation alone and in combination with other therapies CORPORATE PRESENTATION Global Development Strategy May 20
Slide 13: Global development strategy
global development strategy Product with Physical and Universal Mode of Action Transferability across solid tumors Front line treatment & metastatic treatment Clinical PoC demonstrated in Soft Tissue Sarcoma Phase II/III CE Marking obtained New mode of action validated in randomized trial Primary en
Slide 14: Global development strategy
global development strategy CORPORATE PRESENTATION GLOBAL DEVELOPMENT STRATEGY May 20
Slide 15: Positive Phase II/III results in Soft Tissue Sarcoma
Positive Phase II/III results in Soft Tissue Sarcoma (THE LANCET ONCOLOGY, August 2019) CORPORATE PRESENTATION Global Development Strategy May 20
Slide 16: Proof of concept: high risk tumor
PROOF OF CONCEPT High risk tumor Borderline unresectable tumor or unfeasible carcinological surgical resection Preoperative radiotherapy alone is Standard of Care CORPORATE PRESENTATION GLOBAL DEVELOPMENT STRATEGY May 20
Slide 17: Phase II/III randomized study design in STS
PROOF OF CONCEPT Phase II/III randomized, multi-center, open-label and active controlled two arms study Soft Tissue sarcoma (STS) of Primary endpoint: the extremity and trunk wall • Pathological complete response rate# (pCRR) ▪ Age ≥ 18 years-old following EORTC Guidelines(1) Arm A ▪ Locally advance
Slide 18: Primary endpoint met: pathological complete response
PROOF OF CONCEPT Primary endpoint met Pathological Complete Response 20, p-value 0.0448* NBTXR3 activated by radiotherapy (N=87) 16,1 Radiotherapy alone (N=89) 15, % of patients with pCR X2 10, 7,9 5, 0, Complete Pathological Response 180 patients / RTx vs RTx+NBTXR3 *pCRR = Pathological Complete Re
Slide 19: Safety and impact on standard of care in STS
PROOF OF CONCEPT NBTXR3 impact on the Safety – Phase II/III in STS standard of care (planned Arm A NBTXR3 Arm B RT alone radiation and surgery) activated by RT (N=90) (N=89) No change in Median Relative Radiation therapy dose intensity* Patients with any TEAEa 87 (97.8%) 87 (96.7%) No change in Medi
Slide 20: Focusing on head and neck to show survival and quality of life improvement
Focusing on to show improvement in Overall Survival and Quality of Life (ASCO/ASTRO 2019) CORPORATE PRESENTATION Global Development Strategy May 20
Slide 21: Locally advanced head and neck cancer in elderly and frail patients
Head & NECK CANCER Locally-advanced Head and Neck cancer in elderly and frail patients Stage III and IV >70 years old, frail Oral cavity, Oropharynx HPV all status (positive & negative) Ineligible for chemotherapy and intolerant to cetuximab in combination with RT CORPORATE PRESENTATION GLOBAL DEVEL
Slide 22: Head and neck Phase I study design
Head & NECK CANCER PATIENT POPULATION 3 + 3 Design to assess 4 dose levels ENDPOINTS ▪ ≥ 65 years-old ▪ Assess DLTs, RP2D, ▪ KPS > 70 MTD if possible ▪ Stage III or IV HNSCC* of the oral Injected volume calculated as a % of tumor ▪ Safety and tolerability cavity or oropharynx volume determined on an
Slide 23: Literature data for head and neck
Head & NECK CANCER Amini et al. Bourhis et al. Moye et al. Literature data: 2016 2006 2015 NBTXR3 Phase I/II Study Population has a poor Overall Survival prognostic Stage III and IV Median OS at 12-13 months NBTXR3 PI/II patients should have equal or poorer prognosis Tumor location (Oropharynx & Ora
Slide 24: Depth of best response
Head & NECK CANCER Depth of best response* (update MHNCS 2020) 9 CR, ~70% response rate at dose levels ≥ 10% CR linked to QoL CORPORATE PRESENTATION GLOBAL DEVELOPMENT STRATEGY May 20
Slide 25: Target lesion response and median OS from literature
Target lesion response by recist 1.1/MRI – All patients Median OS from literature Subtherapeutic dose Data from Real World Evidence, presented at MHNCS 2020 demonstrateD a median PFS* of 7,3 months for patients receiving radiotherapy or radiotherapy and Cetuximab *defined as “change in N or M stangi
Slide 26: NBTXR3 expected value in head and neck cancer
Head & NECK CANCER NBTXR3 expected value in Head and Neck cancer (ICHNO/ASCO 2019) No SAEs related to NBTXR3/ well tolerated 100% of disease control at all doses* Potential impact on QoL for patients 9/11 CR at higher doses* (10%, 15%, 22%) OS Median follow up of >20 months* Potential impact on Surv
Slide 27: Randomized Phase III trial in an advanced population
US/EU Head & neck STUDY DESIGN Randomized Phase III trial in an advanced population A NBTXR3 + RT ± Cetuximab (250 pts) Endpoints Investigator’s choice • Primary: PFS R • Radiotherapy alone • Secondary: OS, ORR, AEs, QoL 1:1 B • Radiotherapy + Cetuximab RT (trial powered to demonstrate a significant
Slide 28: Strong Phase I results (ASCO-GI 2020)
strong phase I results (ASCO-GI 2020) CORPORATE PRESENTATION Global Development Strategy May 20
Slide 29: Hepatocellular Carcinoma and Liver Mets
HCC & LIVER METS Hepatocellular Carcinoma (HCC) & Liver Mets Hard to treat patient population: Previous resection/local treatment is permitted Hepatocellular carcinoma or Liver Mets Unrespectable/Medically Inoperable tumors ECOG 0 or 1 CORPORATE PRESENTATION GLOBAL DEVELOPMENT STRATEGY May 20
Slide 30: Phase 1 dose escalation study design
HCC & LIVER METS Material/Methods: Study design: Phase 1 dose escalation PATIENT POPULATION 3 + 3 Design to assess 5 dose levels ▪ ≥ 18 years-old ENDPOINTS ▪ ECOG 0 or 1 ▪ Assess DLTs, RP2D, MTD ▪ Hepatocellular Carcinoma (HCC) patients ▪ Safety and tolerability Injected volume calculated as a % of
Slide 31: HCC: follow up of patients, PFS, survival
HCC & LIVER METS HCC: Follow up of patients, PFS, Survival Oral presentation at ASCO-GI 2020 Dose Evaluable Patients Complete Response Partial Response Level n n, (%) n, (%) ALL 8 5 (62.5) 3 (37.5) Patients are recruited at different time points during the trial, those receiving the highest doses ar
Slide 32: Liver mets: follow up of patients, PFS, survival
HCC & LIVER METS Liver mets: Follow up of patients, PFS, Survival Oral presentation at ASCO-GI 2020 Dose Evaluable Patients Partial Response Stable Disease Level n n, (%) n, (%) ALL 7 5 (71,4) 1 (14.3) Patients are recruited at different time points during the trial, those receiving the highest dose
Slide 33: Expanding to prime an immune response and combine with checkpoint inhibitors
EXPANDING to prime an immune response and combine with checkpoint inhibitors CORPORATE PRESENTATION May 20
Slide 34: NBTXR3 plus checkpoint inhibitors: cold to hot tumors
NBTXR3 + Checkpoint inhibitors Hot Cold Hot CD8 Cold No infiltration Limited infiltration Massive infiltration of immune cell of immune cell of immune cell Adapted from Alexandrov et al. (2013) and Gentles et al. (2015) CORPORATE PRESENTATION GLOBAL DEVELOPMENT STRATEGY May 20
Slide 35: Nivolumab Checkmate 141 in recurrent head and neck
NBTXR3 + Checkpoint inhibitors Example: Immunotherapy Nivolumab: Checkmate 141 Nivolumab Recurrent Head and Neck in recurrent patients H&N Non-responder Responder CORPORATE PRESENTATION GLOBAL DEVELOPMENT STRATEGY May 20
Slide 36: Phase I/II in NSCLC and H&N with PD-1 inhibitors
NBTXR3 + Checkpoint inhibitors Phase I/II in NSCLC & H&N to be initiated in combination with PD-1 Inhibitors Checkpoint inhibitors refractory patients in NSCLC & H&N Nivolumab: Checkmate 141 Recurrent Head and Neck Transform the non-responders Non-responder into responders with NBTXR3 and RTx Respon
Slide 37: Phase I dose escalation cohorts
NBTXR3 + Checkpoint inhibitors Phase I Dose Escalation COHORT 1: anti PD-1 non responders Locoregionally recurrent AND metastatic (pembrolizumab or nivolumab): SD for at least 12 weeks or confirmed PD at 12 HNSCC weeks COHORT 2: Patients with lung metastasis Any primary tumor COHORT 3: Patients with
Slide 38: NBTXR3 increases activated CD8 tumor infiltration
NBTXR3 + Checkpoint inhibitors NBTXR3 increases RTx + NBTXR3 activated CD8 Biopsy Baseline Pre Treatment Tumor Tissue Post Treatment tumor infiltration Phase III Soft Tissue Sarcoma RTx Alone biomarker data Biopsy Baseline Pre Treatment Tumor Tissue Post Treatment PD-1 log2 ≥1 log2 ≥1 6/26 (23%) 11/
Slide 39: Across the oncology treatment paradigm with MD Anderson
ACROSS the oncology treatment paradigm WITH MD ANDERSON CORPORATE PRESENTATION May 20
Slide 40: Expanding across oncology with MD Anderson: 9 clinical trials planned
SUMMARY Phase II Trial of reirradiation with NBTXR3 Expanding across oncology combined with anti-PD-1/L1 for inoperable, locally advanced HN cancer with MD Anderson: 9 clinical trials planned Phase II Trial for NBTXR3 for recurrent/metastatic HNSCC patients with limited PD-L1 expression Clinical col
Slide 41: NBTXR3 has the potential to help millions of patients
SUMMARY NBTXR3 has the potential to help millions of patients each year across the standard of care CORPORATE PRESENTATION SUMMARY May 20
Slide 42: Summary
SUMMARY NBTXR3 is a radioenhancer with the potential to improve outcomes for millions of oncology patients Disruptive technology with universal, physical MoA 15 clinical trials (H&N, lung, liver, pancreas, prostate, etc.) Clinical proof of concept established in a randomized PIII trial in STS (featu
Slide 43: Summary
Summary CORPORATE PRESENTATION GLOBAL DEVELOPMENT STRATEGY May 20
Slide 44: Next Steps
44 NExT STEPS* Feedback from FDA for the phase III design in the coming weeks Phase I expansion first data on efficacy and safety to be presented at ASCO 2020 (End of May 2020) Completion of Phase I expansion First data in IO trial to be reported in the coming months at first possible conference (AS
Slide 45: Financials, shareholding structure and analyst coverage
45 SUMMARY 2019 2018 FINANCIALS In K€ SHAREHOLDING STRUCTURE AS OF APRIL 2019 Total revenue and other income 2,541 3,479 Institutional Investors Family offices Sales 68 116 Management & employees Service 40 109 Retail Other sales 28 7 33,00% Licences - - 22,731,122 Other revenues 2,473 3,363 shares
Slide 46: Contact
contact@nanobiotix.com investors@nanobiotix.com
Slide 47: Appendix
CORPORATE PRESENTATION appendix May 20
Slide 48: Nanobiotix Publications
Appendix Nanobiotix Publications • Mariagrazia Di Marco et al., International Journal of Nanomedicine, 2010, "Overview of the main methods used to combine proteins with nanosystems: absorption, bioconjugation, and encapsulation" • Virginie Simon et al., Photochemistry and Photobiology, 2010, "Pp IX
Slide 49: NBTXR3 abscopal assay: local and distant control
Appendix NBTXR3 – abscopal assay – local and distant control 2 independent experiments 12-14 mice per group SITC 2017 Annual Meeting, November 8-12, 2017, National Harbor, Maryland, USA CORPORATE PRESENTATION APPENDIX May 20