Nanobiotix Sa · EURONEXT:NANO
Nanobiotix Sa — Investor Presentation (December 2020)
41 slides from Nanobiotix Sa's investor presentation, Dec 1, 2020
Slide 1: Corporate Presentation
CORPORATE PRESENTATION 1 DECEMBER 2020
Slide 2: Important: You must read the following before continuing
IMPORTANT: You must read the following before continuing. In accessing this document, you agree to be bound by the following terms and conditions. The Presentation is not, and should not be construed as, an offer of any securities or the solicitation of an offer to subscribe for or purchase any secu
Slide 3: Our vision: 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. DECEMBER 2020
Slide 4: Potential First-in-class Oncology Product
Potential First-in-class Oncology Product With Potential To Address More Than 10M Patients Who Are 1 Candidates For Radiotherapy Established Human Proof-of-concept As A Single Agent In Soft Tissue Sarcoma Randomized Phase III 2 Trial, And Positive Preliminary Data In Advanced Head and Neck And Liver
Slide 5: The Unmet Need
THE UNMET NEED Millions of patients receive radiotherapy each year but still have significant unmet medical needs. DECEMBER 2020
Slide 6: 18M RTx new patients per year
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 diagnosed 80% CNS 237,000 with cancer worldwide … … DECEMBER 2020 Source: * World Health Organi
Slide 7: Inadequate local and systemic control
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) diagnosed with cancer worldwide DECEMBER 2020 Source: * World Health Organization (2014);
Slide 8: Potential First-in-class Radioenhancer
POTENTIAL FIRST-IN-CLASS RADIOENHANCER NBTXR3 is a potential first-in-class, universal solution to transform radiotherapy into nanoradiotherapy. DECEMBER 2020
Slide 9: Potential First-in-class Radioenhancer
• Potential 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 DECEMBER 2020
Slide 10: Radiotherapy vs Radiotherapy with NBTXR3
Dose Dose dose* around nanoparticles Usual dose delivered Radiotherapy in the cell Radiotherapy with NBTXR3 Usual dose delivered in the cell Clusters of XRay XRay Nanoparticles Local absorption 2 µm of energy *Dose enhancement determined by Monte Carlo simulation (CEA Saclay, France). *Note: Dose en
Slide 11: Local control mechanism of NBTXR3
11 Local control IRRADIATED lesion Injected lesion Direct cell death NBTXR3 X-Rays (apoptosis, necrosis) Potential for Local and Systemic Control Maggiorella et al. Future Oncol. 2012;8(9):1167-1181; Thariat et al. Int J Radiat Oncol Biol Phys. 2019;105(1S):E651. Abs 3513.; Marill et al. Radiother O
Slide 12: Development Overview NBTXR3
INDICATION* IND PHASE I PHASE II PHASE III Soft Tissue Sarcoma of Extremity & Trunk Wall* Head & Neck Locally Advanced Cancer Development Liver Overview Hepatocellular Cancer & Liver Metastases Prostate Adenocarcinoma NBTXR3 Pancreas activated by Locally Advanced or Borderline Resectable RT alone NS
Slide 13: Clinical proof of concept in soft tissue sarcoma
INDICATION* IND PHASE I PHASE II PHASE III Soft Tissue Sarcoma of Extremity & Trunk Wall* Head & Neck Locally Advanced Cancer CLINICAL PROOF OF CONCEPT ESTABLISHED Development Liver IN A RANDOMIZED PHASE II/III TRIAL IN SOFT TISSUE SARCOMA Overview Hepatocellular Cancer & Liver Metastases Prostate N
Slide 14: Head & Neck: positive phase I results
INDICATION* IND PHASE I PHASE II PHASE III Soft Tissue Sarcoma of Extremity & Trunk Wall* Head & Neck Locally Advanced Cancer Development Liver A target population with high unmet needs: frail elderly H&N patients that Hepatocellular Cancer & Overview are ineligible for cisplatin and intolerant to c
Slide 15: H&N phase I dose escalation and expansion
INDICATION* IND PHASE I PHASE II PHASE III Soft Tissue Sarcoma of Extremity & Trunk Wall* Head & Neck Locally Advanced Cancer Development Liver Overview Hepatocellular Cancer & H&N Liver PI: Dose escalation and expansion Metastases Frail elderly patient not eligible for chemo Prostate Adenocarcinoma
Slide 16: Published data: radiotherapy with cisplatin
Summary data from certain published scientific literature relating to head and neck trials evaluating radiotherapy combined with cisplatin. Harrington et al. 2013 Harrington et al. RT + Cisplatin 2013 N=33 RT + Cisplatin N=26µ Median age (years) 57 ECOG (%) Best Observed Target 6 months post 0 (KPS
Slide 17: Published data: radiotherapy with cetuximab
Summary data from certain published scientific literature relating to head and neck cancer trials evaluating radiotherapy combined with cetuximab and induction chemotherapy. E1308 Study E1308 Study IC+IMRT+Cetux IC+IMRT+Cetux N=80§ N=80§ Median age (years) 57 Best Observed Target 3-6 months post ECO
Slide 18: Dose expansion RT + NBTXR3: HPV- OPSCC
102 dose 102 dose expansion 102 dose RT + NBTXR3 expansion expansion N=31 (evaluable) RT + NBTXR3 RT + NBTXR3 HPV- OPSCC N=31 (evaluable) Median age (years) 70.7 (N=7) Best Observed Target 3-6 months post 3-6 months post ECOG (%) Lesion Response (%) EoT EoT 0 (KPS 100) 23 1 (KPS 80-90) 65 2 (KPS 60-
Slide 19: Dose expansion RT + NBTXR3: HPV+ OPSCC
102 dose 102 dose 102 dose expansion expansion expansion RT + NBTXR3 RT + NBTXR3 RT + NBTXR3 N=31 (evaluable) N=31 HPV+ OPSCC (evaluable) (N=7) Median age (years) 70.7 Best Observed Target 3-6 months 3-6 months ECOG Lesion Response (%) post EoT post EoT 0 (KPS 100) 23 1 (KPS 80-90) 65 2 (KPS 60-70)
Slide 20: Development Overview NBTXR3
INDICATION IND PHASE I PHASE II PHASE III Soft Tissue Sarcoma of Extremity & Trunk Wall* Head & Neck Locally Advanced Cancer Development Liver Overview Hepatocellular Cancer & Liver Metastases Prostate Adenocarcinoma NBTXR3 Pancreas activated by Locally Advanced or Borderline Resectable RT alone NSC
Slide 21: HCC and liver metastases phase I
INDICATION* IND PHASE I PHASE II PHASE III Soft Tissue Sarcoma of Extremity & Trunk Wall* Head & Neck Locally Advanced Cancer Development Liver Overview Hepatocellular Cancer & Liver Metastases HCCProstate AND LIVER METASTASES PI: Dose escalation Adenocarcinoma NBTXR3 Pancreas activated by Locally A
Slide 22: Local and systemic effect on non-irradiated lesions
Lesion Size Decrease IRRADIATED lesion Injected lesion Direct cell death (apoptosis, necrosis) X-Rays NBTXR3 Tumor antigen Potential for Dendritic cell NON-IRRADIATED lesion activation Local and Non-Injected Systemic Control CD4 & CD8 Local Effect T cell activation Systemic Effect Maggiorella et al.
Slide 23: Development Overview: Immunotherapy combination
INDICATION IND PHASE I PHASE II PHASE III +IMMUNOTHERAPY CPi Recurrent Head & Neck, Lung or Liver Metastasis Head & Neck Inoperable Locoregional Development Recurrent (Re-Irradiation) Overview Head & Neck R/M with Limited PD-L1 expression or refractory NBXTR3 +Combination with CPi The scientific inf
Slide 24: First clinical data showing conversion of anti-PD-1 non responders
/ eee Tite , | —- & ‘AY POSITIVE! 1 WAR m™s FIRST CLINICAL DATA. SHOWING CONVERSION.OF4 ANTI-PD-i NON RESPONDERS 3) RESPONDERS WITH NBTXR3 NANOBIOTID>—<
Slide 25: HNSCC ORR 13-22%
HNSCC ORR 13-22% Overall Survival Progression Free Survival * Burtness B, et al. “Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study.” Lancet. 2019
Slide 26: Primary resistant, secondary resistant and responders
Primary resistant patients Secondary resistant patients Responders * Burtness B, et al. “Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study.” Lance
Slide 27: Phase I study of NBTXR3 with anti-PD-1
Phase I study of intratumoral NBTXR3 in combination with anti-PD-1 in patients with advanced cancers Colette Shen1, Jessica Frakes2, Jiaxin Niu3, Jared Weiss1, Jimmy Caudell2, Katherine Jameson4, Patricia Said4, Tanguy Seiwert5 1-University of North Carolina School of Medicine, Chapel Hill, North Ca
Slide 28: Study 1100 cohorts
Study 1100: A phase I study of NBTXR3 activated by radiotherapy for patients with advanced cancers treated with an anti-PD-1 therapy. Head and –Neck HNSCC Cohort 1 cancers mets – Cohort 2 Lung Mets Mets – Cohort 3 Liver mets Liver • Inoperable LRR or R/M HNSCC • Cancer metastasized to the lung • Can
Slide 29: Anti-PD-1 naive and resistant participants
Across *ALL* Cohorts – Participants are either anti-PD-1 naïve or anti-PD-1 resistant (primary or secondary) as per SITC guidelines NAÏVE PATIENTS A. Has not received priori anti-PD-1 therapy (i.e. anti-PD-1 naïve), or; RESISTANT TO ANTI-PD-1 PATIENTS (primary and secondary) A. Has received prior an
Slide 30: Adverse events by cohort
Cohort 1 – HNSCC Cohort 2 – Lung mets Cohort 3 – Liver mets n=3 n=4 n=2 Any Grade Grade Grade Grade Any Grade Grade Grade Grade Any Grade Grade Grade Grade Grade 1-2 3 4 5 Grade 1-2 3 4 5 Grade 1-2 3 4 5 All AE 3 3 1 1 1 4 4 2 1 1 2 2 1 0 0 AE related to NBTXR3 or 2 2 1 1 1 0 0 0 0 0 2 2 1 0 0 injec
Slide 31: Study 1100: percent change in lesion over time
Study 1100:Anti-PD-1 Naïve Percent Change Over Time StudyAnti-PD-1 Non-Responder 1100: Percent Change Over Time Overall Response Overall Response 50 50 Change in Lesion (mm), % Change in Lesion (mm), % Progressive Progressive Disease Disease Stable Stable 0 0 Disease Disease -50 Partial -50 Partial
Slide 32: Tumor reduction in non-responder patients
Stage IV NSCLC – non responder Stage IV HNSCC – non responder (011) Stage IV NSCLC – non responder (016) Stage II HNSCC – non responder (008) (005) confirmed unconfirmed unconfirmed * * 1 NR patients had 3/4 NR patients experienced tumor delayed tumor regression reduction in lesions that did not 5-6
Slide 33: For illustration: non-responder outcomes
For illustration: 3/7 non responders have responded. 6/7 has experienced tumor reduction. 3/4 non-injected local and/or distant tumor reductions. 2/2 of potential responders responded. DECEMBER 2020
Slide 34: Two new phase I trials approved by US FDA
TWO NEW PHASE I TRIALS EVALUATING NBTXR3 IN COMBINATION WITH ANTI-PD-1 FOR HEAD & NECK CANCER |S RECEIVE APPROVAL TO m PROCEED FROM US FDA
Slide 35: Development Overview: Chemotherapy combination
INDICATION* IND PHASE I PHASE II PHASE III +CHEMOTHERAPY Esophagus Adenocarcinoma Development Overview NBXTR3 activated by RT +Combination with Chemo *In addition, three NBTXR3 clinical trials are currently being run in Asia by PharmaEngine, Inc. (‘‘PharmaEngine’’). NSCLC = non-small cell lung cance
Slide 36: Expected Newsflow
Expected Newsflow DECEMBER 2020
Slide 37: Newsflow NBTXR3 activated by RT alone
INDICATION* EXPECTED NEWSFLOW Soft Tissue Sarcoma Post-registrational trial in EU: Launch expected in Q2 2021; Commercialization strategy to of Extremity & Trunk Wall* be evaluated based on Study 312 data Phase III: Futility analysis expected 18 months after FPI, interim analysis expected 24-30 Head
Slide 38: Newsflow: combination with CPi
INDICATION* EXPECTED NEWSFLOW Recurrent Head & Neck, Lung or Liver Phase I/II: results update by Q2 2021. Metastasis Head & Neck Inoperable Locoregional MDA Phase II: FPI expected by H1 2021. Recurrent (Re-Irradiation) Newsflow Head & Neck R/M with Limited PD-L1 expression or refractory MDA Phase II
Slide 39: Newsflow: combination with chemo
INDICATION* EXPECTED NEWSFLOW Esophagus Adenocarcinoma MDA Phase I: FPI expected by the end of 2020. Newsflow NBTXR3 activated by RT +Combination with Chemo *In addition, three NBTXR3 clinical trials are currently being run in Asia by PharmaEngine, Inc. (‘‘PharmaEngine’’). The scientific information
Slide 40: Financials
6 months to June 30 FINANCIALS in K€ 2020 2019 Total revenue and other income 1,448 1,823 Share capital breakdown (as of August 2020) based on Operating revenues 37 37 33,337,122 shares Other income 1,411 1,786 Research & Development (R&D) expenses (13,077) (13,380) Selling, General and Administrati
Slide 41: Contact Us
CONTACT US NANOBIOTIX contact@nanobiotix.com