Corporate Presentation
July 2019
Corporate Presentation July 2019 1 IMPORTANT NOTICE AND DISCLAIMER
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Corporate Presentation July 2019 2 Past 12 months
Significant global progresses for the company
Positive and significant Phase II/III in STS, presented at ASTRO & ESMO
CE Marking in STS
Positive clinical data in STS (IO), H&N Cancer, Liver Cancer presented at major congresses
Completion of Phase I dose escalation in Head and Neck cancers
Positive preclinical in IO showing additional potential of the product in combination with Immune Checkpoint Inhibitors
Clinical trial authorization process to begin in 2H2019 with FDA filing
Major collaboration with MD Anderson to launch nine additional clinical trials
EIB loan granted (EUR 40m) with two tranches already borrowed
Successful ISO certification
Fund raising with US & EU new & existing specialized investors(EUR 29,5m)
Corporate Presentation July 2019 3 NANOBIOTIX
Company founded in 2003 Listed on Euronext since 2012 Pioneering Nanomedicine for over 10 years
Developing first-in-class radio enhancer for oncology targeting areas of high unmet needs Demonstrated clinical Proof of Concept in randomized Phase III trial Broad ongoing clinical development in 7 clinical trials (targeting ten indications) in EU, US and Asia Accessing the oncology market with first EU market approval obtained in Soft Tissue Sarcoma
Disruptive technology targeting large unaddressed oncology market
Corporate Presentation July 2019 4 Cancer patients treated with RTx represent significant market opportunity with large unmet medical needs
Inadequate local control (invasion) Inadequate local control Head and Neck, Glioblastoma, Liver (relapse) Pancreatic, Rectum, … Pancreatic, Prostate, Lung, Colorectal, Breast, …
Cancer patients
60% RTx**
Inadequate systemic unfavorable safety profile control (dose de-escalation/re- irradiation) Liver, Lung, Brain, …
Prostate, Head and Neck, Breast, Lung, Brain, Colorectal, …
Corporate Presentation July 2019 Source: * World Health Organization (2014); **RADIATION THERAPY EQUIPMENT – A global strategic business report 08/06 RTx: radiotherapy 5 Nanobiotix targets radiation therapy - one of the largest oncology markets with limited competition
Conventional radiation therapy
Around 60%* of cancer patients TUMOR receive radiotherapy as a local treatment
Destroys any cancer cell at the right dose 50 cm
20 cm 20 cm
Important limitations due to toxicity on 100 photons at 6 MEV 100 photons @ 6 MeV healthy tissues Energy deposition Xray track
How to improve the energy dose within the tumor without damaging healthy tissues?
Corporate Presentation July 2019 Source: * RADIATION THERAPY EQUIPMENT – A global strategic business report 08/2006 6 Our solution: NBTXR3 enhances Xray absorption in the tumor
Technology key features:
1 50nm Nanosized to enter cell
2 Designed to strongly absorb Xrays 3 Designed to be non-toxic HfO2 nanoparticles; electron microscopy picture
50 nanometer HfO2* particles were chosen because they have the best ratio for X-ray absorption and non-toxicity
IP: technology and product candidates protected by 20 patent families until at least 2029
* HfO2: Hafnium Oxide Corporate Presentation July 2019 Source: Maggiorella et al. (2012) 7 NBTXR3 has a physical mode of action: Leveraging NanoPhysics to fight cancer
Radiotherapy Radiotherapy with NBTXR3
Dose Dose
9X Dose* around Usual dose nanoparticles delivered in the cell Usual dose delivered in the cell
XRay XRay Clusters of Nanoparticles
Local 2 µm absorption of energy
Corporate Presentation July 2019 *Note: Dose enhancement determined by montecarlo simulation (CEA Saclay, France) 8 NBTXR3 UNIVERSAL MoA triggering cellular destruction and adaptative immune response
NBTXR3 +RTx
large energy deposition in a nano-volume → physical damage
• Structural Damage Clustered • DNA damage Nanoparticles in cytoplasm • Stress • Immunogenic Cell Death Dendritic cell • Sting pathway activation activation
CD4 & CD8 activation Direct Cell Death (Apoptosis, Necrosis, …) Tumor Infiltration and Cell Killing Corporate Presentation July 2019 9 NBTXR3 First in Class Radioenhancer
Physical Mode of Action that could work across all solid tumors to enhance radiotherapy efficacy
Only one administration
Fits into existing standard of care No change in equipment No change in current patient flow No change in protocol
One product addressing areas of high unmet medical needs
CE Marking obtained in Soft Tissue Sarcoma (commercial name: Hensify®)
Corporate Presentation July 2019 10 A product with solid foundations
Validated & protected product Over 19 patent families across the world Manufacturing demonstrated & certified ISO 13485:2016
Clinical reliability Universal Mechanism of Action (transferability) Proof of Concept demonstrated in a randomized Phase III trial in Soft Tissue Sarcoma Positive initial and promising results in different Phase I/II trials (Head and neck, HCC) NBTXR3 has been well tolerated Large clinical development pipeline with 16 contemplated clinical trials across a broad range of indications
Market acceptance (US & EU) Engaged dialogues with payers across US and EU Preclinical and clinical collaborations with major hospitals, including MD Anderson and Weill Cornell Major clinical collaboration with MD Anderson >400 MDs involved in development Fitting existing standard of care and single intra-tumoral injection
Corporate Presentation July 2019 11 Pipeline
Indication Preclinical PI PII PIII Approval
Soft tissue sarcoma EU / Asia
Head and neck cancer EU (RTx alone)
Head and neck cancer Asia NBTXR3 (RTx + chemo)*
as a Liver metastasis Single Agent EU Hepatocellular carcinoma
Rectal cancer* Asia
Prostate cancer US
Recurrent NBTXR3 Head & Neck US in Lung metastasis Inhibitors IO / Combo Checkpoint
NBTXR3 9 Phase I/II or II to be started in: + H&N, LAPC, esophageal US cancer, NSCLC, Pelvic & LN soft tissue masses
Corporate Presentation July 2019 *Conducted by PharmaEngine 12 First in class product – significant market opportunity to address areas of high unmet medical needs
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 Positive Phase II/III New mode of action validated in randomized trial Primary endpoint: Pathological Complete Response Rate doubled vs radiation alone (p-value = 0.0448) ➔ Target: Start diffusing the product in EU
H&N first indication to be registered in US Positive Phase I data on advanced patients Showing potential impact on OS, ORR, QoL and well tolerated ➔ Target: Demonstrate the medical value in a high unmet medical needs population
Clinical development in PD-1 resistant patients Phase I: IND granted in NSCLC & Head and Neck advanced relapsed patient ➔ Target: Demonstrate the value of NBTXR3 in metastatic disease, transforming cold tumors into hot tumors
Expansion of NBTXR3 usage Five ongoing Phase I/II in multiple solid tumors Nine additional clinical development trials planned with MD Anderson global collaboration
Corporate Presentation July 2019 13 NBTXR3 in Soft Tissue Sarcoma
Corporate Presentation July 2019 14 Soft Tissue Sarcoma: patient population
Soft Tissue Sarcoma of the extremities* and trunk wall
Locally advanced soft tissue sarcoma, newly diagnosed or relapsed tumor:
➔High risk tumor ➔Borderline unresectable tumor or unfeasible carcinological surgical resection
Preoperative radiotherapy alone is used as a Standard of Care in this population
Main advantages (long term): • Lower late morbidity (fibrosis, bone fracture, etc.) • Improved long-term functional outcome • Improved quality of life
Unmet medical need for locally advanced soft tissue sarcoma
Corporate Presentation July 2019 * Arms and legs 15 Soft Tissue Sarcoma: treatment objectives
Ideal patient outcome in preoperative setting
• Removal of tumor • No remaining tumor cells in the body after surgery
Surgically remove (resect) tumor to improve patients’ survival and quality of life
Surgery
Corporate Presentation July 2019 16 Phase II/III Study in Soft Tissue Sarcoma
Flowchart and study design Data presented ASTRO/ESMO 2018 Session of RTx according to standard of care (25 x 2 Gy) Surgery
RTx (89 patients)
End of treatment RTx + NBTXR3 (87 patients) Day 1 One time Surgery Intratumoral injection
▪ 180 patients recruited (> 30 sites) ▪ 176 treated patients / Intended-to-treat population, full analysis set (ITT-FAS) ▪ 4 patients have been excluded from the ITT-FAS (outside of eligibility criteria): • 3 patients with no sarcoma • 1 patient randomized by error (patient considered as ineligible for pre-operative radiotherapy by the investigator – untreated patient)
Corporate Presentation July 2019 17 Two important clinical end points in STS Pathological response & Surgery Margin
Primary Endpoint Pathological response*
< 5%
Secondary Endpoint Surgery (Resection) margin
R0 Negative margin
*as per EORTC guidelines (Wardelmann et al., 2016) Corporate Presentation July 2019 18 NBTXR3 impact on the standard of care (planned radiation and surgery)
No change in Median Relative Radiation therapy dose intensity*
No change in Median Duration of radiotherapy schedule (days)
No change in % of surgery performed
The study confirmed: • Feasibility of injection • No change in dosage and schedule of current radiotherapy standard of care • Good local tolerance (similar radiation safety in both arms) • Manageable acute immunological reaction occurring at the time of injection
No impact on planned radiation and surgery
*Relative radiation therapy Dose Intensity = (Actual Dose Intensity / Planned Dose Intensity) ITT FAS (Full Analysis Set)
Corporate Presentation July 2019 19 pCRR: the study met its primary end point
Pathological Complete Response p-value 0.0448* 18 16,1 16 14 12 2x 10 7,9 8 6 % of patients with pCR with patients of % 4 2 0 Complete Pathological Response NBTXR3 activated by radiotherapy (N=87) Radiotherapy alone (N=89)
*Statistically significant at an adjusted α of 0,04575 *ITT FAS (Full Analysis Set)
Corporate Presentation July 2019 20 pCR multiplied by 4 in high grade sarcoma
Pathological Complete Response <5% residual viable cancer cells 35
30
25
20 17.1
15
% of % patients 4x 10
3.9 5 3.9 1.3 0 n=15 n=16 n=61 n=61 Grade 1 Grade 2/3
NBTXR3 activated by radiotherapy Radiotherapy alone Four fold increase in pathological complete response in the NBTXR3 arm in the higher grade sarcoma subgroup
ITT Full analysis set – subgroup: patients with pR and known grade % are calculated on the total number of patients in the subgroup. Arm A: 5 missing pR, 6 pts with unknown grade. Arm B: 6 missing pR, 6 pts with unknown grade
Corporate Presentation July 2019 21 NBTXR3 for local and relapse/metastatic treatment of cancer H&N strategy
Corporate Presentation July 2019 22 Head & Neck Cancer
493,000 The number of people diagnosed with Head & Neck Cancer in US, EU & Asia-Pacific region each year
Chemoradiation The standard of care in locally advanced Head and Neck Cancer
11% The percentage of patients (i.e. elderly and/or fragile) that are not eligible for chemoradiation
MAJOR NEED TO IMPROVE SURVIVAL AND QUALITY OF LIFE
Corporate Presentation July 2019 23 H&N: 3 clinical trials to demonstrate value capturing high unmet medical needs
Cancer diagnosis… …relapse… …Late stage cancer pathway pathway
Cancer patient patient Cancer 1st Line treatment Relapse / Locoregional or Radiotherapy Metastatic alone Radiotherapy + NBTXR3-102 Nivolumab or Pembrolizumab
Radiotherapy + Local relapse Cisplatin Lung Met Liver Met PEP-503 NBTXR3-1100 (PharmaEngine)
NBTXR3 Monotherapy Checkpoint + NBTXR3
Corporate Presentation July 2019 24 Ongoing phase I/II in Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx (H&N)
Poor prognosis patient population:
Stage III and IV
T3 / T4 - Majority of N1 N2
Not eligible for chemo (RTx alone)
> 70 years old, frail
oral cavity, oropharynx
HPV all status (positive & negative)
Radiotherapy is the only reasonable option to treat this fragile H&N cancer patient population with limited benefits: Low ORR, Short PFS, Poor QoL
Corporate Presentation July 2019 25 Literature data: NBTXR3 Phase I/II Study Population has a poor Overall Survival prognostic
Amini et al. Bourhis et al. Moye et al. 2016 2006 2015
Median OS at 12-13 months
NBTXR3 PI/II patients should have equal or poorer prognosis • Tumor location (Oropharynx & Oral cavity) • Stage III-IV only • >70 years
Amini et al., Cancer May 15, 2016 Bourhis et al., Journal of Clinical Oncology, June 2006 Moye et al.,The Oncologist 2015;20:159–165
Corporate Presentation July 2019 26 Depth of best response* (update ICHNO 2019)
9 CR, ~90% ORR at highest doses CR linked to QoL
Corporate Presentation July 2019 27 NBTXR3 expected Value in Head and Neck Cancer Cut-off date: ICHNO 2019
No SAEs related to NBTXR3/Well tolerated with no serious side effects observed
100% of disease control at all doses ➔ Potential impact on QoL for patients 9/11 CR at higher doses* (10%, 15%, 22%)
Median follow up of >20 months ➔ Potential impact on Survival
Corporate Presentation July 2019 * Excluding non-evaluable patients & those recently added in the trial 28 NBTXR3 in combination with Immune Check Point Inhibitors
Corporate Presentation July 2019 29 H&N: 3 clinical trials to demonstrate value capturing several solid tumor indications
Cancer diagnosis… …relapse… …Late stage cancer pathway pathway
Cancer patient patient Cancer 1st Line treatment Relapse / Locoregional or Radiotherapy Metastatic alone Radiotherapy + NBTXR3-102 Nivolumab or Pembrolizumab
Radiotherapy + Local relapse Cisplatin Lung Met Liver Met PEP-503 NBTXR3-1100 (PharmaEngine)
NBTXR3 Monotherapy Checkpoint + NBTXR3
Corporate Presentation July 2019 30 Example Immunotherapy Nivolumab in recurrent patients H&N
Nivolumab: Checkmate 141 Recurrent Head and Neck.
Non responder
responder
Corporate Presentation July 2019 Ferris et al. NEJM 2016 31 Why priming is needed: Many tumors are inadequately responsive to checkpoints & other IO approaches
Hot
Cold
Hot
CD8
Cold No infiltration Limited infiltration Massive infiltration of immune cell of immune cell of immune cell Corporate Presentation July 2019 Adapted from Alexandrov et al. (2013) and Gentles et al. (2015) 32 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.
Non responder To transform the non responder into responder with NBTXR3 and RTx
responder
Corporate Presentation July 2019 Ferris et al. NEJM 2016 33 Phase I Dose Escalation
anti PD-1 non responders (pembrolizumab or nivolumab): SD for at least 12 weeks or confirmed PD at 12 weeks
Cohort 1: Locoregionally recurrent AND metastatic HNSCC
Cohort 2: Patients with lung metastasis Primary tumor from NSCLC or HNSCC
Cohort 3: Patients with liver metastasis pre-treated Primary tumor from NSCLC or HNSCC
Corporate Presentation July 2019 34 NBTXR3 increases activated CD8 tumor infiltration Phase III Soft Tissue Sarcoma biomarker data
RTx + NBTXR3 Biopsy Baseline Pre Treatment Tumor Tissue Post Treatment
RTx Alone Biopsy Baseline Pre Treatment Tumor Tissue Post Treatment
C D 8 PDP D- 11 7 log2 ≥1 log2 ≥1 7 6 6/26 (23%) 11/23 (48%) log2 ≥1 log2 ≥1 6 5 5 9/26 (35%) 9/22 (41%) 4 4 3 3 2 2 1 1 0 0 -1 -1 -2 -2 -3 Log2 (fold change) log2 ≤1 log2 ≤1 -4
-3 8/26 (31%) 4/23 (17%) Log2 (fold change) -5 log2 ≤1 log2 ≤1 -4 -6 11/26 (42%) 5/22 (23%) -7
R T a lo n e H f0 2 -NP activated by RT R T a lo n e H f0 2 -NP activated by RT
Immunorad 2018, Paris, France
Corporate Presentation July 2019 35 Global clinical collaboration with MD Anderson: 9 clinical trials planned to start this year
Clinical collaboration will initially support 9 phase I/II or phase II Multiple indications: head & neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers Involving around 340 patients Risk sharing funding scheme: backloaded payment & post FDA registration payment
H&N: Dose Reduction RT for HPV+ OPSCC Thoracic: H&N: Treatment naïve esophageal cancer Borderline & Unresectable H&N NSCLC: H&N: Inoperable, checkpoint inhibitor combination, w/o chemo R3+SBRT for inoperable H&N (Re-Irradiation) NSCLC: H&N: Inoperable, checkpoint inhibitor combination, w/ chemo Resected high risk oral cavity/salivary Pelvic + LN soft tissue masses: Pancreas (moonshot program): Re-Irradiation: SBRT+R3 in LAPC
Corporate Presentation July 2019 36 First in class product / addressing high unmet medical needs
• Product with Physical and Universal Mode of Action
• Clinical Proof of Concept demonstrated in Soft Tissue Sarcoma PII/III
• H&N first indication to be registered in US
• Clinical development in PD-1 resistant patients
• Expansion of NBTXR3 usage with 5 ongoing Phase I/II in multiple solid tumors + 9 clinical trials in collaboration with MD Anderson
Corporate Presentation July 2019 37 Many growth levers
Indication Preclinical PI PII PIII Approval Cancer patients Soft tissue sarcoma EU / Asia
Head and neck cancer (RTx alone) EU
Head and neck cancer NBTXR3 (RTx + chemo)* Asia Liver metastasis as a Single Agent Hepatocellular EU carcinoma 60% Rectal cancer* Asia RTx Prostate cancer US
Recurrent NBTXR3 Head & Neck Lung US in Inhibitors metastasis IO / Combo Checkpoint
NBTXR3 9 Phase I/II or II to be started in: + H&N, LAPC, esophageal US cancer, NSCLC, Pelvic & LN soft tissue masses
NBTXR3 today is developed in 10 patient & could be expanded populations (+9 with MD Anderson) to many more patients
Corporate Presentation July 2019 *Conducted by PharmaEngine/publication under PharmaEngine responsibility 38 Financials and Shareholders
Financials Shareholding Structure as of June 2019
44,87% 46,87% K€ 2018 2017 Institutional Investors Total revenue and other income 3,479 3,722
Sales Family offices 116 252 22,360,039 Services 109 229 Other sales shares 7 23 Management & Licences - - employees Other revenues Retail 3,470 Research Tax Credit 3,363 Subsidies 3,251 3,259 Other 90 154 22 57 4,55% 3,72% Research & Development (R&D) costs (incl. (20,893) (17,733) Share-based payments) Analyst Coverage Selling, General and Administrative (SG&A) (12,653) (11,255) costs (incl. Share-based payments) Jefferies – Peter Welford Operating loss (30,067) (25,267) Kempen – Anastasia Karpova Financial loss (277) (876) Gilbert Dupont – Jamila Elbougrini Income tax - - Net loss for the period (30,345) (26,143) Kepler Cheuvreux – Arsene Guekam Consolidated cash available as of 30 Jun 2019: €54.9M Stifel – Christian Glennie
H.C. Wainright – Ramakanth Swayampakula
Portzamparc – Christophe Dombu
Degroof Petercam – Benoit Louage
Corporate Presentation July 2019 39 Newsflow
✓ MD Anderson clinical collaboration ✓ Preclinical data in IO (NBTXR3 in combination with cPI) H1 ✓ FDA feedback H&N ✓ CE Marking in Europe for STS ✓ Fundraising (EUR 29,5m)
HCC Phase I/II follow up results Final H&N Phase I dose escalation results Potential early results IO combination trial H2 Multiple launch of Phase I/II or II by MD Anderson
US H&N: clinical trial authorization process to begin in 2H2019 with FDA filing + other news to come
Corporate Presentation July 2019 40