Global Development Strategy...The Presentation is not, and should not be construed as, an offer of...

57
CORPORATE PRESENTATION

Transcript of Global Development Strategy...The Presentation is not, and should not be construed as, an offer of...

Page 1: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

CORPORATE PRESENTATION

Page 2: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

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 accompanying this Presentation provided by Nanobiotix SA (together with its subsidiaries, the “Group”), any question and answersession following that the Presentation and any further information that may be made available in connection with the subject matter contained herein (together with the information, statements and opinions contained in this Presentation, the“Information”).

This Presentation has been prepared by Nanobiotix SA. The Information is provisional and for information purposes only. The Information is provided as of the date of this Presentation only and may be subject to significant changes at any time withoutnotice. The Group is not under any obligation to update the Information. The Information has not been subject to independent verification and is qualified in its entirety by the business, financial and other information that the Group is required topublish in accordance with the rules, regulations and practices applicable to companies listed on Euronext Paris, including in particular the risk factors in the Company’s universal registration document approved by the French Financial Markets Authority(Autorité des marchés financiers – the “AMF”) under number R.20-010 on May 12, 2020, as well as in any other periodic report and in any other press release, which are available free of charge on the websites of the Group (www.nanobiotix.fr) and/orthe AMF (www.amf-france.org).

The Information includes information on the use of the Group’s products and its competitive position. Some of the Information is from third parties. While this third party information has been obtained from sources believed to be reliable, there is noguarantee of the accuracy or completeness of such data. In addition, certain of the industry and market data comes from the Group’s own internal research and estimates based on the knowledge and experience of the Group’s management. While theGroup believes that such research and estimates are reasonable and reliable, they, and their underlying methodology and assumptions, have not been verified by any independent source for accuracy or completeness and are subject to change withoutnotice. Accordingly, undue reliance should not be placed on any of the industry, market or competitive position data contained in the Information.

The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information is not directed to, or intended for distribution to or use by, any person or entity that is a citizen

or resident of, or located in, any jurisdiction where such distribution or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.

The Information contains certain forward-looking statements. All statements in the Information other than statements of historical fact are or may be deemed to be forward looking statements. These statements are not guarantees of the Group’s futureperformance. These forward-looking statements relate without limitation to the Group’s future prospects, developments, marketing strategy regulatory calendar, clinical milestones, assumptions and hypothesis, clinical development approach andfinancial requirements and are based on analyses of earnings forecasts and estimates of amounts not yet determinable and other financial and non-financial information. Such statements reflect the current view of the Group's management, and aresubject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstances that may or may not materialize in the future. Forward-looking statements cannot, under any circumstance, be construed as a guarantee ofthe Group’s future performance as to strategic, regulatory, financial or other matters, and the Group’s actual performance, including its financial position, results and cash flow, as well as the trends in the sector in which the Group operates, may differmaterially from those proposed or reflected in the forward-looking statements contained in this Presentation. Even if the Group’s performance, including its financial position, results, cash-flows and developments in the sector in which the Groupoperates were to conform to the forward-looking statements contained in this Presentation, such results or developments cannot be construed as a reliable indication of the Group’s future results or developments. The Group expressly declines anyobligation to update or to confirm projections or estimates made by analysts or to make public any correction to any prospective information in order to reflect an event or circumstance that may occur after the date of this Presentation.

Page 3: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information
Page 4: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

Physical Mode of Action broadly applicable across multiple solid tumor indications

60% of cancer patients receive radiotherapy

Positive preliminary results in four other clinical trials

Robust intellectual property and established manufacturing facility with substantial production capacity

First market approval in Europe in Soft Tissue Sarcoma (STS)

Positive Head & Neck (H&N) Phase I trial with potential impact on OS and QoL

US FDA Fast Track designation obtained in February 2020

First positive data of expansion trial presented at ASCO in May 2020

US FDA safe-to-proceed for Phase III protocol in June 2020

Short term evaluation of potential clinical value in Immuno-Oncology

Nine clinical trials in collaboration with MD Anderson with first patient to be treated in pancreatic cancer

Upcoming end of clinical trials (PE trials in H&N and rectum) and new readout in H&N and liver trials

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18M60%

RECEIVING RTx NUMBER OF PATIENTS W/RTx

87% Breast cancer 1,800,000

77% Lung cancer 1,600,000

74% H&N 700,000

58% Prostate 740,000

60% Rectum 420,000

49% Pancreas 225,000

80% CNS 237,000

… …

Source: World Health Organization (2014); RADIATION THERAPY EQUIPMENT – A global strategic business report 08/06 ; Delaney et al. 2015; Globocan 2018.

new patientsper year

diagnosed with cancer worldwide

RTx

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Inadequate local control (Local invasion or systemic expansion)

Inadequate systemic control(metastatic patients)

Unfavorable safety profile (dose de-escalation/re-irradiation)

18M60%

new patientsper year

diagnosed with cancer worldwide

RTx

Source: World Health Organization (2014); RADIATION THERAPY EQUIPMENT – A global strategic business report 08/06 ; Delaney et al. 2015; Globocan 2018.

Page 8: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information
Page 9: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

• 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

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Radiotherapy Radiotherapy with NBTXR3

*Dose enhancement determined by Monte Carlo simulation (CEA Saclay, France).

Dose Dose

2 µm

XRayXRay

Usual dose delivered in the cell

Local

absorption

of energy

Clusters of

Nanoparticles

Usual dose delivered in the cell

dose* aroundnanoparticles

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NBTXR3’s UNIVERSAL, PHYSICAL MOA triggers cellular destruction along with potential adaptative immune response.

Direct Cell Death (Apoptosis, Necrosis, …)

Cell Killing by CD8/CD4 activation

Physical damage inducing

• Structural Damage

• DNA damage

• Stress

• Immunogenic Cell Death

• Sting pathway activation

Source: Marril et al, Radiother Oncol, 2019

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Page 13: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

Soft Tissue Sarcoma Head & Neck

Phase

Validated

Phase

Validated

European

Received

EUPhase I

Validated

EU Expansion

Phase IOngoing

Global Phase III

To beLaunched

EU Phase

I/IIOngoing

HCCLiver mets

US Phase

I/II Ongoing

Prostate

USPhase

I/II Ongoing

IO H&NLung

AsiaPhase

I/II Ongoing

Rectum

AsiaPhase

I/II Ongoing

H&N H&N1

To b

eLa

un

ched

H&N2

To b

eLa

un

ched

Lung1

To b

eLa

un

ched

Lung2

To b

eLa

un

ched

Advanced Tumors

To b

eLa

un

ched

Esoph

To b

eLa

un

ched

Pancreas

On

goin

g

Under discussion

To b

eLa

un

ched

Under discussion

To b

eLa

un

ched

Clinical Proof of Concept established in a randomized Phase III & marketing approval received in the EU.

A defined pathway to market in the US & EU with an aim for high medical & economicalvalue creation.

Expansion through multiple ongoing or planned Phase I/II trials.

Nanobiotix Trials

PharmaEngine Trials

MDA Trials

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• High risk tumor

• Borderline unresectable tumor or unfeasible carcinological

surgical resection

• Preoperative radiotherapy alone is the Standard of Care

Page 16: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

Soft Tissue Sarcoma (STS) of the Extremity and Trunk wall

Key inclusion criteria

• Age ≥ 18 years-old

• Locally advanced STS of the extremity and trunk wall, newly diagnosed or relapsed tumor

• High-risk tumor

• Unresectable tumor or unfeasible carcinological surgical resection

• WHO score of 0 to 2

R1:1

Arm ANBTXR31 activated by

EBRT2

Arm BEBRT2 alone

1 IT injection of a dose, 10% of baseline tumor volume2 50 Gy, 25 fractions x 2 Gy, over 5 weeks3 4 patients excluded from the ITT Full analysis set : 3 did not have STS (2 in Arm A, 1 in Arm B), 1 (in Arm A) was not eligible for preoperative RT4 Pathological Response evaluated by an independent central Pathological Review Board5 Wardelmann E et al, Eur J Cancer, 2016Cf Clinicaltrials.gov - NCT01433068

Primary endpoint:• Pathological complete response rate4 (pCRR)

following EORTC Guidelines5

Secondary endpoints:• Safety • Carcinologic resection (surgical margin, R0, …)• Pathological Response (pR)• Amputation rate

Stratification:• Myxoid liposarcoma / other32 sites in 11 countries

in Europe and Asia

N=180 randomized3

Page 17: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

180 patients / RTx vs RTx+NBTXR3

Primary Endpoint pCRR* x2 in ITT FAS** population

16,1

7,9

0,

5,

10,

15,

20,

Complete Pathological Response

Pathological Complete Response

NBTXR3 activated by radiotherapy (N=87)

Radiotherapy alone (N=89)

X2

p-value 0.0448*

% o

f p

atie

nts

wit

h p

CR

*pCRR = Pathological Complete Response Rate**ITT FAS = Intention To Treat Full Analysis Set; statistically significant at α threshold of 0.04575Source: Bonvalot et al, Lancet Oncol, 2019

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1,3

17,1

3,9 3,9

0,

5,

10,

15,

20,

NBTXR3 activated by radiotherapy Radiotherapy alone

% o

f p

atie

nts

n=15 n=16 n=61 n=61Grade 1 Grade 2/3

Pathological Complete Response<5% residual viable cancer cells

X4

Source: Bonvalot et al, Lancet Oncol, 2019

Page 19: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

Significant increase in R0 rate in the NBTXR3 arm

77,0

64,0

60,

65,

70,

75,

80,

Resection margin (RO rate)

NBTXR3 activated by radiotherapy (N=87) Radiotherapy alone (N=89)

p-value 0.0424*

% o

f p

atie

nts

wit

h R

0 r

esec

tio

n m

argi

ns

Significant increase in tumor necrosis/infarction in the NBTXR3 arm

28,8

19,2

0,

8,8

17,5

26,3

35,

Tumor necrosis/infarction

p-value 0.0140*

% o

f p

atie

nts

wit

h t

um

or

nec

rosi

s/in

farc

tio

n

*Statistically significant at an α of 5%; ITT FAS (Full Analysis Set)Source: Bonvalot et al, Lancet Oncol, 2019

Page 20: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

Arm A

NBTXR3

activated by RT

(N=89)

Arm B

RT alone

(N=90)

Patients with any TEAE1 87 (97.8%) 87 (96.7%)

Patients with any NBTXR3 related TEAE 31 (34.8%) NA

Patients with any TEAE leading to death (death regardless

the causality assessment)0 2 (2.2%)

Patients with any serious TEAE 28 (31.5%) 14 (15.6%)

Patients with any serious NBTXR3 related TEAE 9 (10.1%) NA

Patients with any serious TEAE related to radiation therapy 5 (5.6%) 5 (5.6%)

Patients with any serious AE2 35 (39.3%) 27 (30.0%)

Patients withdrawn from study treatment due to TEAE 1 (1.1%) 0

1 Treatment Emergent AEs are AE observed during the on-treatment period.2 Serious AEs are adverse events reported during the whole study period (i.e. on-treatment and follow-up periods).

NA, not applicable

• 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.

Safety – Phase II/III in STS

*Relative radiation therapy Dose Intensity = (Actual Dose Intensity / Planned Dose Intensity)Source: Bonvalot et al, Lancet Oncol, 2019

Page 21: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information
Page 22: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

• A target population with high unmet needs: Frail and elderly patients that are ineligible to cisplatin and intolerant to cetuximabMain characteristics: low response rate, short PFS of ~7.3 months, short OS of ~12 months

• Positive Phase I escalation results: Well tolerated and promising efficacy (Best ORR = 69%) that could impact progression free survival, overall survival and quality of life

• Fast Track designation obtained in February 2020: FDA recognized the unmet need and the potential for NBTXR3 to fulfil that need

• New positive Phase I expansion results presented at ASCO (May 2020): Equivalent or even better efficacy (Best ORR = 83%) than escalation dose and well tolerated

Source: Claims data presented at MHNCS 2020; Amini et al. 2016, Bourhis et al. 2006 and Moye et al. 2015

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• Stage III and IV

• ≥65 years old and/or frail

• Oral cavity, Oropharynx

• HPV all status (positive & negative)

• Ineligible for chemotherapy and intolerant to cetuximab in

combination with RT

Source: Moye et al.,The Oncologist 2015

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Dose escalation: 3 + 3 design to assess 4 dose levels**

* According to AJCC 7th edition for the dose escalation and 8th edition for the dose expansion** Injected volume calculated as a % of tumor volume determined on an MRI performed <14 days prior to injection

Single intratumoral injection of NBTXR3activated by Radiotherapy

PATIENT POPULATION• ≥ 65 years-old

• KPS > 70

• Stage III or IVA HNSCC* of the oral cavity or oropharynx

• Eligible for radiotherapy

• Not eligible for cisplatin or cetuximab

• No metastases

• Adequate organ functions

5% 10% 15% 22%

Dose expansion: 44 additional patients at the RP2D

PRIMARY ENDPOINTSDose escalation

• Assess DLTs, Recommended dose (RP2D), MTD if possible

• Safety and tolerability

Dose expansion

• Objective Response Rate (ORR) and Complete Response Rate (CRR) of the primary tumor, by imaging according to RECIST 1.1

Page 25: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

Moye et al. 2015

Bourhis et al.2006

Amini et al.2016Literature data:

NBTXR3 Phase I/II Study Population has a poor Overall Survival prognostic

Median OS at 12-13 months

Source: Amini et al., Cancer May 15, 2016;Bourhis et al., Journal of Clinical Oncology, June 2006;Moye et al.,The Oncologist 2015

NBTXR3 Phase I/II patients should have equal or poorer prognosis

• Tumor location (Oropharynx & Oral cavity)

• Stage III & IV only

• >70 years

Page 26: Global Development Strategy...The Presentation is not, and should not be construed as, an offer of any securities and is not to be construed as providing investment advice. The information

Dose Level N DLTAEs related to NBTXR3 injection

AE (n) SAE (n)

5% 3 No 0 0

10% 3 No 0 0

15% 5 No Grade 1 tumor hemorrhage (N=1) 0

22% 8 NoGrade 2 oral pain (N=1)Grade 1 asthenia (N+1)

Grade 1 injection site pain (N+1)0

Recommended dose defined by DSMB as 22%

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Dose Level 3-15%

Dose Level 2-10%

Dose Level 4-22%

Dose Level 1-5%

* *

StableDisease

Complete Response

PartialResponse

ProgressiveDisease

-100

-80

-60

-40

-20

0

20

40

Targ

et le

sio

n lo

nge

st d

imen

sio

n

% c

han

ge f

rom

bas

elin

e

* *

69 % Objective Response (incl. 56% complete response)

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Subtherapeutic dose

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• Head and Neck Newly Diagnosed and Treated (oral cavity, oropharynx)

• Elderly (65+)

• Stage III & IV

• No cisplatin use during all treatment lines

• Head and Neck Newly Diagnosed and Treated (oral cavityor oropharynx)

• Elderly (65+)

• Stage III & IV

• Ineligible for cisplatin

• Intolerant to cetuximab

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Note: PFS in RWE data is defined "as change in N or M staging", change of treatment" or "death". Change of treatment is usually correlated to relapse. A second line is therefore mostoften used in patients in this dataset.

7,3

Median PFS: 7.3 monthsN=246

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7,3

Claims data• PFS*• RT or RT + cetuximab• N=246

Study 102 patients• N=19

*PFS in RWE data is defined as «change in N or M staging », « change of treatment » or « death ». Change of treatment is usually correlated to relapse. A second line is therefore most often used in patients in this dataset.

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Baseline CharacteristicsAll Treated Patients

N=40

GenderFemale 11 (27.5%)Male 29 (72.5%)

Age, yearsMedian 70.7

Min, Max 50.7, 89.9Tumor Volume, mL3

Median 43.1Min, Max 1.3, 222.3

Tumor LocationOral cavity 22 (55.0%)Oropharynx 18 (45.0%)

HPV statusMissing 1 (2.5%)HPV 16 + 11 (27.5%)HPV 16 - 23 (57.5%)Not done 5 (12.5%)

Baseline CharacteristicsAll Treated Patients

N=40Primary Tumor Stage1

I2 1 (2.5%)II2 5 (12.5%)III 18 (45.0%)IV/IVA 16 (40.0%)

Karnofsky Score100% 9 (22.5%)90% 10 (25.0%)80% 15 (37.5%)70% 5 (12.5%)Missing 1 (2.5%)

Hyper-polypharmacy≥8 ongoing medication 7 (17.5%)

Comorbidities4

Cardiac disorder risk 28 (70,0%)Gastointestinal disorder risk 21 (52.5%)Weight loss risk 8 (20.0%)

1 According to AJCC 8th edition2 Stage III/IV according to AJCC 7th edition3 As per local imaging data. Abbreviations: HPV, human papilloma virus, OPC, oropharyngeal cancer4 Most frequent

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No fatal Adverse Event related to NBTXR3 or the Injection Procedure

Summary of AE/SAEAll Treated Patients N=40

AEs SAEs

All 404 (100%) 41 (10.1%)

Related to Injection procedure 13 (3.2%) 2 (0.5%)

Related to NBTXR3 18 (4.4%) 3 (0.7%)

Related to Radiotherapy 204 (50.5%) 19 (4.7%)

Note: AE/SAE incidence is calculated based on total number or AEs

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-100

-80

-60

-40

-20

0

20

40

Targ

et le

sio

nlo

nge

std

imen

sio

n

chan

ge f

rom

bas

elin

e(%

)

Complete response

*Unconfirmed response

Stable disease

Partial response

StableDisease

Complete Response

PartialResponse

ProgressiveDisease

* ** *

* * * *

Evaluable Population for Objective Tumor Response has included all patients who have had at least 80% of the intended intratumoral dose of NBTXR3 and 60 Gy of IMRT and the required imaging for tumor burden evaluation (target lesions assessments), at baseline and at least once post treatment.

N = 30 As of 30 April 2020

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Escalation(n=16)

Expansion(n=30)

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CT-scan 24h post IT injection CT-scan post radiotherapy CT-scan 7 months after RT

Tumor

NBTXR3

Tumor

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Investigator’s choice

• Radiotherapy alone• Radiotherapy + Cetuximab

R1:1

RT ± Cetuximab (250 pts)

NBTXR3 + RT ± Cetuximab (250 pts)

A

B

Endpoints

• Primary: PFS

• Secondary: OS, ORR, AEs, QoL

(trial powered to demonstrate a significant difference on OS)

Readout:• Futility analysis: 18 months after first randomization• Interim analysis event-driven: 24-30 months; FDA advised that NBTXR3 could potentially qualify for accelerated approval• Final analysis on OS, PFS and quality of life

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Hard to treat patient population:

• Previous resection/local treatment is permitted

• Hepatocellular carcinoma or Liver Mets

• Unresectable/Medically Inoperable tumors

• ECOG 0 or 1

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PATIENT POPULATION

• ≥ 18 years-old

• ECOG 0 or 1

• Hepatocellular Carcinoma (HCC) patients

– Unsuitable for surgery or local treatment

– Child Pugh A–57

– With or without portal vein thrombosis

– Life expectancy > 3 months

• Liver metastases (Mets) patients

– Unresectable tumor(s)

– Life expectancy > 6 months

3 + 3 Design to assess 5 dose levels

Injected volume calculated as a % of tumorvolume determined on an MRI performed

<14 days prior to injection

Single intratumoral injection of NBTXR3activated by radiotheraoy

ENDPOINTS

• Assess DLTs, RP2D, MTD

• Safety and tolerability

• Liver function: Child-Pugh score (ALBI also explored)

• Early signs of anti-tumor activity per mRECIST (HCC) / RECIST 1.1

(Mets)

10% 15% 22% 33% 42%

Cf Clinicaltrial.gov

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Dose Level

Evaluable Patients n

Complete Response n, (%)

Partial Responsen, (%)

ALL 8 5 (62.5) 3 (37.5)

Patients were recruited at different time points during the trial; those receiving the highest doses are thus the ones with the lowest follow-up.

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NBTXR3 Prospective SBRT 114 cm

(1.1-5.4)90/10/0

45-50 Gy @ 10-15 Gy/fx

- 100% 1yr 100%*

*On evaluable patients

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No NBTXR3 related DLT / No leakage in surrounding tissue

NBTXR3 dose Preferred term Worse grade AE (n) SAE (n)

10% Malaise Grade 2 1 0

15% Abdominal pain Grade 3 2 0

22%

Bilateral pleural effusion

Grade 1 1 0

Bile duct stenosis Grade 3 1 1

33% Fatigue Grade 1 1 0

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Adapted from Alexandrov et al. (2013) and Gentles et al. (2015)

Hot

Cold

No infiltration of immune cell

CD8

Limited infiltration of immune cell

Massive infiltration of immune cell

Cold

Hot

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Nivolumab: Checkmate 141

Recurrent Head and Neck

Responder

Non-responder

Source: Ferris et al, NEJM, 2016

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Checkpoint inhibitors refractory patients in NSCLC and H&N

Goal: Transform the non-responders into responders

with NBTXR3 and RTx

Nivolumab: Checkmate 141Recurrent Head and Neck

Responder

Non-responder

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COHORT 1:

Locoregionally recurrent AND metastatic HNSCC

COHORT 3:

Patients with liver metastasis Any primary tumor eligible for anti-PD-1

COHORT 2:

Patients with lung metastasisAny primary tumor eligible for anti-PD-1

Anti-PD-1 non-responders (pembrolizumab or nivolumab):• SD for at least 12 weeks or confirmed PD

at 8 – 12 weeks after immunotherapy treatment

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Source: Immunorad 2018, Paris, France

Biopsy Baseline Pre Treatment

Biopsy Baseline Pre Treatment

Tumor Tissue Post Treatment

Tumor Tissue Post Treatment

RTx + NBTXR3

RTx Alone

log2 ≥1

6/26 (23%)

log2 ≤1

8/26 (31%)

log2 ≥1

11/23 (48%)

log2 ≤1

4/23 (17%)

log2 ≥1

9/26 (35%)

log2 ≤1

11/26 (42%)

log2 ≥1

9/22 (41%)

log2 ≤1

5/22 (23%)

PD-1

Phase III Soft Tissue Sarcoma biomarker data

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Expanding across oncologywith MD Anderson: 9 clinical trials planned

H&NPhase II Trial of reirradiation with NBTXR3combined with anti-PD-1/L1 for inoperable, locally advanced H&N cancer

H&NPhase II Trial for NBTXR3 for recurrent/metastatic HNSCC patients with limited PD-L1 expression

LungPhase II Trial for NBTXR3 combined with anti-PD-1 or anti-PD-L1 in Stage IV lung cancer

LungPhase I Trial for NBTXR3 in lung cancer patients in need of reirradiation

Advanced Tumors/Lung/LiverPhase I Trial for NBTXR3 combined with anti-CTLA4 and anti-PD-1 or PD-L1 in patients with advanced solid tumors and lung or liver mets

PancreasPhase I Trial for NBTXR3 in pancreatic cancer

EsophagusPhase I Trial for NBTXR3 in esophageal cancer patients

Two additional trials under discussion

• Clinical collaboration will initially support nine (9) phase clinical trials

• Multiple indications: Head & Neck, Pancreatic, Esophagus, Lung

• Involving approximately 340 patients• Risk sharing funding scheme: Backloaded payment

& post FDA registration payment

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• NBTXR3 is a radioenhancer with the potential to improve outcomes for millions of oncology patients

• Disruptive technology with universal, physical MOA

• Eight (8) ongoing clinical trials (H&N, lung, liver, pancreas, prostate, etc.) and an additional 7 contemplated

• Clinical proof of concept established in a randomized Phase III trial in STS (featured in The Lancet Oncology)

• First European market approval (CE Marking) obtained

• IP (300+ patents issued or in process of issuance)

• Positive PI in H&N and Liver showing strong potential for improving survival and quality of life, well

tolerated

• Phase III in locally advanced H&N registration in US to begin

• I/O combination trial results in PD-1 resistant patients in recurrent H&N

• European expansion Phase I end of recruitment in locally advanced H&N

• Publicly-traded, Euronext : NANO – ISIN : FR0011341205

• Cash: EUR 26.6M as at June 30, 2020 + EUR 5M of State-Guaranteed Loan and EUR 20M of private

placement, > 12 months cash visibility

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• Completion of Phase I expansion in H&N by end of 2020.

• Update on efficacy and safety in Phase I expansion in H&N cancer by Q4 2020.

• First data in IO trial to be reported in medical congresses by Q4 2020.

• Preclinical data in I/O by MDA expected at AACR. To be presented later in 2020 at first possible congress.

• Phase I/II in H&N cancer with PE (w/ chemo): recruitment completion by end of 2020.

• Phase I/II in rectum cancer with PE (w/ chemo): recruitment completion by end of 2020.

• MDA trials: Pancreas trial to launch; first patient expected to be injected in by Q3 2020.

• MDA trials: Moving through regulatory process in several indications, FPI to be defined post-COVID-19.

• Phase I in Liver cancer: follow up to be presented by the end of the year.

• Post-approval trial in STS: trials authorization postponed to Q2 2021 due to COVID-19.

* Timelines are subject to changes depending on the COVID-19 situation

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Cash availability as at June 30, 2020 amounted to €26.6M

FINANCIALS in K€6 months to June 30

2020 2019

Total revenue and other income 1,448 1,823Operating revenues 37 37Other income 1,411 1,786

Research & Development (R&D) expenses (13,077) (13,380)

Selling, General and Administrative (SG&A) costs (6,755) (8,910)

Total operating expenses (19,832) (22,290)

Operating income (18,384) (20,467)Financial income 234 724

Financial expenses (2,428) (4,176)

Net financial income (2,194) (3,452)

Income tax (1) -

Net loss for the period (20,579) (23,920)

42%

3%5%

50%

Share capital breakdown (as of August 2020) based on 26,031,122 shares

Institutional investors

Family offices

Management and employees

Retail