nanobiotix corporate presentation · 2020. 9. 14. · important: you must read the following before...
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CORPORATE PRESENTATION
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).
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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
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
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.
• 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
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
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
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
• High risk tumor
• Borderline unresectable tumor or unfeasible carcinological
surgical resection
• Preoperative radiotherapy alone is the Standard of Care
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
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
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
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
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
• 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
• 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
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
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
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%
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)
Subtherapeutic dose
• 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
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
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.
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
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
-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
Escalation(n=16)
Expansion(n=30)
CT-scan 24h post IT injection CT-scan post radiotherapy CT-scan 7 months after RT
Tumor
NBTXR3
Tumor
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
Hard to treat patient population:
• Previous resection/local treatment is permitted
• Hepatocellular carcinoma or Liver Mets
• Unrespectable/Medically Inoperable tumors
• ECOG 0 or 1
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
– Unrespectable 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
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.
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
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
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
Nivolumab: Checkmate 141
Recurrent Head and Neck
Responder
Non-responder
Source: Ferris et al, NEJM, 2016
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
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
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
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
• 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
• 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
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