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1Corporate Presentation July 2019
Corporate Presentation
July 2019
2Corporate Presentation July 2019
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 accompanying this document provided by Nanobiotix SA (together withits subsidiaries, the “Group”), any question and answer session following that oral presentation and any further information that may be made available in connection with the subject mattercontained herein (together with the information, statements and opinions contained in this Presentation, the “Information”).
This Presentation has been prepared by Nanobiotix SA and is for information purposes only. The Information is provisional and for information purposes only and is not to be construed asproviding investment advice. The Information is provided as of the date of this Presentation only and may be subject to significant changes at any time without notice. Neither the Group, nor itsadvisors, nor any other person is under any obligation to update the Information. Subject to applicable law, none of the Company or its advisors accepts any responsibility whatsoever and makesno representation or warranty, express or implied, as to the fairness, accuracy, completeness or correctness of the Information. The Information has not been subject to independent verificationand is qualified in its entirety by the business, financial and other information that the Group is require d to publish in accordance with the rules, regulations and practices applicable tocompanies listed on Euronext Paris, including in particular the risk factors in the Company’s Registration Document (Document de Référence) filed with the French Financial Markets Authority(Autorité des marchés financiers – the “AMF”) under number D.17-0470 on April 28, 2017, as well as in its 2017 annual financial report filed with the AMF on March 29, 2018 in any otherperiodic report and in any other press release, which are available free of charge on the websites of the Group (www.nanobiotix.fr) and/or the 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 beenobtained from sources believed to be reliable, there is no guarantee of the accuracy or completeness of such data. In addition, certain of the industry and market data comes from the Group’sown internal research and estimates based on the knowledge and experience of the Group’s management. While the Group 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 without notice. Accordingly,undue reliance should not be placed on any of the industry, market or competitive position data contained in the Information.
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 locality, state, country or other jurisdiction wheresuch distribution or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction. The Information does not constitute or form part of,and should not be construed as an offer or the solicitation of an offer to subscribe for or purchase of any securities, nor shall there be any sale of these securities in the United States or any otherjurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. No public offering ofsecurities may be conducted in France prior to the delivery by the French Financial Markets Authority of a visa on a prospectus that complies with the provisions of Directive 2003/71/CE asamended. The Information is for information purposes only and does not constitute an offering document or an offer of securities to the public in the United Kingdom to which section 85 of theFinancial Services and Markets Act 2000 of the United Kingdom applies. This Presentation is intended solely for (i) investors in the United States in reliance on the exemption from registrationprovided by Rule 4(a)(2) under the U.S. Securities Act of 1933, as amended (the “Securities Act”) or (ii) to certain non-U.S. persons in offshore transactions outside the United States in relianceon Regulation S under the Securities Act. Securities may not be offered or sold in the United States absent registration under the Securities Act, or an exemption from registration thereunder.
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 future performance. These forward-looking statements relate without limitation to the Group’s future prospects, developments, marketingstrategy regulatory calendar, clinical milestones, assumptions and hypothesis, clinical development approach and financial requirements and are based on analyses of earnings forecasts andestimates of amounts not yet determinable and other financial and non-financial information. Such statements reflect the current view of the Group's management, and are subject to a variety ofrisks 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 anycircumstance, be construed as a guarantee of the Group’s future performance as to strategic, regulatory, financial or other matters, and the Group’s actual performance, including its financialposition, results and cash flow, as well as the trends in the sector in which the Group operates, may differ materially from those proposed or reflected in the forward-looking statements containedin this Presentation. Even if the Group’s performance, including its financial position, results, cash-flows and developments in the sector in which the Group operates were to conform to theforward-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 Groupexpressly declines any obligation 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 orcircumstance that may occur after the date of this Presentation.
3Corporate Presentation July 2019
Past 12 months
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)
Significant global progresses for the company
4Corporate Presentation July 2019
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
5Corporate Presentation July 2019
Cancer patients treated with RTx represent significant market opportunity with large unmet medical needs
Source: * World Health Organization (2014); **RADIATION THERAPY EQUIPMENT – A global strategic business report 08/06
Inadequate local control (invasion)
60% RTx**
Inadequate local control (relapse)
Inadequate systemic controlunfavorable safety profile
(dose de-escalation/re-irradiation)
RTx: radiotherapy
Cancer patients
Head and Neck, Glioblastoma, Liver Pancreatic, Rectum, …
Pancreatic, Prostate, Lung, Colorectal, Breast, …
Liver, Lung, Brain, …
Prostate, Head and Neck, Breast, Lung, Brain, Colorectal, …
6Corporate Presentation July 2019
Nanobiotix targets radiation therapy - one of the largest oncology markets with limited competition
Conventional radiation therapy
Around 60%* of cancer patients receive radiotherapy as a local treatment
Destroys any cancer cell at the right dose
Important limitations due to toxicity on healthy tissues 100 photons @ 6 MeV
20 cm20 cm
50 cm
Xray trackEnergy deposition
How to improve the energy dose within the tumor without damaging healthy tissues?
TUMOR
Source: * RADIATION THERAPY EQUIPMENT – A global strategic business report 08/2006
100 photons at 6 MEV
7Corporate Presentation July 2019
Our solution: NBTXR3 enhances Xray absorption in the tumor
IP: technology and product candidatesprotected by 20 patent families until at least 2029
Technology key features:
50nm
HfO2 nanoparticles; electron microscopy picture
Designed to strongly
absorb Xrays
Designed to be non-toxic
50 nanometer HfO2* particles were chosenbecause they have the best ratio for X-rayabsorption and non-toxicity
Nanosized to enter cell
* HfO2: Hafnium OxideSource: Maggiorella et al. (2012)
3
2
1
8Corporate Presentation July 2019
NBTXR3 has a physical mode of action: Leveraging NanoPhysics to fight cancer
Dose
Usual dose delivered in the cell
*Note: Dose enhancement determined by montecarlo simulation (CEA Saclay, France)
Clusters of Nanoparticles
Dose
2 µm
9X Dose*around nanoparticles
Usual dose delivered in the cell
Local absorption of energy
XRay XRay
Radiotherapy Radiotherapy with NBTXR3
9Corporate Presentation July 2019
NBTXR3 UNIVERSAL MoAtriggering cellular destruction
and adaptative immune response
Clustered Nanoparticles in cytoplasm
large energy deposition in a nano-volume → physical damage
NBTXR3 +RTx
Direct Cell Death (Apoptosis, Necrosis, …)
• Structural Damage• DNA damage• Stress• Immunogenic Cell Death• Sting pathway activationDendritic cell
activation
CD4 & CD8 activation
Tumor Infiltration and Cell Killing
10Corporate Presentation July 2019
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 careNo change in equipmentNo change in current patient flowNo change in protocol
One product addressing areas of high unmet medical needs
CE Marking obtained in Soft Tissue Sarcoma (commercial name: Hensify®)
11Corporate Presentation July 2019
A product with solid foundations
Validated & protected productOver 19 patent families across the worldManufacturing demonstrated & certified ISO 13485:2016
Clinical reliabilityUniversal Mechanism of Action (transferability)Proof of Concept demonstrated in a randomized Phase III trial in Soft Tissue SarcomaPositive initial and promising results in different Phase I/II trials (Head and neck, HCC)NBTXR3 has been well toleratedLarge 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 EUPreclinical and clinical collaborations with major hospitals, including MD Anderson and Weill CornellMajor clinical collaboration with MD Anderson>400 MDs involved in developmentFitting existing standard of care and single intra-tumoral injection
12Corporate Presentation July 2019
Pipeline
*Conducted by PharmaEngine
9 Phase I/II or II to be started in:H&N, LAPC, esophageal cancer, NSCLC, Pelvic & LN soft tissue masses
Preclinical PI PII PIIIIndication
NBTXR3
as aSingle Agent
Soft tissue sarcoma
Head and neck cancer(RTx alone)
Liver metastasis
Hepatocellular carcinoma
Rectal cancer*
Prostate cancer
Approval
Head and neck cancer (RTx + chemo)*
NBTXR3
inIO / Combo C
heck
poin
t In
hibi
tors Recurrent
Head & Neck
Lung metastasis
EU / Asia
EU
Asia
EU
Asia
US
US
+NBTXR3
US
13Corporate Presentation July 2019
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 obtainedPositive Phase II/III New mode of action validated in randomized trialPrimary 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 USPositive Phase I data on advanced patientsShowing 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 patientsPhase 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 tumorsNine additional clinical development trials planned with MD Anderson global collaboration
14Corporate Presentation July 2019
NBTXR3 in Soft Tissue Sarcoma
15Corporate Presentation July 2019
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
* Arms and legs
Soft Tissue Sarcoma: patient population
16Corporate Presentation July 2019
Soft Tissue Sarcoma: treatment objectives
Surgery
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
17Corporate Presentation July 2019
Phase II/III Study in Soft Tissue Sarcoma
Flowchart and study design
End of treatment
Session of RTx according to standard of care
(25 x 2 Gy)
RTx(89 patients)
Surgery
▪ 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)
SurgeryDay 1One timeIntratumoral injection
RTx + NBTXR3
(87 patients)
Data presented ASTRO/ESMO 2018
18Corporate Presentation July 2019
R0 Negative margin
Two important clinical end points in STSPathological response & Surgery Margin
Primary EndpointPathological response*
Secondary Endpoint Surgery (Resection) margin
< 5%
*as per EORTC guidelines (Wardelmann et al., 2016)
19Corporate Presentation July 2019
NBTXR3 impact on the standard of care (planned radiation and surgery)
*Relative radiation therapy Dose Intensity =(Actual Dose Intensity / Planned Dose Intensity) ITT FAS (Full Analysis Set)
No impact on 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 ofcare
• Good local tolerance (similar radiation safety in both arms)
• Manageable acute immunological reaction occurring at the time ofinjection
20Corporate Presentation July 2019
16,1
7,9
0
2
4
6
8
10
12
14
16
18
Complete Pathological Response
Pathological Complete Response
NBTXR3 activated by radiotherapy (N=87)Radiotherapy alone (N=89)
2x
pCRR: the study met its primary end point
p-value 0.0448*
*Statistically significant at an adjusted α of 0,04575*ITT FAS (Full Analysis Set)
% o
f pat
ient
s w
ith p
CR
21Corporate Presentation July 2019
pCR multiplied by 4 in high grade sarcoma
Four fold increase in pathological complete response in the NBTXR3 arm in the higher grade sarcoma subgroup
Pathological Complete Response <5% residual viable cancer cells
0
5
10
15
20
25
30
35
% o
f pat
ient
s
1.3
3.9
17.1
3.9
n=15 n=16 n=61 n=61
Grade 1 Grade 2/3
NBTXR3 activated by radiotherapy Radiotherapy alone
4x
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
22Corporate Presentation July 2019
NBTXR3 for local and relapse/metastatic treatment of cancerH&N strategy
23Corporate Presentation July 2019
Head & Neck Cancer
493,000The number of people diagnosed withHead & Neck Cancer in US, EU & Asia-Pacific region each year
ChemoradiationThe standard of care in locallyadvanced Head and Neck Cancer
11%The percentage of patients (i.e. elderlyand/or fragile) that are not eligible for chemoradiation
MAJOR NEED TO IMPROVE SURVIVAL AND QUALITY OF LIFE
24Corporate Presentation July 2019
H&N: 3 clinical trials to demonstrate value capturing high unmet medical needs
Cancer diagnosis… …Late stage cancer
Radiotherapy alone
NBTXR3-102
1st Line treatment
Radiotherapy +Cisplatin
PEP-503(PharmaEngine)
Checkpoint + NBTXR3
Relapse / Locoregional or
Metastatic
NBTXR3 Monotherapy
Radiotherapy +Nivolumab or
Pembrolizumab
NBTXR3-1100
Local relapseLung MetLiver Met
Can
cer p
atie
nt
path
way
…relapse…
25Corporate Presentation July 2019
Radiotherapy is the only reasonable option to treat this fragile H&N cancer patient population with limited benefits:
Low ORR, Short PFS, Poor QoL
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)
Ongoing phase I/II in Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx (H&N)
26Corporate Presentation July 2019
Literature data: NBTXR3 Phase I/II Study Populationhas a poor Overall Survival prognostic
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, 2016Bourhis et al., Journal of Clinical Oncology, June 2006
Moye et al.,The Oncologist 2015;20:159–165
Amini et al.2016
Moye et al. 2015
Bourhis et al.2006
Median OS at 12-13 months
27Corporate Presentation July 2019
9 CR, ~90% ORR at highest dosesCR linked to QoL
Depth of best response* (update ICHNO 2019)
28Corporate Presentation July 2019
No SAEs related to NBTXR3/Well tolerated with no serious side effects observed
100% of disease control at all doses9/11 CR at higher doses* (10%, 15%, 22%)
Median follow up of >20 months
NBTXR3 expected Value in Head and Neck CancerCut-off date: ICHNO 2019
➔ Potential impact on QoL for patients
➔ Potential impact on Survival
* Excluding non-evaluable patients & those recently added in the trial
29Corporate Presentation July 2019
NBTXR3 in combination with Immune Check Point Inhibitors
30Corporate Presentation July 2019
H&N: 3 clinical trials to demonstrate value capturing several solid tumor indications
Cancer diagnosis… …Late stage cancer
Radiotherapy alone
NBTXR3-102
1st Line treatment
Radiotherapy +Cisplatin
PEP-503(PharmaEngine)
Checkpoint + NBTXR3
Relapse / Locoregional or
Metastatic
NBTXR3 Monotherapy
Radiotherapy +Nivolumab or
Pembrolizumab
NBTXR3-1100
Local relapseLung MetLiver Met
Can
cer p
atie
nt
path
way
…relapse…
31Corporate Presentation July 2019
Example ImmunotherapyNivolumab in recurrent patients H&N
Nivolumab: Checkmate 141
Ferris et al. NEJM 2016
Recurrent Head and Neck.
responder
Non responder
32Corporate Presentation July 2019
Why priming is needed: Many tumors are inadequately responsive to checkpoints & other IO approaches
Hot
Cold
Adapted from Alexandrov et al. (2013) and Gentles et al. (2015)
No infiltration of immune cell
CD8
Limited infiltration of immune cell
Massive infiltration of immune cell
Cold
Hot
33Corporate Presentation July 2019
Phase I/II in NSCLC & H&N to be initiated in combination with PD-1 Inhibitors
Checkpoint inhibitors refractory patients in NSCLC & H&N
To transform the non responder into
responderwith NBTXR3 and RTx
Nivolumab: Checkmate 141
Ferris et al. NEJM 2016
Recurrent Head and Neck.
responder
Non responder
34Corporate Presentation July 2019
Phase I Dose Escalation
Cohort 1: Locoregionally recurrent AND metastatic HNSCC
Cohort 3: Patients with liver metastasis pre-treated Primary tumor from NSCLC or HNSCC
Cohort 2: Patients with lung metastasisPrimary tumor from NSCLC or HNSCC
anti PD-1 non responders (pembrolizumab or nivolumab): SD for at least 12 weeks or confirmed PD at 12 weeks
35Corporate Presentation July 2019
NBTXR3 increases activated CD8 tumor infiltrationPhase III Soft Tissue Sarcoma biomarker data
Biopsy Baseline Pre Treatment
Biopsy Baseline Pre Treatment
Tumor Tissue Post Treatment
Tumor Tissue Post Treatment
RTx + NBTXR3
RTx Alone
Immunorad 2018, Paris, France
-4-3-2-101234567
C D 8
R T a lo n e H f0 2 -N P
a c tiv a te d b y R T
Log2
(fol
d ch
ange
)
log2 ≥16/26 (23%)
log2 ≤18/26 (31%)
log2 ≥111/23 (48%)
log2 ≤14/23 (17%)
-7-6-5-4-3-2-101234567
P D 1
R T a lo n e H f0 2 -N P
a c tiv a te d b y R T
Log2
(fol
d ch
ange
)
log2 ≥19/26 (35%)
log2 ≤111/26 (42%)
log2 ≥19/22 (41%)
log2 ≤15/22 (23%)
PD-1
36Corporate Presentation July 2019
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
H&N: Borderline & Unresectable H&N
H&N:R3+SBRT for inoperable H&N (Re-Irradiation)
H&N:Resected high risk oral cavity/salivary
Pancreas (moonshot program):SBRT+R3 in LAPC
Thoracic:Treatment naïve esophageal cancer
NSCLC:Inoperable, checkpoint inhibitor combination, w/o chemo
NSCLC:Inoperable, checkpoint inhibitor combination, w/ chemo
Pelvic + LN soft tissue masses:Re-Irradiation:
37Corporate Presentation July 2019
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
38Corporate Presentation July 2019
Many growth levers
Cancer patients
60%RTx
NBTXR3 today is developed in 10 patient populations (+9 with MD Anderson)
& could be expanded to many more patients
*Conducted by PharmaEngine/publication under PharmaEngine responsibility
9 Phase I/II or II to be started in:H&N, LAPC, esophageal cancer, NSCLC, Pelvic & LN soft tissue masses
Preclinical PI PII PIIIIndication
NBTXR3
as aSingle Agent
Soft tissue sarcoma
Head and neck cancer(RTx alone)
Liver metastasis
Hepatocellular carcinoma
Rectal cancer*
Prostate cancer
Approval
Head and neck cancer (RTx + chemo)*
NBTXR3
inIO / Combo C
heck
poin
t In
hibi
tors
RecurrentHead & Neck
Lung metastasis
EU / Asia
EU
Asia
EU
Asia
US
US
+NBTXR3
US
39Corporate Presentation July 2019
Financials and Shareholders
Analyst Coverage
Financials Shareholding Structure as of June 2019
22,360,039shares
Jefferies – Peter Welford
Kempen – Anastasia Karpova
Gilbert Dupont – Jamila Elbougrini
Kepler Cheuvreux – Arsene Guekam
Stifel – Christian Glennie
H.C. Wainright – Ramakanth Swayampakula
Portzamparc – Christophe Dombu
Degroof Petercam – Benoit Louage
K€ 2018 2017
Total revenue and other income 3,479 3,722
SalesServicesOther salesLicences
Other revenuesResearch Tax CreditSubsidiesOther
116
109
7
-
3,363
3,251
90
22
252
229
23
-
3,470
3,259
154
57
Research & Development (R&D) costs (incl. Share-based payments)
(20,893) (17,733)
Selling, General and Administrative (SG&A) costs (incl. Share-based payments)
(12,653) (11,255)
Operating loss (30,067) (25,267)
Financial loss (277) (876)
Income tax - -
Net loss for the period (30,345) (26,143)
Consolidated cash available as of 30 Jun 2019: €54.9M
46,87%
3,72%4,55%
44,87%
Institutional Investors
Family offices
Management &employees
Retail
40Corporate Presentation July 2019
Newsflow
H1
H2
✓ MD Anderson clinical collaboration
✓ Preclinical data in IO (NBTXR3 in combination with cPI)
✓ 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
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