Corporate Presentation 2016

Corporate
Presentation
2016
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Presentation 2016
2
NanoXray positioned to become a standard of care
in oncology
First in class radioenhancer that could change everything without
changing anything
1
Lead product has shown to be both safe and efficacious in “ultimate tumor case”
Derisking the all concept
Allows for higher dose/efficacy without increasing toxicity
2
Versatile application to target the majority of the oncology market
Broad pipeline in six major indications with potential expansion in most of solid tumors
NanoXray can easily be combined with chemotherapy, immuno-oncology …
3
Disruptive innovation compatible with care in current hospital setting
Disruptive innovation in existing and well structured radiotherapy market
Does not require change of the existing infrastructure, protocol, training
4
Several key milestones in the coming 12 months
Sarcoma Phase II/III interim data mid 2016 and CE mark end of 2016
Data in Liver cancer Phase I/II starting H2 2016
Results of Phase I/II H&N cancer H1 2016
Presentation 2016
3
Nanobiotix applies physics to cancer treatment
Molecules
(drugs and biologics)
Nanotechnology
supports the effect of
molecules
Nano-object becomes
the active principle
1940’s
1980’s
2000
Today
Chemistry
Biology
Nanosized drug
delivery system
New therapeutic
tools based on
physics
50nm
e.g. Mechlorethamine
e.g. Herceptin
e.g. NanoXray
e.g. Doxil
Physics
Biology
Presentation 2016
4
Company Snapshot
General description
Nanobiotix is a French company headquartered in Paris and
has US affiliate in Cambridge
Nanobiotix develops enhanced radiotherapy through
nanotechnology to treat cancer
History
2003: Founding of Nanobiotix
2012: $57m plus royalties collaboration with PharmaEngine
for NBTRX3 in Asia
2012: Listing on NYSE Euronext Paris
Market cap on NYSE Euronext Paris is € 230 m*
2014: Positive safety and efficacy results of NBTRX3 in STS
Well funded: €25m of cash & cash equivalents**
2015: Start of phase I/II NBTXR3 in liver mets and HCC
NanoXray
Nanobiotix develops innovative nanoparticle technology
dedicated to the local treatment of cancer
Nanoparticles interact with radiotherapy and maximize the
effect of radiotherapy within tumors
Lead product NBTXR3 targets several major cancers
NBTXR3 first registration study in STS (EU, Asia, Can) has
started targeting 2016 for first approval
Presentation 2016
* As of December 2015 (Bloomberg); ** As of end 2015 H1
5
Nanobiotix targets one of the largest oncology market:
radiotherapy
Conventional radiotherapy
60%* of cancer patients receive
radiotherapy as a local
treatment
TUMOR
Destroys any cancer cell at the
right dose…
… but important limitations due to
toxicity on healthy tissues
Energy deposition
Xray track
How to improve the energy dose within the tumor without increasing the
dose in healthy tissues?
Source: * RADIATION THERAPY EQUIPMENT – A global strategic business report 08/06
http://cology4u.blogspot.com/2011/06/cancer-radiotherapy.html
Presentation 2016
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Solution:
NanoXray maximizes Xray absorption in the tumor
NanoXray Technology / key features
50nm
1
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
NanoXray is a true radioenhancer with a physical mode of action
6 patent families protecting concept and products until 2029 minimum
Note: *HfO2: Hafnium Oxide
Presentation 2016
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NanoXray has a purely physical mode of action
Radiotherapy alone
Dose
Usual dose
delivered in the cell
Interaction of Xray with water generates
electrons
Radiotherapy with NanoXray
Dose
9X Dose*
around
nanoparticles
Interaction with Hafnium is higher and
generates much more electrons
NanoXray is a true radioenhancer with a physical mode of action
*Note: Dose enhancement determined by montecarlo simulation (CEA Saclay, France)
Presentation 2016
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Versatile application for the majority of the
oncology market
15 million new cancer patients*
1 Major medical benefits
Of which 60%** receive radiotherapy
as a local treatment
Other markets
and markets
> 3m
patients
3
Opens new indications
for radiotherapy with
Nanoxray
Increase efficacy of
radiotherapy with Nanoxray
6m
patients
2
Additional benefits
and markets
Reduces dose (toxicity)
of radiotherapy with Nanoxray
Radiotherapy becoming nanoRadiotherapy:
Universal type mode of action that could target millions of patients
Positioned across all oncology
Potential synergies with other approaches, cytotoxic, targeted, Immuno
Fit in practice: Use standard RTx equipment and protocols
Presentation 2016
Sources:
* World Health Organization.
** RADIATION THERAPY EQUIPMENT – A global strategic business report 08/06.
http://cology4u.blogspot.com/2011/06/cancer-radiotherapy.html
9
NBTXR3 lead product
Crystalline
HfO2
coating
NBTXR3 has been developed for Intratumoral (IT) and selective Intra-Arterial
(IA) injection
Products manufactured in a qualified
and validated GMP process
Price for manufacturing within the
standard range of a chemical product
Only one injection for all radiotherapy
treatment
Fit in standard of care: No change in
protocol or equipment
Presentation 2016
10
NANOBIOTIX has a broad development pipeline strong
expected news flow
Indication
Soft tissue
sarcoma
Neo
adjuvant
and
definitive
treatment
NTBXR3
water
formulation
for IT and IA
EU
HCC
EU
Head and neck
cancer
NBTXR3 gel
formulation
Presentation 2016
IND
EU, CAN, ASIA
Liver metastasis
EU
PI/II PII/III
RA
Expected news flow
Interim data mid 2016; CE mark YE 2016
Multiple data in 3 populations starting
H2 2016
First complete data H1 2016
Rectum cancer
ASIA
PharmaEngine trial
Prostate cancer
USA
IND just granted
Other solid
tumors and
indications (i.e.
GBM, breast
cancer)
Post
surgery
Preclinical
Other solid
tumors and
indications (i.e.
GBM, breast
cancer, NSCLC)
First NanoXray applications are focused on
improving RTx efficacy
> 3m
patients
6m
patients
11
Clinical development in Soft Tissue Sarcoma
Patient population:
Soft Tissue Sarcoma of the extremities*
and trunk wall
Locally advanced soft tissue sarcoma,
newly diagnosed or relapsed tumor:
Unresectable tumor or unfeasible
carcinological surgical resection
Unmet medical need for locally advanced soft tissue sarcoma
Presentation 2016
* arms and legs
12
Current medical practice in locally advanced soft
tissue sarcoma has poor outcome for patients
Pre-operative radiotherapy is a standard of care to render surgery feasible
Pathological Response (pR), Tumor shrinkage, R0 surgery are key to improve Overall
Survival of patients with locally advanced tumors
* Reference: D. Roberge et al.
Radiotherapy and Oncology 97 (2010)
404–407
D. Roberge et. al. Radiotherapy
and Oncology 97 (2010) 404–7
Tumor shrinkage (mean)
0%
pR
50%
npR
59%
Note: 24% pats with margin less than 1mm
Unmet medical need: current radiation treatment has less than 8%
Pathological Complete Response, without significant tumor shrinking
Presentation 2016
13
PI/II Soft Tissue Sarcoma trial flowchart
D1 NBTXR3
administration
D2
1st RTx
Radiotherapy
25 x 2Gy
D37
end of RTx
D72-79
Surgery
D95-102
End of treatment
Patient registration
CT Scan
CT Scan
NBTXR3 injection feasibility
Primary endpoints
Safety evaluation
NBTXR3 dispersion and persistence
exploratory endpoint
RR (tumor shrinkage), pR, operability
NBTXR3 aims to improve cure chances through successful surgery
and complete response
Presentation 2016
protocol @ http://clinicaltrials.gov/ct2/show/NCT01433068?term=nanobiotix&rank=2
14
NBTXR3 primary endpoints achieved:
Safety & feasibility of the injection procedure
4 dose levels tested in various types of sarcomas:
Shapes
Size from 55ml to 3680ml tumor volume
Histology / structure
All ages and sex (excluding children)
Successful implementation of the intratumoral injection procedure
Single injection procedure and no other
change for patients or health professionals
Excellent systemic safety (few grade 1 AEs)
Excellent safety at Recommended Dose 10%
of tumor volume
Product has been shown easy to inject, safe regardless of the tumor
size and patient variability
Presentation 2016
15
Primary endpoints achieved:
dispersion and residency of NBTXR3 in the tumor
- 54 %
- 70 %
- 82%
Persistence of NBTXR3 during all sessions of RTx: optimal bioavailability over time
Presentation 2016
16
NBTXR3 / response
Radiotherapy alone*
Radiotherapy with NBTXR3
(Result from Literature*/not a direct comparator)
100
80
60
Disease
40
Progression
20
Stable
Disease
0
-20
Partial
Response
-40
Individual cases
(N=21)
Canter et al*
(N=25)
Le Grange et al
(N=55)
Borderline operable patients
NBTXR3
(N=21)
Non resectable patients
DP
20% (5)
2% (1)
5% (1)
SD
80% (20)
90% (50)
70% (15)
PR
-
8% (4**)
23% (5)
**all myxoid
Presentation 2016
17
NBTXR3 Shrinkage and pR evaluation
pathological Response
Radiotherapy alone
(Result from Literature*/not a direct comparator)
99%
pR Mean = 50%
74%
64%
Shrinkage Mean = 0%
Tumor shrinkage
20%
NBTXR3
-13% @ 2.5%
-40% @ 5%
-41% @ 10%
NBTXR3
-41% @ 20%
Presentation 2016
tumor shrinkage and pR increasing with
NBTXR3 volume
Large delta when comparing to
literature
* D. Roberge et. al. Radiotherapy and Oncology 97 (2010) 404–7
18
NBTXR3 Pathological response
and tumor volume evolution
Radiotherapy alone
Radiotherapy with NBTXR3
(Result from Literature*/not a direct comparator)
D. Roberge et. al. Radiotherapy
and Oncology 97 (2010) 404–7
tumor shrinkage (mean)
0%
pR
50%
npR
59%
Note: 24% pats with margin less than 1mm
NBTXR3 (level)
2,5%
5%
10%
20%
tumor shrinkage
(mean)
-13%
-40%
-41%
-41%
pR (mean)
npR
64%
67%
20%
67%
74%
88%
99%
99%
large surgery
margin
6/6
6/6
8/8
2/2
At 10% volume, the pathological Response was 74%
At 10% volume, the tumor shrinkage was -41%
tumor shrinkage increasing with NBTXR3 volume
Recommended
volume
All patients treated in the study had a wide surgical resection of the tumor
Recommended volume for PII/III
Presentation 2016
Note: npR : 100% pR in shrinked volume and pR in remaining volume
19
NBTXR3 worldwide development strategy
Fast track to CE mark and POC
Soft Tissue Sarcoma
Shortest pathway to market (CE mark) in EU,
CE mark targeted in 2016
Establishing the value of NBTXR3
Stand alone
dev
Stand alone
dev
pharmaEngine
Liver Cancers (Liver metastasis and HCC)
Maximize value through OS or PFS / short term end point
Expansion in multiple indications
and territories
H&N cancer
Prostate cancer (to be started)
Rectum cancer
Presentation 2016
Global development optimizing
i) time to market and ii) value
creation through multiple indications
and WW development
20
Phase II/III registration study in Soft Tissue Sarcoma
Study design STS phase II/III
Population: Patients with locally advanced soft tissue sarcoma of the extremity and trunk wall
Number of patients
Sites and countries
Multi center, open-label, randomised trial with active control
Test arm
156 patients
23 to 30 sites
12 countries
NBTXR3 with RTX 50Gy
Mid 2016
interim data of
104 patients
End points
1 Complete path response rate
(pCR)
2 Tumor shrinking rate and
operability
Randomization
EU, CAN, ASIA
1:1
Stratification population:
myxoid Lps vs others
End 2016
CE mark
RTX 50Gy
Progression free survival
Amputation rate
Comparator arm
QoL
pCR primary endpoint
evaluation
Presentation 2016
Implementation of guidelines for pathological response evaluation with:
International board including leaders from the US and EU
Centralized and blinded assessment reading of the treatment response
21
Next high-value market of NBTXR3 is liver cancer
Study design liver cancer phase I/II
Population: patients with liver cancers who need an alternative treatment when the standard of care (SOC) cannot be used or
does not exist
Number of patients
Sites and countries
Multi center, open-label, non-randomised trial
Phase I up to 40 patients
(IT and IA)
Phase II up to 150 patients
(3 arms)
End points
1 Safety (DTL)
2 Recommended dose
Safety (AE)
CR, PFS, OS (efficacy)
Biological markers
Feasibility of injection
Data points
Presentation 2016
First data H2
2016
Phase I/II in liver cancer will yield several data points on 3 different populations:
Interim safety and feasibility data, interim efficacy data and final data
22
Expanding value of NBTXR3 in an ongoing
head and neck cancer pilot study
Study design H&N cancer phase I/II
Population: Patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx
Number of patients
Sites and countries
Multi center, open-label, non-randomised trial
Part 1 (on going)
40 patients
(IT and IA)
4 dose levels: Age >65 and RTx
alone
3 sites
2 countries
Complete set of
data on first arm
H1 2016
Part 2 to be launch
End points
Adults; combo RTx and
chemotherapy (cisplatine)
1 Safety (DTL)
2 Recommended dose
Safety (AE)
ORR and CR (efficacy)
Local PFS and PFS (efficacy)
Head and neck (H&N) cancer patients
11% of H&N patients will receive RTx alone
35% will receive RTx plus chemotherapy
Feasibility of injection
Interim data
Presentation 2016
Intermediate results show the feasibility of the NBTXR3 injection
Good safety on both 5% and 10% dose levels
No leakage of the product surrounding tissues over time
23
Expanding value and development in the US of NBTXR3
with prostate cancer I/II study
Study design prostate cancer phase I/II
Population: patients with newly diagnosed intermediate and high risk prostate adenocarcinoma treated with androgen
deprivation
Number of patients
Sites and countries
US
PI 3 centers (US) : 2 arms; up
to 24 pts (IT)
PII : up to 20 pts per arm
End points
1 Safety (DTL)
Multi center, open-label, non-randomised trial
IND just granted
Phase I
Phase II
EBRT (24 pts)
Dose escaltion (5, 10, 17, 22%)
IT administration
EBRT 20 pts
at the recommended dose
Brachytherapy + EBRT (24 pts)
Dose escaltion (5, 10, 17, 22%)
IT administration
Brachytherapy + EBRT 20 pts
at the recommended dose
IND granted
2 Recommended dose
Safety (AE)
Feasibility of injection
LPFS, RR, OS
Safety and recommended dose
Safety @ recommended dose
Efficacy: RR, LPFS, biochemical failure, OS
biochemical failure
Data points
Presentation 2016
PI involving 3 reference centers in the US, timeline to be communicated
24
Financials and shareholders
Financials
(€ '000)
Operating revenue
Other revenue
Subsidies
Research tax credit
Total revenue
Cost of sales
R&D costs
General costs
Costs associated with payments in shares
Operating loss
Income from cash
Gross costs of debt
Net cost of debt
Other financial income
Other financial expenses
Pre-tax loss
Tax
Net loss
P&L in shareholder's equity
Foreign exchange translation adjustments
Global results
Diluted earnings per share
Shareholder breakdown
30 June 2015
30 June 2014
91
1,568
139
1,429
91
906
240
666
1,659
997
–
(6,124)
(2,848)
(559)
–
(3,362)
(1,785)
(54)
(7,872)
(4,203)
116
(4)
67
(28)
112
39
3
(16)
–
(2)
(7,773)
(4,166)
–
–
(7,773)
(4,166)
211
(4)
(113)
–
(7,567)
(4,280)
(1)
(0)
Positive cash balance of €25m as of 30 June 2015
Management
7%
Family offices
13%
42%
Free float
38%
Institutional investors
Analyst coverage
Gilbert Dupont (Fr) – Guillaume Cuvillier
CM-CIC Securities (Fr) – Arsène Guekam
Stifel (UK Office) – Michael King
Piper Jaffray & Co – Charles Duncan
Edison Research (UK) *– Dr Philippa Gardner
Funding secured to reach CE Mark for STS
Presentation 2016
25
Achievements and upcoming milestones
Achievements since 18 months
Positive safety and efficacy results of phase I/II
NBTRX3 trial in STS
Upcoming milestones
Interim data NBTRX3 pivotal – phase II/III trial
NBTRX3 CE mark for STS
Start of NBTRX3 pivotal – phase II/III trial in STS
Final data NBTRX3 phase I/II trial in H&N
Positive safety interim results of phase I/II
NBTRX3 trial in H&N cancer / 2 first level
Start of NBTRX3 phase I/II trial in liver
metastasis and HCC
Interim safety and feasibility data, interim efficacy
data of NBTRX3 phase I/II trial in liver
metastasis and HCC
Start of NBTRX3 phase I/II trial in rectum cancer
Initiation of PI/II prostate cancer trial
NBTRX3 clinical data in other indications
New program in Immuno Oncology
Nanobiotix has made significant progress in the development of their lead product
NBTRX3 since its IPO in 2012
Presentation 2016
26
NanoXray positioned to become a standard of care
in oncology
First in class radioenhancer that could change everything without
changing anything
1
Lead product has shown to be both safe and efficacious in “ultimate tumor case”
Derisking the all concept
Allows for higher dose/efficacy without increasing toxicity
2
Versatile application to target the majority of the oncology market
Broad pipeline in six major indications with potential expansion in most of solid tumors
NanoXray can easily be combined with chemotherapy, immuno-oncology …
3
Disruptive innovation compatible with care in current hospital setting
Disruptive innovation in existing and well structured radiotherapy market
Does not require change of the existing infrastructure, protocol, training
4
Several key milestones in the coming 12 months
Sarcoma Phase II/III interim data mid 2016 and CE mark end of 2016
Data in Liver cancer Phase I/II starting H2 2016
Results of Phase I/II H&N cancer H1 2016
Presentation 2016
27
Contacts
Laurent Levy
Philippe Mauberna
CEO
[email protected]
CFO
[email protected]
www.nanobiotix.com
Appendix
Product pipeline targets most RTx applications
Lead product
+ gel
INTRA TUMORAL INJECTION
where access is appropriate
NBTXR3 IT & IA
POST SURGERY RADIOTHERAPY
Gel for Tumor bed deposition
during surgery
NBTXR3 TOPO
Local administration to optimally improve the therapeutic index by
delivering the product where needed only
INTRA VENOUS INJECTION
tumor or organ anatomy
access, staging
NBTX IV
Systemic administration when
local is not appropriate
NBTXR3 IT & IA
Targeted indications
• Soft tissue sarcoma
• Liver metastasis
• Head & neck tumors
• Oesophageal cancer
• Hepatocellular carcinoma • Rectal cancer
• Glioblastoma
• Prostate cancer
• Pancreatic cancer
Product Pipeline to fit all RTx practices and patient situations
Presentation 2016
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Focused and Experienced Management Team
Covering all value chain in Product Development
Executive Board
Laurent Levy, CEO and Co-founder
Pioneer in nanomedicine, 20 years in nanobusiness
Leading roles in several nano-organizations (e.g. Vice
President ETP nanomedicine,)
Philippe Mauberna, Chief Financial Officer
Broad financial experience in the Life Sciences Industry
with successful EMEA operational project management in
Financial Effectiveness
Elsa Borghi, Chief Medical Officer
Successful track record in Research and Development
and registration of several oncology products at Sanofi
Bernd Mühlenweg, Chief Business Officer
Track record in partnering, licensing and M&A
Formerly with WILEX AG
Directors
Patrick Tricoli, VP Corporate Development, in charge
of US Affiliate
Broad experience in Pharmaceutical Industry Corporate
and R&D, with strong focus in international Business &
Partnering activities. Formerly with Sanofi.
Maija Hietava-Lorenzi, Senior Director QA
Broad experience in CMC as Qualified Person and as an
international inspector with World Health Organization.
Former key positions at Ark Therapeutics, Fit Biotech Plc
and Finnish Medicines Agency
Thierry Otin, Senior Director Manufacturing, Supply
Former Quality Site Manager (EU Sterile) at Roche and
before then, Head Pharmacist (Pharmaceutical Qualified
Person) and Quality Director at LFB Biotechnologies
Presentation 2016
Mikaela Dimitriu, VP Global Clinical Development
Former R&D Director in the Pharmaceutical Industry with
strong track record in implementation and management of
international Clinical studies in Oncology field
Agnès Pottier, Senior Director Discovery & IP
Expert in synthesis of nanomaterials
R&D leadership roles for more than a decade
Formerly with Rodhia
Sarah Gaubert, Director Communication & Public
Affairs
Former political advisor and communication for French
Ministers (healthcare, Education and research)
Former political advisor of French President
31
Supervisory Board
Supervisory Board
Laurent Condomine, Chairman of SB
Broad experience in Pharmaceutical Industry
Former Vice-President Business Development
AstraZeneca, responsible for: Group strategy,
mergers and acquisitions
Christope Douat, member of SB
Chairman of Medincell and President of Great North
Broad experience in capital venture
Formerly with Matignon Technologies, one of
Europe’s largest funds specialized in Medtech
Alumni of the Boston Consulting Group
Anne-Marie Graffin, member of SB
Over 20 years in the pharmaceutical industry
Former Executive Director Business Management and
Vice-President for Europe of Sanofi-Pasteur MSD
Dr. Alain Herrera, MD, member of SB
25 years of experience in the pharmaceutical industry
Strong focus in oncology drug development and
marketing
Former Head of the Oncology business at Sanofi-Aventis
for ten years
Former Hematologist Consultant at Antoine Beclere
Hospital
Enno Spillner, member of SB
14 years’ experience in the life science industry
CEO and CFO of 4SC AG, listed german biotech
company
Former Head of Finance and Managing Partner of
the German regional biotech venture fund, BioM AG
Presentation 2016
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Strong IP
9 patent families, from which 6 are published, are protecting the concept and
products
Strong IP protection until 2029 at earliest
Presentation 2016
33
First product NBTXR3:
Billion+ Dollar Market Potential for Initial Indications
INDICATIONS WITH HIGH UNMET NEED NBTXR3
Target patient population in USA, Japan and EU top 5 for initial indications of the portfolio
Indication cancer specific
Indication organ specific (secondary cancer)
Incidence (‘000)
Incidence (‘000)
Advanced Prostate
Cancer
549,9
Colorectal Cancer
461,0
Pancreas Cancer
108,3
Head and Neck Cancer
108,3
Glioblastoma
Soft Tissue Sarcoma
518,0
Colorectal Cancer
Pancreas Cancer
461,0
108,3
Total (‘000)
Hepatocellular
Carcinoma
Esophageal Cancer
Breast cancer
1,087
97,3
57,1
300,0
34,8
21,8
Total (‘000)
Target patient population (‘000)
based on planned registration
studies
1,439
272,6
Target patient population (‘000)
based on planned registration
studies
NBTXR3 target more than 500,000
patients in top 7 countries.
Double by addition of Russia, Brazil,
China, India…
Incidence and target population ( 1): US, Japan, Top 5 EU markets. Ref Datamonitor ref. DMHC2593, DMHC 2467, DMHC 2339 and DMHC 2319 ; . ref. HC 00044-001, HC 00160001 and HC 00177-001.. Ref J. Gastro Intest Oncol, 2014, 5, 3 178-189. Ref NCCN 2014
Presentation 2016
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