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Nanobiotix 2013 Review: Significant Corporate and Clinical Progress



  Nanobiotix 2013 Review: Significant Corporate and Clinical Progress

Business Wire

PARIS -- January 7, 2014

Regulatory News:

NANOBIOTIX (Euronext : NANO – ISIN: FR0011341205), a clinical-stage
nanomedicine company pioneering NanoXray, a novel approach for the local
treatment of cancer, summarises its activities and progress made during 2013
and announces its prospective financial communications calendar for the fiscal
year 2014.

I. Key clinical steps for the NanoXray pipeline
II. Strengthening management and corporate governance
III. Increasing international reputation
IV. Outlook and conclusion
V. Financial calendar summary for 2014

I. Key clinical steps for the NanoXray pipeline

The NanoXray pipeline progressed significantly over the past 12 months. Lead
product NBTXR3 achieved clinical proof-of-concept and NBTX-IV and NBTX-TOPO
reached major preclinical milestones.

  * June 2013: NBTXR3 clinical proof-of-concept, first product from the
    NanoXray pipeline

NBTXR3 nanoparticles are designed to absorb X-rays in order to significantly
enhance the radiation dose within cancer cells.

The French National Agency for Medicines and Health Products (ANSM) gave its
approval to Nanobiotix to launch a phase I clinical trial of NBTXR3 in
patients with Soft Tissue Sarcoma (STS) to assess the feasibility of the
concept and the patients’ tolerance to the product.

In June 2013, Nanobiotix published positive interim results from the phase I
trial establishing the proof-of-concept of NBTXR3 by demonstrating adequate
distribution of the nanoparticles within the tumors for over five weeks of
radiation therapy along with patient tolerance to the product.

Achieving the proof-of-concept is a key step in the clinical development of
NBTXR3, the first product from the NanoXray pipeline, and represents the first
stage of Nanobiotix’s transition as a novel therapeutic in humans.

  * June 2013: Start of a second indication for NBTXR3 product, head and neck
    cancers

Following the positive interim results of NBTXR3 in patients with advanced
Soft Tissue Sarcoma, the ANSM gave its approval to start a new clinical trial
for the product in patients with locally advanced head and neck cancers
(cancers of the oral cavity or of the oropharynx).

These types of cancer are a major challenge to treat as the current standard
of care, combining chemotherapy and radiotherapy, has a very high relapse
rate.

This indication is of a high strategic interest as it embodies a new method of
treatment that could mean the avoidance of highly disabling surgery for
patients.

  * June 2013: Initiation of the preclinical development of the second
    NanoXray product, NBTX-IV, in the US

NBTX-IV product was selected by the National Cancer Institute’s (NCI)
Nanotechnology Characterization Laboratory (NCL), in the US, for
characterization studies.

The results from the studies will support Nanobiotix’s filing of an
Investigational New Drug (IND) application for the US Food and Drug
Administration (FDA) authorization towards product registration in the US
market.

  * July 2013: Bpifrance public funding for the development of NBTXR3 in a
    third indication, liver cancer

Nanobiotix received a grant of €2.8 M awarded through Bpifrance’s Strategic
Industrial Innovation (ISI) program, to accelerate the clinical and industrial
development of the Company’s lead product NBTXR3 in a new indication, liver
cancer (hepatocellular carcinoma).

This grant supports the broader launch of NICE (Nano Innovation for CancEr), a
consortium consisting of five public and private partners including
Nanobiotix. Its mission is to build a platform to accelerate the development
and industrialization of nanomedicine in France.

  * December 2013: Launch of the preclinical development of NBTX-TOPO product

The third product from the NanoXray platform, NBTX-TOPO, is a gel containing
NanoXray nanoparticles. This nanotherapeutics with embedded radar combines two
important functions: a more efficient eradication of remaining cancer cells
following the surgical removal of a tumour and a more accurate localization of
the tumour bed (post-surgical cavity). NBTX-TOPO is potentially applicable for
all types of post-operative radiotherapy.

II. Strengthening management and corporate governance

  * February 2013: Appointment of Dr Alain Herrera to the Supervisory Board

A pioneer in industrial oncology, Dr. Alain Herrera has an outstanding
experience in the pharmaceutical industry and business development. He notably
headed the Oncology business at Sanofi-Aventis for ten years, where he was
Vice President for the Global Oncology Business Strategy and Development
(2007-2008) and Head of the Global Oncology Franchise (1998-2007). Dr Herrera
contributed as such to the worldwide registration of many anti-cancer
products. His previous responsibilities within the pharmaceutical industry
include the roles of Chairman of Chiron Therapeutics Europe, Managing Director
at Pierre Fabre Oncology Laboratories and Head of the Oncology Platform at
Roger Bellon (Rhône Poulenc). In addition to these roles, Dr. Herrera has been
a Hematologist Consultant at Antoine Beclere Hospital since 1991.

  * September 2013: Appointment of Philippe Mauberna to the Executive Board,
    CFO of Nanobiotix since May 2013

As an expert in management and the development of financial and operational
projects for the pharmaceutical industry, Philippe Mauberna (ISG-INSEAD), has
been involved in several international projects (UK, Saudi Arabia, South
Africa and Indonesia). Dedicated to the Life Sciences industry for more than
10 years, Philippe has held senior Financial and Operations positions at
Astellas Pharma Europe participating in the reinforcement of EMEA commercial
effectiveness in Africa and in Europe, most notably this was supporting market
authorization for several healthcare products.

Philippe has also been heavily involved in financial projects for start-up
launches and innovative SME development. As a consultant, he has provided
strategic change management support for European pharmaceutical companies
during their development phases.

  * September 2013: Creation of a Communication and Public Affairs Department
    headed up by Sarah Gaubert

Former advisor to the French Presidency and to several Ministries (Health,
Solidarity, Education and Research), Sarah Gaubert, consultant in strategic
communications, heads Nanobiotix’s newly created Communication and Public
Affairs Department.

III. Increasing international reputation

  * Nanobiotix and Laurent Levy received two prestigious awards

       * April 2013: Laurent Levy received the UB Entrepreneurship Award from
         the University at Buffalo, SUNY. The award is given to individuals
         that have championed a UB technology to create a highly successful
         company and whose products will have a beneficial impact on the lives
         of people worldwide. It recognises Laurent’s entrepreneurial
         aspirations that led to the creation of Nanobiotix in 2003, now one
         of the leading companies in the field of nanomedicine.
       * November 2013: Nanobiotix honoured at the Investor Awards 2013 in the
         “Young Talent” category. This prize was awarded by Boursorama and
         Morningstar who jointly organize the largest survey that ranks listed
         companies by individual and professional investors’ preferences. The
         online survey was conducted with investors by OpinionWay in May 2013.
         In total, almost 40,000 votes were collected (two-thirds of
         individuals and a third of professionals).

  * Nanobiotix invited to speak at national and international events

Nanobiotix has been invited to speak at national and international events
providing the opportunity for the Company to present the innovative NanoXray
technology and to meet all of the stakeholders within and beyond the field,
including the pharmaceutical industries, medical community, academia and
potential investors.

Nanobiotix took part in the following events:

  * Future Leaders in the Biotech Industry (BioCentury) -April 2013
  * BIO International Convention 2013 - April 2013
  * Clinical Oncology meeting - Chicago May-June 2013
  * EuroNanoForum - June 2013
  * CLINAM - June 2013
  * ASTRO - September 2013
  * Biotech in Europe Investors Forum (SACHS) - October 2013
  * BioEurope - November 2013
  * New York Academia of Science - November 2013

  * Renewal of Laurent Levy as Vice-chairman of the European Technology
    Platform on Nanomedicine (ETPN) for the second year running

The ETPN is an initiative led by industry and set up together with the
European Commission. Embracing all stakeholders of the nanomedicine ecosystem
from academia and research institutes to SMEs and large industries, the ETPN
is dedicated to the organization of the nanomedicine landscape in Europe by
identifying the current gaps and needs and setting up Roadmaps and Strategic
and Research Agendas (SRAs). In addition to driving the field of nanomedicine
in Europe, the ETPN is striving for the efficient translation of R&D results
into innovative nanomedicine products.

III. Outlook and conclusion

2013 was a year marked by significant progress in its clinical program; this
will continue to be a theme of 2014.

The first intermediate results of the clinical study on head and neck cancers
are expected, the trial on liver cancer is anticipated to start in the last
quarter of 2014, and the phase I study led in France on soft tissue sarcoma
should be finalised.

During the year, Nanobiotix will be focused on accelerating its clinical
development outside Europe, with the initiation of two trials led by
PharmaEngine in Asia.

The Company also intends to extend its ambitious partnership policy
geographically by targeting the US.

The Nanobiotix team is determined to drive the Company’s development forward,
maintaining the momentum seen in 2013. The Company is fortunate to have strong
support from its shareholders to do this and the benefit of a committed
internal team.

III. Financial calendar summary for 2014

Nanobiotix will announce its financial and operating results according to the
following anticipated schedule (which may change slightly):

  * January 31, 2014 - Annual Turnover
  * April 12, 2014 - Annual results
  * May 15, 2014 - Turnover of the first quarter
  * July 11, 2014 – Half yearly turnover
  * August 29, 2014 - Half yearly results
  * November 14, 2014 - Turnover of the third quarter
  * Before June 30, 2014 - Annual General Assembly Paris, France

                                    -Ends-

About NANOBIOTIX : www.nanobiotix.com/en

Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a clinical-stage
nanomedicine company pioneering novel approaches for the local treatment of
cancer. The Company’s first-in-class, proprietary technology, NanoXray,
enhances radiotherapy energy to provide a new, more efficient treatment for
cancer patients. NanoXray products are compatible with current radiotherapy
treatments and are meant to treat a wide variety of cancers via multiple
routes of administration.

Nanobiotix’s lead product NBTXR3, based on NanoXray, is currently under
clinical development for soft tissue sarcoma and locally advanced head and
neck cancer. The Company, based in Paris, France, has partnered with
PharmaEngine for clinical development and commercialization of NBTXR3 in Asia.

Nanobiotix is listed on the regulated market of NYSE Euronext in Paris (ISIN:
FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP).

Disclaimer

This press release contains certain forward-looking statements concerning
Nanobiotix and its business. Such forward-looking statements are based on
assumptions that Nanobiotix considers to be reasonable. However, there can be
no assurance that the estimates contained in such forward-looking statements
will be verified, which estimates are subject to numerous risks including the
risks set forth in the 2012 financial annual report of Nanobiotix (a copy of
which is available on www.nanobiotix.com) and to the development of economic
conditions, financial markets and the markets in which Nanobiotix operates.
The forward-looking statements contained in this press release are also
subject to risks not yet known to Nanobiotix or not currently considered
material by Nanobiotix. The occurrence of all or part of such risks could
cause actual results, financial conditions, performance or achievements of
Nanobiotix to be materially different from such forward-looking statements.

This press release and the information that it contains do not constitute an
offer to sell or subscribe for, or a solicitation of an offer to purchase or
subscribe for, Nanobiotix shares in any country.

Contact:

For more information, please contact:
Nanobiotix
Sarah Gaubert
Head of Communication
and Public Affairs
+33 (0)1 40 26 07 55
contact@nanobiotix.com
or
NewCap.
Financial communication
and investors relations
Louis-Victor Delouvrier / Emmanuel Huynh
+33 (0)1 44 71 98 53
lvdelouvrier@newcap.fr
or
Yucatan
Media relations (France)
Annie-Florence Loyer/ Nadège Le Lezec
+33 (0)1 53 63 27 27 / +33 (0)6 88 20 35 59
afloyer@yucatan.fr
or
College Hill
Media relations (Outside France)
Melanie Toyne Sewell / Donia Al Saffar
+44 (0) 207 457 2020
nanobiotix@collegehill.com
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