NANOBIOTIX : Half Year Results for the period ended 30 June 2013
(Thomson Reuters ONE) -
Small but heading for a big time
Half Year Results for the period ended 30 June 2013
Strong Clinical Progress Achieved
Paris, France, 30 August, 2013 - NANOBIOTIX (the "Company") (Euronext: NANO), a
clinical-stage nanomedicine company pioneering novel approaches for the local
treatment of cancer, has published today its half year results for the six month
period ended 30 June 2013 (HY1). Half year highlights include:
Financial highlights:
* Total revenue of ?0.7m (HY1 2012: ?0.5m) corresponding to the pro-rata share
of the upfront payment from PharmaEngine as planned, amounting to ?0.1m and
corresponding to the research tax credits amounting ?0.6m.
* R&D costs and general costs have risen significantly in the period compared
to HY1 2012 as expected with the acceleration of the clinical development of
lead product, NBTXR3 and the reinforcement of the Company's structure and
governance as stated during the IPO process.
* Underlying loss after tax for the period was ?-4.3m (HY1 2012: ?-2.5m) due
to the increase in costs.
* Cash balance as of 30 June 2013 was ?8.1m (HY1 2012: ?1.0m) as per the
forecast, since cash management remains a key company's focus.
Main operational highlights:
* Clinical achievements
* Clinical proof of concept of NBTXR3 in Phase I trial for soft tissue
sarcoma; next group of patients to be treated in H2 2013.
* Second indication for NBTXR3 in head and neck cancer selected; Phase I
trial to commence in H2 2013.
* The National Cancer's Institute's Nanotechnology Characterization
Laboratory selected NBTX-IV for characterization studies on the basis of
its potential to impact cancer treatment.
* Strengthening of the Supervisory Board with the appointment of Alain
Herrera, a pioneer of industrial oncology.
Post period end main highlights:
* Nanobiotix received a ?2.8m grant from Bpifrance among a ?9.0m French
nanomedicine development program. This will directly support the
development of NBTXR3 in a third new indication, hepatocellular (liver)
cancer.
* Strengthening of the Management Team with the appointment of Philippe
Mauberna as CFO.
Laurent Levy, Chief Executive Officer at Nanobiotix, said:
"We have made excellent clinical progress in the period, beyond what we
originally expected, and we would like to accelerate this further if possible.
The second half of the year started well and we expect the initiation of the new
clinical trial and the reporting of trial results in the period.
We continue to control costs tightly and have focused on strengthening the
Company's structure and governance during the period. We have also received a
grant from the Bpifrance which not only acknowledges the potential impact of our
technology in cancer treatment, but also is helpful in managing the cash flow.
Our strategy is to seek further international collaborations that will allow us
to provide sustainable company growth, but we also want to drive progress
forward ourselves, with the continued support of our shareholders. As part of
our internal plans, we will continue to enhance the operational and commercial
experience of the Supervisory Board and management team as we bring our NanoXray
products through the clinic and onto the market."
CEO's Operational Report
Overview
Nanobiotix is focused on the development of NanoXray, its first-in-class
proprietary technology, which is at the forefront of a new era of nanomedicine,
where nanoparticles are not just a vehicle for targeted drug delivery, but have
become the principal active element. Nanobiotix is developing three different
products that can be administered either by direct injection into the tumor
(NBTXR3), intravenous injection (NBTX-IV) or topical application to fill tumor
cavities during surgery (NBTX-TOPO). Currently, NBTXR3 is regarded as a medical
device in Europe and a drug in the United States (US).
During HY1 2013, we have made strong progress on delivering the commitments made
at the time of the IPO in October 2012. Most notably, we achieved clinical proof
of concept of our lead product, NBTXR3, in Phase I trials for soft tissue
sarcoma (STS). With the authorization of the French National Security Agency for
Medicines and Health Products (ANSM), we are planning to start a new clinical
trial in head and neck cancer in the second half of the year. These achievements
have helped to strengthen interest from the scientific and financial community
in our technology.
Beyond these developments, Nanobiotix has been able to accelerate the
development of its pipeline faster than expected. Notably with the ?2.8 million
funding received after the post period end from Bpifrance that will allow us to
expand NBTXR3 development in liver cancer. We have also entered into
collaboration with the National Cancer Institute (NCI) in the US to initiate
preclinical development of NBTX-IV, the second product from the NanoXray
pipeline.
The Company aims to establish its pipeline of NanoXray products, as cancer
nanomedicine reference points in the oncology market and is working closely with
national and scientific bodies to promote the nanomedicine sector as a whole.
Product development - NBTXR3
NBTXR3 is our most advanced product in the clinic and comprises nanoparticles
designed for direct injection into the tumor. The potential indications for
NBTXR3 are primary head and neck cancers, liver cancer, glioblastoma (a specific
form of brain cancer), rectal and prostate cancer.
Soft tissue sarcoma (STS)
STS is a form of cancer that develops in soft, supporting tissues of the body.
The cancer can occur in cells and tissues such as fat cells, muscles, joints and
in any other tissues that support, surround, and protect organs of the body.
Patients with high grade STS have poor prognoses, with many undergoing
radiotherapy prior to surgery to remove the tumor.
Treatment with a combination of NBTXR3 nanoparticles and radiotherapy aims to
destroy tumors locally and more effectively, in order to facilitate surgery and
complete the removal of the malignant tissue.
NBTXR3 achieved proof-of-concept in a Phase I trial of soft tissue sarcoma and
represents the successful transition of the NanoXray platform from preclinical
models into the clinic. We expect to see the next group of patients treated in
H2 2013.
Head and neck cancer
Head and neck cancer represents a group of biologically similar cancers that
appear in the mouth, the nose, the sinuses and at the top of the aerodigestive
tract. If detected early, the survival rate for this type of cancer is high, and
treatment is usually via surgery or radiation therapy. However, surgery can have
a detrimental effect on the patient's function, in terms of swallowing,
breathing or speech, and cosmetic appearance.
This will be the second indication for NBTXR3 in radiation therapy with the aim
to improve tumor destruction, and to maintain the patients' function and
appearance after treatment. We have received authorization from the ANSM, to
start a clinical trial at Institut Curie, Paris, France.
Hepatocellular (liver) cancer
Post period end, we announced the commencement of NBTXR3 development in a third
indication, liver cancer. Liver cancer is a major global health problem with an
estimated 695,000 deaths per annum worldwide.
To help accelerate this programme, we have been awarded a ?2.8 million grant
from Bpifrance through its Strategic Industrial Innovation (ISI) program.
Bpifrance (formerly OSEO) allocated c.?9 million in funding to the NICE (Nano
Innovation for CancEr) consortium, consisting of Nanobiotix and four other
public and private partners. Through ETPN (European Technology Platform of
Nanomedicine), Nanobiotix is driving nanomedicine in Europe and is now involved
in this first nanomedicine consortium in France with the launch of the NICE
project.
PharmaEngine
Since August 2012, Nanobiotix has a strategic partnership in place with
PharmaEngine for the development of NBTXR3 in the Asia region. PharmaEngine is a
specialty pharma company focused on the development of in-licensed oncology
drugs and has exclusive rights to develop and commercialize NBTXR3 in the Asian-
Pacific region. Nanobiotix received an upfront payment of US$1 million (?811k)
and is eligible to further payments upon agreed milestones.
The partnership is progressing with the preparation of clinical studies in
potential key indications such as head and neck, oesophageal, liver and rectal
cancer.
Lead candidate selection - NBTX-IV
NBTX-IV is the second product generated from Nanobiotix's proprietary NanoXray
platform. In June, Nanobiotix selected the lead candidate (see NCI-NCL section
below). The product is designed to be administered intravenously to target deep-
seated tumors and lymph nodes which may have been invaded locally by cancer
cells. The aim is to enhance radiotherapy energy to destroy cancer cells and to
reduce the subsequent escape of malignant cells in neighbouring tissue cells or
lymph nodes. Target indications include lung carcinoma, pancreatic cancer or
brain metastases.
Collaboration with the National Cancer Institute (NCI) with NBTX-IV
The NCI-NCL has selected NBTX-IV for preclinical characterization to support
Nanobiotix's filing of an Investigational New Drug (IND) with the FDA. In
parallel, Nanobiotix will conduct additional pre-clinical testing to provide a
complete dossier for submission.
This collaboration with the NCL, planned to commence in H2 2013, will accelerate
the preclinical development of NBTX-IV. The results of the characterization are
not only important for the future IND submission, but also to raise Nanobiotix's
profile in the US market.
Product development - NBTX-TOPO
The third product from the NanoXray platform is in the form of a topical
application, developed to be used to fill tumor cavities during surgery. The
product is intended for different types of breast cancer, brain tumors and
retroperitoneal soft tissue sarcomas. It could also be used to delineate the
tumor in CT scans and to prepare the tumor bed for postoperative radiotherapy.
NBTX-TOPO is still at an early stage of development.
Supervisory Board and Management appointments
We are very pleased to welcome Dr. Alain Herrera to our Supervisory Board. He is
an esteemed oncologist and haematologist, and is one of the French pioneers of
industrial oncology. Alain brings important expertise to the Supervisory Board.
We have also strengthened the management team with the appointment of a new
Chief Financial Officer (CFO), Philippe Mauberna, who has significant commercial
and operational experience in the pharma and high tech industries. His
international expertise will be especially important as Nanobiotix realises its
strategic plans for its products.
Outlook and summary
In the relatively short time that we have been operating as a public Company, we
have made significant strides in further developing our platform technology,
NanoXray, while establishing new indications for our lead product, NXBTR3, and
commencing the development of our next programme, NBTX-IV. In parallel with
driving our own programmes, we are committed to promoting nanomedicine as a new
generation cancer treatment for patients. We are doing this through our
membership with the European Technology Platform for Nanomedicine (EPTN) and
through our collaborations with international organisations, such as the NCI-
NCL. We aim to continue to drive forward our clinical development plan and
expect to report on next intermediate trial results in the second half of the
year. We also expect the profile of nanomedicine to continue to grow, which
should benefit both patients and in turn, Nanobiotix.
Laurent Levy
CEO
Financial Review (IFRS)
The detailed financial statement of revenues and costs is laid out below:
+-------------------------+
| 6 months period closed |
+----------------------------------------------------+------------+------------+
|? (0'000) |June 30 2013|June 30 2012|
+----------------------------------------------------+------------+------------+
|Operating revenue | 95| -|
+----------------------------------------------------+------------+------------+
|Other revenue | 572| 466|
+----------------------------------------------------+------------+------------+
|Subsidies | 58| 80|
+----------------------------------------------------+------------+------------+
|Research Tax Credit | 513| 386|
+----------------------------------------------------+------------+------------+
|Total revenue | 666| 466|
+----------------------------------------------------+------------+------------+
|Cost of sales | -| -|
+----------------------------------------------------+------------+------------+
|R&D costs | -2 739| -2 271|
+----------------------------------------------------+------------+------------+
|General costs | -1 809| -578|
+----------------------------------------------------+------------+------------+
|Costs associated with payments in shares | -408| -126|
+----------------------------------------------------+------------+------------+
|Core operating loss | -4 289| -2 509|
+----------------------------------------------------+------------+------------+
|Income from cash | 24| -|
+----------------------------------------------------+------------+------------+
|Gross cost of debt | -13| -13|
+----------------------------------------------------+------------+------------+
|Net cost of debt | 11| -13|
+----------------------------------------------------+------------+------------+
|Other financial income | -| -|
+----------------------------------------------------+------------+------------+
|Other financial expenses | -1| -|
+----------------------------------------------------+------------+------------+
|Core pre-tax loss | -4 279| -2 522|
+----------------------------------------------------+------------+------------+
|Tax | -| -|
+----------------------------------------------------+------------+------------+
|Net loss | -4 279| -2 522|
+----------------------------------------------------+------------+------------+
|Profit and loss recognized directly in | | |
|shareholders' equity | -| -|
+----------------------------------------------------+------------+------------+
|Global results | -4 279| -2 522|
+----------------------------------------------------+------------+------------+
|Diluted earning per share | 0.39| 0.32|
+----------------------------------------------------+------------+------------+
Financial Review
As in the previous quarter, the 2013 half-year sales recorded by Nanobiotix
corresponds to the pro-rata share of the upfront payment received by the Company
in August 2012, within the framework of the licensing contract signed with the
Taiwanese company, PharmaEngine for the development and marketing of NBTXR3 in
the Asia-Pacific region.
This upfront payment amounts to ?811k generating a revenue of ?92k for the first
semester of 2013. The invoicing of services totalled ?3k for the period. In
total, revenue for the first half of 2013 is ?95k which is fully in line with
Company expectations.
Total revenue also includes subsidies and research tax credits. The amount of
research tax credits has risen due to the increased spending in R&D reflecting
our activity in clinical studies amounting ?572k.
Operational costs are amounting ?5.0m compared to ?3.0m as of June, 30(th) 2012.
R&D costs have risen as expected with the strengthening of clinical studies for
our lead product NBTXR3 in the STS indication and the preparation of new
indications such as head and neck. Some recruitment has been done to enhance the
operational and scientific skills within the Company.
General costs have increased due some expected expenses following Company's new
listed status and due to the reinforcement of the Company's governance
structure.
The core operating loss was ?4.3m compared to ?2.5m in H1 2012. The total net
loss amounted to ?4.3m (HY1 2012: ?2.5m).
The cash balance has been carefully managed during the period and as at 30 June
2013, was ?8.1m (HY1 2012: ?1.0m) as per the forecast stated during the IPO, in
order to support company's development plan.
-Ends-
Laurent Levy, CEO of Nanobiotix, will host a conference call for analysts to
provide an overview on Nanobiotix and the Half Year results, followed by a Q&A
session, in the morning on Monday, 2 September 2013.
If you would like further information, please contact College Hill: +44 (0)
207 457 2020.
Next financial press release: revenue for the 3(rd) quarter of 2013 on November
15, 2013
About NANOBIOTIX
Nanobiotix 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 and brachytherapy 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. The Company has partnered with PharmaEngine for clinical
development and commercialization of NBTXR3 in Asia. The Company is based in
Paris, France.
Nanobiotix is listed on the NYSE Euronext regulated market in Paris (ISIN:
FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP).
www.nanobiotix.com
For more information, please contact:
Nanobiotix Yucatan
Sarah Gaubert Media relations (France)
Head of Communication and public Annie-Florence Loyer / Nadège Le Lezec
affairs
+33 (0)1 40 26 07 55
contact(at)nanobiotix.com +33 (0)1 53 63 27 27 / +33 (0)6
88 20 35 59
afloyer(at)yucatan.fr
NewCap. College Hill
Financial communication and investors Media relations (Outside France)
relations Melanie Toyne Sewell / Claire Dickinson
Louis-Victor Delouvrier / Emmanuel +44 (0) 207 457 2020
Huynh nanobiotix(at)collegehill.com
+33 (0)1 44 71 98 53
lvdelouvrier(at)newcap.fr
Press Release (PDF):
http://hugin.info/157012/R/1726365/576042.pdf
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Source: NANOBIOTIX via Thomson Reuters ONE
[HUG#1726365]
Datum: 30.08.2013 - 18:41 Uhr
Sprache: Deutsch
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