NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late
clinical-stage nanomedicine company pioneering novel approaches for
the local treatment of cancer, announces its audited consolidated
results for the fiscal year ended December 31, 2015:
- Consolidated cash position as of December 31, 2015 closed at
€17 million, confirming the control of all expenses
- Increase of expenses corresponds to progression and expansion
of clinical development - five clinical trials running in six
indications - and market access activities, according to plan
- Expenses remained in line with expectations
Philippe MAUBERNA, Chief Financial Officer of
Nanobiotix commented: "2015 has been significant as we have made
important advances across both the business and clinical fronts,
paving the way for 2016 and beyond. Our financial position remains
strong and in line with expectations as we enter 2016 - a decisive
turning point year for Nanobiotix. We focus our resources on
delivering key clinical data that will sustain our future
growth."
As announced in March 2016, the company has
completed a private placement of €21.3 million providing funding
until mid-2017.
Income statement
|
2015 |
2014 |
Total revenue € |
4,015,229 |
2,770,795 |
Sales License Other sales Services Other revenue
Subsidies Research Tax Credit Other |
265,543 183,893 66,179 15,471 3,749,686
199,838 3,546,035 3,814 |
967,500 967,500 - - 1,803,295 314,764
1,483,122 5,408 |
Cost
of sales |
- |
- |
R&D costs |
(13,901,898) |
(8,075,723) |
General costs (market access, G&A, .) |
(5,963,488) |
(4,062,591) |
Costs associated with payments in shares |
(1,291,491) |
(252,257) |
Core operating loss |
(17,141,647) |
(9,619,777) |
Financial gain / (charges) (*) |
138,562 |
142,522 |
Core pre-tax loss |
(17,003,084) |
(9,477,255) |
Tax |
- |
(79,271) |
Net Profit & Loss |
(17,003,084) |
(9,556,525) |
* cost of net financial debt and other financial
expenses
Financial Review
Total Revenue in 2015 amounts to €4M vs.
€2.8M in 2014 mainly due to:
- Sales revenue to PharmaEngine are amounting to €265,5K,
providing from the upfront payment received in 2012 and linearized
on an annual basis for €184K/year, sales of other services for €66K
and Re-invoicing of services for €15K
- Other revenue is amounting to €3.749,7K coming mainly from
Research Tax Credit (CIR) that have risen sharply due to higher
levels of R&D activities and the preparation to launch in new
clinical indications in 2015
Total Operating expenses reach €21,2M in 2015
vs. €12,4M in 2014:
- R&D expenses at €13.9M (+€5,8M) to support the acceleration
of clinical programs (€5M), the manufacturing scale up (€3M) and
the preclinical research developments (€3,5M)
- General cost expenses reached €6M (+€1,9M) mainly due to the
increase of resources in market access and launch readiness (€0.9M)
and the development of Nanobiotix US affiliate (€0.8M)
- Cost associated with share based payment has reached €1,2M
which proceeds to an accounting evaluation (non-cash
impactful)
Total Headcount reached 60 FTEs in 2015 vs. 49
FTEs in 2014.
Total loss after tax 2015 up to €-17M (vs.
€-9.6M FYE 2014) as per budgeted operations development.
FYE 2015 cash balance of €17M as per
expectations.
-------------------------------------
2015: a year of structuring and development
expansion
There have been significant clinical and
business developments for Nanobiotix in 2015. The Company has built
an extensive clinical development program through six indications
(versus two in 2014). Expenses remained in line with planned
budget. The key highlights of the period are summarised below.
The Company continued to strengthen its R&D
to sustain its development.
In perspective of obtaining the CE mark,
expected towards the end of 2016, market access activities have
begun and additional personnel has been hired to support these
programs. The Company also secured a new partnership with
CordenPharma, in anticipation of future NBTXR3 production needs, to
meet the demand from clinical trials (in Europe and United States)
and future commercialization.
In addition, Nanobiotix US affiliate has
increased its activities in particular with the preparation of the
prostate cancer indication to be started in 2016.
In 2015, Nanobiotix also hired the
well-respected Robert Langer as a Scientific Advisor.
Clinical development - NBTXR3
2015 surpassed expectations with many major
clinical developments moving Nanobiotix closer towards
demonstrating the use and transferability of NBTXR3's therapeutic
approach across different types of cancers.
Major clinical developments included:
- Significant progress and expansion of the STS Phase II/III
registration trial ("Act.in.sarc" study) for NBTXR3 in 10
countries
- Positive preliminary results from the head and neck cancer
Phase I/II trial with NBTXR3, showing the feasibility of the NBTXR3
injection and a good safety profile of the product in first dose
levels
- The launch of liver cancers Phase I/II trial with NBTXR3 in two
different populations: HCC and liver metastases
- Nanobiotix also received approval from the US Food and Drug
Administration (FDA) for the Company's Investigational New Drug
(IND) application on December 30, 2015 (announced January 2016).
This allows Nanobiotix to launch its first clinical study in the US
for its lead product NBTXR3 in prostate cancer, a new and very
significant indication
Nanobiotix's focus is on developing NBTXR3 in
multiple cancer indications for use alongside standard radiotherapy
treatment to increase efficacy at the same dose. The Company's
pipeline currently includes soft tissue sarcoma (STS) Phase II/III
registration trial, head and neck cancer Phase I/II trial, liver
cancers Phase I/II trials, prostate cancer Phase I/II trial, and
rectal cancer Phase I/II trial (by PharmaEngine). The trials are
running across Europe, USA and Asia.
-------------------------------------
2016: A critical year to demonstrate the
potential of NBTXR3
2016 got off to a great start for Nanobiotix and
its lead product, NBTXR3, with the launch of a new preclinical
research program and a successful private placement enabling the
Company to remain well funded until mid-2017.
Immuno-oncology research program
On January 5, 2016, Nanobiotix announced the
start of a new preclinical research program in immuno-oncology with
its lead product, NBTXR3, which could have the potential to bring a
new dimension to cancer immunotherapies. This project is in
addition to the Company's core current advanced clinical
development program for NBTXR3 as a single agent.
Financial developments
On March 11, 2016, the Company successfully
completed a €21.3 million private placement of new ordinary shares.
The new ordinary shares were issued primarily with life sciences
specialist investors, the majority of which are from the United
States.
Forthcoming expected newsflow
In the coming months, Nanobiotix expects to
deliver multiple milestones from its clinical and corporate
development activities to validate NBTXR3's potential use as a new
standard of care in oncology with the potential to treat a large
number of patients across the world.
Soft tissue sarcoma (STS)
Nanobiotix expects to announce the interim data
readout from its STS Phase II/III pivotal study in mid-2016. The
interim data readout could allow the filing for CE mark. The
Company will present the final data at a later stage after all
patients have been treated.
Expected CE mark end of 2016
Assuming a positive outcome from the STS trial,
Nanobiotix could obtain CE mark at the end of 2016, its first
market approval.
Head & neck cancer
Nanobiotix is expecting the first complete set
of data from the NBTXR3 head & neck cancer Phase I/II trial in
H1 2016. Positive data could allow Nanobiotix to enter registration
phase, further expanding the potential market for Nanobiotix's lead
product.
In addition, particular attention will be on
comparing the data (with the STS data) to analyze at the
transferability from one indication to another. This could increase
the chance of successful transferability across all solid tumor
indications.
HCC clinical trial and liver metastases clinical
trial
The Company expects the first intermediate
results from the Phase I/II study in liver cancers (HCC and liver
metastases) in the different patient's populations to be announced
in H2 2016. The results are expected to show the safety and
feasibility on first dose levels and could give another hint about
the potential value increase of NBTXR3.
Prostate cancer
Following the IND granted by the FDA on December
30, 2015, Nanobiotix plans to initiate the Phase I/II prostate
cancer trial in the US in 2016. This indication opens additional
Medical Value and significantly enlarges the potential market for
NBTXR3. Nanobiotix will communicate the expected timing of the
trial this year.
Additional development on NBTXR3 in combination
with Immuno-oncology
Early in 2016, Nanobiotix started a new research
program in immuno-oncology with its lead product NBTXR3. The first
preclinical results are expected later this year. These preclinical
results should establish the proof of concept for potential
combination of NBTXR3 with immuno-oncology approaches across
oncology and open new perspectives for potential deals.
The core business of Nanobiotix is to develop
NBTXR3 as a single agent with radiotherapy and this year is
critical to demonstrate the value potential.
-Ends-
Next financial press release: revenue for Q1 2015 on May 13,
2016.
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late 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 with a view to provide a new, more efficient
treatment for cancer patients.
NanoXray products are compatible with current
radiotherapy treatments and are meant to treat potentially a wide
variety of solid tumors including soft tissue sarcoma, head and
neck cancers, liver cancers, prostate cancer, breast cancer,
glioblastoma, etc., via multiple routes of administration.
Nanobiotix's lead product NBTXR3, based on
NanoXray, is currently under clinical development for soft tissue
sarcoma, head and neck Cancer, prostate cancer, rectal cancer
(PharmaEngine) and liver cancers (HCC and liver metastases). The
Company has partnered with PharmaEngine for clinical development
and commercialization of NBTXR3 in Asia.
Nanobiotix is listed on the regulated market of
Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO,
Bloomberg: NANO: FP). The Company Headquarter is based in Paris,
France. Affiliate in Cambridge, United States.
Contact
Nanobiotix |
|
Sarah Gaubert Head of Communication and Public
Affairs +33 (0)1 40 26 07 55 contact@nanobiotix.com |
|
Media relations |
France - NewCap
Annie-Florence Loyer +33 (0)6 88 20 35 59
afloyer@newcap.fr |
|
Outside France -
Instinctif Partners Melanie Toyne Sewell +44 (0) 207 457
2020 nanobiotix@instinctif.com |
Disclaimer
This press release has not been audited.
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 reference
document of Nanobiotix registered by the French Financial
Markets Authority (Autorité des marchés financiers) on January 12,
2016 under number R.16-001 (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.
HUG#2008690
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