Nanobiotix 2017 Annual
Results
Paris, France and Cambridge, Massachusetts,
USA, March 30, 2018 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering new approaches to the treatment of cancer, today
announces its audited consolidated results for the fiscal year
ended December 31, 2017:
- Expansion of the Nanobiotix clinical development program
activities - seven clinical trials running in eight indications on
3 continents - in relation to the market access of NBTXR3,
Nanobiotix's lead product, have impacted operating expenses as
planned.
- Continuation of the structuration of the Company: several
recruitments, notably within the Medical Affairs department,
opening of 2 affiliates in Europe and preparation of a new
manufacturing site.
- Consolidation of the cash available at €47.2M strengthened by
the completion of two private placements executed in April and
October 2017.
The audited consolidated financial statements
for the fiscal year ended December 31, 2017 have been approved by
the management board and reviewed by the supervisory board of the
Company dated on March 29, 2018.
Consolidated Income statement[1]
€ |
2017 |
2016 |
Total revenue |
3,721,525 |
5,421,613 |
SalesLicenseOther salesServices Other
revenuesSubsidiesResearch Tax CreditOther |
251,96814623,205228,617
3,468,557153,7213,259,47856,358 |
1,558,1011,075,37299,450383,279
3,863,51298,0953,703,27862,139 |
Cost of sales |
- |
- |
R&D costs |
(16,336,844) |
(16,915,243) |
Selling, General and Administrative (SG&A) (Market Access, BD
and other corporate costs) |
(9,708,781) |
(8,370,208) |
Costs associated with payments in shares |
(2,605,054) |
(1,990,855) |
Core operating loss |
(24,929,153) |
(21,854,693) |
Other operational costs |
(337,888) |
- |
Core loss |
(25,267,041) |
(21,854,693) |
Financial result |
(876,187) |
64,607 |
Core pre-tax loss |
(26,143,228) |
(21,790,086) |
Tax |
(20) |
(90,425) |
Net Profit & Loss |
(26,143,249) |
(21,880,511) |
Financial Review
Total Revenue in 2017 amounts to €3.7M vs.
€5.4M in 2016, in line with our operational development
expectations, mainly due to:
- Revenues from PharmaEngine amounting to €252K (vs. €1,558K in
2016), generated by the recharge of goods and services provided
related to activities planned as per the partnership convention
with PharmaEngine; and
- Other revenues of €3,469K (vs. €3,864K in 2016) mainly related
to the Research Tax Credit (CIR), moving in line with the level of
R&D activities.
Total Operating expenses reach €28.7M in 2017
vs. €27.3M in 2016:
- R&D expenses in 2017 were €16.3M, lower than 2016 R&D
costs by -€ 0.6M, due to lower clinical development costs as per
fluctuation in patient recruitment phases during the year, as well
as lower research costs. This decrease is offset by the increase in
R&D headcount in the U.S. subsidiary.
- SG&A costs reached €9.7M (+€1.4M ), mainly due to some
changes in the structure (creation of the COO position in February
2017), and the increase of headcount, as well as consulting fees,
hiring fees and communication costs in accordance with the group's
growth strategy.
- Share based payment-related costs were €2.6M in 2017 (vs. €2.0M
in 2016), being the result of an accounting treatment (having no
cash impact).
Total consolidated headcount reached 85 as of
December 31, 2017 vs. 67 in 2016, in line with the company's
growth.
Net loss after tax amounts to €26.1M (vs. €21.9M
(loss) in 2016), in line with operational development
expectations.
Cash available at December 31, 2017 amounts
to €47.2M.
In April, the Company completed a private
placement of €25.1M providing additional resources to support the
group's development. This operation has been an opportunity for
Nanobiotix's institutional shareholders to reinforce their position
and to welcome new shareholders from U.S. and EU.
In October, Nanobiotix successfully completed an
approximately €27.2M placement of new shares. This operation opened
the opportunity for Nanobiotix to welcome new investors specialized
in life sciences and biotechnology mainly from the U.S. and from
Europe.
The cumulated amount of money raised in 2017 is
about €52.3M.
-------------------------------------
Nanobiotix activities and achievements in
2017
- Reported positive interim phase I/II data withNBTXR3 in Head
& Neck cancer / ASCO
- Interim readout and completion of recruitment in phase II/III
withNBTXR3 in Soft Tissue Sarcoma
- Advanced phase I/II in HCC/liver metastasis
- Initiated phase I/II in prostate cancer under company IND
- Reported positive IO biomarker study data in STS patients /
SITC
- IND granted to start phase I/II combination study with
checkpoint inhibitors
- Company buildout and expansion with the addition of Chief
Operating Officer and establishment of European Operations
2018 perspectives
NBTXR3 is now being evaluated in head and neck
cancer (locally advanced squamous cell carcinoma of the oral cavity
or oropharynx), and the trial targets frail and elderly patients
who have advanced cancer with very limited therapeutic options. The
use of Nanobiotix's NBTXR3 in this population aims to provide
better local and systemic disease and prolongs survival with the
improvement of Quality of Life.
Given the very promising Phase I/II trial
results presented at ASCO 2017, Nanobiotix has filed a protocol
amendment to expand the study to more patients in order to confirm
the efficacy of NBTXR3. Nanobiotix is also planning to open 12-15
additional clinical trial sites in Europe and to expand this study
to the U.S. at a later stage.
This indication is critical to establish the
medical value of the product regarding the local control of the
tumors, the potential metastatic control through in situ
vaccination, and its rare safety profile.
Nanobiotix is running an Immuno-Oncology program
with NBTXR3 that includes several studies. In the U.S., the Company
received the FDA's approval to launch a clinical study of NBTXR3
activated by radiotherapy in combination with anti-PD1 antibody in
lung, and head and neck cancer patients (head and neck squamous
cell carcinoma and non-small cell lung cancer). This trial that
shall start in Q2 2018, aims to expand the potential of NBTXR3,
including using it to treat recurrent or metastatic disease.
Many IO combination strategies focus on
'priming' the tumor, which is now becoming a prerequisite for
turning a "cold" tumor into a "hot" tumor. Compared to other
products that could be used for priming the tumor, NBTXR3 could
have a number of advantages: it is a physical and universal mode of
action that could be used widely across oncology; it involves a
one-time local injection; it is a good fit within existing medical
practice already used as a basis for cancer treatment; it has a
very good chronic safety profile and a well-established
manufacturing process.
Nanobiotix is focusing on delivering new
clinical and pre-clinical data confirming that NBTXR3 could play a
key role in oncology and could become a backbone in
immuno-oncology.
The Company expects to present the results of
its Phase II/III trial of NBTXR3 in soft tissue sarcoma in Q2
2018.
In December 2017, regarding the technical file,
LNE/G-MED informed Nanobiotix at this time they would need a few
more months to finalize the evaluation required for CE marking for
soft tissue sarcoma (STS).
Nanobiotix is also running multiple Phase I/II
trials in order to widen the usage of the product.
2018 should be another year of growth for
Nanobiotix with various milestones:
- First patient recruitment in Phase I/II clinical trial in
the U.S. looking at the potential of NBTXR3 to transform anti-PD1
non-responders into responders. The multi-arm trial will include
recurrent and/or metastatic lung, and head & neck cancer
patients
- Presentation of the results of Phase II/III STS, when the
analysis is complete
- First market approval in Europe (CE Marking)
- Interim update from Phase I/II head and neck cancer trial
with high risk elderly patients
- Additional news on other clinical trials and
programs
Updated composition of Nanobiotix
shareholding structure as of December 31, 2017
The proportion of institutional investors
slightly increased in 2017 to 47% of the shareholding base (vs. 39%
FYE 2016), following the successful completion of both private
placements in April and October 2017. These operations have been an
opportunity for Nanobiotix's institutional shareholders to
reinforce their position and to welcome new investors, mainly from
the U.S. as well as from Europe, that are specialized in life
science and biotechnology.
-Ends-
Next financial press release: revenue
for Q1 2017 on May 15, 2018
Nanobiotix informs that its Annual General
Meeting will be held on May 23, 2018 at 2:30 pm,
InterContinental Marceau - Marceau room - 64, avenue Marceau
75008 Paris, France.
About NANOBIOTIX:
www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading,
late clinical-stage nanomedicine company pioneering new approches
to significantly change patient outcomes, and bringing nanophysics
to the heart of the cell.
The Nanobiotix philosophy is one rooted in
designing pioneer physical based approaches to bring
highly effective and generalized solutions to address high uned
medical needs and challenges.
The Company's first-in-class, proprietary lead
technology, NanoXray, aims to expand radiotherapy benefits for
millions of cancer patients. Furthermore, the Company's
Immuno-Oncology program has the potential to bring a new dimension
to cancer immunotherapies.
Nanobiotix is listed on the regulated market of
Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg:
NANO: FP). The Company's Headquarters are based in Paris, France,
with a U.S. affiliate in Cambridge, MA, and european affiliates in
Spain and Germany.
Contact
Nanobiotix |
Sarah GaubertDirector, Communications & Public
Affairs+33 (0)1 40 26 07 55sarah.gaubert@nanobiotix.com
/contact@nanobiotix.com |
Noël Kurdi Director, Investor
Relations +1 (646) 241-4400 noel.kurdi@nanobiotix.com /
investors@nanobiotix.com |
Media relations |
France -
Springbok ConsultantsMarina Rosoff+33 (0)6 71 58 00
34marina@springbok.fr |
|
United States -
RooneyPartners Marion Janic +1 (212)
223-4017mjanic@rooneyco.com |
|
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 reference
document of Nanobiotix filed with the French Financial Markets
Authority (Autorité des Marchés Financiers) under number D.17-0470
on April 28, 2017 (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. At the moment NBTXR3 does not bear a CE mark
and is not permitted to be placed on the market or put into service
until NBTXR3 has obtained a CE mark.
[1] Financial statements have been audited
Nanobiotix (EU:NANO)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
Nanobiotix (EU:NANO)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024