Updated shareholder composition
Regulatory News:
NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late
clinical-stage nanomedicine company pioneering novel approaches for
the local treatment of cancer, announces its half year results for
the six months ended 30 June 2016 and outlines its updated share
capital breakdown as of 30 June 2016.
Laurent Levy, CEO of Nanobiotix, commented: “We are pleased with
the progress made during the first half of 2016. The company has
announced successful clinical results from our Phase I/II Trial of
NBTXR3 in Head & Neck Cancer, bringing us a step closer to
proving the transferability of our approach across other cancers.
The private placement completed in March 2016 enabled new
investors, mainly from the US, to invest in Nanobiotix and puts us
in a strong position to remain well funded until mid-2017. The
promising proof of concept results for our new immuno-oncology
preclinical research program show that NBTXR3 may also enhance
immunogenicity of the tumor. We expect this momentum of positive
clinical and operational developments to continue in the coming
months.”
Financial highlights
- Total revenue of circa €3m (H1 2015:
€1.7m) includes the pro-rata share of the initial upfront payment
from PharmaEngine (€92k), a milestone payment of $1.0m (€890k) from
PharmaEngine, research tax credit (€1.991k) and other subsidies
(€63k)
- Increase of expenses corresponds to
progression and expansion of clinical development, with five
clinical trials running in six indications, and market access
activities, according to plan
- R&D expenses and SG&A costs
amounted to €8.2m and €3.8m respectively. These remain fairly
constant over the half year, consisting of 69% and 31% respectively
of the expenditure incurred in H1 2016 (H1 2015: 68% and 32%)
- Loss after tax for the period of €10m
(H1 2015: loss of €7.8m) in line with expectations
- Cash balance as of 30 June 2016 amounts
to €25m (H1 2015: €25m)
Financial events
- Successful completion in March 2016 of
a €21.3 million private placement of new ordinary shares primarily
subscribed by life sciences specialist investors, the majority of
which are based in the United States
- Received a milestone payment of $1.0m
(€890) from PharmaEngine, the Company’s Taiwanese partner,
triggered by the first patient undergoing treatment in Nanobiotix’
Soft Tissue Sarcoma (STS) phase II/III in the Asia-Pacific
region
- Exercise of warrants by Capital
Ventures International (CVI) giving access to 50,000 ordinary
shares representing a share capital increase of an aggregate amount
of €893,500
Operational highlights
- The US Food and Drug Administration
(FDA) approved the Company’s Investigational New Drug (IND)
application. 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
- Preliminary preclinical
proof-of-concept (POC) established with the lead product, NBTXR3,
for its new program in immuno-oncology (IO) started in January
2016. The first promising data showed that NBTXR3 might be used not
only to destroy tumors (as it is currently being clinically
developed), but also to amplify the power of radiotherapy to create
intratumoral vaccines for IO, enhancing the immunogenicity of the
tumor
Post period end main highlights
- Successful results from Phase I/II
Trial of NBTXR3 in Head & Neck Cancer
Financial Review (IFRS)
The detailed Profit & Loss financial statement is laid out
below: 6 months period closed on :
(€ ‘000)
June 30 2016 June 30 2015 Operating
revenue 982 91 Other revenue 2,054
1,568 Subsidies 63 139 Research Tax Credit
1,991 1,429 Total revenue 3,036 1,659 Cost of
sales - - R&D costs -8,209 -6,124
General costs -3,773 -2,848 Costs associated with
payments in shares -1,127 -559 Core operating loss
-10,073 -7,872 Income from cash 35 116
Gross cost of debt -49 -4 Net cost of debt -14
112 Other financial income 15 3 Other
financial expenses -6 -16 Core pre-tax loss
-10,079 -7,773 Tax -89 - Net loss
-10,169 -7,773 Profit and loss recognized directly in
shareholders' equity 21 211 Foreign exchange
translation adjustments 5 -5 Global results
-10,143 -7,567 Diluted earning per share -0.68
-0.52
Total revenue for H1 2016 amounts to €3,036k (H1 2015:
€1,659k) mainly due to:
- the pro-rata shares of the initial
upfront payment from PharmaEngine, received in August 2012 and
linearized on an annual basis for €184K/year, amounts to €92k
- a milestone payment of $1.0m (€890k)
from PharmaEngine, triggered by the first patient undergoing
treatment in Nanobiotix’ Soft Tissue Sarcoma (STS) pivotal phase in
the Asia-Pacific region
- other revenue of €2,054k mainly from
Research Tax Credit (CIR) that has risen sharply due to higher
levels of R&D activities and the acceleration of the global
clinical development program, with five clinical trials running in
six indications in the USA, Europe and the Asia-Pacific region
Total operating expenses as of 30 June 2016 reached €13.1m
(H1 2015: €9.6m) due to:
- costs in H1 2016 amounted to 11,982k,
representing an increase of 34% compared to H1 2015. This
corresponds to the launch of new clinical trials, expansion of STM
pivotal phase, NBTXR3 market access and launch preparation
activities, and the development of Nanobiotix’s US affiliate
- R&D expenses up to €8.2m (H1 2015:
€6.1m) to support extending the research scope of the Company,
starting the liver and prostate cancers clinical trials, and
launching the preclinical research program in immuno-oncology
- general cost expenses reached €3.8m (H1
2015: €2.8m) mainly due to an increase in the resources available
for NBTXR3 market access, launch readiness activities and the
increase in staffing costs
- R&D expenses and SG&A costs
amounted to €8.2m and €3.8m respectively. These remain fairly
constant over the half year, consisting of 69% and 31% respectively
of the expenditures incurred in H1 2016 (H1 2015: 68% and 32%)
The core operating loss amounts to €10m (H1 2015: €7.9m) in line
with expectations. This operating loss increased sharply and
remains in close correlation with Nanobiotix’s business and
activities.
The total net loss amounts to €10.2m.
Cash balance as of 30 June 2016 was €25m as per
expectations.
The shareholding structure remains similar to how it was in
December 31, 2015. However, following the successful completion of
the private placement in March 2016, the majority of new qualified
and institutional investors that became shareholders are based in
the US. This has altered the composition of the Company’s
institutional investors.
In total, institutional investors now hold 43% of the
shareholding (vs. 38% previously) and family offices hold 9% (vs.
13% previously).
Finally, retail and management shareholders remained at the same
level with 42% and 6% respectively.
●●●
Next financial press release: revenue for the third quarter
of 2016 on November 15, 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.
For more information, please visit www.nanobiotix.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.16-0732 on July 22, 2016 (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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160831006243/en/
NanobiotixSarah GaubertHead of Communication and Public
Affairs+33 (0)1 40 26 07 55contact@nanobiotix.comorMedia
relationsFrance - NewCapAnnie-Florence Loyer+33 (0)6
88 20 35 59afloyer@newcap.frorEU Outside France - Instinctif
PartnersMelanie Toyne Sewell+44 (0) 207 457
2020nanobiotix@instinctif.comorUnited States – The Ruth
GroupKirsten Thomas / Chris Hippolyte+1 508-280-6592 /
+1 646-536-7023Nanobiotix@theruthgroup.com
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