Regulatory News:
NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205), a
late clinical-stage nanomedicine company pioneering new approaches
to the treatment of cancer, today announces its half year results
for the six months ended 30 June 2017.
- Philippe Mauberna, CFO of Nanobiotix,
commented: “We are pleased with the progress made during the first
half of 2017. Following the recommendation from the IDMC to
continue the phase II/III trial in Soft Tissue Sarcoma, the company
has also announced successful clinical results from the Phase I/II
Trial of NBTXR3 in Head & Neck Cancer. The private placement
completed in April 2017 enabled new investors, mainly from the US
and Europe, to invest in Nanobiotix in order to support our
clinical programs expansion in head and neck cancer with NBTXR3 and
in the Immuno-Oncology program into patients.”
Financial highlights
- Total revenue of circa €1.9m (H1 2016:
€3.0m) includes re-invoicing of materials and services (€59k),
research tax credit (€1.760k) and other subsidies (€63k)
- Total expenses are stable compared to
last year (€13.7m for H1 2017 vs. €13.1m for H1 2016). R&D
expenses amounts to €7.2m on line with clinical developments
activities while SG&A, at €4.5m vs. €3.8m for H1 2016, reflect
the investment made in the market access phase
- Headcount to support company projects
has increased to 71 in June 30, 2017 compare to 63 as of June 30,
2016
- After tax losses of €12m for H1 2017
(compared to €10m for H1 2016) in line with expectations
- Cash balance as June 30, 2017 amounts
to €31m (H1 2016: €25m)
Financial events
- Successful completion in April 2017 of
a €25.1 million private placement, corresponding to 1,596,527 new
shares, providing additional resources to support the Company
development. This operation has provided the opportunity for
Nanobiotix to welcome new shareholders from US and EU and allow
existing shareholders to reinforce their current positions.
Operational highlights
- Recommendation of the Independent Data
Monitoring Committee (IDMC) to continue the ongoing phase II/III
trial of NBTXR3 in Soft Tissue Sarcoma (Act.in.sarc study), based
on the safety and efficacy data
- Results of the Phase I/II head and neck
cancer trial with its lead product candidate, NBTXR3, presented at
the American Society of Clinical Oncology (ASCO), Chicago in June.
The excellent safety profile demonstrated in this elderly and frail
population indicates that NBTXR3 would represent a valuable option
to preserve and improve patients’ Quality of Life compared to other
treatments
- Presentation of NBTXR3 preclinical data
demonstrating 1) the antitumor efficacy of NBTXR3 in five different
in vivo human cancer models and 2) the antitumor efficacy of NBTXR3
in combination with chemotherapy, in both in vitro and in vivo
studies
- Presentation of a first set of clinical
data from its immuno-oncology (IO) program, showing the potential
ability of NBTXR3 to transform “cold” tumors into “hot” tumors. The
new clinical data and previous pre-clinical data indicate that
NBTXR3 could play a key role in oncology and could become a
backbone in immuno-oncology. NBTXR3 with radiotherapy could
transform tumors into an effective in situ vaccine, opening up very
promising perspectives in the treatment of local cancer and
metastases
- Appointment of Alain Dostie, a senior
executive from the pharmaceutical industry, as its Chief Operating
Officer (COO) to oversee operations and product
commercialization
Financial Review (IFRS)
The detailed Profit & Loss financial statement is laid out
below: 6 months period closed on :
(€
‘000) June 30 2017 June 30 2016
Operating revenue 59 982 Other revenue 1,823
2,053 Subsidies 63 63 Research Tax Credit
1,760 1,991 Total revenue 1,882 3,036
Cost of sales - - R&D costs -7,238
-8,209 Selling, general and administrative costs (SG&A)
-4,531 -3,773 Costs associated with payments in shares
-1,919 -1,127 Core operating loss -11,806
-10,073 Income from cash 19 35 Gross cost of
debt -57 -49 Net cost of debt -38 -14
Other financial income 18 15 Other financial expenses
-364 -6 Core pre-tax loss -12,190
-10,079 Income tax 0 -89 Net loss -12,190
-10,169 Actuarial gains 8 21 Foreign exchange
translation adjustments 237 4 Comprehensive loss
-11,945 -10,143 Diluted earnings per share
-0.76 -0.68
Total revenue for H1 2017 amounts to €1,882k (H1 2016:
€3,036k):
- Re-invoicing of materials and services
related to activities planned into partnership convention with
PharmaEngine have been smaller than last year while no milestone
payment was triggered during the period, and
- Other revenue amounts to €1,823k mainly
composed of the Research Tax Credit (CIR). This amount is in
slightly decreased compared to last year (-€230k) as a reflection
of the R&D expenses level.
Total operating expenses as of 30 June 2017 reached €13.7m
(H1 2016: €13.1m). In total, the stability of expenses is explained
as follows:
- Operating costs, excluding share based
payments, amounted in H1 2017 to €11,770k (H1 2016: €11,982k), as
per company expectations,
- R&D expenses amounted to €7.2m (H1
2016: €8.2m), which correspond to the current level of activity of
on-going clinical programs,
- Selling, general and administrative
cost expenses reached €4.5m (H1 2016: €3.8m) mainly due to the
continuation of market access preparation, with some new
recruitments and market studies activities, and
- Shares based payment amounts to €1.9m
(+€0.8m) because of plans allocated on the period.
The core operating loss amounts to €11.8m (H1 2016: €10.1m) in
line with expectations. This operating loss increase is mainly due
to the decrease of revenue level.
The total net loss amounts to €12.2m.
Cash balance as of 30 June 2017 reaches €31m as per
expectations.
The half year financial report has been the object of a limited
review by the Statutory Auditors. The company published full
financial statements that comply with IFRS that are available on
its website at www.nanobiotix.com.
●●●
Next financial press release: revenue for the third quarter
of 2017 on November 15, 2017.
●●●
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late
clinical-stage nanomedicine company pioneering novel approaches for
the 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.
NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head
and neck cancers, prostate cancer, and liver cancers (primary and
metastases). Additionally, head and neck cancer and rectal cancer
trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are
underway in the Asia Pacific region. The Company has filed in
August 2016 for market approval (CE Marking) in Europe for its lead
product NBTXR3.
The Company started in 2016 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.
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.
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170831006107/en/
NanobiotixSarah Gaubert, +33 (0)1 40 26 07 55Director,
Communications & Public Affairssarah.gaubert@nanobiotix.com /
contact@nanobiotix.comorNoël Kurdi, +1-646-241-4400Director,
Investor Relationsnoel.kurdi@nanobiotix.com /
investors@nanobiotix.comorMedia relationsFrance - Springbok
ConsultantsMarina Rosoff, +33 (0)6 71 58 00
34marina@springbok.frorUnited States –
RooneyPartnersMarion Janic,
+1-212-223-4017mjanic@rooneyco.com
Nanometrics (NASDAQ:NANO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Nanometrics (NASDAQ:NANO)
Historical Stock Chart
From Apr 2023 to Apr 2024