NANOBIOTIX half year results for the six months ended 30 June 2017
August 31 2017 - 1:30PM
Nanobiotix half year results for
the six monthsended 30 June 2017
Paris, France and Cambridge, Massachusetts,
USA, August 31, 2017 - NANOBIOTIX (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.
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.
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