NANOBIOTIX half year results for the six months ended June 30, 2018
September 04 2018 - 12:20PM
Nanobiotix half year results for the six
months ended June 30, 2018
- Major milestones achieved with the success of Soft Tissue
Sarcoma phase III clinical trial with first-in-class NBTXR3
product
- Overall expenses according to plan
- Post cloture event: financial partnership with
European Investment Bank (EIB) allowing visibility beyond
2019
Paris, France and Cambridge, Massachusetts,
USA, September 4, 2018 - 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 June 30
2018, from the consolidated financial statements at June 30, 2018
that have been reviewed by the supervisory board dated September 4,
2018.
Philippe Mauberna, CFO of Nanobiotix, commented:
"For the first half of 2018, the group pursued its growth in line
with operational development expectations. The period has been
marked by the positive topline results on the phase II/III soft
tissue sarcoma clinical study and by the formation of new
immuno-oncology partnerships with high level research institutes in
the USA. The cash position at the end of June, strengthened by the
partnership with the European Investment Bank after reporting
period, enables us to secure our growth beyond 2019."
Financial highlights
- Operating revenues for the first half of 2018 were €2.1m (H1
2017: €1.9m), including €1.8 m of Research Tax Credits (CIR)
- As expected, operating expenses were higher compared to last
year (€15.0m in H1 2018 vs. €13.7m in H1 2017)
- The operating result for the period was a €13.0m loss compared
to a €11.8m loss in H1 2017
- The Group had cash and cash equivalents at June 30, 2018 of
€32.7 m (31 December 2017: €47.2m)
Financial events
- Nanobiotix entered Euronext's Tech40 label, recognizing the
best performing Tech SMEs listed on Euronext markets.
Operational highlights
- Nanobiotix announced positive phase II/III topline data in Soft
Tissue Sarcoma with NBTXR3. The trial achieved its primary endpoint
of pathological Complete Response Rate and its secondary endpoint
in operability (R0 rate). NBTXR3 demonstrated significant
superiority and clinical benefits for patients compared to the
standard of care. The safety profile was confirmed. This randomized
trial validated the first-in-class mode of action of NBTXR3.
- Nanobiotix presented first promising data from I/II trial
evaluating NBTXR3 in liver cancers, including primary
(Hepatocellular, HCC) and liver metastasis from other tumors, at
the American Society of Clinical Oncology Gastrointestinal Annual
Meeting (ASCO-GI).
- Nanobiotix presented preclinical data showing that NBTXR3
nanoparticles can activate the cGAS-STING pathway at the American
Association for Cancer Research (AACR) Annual Meeting 2018 in
Chicago, Illinois, USA. These observations support the rationale
for using NBTXR3 with radiation therapy in combination with
immunotherapeutic agents and/or STING agonist to transform tumors
into an in-situ cancer vaccine.
- Nanobiotix partnered with the Providence Cancer Institute to
run immunotherapeutic preclinical research in pancreatic cancers.
The collaboration with Providence Cancer Institute will enable to
provide essential preclinical data on the ability of NBTXR3
activated by radiotherapy to induce an antitumoral immune
response.
- Nanobiotix also announced that it will cooperate with The
University of Texas MD Anderson Cancer Center, Houston TX, USA, to
run immunotherapeutic pre-clinical research in lung cancer,
combining NBTXR3 and Nivolumab. This project with MD Anderson, one
of the world's leading oncological research centers, will enable to
provide an unparalleled ability to develop pre-clinical data using
NBTXR3 activated by radiotherapy plus anti-PD1 Nivolumab (murine
version of Opdivo(TM)).
- Nanobiotix announced that it is launching a research
collaboration with Weill Cornell Medicine to begin nonclinical
studies to evaluate the impact of NBTXR3 on cGAS-STING pathway in
mammary cancers. The research collaboration will be conducted over
the course of one year, with the goal of continuing the exploration
of the role of NBTXR3 in immuno-oncology.
Post period end main highlights
- The Company launched in July 2018, a non-dilutive financial
partnership with the European Investment Bank (EIB) to boost its
research, development and innovation activities. The financing
agreement will allow the Company to borrow up to €40m through loan
over the coming five years subject to achieving a set of agreed
performance criteria. This financing agreement will enable
Nanobiotix to accelerate both the development of NBTXR3 clinical
trial in the head and neck cancers indication and to support the
European go-to-market strategy.
Financial
Review (IFRS)
Statement of profit or loss and other comprehensive
income |
|
6 months to: |
(€ '000) |
June 30, 2018 |
June 30, 2017 |
Operating revenue |
73 |
59 |
Other revenues |
1,987 |
1,823 |
Subsidies |
214 |
63 |
Research Tax Credit |
1,773 |
1,760 |
Total revenue |
2,060 |
1,882 |
Cost of sales |
- |
- |
R&D costs |
(8,571) |
(7,238) |
Selling, general and administrative costs (SG&A) |
(5,330) |
(4,531) |
Share based payment expense |
(1,133) |
(1,919) |
Operating loss |
(12,974) |
(11,806) |
Other expenses |
(3) |
- |
interest income |
16 |
19 |
Gross cost of debt |
(189) |
(57) |
Net finance costs |
(176) |
(38) |
Other financial income |
798 |
18 |
Other financial expenses |
(263) |
(364) |
Loss before tax |
(12,614) |
(12,190) |
Income tax expense |
- |
- |
Loss |
(12,614) |
(12,190) |
Actuarial gains/ (losses) |
(5) |
8 |
Foreign exchange translation adjustments |
(55) |
237 |
Total Comprehensive loss |
(12,674) |
(11,945) |
Diluted earnings per share |
(0.64) |
(0.76) |
Total revenue for H1 2018 amounted to €2.1m
(H1 2017: €1.9m), made of:
- The recharge of costs related to activities planned from
partnerships with PharmaEngine, slightly higher than prior year
(€0.1m vs. €0.1m in H1 2017)
- Other revenues amounted to €2.0m mainly made of subsidies
(€0.2m) and the Research Tax Credit (CIR) for €1.8m, stable
compared to prior year
Operating expenses for the 6 months to June
30, 2018 were €15.0m (H1 2017: €13.7m), broken down
as follows:
- Operating costs, excluding share-based payments, amounted to
€13.9m (H1 2017: €11.8m)
- R&D expenses amounted to €8.6m (H1 2017: €7.2m), in line
with the current level of activity of on-going clinical programs as
well as the strengthening of the teams, whereas selling, general
and administrative (SG&A) costs were €5.3m (H1 2017: €4.5m).
This increase was also primarily due to the strengthening of teams,
particularly in view of the next steps in market access, while
external costs were stable.
- Shares based payment amounted to €1.1m (-€0.8m compared to H1
2017)
The Group reports an operating loss of €13.0m
for the half year 2018 (H1 2017: €11.8m loss).
The total comprehensive loss for the period
was €12.6m (H1 2017: €12.2m).
At June 30, 2018, the cash balance was €32.7m
(December 31, 2017: €47.2m).
Total Group headcount continues to increase in
order to support the Group's strategy and reached 95 employees on
June 30, 2018 (compared to 85 at December 31, 2017).
Breakdown of Nanobiotix's shareholding
structure as of June 30, 2018
The half year financial report has been subject
to a limited review by Nanobiotix' statutory auditors. The
consolidated financial statements at June 30, 2018 were established
in accordance with IAS 34 norm. Such documents are available on the
Company's website at www.nanobiotix.com.
***
Next financial press release: revenue for the third quarter
of 2018 on 15 November 2018.
***
About NANOBIOTIX:
www.nanobiotix.com Incorporated in 2003, Nanobiotix is a leading,
late clinical-stage nanomedicine company pioneering new approaches
to significantly change patient outcomes by 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 unmet 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, Communication & 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 |
Ricky Bhajun Investor Relations Europe +33 (0)1 79 97 29 99
ricky.bhajun@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 as well as in its 2017 annual financial report
filed with the French Financial Markets Authority on March 29, 2018
(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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