Paris, France and Cambridge,
Massachusetts, USA, March 15, 2019 –
NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205 – the
“Company”), a clinical-stage nanomedicine company
pioneering new approaches to the treatment of cancer, today
announced its unaudited1 consolidated results for the fiscal year
ended December 31, 2018:
- Major milestones achieved during the year:
- Positive Phase II/III results for NBTXR3 in patients
with locally advanced Soft Tissue Sarcoma demonstrating clinical
meaningful benefits versus standard of care
- Positive clinical update from Phase I Head and Neck and
Phase I/II Liver cancers trials presented at major
congresses
- Completion of Phase I dose escalation in Head and Neck
cancers
- Engaged major preclinical collaborations with highly
respected U.S. cancer centers including the University of Texas MD
Anderson Cancer Center, the Providence Cancer Institute and Weill
Cornell Medicine
- Consolidated cash available of €36.2M at December 31,
2018
- Strengthened by the payment of a €16M first tranche
pursuant to a €40M non-dilutive financing agreement established
with the European Investment Bank in 2018
- Expenses in R&D proceeding as expected according to
clinical development plan
Philippe
Mauberna, Chief Financial Officer of Nanobiotix said: “2018 has
been a major year for Nanobiotix, we made significant progress in
the financial and clinical plan of the company. R&D expenses
are linked to our development plan and the hiring of experts in key
positions. We are delighted by the positive results in Soft Tissue
Sarcoma Phase II/III and the encouraging update from Head and Neck
and Liver cancers Phase I/II trials. Indeed, the support of the
European Investment Bank strengthens our balance sheet, which
allows us to move forward with our 2019 upcoming key
milestones.”
The unaudited1 consolidated financial statements
for the fiscal year ended December 31, 2018 were approved by the
executive board and reviewed by the supervisory board of the
Company on March 15, 2019.
Consolidated Income statement
(unaudited)1
K€ |
2018 |
|
2017 |
|
Total revenue and other income |
3,479 |
|
3,722 |
|
SalesServicesOther salesLicences
Other revenuesResearch Tax
CreditSubsidiesOther |
1161097-
3,3633,2519022 |
25222923-
3,4703,25915457 |
Research & Development (R&D) costs (incl. Share-based
payments) |
(20,893 |
) |
(17,733 |
) |
Selling, General and Administrative (SG&A) costs (incl.
Share-based payments) |
(12,653 |
) |
(11,254 |
) |
Operating loss |
(30,066 |
) |
(25,267 |
) |
Financial loss |
(277 |
) |
(876 |
) |
Income tax |
- |
|
- |
|
Net loss for the period |
(30,345 |
) |
(26,143 |
) |
Financial Review
(unaudited)1
Total Revenue in 2018 amounted to €3.5M
vs. €3.7M in 2017, mainly due to:
- Revenues related to services
provided mainly by the Company to its partner, PharmaEngine,
pursuant to a commercial agreement, amounted to €116K in 2018 (vs.
€252K in 2017); and
- Other revenues of €3,363K in 2018
(vs. €3,469K in 2017) mainly related to the Research Tax Credit
(Crédit d’Impôt Recherche - CIR).
Total Operating expenses reached €33.5M
in 2018 vs. €29.0M in 2017:
- R&D expenses (including
share-based payments) in 2018 amounted to €20.9M (vs. €17.7M in
2017); the variance comes from an increase in operations (opening
of the new production site, launch and extension of new studies) as
well as the addition of highly-qualified staff;
- SG&A costs (including
share-based payments) in 2018 were €12.7M (vs. €11.3M in
2017).
Total headcount on a consolidated basis reached
102 as of December 31, 2018 vs. 85 as of December 31, 2017, in line
with the Company’s growth.
Net loss after tax amounts to €30.3M as of
December 31, 2018 (vs. €26.1M loss as of December 31, 2017).
Cash available at December 31, 2018
amounted to €36.2M.
-------------------------------------
Nanobiotix activities and achievements
in 2018
Clinical Positive Phase
II/III results for NBTXR3 in patients with locally advanced Soft
Tissue Sarcoma demonstrated clinical meaningful benefits versus
standard of careNanobiotix announced positive results from
its Phase II/III clinical trial of NBTXR3 in patients with locally
advanced soft tissue sarcoma. The trial achieved its primary
endpoint with a pathological complete response rate. It also
achieved its secondary endpoint in operability. NBTXR3 demonstrated
clinical meaningful benefits for such patients versus standard of
care. The data also showed that NBTXR3 was well tolerated. The
randomized trial validated the first-in-class mode of action of
NBTXR3. These positive results were presented by Dr. Sylvie
Bonvalot at the ESMO and ASTRO annual conferences.
Positive Update on Head and Neck cancers Phase I trial showing
potential impact for survivalNanobiotix provided an update
on the Head and Neck Phase I Trial with NBTXR3 data presented at
ImmunoRad 2018. The Phase I Trial focus on elderly and frail
patients ineligible for cisplatin or intolerant to cetuximab. The
data show the potential impact on survival in this patient
population.
Encouraging Data from Phase I/II Liver cancers
trialNanobiotix presented initial promising data from
Phase I/II Liver trial evaluating NBTXR3 in liver cancers,
including primary (Hepatocellular, HCC) and liver metastasis from
other tumors at the American Society of Clinical Gastrointestinal
annual meeting (ASCO GI). These positive results show that NBTXR3
was well tolerated with no adverse event related to NBTXR3 and no
dose-limiting toxicity.
Collaboration in preclinical
research
Collaboration with the Providence Cancer Institute
Nanobiotix partnered with the Providence Cancer Institute to run
immunotherapeutic preclinical research in pancreatic cancer. This
collaboration will provide essential preclinical data on the
ability of NBTXR3 activated by radiotherapy to induce an
antitumoral immune response.
The University of Texas MD Anderson Cancer
Center and Nanobiotix have an agreement in pre-clinical
researchNanobiotix and the University of Texas MD Anderson
Cancer Center have an agreement to run immunotherapeutic
pre-clinical research in lung cancer. The main objectives of this
project, with one of the world’s leading oncology research centers,
is to provide preclinical data using NBTXR3 activated by
radiotherapy plus anti PD-1 Nivolumab (murine version of
Opdivo™).
Partnering with Weill Cornell Medicine on pre-clinical
studiesNanobiotix and Weill Cornell Medicine partnered to
perform pre-clinical studies to evaluate the impact of NBTXR3 on
cGAS-STING pathway in mammary cancers. The main objective is to
study the impact of NBTXR3 activated by radiotherapy on cGAS-STING,
a key component of the anti-tumor immune response. Data generated
from this collaboration could provide support for the assertion
that NBTXR3 activated by radiotherapy can increase the anti-tumor
immune response compared to radiotherapy alone.
Preclinical data showing NBTXR3 can
activate cGAS-STING pathwayNanobiotix presented
preclinical data showing NBTXR3 nanoparticles can activate the
cGAS-STING pathway at the American Association for Cancer Research
(AACR). 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.
Financial
events
Launch of a €40M non-dilutive financing agreement with the European
Investment BankNanobiotix announced in July 2018, the
launching of a non-dilutive financing agreement with the European
Investment Bank to boost its research, development and innovation
activities. This agreement will allow the Company to borrow up to
€40M through loans before July 26, 2020 subject to achieving a set
of agreed performance criteria. In October 2018, Nanobiotix
received the first tranche disbursement of €16M. The proceeds will
be used to speed up development of lead product NBTXR3 in Head and
Neck cancers and to support the European go-to-market strategy.
Selection to the Euronext Tech 40 This honor
recognizes the best performing Tech SMEs listed on Euronext
markets. An independent group of European experts annually selects
40 great companies on the basis of their business, financial and
stock market performance.
Events 2019
Large-scale collaboration on NBTXR3 with
the University of Texas MD Anderson Cancer CenterIn
January 2019, Nanobiotix and the University of Texas MD Anderson
Cancer Center announced a large-scale comprehensive clinical
collaboration on NBTXR3. The collaboration will initially support
nine new Phase I/II clinical trials with NBTXR3 for use in treating
six cancer types – head and neck, pancreatic, thoracic, lung,
gastrointestinal and genitourinary cancers – and will involve
around 340 patients. Most of the trials are expected to be launched
in 2019. Nanobiotix will finance at least approximately $11M, a
portion of which has been paid as of the start of the
collaboration, with additional amounts payable during development
and upon specified regulatory milestone.
Announced plans to conduct registered
public offering in the US In January 2019, Nanobiotix
announced that it plans to conduct a registered public offering of
its ordinary shares, including the form of American Depositary
Shares (ADSs) in the United States. Nanobiotix submitted a
confidential draft registration statement on Form F-1 to the U.S.
Securities and Exchange Commission.
Second tranche disbursement from the
European Investment BankIn March 2019, Nanobiotix received
the second tranche of disbursement of €14M from the European
Investment Bank. This payment was granted because of the company’s
achievement on two criteria: determination of the recommended dose
at 22% of the tumor volume for head and neck cancers treatment
following the end of Phase I clinical trial with NBTXR3 and
positive evaluation of the clinical benefit/risk ratio of NBTXR3 in
soft tissue sarcomas Phase II/III by the clinical expert mandated
by the French medical device notified body, GMED.
2019 Perspectives
This year, Nanobiotix expects to receive its CE
mark for NBTXR3 for the treatment of Soft Tissue Sarcoma, which
would improve access to the product for cancer patients.In
parallel, clinical development should advance with the publication
of data in several cancer types.
Newsflow (anticipated)
- 2019 – European market approval/CE mark for the treatment of
Soft Tissue Sarcoma cancer
- 1H2019 -- Preclinical data regarding immuno-oncology using
NBTXR3 in combination with checkpoint inhibitors
- 1H2019 -- FDA feedback on NBTXR3 clinical plan in Head and Neck
cancers
- 2H2019 – Presentation of final Head & Neck Phase I dose
escalation results
- 2H2019 -- Potential early results in immuno-oncology with
anti-PD-1 study
- Multiple launches of clinical trials within MD Anderson
collaboration
- Additional news on other clinical trials and preclinical
programs
- Additional news on plans to conduct registered public offering
in the United States
Development Plan
-Ends-
Next financial press release:
revenue for Q1 2019 on April 30, 2019
Nanobiotix’ Annual General Meeting will
be held on April 11, 2019 at 2:30 pm Pullman Bercy
– Saumur Champigny – 1 rue de Libourne 75012 Paris,
France.
About
NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading,
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 rooted in designing
pioneering, physical-based approaches to bring highly effective and
generalized solutions to address unmet medical needs and
challenges.
Nanobiotix’s first-in-class, proprietary lead
technology, NanoXray, aims to expand radiotherapy benefits for
millions of cancer patients. Nanobiotix’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 in Paris, France, with a
U.S. affiliate in Cambridge, MA, and European affiliates in Spain
and Germany.
Contacts
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 |
|
US –
RooneyPartners Marion Janic +1
(212) 223-4017mjanic@rooneyco.com |
|
|
DisclaimerThis 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
forwardlooking 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.
1 The Company’s statutory auditors have
completed their audit work on the 2018 financial statements and
expect to issue their audit report on March 20th, 2019.
- 2018_Nanobiotix_PR Annual Results VFinal
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