NANOBIOTIX Reports Full Year 2020 Financial Results and Highlights Operational Progress
17 Marzo 2021 - 10:15PM
Business Wire
- Substantial progress in priority development pathway in head
and neck cancer with clinical registration plan announced, Fast
Track designation granted by US Food and Drug Administration, and
new data from phase I dose expansion showing 83% objective response
rate in primary lesion.
- First clinical data reported phase I immuno-oncology trial
showing conversion of anti-PD-1 non-responders to responders.
- Extended global capital markets presence with a successful
Nasdaq IPO that provided gross proceeds of €93.5 million ($113.3
million).
- Cash, cash equivalents, and short-term investments were €119.2
million at December 31, 2020, supporting robust development plans
into the second quarter of 2023.
Regulatory News:
NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (Euronext : NANO ––
NASDAQ: NBTX – the ‘‘Company’), a late-stage clinical
biotechnology company pioneering physics-based approaches to expand
treatment possibilities for patients with cancer, reported business
highlights and financial results for the fiscal year ending
December 31, 2020.
“2020 was a banner year for Nanobiotix, despite challenges posed
by COVID-19. Our company achieved several milestones to advance our
priority development pathways in head and neck cancer and
immuno-oncology; and our successful Nasdaq IPO positioned us to
keep our pace in 2021. We look forward to building on our progress
to ensure that we deliver the potential benefits of NBTXR3 to
patients with deliberate speed,” commented Laurent Levy, founder
and chairman of the executive board of Nanobiotix.
2020 Financial
Highlights
- In 2020 total revenue remained stable compared to 2019 and
amounted to €2.5M. €0.05M corresponded to the license and
collaboration agreement signed with PharmaEngine, a former partner.
€1.9M corresponded to the Research Tax Credit (CIR). There we €0.5M
in subsidies from the government of France, of which €0.3M was in
the context of partial unemployment and €0.2M went to Curadigm SAS
from BPI.
- Research and development expenses decreased from €30.4M in
2019to €24.3M. This decrease is primarily a result of the Company's
cost-control efforts relating to R&D subcontracting and
consulting fees, as well as a reduction in the number of Group
employees assigned to research and development.
- Selling, general and administrative expenses in 2020 were
€14.6M compared to €18.9M in 2019. This decrease is due mainly to
the decrease in external costs mainly related to savings due to the
COVID-19 pandemic (especially consulting fees) and to the 2019
reclass of the Nasdaq IPO costs.
- Net loss for the year ended December 31, 2020 was €33.6M, or
€1.4 per share (basic and diluted), compared to net loss of €50.9
million, or €2.3 per share for the same period in 2019.
- Cash, cash equivalents, and short-term investments were €119.2
million on December 31, 2020.
Clinical activities and achievements advancing NBTXR3 toward
global phase III registration trial in head & neck
cancer:
- Clinical registration plan for global phase III head and
neck cancer study for elderly patients ineligible for
platinum-based chemotherapy announced following feedback from
the US Food and Drug Administration (FDA) in January 2020. The FDA
also agreed to the chemistry, manufacturing, and controls (CMC)
development plan for NBTXR3, to support the future New Drug
Application (NDA) for the product candidate and its use in the
phase III clinical study.
- Fast track designation granted by FDA for the patient
population in the global phase III head and neck cancer study
in February 2020.
- Preliminary safety and efficacy data from the dose expansion
part of phase I study in head and neck cancer reinforcing NBTXR3 as
a potential new option for patients presented in October 2020
at the annual meeting of the American Society for Radiation
Oncology (“ASTRO”). Among 31 evaluable patients, overall response
rate according to RECIST 1.1 was 83.9% of the evaluable patients,
67.7% had achieved a complete response of the injected lesion.
Clinical activities and achievements advancing I/O
combination strategy:
- First clinical data suggesting NBTXR3 could convert
anti-PD-1 non-responders to responders presented at the 35th
Anniversary Annual Meeting of The Society for Immunotherapy of
Cancer (SITC) in November 2020. Data from company-sponsored study
1100 provided a strong signal that NBTXR3 activated by radiation
therapy in combination with pembrolizumab or nivolumab (anti-PD-1
checkpoint inhibitors) could convert anti-PD-1 non-responders to
responders. Eight of nine patients treated on study showed tumor
regression, including six of seven prior anti-PD-1 non-responders.
Four of the anti-PD-1 non-responders had multiple lesions, and
three of the four experienced tumor regression in the non-injected
local and/or distant lesions. One patient with prior anti-PD-1
resistance experienced delayed tumor regression, suggesting an
adaptive immune response aided by NBTXR3 activated by radiation
therapy. The early data also demonstrated that administration of
NBTXR3 via intra-tumoral injection had been feasible and well
tolerated in all patients (head and neck cancer, lung metastasis,
and liver metastasis). One patient in the head and neck cancer
cohort experienced 4 severe adverse events related to anti-PD-1, of
which 2 events were also reported as possibly related to
NBTXR3.
- Positive new preclinical data from two studies suggesting
that NBTX3 could have a significant impact in immunotherapy
presented at SITC in November 2020. The first study demonstrated
that NBTXR3 activated by radiotherapy produced a strong abscopal
effect without checkpoint inhibitor combination, stimulated
adaptive antitumor immunity and increased TCR repertoire diversity
in treated tumors compared to radiation therapy alone. The second
study suggested that NBTXR3 plus high dose and low dose radiation
(RadScopal™) combined with anti-PD-1 and anti-CTLA-4 could
significantly improve the control of both the primary and secondary
tumors, extended survival, and reduced lung metastases in an
anti-PD-1 resistant lung cancer model. The NBTXR3 combination also
promoted anti-tumor response both at molecular and cellular levels
and produced long-term anti-tumor memory.
Clinical activities and achievements advancing clinical
collaboration with The University of Texas MD Anderson Cancer
Center and expanding the evaluation of NBTXR3:
- Activation of first study in the collaboration and first
patient injected in pancreatic cancer, in May 2020 and
September 2020, respectively.
- Regulatory ‘safe to proceed’ granted for a phase I
esophageal cancer study in October 2020 and was activated in
November 2020. The first patient was subsequently injected in
January 2021.
- Regulatory ‘safe to proceed’ granted for two phase II head
and neck cancer studies evaluating NBTXR3 in combination with
anti-PD-1 in November 2020. The first clinical study (Study
2020-0541) targets patients with recurrent or metastatic head and
neck squamous cell carcinoma with limited PD-L1 expression, or that
are refractory to PD-1 blockade. The second clinical study (Study
2020-0354) targets patients with inoperable locoregional recurrent
head and neck squamous cell carcinoma amenable to
re-irradiation.
- Regulatory ‘safe to proceed’ granted for a phase I
study in lung cancer amenable to re-irradiation in October
2020.
Corporate activities and achievements enhancing Nanobiotix
balance sheet and advancing subsidiary Curadigm:
- Successful IPO on Nasdaq Global Select Market in
December 2020. The offering, including the full exercise of the
underwriters’ over-allotment option, included a capital increase of
8,395,000 new shares consisting of 6,540,000 ordinary shares in the
form of American Depositary Shares (ADSs), each representing one
ordinary share, and 1,855,000 ordinary shares placed in certain
jurisdictions outside of the United States. The total gross
proceeds of the global offering amounted to €93.5 million ($113.3
million), or net proceeds of €82.8 million ($100.4 million) after
deducting underwriting commissions and other estimated offering
expenses.
- Successful raise of €20 million in placement of ordinary
shares with US and EU investors in July 2020. Nanobiotix placed
3,300,000 new ordinary shares for total gross proceeds of
approximately €20.1 million by means of an accelerated bookbuild
offering reserved for a specific class of investors in the US and
EU.
- €10M in non-dilutive financing secured in June 2020.
Nanobiotix a total of €10 million from HSBC and Bpifrance for in
the form of state-guaranteed loans (Prêts Garantis par l’Etat, or
PGE in France).
- Validation of novel nanoprimer technology from subsidiary
Curadigm in RNA therapeutics with preclinical data presented at
the American Association for Cancer Research (AACR) in June 2020.
The data showed that the Curadigm nanoprimer could increase the
efficacy of RNA-based therapeutics up to 50% by decreasing rapid
liver clearance.
Expected 2021 Milestones
- 2021 – Expect first patient injected in phase III trial for
elderly head and neck cancer patients (NANORAY-312).
- Q2 2021 – Presentation of updated phase I dose expansion
results in head and neck cancer (Study 102 Expansion)
- Q2 2021- Updated results with new patients and additional
follow up in phase I I/O basket study (Study 1100)
- H1 2021 – Expect first patient injected in phase II study of
NBTXR3 in combination with anti-PD-1 for patients with
recurrent/metastatic head and neck cancer
- H1 2021- Expect first patient injected in phase II study of
NBTXR3 in combination with anti-PD-1/L1 for patients with
inoperable head and neck cancer
- H1 2021 – Expect first patient irradiated in phase I lung
reirradiation study (first patient injected H2)
- H2 2021 – Expect launch of post-registration study in soft
tissue sarcoma to launch in EU
- Additional news on other clinical trials and preclinical
programs
Next financial press release: revenue for Q1 2021 on April 30,
2021
Annual General Meeting will be held on April 28, 2021.
About NANOBIOTIX:
Nanobiotix is a late-stage clinical biotechnology company
pioneering disruptive, physics-based therapeutic approaches to
revolutionize treatment outcomes for millions of patients;
supported by people committed to making a difference for humanity.
The company’s philosophy is rooted in the concept of pushing past
the boundaries of what is known to expand possibilities for human
life.
Incorporated in 2003, Nanobiotix is headquartered in Paris,
France and Cambridge, Massachusetts (United States) and is
currently staffed by 90 employees (70 in France, 20 in the US). The
company also has subsidiaries in France, Spain, and Germany.
Nanobiotix has been listed on Euronext: Paris since 2012 and
completed a successful initial public offering (IPO) on the Nasdaq
Global Select Market in New York City in December 2020. The company
is one of only 7 dual-listed biotech companies with headquarters in
France.
Nanobiotix is the owner of more than 30 umbrella patents
associated with three (3) nanomedicine platforms: 1) applied to
oncology; 2) applied to bioavailability and biodistribution; and 3)
applied to disorders of the central nervous system. The lion's
share of the company's resources are devoted to the development of
its lead product candidate–NBTXR3—which was born from its
proprietary oncology platform and is has already achieved market
authorization in Europe for the treatment of patients with soft
tissue sarcoma under the brand name Hensify®.
For more information about Nanobiotix, visit us at
www.nanobiotix.com or follow us on LinkedIn and Twitter
Disclaimer
This press release contains certain “forward-looking” statements
within the meaning of applicable securities laws, including the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements may be identified by words such as “at this time,”
“anticipate,” “believe,” “expect,” “intend,” “on track,” “plan,”
“scheduled,” and “will,” or the negative of these and similar
expressions. These forward-looking statements, which are based on
our management’s current expectations and assumptions and on
information currently available to management, include statements
about the timing and progress of clinical trials, the timing of our
presentation of data, the results of our preclinical studies and
their potential implications. Such forward-looking statements are
made in light of information currently available to us and based on
assumptions that Nanobiotix considers to be reasonable. However,
these forward-looking statements are subject to numerous risks and
uncertainties, including with respect to the risk that subsequent
studies and clinical trials may not generate favorable data
notwithstanding positive preclinical result and the risks
associated with the evolving nature of the duration and severity of
the COVID-19 pandemic and governmental and regulatory measures
implemented in response to it. Furthermore, many other important
factors, including those described in our prospectus filed with the
U.S. Securities and Exchange Commission on December 11, 2020 under
the caption “Risk Factors” and those set forth in the universal
registration document of Nanobiotix registered with the French
Financial Markets Authority (Autorité des Marchés Financiers) under
number R.20-010 on May 12, 2020 (a copy of which is available on
www.nanobiotix.com), as well as other known and unknown risks and
uncertainties may adversely affect such forward-looking statements
and cause our actual results, performance or achievements to be
materially different from those expressed or implied by the
forward-looking statements. Except as required by law, we assume no
obligation to update these forward-looking statements publicly, or
to update the reasons why actual results could differ materially
from those anticipated in the forward-looking statements, even if
new information becomes available in the future.
The consolidated financial statements for the fiscal year ending
December 31, 2020 have been approved by the Company’s executive
board and reviewed by the supervisory board on March 17, 2021. The
Company’s statutory auditors have completed their audit work on the
2020 financial statements, but they have not issued their audit
report yet.
Consolidated Income
Statement:
In K€
2020
2019
Total revenue and other income
2.512
2.541
Sales
50
68
Service
50
40
Other sales
-
28
Other revenue
2.462
2.473
Research Tax Credit
1.927
2.437
Subsidies
526
20
Other
10
17
Research & Development (R&D)
costs
(24.330)
(30.411)
Selling, General and Administrative
(SG&A) costs
(14.611)
(18.909)
Operating loss
(36.428)
(46.779)
Financial loss
2.847
(4.133)
Income tax
(9)
(3)
Net loss for the period
(33.590)
(50.915)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210317005817/en/
Nanobiotix Communications Department Brandon Owens VP,
Communications +1 (617) 852-4835 contact@nanobiotix.com
Investor Relations Department Kate McNeil SVP, Investor
Relations +1 (609) 678-7388 investors@nanobiotix.com
Media Relations France – Ulysse Communication
Pierre-Louis Germain + 33 (0) 6 64 79 97 51
plgermain@ulysse-communication.com
US – Porter Novelli Stefanie Tuck +1 (917) 390-1394
Stefanie.tuck@porternovelli.com
Grafico Azioni Nanobiotix (EU:NANO)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Nanobiotix (EU:NANO)
Storico
Da Apr 2023 a Apr 2024