OSLO, Norway, Feb. 27, 2020 /PRNewswire/ -- Nordic Nanovector
ASA (OSE: NANO) announces its results for the fourth quarter and
full year 2019. A presentation by the company's senior management
team will take place today in Oslo
at 08:30 CET, see details below.
Jan H. Egberts, MD, Chairman of Nordic Nanovector,
commented: "We currently have 47 patients enrolled in
our pivotal PARADIGME Phase 2b
trial evaluating Betalutin®. The company will under its
new management look into the current strategy and operational trial
initiatives. We still aim to complete the patient enrolment in
PARADIGME in the second half of 2020. The encouraging efficacy and
safety profile demonstrated in the first part of the LYMRIT 37-01
Phase 1/2 trial with a single administration of Betalutin® give the
Board and management confidence in its potential to become an
important option for patients with non-Hodgkin's lymphoma
(NHL).
Highlights Q4 2019
- Pivotal Phase 2b PARADIGME trial
of Betalutin® in 3rd-line FL is progressing
-
- 47 patients have been enrolled in the PARADIGME trial
- The company continues to aim for patient enrolment to be
completed in the second half of 2020
- A global agreement was signed with Isotope Technologies
Garching GmbH (ITG) to ensure the supply of no-carrier-added
lutetium-177, a key component of Betalutin®
- Successful completion of private placement of new shares
raising approximately NOK 243
(USD 26.4 million) (gross)
- DLBCL - 3 additional patients being enrolled into final dose
cohort as one patient experienced a reversible DLT
- Alpha37 project received grant funding of NOK 6 million (~USD
0.65 million) from Eurostars and NOK
12 million (~USD 1.3
million) from the Norwegian Research Council
- New preclinical data offering insights to enchancing
Betalutin®-based combination therapies in NHL presented at ASH
Events after Q4 2019
- As announced in a separate release on 26
February 2020, Lars Nieba, Chief Technology Officer of
Nordic Nanovector, has been appointed interim Chief Executive
Officer to replace Eduardo Bravo,
who has left the company to pursue other career opportunities.
Financial Highlights Q4 and FY'19
(Figures in brackets = same period 2018 unless otherwise
stated)
- Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.0
million). Revenues for the full year 2019 were NOK 0.0 million (NOK 0.0
million).
- Total operating expenses for the fourth quarter were
NOK 139.3 million (NOK 96.3 million). Total operating expenses for
the full year 2019 amounted to NOK 440.4
million (NOK 340.0
million).
- Comprehensive loss for the fourth quarter amounted to
NOK 137.5 million (loss of
NOK 87.7 million). Comprehensive loss
for the full year 2019 was NOK 433.2
million (NOK 336.8
million).
- Cash and cash equivalents amounted to NOK 471 million at the end of December 2019 (NOK 440.1
million).
Outlook
Nordic Nanovector aspires to become a leader in the field of
targeted radioimmunotherapies for haematological cancers by
developing, manufacturing and commercialising innovative products
to address major unmet medical needs and advance cancer care.
Betalutin®, the company's most advanced radioimmunotherapy
candidate, is developing a highly differentiated, competitive,
clinical profile. Nordic Nanovector is confident that Betalutin®
could become an attractive and convenient once-only therapeutic
option, which, based on detailed market research, has the potential
to be commercially successful.
Betalutin® is being developed for recurrent FL, based on the
promising results from the LYMRIT 37-01 Phase 1/2 clinical trial.
The company's pivotal Phase 2b
PARADIGME trial with Betalutin® in 3L R/R FL is underway. The
company will under its new management look into the current
strategy and operational trial initiatives. We still aim to
complete the patient enrolment in PARADIGME in the second half of
2020. The study's preliminary data read-out is planned a few months
later. A BLA filing to gain marketing approval for Betalutin® is
expected to start in the first half of 2021. Nordic Nanovector
intends to retain marketing rights and to actively participate in
the commercialisation of Betalutin® in core markets.
Nordic Nanovector intends to maximize the value of Betalutin®
across the major types of NHL (FL and DLBCL) and in earlier
treatment lines in combination with standard treatments. The
company is also evaluating opportunities with other CD37-targeting
radioimmunotherapies across NHL and other haematological cancer
indications.
Presentation and webcast - Q4 and Full Year 2019
results
A presentation by Nordic Nanovector's senior management team
will take place today at 8:30 am CET
at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: BJØRVIKA
The presentation will be recorded as a webcast and will be
available at www.nordicnanovector.com in the section:
Investors & Media
The results report and the presentation is available
at www.nordicnanovector.com in the section: Investors
& Media/Reports and Presentation/Interim Reports/2019.
About Nordic Nanovector:
Nordic Nanovector is committed to develop and deliver innovative
therapies to patients to address major unmet medical needs and
advance cancer care. The Company aspires to become a leader in the
development of targeted therapies for haematological cancers.
Nordic Nanovector's lead clinical-stage candidate is Betalutin®,
a novel CD37-targeting antibody-radionuclide-conjugate designed to
advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an
indication with substantial unmet medical need, representing a
growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector retains
global marketing rights to Betalutin® and intends to actively
participate in the commercialisation of Betalutin® in the US and
other major markets.
Further information can be found
at www.nordicnanovector.com.
Forward-looking statements
This press release contains certain forward-looking
statements. These statements are based on management's
current expectations and are subject to uncertainty and changes in
circumstances, since they relate to events and depend on
circumstances that will occur in the future and which, by their
nature, will have an impact on Nordic Nanovector's business,
financial condition and results of operations. The terms
"anticipates", "assumes", "believes", "can", "could", "estimates",
"expects", "forecasts", "intends", "may", "might", "plans",
"should", "projects", "targets", "will", "would" or, in each case,
their negative, or other variations or comparable terminology are
used to identify forward-looking statements. These forward-looking
statements are not historic facts. There are a number of factors
that could cause actual results and developments to differ
materially from those expressed or implied in the forward-looking
statements. Factors that could cause these differences include, but
are not limited to, risks associated with implementation of Nordic
Nanovector's strategy, risks and uncertainties associated with the
development and/or approval of Nordic Nanovector's product
candidates, ongoing and future clinical trials and expected trial
results, the ability to commercialise Betalutin®, technology
changes and new products in Nordic Nanovector's potential market
and industry, Nordic Nanovector's freedom to operate (competitors
patents) in respect of the products it develops, the ability to
develop new products and enhance existing products, the impact of
competition, changes in general economy and industry conditions,
and legislative, regulatory and political factors. No assurance can
be given that such expectations will prove to have been correct.
Nordic Nanovector disclaims any obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
This information is subject to a duty of disclosure pursuant
to Sections 4-2 and 5-12 of the Securities Trading Act.
For further information, please contact:
IR
enquiries
Malene Brondberg
VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: ir@nordicnanovector.com
Media Enquiries
Mark Swallow/Frazer
Hall/David Dible (Citigate Dewe
Rogerson)
Tel: +44-203-926-8535
Email: nordicnanovector@citigatedewerogerson.com
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http://news.cision.com
https://news.cision.com/nordic-nanovector/r/nordic-nanovector-asa---results-for-the-fourth-quarter-and-full-year-2019,c3047190
The following files are available for download:
https://mb.cision.com/Public/9819/3047190/af89282d512f761b.pdf
|
Q4 2019
Presentation
|
https://mb.cision.com/Public/9819/3047190/acbe4b06c65a73ec.pdf
|
Q4 and FY 2019
report
|
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SOURCE Nordic Nanovector