Vis børsmeldingen
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.
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
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.
Kilde
