OSLO, Norway, Nov. 19, 2019 /PRNewswire/ -- Nordic Nanovector
ASA (OSE: NANO) announces its results for the third quarter 2019. A
presentation by the company's senior management team will take
place today in Oslo at
08:30 CET, see details
below.
Eduardo Bravo, CEO,
commented: "We are encouraged with the clinical results
emerging from the different clinical trials with Betalutin® in
non-Hodgkin's lymphoma (NHL). As stated by key opinion leaders in
the field during the R&D Day hosted by Nordic Nanovector in
September, the emerging profile of Betalutin® is unique and very
competitive. There are many patients who suffer from these
devastating diseases who lack effective, safe and convenient
treatment options. We remain fully committed to deliver on our
timelines to bring this novel product to the market as quickly as
possible."
Highlights Q3 `19
- Updated analysis from Phase 1/2a LYMRIT 37-01 trial of
Betalutin® in relapsed/refractory follicular lymphoma (R/R FL)
presented at R&D Day (September)
- Median duration of response of 13.6 months for all responders
and 32.0 months for complete responders (vs 9.0 and 20.7 months,
respectively reported at ASH 2018
- Median follow-up time for responders of 30.0 months (range:
12.0 - 60.7 months)
- Pivotal Phase 2b PARADIGME trial
of Betalutin® in advanced, recurrent and CD20 antibody treatment
refractory 3L Follicular Lymphoma (FL) is progressing
- 87 sites in 24 countries open for enrolment as of November 18th, 2019
- Patient enrolment is expected to be completed in the second
half of 2020
- Phase 1b Archer-1 trial of
Betalutin® in combination with rituximab (RTX) in patients with R/R
2nd line FL (2L FL) advanced to second cohort
- 100% Overall Response Rate (3/3 Complete Responses) observed in
the first patient cohort
- Promising preclinical results with Alpha37 for B-cell tumours
presented at EANM conference by partner Orano
Med
- Alpha37 project received grant funding of EUR 0.6 million from Eurostars
- Approximately NOK 243 million
(USD 26.4m) (gross) raised 18th
October in private placement of new shares providing additional
funds to support the continued clinical development of Betalutin®
(including completion of enrolment of PARADIGME and all ongoing
clinical trials), manufacturing and other activities in preparation
for the commercialisation of Betalutin®
- Dr Gabriele Elbl appointed as VP
Global Regulatory Affairs to drive the company's Regulatory Affairs
strategy
Financial Highlights Q3 `19
(Figures in brackets = same period 2018 unless otherwise
stated)
- Revenues for the third quarter amounted to NOK 0.0 (NOK 0.0
million). Revenues for the first nine months 2019 were
NOK 0.0 (NOK 0.0 million)
- Total operating expenses for the third quarter were
NOK 100.2 million (NOK 76.9 million). Total operating expenses
for the first nine months of 2019 amounted to NOK 301.1 million (NOK 243.7 million)
- Research and development (preclinical, clinical, medical
affairs, regulatory and CMC (Chemistry, Manufacturing and Controls)
activities expenses accounted for 78 % of total operating expenses
for the first nine months of 2019 (73 %)
- Comprehensive loss for the third quarter amounted to
NOK 93.6 million (loss of
NOK 75.4 million).
Comprehensive loss for the first nine months was NOK 295.6 million (loss of NOK 249.1 million)
- Cash and cash equivalents amounted to NOK 345.9 million at the end of September 2019 (NOK
440.1 million at 31 December
2018), exclusive of new funds raised in October 2019 of NOK 243
million (gross)
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. Patient
enrolment is expected to be completed 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 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
A presentation by Nordic Nanovector's senior management team
will take place today at 8:30am CET
at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: AKER
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 will be 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/David Dible (Citigate
Dewe Rogerson)
Tel: +44-207-638-9571
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 radioimmunotherapy 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 intends to retain
marketing rights and to actively participate in the
commercialisation of Betalutin® in core 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 Section 5-12 of the Securities Trading Act.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/nordic-nanovector/r/nordic-nanovector-asa---results-for-the-third-quarter-2019,c2967389
The following files are available for download:
https://mb.cision.com/Main/9819/2967389/1146417.pdf
|
Release
|
https://mb.cision.com/Public/9819/2967389/a030761d16fcf011.pdf
|
Q3 19
Presentation
|
View original
content:http://www.prnewswire.com/news-releases/nordic-nanovector-asa---results-for-the-third-quarter-2019-300960626.html
SOURCE Nordic Nanovector