OSLO, Norway, Aug. 22, 2019 /PRNewswire/ -- Nordic Nanovector
ASA (OSE: NANO) announces its results for the second quarter and
first half 2019. A presentation by the company's senior management
team will take place today in Oslo
at 08:30 CEST, see details
below.
Eduardo Bravo, CEO,
commented: "We continue to progress our clinical development
programmes with Betalutin® in major NHL indications. In PARADIGME,
we have reached our target range in terms of activated sites and
while the recruitment rate has accelerated in recent months, this
has not been at the rate we anticipated. This has led us to
reassess the trial timelines and we now estimate to complete
patient enrolment in 2H 2020 rather than 1H 2020 as previously
guided. We would expect the data read-out from the trial a few
months after the final patient has been dosed. As a one-off
treatment, Betalutin® has an exciting product profile, and we have
been encouraged by the preliminary analysis of the extended median
duration of response data that we have disclosed today. We remain
focused on advancing PARADIGME and our other clinical programmes as
quickly as possible given the clear benefits that Betalutin® could
deliver to NHL patients around the globe."
Highlights
- Preliminary analysis shows median duration of response
(mDoR) of 13.5 months (formerly 9.0 months in December 2018) for Phase 1/2a LYMRIT 37-01 trial
of Betalutin® in R/R FL
- Pivotal Phase 2b PARADIGME trial
of Betalutin® in advanced recurrent follicular lymphoma (FL)
progressing with 81 sites in 23 countries open for enrolment
as of August 21st, 2019
-
- Patient recruitment has accelerated in recent months but
not at the rate anticipated
- Full enrolment now expected 2H 2020 compared with 1H 2020
as previously guided
- Phase 1b Archer-1 trial of
Betalutin® plus rituximab (RTX) in patients with
relapsed/refractory (R/R) 2nd line FL advanced into second
cohort
- Global patent portfolio strengthened with grant of
European patent covering the use of Betalutin® (and other anti-CD37
targeting agents) in combination with anti-CD20 antibodies
(including rituximab) for the treatment of non-Hodgkin's lymphoma
(NHL)
- Promising preclinical results from R&D collaboration
to develop a novel CD37-targeting alpha therapy for B-cell tumours
presented at international scientific congresses (TAT11 and
TRP19)
- Recruitment completed for dose escalation phase of LYMRIT
37-05 trial of Betalutin® in relapsed/refractory diffuse large
B-cell lymphoma (DLBCL) – preliminary results expected in 2H
2019
- Dr Lars Nieba appointed as Chief
Technology Officer to drive the company's CMC strategy
Financial Highlights Q2 and 1H'19
(Figures in brackets = same period 2018 unless otherwise
stated)
- Revenues for the second quarter amounted to NOK 0.0 (NOK 0.0
million). Revenues for the first half of 2019 were
NOK 0.0 (NOK 0.0 million).
- Total operating expenses for the second quarter were
NOK 111.0 million (NOK 84.5 million). Total operating expenses
for the first half of 2019 amounted to NOK
200.9 million (NOK 166.8 million)
- Research and development (preclinical, clinical, medical
affairs, regulatory and CMC activities) expenses accounted for 77 %
of total operating expenses (72.2 %) for the first half of
2019.
- Comprehensive loss for the second quarter amounted to
NOK 110.4 million (loss of
NOK 82.9 million).
Comprehensive loss for the first half was NOK 202.0 million (loss of NOK 173.6 million)
- Cash and cash equivalents amounted to NOK 443.5 million at the end of June 2019 (NOK 570.1
million at June 2018 and
NOK 440.1 million at
31 December 2018)
Upcoming R&D Day
Nordic Nanovector is planning to host and R&D Day in
September. During the event the senior management team and external
speakers will provide updates and further information on the
company's key activities. The R&D Day will take place in
Oslo and will also be webcast
live. Details on the date and how to register to attend will be
announced within the next two weeks.
Outlook
Nordic Nanovector aspires to become a leader in the field of
targeted therapies for haematological cancers by developing,
manufacturing and commercialising innovative therapies to address
major unmet medical needs and advance cancer care.
Betalutin®, the company's most advanced product candidate, has a
highly differentiated, competitive, clinical profile 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 a once-only
administration of Betalutin® in 3L R/R FL is underway. Patient
enrolment is expected to be completed in the second half of 2020. A
data read-out is expected a few months after the final patient is
dosed enabling filing for marketing approval in the first half of
2021.
The company maintains its guidance that current cash resources
are expected to be sufficient to reach mid-2020.
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 and antibody drug conjugates across NHL and
other haematological cancer indications.
The company is confident that Betalutin® could become an
attractive and convenient therapeutic option, which, based on
detailed market research, has the potential to be commercially
successful.
Presentation and Webcast
A presentation by Nordic Nanovector's senior management team
will take place today at 8:30am CEST
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 from
7:00am CEST the same day.
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.
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
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The following files are available for download:
https://mb.cision.com/Public/9819/2886088/a5b027739ad1ed46.pdf
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Q2 and 1H 2019
report
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https://mb.cision.com/Public/9819/2886088/81807770a9bf1582.pdf
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Q2 and 1H 2019
Presentation
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