Vis børsmeldingen
- 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.
Kilde
