Vis bĂžrsmeldingen
and first half 2019. A presentation by the companyâs senior management team will
take place today in Oslo at 08:30 CEST, see details below.
Eduardo Bravo, CEO, commented: âWe continue to progress our clinical development
programmes with BetalutinÂź 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, BetalutinÂź 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 BetalutinÂź could deliver to
NHL patients around the globe.â
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
BetalutinÂź in R/R FL
· Pivotal Phase 2b PARADIGME trial of BetalutinŸ 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 BetalutinŸ 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 BetalutinÂź (and other anti-CD37 targeting agents) in combination with
anti-CD20 antibodies (including rituximab) for the treatment of non
-Hodgkinâs 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
BetalutinÂź 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 companyâs
CMC strategy
Financial Highlights Q2 and 1Hâ19
(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 companyâs 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.
BetalutinÂź, the companyâs 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 companyâs
pivotal Phase 2b PARADIGME trial with a once-only administration of BetalutinÂź
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 BetalutinÂź 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 BetalutinÂź 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 Nanovectorâs 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.
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 Nanovectorâs lead clinical-stage candidate is BetalutinÂź, a novel CD37
-targeting radioimmunotherapy designed to advance the treatment of non-Hodgkinâs
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 BetalutinÂź 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 managementâs 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 Nanovectorâs business, financial condition and results
of operations. The terms âanticipatesâ, âassumesâ, âbelievesâ, âcanâ, âcouldâ,
âestimatesâ, âexpectsâ, âforecastsâ, âintendsâ, âmayâ, âmightâ, âplansâ,
âshouldâ, âprojectsâ, âtargetsâ, âwillâ, âwouldâ 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 Nanovectorâs
strategy, risks and uncertainties associated with the development and/or
approval of Nordic Nanovectorâs product candidates, ongoing and future clinical
trials and expected trial results, the ability to commercialise BetalutinÂź,
technology changes and new products in Nordic Nanovectorâs potential market and
industry, Nordic Nanovectorâs 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
