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Land | Norge |
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Lista | OB Match |
Sektor | Hälsovård |
Industri | Läkemedel & Handel |
2021-11-18 07:01:17
Oslo, Norway, 18 November 2021
Nordic Nanovector ASA (OSE: NANOV) announces its results for the third quarter
2021. A presentation by Nordic Nanovector's senior management team will be held
in-person today in Oslo and webcast live beginning at 8:30am CET - details
below.
Erik Skullerud, CEO of Nordic Nanovector, said: "We are entering an exciting
period for Nordic Nanovector, as the Company draws closer to completing patient
recruitment for the PARADIGME trial, for which we expect readout of preliminary
data in H1' 2022. The Company is convinced that Betalutin® is uniquely
positioned to meet the need for a chemo-free, effective yet tolerable treatment
for non-Hodgkin's lymphoma patients, coupled with a convenient administration
schedule. In the meantime, we look forward to sharing our vision for Nordic
Nanovector and Betalutin® as well as an update on our pipeline at our R&D day on
30 November."
Operational Highlights
· 102 of a targeted 120 patients have been enrolled into the pivotal PARADIGME
Phase 2b trial for Betalutin® as of 17 November 2021 (94 patients enrolled as of
26 August 2021)
· Three patients were enrolled in the same quarter in 2020
· Preliminary three-month data readout expected during H1'2022, following
timeline revisions announced on 3 August 2021
· Erik Skullerud appointed as new Chief Executive Officer (CEO)
· Mr Skullerud brings more than 25 years' experience in the biopharma
industry including more than 15 years at Amgen, including as Marketing Director
Europe Oncology/Hematology, and seven years at Bayer
· He has launched numerous highly innovative products in therapeutic areas
including oncology and haematology, and as a consultant, he has worked with some
of the world's top pharma and biotech companies as well as small, highly
specialised start-ups on a wide range of projects
· Pierre Dodion MD appointed as Chief Medical Officer
· Dr Dodion has over 30 years' experience in the biopharmaceutical industry,
spent mostly in the oncology and haematology areas. He brings deep clinical
development and medical affairs expertise and has provided strategic insight and
overseen multiple clinical trials
· Nordic Nanovector announced its support for The Health Policy Partnership's
initiative to improve readiness for the use of radioimmunotherapy and to
facilitate appropriate integration of this innovative cancer treatment modality
in lymphoma
· The Company entered a research collaboration with the University of
Pennsylvania to generate a novel CD37-targeting CAR-T cell therapy approach as a
potential treatment for patients with B-cell malignancies
· Nordic Nanovector will have an option to license exclusive worldwide
rights to any CD37-targeting CAR-T cells that result from the collaboration
Financial Highlights
(Figures in brackets = same period 2020 unless otherwise stated)
· Revenues for the third quarter 2021 and the first nine months of 2021
amounted to NOK 0.0 million (NOK 0.0 million)
· Total operating expenses for the third quarter 2021 were NOK 104.3 million
(NOK 88.1 million). Total operating expenses for the first nine months of 2021
were NOK 309.3 million (NOK 327.3 million)
· Comprehensive loss for the third quarter 2021 amounted to NOK 103.6 million
(loss of NOK 88.2 million). Comprehensive loss for the first nine months of 2021
was NOK 307.6 (NOK 305.4 million)
· Cash and cash equivalents amounted to NOK 369.5 million at the end of
September 2021, compared to NOK 450.1 million at the end of June 2021, and NOK
294.0 million at the end of December 2020
Outlook
Nordic Nanovector is close to completing patient enrolment into PARADIGME and is
targeting the readout of preliminary three-month top line data during H1'2022.
The company's current cash position will support its operations into H2'2022 and
will enable further preparatory work on the potential Betalutin® BLA filing and
planning for commercialisation to be undertaken.
The company believes that, if positive, the PARADIGME trial data could represent
a significant value inflection point for the company and its shareholders,
confirming Betalutin® as a highly promising new targeted radioimmunotherapy that
can address the unmet needs of R/R FL patients.
The company intends to discuss the development plan and opportunities for
expanding the market for Betalutin® into other NHL indications, together with
other potential areas for pipeline expansion and collaboration based on CD37
-targeting immunotherapies, at its R&D Day, which is planned to take place on 30
November 2021.
Presentation and Webcast
A presentation by Nordic Nanovector's senior management team will take place in
Oslo today at 8:30am CET at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: Bjørvika
The presentation will webcast live 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/2021.
For further information, please contact:
IR enquiries
Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
Media Enquiries
Mark Swallow/Frazer Hall/David Dible (MEDiSTRAVA Consulting)
Tel: +44 207 638 9571
Email: nordicnanovector@medistrava.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 26 billion by 2028. 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 (https://nam10.safelinks.protection.outlook.com/?url
=
http%3A%2F%2Fwww.nordicnanovector.com%2F&data=04%7C01%7CMark.Swallow%40medistrav
a
.com%7Ca91a12b7fd1942b911c508d9639fcaf4%7C5c24475f929349d0b4e1ba6d190e92f9%7C0%7
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0%7C637650361008661079%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luM
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IiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=YpIUKimx78JX14KG4Tcg6D3vx2RnTkqhO2
n
06S0%2B8ag%3D&reserved=0).
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.