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and full year 2021. A live webcast presentation by Nordic Nanovector’s
management team will take place today at 08.30 CET at Thon Hotel Vika Atrium,
Munkedamsveien 45, 0250 Oslo, meeting room Bjørvika. A link to the webcast and
the presentation is available from the Company’s homepage
(www.nordicnanovector.com).
Erik Skullerud, Chief Executive Officer of Nordic Nanovector, commented: “The
fourth quarter was a productive period for the Company as we continued to drive
PARADIGME recruitment, made key appointments, and hosted our R&D Day
highlighting the vision and strategy for Betalutin® and our wider pipeline.
Combined with the proceeds from our recent NOK 250 million private placement,
this means we are beginning 2022 in a strong position to complete PARADIGME and
deliver the three-month data readout later in the year, despite the delays
imposed by the COVID-19 pandemic. We remain focussed on our goal of advancing
Betalutin® to meet the need for a chemo-free, effective yet tolerable treatment
for non-Hodgkin’s lymphoma patients.”
Q4’2021 Highlights
· 106 of a targeted 120 evaluable patients have been enrolled into the pivotal
PARADIGME Phase 2b trial for Betalutin® as of 28 February 2022
· Given the ongoing impact from the SARS-CoV-2 omicron variant on patient
recruitment, the Company anticipates the preliminary three-month data readout
from PARADIGME to be reported during H2’2022
· Sandra Jonsson appointed as Chief Operating Officer
· Dr Jonsson takes over from Marco Renoldi, who is retiring from the role
but will remain as a consultant to the Company
· Dr Jonsson is a results-driven international Life Science executive, with
15 years of cross-functional experience in global pharmaceutical and
biotechnology companies. She joins Nordic Nanovector from Alexion
Pharmaceuticals, where she was Senior Director, Commercial International
· 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
· In November 2021, the Company hosted an R&D Day highlighting its vision and
strategy for creating value from Betalutin® as well as through the development
of exciting opportunities that leverage its deep expertise and experience in
CD37 biology
· 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 treatment
· 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
Post-period highlights
· In January 2022 Nordic Nanovector raised approximate NOK 250 million gross
from a private placement of new shares. The proceeds will be used to:
· fund preparation of activities required for the regulatory filing of
Betalutin[®] and pre-approval inspections
· continue the preparatory activities for the confirmatory Phase 3 trial
including production of clinical material
· preparations for market launch, and
· general corporate purposes
· Following the successful private placement, Nordic Nanovector is undertaking
a subsequent Repair Offering with a subscription period that commenced on 28
February 2022 and ends at 16.30 hours CET on 11 March 2022
The proceeds together with existing cash resources are expected to ensure
financing beyond the preliminary 3-month data readout from PARADIGME targeted
for H2’2022 and for at least an additional three months into 2023 to enable the
Company to maximize shareholder value from the PARADIGME clinical trial.
Financial Highlights Q4 and FY’2020
(Figures in brackets = same period 2020 unless otherwise stated)
· Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.0
million). Revenues for the full year 2021 were NOK 0.0 million (NOK 0.0
million).
· Total operating expenses for the fourth quarter were NOK 133.1 million (NOK
106.8 million). Total operating expenses for the full year 2021 amounted to NOK
442.4 million (NOK 434.2 million).
· Research and development (preclinical, clinical, medical affairs, regulatory
and CMC activities) expenses accounted for 85% of total operating expenses in
2021 (84%).
· Comprehensive loss for the fourth quarter amounted to NOK 134.1 million
(loss of NOK 112.1million). Comprehensive loss for the full year 2021 was NOK
441.7 million (NOK 417.6 million).
· Cash and cash equivalents amounted to NOK 277.7 million at the end of
December 2021 (NOK 294.0 million).
Outlook
Nordic Nanovector remains focused on completing PARADIGME and is targeting the
preliminary readout of three-month top line data from the study in H2’2022.
The Company believes that, if positive, these 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.
Presentation and Live Webcast
A live webcast presentation by Nordic Nanovector’s management team will take
place today at 08.30 CET. The webcast can be accessed from
www.nordicnanovector.com in the section: Investors & Media and a recording will
also be available on this page after the event.
The results report and the presentation will be available at
www.nordicnanovector.com in the section: Investors & Media/Reports and
Presentation/Interim Reports/2021 from 7:00am CET the same day
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: +44 203 928 6900
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. The Company aspires to become a
leader in the development of CD37-targeted therapies for haematological cancers
and immune diseases. 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.
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.
Kilde
