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Beskrivning

LandNorge
ListaOB Match
SektorHälsovård
IndustriLäkemedel & Handel
Thor Medical är ett läkemedelsbolag. Bolaget specialiserar sig inom utveckling av antikroppsläkemedel för behandling utav hematologisk cancer. Störst specialisering återfinns inom precisionsterapi som används i den kliniska fasen. Övriga sjukdomar som behandlas är non-hodgkins lymfom (NHL). Bolaget grundades under 2009 och har sitt huvudkontor i Oslo, Norge.
2020-04-01 16:53:15
Oslo, Norway, 1 April 2020

Nordic Nanovector ASA (OSE: NANO) today announces a number of initiatives to
speed up recruitment into its pivotal Phase 2b PARADIGME trial with Betalutin®
in advanced follicular lymphoma (FL) as well as to extend its cash runway into
2021. A webcast will take place on Thursday 2 April at 10:00 am CET. Details
below.

At the time of the Q4 results in February, the company noted that it would,
under its new management, critically assess the current strategy and clinical
trial operations.

Following this assessment several key development decisions have been made:

  · Streamlined strategy with all resources focused on PARADIGME - all other
clinical trials to be suspended following completion of the current cohorts and
all investments in pre-clinical assets to be halted
  · Request type C meeting with FDA to amend the current PARADIGME protocol
  · Intend to broaden PARADIGME's inclusion criteria to increase rate of
recruitment.

We have recently seen a slowdown in recruitment into the PARADIGME study due to
measures taken by many governments in respons to contain the COVID-19 pandemic,
as well as the need for hospitals to prioritise resources on treating infected
patients.

In parallel, several cost savings initiatives are being implemented to extend
the Company's cash runway into 2021:

  · Reduction in staffing levels by approximately 20% to be completed by end
April
  · Consolidating several staff functions and closing offices
  · Resources focused on core clinical operations and CMC (Chemistry,
Manufacturing and Controls)
  · Phased investment in CMC and pre-commercialisation activities with some
spending moved into 2021

The company will provide a further update on PARADIGME when it has received and
reviewed the feedback from its discussions with the FDA. Nordic Nanovector still
plans a rolling submission for Betalutin® with FDA once it has the top line data
from the PARADIGME trial.

Commenting on today's announcement, Lars Nieba, Interim CEO of Nordic
Nanovector, said: "The actions that we have announced today are designed to
significantly improve patient recruitment into our pivotal Phase 2b PARADIGME
trial with Betalutin® and to extend our cash runway into 2021. We are confident
that the changes we are making will enable us to deliver the key clinical data
needed to support a planned US filing with Betalutin® in a timely manner. I look
forward to keeping you updated on our progress."

Webcast

A webcast to discuss the restructuring plans and clinical trials will take place
on Thursday 2 April at 10:00 am CET. A link to the webcast and a presentation
will be uploaded to the company's frontpage website at 9:00 am CET on Thursday 2
April.

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/Frazer Hall/David Dible (Citigate Dewe Rogerson)

Tel: +44 203 926 8535

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 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 29
billion by 2026. 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.