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- A live webcast presentation by Nordic Nanovector’s management team will
take place today at 08.30 CEST. A link to the webcast is available on
www.nordicnanovector.com.
The results report and the presentation are also available on the company’s
website in the section: Investors & Media/Reports and Presentation/Interim
Reports/2021. A replay of the webcast will be made available at the same
location after the event.
Peter L. Braun, Chief Executive Officer of Nordic Nanovector, commented: “Nordic
Nanovector has made important progress so far in 2021, including raising the
money needed to deliver the preliminary top-line three-month data from the
PARADIGME study and to prepare for a subsequent potential BLA filing for
Betalutin®. The company has also implemented a range of initiatives aimed at
improving patient recruitment into PARADIGME, and which we believe will further
improve patient enrolment when the impact of COVID-19 recedes. I am convinced
that effective and well-tolerated, targeted radiopharmaceuticals, such as
Betalutin®, a one-time treatment, can make a real difference to NHL patients
worldwide.”
Operational Highlights
· Peter L. Braun was appointed Chief Executive Officer in March
· Mr Braun is an experienced and entrepreneurial pharmaceutical leader with
extensive commercialisation and innovative oncology experience from a career
spanning nearly 30 years at Roche
· Successful Private Placement and oversubscribed Repair Offering completed in
February and April, respectively, raised approximately NOK 422 million (USD 49.7
million) in gross proceeds
· Extends the company’s cash runway into H2’2022
· Operational improvements and protocol changes have improved PARADIGME
recruitment rate in recent months, despite impact from the on-going COVID-19
pandemic
· 83 patients enrolled as of 25 May 2021 (73 enrolled as of 17 February
2020)
· Company remains on track to report preliminary three-month top-line data
by the end of 2021
· Promising Phase 1b data from the Archer-1 study evaluating Betalutin® in
combination with rituximab in 2L FL
· Board changes
· Hilde Hermansen Steineger, PhD, decided not to stand for re-election at
AGM
· Solveig Hellebust, PhD, appointed Non-executive Director at the AGM on 28
April 2021
Financial Highlights Q1 2021
(Figures in brackets = same period 2020 unless otherwise stated)
· Revenues for the first quarter amounted to NOK 0.0 million (NOK 0.0
million).
· Total operating expenses for the first quarter were NOK 101.2 million (NOK
125.9 million).
· Research and development (preclinical, clinical, medical affairs, regulatory
and CMC activities) expenses accounted for 85.9 % of total operating expenses
year to date 2021 (80.8 %).
· Comprehensive loss for the first quarter amounted to NOK 102.1 million (loss
of NOK 91.7 million).
· Cash and cash equivalents at the end of March 2021 amounted to NOK 497.9
million, compared to NOK 294.0 million at the end of December 2020.
Outlook
Nordic Nanovector’s current focus is to complete patient enrolment into
PARADIGME and the target is to announce the preliminary readout of three-month
top line data from PARADIGME by end 2021.
Following the recent successful Private Placement and Repair Offering, the
company has extended its cash runway into H2’2022, which in addition to allowing
it to deliver the top line data from PARADIGME, will enable further preparatory
work on the potential Betalutin® BLA filing 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.
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 (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 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 the disclosure requirements pursuant to Section 5
-12 the Norwegian Securities Trading Act
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