Lars Nieba, Interim CEO of
Q3'2020 Highlights
· Result of PARADIGME Interim Analysis: Independent Review Committee recommendation to focus on single arm investigating the "40/15" dosing regimen
· Target set to report three-month top-line data in H2'2021
· Approval of amendments to PARADIGME protocol is proceeding as planned and completed in the best-recruiting countries
· Designed to enlarge the eligible patient population and increase the rate of enrolment into the trial
· Pivotal Phase 2b PARADIGME trial of Betalutin® progressing in 3rd-line relapsed/refractory follicular lymphoma (3L R/R FL)
· COVID-19 pandemic continues to have a negative impact on PARADIGME patient recruitment - the target patient population is a high-risk group for COVID-19
· 59 patients enrolled as of
· Private placement was oversubscribed and successfully completed raising approximately
· Funds to be used to advance PARADIGME study and conduct other essential activities to enable a timely filing pending top-line data
· Dr
Events after Q3'2020
· Final two patients enrolled into Archer-1 Phase 1 safety trial of Betalutin® plus rituximab in 2L R/R FL
· Preliminary data readout expected in H1'2021
· Trial to be paused pending analysis of data and evaluation of plans for further development
· Results of preclinical studies demonstrating Betalutin® reverses tumour resistance to rituximab in NHL disease models published in
Financial Highlights
(Figures in brackets = same period 2019 unless otherwise stated)
· Revenues for the third quarter and for the first nine months of 2020 amounted to
· Total operating expenses for the third quarter were
· Comprehensive loss for the third quarter amounted to
· Cash and cash equivalents amounted to
Outlook
The company continues to target the readout of three-month top line data from PARADIGME in H2'2021. Approval of protocol amendments is proceeding as planned and completed in the best-recruiting countries, and other initiatives to increase the rate of enrolment are underway. The company also targets the readout of three-month top line data from the second cohort of the Archer-1 trial in H1'2021.
However, the impact of the COVID-19 pandemic on patient recruitment has worsened in light of the emergence of a second wave resulting in severe travel restrictions being implemented in the various countries where we are executing our clinical studies. These restrictions and uncertainty around the duration, severity and geographic scope of the COVID-19 outbreak are projected to slow down the enrolment of patients due to re-prioritisation of hospital activities towards COVID-19 patients and away from clinical studies such as PARADIGME. In addition, travel restrictions could create logistical challenges for the shipment of clinical supplies. Several proactive actions have been taken to minimize the impact of these travel restrictions which could blunt further delays in completing enrolment and delivering preliminary results as targeted.
The company has taken steps to conserve cash and following the recent successful private placement,
Despite the challenging times, the many positive actions the company has made in the last nine months have improved the prospects of delivering pivotal results from PARADIGME in H2'2021.
The company continues to believe 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 therapy that can address the unmet needs of R/R FL patients.
Presentation and live webcast - Q3 2020 results
A presentation and live webcast by
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 is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020.
For further information, please contact:
IR enquiries
Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
Media Enquiries
Tel: +44 203 926 8535
Email: nordicnanovector@citigatedewerogerson.com
About
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
This information is subject to a duty of disclosure pursuant to Sections 4-2 and 5-12 of the Securities Trading Act.
https://news.cision.com/nordic-nanovector/r/nordic-nanovector-asa--results-for-the-third-quarter-2020,c3239830
https://mb.cision.com/Public/9819/3239830/aba2ac8be1722b4a.pdf
https://mb.cision.com/Public/9819/3239830/ab0be18ff7ad1486.pdf
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