Nordic Nanovector ASA: results for the Q3 2020

Nordic Nanovector ASA announces its results for the third quarter 2020. A live webcast presentation by Nordic Nanovector’s management team will take place today in Oslo at 08.30 CET, see details below. A link to the webcast and the presentation is available from the company’s homepage (www.nordicnanovector.com).

Lars Nieba, Interim CEO of Nordic Nanovector, said: “Following the successful interim analysis in August and completion of our private placement in September, we are progressing towards the major value inflection point of three-month top-line data from the PARADIGME clinical study, which is targeted for H2 2021. Generating these data will require us to successfully navigate the latest challenges of increased COVID-19 restrictions. We remain confident in our ability to achieve this goal, aided by the protocol amendments, the possibility to reduce the patient sample, and all the other measures we are actively implementing to drive patient recruitment into PARADIGME.”

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 18 November 2020
• Private placement was oversubscribed and successfully completed raising approximately NOK 231 million (approximately USD 25 million) in gross proceeds, extending cash runway into Q3’2021
  • Funds to be used to advance PARADIGME study and conduct other essential activities to enable a timely filing pending top-line data
• Dr Christine Wilkinson Blanc appointed Chief Medical Officer

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 Journal of Nuclear Medicine

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 NOK 0.0 million (NOK 0.0 million)

• Total operating expenses for the third quarter were NOK 88.1 million (NOK 100.2 million); total operating expenses for the first nine months of 2020 were NOK 327.3 million (NOK 301.1 million)
• Comprehensive loss for the third quarter amounted to NOK 88.2 million (loss of NOK 93.6 million); comprehensive loss for the first nine months of 2020 was NOK 305.4 (NOK 295.6 million)
• Cash and cash equivalents amounted to NOK 380.7 million at the end of September 2020, compared to NOK 470.8 million at the end of December 2019. PR NewsWire