On November 18, 2020 Nordic Nanovector ASA (OSE: NANO) reported its results for the third quarter 2020 (Press release, Nordic Nanovector, NOV 18, 2020, View Source [SID1234571373]). 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).
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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
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, Nordic Nanovector has a cash runway that extends into Q3’2021.
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 Nordic Nanovector’s management team will take place today at 8:30 am 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 is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020.