On February 18, 2021 Nordic Nanovector ASA (OSE: NANOV) reported its results for the fourth quarter and full year 2020 (Press release, Nordic Nanovector, FEB 18, 2021, View Source [SID1234575218]). A live webcast presentation by Nordic Nanovector’s management team will take place today at 08.30 CET. 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 Chief Executive Officer of Nordic Nanovector, commented: "The company has made significant efforts during 2020 to improve both the execution of PARADIGME and the chances of a viable regulatory filling outcome. The progress made, despite the challenging global environment, has been encouraging and we are pleased to see the enrolment rate into PARADIGME improving. We remain convinced of the commercial potential of Betalutin based on the competitive efficacy data that was seen at the time of the Interim Analysis and in earlier studies, which could allow it to address an important unmet need in advanced FL. We continue to work hard to ensure that we complete PARADIGME in a timely fashion such that we can report preliminary three-month top-line data in H2’2021."
Q4’2021 Highlights
Operational improvements and protocol changes implemented during 2020 have resulted in a significant recent acceleration in PARADIGME recruitment rate
Recruitment rate increased from approx. two patients to approx. five patients per month despite COVID
After the expected lessening of COVID restrictions plus the ongoing operational improvements, this rate could further increase to at least seven patients on average per month by late spring
73 patients enrolled as of 17 February 2021 (59 enrolled as of 18 November 2020)
14 patients were enrolled from November 2020 to 17 February 2021 (3 patients from Aug-Nov 2020)
Operational improvements that have significantly boosted PARADIGME recruitment include:
Much improved management of the study CRO
Appointment of a specialist firm focused on further improving the rate of recruitment
A broadening of the inclusion criteria based on safety data from the Interim Analysis is estimated to increase the size of the pool of eligible patients by 30-50%
Following interactions with FDA and an internal review, the company believes that it has clarity on the clinical data set (safety and efficacy) needed to support a filing at the designated dosing regimen of "40/15" and that this can be achieved with a reduction of the initially targeted population from 130 to 120 patients
On this basis, 47 more patients are required to complete PARADIGME for regulatory submission of Betalutin
Increased confidence in target of reporting preliminary three-month top-line data in H2’2021
Pipeline update: Final patients enrolled into second safety cohort of Archer-1 Phase 1 trial of Betalutin plus rituximab in 2L R/R FL and into LYMRIT 37-05 Phase 1 trial of Betalutin in patients with DLBCL
Preliminary data readouts expected in H1’2021
Both trials 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 Q4 and FY’2020
(Figures in brackets = same period 2019 unless otherwise stated)
Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.0 million). Revenues for the full year 2020 were NOK 0.0 million (NOK 0.0 million).
Total operating expenses for the fourth quarter were NOK 106.8 million (NOK 139.3 million). Total operating expenses for the full year 2020 amounted to NOK 434.2 million (NOK 440.4 million).
Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 84 of total operating expenses in 2020 (80 %).
Comprehensive loss for the fourth quarter amounted to NOK 112.1 million (loss of NOK 137.5 million). Comprehensive loss for the full year 2020 was NOK 417.6 million (NOK 433.2 million).
Cash and cash equivalents amounted to NOK 294.0 million at the end of December 2020 (NOK 470.8 million).
Outlook
Nordic Nanovector will continue to focus its resources on completing PARADIGME and continues to target the preliminary readout of three-month top line data from PARADIGME in H2’2021.
The company believes 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 radioimmunotherapy that can address the unmet needs of R/R FL patients.
The company has streamlined its organisation and taken further steps to conserve cash. Following the successful private placement in September 2020, Nordic Nanovector has a cash runway that extends into Q3’2021.
Despite the challenging times, the many positive actions the company has taken during 2020 have improved the prospects of delivering preliminary readout of three-month top line data from PARADIGME in H2’2021 although the future impact of COVID-19 remains uncertain and may still impact the trial timelines. However, the recent improvements in recruitment pace for PARADIGME, while the COVID-19 pandemic has been severe, are encouraging.
The company also expects the readout of three-month top line data from the second cohort of the Archer-1 trial and the LYMRIT 37-05 trial in DLBCL in H1’2021. As stated, the company will assess these data and evaluate its plans for further development in these important NHL indications.
Presentation and Live Webcast
A live webcast presentation by Nordic Nanovector’s management team will take place today at 08.30 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 will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020 from 7:00am CET the same day