On August 27, 2020 Nordic Nanovector ASA (OSE: NANO) reported its results for the second quarter and first half 2020 (Press release, Nordic Nanovector, AUG 27, 2020, View Source [SID1234564068]). A 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: "The management team together with the board have taken a range of actions during the last several months to increase focus, improve patient recruitment while at the same time conserve cash. These initiatives along with the positive PARADIGME interim analysis and on-going protocol amendments have put Nordic Nanovector in a significant improved position to deliver the three-month top line data from PARADIGME in H2’2021. "
Q2 and H1 2020 Highlights
Strategic review completed: clinical development strategy revised, and cost-saving initiatives implemented
Pivotal Phase 2b PARADIGME trial of Betalutin progressing in 3rd-line follicular lymphoma (3L FL)
COVID-19 continued to have a negative impact on PARADIGME patient recruitment during Q3
56 patients enrolled as of August 26th, 2020
Protocol amendments are being made to PARADIGME to enlarge the eligible patient population and increase the rate of enrolment into the study
Dr Lars Nieba appointed as interim Chief Executive Officer and Malene Brondberg as Chief Financial Officer
Planned restructuring completed
Corporate and personnel reorganisation implemented, headcount reduced by approximately 20%
Cost savings of approximately NOK 35 million per annum are expected from the restructuring
Betalutin granted Fast Track designation in the US and Orphan Drug Designation in the European Union for Marginal Zone Lymphoma (MZL)
Events after Q1 2020
Result of PARADIGME Interim Analysis: recommendation to focus on single arm investigating the "40/15" dosing regimen
Comprehensive review of data by Independent Review Committee
Both dosing regimens were well-tolerated and associated to a manageable safety profile
Both arms were active based on efficacy measures of Complete Response, Partial Response and Stable Disease
"40/15" arm demonstrated consistency across all sub-groups
"100/20" arm to be discontinued – dosed patients to be monitored for the remainder of the trial
Maintain target to recruit 130 patients
Although we see improvements in certain geographies, the negative impact due to COVID-19 continues to impact PARADIGME patient recruitment during Q3. The target patient population is a high-risk group for COVID-19
Target set to announce PARADIGME three-month top-line data in H2’2021
Dr Christine Wilkinson Blanc appointed Chief Medical Officer
Financial Highlights
(Figures in brackets = same period 2019 unless otherwise stated)
Revenues for the second quarter amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the second quarter were NOK 113.4 million (NOK 111.0 million)
Comprehensive loss for the second quarter amounted to NOK 125.6 million (loss of NOK 110.4 million)
Revenues for the first half of 2020 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the first half of 2020 increased to NOK 239.3 million (NOK 200.9 million)
Comprehensive loss for the first half was NOK 217.2 (NOK 202.0 million)
Cash and cash equivalents amounted to NOK 246.2 million at the end of June 2020, compared to NOK 470.8 million at the end of December 2019
Outlook
The company is targeting the readout of three-month top line data from PARADIGME in H2’2021. This timeline assumes the efficient implementation of the protocol amendments and other initiatives to increase the rate of enrolment and the impact of the COVID pan-epidemic on patient recruitment to slowly subside over the next few months.
The steps the company has taken to conserve cash, including reducing headcount and pausing certain clinical trials, will extend the cash runway into 2021. The company expects to see the impact of these cost-saving initiatives emerge over the remainder of 2020.
Following a broad range of actions carried out by the management team during the course of 2020, the company now believes it is in a much-improved position to deliver the pivotal results from PARADIGME in a timely manner. This would be a key milestone for Nordic Nanovector as the company seeks to bring this exciting new targeted NHL treatment to patients and maximise the value of Betalutin.
Presentation and webcast – Q2 and H1 2020 results
A presentation by Nordic Nanovector’s management team will take place today at 8:30 am CET at Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo, Meeting Room: Vika Atrium
The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media
The results report and the presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2020.