Nordic Nanovector ASA: Results for the Second Quarter and First Half 2020

OSLO, Norway, Aug. 27, 2020 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces its results for the second quarter and first half 2020. 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).

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 3^rd-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 26^th, 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.

For further information, please contact:
IR enquiries
Malene Brondberg, CFO
Cell: +44-7561-431-762
Email: [email protected]

Media Enquiries
Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
Tel: +44-203-926-8535
Email: [email protected]

About Nordic Nanovector:

Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector retains global marketing rights to Betalutin® and intends to actively participate in the commercialisation of Betalutin® in the US and other major markets.

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 Nordic Nanovector's business, financial condition and results of operations. The terms "anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "targets", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. These forward-looking statements are not historic facts. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in the forward-looking statements. Factors that could cause these differences include, but are not limited to, risks associated with implementation of Nordic Nanovector's strategy, risks and uncertainties associated with the development and/or approval of Nordic Nanovector's product candidates, ongoing and future clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector's potential market and industry, Nordic Nanovector's freedom to operate (competitors patents) in respect of the products it develops, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions, and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

This information is subject to a duty of disclosure pursuant to Sections 4-2 and 5-12 of the Securities Trading Act.

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SOURCE Nordic Nanovector