Nordic Nanovector ASA: Results for the Third Quarter 2020

OSLO, Norway, Nov. 19, 2020 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) 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
  

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.

For further information, please contact:

IR enquiries

Malene Brondberg, CFO

Cell: +44 7561 431 762

Email: ir@nordicnanovector.com  

Media Enquiries

Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)

Tel: +44 203 926 8535

Email: nordicnanovector@citigatedewerogerson.com  

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