Nordic Nanovector ASA: Results for the First Quarter 2022

OSLO, Norway, May 13, 2022 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANOV) announces its results for the first quarter 2022. A presentation by Nordic Nanovector's senior management team will be held in-person today in Oslo and webcast live beginning at 8:30am CET - details below.

Erik Skullerud, CEO of Nordic Nanovector, said: "The impacts from COVID-19 continued to linger during Q1 and meant the pick-up in recruitment into PARADIGME that we expected has not yet materialised. Nonetheless, we remain highly committed to completing patient recruitment for this important trial and expect to meet our timeline for readout of preliminary data in H2'2022. At the same time, our preparations for filing and commercialisation of Betalutin® are moving forward in advance of our planned BLA filing. New data presented or published in recent months continue to build and support the breadth and depth of our CD-37 focussed pipeline, from which, together with Betalutin®, we believe we can create significant value for shareholders over the longer term."

Operational Highlights

• 108 of a targeted 120 patients have been enrolled into the pivotal PARADIGME Phase 2b trial for Betalutin® as of 12 May 2022 (106 patients enrolled as of 28 February 2022)  
• COVID-19 continued to impact recruitment during Q1
• Two further patients enrolled
• Preliminary three-month data readout expected during H2'2022, following timeline revision announced 7 January 2022
• Private placement in January 2022 raised NOK 250 million gross (USD 28.4 million)
• Preclinical data on Alpha37, a novel CD37-targeting alpha-particle emitting radioimmunotherapy, presented at the American Association for Cancer Research (AACR) 2022 Annual Meeting 
• Showing single dose is safe and effective for treatment of CD37-positive chronic lymphocytic leukaemia (CLL) and non-Hodgkin's lymphoma (NHL) in mouse models

Post-period events

• Two new publications highlight approaches to improve the potential therapeutic effect of CD37-targeted radioimmunoconjugate Humalutin® in B-cell malignancies, such as NHL
• New publication in PLOS One highlights synergistic potential of Humalutin® in combination with the PARP-inhibitor olaparib, an approved treatment for breast and ovarian cancer
• New publication in Scientific Reports reports on CD37-targeting imaging approach to select NHL patients who might respond best to Humalutin® treatment
• Board changes
• Former Algeta CEO Thomas Ramdahl joins Board of Directors
• Per Samuelsson and Rainer Boehm M.D. decide not to stand for re-election as Non-executive Directors  

Financial Highlights

(Figures in brackets = same period 2021 unless otherwise stated)

• Revenues for the first quarter 2022 amounted to NOK 0.0 million (NOK 0.0 million)
• Total operating expenses for the first quarter 2022 were NOK 100.3 million (NOK 101.2 million).
• Comprehensive loss for the first quarter 2022 amounted to NOK 105.1 million (loss of NOK 102.1 million).
• Cash and cash equivalents amounted to NOK 356.3 million at the end of March 2022, compared to NOK 277.7 million at the end of December 2021, and NOK 497.9 million at the end of March 2021.

Outlook

Nordic Nanovector remains disciplined in the patient enrolment into PARADIGME and is targeting the readout of preliminary three-month top line data during H2'2022.

The company's current cash position will support its operations into H1'2023 and will enable further preparatory work on the potential Betalutin® BLA filing and planning for commercialisation to be undertaken.

The company believes that, if positive, the PARADIGME 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 continues to pursue opportunities for the development and expansion of its pipeline based on CD37-targeting immunotherapies, which offer risk diversification and multiple shots on goal.

Presentation and Webcast

A presentation by Nordic Nanovector's senior management team will take place in Oslo today at 8:30am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Bjørvika

The presentation will webcast live and will be available at www.nordicnanovector.com in the section: Investors & Media.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2022.

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 (MEDiSTRAVA Consulting)

Tel: +44 203 928 6900

Email: nordicnanovector@medistrava.com

About Nordic Nanovector:

Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs. The Company aspires to become a leader in the development of CD37-targeted therapies for haematological cancers and immune diseases. 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 27 billion by 2029. 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.

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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