Nordic Nanovector ASA: Results for the Fourth Quarter and Full Year 2021

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Mar 01, 2022, 01:24 ET

OSLO, Norway, March 1, 2022 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANOV) announces its results for the fourth quarter and full year 2021. A live webcast presentation by Nordic Nanovector's management team will take place today at 08.30 CET at Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo, meeting room Bjørvika. A link to the webcast and the presentation is available from the Company's homepage (www.nordicnanovector.com).

Erik Skullerud, Chief Executive Officer of Nordic Nanovector, commented: "The fourth quarter was a productive period for the Company as we continued to drive PARADIGME recruitment, made key appointments, and hosted our R&D Day highlighting the vision and strategy for Betalutin® and our wider pipeline. Combined with the proceeds from our recent NOK 250 million private placement, this means we are beginning 2022 in a strong position to complete PARADIGME and deliver the three-month data readout later in the year, despite the delays imposed by the COVID-19 pandemic. We remain focussed on our goal of advancing Betalutin® to meet the need for a chemo-free, effective yet tolerable treatment for non-Hodgkin's lymphoma patients."

Q4'2021 Highlights

106 of a targeted 120 evaluable patients have been enrolled into the pivotal PARADIGME Phase 2b trial for Betalutin® as of 28 February 2022

Given the ongoing impact from the SARS-CoV-2 omicron variant on patient recruitment, the Company anticipates the preliminary three-month data readout from PARADIGME to be reported during H2'2022

Sandra Jonsson appointed as Chief Operating Officer

Dr Jonsson takes over from Marco Renoldi, who is retiring from the role but will remain as a consultant to the Company
Dr Jonsson is a results-driven international Life Science executive, with >15 years of cross-functional experience in global pharmaceutical and biotechnology companies. She joins Nordic Nanovector from Alexion Pharmaceuticals, where she was Senior Director, Commercial International

Pierre Dodion MD appointed as Chief Medical Officer

Dr Dodion has over 30 years' experience in the biopharmaceutical industry, spent mostly in the oncology and haematology areas. He brings deep clinical development and medical affairs expertise and has provided strategic insight and overseen multiple clinical trials

In November 2021, the Company hosted an R&D Day highlighting its vision and strategy for creating value from Betalutin® as well as through the development of exciting opportunities that leverage its deep expertise and experience in CD37 biology
Nordic Nanovector announced its support for The Health Policy Partnership's initiative to improve readiness for the use of radioimmunotherapy and to facilitate appropriate integration of this innovative cancer treatment modality in lymphoma treatment
The Company entered a research collaboration with the University of Pennsylvania to generate a novel CD37-targeting CAR-T cell therapy approach as a potential treatment for patients with B-cell malignancies
Nordic Nanovector will have an option to license exclusive worldwide rights to any CD37-targeting CAR-T cells that result from the collaboration

Post-period highlights

In January 2022 Nordic Nanovector raised approximate NOK 250 million gross from a private placement of new shares. The proceeds will be used to:

fund preparation of activities required for the regulatory filing of Betalutin^® and pre-approval inspections
continue the preparatory activities for the confirmatory Phase 3 trial including production of clinical material
preparations for market launch, and
general corporate purposes

Following the successful private placement, Nordic Nanovector is undertaking a subsequent Repair Offering with a subscription period that commenced on 28 February 2022 and ends at 16.30 hours CET on 11 March 2022

The proceeds together with existing cash resources are expected to ensure financing beyond the preliminary 3-month data readout from PARADIGME targeted for H2'2022 and for at least an additional three months into 2023 to enable the Company to maximize shareholder value from the PARADIGME clinical trial.

Financial Highlights Q4 and FY'2020

(Figures in brackets = same period 2020 unless otherwise stated)

Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.0 million). Revenues for the full year 2021 were NOK 0.0 million (NOK 0.0 million).
Total operating expenses for the fourth quarter were NOK 133.1 million (NOK 106.8 million). Total operating expenses for the full year 2021 amounted to NOK 442.4 million (NOK 434.2 million).
Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 85% of total operating expenses in 2021 (84%).
Comprehensive loss for the fourth quarter amounted to NOK 134.1 million (loss of NOK 112.1million). Comprehensive loss for the full year 2021 was NOK 441.7 million (NOK 417.6 million).
Cash and cash equivalents amounted to NOK 277.7 million at the end of December 2021 (NOK 294.0 million).

Outlook

Nordic Nanovector remains focused on completing PARADIGME and is targeting the preliminary readout of three-month top line data from the study in H2'2022.

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.

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/2021 from 7:00am CET the same day

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 (MEDiSTRAVA Consulting)
Tel: +44 203 928 6900
Email: [email protected]

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 26 billion by 2028. 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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