Nordic Nanovector ASA: Results for the Third Quarter 2021

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Nov 18, 2021, 01:30 ET

OSLO, Norway, Nov. 18, 2021 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANOV) announces its results for the third quarter 2021. 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: "We are entering an exciting period for Nordic Nanovector, as the Company draws closer to completing patient recruitment for the PARADIGME trial, for which we expect readout of preliminary data in H1' 2022. The Company is convinced that Betalutin® is uniquely positioned to meet the need for a chemo-free, effective yet tolerable treatment for non-Hodgkin's lymphoma patients, coupled with a convenient administration schedule. In the meantime, we look forward to sharing our vision for Nordic Nanovector and Betalutin® as well as an update on our pipeline at our R&D day on 30 November."

Operational Highlights

102 of a targeted 120 patients have been enrolled into the pivotal PARADIGME Phase 2b trial for Betalutin® as of 17 November 2021 (94 patients enrolled as of 26 August 2021)

Three patients were enrolled in the same quarter in 2020
Preliminary three-month data readout expected during H1'2022, following timeline revisions announced on 3 August 2021

Erik Skullerud appointed as new Chief Executive Officer (CEO)

Mr Skullerud brings more than 25 years' experience in the biopharma industry including more than 15 years at Amgen, including as Marketing Director Europe Oncology/Hematology, and seven years at Bayer
He has launched numerous highly innovative products in therapeutic areas including oncology and haematology, and as a consultant, he has worked with some of the world's top pharma and biotech companies as well as small, highly specialised start-ups on a wide range of projects

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

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
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

Financial Highlights

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

Revenues for the third quarter 2021 and the first nine months of 2021 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the third quarter 2021 were NOK 104.3 million (NOK 88.1 million). Total operating expenses for the first nine months of 2021 were NOK 309.3 million (NOK 327.3 million)
Comprehensive loss for the third quarter 2021 amounted to NOK 103.6 million (loss of NOK 88.2 million). Comprehensive loss for the first nine months of 2021 was NOK 307.6 (NOK 305.4 million)
Cash and cash equivalents amounted to NOK 369.5 million at the end of September 2021, compared to NOK 450.1 million at the end of June 2021, and NOK 294.0 million at the end of December 2020

Outlook

Nordic Nanovector is close to completing patient enrolment into PARADIGME and is targeting the readout of preliminary three-month top line data during H1'2022.

The company's current cash position will support its operations into H2'2022 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 intends to discuss the development plan and opportunities for expanding the market for Betalutin® into other NHL indications, together with other potential areas for pipeline expansion and collaboration based on CD37-targeting immunotherapies, at its R&D Day, which is planned to take place on 30 November 2021.

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/2021.

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: +44 207 638 9571

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 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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