Nordic Nanovector ASA - Results for the Fourth Quarter and Full Year 2019

Nordic Nanovector ASA (OSE: NANO) announces its results for the fourth quarter and full year 2019. A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

Jan H. Egberts, MD, Chairman of Nordic Nanovector, commented: “We currently have 47 patients enrolled in our pivotal PARADIGME Phase 2b trial evaluating Betalutin®. The company will under its new management look into the current strategy and operational trial initiatives. We still aim to complete the patient enrolment in PARADIGME in the second half of 2020. The encouraging efficacy and safety profile demonstrated in the first part of the LYMRIT 37-01 Phase 1/2 trial with a single administration of Betalutin® give the Board and management confidence in its potential to become an important option for patients with non-Hodgkin’s lymphoma (NHL).

 

Highlights Q4 2019

  • Pivotal Phase 2b PARADIGME trial of Betalutin® in 3rd-line FL is progressing
    • 47 patients have been enrolled in the PARADIGME trial
    • The company continues to aim for patient enrolment to be completed in the second half of 2020
  • A global agreement was signed with Isotope Technologies Garching GmbH (ITG) to ensure the supply of no-carrier-added lutetium-177, a key component of Betalutin®
  • Successful completion of private placement of new shares raising approximately NOK 243 (USD 26.4 million) (gross)
  • DLBCL - 3 additional patients being enrolled into final dose cohort as one patient experienced a reversible DLT
  • Alpha37 project received grant funding of NOK 6 million (~USD 0.65 million) from Eurostars and NOK 12 million (~USD 1.3 million) from the Norwegian Research Council
  • New preclinical data offering insights to enchancing Betalutin®-based combination therapies in NHL presented at ASH

 

Events after Q4 2019

  • As announced in a separate release on 26 February 2020, Lars Nieba, Chief Technology Officer of Nordic Nanovector, has been appointed interim Chief Executive Officer to replace Eduardo Bravo, who has left the company to pursue other career opportunities.
     

Financial Highlights Q4 and FY’19

(Figures in brackets = same period 2018 unless otherwise stated)

  • Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.0 million). Revenues for the full year 2019 were NOK 0.0 million (NOK 0.0 million).
  • Total operating expenses for the fourth quarter were NOK 139.3 million (NOK 96.3 million). Total operating expenses for the full year 2019 amounted to NOK 440.4 million (NOK 340.0 million).
  • Comprehensive loss for the fourth quarter amounted to NOK 137.5 million (loss of NOK 87.7 million). Comprehensive loss for the full year 2019 was NOK 433.2 million (NOK 336.8 million).
  • Cash and cash equivalents amounted to NOK 471 million at the end of December 2019 (NOK 440.1 million).

Outlook

Nordic Nanovector aspires to become a leader in the field of targeted radioimmunotherapies for haematological cancers by developing, manufacturing and commercialising innovative products to address major unmet medical needs and advance cancer care.

Betalutin®, the company’s most advanced radioimmunotherapy candidate, is developing a highly differentiated, competitive, clinical profile. Nordic Nanovector is confident that Betalutin® could become an attractive and convenient once-only therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Betalutin® is being developed for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical trial. The company’s pivotal Phase 2b PARADIGME trial with Betalutin® in 3L R/R FL is underway. The company will under its new management look into the current strategy and operational trial initiatives. We still aim to complete the patient enrolment in PARADIGME in the second half of 2020. The study’s preliminary data read-out is planned a few months later. A BLA filing to gain marketing approval for Betalutin® is expected to start in the first half of 2021. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.

Nordic Nanovector intends to maximize the value of Betalutin® across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies across NHL and other haematological cancer indications.

 

Presentation and webcast – Q4 and Full Year 2019 results

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

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: BJØRVIKA

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/2019.

For further information, please contact:

IR enquiries

Malene Brondberg, VP Investor Relations and Corporate Communications
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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About Us

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 intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. Further information can be found at www.nordicnanovector.com. This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.