Nordic Nanovector ASA – Results for the First Quarter 2019

Oslo, Norway, 23 May 2019

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

Eduardo Bravo, CEO, commented:

“As we advance the clinical development programmes with Betalutin®, including PARADIGME, we are also beginning to initiate some of the other pre-commercialisation activities, such as manufacturing, that are crucial to ensure that we can submit our regulatory filing in a timely and efficient manner. The recent fundraising is key to this and we expect to intensify these activities as we get closer to the initial data read-out from PARADIGME.”

Q1’19 Highlights

  • Approximately NOK 225 million (USD 26.4m) (gross) raised in a private placement and subsequent repair offering to support manufacturing and other activities in preparation for the commercialisation of Betalutin®.
  • Pivotal Phase 2b PARADIGME trial of Betalutin® in advanced recurrent follicular lymphoma (FL) progressing with 74 (of 80-85) sites in 23 countries open for enrolment, as of 22 May 2019.
  • Jan H. Egberts, M.D. elected new Chairman of the Board of Directors.
  • Dr Mark Wright appointed as Head of Manufacturing to lead production of Betalutin® for clinical trials and future commercialisation, and of CD37-targeting candidates emerging from the company’s pipeline.

Events after Q1’19

  • Phase 1b Archer-1 trial of Betalutin® plus rituximab (RTX) in patients with relapsed/refractory 2L FL advanced into second safety cohort.
  • Phase 1 LYMRIT 37-05 trial of Betalutin® in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) advanced to the final dosing cohort – preliminary results from the dose-escalation expected in 2H 2019.
  • Promising preclinical results from R&D collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours were presented at the 11th International Symposium on Targeted-Alpha-Therapy.
  • Fredrik Haavind appointed Head of Legal and Compliance bringing significant experience in domestic and international corporate law.

Financial Highlights Q1’19

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

  • Revenues for the first quarter amounted to NOK 0.0 million (NOK 0.0 million).
  • Total operating expenses for the first quarter were NOK 90.0 million (NOK 82.3 million).
  • Comprehensive loss for the first quarter amounted to NOK 91.6 million (loss of NOK 90.7 million).
  • Cash and cash equivalents amounted to NOK 538.5 million as at 31 March 2019 (NOK 440.1 million as 31 December 2018).

Outlook

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

Betalutin®, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with a once-only administration of Betalutin® in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.

Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in the first half of 2020.

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 and antibody drug conjugates across NHL and other haematological cancer indications.

The company is confident that Betalutin® could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Presentation and Webcast

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

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND 

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 will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2019 from 7:00am CEST the same day.

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/David Dible (Citigate Dewe Rogerson)

Tel: +44 207 638 9571

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 radioimmunotherapy 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 to a duty of disclosure pursuant to Sections 4-2 and 5-12 of the Securities Trading Act. 

 

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