On May 23, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the first quarter 2019 (Press release, Nordic Nanovector, MAY 23, 2019, View Source [SID1234553450]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.

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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.