On February 27, 2020 Nordic Nanovector ASA (OSE: NANO) reported its results for the fourth quarter and full year 2019 (Press release, Nordic Nanovector, FEB 27, 2020, View Source;results-for-the-fourth-quarter-and-full-year-2019-301012304.html [SID1234554952]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.
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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 (Free ASH Whitepaper)
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.