On February 27, 2019 Nordic Nanovector ASA (OSE: NANO) reported its results for the fourth quarter and full year 2018 (Press release, Nordic Nanovector, FEB 27, 2019, View Source;results-for-the-fourth-quarter-and-full-year-2018-300802989.html [SID1234533702]). 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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Eduardo Bravo, CEO, commented:
"We believe we have made solid progress during 2018 advancing the key clinical development programmes for Betalutin as a single agent and in combination with rituximab in non-Hodgkin’s lymphoma patients. The latest results from the LYMRIT 37-01 trial, presented at ASH (Free ASH Whitepaper) in December, continue to highlight strong clinical profiles of two dosing regimens that we are now testing in the pivotal PARADIGME trial. Furthermore, the recent financing enables us to expand our preparatory activities for the future commercialisation of our exciting lead asset, pending completion of PARADIGME and successful regulatory review. Our clear priority for the coming year is on recruiting patients into PARADIGME to ensure we can achieve our goal of data read-out in the first half of 2020."
Q4’18 Highlights
• Updated results from Phase 1/2 LYMRIT 37-01 demonstrating that single-administration Betalutin is effective and well-tolerated in relapsed/refractory indolent non-Hodgkin’s lymphoma (R/R iNHL) patients reported at ASH (Free ASH Whitepaper) (December)
• Pivotal Phase 2b PARADIGME trial progressing with 69 (of 80-85) sites in 23 countries open for enrolment, as of 26 February 2019, including the first site in the US
• Promising Innovative Medicine (PIM) designation (October) in the UK granted for the treatment of advanced R/R FL, adding to US Fast Track designation (granted in June)
• First patient dosed in Phase 1b Archer-1 trial of Betalutin in combination with rituximab in second-line (2L) FL patients (November)
• Promising results from an R&D collaboration to develop a CD37-targeted alpha therapy published at ASH (Free ASH Whitepaper)
Events after Q4’18
• Approximately NOK 222 million (USD 26m) (gross) raised in an oversubscribed private placement which provides funds to support manufacturing and other activities in preparation for the commercialisation of Betalutin
• Jan H. Egberts, M.D. elected new Chairman, succeeding Ludvik Sandnes who stepped down from 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
Financial Highlights Q4 and FY’18
(Figures in brackets = same period 2017 unless otherwise stated)
• Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.05 million). Revenues for the full year 2018 were NOK 0.0 million (NOK 0.3 million).
• Total operating expenses for the fourth quarter were NOK 96.3 million (NOK 102.0 million). Total operating expenses for the full year 2018 amounted to NOK 340.0 million (NOK 316.8 million).
• Comprehensive loss for the fourth quarter amounted to NOK 87.7 million (loss of NOK 87.6 million). Comprehensive loss for the full year 2017 was NOK 336.8 million (NOK 295.6 million).
• Cash and cash equivalents amounted to NOK 440.1 million at the end of December 2018 (NOK 756.6 million).
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 R/R 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.
Nordic Nanovector intends to maximize the value of Betalutin and other CD37-targeting opportunities across other stages of FL, 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.
Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in the first half of 2020.
Presentation and webcast – Q4 and Full Year 2018 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: AKER
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/2018.
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44-7561-431-62
Email: [email protected]
Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44-207-638-9571
Email: [email protected]