OSLO, Norway--(BUSINESS WIRE)--Nordic Nanovector ASA (OSE: NANO) announces its results for the fourth quarter and full year 2015. The presentation of the results by Nordic Nanovector’s senior management team will take place today in Oslo at 8.30 a.m. CET – details below.
Luigi Costa, CEO of Nordic Nanovector, comments: “During the fourth quarter, we made the decision to revise the clinical development plan for Betalutin® in follicular lymphoma (FL), based on new data that demonstrate the importance of pre-dosing to optimize its tumour-targeting properties. As a result, we have expanded the current Phase 1/2 study to investigate different pre-dosing regimens that may allow us to increase the dose of Betalutin® to achieve a stronger efficacy/safety profile than we have previously seen. We believe that this adapted strategy will maximize the possibility of demonstrating that Betalutin® is a competitive treatment option for patients suffering from FL, a common form of non-Hodgkin lymphoma (NHL).”
Mr Costa continues: “We are pleased to report that patient recruitment in the amended study is progressing well and we are on track to select the optimized Betalutin® dose regimen to be used in PARADIGME, the pivotal Phase 2 study planned to start in 1H 2017. In addition, we have made good progress across other areas, including the initiation of a clinical study for Betalutin® in a second NHL indication and promising preclinical research highlighting further opportunities for our pipeline. Our cash position remains solid, and this is expected to be sufficient for us to reach the first regulatory submission of Betalutin® in the first half of 2019.”
Q4 2015 Operational Highlights
• New clinical development plan for Betalutin® in FL
• Good progress in the Phase 1/2 study (Lymrit 37-01) enrollment
• Progress made to initiate clinical plan for Betalutin® in a second NHL indication
• Promising preclinical research presented at international cancer conferences European Association of Nuclear Medicine (EANM) and American Society of Hematology (ASH)
Q4 2015 Financial Highlights
• Revenues for Q4 2015 at MNOK 0.143 (MNOK 0.126, Q4 2014). Revenues came from incubator services and the sublease of office and laboratory space.
• Operating expenses for Q4 2015 were MNOK 33.4 (MNOK 29.3, Q4 2014), mainly driven by higher payroll expenses following additional headcounts due to planned increase in the activity level.
• Loss for the quarter amounted to MNOK 31.1 (loss of MNOK 26.9, Q4 2014).
• Cash and cash equivalents amounted to MNOK 743.4 as of 31 December 2015, compared with MNOK 337.0 as of December 31st 2014.
• Total shareholders’ equity was MNOK 712.7 at the end of December 2015, with an equity ratio of 93.7%, compared to MNOK 330.2 and an equity ratio of 95.5% at the end of December 2014.
The current clinical development plan for Betalutin® in FL, the good progress made in advancing this new study and encouraging findings from the R&D pipeline bode well for Nordic Nanovector’s operations going forward. Management will continue to focus its efforts on the efficient execution of current development plans, to meet expected clinical milestones. Current cash resources are expected to be sufficient to reach the first regulatory submission for Betalutin® in FL in 1H 2019.
Presentation and web cast details:
A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CET 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: Investor Relations/Webcast.
The results report and the presentation will be available at www.nordicnanovector.com in the section: Investor Relations/Reports and Presentation/Quarterly Reports/2015 from 7:00 am CET the same day.
About Nordic Nanovector
Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018. Betalutin® comprises a tumour-seeking anti-CD37 antibody (HH1) conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat multiple selected cancer indications. Further information about the Company can be found at www.nordicnanovector.com
This information was brought to you by Cision http://news.cision.com