OSLO, Norway--(BUSINESS WIRE)--Regulatory News:
Nordic Nanovector ASA (OSE: NANO) announces its results for second quarter and half year 2016. A presentation of the results by the company’s senior management team will take place today at 8:30 a.m. CEST in Oslo - details below.
Nordic Nanovector has continued to make good progress in executing its clinical development plan for Betalutin®. Patient recruitment is on track and all study sites have been recruited. Given this progress, Lymrit 37-01 study remains on track to define the optimized dose regimen to be used in PARADIGME, the pivotal Phase 2 study that is planned to start in 2H 2017. Updated data from this ongoing clinical study, presented at AACR in April, confirmed Betalutin®’s efficacy potential, durability of response and favourable safety profile in patients with advanced FL. The company continues to advance its product pipeline. Nordic Nanovector is ready to initiate its Phase 1 clinical study for Betalutin® in diffuse large B cell lymphoma (DLBCL) having received clearance of the Investigational New Drug (IND) Application from the FDA and acceptance of the protocol design from EU Authorities.
Nordic Nanovector has signed two research and development collaborations with Paul Scherrer Institute and AREVA Med with the goal of developing new Antibody-Radionuclide-Conjugates (ARCs) for treatment of single cell leukaemias. The company has received a grant of up to NOK 15 million from the Research Council of Norway’s User-driven Research-based Innovation programme to support the discovery and development of novel targeted therapeutics for leukaemias and non-Hodgkin lymphoma (NHL).
Luigi Costa, CEO of Nordic Nanovector, comments: “The first half of 2016 has been very positive for Nordic Nanovector and continues the positive momentum of 2015. We are pleased to report the continued good progress with the Lymrit 37-01 study as we remain on track to define the optimized dose regimen to be used in the pivotal Phase 2 study that is planned to start in 2H 2017. The updated results from Betalutin® in FL that were presented at AACR reinforce our belief in its promise to become a significant new treatment of NHL. We have also made good progress across all other key areas, including signing two new R&D collaborations to develop new ARCs for the treatment of leukemias. We believe we are now well positioned to achieve our goal of becoming a leader in the development of targeted ARCs for haematological cancers.”
Operational Highlights Q2 and First Half 2016
• Clinical study on Betalutin® in FL on track to meet timelines for selection of optimal dose regimen for the pivotal Phase 2 PARADIGME trial
• Updated clinical results presented in April continue to show Betalutin®’s promising efficacy and increasing Duration of Response
• Preparations towards initiation of clinical studies of Betalutin® in second NHL indication, DLBCL
• Progress on advancing platform to deliver future pipeline products; R&D collaborations entered with Paul Scherrer Institute and AREVA Med to develop new ARCs targeting leukaemias
• New Chief Medical Officer signed on
• Board of Directors strengthened further with international experts in development and commercialization of innovative cancer therapies
Post Period Event
• Completed recruitment of the first cohorts of Arm 3 and Arm 4 of expanded Phase 1/2 study of Betalutin® in NHL patients
Financial Highlights Q2 and First Half 2016
(Figures in brackets = same period 2015 unless otherwise stated)
• Revenues for the second quarter amounted to MNOK 0.079 million (MNOK 0.142). Revenues for the first half of 2016 were MNOK 0.157 (MNOK 0.218).
• Total operating expenses for the second quarter were MNOK 48.1 (MNOK 51.2). Total operating expenses for the first half of 2016 amounted to MNOK 100.9 (NOK 87.1)
• Comprehensive loss for the second quarter amounted to MNOK 51.1 (loss of MNOK 47.7). Comprehensive loss for the first half was MNOK 115.2 (MNOK 81.4)
• Cash and cash equivalents amounted to MNOK 618.4 at the end of June 2016 (MNOK 671.9 at 31 March 2016 and MNOK 743.4 at 31 December 2015)
Nordic Nanovector is committed to develop, manufacture and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The market landscape for the company’s lead drug candidate Betalutin® is promising. Strong results and good progress in the Phase 1/2 study in addition to encouraging findings from the research and development pipeline bode well for Nordic Nanovector’s future. Management will continue to focus its efforts on the efficient execution of its plans and to meet anticipated clinical milestones. Current cash resources are expected to be sufficient to reach the first regulatory submission for Betalutin® in FL in the first half of 2019.
Presentation and webcast details
A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 a.m. 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:
The results report and the presentation will be available at www.nordicnanovector.com in the section:
Investor Relations/Reports and Presentation/Quarterly Reports/2016 from 7:00 am CEST 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, lilotomab (previously referred to as 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 announcement may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Nordic Nanovector’s business, financial condition and results of operations. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of Nordic Nanovector’s strategy and its ability to further grow, risks associated with the development and/or approval of Nordic Nanovector’s products candidates, ongoing clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector’s potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
This information is subject to a duty of disclosure pursuant to Section 5-12 of the Securities Trading Act.
This information was brought to you by Cision http://news.cision.com
For Nordic Nanovector:
Luigi Costa, +41 79 124 8601
Chief Executive Officer
Tone Kvåle, +47 91 51 95 76
Chief Financial Officer
Citigate Dewe Rogerson
Mark Swallow/David Dible,+44 207 282 2948/+44 207 282 2949
Last updated on: 25/08/2016
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