Nordic Nanovector — Results For Second Quarter And Half Year 2016

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)

Outlook

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: 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/2016 from 7:00 am CEST the same day.

Back to news