11/23/2016 9:12:18 AM
Oslo, Norway, 23 November 2016
Nordic Nanovector ASA (OSE: NANO) announces its results for the third quarter 2016. A presentation of the results by the company’s senior management team will take place today at 8:30 a.m. CET in Oslo - details below. The Q3 report is attached.
The ongoing Lymrit 37-01 clinical trial for Nordic Nanovector’s lead product candidate, Betalutin®, has reached a new important milestone with the SRC recommendation to test a higher dosing regimen. The new dosing regimen has the potential to provide both an even better efficacy and improved safety for treatment of 3rd line FL with Betalutin®. Patient recruitment into the Phase 1/2 study is on track to enable the decision on the optimal dosing regimen for the pivotal Phase 2 PARADIGME trial in the first quarter of 2017. Updated results from the Phase 1/2 trial will be presented at the ASH annual meeting on 3 December.
As part of its strategy to broaden and diversify its pipeline, the company continues to leverage its expertise in the field of antibody conjugates and has initiated additional R&D activities, supported by complementary technologies from expert partners. The collaboration agreements with LegoChem and Heidelberg Pharma are in line with the execution of this strategy and follow similar collaborations in the ARC area in the second quarter.
Luigi Costa, CEO of Nordic Nanovector, comments: “Q3 continues the positive momentum of 2016. We are pleased with the progress made and the milestones reached in all our strategic priorities. In particular, the ongoing Lymrit 37-01 clinical trial which has entered its final stages following the recommendation of the Safety Review Committee. The new dosing regimen has the potential to deliver an even better efficacy and duration of response than previously observed, alongside a favourable safety profile. In addition, we continue to extend the company’s pipeline around our core expertise, by partnering with companies to access complementary technologies where required. We believe we are making exciting progress and look forward to reporting further advancements in the future.”
Operational Highlights Q3 2016
• Lymrit 37-01 clinical study with Betalutin® in FL on track
• Completed recruitment of the first cohorts of Arm 3 and Arm 4 investigating Betalutin® treatment with two different pre-dosing regimens
Post Period Events
• Safety Review Committee for Lymrit 37-01 trial recommended:
• Progress Arm 4 at 20 MBq/kg Betalutin® with 100mg/m2 lilotomab
• Change treatment regimen in Arm 1/Phase 2 to match that used in Arm 4, pending confirmation of safety from Arm 4 and approval of protocol amendment
• Discontinue Arm 3
• Latest available results from Lymrit 37-01 to be presented at the 58th American Society of Hematology Annual Meeting on 3 December
• Safety, efficacy and duration of response data from all evaluable NHL patients to be reported
• Further progress on pipeline
• Entered into R&D collaborations with LegoChem Biosciences and Heidelberg Pharma to explore potential of ADCs with non-radionuclide payloads for the treatment of leukaemias
• New members join Executive Management Team and Board of Directors
• Dr Lisa Rojkjaer, MD, joins as Chief Medical Officer
• Dr Joanna Horobin, MD, elected as Non-executive Director
Financial Highlights Third Quarter 2016
(Figures in brackets = same period 2015 unless otherwise stated)
• Revenues in the third quarter 2016 amounted to NOK 0.078 million (NOK 0.076 million). Revenues for the first nine months of 2016 were NOK 0.235 million (NOK 0.294 million).
• Total operating expenses for the third quarter were NOK 50.4 million (NOK 63.0 million). Total operating expenses for the first nine months of 2016 were NOK 151.3 million (NOK 150.1 million).
• Comprehensive loss for the third quarter amounted to NOK 61.3 million (loss of NOK 60.7 million). Comprehensive loss for the first nine months was NOK 176.5 million (NOK 142.1 million).
• Cash and cash equivalents amounted to NOK 560.1 million at the end of September 2016 (NOK 618.4 million at the end of June 2016 and NOK 743.4 million at the end of 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 competitive landscape for the company’s lead drug candidate Betalutin® is promising. Strong results and good progress in the Phase 1/2 study, including the opportunity to test a higher Betalutin® dosing regimen, in addition to encouraging findings from the research and development pipeline bode well for Nordic Nanovector’s operations going forward. 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. CET at:
Thon Hotel Vika Atrium
Meeting Room: BJØRVIKA
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 CET today.
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