Nordic Nanovector ASA – Results for third quarter 2016
All operations advancing according to schedule
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 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 December 3rd.
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
o 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:
o Progress Arm 4 at 20 MBq/kg Betalutin® with 100mg/m2 lilotomab
o 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
o Discontinue Arm 3
• Latest available results from Lymrit 37-01 to be presented at the 58th American Society of Hematology Annual Meeting on December 3rd
o Safety, efficacy and duration of response data from all evaluable NHL patients to be reported
• Further progress on pipeline
o 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
o Dr Lisa Rojkjaer, MD, joins as Chief Medical Officer
o 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).
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 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
Munkedamsveien 45
0250 Oslo
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.
For further information, please contact:
IR enquiries:
Luigi Costa, Chief Executive Officer
Cell: +41 79 124 8601
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Email: ir@nordicnanovector.com
Media enquiries:
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
Email: nordicnanovector@citigatedr.co.uk
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
Forward-looking statements
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.
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