Nordic Nanovector ASA: Results for the Third Quarter 2018
Oslo, Norway, 6 November 2018
Nordic Nanovector ASA (OSE: NANO) announces its third quarter 2018 results today. A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.
Eduardo Bravo, CEO, commented: “The latest updated clinical results from a once-only administration of Betalutin®, to be presented at ASH in December, highlight the very promising clinical profiles of the two dosing regimens that are being evaluated in patients with relapsed/refractory indolent NHL. We are working hard to advance the PARADIGME study to confirm these results in a trial with 130 patients and to enable the selection of the best dosing regimen for our regulatory submissions. We are also pleased that Betalutin® has received PIM designation in the UK reflecting the high unmet medical need of the FL patient population as well as the potential of Betalutin® to offer therapeutic benefits to these patients. Both the PIM and Fast Track designations (granted by the FDA in June) provide opportunities for enhanced dialogue with health authorities and a route to bring Betalutin® to patients quicker. We have a clear focus on delivering results from PARADIGME in 1H 2020 and in building further value in Nordic Nanovector from our CD37-targeting approach to treating patients with NHL.”
• Abstract reporting promising clinical results from LYMRIT 37-01 trial with Betalutin® published ahead of poster presentation at ASH
o Overall response rates of 69% in Arm 4 (100 mg/m2 lilotomab followed by 20 MBq/kg Betalutin®) and 64% in Arm 1 (40 mg lilotomab followed by 15 MBq/kg Betalutin®) in relapsed/refractory follicular lymphoma patients
o Median duration of response of 13.3 months for all patients (20.5 months for those with a complete response)
o Well tolerated with predictable and manageable safety profile
• Site activations and patient recruitment progressing for pivotal Phase 2b PARADIGME trial
o As of 5 November, 51 (of 80-85) sites in 16 (of 20) countries are open for enrolment
o First US site in Long Beach, CA open for enrolment
• Betalutin® granted Promising Innovative Medicine (PIM) Designation in the UK for the treatment of advanced relapsed/refractory FL
• First patient dosed in Phase 1b Archer-1 trial of Betalutin® in combination with rituximab in second-line (2L) FL patients
• Promising results from a collaborative R&D project to develop a CD37-targeted alpha therapy published in abstract ahead of ASH presentation
o Next-generation targeted alpha therapy comprises Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) linked to lead-212 for treating B-cell malignancies
Financial Highlights Third Quarter 2018
(Figures in brackets = same period 2017 unless otherwise stated)
• Revenues for the third quarter amounted to NOK 0 (NOK 0.1 million).
• Total operating expenses for the third quarter were NOK 76.9 million (NOK 72.7 million). Total operating expenses for the first nine months of 2018 amounted to NOK 243.7 million (NOK 214.9 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 73.0 % of total operating expenses (71.0 %) for the first nine months of 2018.
• Comprehensive loss for the third quarter amounted to NOK 75.4 million (loss of NOK 85.9 million). Comprehensive loss for the first nine months of 2018 was NOK 249.1 million (loss of NOK 207.9 million)
• Cash and cash equivalents amounted to NOK 499.7 million at the end of September 2018 (NOK 570.1 million at 30 June 2018 and NOK 756.6 million at 31 December 2017)
Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.
Betalutin®, the company’s most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin® in 3L R/R FL is underway with the initial clinical data read-out targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.
Betalutin® has been granted Fast Track and PIM designations in the US and UK, respectively, for the treatment of patients with R/R FL.
Nordic Nanovector intends to maximize the value of Betalutin® and other CD37-targeting opportunities across other stages of FL, NHL and other haematological cancer indications.
The company is confident that Betalutin® could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.
Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.
Third Quarter 2018 Results Presentation and Webcast
A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am CET at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: HOLMENKOLLEN
The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media
The results report and the presentation are available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018.
For further information, please contact:
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
About Nordic Nanovector
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's Lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. Further information about the Company can be found at www.nordicnanovector.com
This press release contains certain forward-looking statements. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances, 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", "targets", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. These forward-looking statements are not historic facts. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in the forward-looking statements. Factors that could cause these differences include, but are not limited to, risks associated with implementation of Nordic Nanovector's strategy, risks and uncertainties associated with the development and/or approval of Nordic Nanovector's product candidates, ongoing and future clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector's potential market and industry, Nordic Nanovector's freedom to operate (competitors patents) in respect of the products it develops, 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.