2016 was a very successful year for Nordic Nanovector. We achieved important milestones with regard to the clinical development of Betalutin®, progressed with our preclinical candidates and build the foundation of R&D innovation and expertise for the development of a pipeline of novel targeted therapies for major haematological cancers.
The successful completion of a NOK 499 million private placement in December was a key event that will enable the company to work towards its broader long-term ambition. With its strengthened financial position, Nordic Nanovector aims at maximizing the value of its novel targeted biopharmaceutical candidates (Betalutin®, alone and in combination with rituximab, and the chimeric anti-CD37 ARC) across all stages of follicular lymphoma (FL) and other major haematological cancer indications. The company intends to prepare for the commercialisation of Betalutin®, and to selectively extend its pipeline leveraging internal and external innovation and expertise in ARCs and ADCs.
The company's confidence in Betalutin® in 3rd line FL was confirmed during the fourth quarter 2016. On the basis of recommendations from the trial's Safety Review Committee, a new, higher dosing regimen is being tested in the Lymrit 37-01 trial. Patient recruitment into Arm 4 of the study is on track to enable the selection of an optimal dosing regimen for the pivotal Phase 2 PARADIGME trial, which is planned to start in the second half of 2017. Updated results from the trial presented at ASH 2016 in December continue to support the promising clinical profile of Betalutin® in 3rd line FL.
The synergistic anti-tumour effect of Betalutin® in combination with rituximab in a preclinical in vivo model of NHL, was also presented at ASH. These data support the company's decision to advance this combination into clinical development targeting 2nd line FL. Furthermore, preclinical development with the chimeric anti-CD37 ARC was completed successfully, and the company plans to start first clinical studies during 2017. The potential to access the combined FL market presents a significantly larger market opportunity for Nordic Nanovector's candidates than 3rd line FL alone.
Finally, as part of its strategy to broaden and diversify its pipeline, the company entered collaboration agreements with LegoChem and Heidelberg Pharma to explore potential of ADCs with non-radionuclide payloads for the treatment of leukaemias.
Luigi Costa, CEO of Nordic Nanovector, comments: "The company has made excellent progress during 2016 reaching significant milestones across the business and generating important momentum going into 2017. In particular, we anticipate the completion of the Lymrit 37-01 study with Betalutin® and the selection of a dosing regimen to take into the pivotal Phase 2 trial later in the year. Also, the recent financing is enabling the company to pursue multiple opportunities to capture more value across the NHL space and potentially beyond into other haematological cancers. We are looking forward to an exciting year ahead."
Operational Highlights Q4 2016
• Lymrit 37-01 trial advancing with a higher dosing regimen for Betalutin® in Arm 4
o Recruitment and treatment into Arm 4 on-track for a timely SRC evaluation and selection of dosing regimen for pivotal Phase 2 PARADIGME trial
• Results presented at ASH 2016 continue to highlight Betalutin®'s promising clinical profile
o Significant anti-tumour activity observed in monotherapy: ORR of 62%, CR 38% in Arm 1 patients receiving 15MBq/kg; consistent for 16 patients treated in Arm 1/Phase 2 (ORR 69%, CR 38%)
o Durable responses observed: median duration of response of 20.7 months for patients in Arm 1
o Well tolerated with predictable and manageable safety profile
• Further progress on R&D 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, joined as Chief Medical Officer
o Dr Joanna Horobin, MD, elected as Non-executive Director
• New funds raised enable expanded and extended development strategy for novel targeted therapeutics
o Successful private placement raised NOK 499 million in gross proceeds (December 2016)
Post Period Events
• Decision to initiate clinical programmes targeting 2nd and 1st line FL in 2017 supported by preclinical data
o Results presented at ASH 2016 show synergistic anti-tumour effect of Betalutin® in combination with rituximab
• First sites in US are now open for the Phase 1 study in relapsed DLBCL
Financial Highlights Fourth Quarter and Full Year 2016
(Figures in brackets = same period 2015 unless otherwise stated)
• Revenues in the fourth quarter 2016 amounted to NOK 0.079 million (NOK 0.143 million). Revenues for the full year 2016 were NOK 0.314 million (NOK 0.437 million).
• Total operating expenses for the fourth quarter were NOK 65.4 million (NOK 33.4 million). Total operating expenses for the full year 2016 were NOK 216.7 million (NOK 183.5 million).
• Comprehensive loss for the fourth quarter amounted to NOK 59.3 million (loss of NOK 31.0 million). Comprehensive loss for the full year 2016 was NOK 235.8 million (NOK 173.1 million).
• Cash and cash equivalents amounted to NOK 1,018.2 million at the end of December 2016 (NOK 560.1 million at the end of September 2016 and NOK 743.4 million at the end of December 2015).
Looking forward, the company intends to leverage this progress and its strengthened financial position to drive an expanded and extended strategy towards achieving its broader long-term ambitions: maximize the value of its novel targeted biopharmaceutical candidates across all stages of FL and other major haematological cancer indications, to prepare for the commercialisation of Betalutin® and to selectively extend its pipeline.
The competitive profile for Betalutin® remains promising. Strong results and good progress in the Lymrit 37-01 clinical study give the company confidence that it is on track to select a dosing regimen for Betalutin® in Phase 2. Management will continue to focus its efforts on the efficient execution of its plans and to meet anticipated clinical milestones. Current cash resources are now expected to be sufficient to take the company beyond a planned first regulatory submission for Betalutin® in FL in the first half of 2019 and to meet value-generating clinical milestones in its other programmes.
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: 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 CET today.
For further information, please contact:
Luigi Costa, Chief Executive Officer
Cell: +41 79 124 8601
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
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-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 forecast to be worth nearly USD 20 billion by 2024.
The Company aims to rapidly develop Betalutin®, alone and in combination with other cancer therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple 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.
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SOURCE Nordic Nanovector