On November 18, 2021 Nordic Nanovector ASA (OSE: NANOV) reported its results for the third quarter 2021 (Press release, Nordic Nanovector, NOV 18, 2021, View Source [SID1234595831]). A presentation by Nordic Nanovector’s senior management team will be held in-person today in Oslo and webcast live beginning at 8:30am CET – details below.
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Erik Skullerud, CEO of Nordic Nanovector, said: "We are entering an exciting period for Nordic Nanovector, as the Company draws closer to completing patient recruitment for the PARADIGME trial, for which we expect readout of preliminary data in H1′ 2022. The Company is convinced that Betalutin is uniquely positioned to meet the need for a chemo-free, effective yet tolerable treatment for non-Hodgkin’s lymphoma patients, coupled with a convenient administration schedule. In the meantime, we look forward to sharing our vision for Nordic Nanovector and Betalutin as well as an update on our pipeline at our R&D day on 30 November."
Operational Highlights
102 of a targeted 120 patients have been enrolled into the pivotal PARADIGME Phase 2b trial for Betalutin as of 17 November 2021 (94 patients enrolled as of 26 August 2021)
Three patients were enrolled in the same quarter in 2020
Preliminary three-month data readout expected during H1’2022, following timeline revisions announced on 3 August 2021
Erik Skullerud appointed as new Chief Executive Officer (CEO)
Mr Skullerud brings more than 25 years’ experience in the biopharma industry including more than 15 years at Amgen, including as Marketing Director Europe Oncology/Hematology, and seven years at Bayer
He has launched numerous highly innovative products in therapeutic areas including oncology and haematology, and as a consultant, he has worked with some of the world’s top pharma and biotech companies as well as small, highly specialised start-ups on a wide range of projects
Pierre Dodion MD appointed as Chief Medical Officer
Dr Dodion has over 30 years’ experience in the biopharmaceutical industry, spent mostly in the oncology and haematology areas. He brings deep clinical development and medical affairs expertise and has provided strategic insight and overseen multiple clinical trials
Nordic Nanovector announced its support for The Health Policy Partnership’s initiative to improve readiness for the use of radioimmunotherapy and to facilitate appropriate integration of this innovative cancer treatment modality in lymphoma
The Company entered a research collaboration with the University of Pennsylvania to generate a novel CD37-targeting CAR-T cell therapy approach as a potential treatment for patients with B-cell malignancies
Nordic Nanovector will have an option to license exclusive worldwide rights to any CD37-targeting CAR-T cells that result from the collaboration
Financial Highlights
(Figures in brackets = same period 2020 unless otherwise stated)
Revenues for the third quarter 2021 and the first nine months of 2021 amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses for the third quarter 2021 were NOK 104.3 million (NOK 88.1 million). Total operating expenses for the first nine months of 2021 were NOK 309.3 million (NOK 327.3 million)
Comprehensive loss for the third quarter 2021 amounted to NOK 103.6 million (loss of NOK 88.2 million). Comprehensive loss for the first nine months of 2021 was NOK 307.6 (NOK 305.4 million)
Cash and cash equivalents amounted to NOK 369.5 million at the end of September 2021, compared to NOK 450.1 million at the end of June 2021, and NOK 294.0 million at the end of December 2020
Outlook
Nordic Nanovector is close to completing patient enrolment into PARADIGME and is targeting the readout of preliminary three-month top line data during H1’2022.
The company’s current cash position will support its operations into H2’2022 and will enable further preparatory work on the potential Betalutin BLA filing and planning for commercialisation to be undertaken.
The company believes that, if positive, the PARADIGME trial data could represent a significant value inflection point for the company and its shareholders, confirming Betalutin as a highly promising new targeted radioimmunotherapy that can address the unmet needs of R/R FL patients.
The company intends to discuss the development plan and opportunities for expanding the market for Betalutin into other NHL indications, together with other potential areas for pipeline expansion and collaboration based on CD37-targeting immunotherapies, at its R&D Day, which is planned to take place on 30 November 2021.
Presentation and Webcast
A presentation by Nordic Nanovector’s senior management team will take place in Oslo today at 8:30am CET at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: Bjørvika
The presentation will webcast live and will be available at www.nordicnanovector.com in the section: Investors & Media.
The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2021.