Nordic Nanovector Announces Focus on Advancing PARADIGME and Actions to Extend Cash Runway into 2021
Oslo, Norway, 1 April 2020
Nordic Nanovector ASA (OSE: NANO) today announces a number of initiatives to speed up recruitment into its pivotal Phase 2b PARADIGME trial with Betalutin® in advanced follicular lymphoma (FL) as well as to extend its cash runway into 2021. A webcast will take place on Thursday 2 April at 10:00 am CET. Details below.
At the time of the Q4 results in February, the company noted that it would, under its new management, critically assess the current strategy and clinical trial operations.
Following this assessment several key development decisions have been made:
- Streamlined strategy with all resources focused on PARADIGME – all other clinical trials to be suspended following completion of the current cohorts and all investments in pre-clinical assets to be halted
- Request type C meeting with FDA to amend the current PARADIGME protocol
- Intend to broaden PARADIGME’s inclusion criteria to increase rate of recruitment.
We have recently seen a slowdown in recruitment into the PARADIGME study due to measures taken by many governments in respons to contain the COVID-19 pandemic, as well as the need for hospitals to prioritise resources on treating infected patients.
In parallel, several cost savings initiatives are being implemented to extend the Company’s cash runway into 2021:
- Reduction in staffing levels by approximately 20% to be completed by end April
- Consolidating several staff functions and closing offices
- Resources focused on core clinical operations and CMC (Chemistry, Manufacturing and Controls)
- Phased investment in CMC and pre-commercialisation activities with some spending moved into 2021
The company will provide a further update on PARADIGME when it has received and reviewed the feedback from its discussions with the FDA. Nordic Nanovector still plans a rolling submission for Betalutin® with FDA once it has the top line data from the PARADIGME trial.
Commenting on today’s announcement, Lars Nieba, Interim CEO of Nordic Nanovector, said: “The actions that we have announced today are designed to significantly improve patient recruitment into our pivotal Phase 2b PARADIGME trial with Betalutin® and to extend our cash runway into 2021. We are confident that the changes we are making will enable us to deliver the key clinical data needed to support a planned US filing with Betalutin® in a timely manner. I look forward to keeping you updated on our progress.”
A webcast to discuss the restructuring plans and clinical trials will take place on Thursday 2 April at 10:00 am CET. A link to the webcast and a presentation will be uploaded to the company’s frontpage website at 9:00 am CET on Thursday 2 April.
For further information, please contact:
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
Tel: +44 203 926 8535
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 29 billion by 2026. Nordic Nanovector retains global marketing rights to Betalutin® and intends to actively participate in the commercialisation of Betalutin® in the US and other major markets.
Further information 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 Sections 4-2 and 5-12 of the Securities Trading Act.
Source: Nordic Nanovector