OSLO, Norway, May 26, 2020 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces its results for the first quarter 2020. A presentation by Nordic Nanovector's senior management team will take place today via a webcast at 08:30 am CET. A link to the webcast and a presentation is available from the company's homepage (www.nordicnanovector.com).
Lars Nieba, interim CEO of Nordic Nanovector, said: "Despite a number of significant challenges, the new senior management team together with the Board and all our employees have moved decisively to conduct a thorough strategic review and to implement an action plan based on its conclusions. With a clear focus on PARADIGME and a cash runway into 2021, I believe we are well placed to demonstrate and deliver the value of Betalutin® to patients and to our shareholders."
- Dr Lars Nieba appointed as interim Chief Executive Officer
- Dr Dominic Smethurst appointed as interim Chief Medical Officer
- Pivotal Phase 2b PARADIGME trial of Betalutin® in 3rd-line follicular lymphoma (3L FL) progressing
- COVID-19 has had a negative impact on PARADIGME during H1'2020
- 51 patients enrolled as of May 25th, 2020
- Initiated strategic review with focus on advancing PARADIGME and extending cash runway into 2021
Events after Q1'20
- Strategic review completed: clinical development strategy revised, and cost-saving initiatives implemented
- FDA meeting sought to discuss PARADIGME protocol amendments designed to enlarge eligible patient population and increase rate of enrolment
- Enrolment timelines for PARADIGME to be updated once FDA feedback is received and when there is more clarity on the impact created by COVID-19
- Planned restructuring completed
- Malene Brondberg appointed as Chief Financial Officer
- Corporate and personnel reorganisation implemented
- Headcount reduced by approx. 20%
- Cost savings of approx. NOK 35 million in connection with the restructuring on an annual basis
- Betalutin® recommended for Orphan Drug Designation in the European Union for Marginal Zone Lymphoma (MZL)
(Figures in brackets = same period 2019 unless otherwise stated)
- Revenues for the first quarter amounted to NOK 0.0 million (NOK 0.0 million)
- Total operating expenses for the first quarter were NOK 125.9 million (NOK 90.0 million)
- Comprehensive loss for the first quarter amounted to NOK 91.7 million (loss of NOK 91.6 million)
- Cash and cash equivalents amounted to NOK 384.3 million at the end of March 2020, compared to NOK 470.8 million at the end of December 2019
The company continues to target the readout of top line data from PARADIGME in 2021. However, due to uncertainties created by the current COVID-19 situation, there is a need to review the timeline for the enrolment of PARADIGME, which previously was guided for H2'2020. Updated timelines for PARADIGME are expected to be provided once there is more clarity on the impact of COVID-19 and when all the relevant regulatory feedback has been received.
Nordic Nanovector is fully committed to ensuring that PARADIGME has the best chance of success and the proposed protocol amendments are an important part of this. Following FDA feedback, the company intends to seek approval for these amendments at an individual country level and begin their implementation as they are approved.
The company believes that the improvements it has made to the conduct of PARADIGME puts it in a strong position to improve the rate of patient enrolment once COVID-19 restrictions are eased.
The steps the company has taken to conserve cash, including reducing headcount and pausing certain clinical trials, will extend the cash runway into 2021. The company expects to see the impact of these cost-saving initiatives emerge over the remainder of this year.
Following the comprehensive strategic review carried out by the new management team, the company believes it is now in a much-improved position to deliver the pivotal results from PARADIGME in a timely manner. This is a key milestone for Nordic Nanovector as the company seeks to bring this exciting new targeted NHL treatment to patients and maximise the value of Betalutin®.
For further information, please contact:
Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
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.
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The following files are available for download:
Nordic Nanovector Q1 2020 report
SOURCE Nordic Nanovector