Oslo, Norway, 26 May 2021
Nordic Nanovector ASA (OSE: NANOV) announces its results for the first quarter 2021. A live webcast presentation by Nordic Nanovector’s management team will take place today at 08.30 CEST. A link to the webcast is available on www.nordicnanovector.com.
The results report and the presentation are also available on the company’s website in the section: Investors & Media/Reports and Presentation/Interim Reports/2021. A replay of the webcast will be made available at the same location after the event.
Peter L. Braun, Chief Executive Officer of Nordic Nanovector, commented: “Nordic Nanovector has made important progress so far in 2021, including raising the money needed to deliver the preliminary top-line three-month data from the PARADIGME study and to prepare for a subsequent potential BLA filing for Betalutin®. The company has also implemented a range of initiatives aimed at improving patient recruitment into PARADIGME, and which we believe will further improve patient enrolment when the impact of COVID-19 recedes. I am convinced that effective and well-tolerated, targeted radiopharmaceuticals, such as Betalutin®, a one-time treatment, can make a real difference to NHL patients worldwide.”
- Peter L. Braun was appointed Chief Executive Officer in March
- Mr Braun is an experienced and entrepreneurial pharmaceutical leader with extensive commercialisation and innovative oncology experience from a career spanning nearly 30 years at Roche
- Successful Private Placement and oversubscribed Repair Offering completed in February and April, respectively, raised approximately NOK 422 million (USD 49.7 million) in gross proceeds
- Extends the company’s cash runway into H2’2022
- Operational improvements and protocol changes have improved PARADIGME recruitment rate in recent months, despite impact from the on-going COVID-19 pandemic
- 83 patients enrolled as of 25 May 2021 (73 enrolled as of 17 February 2020)
- Company remains on track to report preliminary three-month top-line data by the end of 2021
- Promising Phase 1b data from the Archer-1 study evaluating Betalutin® in combination with rituximab in 2L FL
- Board changes
- Hilde Hermansen Steineger, PhD, decided not to stand for re-election at AGM
- Solveig Hellebust, PhD, appointed Non-executive Director at the AGM on 28 April 2021
Financial Highlights Q1 2021
(Figures in brackets = same period 2020 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 101.2 million (NOK 125.9 million).
- Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 85.9 % of total operating expenses year to date 2021 (80.8 %).
- Comprehensive loss for the first quarter amounted to NOK 102.1 million (loss of NOK 91.7 million).
- Cash and cash equivalents at the end of March 2021 amounted to NOK 497.9 million, compared to NOK 294.0 million at the end of December 2020.
Nordic Nanovector’s current focus is to complete patient enrolment into PARADIGME and the target is to announce the preliminary readout of three-month top line data from PARADIGME by end 2021.
Following the recent successful Private Placement and Repair Offering, the company has extended its cash runway into H2’2022, which in addition to allowing it to deliver the top line data from PARADIGME, will enable further preparatory work on the potential Betalutin® BLA filing 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.
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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 26 billion by 2028. 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 the disclosure requirements pursuant to Section 5-12 the Norwegian Securities Trading Act
Source: Nordic Nanovector