Nordic Nanovector ASA: Results for the Second Quarter and First Half 2021

OSLO, Norway, Aug. 27, 2021 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANOV) announces its results for the second quarter and first half 2021. A presentation by Nordic Nanovector's senior management team will be webcasted live today beginning at 8:30am CEST. The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation are available on the company's website in the section: Investors & Media/Reports and Presentation/Interim Reports/2021.

Malene Brondberg, interim CEO of Nordic Nanovector, said: "Nordic Nanovector continues to make important progress towards completing patient enrolment into the pivotal PARADIGME trial despite ongoing disruption from the COVID-19 pandemic. This disruption has reduced the acceleration in recruitment that we anticipated as a result of the amendments we made to the trial protocol and the multiple recruitment initiatives we have implemented. We now expect to report the preliminary readout from PARADIGME in H1'2022 and are focused on delivering this crucial milestone. The Company remains convinced that Betalutin® is uniquely positioned to meet the need for a chemo-free, effective yet tolerable treatment for NHL patients, coupled with its convenient administration schedule, with potential quality of life advantages for elderly and frail patients."

Operational Highlights

• PARADIGME timelines revised following review of patient recruitment rate and expected impact of continuing COVID-19 pandemic caused by the spread of the more infectious SARS-CoV-2 delta variant         
• Preliminary three-month data readout now expected during H1'2022
• 94 of a targeted 120 patients have been enrolled into PARADIGME as of 26 August 2021 (83 patients enrolled as of 25 May 2021)
• 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
• Promising Phase 1b data reported from the Phase 1 Archer-1 study evaluating Betalutin® in combination with rituximab in 2L follicular lymphoma (FL)        
• The combination showed a very good safety profile comparable to that of single agent Betalutin®, and early signs of efficacy, with all seven patients responding to treatment, with 6 out of 7 patients still in remission
• On 3 August 2021, the Company announced that the findings from Archer-1 will be important to inform the future development strategy for Betalutin® in 2L FL and that it will invest no further funds in Archer-1.
• Betalutin® was found to be well tolerated, with a good safety profile consistent with all previous studies, in the LYMRIT 37-05 Phase 1 trial in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)         
• Clinical activity of Betalutin® was seen in the six evaluable patients receiving the highest dosing regimen
• Next steps for development of Betalutin® in DLBCL are under consideration
• The Company has committed to hosting an R&D Day in Q4'2021 to discuss the positioning and next steps for Betalutin® development and commercialisation, as well as further pipeline opportunities
• Malene Brondberg was appointed interim Chief Executive Officer in July    
• Ms Brondberg replaces Peter Braun, who left Nordic Nanovector for personal reasons. Ms Brondberg will continue in her role as CFO. The Board has initiated a search for a new CEO
• Board changes            
• Hilde Hermansen Steineger, PhD, decided not to stand for re-election at the AGM on 28 April 2021 
• Solveig Hellebust, PhD, was appointed Non-executive Director at the AGM

Financial Highlights

(Figures in brackets = same period 2020 unless otherwise stated)

• Revenues for the second quarter 2021 amounted to NOK 0.0 million (NOK 0.0 million)
• Total operating expenses for the second quarter 2021 were NOK 103.9 million (NOK 113.4 million)
• Comprehensive loss for the second quarter 2021 amounted to NOK 101.8 million (loss of NOK 125.6 million)
• Revenues for the first half 2021 amounted to NOK 0.0 million (NOK 0.0 million)
• Total operating expenses for the first half 2021 decreased to NOK 205.1 million (NOK 239.3 million)
• Comprehensive loss for the first half 2021 was NOK 204.0 (NOK 217.2 million)
• Cash and cash equivalents amounted to NOK 450.1 million at the end of June 2021, compared to NOK 497.9 million at the end of March 2021, and NOK 294.0 million at the end of December 2020

Outlook

Nordic Nanovector's current focus is to complete 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 based on CD37-targeting immunotherapies, at its R&D Day, which is planned to take place in Q4'2021.

For further information, please contact:

IR enquiries

Malene Brondberg, Interim CEO & CFO
Cell: +44 7561 431 762
Email: [email protected]

Media Enquiries

Mark Swallow/Frazer Hall/David Dible (MEDiSTRAVA Consulting)
Tel: +44 203 926 8535
Email: [email protected]

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.

Forward-looking statements

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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SOURCE Nordic Nanovector