Nordic Nanovector ASA - Results for the Third Quarter 2019
OSLO, Norway, Nov. 19, 2019 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces its results for the third quarter 2019. A presentation by the company's senior management team will take place today in Oslo at 08:30 CET, see details below.
Eduardo Bravo, CEO, commented: "We are encouraged with the clinical results emerging from the different clinical trials with Betalutin® in non-Hodgkin's lymphoma (NHL). As stated by key opinion leaders in the field during the R&D Day hosted by Nordic Nanovector in September, the emerging profile of Betalutin® is unique and very competitive. There are many patients who suffer from these devastating diseases who lack effective, safe and convenient treatment options. We remain fully committed to deliver on our timelines to bring this novel product to the market as quickly as possible."
Highlights Q3 `19
- Updated analysis from Phase 1/2a LYMRIT 37-01 trial of Betalutin® in relapsed/refractory follicular lymphoma (R/R FL) presented at R&D Day (September)
- Median duration of response of 13.6 months for all responders and 32.0 months for complete responders (vs 9.0 and 20.7 months, respectively reported at ASH 2018
- Median follow-up time for responders of 30.0 months (range: 12.0 - 60.7 months)
- Pivotal Phase 2b PARADIGME trial of Betalutin® in advanced, recurrent and CD20 antibody treatment refractory 3L Follicular Lymphoma (FL) is progressing
- 87 sites in 24 countries open for enrolment as of November 18th, 2019
- Patient enrolment is expected to be completed in the second half of 2020
- Phase 1b Archer-1 trial of Betalutin® in combination with rituximab (RTX) in patients with R/R 2nd line FL (2L FL) advanced to second cohort
- 100% Overall Response Rate (3/3 Complete Responses) observed in the first patient cohort
- Promising preclinical results with Alpha37 for B-cell tumours presented at EANM conference by partner Orano Med
- Alpha37 project received grant funding of EUR 0.6 million from Eurostars
- Approximately NOK 243 million (USD 26.4m) (gross) raised 18th October in private placement of new shares providing additional funds to support the continued clinical development of Betalutin® (including completion of enrolment of PARADIGME and all ongoing clinical trials), manufacturing and other activities in preparation for the commercialisation of Betalutin®
- Dr Gabriele Elbl appointed as VP Global Regulatory Affairs to drive the company's Regulatory Affairs strategy
Financial Highlights Q3 `19
(Figures in brackets = same period 2018 unless otherwise stated)
- Revenues for the third quarter amounted to NOK 0.0 (NOK 0.0 million). Revenues for the first nine months 2019 were NOK 0.0 (NOK 0.0 million)
- Total operating expenses for the third quarter were NOK 100.2 million (NOK 76.9 million). Total operating expenses for the first nine months of 2019 amounted to NOK 301.1 million (NOK 243.7 million)
- Research and development (preclinical, clinical, medical affairs, regulatory and CMC (Chemistry, Manufacturing and Controls) activities expenses accounted for 78 % of total operating expenses for the first nine months of 2019 (73 %)
- Comprehensive loss for the third quarter amounted to NOK 93.6 million (loss of NOK 75.4 million). Comprehensive loss for the first nine months was NOK 295.6 million (loss of NOK 249.1 million)
- Cash and cash equivalents amounted to NOK 345.9 million at the end of September 2019 (NOK 440.1 million at 31 December 2018), exclusive of new funds raised in October 2019 of NOK 243 million (gross)
Outlook
Nordic Nanovector aspires to become a leader in the field of targeted radioimmunotherapies for haematological cancers by developing, manufacturing and commercialising innovative products to address major unmet medical needs and advance cancer care.
Betalutin®, the company's most advanced radioimmunotherapy candidate, is developing a highly differentiated, competitive, clinical profile. Nordic Nanovector is confident that Betalutin® could become an attractive and convenient once-only therapeutic option, which, based on detailed market research, has the potential to be commercially successful.
Betalutin® is being developed for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical trial. The company's pivotal Phase 2b PARADIGME trial with Betalutin® in 3L R/R FL is underway. Patient enrolment is expected to be completed in the second half of 2020. The study's preliminary data read-out is planned a few months later. A BLA filing to gain marketing approval for Betalutin® is expected in the first half of 2021. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
Nordic Nanovector intends to maximize the value of Betalutin® across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies across NHL and other haematological cancer indications.
Presentation and Webcast
A presentation by Nordic Nanovector's senior management team will take place today at 8:30am CET at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: AKER
The presentation will be recorded as a webcast 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/2019.
For further information, please contact:
IR enquiries
Malene Brondberg
VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: [email protected]
Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44-207-638-9571
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 radioimmunotherapy 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 intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core 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 Section 5-12 of the Securities Trading Act.
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