OSLO, Norway, May 30, 2018 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces its results for the first quarter 2018. A presentation by the company's senior management team will take place today in Oslo at 08:30 CET, see details below.
Tone Kvåle, CFO and Interim CEO, commented: "We have been focusing our efforts, since the beginning of the year, on getting PARADIGME approved and started. While our progress with the start-up of this pivotal study has been encouraging, we saw reason in April to announce adjustments to the timelines for its duration and are now targeting the first data read-out from the study in the first half of 2020.
"We remain convinced of the significant potential of Betalutin® based on the promising clinical data generated to-date. We also believe that PARADIGME provides a robust trial design to generate the data needed to support our regulatory and commercialisation strategy for Betalutin® to become an important new treatment option for 3L FL patients."
Operational Highlights Q1'18
- Start-up activities ongoing for pivotal Phase 2b PARADIGME trial investigating Betalutin® as a potential new treatment for patients with third-line relapsed/refractory follicular lymphoma (3L R/R FL)
o As at May 29th, 23 sites in 8 countries are open for enrolment
- Malene Brondberg appointed as Vice President, IR and Corporate Communications
Events after Q1'18
- Luigi Costa stepped down as CEO
o Tone Kvåle appointed as Interim CEO in addition to existing role as CFO
o Search for new CEO underway
- PARADIGME timelines revised with first results targeted for 1H 2020 (previously 2H 2019)
o Start-up activities and site initiations progressing
- Clinical development of Humalutin® postponed for the foreseeable future as resources are re-focused on PARADIGME and the Betalutin® development programme
Financial Highlights Q1 '18
(Figures in brackets = same period 2017 unless otherwise stated)
- Revenues in the first quarter 2018 amounted to NOK 0 (NOK 0.1 million).
- Total operating expenses for the quarter were NOK 82.3 million (NOK 65.8 million).
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 76.2 % of total operating expenses in the first quarter 2018 (72.2 %).
- Operating loss for the quarter was NOK 82.3 million (loss of NOK 65.7 million).
- Comprehensive loss for the quarter was NOK 90.7 million (loss of NOK 55.8 million).
- Cash and cash equivalents as at 31 March 2018 amounted to NOK 641.5 million, down from NOK 756.6 million at the end of 31 December 2017.
Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.
Betalutin®, the company's most advanced product candidate, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising results from the LYMRIT 37-01 Phase 1/2a clinical study. The company's pivotal Phase 2b PARADIGME trial with Betalutin® in 3L R/R FL is underway with initial data read-outs from the study targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.
Nordic Nanovector intends to maximize the value of Betalutin® across other stages of FL, NHL and other haematological cancer indications.
The company is confident that Betalutin® could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.
Current cash resources are expected to be sufficient to reach data read-out from PARADIGME in 1H 2020.
Presentation and webcast – First quarter 2018 results and webcast
A presentation by Nordic Nanovector's senior management team will take place at 8:30 am CEST on 30 May at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: NYLAND
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/2018 from 7:00 am CEST the same day.
Results presentation in Norwegian
As announced in April, a separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector's CFO and Interim CEO, and its VP IR & Corporate Communications, will take place on Thursday, 31 May 2018 at 8:30 am CEST at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: VIPPETANGEN
To attend the meeting please email - firstname.lastname@example.org
The presentation will NOT be recorded as a webcast
For further information, please contact:
IR enquiries Malene Brondberg
VP Investor Relations and Corporate Communications
Media Enquiries Mark Swallow/David Dible/Isabelle Andrews (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 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
Further information about the Company can be found at www.nordicnanovector.com
This announcement may contain certain forward-looking statements and forecasts based on uncertainty, 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", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of Nordic Nanovector's strategy and its ability to further grow, risks associated with the development and/or approval of Nordic Nanovector's products candidates, ongoing clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector's potential market and industry, 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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The following files are available for download:
Q1 2018 presentation