Nordic Nanovector ASA: Results for the Second Quarter and First Half 2018
OSLO, Norway, Aug. 22, 2018
OSLO, Norway, Aug. 22, 2018 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces its second quarter and first half 2018 results today. A presentation by the company's senior management team will take place today in Oslo at 08:30 CEST, see details below.
Eduardo Bravo, CEO, commented: "I am pleased to report a quarter marked by important progress in the development of lead candidate Betalutin® in follicular lymphoma (FL). The first patients in the PARADIGME trial have now been dosed. Betalutin® was also granted Fast Track designation in June for relapsed or refractory 3L FL, adding to the Orphan drug designation for treating FL it received in 2014. These designations, granted based on the potential of Betalutin® to address an unmet patient need in FL, could support a quicker and smoother regulatory process and path to market, if PARADIGME is successful. We are also pleased that Archer-1 has been approved in Norway and we expect the first patient to be dosed before the end of 2018."
"Betalutin® is an exciting therapeutic candidate for non-Hodgkin's lymphoma (NHL) and Nordic Nanovector is well positioned to drive its development through clinical trials. I'm excited to join the Company at this important time and look forward to working with the excellent board and management team to realise the significant potential of Betalutin® and to provide a new treatment option to NHL patients who are in need of effective therapies."
• Eduardo Bravo appointed as Chief Executive Officer
o Brings more than 25 years' experience from the biopharmaceutical industry
• First patient dosed in pivotal Phase 2b PARADIGME trial investigating Betalutin® as a potential new treatment for patients with third-line relapsed antiCD20 refractory follicular lymphoma (3L R/R FL)
o Site activations continuing - as of August 21st, 41 (of 80-85) sites in 13 (of 20) countries are open for enrolment
o First data read-out targeted for 1H 2020
• Betalutin® granted Fast Track designation in the US for FL
o Based on promising safety and preliminary efficacy data from the LYMRIT 37-01 study
• Phase 1b Archer-1 trial of Betalutin® in combination with rituximab in second-line (2L) FL patients approved in Norway
o First patient expected to be dosed in 2H 2018
• Phase 1 study with Betalutin® in DLBCL advances to next dosing level
o First dosing levels found to be safe and well-tolerated
• Further appointments to strengthen the Management Team and Board of Directors
o Maureen Deehan, PhD, appointed as Head of Corporate Development and Strategy
o Rainer Boehm, MD, elected as a member of the Board of Directors
Financial Highlights Q2 and 1H 2018
(Figures in brackets = same period 2017 unless otherwise stated)
• Revenues for the second quarter amounted to NOK 0 (NOK 0.1 million). Revenues for the first half of 2018 were NOK 0 (NOK 0.1 million).
• Total operating expenses for the second quarter were NOK 84.5 million (NOK 76.3 million). Total operating expenses for the first half of 2018 amounted to NOK 166.8 million (NOK 142.1 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 72.2 % of total operating expenses (71 %) for the first half of 2018.
• Comprehensive loss for the second quarter amounted to NOK 82.9 million (loss of NOK 66.3 million). Comprehensive loss for the first half was NOK 173.6 million (loss of NOK 122.1 million)
• Cash and cash equivalents amounted to NOK 570.1 million at the end of June 2018 (NOK 641.5 million at 31 March 2018 and NOK 756.6 million at 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 clinical data read-outs targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.
Betalutin® has been granted Fast Track designation in the US for the treatment of patients with R/R FL.
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.
Second Quarter and First Half 2018 Results Presentation and Webcast
A presentation by Nordic Nanovector's senior management team in English will take place today at 8:30 am CEST 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 are available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018.
Results presentation in Norwegian
A separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector's CFO, and its VP IR & Corporate Communications, will take place on Thursday, 23 August 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:
VP Investor Relations and Corporate Communications
International Media Enquiries
Mark Swallow/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 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 can be found at www.nordicnanovector.com.
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The following files are available for download:
Q2 Presentation 2018
Q2 and First Half Report 2018