All operations on track, strong data presented at ICML confirm Betalutin®'s promising efficacy and safety profile in recurrent iNHL patients, pivotal Phase 2 study, PARADIGME to start in 2H 2017
OSLO, Norway, August 23, 2017 /PRNewswire/ --
Nordic Nanovector ASA (OSE: NANO) announces results for the second quarter and half year of 2017. A presentation by the company's senior management team will take place today at 8:30 a.m. CEST in Oslo - details below.
Nordic Nanovector reported continued solid operational progress during the second quarter, with very encouraging clinical results from the ongoing Phase 1/2 study with Betalutin® presented at the International Conference on Malignant Lymphoma (ICML) in June. These results continue to highlight the significant potential of single dose Betalutin® for the treatment of recurrent indolent non-Hodgkin's lymphoma (iNHL) and provide confidence that the company is on track to initiate the pivotal Phase 2 study, PARADIGME, in the second half of 2017. A phase 1 dose-escalation study in diffuse large B-cell lymphoma (DLBCL) is actively enrolling patients, and initial preparations for Phase 2 combination study of Betalutin® and rituximab as well as a Phase 1 study of Humalutin™ in iNHL patients are progressing.
Luigi Costa, CEO of Nordic Nanovector, comments: "We are very pleased with progress made during the first half of 2017 and we continue to be very encouraged by the strong data presented at ICML in June, which support Betalutin®'s potential in the treatment of patients with iNHL. The team has worked hard to lay a strong foundation for a busy and exciting second half to the year, when we anticipate initiating several new clinical studies, including the Phase 2 PARADIGME study."
Operational Highlights Q2'17
• Progress continues as planned towards start of the pivotal Phase 2 study, PARADIGME in 2H 2017, to investigate Betalutin® in patients with relapsed FL
• Results presented at ICML in June highlight strong clinical profile of single dose Betalutin® in recurrent iNHL patients
o Single dose Betalutin® is highly active in recurrent iNHL, especially in FL
o Well-tolerated, no unexpected safety findings, predictable and manageable safety profile
• Safety Review Committee recommends enrolling new patients into a Phase 2 expansion cohort of Arm 4
o To validate whether a higher lilotomab pre-dosing regimen may enable the use of a higher dose of Betalutin®
• Recruitment of DLBCL patients into Phase 1 dose-escalation study with Betalutin® ongoing
o The study is actively enrolling patients in the US and Europe
• Preparations advancing for Phase 2 clinical trial to investigate the potential of Betalutin® combined with rituximab in 2nd line FL
o Phase 2 trial expected to begin in 2H 2017
• Preparations advancing for Phase 1 clinical study to investigate potential of Humalutin™ for treating 1st line NHL
o Phase 1 trial expected to begin in 2H 2017
Events after Q2'17
• Dr. Reza Safaei, former Head of Medical Affairs, Europe with Seattle Genetics, appointed as Head of Medical Affairs
Financial Highlights Second Quarter 2017
(Figures in brackets = same period 2016 unless otherwise stated)
• Revenues for the second quarter amounted to NOK 0.1 million (NOK 0.1 million). Revenues for the first half of 2017 were NOK 0.1 million (NOK 0.2 million).
• Total operating expenses for the second quarter were NOK 76.3 million (NOK 48.1 million). Total operating expenses for the first half of 2017 amounted to NOK 142.1 million (NOK 100.9 million)
• Comprehensive loss for the second quarter amounted to NOK 66.3 million (loss of NOK 51.1 million). Comprehensive loss for the first half was NOK 122.1 million (NOK 115.2 million)
• Cash and cash equivalents amounted to NOK 881.4 million at the end of June 2017 (NOK 933.3 million at 31 March 2017 and NOK 1 018.2 million at 31 December 2016)
Nordic Nanovector aspires to become a leader in the field of targeted therapies for haematological cancers. It intends to achieve this by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.
Nordic Nanovector's operations remain on track. The company intends to maximise the value of Betalutin® across all stages of NHL and other haematological cancer indications. The company has made initial steps in preparing for the commercialisation of Betalutin®. A further element of Nordic Nanovector's strategy is to selectively extend its pipeline of novel targeted biopharmaceutical candidates to support future growth.
The profile of Betalutin® is well differentiated within the competitive landscape. Promising preliminary results and good progress in the LYMRIT 37-01 clinical study give the company confidence that it is on track to initiate the pivotal Phase 2 PARADIGME trial during the second half of 2017. Management will continue to focus its efforts on the efficient execution of its plans and to meet clinical milestones.
Current cash resources are expected to be sufficient to take the company beyond a first regulatory submission for Betalutin® in FL in the first half of 2019 and to meet value-generating clinical milestones in its other programmes.
Presentation and webcast details
A presentation by Nordic Nanovector's senior management team will take place today at 8:30 a.m. CEST at:
Thon Hotel Vika Atrium
Meeting Room: BJØRVIKA
The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investor Relations/Webcast.
The results report and the presentation will be available at www.nordicnanovector.com in the section: Investor Relations/Reports and Presentation/Quarterly Reports/2017 from 7:00 am CEST today.
For further information, please contact:
Luigi Costa, Chief Executive Officer
Tone Kvåle, Chief Financial Officer
Mark Swallow/David Dible/Marine Perrier (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 (ARC) 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.
The Company aims to rapidly develop Betalutin®, alone and in combination with other therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple cancer indications.
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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