Nordic Nanovector: Results For The Third Quarter And First Nine Months Of 2015
OSLO, Norway--(BUSINESS WIRE)--Nordic Nanovector ASA (OSE: NANO), a company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology, announces its results for the third quarter and first nine months 2015.
A presentation of the results by Nordic Nanovector’s senior management team will take place today in Oslo at 8.30 a.m. CEST – details below.
Luigi Costa, CEO of Nordic Nanovector, said: “As announced last week, Nordic Nanovector made a strategic decision to revise the clinical development plan for Betalutin®. We believe that this updated plan provides us with a new opportunity to determine the best regimen to take into the pivotal Phase 2 PARADIGME trial, greatly improving the chances of successfully gaining regulatory approval for Betalutin® with a product profile that would make it a highly competitive new treatment for follicular lymphoma, a sizeable and growing market opportunity.”
Strategic decision made to adapt the clinical development plan for
Betalutin® in follicular lymphoma
- Changes driven by new data and endorsed by Scientific Advisory Board, clinical and regulatory advisors
- As a result, the first regulatory submission for Betalutin® is expected in 1H 2019, compared with 2H 2017 in the original plan
- Revised plan will allow the Company to explore new pre-dosing regimens and more potent doses of Betalutin® to potentially deliver an even better treatment outcomes
New plan designed to enhance the chances of Betalutin® gaining
regulatory approval with a more competitive product profile
- Lower risk: optimal dosing regimen established before starting pivotal Phase 2 PARADIGME trial
- Key milestone: selection of Betalutin® optimal dose regimen by 1H 2017
- Increased efficiency: PARADIGME trial will enroll fewer patients and use a clearly defined dose
- New plan opens the possibility of an earlier IND and an earlier involvement of US sites
Based on approved plan, cash resources are expected to be sufficient
until first regulatory submission, anticipated 1H 2019
- New plan requires fewer patients
- No run-in phase of PARADIGME
- Different cost phasing on the clinical program
Presentation at European Association of Nuclear Medicine (EANM)
- Preclinical research highlighting potential of 177Lu-conjugated chimeric HH1 antibody in multiple indications
Capital Markets Day announced
- Oslo, Tuesday 17 November 2015
• Revenues for the third quarter 2015 amounted to NOK 75,825 compared to NOK 76,807 in the third quarter 2014. Revenues for the first nine months 2015 decreased to NOK 293,827 from NOK 313,411 for the same period in 2014.
• Net operating expenses increased to NOK 63.0 million in the third quarter 2015 from NOK 11.9 million in the same quarter of 2014. Net operating expenses for the first nine months of 2015 increased to NOK 150.1 million from NOK 39.8 million for the same period in 2014.
• Cash and cash equivalents amounted to NOK 769.5 million as of 30 September 2015, compared with NOK 817.1 million as at 30 June 2015 and NOK 781.4 million as at 31 March 2015.
Conference call details
A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am 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/2015 from 7:00 am CEST the same day.
About Nordic Nanovector
Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018. Betalutin® comprises a tumour-seeking anti-CD37 antibody (HH1) conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat multiple selected cancer indications. Further information about the Company can be found at www.nordicnanovector.com
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