Regulatory News:
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 first quarter 2015.
A presentation of the results by Nordic Nanovector’s senior management team will take place today at 8:30am CEST in Oslo, details are below.
Luigi Costa, CEO of Nordic Nanovector, said: “The Company made a positive start to 2015. We were delighted with the widespread support from domestic and international investors to our up-sized and oversubscribed IPO. The IPO funds, together with those raised in 2014, provide a strong financial position from which to execute our development strategy for Betalutin™, our lead product. Betalutin™ is our first-in-class Antibody-Radionuclide-Conjugate designed to improve upon and complement current treatment options for Non-Hodgkin’s Lymphoma. We have set multiple development targets for Betalutin™ between now and first regulatory submission, anticipated in 2017, and the delivery of these is expected to create significant value for shareholders and an important new therapeutic option for NHL patients.”
Operational Highlights
• Upsized and oversubscribed Initial Public Offering (IPO) completed in March (plus Over-allotment Option exercised in April) raised NOK 575 million ($72 million*) in gross proceeds to advance the development of Betalutin™ beyond first regulatory submission, planned in 2017.
• The IPO was conducted in conjunction with the listing of the Company’s shares on Oslo Stock Exchange (OSE). The first day of trading for its shares on OSE was 23 March.
• Part 1 of Phase 1/2 study with Betalutin™ in patients with relapsed/refractory CD37+ Follicular Lymphoma (FL) is completed. Preliminary results (presented at ASH, December 2014) demonstrated a promising efficacy and safety profile for Betalutin™ and identified a recommended dose for the Phase 2 part of the study, which is expected to start in Q2 2015. Updated results from the Phase 1 part of the study will be presented at the International Conference on Malignant Lymphoma in Lugano (Switzerland) on 18-19 June.
• Gisela M. Schwab, M.D., Executive Vice President and Chief Medical Officer at Exelixis, Inc. joined the Company’s Board of Directors in February. Dr. Schwab brings considerable experience in the development of new drugs in oncology and haematology. At the same time, Alexandra Morris, Portfolio Manager at Odin Fund Management, stepped down from the Board.
• A new Scientific Advisory Board, including experts in haematology-oncology and cancer drug development from leading academic/research institutions in the US and Europe, has been established.
(* NOK 1 = USD 8.06 per 31 March 2015)
Financial Highlights
• Revenues for the first quarter 2015 amounted to NOK 76,041 (2014: NOK 118,143).
• Net operating expenses for the quarter amounted to NOK 35.9 million (2014: NOK 12.0 million).
• Cash and cash equivalents amounted to NOK 781.4 million as of 31 March 2015, compared to NOK 337.0 million as at 31 December 2014.
• Nordic Nanovector issued 17,968,750 new shares at NOK 32 in connection with the Offering (including the Over-allotment Option), raising gross proceeds of NOK 575 million. There are in total 44,519,041 shares in issue following the issuance of the new shares.
Outlook
The focus of the Company in 2015 and beyond will be on the Betalutin™ clinical development programme, with an aim to obtain a first regulatory approval in 3rd line FL in 2018 and in parallel to run additional trials in 2nd line FL and DLBCL. The strategic priorities for Nordic Nanovector for 2015 include the development of a commercial-scale manufacturing process for Betalutin™, the optimisation of the Betalutin™ positioning and messaging platform and the expansion of the R&D pipeline.
First Quarter 2015 Results Presentation and Webcast
A presentation by Nordic Nanovector’s senior management team will take place today at 8:30am CEST at:
Thon Hotel Vika Atrium
Munkedamsveien 45
0250 Oslo
Meeting
Room: NYLAND
The presentation will be recorded as a webcast and will be available after the event on www.nordicnanovector.com in the section: Investor Relations/Webcast.
The results report and the presentation are attached this press release and will be available at www.nordicnanovector.com in the section: Investor Relations/Reports and Presentation/Quarterly Reports.
For further information, please contact:
Luigi Costa, CEO, or Tone
Kvåle, CFO
Tel: +47 22 18 33 01
ir@nordicnanovector.com
Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel:
+44 207 282 2948
mark.swallow@citigatedr.co.uk
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’s), 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 conjugated to a low intensity radionuclide (lutetium- 177). It has shown promising efficacy and a favourable safety profile in a Phase 1 study, in a difficult-to-treat NHL patient population. The Company is aiming at rapidly developing Betalutin™ for the treatment of major types of NHL with first approval anticipated by the end of 2018.
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
Forward-looking statement
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 BetalutinTM, 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.
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