NORDIC NANOVECTOR: RESULTS FOR THE SECOND QUARTER AND HALF YEAR 2015
Oslo, Norway, 26 August 2015:
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 second quarter and half year 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: “Following the great start to 2015, which saw the Company complete an upsized and oversubscribed IPO, we continue to execute the clinical development strategy for Betalutin®, our lead Antibody-Radionuclide-Conjugate (ARC), which has been designed to become an important new treatment option for patients with non-Hodgkin’s lymphoma. With funding secured, we are now making progress towards starting a pivotal Phase 2 clinical study with Betalutin® in follicular lymphoma and to initiate new clinical studies in a second NHL indication, diffuse large B-cell lymphoma. Both indications represent major unmet medical needs and we see great potential for Betalutin to improve on and complement existing therapeutic options.”
Operational Highlights – Q2 and First half 2015
• Updated results from the now fully enrolled part 1 of the Phase 1/2 study with Betalutin® in patients with relapsed/refractory CD37+ Follicular Lymphoma (FL) were presented at 13-ICML (Lugano, Switzerland) in June. The updated data confirmed the manageable safety profile of Betalutin® and its promising efficacy. New data also highlighted that clinical responses observed are sustained, with 5 out of 7 (71%) patients still in response, and duration of response ranging from 6 to 21+ months. Other key findings were consistent with those presented at the American Society of Hematology Conference in December 2014. The ongoing Phase 1/2 study continues with the intention to provide further insight on the selection of doses for the pivotal Phase 2 study. Further updates will be given in presentations at scientific and clinical congresses.
• Preparations are well underway to initiate the pivotal Phase 2 study (PARADIGME) in the second half 2015. This study has been designed to meet the regulatory filing requirements for a third line FL indication.
• Initial clinical studies of Betalutin® in patients with diffuse large B-cell lymphoma are being prepared to begin during the second half 2015.
• A new Scientific Advisory Board, including experts in haematology-oncology and cancer drug development from leading academic/research institutions in the US and Europe, was established in May.
• The over-allotment option, in relation to the Company’s upsized and oversubscribed Initial Public Offering (IPO) in March, was exercised in April adding a further NOK 75 million to the NOK 500 million raised in the primary offer. Total gross proceeds of the IPO were NOK 575 million (USD 73 million*) and will be used to advance the development of Betalutin® beyond first regulatory submission, planned in 2017.
• Board changes in connection with the IPO: Gisela M. Schwab, M.D., Executive VP and CMO at Exelixis, Inc. was elected to the Board of Directors in March replacing Alexandra Morris, Portfolio Manager at Odin Fund Management.
(* USD 1 = NOK 7.86 per 30 June 2015)
Financial Highlights
• Revenues for the second quarter 2015 amounted to NOK 141,961 (Q2 2014: NOK 118,143). Revenues for the first half 2015 were NOK 218,002 (1H 2014: NOK 236,604).
• Net operating expenses for the quarter amounted to NOK 51.2 million (Q2 2014: NOK 15.8 million) and for the first half were NOK 87.1 million (1H 2014: NOK 27.8 million).
• Cash and cash equivalents amounted to NOK 817.1 million as of 30 June 2015, compared to NOK 781.4 million as at 31 March 2015.
• Nordic Nanovector issued 17,968,750 new shares at NOK 32 in connection with the Initial Public 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 third line FL in 2018 and in parallel to run additional trials in second line FL and DLBCL. Activities focused on the commercialisation of Betalutin® are underway and will be increased as key stages in development are reached. Nordic Nanovector is also evaluating options for the expansion of its R&D pipeline.
Second Quarter and Half Year 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.
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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/+44 207 282 2949
mark.swallow@citigatedr.co.uk / david.dible@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) 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). It has shown promising efficacy and a favourable safety profile in a Phase 1/2 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 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.
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