Nordic Nanovector ASA – Fourth quarter report 2014
Oslo, 23 February 2015:
“Nordic Nanovector is about to enter a very important and exciting phase of its history. We are very proud about the company’s progress in the last few months, with a strengthened organisation, on clinical development, commercialisation strategy and international presence. We are confident that this opportunity will bring significant value to patients and shareholders, says Luigi Costa, CEO of Nordic Nanovector ASA.
Highlights for fourth quarter 2014
Clinical data from Betalutin™ presented at ASH in December 2014
The clinical data from Betalutin™ phase I study was presented at the American Society of Haematology (ASH) Conference in San Francisco in December 2014. The study demonstrated that the safety profile of Betalutin™ was both predictable and manageable. The clinical data showed an overall tumour response of 64% and a complete response of 36%. This is encouraging and warrants further clinical development of Betalutin™ as a new targeted agent for the treatment of B-cell non-Hodgkin Lymphoma (NHL).
Financial review
Income statement
Revenues for the fourth quarter ended December 2014 amounted to NOK 0.13 million compared to NOK 0.07 million fourth quarter ended December 2013. Revenues for the twelve months ended December 2014 and December 2013 amounted to NOK 0.4 million compared to NOK 0.3 million respectively. Revenues relate to incubator services and sublease of office and laboratory.
Net operating expenses increased from NOK 9.2 million in the fourth quarter 2013 to NOK 29.3 million in the fourth quarter of 2014. Net operating expenses for the twelve months ended December 2014 amounted to NOK 69.1 million compared to NOK 18.4 million for the twelve months ended December 2013. The cost increase was driven by employment of 10 new employees during 2014 and acceleration of the development program.
Nordic Nanovector’s total comprehensive income shows a net loss of NOK 26.9 million in the fourth quarter of 2014 compared to NOK – 8.5 million in the fourth quarter of 2013 and a net loss of NOK 63.8 million for the twelve months ended December 2014 and NOK -17.0 million for the twelve months ended December 2013.
Financial position and cash flow
Property, plant and equipment increased from NOK 0.3 million end of 2013 to NOK 1.6 million end of 2014, reflecting investment in infrastructure, lab equipment, IT hardware/software and depreciation of NOK 0.3 million.
Total liabilities for the Group totalled NOK 15.5 million compared to NOK 7.2 million at the end of December 2013.
Shareholders’ equity for the Group was NOK 330.2 million end of 2014, with an equity ratio of 95.5%, compared to NOK 78.8 million in 2013 (equity ratio of 91.5%).
Total cash flow from operating activities for the Group was net NOK -58.2 million in 2014, compared to NOK -14.2 million in 2013. Total cash flow from investing activities for the Group was net NOK 2.8 million in 2014, compared to NOK – 0.3 million in 2013, mainly due to interests received for bank deposits. Total cash flow from financing activities for the Group were net NOK 312.9 million for 2014 compared to NOK 87.4 million in 2013.
Cash and cash equivalents were NOK 337.0 million end of 2014 for the Group compared to NOK 79.6 million end of 2013. The increase reflected the successful private placement and the subsequent repair issue with total gross proceeds amounting to NOK 300 million. HealthCap VI L.P. paid in September 2014, NOK 25 million for 1,666,666 shares as agreed regarding the second tranche investment, committed in 2013.
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 Follicular Lymphoma. In parallel to the execution of the development plan, the strategic priorities for Nordic Nanovector for 2015 include the development of a Betalutin™ commercial scale manufacturing process, the optimization of the Betalutin™ positioning and messaging platform, and the expansion of the R&D pipeline.
Luigi Costa, CEO
Cell: (41) 79 124 8601
Fax: (47) 22 58 00 07
E-mail: lcosta@nordicnanovector.com
Tone Kvåle, CFO
Cell: (47) 91 51 95 76
Fax: (47) 22 58 00 07
E-mail: tkvale@nordicnanovector.com
About Nordic Nanovector ASA (ticker: NANO on NOTC)
Nordic Nanovector was established in 2009 and has its main office and laboratories in Oslo, Norway. The Company aspires to become a leading provider of Antibody-Radionuclide-Conjugate (“ARC”) clinical solutions, to address major unmet medical needs and to advance cancer care through its innovative therapy programs and patented technologies. The Company intends to directly commercialize its product candidates, by creating a differentiated and specific positioning, investing in cross-specialty collaboration and medical education. The Company is also committed to continue developing the ARC pipeline leveraging on its proprietary nanovector targeting technology.
The Company’s lead product candidate, Betalutin™, is an Antibody-Radionuclide-Conjugate that aims to prolong the survival and improve the quality of life of patients who suffer from non-Hodgkin Lymphoma (“NHL”), a life-threatening blood cancer with a high unmet medical need. The product candidate is currently undergoing a Phase I/II clinical trial for treatment of relapsed NHL. Further information about the Company can be found at www.nordicnanovector.com.
About non-Hodgkin Lymphoma
NHL is a life-threatening blood cancer that originates in lymphocytes and spreads and develops in lymph nodes and other lymphoid tissues. The incidence rate of NHL worldwide has been dramatically increasing over the past decades and NHL is today the 10th most commonly diagnosed cancer and is associated to a high mortality rate. Despite recent improvements in available therapies, there is still a high unmet medical need. NHL market is expected to grow by 7% annually for the next four years to exceed USD 12 billion in 2018 worldwide.
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