TURKU – FINLAND, 10 March 2016 – Faron Pharmaceuticals Ltd (”Faron”) (LON: FARN), a drug discovery and development company, today announces its Annual Results for the year ended 31 December 2015. The Annual Report 2015 and accounts are available on the Company’s website and will be posted to Shareholders in due course.
KEY HIGHLIGHTS
Operational Highlights
Traumakine®
• Established the pivotal pan-European Phase III INTEREST trial for Traumakine, which is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”). This includes 55 hospitals with significant intensive care units in seven European countries (UK, France, Germany, Spain, Italy, Belgium and Finland).
• First Patient recruited in Phase III INTEREST trial in December 2015.
• Entered into agreements with A&B (HK) Company Limited and CMS Pharma Co. Ltd in mainland China, Hong Kong, Macau and Taiwan (the “Greater China Area”) to license Traumakine in May 2015.
• Reported second contract period on the EU FP7 grant programme for Traumakine ending 30 November 2015, triggering next period payment.
Clevegen®
• Entered into a collaboration agreement with the Turku PET Centre, one of the largest positron emission tomography centres in Europe, on the development of novel cancer immunotherapy Clevegen in June 2015.
• Agreement with Swiss-based Selexis SA for SUREtechnology Platform™ and SURE CHO-M Cell Line™ for use in the development and production of Clevegen in November 2015.
• Key Publication on Novel Cancer Immunotherapy Mechanism Related to Clevegen published in Journal of Immunology in November 2015.
• Granted €1.5 million in funding by Tekes, the Finnish Funding Agency for Innovation, to progress the preclinical development of Clevegen in December 2015.
Financial Highlights
• Successful AIM IPO in November 2015, raising €14.2 million in new funds for the Company. • €5.1 million pre-IPO funding from A&B (HK) Company Limited in May 2015, in conjunction with Traumakine agreement for Greater China.
• Total equity raised of €19.3 million (net €16.9 million) to fund initial pan-European Phase III INTEREST trial of Traumakine for treatment of Acute Respiratory Distress Syndrome (“ARDS”) as well as progressing Clevegen, the Company’s early stage cancer immunotherapy programme.
• Generated €0.5 million (2014: €1.0 million) revenues mainly from milestone payments from Maruishi Pharmaceutical Co., Ltd. In addition the Company recorded grant income of €0.7 million (2014: €0.1 million) from the EU FP7 grant.
• Tekes granted a €1.5 million R&D loan to progress the Clevegen programme.
• On 31 December 2015 the Company held cash balances of €11.1 million (2014: €0.2 million).
• The operating loss for the financial year ended 31 December 2015 was €6.2 million (2014: €1.4 million loss).
• Net assets on 31 December 2015 were €11.2 million (2014: €0.5 million[1])
Post-Period End Highlights
• On 7 January 2016, Faron announced positive results from the Phase II Japanese study for Traumakine conducted by Faron’s Japanese licensing partner, Maruishi Pharmaceutical Co., Ltd.
• On 1 March 2016, Faron announced a patent application to further strengthen protection for its novel Traumakine formulation (FP-1201-lyo), seeking to protect this discovery for the next 20 years. This reinforces Faron’s global patent protection strategy for the product.
• Recruitment is on track and Faron anticipates that all 55 sites for the Traumakine clinical trial will be open in April 2016.
Commenting on the results, Dr Markku Jalkanen, CEO of Faron, said:
“2015 was a transformational year for Faron as we took three significant steps in our strategic development. Firstly, we successfully financed our operations with €19.3 million equity investments. Secondly, we moved our lead product Traumakine targeting the treatment of ARDS into a pan-European pivotal Phase III INTEREST trial. Thirdly, we continued the pre-clinical development of our novel cancer immunotherapy drug candidate Clevegen, for which we obtained €1.5 million funding from Tekes. We are looking forward to making significant progress with these innovations to develop new treatments for these true unmet medical needs.”
Please see full Annual Results for the year ended 31 December 2015 here.
For more information contact:
Faron Pharmaceuticals Ltd
Katja Wallenlind
Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson and Rebecca Anderson
Phone: +44 207 148 7900
Whitman Howard Limited, Nominated Broker
Ranald McGregor-Smith, Francis North
Phone: +44 207 659 1234
Hume Brophy, PR
Mary Clark, Eva Haas, Hollie Vile
Phone: +44 207 862 6390
E-mail: faron@humebrophy.com
About Faron Pharmaceuticals Ltd
Faron Pharmaceuticals Ltd is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. Faron is based in Turku, Finland. The Company has identified several molecular mechanisms involved in the control of endothelial functions as a source of innovations. Faron currently has a pipeline of products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life threatening medical condition for which there is currently no approved pharmaceutical treatment. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen®. Clevegen® is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating representing a novel immuno-oncology approach. Further information is available at www.faronpharmaceuticals.com.
