TURKU – FINLAND, 5 September 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces its unaudited Interim Results for the six months ended 30 June 2016 (the “Period”). FULL RESULTS STATEMENT can be found on the company website: http://www.faronpharmaceuticals.com/investor-relations/regulatory-news-service-announcements
KEY HIGHLIGHTS
Operational Highlights (including Post Period-end)
Traumakine® - for treatment of Acute Respiratory Distress Syndrome (“ARDS”)
• Continued to progress the Phase III pan-European INTEREST trial as planned. In June 2016, Faron received the first IDMC (Independent Data Monitoring Committee Chaired by Prof. Arthur Slutsky from Toronto, Canada) recommendation to continue the study.
• Announced positive results from the Phase II Japanese study for Traumakine conducted by Faron’s Japanese licensing partner, Maruishi Pharmaceutical Co., Ltd. (“Maruishi”), in January 2016.
• Filed a patent application in Finland in March 2016 to further strengthen the Company’s protection of its novel Traumakine formulation (FP-1201-lyo) for the intravenous treatment of ARDS and other vascular diseases. The patent filings will be expanded over the next 2 years to most countries worldwide under the Patent Co-operation Treaty (“PCT”). Through its patent filings Faron is seeking to protect its rights to this discovery for the next 20 years.
• Entered into a licensing agreement in June 2016 with Pharmbio Korea Inc. (“Pharmbio”) for the development and commercialisation of Traumakine in Korea to supplement the agreements in place for Japan and China.
Clevegen® - novel cancer immunotherapy checkpoint antibody
• Filed two new patent applications for novel cancer immunotherapy candidate Clevegen in April 2016 in Finland. Under the PCT patent filings will be expanded globally over the next few years. The applications open up new opportunities for wider application of this antibody in conditions where removal of suppression of the local or systemic immunity is desired.
• Expanded the development strategy for Clevegen indications by extending the range through the Tumour Immunity Enabling Technology Platform (“TIET”), the Company’s new technology platform announced in May 2016, and presented at an R&D Day in London in June 2016, which can be evaluated alone or in combination with other immune checkpoint molecules in the treatment of common cancers. • Entered into an agreement with Abzena plc (AIM: ABZA) for the manufacture of Clevegen for clinical development in July 2016.
Financial Highlights
• Received a €750,000 fee from the licensing agreement with Pharmbio Korea Inc. for the development and commercialisation of Traumakine in Korea. The Company will be entitled to receive further development milestone payments and one third of the profits from Traumakine in Korea.
• Recorded significant other operating income of €1.0 million for the period from the Company’s existing European Union FP7 Traumakine grant, in-line with the Company’s strategy to utilise non-dilutive funding sources to support the Company’s R&D program where possible.
• As at Period-end, the Company held cash balances of €8.9 million.
• The cash position at the end of the Period was stronger than anticipated. In the future, the Company will continue its active and successful strategy to utilise various forms of public funding – both grants and loans.
• The operating loss for the Period was €2.6 million.
• Net assets as at Period-end were €8.4 million.
Commenting on the results, Dr Markku Jalkanen, CEO of Faron, said:
“Faron has delivered on its key strategic aims for the first half of 2016. We have clear plans to advance our exciting pipeline over the next two to three years, maintaining our focus on the most advanced projects Traumakine and Clevegen, which we believe have tremendous potential for expansion into new indications and territories. Our lead product, Traumakine for acute lung injury, is progressing well. The pivotal pan-European Phase III INTEREST trial is underway at more than 50 sites and we have received encouraging Phase II data from our Japanese partner Maruishi. The Korean licensing deal with Pharmbio is in-line with our growth strategy to partner Traumakine in territories where both clinical and financial impact can be optimised in conjunction with a local partner.
“We have also made substantial progress with our immunotherapy candidate Clevegen through the development of our new TIET platform. In addition to its potential use in combination cancer therapies, new opportunities include chronic infections and vaccination enhancement. We believe the approach offers significant advantages to future collaborators and licensing partners.”
For more information please contact:
Faron Pharmaceuticals Ltd
Katja Wallenlind
Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com
Hume Brophy, PR
Mary Clark, Eva Haas, Hollie Vile
Phone: +44 207 862 6390
E-mail: faron@humebrophy.com
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson, Rebecca Anderson
Phone: +44 207 148 7900
Panmure Gordon (UK) Limited, Joint Broker
Freddy Crossley, Duncan Monteith (Corporate Finance)
Tom Salvesen (Corporate Broking)
Phone: +44 207 886 2500
Whitman Howard Limited, Nominated Broker
Ranald McGregor-Smith, Francis North
Phone: +44 207 659 1234
About Faron Pharmaceuticals Ltd
Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (”ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in a pan-European pivotal Phase III study (INTEREST). Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology (”TIET”) and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com
