Faron Pharmaceuticals Oy
("Faron" or the "Company")
Faron update for 2017
TURKU - FINLAND, 09 February 2017 - Faron Pharmaceuticals Ltd ("Faron") (LON: FARN), the clinical stage biopharmaceutical company, is pleased to provide the following update for the year ahead, 2017. The Company's full year 2016 audited financial results will be announced on 29 March 2017.
Targeted pipeline progress for 2017:
Traumakine®:
· The Company expects to obtain the read-out for the pan-European phase III trial (INTEREST) results (all-cause mortality at day 28) during H2 2017.
· The Company has recently received the third recommendation from the trial IDMC (Independent Data Monitoring Committee) to continue the study without any modifications.
· The Company has established a manufacturing plan to build its stocks of Traumakine®. Subject to a positive outcome of the INTEREST study, having manufacturing in place should facilitate the application process for market approval of Traumakine®.
· The Company plans to commence a Phase II US safety study (INTRUST) with Traumakine® in H2 2017. It is expected that the full study will take 12 months to complete. Timing remains subject to regulatory approvals with a pre-IND FDA meeting targeted to occur in Q3 2017.
· The Company currently expects the Japanese Phase III pivotal study recruitment for the treatment of ARDS with Traumakine®, run by its Japanese licensing partner Maruishi Pharmaceutical Co., to progress towards completion during 2017.
· The first recruited patient for the Company's Traumakine® clinical study (INFORAAA) for the treatment of patients with rupture of acute abdominal aorta (RAAA) is expected in Q1 2017. The Company expects to get interim results from this 160-patient trial in 12 to 18 months. The aim of this trial is to reduce mortality in operated RAAA patients, which normally varies from 30 to 50% of all patients surgically operated on. The INFORAAA study will also assist in the design of Traumakine® trials for single organ failures.
Clevegen®:
· The Company expects to file the first clinical trial application (CTA) with the UK regulatory authorities (MHRA) in late 2017 / early 2018.
· The first, and primarily safety focused, trial is to be conducted with liver cancer patients at the Birmingham University Liver Cancer Centre and is expected to continue into a Phase II study via an adapted trial design for hepatocellular carcinomas (HCC) patients to recognise early efficacy signals.
· The high yield Clevegen® production clones prepared by Selexis for Faron have demonstrated 5+ g/l production levels without optimisation of the bioreactor conditions. Faron expects that its manufacturing partner Abzena will provide purified drug substance for the Clevegen® pre- and clinical studies during Q2 2017.
Financials:
· Faron will provide full year results on 29 March 2017.
· At the end of 2016, Faron had approximately €11.5 million in cash.
Business development:
· Whilst Faron is focusing on the completion of the INTEREST study and planned CTA filing for Clevegen®, the Company continues to explore potential business opportunities for both assets in order to consider how best to produce maximum value for its shareholders.
Additional corporate matters:
· Due to the retirement of the Company's Chief Medical Officer, Dr Ilse Piippo MD, the Company's Medical Director Dr Matti Karvonen MD has taken the position from 1 February 2017. Dr Ilse Piippo will continue to support the Company as a Regulatory Consultant and will support the Company in setting up a planned paediatric Traumakine® study programme. The plan for this programme will be required for European marketing authorisation of Traumakine® and should also provide a two (2) year extension for Traumakine's® orphan status in Europe (to a total of 12 years post approval).
· The recently hired Director for Research, Dr Jami Mandelin, will join the Management Team and will be responsible for pre-clinical drug development and research collaborations with Faron's scientific network.
Dr Markku Jalkanen, CEO of Faron, said: "We are very excited about Faron's prospects for 2017 and beyond. We are getting close to read-out of the INTEREST trial, which we believe could revolutionise intensive care practices for ARDS patients. We are therefore continuing to prepare the business in anticipation of commercial launch soon after the trial results are received. In addition, the Company continues to progress and expand its clinical development programme in order to increase indications targeted and maximise shareholder value. The Company has made new hires and I would also like to take the opportunity to thank Dr Ilse Piippo for working with us since 2007 and building the current regulatory pathway for Traumakine®. The skills and commitment she has shown over the years are still evident as she builds the road for treatment with Traumakine® in paediatric applications. As a replacement, Dr Matti Karvonen has already demonstrated his strengths in the past eight months and I am confident that the Faron pipeline will progress well under his supervision."
The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.
For more information please contact:
Hume Brophy, PR (UK)
Conor Griffin, Alexia Faure, Alex Protsenko
Phone: +44 207 862 6381
E-mail: [email protected]
Westwicke Partners, IR (US)
Chris Brinzey
Phone: +1 339 970 2843
E-Mail: [email protected]
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson, Rebecca Anderson
Phone: +44 207 213 0880
Panmure Gordon (UK) Limited, Joint Broker
Freddy Crossley, Duncan Monteith (Corporate Finance)
Tom Salvesen (Corporate Broking)
Phone: +44 207 886 2500
Whitman Howard Limited, 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 pan-European (INTEREST) and Japanese pivotal Phase III studies, and is commencing a European Phase II trial for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). 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
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ''believe'', ''could'', "should", "expect", ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.
A number of factors could cause actual results to differ materially from the results discussed in the forward looking statements including risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors, many of which are beyond the control of the Company. Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.
