Faron, etusivu

Raises £8.0 M through a Placing and Subscription

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, THE REPUBLIC OF IRELAND, NEW ZEALAND OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Results of Placing and Subscription,

Issue of Equity

and

Director/PDMR Shareholding

Faron successfully raises £8.0 million through a Placing and Subscription

TURKU – FINLAND, 21 September 2016 – Faron Pharmaceuticals Oy (“Faron” or “Company”) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce that following the announcement on 20 September 2016, the proposed Placing and Subscription has now been subscribed in full. Pursuant to the Placing and Subscription, the Company is raising approximately £8.0 million before expenses by way of the Placing of 2,868,000 Placing Shares and the Subscription of 332,000 Subscription Shares at the Issue Price of 250 pence per share. The Placing and Subscription have been supported by the participation of existing and new shareholders and certain Directors of the Company. The Board of Directors of Faron has resolved on the issuance of the Placing Shares and the Subscription Shares pursuant to the authorisation granted by the Annual General Meeting of Shareholders granted in May 2016 and approved the subscriptions. The Placing Shares and the Subscription Shares are expected to be registered with the Finnish Trade Register on or about 21 September 2016.

Application has been made to the London Stock Exchange for admission to AIM of the 3,200,000 Placing Shares and Subscription Shares (in aggregate) (“Admission”), and it is expected that Admission will take place at 8:00 a.m. on 23 September 2016 and that dealings in the Placing Shares and Subscription Shares on AIM will commence at the same time.

The Placing Shares and Subscription Shares will, when registered, be credited as fully paid and will rank pari passu in all respects with the existing Ordinary Shares, including the right to receive all dividends or other distributions made, paid or declared in respect of such shares after the date of registration of the Placing Shares and Subscription Shares with the Finnish Trade Register.

Faron’s enlarged issued number of shares immediately following registration and Admission will be 26,311,704 Ordinary Shares with voting rights attached. The Company has no shares in Treasury; therefore upon, and subject to, registration, the total number of voting rights in Faron will be 26,311,704 (the “Enlarged Number of Shares and Votes”). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the issued shares and votes of the Company.

Director/PDMR Shareholding

Certain of the Company’s directors have subscribed for, in aggregate, 6,866 Placing Shares and 12,000 Subscription Shares at the Issue Price. The beneficial interests of the participating directors in the issued shares and votes of the Company are set out below:

Before Placing and Subscription

Number of Subscription Shares / Placing Shares subscribed for

After Placing and Subscription

Director/PDMR

No. of Ordinary Shares held

Holding as a % of the Company’s existing issued shares and votes

No. of Ordinary Shares held

Holding as a % of the Company’s Enlarged Number of Shares and Votes

Dr Frank Armstrong

 3,846

0.02%

4,000

7,846

0.03%

Matti Manner

480,900

2.08%

                         4,000

                     484,900

1.84%

Dr Jonathan Knowles

3,846

0.02%

                         6,866

                       10,712

0.04%

Dr Huaizheng Peng

–

–

                         4,000

                       4,000

0.02%

The participation by Dr Frank Armstrong, Matti Manner, Dr Jonathan Knowles and Dr Huaizheng Peng (by way of the participation by Vantage Link Limited, a company majority-owned by Dr Huaizheng Peng’s wife Sally Yinghui Mao) in the Placing and Subscription constitutes a related party transaction for the purposes of the AIM Rules. The independent directors for the purposes of the Subcription, being Dr Markku Jalkanen, Yrjö Wichmann, Leopoldo Zambeletti and Dr Juho Jalkanen, having consulted with the Company’s nominated adviser, Cairn, consider that the terms of the related party transaction are fair and reasonable insofar as the Shareholders are concerned.

Commenting on the Placing and Subscription, Dr Markku Jalkanen, CEO of Faron, said:

“We are delighted to welcome numerous new institutional investors and would like to thank our existing shareholders for their continued support. We are pleased to have seen strong demand during pre-marketing of the Placing and Subscription, an encouraging sign of trust in our performance. We look forward to progressing the Company on multiple fronts and continuing to build shareholder value.”

The information contained within this announcement constitutes inside information stipulated under the Market Abuse Regulation (EU) No. 596/2014.

All capitalised terms in this announcement are with reference to the announcement made by Faron at 7.00 a.m. on 20 September 2016.

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

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 Oy

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

Proposed Placing & Subscription to raise £8M

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, THE REPUBLIC OF IRELAND, NEW ZEALAND OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON PHARMACEUTICALS OY OR ANY OTHER ENTITY IN ANY JURISDICTION. NEITHER THIS ANNOUNCEMENT NOR THE FACT OF ITS DISTRIBUTION, SHALL FORM THE BASIS OF, OR BE RELIED ON IN CONNECTION WITH ANY INVESTMENT DECISION IN RESPECT OF FARON PHARMACEUTICALS.

THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT WOULD BE MADE PURSUANT TO A PRIVATE PLACEMENT EXEMPTION UNDER THE EUROPEAN DIRECTIVE 2003/71/EC (AND AMENDMENTS THERETO (THE “PROSPECTUS DIRECTIVE”), AS IMPLEMENTED IN THE MEMBER STATES OF THE EUROPEAN ECONOMIC AREA, FROM THE REQUIREMENTS TO PRODUCE A PROSPECTUS UNDER THE PROSPECTUS DIRECTIVE (AND AMENDMENTS THERETO) FOR OFFERS OF SECURITIES. FARON PHARMACEUTICALS HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY SECURITIES OR ANY OTHER DOCUMENTS RELATING TO THE PROPOSED TRANSACTION TO THE PUBLIC IN FINLAND, SWEDEN, NORWAY OR DENMARK, OR IN ANY OTHER JURISDICTION IN ANY FORM WHICH WOULD CONSTITUTE AN OFFER TO THE PUBLIC. 

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Proposed Placing and Subscription to raise £8.0 million

TURKU – FINLAND, 20 September 2016 – Faron Pharmaceuticals Oy (“Faron” or “Company”) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce a proposed placing of up to 2,868,000 new ordinary shares in the capital of the Company (the “Placing Shares”) and a proposed subscription of up to 332,000 new ordinary shares in the capital of the Company (the “Subscription Shares”) at a price of 250 pence per share (the “Issue Price”) to raise, in aggregate, up to approximately £8.0 million before expenses.

KEY HIGHLIGHTS

·     Proposed conditional placing of up to 2,868,000 Placing Shares at the Issue Price (“Placing”) and conditional subscription of up to 332,000 Subscription Shares at the Issue Price (“Subscription”), to raise up to approximately £8.0 million before expenses

·      The Placing Shares and Subscription Shares if subscribed for in full will represent, in aggregate, approximately 13.8% of the Company’s existing issued share capital

·      The Issue Price of 250 pence per share is equal to the closing mid-market price of 250 pence on 19 September 2016, being the last practicable date prior to this announcement

·     The net proceeds of the proposed Placing and Subscription (approximately £7.4 million if fully subscribed) would be used to fund:

o  Safety trials for the US development of its lead product Traumakine for the treatment of Acute Respiratory Distress Syndrome (“ARDS”)

o  Pre-clinical and clinical development of Clevegen, the Company’s novel cancer immunotherapy checkpoint antibody, to Phase I/II

o  European clinical development to Phase I/II of Traumakine for the treatment of patients with Rupture of Abdominal Aorta Aneurysm (“RAAA”)

o  Further R&D and operational expenses

·      The proposed Placing and Subscription builds on the significant progress made by Faron since its admission to AIM in November 2015 and delivery on its key strategic aims, including the continued progress of the Company’s Traumakine product through its pivotal pan-European Phase III INTEREST trial

·      The Company has received advance assurance from HM Revenue and Customs that it continues to be a qualifying holding for the purposes of the Venture Capital Trust rules and a qualifying company for the purposes of the Enterprise Investment Scheme

·     The proposed Placing and Subscription is to be implemented through a private placement with a limited number of institutional and other investors. It is expected that finalisation of the proposed Placing and Subscription will commence immediately following this announcement. Further terms of the proposed Placing and Subscription are set out below

·      Panmure Gordon (UK) Limited (“Panmure Gordon”) is acting as Lead Bookrunner and Joint Broker, Whitman Howard Limited (Whitman Howard”) as Joint Broker and Cairn Financial Advisers LLP (“Cairn”) as Nominated Adviser to the Company

Commenting on the proposed Placing and Subscription, Dr Markku Jalkanen, CEO of Faron, said:

“The new funding would enable us to continue to deliver on our business objectives as we advance our exciting pipeline over the next two-to-three years. Given the positive data collected to date, we believe Traumakine presents a significant opportunity for several hundred thousand patients globally suffering from ARDS, a severe, life threatening medical condition with a mortality rate of approximately 30-45%, for which there is currently no approved pharmaceutical treatment. The US represents a large opportunity to Faron for Traumakine, and the funding would allow us to take the first step in its development and FDA registration process.

“We have made substantial progress with our immunotherapy candidate Clevegen and expanded the development strategy to focus on chronic infections and vaccination enhancement. We expect to create significant shareholder value by progressing Clevegen into clinical development through the application of the funding.”

BACKGROUND TO AND REASONS FOR THE PROPOSED PLACING AND SUBSCRIPTION, AND USE OF PROCEEDS

Advance development of Traumakine® for ARDS – US safety trial

·     Funding would be used to commence the preliminary US safety trial (FCPLI005) for Traumakine allowing biologics license application (BLA) filing in US

·      ARDS is a severe, life threatening medical condition characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of sepsis, pneumonia or significant trauma

·      Currently there are no pharmacological treatments for ARDS, an orphan disease with a high (30-45%) mortality rate. ARDS incidence per annum is approximately 295,000 in US and Europe

·      Traumakine shown to significantly reduce prospect of mortality and reverse disease progression.  Phase I/II data were highly encouraging, where treatment with Traumakine was associated with an 81% reduction in the odds of 28 day mortality rate in patients with ARDS, with positive secondary endpoints. These data were published in The Lancet Respiratory Medicine, a leading medical journal

·     Traumakine is currently in pivotal development stage in Europe and Japan, with the pivotal pan-European Phase III INTEREST trial for Traumakine ongoing with results expected H2 2017, and with patient recruitment expected to be initiated in H2 2016 for the Japanese Phase III trial

·     Third party validation through partnership agreements with Maruishi Pharmaceutical Co., Ltd. (“Maruishi”) in Japan, Pharmbio Korea Inc. (“Pharmbio”) in Korea and CMS in Greater China (“CMS”)

Progress pre-clinical and clinical development of Clevegen®

·    Faron intends to advance the pre-clinical and clinical development of Clevegen, its novel cancer immunotherapy checkpoint antibody, to Phase I/II (FPCLI011)

·      Clevegen offers further long-term upside with potential immunotherapy products across oncology, infectious disease, and vaccination by removing local immune suppression maintained by type-2 macrophages

·      Clevegen revolves around Clever-1, a cell surface receptor on endothelial cells and macrophages involved in cancer growth and spread

·   The Directors believe that Clevegen’s ability to convert pro-tumoural M2 macrophages to pro-inflammatory M1 macrophages could help the human body’s own immune system to combat cancer and significantly differentiates it from competing products

Traumakine® for the treatment of patients with RAAA

·      Faron is planning preliminary evaluations of safety, PK and efficacy in RAAA (Rupture of Abdominal Aorta Aneurysm) in a European Phase I/II trail (FPCLI006)

·      RAAA patients often die from multi organ failure, similar to ARDS patients, with 50% mortality 5-10 days post-surgery

·      Currently there are an estimated 20,000 US and European patients per annum eligible for treatment

DETAILS OF THE PROPOSED PLACING AND SUBSCRIPTION AND ISSUE OF EQUITY

Subject to the Placing Shares and Subscription Shares being subscribed in full, they are to be issued by the Company pursuant to the Directors’ existing authority to allot ordinary shares in the capital of the Company (“Ordinary Shares”) for cash on a non-pre-emptive basis approved by shareholders at the Company’s annual general meeting held on 26 May 2016. The Company has received non-binding indications of interest from potential institutional investors for the Placing and Subscription during a pre-marketing process.

In connection with the proposed Placing, the Company has entered into a placing agreement with Panmure Gordon, Whitman Howard and Cairn Financial (together the “Placing Advisers”) (the “Placing Agreement”). The Placing is conditional upon, inter alia:

·      the Placing Agreement having become unconditional in all respects;

·      the Company having performed, in all material respects, its obligations under the Placing Agreement and not being in material breach of the Placing Agreement;

·      Legally binding commitments being received in respect of all of the Placing Shares and the Subscription Shares (the “Placee Condition“); and

·      The Placing Shares and the Subscription Shares being issued and being registered at the Finnish Trade Registry (the “Issue Condition“).

Pursuant to the terms of the Placing Agreement, Panmure Gordon and Whitman Howard have agreed to use reasonable endeavours to procure placees for the Placing Shares at the Issue Price. The Placing is being implemented through a private placement with a limited number of institutional and other investors. A further announcement will be made to confirm its completion in due course, but by no later than 4.30 p.m. on 21 September 2016. The Placing Agreement contains customary warranties and an indemnity from the Company in favour of the Placing Advisers together with provisions which enable the Placing Advisers to terminate the Placing Agreement in certain circumstances before satisfaction of the Issue Condition, including where there has been a material breach of any of the warranties in the reasonable opinion of any Placing Adviser or where there is a material adverse change in the business or financial affairs of the Company. In order to satisfy the Issue Condition prior to Admission, pursuant to the terms of the Placing Agreement, Panmure Gordon has agreed to underwrite the subscription for and payment to the Company of the total of the Issue Price for the Placing Shares upon satisfaction of the Placee Condition.

Assuming that the Placing Shares and Subscription Shares are fully subscribed for, an application will be made for admission of the Placing Shares and Subscription Shares to trading on AIM (“Admission”) and it is expected that Admission will become effective and that dealings in the Placing Shares and Subscription Shares will commence on or around 8.00 a.m. on 23 September 2016. A further update announcement will be made in due course. 

MARKET ABUSE REGULATION

The Market Abuse Regulation (“MAR”) became effective from 3 July 2016. Market Soundings, as defined in MAR, were taken in respect of the proposed Placing and Subscription with the result that certain persons became aware of inside information, as permitted by MAR. That inside information is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in a Market Sounding are no longer in possession of inside information relating to the Company and its securities.

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

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 Oy

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

Forward Looking Statements

Certain statements included herein express Faron Pharmaceutical’s expectations or estimates of future performance and constitute “Forward-looking Statements”.  Forward-looking Statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Faron Pharmaceuticals are inherently subject to significant business, economic and competitive uncertainties and contingencies.  Such Forward-looking Statements involve known and unknown risks, uncertainties and other factors that may cause the actual financial results, performance or achievements to be materially different from estimated future results, performance or achievements expressed or implied by those Forward-looking Statements and, as such, the Forward-looking Statements are not guarantees of future performance. 

Interim Results for six months ended 30 June 2016

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Interim Results for the six months ended 30 June 2016

Progress continued in Traumakine® Phase III and with Clevegen® indications extended

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”).

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

Chairman’s and Chief Executive Officer’s Review

INTRODUCTION

We are pleased to report on the progress of Faron Pharmaceuticals for the six months ended 30 June 2016.

Implementing a strategy of bringing novel treatments for significant unmet medical needs to market in a timely and cost-effective manner, Faron’s pipeline is built on its thorough scientific knowledge regarding control of the endothelial barrier, a membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. Both lead indications – acute lung injury and intervening in tumour immune suppression – are based on controlling malfunction of the endothelial barrier.

We continue to strengthen our business and support our objectives of progressing our lead programme, Traumakine, through the on-going pan-European pivotal Phase III INTEREST trial, and the development of our pre-clinical cancer immunotherapy candidate, Clevegen.

OPERATIONAL REVIEW

Pipeline developments

Traumakine® – targeting a breakthrough for ARDS and initiating RAAA plans

Faron’s lead candidate Traumakine is in a pan-European pivotal Phase III INTEREST trial which is progressing as expected. In June 2016, Faron received the first IDMC (Independent Data Monitoring Committee) recommendation to continue the study as planned.

Faron’s Japanese partner, Maruishi, completed a phase II study in Japan, the results of which were announced in January 2016 with encouraging results which are consistent with Faron’s prior Phase I/II data. Maruishi is now preparing for the next pivotal clinical trial which will enable progress towards filing of Traumakine marketing approval in Japan.

Faron has started preparations for a Traumakine US safety trial as requested by the FDA.

In relation to the Company’s application for Orphan Drug Designation (“ODD”) for Traumakine® in the US, the US Office of Orphan Products Development (“OOPD”) has informed Faron that Traumakine is not currently eligible to be granted ODD in the US as according to OOPD’s view there is insufficient nationwide evidence to demonstrate that the US incidence of ARDS is less than the statutory “orphan” limit of 200,000 patients per year. Accurate analysis of the US incidence of ARDS is difficult to determine for a number of reasons and there are varying estimates of the incidence, however the Directors believe that based on the latest available data, the true incidence of ARDS is less than 200,000 patients per annum in the US. Therefore, Faron is appealing the decision made by the OOPD and intends to continue to file additional material in further support of its claim. Separately Traumakine has already been granted orphan status in Europe.

Regardless of Traumakine’s ODD status in the US, the Company is not aware of any other treatment for ARDS that is in a similar advanced stage of development. Additionally, the Directors believe that Traumakine® could be entitled to a US regulatory package called a biologics license application (BLA), which could allow 12 years of data exclusivity in the US, reducing the risk of biosimilar competition in the US market. The Company expects also additional long-term IP protection for its new IV formulation filed earlier this year.

In June, Faron entered into a licensing agreement with Pharmbio for the development and commercialisation of Traumakine in Korea. Under the terms of the agreement, Pharmbio will obtain exclusive Korean rights to Traumakine. Faron received the initial signing fee of €750,000, which was recorded as revenue in H1 2016 financial results, and is entitled to receive additional, undisclosed development based milestones. Pharmbio will also pay Faron one third of Traumakine profits, representing a double digit royalty on net sales, depending on end user pricing, and has agreed to cover development costs for Traumakine in Korea. Additionally, Faron will supply Traumakine drug product to Pharmbio at an agreed transfer price.

Faron is planning to file a Clinical Trial Application in H2 2016 to the Finnish Medicines Agency (“FIMEA”) for the INFORAA clinical trial in patients with surgically treated Rupture of Abdominal Aorta Aneurysm (“RAAA”). These patients often suffer from multi-organ failure, similar to ARDS patients, thus Traumakine may improve their condition. The total incidence of RAAA is 13.5 per 100,000. As RAAA is frequently fatal it accounts for the death of at least 4.5 individuals per 100,000 population. 

New indications for macrophage-directed immunotherapy candidate Clevegen®

Faron’s preclinical drug development project Clevegen revolves around Clever-1, a cell surface receptor on endothelial cells and macrophages involved in cancer growth and spread. Clevegen binds to Clever-1 which reduces suppression of the immune system and converts the immune environment around a tumour from immuno-supressive to immune stimulating, allowing a patient’s own immune system to combat cancer.

In May 2016, Faron announced the expansion of the development strategy for Clevegen introducing the TIET platform, based on Clevegen´s ability to convert pro-tumoural, immune supressing M2 macrophages to pro-inflammatory M1 macrophages which could provide a significant boost to the efficacy of other immune checkpoint molecules already in use or under development. The TIET platform may allow licensing opportunities and wider use of Clevegen as part of combination cancer therapies. As the TIET technology is based on a humanised antibody, the Faron Directors believe it can be combined with a number of other immune therapies without a significant risk of increased adverse events.

Two additional new technology platforms related to TIET, covering chronic infections and inefficient vaccination were also presented at the Company’s R&D Day in London on 14th June 2016. The additional related technology platforms are called Chronic Infection Removal Therapy (“CIRT”) and Vaccination Response Enhancement Technology (“VRET”).

Faron intends to develop Clevegen in-house for immune dependent cancers such as hepatocellular carcinoma, a significant unmet medical need, and other cancers known to depend on tumour associated macrophages (“TAM”).

High quality cGMP manufacturing of Clevegen was assured through a July 2016 agreement with Abzena plc for the manufacture of Clevegen in July 2016.

FINANCIAL REVIEW

During the six months ended 30 June 2016, Faron continued to maintain its focused and cost-conscious strategy without compromising the intensity of its development work. Though the R&D expenses more than doubled (as planned within the Company’s strategy), the combination of higher than anticipated income – in the form of both revenue and grant income – and lower operating costs resulted in a modest cash outflow over the Period. Thus 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.

Statement of Comprehensive Income

The loss from operations for the Period was €2.6 million (six months ended 30 June 2015: loss of €2.4 million). The Company’s revenue for the Period was €1.2 million (2015: €0.5 million), which comprised of a €0.8 million signing fee from Pharmbio, €0.3 million of prepayment of IFN-beta production and €0.1 million from product sales to Maruishi Pharmaceutical. The Company also recorded €1.0 million (2015: €nil) of other operational income from the EU FP7 grant. Research and development expenditure increased to €3.4 million (2015: €1.7 million) caused mainly by the increase of the clinical trial costs when patient recruitment for the INTEREST trial commenced at the very end of 2015. The administrative expenses were slightly lower at €1.0 million (2015: €1.1 million) mainly due to lower funding expenses during the Period compared to the same period in 2015. Both the research and development and the administrative expenses include the IFRS charge resulting from the options allocated by the Board to personnel in May 2016. The total charge was €0.2 million (2015: €nil.). This charge had no cash impact on the results for the year.

The loss after tax for the Period was €3.0 million (H1 2015: loss of €2.4 million) and the basic loss per share was €0.13 (H1 2015: loss per share of €0.15)

Statement Of Financial Position and Cash Flows

At 30 June 2016, net assets amounted to €8.4 million (30 June 2015: €1.4 million). The net cash outflow for the first six months in 2016 was €2.2 million (H1 2015: inflow of €2.0 million). As at 30 June 2016, total cash and cash equivalents held were €8.9 million (H1 2015: €2.3 million; H2 2015: €11.1 million).

OUTLOOK

The key aim for Faron in 2016 is the completion of the Phase III INTEREST trial recruitment. We confirm our initial estimate that patient recruitment will be carried out in 12 to 18 months from first patient treatment, which occurred in December 2015. We also reiterate that the INTEREST trial results should be available by mid-2017. In respect of our immunotherapy candidate Clevegen, our contracted partner Abzena will produce the Master Cell Bank and manufacture the anti-Clever-1 antibody for clinical development. Faron also plans to intensify commercial efforts around Tumour Immunity Enabling Technologies and make them available for interested licensing partners while at the same time focusing on internal development programmes as well. 

Frank M Armstrong                                   Markku Jalkanen

Chairman                                                    Chief Executive Officer

5 September 2016

Statement of comprehensive income

(Stated in 1,000 euros)

Note

Unaudited six months ended 30 Jun 2016

Unaudited six months ended 30 Jun 2015

Year ended 31 Dec 2015

Revenue

2

 1,169

 454

 520

Cost of sales

(357)

(50)

(25)

Gross profit

 813

 404

 496

Other operating income

3

 968

 – 

 701

Administrative expenses

(974)

(1,074)

(3,061)

Research and development expenses

(3,439)

(1,681)

(3,971)

Operating result

(2,632)

(2,350)

(5,835)

Financial income

 0

 – 

 0

Financial expenses

(305)

(40)

(311)

Net financial costs

(305)

(40)

(311)

Loss before income taxes

(2,936)

(2,390)

(6,146)

Income tax expense

(75)

(42)

(42)

Total comprehensive income for the period

(3,011)

(2,432)

(6,188)

Total comprehensive income, attributable to:

Equity holders of the Company

(3,011)

(2,432)

(6,188)

Loss per share attributable to equity holders of the Company

Basic and diluted loss per share, euro

5

(0.13)

(0.15)

(0.30)

Unaudited

Unaudited

Balance sheet

(Stated in 1,000 euros)

Note

30 Jun
2016

30 Jun
2015

31 Dec
2015

Assets

Non-current assets

Propertly, plant and equipment

 24

 0

 28

Intangible assets

 926

 1,180

 1,001

 950

 1,180

 1,029

Current assets

Inventories

 1,021

 649

 649

Trade and other receivables

 3,836

 647

 2,074

Cash and cash equivalents

 8,862

 2,276

 11,068

 13,719

 3,572

 13,791

Total assets

 14,669

 4,753

 14,821

Equity and liabilities

Capital and reserves attributable to equity holders of the Company

Share capital

 2,691

 2,691

 2,691

Reserve for invested non-restricted equity

 24,533

 11,503

 24,533

Retained earnings

(18,820)

(12,764)

(16,046)

Total equity

 8,404

 1,431

 11,178

Non-current liabilities

Interest-bearing financial liabilities

4

 2,057

 1,691

 1,446

 2,057

 1,691

 1,446

Current liabilities

Interest-bearing financial liabilities

 93

 – 

 245

Non-interest-bearing financial liabilities

 1,009

 – 

 436

Other current liabilities

 3,105

 1,631

 1,517

 4,207

 1,631

 2,197

Total liabilities

 6 265

 3 322

 3 643

Total equity and liabilities

 14 669

 4 753

 14 821

Statement of changes in equity

(Stated in 1,000 euros)

Share capital

Reserve for invested non-restricted equity

Retained earnings

Total equity

Balance at 1 January 2015

 2,691

 6,453

(10,332)

(1,188)


Total comprehensive income for the first six months 2015

–

–

(2,432)

(2,432)

Increase of share capital

–

 5,050

 – 

 5,050

 5,050

(2,432)

 2,618

Balance at 30 June 2015

 2,691

 11,503

(12,764)

 1,431

Total comprehensive income for the financial year 2015

–

–

(6,188)

(6,188)

Share base payment

–

–

 474

 474

Increase of share capital

–

 19,261

 – 

 19,261

Transaction costs on share capital issued

–

(1,181)

–

(1,181)

 – 

 18,080

(5,714)

 12,366

Balance at 31 December 2015

 2,691

 24,533

(16,046)

 11,178

Total comprehensive income for the first six months 2016

–

–

(3,011)

(3,011)

Share base payment

–

–

237

 237

 – 

 – 

(2,774)

(2,774)

Balance at 30 June 2016

 2,691

 24,533

(18,820)

 8,404

Statements of cash flows

(Stated in 1,000 euros)

Unaudited 1 Jan – 30 Jun
2016

Unaudited 1 Jan – 30 Jun
2015

1 Jan – 31 Dec
2015

Cash flow from operating activities

Loss(-) / profit(+) attributable to equity holders of the Company

(3,011)

(2,432)

(6,188)

Adjustments for

Depreciation and amortization

 79

 74

 184

Financial items

 305

 40

 298

Income taxes

 75

 42

 42

Expensed R&D

 – 

–

 78

Non-cash items (options granted)

 237

–

 474

Change in net working capital:

Trade and other receivables

(1,761)

(608)

(2,035)

Inventories

(372)

 50

 50

Trade and other current liabilities

 2,162

(30)

 278

Interest and other financial costs paid

(305)

(40)

(285)

Interest and other financial income received

 0

 0

 0

Income taxes paid

(75)

(42)

(42)

Net cash used in / from operating activities (A)

(2,666)

(2,945)

(7,146)

Cash flow from investment activities

Investments in machinery and equipment and intangible assets

 – 

(70)

(107)

Net cash from/used in investing activities (B)

 – 

(70)

(107)

Cash flow from financing activities

Proceeds from issue of share capital issue, net

 – 

 5,050

 18,080

Proceeds from issue of convertible notes

 – 

–

–

Proceeds from current borrowings

 – 

 – 

 – 

Proceeds from non-current borrowings

 611

 – 

 – 

Repayment of current borrowings

(151)

 – 

 – 

Net cash used in financing activities (C)

 460

 5,050

 18,080

Net increase(+) / decrease (-) in cash and cash equivalents (A+B+C)

(2,206)

 2,034

 10,827

Cash and cash equivalents at 1 January

 11,068

 242

 242

Cash and cash equivalents at end of period

 8,862

 2,276

 11,068

Note 1  Basis of Preparation

Corporate information

Faron Pharmaceuticals Ltd (hereafter “Faron” or “Company”) is a Finnish limited liability company organised under the laws of Finland and domiciled in Turku, Finland. The Company’s registered address is Joukahaisenkatu 6 B, 20520 Turku, Finland. Faron Pharmaceuticals Ltd is a privately owned clinical stage drug discovery and development company. Currently Faron has two major drug development projects focusing on: acute trauma, inflammatory diseases and cancer growth and spread.

Basis of accounting

The unaudited interim financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union and as published by the International Accounting Standards Board (IASB) and in force as at 30 June 2016. In the EU IFRS are standards and their interpretations adopted in accordance with the procedure laid down in regulation (EC) No 1606/2002 of the European Parliament and of the Council. These policies are consistent with those used in the financial statements for the year ended 31 December 2015 and with those that the Company expects to apply in its financial statements for the year ending 31 December 2016.

The interim financial statements do not include all of the information required for full annual financial statements and do not comply with all the disclosures in IAS 34 “Interim Financial Reporting”. Additionally though the interim financial statements have been prepared in accordance with IFRS, they are not in full compliance with IFRS.

Going Concern

The Company has prepared forecasts to estimate the cash requirements over the next twelve months. In order to make these forecasts the Company has made a number of assumptions regarding the quantity and timing of future expenditure and income as well as other key factors. Though these estimates have been made with caution and care, they continue to contain significant amount of uncertainty. Based on the forecast the Company believes that it has adequate financial resources to continue its operations for the foreseeable future (at least twelve months from the date of this report) and therefore these interim financial statements have been prepared on a going concern basis. 

Note 2  Revenue

The revenue for the first six months in 2016 totalled EUR 1,169,494. This consisted of EUR 750,000 signing fee from Pharmbio Korea, EUR 356,500 payment of IFN-beta production and EUR 62,994 from sales of active drug product and placebo to Maruishi.

Note 3  Other operating income

Other operating income totalling EUR 967,557 consists almost entirely of the EU FP7 grant income. Of this EUR 620,459 is grant income that is recorded based on the eligible project costs for the first six months of 2016. The next EUR 343,448 is grant income for project expenses for year 2015, for which Faron did not record grant income in 2015 as those expenses had not been budgeted or pre-approved by EU. After the date of publishing the annual accounts for 2015, EU approved all the reported expenses for the year 2015 and thus Faron has recorded that part of the 2015 grant income as other operating income for the first six months in 2016. When recording grant income, Faron has consistently followed the same accounting practice where it records 75% of the eligible project expenses for each period as grant income.

The remaining other operating income is income that derives from a tax-litigation that Faron won, where the court ordered the Finnish tax authorities to cover some of Faron’s legal expenses.

Note 4  Tekes loans

In March 2016, Faron utilised a possibility to apply for two additional amortisation-free years for the first of its two Tekes development loans. The application was approved and Tekes granted two additional amortisation-free years for the loan. Thus the first amortisation of the loan EUR 244,720 will be due in March 2018. Additionally in April 2016, Faron raised the first instalment of the Tekes loan for the Clevegen development work. The loan has a maturity of 10 years of which first five years are amortisation-free. The interest is currently one per cent. The loan is unsecured and if the project falls short of its goals and results cannot be commercialised, part of the loan may afterwards be converted into a grant.

Note 5  Loss per share

1H2016

1H2015

2015

€ ‘000

€ ‘000

€ ‘000

Basic

Basic loss per share is calculated by dividing the loss attributable to equity holders of the Company by the weighted average number of ordinary shares in issue during the year.

Loss attributable to equity holders of the Company
(EUR 1,000)

(3,011)

(2,432)

(6,188)

Weighted average number of ordinary shares in issue

 23,111,704

16,606,406

 20,686,854

Basic (and dilutive) loss per share, EUR

(0.13)

(0.15)

(0.30)

Weighted-average number of ordinary shares

Issued ordinary shares at 1 January

 23,111,704

15,456,250

 15,456,250

Effect of shares issued

 – 

1,150,156

 5,230,604

Weighted-average number of ordinary shares at end of period

 23,111,704

 16,606,406

 20,686,854

Diluted

Diluted loss per share is calculated by adjusting the weighted average number of ordinary shares outstanding to assume conversion of all dilutive potential ordinary shares.

Loss attributable to equity holders of the Company
(EUR 1,000)

(3,011)

(2,432)

(6,188)

Interest adjustment

 – 

9

 9

Convertible loan interest adjusted loss attributable to equity holders

(3,011)

(2,423)

(6,179)

Diluted weighted average number of ordinary shares in issue

 23,164,610

 16,606,406

 20,686,854

Basic loss per share, EUR

(0.13)

(0.15)

(0.30)

Weighted-average number of ordinary shares

Issued ordinary shares at 1 January

23,111,704

15,456,250

 15,456,250

Effect of shares issued

–

1,150,156

 5,230,604

Weighted-average number of ordinary shares at end of period

 23,111,704

 16,606,406

 20,686,854

Dilution effect of convertible loans

 52,906

 – 

 – 

Diluted weighted-average number of ord. shares at end of period

 23,164,610

 16,606,406

 20,686,854

FURTHER INFORMATION TO SHAREHOLDERS

AIM:                                     FARN

Company number:                 (ISIN) FI4000153309

Investor website:                    http://www.faronpharmaceuticals.com/investor-relations

Registered office:                   Joukahaisenkatu 6, 20900 Turku, FINLAND

Directors:                              Frank Armstrong (Non-Executive Chairman)

                                            Matti Manner (Non-Executive Vice-Chairman)

                                            Markku Jalkanen (CEO)

                                            Juho Jalkanen (Non-Executive Director)

                                            Jonathan Knowles (Non-Executive Director)

                                            Huaizheng Peng (Non-Executive Director)

Leopoldo Zambeletti (Non-Executive Director)

Yrjö Wichmann (CFO)

faron-interim-results-2016

Faron Pharmaceuticals Notice of Interim Results

RNS Number : 7149G
Faron Pharmaceuticals Oy
10 August 2016
 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Notice of Interim Results

TURKU – FINLAND 10 August 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, will announce its Interim Results for the six months ended 30th June, 2016 on Monday 5th September, 2016.

Dr Markku Jalkanen, Chief Executive Officer, will host a presentation for analysts at 9am BST on the day of results at Panmure Gordon’s offices, One New Change, London EC4M 9AF.

– END –

For more information, please contact:

Faron Pharmaceuticals Oy

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 and 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, Joint 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


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

NORSSMFLUFMSELA

Faron Provides Update at R&D Day

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Provides Update at R&D Day

TURKU – FINLAND 14 June 2016 – Faron Pharmaceuticals Ltd (LON: FARN), the clinical stage biopharmaceutical company, today presents an update on the Company’s pipeline activities around Traumakine® and its novel cancer immunotherapy drug candidate Clevegen® at its R&D Day in London. On 26 May 2016 the Board of Directors announced that the development strategy for Clevegen has been expanded to open up new application opportunities in conditions where removal of suppression of local or systemic immunity is desirable. The Company has introduced two additional technology platforms related to Tumour Immunity Enabling Technology, or TIET to cover new development areas, chronic infections and inefficient vaccination.

The following updates are being presented at the R&D Day:

Clevegen:

  • An introduction of Chronic Infection Removal Therapy, CIRT, which would allow combat against bacteria, when they use M2 macrophages to hide host immune system
  • An introduction of Vaccination Response Enhancement Technology, VRET to use Clevegen as an adjuvant in vaccination protocols
  • A potential key target group for TIET program, hepatocellular carcinoma (HCC) patients

Traumakine:

  • Faron is currently preparing plans for US safety trial as requested by FDA
  • Confirmation that Faron plans to file Traumakine CTA in H2 2016 to the Finnish Medicines Agency (FIMEA) for clinical trial INFORAA on patients suffering from Rupture of Abdominal Aorta Aneurysm and operated surgically.

The updated Faron pipeline as of 14 June, 2016 can be found on the Company website: http://www.faronpharmaceuticals.com/pipeline

Dr. Markku Jalkanen, CEO of Faron, said: “We have clear plans to advance our exciting pipeline over the next two to three years and maintain focus on our most advanced projects Traumakine and Clevegen, which represent tremendous expansion potential into new indications and territories. Our Board fully recognise the potential of Clevegen towards several non-tumoural indications. Our scientific collaborators are already exploring these new CIRT and VRET technologies in order to provide pre-clinical data for our clinical plans. As stated on our TIET RNS on 26 May 2016, Faron plan to intensify commercial efforts around these three exciting technologies and make them available for interested licensing partners while at the same time focusing on our own development as well.”

“Tumour Immunity Enabling Technology”, or TIET, can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. The Directors also believe that Clevegen’s ability to convert M2 macrophages to M1 macrophages could provide additional applications to control immune suppression causing inadequate immune response. These are related to many chronic infections and inefficient vaccination due to low adjuvant effect. Faron will now introduce two additional technology platforms to cover these exciting development areas and starts to promote their development and use worldwide.

Presentations are available for viewing on Faron’s Company website: http://www.faronpharmaceuticals.com/investor-relations/events

For more information, please contact:

Faron Pharmaceuticals Oy

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 and 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 drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage 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 characterised by widespread inflammation in the lungs. 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 and represents a novel immuno-oncology approach called TIET (Tumour Immunity Enabling Technology). Faron Pharmaceuticals Ltd. is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

About Tumor Immunity Enabling Technology (TIET) 

The TIET technology is built around the humanised anti-Clever-1 antibody FP-1305, which binds to a specific Clever-1 proprietary epitope. Clevegen® binding to this epitope activates conversion of type 2 tumour associated macrophages to type 1 macrophages, resulting in the transformation of the tumour environment from immune suppression to immune activation. As the TIET technology is based on a humanised antibody, the Faron Directors believe it can be combined with a number of other immune therapies without a significant risk of increased adverse events. The TIET technology could provide a significant boost for the efficacy of other immune checkpoint molecules, as its target is unique and represents a completely separate control of immunity.

Faron Licenses Traumakine Rights to Pharmbio Korea

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Licenses Traumakine® Korean Rights to Pharmbio Korea Inc. (“Pharmbio”)

TURKU – FINLAND 13 June 2016 – Faron Pharmaceuticals Ltd (LON: FARN), the clinical stage biopharmaceutical company, announces today that it has entered into a licensing agreement with Pharmbio Korea Inc., for the development and commercialisation of Traumakine® in Korea. Pharmbio is based in Seoul and specialises in hospital sales of novel pharmaceutical products. Traumakine is in development for the treatment of 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 the pivotal pan-European Phase III INTEREST trial.

Under the terms of the agreement Pharmbio will obtain exclusive Korean rights to Traumakine. Faron will receive an initial signing fee of €750,000, which will be recorded as a revenue in H1-2016 financial results, and is entitled to receive additional, undisclosed development based milestones. In addition, Pharmbio will pay Faron one third of Traumakine profits, representing a double digit royalty on net sales, depending on end user pricing, and has agreed to cover development costs for Traumakine in Korea. Additionally, Faron will provide European approval material for Pharmbio to obtain market authorisation in Korea and will also supply Traumakine drug product to Pharmbio at an agreed transfer price.

Dr. Markku Jalkanen, CEO of Faron, said: “We are very pleased to have signed this agreement with Pharmbio which represents a great opportunity for Traumakine to enter the Korean market. Given the successful track record of Pharmbio sales team, achieving a steady 30% sales growth over the last five years, it is an excellent partner for Traumakine in the Korean market. This licensing deal follows our growth strategy to partner Traumakine in territories where Faron has limited presence, while maintaining rights in major territories including Europe and North America. We believe this agreement represents the best way to accelerate the development of Traumakine and create long term value for our shareholders.”

Dr. Junsang Nam, CEO of Pharmbio, said: “We are very excited to license Traumakine in Korea and for the opportunity to introduce this product targeting significant unmet medical need to Korean hospitals and ARDS patients. During the MERS virus outbreak in South Korea, a year ago many people suffered from serious lung infections and acute loss of respiration. We believe Traumakine, offers a new treatment option for these patients as well as ARDS patients with other underlying conditions.”

For more information, please contact:

Faron Pharmaceuticals Oy

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 and 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 drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage 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 characterised by widespread inflammation in the lungs. 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 and represents a novel immuno-oncology approach called TIET (Tumour Immunity Enabling Technology). Faron Pharmaceuticals Ltd is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

About Pharmbio Korea Inc

Pharmbio started business in 1999 in South Korea and claims to have annual turnover of over USD 47 million. It has continued expanding its scope of services and growing its revenue by 24% (8-year CAGR). Pharmbio developed the first treatment of urinary stone in Korea, UROCITRA, and has provided a pipeline of innovative products in urology, gastroenterology, general surgery, ob-gyn among others. Pharmbio has licensed and marketed products in a close collaboration with pharmaceutical companies in the EU, Japan, and Canada and has exported its patent products to SE Asian countries including Myanmar, Philippines, Vietnam, and Pakistan to fulfill unmet worldwide medical needs. Further information is available at www.pharmbio.co.kr

About Traumakine®

Faron completed a Phase I/II trial in respect of Traumakine® in 2011 where treatment with Traumakine® was associated with an 81% reduction in the odds of 28 day mortality in patients with ARDS. These data were published in The Lancet Respiratory Medicine, a leading medical journal (Bellingan et al. 2014) 1.  Comparable results were obtained from Traumakine Phase II Japanese study conducted by Faron´s Japanese licencing partner Maruishi Pharmaceutical Co. Ltd. in Japan, as announced in January 2016.

The presently ongoing pivotal Phase III trial called INTEREST is to be conducted in about 55 ICUs (Intensive Care Units) in seven European countries: Belgium, Finland, France, Germany, Italy, Spain and UK. A total of 300 adult patients with moderate or severe ARDS will be enrolled, and the first patient was enrolled in December 2015. INTEREST has received €6 million funding from the European Union Seventh Framework Programme (FP7).

The scientific rationale for Traumakine treatment is based on the proprietary use of room temperature stable formulation of interferon-beta-1a (FP-1201-lyo) for the restoration of the endothelial barrier function in ARDS patients. In Phase I/II trials interferon-beta was found to be safe and well tolerated in ARDS patients and the optimal tolerated dose was established. The selected pharmacodynamic marker for interferon-beta bioactivity showed clear dose response and the treatment target molecule CD73 levels were induced during the dosing period.

References:

1.   Bellingan, G., Maksimow, M., Howell D.C., Stoltz, M., Beale, R., Beatty, M., Walsh, T., Binning, A., Davidson, A., Kuper, M., Shah, S., Cooper, J., Waris, M., Yegutkin, G.G., Jalkanen, J., Salmi, M., Piippo, I., Jalkanen, M., Montgomery, H., Jalkanen, S.: “The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73 expression and on acute respiratory distress syndrome mortality: an open-label study”. Lancet Respiratory Medicine 2014.

Faron Result of Annual General Meeting

RNS Number : 4092Z
Faron Pharmaceuticals Oy
26 May 2016
 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Result of Annual General Meeting

TURKU – FINLAND 26 May 2016 – Faron Pharmaceuticals Ltd (LON: FARN) is pleased to announce that all resolutions proposed at its Annual General Meeting held today and as set out in the Company’s announcement dated 4 May 2016, were duly passed by shareholders.

Commenting on the meeting, Frank Armstrong, Chairman of Faron, said: “We are delighted to have such support from our shareholders at the very first Annual General Meeting as a listed company. We thank our shareholders for sharing Faron´s mission of life-saving drug development. We are looking forward to making further significant progress with our innovations to develop new treatments for true unmet medical needs.”

For more information, please contact:

Faron Pharmaceuticals Oy

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

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

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

 

About Faron Pharmaceuticals Ltd.

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage 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 characterised by widespread inflammation in the lungs. 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 and represents a novel immuno-oncology approach called TIET (Tumour Immunity Enabling Technology). Faron Pharmaceuticals Ltd. is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

RAGLIFEAELIRFIR

Faron Expands R&D Strategy for Clevegen

RNS Number : 3235Z
Faron Pharmaceuticals Oy
26 May 2016
 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Expands R&D Strategy for Novel Immunotherapy Drug Candidate, Clevegen®

TURKU – FINLAND 26 May 2016 – Faron Pharmaceuticals Ltd (LON: FARN) announces today that its Board of Directors has expanded the development strategy for Clevegen®, its novel cancer immunotherapy drug candidate. As announced on 19 April 2016, Faron recently filed patents which have opened up new application opportunities for Clevegen in conditions where removal of suppression of local or systemic immunity is desirable.

Faron will now aim to extend the range of Clevegen indications through a technology platform called “Tumour Immunity Enabling Technology”, or TIET, which can be used alone or in combination with other immune checkpoint molecules. The Directors believe that Clevegen’s ability to convert pro-tumoural M2 macrophages to pro-inflammatory M1 macrophages could help the human body’s own immune system to combat cancer and significantly differentiates it from competing products. At the same time, the removal of immune suppression caused by M2 macrophages could provide a significant boost to the efficacy of other immune checkpoint molecules already in use or under development. Faron intends to develop Clevegen in-house for immune dependent cancers such as hepatocellular carcinoma and other cancers known to depend on tumour associated macrophages (TAM). In addition the strategic decision by Faron to leverage the TIET technology platform may allow licensing opportunities and wider use of Clevegen as part of combination cancer therapies, maximising the value to cancer patients.

Dr. Markku Jalkanen, CEO of Faron, said: “We have made significant progress with Clevegen this Spring, culminating in development of the new TIET technology platform. We will intensify our efforts in commercialising the TIET technology globally while also initiating our own cancer treatment programme. We will report these plans at our R&D day on 14 June, as announced on 13 May 2016, and welcome all interested parties to join the London event.”

The TIET technology could significantly enhance lymphocyte activation programmes enabling them to be more effective in their fight against cancer cells, making TIET attractive to potential collaborators and licensing partners. Faron was granted €1.5 million funding from Tekes, the Finnish Funding Agency for Innovation, in December 2015 to progress the preclinical development of Clevegen.

For more information, please contact:

Faron Pharmaceuticals Oy

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 and 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 Clevegen®

Faron´s preclinical drug development project Clevegen revolves around Clever-1, a cell surface receptor expressed mainly by endothelial cells and monocytes/macrophages. Clever-1 is involved in cancer growth and spread. The active pharmaceutical ingredient of Clevegen is a humanised anti-Clever-1 antibody.

Clevegen, by binding Clever-1 prevents Tumor Associated Macrophage (TAM) infiltration into a tumour and blocks TAM-to-Tumour cell interaction triggering TAM transformation into tumour supportive cell types. It therefore reduces suppression of the human immune system and converts the whole immune environment around a tumour to immune stimulating allowing a patient’s own immune system to combat cancer, known as “immunotherapy”. Clevegen has a local tumour effect which also allows the cell-mediated immune response to attack infections in normal tissues. Removal of immune suppression locally also limits the risk of autoimmune reaction, a potentially severe side effect observed with some immune checkpoint inhibitors. The Directors of Faron believe that Clevegen is well differentiated from competing products as it specifically targets M2 TAMs which facilitate tumour growth, while leaving intact the M1 TAMs which support immune activation against tumours. Clever-1 blocking results especially in activation of Th1 mediated immunity.

About Tumor Immunity Enabling Technology (TIET) 

The TIET technology is built around the humanised anti-Clever-1 antibody FP-1305, which binds to a specific Clever-1 proprietary epitope. Clevegen® binding to this epitope activates conversion of type 2 tumour associated macrophages to type 1 macrophages, resulting in the transformation of the tumour environment from immune suppression to immune activation. As the TIET technology is based on a humanised antibody, the Faron Directors believe it can be combined with a number of other immune therapies without a significant risk of increased adverse events. The TIET technology could provide a significant boost for the efficacy of other immune checkpoint molecules, as its target is unique and represents a completely separate control of immunity.

About Faron Pharmaceuticals Ltd.

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage 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 characterised by widespread inflammation in the lungs. 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 and represents a novel immuno-oncology approach called TIET (Tumour Immunity Enabling Technology). Faron Pharmaceuticals Ltd. is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

MSCQELFLQEFBBBE

Faron Pharmaceuticals Ltd to host an R&D Day

RNS Number : 1338Y
Faron Pharmaceuticals Oy
13 May 2016
 

Faron Pharmaceuticals Ltd

R&D Day – Save The Date

10.30-13.00

Tuesday, 14th June 2016

Panmure Gordon, One New Change, London, EC4M 9AF

Faron Pharmaceuticals Ltd (“Faron”) is hosting an R&D Day which will take place on Tuesday, 14 June 2016. The event provides the opportunity to hear about the Company, its pipeline and R&D strategy. There will also be presentations from eminent Key Opinion Leaders – Prof Sirpa Jalkanen, a leading cell trafficking scientist in inflammation and cancer; Prof Geoff Bellingan, who is a world leading expert in Acute Respiratory Distress Syndrome (ARDS) and Principal Investigator of the INTEREST trial; and Prof David Adams, who directs the NIHR Birmingham Liver Biomedical Unit and is one of the leading scientists in liver diseases.

The event will take place at Panmure Gordon’s offices, One New Change, London, EC4M 9AF.

If you are interested in attending the Faron Pharmaceuticals Ltd R&D Day or have any questions on the event, please contact Angelina De Souza Callaghan at angelina.desouzacallaghan@humebrophy.com or telephone +44 (0)20 7862 6397.

About Faron Pharmaceuticals Ltd.

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage 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 characterised by widespread inflammation in the lungs. 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 and represents a novel immuno-oncology approach. Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

MSCATMFTMBTBBIF

Notice of AGM

RNS Number : 1433X
Faron Pharmaceuticals Oy
04 May 2016
 

NOTICE OF faron pharmaceuticals LTD’s ANNUAL GENERAL MEETING

Shareholders of Faron Pharmaceuticals Ltd are invited to attend the Annual General Meeting to be held on 26 May 2016 at 10 a.m. at the premises of the BioCity building, Mauno Conference Center, address Tykistökatu 6, 20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 9 a.m.

A. MATTERS ON THE AGENDA OF THE ANNUAL GENERAL MEETING

1. Opening of the meeting

2. Calling the meeting to order

3. Election of persons to scrutinise the minutes and to supervise the counting of votes

4. Recording the legality of the meeting

5. Recording the attendance at the meeting and adoption of the list of votes

6. Presentation of the financial statements, the Report of the Board of Directors and the Auditor’s Report for 2015

Review by the CEO

7. Adoption of the Financial Statements

8. Resolution on the use of the profit shown on the balance sheet and the payment of dividend

The Board of Directors proposes that no dividend for the financial year 2015 will be paid and that the losses of the Company for the financial year, amounting to EUR 6.2 million (IFRS), will be carried forward to reserve for invested unrestricted equity.

9. Resolution on the discharge of the members of the Board of Directors and the CEO of the Company from liability

10. Resolution on the remuneration of the members of the Board of Directors

The Board of Directors proposes, on the basis of the proposal of the Remuneration Committee, that the fees payable to the members and the Chairman of the Board will remain unchanged from 2015 and be as follows: an annual remuneration of EUR 35,000 will be paid to the Board members, in addition to which EUR 33,000 will be paid to the Chairman of the Board of Directors. In addition, it is proposed that a further annual remuneration of EUR 5,000 will be paid to Chairman of the Audit Committee, the Nomination Committee and the Remuneration Committee. Finally, it is proposed that all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board of Directors would be compensated.

The Board of Directors also propose, on the basis of the proposal of the Remuneration Committee, that Markku Jalkanen as the Company’s CEO and Yrjö Wichmann as the Company’s CFO will not receive such remuneration as a member of the Board of Directors.

11. Resolution on the number of members of the Board of Directors

The Board of Directors proposes on the basis of the proposal of the Nomination Committee that eight (8) members be elected to the Board of Directors.

12. Election of members of the Board of Directors

The Board of Directors propose, on the basis of the proposal of the Nomination Committee, that Frank Armstrong, Markku Jalkanen, Juho Jalkanen, Jonathan Knowles, Matti Manner, Huaizheng Peng, Yrjö Wichmann and Leopoldo Zambeletti will be re-elected to the Board of Directors until the next Annual General Meeting.

The proposed Board members have informed the Company that in the event they are re-elected, they intend to elect Frank Armstrong as Chairman of the Board and Matti Manner as Deputy Chairman of the Board.

In addition, the proposed Board members have advised that the members of the Board committees would remain unchanged and would therefore be as follows: Leopoldo Zambeletti would be the Chairman and Frank Armstrong and Huaizheng Peng members to the Audit Committee, Frank Armstrong would be the Chairman and Leopoldo Zambeletti and Huaizheng Peng as members to the Remuneration Committee, and Matti Manner would be the Chairman and Frank Armstrong and Jonathan Knowles as members to the Nomination Committee.

13. Resolution on the remuneration of the Auditor

The Board of Directors propose to the Annual General Meeting, on the basis of the proposal of the Audit Committee, that the Auditor be remunerated in accordance with the invoice presented.

14. Election of the Auditor

The Board of Directors propose to the Annual General Meeting on the basis of the proposal of the Audit Committee that PricewaterhouseCoopers Oy, Authorised Public Accountants, continue to act as the Company’s auditor.

PricewaterhouseCoopers Oy has informed the Company that it will appoint Kalle Laaksonen, Authorised Public Accountant, as the Auditor with principal responsibility for the completion of the Audit.

15. Resolution on the amendment of the option programme

The Board of Directors propose, on the basis of the proposal of the Remuneration Committee, that the Annual General Meeting would resolve to amend the option programme adopted by the Extraordinary General Meeting of the Company on 15 September 2015 in respect of the total of 150,000 A options that have remained unallocated and unsubscribed for, to confirm the validity of the said 150,000 A options and that they are available to be allocated to key management and personnel and that the said A options may be subscribed during a term ending on 9 June 2016. Otherwise the terms and conditions would remain unchanged and apply also to the said A options (Appendix 1). Following the amendment, any A options that have not been subscribed at the latest on 9 June 2016 will lapse.

16. Authorising the Board of Directors to decide on the issuance of shares

The Board of Directors propose that the Annual General Meeting would authorise the Board of Directors to resolve by one or several decisions on issuances of shares which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation would consist of up to 4,622,340 shares in the aggregate, which corresponds to approximately 20 per cent of the existing shares and votes in the Company.

The authorisation would not exclude the Board of Directors’ right to decide on the issuance of shares in deviation from the shareholders’ pre-emptive rights. The authorisation is proposed to be used for material arrangements from the Company’s point of view, such as financing or implementing business arrangements, investments or for other such purposes determined by the Board of Directors in which case a weighty financial reason for issuing shares, and possibly deviating from the shareholders’ pre-emptive rights would exist.

The Board of Directors would be authorised to resolve on all other terms and conditions of the issuance of shares.

The authorisation will be effective until 30 June 2017. The Board of Directors propose that the authorisation would supersede the authorisation granted by the Extraordinary General Meeting held on 15 September 2015.

17. Authorisation to make communication to shareholders in electronic form and to communicate by means of a website

The Board of Directors propose that in future the Company shall be permitted to fulfil its obligations in respect of communication to its shareholders (including the Company’s annual accounts) through the use of the Electronic Communication methods as defined in the AIM Rules for Companies (as amended from time to time). Any such methods of communication will be established and operated in accordance with the requirements of the AIM Rules for Companies, the Company’s articles of association and any legal requirements in its jurisdiction of incorporation, Finland.

18. Closing of the meeting

B. DOCUMENTS OF THE ANNUAL GENERAL MEETING

The above-mentioned proposals to the Annual General Meeting and this notice are available on Faron Pharmaceutical’s website at www.faronpharmaceuticals.com under Investor Relations/Financial calendar. Faron Pharmaceutical’s financial statements, the Report of the Board of Directors and the Auditor’s report, are available on the front page of the Company’s website and under Investor Relations/Results and will be posted to all shareholders shortly. The Board proposals and the other above-mentioned documents will also be available at the Annual General Meeting. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the Annual General Meeting will be available to be viewed on the Company’s website from 9 June 2016 at the latest.

C. INSTRUCTIONS FOR THE PARTICIPANTS

1. The right to participate and registration

Each shareholder who on the record date of the Annual General Meeting, being 16 May 2016, is registered in the Company’s shareholders’ register held by Euroclear Finland Ltd has the right to participate in the Annual General Meeting. A shareholder whose shares are registered on his/her personal book-entry account is registered in the Company’s shareholders’ register.

A shareholder who is registered in the Company’s shareholders’ register and who wants to participate in the Annual General Meeting should register for the meeting by no later than 4 p.m. (Finnish time) on Friday 20 May 2016  by giving a prior notice of participation:

•     by completing the registration form on the Company’s website www.faronpharmaceuticals.com under Investor Relations/ Financial calendar;

•     by email to katja.wallenlind@faronpharmaceuticals.com; or

•     by mail to Faron Pharmaceuticals Ltd, C/o Katja Wallenlind, Joukahaisenkatu 6, FI-20520 Turku, Finland.

When registering, a shareholder shall state his/her name, personal identification number / business identity code, address, telephone number and the name of a possible proxy representative or assistant and the personal identification number of the proxy representative. The personal data given by shareholders to Faron Pharmaceuticals is used only in connection with the Annual General Meeting and the necessary processing of related registrations.

The shareholder, his/her authorised representative or proxy representative should, when necessary, be able to prove his/her identity and/or right of representation.

2. Proxy representative and powers of attorney

A shareholder may participate in the Annual General Meeting and exercise his/her rights at the meeting by way of proxy representation. A proxy representative must present a dated power of attorney or other reliable proof of their authority to represent the shareholder.

A shareholder may participate in the Annual General Meeting by means of several proxy representatives, who represent the shareholder with shares held on different book-entry accounts. In such case, the shares represented by each proxy representative shall be identified when registering for the Annual General Meeting.

Possible proxy documents should be sent in originals to Faron Pharmaceuticals, Joukahaisenkatu 6, FI-20520 Turku, Finland, before the end of registration period.

3. Holder of nominee-registered shares (including depositary interest holders)

A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the Annual General Meeting by virtue of such shares based on which the holder would be entitled to be registered in the Company’s shareholders’ register held by Euroclear Finland Ltd on the Annual General Meeting’s record date of 16 May 2016.

Additionally, participation requires that the holder of nominee-registered shares is temporarily registered in the Company’s shareholders’ register held by Euroclear Finland Ltd by 10 a.m. Finnish time on Monday 23 May 2016. Temporary registration in the shareholders’ register shall be deemed to be a registration for the Annual General Meeting.

Holders of nominee-registered shares are advised to request the necessary instructions regarding the temporary registration in the shareholders’ register, the issuing of proxy documents and registration for the General Meeting from their custodian bank without delay. The account management organisation of the custodian bank shall notify a holder of nominee-registered shares, who wants to participate in the Annual General Meeting, to be temporarily entered into the Company’s shareholders’ register by the above-mentioned time.

4. Other instructions and information

Pursuant to Chapter 5, Section 25 of the Finnish Companies Act, shareholders who are present at the Annual General Meeting are entitled to request information regarding the matters addressed by the meeting.

On the date of this notice, 4 May 2016, the total number of shares and votes in Faron Pharmaceuticals is 23,111,704.

The Annual General Meeting shall be held in Finnish and in English.

Turku, 4 May 2016

FARON PHARMACEUTICALS LTD

Board of Directors

FOR MORE INFORMATION, PLEASE CONTACT:

Faron Pharmaceuticals Oy

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 and 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, Joint Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage 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 characterised by widespread inflammation in the lungs. 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 and represents a novel immuno-oncology approach. Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

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