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, OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Results of the Placing and Subscription

and Issue of Equity

Successful over-subscribed fundraising of £15.0 million through Placing and Subscription

TURKU – FINLAND, 21 February 2018 – Faron Pharmaceuticals Oy (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, is pleased to announce that, following the announcement on 16 February 2018, the proposed Placing and Subscription has been subscribed for in full, in satisfaction of the Placee Condition. Pursuant to the Placing and Subscription, the Company is raising approximately £15.0 million before expenses by way of the Placing of 1,729,350 Placing Shares and the Subscription of 134,000 Subscription Shares at the Issue Price of 805 pence per share. The Placing and Subscription have been supported by the participation of existing and new institutional shareholders. The Board of Directors of Faron has resolved on and approved the issuance of the Placing Shares and the Subscription Shares pursuant to the existing authorisation granted by shareholders at the Company’s Annual General Meeting held on 16 May 2017.

The First Issue Shares, being 837,200 Placing Shares, including those to be issued to the VCT Investors and the EIS Investors, and 93,000 Subscription Shares, are expected to be registered with the Finnish Trade Register shortly. The First Issue Shares will, when registered, be credited as fully paid and will rank pari passu with the existing Ordinary Shares in issue in all respects, including the right to receive all dividends or other distributions declared, made or paid by the Company by reference to record dates falling after the date of registration of the First Issue Shares with the Finnish Trade Register.

Application has been made to the London Stock Exchange for admission to trading on AIM of the 930,200 First Issue Shares (“Admission“), and it is expected that Admission of the First Issue Shares will become effective and that dealings in the First Issue Shares will commence on or around 8:00 a.m. (GMT) on 23 February 2018.

Faron’s enlarged issued number of shares immediately following registration and Admission of the First Issue Shares will be 30,094,744 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 30,094,744 (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 Enlarged Number of Shares and Votes of the Company.

A further announcement will be made regarding the issuance, and application for Admission, of the Second Issue Shares (being the remaining Placing Shares and Subscription Shares to be issued pursuant to the Placing and Subscription) and the new total number of voting rights in Faron following such Admission in due course. It is expected that Admission of the Second Issue Shares will take place on or around 28 February 2018. The issue and allotment of the Second Issue Shares remains conditional upon, inter alia, Admission of the First Issue Shares taking place, the Issue Condition relating to the Second Issue Shares being satisfied and the Placing Agreement otherwise remaining in full force and no material breach of its terms having occurred.

Commenting on the successful Placing and Subscription, Dr Markku Jalkanen, CEO of Faron, said: “We are delighted by the level of investor enthusiasm we received during this financing round, based on both the potential of Traumakine as we advance towards commercialisation, and for our second wholly-owned asset Clevegen. This funding will allow us to accelerate preparations for the anticipated market launch of Traumakine and also expedite our clinical development activities for Clevegen. We would like thank our current investors for their continued support and welcome our new institutional investors to Faron.”

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 made with reference to the announcement made by Faron at 7.00 a.m. (GMT) on 16 February 2018.  

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Philippa Gardner, Matthew Neal, Lindsey Neville

Phone: +44 203 709 5700

E-mail: faron@consilium-comms.com

Panmure Gordon (UK) Limited, Nomad and Broker

Freddy Crossley, Ryan McCarthy (Corporate Finance)

Tom Salvesen, Amy Sarra (Corporate Broking)

Phone: +44 207 886 2500

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Oy

Faron (AIM:FARN) 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, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, could be the first ever drug for Acute Respiratory Distress Syndrome (“ARDS”) undergoing Phase III clinical trials and in 2017 received advice from US FDA that it may proceed directly to BLA submission following successful completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology (“TIET”) may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward looking statements, many of which are beyond the control of the Company. In particular, the outcome of clinical trials (including, but not limited to the Company’s INTEREST trial) may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

FDA grants Fast Track Designation to Faron for Traumakine^®

Faron’s wholly-owned product for Acute Respiratory Distress Syndrome on track for Phase III data in H1 2018

TURKU – FINLAND, 29 January 2018 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces it has received Fast Track designation from the US Food and Drug Administration (FDA) for Traumakine^®, the Company’s wholly-owned product for the treatment of Acute Respiratory Distress Syndrome (ARDS). Traumakine is currently in two Phase III trials (INTEREST in Europe and MR11A8-2 in Japan), with top-line data from the INTEREST study on track for the first half of 2018.

Fast Track designation is granted by the FDA to expedite the review and facilitate the development of drugs to treat serious conditions with significant unmet medical need. The purpose of the process is to get new drugs to patients quicker. Today’s announced Fast Track designation is in addition to Traumakine’s Promising Innovative Medicines (PIM) designation from the MHRA, which is the first stage of the MHRA’s Early Access Medicines Scheme (EAMS).

ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%^[1],[2],[3], for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma. Faron estimates there are around 300,000 plus annual cases in Europe and US alone. Faron completed the recruitment of 300 patients with moderate and severe ARDS for the pan-European pivotal trial INTEREST in December 2017.

Dr Markku Jalkanen, CEO of Faron, said: “We are very pleased that the FDA has granted Fast Track designation for Traumakine. This represents significant additional recognition of the potential that our drug holds to save lives and, in turn, relieve pressure and costs for healthcare systems. With Fast Track designation in the US, and PIM status in the UK, Traumakine is now ideally placed for an expedited route to market, following the top-line data which is on track and due in H1 2018. In accordance with our wider strategy, we continue to accelerate our plans to enable rapid and broad commercial adoption of Traumakine.”

Traumakine also has an orphan status in Europe, which normally expedites the review also at the European Medicine Agency (EMA). The Company also expects that Faron’s partner in Japan, Maruishi will file an orphan application this year following the INTEREST trial read-out.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (“MAR”).

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Matthew Neal, Philippa Gardner, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) 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, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology (“TIET”) may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Recruitment completed in Traumakine INTEREST Trial

The upcoming read-out will collate intact 90 day morbidity/mortality data alongside 28 day mortality data as requested by the study IDMC

Phase III INTEREST top line results expected in H1 2018

TURKU – FINLAND, 11 December 2017 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces that it has completed recruitment, on track, for its Phase III INTEREST trial of Traumakine^® for the treatment of moderate to severe Acute Respiratory Distress Syndrome (ARDS).

In addition to the completion of recruitment, the Company reports that it has adopted recommendations from the INTEREST trial’s Independent Data Monitoring Committee (IDMC) and Steering Committee (SC) to present patient data showing blinded ARDS outcomes (mortality/morbidity) at 90 days (D90), in addition to the day 28 (D28) mortality endpoint. Outcomes at D90 are widely recognised to be as important clinically when judging the benefit of treatment alongside the D28 data. This recommendation was made following the FDA’s recent proposal for Faron to proceed directly to BLA filing for Traumakine in the US using data obtained from the European and Japanese trials. The Company expects therefore that the INTEREST top-line data from the trial will become available in H1 2018 following collation of the D90 data. Faron’s Japanese partner Maruishi also expects Japanese phase III results in 2018. 

The INTEREST trial is a Phase III double-blind, randomised, parallel-group comparison of efficacy and safety of Traumakine (FP-1201-lyo) and placebo in the treatment of patients with moderate to severe ARDS. The study, which has successfully recruited its target of 300 patients, is currently being conducted in more than 60 hospital intensive care units (ICU) in Belgium, Finland, France, Germany, Italy, Spain, UK and Czech Republic. The key efficacy endpoint in the INTEREST trial is the all-cause mortality rate at day 28. The INTEREST trial protocol is targeting a 50% reduction in all cause mortality at day 28 between placebo and treatment arm (from 30% down to 15%).

ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%, for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma with around 300,000 plus annual cases in Europe and US alone.

Dr Markku Jalkanen, CEO of Faron, said: “We are extremely pleased to have completed recruitment for the INTEREST study within our expected timelines and are grateful for all parties involved in reaching this milestone. Closing the recruitment marks another important step for Traumakine and Faron. Our focus is now on closing the data basis for read-out purposes and bringing this product to the market as expediously as possible in order to provide patients with this life threathening condition a treatment option where currently there is none.”

Professor Geoff Bellingan from the University College London Hospital and the Co-principal Investigator of the INTEREST trial, added: “All  of us who have been involved with this study have shared the excitement of the INTEREST trial as it offers the potential to finally have an effective pharmacological treatment for ARDS patients. We fully support the advice from the IDMC and SC to hold reporting results until we have both D28 and D90 data as this offers the ideal non-biased means of protecting the data integrity for regulatory purposes. We are aware that the FDA, in particular, has appreciated the inclusion of D90 survival data alongside the D28 endpoints. Given the need for this treatment for our patients, we now look forward to completing the data verification and presenting top line results in the first half of 2018.”  

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Philippa Gardner, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) 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, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology (“TIET”) may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

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”)

Issue of Equity
and
PDMR Shareholding

TURKU – FINLAND, 2.00 P.M. BST, 11 October 2017 – Faron Pharmaceuticals Oy (“Faron” or “Company“) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce the registration and issue of the Second Issue Shares in relation to the Placing and Subscription announced on 5 October 2017.

The Second Issue Shares, being 586,037 Placing Shares and 66,365 Subscription Shares, are credited as fully paid and rank pari passu with the existing Ordinary Shares in issue in all respects, including the right to receive all dividends or other distributions declared, made or paid by the Company.

Application has been made to the London Stock Exchange for admission to trading on AIM of the 652,402 Second Issue Shares (“Admission“), and it is expected that Admission of the Second Issue Shares will become effective and that dealings in the Second Issue Shares will commence on or around 8.00 a.m. (BST) on 13 October 2017.

Faron’s enlarged issued number of shares immediately following registration and Admission of the Second Issue Shares will be 29,164,544 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 29,164,544 (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 Enlarged Number of Shares and Votes of the Company.

Director/PDMR Shareholding

Dr Frank Armstrong has subscribed for 1,250 Subscription Shares at the Issue Price, to be completed within Admission of the Second Issue Shares. The beneficial interests of Dr Frank Armstrong in the issued shares and votes of the Company is set out below:

The participation by Dr Frank Armstrong in the Placing and Subscription constitutes a related party transaction for the purposes of the AIM Rules. The independent directors for the purpose of the Placing and Subscription, being all directors of the Company other than Dr Frank Armstrong, 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.

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. (BST) on 5 October 2017.

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

E-mail: investor.relations@faron.com

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Philippa Gardner, Lindsey Neville

Phone: +44 203 709 5700

E-Mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: +1 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Sole Bookrunner and Corporate Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Joint Corporate Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) 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, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology (“TIET”) may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward looking statements, many of which are beyond the control of the Company. In particular, the outcome of clinical trials (including, but not limited to the Company’s INTEREST trial) may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based. 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron’s Traumakine Receives Promising Innovative Medicine (PIM) Designation from the MHRA for the Treatment of ARDS

TURKU – FINLAND, 02 October 2017 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announced today that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Promising Innovative Medicines (PIM) designation for its lead product, Traumakine^® which is curently undergoing Phase III clinical trials for the treatment of Acute Respiratory Distress Syndrome (ARDS).

The award of PIM designation is the first stage of the MHRA’s Early Access Medicines Scheme (EAMS) and is granted when a medicine shows early signals, based on evidence to date, that it may be a possible candidate for the scheme. PIM designation under the EAMS also illustrates that a medicine has potential value in a disease area with significant and urgent unmet need and further qualifies an accompanying application and progression of the medicine towards the next stage in the EAMS process, which also allows early pricing negotiation with the UK National Institute for Health and Care Excellence (NICE).

Commenting on the MHRA’s advice, Dr Markku Jalkanen, CEO of Faron, said: “We welcome the news that the MHRA has granted PIM status to Traumakine. This designation opens up the pathway to the EAMS  and brings us one step closer to providing patients in the UK with access to Traumakine as we await the completion of the ongoing INTEREST phase III trial. There is currently no approved pharmaceutical treatment for ARDS and Traumakine has the potential to address a significant unmet medical need in terms of mortality and cost savings for healthcare providers.”

ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%, for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma with around 300,000+ annual cases in Europe and US.

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Philippa Gardner, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson

Phone: +44 207213 0880

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

.

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) 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, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology (“TIET”) may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward looking statements, many of which are beyond the control of the Company. In particular, the outcome of clinical trials (including, but not limited to the Company’s INTEREST trial) may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron announces that US FDA proposes proceeding directly to BLA submission for Traumakine^® following completion of European and Japanese Phase III studies

TURKU – FINLAND, 4 September 2017 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces that the FDA has proposed that Faron can proceed directly to Biologics License Application (BLA) submission pending positive results from the two on-going Phase III trials (INTEREST in Europe and MR11A8-2 in Japan) with the Company’s wholly-owned product, Traumakine^® for the treatment of Acute Respiratory Distress Syndrome (ARDS). In the letter received on 1 September 2017, the FDA proposed that, subject to the FDA being satisfied with data from the trials, the BLA application for Traumakine can be filed purely with data obtained from the ongoing trials outside of the US. In the event of positive outcomes of the ongoing trials this FDA feedback is therefore expected to shorten the time for approval of Traumakine in US.

Commenting on the FDA’s advice, Dr Markku Jalkanen, CEO of Faron, said: “We welcome the news that the FDA have proposed that we proceed directly to BLA submission for the US development of Traumakine. This important feedback potentially speeds up the regulatory approval process in the US and brings us one step closer to delivering Traumakine to patients in the world’s largest pharmaceutical market. There is currently no approved pharmaceutical treatment for ARDS and Traumakine has the potential to address a significant unmet medical need in terms of mortality and savings for society. We now eagerly await the outcome of our ongoing Phase III trials and continue to build our presence in the US.”

ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%, for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma with around 300,000+ annual cases in Europe and US.

As the INTEREST Phase III study nears completion, Faron plans to initiate an expanded access program for Traumakine to start once the trial is closed to new patients. This will allow compassionate use of Traumakine in eligible named patients at European ICU hospitals, who may benefit from Traumakine treatment ahead of the product’s potential regulatory approval. The Company is also considering providing this access to US ARDS patients.

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Philippa Gardner, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson

Phone: +44 207213 0880

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

Glossary

BLA: a request for permission to introduce, or deliver for introduction, a biologic product into US commerce.

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) 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, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology (“TIET”) may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward looking statements, many of which are beyond the control of the Company. In particular, the outcome of clinical trials (including, but not limited to the Company’s INTEREST trial) may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Exercise of Warrants and Options

Issue of Equity

TURKU – FINLAND, 1 June 2017 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announces that it has received a notification from a warrant holder to exercise warrants over 71,370 ordinary shares in the Company at an exercise price of €1.55 per share and a further 27,040 ordinary shares in the Company at an exercise price of €2.01 per share providing the Company with gross proceeds of €164,973.90 (approximately £143,082).

The Company further announces that it has received a notification from an option holder to exercise options over 15,000 ordinary shares in the Company at an exercise price of €3.71 per share and a further 14,100 ordinary shares in the Company at an exercise price of €2.90 per share providing the Company with gross proceeds of €96,540.00 (approximately £83,729).

Application will be made to the London Stock Exchange to admit the 127,510 new ordinary shares to trading on AIM. Admission of the new ordinary shares is expected to occur on or around 06 June 2017 (“Admission”).  The new ordinary shares will rank pari passu with existing ordinary shares. Issue of the new ordinary shares remains subject to such shares being registered at the Finnish Trade Registry.

Faron’s enlarged issued number of shares immediately following registration and Admission will be 27,914,544 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 27,914,544. 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.

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker (UK)

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in pan-European (INTEREST) and Japanese pivotal Phase III studies. 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

Faron Pharmaceuticals Oy
 

(“Faron” or the “Company”)

Exercise of Warrants

Issue of Equity

TURKU – FINLAND, 27 April 2017 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announces that it has received a notification from a warrant holder to exercise warrants over 38,430 ordinary shares in the Company at an exercise price of €1.55 per share and a further 14,560 ordinary shares in the Company at an exercise price of €2.01 per share providing the Company with gross proceeds of €88,832.10 (approximately £75,518).

Application will be made to the London Stock Exchange to admit the 52,990 new ordinary shares to trading on AIM. Admission of the new ordinary shares is expected to occur on or around 4 May 2017.  The new ordinary shares will rank pari passu with existing ordinary shares. Issue of the new ordinary shares remains subject to such shares being registered at the Finnish Trade Registry.

Faron’s enlarged issued number of shares immediately following registration and Admission will be 27,787,034 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 27,787,034. 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.

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker (UK)

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in pan-European (INTEREST) and Japanese pivotal Phase III studies. 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

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron and the University of Birmingham to collaborate on Clevegen^® clinical program in liver cancer

TURKU – FINLAND, 18 April 2017. Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce that it has signed an agreement with the University of Birmingham Medical School, UK, to initiate a liver cancer program testing Clevegen, the Company’s immuno switch antibody, in clinical trials. This collaboration will focus on trial and protocol design for a Phase I/II trial, TIETALC, (Tumour Immunity Enabling Technology Against Liver Cancer) in liver cancer patients at Birmingham Health Partners’ NIHR Clinical Research Facility and the Centre for Liver Research.

As part of the preparations, approval will be sought from the UK regulatory authorities (MHRA) for an adaptive protocol, which would allow flexible administration of Clevegen based on results obtained in previous dosings. Faron and the University of Birmingham anticipate filing the clinical trial application (CTA) with the MHRA in late 2017 or early 2018. In the event of successful collaboration and CTA approval, it is expected that Faron and the University of Birmingham will conduct the TIETALC trial together. 

The main focus of TIETALC is to study the safety, pharmacokinetics/pharmacodynamics and initial efficacy of Clevegen in liver cancer patients, focusing on those with hepatocellular carcinoma (HCC). The study will also examine the efficacy of Clevegen in reducing the number of Clever-1 positive, immune suppressive myeloid cells, circulating in the blood and entering tumour tissue of cancer patients where they can suppress anti-cancer immunity.

TIETALC may also assist Faron with its aim to develop a liquid biopsy based on recognition of Clever-1 positive circulating myeloid cells. This detection could potentially become a surrogate marker of improved immune capacity in response to Clevegen and assist in the selection of those target cancer patients who are likely to benefit most from Clevegn treatment.

Dr Markku Jalkanen, CEO of Faron, said: “We are excited to start this collaboration with this world-renowned liver cancer unit in Birmingham. Their substantial clinical expertise and numerous research programmes in liver cancer treatment will provide us with a unique opportunity to assess the effect Clevegen has on immune function in these patients.  We are optimistic that Clevegen will stimulate strong immune responses against the cancer, restricting tumour growth and metastasis, and thereby improving the long term survival of these patients, whose prognosis with current therapies is very poor.”

Prof. David Adams, Director of the NIHR Biomedical Research Centre and Head of the College of Medical and Dental Sciences at University of Birmingham, said: “We are very familiar with the Clever-1 target molecule. Previously, we have demonstrated that it controls the accumulation of immunosuppressive regulatory lymphocytes in the liver¹ and we have also shown in previous studies that liver cancer can be treated by stimulating anti-tumour immunity².  We are excited to move towards commencement of trials using Clevegen which we believe has the ability to boost immune responses against liver cancer through a novel mechanism.  The current prognosis for liver cancer patients is very poor and so potential treatments, like Clevegen, offer new possibilities in fighting this aggressive and poorly responsive cancer.”

About Liver Cancer

Hepatocelluar cellular carcinoma (HCC) is the most common liver cancer type and the leading cause of cancer-related morbidity and mortality worldwide. Less than 20% of HCC patients are alive five years post diagnosis and there is a clear unmet need for effective targetted therapies. HCC is usually a complication of liver cirrhosis which may be caused by viruses, toxins (including alcohol) or autoimmune liver diseases. Additionally, the liver is a frequent site of metastasis from other cancers, particularly colorectal cancer. The immune positive phenotype of HCC and reports of responses to immunotherapy suggest that is an excellent target tumour for immuno-oncology treatments by the removal of immunosuppressive white blood cells including macrophages.

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 and removal of immune suppression locally also limits 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.

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

For more information, please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker (UK)

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) 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, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen® is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology (“TIET”) may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faronpharmaceuticals.com

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results discussed in the forward looking statements including risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors, many of which are beyond the control of the Company. Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

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
and

Issue of Equity

Successful over-subscribed fundraising of £5.0 million through a Placing and Subscription

TURKU – FINLAND, 11.30 A.M. GMT, 1 March 2017 – Faron Pharmaceuticals Oy (“Faron” or “Company”) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce that, following the announcement on 28 February 2017, the proposed Placing and Subscription has been subscribed in full, in fulfilment of the Placee Condition, and all subscription monies have now been received by the Company. Pursuant to the Placing and Subscription, the Company is raising approximately £5.0 million before expenses by way of the Placing of 1,362,340 Placing Shares and the Subscription of 60,000 Subscription Shares at the Issue Price of 350 pence per share. The Placing and Subscription have been supported by the participation of existing and new institutional shareholders. 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 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 today, 1 March 2017.

Application has been made to the London Stock Exchange for admission to trading on AIM of the 1,422,340 Placing Shares and Subscription Shares (in aggregate) (“Admission”), and it is expected that Admission will take place at 8:00 a.m. on Friday 3 March 2017.

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 27,734,044 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 27,734,044 (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 Enlarged Number of Shares and Votes of the Company.

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

“We are delighted by the interest we have received in this oversubscribed financing round, and would like to thank our existing and new institutional investors for their support and continued committment to Faron. This funding will be invaluable as we continue the advancement of our programmes during what is set to be a pivotal year for the Company. As well as expecting to receive data from our Phase III INTEREST trial in the second half of the year, we can now look forward to expanding the pre-clinical and planned clinical development of Clevegen into further solid tumour indications including ovarian, pancreatic and melanoma. We believe that Clevegen’s ability to remove immune suppressision around tumours will be the next important step in the fight against tumour growth and spread, and could lead to complete cancer remission as well as providing long term vaccination against future tumours from the patient’s own immune system.”

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 28 February 2017.

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

E-mail: investor.relations@faronpharmaceuticals.com

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Lindsey Neville, Rosie Phillips

Phone: +44 203 709 5700

E-Mail: Faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: +1 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Lead Bookrunner and Corporate Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Joint Corporate 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 pan-European (INTEREST) and Japanese pivotal Phase III studies, and is commencing a European Phase II trial for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology (“TIET”) and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

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.