Faron, etusivu

FDA grants Fast Track Designation for Traumakine®

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

FDA approval of Faron’s Traumakine® IND

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

FDA has approved Faron’s Traumakine® IND

TURKU – FINLAND, 24 January 2018 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) Application for Traumakine, the Company’s wholly-owned product for the treatment of Acute Respiratory Distress Syndrome (ARDS), which is part of the regulatory process towards BLA submission.

The FDA has already proposed that Faron can proceed directly to Biologics License Application (BLA) pending positive results from the two on-going Phase III trials (INTEREST in Europe and MR11A8-2 in Japan) and the IND forms part of this process towards BLA submission. Faron also continues to consider providing access to Traumakine in the US to ARDS patients under an expanded access program, which requires an IND. Top-line data from the INTERST study is due in the first half of 2018.

Faron is also planning to conduct a small open label study in the US for pharmacological purposes and the IND will allow opening of clinical activities in the US. This first US study will target Traumakine (drug product FP-1201-lyo) in moderate and severe ARDS patients, especially with end organ (kidney and liver) failures.

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 to receive this IND approval from the FDA which will allow us to further advance our Traumakine plans in the US. It also allows rolling dossier build up for FDA, which can speed up the final BLA acceptance. With data expected in H1 2018 and, following previous guidance from the FDA, we remain hopeful that we can expedite Traumakine’s route to market addressing this significant unmet medical need in terms of reducing mortality and providing savings for healthcare systems.”

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, 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

INFORAAA trial receives recommendation from IDMC

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Study update: Traumakine® Phase II/III INFORAAA trial for Multi-Organ Failure receives recommendation from IDMC

First recommendation received from the IDMC to continue study as planned

TURKU – FINLAND, 19 December 2017 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces that it has received the first recommendation from the Independent Data Monitoring Committee (IDMC) of the INFORAAA study to continue the trial as planned using Faron’s wholly owned lead product, Traumakine®.  The study currently has six open sites in Finland, two in Lithuania and one in Estonia. The first sites in the UK will open in the beginning of 2018. The INFORAAA study aims to treat a total of 160 post-operative Ruptured Abdominal Aorta Aneurysm (RAAA) patients and the interim results are expected in H2 2018.

The Phase II/III INFORAAA clinical trial of Traumakine for the treatment of Multi-Organ Failure (MOF) and mortality prevention in surgically operated RAAA patients is based on a similar treatment regimen to the regimen used in patients in the Company’s recently completed Phase III INTEREST trial for Acute Respiratory Distress Syndrome (ARDS). The high mortality rate of RAAA, which accounts for 4-5 deaths per 100,000 population (Karthikesalingam et al., 2014), requires new treatments to prevent post-operative reperfusion injury, the principal cause leading to the death of RAAA patients, who demonstrate a 30-50% mortality rate post-operatively. RAAA accounts for 13-14/100,000 hospital admissions annually (Anjum et al., 2012), and is Faron’s second indication for Traumakine in clinical evaluation. 

Patients with RAAA frequently experience Systemic Inflammatory Response Syndrome (SIRS), despite successful open surgical repair, which can especially affect the heart, lungs, kidneys, and intestines. The death of approximately 80% of the operated RAAA patients is caused by MOF, similar to patients with Acute Respiratory Distress Syndrome (ARDS). The Directors of Faron consider that data seen to date support the rationale for extending the use of Traumakine in similar conditions to potentially treat single, and multiple, organ failures. Data demonstrated during the Traumakine Phase I/II study showed a reduced need for haemodialysis (an indication of improved kidney function) among the ARDS patients dosed with Traumakine.

Separately, in Faron’s Phase III INTEREST trial of Traumakine, the Company recently completed recruiting patients being studied for the treatment of moderate to severe ARDS.  Top-line data from the INTEREST trial is due in H1 2018.  In September 2017 Faron received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  In October 2017, Faron received notification from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) that Traumakine was granted Promising Innovative Medicines (PIM) designation.  There is currently no approved pharmaceutical treatment for ARDS.

Dr Markku Jalkanen, CEO of Faron, said: “This is another piece of good news for Faron during a highly successful year and we are now focused on demonstrating that our wholly-owned lead product, Traumakine, has applicability in RAAA patients as well as in the ARDS indication. RAAA patients go through a serious surgical procedure which currently often results in major organ failure. This study is designed to demonstrate that major organs including the kidney, liver and GI-tract could recover if patients are dosed with Traumakine. 2018 is well set to be a pivotal year for Faron given our Phase III INTEREST read out in H1 and we look forward to the coming months with great confidence.”

About Ruptured Abdominal Aortic Aneurysm (RAAA)

Ruptured Abdominal Aortic Aneurysm (RAAA) is a surgical emergency with an overall mortality of 70 to 80%. It requires immediate surgery and aortic repair. Approximately half of the deaths of RAAA patients are due to not reaching the hospital in time, and despite immediate surgery and intensive care treatment, the second half dies in hospital within 30 days post-operatively, mostly due to multi-organ failure. The cause of high post-operative mortality is mainly due to prolonged hypotension/hypoxia from the ruptured aorta and the aftermath of restoring blood flow: reperfusion, vascular leakage and failure of vital organs. Currently there are an estimated 40,000 US and European patients per annum eligible for the treatment.

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

Faron announces R&D Day in February 2018

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron announces R&D Day in February 2018

TURKU – FINLAND, 14 December 2017 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announces plans to host an R&D Day on Wednesday, 21 February 2018, at Panmure Gordon’s offices, One New Change, London, EC4M 9AF. The event will provide an opportunity to hear about the Company, its R&D strategy and pipeline developments, with a focus on Clevegen, Faron’s second wholly-owned pipeline product approaching the start of Phase I/II development in 2018.

Clevegen is a novel anti-Clever-1 antibody, which causes changes in the immune environment of solid tumours by switching immune suppressive M2 macrophages to immune active M1 macrophages. Based on this unique mechanism of action, promising pre-clinical data and human ex vivo data, Clevegen could have potential in a broad range of indications, including immuno-oncology, chronic infections and vaccination enhancement.

The R&D event will provide an update on Clevegen’s manufacturing, regulatory and scientific progress, in addition to an update on the clinical development plan. The Phase I/II trial will target patients with liver, melanoma, ovarian and pancreatic cancer as part of an adaptive protocol design, which is currently under review by regulators, with feedback anticipated in early 2018.

Faron will also provide an update on Traumakine, its lead wholly-owned product for the treatment of moderate to severe Acute Respiratory Distress Syndrome (ARDS) following the completion of recruitment in the Phase III INTEREST trial, and for which the top-line data are expected to become available in H1 2018.

For further information on the R&D day, or to register for the event, please contact Consilium Strategic Communications at faron@consilium-comms.com or telephone +44 (0)20 3709 5700.

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

Recruitment completed in Traumakine INTEREST Trial

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

Holding(s) in Company

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:

Faron Pharmaceuticals Oy
7437009H31TO1DC0EB42

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

X

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii:  Disclosure as per company’s Articles of Association

X

3. Details of person subject to the notification obligationiv

Name

Legal & General Group Plc (Group)

Legal & General Investment Management Limited (LGIM)

City and country of registered office (if applicable)

1 Coleman St, London EC2R 5AA

4. Full name of shareholder(s) (if different from 3.)v

Name


Legal & General Assurance Society (LGAS)

City and country of registered office (if applicable)

1 Coleman St, London EC2R 5AA

5. Date on which the threshold was crossed or reachedvi:

22 November 2017

6. Date on which issuer notified (DD/MM/YYYY):

23 November 2017

7. Total positions of person(s) subject to the notification obligation

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights of issuervii

Resulting situation on the date on which threshold was crossed or reached

4.68%

–

4.68%

29,164,544

Position of previous notification (if

applicable)

5.19%

–

5.19%

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

ORD NPV

1,365,000

4.68%

SUBTOTAL 8. A

1,365,000

4.68%

B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Periodxi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Period xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

SUBTOTAL 8.B.2

9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary)

x

Namexv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

Legal & General Group (Direct/Indirect)

4.68%

4.68%

Legal & General Investment Management (Holdings) Limited

(Direct/Indirect)

4.68%

4.68%

Legal & General Assurance Society (Direct)

0.66%

0.66%

Legal & General Group (Direct/Indirect)

4.68%

4.68%

Legal & General Investment Management (Holdings) Limited

(Direct/Indirect)

4.68%

4.68%

Legal & General Assurance (Pensions Management) Limited

(Direct)

–

–

Legal & General Group (Direct/Indirect)

4.68%

4.68%

Legal & General Investment Management (Holdings) Limited

(Direct/Indirect)

4.68%

4.68%

Legal & General Investment Management Limited (Indirect)

4.68%

4.68%

Legal & General Group (Direct/Indirect)

4.68%

4.68%

Legal & General Investment Management (Holdings) Limited

(Direct/Indirect)

4.68%

4.68%

Legal & General (Unit Trust Managers) Limited (Indirect)

4.01%

4.01%

10. In case of proxy voting, please identify:

Name of the proxy holder

N/A

The number and % of voting rights held

N/A

The date until which the voting rights will be held

N/A

11. Additional informationxvi

Notification using the total voting rights figure of 29,164,544

Place of completion

Brunel House, 2 Fitzalan Road, Cardiff, CF24 0EB

Date of completion

22/11/2017

Holdings in Company

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:

Faron Pharmaceuticals Oy

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

X

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii: New issue

3. Details of person subject to the notification obligationiv

Name

City Financial Investment Company Limited, acting as Investment Manager and Authorised Corporate Director of the City Financial Absolute Equity Fund

City and country of registered office (if applicable)

London, United Kingdom

4. Full name of shareholder(s) (if different from 3.)v

Name

BNY Mellon Trust and Depositary as Trustee to the City Financial Absolute Equity Fund

City and country of registered office (if applicable)

London, United Kingdom

5. Date on which the threshold was crossed or reachedvi:

30/11/2017

6. Date on which issuer notified (DD/MM/YYYY):

01/12/2017

7. Total positions of person(s) subject to the notification obligation

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights of issuervii

Resulting situation on the date on which threshold was crossed or reached

3.88%

0

3.88%

1,132,530

Position of previous notification (if

applicable)

4.02%

N/A

4.02%

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

FI4000153309

1,132,530

0

3.88%

0

SUBTOTAL 8. A

1,132,530

3.88%

B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Periodxi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Period xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

SUBTOTAL 8.B.2

9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii

X

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary)

Namexv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

10. In case of proxy voting, please identify:

Name of the proxy holder

NA

The number and % of voting rights held

NA

The date until which the voting rights will be held

NA

11. Additional informationxvi

Place of completion

City Financial Investment Company Limited, London

Date of completion

01/12/2017

Appointment of Chief Commercial Officer

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Appointment of Chief Commercial Officer

Dr. Juhana Heinonen, previously AstraZeneca’s Global Marketing Director, to steer commercialisation strategy for Faron’s lead candidate Traumakine  

TURKU – FINLAND, 01 December 2017 – Faron Pharmaceuticals Oy (“Faron” or “Company“) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce the appointment of Dr. Juhana Heinonen as Chief Commercial Officer to join the Company in January 2018.

Dr Heinonen joins Faron from AstraZeneca where he served as the Global Marketing Director for AstraZeneca/Medimmune’s Fasenra (benralizumab) for the treatment of asthma, the first biologic medication launched from the AstraZeneca respiratory unit. Dr Heinonen led global market shaping and patient and healthcare professional support strategy development for the new monoclonal antibody, which met the primary endpoints in two Phase III clinical trials in 2016. Prior to this, he held a variety of positions in sales and marketing at Roche between 2008 and 2015, successfully leading the launch and development of a global marketing strategy for the blockbuster treatment for rheumatoid arthritis, RoACTEMRA (tocilizumab).

At Faron, Dr Heinonen will be directly responsible for the development and execution of a pre-launch and launch commercialisation strategy for Faron‘s wholly-owned lead candidate, Traumakine. Traumakine is currently in late stage Phase III clinical trials for the treatment of Acute Respiratory Distress Syndrome (ARDS). This work will pave the way for Traumakine to enter markets post approval of European MAA and US BLA.

Commenting on the CCO’s appointment, Dr Markku Jalkanen, CEO of Faron, said:

“I am delighted to announce the appointment of Juhana to the new role of Chief Commercial Officer. He has a wealth of expertise in the commercialisation and marketing of blockbuster drugs, and will be a key addition to the Faron team as we continue our preparations to enter commercialisation. We look forward to benefitting from his experience and valuable insights as our wholly-owned lead product, Traumakine, approaches the completion of its pivotal Phase III INTEREST trial.”

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

Panmure Gordon (UK) Limited, Nominated Adviser and Broker

Freddy Crossley, Duncan Monteith (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

Holding(s) in Company

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:

Faron Pharmaceuticals Oy
7437009H31TO1DC0EB42

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

X

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii:

3. Details of person subject to the notification obligationiv

Name

Legal & General Group Plc (Group)

Legal & General Investment Management Limited (LGIM)

City and country of registered office (if applicable)

1 Coleman St, London EC2R 5AA

4. Full name of shareholder(s) (if different from 3.)v

Name


Legal & General Assurance Society (LGAS)

City and country of registered office (if applicable)

1 Coleman St, London EC2R 5AA

5. Date on which the threshold was crossed or reachedvi:

22 November 2017

6. Date on which issuer notified (DD/MM/YYYY):

23 November 2017

7. Total positions of person(s) subject to the notification obligation

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights of issuervii

Resulting situation on the date on which threshold was crossed or reached

Below 5%

–

Below 5%

29,164,544

Position of previous notification (if

applicable)

5.19%

–

5.19%

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

ORD NPV

Below 5%

Below 5%

SUBTOTAL 8. A

Below 5%

Below 5%

B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Periodxi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Period xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

SUBTOTAL 8.B.2

9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary)

x

Namexv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

Legal & General Group (Direct/Indirect)

Below 5%

Below 5%

Legal & General Investment Management (Holdings) Limited

(Direct/Indirect)

Below 5%

Below 5%

Legal & General Assurance Society (Direct)

Below 3%

Below 3%

Legal & General Group (Direct/Indirect)

Below 5%

Below 5%

Legal & General Investment Management (Holdings) Limited

(Direct/Indirect)

Below 5%

Below 5%

Legal & General Assurance (Pensions Management) Limited

(Direct)

–

–

Legal & General Group (Direct/Indirect)

Below 5%

Below 5%

Legal & General Investment Management (Holdings) Limited

(Direct/Indirect)

Below 5%

Below 5%

Legal & General Investment Management Limited (Indirect)

Below 5%

Below 5%

Legal & General Group (Direct/Indirect)

Below 5%

Below 5%

Legal & General Investment Management (Holdings) Limited

(Direct/Indirect)

Below 5%

Below 5%

Legal & General (Unit Trust Managers) Limited (Indirect)

Below 5%

Below 5%

10. In case of proxy voting, please identify:

Name of the proxy holder

N/A

The number and % of voting rights held

N/A

The date until which the voting rights will be held

N/A

11. Additional informationxvi

Notification using the total voting rights figure of 29,164,544

Place of completion

Brunel House, 2 Fitzalan Road, Cardiff, CF24 0EB

Date of completion

22/11/2017

Grant of options

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Grant of options

TURKU – FINLAND, 21 November 2017 – Faron (LON: FARN), the clinical stage biopharmaceutical company, announces that on 16 November 2017 the Board of Faron confirmed the subscription for a total of 500,000 C options over ordinary shares in the Company (“Options”) under the Faron 2015 Option Plan. The Options have been allocated under the Faron 2015 Option Plan and are exercisable between 8 October 2017 and 30 September 2021 at an exercise price of 839 euro cents per share. The exercise price is calculated based on the average share price between 1 July and 30 September 2017. The details of the 2015 Option Plan, as amended, are described in the 2017 annual general meeting material, which is available on Company’s website.

The granted 500,000 Options entitle the option holders to subscribe for a total of 500,000 new ordinary shares in the Company, if exercised in full, and represent 1.68% of the fully-diluted Ordinary Share Capital of the Company.

Included in the number of Options in respect of which the Board of Faron has confirmed subscriptions are the following Options which were issued to Directors and other Persons Discharging Managerial Responsibility (“PDMRs”):

Director                                 

Options granted

Markku Jalkanen

80,000

Frank Armstrong

40,000

Yrjö E K Wichmann

30,000

Matti Manner

20,000

Jonathan Knowles

20,000

Huaizheng Peng

20,000

Leopoldo Zambeletti

20,000

Gregory Brown

20,000

John Poulos

20,000

Total Directors

270,000

PDMRs 

Mikael Maksimow

32,270

Matti Karvonen

32,270

Jami Mandelin

32,270

Juho Jalkanen

32,270

Total PDMRs

129,080

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

Panmure Gordon (UK) Limited, Nominated Adviser and Broker

Freddy Crossley, Duncan Monteith (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

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Markku Jalkanen

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

80,000

d.

Aggregated information

– Aggregated Volume

– Price

80,000

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Frank Armstrong

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

40,000

d.

Aggregated information

– Aggregated Volume

– Price

40,000

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Yrjö E K Wichmann

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

30,000

d.

Aggregated information

– Aggregated Volume

– Price

30,000

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Matti Manner

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

20,000

d.

Aggregated information

– Aggregated Volume

– Price

20,000

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Jonathan Knowles

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

20,000

d.

Aggregated information

– Aggregated Volume

– Price

20,000

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Huaizheng Peng

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

20,000

d.

Aggregated information

– Aggregated Volume

– Price

20,000

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Leopoldo Zambeletti

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

20,000

d.

Aggregated information

– Aggregated Volume

– Price

20,000

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Gregory Brown

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

20,000

d.

Aggregated information

– Aggregated Volume

– Price

20,000

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

John Poulos

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

20,000

d.

Aggregated information

– Aggregated Volume

– Price

20,000

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Mikael Maksimow

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

32,270

d.

Aggregated information

– Aggregated Volume

– Price

32,270

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Matti Korvonen

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

32,270

d.

Aggregated information

– Aggregated Volume

– Price

32,270

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Jami Mandelin

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

32,270

d.

Aggregated information

– Aggregated Volume

– Price

32,270

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Juho Jalkanen

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 839 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

32,270

d.

Aggregated information

– Aggregated Volume

– Price

32,270

Nil

e.

Date of the transaction

16 November 2017

f.

Place of the transaction

Turku
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