News – Page 34

New data published on Clever-1 function

12.9.2018

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Clever-1 participates in the control of humoral (antibody-mediated) immunity

– New data published by Frontiers in Immunology

TURKU – FINLAND, 12 September 2018 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces today new data on Clever-1 function in the control of antibody production by B-lymphocytes (B cells).

Clever-1, a cell surface receptor expressed mainly by endothelial cells and monocytes/macrophages, has previously been shown to control cell-mediated immunity (Palani et al. 2016). The recent work by Dunkel and colleagues, published online by Frontiers in Immunology, shows for the first time that Clever-1 also participates in the control of B cell response and humoral antibody production. The data suggest that Clever-1 serves as an endogenous immunosuppressive molecule in monocytes/macrophages, where it maintains the production of inflammatory cytokines at physiological levels. When Clever-1 is removed from monocytes/macrophages, one consequence of the unrestrained production of inflammatory cytokines is the increased antibody production by B cells.

Deleting or neutralizing Clever-1 has previously been reported to augment antitumor immune responses in melanoma, lymphoma and breast cancer. The efficacy of anti-Clever-1 antibodies in these experimental models supports Faron’s development of Clevegen, its fully human anti-Clever-1 antibody, under investigation as a potential cancer immunotherapy and due to enter the clinic later this year.

The observations by Dunkel et al suggest that disrupting the function of Clever-1 should not lead to the suppression of antibody production but, rather, could improve humoral immune responses against tumor antigens and during vaccinations.

Commenting on this finding, Dr Markku Jalkanen, CEO of Faron, said: “This is a fascinating finding and builds up further evidence for the importance to control Clever-1 function in conditions where active immune suppression can cause disease or worsen disease development. It provides further scientific rationale for our Vaccination Response Enhancement Technology (VRET) programme, which is currently under early investigation with Clevegen.”

Referred article: Dunkel J, Viitala M, Karikoski M, Rantakari P, Virtakoivu R, Hollmén M, Jalkanen S and Salmi M. Macrophage Clever-1 regulates antibody production. Frontiers in Immunolgy. On line code Front. Immunol. | doi: 10.3389/fimmu.2018.02257

https://www.frontiersin.org/articles/10.3389/fimmu.2018.02257/abstract

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Matthew Neal, 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

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, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (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

9.7.2018

RNS Number : 9946T

Faron Pharmaceuticals Oy

09 July 2018

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:
3. Details of person subject to the notification obligation^iv
Name			Tom-Erik Lind
City and country of registered office (if applicable)
4. Full name of shareholder(s) (if different from 3.)^v
Name
City and country of registered office (if applicable)
5. Date on which the threshold was crossed or reached^vi:			05.07.2018
6. Date on which issuer notified (DD/MM/YYYY):			06.07.2018
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 issuer^vii
Resulting situation on the date on which threshold was crossed or reached	9,07 %			9,07 %	31,027,894
Position of previous notification (if applicable)	8,23 %			8,23 %

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached^viii
A: Voting rights attached to shares
Class/type of shares ISIN code (if possible)		Number of voting rights^ix					% 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		2,813,835					9,07 %


SUBTOTAL 8. A		2,813,835					9,07 %

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 date^x	Exercise/ Conversion Period^xi			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 date^x		Exercise/ Conversion Period ^xi		Physical or cash settlement^xii			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) issuer^xiii				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 entity^xiv (please add additional rows as necessary)
Name^xv	% 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
The number and % of voting rights held
The date until which the voting rights will be held

11. Additional information^xvi

Place of completion	Tampere
Date of completion	09/07/2018

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com or visit
www.rns.com.

END

HOLFMGGNNLKGRZG

Clevegen successful toxicity studies

28.6.2018

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Clevegen shows good safety and potential to block Clever-1 on circulating monocytes

· Wholly-owned Clevegen (FP-1305) shows no toxicity in dose escalation studies in large preclinical models

· The no-observed-adverse-effect-level (NOAEL) was 100 mg/kg, which is roughly 30 times higher concentration than needed for Clever-1 occupancy in vivo

· Clevegen also blocked Clever-1 on circulating monocytes as expected. The duration of blocking was dose dependent and resumed to normal level in 20 days in the highest dose

· The Company expects CTA filing for MATINS study in Q3 2018 and first patient recruitment in Q4 2018

TURKU – FINLAND, 28 June 2018 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, today announces successful toxicity studies and control of blood Clever-1 positive monocytes, precursor cells to tumour associated macrophages (TAM) in large preclinical models.

The toxicity studies were designed to fulfil regulatory requirements for 3-week interval intravenous administration of Clevegen, typical for other anti-cancer antibodies currently in use. FP-1305 is a humanized IgG4 monoclonal antibody produced in CHO -cells by Faron collaborator Abzena. The FP-1305 drug product in its final formulation was administered as a single dose at 3, 30 and 100 mg/kg.

No toxicologically relevant changes were observed in any subject. No major changes were observed after treatment with FP-1305 in T lymphocytes subsets. The binding of Clevegen to its receptor on circulating CD14+ monocytes was confirmed by investigating the receptor occupancy, the recovery of which occurred between 3 to 20 days after dosing in a dose-dependent manner. No relevant changes were present in cytokines and no anti-drug antibodies (ADA) were detected in any subject. Therefore, the highest dose of 100 mg/kg was considered the no-observed-adverse-effect-level (NOAEL).

Dr Markku Jalkanen, CEO of Faron, said: “We are very encouraged to find out about the good safety profile of our wholly-owned asset Clevegen and the high NOAEL concentration. We were also delighted to learn that Clevegen administration blocks Clever-1 on circulating monocytes, which are one group of our target cells in our MATINS Phase I/II clinical trial. Our plan is now to file the MATINS clinical trial application (CTA) during Q3 2018 and, as previously announced, initiate this first Clevegen human trial in Q4 2018.”

About MATINS trial: MATINS study is first-in-human open label Phase I/II adaptive clinical trial in selected metastatic or inoperable solid tumours to investigate the safety and efficacy of Clevegen (FP-1305). The selected tumours are cutaneous melanoma, hepatobiliary, pancreatic, ovarian or colorectal cancer, which are all known to contain high amounts of Clever-1 positive TAMs. The trial is to be run in three parts. Part I will be conducted to determine the safe and tolerable dose of Clevegen, which will then be used in Part II to expand the cohorts of individual tumour types. Part III of the trial aims to confirm the efficacy of Clevegen with the cohorts selected based on Part II.

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, 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, Emma Earl, Ryan McCarthy

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Holdings in Company

22.6.2018

TR-1: Standard form for notification of major holdings


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 obligation^iv
Name			Legal & General Group Plc (Group) Legal & General Investment Management Limited (LGIM) Legal & General (Unit Trust Managers) Limited
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 reached^vi:			19 June 2018
6. Date on which issuer notified (DD/MM/YYYY):			21 June 2018
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 issuer^vii
Resulting situation on the date on which threshold was crossed or reached (LGIM)	0.37%	–		0.37%	31,027,894
Position of previous notification (if applicable) (LGIM)	1.53%	–		1.53%
Resulting situation on the date on which threshold was crossed or reached (UTM)	0.30%	–		0.30%	31,027,894
Position of previous notification (if applicable) (UTM)	1.26%	–		1.26%

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached^viii
A: Voting rights attached to shares
Class/type of shares ISIN code (if possible)		Number of voting rights^ix					% 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		–		116,000			–		0.37%
SUBTOTAL 8. A		116,000					0.37%

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 date^x	Exercise/ Conversion Period^xi			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 date^x		Exercise/ Conversion Period ^xi		Physical or cash settlement^xii			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) issuer^xiii
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 entity^xiv(please add additional rows as necessary)				x
Name^xv	% 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)	0.37%		0.37%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	0.37%		0.37%
Legal & General Assurance Society (Direct)	0.06%		0.06%

Legal & General Group (Direct/Indirect)	0.37%		0.37%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	0.37%		0.37%
Legal & General Assurance (Pensions Management) Limited (Direct)	–		–

Legal & General Group (Direct/Indirect)	0.37%		0.37%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	0.37%		0.37%
Legal & General Investment Management Limited (Indirect)	0.37%		0.37%

Legal & General Group (Direct/Indirect)	0.37%		0.37%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	0.37%		0.37%
Legal & General (Unit Trust Managers) Limited (Indirect)	0.31%		0.31%

Legal & General Group (Direct/Indirect)	0.37%		0.37%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	0.37%		0.37%
Go ETF Solutions	–		–

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 information^xvi
Notification using the total voting rights figure of 31,027,894

Place of completion	Brunel House, 2 Fitzalan Road, Cardiff, CF24 0EB
Date of completion	21/06/2018

Director/PDMR Shareholding

21.6.2018

RNS Number : 1926S

Faron Pharmaceuticals Oy

21 June 2018

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

PDMR Dealings and

Person Closely Associated with PDMR Dealings

TURKU – FINLAND, 21 June 2018 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announces that on 21 June 2018 it was notified of the following PDMR and persons closely associated dealings.

On 19 June 2018, Mr Matti Manner, the Non-Executive Director of Faron had acquired 15,500 ordinary shares in Faron at a price of 56 pence per ordinary share, and a person closely associated with him had acquired 7,900 ordinary shares in Faron at a price of 56 pence per ordinary share.

On 20 June 2018, Mr Yrjö Wichmann, Chief Financial Officer of Faron had acquired 5,200 ordinary shares in Faron at a price of 67 pence per ordinary share and on 21 June 2018, Dr. Pessi Honkasalo, Corporate Legal Counsel of Faron had acquired 1,500 ordinary shares in Faron at a price of 75 pence per ordinary share.

On 21 June 2018, Dr Matti Karvonen, Medical Director of Faron, had acquired 15,000 ordinary shares in Faron at a price of 56 pence per ordinary share and a person closely associated with him had acquired 31,000 ordinary shares in Faron at a price of 57 pence per ordinary share.

On 21 June 2018, Dr. Markku Jalkanen, Chief Executive Officer of Faron, had acquired 12,000 ordinary shares and a person closely associated with him had acquired 24,000 ordinary shares in Faron at a price of 71 pence per ordinary share. Also on 21 June 2018, Dr. Juho Jalkanen, Chief Development Officer of Faron had acquired 12,000 ordinary shares in Faron at a price of 71 pence per ordinary share.

The notification below, which has been made in accordance with the requirements of the EU Market Abuse Regulation, provides further detail.

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

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 Susanna Hedenström Yrjö Wichmann Pessi Honkasalo Matti Karvonen Minja Pfeiffer Markku Jalkanen Mehto Saima Kuolinpesä Juho Jalkanen
2	Reason for notification
a.	Position/Status	Person discharging managerial responsibilities / person closely associated – Non-Executive Director and a person closely associated with him – Chief Financial Officer – Corporate Legal Counsel – Medical Director and a person closely associated with him – Chief Executive Officer and a person closely associated with him – Chief Development Officer
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	Ordinary shares ISIN: FI4000153309
b.	Nature of the transaction	Purchase of ordinary shares
c.	Price(s) and volume(s)
			Price(s)	Volume(s)
			56.00 GBPp 56.00 GBPp 67.00 GBPp 75.00 GBPp 56.00 GBPp 57.00 GBPp 71.00 GBPp 71.00 GBPp 71.00 GBPp	15,500 7,900 5,200 1,500 15,000 31,000 12,000 24,000 12,000

d.	Aggregated information – Aggregated Volume – Price	N/A N/A
e.	Date of the transaction	June 19, 2018, June 20, 2018 and June 21, 2018
f.	Place of the transaction	London Stock Exchange, AIM Market

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com

Consilium Strategic Communications
Mary-Jane Elliott, Philippa Gardner, Matthew Neal, 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, Emma Earl, Ryan McCarthy
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, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (“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 preclinical 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

END

DSHFKDDPQBKDAAB

Director/PDMR Shareholding

21.6.2018

RNS Number : 1056S

Faron Pharmaceuticals Oy

21 June 2018

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

PDMR Dealing

TURKU – FINLAND, 21 June 2018 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announces that on 20 June 2018 it was notified that Dr Frank Armstrong, the Non-Executive Chairman of Faron, had acquired 13,300 ordinary shares in Faron at a price of 75 pence per ordinary share.

The notification below, which has been made in accordance with the requirements of the EU Market Abuse Regulation, provides further detail.

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

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 Non-Executive Director
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	Ordinary shares ISIN: FI4000153309
b.	Nature of the transaction	Purchase of ordinary shares
c.	Price(s) and volume(s)
			Price(s)	Volume(s)
			75.00 GBPp	13,300

d.	Aggregated information – Aggregated Volume – Price	N/A N/A
e.	Date of the transaction	June 20, 2018
f.	Place of the transaction	London Stock Exchange, AIM Market

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, 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, Emma Earl, Ryan McCarthy
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, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (“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 preclinical 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

END

DSHFKDDNABKKFAB

Holding(s) in Company

20.6.2018

TR-1: Standard form for notification of major holdings


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 obligation^iv
Name			Legal & General Group Plc (Group) Legal & General Investment Management Limited (LGIM) Legal & General (Unit Trust Managers) Limited
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 reached^vi:			15 June 2018
6. Date on which issuer notified (DD/MM/YYYY):			19 June 2018
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 issuer^vii
Resulting situation on the date on which threshold was crossed or reached (LGIM)	1.53%	–		1.53%	31,027,894
Position of previous notification (if applicable) (LGIM)	2.98%	–		2.98%
Resulting situation on the date on which threshold was crossed or reached (UTM)	1.26%	–		1.26%	31,027,894
Position of previous notification (if applicable) (UTM)	2.90%	–		2.90%

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached^viii
A: Voting rights attached to shares
Class/type of shares ISIN code (if possible)		Number of voting rights^ix					% 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		–		476,000			–		1.53%
SUBTOTAL 8. A		476,000					1.53%

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 date^x	Exercise/ Conversion Period^xi			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 date^x		Exercise/ Conversion Period ^xi		Physical or cash settlement^xii			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) issuer^xiii
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 entity^xiv(please add additional rows as necessary)				x
Name^xv	% 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)	1.53%		1.53%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	1.53%		1.53%
Legal & General Assurance Society (Direct)	0.27%		0.27%

Legal & General Group (Direct/Indirect)	1.53%		1.53%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	1.53%		1.53%
Legal & General Assurance (Pensions Management) Limited (Direct)	–		–

Legal & General Group (Direct/Indirect)	1.53%		1.53%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	1.53%		1.53%
Legal & General Investment Management Limited (Indirect)	1.53%		1.53%

Legal & General Group (Direct/Indirect)	1.53%		1.53%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	1.53%		1.53%
Legal & General (Unit Trust Managers) Limited (Indirect)	1.26%		1.26%

Legal & General Group (Direct/Indirect)	1.53%		1.53%
Legal & General Investment Management (Holdings) Limited (Direct/Indirect)	1.53%		1.53%
Go ETF Solutions	–		–

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 information^xvi
Notification using the total voting rights figure of 31,027,894

Place of completion	Brunel House, 2 Fitzalan Road, Cardiff, CF24 0EB
Date of completion	19/06/2018

Holdings in Company

18.6.2018

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:
3. Details of person subject to the notification obligation^iv
Name			CANACCORD GENUITY GROUP INC
City and country of registered office (if applicable)			VANCOUVER, CANADA
4. Full name of shareholder(s) (if different from 3.)^v
Name			DISCRETIONARY CLIENTS
City and country of registered office (if applicable)			As above
5. Date on which the threshold was crossed or reached^vi:			14 JUNE 2018
6. Date on which issuer notified (DD/MM/YYYY):			18 JUNE 2018
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 issuer^vii
Resulting situation on the date on which threshold was crossed or reached	4.7566			4.7566	31,027,894
Position of previous notification (if applicable)	5.2686			5.2686

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached^viii
A: Voting rights attached to shares
Class/type of shares ISIN code (if possible)	Number of voting rights^ix		% of voting rights
Class/type of shares ISIN code (if possible)	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	N/A	1,475,875	N/A	4.7566

SUBTOTAL 8. A		1,475,875				4.7566

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 date^x	Exercise/ Conversion Period^xi		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 date^x		Exercise/ Conversion Period ^xi	Physical or cash settlement^xii			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) issuer^xiii
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 entity^xiv(please add additional rows as necessary)				X
Name^xv	% 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
Canaccord Genuity Group Inc.	4.7566		4.7566
Canaccord Genuity Wealth Group Holdings Limited	4.7566		4.7566
Canaccord Genuity Wealth Group Holdings (Jersey) Limited	4.7566		4.7566
Hargreave Hale Ltd	4.7566		4.7566

10. In case of proxy voting, please identify:
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held

11. Additional information^xvi

Place of completion	BLACKPOOL, ENGLAND
Date of completion	18 JUNE 2018

Biomarker analysis of Phase III INTEREST trial

14.6.2018

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Traumakine biomarker analysis of the Phase III INTEREST trial

· Sub-group of patients with elevated interferon-beta biomarkers show a reduced mortality

· This sub-group of patients (n=48) showed a reduced Day 28 (D28) mortality rate of 14.6% compared to 32.3% (p=0.02) in Traumakine treated patients without a defined biomarker response (n=96).

· The sub-group of patients with a defined biomarker response also demonstrated an increase in ventilator free days to 16 days compared to 6.5 days (p=0.06)

· Analyses are ongoing to understand the underlying causes of the inconsistent biomarker response of the Traumakine treatment group

TURKU – FINLAND, 14 June 2018 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, today announces preliminary biomarker data from its Phase III INTEREST trial of Traumakine for the treatment of ARDS. Top-line trial data were previously reported on 8 May 2018 and an update was provided on 11 May 2018.

The biomarker data confirms that Traumakine treatment did not produce consistent interferon-beta bioactivity across the treatment group. A retrospective stratification of Traumakine treated patients has been conducted, based on subjects in the INTEREST trial that demonstrated a defined biomarker response. These were defined as patients with a 2-fold increase in CD73 serum levels during the first seven days of treatment and 3-fold MxA activation (during the first four days of treatment) in peripheral blood cells.

This sub-group of patients (n=48) demonstrated a reduced D28 all-cause mortality, with a mortality rate of 14.6% compared to 32.3% in the remaining patients (n=96) in the Traumakine treatment arm (p=0.02). In addition, this sub-group of patients demonstrated a trend toward an increase in ventilator free days at D28, with 16 ventilator free days (VFDs) compared to 6.5 days (p=0.06).

While these remain initial findings, this data suggests a correspondence to previous results observed in the Phase II study. In the Phase II trial patients with an elevated MxA and CD73 biomarker response also demonstrated an improved D28 mortality and reduced need for ventilation compared to patients with low or no increase in biomarkers.

Dr Markku Jalkanen, CEO of Faron, said: “We have observed that a sub-group of patients with higher levels of biomarkers in the INTEREST trial did demonstrate reduced mortality and increased ventilator free days, as expected based on the positive Phase II study. While this is encouraging this still does not explain many of the other results observed from the trial including why Traumakine activity was variable in the INTEREST trial compared to previous studies nor the low mortality of the placebo group. This analysis will continue and we will keep our shareholders and the market informed with progress in due course.”

The INTEREST trial was a Phase III double-blind, randomised, parallel-group comparison to assess the efficacy and safety of Traumakine^® (FP-1201-lyo) versus placebo in the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). The study, which recruited 300 patients, was conducted in 64 hospital intensive care units (ICU) in Belgium, the Czech Republic, Finland, France, Germany, Italy, Spain and the UK.

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.

The Company has initiated a cash preservation program by suspending the Traumakine commercialization activities and regulatory filings and minimizing the cost burden on Traumakine manufacturing and general and administrative costs. The Management and Directors are working to ensure that the Company’s cash position is preserved and that value is delivered to shareholders. The Company had €18.7 million of cash at the end of Q1 2018.

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, Philippa Gardner, Matthew Neal, 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, Emma Earl, Ryan McCarthy

Phone: +44 207 886 2500

¹ JAMA. 2016 Feb;315(8):788-800

² Intensive Care Med. 2011;37(12):1932

³ N Engl J Med. 2005;353(16):1685

About Faron Pharmaceuticals Ltd

Result of AGM

31.5.2018

RNS Number : 8891P

Faron Pharmaceuticals Oy

31 May 2018

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Results of the Annual General Meeting and Decisions of the Board of Directors

TURKU – FINLAND, 31 May 2018 – The Annual General Meeting of Faron Pharmaceuticals Ltd (LON: FARN) took place in Turku, Finland, today, 31 May 2018. The Annual General Meeting approved all the proposals of the Board of Directors and its committees, as set out in the notice of the Annual General Meeting published on 10 May 2018.

Decisions of the Annual General Meeting

The Annual General Meeting adopted the Financial Statements of the Company and resolved to discharge the members of the Board of Directors and the CEO of the Company from liability for the financial year 2017. No dividend for the financial year 2017 will be paid, and the losses of the Company for the financial year, amounting to EUR 21,060,638.95 (IFRS), will be carried forward to the reserve for invested unrestricted equity.

Composition and remuneration of the Board of Directors

The number of members of the Board of Directors was confirmed as nine (9). Frank Armstrong, Markku Jalkanen, Jonathan Knowles, Matti Manner, Huaizheng Peng, Yrjö Wichmann, Leopoldo Zambeletti, Gregory Brown and John Poulos were re-elected to the Board of Directors for a term that ends at the end of the next Annual General Meeting.

The Annual General Meeting resolved that an annual remuneration of EUR 35,000 will be paid to the Board members, in addition to which an annual remuneration of EUR 35,000 will be paid to the Chairman of the Board of Directors. In addition, a further annual remuneration of EUR 11,000 will be paid to the Chairman of the Audit Committee, a further annual remuneration of EUR 9,000 will be paid to the Chairman of the Remuneration Committee and a further annual remuneration of EUR 6,000 will be paid to the Chairman of the Nomination Committee. In addition, a further annual remuneration of EUR 6,000 will be paid to the Audit Committee members, a further annual remuneration of EUR 5,000 will be paid to the Remuneration Committee members and a further annual remuneration of EUR 3,000 will be paid to the Nomination Committee members. The meeting fees will be paid to the Board members as follows:

· A meeting fee of EUR 1,000 will be paid to Board members who are resident outside the European Union (“EU”) or the European Economic Area (“EEA”) per Board meeting where the Board member was physically present; and

· No meeting fees will be paid to Board members who are resident within the EU or the EEA or who were attending a Board meeting but not physically present.

In addition, all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board of Directors will be compensated. No remuneration will be paid based on the Board membership of the CEO of the Company or a person serving the Company under a full-time employment or service agreement.

Amendment of the Articles of Association

The Annual General Meeting resolved that the following sentence be removed from Article 17.1 of the Company’s Articles of Association:

“Each shareholder shall make a Notification when he becomes a party to an agreement or an arrangement that upon implementation would result in the holdings of the shareholder reaching, exceeding or decreasing below any of above-mentioned thresholds.“

The Annual General Meeting further resolved that sections i) – k) be removed from Article 17.5 of the Company’s Articles of Association.

Auditor

PricewaterhouseCoopers Oy, Authorised Public Accountants, was re-elected as the Company’s auditor. PricewaterhouseCoopers Oy has appointed Panu Vänskä, Authorised Public Accountant, as the Auditor with principal responsibility for the completion of the audit. It was decided that the Auditor be remunerated in accordance with the invoice presented.

Authorisation to the Board of Directors to decide on the issuance of shares

The Board of Directors was authorised to resolve by one or several decisions on issuances of shares which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation consists of up to 6,206,000 shares in the aggregate, which corresponds to approximately 20 per cent of the existing shares and votes in the Company.

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

The Board of Directors was authorised to resolve on all other terms and conditions of the issuance of shares. The authorisation will be effective until 30 June 2019.

Decisions of the Board of Directors

At the meeting of the Board of Directors held following the Annual General Meeting, Frank Armstrong was re-elected Chairman of the Board and Matti Manner was re-elected Deputy Chairman of the Board.

In addition, the Board of Directors elected the Chairmen and other members to the Board committees from among its members as follows:

· Leopoldo Zambeletti was elected the Chairman of the Audit Committee, and Matti Manner and Gregory Brown were elected as the other members of the Audit Committee.

· Matti Manner was elected the Chairman of the Nomination Committee, and Huaizheng Peng and Frank Armstrong were elected as the other members of the Nomination Committee.

· Frank Armstrong was elected as the Chairman of the Remuneration Committee, and Jonathan Knowles and John Poulos were elected as the other members of the Remuneration committee.

Minutes of the Annual General Meeting

The minutes of the Annual General Meeting will be available on the Company’s website from 14 June 2018 at the latest.

For more information, please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Consilium Strategic Communications

Mary-Jane Elliott, Philippa Gardner, Matthew Neal, 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, Emma Earl, Ryan McCarthy

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

END

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