Grant of options

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Grant of options

TURKU – FINLAND, 21 November 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announces that on 18 November 2016 the Board of Faron granted 400,000 options over ordinary shares in the Company (“Options”) under the Faron 2015 Option Plan at an exercise price of 290 euro cents per share. The options are exercisable between 8 October 2016 and 30 September 2021. The details of the 2015 Option Plan are described in the AIM Admission Document dated 11 November 2015, which is available on Company’s website.

The granted 400,000 options represent 1.49% of the fully-diluted Ordinary Share Capital of the Company.

Included in the number of options granted on 18 November 2016, the following options were issued to Directors and other Persons Discharging Managerial Responsibility (“PDMRs”):

Director                                

Options granted

Frank Armstrong

40,000

Matti Manner

20,000

Markku Jalkanen

80,000

Yrjö E K Wichmann

30,000

Juho Jalkanen

20,000

Jonathan Knowles

20,000

Huaizheng Peng

20,000

Leopoldo Zambeletti

20,000

Total directors

250,000

PDMRs

Ilse Piippo

37 400

Mikael Maksimow

28 100

Matti Karvonen

28 100

Total PDMRs

93 600

For more information please contact:

Faron Pharmaceuticals Ltd

Katja Wallenlind

Phone +358 (50) 577 4807

E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in pan-European (INTEREST) and Japanese pivotal Phase III studies. Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology (“TIET”) and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

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(s)

1.    Dr Markku Jalkanen

2.    Dr Frank Armstrong

3.    Matti Manner

4.    Dr Juho Jalkanen

5.    Yrjö Wichmann

6.    Leopoldo Zambeletti

7.    Dr Huaizheng Peng

8.    Professor Jonathan Knowles

2

Reason for notification

a.

Position/Status

Directors of the Company

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 to subscribe for Ordinary Shares

c.

Price(s) and volume(s)

Price(s)

Volume(s)

1.    2.90

2.    2.90

3.    2.90

4.    2.90

5.    2.90

6.    2.90

7.    2.90

8.    2.90

80,000

40,000

20,000

20,000

30,000

20,000

20,000

20,000

d.

Aggregated information

– Aggregated Volume

– Price

250,000

e.

Date of the transaction

18 November 2016

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

1.    Ilse Piippo

2.    Mikael Mksimow

3.    Matti Karvonen

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 to subscribe for Ordinary Shares

c.

Price(s) and volume(s)

Price(s)

Volume(s)

1.    2.90

2.    2.90

3.    2.90

37,400

28,100

28,100

d.

Aggregated information

– Aggregated Volume

– Price

93,600

e.

Date of the transaction

18 November 2016

f.

Place of the transaction

Turku

New Application Accepted by Finnish Patent Office

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

New Patent Application Accepted by Finnish Patent Office

Protect the intravenous use of interferon-beta in a novel formulation

TURKU – FINLAND, 31 October 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce that its patent application to protect the intravenous use of interferon-beta (IFN-beta) in a novel formulation has been accepted by the Finnish patent office. The allowed claims cover single intravenous dose of IFN-beta at the range of 2-15 micrograms in a formulation that allows a precise dosing of IFN-beta. This formulation is being used in both on-going pivotal Traumakine® trials in Europe and Japan for acute respiratory distress syndrome (“ARDS”) and will be the drug for which Faron is targeting approval in various territories for the treatment of ARDS and other vascular dysfunctions.

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. An earlier Phase I/II trial conducted in the UK and published in The Lancet Respiratory Medicine, (Bellingan et al. 2014: 2: 98-107), showed a decline in the odds of all-cause mortality at day 28 of 81%. Faron has developed the first intravenous formulation of IFN-beta to enable treatment of vascular leakage in lungs and other central organs. The allowed claims cover this use but are not limited to ARDS.

Dr Markku Jalkanen, CEO of Faron said: “We are delighted that the patent claims for the intravenous use of IFN-beta in vascular dysfunctions have been accepted as they enable us to build a strong global proprietary position for Traumakine®. We have already granted patents for INF-beta in ischemic conditions in many countries, and these additional claims significantly extend protection for Traumakine® as a drug to treat life threatening conditions like acute lung injuries up to 2036-37. Faron plans to file application to the US patent office with same scope of protection. Furthermore, in spring 2017 we will file the international PCT to initiate the patenting process in other countries too.”

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

For more information please contact:

Faron Pharmaceuticals Ltd

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in pan-European (INTEREST) and Japanese pivotal Phase III studies. Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology (“TIET”) and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

First patient recruited in Japanese Ph III trial

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

First Traumakine® Phase III patient in Japan recruited for the treatment of acute respiratory distress syndrome

and

Update on Pan-European Phase III Traumakine trial

TURKU – FINLAND, 24 October 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce that its Japanese licensing partner Maruishi Pharmaceutical Co., Ltd. (“Maruishi”) has recruited the first patient in the Japanese Phase III pivotal clinical trial for the treatment of acute respiratory distress syndrome (“ARDS”) with FP-1201-lyo (also known as Traumakine®).

Faron has also recently received the second IDMC (Independent Data Monitoring Committee) recommendation to continue the INTEREST pan-European Phase III trial with Traumakine without any modifications.

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. An earlier Phase I/II trial conducted in the UK and published in The Lancet Respiratory Medicine, (Bellingan et al. 2014: 2: 98-107), showed a decline in the odds of all-cause mortality at day 28 of 81%. A Japanese Phase II trial was completed with comparable mortality results and no observed severe adverse events as announced in January 2016.

The Japanese Phase III clinical trial (JapicCTI-163320) is a double-blinded, randomised, parallel-group comparison of efficacy and safety of FP-1201-lyo against placebo in the treatment of maximum 120 patients with moderate to severe ARDS. The initiation of the Japanese study means that the Pan-European and Japanese Phase III trials combined aim to treat maximum 420 moderate to severe ARDS patients with results expected to become available in 2017-2018.

Dr Markku Jalkanen, CEO of Faron said: “We are delighted that patient recruitment for the Japanese Phase III trial has commenced as this trial will significantly increase the total number of patients in Traumakine pivotal studies. It was also encouraging to receive the second IDMC recommendation for the INTEREST pan-European Phase III trial continuation demonstrating the studies are progressing in line with protocol expectations and design.”

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

For more information please contact:

Faron Pharmaceuticals Ltd

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in pan-European (INTEREST) and Japanese pivotal Phase III studies. Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology (“TIET”) and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

Notification of Major Interest in Shares

RNS Number : 0225M
Faron Pharmaceuticals Oy
07 October 2016
 

TR-1: NOTIFICATION OF MAJOR INTEREST IN SHARESi

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

Faron Pharmaceuticals Oy

2 Reason for the notification (please tick the appropriate box or boxes):

An acquisition or disposal of voting rights

An acquisition or disposal of qualifying financial instruments which may result in the acquisition of shares already issued to which voting rights are attached

An acquisition or disposal of instruments with similar economic effect to qualifying financial instruments

An event changing the breakdown of voting rights

Other (please specify):

Disclosure as per Company´s Articles of Association

Yes

3. Full name of person(s) subject to the
notification obligation:
iii

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

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

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

5. Date of the transaction and date on
which the threshold is crossed or
reached:
v

21.9.2016

6. Date on which issuer notified:

4.10.2016

7. Threshold(s) that is/are crossed or
reached:
vi, vii

Above 3%, 3.80%

8. Notified details:

A: Voting rights attached to shares viii, ix

Class/type of
shares


if possible using
the ISIN CODE

Situation previous
to the triggering
transaction

Resulting situation after the triggering transaction

Number
of
Shares

Number
of
Voting
Rights

Number
of shares

Number of voting
rights

% of  voting rights x

Direct

Direct xi

Indirect xii

Direct

Indirect

zero

zero

1,000,000

1,000,000

zero

3.80%

zero

Ordinary Shares

FI40000153309

B: Qualifying Financial Instruments

Resulting situation after the triggering transaction

Type of financial
instrument

Expiration
date
xiii

Exercise/
Conversion Period
xiv

Number of voting
rights that may be
acquired if the
instrument is
exercised/ converted.

% of voting
rights

C: Financial Instruments with similar economic effect to Qualifying Financial Instruments xv, xvi

Resulting situation after the triggering transaction

Type of financial
instrument

Exercise price

Expiration date xvii

Exercise/
Conversion period
xviii

Number of voting rights instrument refers to

% of voting rights xix, xx

Nominal

Delta

Total (A+B+C)

Number of voting rights

Percentage of voting rights

1,000,000

3.80%

9. Chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held, if applicable:
xxi

The voting rights are managed and controlled by City Financial Investment Company Limited, Investment manager and ACD to the City Financial Absolute Equity Fund.

Proxy Voting:

10. Name of the proxy holder:

11. Number of voting rights proxy holder will cease
to hold:

12. Date on which proxy holder will cease to hold
voting rights:


13. Additional information:

Notification using the total voting rights figure of 26,311,704

14. Contact name:

Chris Sturdee

15. Contact telephone number:

+44 (0)20 7726 9869


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

END

 
 

HOLBDBDGGSGBGLR

Notification of Major Interest in Shares

RNS Number : 8801L
Faron Pharmaceuticals Oy
06 October 2016
 

TR-1: NOTIFICATION OF MAJOR INTEREST IN SHARES

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

Faron Pharmaceuticals Oy

2. Reason for the notification (please tick the appropriate box or boxes):

An acquisition or disposal of voting rights

An acquisition or disposal of qualifying financial instruments which may result in the acquisition of shares already issued to which voting rights are attached.

An acquisition or disposal of instruments with similar economic effect to qualifying financial instruments

An event changing the breakdown of voting rights

Other (please specify):

Disclosure as per company’s Articles of Association

Yes

3. Full name of person(s) subject to the
notification obligation:

Legal & General Investment Management Limited (LGIM)

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

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

5. Date of the transaction and date on
which the threshold is crossed or
reached:

21 September 2016

6. Date on which issuer notified:

05 October 2016

7. Threshold(s) that is/are crossed or
reached:

LGIM (Above 3%, 4%)

UTM (Above 3%, 4%)

8. Notified details:

A: Voting rights attached to shares

Class/type of
shares


if possible using
the ISIN CODE

Situation previous
to the triggering
transaction

Resulting situation after the triggering transaction

Number
of
Shares

Number
of
Voting
Rights

Number
of shares

Number of voting
rights

% of  voting rights

Direct

Indirect

Direct

Indirect

ORD NPV

Nil

 1,080,000

1,080,000

4.10%

B: Qualifying Financial Instruments

Resulting situation after the triggering transaction

Type of financial
instrument

Expiration
date

Exercise/
Conversion Period

Number of voting
rights that may be
acquired if the
instrument is
exercised/ converted.

% of voting
rights

C: Financial Instruments with similar economic effect to Qualifying Financial Instruments

Resulting situation after the triggering transaction

Type of financial
instrument

Exercise price

Expiration date

Exercise/
Conversion period

Number of voting rights instrument refers to

% of voting rights

Nominal

Delta

Total (A+B+C)

Number of voting rights

Percentage of voting rights

1,080,000 (LGIM)

4.10%

1,080,000 (UTM)

4.10%

9. Chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held, if applicable:

Legal & General Group Plc (Direct and Indirect) (Group)  (1,080,000, 4.10% = Total Position)

Legal & General Investment Management (Holdings) Limited (LGIMH) (Direct and Indirect)  (1,080,000, 4.10% = Total Position)

Legal & General Investment Management Limited (Indirect) (LGIM) (1,080,000, 4.10% = Total Position)

Legal & General (Unit Trust Managers) Limited (1,080,000, 4.10% = UTM)

Proxy Voting:

10. Name of the proxy holder:

N/A

11. Number of voting rights proxy holder will cease
to hold:

N/A

12. Date on which proxy holder will cease to hold
voting rights:

N/A


13. Additional information:

Notification using the total voting rights figure of  26,311,704  

14. Contact name:

Victoria Davies (LGIM)

15. Contact telephone number:

029 2035 4147


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

END

 
 

HOLGIBDGSSGBGLL

Notification of Major Interest in Shares

RNS Number : 8079L
Faron Pharmaceuticals Oy
05 October 2016
 

TR-1: NOTIFICATION OF MAJOR INTEREST IN SHARESi

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

Faron Pharmaceuticals Oy

2 Reason for the notification (please tick the appropriate box or boxes):

An acquisition or disposal of voting rights

An acquisition or disposal of qualifying financial instruments which may result in the acquisition of shares already issued to which voting rights are attached

An acquisition or disposal of instruments with similar economic effect to qualifying financial instruments

An event changing the breakdown of voting rights

Other (please specify):

3. Full name of person(s) subject to the
notification obligation:
iii

Aviva plc & its subsidiaries    

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

Registered Holder:

BNY Norwich Union Nominees Limited       122,189*

Chase (GA Group) Nominees Limited        1,697,607*

State Street Nominees Limited                          319,947*

            * denotes direct interest

Chase (GA Group) Nominees Limited              79,797

Chase Nominees Limited                                     52,129

5. Date of the transaction and date on
which the threshold is crossed or
reached:
v

03 October 2016

6. Date on which issuer notified:

04 October 2016

7. Threshold(s) that is/are crossed or
reached:
vi, vii

9% to 8% Change at Combined Interest Level.  Figures are provided in accordance with provisions of your company articles and not in fulfilment of the requirements of the Transparency Directive.

8. Notified details:

A: Voting rights attached to shares viii, ix

Class/type of
shares


if possible using
the ISIN CODE

Situation previous
to the triggering
transaction

Resulting situation after the triggering transaction

Number
of
Shares

Number
of
Voting
Rights

Number
of shares

Number of voting
rights

% of  voting rights x

Direct

Direct xi

Indirect xii

Direct

Indirect

Ordinary Shares

FI4000153309

2,305,769

As per last TR-1 Disclosure

2,305,769

As per last TR-1 Disclosure

2,271,669

2,139,743

131,926

8.13%

0.50%

B: Qualifying Financial Instruments

Resulting situation after the triggering transaction

Type of financial
instrument

Expiration
date
xiii

Exercise/
Conversion Period
xiv

Number of voting
rights that may be
acquired if the
instrument is
exercised/ converted.

% of voting
rights

C: Financial Instruments with similar economic effect to Qualifying Financial Instruments xv, xvi

Resulting situation after the triggering transaction

Type of financial
instrument

Exercise price

Expiration date xvii

Exercise/
Conversion period
xviii

Number of voting rights instrument refers to

% of voting rights xix, xx

Nominal

Delta

Total (A+B+C)

Number of voting rights

Percentage of voting rights

2,271,669

8.63%

9. Chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held, if applicable:
xxi

The voting rights are managed and controlled by Aviva Investors Global Services Limited, with the following chains of controlled undertakings:-

Aviva Investors Global Services Limited:

·      Aviva plc (Parent Company)

·      Aviva Group Holdings Limited (wholly owned subsidiary of Aviva plc)

·      Aviva Investors Holdings Limited (wholly owned subsidiary of Aviva Group Holdings Limited)

·      Aviva Investors Global Services Limited (wholly owned subsidiary of Aviva Investors Holdings Limited)

Proxy Voting:

10. Name of the proxy holder:

See Section 4

11. Number of voting rights proxy holder will cease
to hold:

12. Date on which proxy holder will cease to hold
voting rights:


13. Additional information:


Figures are based on a total number of voting rights of  26,311,704 as per the Company’s Results of Placing and Subscription, Issue of Equity and Director/PDMR Shareholding Announcement of

21 September 2016.

14. Contact name:

Neil Whittaker, Aviva plc

15. Contact telephone number:

00 44 1603 684420


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

END

 
 

HOLBUBDGDGGBGLU

Director Dealing

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Director Dealing

TURKU – FINLAND, 26 September 2016 – Faron Pharmaceuticals Oy (“Faron” or “Company”) (LON: FARN), the clinical stage biopharmaceutical company, today announces that Leopoldo Zambeletti, a Non-Executive Director of the Company, purchased 4,000 ordinary shares in the capital of the Company at 250 pence each on 23 September 2016.

Following this transaction, Leopoldo Zambeletti now holds 17,461 Ordinary Shares representing 0.07% of the issued share capital of the Company.

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Oy

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in a pan-European pivotal Phase III study (INTEREST). Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology (“TIET”) and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

Raises £8.0 M through a Placing and Subscription

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

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Results of Placing and Subscription,

Issue of Equity

and

Director/PDMR Shareholding

Faron successfully raises £8.0 million through a Placing and Subscription

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

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

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

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

Director/PDMR Shareholding

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

Before Placing and Subscription

Number of Subscription Shares / Placing Shares subscribed for

After Placing and Subscription

Director/PDMR

No. of Ordinary Shares held

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

No. of Ordinary Shares held

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

Dr Frank Armstrong

 3,846

0.02%

4,000

7,846

0.03%

Matti Manner

480,900

2.08%

                         4,000

                     484,900

1.84%

Dr Jonathan Knowles

3,846

0.02%

                         6,866

                       10,712

0.04%

Dr Huaizheng Peng

                         4,000

                       4,000

0.02%

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

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

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

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

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

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Oy

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in a pan-European pivotal Phase III study (INTEREST). Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology (“TIET”) and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

Proposed Placing & Subscription to raise £8M

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

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

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

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Proposed Placing and Subscription to raise £8.0 million

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

KEY HIGHLIGHTS

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

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

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

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

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

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

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

Further R&D and operational expenses

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

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

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

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

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

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

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

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

Advance development of Traumakine® for ARDS – US safety trial

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

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

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

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

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

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

Progress pre-clinical and clinical development of Clevegen®

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

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

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

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

Traumakine® for the treatment of patients with RAAA

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

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

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

DETAILS OF THE PROPOSED PLACING AND SUBSCRIPTION AND ISSUE OF EQUITY

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

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

·      the Placing Agreement having become unconditional in all respects;

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

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

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

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

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

MARKET ABUSE REGULATION

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

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Oy

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in a pan-European pivotal Phase III study (INTEREST). Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology (“TIET”) and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

Forward Looking Statements

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

Interim Results for six months ended 30 June 2016

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Interim Results for the six months ended 30 June 2016

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

TURKU – FINLAND, 5 September 2016 – Faron Pharmaceuticals Ltd (Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces its unaudited Interim Results for the six months ended 30 June 2016 (the “Period”).

KEY HIGHLIGHTS

Operational Highlights (including Post Period-end)

Traumakine® – for treatment of Acute Respiratory Distress Syndrome (“ARDS”)

Continued to progress the Phase III pan-European INTEREST trial as planned. In June 2016, Faron received the first IDMC (Independent Data Monitoring Committee Chaired by Prof. Arthur Slutsky from Toronto, Canada) recommendation to continue the study.

Announced positive results from the Phase II Japanese study for Traumakine conducted by Faron’s Japanese licensing partner, Maruishi Pharmaceutical Co., Ltd. (“Maruishi”), in January 2016.

Filed a patent application in Finland in March 2016 to further strengthen the Company’s protection of its novel Traumakine formulation (FP-1201-lyo) for the intravenous treatment of ARDS and other vascular diseases. The patent filings will be expanded over the next 2 years to most countries worldwide under the Patent Co-operation Treaty (“PCT”). Through its patent filings Faron is seeking to protect its rights to this discovery for the next 20 years.

Entered into a licensing agreement in June 2016 with Pharmbio Korea Inc. (“Pharmbio”) for the development and commercialisation of Traumakine in Korea to supplement the agreements in place for Japan and China.

Clevegen® – novel cancer immunotherapy checkpoint antibody

Filed two new patent applications for novel cancer immunotherapy candidate Clevegen in April 2016 in Finland. Under the PCT patent filings will be expanded globally over the next few years. The applications open up new opportunities for wider application of this antibody in conditions where removal of  suppression of the local or systemic immunity is desired.

Expanded the development strategy for Clevegen indications by extending the range through the Tumour Immunity Enabling Technology Platform (“TIET”), the Company’s new technology platform announced in May 2016, and presented at an R&D Day in London in June 2016, which can be evaluated alone or in combination with other immune checkpoint molecules in the treatment of common cancers.

Entered into an agreement with Abzena plc (AIM: ABZA) for the manufacture of Clevegen for clinical development in July 2016.

Financial Highlights

Received a €750,000 fee from the licensing agreement with Pharmbio Korea Inc. for the development and commercialisation of Traumakine in Korea. The Company will be entitled to receive further development milestone payments and one third of the profits from Traumakine in Korea.

Recorded significant other operating income of €1.0 million for the period from the Company’s existing European Union FP7 Traumakine grant, in-line with the Company’s strategy to utilise non-dilutive funding sources to support the Company’s R&D program where possible.

As at Period-end, the Company held cash balances of €8.9 million.

The cash position at the end of the Period was stronger than anticipated. In the future, the Company will continue its active and successful strategy to utilise various forms of public funding – both grants and loans.

The operating loss for the Period was €2.6 million.

Net assets as at Period-end were €8.4 million.

Commenting on the results, Dr Markku Jalkanen, CEO of Faron, said:

“Faron has delivered on its key strategic aims for the first half of 2016. We have clear plans to advance our exciting pipeline over the next two to three years, maintaining our focus on the most advanced projects Traumakine and Clevegen, which we believe have tremendous potential for expansion into new indications and territories. Our lead product, Traumakine for acute lung injury, is progressing well. The pivotal pan-European Phase III INTEREST trial is underway at more than 50 sites and we have received encouraging Phase II data from our Japanese partner Maruishi. The Korean licensing deal with Pharmbio is in-line with our growth strategy to partner Traumakine in territories where both clinical and financial impact can be optimised in conjunction with a local partner.

“We have also made substantial progress with our immunotherapy candidate Clevegen through the development of our new TIET platform. In addition to its potential use in combination cancer therapies, new opportunities include chronic infections and vaccination enhancement. We believe the approach offers significant advantages to future collaborators and licensing partners.”

For more information please contact:

Faron Pharmaceuticals Ltd

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The pipeline is built on Faron’s scientific knowledge and control of the endothelial barrier, the membrane of cells lining blood and lymphatic vessels to separate blood content from tissues. The Company’s lead candidate Traumakine® is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine is currently in a pan-European pivotal Phase III study (INTEREST). Additionally, Faron is developing Clevegen® a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to convert the immune environment around a tumour from being immune suppressive to immune stimulating. This novel macrophage-directed immuno-oncology approach is called Tumour Immunity Enabling Technology (“TIET”) and can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. New application opportunities related to TIET cover chronic infections and inefficient vaccination. Based in Turku, Finland, Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

Chairman’s and Chief Executive Officer’s Review

INTRODUCTION

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

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

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

OPERATIONAL REVIEW

Pipeline developments

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

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

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

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

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

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

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

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

New indications for macrophage-directed immunotherapy candidate Clevegen®

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

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

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

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

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

FINANCIAL REVIEW

During the six months ended 30 June 2016, Faron continued to maintain its focused and cost-conscious strategy without compromising the intensity of its development work. Though the R&D expenses more than doubled (as planned within the Company’s strategy), the combination of higher than anticipated income – in the form of both revenue and grant income – and lower operating costs resulted in a modest cash outflow over the Period. Thus the cash position at the end of the Period was stronger than anticipated. In the future, the Company will continue its active and successful strategy to utilise various forms of public funding – both grants and loans.

Statement of Comprehensive Income

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

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

Statement Of Financial Position and Cash Flows

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

OUTLOOK

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

Frank M Armstrong                                   Markku Jalkanen

Chairman                                                    Chief Executive Officer

5 September 2016

Statement of comprehensive income

(Stated in 1,000 euros)

Note

Unaudited six months ended 30 Jun 2016

Unaudited six months ended 30 Jun 2015

Year ended 31 Dec 2015

Revenue

2

 1,169

 454

 520

Cost of sales

(357)

(50)

(25)

Gross profit

 813

 404

 496

Other operating income

3

 968

 – 

 701

Administrative expenses

(974)

(1,074)

(3,061)

Research and development expenses

(3,439)

(1,681)

(3,971)

Operating result

(2,632)

(2,350)

(5,835)

Financial income

 0

 – 

 0

Financial expenses

(305)

(40)

(311)

Net financial costs

(305)

(40)

(311)

Loss before income taxes

(2,936)

(2,390)

(6,146)

Income tax expense

(75)

(42)

(42)

Total comprehensive income for the period

(3,011)

(2,432)

(6,188)

Total comprehensive income, attributable to:

Equity holders of the Company

(3,011)

(2,432)

(6,188)

Loss per share attributable to equity holders of the Company

Basic and diluted loss per share, euro

5

(0.13)

(0.15)

(0.30)

Unaudited

Unaudited

Balance sheet

(Stated in 1,000 euros)

Note

30 Jun
2016

30 Jun
2015

31 Dec
2015

Assets

Non-current assets

Propertly, plant and equipment

 24

 0

 28

Intangible assets

 926

 1,180

 1,001

 950

 1,180

 1,029

Current assets

Inventories

 1,021

 649

 649

Trade and other receivables

 3,836

 647

 2,074

Cash and cash equivalents

 8,862

 2,276

 11,068

 13,719

 3,572

 13,791

Total assets

 14,669

 4,753

 14,821

Equity and liabilities

Capital and reserves attributable to equity holders of the Company

Share capital

 2,691

 2,691

 2,691

Reserve for invested non-restricted equity

 24,533

 11,503

 24,533

Retained earnings

(18,820)

(12,764)

(16,046)

Total equity

 8,404

 1,431

 11,178

Non-current liabilities

Interest-bearing financial liabilities

4

 2,057

 1,691

 1,446

 2,057

 1,691

 1,446

Current liabilities

Interest-bearing financial liabilities

 93

 – 

 245

Non-interest-bearing financial liabilities

 1,009

 – 

 436

Other current liabilities

 3,105

 1,631

 1,517

 4,207

 1,631

 2,197

Total liabilities

 6 265

 3 322

 3 643

Total equity and liabilities

 14 669

 4 753

 14 821

Statement of changes in equity

(Stated in 1,000 euros)

Share capital

Reserve for invested non-restricted equity

Retained earnings

Total equity

Balance at 1 January 2015

 2,691

 6,453

(10,332)

(1,188)


Total comprehensive income for the first six months 2015

(2,432)

(2,432)

Increase of share capital

 5,050

 – 

 5,050

 5,050

(2,432)

 2,618

Balance at 30 June 2015

 2,691

 11,503

(12,764)

 1,431

Total comprehensive income for the financial year 2015

(6,188)

(6,188)

Share base payment

 474

 474

Increase of share capital

 19,261

 – 

 19,261

Transaction costs on share capital issued

(1,181)

(1,181)

 – 

 18,080

(5,714)

 12,366

Balance at 31 December 2015

 2,691

 24,533

(16,046)

 11,178

Total comprehensive income for the first six months 2016

(3,011)

(3,011)

Share base payment

237

 237

 – 

 – 

(2,774)

(2,774)

Balance at 30 June 2016

 2,691

 24,533

(18,820)

 8,404

Statements of cash flows

(Stated in 1,000 euros)

Unaudited 1 Jan – 30 Jun
2016

Unaudited 1 Jan – 30 Jun
2015

1 Jan – 31 Dec
2015

Cash flow from operating activities

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

(3,011)

(2,432)

(6,188)

Adjustments for

Depreciation and amortization

 79

 74

 184

Financial items

 305

 40

 298

Income taxes

 75

 42

 42

Expensed R&D

 – 

 78

Non-cash items (options granted)

 237

 474

Change in net working capital:

Trade and other receivables

(1,761)

(608)

(2,035)

Inventories

(372)

 50

 50

Trade and other current liabilities

 2,162

(30)

 278

Interest and other financial costs paid

(305)

(40)

(285)

Interest and other financial income received

 0

 0

 0

Income taxes paid

(75)

(42)

(42)

Net cash used in / from operating activities (A)

(2,666)

(2,945)

(7,146)

Cash flow from investment activities

Investments in machinery and equipment and intangible assets

 – 

(70)

(107)

Net cash from/used in investing activities (B)

 – 

(70)

(107)

Cash flow from financing activities

Proceeds from issue of share capital issue, net

 – 

 5,050

 18,080

Proceeds from issue of convertible notes

 – 

Proceeds from current borrowings

 – 

 – 

 – 

Proceeds from non-current borrowings

 611

 – 

 – 

Repayment of current borrowings

(151)

 – 

 – 

Net cash used in financing activities (C)

 460

 5,050

 18,080

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

(2,206)

 2,034

 10,827

Cash and cash equivalents at 1 January

 11,068

 242

 242

Cash and cash equivalents at end of period

 8,862

 2,276

 11,068

Note 1  Basis of Preparation

Corporate information

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

Basis of accounting

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

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

Going Concern

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

Note 2  Revenue

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

Note 3  Other operating income

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

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

Note 4  Tekes loans

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

Note 5  Loss per share

1H2016

1H2015

2015

€ ‘000

€ ‘000

€ ‘000

Basic

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

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

(3,011)

(2,432)

(6,188)

Weighted average number of ordinary shares in issue

 23,111,704

16,606,406

 20,686,854

Basic (and dilutive) loss per share, EUR

(0.13)

(0.15)

(0.30)

Weighted-average number of ordinary shares

Issued ordinary shares at 1 January

 23,111,704

15,456,250

 15,456,250

Effect of shares issued

 – 

1,150,156

 5,230,604

Weighted-average number of ordinary shares at end of period

 23,111,704

 16,606,406

 20,686,854

Diluted

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

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

(3,011)

(2,432)

(6,188)

Interest adjustment

 – 

9

 9

Convertible loan interest adjusted loss attributable to equity holders

(3,011)

(2,423)

(6,179)

Diluted weighted average number of ordinary shares in issue

 23,164,610

 16,606,406

 20,686,854

Basic loss per share, EUR

(0.13)

(0.15)

(0.30)

Weighted-average number of ordinary shares

Issued ordinary shares at 1 January

23,111,704

15,456,250

 15,456,250

Effect of shares issued

1,150,156

 5,230,604

Weighted-average number of ordinary shares at end of period

 23,111,704

 16,606,406

 20,686,854

Dilution effect of convertible loans

 52,906

 – 

 – 

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

 23,164,610

 16,606,406

 20,686,854

FURTHER INFORMATION TO SHAREHOLDERS

AIM:                                     FARN

Company number:                 (ISIN) FI4000153309

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

Registered office:                   Joukahaisenkatu 6, 20900 Turku, FINLAND

Directors:                              Frank Armstrong (Non-Executive Chairman)

                                            Matti Manner (Non-Executive Vice-Chairman)

                                            Markku Jalkanen (CEO)

                                            Juho Jalkanen (Non-Executive Director)

                                            Jonathan Knowles (Non-Executive Director)

                                            Huaizheng Peng (Non-Executive Director)

Leopoldo Zambeletti (Non-Executive Director)

Yrjö Wichmann (CFO)

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