Faron update for 2017

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron update for 2017

TURKU – FINLAND, 09 February 2017 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to provide the following update for the year ahead, 2017. The Company’s full year 2016 audited financial results will be announced on 29 March 2017.

Targeted pipeline progress for 2017:

Traumakine®:

·      The Company expects to obtain the read-out for the pan-European phase III trial (INTEREST) results (all-cause mortality at day 28) during H2 2017.

·      The Company has recently received the third recommendation from the trial IDMC (Independent Data Monitoring Committee) to continue the study without any modifications.

·      The Company has established a manufacturing plan to build its stocks of Traumakine®. Subject to a positive outcome of the INTEREST study, having manufacturing in place should facilitate the application process for market approval of Traumakine®.

·      The Company plans to commence a Phase II US safety study (INTRUST) with Traumakine® in H2 2017. It is expected that the full study will take 12 months to complete. Timing remains subject to regulatory approvals with a pre-IND FDA meeting targeted to occur in Q3 2017.

·      The Company currently expects the Japanese Phase III pivotal study recruitment for the treatment of ARDS with Traumakine®, run by its Japanese licensing partner Maruishi Pharmaceutical Co., to progress towards completion during 2017.

·      The first recruited patient for the Company’s Traumakine® clinical study (INFORAAA) for the treatment of patients with rupture of acute abdominal aorta (RAAA) is expected in Q1 2017. The Company expects to get interim results from this 160-patient trial in 12 to 18 months. The aim of this trial is to reduce mortality in operated RAAA patients, which normally varies from 30 to 50% of all patients surgically operated on. The INFORAAA study will also assist in the design of Traumakine® trials for single organ failures.

Clevegen®:

·      The Company expects to file the first clinical trial application (CTA) with the UK regulatory authorities (MHRA) in late 2017 / early 2018.

·      The first, and primarily safety focused, trial is to be conducted with liver cancer patients at the Birmingham University Liver Cancer Centre and is expected to continue into a Phase II study via an adapted trial design for hepatocellular carcinomas (HCC) patients to recognise early efficacy signals.

·      The high yield Clevegen® production clones prepared by Selexis for Faron have demonstrated 5+ g/l production levels without optimisation of the bioreactor conditions. Faron expects that its manufacturing partner Abzena will provide purified drug substance for the Clevegen® pre- and clinical studies during Q2 2017.

Financials:

·      Faron will provide full year results on 29 March 2017.

·      At the end of 2016, Faron had approximately €11.5 million in cash.

Business development:

·      Whilst Faron is focusing on the completion of the INTEREST study and planned CTA filing for Clevegen®, the Company continues to explore potential business opportunities for both assets in order to consider how best to produce maximum value for its shareholders.

Additional corporate matters:

·      Due to the retirement of the Company’s Chief Medical Officer, Dr Ilse Piippo MD, the Company’s Medical Director Dr Matti Karvonen MD has taken the position from 1 February 2017. Dr Ilse Piippo will continue to support the Company as a Regulatory Consultant and will support the Company in setting up a planned paediatric Traumakine® study programme. The plan for this programme will be required for European marketing authorisation of Traumakine® and should also provide a two (2) year extension for Traumakine’s® orphan status in Europe (to a total of 12 years post approval).

·      The recently hired Director for Research, Dr Jami Mandelin, will join the Management Team and will be responsible for pre-clinical drug development and research collaborations with Faron’s scientific network.

Dr Markku Jalkanen, CEO of Faron, said: “We are very excited about Faron’s prospects for 2017 and beyond. We are getting close to read-out of the INTEREST trial, which we believe could revolutionise intensive care practices for ARDS patients. We are therefore continuing to prepare the business in anticipation of commercial launch soon after the trial results are received. In addition, the Company continues to progress and expand its clinical development programme in order to increase indications targeted and maximise shareholder value. The Company has made new hires and I would also like to take the opportunity to thank Dr Ilse Piippo for working with us since 2007 and building the current regulatory pathway for Traumakine®. The skills and commitment she has shown over the years are still evident as she builds the road for treatment with Traumakine® in paediatric applications. As a replacement, Dr Matti Karvonen has already demonstrated his strengths in the past eight months and I am confident that the Faron pipeline will progress well under his supervision.”

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

For more information please contact:

Hume Brophy, PR (UK)

Conor Griffin, Alexia Faure, Alex Protsenko

Phone: +44 207 862 6381

E-mail: faron@humebrophy.com 

Westwicke Partners, IR (US)

Chris Brinzey

Phone: +1 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

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

Caution regarding forward looking statements

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

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

Notification of Major Interest in Shares

RNS Number : 4748R
Faron Pharmaceuticals Oy
09 December 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

Yes

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:

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

Legal & General Investment Management Limited (LGIM)

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

N/A

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

07 December 2016

6. Date on which issuer notified:

09 December 2016

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

LGIM (Above 5%), UTM (Above 5%)

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

LGIM

1,080,000.00

LGIM

1,365,000

LGIM

1,365,000

LGIM

5.19%

UTM

1,080,000.00

UTM

1,365,000

UTM

1,365,000

UTM

5.19%

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

 1,365,000

LGIM

5.19%

 1,365,000

UTM

5.19%

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)  ( 1,365,000 -5.19% = Total Position)

Legal & General Investment Management (Holdings) Limited (LGIMH) (Direct and Indirect)  ( 1,365,000 – 5.19% = Total Position)

Legal & General Investment Management Limited (Indirect) (LGIM) ( 1,365,000 – 5.19% = Total Position)

Legal & General (Unit Trust Managers) Limited ( 1,365,000 – 5.19% = UTM)

Legal & General Group Plc (Direct) (L&G)

Legal & General Investment Management (Holdings) Limited (Direct) (LGIMHD)

Legal & General Insurance Holdings Limited (Direct) (LGIH) LGAS & LGPL)

Legal & General Assurance (Pensions Management) Limited  (PMC)

Legal & General Assurance Society Limited  (LGAS & LGPL) (LGAS & LGPL)

Legal & General Pensions Limited (Direct)  (LGPL)

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

 
 

HOLBDBDDLXGBGLC

Notification of Major Interest in Shares

RNS Number : 4742R
Faron Pharmaceuticals Oy
09 December 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       76,289*

Chase (GA Group) Nominees Limited        1,469,439*

State Street Nominees Limited                          314,604*

            * denotes direct interest

Chase (GA Group) Nominees Limited              74,116

Chase Nominees Limited                                     52,129

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

07 December 2016

6. Date on which issuer notified:

08 December 2016

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

8% to 7% 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

2,271,669

2,271,669

1,986,577

1,860,332

126,245

7.07%

0.48%

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

1,986,577

7.55%

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

 
 

HOLBDBDDRDGBGLC

PDMR Shareholding

Faron Pharmaceuticals Oy
(“Faron” or the “Company”)

PDMR Shareholding

TURKU – FINLAND, 5 December 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, announces that on 16th and 19th September 2016 Dr Matti Karvonen, Medical Director of Faron, acquired ordinary shares in Faron on his own behalf and on behalf of his closely associated persons. As a member of the management group of Faron, Dr Karvonen is regarded as a person discharging managerial responsibility (“PDMR”).    

PDMR                                                        Shares purchased

Matti Karvonen                                                        25,770

                                                                              25,770                                                              

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

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

1.    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

Ordinary shares

ISIN: FI4000153309
 

b.

Nature of the transaction

Purchase of Ordinary Shares  

c.

Price(s) and volume(s)

Price(s)

Volume(s)

1.    3.04€

16,770

d.

Aggregated information

– Aggregated Volume

– Price

N/a (Single transaction)

e.

Date of the transaction

16 September 2016

f.

Place of the transaction

Turku

                 

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)

1.     €2.78

9,000

d.

Aggregated information

– Aggregated Volume

– Price

N/a (Single transaction)

e.

Date of the transaction

19 September 2016

f.

Place of the transaction

Turku

                 

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

Back to top