Faron´s financial calendar for 2020

RNS Number : 8985U
Faron Pharmaceuticals Oy
27 November 2019
 

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

Faron´s financial calendar for 2020

Company announcement, 27 November 2019 at 6.00 pm (EET)

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN) (“Faron” or the “Company”), the clinical stage biopharmaceutical company, announces the following dates for the Company’s financial reporting in 2020:

20 March        Financial Statement release for full year 2019

27 March        Financial Statements for full year 2019

24 September Half-Year Financial Report for the period 1 January – 30 June 2020

The Annual General Meeting is planned for 13 May 2020. A separate stock exchange notice will be issued by Faron´s Board of Directors to convene the meeting.

For more information please contact:

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

Panmure Gordon (UK) Limited, Nomad and Broker on AIM
Emma Earl, Freddy Crossley
Phone: +44 (0)20 7886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen, Jussi Majamaa
Phone: +358 (0)40 555 4727

Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
Email:
faron@consilium-comms.com

Distribution:
Nasdaq Helsinki Ltd
Key media
www.faron.com

About Faron Pharmaceuticals Oy

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen®, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen® has potential as a single-agent therapy or in combination with other immune checkpoint molecules or other cancer standard cares. Traumakine®, the Company’s pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine®. Faron is based in Turku, Finland. Further information is available at www.faron.com.


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END

 
 

NORUBVVRKUAAUAA

Holdings in Company

Faron Pharmaceuticals Oy

Company announcement, Turku, 21 November 2019 at 16:00 (EET)

TR-1: Standard form for notification of major holdings

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

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

Faron Pharmaceuticals Ltd

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

Non-UK issuer

X

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

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii:

3. Details of person subject to the notification obligationiv

Name

Timo Syrjälä

City and country of registered office (if applicable)

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

Name

City and country of registered office (if applicable)

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

20.11.2019

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

21.11.2019

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

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

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

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

Total number of voting rights of issuervii

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

15.01%

15.01%

43.290.747

Position of previous notification (if

applicable)

14.06%

14.06%

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

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

Indirect

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

Direct

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

Indirect

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

FI4000153309

2.680.647 

3.815.965

6.19%

8.81%

SUBTOTAL 8. A

6.496.612

15.01%

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

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period
xi

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

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

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

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period
xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

SUBTOTAL 8.B.2

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

applicable box with an “X”)

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

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

X

Namexv

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

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

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

Timo Syrjälä (Direct)

              6.19%

6.19%

Acme Investments SPF Sarl (Indirect)

              8.81%

8.81%

10. In case of proxy voting, please identify:

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional informationxvi  

Place of completion

Lausanne

Date of completion

21/11/2019

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Panmure Gordon (UK) Limited, Nomad and Broker on AIM

Emma Earl, Freddy Crossley

Phone: +44 (0)20 7886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

Email: faron@consilium-comms.com

Distribution:

Nasdaq Helsinki Ltd

Key media

www.faron.com

About Faron Pharmaceuticals Oy

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen®, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen® has potential as a single-agent therapy or in combination with other immune checkpoint molecules or other cancer standard cares. Traumakine®, the Company’s pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine®. Faron is based in Turku, Finland. Further information is available at www.faron.com.

Results of EGM

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Results of the Extraordinary General Meeting

TURKU – FINLAND, 25 October 2019 – The extraordinary general meeting (“EGM”) of Faron Pharmaceuticals Ltd (LON: FARN) took place in Turku, Finland today, 25 October 2019. The EGM approved all the proposals of the board of directors (“Board”), as set out in the notice of the EGM published on 4 October 2019.

Decisions of the EGM – share authorities


The Board was unanimously authorised to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act (“Companies Act”), which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation gives the Company the right to issue up to 7,871,000 shares in aggregate (including shares to be received based on options or other special rights), which corresponds to approximately 20 per cent of the existing shares and votes in the Company on the date of the EGM (“Authorisation”).

The Authorisation includes the Board’s right to decide on the issuance of shares, options or other special rights entitling to shares in deviation from shareholders’ pre-emptive rights. The Authorisation can be used for material Company arrangements, such as financing or implementing business arrangements, investments or for other such purposes determined by the Board where a weighty financial reason for issuing shares, options or other special rights entitling to shares, and possibly deviating from the shareholders’ pre-emptive rights, exists.

The Board was authorised to resolve on all other terms and conditions of the issuance of shares, options or other special rights entitling to shares relating to the Authorisation. The Authorisation will be effective until 30 June 2020. It will replace the authorisation for up to 7,095,000 shares (of which 2,121,353 had been used) in the aggregate granted by the Company’s annual general meeting held on 28 May 2019 (“2019 AGM”) concerning the issuance of shares, options or other special rights entitling to shares. The Authorisation will not replace the authorisation for up to 2,000,000 shares in the aggregate granted by the 2019 AGM concerning issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Companies Act to be used for implementing an option plan for the employees and directors of, and persons providing services to, the Company’s group.

Minutes of the EGM

The minutes of the EGM will be available on the Company’s website from 8 November 2019 at the latest.

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd 

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy, in combination with other immune checkpoint molecules or other cancer standard cares. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. Faron is based in Turku, Finland. Further information is available at www.faron.com.

Holdings in Company

TR-1: Standard form for notification of major holdings

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

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

Faron Pharmaceuticals Ltd

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

Non-UK issuer

X

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

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii:

3. Details of person subject to the notification obligationiv

Name

Timo Syrjälä

City and country of registered office (if applicable)

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

Name

City and country of registered office (if applicable)

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

24.09.2019

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

25.09.2019

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

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

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

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

Total number of voting rights of issuervii

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

15.18%

15.18%

39.355.247

Position of previous notification (if

applicable)

14.53%

14.53%

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

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

Indirect

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

Direct

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

Indirect

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

FI4000153309

2.279.150

3.694.423

5.79%

9.39%

SUBTOTAL 8. A

5.973.573

15.18%

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

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period
xi

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

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

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

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period
xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

SUBTOTAL 8.B.2

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

applicable box with an “X”)

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

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

X

Namexv

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

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

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

Timo Syrjälä (Direct)

              5.79%

5.79%

Acme Investments SPF Sarl (Indirect)

              9.39%

9.39%

10. In case of proxy voting, please identify:

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional informationxvi  

Place of completion

Lausanne

Date of completion

25/09/2019

Holding(s) in Company

TR-1: Standard form for notification of major holdings

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

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

Faron Pharmaceuticals Ltd

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

Non-UK issuer

X

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

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii:

3. Details of person subject to the notification obligationiv

Name

Timo Syrjälä

City and country of registered office (if applicable)

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

Name

City and country of registered office (if applicable)

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

05.08.2019

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

15.08.2019

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

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

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

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

Total number of voting rights of issuervii

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

14.36%

14.36%

38.175.734

Position of previous notification (if

applicable)

13.11%

13.11%

             

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

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

Indirect

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

Direct

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

Indirect

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

FI4000153309

2.205.025

3.275.350

5.78%

8.58%

SUBTOTAL 8. A

5.480.375

14.36%

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

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period
xi

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

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

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

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period
xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

SUBTOTAL 8.B.2

                   

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

applicable box with an “X”)

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

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

X

Namexv

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

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

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

Timo Syrjälä (Direct)

              5.78%

5.78%

Acme Investments SPF Sarl (Indirect)

              8.58%

8.58%

10. In case of proxy voting, please identify:

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional informationxvi  Threshold announced in company stock market release 5.8.2019

         

Place of completion

Lausanne

Date of completion

15/08/2019

Notice of Interim Results

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Notice of Interim Results

TURKU – FINLAND, 16 August 2019 – Faron Pharmaceuticals Ltd (Faron”) (LON: FARN), the clinical stage biopharmaceutical company, will announce its unaudited interim results for the six months ended 30 June 2019 on Monday 23 September 2019.

Dr Markku Jalkanen, Chief Executive Officer, Toni Hänninen, Chief Financial Officer and Yrjö Wichmann, Vice President, Financing and Investor Relations will host a presentation and conference call for analysts at 9.30am BST on the day of the results at the offices of Panmure Gordon, One New Change, London, EC4M 9AF. Please contact Consilium Strategic Communications for further details.

ENDS

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: +44 207 886 2500

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS) and progressing in phase II trial for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. Faron is based in Turku, Finland. Further information is available at www.faron.com

MATINS study update

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

MATINS study update

–           High Clevegen dosing well tolerated: 9 patients dosed to date

–           Switch of immune cell profiles towards immune activation seen across all study subjects immediately post dosing

–           Filing of pre-IND package with the FDA

TURKU – FINLAND, 12 July 2019 – Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces additional data from the open label phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen, Faron’s wholly-owned novel precision cancer immunotherapy, in selected metastatic or inoperable solid tumours.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “We are thrilled with the progress the MATINS study has made during the last few months. We believe we have the first macrophage immune checkpoint drug in clinical development promoting immune activation and are encouraged by the latest data indicating potential early efficacy and good tolerability. We expect to progress the cohort expansion phase of the study in Q3 2019 in patients with late-stage colorectal cancer and as more data are generated we will seek guidance from regulators regarding the best and fastest pathway to secure initial approval of Clevegen as a single-agent treatment.

“We also hope to conclude partnering discussions during H2-2019, which should enable us to expand clinical development to include combination studies exploring the potential of Clevegen in combination with existing immunotherapies.”

·    Clevegen well tolerated also at high doses

Clevegen dosing reached its planned maximum of 10mg/kg in mid-June, which has continued to be well tolerated. No dose limiting toxicity (DLT) nor maximally tolerated dose (MTD) has been observed so far. The trial includes an option to administer a 20mg/kg dose, which the Company intends to propose to the trial’s independent data monitoring board. Safe administration of this higher dose would demonstrate a high tolerability and an unusually wide safety margin for Clevegen compared to other immuno-oncology (IO) products. This Directors believe this could allow the Company to move forward rapidly and initiate new clinical studies in first-line and neo-adjuvant study settings and would, in turn, help to demonstrate the full potential of Clever-1 blockade early in the treatment pathway, accelerate time-to-market and increase the market potential of Clevegen.

·    Continuous induction of immune activation

All MATINS study subjects have consistently shown a switch in their immune cell profiles towards increased immune activation, observed by an increase in CD8+ cells, an increased in the CD8+/CD4+ ratio, a decrease in regulatory T-cells (T-regs) and a substantial increase in mobile natural killer (NK) cells in the blood. These changes are measurable immediately post-dosing, indicating a dynamic response in the immunological switch to immune-activation after the immunotherapeutic blockade of Clever-1.

Latest data also show that dose escalation results in prolonged Clever-1 occupancy of the blood monocytes during the first two weeks of the three-week dosing cycle before a decrease to baseline levels prior to the next dosing cycle. Longer exposure of blood monocytes to Clevegen is also expected to induce a stronger pro-inflammatory response in study subjects.

·    Further molecular evidence of immune activation

A new discovery following study of subjects’ cellular responses, has been the identification of an increase in interferon gamma (IFNγ) production by the host immune system, accompanied by an increase in circulating Th1 differentiated CD4+ and CD8+ T cells. The Company believes the decrease in tumour burden seen in the partial responder is partially (if not completely) explained by this effect of Clevegen on the immune system. Blood myeloid cell analyses also indicate that the proportion of CD163/CD206 positive cells (considered as M2 type immunosuppressive myeloid cells) decrease, as expected, among the whole CD14 positive monocytes of the responder. This is consistent with the M2 to M1 immune switch in their immune profile towards more immune activation, induced by Clevegen, which has been previously observed in animal models.

·    Anti-cancer responses continue in the clinics

Among the nine subjects dosed so far, across three clinical trial sites in Finland and the UK, two subjects have shown clinical anti-cancer responses. The first patient, a partial responder with colorectal cancer (CRC) whose initial treatment progress was announced on 11 April 2019, showed a continuation of lung metastasis shrinkage according to the latest tumour imaging report at the end of May. The subject’s tumour load marker CEA (carcinogenic embryonal antigen), which measures tumour mass of CRC, has also normalised. A second subject with CRC has shown an initial decrease in CEA (-40%) and tumour stabilization.

Faron is investigating why the observed immune activation has not turned into anti-tumour activity in all study subjects. In part, the Company believes the patient’s immune system receiving Clevegen as a last line of therapy could have been adversely affected by the underlying therapies they have received prior to taking part in the MATINS study, as previous chemotherapies can inactivate bone marrow, preventing revitalization of the immune system. Majority of patients have received 5-7 different treatment lines prior entering the MATINS study.

·    Expanding clinical development plans

These data support Clevegen’s potential, with promising single-agent activity as a last-line therapy in CRC patients who are refractory to all other treatment options. The Company intends to keep the CRC expansion cohort open and enrolling and while more data is generated, to approach regulatory authorities to seek scientific advice regarding the path to regulatory approval. On the basis of Clevegen’s current safety profile and potential in patients who have exhausted by all other treatment options, the Company believes it may seek initial regulatory approval supported by data from the expanding MATINS trial by 2022. Faron also intends, subject to regulatory approval, to amend the MATINS trial to allow inclusion of hormone receptor-positive breast cancer, gastric cancer and uveal melanoma, based on striking translational data on CLEVER-1 positive cancer types and current poor survival rates. The Directors believe that earlier lines of treatment for these illnesses which currently lack successful treatments may be possible based on the safety profile of Clevegen seen to date and would allow Clevegen to activate more naïve and responsive immune systems.

Faron has recently also filed a pre-IND package to the FDA. If accepted, Faron plans to open new sites in the US and facilitate expansion of the CRC cohort as fast as possible. Similarly, Faron is planning to include top cancer centres in France and Spain as the next European countries to join the MATINS trial.

·    Clever-1 expression predicts resistance to other immune-oncology (IO) treatments

Increasing data from IO-treated patients has become available through publicly-accessible data sources. Interestingly, data from The Cancer Genome Atlas (TCGA, the National Cancer Institute, USA) indicate that tumours with high Clever-1 (also known as Stab-1) expression do not respond to current IO treatments (p<0.00001) and correlates to a decreased survival (p<0.001). This finding strongly supports earlier research indicating the potential synergistic anti-tumour benefit when immunotherapeutic blockade of Clever-1 is combined with other IO treatments. It also supports the potential of measuring Clever-1 (e.g. from blood myeloid cells) to provide selection criteria for current IO treatments which lack good biomarkers.

About the MATINS study

The MATINS study is the first-in-human open label Phase I/II clinical trial with an adaptive design to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours. The selected tumours under investigation are cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). All together these five target groups consist of approximately 2 million annual cases worldwide. Cancer patients with high Clever-1 expression are identified with a simple blood myeloid cell staining with Clevegen (“liquid biopsy”).

Part I of the trial deals with tolerability, safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report findings as the dosing progresses. The cohort expansion during part two will focus on identification of patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. The Company has already announced that colorectal cancer (CRC) has been selected as the first expansion cohort in Part II. During Part III, the main focus will be on assessing the efficacy of Clevegen on study subjects who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy. The treatment, if successful, may ultimately be used as a standalone therapy or in combination with other immunotherapies like PD-1 inhibitors.

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

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS) and progressing in phase II trial for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. Faron is based in Turku, Finland. Further information is available at www.faron.com

Caution regarding forward looking statements

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

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

Holdings in Company

TR-1: Standard form for notification of major holdings

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

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

Faron Pharmaceuticals Ltd

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

Non-UK issuer

X

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

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii:

3. Details of person subject to the notification obligationiv

Name

Timo Syrjälä

City and country of registered office (if applicable)

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

Name

City and country of registered office (if applicable)

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

03.07.2019

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

04.07.2019

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

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

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

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

Total number of voting rights of issuervii

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

13.11%

13.11%

37.233.894

Position of previous notification (if

applicable)

12.14%

12.14%

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

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

Indirect

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

Direct

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

Indirect

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

FI4000153309

1.905.025

2.975.350

5.12%

7.99%

SUBTOTAL 8. A

4.880.375

13.11%

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

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period
xi

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

exercised/converted.

% of voting rights

SUBTOTAL 8. B 1

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

Type of financial instrument

Expiration
date
x

Exercise/
Conversion Period
xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

SUBTOTAL 8.B.2

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

applicable box with an “X”)

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

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

X

Namexv

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

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

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

Timo Syrjälä (Direct)

5.12%

5.12%

Acme Investments SPF Sarl (Indirect)

              7.99%

7.99%

10. In case of proxy voting, please identify:

Name of the proxy holder

The number and % of voting rights held

The date until which the voting rights will be held

11. Additional informationxvi

Place of completion

Lausanne

Date of completion

03/07/2019

Grant of options

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Grant of options

TURKU – FINLAND, 1 July 2019 – Faron (LON: FARN), the clinical stage biopharmaceutical company, announces that the Board of Faron has on 1 July 2019 confirmed the grant of 40,000 D options over ordinary shares in the Company (“Options”) under the Faron 2015 Option Plan to Mr. Toni Hänninen, who was appointed as Faron’s new CFO from 1 June 2019. The Options have been allocated under the Faron 2015 Option Plan and are exercisable between 8 October 2018 and 30 September 2021 at an exercise price of 109 euro cents per share, as announced on 22 May 2019. The exercise price is calculated based on the average share price between 1 July and 30 September 2018. The terms of the 2015 Option Plan are as described in the Company’s Admission Document (available on the Company’s website), as amended at the Company’s 2017 annual general meeting, details of which were announced on 16 May 2017.

The granted 40,000 Options entitle the option holder to subscribe for a total of 40,000 new ordinary shares in the Company, if exercised in full, and represent 0.1% of the fully-diluted ordinary share capital of the Company.

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville 

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s first candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking early clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com

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

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Toni Hänninen

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

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

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

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

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2015 Option Plan exercisable at 109 Euro cents per Ordinary Share

c.

Price(s) and volume(s)

Price(s)

Volume(s)

Nil

40,000

d.

Aggregated information

– Aggregated Volume

– Price

40,000

Nil

e.

Date of the transaction

1 July 2019

f.

Place of the transaction

Turku

Results of AGM

Faron Pharmaceuticals Ltd

(“Faron or the “Company”)

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

TURKU – FINLAND, 28 May 2019 – The annual general meeting (“AGM”) of Faron Pharmaceuticals Ltd (LON: FARN) took place in Turku, Finland today, 28 May 2019. The AGM approved all the proposals of the board of directors (“Board”) and its committees, as set out in the notice of the AGM published on 7 May 2019 and the update on it published on 24 May 2019.

Decisions of the AGM

The AGM adopted the financial statements of the Company and resolved to discharge the members of the Board and the CEO of the Company from liability for the financial year 2018. No dividend for the financial year 2018 will be paid, and the losses of the Company for the financial year, amounting to EUR 20,075,949.50 (IFRS), will be carried forward to the reserve for invested unrestricted equity.

Composition and remuneration of the Board

The number of members of the Board was confirmed as six. Frank Armstrong, Markku Jalkanen, Matti Manner, Leopoldo Zambeletti, Gregory Brown and John Poulos were re-elected to the Board for a term that ends at the end of the next AGM.

The AGM resolved that an annual remuneration of EUR 35,000 will be paid to the Board members, in addition to which an annual remuneration of EUR 35,000 will be paid to the Chair of the Board. In addition, a further annual remuneration of EUR 11,000 will be paid to the Chair of the Audit Committee, a further annual remuneration of EUR 9,000 will be paid to the Chair of the Remuneration Committee and a further annual remuneration of EUR 6,000 will be paid to the Chair of the Nomination Committee. In addition, a further annual remuneration of EUR 6,000 will be paid to the Audit Committee members, a further annual remuneration of EUR 5,000 will be paid to the Remuneration Committee members and a further annual remuneration of EUR 3,000 will be paid to the Nomination Committee members.

Meeting fees will be paid to the Board members as follows:

·    A meeting fee of EUR 1,000 will be paid to Board members per Board meeting where the Board member was physically present, and which was held on another continent than the member’s place of residence.

·    No meeting fees will be paid to Board members who were attending a Board meeting but not physically present or for Board meetings held on the same continent than the member’s place of residence.

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

Auditor

Audit firm PricewaterhouseCoopers Oy (“PwC”) was re-elected as the Company’s auditor. PwC has appointed Panu Vänskä, authorised public accountant (KHT), as the key audit partner. It was decided that the auditor be remunerated in accordance with the invoice presented.

Authorisation to the Board to decide on the issuance of options or other special rights entitling to shares

The Board was authorised to resolve by one or several decisions on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act (“Companies Act”). The authorisation consists of up to 2,000,000 shares in the aggregate, which corresponds to approximately 5.4 per cent of the existing shares and votes in the Company on the date of the AGM.

The authorisation does not exclude the Board’s right to decide on the issuance of options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights. The authorisation can be used for implementing an option plan for the employees and directors of, and persons providing services to, the group, substantially in the form of the option plan attached as Annex 1 to the notice of the AGM available on the Company’s website. There is a weighty financial reason for issuing options, as options are an integral part of the incentivisation system for the management and personnel of the Company.

Maximum number of options that may be granted to the members of the Company’s management and the Board is as follows:

·    to the Chair of the Board, a maximum of 180,000 options;

·    to each member of the Board (excluding the Chair of the Board and the CEO and the CFO if they would be considered as members of the Company’s Board), a maximum of 90,000 options;

·    to the CEO, a maximum of 360,000 options; and

·    to the CFO, a maximum of 130,000 options.

The exercise of options will be subject to fulfilment of certain criteria to be resolved by the Board (“Exercise Conditions”). Subject to fulfilment of the Exercise Conditions, the options may be exercised at an exercise price which may not be less than the market value of a share at the grant date, as determined by the Board (“Exercise Price”). In determining such market value, if shares are traded on the AIM market of the London Stock Exchange, the Board will have regard to the average price per share at which shares have been so traded over a period of 90 days immediately preceding the grant date. The Exercise Price will be determined so as to create a sufficient incentive for the recipients of options. The Exercise Price will be recorded in the Company’s reserve for invested unrestricted equity.

The Board was authorised to resolve on all other terms and conditions of the issuance of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Companies Act. The authorisation will be effective until 30 June 2023 and will not replace previous authorisations granted to the Board.

Authorisation to the Board to decide on the issuance of shares, options or other special rights entitling to shares

The Board was authorised to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in chapter 10, section 1 of the Companies Act, which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation consists of up to 7,095,000 shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately 19.1 per cent of the existing shares and votes in the Company on the date of the AGM.

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

The Board was authorised to resolve on all other terms and conditions of the issuance of shares, options or other special rights entitling to shares. The authorisation will be effective until 30 June 2020 and will not replace previous authorisations granted to the Board.

Decisions of the Board

At the meeting of the Board held following the AGM, Frank Armstrong was re-elected Chair of the Board and Matti Manner was re-elected Deputy Chair of the Board.

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

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

·    Matti Manner was elected the Chair of the Nomination Committee and Frank Armstrong was elected as the other member of the Nomination Committee.

·    Frank Armstrong was elected as the Chair of the Remuneration Committee and John Poulos and Leopoldo Zambeletti were elected as the other members of the Remuneration Committee.

Minutes of the AGM

The minutes of the AGM will be available on the Company’s website from 11 June 2019 at the latest.

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s first candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (RAAA). Faron’s second candidate Clevegen is a ground breaking early clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com.

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