Managers’ transactions

RNS Number : 6920M
Faron Pharmaceuticals Oy
12 May 2020
 

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Managers’ transactions

Company announcement, 12 May 2020 at 8 PM (EEST)

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that Mr Toni Hänninen, Chief Financial Officer of the Company, acquired 3,500 ordinary shares in Faron at a price of €4.3255 per share on 12 May 2020. Following these purchases, Mr Hänninen holds 50,297 ordinary shares in the Company.

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

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

Chief Financial Officer

b.

Initial notification/

Amendment

Initial Notification

3

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

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

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

a.

Description of the financial instrument, type of instrument

Identification Code

Ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Purchase of ordinary shares

c.

Price(s) and volume(s)

Price(s)

Volume(s)

€4.3337

€4.3146

2,000

1,500

d.

Aggregated information

– Aggregated Volume

– Price

3,500

€15,139.30

e.

Date of the transaction

May 12, 2020

f.

Place of the transaction

Nasdaq First North Growth Market

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

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

E-mail: faron@consilium-comms.com
 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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). 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


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

END

 
 

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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

An acquisition or disposal of financial instruments

An event changing the breakdown of voting rights

Other (please specify)iii: Share issues

X

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:

29.04.2020

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

29.04.2020

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

13.94%

13.94%

46.790.747

Position of previous notification (if

applicable)

15.01%

15.01%

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

2.597.902

3.922.575

5.56%

8.38%

SUBTOTAL 8. A

6.520.477

13.94%

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)

              5.56%

5.56%

Acme Investments SPF Sarl (Indirect)

              8.38%

8.38%

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  

The change of ownership percentage from 15.01 % to 13.94% is mainly due to the Faron share issues described in the company stock exchange releases 22-23.4.2020 (the number of shares issued and registered have increased by 3.500.000 shares) and a small increase in holdings.

Place of completion

Lausanne

Date of completion

29/04/2020

Holding(s) in Company

RNS Number : 0057L
Faron Pharmaceuticals Oy
27 April 2020
 

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

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

The Fourth Swedish National Pension Fund

City and country of registered office (if applicable)

Stockholm, Sweden

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

Name

The Fourth Swedish National Pension Fund

City and country of registered office (if applicable)

Stockholm, Sweden

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

27/4/2020

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

27/4/2020

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

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

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

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

Total number of voting rights of issuervii

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

4.78

4.78

46,133,510

Position of previous notification (if

applicable)

2.90

2.90

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)

2,205,432

4.78

SUBTOTAL 8. A

2,205,432

4.78

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

X

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

Namexv

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

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

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

The Fourth Swedish National Pension Fund

4.78

4.78

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

Stockholm, Sweden

Date of completion

27.4.2020


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

END

 
 

HOLGZGZDFNRGGZM

Traumakine to be a part of WHO’s Solidarity trial

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Traumakine to be a part of WHO’s Solidarity trial investigating potential COVID-19 treatments

Company announcement, 27 April 2020 at 9.00 AM (EEST)
Inside information

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that the Company will donate supplies of its investigational intravenous (IV) interferon (IFN) beta-1a for 2,000 patients in the World Health Organization’s (WHO) Solidarity trial investigating potential COVID-19 treatments.

The global Solidarity trial is comparing four treatment options against standard of care, to assess their relative effectiveness against COVID-19 – remdesivir; lopinavir/ritonavir; lopinavir/ritonavir with IFN beta-1a; and chloroquine or hydroxychloroquine. Over 90 countries are involved in the trial, which aims to rapidly discover whether any of the drugs slow disease progression or improve survival, using an adaptive trial design to enable the rapid worldwide comparison of multiple interventions simultaneously.

Separate from this Solidarity trial the Company has previously announced participation in the global REMAP-CAP trial (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) underway across more than 60 sites and 13 countries (announced on 01 April 2020).

Dr. Markku Jalkanen, Faron’s CEO, said: “We are pleased that the WHO has included IFN beta-1a on its list of priority drugs to be tested against COVID-19, especially the IV form of the drug, which is what we believe critically ill patients need.

“One of the body’s main first lines of defence against viral infection is endogenous IFN-beta production1. We believe Traumakine treatment can further strengthen this natural defence with intravenous dosing of IFN beta-1a to provide optimal exposure to the lung vasculature and increase protection against serious lung complications.

“We are very proud to support the WHO’s global effort against COVID-19 by providing a potential therapy to treat acute respiratory distress syndrome (ARDS) that significantly impacts patients with severe COVID-192.”

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

References

1.    Global virus outbreaks: Interferons as 1st responders; Seminars in Immunology 43 (2019) 101300 https://doi.org/10.1016/j.smim.2019.101300 

2.    Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study; The Lancet, published online 29 January 2020 https://doi.org/10.1016/S0140-6736(20)30211-7 

Notes to editors

Further information on the Solidarity trial is available at https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments 

Further information about REMAP-CAP is available at https://www.remapcap.org

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

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

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Oy

Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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). 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”, “hope”, “seek”, ”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 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 the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, 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 or other sources of funding, 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.

Notice of Annual General Meeting

NOTICE OF faron pharmaceuticals LTD’s ANNUAL GENERAL MEETING

Shareholders of Faron Pharmaceuticals Ltd (the “Company“) are notified of the annual general meeting (the “AGM“) to be held on 18 May 2020 at 10:00 a.m. (Finnish time) at the offices of the Company at Joukahaisenkatu 6, 20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 9:00 a.m. (Finnish time).

Due to the SARS-CoV-2 situation, the AGM will only be held if the number of participants at the meeting is low enough to allow the AGM to be conducted safely and in compliance with the regulations issued by the authorities. The Company encourages its shareholders to participate in the AGM by way of centralised proxy representation and to follow the AGM by webcast. The special arrangements are described in more detail under section C.5.

The Company’s annual report for 2019 is available on the Company’s website at https://www.faron.com/investors/results.

A.  MATTERS ON THE AGENDA OF THE AGM

1.   Opening of the meeting

2.   Calling the meeting to order

3.   Election of persons to scrutinise the minutes and to supervise the counting of votes

4.   Recording the legality of the meeting

5.   Recording the attendance at the meeting and adoption of the list of votes

6.   Presentation of the financial statements, the Board’s report and the auditor’s report for 2019

Review by the CEO; measures to remedy equity shortfall.

7.   Adoption of the financial statements

8.   Resolution on the use of the profit shown on the balance sheet and the payment of dividend

The board of directors (the “Board“) proposes that no dividend for the financial year 2019 will be paid and that the losses of the Company for the financial year, amounting to EUR 13,261,911.93 (IFRS), will be carried forward to the reserve for invested unrestricted equity.

9.   Resolution on the discharge of the members of the Board and the CEO of the Company from liability

10. Resolution on the remuneration of the members of the Board

The Board proposes, on the basis of the proposal of the remuneration committee, 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.

The Board furthermore proposes that 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; and

·    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, it is proposed that all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board would be compensated.

The Board also proposes, on the basis of the proposal of the remuneration committee, that 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.

11. Resolution on the number of members of the Board

The Board proposes, on the basis of the proposal of the nomination committee, that six (6) members be elected to the Board.

12. Election of members of the Board

The Board proposes, on the basis of the proposal of the nomination committee, that Frank Armstrong, Markku Jalkanen, Matti Manner, Leopoldo Zambeletti, Gregory Brown and John Poulos be re-elected to the Board for a term that ends at the end of the next AGM.

Descriptions of the Board member candidates are available on the Company’s website at https://www.faron.com/faron/our-people.

The proposed Board members have informed the Company that in the event they are elected, they intend to elect Frank Armstrong as chair of the Board and Matti Manner as vice-chair of the Board.

13. Resolution on the remuneration of the auditor

The Board proposes, on the basis of the proposal of the audit committee, that the auditor be remunerated in accordance with the invoice presented.

14. Election of the auditor

The Board proposes, on the basis of the proposal of the audit committee, that PricewaterhouseCoopers Oy (“PwC“), a firm of authorised public accountants, continue to act as the Company’s auditor.

PwC has informed the Company that it will appoint Panu Vänskä, authorised public accountant (KHT), as the key audit partner.

15. Resolution on the amendment of the option programmes

A. The Company’s extraordinary general meeting has on 15 September 2015 adopted the terms and conditions of an option programme which have later been amended by the decision of the AGM held on 16 May 2017 (the “Option Plan 2015“). The options cannot currently be transferred or pledged before the subscription of shares without the consent of the Board. The Board proposes, on the basis of the proposal of the remuneration committee, that the AGM resolves to amend the terms and conditions of the Option Plan 2015 so that the options may be transferred or pledged after the conditions for share subscription have been fulfilled under the terms and conditions of the Option Plan 2015. The Board deems that the proposed amendment will enhance the usability of the options and thereby significantly increase the desired benefits of the incentivisation system for the management and personnel of the Company.

The consolidated terms and conditions of the Option Plan 2015, incorporating the amendments proposed herein, are attached hereto.

B. The Company’s AGM has on 28 May 2019 decided to authorise the Board to resolve 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. Pursuant to the decision of the AGM, the authorisation may 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 rules attached to that decision (the “Share Option Plan 2019“). The options cannot currently be transferred or pledged before the subscription of shares. The Board proposes, on the basis of the proposal of the remuneration committee, that the AGM resolves to approve implementing a change corresponding the aforementioned in the rules of the Share Option Plan 2019 so that the options may be transferred or pledged after the conditions for share subscription have been fulfilled. The Board deems that the proposed amendment will enhance the usability of the options and thereby significantly increase the desired benefits of the incentive system for the management and personnel of the Company.

The consolidated rules of the Share Option Plan 2019, incorporating the amendments proposed herein, are attached hereto.

16. Authorising the Board to decide on the issuance of shares, options or other special rights entitling to shares

The Board proposes that the AGM authorise the Board 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, which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation would consist of up to 8,650,000 shares in the 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.

The authorisation would 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 is proposed to 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, options or other special rights entitling to shares, and possibly deviating from the shareholders’ pre-emptive rights, would exist.

The Board would be 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 2021. This authorisation shall not replace the authorisation referred to in item 15 of this notice.

17. Closing of the meeting

B.   DOCUMENTS OF THE AGM

The above-mentioned proposals to the AGM and this notice are available immediately after publication of this notice on the Company’s website at https://www.faron.com/investors/general-meetings. The Company’s annual report for 2019, including the financial statements, the report of the Board and the auditor’s report, is available on the Company’s website at https://www.faron.com/investors/results. The Board proposals and the other above-mentioned documents will also be available at the AGM. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the AGM will be available to be viewed on the Company’s website from 1 June 2020 at the latest.

C.  INSTRUCTIONS FOR THE PARTICIPANTS

1.   The right to participate and registration

Each shareholder who on the record date of the AGM, being 6 May 2020, is registered in the Company’s shareholders’ register held by Euroclear Finland Ltd (“Euroclear“) has the right to participate in the AGM. A shareholder whose shares are registered on their personal book-entry account is registered in the Company’s shareholders’ register.

A shareholder who is registered in the Company’s shareholders’ register and who wants to participate in the AGM should register for the meeting by no later than 4 p.m. (Finnish time) on Wednesday, 13 May 2020 by giving a prior notice of participation:

•     by email to general.meeting@faron.com; or

•     by mail to Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland.

When registering, a shareholder shall state their name, personal identification number or business identity code, address, telephone number and the name of a possible proxy representative or assistant and the personal identification number of the proxy representative. In addition, the shareholder shall state whether they will follow the AGM by webcast. The personal data given by shareholders to the Company are used only in connection with the AGM and the necessary processing of related registrations.

Shareholders and their authorised representatives or proxy representatives should, when necessary, be able to prove their identity and/or right of representation.

Registrations submitted to the cancelled annual general meeting, convened to be held on 15 April 2020, will not be valid for this AGM. Therefore, the previously registered shareholders must re-register.

2.   Following the AGM by webcast

The Company’s shareholders can follow the AGM by webcast. By following the meeting by webcast, a shareholder does not attend the meeting nor can use the right to request information in accordance with the Finnish Limited Liability Companies Act nor exercise their voting rights. A link to the webcast will be sent to all shareholders who have given notice of attendance to the meeting and provided their email address.

Shareholders may pose questions about the items on the agenda of the AGM by 4 p.m. (Finnish time), 13 May 2020 by sending email to general.meeting@faron.com. The presentations by the Company will be prepared, to the extent possible, so that such questions will be answered.

3.   Proxy representative and powers of attorney

Shareholders may participate in the AGM and exercise their rights at the meeting by way of proxy representation. A proxy representative must present a dated power of attorney or other reliable proof of their authority to represent the shareholder.

Due to the SARS-CoV-2 situation, the Company encourages its shareholders to participate in the AGM by way of a centralised proxy representation. Shareholders are able to exercise their voting rights at the AGM without physical presence through the centralised proxy representation service provided by the Company’s General Counsel Pessi Honkasalo. Shareholders who wish to participate in the AGM through authorising Dr Honkasalo as proxy representative are required to register to the AGM as specified in this notice and deliver the proxy form, available on the Company’s website at https://www.faron.com/investors/general-meetings, to the Company before the end of registration period. Authorising Dr Honkasalo as proxy representative will not accrue any costs for the shareholder (excluding potential postal fees).

A shareholder may participate in the AGM by means of several proxy representatives who represent the shareholder with shares held on different book-entry accounts. In such case, the shares represented by each proxy representative shall be identified when registering for the AGM.

Proxy documents should be sent to Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland or by email to general.meeting@faron.com before the end of registration period.

4.   Holder of nominee-registered shares (including depositary interest holders)

A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the AGM by virtue of such shares based on which the holder would be entitled to be registered in the Company’s shareholders’ register held by Euroclear on the AGM’s record date of 6 May 2020.

Additionally, participation requires that the holder of nominee-registered shares is temporarily registered in the Company’s shareholders’ register held by Euroclear by 10 a.m. (Finnish time) on Wednesday, 13 May 2020. Temporary registration in the shareholders’ register shall be deemed to be a registration for the AGM.

Holders of nominee-registered shares are advised to request the necessary instructions regarding the temporary registration in the shareholders’ register, the issuing of proxy documents and registration for the AGM from their custodian bank without delay. The account management organisation of the custodian bank shall notify a holder of nominee-registered shares who wants to participate in the AGM to be temporarily entered into the Company’s shareholders’ register by the above-mentioned time.

5.   Other instructions and information

The AGM will be organised in compliance with the regulations issued by the Finnish authorities in response to SARS-CoV-2. Due to the SARS-CoV-2 situation, the Company intends to limit the amount of the physical participants of the AGM to the minimum. Developments in the SARS-CoV-2 situation and complying with the governmental regulations may even lead to a situation where the number of participants arriving at the meeting venue will need to be limited. The Company requests its shareholders to comply with the following instructions regarding the meeting that are aimed to enable organising the meeting in consideration of the health and the safety of the Company’s shareholders:

·    All of the shareholders are asked to participate in the AGM by way of centralised proxy representation and to follow the AGM by webcast (see detailed provisions under sections 1-3 above).

·    No food or refreshments will be served at the meeting.

·    The AGM and all of the presentations, including the review by the CEO, will be kept as short as possible.

·    The participation by the Board and management will be restricted to minimum.

Shareholders are asked to comply with authority regulations and recommendations for their own part. The Company takes the threat of SARS-CoV-2 seriously and is following the situation carefully. Developments in the SARS-CoV-2 situation may require other special arrangements to organise the AGM or even to postpone the AGM to a later date. The Company’s shareholders are asked to follow the Company’s announcements as well as the web page https://www.faron.com/investors/general-meetings for any possible changes or additional information.

Pursuant to chapter 5, section 25 of the Finnish Limited Liability Companies Act, shareholders who are present at the AGM are entitled to request information regarding the matters addressed by the meeting.

On the date of this notice, 14 April 2020, the total number of shares and votes in the Company is 43,290,747.

The AGM shall be held in Finnish and in English.

Turku, 14 April 2020

FARON PHARMACEUTICALS LTD

Board of Directors

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, CEO

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

+44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

+358 40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

+44 20 3709 5700

faron@consilium-comms.com 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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). 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.

AGM to be postponed

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

AGM to be postponed

Company announcement, 3 April 2020 at 4.45pm (EEST)

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that, due to the prevailing Covid-19 situation, the Company’s Board of Directors has decided to cancel the Company’s annual general meeting (“AGM”) scheduled to be held on 15 April 2020.

A new notice will be published in due course to convene the AGM at a later stage.

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

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

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Oy

Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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). 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.

Notice of Annual General Meeting

NOTICE OF faron pharmaceuticals LTD’s ANNUAL GENERAL MEETING

Company announcement, 20 March 2020 at 1.30 PM (EET)

Shareholders of Faron Pharmaceuticals Ltd (the “Company“) are notified of the annual general meeting (the “AGM“) to be held on 15 April 2020 at 2:00 p.m. (Finnish time) at the BioCity building, meeting room Manu at Tykistökatu 6, 20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 1:00 p.m. (Finnish time). Due to the prevailing SARS-CoV-2 situation, the Company encourages its shareholders to participate in the AGM by way of centralised proxy representation and to follow the AGM by webcast.

The annual financial statement release containing the most important information from the Company’s annual report for 2019 has been published on the date of this notice. The Company’s annual report for 2019 will be available on the “Results” section of the Company’s website at https://www.faron.com/investors/results no later than three weeks before the AGM, i.e. as of 25 March 2020 at the latest.

A.  MATTERS ON THE AGENDA OF THE AGM

1.   Opening of the meeting

2.   Calling the meeting to order

3.   Election of persons to scrutinise the minutes and to supervise the counting of votes

4.   Recording the legality of the meeting

5.   Recording the attendance at the meeting and adoption of the list of votes

6.   Presentation of the financial statements, the Board’s report and the auditor’s report for 2019

Review by the CEO; measures to remedy equity shortfall.

7.   Adoption of the financial statements

8.   Resolution on the use of the profit shown on the balance sheet and the payment of dividend

The board of directors (the “Board“) proposes that no dividend for the financial year 2019 will be paid and that the losses of the Company for the financial year, amounting to EUR 13,261,911.93 (IFRS), will be carried forward to the reserve for invested unrestricted equity.

9.   Resolution on the discharge of the members of the Board and the CEO of the Company from liability

10. Resolution on the remuneration of the members of the Board

The Board proposes, on the basis of the proposal of the remuneration committee, 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.

The Board furthermore proposes that 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; and

·     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, it is proposed that all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board would be compensated.

The Board also proposes, on the basis of the proposal of the remuneration committee, that 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.

11. Resolution on the number of members of the Board

The Board proposes, on the basis of the proposal of the nomination committee, that six (6) members be elected to the Board.

12. Election of members of the Board

The Board proposes, on the basis of the proposal of the nomination committee, that Frank Armstrong, Markku Jalkanen, Matti Manner, Leopoldo Zambeletti, Gregory Brown and John Poulos be re-elected to the Board for a term that ends at the end of the next AGM.

Descriptions of the Board member candidates are available on the Company’s website at https://www.faron.com/.

The proposed Board members have informed the Company that in the event they are elected, they intend to elect Frank Armstrong as chair of the Board and Matti Manner as vice-chair of the Board.

13. Resolution on the remuneration of the auditor

The Board proposes, on the basis of the proposal of the audit committee, that the auditor be remunerated in accordance with the invoice presented.

14. Election of the auditor

The Board proposes, on the basis of the proposal of the audit committee, that PricewaterhouseCoopers Oy (“PwC“), a firm of authorised public accountants, continue to act as the Company’s auditor.

PwC has informed the Company that it will appoint Panu Vänskä, authorised public accountant (KHT), as the key audit partner.

15. Resolution on the amendment of the option programmes

A. The Company’s extraordinary general meeting has on 15 September 2015 adopted the terms and conditions of an option programme which have later been amended by the decision of the AGM held on 16 May 2017 (the “Option Plan 2015“). The options cannot currently be transferred or pledged before the subscription of shares without the consent of the Board. The Board proposes, on the basis of the proposal of the remuneration committee, that the AGM resolves to amend the terms and conditions of the Option Plan 2015 so that the options may be transferred or pledged after the conditions for share subscription have been fulfilled under the terms and conditions of the Option Plan 2015. The Board deems that the proposed amendment will enhance the usability of the options and thereby significantly increase the desired benefits of the incentivisation system for the management and personnel of the Company.

The consolidated terms and conditions of the Option Plan 2015, incorporating the amendments proposed herein, are attached hereto.

B. The Company’s AGM has on 28 May 2019 decided to authorise the Board to resolve 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. Pursuant to the decision of the AGM, the authorisation may 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 rules attached to that decision (the “Share Option Plan 2019“). The options cannot currently be transferred or pledged before the subscription of shares. The Board proposes, on the basis of the proposal of the remuneration committee, that the AGM resolves to approve implementing a change corresponding the aforementioned in the rules of the Share Option Plan 2019 so that the options may be transferred or pledged after the conditions for share subscription have been fulfilled. The Board deems that the proposed amendment will enhance the usability of the options and thereby significantly increase the desired benefits of the incentive system for the management and personnel of the Company.

The consolidated rules of the Share Option Plan 2019, incorporating the amendments proposed herein, are attached hereto.

16. Authorising the Board to decide on the issuance of shares, options or other special rights entitling to shares

The Board proposes that the AGM authorise the Board 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, which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation would consist of up to 8,650,000 shares in the 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.

The authorisation would 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 is proposed to 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, options or other special rights entitling to shares, and possibly deviating from the shareholders’ pre-emptive rights, would exist.

The Board would be 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 2021. This authorisation shall not replace the authorisation referred to in item 15 of this notice.

17. Closing of the meeting

B.  DOCUMENTS OF THE AGM

The above-mentioned proposals to the AGM and this notice are available immediately after publication of this notice on the Company’s website at https://www.faron.com/investors/general-meetings. The Company’s annual report for 2019, including the financial statements, the report of the Board and the auditor’s report, will be made available as of 25 March 2020 at the latest on the Company’s website under the section Investors > Results. The Board proposals and the other above-mentioned documents will also be available at the AGM. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the AGM will be available to be viewed on the Company’s website from 29 April 2020 at the latest.

C.  INSTRUCTIONS FOR THE PARTICIPANTS

1.   The right to participate and registration

Each shareholder who on the record date of the AGM, being 1 April 2020, is registered in the Company’s shareholders’ register held by Euroclear Finland Ltd (“Euroclear“) has the right to participate in the AGM. A shareholder whose shares are registered on their personal book-entry account is registered in the Company’s shareholders’ register.

A shareholder who is registered in the Company’s shareholders’ register and who wants to participate in the AGM should register for the meeting by no later than 4 p.m. (Finnish time) on Wednesday, 8 April 2020 by giving a prior notice of participation:

•     by email to general.meeting@faron.com; or

•     by mail to Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland.

When registering, a shareholder shall state their name, personal identification number or business identity code, address, telephone number and the name of a possible proxy representative or assistant and the personal identification number of the proxy representative. In addition, the shareholder shall state whether they will follow the AGM by webcast. The personal data given by shareholders to the Company are used only in connection with the AGM and the necessary processing of related registrations.

Shareholders and their authorised representatives or proxy representatives should, when necessary, be able to prove their identity and/or right of representation.

Due to the SARS-CoV-2 situation, the Company intends to limit the amount of the physical participants of the AGM to the minimum. Developments in the SARS-CoV-2 situation and complying with the governmental regulations may even lead to a situation where the number of participants arriving at the meeting venue will need to be limited. Therefore, the Company encourages its shareholders to participate in the AGM by way of proxy representation and to follow the AGM by webcast.

2.   Following the AGM by webcast

The Company’s shareholders can follow the AGM by webcast. By following the meeting by webcast, a shareholder does not attend the meeting nor can use the right to request information in accordance with the Finnish Limited Liability Companies Act nor exercise their voting rights. A link to the webcast will be sent to all shareholders who have given notice of attendance to the meeting and provided their email address.

3.   Proxy representative and powers of attorney

Shareholders may participate in the AGM and exercise their rights at the meeting by way of proxy representation. A proxy representative must present a dated power of attorney or other reliable proof of their authority to represent the shareholder.

A shareholder may participate in the AGM by means of several proxy representatives who represent the shareholder with shares held on different book-entry accounts. In such case, the shares represented by each proxy representative shall be identified when registering for the AGM.

Shareholders are also able to exercise their voting rights at the AGM without physical presence through the centralized proxy representation service provided by the Company’s Corporate Legal Counsel Pessi Honkasalo. Shareholders who wish to participate in the AGM through authorising Dr Honkasalo as proxy representative are required to register to the AGM as specified in this notice and deliver the proxy form, available at the Company’s website at https://www.faron.com/investors/general-meetings, to the Company before the end of registration period. Authorising Dr Honkasalo as proxy representative will not accrue any costs for the shareholder (excluding postal fees).

Proxy documents should be sent to Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland or by email to general.meeting@faron.com before the end of registration period.

4.   Holder of nominee-registered shares (including depositary interest holders)

A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the AGM by virtue of such shares based on which the holder would be entitled to be registered in the Company’s shareholders’ register held by Euroclear on the AGM’s record date of 1 April 2020.

Additionally, participation requires that the holder of nominee-registered shares is temporarily registered in the Company’s shareholders’ register held by Euroclear by 10 a.m. (Finnish time) on Wednesday, 8 April 2020. Temporary registration in the shareholders’ register shall be deemed to be a registration for the AGM.

Holders of nominee-registered shares are advised to request the necessary instructions regarding the temporary registration in the shareholders’ register, the issuing of proxy documents and registration for the AGM from their custodian bank without delay. The account management organisation of the custodian bank shall notify a holder of nominee-registered shares who wants to participate in the AGM to be temporarily entered into the Company’s shareholders’ register by the above-mentioned time.

5.   Other instructions and information

The Company takes the threat of SARS-CoV-2 seriously and is following the situation carefully. Developments in the SARS-CoV-2 situation may require special arrangements to organise the AGM or even to postpone the AGM to a later date. The Company’s shareholders are asked to follow the Company’s announcements as well as its website, https://www.faron.com/investors/general-meetings, for any possible changes or additional information.

Pursuant to chapter 5, section 25 of the Finnish Limited Liability Companies Act, shareholders who are present at the AGM are entitled to request information regarding the matters addressed by the meeting.

On the date of this notice, 20 March 2020, the total number of shares and votes in the Company is 43,290,747.

The AGM shall be held in Finnish and in English.

Turku, 20 March 2020

FARON PHARMACEUTICALS LTD

Board of Directors

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, CEO

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

+44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

+358 40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

+44 20 3709 5700

faron@consilium-comms.com 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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). 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.

Faron to acquire AOC3 antagonist platform

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron to acquire AOC3 antagonist platform technology

Company announcement, 02 March 2020 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that it has acquired rights for the potential new use of AOC3 inhibitors (“Agreement”) covered by a recently filed patent application (“Invention”).

The AOC3 enzymatic domain, a semicarbazide-sensitive amine oxidase is known to produce hydrogen peroxide, a potent inflammatory mediator.  Being expressed by many inflamed vascular endothelial cells, the AOC3 overexpression has been connected with many vascular diseases. The Invention has been discovered by Faron’s scientific network (“Inventors”).

Faron will be responsible for the management, prosecution and maintenance of any patent applications assigned from the Inventors to Faron, as well as for the filing of new patent applications for the AOC3 protein inhibitor. Faron is also responsible for the future development of the Invention. Under the terms of the Agreement, in consideration for assignment of the Invention to Faron, the Inventors are eligible to receive low single digit royalties of net revenues of products associated with the Invention and a low single digit percentage of payments to Faron in the event of a third party license being entered into in respect of the Invention. Pre-clinical studies with humanized AOC3 mice and with ex vivo human cells in relation to the Invention are currently ongoing and further information will be provided later in the year.

RELATED PARTY TRANSACTION

Academician Sirpa Jalkanen, one of the Inventors, is the wife of Markku Jalkanen, Chief Executive Officer, and therefore the Agreement constitutes a related party transaction for the purposes of the AIM Rules. The Directors, Frank Armstrong, Matti Manner, Gregory Brown, John Poulos and Leopoldo Zambeletti, all of whom are independent of Mrs Jalkanen, having consulted with Panmure Gordon, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the Agreement to be fair and reasonable insofar as Shareholders are concerned.

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

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

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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). 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”, “hope”, “seek”, ”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 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 the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, 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 or other sources of funding, 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.

Traumakine update

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Traumakine update 

–     New trial protocol preventing concomitant corticosteroid use with Traumakine

–     Company notes WHO recommendations on use of steroids in coronavirus patients

Company announcement, 06 February 2020 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today provides an update on Traumakine’s clinical continuation following a meeting with the U.S. Food and Drug Administration (FDA) in December 2019.

Following feedback from the FDA regarding the design of the next Traumakine study and receipt of agreed meeting minutes, Faron has updated the proposed study design and has submitted the amended trial protocol to the FDA. The trial protocol has been amended to reflect the FDA’s feedback that further studies with interferon-beta (IFN-beta) should exclude the use of overlapping steroids since they are likely to block the desired therapeutic effect of Traumakine and may have a potentially deleterious impact on patient outcomes. Faron will continue to work in close collaboration with the FDA to achieve final approval for the next study.

The Company notes with interest a recent recommendation by the World Health Organization (WHO) that steroids should not be used on coronavirus infected patients1. One of the main first lines of defence against viral infection is endogenous IFN-beta production2. Blocking endogenous IFN-beta production using steroids may be deleterious to treatment outcomes in these patients. Therefore, exogenous IFN-beta (like Traumakine) can strengthen further this endogenous IFN-beta action and provide maximal protection against viral infections but it has to be administered without concomitant corticosteroids, which have the capacity to disturb or block IFN-beta action.

A recent descriptive study published in The Lancet3 on the 2019 novel coronavirus (2019-nCoV) outbreak in Wuhan, China reports that 17% of the 99 patients with 2019-nCoV pneumonia developed Acute Respiratory Distress Syndrome (“ARDS”) and 11% worsened in a short period of time and died of multiple organ failure. 19% of patients in the study received corticosteroids, a treatment option no longer recommended by the WHO.

Dr. Markku Jalkanen, Faron’s CEO, said: “With no currently approved pharmacological treatments available, ARDS remains a significant problem for patients and healthcare systems. We are pleased to note that the WHO has recognised the risk of using corticosteroids on patients with coronavirus, which aligns with our findings from post-hoc analysis of the INTEREST study.

“One of the main first lines of defence against viral infection is endogenous interferon-beta production. Faron believes Traumakine treatment, in the absence of concomitant corticosteroid use, can further strengthen this endogenous IFN-beta action and provide increased protection against serious lung complications arising from viral infections. Faron remains committed to developing Traumakine for the potentially fatal condition ARDS.”

References

1.    Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected; WHO interim guidance, 28 January 2020 https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected 

2.    Global virus outbreaks: Interferons as 1st responders; Seminars in Immunology 43 (2019) 101300 https://doi.org/10.1016/j.smim.2019.101300 

3.    Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study; The Lancet, published online 29 January 2020 https://doi.org/10.1016/S0140-6736(20)30211-7 

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

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

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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). 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”, “hope”, “seek”, ”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 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 the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, 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 or other sources of funding, 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.

Update on Traumakine drug substance manufacturing

       Faron Pharmaceuticals Oy

Update on Traumakine drug substance manufacturing

–     Faron contests termination of the agreement and files for arbitration

–     Proceedings funded by a third party on a non-recourse basis

Company announcement, 30 December 2019 at 11.30 am (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) (“Faron” or the “Company“), the clinical stage biopharmaceutical company, announces that, further to the update on Traumakine® drug substance (“API“) manufacturing announced on 2 October 2019, the Company has carried out a detailed investigation into the circumstances around manufacturing arrangements and concluded that it considers the letter in which Rentschler Biopharma SE (“Rentschler“) states that it terminates the agreement concerning the API manufacturing process for Traumakine® to be without merit and in breach of the underlying agreement between the parties. Faron also considers Rentschler to have otherwise breached the agreement.

As a remedy, the Company has filed a request for arbitration with the Arbitration Institute of the Stockholm Chamber of Commerce seeking damages. To fund the proceedings, the Company has entered into a litigation funding agreement with a third-party recovery services provider offering non-recourse financing which, subject to final quantum, is expected to cover both the Company’s legal expenses and the adverse party costs. The funder would receive a typical portion of any damages awarded in the event of success.

Further updates will be provided in due course as and when appropriate.

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

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

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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). 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”, “hope”, “seek”, ”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, opportunities and results of arbitration. 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 outcome of the arbitration could be materially different to the damages sought. Furthermore, 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 the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, 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 or other sources of funding, 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.

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