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TURKU – FINLAND, 14 May 2019 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces a subscription for new ordinary shares in aggregate in the capital of the Company (“Ordinary Shares”) at a price of EUR 0.7598 (£0.65) per share (“Issue Price”) (the “Subscription”) raising gross proceeds of approximately EUR 1.34 million.
Timo Syrjälä and Acme Investments SPF Sarl (“Acme”), an entity wholly owned by Mr Syrjälä, an existing shareholder in the Company, has subscribed for 1,757,375 Ordinary Shares (the “Subscription Shares”) for a subscription value of EUR 1.34 million (£1.15 million). Following this Subscription, Mr Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme, is 4,519,375 shares, representing 12.14 per cent. of the enlarged issued share capital.
The Ordinary Shares are being issued by the Company pursuant to the remaining balance of the Directors’ existing authority to allot ordinary shares in the capital of the Company for cash on a non-pre-emptive basis, as approved by shareholders at the Company’s last annual general meeting which was held on 31 May 2018.
The net proceeds of the Subscription are expected to extend the Company’s working capital into mid-Q4 2019 and will also be applied towards advancement of the Company’s key products in line with the Company’s strategy set out in the recent placing announcement on 26 March 2019 and the annual results announcement on 7 May 2019. The Company will continue to explore further funding opportunities and in particular continue its discussions with potential licensing partners.
The Ordinary Shares are fully paid and will rank pari passu in all respects with the existing Ordinary Shares, including the right to receive all dividends or other distributions made, paid or declared in respect of such shares after Registration.
Application has been made to the London Stock Exchange for admission to AIM of the 1,757,375 Subscription Shares (“Admission”), and it is expected that Admission will take place at 8:00 a.m. on 16 May 2019.
Faron’s enlarged issued number of shares is now 37,233,894 Ordinary Shares with voting rights attached. The Company has no shares in Treasury; therefore upon, the total number of voting rights in Faron is 37,233,894 (the “Enlarged Number of Shares and Votes”).This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the Enlarged Number of Shares and Votes of the Company.
Commenting on the Share Subscription Dr Markku Jalkanen, CEO of Faron, said: “Following the financing raised from new and existing shareholders earlier this year, we are very pleased to receive this additional shareholder support. The year 2019 is significant for Faron, as we seek to advance our clinical programmes for Traumakine, and especially for Clevegen. We are highly encouraged by the confidence our shareholders continue to show in the Company.”
Exchange rate
Unless otherwise specified, this announcement contains certain translations of Euros into amounts in Pounds Sterling based on the exchange rate of £1.00 = €1.169.
The information contained within this announcement constitutes inside information stipulated under the Market Abuse Regulation (EU) No. 596/2014.
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
NOTICE OF faron pharmaceuticals LTD’s ANNUAL GENERAL MEETING
Shareholders of Faron Pharmaceuticals Ltd (the “Company“) are invited to attend the Annual General Meeting to be held on 28 May 2019 at 10.00 a.m. (Finnish time) at the BioCity building, Mauno Conference Center, address Tykistökatu 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).
The Company’s Annual Report 2018 is available to view and download on the “Results” section of the Company’s website at https://www.faron.com/investors/results.
A. MATTERS ON THE AGENDA OF THE ANNUAL GENERAL MEETING
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 Report of the Board of Directors and the Auditor’s Report for 2018
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 proposes that no dividend for the financial year 2018 will be paid and that 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.
9. Resolution on the discharge of the members of the Board of Directors and the CEO of the Company from liability
10. Resolution on the remuneration of the members of the Board of Directors
The Board of Directors 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 Chairman of the Board of Directors. In addition, a further annual remuneration of EUR 11,000 will be paid to the Chairman of the Audit Committee, a further annual remuneration of EUR 9,000 will be paid to the Chairman of the Remuneration Committee and a further annual remuneration of EUR 6,000 will be paid to the Chairman of the Nomination Committee. In addition, a further annual remuneration of EUR 6,000 will be paid to the Audit Committee members, a further annual remuneration of EUR 5,000 will be paid to the Remuneration Committee members and a further annual remuneration of EUR 3,000 will be paid to the Nomination Committee members.
The Board of Directors 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 of Directors would be compensated.
The Board of Directors 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.
The Board of Directors notes that, in order to support the Company’s cost savings measures, the members of the Board of Directors have voluntarily waived 20 per cent of their annual remuneration and meeting fees between 1 July 2018 and 31 March 2019, the Company’s CEO Markku Jalkanen has voluntarily agreed on a salary reduction of 40 per cent between 1 June 2018 and 30 April 2019, and the Company’s CFO Yrjö Wichmann has been laid off by 40 per cent between 16 July 2018 and 31 March 2019.
11. Resolution on the number of members of the Board of Directors
The Board of Directors proposes on the basis of the proposal of the Nomination Committee that seven (7) members be elected to the Board of Directors.
12. Election of members of the Board of Directors
The Board of Directors proposes, on the basis of the proposal of the Nomination Committee, that Frank Armstrong, Markku Jalkanen, Matti Manner, Yrjö Wichmann, Leopoldo Zambeletti, Gregory Brown and John Poulosbe re-elected for a term that ends at the end of the next Annual General Meeting.
The proposed Board members have informed the Company that in the event they are elected, they intend to elect Frank Armstrong as Chairman of the Board and Matti Manner as Deputy Chairman of the Board.
13. Resolution on the remuneration of the Auditor
The Board of Directors 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 of Directors proposes, on the basis of the proposal of the Audit Committee, that PricewaterhouseCoopers Oy, Authorised Public Accountants, continue to act as the Company’s auditor.
PricewaterhouseCoopers Oy has informed the Company that it will appoint Panu Vänskä, Authorised Public Accountant, as the Auditor with principal responsibility for the completion of the Audit.
15. Authorising the Board of Directors to decide on the issuance of options or other special rights entitling to shares
The Board of Directors proposes, on the basis of the proposal of the Remuneration Committee, that the Annual General Meeting authorise the Board of Directors 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. The authorisation would consist of up to 2,000,000 shares in the aggregate, which corresponds to approximately 5.6 per cent of the existing shares and votes in the Company.
The authorisation would not exclude the Board of Directors’ 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 is proposed to 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 hereto as Annex 1. 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 to be granted to the members of the Company’s management and the Board of Directors shall be as follows:
· to the Chairman of the Board, a maximum of 180,000 options;
· to each member of the Board (excluding the Chairman 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 of Directors (the “Exercise Conditions“).
Subject to fulfilment of the Exercise Conditions, the options may be exercised at the exercise price, which may not be less than the market value of a share at the grant date, as determined by the Board of Directors (the “Exercise Price“). In determining such market value, if shares are traded on the AIM market of the London Stock Exchange, the Board of Directors shall 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 shall be recorded in the Company’s reserve for invested unrestricted equity.
The Board of Directors would be 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 Finnish Limited Liability Companies Act.
The authorisation will be effective until 30 June 2023. This authorisation shall not replace previous authorisations granted to the Board of Directors.
16. Authorising the Board of Directors to decide on the issuance of shares, options or other special rights entitling to shares
The Board of Directors proposes that the Annual General Meeting authorise the Board of Directors 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 7,095,000 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 of Directors’ 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 of Directors in which case a weighty financial reason for issuing shares, and possibly deviating from the shareholders’ pre-emptive rights, would exist.
The Board of Directors 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 2020. This authorisation shall not replace previous authorisations granted to the Board of Directors.
17. Closing of the meeting
B. DOCUMENTS OF THE ANNUAL GENERAL MEETING
The above-mentioned proposals to the Annual General Meeting, the Company’s Annual Report 2018, including the financial statements, the Report of the Board of Directors and the Auditor’s Report, and this notice are available immediately after publication of this notice on the Company’s website at https://www.faron.com/investor-relations/annual-general-meeting-material. The Board proposals and the other above-mentioned documents will also be available at the Annual General Meeting. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the Annual General Meeting will be available to be viewed on the Company’s website from 11 June 2019 at the latest.
C. INSTRUCTIONS FOR THE PARTICIPANTS
1. The right to participate and registration
Each shareholder who on the record date of the Annual General Meeting, being 16 May 2019, is registered in the Company’s shareholders’ register held by Euroclear Finland Ltd has the right to participate in the Annual General Meeting. 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 Annual General Meeting should register for the meeting by no later than 4 p.m. (Finnish time) on Thursday 23 May 2019 by giving a prior notice of participation:
• 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 / 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. The personal data given by shareholders to the Company are used only in connection with the Annual General Meeting and the necessary processing of related registrations.
Shareholder, and their authorised representatives or proxy representatives should, when necessary, be able to prove their identity and/or right of representation.
2. Proxy representative and powers of attorney
Shareholders may participate in the Annual General Meeting 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 Annual General Meeting 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 Annual General Meeting.
Possible proxy documents should be sent in originals to Faron Pharmaceuticals Ltd, Joukahaisenkatu 6, FI-20520 Turku, Finland before the end of registration period.
3. 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 Annual General Meeting 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 Finland Ltd on the Annual General Meeting’s record date of 16 May 2019.
Additionally, participation requires that the holder of nominee-registered shares is temporarily registered in the Company’s shareholders’ register held by Euroclear Finland Ltd by 10 a.m. (Finnish time) on Thursday 23 May 2019. Temporary registration in the shareholders’ register shall be deemed to be a registration for the Annual General Meeting.
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 General Meeting 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 Annual General Meeting to be temporarily entered into the Company’s shareholders’ register by the above-mentioned time.
4. Other instructions and information
Pursuant to chapter 5, section 25 of the Finnish Limited Liability Companies Act, shareholders who are present at the Annual General Meeting are entitled to request information regarding the matters addressed by the meeting.
On the date of this notice, 7 May 2019, the total number of shares and votes in the Company is 35,476,519.
The Annual General Meeting shall be held in Finnish and in English.
Turku, 7 May 2019
FARON PHARMACEUTICALS LTD
Board of Directors
The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.
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.
TURKU – FINLAND, 2 May 2019 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, notes the recent movement in its share price and the Company confirms that it knows of no operational or corporate reason for the share price move.
As noted in the Company’s announcements on 26 March 2019 and 11 April 2019, the Company continues to progress both its key products, Clevegen and Traumakine. In particular, as announced, the Company has seen encourgaing early observations in the MATINS trial of potential early clinical benefits in dosed patients and the Company is currently engaged in partnering discussions with several parties. Whilst there can be no guarantee, the Company hope for a positive outcome from these negotiations during 2019.
Faron (AIM:FARN) is aclinical stage biopharmaceutical companydeveloping novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy.The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies. There is currently no approved pharmaceutical treatment for ARDS.An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called 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
Results from theJapanese Phase III study with Traumakine in the treatment of ARDS
TURKU – FINLAND, 29 April 2019 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, today announces that its Japanese licensing partner Maruishi Pharmaceutical Co., Ltd. (“Maruishi”) has provided clinical trial results on its Phase III Japanese Traumakine® study for the treatment of acute respiratory distress syndrome (“ARDS”).
The results of the trial are in line with Faron’s expectations which were detailed in the Proposed Placing announcement on 26 March 2019. In particular:
Treatment with Traumakine did not result in reduced mortality or increased number of ventilator free survival days when compared to placebo.
Overall, the placebo and Traumakine treatment groups were well balanced in basic demographics, except that the Traumakine group had more sepsis and less pneumonia as the etiology of ARDS when compared to the placebo group.
According to the post-hoc analysis, the overall percentage of study subjects who received concomitant glucocorticoids was 77%, which was higher than that of the INTEREST study. The effect of glucocorticoids showed similar trends to that observed from the INTEREST study. Due to the limited trial size, further sub-group analysis is not meaningful.
Dr Markku Jalkanen, CEO of Faron, said: “As we had already observed in the INTEREST trial, it appears likely that corticosteroid use diminished the treatment benefit of Traumakine in ARDS patients in the Japanese Phase III study. Unfortunately, the use of steroids has become a standard in ARDS despite any evidence base and this requires critical reassessment, as the use of steroids appears to worsen outcomes in certain ARDS subgroups.”
The information contained within this announcement constitutes inside information stipulated under the Market Abuse Regulation (EU) No. 596/2014.
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
About Maruishi Pharmaceutical Co., Ltd.
Maruishi, an Osaka-based, R&D-orientated company with over 130-year history, has a strong presence in the Japanese market as a specialty pharma developing, manufacturing, and marketing perioperative drugs and drugs used in the acute settings. Maruishi continues to be proactively engaged in R&D activities to contribute to the improvement of the quality of life (QOL) of patients.
TR-1: Standard form for notification of major holdings
NOTIFICATION OF MAJOR HOLDINGS(to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:
Faron Pharmaceuticals Oy
1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate)
Non-UK issuer
X
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights
X
An acquisition or disposal of financial instruments
An event changing the breakdown of voting rights
Other (please specify)iii:
3. Details of person subject to the notification obligationiv
Name
Tom-Erik Lind
City and country of registered office (if applicable)
4. Full name of shareholder(s) (if different from 3.)v
Name
City and country of registered office (if applicable)
5. Date on which the threshold was crossed or reachedvi:
25.04.2019
6. Date on which issuer notified (DD/MM/YYYY):
25.04.2019
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
10,00 %
10,00 %
35,476,519
Position of previous notification (if
applicable)
9,07 %
9,07 %
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)
3,547,712
10,00 %
SUBTOTAL 8. A
3,547,712
10,00 %
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 datex
Exercise/ Conversion Periodxi
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 datex
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
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
Sliema
Date of completion
25.04.2019
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.
TR-1: Standard form for notification of major holdings
NOTIFICATION OF MAJOR HOLDINGS(to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:
Faron Pharmaceuticals Oy
1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate)
Non-UK issuer
x
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights
An acquisition or disposal of financial instruments
An event changing the breakdown of voting rights
Other (please specify)iii: Admission of Placing and Subscription Shares
x
3. Details of person subject to the notification obligationiv
Name
Marko Salmi
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:
29.03.2019
6. Date on which issuer notified (DD/MM/YYYY):
12.04.2019
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
8,44%
8,44%
35,476,519
Position of previous notification (if
applicable)
9,97%
9,97%
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
2,995,639
8,44%
SUBTOTAL 8. A
2,995,639
8,44%
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 datex
Exercise/ Conversion Periodxi
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 datex
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 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
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
Turku
Date of completion
12.04.2019
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.
Colorectal cancer selected as a first expansion cohort for MATINS trial part 2
Selection based on observed activation of patient’s immune system and shrinkage of colorectal cancer metastasis in the lung
TURKU – FINLAND, 11 April 2018 – Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces that the cohort expansion part of its phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen, Faron’s wholly-owned novel precision cancer immunotherapy, will begin with patients suffering from late-stage colorectal cancer as soon as the optimal dosing has been determined.
Clevegen is a novel anti-Clever-1 antibody, which causes changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive myeloid cells to immune active macrophages. This immune switch results in increased number of active tumour-killing CD8+ cells leading to robust anti-tumour activity in pre-clinical models (Viitala et al. (2019) Clinical Cancer Research, on-line DOI:10.1158/1078-0432.CCR-18-3016), and also reviewed by Mantovani and Bonecchi (2019) (Clinical Cancer Research, on-line DOI:10.1158/1078-0432.CCR-19-0483).
The decision to target colorectal cancer during the cohort expansion stage of the MATINS Phase I/II study (part 2) follows previously reported early data from the ongoing dose escalation and safety stage of MATINS which has now recruited four subjects with no safety concerns at 0.3 and 1.0 mg/kg dosing and has moved to 3 mg/kg dosing level. All dosed patients have, thus far, shown a switch in their immune profile towards more immune activation, observed as an increase in CD8+ cells, an increased CD8/CD4 ratio, decreased regulatory T-cells (T-regs) and a high appearance of mobile NK cells in the blood.
As previously reported, Faron has also received a tumour imaging report of a patient with colorectal cancer, which indicates significant shrinkage of lung metastasis (classified as a partial response according to the RECIST classification). Positively, the patient has also shown a decrease in the tumour load marker CEA (carcinoembryonic antigen), which has normalized along with treatment. In addition, the patient shows an increase in circulating B-cells, which could indicate an antibody-mediated response against the tumour. This patient, whose tumour has been classified as microsatellite instability (MSI)-low, had previously been treated with six different anti-cancer drugs, which had all failed. MSI-low colorectal patients represent around 90% of all colorectal cancers and over one million annual cases globally.
With this patient demonstrating a clinical partial response and expected immune switch, Faron is confident it has identified one group of patients who are thought to most likely respond to treatment and demonstrate an immune switch in these immunosuppressive Clever-1-positive tumour associated macrophages (TAMs).
Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “We are encouraged by the data gathered so far from the MATINS study, particularly the tumour imaging report from a colorectal patient in whom all other treatments have failed, which demonstrates a partial response according to RECIST already in nine weeks. This information further supports our belief that Clevegen has the ability to function as anovel macrophage checkpoint immunotherapy for patients with currently untreatable solid cancers. Advancing MATINS into the cohort expansion stage later this year indicates our commitment to rapidly advance development of this potential therapy for patients in need of new treatment options.”
About the MATINS study
The MATINS study is a 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. The cancer patients with high Clever-1 expression will be identified with a simple blood myeloid cell staining with Clevegen (“liquid biopsy”).
The first part of the trial deals with safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report initial 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. During part three the main focus will be on assessing the efficacy of Clevegen on patients 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”).
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
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.
A number of factors could cause actual results to differ materially from the results 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.
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:
09.04.2019
6. Date on which issuer notified (DD/MM/YYYY):
10.04.2019
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
7.05%
7.05%
35.476.519
Position of previous notification (if
applicable)
6.77%
6.77%
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
1.064.650
1.437.350
3.00%
4.05%
SUBTOTAL 8. A
2.502.000
7.05%
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 datex
Exercise/ Conversion Periodxi
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 datex
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 entityxiv (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)
3.00%
3.00%
Acme Investments SPF Sarl (Indirect)
4.05%
4.05%
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
TURKU – FINLAND, 5 April 2019 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, will announce its full year audited results for the year ended 31 December 2018 on Tuesday 7 May 2019.
Dr Markku Jalkanen, Chief Executive Officer, and Yrjö Wichmann, Chief Financial Officer, 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.
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.
TR-1: Standard form for notification of major holdings
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:
Faron Pharmaceuticals Oy
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
X
An event changing the breakdown of voting rights
Other (please specify)iii:
3. Details of person subject to the notification obligationiv
Name
Aviva plc & its subsidiaries
City and country of registered office (if applicable)
London, England
4. Full name of shareholder(s) (if different from 3.)v
Name
Registered Holder:
Chase (GA Group) Nominees Limited 963,938*
HSBC Global Custody Nominee (UK) Limited
284,539*
State Street Nominees Limited 8,365*
*denotes direct interest
BNY (Nominees) Limited 30,420
City and country of registered office (if applicable)
5. Date on which the threshold was crossed or reachedvi:
29/03/2019
6. Date on which issuer notified (DD/MM/YYYY):
01/04/2019
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
3.63%
3.63%
35,476,519
Position of previous notification (if
applicable)
4.86%
0.03%
4.89%
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)
Ordinary Shares
FI4000153309
1,256,842
30,420
3.54%
0.09%
SUBTOTAL 8. A
1,287,262
3.63%
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 datex
Exercise/ Conversion Periodxi
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 datex
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 entityxiv (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
Aviva plc
Aviva Group Holdings Limited
Aviva Investors Holdings Limited
Aviva Investors Global Services Limited
10. In case of proxy voting, please identify:
Name of the proxy holder
See Section 4
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional informationxvi
This notification is prompted by a 4% to 3% change at Combined Interest Level
