Faron, etusivu

Notice of Faron Pharmaceuticals Ltd’s AGM

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 23 April 2021 at 2:00 p.m. EEST (Finnish time) at the premises of Inderes Oy at Itämerentori 2, FI-00180 Helsinki, Finland. The shareholders of the Company may participate in the AGM and exercise their shareholder rights only by voting in advance, by submitting counterproposals in advance and asking questions in advance in accordance with the instructions given in this notice and otherwise by the Company. It is not possible to participate in the AGM at the meeting venue.

The Board of Directors (the “Board”) has resolved on exceptional meeting procedures based on the temporary legislation approved by the Finnish parliament, which entered into force on 3 October 2020. In order to prevent the spread of the COVID-19 pandemic, the AGM will be held without shareholders’ and their proxy representatives’ presence at the meeting venue. This is necessary in order to ensure the health and safety of the shareholders, employees and other stakeholders of the Company as well as to organize the AGM in a predictable way allowing equal means for shareholders to participate while also ensuring compliance with the current restrictions set by the authorities. For these reasons, shareholders and their proxy representatives can participate in the AGM and use shareholder rights only by voting in advance, by submitting counterproposals in advance and by asking questions in advance. Further instructions can be found in part C of this notice (Instructions for the Participants).

The AGM can be followed on the Company’s website. Persons following the meeting in this manner are not considered participants in the AGM. Accordingly, shareholders will not have the possibility to address the meeting or participate in any vote, among other things, during the meeting. The webcast will be arranged only if it can be arranged in compliance with all regulatory rules and restrictions imposed by the authorities due to the COVID-19 pandemic.

The CEO of the Company will attend the meeting. The Chairman of the Board, the members of the Board, other management of the Company and the auditor will not attend the AGM.

  1. MATTERS ON THE AGENDA OF THE AGM
  1. Opening of the meeting
  1. Calling the meeting to order

Attorney-at-law Riikka Rannikko shall act as the Chairman of the meeting. If due to weighty reasons Riikka Rannikko is not able to act as Chairman, the Board shall appoint another person it deems most suitable to act as Chairman.

  1. Election of persons to scrutinize the minutes and to supervise the counting of votes

The Company’s General Counsel Pessi Honkasalo shall scrutinize the minutes and supervise the counting of the votes. In case Pessi Honkasalo would not be able to act as the person to scrutinize the minutes and to supervise the counting of the votes due to weighty reasons, the Board shall appoint another person it deems most suitable to act in that role.

  1. Recording the legality of the meeting
  1. Recording the attendance at the meeting and adoption of the list of votes

The shareholders who have voted in advance and who have the right to participate in the meeting pursuant to Chapter 5, Sections 6 and 6a of the Finnish Limited Liability Companies Act (624/2006, as amended; the “Companies Act”) will be recorded to have been represented at the meeting. The list of votes will be adopted according to the information provided by Euroclear Finland Oy (“Euroclear”) and Innovatics Ltd (“Innovatics”).

  1. Presentation of the financial statements, the Board’s report and the auditor’s report for 2020

As shareholders can only participate in the AGM by voting in advance, the financial statements, the Board’s report and the auditor’s report for 2020, published by the Company on 25 March 2021 and which have been made available on the Company’s website at https://www.faron.com/investors/general-meetings, will be deemed to have been presented to the AGM.

  1. Adoption of the financial statements
  1. Resolution on the use of the profit shown on the balance sheet and the payment of dividend

The Board proposes that no dividend for the financial year 2020 will be paid and that the losses of the Company for the financial year, amounting to EUR 16,946,216.84 (IFRS), will be carried forward to the reserve for invested unrestricted equity.

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

The Board proposes, on the basis of the proposal of the remuneration committee, that the annual remuneration of the members of the Board remain unchanged and that 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 as 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.

  1. Resolution on the number of members of the Board

The Board proposes, on the basis of the proposal of the nomination committee, that seven (7) members be elected to the Board.

  1. Election of members of the Board

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

Anne Whitaker (born 1967), Bachelor of Science, a citizen of the United States, currently serves as a member of the board of directors of three publicly listed companies: UDG Healthcare Plc, Caladrius Biosciences Inc., Mallinckrodt Plc and privately held Aerami Therapeutics Inc. Previously, she has acted as the CEO at, inter alios, Aerami Therapeutics, Inc., KNOW Bio LLC, Novoclem Therapeutics, Inc. and Synta Pharmaceuticals Inc., and as the Executive Vice President, Company Group Chairman of Bausch Health Company and President of North America for Sanofi.

Anne Whitaker is independent of the Company and its significant shareholders.

All proposed Board member candidates have given their consent for the election. 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.

Descriptions of the Board member candidates proposed to be re-elected are available on the Company’s website at https://www.faron.com/faron/leadership/board-directors.

  1. 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.

  1. 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.

  1. Resolution on the amendment of the Option Plan 2015

The Company’s Extraordinary General Meeting has on 15 September 2015 adopted the terms and conditions of an option plan which has later been amended by the decisions of the AGMs held on 16 May 2017 and 18 May 2020 (the “Option Plan 2015”). The subscription period for shares based on options is currently scheduled to end on 30 September 2021. The Board proposes that the AGM resolves to amend the terms and conditions of the Option Plan 2015 so that the subscription period for shares based on the options is extended by two (2) years, i.e., until 30 September 2023. For the sake of clarity, it is noted that the proposal applies to all options under the Option Plan 2015 (A options, B options, C options and D options). 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 to this notice.

  1. Amendment of the Articles of Association

The Board proposes that article 13 (regarding the reduction of equity of the company) be removed from the Articles of Association as the rules applicable to the Company are directly based on the Companies Act.

  1. 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 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 ten million (10,000,000) shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately twenty (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 would be effective until 30 June 2022. This authorisation shall not replace the authorisation relating to item A.15 of this notice.

  1. Closing of the meeting
  1. DOCUMENTS OF THE AGM

The proposals of the Board to the AGM and this notice are available on the Company’s website at https://www.faron.com/investors/general-meetings. The financial statements, the Board’s report and the auditor’s report for 2020 are available on the above-mentioned website no later than on 25 March 2021. 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 7 May 2021 at the latest.

  1. INSTRUCTIONS FOR THE PARTICIPANTS

In order to prevent the spread of the COVID-19 pandemic, the AGM will be organized so that the shareholders and their proxy representatives are not allowed to be present at the meeting venue. The shareholders and their proxy representatives can participate in the meeting and use their shareholder rights only by voting in advance, by submitting counterproposals in advance and asking questions in advance in the manner described below. Proxy representatives shall also vote in advance in the manner described below.

  1. The right to participate

Each shareholder who on the record date of the AGM, being 13 April 2021, is registered in the Company’s shareholders’ register held by Euroclear has the right to participate in the AGM. A shareholder whose shares are registered on their personal Finnish book-entry account is registered in the Company’s shareholders’ register. If you do not have a Finnish book-entry account, see section C.4 (Holder of nominee-registered shares (including depositary interest holders)) for all instructions on participating and voting in advance.

A shareholder may only participate in the meeting by voting in advance or by way of proxy representation and by submitting counterproposals and asking questions in advance in accordance with the instructions below.

  1. Registration and advance voting

Registration for the AGM and advance voting will begin on 1 April 2021 at 12:00 noon EEST (Finnish time) when the deadline for submitting counterproposals has passed. A shareholder entered in the Company’s shareholders’ register who wishes to participate in the AGM by voting in advance must register and vote in advance at the latest on 19 April 2021 at 10:00 a.m. EEST (Finnish time), by which time the registration shall be completed and votes need to be received.

A shareholder whose shares are registered on their Finnish book-entry account can register and vote in advance on certain items on the agenda of the AGM from 12:00 noon EEST (Finnish time) on 1 April 2021 until 10:00 a.m. EEST (Finnish time) on 19 April 2021 by the following means:

a) Through the Company’s website

The Finnish personal identity code or business ID as well as strong identification with Finnish banking codes or mobile ID is needed for electronic registration and advance voting. The terms and other instructions concerning electronic voting are available on the Company’s website at https://www.faron.com/investors/general-meetings.

b) By mail or email

The advance voting form and instructions relating to the advance voting will be available on the Company’s website at https://www.faron.com/investors/general-meetings no later than on 1 April 2021 at 12:00 noon EEST (Finnish time). A shareholder may send the advance voting form available on the aforementioned website or corresponding information to Innovatics by regular mail to Innovatics Ltd, Yhtiökokous / Faron Pharmaceuticals Ltd, Ratamestarinkatu 13 A, FI-00520 Helsinki, Finland or by email to agm@innovatics.fi. If the shareholder participates in the meeting by sending the votes in advance by mail or email to the above-mentioned addresses, this constitutes registration for the AGM, provided that the above-mentioned information required for registration is provided. Additional information is also available through email at general.meeting@faron.com.

In connection with the registration, a shareholder or a proxy representative is required to provide the requested personal information such as the shareholder’s name, personal ID and email address and/or phone number. The personal data given to the Company and Innovatics by shareholders and proxy representatives is only used in connection with the AGM and with the processing of related necessary registrations.

  1. Proxy representative and powers of attorney

A shareholder may participate in the AGM and exercise their rights at the meeting by way of proxy representation. Also the proxy representative of a shareholder may only participate by voting in advance in the manner instructed above. Shareholders who do not vote in advance are requested, due to the COVID-19 pandemic, to exercise shareholders’ rights through a centralized proxy representative designated by the Company by authorizing attorney-at-law Anniina Järvinen from Hannes Snellman Attorneys Ltd, or a person appointed by her, to represent them at the AGM in accordance with the shareholder’s voting instructions. Authorizing the designated proxy representative will not accrue any costs for the shareholder, excluding possible postal fees for proxy documents. Further information on the designated proxy representative is available at the following website: www.hannessnellman.com/people/all/anniina-jaervinen/.

Shareholders may also participate in the AGM and exercise their rights at the meeting by way of another proxy representative. A proxy representative shall present a dated proxy document or otherwise in a reliable manner demonstrate their right to represent the shareholder at the AGM. When a shareholder participates in the AGM by means of several proxy representatives representing the shareholder with shares at different securities accounts, the shares by which each proxy representative represents the shareholder shall be identified in connection with the registration for the AGM.

Proxy and voting instruction templates are available on the Company’s website at https://www.faron.com/investors/general-meetings on 1 April 2021 at the latest. Possible proxy documents shall be delivered primarily through email to general.meeting@faron.com or as originals to the address Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland before the end of the registration period, by which time the proxy documents must be received.

If a shareholder delivers a proxy to the Company in accordance with the applicable instructions before the expiry of the registration and advance-voting period, this constitutes due registration for the AGM, provided that all required information is included in the proxy documents. In addition, proxy representatives must also vote in advance in the manner described in this notice.

Further information is available on the Company’s website at https://www.faron.com/investors/general-meetings.

  1. 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 maintained by Euroclear on the AGM’s record date of 13 April 2021. The right to participate in the AGM requires, in addition, that the shareholder on the basis of such shares has been registered into the temporary shareholders’ register maintained by Euroclear by 20 April 2021 at 10:00 a.m. EEST (Finnish time), at the latest. As regards nominee-registered shares this constitutes due registration for the AGM.

A holder of nominee-registered shares is advised to request necessary instructions regarding the registration in the temporary shareholders’ register of the Company, the issuing of proxy documents and registration for the AGM from their custodian bank in good time. A holder of nominee-registered shares shall note that custodian banks may apply deadlines for the registration and advance voting of holders of nominee-registered shares. The account management organisation of the custodian bank has to register a holder of nominee-registered shares into the temporary shareholders’ register of the Company at the latest by the time stated above and see to the voting in advance on behalf of a holder of nominee-registered shares.

Further information on holders of nominee-registered shares is available on the Company’s abovementioned website.

  1. Other instructions and information

Shareholders who hold at least one hundredth (1/100) of all the shares in the Company have the right to pose counterproposals concerning the matters on the agenda of the AGM to be placed for a vote. Such counterproposals shall be delivered to the Company by email to general.meeting@faron.com by no later than 30 March 2021 at 4:00 p.m. EEST (Finnish time), by which time the counterproposals must be received by the Company.

The shareholders shall in connection with the counterproposal present adequate evidence of their shareholding in the Company. The counterproposal is admissible for consideration at the AGM if the shareholders who have made the counterproposal have the right to attend the meeting and on the record date of the AGM represent at least one hundredth (1/100) of all shares in the Company. If a counterproposal will not be taken up for consideration at the AGM, the votes given in favour of the counterproposal will not be taken into account. The Company will publish possible counterproposals to be put to a vote on the Company’s website at https://www.faron.com/investors/general-meetings by no later than 1 April 2021.

A shareholder has the right to ask questions referred to in Chapter 5, Section 25 of the Companies Act with respect to the matters to be considered at the AGM. Such questions may be delivered by email to general.meeting@faron.com or by regular mail to Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland by no later than 9 April 2021, by which time the questions must have been received.

Such questions by shareholders, the Company’s management’s answers as well as other counterproposals than those admissible for voting will be available on the Company’s website at https://www.faron.com/investors/general-meetings on 14 April 2021 at the latest. In connection with asking questions, shareholders are required to provide adequate evidence of shareholding.

The AGM can be followed on the Company’s website. Persons following the meeting in this manner are not considered participants in the AGM. Accordingly, shareholders will not have the possibility to address the meeting pursuant to Chapter 5, Section 25 of the Companies Act or participate in any vote, among other things, during the meeting. The attendance list of the AGM and voting results are determined solely based on the advance votes. Shareholders cannot thus exercise their voting rights when following the meeting through the webcast, i.e., votes must be cast in advance.

Changes in the share ownership following the record date of the AGM do not have an impact on the right to participate in the AGM nor on the number of votes of the shareholder.

On the date of this notice, 25 March 2021, the total number of shares and votes in the Company is 50,417,874.

Turku, 25 March 2021

FARON PHARMACEUTICALS LTD

Board of Directors

Faron Pharmaceuticals - AGM notice - 250321

Notice of Full-Year Results and Annual Report

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Notice of Full-Year Results and Annual Report

Company announcement, 25 February 2021 at 7.00 am GMT / 9.00 am EET

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company, will publish its audited full-year results for the twelve months ended 31 December 2020 on Thursday 25 March 2021 at 7:00 GMT / 9:00 EET. The Annual Report 2020, including audited financial statements for the full year, will be published on the same day.

A virtual briefing and Q&A session for analysts will be hosted by Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, at 12:00 pm GMT / 2:00 pm EET / 8:00 am EST on the day of results. The Full-year results release for 2020, presentation, webcast details, and Annual Report 2020 will be made available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards. 

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone: +44 207 213 0880 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel, Naina Zaman

Phone: +1 212 362 1200

E-mail: faron@sternir.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 caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanised antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in phase I/II clinical development as a potential therapy for patients with untreatable solid tumours, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalised patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

Holding(s) in the Company

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Holding(s) in the Company

Company announcement, 17 February 2021 at 3.40pm GMT / 5.40pm EET

TURKU – FINLAND – Faron Pharmaceuticals Oy (First North: FARON, AIM: FARN), the clinical stage biopharmaceutical company, has on 16 February 2021 received notifications from Mr. Timo Syrjälä and Mr. Tom-Erik Lind of the decrease of their holdings due to issuance of new shares. 

Trading in the Placing Shares commenced on First North and AIM on 16 February 2021.

The mentioned notifications are attached in this announcement.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: + 44 207 213 0880

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 40 555 4727

Jukka Järvelä

Phone: +358 50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel, Naina Zaman

Phone: +1 (212) 362-1200

E-mail: julie.seidel@sternir.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. Bexmarilimab is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. With the ability to switch immune suppression to immune activation in various conditions, bexmarilimab has potential across oncology, infectious diseases and vaccine development. Currently in phase I/II clinical development as a potential therapy for patients with untreatable solid tumours, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. In addition to its profound antiviral effect, Traumakine upregulates the cell surface protein Cluster of Differentiation 73 (CD73), an enzyme that suppresses pro-inflammatory responses in endothelial cells. Using an IV administration of interferon beta-1a provides optimal exposure to the lung vasculature, increasing protection against serious lung complications and helping to prevent vascular leakage by enhancing endothelial barrier function. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalised patients with COVID-19. As part of a working relationship established with Faron, the 59th Medical Wing of the US Air Force and the US Department of Defense are also evaluating Traumakine’s role in preventing multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.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 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: (Decrease of holding due to issuance of new shares) 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: 12.2.2021
6. Date on which issuer notified (DD/MM/YYYY): 16.2.2021
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  13.57 13.57  50,417,874
Position of previous notification (if applicable) 14.08% 14.08%
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
sharesISIN 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 2,561,402 4,277,837 5.08% 8.48%
SUBTOTAL 8. A 6,839,239 13.57%
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
Timo Syrjälä (Direct) 5.08% 5.08%
Acme Investments SPF Sarl (Indirect) 8.48% 8.48%
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
Decrease due to issuance of shares
Place of completion Luxembourg
Date of completion 16.02.2021

 

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: (Decrease of holding due to issuance of new shares) x
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: 12.2.2021
6. Date on which issuer notified (DD/MM/YYYY): 16.2.2021
7. Total positions of person(s) subject to the notification obligation
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Resulting situation on the date on which threshold was crossed or reached  7.55 7.55  50,417,874
Position of previous notification (if applicable) 10.00% 10.00%
8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii
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FI4000153309 3,806,611 7.55
SUBTOTAL 8. A 3,806,611 7.55%
B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))
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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
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10. In case of proxy voting, please identify:
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11. Additional informationxvi
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Date of completion 16.2.2021
Release

Bexmarilimab (Clevegen) development update

  • Cholangiocarcinoma becomes fifth tumour cohort to show early signs of efficacy
  • Increased bexmarilimab dosing schedule and high baseline regulatory T cell count associated with clinical benefit
  • High levels of soluble Clever-1 observed in MATINS patients
  • Soluble Clever-1 has the capacity to suppress T cell activation
  • Increased bexmarilimab dosing frequency to counter high levels of soluble Clever-1 underway

 

Company announcement, 20 January 2021 at 9.00 AM PM (EEST)

Insider information
 

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company, today announces new observations from its ongoing MATINS trial and an update on the study.

The phase I/II MATINS clinical trial is investigating the tolerability, safety and preliminary efficacy of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1, a receptor known to be expressed on immunosuppressive macrophages in the tumour microenvironment.

Working with Kaiku Health Ltd (“Kaiku”), a health data science company (www.kaikuhealth.com), Faron is using Kaiku’s artificial intelligence platform designed to analyse patient outcomes following treatment with cancer immunotherapies to undertake further efficacy analysis of patient data from Part I of the MATINS trial. This platform provides insight through data analyses of the immunological and disease characteristics of the MATINS patients to better define patients who respond to bexmarilimab and should enable further refinement of bexmarilimab’s clinical development. 

Latest scientific observations from the trial include the identification of a new role for soluble Clever-1, related to its capacity to control T-cell activation. This suggests that the inactivation of Clever-1 as an immune suppressive molecule could be even broader and more important than previously thought as the immune-stimulating effects are not only limited to tumour associated macrophages (TAM) but may also act systemically.

Dr. Markku Jalkanen, Faron’s CEO, said: “I am extremely happy about these results and wish to thank our team, our scientific network and the MATINS clinical group for the impressive work they have done, both progressing the trial and undertaking complex analyses of the data during challenging times in the face of the current pandemic. Never during my career have I seen that a high baseline count of regulatory T cells (Tregs) predicts a good response to a therapy. Until now, it has always been the opposite. This is remarkable. Such observations now provide us with a much better understanding of the next steps required for bexmarilimab’s clinical development in pivotal studies and support its potential as a breakthrough therapy to deliver optimal clinical results in patients with hard to treat cancers.

“The new discovery of the role of soluble Clever-1 as an immune suppressive molecule is striking, indicating the soluble part of this receptor could cause systemic inhibition of T-cells in all locations of body, therefore controlling the general immune capacity in cancer patients. We hope to be able to overcome this inhibition just by increasing the dosing frequency of bexmarilimab to provide maximal binding and the removal of Clever-1 from body fluids and tissues, including tumours.” 

 

Data details

Five solid tumour types showing early signs of efficacy

As previously communicated, four solid tumour cohorts in the first expansion stage (Part II) of the study (cutaneous melanoma, colorectal cancer (CRC), hepatocellular cancer and ovarian cancer) have demonstrated early signs of clinical efficacy from bexmarilimab therapy. This group is now joined by cholangiocarcinoma (also known as bile duct cancer) as a fifth responsive tumour cohort. The exact way how these cohorts will be taken forward into the protocol for Part III of the MATINS trial will be decided in Q3-2021 after further data on the effect of increased dosing frequency is available (recruitment currently ongoing). More frequent dosing either weekly or at two week intervals could increase bexmarilimab treatment efficacy further, compared to the original dosing interval of every three weeks, which has already led to some very promising results in several advanced cancer types.

Regulatory T cell (Treg) marker FOXP3 and increased bexmarilimab dosing associated with increased clinical benefit

Part I MATINS study patients had received a median of three previous cancer treatments (mainly various chemotherapy combinations). Half of the study patients had received four or more lines of therapy before joining the MATINS study. Patient blood samples have indicated reduced immune capacity reflected in low counts of effector immune cells. To better understand patient outcomes after bexmarilimab treatment around 50 biomarkers have now been analysed using Kaiku’s Immuno-Oncology platform resulting in the following findings:

  • Increased bexmarilimab dosing level with three week interval was associated with a clinical response

  • High baseline count of Treg cell marker FOXP3 was associated with a clinical response

These findings are consistent with the Company’s previous findings and understanding that cellular immune activation and the removal of immunosuppressive elements are required for clinical benefit from bexmarilimab. The association of clinical benefit in patients with a high baseline count of Tregs indicates that patients were significantly immunosuppressed before the treatment. In these subjects, removal of immunosuppression using bexmarilimab to inactivate Clever-1 positive myeloid cells could therefore result in removal of Tregs known to be supported by macrophages. The Company believes that increased dosing frequency has the potential to produce more complete inactivation of Clever-1, either expressed on the surface of myeloid cells or circulating in blood and lymph as a soluble immunosuppressive molecule.

Cancer patient plasma can contain significant amounts of soluble Clever-1

The transient Clever-1 receptor occupancy observed in all MATINS Part I dose levels (0.1-10 mg/kg) supports the decision to increase dosing frequency from every three weeks to either weekly or two week intervals. Latest data show that MATINS patients’ plasma (blood devoid of cells) could contain up to a 10-fold increased level of soluble Clever-1 compared to healthy controls. These elevated values could explain the rapid uptake of bexmarilimab in cancer patients. This finding also supports the potential of higher administration frequency, which is currently ongoing in CRC patients, with first results expected in H1-2021.

Soluble Clever-1 has the capacity to suppress T cell activation

The role of increased soluble Clever-1 in the circulation was tested in experimental settings. The most interesting finding from this experimental work elucidated a new role for Clever-1:  it can control T cell activation directly, including naïve T cells. This is a significant finding because it proposes that by producing soluble Clever-1 the malignant process can also suppress T cell activation in remote locations and, by targeting naïve T cells, can prevent expansion of the T cell repertoire. Soluble Clever-1 can therefore be a substantial inhibitor of T cell activating therapies.

A new patent application has been filed seeking global protection for these findings and related applications.

The observations detailed in this statement are being prepared for peer-reviewed publication and/or presentation at future scientific congresses.

 

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

About bexmarilimab

Bexmarilimab is Faron’s investigative precision immunotherapy, 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.

 

About the MATINS study

The MATINS study is the first-in-human open label Phase I/II clinical trial with an adaptive design to investigate the safety and efficacy of bexmarilimab in ten selected metastatic or inoperable solid tumours – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM).

Part I of the trial dealt with tolerability, safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report findings as the dosing progresses. The cohort expansion during Part II is focused on identifying patients who show an increased number of Clever-1 positive tumour macrophages and the safety and efficacy of the treatment. During Part III, the main focus will be on assessing the efficacy of Clevegen on study subjects who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy.

 

For more information please contact:

 

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone: +44 207 213 0880   

 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel, Naina Zaman

Phone: +1 212 362 1200

E-mail: faron@sternir.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 the immune response in oncology and organ damage. Clevegen (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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.

Release

Faron’s financial calendar for 2021

Company announcement, 21 December 2020 at 9.00 am (EET)

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces the following dates for the Company’s financial reporting in 2021:

25 March    Financial statement release for the full year 2020 and Annual Report 2020 including financial statements for the full year

26 August   Half-year financial report for the period 1 January to 30 June 2021

The annual general meeting is planned to be held on Friday 23 April 2021. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

 

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 207 213 0880

 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

Email: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel, Naina Zaman

Phone: +1 (212) 362-1200

Email: faron@sternir.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® (bexmarilimab), its investigative 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 is currently being tested in several phase III studies around the world against COVID-19. Traumakine® is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. Faron is based in Turku, Finland. Further information is available at www.faron.com.

Release

Bexmarilimab (Clevegen) development update

· Accumulating MATINS data build foundation for further clinical development
· Five patient cohorts in MATINS study Part II already fully recruited
· Higher frequency of dosing introduced to investigate potential for enhanced clinical responses
· Three new trials will study bexmarilimab treatment in neoadjuvant setting, in combination with PD(L)-1 checkpoint inhibitor and in haematological malignancies

Company announcement, 23 November 2020 at 9.00 AM (EET)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today an update on the MATINS study and further details on the clinical expansion plans for bexmarilimab, its wholly-owned novel precision cancer immunotherapy, targeting Clever-1 positive tumour associated macrophages (TAMs) in selected metastatic or inoperable solid tumours.

The expanded clinical development programme is intended to generate data beyond existing hard-to-treat cancer cohorts, exploring new patient populations and investigating combinations with existing treatments, to build full understanding of bexmarilimab’s commercial potential dependent on this unique and proprietary myeloid cell target.

MATINS study update

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of bexmarilimab across ten different hard-to-treat solid tumour cohorts (cutaneous melanoma, uveal melanoma, ovarian cancer, colorectal cancer, hepatocellular cancer, ER+ breast cancer, pancreatic cancer, gastric cancer, cholangiocarcinoma, anaplastic thyroid carcinoma) in the first expansion stage (Part II) of the study. Latest data from four cohorts – cutaneous melanoma, ovarian cancer, colorectal cancer (CRC), and hepatocellular cancer – have demonstrated early signs of efficacy from bexmarilimab monotherapy which, according to the MATINS study protocol, allows them to move to Part III. Further data from all cohorts in Part II will enable the Company to evaluate which indications are most likely to achieve success and should be continued further in development.

Of the cohorts in Part II, uveal melanoma, ovarian cancer, colorectal cancer, pancreatic cancer, and cholangiocarcinoma are now fully recruited and the rest, between 50-90 per cent recruited, except anaplastic thyroid carcinoma, which is a new cohort awaiting enrolment of the first patient.

Investigating alternative dosing schedules

As a result of key pharmacokinetic and pharmacodynamic biomarkers suggesting the potential for improved clinical response of bexmarilimab administered with a higher frequency than the current three week interval, regulatory authorities have approved an expansion of MATINS to include two additional CRC cohorts receiving 1 mg/kg dosed at either weekly or two week intervals. These cohorts have started recruiting with results expected during H1 2021. Data from these cohorts will support the design of new and pivotal trials for bexmarilimab.

Study of neoadjuvant bexmarilimab in colorectal and kidney cancers

Faron expects to initiate a neoadjuvant bexmarilimab study in colorectal cancer and clear cell renal cell carcinoma (ccRCC) patients soon after diagnosis and prior to any other treatments. The Company plans to evaluate bexmarilimab’s ability to induce an anti-cancer immune response in patients previously untreated or with minimal exposure to anti-cancer treatments. Disease-free survival will be also investigated to determine the clinical benefit for neoadjuvant treatment.

Lung cancer combination study with anti-PD-(L)1 therapy

The Company previously reported that bexmarilimab administration down regulates a range of immune checkpoint molecules (CTL-4, PDL-1 and PD-1) on the peripheral immune cells of cancer patients,  signalling immune activation and removal of T cell exhaustion. This finding is consistent with the current understanding that Clever-1 is major source of T cell exhaustion and treatment resistance against marketed checkpoint inhibitors1. Based on these findings, Faron now plans to expand the bexmarilimab programme to evaluate its safety and efficacy in a pilot study in combination with anti-PD-(L)1 therapy in non-small cell lung carcinoma (NSCLC) patients, where PD-(L)1 inhibition has become the standard of care, though resistance develops in roughly 70 per cent of patients2.

Potential of bexmarilimab in haematological cancers

Faron, together with Helsinki University Hospital, Finland, plans to initiate a phase I/II bexmarilimab study in combination with standard of care in acute myeloid leukaemia (AML)/ myelodysplastic syndrome (MDS) patients in H2 2021 to investigate the safety and preliminary efficacy of bexmarilimab in haematological cancers. Both AML and MDS originate from myeloid lineage of bone marrow cells and result in impaired haematopoiesis (the production of blood and immune cells). Due to this nature of cell origin, they also express cell surface Clever-1, which has been identified as a prognostic factor in AML3. Faron believes that controlling Clever-1 activity on malignant cells can also control their replication. This is evident in ex vivo experimental settings and could be potentiated with anti-apoptotic compounds like bcl-2 inhibitors3 which promote cell death. Diagnostics and ex vivo drug screen development for bexmarilimab will be included in the study to optimise patient outcomes for targeted bexmarilimab therapy.

Dr. Markku Jalkanen, Faron’s CEO, said: “Bexmarilimab is rapidly advancing through development and its exciting clinical activity across multiple cancer types continues to give us confidence in this asset’s potential as a next generation immunotherapy with broad opportunities. With the data we have seen to-date, we are pleased to expand our bexmarilimab development programme, giving us the opportunity to explore its potential to activate the immune system in early stage cancers and in combination with checkpoint inhibitors, a study of high interest for everyone in the field.”

“Our deep understanding of Clever-1 and its role in cancer immunotherapy has brought us to where we are today and we look forward to advancing this novel programme into haematological cancers, the neoadjuvant setting and combination trials, in addition to our ongoing robust basket study in late-line solid tumours, which produces continuous data and understanding of bexmarilimab as a foundational treatment for the removal of immune suppression and T cell exhaustion.”     

 

References:

1) Hollmén et al. Brit. J. Cancer 2020

2) Gandhi et al. N. Eng. J. Med. 2018; 378; 2078-92

3) Lin et al. Mol. Therapy Nucleic Acids 2019; 18; 476-484

 

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner,  Mark Rogers

Phone. +44 (0)20 7213 0880       

 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 (0)20 7886 2500       

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel

Phone: +1 212 362 1200

Email: julie.seidel@sternir.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 (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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.

Release

First Results from WHO Solidarity Trial

WHO concludes that subcutaneous IFN beta-1a is ineffective in hospitalized COVID-19 patients

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

Company announcement, 16 October 2020 at 1.35 PM (EEST)
 

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company, today announces that the first results from the World Health Organization’s (WHO)  Solidarity trial have been made available as a preprint at medRxiv1 while under review for publication in a medical journal. The results show that subcutaneous interferon (IFN) beta-1a was found to be safe, but ineffective to reduce overall mortality in hospitalized patients with COVID-19.

The WHO’s intent-to-treat analysis compared 1412 patients who received IFN beta-1a and 2050 control subjects not receiving IFN beta-1a. The use of corticosteroids was 50% across the study. Overall in-hospital mortality (the primary endpoint) was 12.9% in the IFN beta-1a group and 11% in the control group, RR 1.16 (95% CI, 0.96 – 1.39, NS). The WHO reports that patients mainly received subcutaneous IFN beta-1a (Rebif, Merck KGaA). At the time of the data-cut for this analysis, Traumakine, the Company’s intravenous (iv) formulation of IFN beta-1a, became available very late in the observation period and it is the Company’s understanding it had seldom been used. The WHO has not been able to verify how many patients received Traumakine at the time of this analysis. About half of the patients receiving IFN beta-1a also received concomitant corticosteroids.

Dr. Markku Jalkanen, Faron’s CEO, said: “These first results from the Solidarity Trial are disappointing, given the need for new therapeutics to support the global response to COVID-19. They do support our long held view that IFN beta-1a is likely to be ineffective when given subcutaneously. The science behind Traumakine and its potential to prevent multi-organ failure, through the upregulation of the key endothelial enzyme CD73, is compelling and we continue to believe that an intravenous formulation of IFN beta-1a is what patients need, to strengthen the body’s own IFN beta signalling – the first line of defence against viral infection – and provide optimal exposure to the lung vasculature2.

“Compared to subcutaneous IFN beta-1a, the same amount of intravenous IFN beta-1a achieves over 150x higher peak concentration in the lung vasculature without higher systemic exposure3, which we believe makes this method of administration highly effective and safe. We will continue to pursue the science behind this.”

Traumakine continues to be investigated in the ongoing global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) trial, which is evaluating potential treatments for community-acquired pneumonia, including in COVID-19 patients, and is currently ongoing across more than 200 sites and 19 countries.

Faron is also supporting a US trial to investigate the potential of Traumakine to treat COVID-19.  HIBISCUS (Human Interferon Beta In Severe CoronavirUS), an investigator initiated study at Harvard Medical School’s Beth Israel Deaconess Medical Center (BIDMC), focused on ICU patients with ARDS caused by viral infection (e.g. COVID-19, influenza). Commencement of this Phase II/III pivotal, randomized, placebo-controlled study, remains subject to finalisation of funding arrangements and regulatory approval. The study will test Traumakine against both placebo and dexamethasone, which is now a part of the standard of care in the US.

References

  1. https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1
  2. Interferon beta-1a for COVID-19: critical importance of the administration route, Jalkanen et al., Critical Care (2020) 24:335 https://doi.org/10.1186/s13054-020-03048-5 
  3. Buchwalder et al. Pharmacokinetics and Pharmacodynamics of IFN-b1a in Healthy Volunteers. Journal of Interferon and Cytokine Research 2020; 20:857-866.

Notes to editors

Further information on the results of the Solidary trial is available at https://www.who.int/news/item/15-10-2020-solidarity-therapeutics-trial-produces-conclusive-evidence-on-the-effectiveness-of-repurposed-drugs-for-covid-19-in-record-time .

The preprint is available at https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone: +44 207 213 0880 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

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

Stern Investor Relations

Julie Seidel, Naina Zaman

Phone: +1 212 362 1200

E-mail: faron@sternir.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 (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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.

Grant of options

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces that the Company’s board has confirmed the grant of a total of 690,333 options over ordinary shares in the Company (“Options”) under the Company’s Share Option Plan 2019. The Options have been allocated under the Share Option Plan 2019 and are exercisable between 23 July 2021 and 23 July 2025 at an exercise price of €3.80 per share (£3.44), vesting 25% per annum over a period of four years. The exercise price is calculated based on the average price per share at which the ordinary shares in the Company have been traded on AIM over a period of 90 days preceding the allocation date of 23 July 2020. The amended terms of the Share Option Plan 2019 are as attached to the notice of the Company’s 2020 annual general meeting, available on the Company’s website, results of which were announced on 18 May 2020.

The granted 690,333 Options entitle the option holders to subscribe for a total of 690,333 new ordinary shares in the Company, if exercised in full, and represent 1.5% of the fully-diluted ordinary share capital of the Company.

Included in the number of Options granted are the following Options which were issued to directors, other persons discharging managerial responsibilities (“PDMRs”), Scientific Advisory Board (“SAB”) persons closely associated with them (“PCAs”) and Company personnel:

Director Options granted
Armstrong Frank 60,000
Brown Gregory 30,000
Jalkanen Markku 120,000
Manner Matti 30,000
Poulos John 30,000
Zambeletti Leopoldo 30,000
Total directors 300,000
Other PDMR
Honkasalo Pessi 12,000
Hänninen Toni 43,333
Jalkanen Juho 32,500
Karvonen Matti 32,500
Lahtinen Maria 21,000
Mandelin Jami 21,000
Wichmann Yrjö 12,000
Total other PDMRs 174,333
Scientific Advisory Board
Jalkanen Sirpa* 10,000
Knowles Jonathan 10,000
Curiel Tyler 10,000
Total SAB 30,000
*Jalkanen Sirpa is a person closely associated (“PCA”) to Jalkanen Markku
Total Company personnel 186,000

 

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 Armstrong Frank
Brown Gregory
Honkasalo Pessi
Hänninen Toni
Jalkanen Juho
Jalkanen Markku
Jalkanen Sirpa
Karvonen Matti
Lahtinen Maria
Mandelin Jami
Manner Matti
Poulos John
Wichmann Yrjö
Zambeletti Leopoldo
2 Reason for notification
a. Position/Status Person discharging managerial responsibilities/person closely associated
b. Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a. Name Faron Pharmaceuticals Oy
b. LEI 7437009H31TO1DC0EB42
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a. Description of the financial instrument, type of instrument

Identification Code

 Options over ordinary shares

ISIN: FI4000153309
b. Nature of the transaction Grant of options made pursuant to the Faron Share Option Plan 2019 exercisable at €3.80 per ordinary share
c. Price(s) and volume(s)
Price(s) Volume(s)
Nil
60,000
30,000
12,000
43,333
32,500
120,000
10,000
32,500
21,000
21,000
30,000
30,000
12,000
30,000
d. Aggregated information– Aggregated Volume– Price 484,333Nil
e. Date of the transaction 13 October 2020
f. Place of the transaction Turku

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone: +44 207 213 0880    

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

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

Email: faron@consilium-comms.com

 

Stern Investor Relations, Inc.
Julie Seidel
Phone: +1 (212) 362-1200
Email: Julie.Seidel@sternir.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 (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. Faron is based in Turku, Finland. Further information is available at www.faron.com 

Grant of options

TR-1: S tandard form for notification of major holdings

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: 28.09.2020
6. Date on which issuer notified (DD/MM/YYYY): 30.09.2020
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 14.08% 14.08% 46.799.747
Position of previous notification (if applicable) 13.94% 13.94%

 

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)               5.54%     5.54%
Acme Investments SPF Sarl (Indirect)               8.55% 8.55%
10. In case of proxy voting, please identify:
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional informationxvi

 

Place of completion Lausanne
Date of completion 30/09/2020
TR-1: Standard form for notification of major holdings

MATINS trial data presented at ESMO

Data from completed Part I of bexmarilimab MATINS trial presented at ESMO Virtual Congress 2020

TURKU – FINLAND, 18 September 2020 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces details from an oral presentation being held at the European Society of Medical Oncology (ESMO) Virtual Congress 2020, showcasing data from the Company’s ongoing MATINS trial to the scientific community.

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM) in selected metastatic or inoperable solid tumours. During the on-demand mini oral session, Petri Bono, M.D., Ph.D., principal investigator of the MATINS study, presents data on all 30 patients in Part I of the trial with advanced solid tumours and who had exhausted standard therapeutic options. The presentation includes previously announced data, highlighting:

  • Key pharmacokinetics (PK) and Clever-1 receptor occupancy data showing that exposure to bexmarilimab in the trial was more than dose proportional, that full (transient) Clever-1 receptor occupancy was achieved and, despite its relatively fast clearance from circulation, sustained pharmacodynamic effects by bexmarilimab were observed.
  • Very good tolerability across all dosing levels with no observed dose limiting toxicity.
  • Th1-weighted immune activation in all subjects measured following treatment with bexmarilimab. The patients also increased circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory T-cells (T-regs) or had a substantial increase in natural killer cells in the blood, all of which are considered as strong signs of this desired immune activation.
  • Promising clinical anti-tumour activity including, 1) a long-lasting partial response of a heavily pre-treated microsatellite stable metastatic colorectal cancer patient who had previously been treated with six different anti-cancer drugs, which had all failed, 2) target lesion responses in heavily pre-treated melanoma and ovarian cancer patients.
  • Conversion of immunologically non-inflamed (cold) tumours into inflamed (hot) tumours in patients traditionally not responsive to currently available checkpoint inhibitors.

Commenting on the presented data, Petri Bono M.D., Ph.D., Terveystalo, Helsinki, Finland and principal investigator of the MATINS trial, said: “The emerging tolerability profile and evidence of clinical anti-tumour activity for this novel anti Clever-1 antibody are promising. These data are from patients with difficult-to-treat cancers who had already failed all standard therapy options and received as many as six different lines of therapy, exhausting all future treatment options.  As this trial continues, we will learn more about this novel immunotherapy’s potential to help those cancer patients who desperately need new treatment options.”

Title: A phase I/II MATINS trial: Part 1 pharmacokinetic, safety and efficacy results of Clever-1 blockade in advanced cancer

Presentation number: 1024MO

www.esmo.org

 

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone. +44 207 213 0880            

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

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

Stern Investor Relations, Inc.

Julie Seidel, Naina Zaman

Phone: +(1)212 362 1200

Email: faron@sternir.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.

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