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 March 24, 2023 at 9:00 a.m. EET (Finnish time) at BioCity, meeting room “Ministeri” at Tykistökatu 6, FI-20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 8:30 a.m. EET (Finnish time).

The Company’s Annual Report 2022 is available to view and download on the Company’s website at https://www.faron.com/.

 

  1. MATTERS ON THE AGENDA OF THE ANNUAL GENERAL MEETING

 

  1. Opening of the meeting

 

  1. Calling the meeting to order

 

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

 

  1. Recording the legality of the meeting

 

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

 

  1. Presentation of the financial statements, the report of the Board of Directors and the auditor’s report for 2022

 

Review by the CEO.

 

  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 of Directors (the “Board”) proposes that no dividend for the financial year 2022 will be paid and that the losses of the Company for the financial year, amounting to EUR 28.7 million (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, John Poulos, Leopoldo Zambeletti, Markku Jalkanen, Anne Whitaker and Erik Ostrowski 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 Tuomo Pätsi be elected as a new member to the Board for a term that ends at the end of the next AGM.

 

Tuomo Pätsi, citizen of Finland and Switzerland, holds no other board memberships at the moment. He is

independent of the Company and its significant shareholders. Information on the proposed new Board member is available on the Company’s website at https://www.faron.com/investors/general-meetings.

 

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.

 

Information on 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 approved.

 

  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. Amendment of the Articles of Association

 

The Board proposes that article 11 § of the Articles of Association of the Company (Meeting venue) be amended to enable holding a General Meeting entirely without a meeting venue as a so-called remote meeting in addition to the Company’s domicile and London. The said clause would read amended as follows:

 

“11§ Meeting venue

 

A General Meeting may in addition to the Company’s domicile be held in the city of London, United Kingdom, on the basis of a resolution of the Board of Directors. In addition, the Board of Directors may decide that the General Meeting of the Shareholders be held without a meeting venue so that the shareholders exercise their power of decision in full in real time during the meeting using a telecommunications connection and technical means (remote meeting).”

 

It is proposed that the Articles of Association remain unchanged in other respects.

 

The proposal is based on the changes to Chapter 5 of the Finnish Companies Act, including the possibility to arrange general meetings remotely. Arranging a General Meeting as a remote meeting only, requires specific language in the Articles of Association. The legislative changes are based on the premise that, irrespective of the chosen General Meeting format, shareholders’ rights must not be compromised and that all participating shareholders can exercise their shareholder rights in full in real time, including the right to present questions and vote. The possibility to organize General Meetings remotely enables the Company to prepare for rapid changes in the Company’s operating environment and society in general, which may be caused, for example, by pandemics. It is important that the Company has the necessary means to offer its shareholders the possibility to exercise their shareholder rights and resolve on any matters that are presented in a General Meeting under any circumstances.

 

  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 Finnish Limited Liability Companies Act, which authorisation contains the right to issue new shares or dispose of the Company’s own shares in the possession of the Company. The authorisation would consist of up to twelve million five hundred thousand (12,500,000) new 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, as well as the conveyance of up to the same maximum number (twelve million five hundred thousand (12,500,000)) of treasury shares in the possession of the Company.

 

In practise, the above authorisation includes that the Board may first resolve on one or several share issues (up to the maximum number of twelve million five hundred thousand (12,500,000) new shares) without consideration to the Company itself and then further convey such treasury shares (up to the maximum number of twelve million five hundred thousand (12,500,000) shares) against consideration.

 

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 (including, without limitation, issuance of warrants under the funding agreement with IPF Partners announced on February 28, 2022) 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.

 

For the sake of clarity, it is noted that in no circumstances can the total number of new shares to be registered under this authorisation exceed twelve million five hundred thousand (12,500,000) new shares in aggregate.

 

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 June 30, 2024.

 

  1. Resolution on the amendment of the option programme and authorising the Board to decide on the issuance of options or other special rights entitling to shares

The Company’s AGM has on May 28, 2019 decided to authorise the Board to resolve on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act, and the terms and conditions have later been amended by the decision of the Company’s AGM on May 18, 2020 (the “Share Option Plan 2019”). The Board proposes, on the basis of the proposal of the remuneration committee, that the AGM would resolve to amend the terms and conditions of the Share Option Plan 2019, so that a maximum total of four million three hundred and fifty thousand (4,350,000) options (previously two million (2,000,000) options) would be offered under said terms and conditions as follows:

 

• to the chair of the Board, a maximum of two hundred and fifty thousand (250,000) options (before the amendment one hundred and eighty thousand (180,000) options);

• to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein), a maximum of one hundred and twenty five thousand (125,000) options (before the amendment ninety thousand (90,000) options);

• to the Chief Executive Officer, a maximum of four hundred and ninety five thousand (495,000) options (before the amendment three hundred and sixty thousand (360,000) options);

• to the Chief Financial Officer, a maximum of one hundred and eighty thousand (180,000) options (before the amendment one hundred and thirty thousand (130,000) options); and

• for any other non-employee person as determined by the Board, a maximum of seventy thousand (70,000) options (before the amendment fifty thousand (50,000) options).

 

Excluding the addition concerning the listing on Nasdaq Helsinki and the extension of the duration of the authorisation, the terms and conditions of the option programme would remain otherwise unchanged. The consolidated rules of the Share Option Plan 2019, incorporating the amendments proposed herein, are attached hereto as Annex 1. The proposed amendments provide greater flexibility to offer competitive equity incentive awards to senior leadership and wider employees in a competitive global talent market.

 

The proposed amendment would increase the maximum total number of options under the Share Option Plan 2019 by two million three hundred and fifty thousand (2,350,000) options. This would increase the aggregate per centage of shares that can be subscribed for based on options from 3,1 per cent to 6,9 per cent of all shares registered at the date of this proposal. The maximum number of options granted to the chair of the Board would increase by seventy thousand (70,000) options, representing an increase of approximately 38.9 per cent, the maximum number of options granted to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein) would increase by thirty five thousand (35,000) options, representing an increase of approximately 38.9 per cent, the maximum number of options granted to the Chief Executive Officer would increase by one hundred and thirty five thousand (135,000) options, representing an increase of 37.5 per cent, the maximum number of options granted to the Chief Financial Officer would increase by fifty thousand (50,000) options, representing an increase of approximately 38.5 per cent and the maximum number of options granted to other non-employee persons as determined by the Board would increase by twenty thousand (20,000) options, representing an increase of 40.0 per cent, over the current maximum totals.

 

In relation to the amendment proposed above, the Board further proposes, on the basis of the proposal of the remuneration committee, that the AGM authorise the Board 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 two million four hundred seventy-three thousand and eighty four (2,473.084) shares, options or other special rights entitling to shares in the aggregate, which corresponds to approximately 3.9 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 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 amended Share Option Plan 2019 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. The maximum numbers of options to be granted shall be as presented above. For the sake of clarity it is noted that, as described above, the new amended maximum amounts include the options already granted under the Share Option Plan 2019, which is why the proposed size of the authorisation also takes into account the options already granted based on the previous authorisation.

 

The exercise of options will be subject to fulfilment of certain criteria to be resolved by the Board (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 (the “Exercise Price”). In determining such market value, if shares are traded on Nasdaq Helsinki and/or on the AIM market of the London Stock Exchange, the Board shall have regard to the average price per share at which shares have been traded over a period of 90 days immediately preceding the grant date. The Exercise Price will be determined 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 Company’s Board 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 2026. This authorisation shall not replace other authorisations granted to the Board (but for the sake of clarity, replaces the authorisation granted in 2019 relating to the Share Option Plan 2019).

 

  1. Closing of the meeting

 

 

  1. DOCUMENTS OF THE ANNUAL GENERAL MEETING

The above-mentioned proposals to the AGM, the Company’s Annual Report 2022 including the financial statements, the Report of the Board of Directors and the Auditor’s Report and this notice are available on the Company’s website at https://www.faron.com/investors as of the date of publication of this notice. The Board’s proposals and the other above-mentioned documents will also be available at the AGM. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the AGM will be available on the Company’s website from 6 April 2023 at the latest.

  1. INSTRUCTIONS FOR THE PARTICIPANTS

 

  1. The right to participate and registration

Each shareholder who on the record date of the AGM, being March 14, 2023, is registered in the Company’s shareholders’ register held by Euroclear Finland Oy 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 C3 “Holder of nominee-registered shares (including depositary interest holders)”.

A shareholder who is registered in the Company’s shareholders’ register and who wants to participate in the AGM should register for the meeting by no later than 10:00 a.m. EET (Finnish time) on Tuesday, March 21, 2023 by giving a prior notice of participation. The notice must be received before the end of the registration period. Notice of participation can be given:

          by email to general.meeting@faron.com or

          by mail to Faron Pharmaceuticals Ltd, attn. Kaisa Kyttä, 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, legal representative or assistant and the personal identification number of the proxy representative or legal representative. The personal data given by shareholders to the Company are used only in connection with the AGM and the necessary processing of related registrations.

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

  1. Proxy representative and powers of attorney

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

If a shareholder participates in the AGM by means of several proxy representatives, who represent the shareholder with shares held on different book-entry accounts, the shares represented by each proxy representative shall be identified when registering for the AGM.

The Company offers the possibility for shareholders to designate Yrjö Wichmann, VP, Financing & IR, as their proxy representative, to represent them at the AGM in accordance with shareholder’s voting instructions. Authorizing the designated proxy representative will not accrue any costs for the shareholder, excluding possible postal fees for proxy documents.

Possible proxy documents should be sent by email to general.meeting@faron.com and in originals to Faron Pharmaceuticals Ltd, attn. Kaisa Kyttä, Joukahaisenkatu 6, FI-20520 Turku, Finland before the end of registration period by which time the proxy documents must be received.

In addition to providing proxy documents, the shareholder or their proxy representative must take care of registering for the AGM in the manner described in this notice.

  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 held by Euroclear Finland Oy on the AGM’s record date of March 14, 2023.

Additionally, participation requires that the holder of nominee-registered shares is on the basis of such shares temporarily registered in the Company’s shareholders’ register held by Euroclear Finland Oy by 10:00 a.m. EET (Finnish time) on Tuesday, March 21, 2023. As regards nominee-registered shares, this constitutes due registration for the AGM.

A holder of nominee-registered shares is advised to request the necessary instructions regarding the temporary registration in the shareholders’ register, the issuing of proxy documents and registration for the AGM from their custodian bank without delay. A holder of nominee-registered shares shall note that custodian banks may apply deadlines for the registration and the providing of voting instructions of holders of nominee-registered shares. The account management organisation of the custodian bank must register a holder of nominee-registered shares who wants to participate in the AGM to be temporarily entered into the Company’s shareholders’ register by the above-mentioned time.

  1. Other instructions and information

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

Changes in shareholding occurred after the record date of the AGM do not affect the right to participate in the AGM or the number of votes held by a shareholder.

On the date of this notice, March 3, 2023, the total number of shares and votes in the Company is 63,497,691.

The AGM shall be held in Finnish, partially translated into English.

 

Turku, March 3, 2023

FARON PHARMACEUTICALS LTD

Board of Directors

 

For more information please contact:

Media / Investor Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

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

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. Bexmarilimab, a novel anti-CLEVER-1 humanized 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

 

Notice of 2022 Full-Year Results and Annual Report

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

Notice of 2022 Full-Year Results and Annual Report

 

Press release, February 6, 2023 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, will publish its audited full-year results for the twelve months ended December 31, 2022, on Thursday, March 2, 2023, at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET). The Annual Report 2022, including audited financial statements for the full year, will be published on the same day.

 

Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, will host a virtual briefing and Q&A session for analysts at 7:00 AM (EST) / 12:00 PM (GMT) / 2:00 PM (EET) on the day of results.

 

The full-year results press release for 2022, presentation, virtual briefing webcast details, and Annual Report 2022 will be made available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards.

 

For more details about the analysts’ briefing, please contact Faron@consilium-comms.com.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

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 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 humanized 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 solid tumors and hematologic malignancies, 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 ischemic and hyperinflammatory conditions. Traumakine is currently being evaluated by 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.

 

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.

 

 

Holding(s) in Company

 

TR-1: Standard form for notification of major holdings

 

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

 

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

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

X

Other (please specify) iii: (Decrease of holding due to issuance of new shares)

X

3. Details of person subject to the notification obligation iv

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 reached vi:

27.01.2023

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

30.01.2023

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 held in issuer (8.A + 8.B) vii

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

5.77%

 

5.77%

3,666,647

Position of previous notification (if

applicable)

6.13%

 

6.13%

 

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

3,666,647

 

5.77%

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

3,666,647

5.77%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

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

exercised/converted.

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. B 1

 

 

 

 

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

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) issuer xiii

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 entity (please add additional rows as necessary) xiv

 

Name xv

% 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

Tom-Erik Lind

5.77%

 

5.77%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 information xvi

Faron share issue per 27.01.2023

 

Place of completion

Bangkok, Thailand

Date of completion

27.01.2023

 

 

 

 

 

Holding(s) in Company

 

TR-1: Standard form for notification of major holdings

 

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

 

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

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: (Increase of holding due to issuance of new shares)

X

3. Details of person subject to the notification obligation iv

Name

Varma Mutual Pension Insurance Company

City and country of registered office (if applicable)

Helsinki, Finland

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 reached vi:

27.01.2023

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

27.01.2023

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 held in issuer (8.A + 8.B) vii

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

4.16%

 

4.16%

2,641,503

Position of previous notification (if

applicable)

3.16%

 

3.16%

 

 

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

2,641,503

 

4.16%

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

2,641,503

4.16%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

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

exercised/converted.

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. B 1

 

 

 

 

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

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) issuer xiii

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 entity (please add additional rows as necessary) xiv

 

Name xv

% 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

Varma Mutual Pension Insurance Company

4.16%

 

4.16%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 information xvi

Faron share issue per 27.01.2023

 

Place of completion

Helsinki, Finland

Date of completion

27.01.2023

 

 

 

 

BEXMAB study update

Faron Pharmaceuticals Oy

(“Faron or Company”)

 

Inside Information: Encouraging Additional Data for Bexmarilimab for the Treatment of Hematological Malignancies

 – BEXMAB Study Update

 

  • Objective response observed in 3 out of 5 patients in the first doublet cohort
  • 2 of the 3 responders were refractory to prior azacitidine monotherapy
  • No additional adverse events observed adding bexmarilimab to standard of care
  • Rapid enrollment into both doublet and triplet combinations
  • CMO Marie-Louise Fjällskog to discuss further details at The Leukemia & Lymphoma Society (LLS) Therapeutic Acceleration Program (TAP) virtual panel on January 18, 2023

Company announcement, January 16, 2023 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EEST)

Inside information

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces objective responses in 3 out of 5 patients dosed in the first doublet cohort of the Company’s Phase I/II BEXMAB study. BEXMAB is investigating bexmarilimab, Faron’s wholly-owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.

 The responses from these patients are further defined as:

  • Complete remission (CR) with incomplete blood count recovery (CRi) in a patient with relapsed/refractory acute myeloid leukemia (AML) observed after 4 treatment cycles
  • CR in a patient with previously untreated myelodysplastic syndrome (MDS) observed after 6 cycles of treatment
  • Partial remission (PR) in a patient with MDS with prior failure to azacitidine observed after 2 treatment cycles

“The additional BEXMAB data indicates that bexmarilimab contributed to positive responses in the refractory setting where patients failed standard of care,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “We are excited about the initial promising results and look forward to gathering additional clinical data for more robust read-outs.”

The primary objective of the BEXMAB study (https://www.clinicaltrials.gov/ listing: NCT05428969) is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine and venetoclax) treatment and to identify the recommended Phase II dose. Secondary objectives include characterizing preliminary efficacy as well as bexmarilimab’s pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity.

The first cohort dosed at 1mg/kg of bexmarilimab has been completed for the doublet, and currently enrollment is ongoing into the 3mg/kg cohort. The Company has opened the first triplet cohort with bexmarilimab (1mg/kg), azacitidine and venetoclax in newly diagnosed AML patients who are not able to tolerate chemotherapy.

In December 2022, the Company announced for the first cohort that the azacitidine-refractory AML patient achieved a CR, with incomplete blood cell count recovery after four treatment cycles. This was followed by full blood count recovery after five treatment cycles. It was also announced that another patient demonstrated a PR, and this patient now has become a CR.  

The safety profile remains strong. In December, the Company announced that bexmarilimab continues to be well-tolerated with no dose-limiting toxicities or safety concerns observed in the five patients receiving 1mg/kg weekly dosing together with azacitidine. The 5-patient doublet arm at 3mg/kg is fully enrolled, with the triplet arm at three patients recruited. All sites are in Finland, but the Company anticipates sites in the U.S. to be opened during Q1 2023 to speed up recruitment even further.

Marie-Louise Fjällskog will discuss the most recent BEXMAB findings at the LLS TAP virtual panel on January 18. The panel, titled “European Partners: Dream Big, Make Bold Progress”, will highlight companies that have worked in close collaboration with the LLS TAP program, including Faron, to advance their therapeutic portfolios. Register at this link: https://na.eventscloud.com/website/49472/welcome/.

“We are incredibly proud of our work with the LLS TAP,” said CEO Markku Jalkanen. “The leadership in hematological malignancies has provided us with not only financial assistance but also invaluable advice and connections to progress the bexmarilimab program, especially in the U.S.”

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

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-CLEVER-1 humanised antibody, bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in the tumor microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

About BEXMAB

The BEXMAB study is a first-in-human, open label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplatic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment and to identify the recommended Phase II dose. Directly targeting CLEVER-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current chemotherapy treatments to be more effective. CLEVER-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

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 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 humanized 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 solid tumors and hematologic malignancies, 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 by 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.

 

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.

 

Faron’s Financial Calendar for 2023

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

 

Faron’s Financial Calendar for 2023

 

Company announcement, December 23, 2022 at 9.00 am (EET) / 07:00 AM (GMT) / 02:00 AM (EDT)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces the following dates for the Company’s financial reporting in 2023:

 

March 2 Financial statement release for the full year 2022 and Annual Report 2022 including financial statements for the full year

August 29  Half-year financial report for the period January 1 to June 30, 2023

 

The annual general meeting is planned to be held on March 24, 2023. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Toni Hänninen

CFO

toni.hanninen@faron.com

Phone: +41 79 387 2643

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

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 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 humanized 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 solid tumors and hematologic malignancies, 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 by 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.

 

BEXMAB Study Update

Faron Pharmaceuticals Oy

(“Faron” or “Company”)

 

Inside Information: Promising start to a new study investigating bexmarilimab for the treatment of hematological malignancies

 – BEXMAB Study Update

 

  • Dose escalation to the second predefined level in first clinical study to investigate bexmarilimab in hematological malignancies
  • No dose-limiting toxicities or safety concerns observed among five patients to have received initial dose at 1 mg/kg every week
  • Early signs of efficacy with partial response observed in one patient after three dosing cycles
  • New triplet cohort to be opened combining bexmarilimab with azacitidine and venetoclax
  • Good target coverage as shown by reduced Clever-1 levels in patients’ blood and bone marrow aspirates

 

Company announcement, October 31, 2022 at 03:00 AM (EDT) / 07:00 AM (GMT) / 09:00 AM (EET)

Inside information

 

TURKU, FINLAND / BOSTON, MA Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces that dosing has moved to the second level in the Company’s Phase I/II BEXMAB study. BEXMAB is investigating bexmarilimab, Faron’s wholly-owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.

 

The primary objective of the BEXMAB study is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine and venetoclax) treatment and to identify the recommended Phase II dose. Secondary objectives include characterizing bexmarilimab’s pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity.

 

The first stage of the BEXMAB study comprises four predefined dose levels commencing at bexmarilimab 1mg/kg. Following the announcement of patient dosing commencement in June 2022, five patients have received 1mg/kg weekly dosing of bexmarilimab with no dose-limiting toxicities or safety concerns observed. These data warrant escalation of dosing with bexmarilimab to the second predefined weekly dosing level of 3mg/kg. 

 

All first stage cohort patients are alive. The longest treated patient at three cycles has revealed partial response as observed by reduced cancer activity with reduced blast (cancer cell) counts and normalised blood cell counts.

 

Initial data from patients dosed with bexmarilimab also show a significant reduction in levels of soluble Clever-1 protein in the blood of treated patients. Earlier research from the Company’s MATINS study, investigating the safety and efficacy of bexmarilimab monotherapy in solid tumor cohorts, indicates that this soluble form of the Clever-1 protein is a direct inhibitor of T cells and could have an immunosuppressive effect in all locations of the body, therefore decreasing the general immune capacity of patients. This initial finding will be followed in all patients throughout the BEXMAB study.

 

“The escalation of dosing with bexmarilimab to the second level in the BEXMAB study, following confirmation of no dose limiting toxicities, is an encouraging early signal as we pursue this immunotherapy’s potential to treat hematological malignancies in the combination setting,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “We have also observed an early indicator of clinical benefit in the first patient dosed, alongside the observation of a reduction in levels of immunosuppressive soluble Clever-1 protein in the blood of treated patients. We look forward to generating further data as the trial progresses to help determine the optimal dose of bexmarilimab to take forward into Phase II.”  

 

“The safety findings in the trial’s first five patients, showing no dose-limiting toxicities or safety concerns with the 1mg/kg weekly dosing of bexmarilimab, is a very encouraging step supporting the scientific rationale to combine bexmarilimab and azacitidine with the aim to activate an immune response to control the disease,” said Mika Kontro, M.D., Ph.D., Helsinki University Hospital Comprehensive Cancer and Principal Investigator of the BEXMAB trial. “The initial safety data that we gather will inform the potential for expansion into a Phase II study in combination with azacitidine. The study may now also progress to include first-line triplet therapy with bexmarilimab, azacitidine and venetoclax in newly diagnosed acute myeloid leukemia patients not benefitting from conventional chemotherapy.”

 

“The BEXMAB study is off to a great start, and we are eagerly waiting to see the first data from the triplet therapy, where bexmarilimab could become a cornerstone of first-line treatment in newly diagnosed AML patients,” said CEO Markku Jalkanen. “We wish to thank our investigators, and especially patients, for the wonderful start of this trial, and their commitment in helping to find new treatments for this grave condition.”

 

“For investors these are very encouraging – though early – results. We should remember that AML is an extremely serious indication with over 90% mortality in five years and all new approaches that can change this are urgently needed,” said Yrjö Wichmann, Faron’s VP Funding and IR. “Earlier we were able to show clinical benefit in solid tumor cancers and now we have positive indication also in blood cancers, in which the Clever-1 target molecule is expressed directly on the surface of the cancer cells themselves. Additionally, as AML is a very serious condition, the route to regulatory approval can be faster if results are exceptional.”  

 

 

Further details of the BEXMAB study are available on ClinicalTrials.gov (Identifier: NCT05428969).

 

Faron will also host a special event in December where further details of the BEXMAB study will be presented together with current treatment practices for hematological malignancies.

 

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

 

 

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Yrjö Wichmann

VP, Investor Relations and Funding

Yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979
 

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell 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. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

 

About BEXMAB

The BEXMAB study is a first-in-human open label phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplatic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment and to identify the recommended Phase II dose. Based on initial safety data, there is potential for expansion to include a first line triplet therapy of bexmarilimab, azacitidine and venetoclax in newly diagnosed AML patients who are not able to tolerate chemotherapy. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current chemotherapy treatments to be more effective.

 

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 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 humanized 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 solid tumors and hematologic malignancies, 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 by 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.

 

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.

Holding(s) in Company

 

TR-1: Standard form for notification of major holdings

 

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

 

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

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: (Increase of holding due to issuance of new shares)

 

3. Details of person subject to the notification obligation iv

Name

Varma Mutual Pension Insurance Company

City and country of registered office (if applicable)

Helsinki, Finland

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 reached vi:

14.10.2022

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

18.10.2022

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 held in issuer (8.A + 8.B) vii

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

3.16%

 

3.16%

1,891,891

Position of previous notification (if

applicable)

 

 

 

 

 

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

1,891,891

 

3.16%

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

1,891,891

3.16%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

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

exercised/converted.

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. B 1

 

 

 

 

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

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) issuer xiii

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 entity (please add additional rows as necessary) xiv

 

Name xv

% 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

Varma Mutual Pension Insurance Company

3.16%

 

3.16%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 information xvi

Faron share issue per 14.10.2022

 

Place of completion

Helsinki, Finland

Date of completion

18.10.2022

 

 

 

 

 

Holding(s) in Company

 

TR-1: Standard form for notification of major holdings

 

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

 

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

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

X

An event changing the breakdown of voting rights

 

Other (please specify) iii: (Increase of holding due to issuance of new shares)

X

3. Details of person subject to the notification obligation iv

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 reached vi:

14.10.2022

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

14.10.2022

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 held in issuer (8.A + 8.B) vii

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

20.58%

 

20.58%

 12,306,957

Position of previous notification (if

applicable)

19.74%

 

19.74%

 

 

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

4,867,366

7,439,591

8.14%

12.44%

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

12,306,957

20.58%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

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

exercised/converted.

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. B 1

 

 

 

 

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

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) issuer xiii

 

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

X

Name xv

% 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)

8.14%

 

8.14%

Acme Investments SPF Sarl (Indirect)

12.44%

 

12.44%

 

 

 

 

 

 

 

 

 

 

 

 

 

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 information xvi

Faron share issue per 14.10.2022

 

Place of completion

Lausanne

Date of completion

14.10.2022

 

 

 

 

 

Grant of Options

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Grant of options

 

Company announcement, September 22, 2022 at 09:00 AM (EEST) / 07:00 AM (BST) / 02:00 AM (EST)

 

TURKU, FINLAND / BOSTON, MA  Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, announces that the Board of Faron has confirmed the grant of a total of 129,000 options options over ordinary shares in the Company (“Options”) under Company’s Share Option Plan 2019 (including its UK and US sub plans).

 

The Options have been allocated under the Share Option Plan 2019 and are exercisable between 24 August 2023 and 24 August 2027, vesting 25% per annum over a period of four years. The exercise price for Options allocated under the Share Option plan is €2.50 per share (£2.11), which is calculated based on the average price per share at which the ordinary shares in the Company have been traded on AIM for 90 days preceding the allocation date of 24 August 2022. The exercise price for Options allocated under the US sub plan is €2.38 per share (£2.01), which is calculated based on the average price per share at which the ordinary shares in the Company have been traded on AIM for 30 days preceding the allocation date of 24 August 2022. The terms of the Share Option Plan 2019 are available on the Company’s website at https://www.faron.com/investors/general-meetings/2020.   

 

The granted Options entitle the option holders to subscribe for a total of 129,000 new ordinary shares in the Company, if exercised in full, and represent 0.23 % 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 a director or other persons discharging managerial responsibilities (“PDMRs”):

 

 

Director 

Options granted 

 

 

 

 

Erik Ostrowski (U.S Sub-Plan)

30,000 

 

 

 

 

Other PDMRs  

 

 

 

 

 

Vesa Karvonen (Share Option plan)

30,000 

 

Juuso Vakkuri (Share Option plan)

20,000 

 

 

 

 

For more information please contact: 

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

Julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad 

Sandy Jamieson, Jo Turner 

Phone: +44 (0) 207 213 0880 

 

Peel Hunt LLP, Broker 

Christopher Golden, James Steel 

Phone: +44 (0) 20 7418 8900 

 

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 

faron@consilium-comms.com 

Phone: +44 (0)20 3709 5700 

     
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 humanized 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 tumors, 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 hospitalized 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. 

 

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

a)       Erik Ostrowski

b)       Vesa Karvonen

c)       Juuso Vakkuri

2

Reason for notification

 

 

 

a.

Position/Status

Person discharging managerial responsibilities

b.

Initial notification/

Amendment

Initial Notification

3

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

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

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

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309
 

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2019 Option Plan

c.

Price(s) and volume(s)

 

 

 

 

 

 

Price(s)

Volume(s)

 

 

a)       €2.38(£2.01)

b)       €2.50(£2.11)

c)       €2.50(£2.11)

 

a)       30,000

b)       30,000

c)       20,000

 

 

 

d.

Aggregated information

 

– Aggregated Volume

 

– Price

 

 

 

Nil

 

 

e.

Date of the transaction

19 September 2022

f.

Place of the transaction

Turku

 

 

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