Faron, etusivu

Inside Information: FDA Grants Orphan Drug Designation for Bexmarilimab in MDS

Faron Pharmaceuticals Ltd | Company announcement | March 03, 2025 at 14:00:00 EET

Inside Information: FDA Grants Orphan Drug Designation for Bexmarilimab in MDS

Key highlights

  • Orphan Drug Designation further strengthens bexmarilimab program by offering clinical development and commercialization benefits
  • Faron is on track to report frontline and HMA-failed (r/r) MDS top-line efficacy results in April 2025

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumors, today announces that their lead candidate bexmarilimab has been granted Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS) by the USA Food and Drug Administration (the FDA).

The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. The FDA previously granted Orphan Drug Designation to bexmarilimab for the treatment of acute myeloid leukemia (AML) in August 2023.

“Receiving FDA’s orphan drug designation for bexmarilimab for the treatment of myelodysplastic syndrome marks a significant milestone for Faron Pharmaceuticals as we continue to develop bexmarilimab for MDS and other cancers. This FDA ODD along with the previously granted FDA fast track designation highlights our continued progress and reinforces our belief in the potential of bexmarilimab to address this significant unmet need for treatment of MDS. These designations allow us to receive important regulatory guidance for the development of bexmarilimab and potential additional market exclusivity upon approval” says Dr. Bono, the CMO of Faron.

For more information please contact:
ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@icrhealthcare.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

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

About BEXMAB
The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current 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 Bexmarilimab
Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd.
Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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 addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

NOTICE OF FARON PHARMACEUTICALS LTD’S ANNUAL GENERAL MEETING

Faron Pharmaceuticals Ltd | Company announcement | February 28, 2025 at 14:00:00 EET

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 21 March 2025 at 10:00 a.m. EET (Finnish time) at Biocity, meeting room “Presidentti” at Tykistökatu 6, FI-20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 9:30 a.m. EET (Finnish time).

The Company’s Annual Report 2024 is available for review and downloading on the Company’s website at https://www.faron.com/.

A. MATTERS ON THE AGENDA OF THE ANNUAL GENERAL MEETING

1. Opening of the meeting

2. Calling the meeting to order

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

4. Recording the legality of the meeting

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

6. Presentation of the financial statements, the report of the Board of Directors and the auditor’s report for 2024

Review by the CEO.

7. Adoption of the financial statements

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

The Board of Directors (the “Board”) proposes that no dividend for the financial year 2024 will be paid and that the losses of the Company for the financial year, amounting to EUR 26.0 million (IFRS), will be carried forward to the reserve for invested unrestricted equity.

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

10. Resolution on the remuneration of the members of the Board
The Shareholders’ Nomination Board proposes 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 Shareholders’ Nomination 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 Shareholders’ Nomination Board also proposes 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, if such person is elected by the Annual General Meeting.

11. Resolution on the number of members of the Board

The Shareholders’ Nomination Board proposes to the Annual General Meeting, that six (6) members be elected to the Board.

12. Election of members of the Board

The Shareholders’ Nomination Board proposes to the Annual General Meeting, that John Poulos, Markku Jalkanen, Tuomo Pätsi, Christine Roth and Marie-Louise Fjällskog be re-elected, and that Juho Jalkanen be elected as a new member to the Board for a term that ends at the end of the next AGM.

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 Tuomo Pätsi as chair of the Board.

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

13. Resolution on the remuneration of the auditor

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

14. Election of the auditor

The Board proposes, on the basis of the proposal of the audit committee, that PricewaterhouseCoopers Oy (“PwC”), a firm of authorised public accountants, be re-elected as the Company’s auditor.

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

15. Resolution on the amendment of the option programme 2019

The Company’s AGM has on 28 May 2019 decided to authorise the Board to resolve on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act, and the terms and conditions have later been amended by the decisions of the Company’s AGM on 18 May 2020 and 24 March 2023 (the “Share Option Plan 2019”).

In accordance with the Share Option Plan 2019 the granted options will lapse latest on the fifth anniversary of the grant date. The Board proposes that the AGM would resolve to amend the terms and conditions of the Share Option Plan 2019, so that the validity period of the options granted under the Share Option Plan 2019 is extended by one (1) year, i.e. the granted options will lapse latest on the sixth anniversary of the grant date. For the sake of clarity, it is noted that the proposal applies to all options granted under the Share Option Plan 2019. 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.

Furthermore, the Board proposes that the AGM would resolve to amend the terms and conditions of the Share Option Plan 2019, so that a maximum of two hundred thousand (200,000) options (before the amendment one hundred and twenty-five thousand (125,000) options) could be offered 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). The maximum number of options offered under the Share Option Plan 2019 to the chair of the Board, the Chief Executive Officer, the Chief Financial Officer and to any other non-employee person as determined by the Board, would remain unchanged.

Excluding the proposed amendments presented above, the terms and conditions of the option programme remain otherwise unchanged. The consolidated terms and conditions of the Share Option Plan 2019, incorporating the amendments proposed herein, are attached hereto as Annex 1.

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 seventy-five thousand (75,000) options, representing an increase of 60 per cent over the current maximum totals.

16. Resolution on the amendment of the Articles of Association

The Board proposes that Article 17 (Notification on the Change of Holdings in the Company) of the Articles of Association of the Company be amended such that a new Article 17.1 is added. The purpose of the amendment is to clarify the situation with regards to the provisions applicable to the Company and its shareholders regarding notifications of shareholdings and voting rights in light of the Company’s dual listing of shares on Nasdaq First North Growth Market Finland and AIM. Article 17, as currently in force, partly deviates from the applicable provisions under the Finnish Securities Markets Act now directly applicable on the Company and its shareholders. However, due to the AIM listing, the shareholders are also required to comply with the provisions set out in the Articles of Association in order to satisfy their, and the Company being able to satisfy its, obligations under the AIM Rules related to changes of holdings.

The proposed new Article 17.1 would read as follows:

“17.1 Applicability

For as long as the Company is listed on AIM, the procedure described in this Article 17 will be adhered to. In addition, the relevant legislation concerning notifications of holdings and proportions of voting rights from time to time in force shall be taken into account.”

The Board further proposes that Article 18 (Obligation to Purchase Shares) of the Articles of Association of the Company be removed.

The proposal is based on the changes to takeover rules in the Finnish Securities Markets Act. Due to the change, the provisions concerning takeover bids will apply to shares admitted to trading on a multilateral trading facility. As the Company’s shares are listed on Nasdaq First North Growth Market Finland, which is a multilateral trading facility, it is proposed that the article contradicting applicable legislation is removed.

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

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

The Board proposes that the AGM authorise the Board to resolve by one or more decisions on issuances of shares, option rights or other special rights entitling to shares as 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 treasury shares held by the Company. The authorisation would consist of up to thirty million (30,000,000) new shares in the aggregate (including shares to be received based on option rights or other special rights), which corresponds to approximately twenty-seven (27) per cent of the existing shares and votes in the Company (as of the date of this notice), as well as the conveyance of up to the same maximum number (thirty million (30,000,000)) of treasury shares held by the Company. Further, should the Board resolve to issue option rights or other special rights entitling to treasury shares held by the Company, the same authorisation could be used to issue the afore-mentioned up to thirty million (30,000,000) new shares in the aggregate to the Company itself without consideration (to be further issued as shares to be received based on such option rights or other special rights).

In practise, the above authorisation includes that the Board may first resolve on one or more share issues (up to the maximum number of thirty million (30,000,000) new shares) without consideration to the Company itself and then further convey such treasury shares (up to the maximum number of thirty million (30,000,000) shares) against consideration (including as shares to be received based on option rights or other special rights issued based on the same authorisation).

The authorisation would not exclude the Board’s right to decide on the issuance of shares, option rights 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 28 February 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, option rights 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 thirty million (30,000,000) new shares in aggregate.

The Board would be authorised to resolve on all other terms and conditions of the issuance of shares, option rights or other special rights entitling to shares.

The authorisation would be effective until 30 June 2026. This authorisation does not cancel the authorisation given to the Board by the Annual General Meeting on 5 April 2024 to resolve on issuances of shares, option rights or other special rights entitling to shares.

18. Closing of the meeting

B. DOCUMENTS OF THE ANNUAL GENERAL MEETING

The above-mentioned resolution proposals to the AGM, the Company’s Annual Report 2024 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 as of 4 April 2025 at the latest.

C. INSTRUCTIONS FOR THE PARTICIPANTS OF THE ANNUAL GENERAL MEETING

1. The right to participate and registration
Each shareholder who on the record date of the AGM, being 11 March 2025 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 C.3 “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, 18 March 2025 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 be able to prove their identity and/or right of representation at the meeting venue upon request.

2. 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 in 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 Paavo Koivisto, Director, IR&Funding, 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.

3. Holder of nominee-registered shares (including depositary interest holders)
A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the 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 11 March 2025.

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, 18 March 2025. 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 temporary registration in the shareholders’ register, 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.

4. 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 on the agenda of the AGM.

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, 28 February 2025, the total number of shares and votes in the Company is 111,601,608.

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

Turku, 28 February 2025

FARON PHARMACEUTICALS LTD

Board of Directors

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@icrhealthcare.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

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

Inside Information: Faron Receives Positive EMA Opinion on Orphan Drug Designation for Bexmarilimab for the treatment of myelodysplastic syndrome (MDS)

Faron Pharmaceuticals Ltd | Company announcement | February 27, 2025 at 09:30:00 EET

Inside Information: Faron Receives Positive EMA Opinion on Orphan Drug Designation for Bexmarilimab for the treatment of myelodysplastic syndrome (MDS)

Key highlights

  • Given strong efficacy data of bexmarilimab in the treatment of MDS patients, the EU’s Committee for Orphan Medicinal Products (COMP) issued positive opinion on Orphan Drug Designation (ODD) for bexmarilimab
  • Positive opinion on Orphan Drug Designation further strengthens bexmarilimab program by offering clinical development and commercialization benefits
  • Faron is on track to report frontline and HMA-failed (r/r) MDS top-line efficacy results in April 2025

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumors, today announces that their lead candidate bexmarilimab has been issued positive opinion on Orphan Drug Designation (ODD) for the treatment of myelodysplastic syndrome (MDS) in combination with azacitidine by the Committee for Orphan Medicinal Products (COMP) of the European Medicine Agency (EMA).

The EMA’s ODD program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases. The ODD qualifies the sponsor of the drug for certain development incentives, including protocol assistance, specific advice, and market exclusivity once the medicine is on the market. Fee reductions are also available depending on the status of the sponsor and the type of service required.

Previously, in August 2024, bexmarilimab was granted fast track designation by the FDA which aims to expedite the review process for promising medicines in areas of unmet medical needs.

“Receiving positive opinion on orphan drug designation for bexmarilimab for the treatment of myelodysplastic syndrome (MDS) in combination with azacitidine marks a significant milestone for Faron Pharmaceuticals as we continue to develop bexmarilimab for MDS and other cancers. The interim results of bexmarilimab’s ongoing phase I/II BEXMAB MDS trial reviewed by the EMA included also a median Overall Survival estimate. That was 13.4 months which is significantly longer than the median Overall Survival of 5-6 months described in earlier published r/r MDS survival reports. We are excited by this EMA positive opinion which demonstrates our continued progress and reinforces our belief in the potential of bexmarilimab to become a new and effective therapy for MDS.” says Dr. Bono, the CMO of Faron.

For more information please contact:
ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@icrhealthcare.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

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

About BEXMAB
The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current 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 Bexmarilimab
Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd.
Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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 addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs 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

Faron Pharmaceuticals Ltd | Company announcement | February 14, 2025 at 14:00:00 EET

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are 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: Change due the Private Placement X
3. Details of person subject to the notification obligation iv
Name The Fourth Swedish National Pension Fund
City and country of registered office (if applicable) Stockholm, Sweden
4. Full name of shareholder(s) (if different from 3.) v
Name
City and country of registered office (if applicable)
5. Date on which the threshold was crossed or reached vi: 6.2.2025
6. Date on which issuer notified (DD/MM/YYYY): 7.2.2025
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% <3%
Position of previous notification (if
applicable)		 3,01% 3,150,000
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% <3%
SUBTOTAL 8. A <3% <3%
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
The Fourth Swedish National Pension Fund <3% <3%
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 Private Placement 06.02.2025
Place of completion Stockholm, Sweden
Date of completion 07.02.2025

Change of Broker

Faron Pharmaceuticals Ltd | Company announcement | February 11, 2025 at 09:30:00 EET

Change of Broker

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, announces the appointment of Cairn Financial Advisers LLP as broker to the Company with immediate effect in place of Peel Hunt LLP. Cairn Financial Advisers LLP will also continue to act as the Company’s Nominated Adviser.

For more information please contact:
ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

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

Holding(s) in Company

Faron Pharmaceuticals Ltd | Company announcement | February 06, 2025 at 17:00:00 EET

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are 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: Change due the Private Placement X
3. Details of person subject to the notification obligation iv
Name Timo Syrjälä
City and country of registered office (if applicable) Monaco
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: 6.2.2025
6. Date on which issuer notified (DD/MM/YYYY): 6.2.2025
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 15,15% 16,903,396
Position of previous notification (if
applicable)		 15,32% 16,024,023
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 5,475,368 11,428,028 4,91% 10,24%
SUBTOTAL 8. A 16,903,396 15,15%
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) 4,91% 4,91%
Acme Investments SPF Sarl (Indirect) 10,24% 10,24%
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 Private Placement 06.02.2025
Place of completion Monaco
Date of completion 06.02.2025

Results of the Significantly Oversubscribed Placing

Faron Pharmaceuticals Ltd | Company announcement | February 06, 2025 at 09:00:00 EET

Inside Information: Announcement of the Results of the Significantly Oversubscribed Placing, the Issue Price and registration of Placing Shares with the Trade Register

Capitalised terms used in this announcement have the meanings given to them in the announcement made on 5 February 2025 regarding the proposed issue of new ordinary shares in the Company to the Company itself without consideration and placing of treasury shares in the Company (the “Launch Announcement“), unless the context provides otherwise.

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, announces that the Bookbuild, announced on 5 February 2025, is now closed. The Placing was oversubscribed 1.8 times and thus the Board decided to upsize the offering and raise gross proceeds of EUR 12 million.

The Placing comprises of the issuance of 6,976,744 Placing Shares to Faron itself without consideration, which have today been registered in the Finnish Trade Register, and subsequent conveyance of these Placing Shares, to investors at the Issue Price of EUR 1.72 per Placing Share. The Issue Price represents a 10.3 % discount to the close price on 5 February 2025 on NASDAQ Helsinki First North Growth. The settlement (delivery against payment of the Issue Price in full) of the Placing Shares is expected to be completed on or about 10 February 2025. Carnegie Investment Bank AB (publ), Finland Branch (“Carnegie”), Bryan, Garnier & Co Ltd. and Bryan Garnier Securities SAS (together with Bryan, Garnier & Co Ltd., “Bryan Garnier”) acted as joint bookrunners in the Placing.

The Placing Shares conveyed to investors amount to approximately 6.67 per cent of the issued shares and votes in the Company, immediately prior to the Placing. The Company has raised aggregate gross proceeds of approximately EUR 12 million in the Placing. The Placing primarily targeted long-term institutional and other qualified investors due to their capability of offering substantial investments cost-effectively, at attractive terms and was supported by existing shareholders, including long-only institutional investors and family offices, as well as new investors. As the Issue Price was determined through the Bookbuild, it is the Board’s assessment that the Issue Price has been determined on market terms, reflecting current market conditions and investor demand. With these proceeds and the current level of activities the Company has sufficient working capital until December 2025 and be able to meet its financial covenants into September 2025.

“This fundraising is pivotal and comes at an exciting time for Faron. As we will soon see topline data from the Phase II of the BEXMAB clinical trial, it was important to raise funds to provide a cash runway into December 2025.” said Yrjö Wichmann, Chief Financial Officer of Faron. “The investor interest has been stronger than anticipated which demonstrates that the market shares our strong belief in the Company and bexmarilimab. We would like to thank all our investors for their continued support in developing this novel immunotherapy!”.

Use of Proceeds and registration of Placing Shares in the Trade Register

The primary reason for conducting the Placing was to strengthen the Company’s financial position ahead of its upcoming BEXMAB Phase II trial topline readout, which is expected in April 2025. The proceeds will be used for the continuation of the BEXMAB Phase II trial, mainly to produce follow-up data (duration of response and survival) and prepare the package for end of Phase II FDA meeting and to enhance the Company’s balance sheet. The Company will continue to evaluate further business transactions such as licensing agreements as well as other financing alternatives (e.g. equity, convertible or debt instruments) in order to achieve the best commercial outcome to its shareholders. The Placing improves the Company’s negotiation position ahead of the BEXMAB Phase II efficacy and safety readout, while also ensuring compliance with the financial covenants. 

A total of 6,976,744 Placing Shares have been issued and registered in the Finnish Trade Register today on 6 February 2025. Following the issuance, the aggregate number of ordinary shares in the Company is 111,601,608. As a part of the Placing, the 6,976,744 Placing Shares are further conveyed to investors with payment and settlement (delivery against payment of the Issue Price in full) expected to be completed on or about 10 February 2025. The Placing Shares confer a right to dividends and other shareholder rights from the payment and settlement to investors. One Placing Share entitles the holder to one vote in the general meeting of the Company. Following, and subject to, the completion of the settlement in full, the Company will have no shares in treasury and therefore, the total number of voting rights in Faron will be 111,601,608 (the “New Number of Shares and Votes“). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the New Number of Shares and Votes of the Company.

Trading in the Placing Shares is expected to commence on First North and AIM on or about 10 February 2025.

Applications have been made for the admission to trading of the Placing Shares on the Nasdaq First North Growth Market Finland (“First North“) maintained by Nasdaq Helsinki Ltd (“Nasdaq Helsinki“) under the current trading code “FARON”, and on AIM (“AIM“), the market of that name operated by London Stock Exchange plc (the “LSE“) under the trading code “FARN”. It is expected that the admission of the Placing Shares to trading on First North and AIM will become effective at 10:00 a.m. EEST / 8:00 a.m. BST on 10 February 2024. Trading in the Placing Shares is expected to commence on 10 February 2025 subject to the admission of the New Shares to trading on First North and AIM.

Related Party Transaction
Timo Syrjälä, an existing shareholder in the Company, has subscribed through Acme Investments SPF Sarl (“Acme“) for 930,232 Placing Shares in aggregate, for an aggregate subscription value of EUR 1,599,999.04 at the Issue Price. Mr. Syrjälä held more than 10% of all shares in the Company prior to the Placing, which includes his indirect holding through Acme, an entity wholly owned by Mr. Syrjälä, and has been allocated more than 10% of the Placing Shares. Following the Placing, Mr. Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme, will be 16,903,396shares, representing 15.15 % of the New Number of Shares and Votes. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules for Companies (the “AIM Rules“). His subscription for Placing Shares pursuant to the Placing is a related party transaction for the purposes of the AIM Rules. The Directors of the Company, all of whom are independent of Mr. Syrjälä, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the participation by Mr. Syrjälä in the Placing to be fair and reasonable insofar as shareholders are concerned.

For more information please contact:

Investor Contact, Media Contact
Faron Pharmaceuticals
E-mail: investor.relations@faron.com

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@icrhealthcare.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

THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF REGULATION 2017/1129/EU AS INCORPORATED INTO UK DOMESTIC LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 WHO ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON BEING REFERRED TO AS A “RELEVANT PERSON”). ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE INTO THE UNITED STATES. THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO INTENTION TO REGISTER THE PLACING SHARES IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE PLACING SHARES IN THE UNITED STATES WAS MADE SOLELY TO “QUALIFIED INSTITUTIONAL BUYERS” AS DEFINED IN RULE 144A IN RELIANCE ON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT.

About BEXMAB

The BEXMAB trial is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com.

IMPORTANT INFORMATION

Market Abuse Regulation
Market soundings, as defined in (i) Regulation (EU) No 596/2014 (“MAR“) and (ii) MAR as it applies to domestic law in the United Kingdom by virtue of the European Unition (Withdrawal) Act 2018 (“UK MAR”), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR and UK MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with article 17 of MAR AND UK MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

This announcement contains inside information for the purposes of Article 7 of MAR and Article 7 of UK MAR.

EEA product governance
Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Placing.

UK product governance
Solely for the purposes of the product governance requirements contained within of Chapter 3 of the FCA Handbook Production Intervention and Product Governance Sourcebook (the “UK Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the UK Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that such securities are: (i) compatible with an end target market of investors who meet the criteria of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in paragraph 3 of the FCA Handbook Conduct of Business Sourcebook; and (ii) eligible for distribution through all distribution channels (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors (for the purposes of UK Product Governance Requirements) should note that: (a) the price of the Placing Shares may decline and investors could lose all or part of their investment; (b) the Placing Shares offer no guaranteed income and no capital protection; and (c) an investment in the Placing Shares compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Placing.

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes, 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.

Proposed Issue and Placing

Faron Pharmaceuticals Ltd | Company announcement | February 05, 2025 at 18:30:00 EET

Inside Information: Proposed Issue and Placing of preliminarily approx. EUR 10 million by way of an accelerated book-building

KEY HIGHLIGHTS

  • A proposed private placement of newly issued treasury shares (“Placing Shares”) to raise preliminarily approximately EUR 10 million, to be conducted by way of an accelerated book-building, directed to a limited number of institutional and other investors.
  • Subject to the Company raising approximately EUR 10 million, the Company will have sufficient funding for its working capital needs into Q4 2025 and be able to meet its financial covenants into August 2025. The total cash and cash equivalents held by the Company as of 31 December 2024 was ca. EUR 9.5 million.
  • The net proceeds will strengthen the Company’s financial position ahead of its upcoming BEXMAB Phase II trial topline readout, which is expected in April 2025. The proceeds will be used for the continuation of the BEXMAB Phase II trial, mainly to produce follow-up data (duration of response and survival) and to prepare the package for end of Phase II FDA meeting and to enhance the Company’s balance sheet.  
  • The Company will continue to actively evaluate further business transactions such as licensing as well as financing alternatives (e.g. equity, convertible or debt instruments) in order to achieve the best commercial outcome for its shareholders. The proposed Placing would improve the Company’s negotiation position ahead of the BEXMAB Phase II efficacy and safety readout, while also ensuring compliance with the financial covenants.
  • Carnegie Investment Bank AB (publ), Finland Branch (“Carnegie”), Bryan, Garnier & Co Ltd. and Bryan Garnier Securities SAS (together with Bryan, Garnier & Co Ltd., “Bryan Garnier”) are acting as joint bookrunners (“Joint Bookrunners”) in the placing.

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces a proposed private placement to raise preliminarily approximately EUR 10 million before expenses to a limited number of institutional investors and other investors (“Placing”). Carnegie and Bryan Garnier are acting as Joint Bookrunners in the Placing.

The Placing will be conducted in a private placement by way of an accelerated book-building process in which selected investors may submit bids for the Placing Shares (the “Bookbuild”). The subscription price per Placing Share is to be determined on the basis of the bids received in the Bookbuild in EUR. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 a.m. EET on 6 February 2025 at the latest. The Bookbuild may be discontinued or extended at any time during the book-building process. Following the close of the Bookbuild, the Board of Directors of Faron (the “Board“) will first make the decision to issue the relevant number of treasury shares to Faron itself without consideration, followed by the decision to then convey such Placing Shares, including, as applicable, acceptance of the received bids, the number of Placing Shares to be conveyed to investors and the subscription price per Placing Share (the “Issue Price“), subject to the registration of the Placing Shares in the Finnish Trade Register. The Company has received non-binding indications of interest from potential investors to subscribe for the Placing Shares under the Placing during a pre-marketing process.

As soon as practicable after the close of the Bookbuild, and following receipt of binding commitments from investors, an announcement will be made on the final number of the Placing Shares to be issued first to Faron itself without consideration and then to be conveyed to investors in the Placing, the expected registration date of the Placing Shares and the Issue Price.

Further details on the terms and conditions of the Placing are set out below. The Placing Shares are expected to be admitted to trading on Nasdaq First North Growth Market Finland (“First North”) and AIM (“AIM”) in London as set out below.

“This fundraise will enable us to continue our ambitious bexmarilimab development program as previously communicated, with a specific focus on hematologic malignancies,” said Dr. Juho Jalkanen, Chief Executive Officer of Faron.

As to alternative funding options and partnering discussions, the Company continues to evaluate timing, scope and the best available options and terms for a commercial deal. To allow continued flexibility in pursuing the best commercial outcome for the Company and its shareholders through being in a better negotiation position with BEXMAB Phase II efficacy and safety readout, while also ensuring compliance with the financial covenants, the Company will, while taking into account the actual equity raised in the Placing, also continue to actively evaluate further financing alternatives and business transactions (which could include equity or convertible instruments).  

REASONS FOR THE PROPOSED PLACING

The development of bexmarilimab has advanced significantly over the past 12 months and the furthering of its development provides an opportunity to build additional value for shareholders. The proceeds of the Placing are to be used to advance the development of the Company’s pipeline and to strengthen the financial position of the Company.

  • Bexmarilimab development
    • Securing topline readout of Phase II BEXMAB trial in April 2025.
    • Continuation of the BEXMAB Phase II trial to generate high-quality follow-up data (duration of response and survival)
    • Preparing for a meeting with FDA after Phase II topline response rate readout.
  • Strengthening of financial position of the Company to enhance its position while securing compliance with financial covenants relating to financial arrangements.

DETAILS OF THE PROPOSED PLACING AND ISSUE OF EQUITY

  • Faron intends to raise preliminarily approximately EUR 10 million by offering Placing Shares to a limited number of institutional and other investors in the Placing. The Company has an authorization to offer a maximum of 19,113,496 Placing Shares in the Company.
  • Subject to the Company raising preliminarily approximately EUR 10 million, the Company will have sufficient funding for its working capital needs into Q4 2025.
  • Carnegie and Bryan Garnier are acting as Joint Bookrunners in the Placing.

The proposed Placing is being carried out within the authorisation granted to the Board by shareholders at the Company’s Annual General Meeting held on 5 April 2024 to issue up to a total of 20,000,000 new ordinary shares in the Company as well as to convey up to the same maximum number (20,000,000) of treasury shares in the possession of the Company, in a directed share issue and in deviation from the shareholders’ pre-emptive rights. A total of 886,504 warrants have been issued by the Company in connection with a previous funding arrangement. Therefore, pursuant to the outstanding authority, the Company may issue and further convey up to a maximum of 19,113,496 ordinary shares, which represents approximately 18.3 per cent of all the issued shares and votes in the Company immediately prior to the Placing.

The Placing, arranged by Carnegie and Bryan Garnier, will be conducted in a private placement by way of the Bookbuild, which is an accelerated book-building process in which selected investors may submit bids for the Placing Shares. In the Placing, the Company is primarily targeting long-term institutional and other qualified investors that are capable of offering substantial investments cost-effectively, at attractive terms. The Issue Price is to be determined on the basis of the bids received in the Bookbuild. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 EET a.m. on 6 February 2025 at the latest. The Bookbuild may be discontinued at any time during the book-building process. Following the close of the Bookbuild, the Board will make the decision to issue the relevant number of new Placing Shares to the Company itself and subsequently convey the Placing Shares to the investors in the Placing, including deciding upon, as applicable, the acceptance of the received bids, the number of Placing Shares to be conveyed and the Issue Price. As soon as practicable after the close of the Bookbuild, receipt of binding commitments from investors and the Board having resolved on carrying out the Placing, an announcement will be made on the final outcome of the Bookbuild and, as applicable, the number of the Placing Shares to be issued to the Company itself and then conveyed to investors, the Issue Price as well as the expected registration date of the Placing Shares.
 
In connection with the proposed Placing, the Company has entered into a placing agreement with Carnegie and Bryan Garnier (the “Placing Agreement“). Pursuant to the terms of the Placing Agreement, the Joint Bookrunners have agreed to use their reasonable endeavours to procure the subscription of Placing Shares.
 
The Placing Agreement contain customary warranties and an indemnity from the Company in favour of the Joint Bookrunners. The Placing Agreement also contain provisions which enable the Joint Bookrunners to terminate the Placing Agreement in certain circumstances before the completion of the Bookbuild, the Board’s resolution on carrying out the Placing and the settlement of the Placing Shares to investors, including where there has been a material breach of any of the warranties contained in the Placing Agreement or where there is a material adverse change, e.g., in the business or financial affairs of the Company. The Company has agreed to pay the Joint Bookrunners certain commissions and fees in connection with the Placing. Pursuant to the terms of the Placing Agreement, the Joint Bookrunners shall collect payment of the gross Issue Price from the investors in respect of the Placing Shares allocated in the Placing, paying such amounts to the Company on behalf of the investors and organizing the delivery of the Placing Shares to the investors against payment of the Issue Price in full (DVP).

 The Placing is conditional upon, inter alia:

  • the Placing Agreement having become unconditional in all respects;
  • the Board resolving to carry out the Placing at the Issue Price and the Company and Joint Bookrunners entering into a separate pricing agreement confirming the Issue Price and the number of the Placing Shares; and
  • the Placing Shares being issued and being registered with the Finnish Trade Register.

Subject to all conditions being met, the Placing Shares are expected to be entered in the Finnish Trade Register approximately on 6 February 2025.

DEVIATION FROM THE PRE-EMPTIVE SUBSCRIPTION RIGHT OF SHAREHOLDERS

As previously announced by the Company on 22 October 2024, in order to enable more flexibility in pursuing the best commercial outcome for the Company and its shareholders, in continued compliance with the financial covenants and to facilitate availability of high-quality Phase II BEXMAB efficacy data, the Company could, subject to market conditions, consider strengthening its financial position before concluding discussions concerning partnering as it believes that the better the Company is financed, the better its position is to conclude a partnership. The Company has been exploring and continues to explore several funding alternatives and has concluded that a promptly executed private placement by way of a book-building process is the most suitable option available to the Company at this time.

The Placing represents a deviation from the shareholders’ pre-emptive subscription right. Prior to resolving to pursue the Placing, the Board has conducted an overall assessment and carefully investigated the alternatives for raising capital, also observing the broader fundraise arranged by the Company in June 2024 enabling shareholder participation. As previously announced, the Company’s current funding provides sufficient working capital into Q2 2025 and the Company’s ability to satisfy its financial covenants until the latter half of March 2025. The Placing, in the form of accelerated book-building, reduces both execution and completion risk as it enables an equity raise efficiently and in a timely manner, typically with a lower discount to the current trading price, less exposure to market volatility, at a lower cost and with significantly reduced completion risk compared to a share issue enabling broader shareholder and investor participation. In the Placing, the Company is primarily targeting long-term institutional and other qualified investors due to their capability of offering substantial investments cost-effectively, at attractive terms. In particular, the rapidness of the Placing is considered as a significant advantage as it would provide the Company with funding prior to the forthcoming topline readout of Phase II BEXMAB trial and, consequently, continued operations and flexibility in pursuing the best commercial outcome in the partnering discussions. As indicated by the Company in the summer 2024, a rights issue or a broader share issue, the latter as organised by the Company in June 2024 enabling wider shareholder participation would be significantly more time-consuming and require resources from the Company which the Company does not currently have. The private placement structure is known to the market from previous funding actions of the Company. Based on an overall assessment, the Board considers the Placing to be the most favourable alternative for the Company to raise capital.

In light of the above, the Board considers that that the Placing is in the best interest of the Company and all of its shareholders, and that there is a weighty financial reason for the Company to deviate from the shareholders’ pre-emptive subscription right.

As the subscription price in the Placing would be determined through an accelerated book-building process, it is the Board’s assessment that the subscription price is determined on market terms, reflecting current market conditions and investor demand.

ISSUE OF THE PLACING SHARES AND ADMISSION TO TRADING

The Placing Shares are expected to be issued in one tranche to the Company itself as treasury shares and subsequently conveyed to the investors, and applications will be made for the admission of the Placing Shares to trading on First North and AIM with said admissions expected to become effective and trading to commence on or around 7 February 2025 (the “Admissions“). The dates above may be subject to change.

A further announcement will be made to confirm the outcome of the Placing (subject to, inter alia, satisfaction of the above conditions) and to confirm the expected timing of issue of the Placing Shares to the Company itself and subsequent issuance to investors, and the Admissions.

Upon registration with the Finnish Trade Register and further conveyance of the Placing Shares to investors (DVP), the Placing Shares will rank pari passu in all respects with the existing shares of the Company.

For more information please contact:

Investor Contact, Media Contact
Faron Pharmaceuticals
E-mail: faron@icrhealthcare.com

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.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

MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON PHARMACEUTICALS LTD (“FARON”) PURSUANT TO THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT. THIS ANNOUNCEMENT IS THEREFORE DIRECTED ONLY AT, IN A MEMBER STATE OF THE EUROPEAN ECONOMIC AREA, PERSONS WHO ARE “QUALIFIED INVESTORS” AS DEFINED IN ARTICLE 2(E) OF THE EU PROSPECTUS REGULATION (WHICH MEANS REGULATION (EU) 2017/1129) (THE “PROSPECTUS REGULATION”). THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON OR ANY OTHER ENTITY IN ANY JURISDICTION IN WHICH ANY SUCH OFFER WOULD BE UNLAWFUL.

IN ADDITION, IN THE UNITED KINGDOM, THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF THE PROSPECTUS REGULATION AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON, TOGETHER WITH QUALIFIED INVESTORS AS DEFINED IN THE PROSPECTUS REGULATION, BEING REFERRED TO AS A “RELEVANT PERSON”).

ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT WOULD BE MADE PURSUANT TO A PRIVATE PLACEMENT EXEMPTION UNDER THE PROSPECTUS REGULATION FROM THE REQUIREMENTS TO PRODUCE A PROSPECTUS UNDER THE PROSPECTUS REGULATION FOR OFFERS OF SECURITIES. FARON HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY OF THE PLACING SHARES THAT ARE TO BE SUBSCRIBED FOR PURSUANT TO THE TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT OR ANY DOCUMENTS RELATING TO THE PLACING TO THE PUBLIC IN FINLAND, SWEDEN, NORWAY OR DENMARK, OR IN ANY OTHER JURISDICTION IN ANY FORM WHICH WOULD CONSTITUTE AN OFFER TO THE PUBLIC.

THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE INTO THE UNITED STATES. THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO INTENTION TO REGISTER THE PLACING SHARES IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES.

About BEXMAB

The BEXMAB trial is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com.

IMPORTANT INFORMATION

Market Abuse Regulation
Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

This announcement contains inside information for the purposes of Article 7 of MAR and Article 7 of UK MAR.

MiFID II
Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offer.

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes, 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 2025

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Faron’s Financial Calendar for 202 5

Company announcement, 13 December 2024

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces the following dates for the Company’s financial reporting in 202 5 :

February 27

Financial statement release for the full year 2024 and Annual Report 2024 including financial statements for the full year

August 2 7

Half-year financial report for the period January 1 to June 30, 2025

The Annual General Meeting is planned to be held on March 2 1 , 202 5 . A separate stock exchange notice will be issued by Faron’s Board of Directors to convene the meeting.

For more information please contact:

ICR Healthcare
 Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:  faron@icrhealthcare.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 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at  www.faron.com .

Grant of options

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Grant of options

Company announcement, August 30, 2024

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherap ies , today announces that the Company’s board has confirmed the grant of a total of 100,000 options over new 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 August 26, 2025 and August 26, 2028, vesting 25% per annum over four years. The exercise price for the 100,000 Options allocated under the Option Plan 2019 is €1.48 per share, which is calculated based on the 90-day average price of the Shares prior to the Grant Date.

The terms of the Share Option Plan 2019 are available on the Company’s website at https://www.faron.com/sites/faron-corp/files/faron/investor/general-meeting/2023/annex-1-amended-option-plan-2019.pdf .

The granted 100,000 Options entitle the option holders to subscribe for a total of 100,000 new ordinary shares in the Company, if exercised in full, and represent 0.1 % of the fully diluted ordinary share capital of the Company.

Included in the number of Options granted are the following Options which were issued to other persons discharging managerial responsibilities (“PDMRs”):

Other PDMR

Petri Bono

100,00

Total other PDMRs

100,000

For the purposes of MAR and UK MAR, the person responsible for arranging for the release of this announcement on behalf of Faron is Juho Jalkanen, Chief Executive Officer.

For more information please contact:

ICR Consilium
 Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:   faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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

Petri Bono

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 new 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)

Exercise Price(s)

Volume(s)

€1.48

100,000

d.

Aggregated information

– Aggregated Volume

– Price

N/A

e.

Date of the transaction

26 August 2024

f.

Place of the transaction

Turku

annex-1-amended-option-plan-2019
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