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.

Update on settlement

Faron Pharmaceuticals Ltd

(“Faron” or the “Company“)

Update on settlement under the UK Open Offer and the REX Retail Offer

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND OR THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO ACQUIRE ANY SECURITIES. PLEASE SEE THE IMPORTANT NOTICES AT THE END OF THIS ANNOUNCEMENT.

Company announcement, 25 June 2024 at 4pm (EEST) / 2pm (BST) / 9am (EDT)

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 tumor microenvironments, announces an update on settlement of the UK Open Offer and the REX Retail Offer, which are part of the fully subscribed EUR 30.7 million share offering.  Capitalised terms used but not defined herein have the meaning given to them in the announcement of final results of the share offering dated 20 June 2024.

The New Shares were admitted to trading on First North and AIM at 8:00 a.m. BST on 24 June 2024. Due to a technical delay with settlement, CREST accounts are now expected to be credited in respect of shares under the UK Open Offer on 26 June 2024 and settlement of the REX Retail Offer is expected to occur on 25 June 2024.

Faron Pharmaceuticals Ltd

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) state, 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 notice

This announcement is not an offer of securities for sale into the United States. The Offer 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 Offer Shares in the United States or to make a public offering in the United States. Any sale of the Offer Shares in the United States will be made solely to a limited number of “qualified institutional buyers” or accredited investors, each as defined in Rule 144A in reliance on an exemption from the registration requirements of the Securities Act.

The distribution of this release may be restricted by law and persons into whose possession any document or other information referred to herein comes should inform themselves about and observe any such relevant legal restrictions. The information contained herein is not for publication or distribution, directly or indirectly, in or into the United States, Australia, Canada, Japan, New Zealand or the Republic of South Africa. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such aforementioned jurisdiction. This release is not directed to, and is not intended for distribution to or use by, any person or entity that is a citizen, resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would violate law or regulation or which would require any registration or licensing within such jurisdiction.

In any European Economic Area Member State, other than Finland, this release is only addressed to and is only directed at “qualified investors” in that Member State within the meaning of Article 2(e) of Regulation (EU) 2017/1129 (the “Prospectus Regulation“).

In the United Kingdom, this release is only being distributed to and is only directed at “qualified investors” within the meaning of Article 2(e) of the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation“) who are (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 companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “UK Relevant Persons“). Any investment activities to which this announcement relates will only be available to and will only be engaged in with UK Relevant Persons. Any person who is not a UK Relevant Person should not act or rely on this release or any of its contents.

This release does not constitute a prospectus as defined in either the Prospectus Regulation or the UK Prospectus Regulation and, as such, it does not constitute or form part of, and should not be construed as, an offer to sell, or a solicitation or invitation of any offer to buy, acquire or subscribe for, any securities or an inducement to enter into investment activity in relation to any securities.

No part of this release, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. The information contained in this release has not been independently verified. No representation, warranty or undertaking, expressed or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein. The Company or any of its respective affiliates, advisors or representatives or any other person, shall have no liability whatsoever (in negligence or otherwise) for any loss, however arising from any use of this release or its contents or otherwise arising in connection with this release. Each person must rely on their own examination and analysis of the Company, its subsidiaries, its securities and the transactions, including the merits and risks involved.

Carnegie Investment Bank AB, Finland Branch and Peel Hunt LLP are acting as lead managers (the “Lead Managers“) and bookrunners for the Offering. The Lead Managers are acting exclusively for the Company and no one else in connection with the Offering. They will not regard any other person as their respective client in relation to the Offering. The Lead Managers will not be responsible to anyone other than the Company for providing the duties afforded to their respective clients, nor for giving advice in relation to the Offering or any transaction or arrangement referred to herein.

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 Company’s current expectations and assumptions regarding the completion and use of proceeds from the Offering, 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 Company’s current beliefs and assumptions and are based on information currently available to the Company.

A number of factors could cause actual results to differ materially from the results and expectations dis-cussed 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 Company believes to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Update on financial status

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Inside Information: Update on financial status

  • Further cash preservation extends runway into Q3/2024
  • Understanding on conditional Waiver Extension reached with IPF, covering the Company until end of June 2024 to conduct the planned activities securing the further development of bexmarilimab in HMA-failed MDS

Company announcement, 30 April 2024 at 16:00 (EEST) / 14:00 (BST) / 9:00 AM (EDT)

Inside information  

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces that it has reached an understanding with its lender IPF Fund II SCA, SICAV-FIAR (“IPF”), an extension to the waiver that it originally announced on 4 March 2024 (“Waiver Extension”). With the Waiver Extension the Company continues to finalize its preparations to secure longer term funding.

 

The Waiver Extension is conditional on certain terms, those being, among others, (i) the minimum cash covenant being set to 6.0 million euros until 20 May 2024 and thereafter, subject to continued clinical success with the BEXMAB trial, (ii) first decreasing to 5.5 million euros on 21 May 2024 and (iii) then to 4.5 million euros on 12 June 2024 until a minimum equity raise of 10 million euros has been cashed in. As a part of the understanding on the Waiver Extension terms, IPF will receive a waiver fee and additional new warrants amounting to 500 000 euros in total with a strike price of the lower of 1.50 euros and the last 3 trading days VWAP preceding the issuance of the warrants. The warrants are expected to be issued and related actions completed by 15 May 2024. The Waiver Extension will be valid until 27 June 2024 at maximum, subject to terms above being followed and the Company securing subscriptions or guarantees for a public offer in the amount of 10 million euros by 11 June 2024, unless other financing of the same value is secured prior to that. Thereafter the minimum cash covenant will return to its normal level. On the date of this announcement IPF holds a number of warrants, which if converted into shares in the Company, would correspond to 1.4% of the current total number of shares in the Company.

 

The Company has completed significant cash preservation actions during the past few months and expects to have cash runway into Q3/2024. Faron’s incoming Chief Executive Officer, Dr. Juho Jalkanen, says: “I want to truly thank all our vendors, employees, IPF and everybody involved. These decisions and actions are never easy, but it really feels like a true group effort that has come together to back the development of bexmarilimab for HMA-failed MDS. We are deeply grateful”. Dr. Jalkanen will start in his new position on 1 May 2024.

 

The Company continues its active endeavors to secure its longer-term funding that would take bexmarilimab into a pivotal trial post the US Food and Drug Administration’s advice and partnership for commercialization. As previously announced the Company is planning to publish initial data from the ongoing Phase II part of the BEXMAB trial, evaluating the safety and efficacy of bexmarilimab in combination with standard of care in patients with hypomethylating agents refractory or relapsed myelodysplastic syndrome (MDS), during the week commencing 20 May 2024.

 

 

For more information please contact:

Faron Pharmaceuticals

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

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 Faron Pharmaceuticals Oy 

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 targeting 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 and as a monotherapy in last line solid cancers. Further information is available at www.faron.com.

 

 

BEXMAB study update

Faron Pharmaceuticals Oy

(“Faron or Company”)

 

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

 – BEXMAB Study Update

 

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

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

Inside information

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

 The responses from these patients are further defined as:

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

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

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

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

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

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

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

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

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

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

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

About BEXMAB

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

About Faron Pharmaceuticals Ltd. 

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with solid tumors and hematologic malignancies, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated by the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

Forward-Looking Statements

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

 

BEXMAB Study Update

Faron Pharmaceuticals Oy

(“Faron” or “Company”)

 

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

 – BEXMAB Study Update

 

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

 

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

Inside information

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

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

 

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

 

 

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Yrjö Wichmann

VP, Investor Relations and Funding

Yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979
 

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

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

 

About BEXMAB

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

 

About Faron Pharmaceuticals Ltd. 

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

 

Forward Looking Statements

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

 

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Faron Announces US Food and Drug Administration and Finnish Medicines Agency Approval to Initiate Phase I/II Bexmarilimab Combination Study in Hematologic Malignancies

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Faron Announces US Food and Drug Administration and Finnish Medicines Agency Approval to Initiate

Phase I/II Bexmarilimab Combination Study in Hematologic Malignancies

 

  • Phase 1 dose escalation study will evaluate the safety and tolerability of combination therapy and determine the recommended dose for Phase 2 expansion
  • Patient recruitment will commence in the coming weeks
  • Supporting pre-clinical bexmarilimab hematology data was presented at recent European Hematology Association 2022 Congress
     

Company Announcement, May 16, 2022 at 09:00 AM (EEST) / 07:00 AM (BST) / 2:00 AM (EDT) 

 

TURKU, FINLAND / BOSTON, MA Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces that both the U.S. Food and Drug Administration (FDA) and Finnish Medicines Agency (FIMEA) have cleared Faron’s Investigational New Drug (IND) application to begin the Company sponsored BEXMAB study. BEXMAB is a novel Phase I/II study to assess safety, tolerability and preliminary efficacy of bexmarilimab, Faron’s wholly-owned investigational precision cancer immunotherapy, in combination with standard of care (SoC) therapy in patients with relapsed acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CML). This marks the first time bexmarilimab will be assessed as part of a clinical study in hematologic malignancies.

 

“We are pleased that our IND application was cleared to proceed, and we can further explore the strong scientific rationale for combining bexmarilimab and azacitidine.” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “Research has shown a clear survival benefit among certain blood cancer patients with low Clever-1 expression, a receptor known to be expressed on immunosuppressive macrophages in the tumor microenvironment. By adding bexmarilimab to standard of care we expect to downregulate Clever-1 expression, thereby increasing antigen presentation and allowing the immune system to better identify and kill cancer cells.”

 

The primary objective of the BEXMAB study is to determine the safety and tolerability of bexmarilimab in combination with SoC treatment and to identify the recommended Phase 2 dose. Secondary objectives include characterizing the pharmacokinetic profile of bexmarilimab in combination with SoC treatment (azacitidine) and to assess the immunogenicity of bexmarilimab. Based on initial safety data, there is potential for Phase II expansion and to include a first line triplet therapy of bexmarilimab, azacitidine and venetoclax in newly diagnosed AML patients who are not able to tolerate chemotherapy. Patient recruitment is expected to begin in the coming weeks.

 

“We know from pre-clinical research, some of which was presented recently at EHA, that certain blood cancer cells, especially with myeloid background, carry significant amounts of cell surface Clever-1,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “This corresponds with the presence of considerable amounts of soluble Clever-1, which limits T cell activation leading to a possible systemic loss of immune capacity. Directly targeting Clever-1 could ignite the immune system, limit the replication capacity of cancer cells, and allow current chemotherapy treatments to be more effective.”

 

In addition to the BEXMAB study focused on hematologic malignancies, Faron is also investigating bexmarilimab in solid tumors. The ongoing Phase I/II MATINS clinical trial is assessing bexmarilimab as a potential monotherapy in late-stage, heavily pre-treated patients across multiple tumor types. Additionally, the Company expects to initiate a trial assessing the safety and tolerability of bexmarilimab in combination with an approved anti-PD-1 molecule in multiple solid tumors later this year.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. In mouse models, bexmarilimab has successfully blocked or silenced Clever-1, activating antigen presentation and promoting interferon gamma secretion by leukocytes. Additional pre-clinical studies have proven that Clever-1, encoded by the Stabilin-1 or STAB-1 gene, is a major source of T cell exhaustion and involved in cancer growth and spread. Observations from clinical studies to date indicate that Clever-1 has the capacity to control T cell activation directly, suggesting that the inactivation of Clever-1 as an immune suppressive molecule could be more broadly applicable and more important than previously thought. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

 

About Faron Pharmaceuticals Ltd

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

 

Forward Looking Statements

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

 

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

 

US rights to patent related to Traumakine

 Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron secures U.S. rights to patent related to Traumakine 

Company announcement, 14 May 2021 at 9.00 AM (EEST)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that it has signed a sub-license agreement for the rights to U.S. patent US9,376,478, which currently extends to 2033.

The agreement clarifies Faron’s intellectual property position in the U.S. ahead of any launch of Traumakine for the treatment of capillary leak and systemic inflammatory response syndromes (SIRS) including acute respiratory distress syndrome (ARDS) in the U.S. (subject to marketing approval from the U.S. Food and Drug Administration).  Faron will pay a small signing-fee, as well as single-digit standard market royalties from future sales of its intravenous (IV) IFN beta-1a (Traumakine) in the U.S.  This sub-licence specifically covers a manufacturing patent valid only in the U.S. (no corresponding patents exist in other countries) and adds to Faron’s existing comprehensive patent portfolio for Traumakine which includes use and IV formulation patents, as well as market exclusivity in Europe as an orphan medicine.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are pleased to agree this sub-licence. We continue to believe in Traumakine’s potential as a much-needed new treatment for respiratory failure and organ protection.

“Several recent publications have connected type 1 IFN with the severity of COVID-19 infections1,2. Multiple associations have been drawn across the literature including deficiency of type 1 IFN3; inborn errors of IFN-beta signalling4; and the presence of auto-antibodies that neutralise the protective effect of type 1 IFN in viral infections5. Patients who do not have an early IFN response appear to develop severe disease irrespective of the underlying reason for the deficiency2,6. The continued further evidence supports the hypothesis that COVID-19 patients may become very ill because of an impaired interferon response.

“The administration of IFN is likely to benefit patients and relieve them from the hyper-inflammatory state that leads to severe disease3,7,8. We believe intravenous administration of IFN-beta is the optimal route9 to compensate for this loss of first line viral defence and, in tandem induce CD73 a critical enzyme in organ protection during severe illness10.”

References:

  1. C. Turk et al. Eur Rev Med Pharmacol Sci 10.26355/eurrev_202008_22660 (2020)

  2. V. Feuillet et al. Trends in Immunology. 10.1016/j.it.2020.11.003 (2021)
  3. J. Hadjadj et al. Science 10.1126/science.abc6027 (2020)
  4. Q. Zhang et al. Science 10.1126/science.abd4570 (2020)
  5.  P. Bastard et al. Science 10.1126/science.asd4585 (2020)
  6. L. Walz et al. BMC Infect Dis 10.1186/s12879-020-05730-z (2020)
  7. Z. Wang et al. Sig Transduct Target Ther. 10.1038/s41392-020-00306-4 (2020)
  8. G. Schreiber et al. Front. Immunol. 10.3389/fimmu.2020.595739 (2020)
  9. J. Jalkanen et al Crit Care. 10.1186/s13054-020-03048-5
  10. Hanidziar and Robson Am J Physiol Lung Cell Mol Physiol 10.1152/ajplung.00304.2020 (2021)

For more information please contact:

 

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Peel Hunt LLP, Broker

Dr Christopher Golden, James Steel        

Phone: + 44 (0)20 7418 8900

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner,  Mark Rogers

Phone. +44 (0)20 7213 0880      

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel

Phone: +1 212 362 1200

Email: julie.seidel@sternir.com

 

About Faron Pharmaceuticals Ltd

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

Caution regarding forward looking statements

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product.  In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based. 

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