Faron, etusivu

Results of Placing

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS IT FORMS PART OF UK DOMESTIC LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”).

 

 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Inside Information: Announcement of the Results of 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 26 October 2023 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.

 

Company announcement, 27 October 2023 at 7:00 a.m. GMT / 9:00 a.m. EEST

Inside information

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), a clinical stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, announces today that the Bookbuild, announced on 26 October 2023, is now closed. The Placing comprises of the issuance of 2,491,998 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 2.85 per Placing Share. The Issue Price represents a 14.8% discount to the close price on 26 October 2023 on NASDAQ Helsinki First North Growth and a 11.8% premium to the last share issue completed on 29 June 2023. The payment and settlement (delivery against payment of the Issue Price in full) of the Placing Shares is expected to be completed on or about 31 October 2023. Carnegie Investment Bank AB (publ), Finland Branch (“Carnegie”) acted as sole bookrunner and lead manager in the Placing.

 

The Placing Shares conveyed to investors amount to approximately 3.8% of the issued shares and votes in the Company, immediately prior to the Placing. The Company has raised aggregate gross proceeds of approximately EUR 7,1 million in the Placing. The Placing was supported by new investors and existing shareholders such as local long-only institutional investors and family offices, and Mr. Timo Syrjälä. With these proceeds and the current level of activities the Company has sufficient working capital into Q2 2024.

 

“This fundraising is pivotal and comes at an exciting time for Faron. As we enter a new phase of the BEXMAB clinical trial, it was important to raise funds to provide a cash runway into the second quarter of 2024.” said Jim O’Brian, Chief Financial Officer of Faron. “We would like thank 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 accelerate and expand the clinical development of the Company’s main drug candidate, bexmarilimab. The proceeds will also be used to advance bexmarilimab commercial scale production, to support general corporate purposes and other pipeline development, and to strengthen the Company’s balance sheet. Raising of at least EUR 3.0 million was also required to secure that the Company meets all its financial and operational covenants by 27 October 2023, as per agreed waivers with IPF Partners.

 

A total of 2,491,998 Placing Shares have been issued and registered in the Finnish Trade Register today on 27 October 2023. Following the issuance, the aggregate number of ordinary shares in the Company is 68,738,520. As a part of the Placing, the 2,491,998 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 31 October 2023. 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 68,738,520 (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 30 October 2023.

 

Related Party Transaction

Timo Syrjälä, an existing shareholder in the Company, has subscribed for 350,000 Placing Shares in aggregate, for an aggregate subscription value of EUR 997,500 at the Issue Price. Following the Placing, Mr. Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme Investments SPF Sarl (“Acme“), an entity wholly owned by Mr. Syrjälä, will be 13,410,336 shares, representing 19.5 % 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 First North Rulebook and the Finnish Limited Liability Companies Act. 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 

 

LifeSci Advisors 

Daniel Ferry 

Managing Director 

daniel@lifesciadvisors.com  

+1 (617) 430-7576 

Faron Pharmaceuticals

Yrjö Wichmann

VP, Investor Relations and Funding

yrjo.wichmann@faron.com
Phone: +358 (0) 40 5868 979

 

Cairn Financial Advisers LLP, Nominated Adviser

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

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

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 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 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. 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.

Results of Placing 271023

Proposed Issue and Placing

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS IT FORMS PART OF DOMESTIC LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”).

 

 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Inside Information: Proposed Issue and Placing of a minimum of approx. EUR 6.0 million by way of an accelerated book-building

 

 

Company announcement, 26 October 2023 at 4:30 p.m. GMT / 6:30 p.m. EEST

Inside information

 

KEY HIGHLIGHTS

  • A proposed private placement of newly issued treasury shares (“Placing Shares”) to raise approximately EUR 6.0 million, to be conducted by way of an accelerated book-building, directed to a limited number of institutional and other investors.
  • The minimum amount to be raised is approximately EUR 6.0 million. Subject to the Company raising the minimum amount, the Company will have sufficient funding for its working capital needs into Q1 2024 and be able to meet its financial and operational covenants by 27 October 2023, (with a minimum of EUR 3.0 million needed to meet the covenant as per agreed waivers with IPF Partners). The total cash and cash equivalents held by the Company was ca. EUR 6.3 million as of 30 June 2023 and ca. EUR 6.1 million as of 30 September 2023, respectively.
  • Significant majority of the net proceeds of the placing would be used for the acceleration of the bexmarilimab clinical development program and manufacturing.
  • Carnegie Investment Bank AB (publ), Finland Branch (“Carnegie”) is acting as sole bookrunner and lead manager in the placing.

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), a clinical stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces a proposed private placement to raise a minimum of approximately EUR 6.0 million before expenses to a limited number of institutional and other selected investors (“Placing”). Carnegie is acting as sole bookrunner and lead manager 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. EEST on 27 October 2023 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 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 accelerate our ambitious bexmarilimab development program. The emerging data from Phase 1/2 study has continued to be extremely promising, showing continued good safety, encouraging efficacy and long durations of response,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “These results strongly support the planned next step of beginning enrollment of the Phase 2 part of the BEXMAB study. We also believe that bexmarilimab has the potential to provide better patient outcomes and improve the quality of life of those suffering from relapsed/refractory AML and MDS, which are conditions with dire prognosis and limited new therapies in the last decades.”

 

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 of drug candidates and to strengthen the financial position of the Company. Raising at least EUR 3.0 million is required to secure that the Company meets all its financial and operational covenants by 27 October 2023, as per agreed waivers with IPF Partners.

 

Should the Company raise approximately EUR 6.0 million, the Company would have sufficient funding for its working capital needs into Q1 2024. The Company intends to use the proceeds of the Placing for the following:

  • BEXMAB program (approx. 29%)
    • Initiation of Phase 2
    • Opening 5 new sites in the US
    • Full Phase 1 data readout
  • Bexmarilimab CMC (approx. 38%)
    • First commercial scale production batch of Bex (2000 L)
  • Other clinical development (approx. 5%)
  • G&A (approx. 15%)
  • Financing (approx. 13%)

 

The use of proceeds from the Placing above is based on streamlined focus on BEXMAB study and resulted in significant cost savings.

 

Under the terms of the facilities arrangement with IPF Partners, the Company is required to maintain a minimum cash

balance of EUR 6.0 million while maintaining three months cash runway. Faron will commence monthly amortisations of the IPF facility at the end of October 2023 with 4.5% PIK interest added to the monthly amortisation instead of earlier agreed quarterly amortisations with no PIK interest payable.

 

DETAILS OF THE PROPOSED PLACING AND ISSUE OF EQUITY

 

  • Faron intends to raise a minimum of approximately EUR 6.0 million by offering Placing Shares to a limited number of domestic and international institutional and other selected investors in the Placing. The Company has an authorization to offer a maximum of 9,298,490 Placing Shares in the Company.
  • With the minimum amount of approximately EUR 6.0 million, the Placing Shares issued would correspond to at least approximately 2.7 % of all the shares and voting rights in the Company immediately prior to the Placing.
  • Subject to the Company raising the minimum amount of approximately EUR 6.0 million, the Company will have sufficient funding for its working capital needs until Q1 2024.
  • IPF has agreed to waive certain covenants under the terms of the facilities agreement until completion of the Placing, subject to the Company raising a minimum of EUR 3.0 million by 27 October 2023, amongst other conditions. Under the terms of the facilities arrangement with IPF, the Company is required to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash runway.
  • The Placing Shares will be offered by way of an accelerated book building process to institutional investors outside of the U.S. in accordance with Regulation S of the U.S Securities Act and in a private placement in the U.S. to a limited number of qualified institutional buyers, or QIBS, pursuant to an exemption from registration under the U.S. Securities Act.
  • The Company has entered into a lock-up undertaking for a period of 90 days with customary and certain other exemptions, including the possibility to issue further shares provided that Carnegie is provided reasonable notice and consultation, any such further issue is at least at the prevailing market price taking into account customary and market standard discount and other terms, is made to qualifying long-only investors and is within the existing authorities granted at the Company’s Annual General Meeting held on 24 March 2023 (taking into account the authorities used in connection with the contemplated Placing). The Company’s existing authorities, without factoring in the authorities used in connection with the proposed Placing, equate to the conveyance of up to 9,298,490 shares in total.
  • Carnegie acts as sole bookrunner and lead manager.

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 24 March 2023 to issue up to a total of 12,500,000 new ordinary shares in the Company as well as to convey up to the same maximum number (12,500,000) 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 2,601,510 new ordinary shares have been issued and conveyed by the Company and up to 600,000 new shares are reserved for share issuances based on the exercise of warrants pursuant to the funding arrangement entered into by Faron with IPF Partners, as disclosed on 28 February 2022. Therefore, pursuant to the outstanding authority, the Company may issue and further convey up to a maximum of 9,298,490 ordinary shares, which represents approximately 14.0 per cent of all the issued shares and votes in the Company immediately prior to the Placing.

 

The Placing, arranged by Carnegie, 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. 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 a.m. EEST on 27 October 2023 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 (the “Placing Agreement“). Pursuant to the terms of the Placing Agreement, the sole bookrunner has agreed to use its reasonable endeavours to procure the subscription of Placing Shares.

 

The Placing Agreement contains customary warranties and an indemnity from the Company in favour of the sole bookrunner. The Placing Agreement also contains provisions which enable the sole bookrunner 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 sole bookrunner certain commissions and fees in connection with the Placing. Pursuant to the terms of the Placing Agreement, the sole bookrunner 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 sole bookrunner 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.

In connection with the Placing, Faron has entered into a lock-up undertaking for a period of 90 days with customary and certain other exemptions, including the possibility to issue further shares provided that Carnegie is provided reasonable notice and consultation, any such further issue is at least at the prevailing market price taking into account customary and market standard discount and other terms, is made to qualifying long-only investors and is within the existing authorities granted at the Company’s Annual General Meeting held on 24 March 2023 (taking into account the authorities used in connection with the contemplated Placing). The Company’s existing authorities, without factoring in the authorities used in connection with the proposed Placing, equate to the conveyance of up to 9,298,490 shares in total.

Subject to all conditions being met, the Placing Shares are expected to be entered in the Finnish Trade Register approximately on 27 October 2023.

 

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 30 October 2023 (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, US  

LifeSci Advisors 

Daniel Ferry 

Managing Director 

daniel@lifesciadvisors.com 

+1 (617) 430-7576 

 

Investor Contact, EUR

Faron Pharmaceuticals

Yrjö E K Wichmann

SVP, Investor Relations

yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979

 

Cairn Financial Advisers LLP, Nomad

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

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON PHARMACEUTICALS OY (“FARON”) PURSUANT TO THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT. THIS ANNOUNCEMENT IS THEREFORE DIRECTED ONLY AT, IF 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 IT FORMS PART OF  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, 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. ANY SALE OF THE PLACING SHARES IN THE UNITED STATES WILL BE 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 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 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. Further information is available at www.faron.com.

 

 

IMPORTANT INFORMATION

 

Market Abuse Regulation

Market soundings, as defined in 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 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.

 

 

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.

20231026_Onas Launch Announcement

Faron Announces Positive BEXMAB Study Update

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

 

Inside information: Faron Announces Positive BEXMAB Study Update in Relapsed/Refractory AML and HMA-Refractory MDS Patients

 

      Bexmarilimab produces a 50% remission rate in doublet dose cohorts (11 out of 22 patients)

      Eight of the 11 patients are Complete Responders (CR) or CR with incomplete blood recovery (CRi)

      Highest overall response rate (ORR) of 80% observed in prior HMA-failure MDS group (4 out of 5 patients)

      Bexmarilimab continues to be well-tolerated with no dose-limiting toxicity observed

      Company to host virtual investor call to discuss data, today at 8:00 am EST

 

Company announcement, Inside Information

TURKU, Finland / BOSTON, Massachusetts – October 11, 2023 – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces updated data from the Phase 1/2 BEXMAB study investigating bexmarilimab in combination with standard of care (SoC) in relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients having failed hypomethylating agents (HMAs).

The updated data are consistent with the high objective response rate observed in the previous results. The most recent data includes read outs from a total of 22 patients (r/r AML with 12 patients, MDS frontline and MDS HMA-failed patients with five patients each) who have completed at least two or more treatment cycles. Eight of 11 patients achieved complete remission in the bone marrow with or without blood count recovery.

The highest single indication-specific ORR was observed among HMA-failed MDS patients (4 out of 5 patients; 80%). The combined study ORR continues to be high (11 out of 22 patients; 50%) across all patient groups having received two or more treatment cycles in the doublet. In most patients (75%), blast reduction was observed. A total of 29 patients have been recruited into the doublet cohort as of October 5, 2023.

Bexmarilimab continues to be well-tolerated at all tested dose levels as no dose-limiting toxicity has been observed. A total of 18 drug-related events were observed with the majority below Grade 3. Five drug-related events were reported as Grade 3 and above, including immune-related events (capillary leak syndrome, hemophagocytic lymphohistiocytosis and cryptogenic organizing pneumonia), as well as one event of increased liver enzymes.

“The emerging data from Phase 1/2 continue to be extremely promising, showing continued good safety, encouraging efficacy and long durations of response,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “These results strongly support the planned next step of beginning enrollment of the Phase 2 part of the BEXMAB study.”

Dr. Jalkanen continued: “We believe that bexmarilimab has the potential to provide better patient outcomes and improve the quality of life of those suffering from relapsed/refractory AML and MDS, which are conditions with dire prognosis and limited new therapies in the last decades.”

 

Faron plans to initiate the Phase 2 part of the BEXMAB study in HMA-failed MDS and r/r AML patients in Q4 2023. Consistent with the FDA’s Project Optimus initiative, the planned Phase 2 will start with dose optimization and is expected to enroll 28-32 patients randomized between two selected doses. Faron plans to increase the number of US clinical sites from two to five sites to accelerate study recruitment. For more information on BEXMAB, please visit ClinicalTrials.gov and reference Identifier NCT05428969.

 

Faron will host a virtual call for investors to discuss the data today at 08.00 EST/13.00 BST/15.00 EEST. There will also be an opportunity to ask questions during the webcast. To register for the webcast, please visit: https://faron.videosync.fi/recent-bexmab-results-and-future-outlook-event or contact the IR team for more information at investor.relations@faron.com.

 

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

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

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 BEXMAB

The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment 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 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 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. Further information is available at www.faron.com.

Forward-Looking Statements

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

 

Faron Announces Positive BEXMAB Study Update in Relapsed Refractory AML and HMA-Refractory MDS Patients

Board Changes

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

 

 

Board Changes

 

 

Company announcement, September 22, 2023

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, is pleased to announce the appointment of Ms. Christine Roth and Dr. Marie-Louise Fjällskog as Non-Executive Directors of the Company with immediate effect following the passing of all resolutions put to shareholders of the Company at the Extraordinary General Meeting held earlier today. 

 

Christine Ann Roth – Non-Executive Director

 

Ms. Christine Roth is a pharmaceutical executive with over three decades of experience in the industry. She has played key roles in the development and launch of several therapies, including the first immune-oncology therapy and intentionally designed targeted therapy combinations. Her career includes leadership positions at major pharmaceutical companies, such as Novartis, Bristol-Myers Squibb, GlaxoSmithKline (GSK), and most recently, Bayer AG, where she serves as the Executive Vice President of the Oncology Strategic Business Unit focussing on precision molecular oncology, next-generation immuno-oncology medicines, and radioligand therapies. At GSK, she was responsible for the rebuild of the oncology business, including the integration of assets following the acquisition of Tesaro. Ms. Roth’s expertise extends across various therapy areas, including Oncology, Cardiovascular, Metabolic, and Infectious Diseases. She is actively involved in industry associations, such as the American Society of Clinical Oncology and the American Society of Hematology. She holds a Bachelor’s degree in Chemistry from the University of North Carolina at Chapel Hill.

 

The following information regarding the appointment of Ms Christine Ann Roth (aged 60), is disclosed under Schedule 2(g) of the AIM Rules for Companies and Nasdaq First North Growth Market Rulebook.

 

Current positions, directorships and/or partnerships:

 

Former positions, directorships and/or partnerships (within the last five years):

Vividion Therapeutics, Inc

 

 

Ms Roth does not hold any ordinary shares or options over new ordinary shares of the Company.

 

Save as set out above, no further information regarding Ms Roth is required to be disclosed pursuant to the AIM Rules for Companies or Nasdaq First North Growth Market Rulebook.

 

Dr. Marie-Louise Helena Fjällskog – Non-Executive Director

 

Dr. Marie-Louise Fjällskog is a professional with extensive experience in the pharmaceutical and biopharmaceutical industry, particularly in the field of clinical oncology, translational research, and drug development. She holds an MD degree and a Ph.D. from Uppsala University, Sweden, and is an Associate Professor of Oncology at the same institution. With over 25 years of clinical experience, Dr. Fjällskog has made significant contributions to the development of targeted therapies for cancer. She has held key roles in various pharmaceutical companies, such as Sensei Biotherapeutics, Merus, and Infinity Pharmaceuticals, where she led clinical development programs and played instrumental roles in their success, including Sensei’s $152 million IPO in 2021. Her extensive expertise and leadership have also earned her a position on the board of Biovica International AB, a prominent biotech company in Sweden and in the US, respectively. She is also on the board of Norwegian company Lytix Biopharma.

 

In January 2022, Dr. Fjällskog assumed the role of Chief Medical Officer at Faron where she lead Faron’s clinical development programs, particularly the bexmarilimab program. Dr. Fjällskog stepped down from the CMO role on September 21, 2023.

 

The following information regarding the appointment of Marie-Louise Helena Fjällskog (aged 58), is disclosed under Schedule 2(g) of the AIM Rules for Companies and Nasdaq First North Growth Market Rulebook.

 

Current positions, directorships and/or partnerships:

 

Former positions, directorships and/or partnerships (within the last five years):

Biovica Inc

None

Biovica International AB

 

Lytix Biopharma AS

 

 

Dr. Fjällskog does not hold any ordinary shares of the Company, but she has been granted 180,000 options over new ordinary shares of the Company, of which 35,000 has vested.

 

Save as set out above, no further information regarding Dr. Fjällskog is required to be disclosed pursuant to the AIM Rules for Companies or Nasdaq First North Growth Market Rulebook.

 

“I am pleased to welcome Ms. Roth and Dr. Fjällskog to the Faron Board as Non-Executive Directors,” said Dr. Frank Armstrong, Chairman of the Board of Faron Pharmaceuticals. “Their combined executive experience in the oncology field and medical expertise will greatly support the advanced of bexmarilimab, Faron’s wholly owned, investigational immunotherapy, in clinical development.”

 

 

For more information please contact:

 

Investor Contact

 

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

 

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

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 targeting myeloid cell function. Bexmarilimab is being investigated in a Phase I/II clinical trial as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com.

 

Forward-Looking Statements

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

 

Board Changes 220923

Results of EGM

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Results of

the Extraordinary General Meeting

 

Company Announcement, September 22, 2023

 

TURKU – FINLAND / BOSTON, MA, September 22, 2023 – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, announces that the extraordinary general meeting (the “EGM”) of the Company took place today, September 22, 2023 in Turku, Finland. The EGM approved all proposals of the Board of Directors (“Board”) as set out in the notice of the EGM published on September 1, 2023.

 

Decisions of the EGM

 

Composition of the Board

 

The number of members of the Board was confirmed as seven. Christine Roth and Marie-Louise Fjällskog were elected as new members to the Board for a term that ends at the end of the next annual general meeting. Following the election, the Board of the Company comprises of the following members: Frank Armstrong (Chair), Marie-Louise Fjällskog, Markku Jalkanen, Erik Ostrowski, John Poulos, Tuomo Pätsi and Christine Roth.

 

Amendment of the Option Plan 2015

 

The EGM resolved to amend the terms and conditions of the option programme adopted by the Company’s extraordinary general meeting on September 15, 2015, which has later been amended by the decision of the annual general meetings held on May 16, 2017, May 18, 2020 and April 23, 2021 (the “Option Plan 2015”) so that the subscription period for shares based on the options is extended by two (2) years, i.e., until 30 September 2025. The amendment applies to all options under the Option Plan 2015 (A options, B options, C options and D options). The terms and conditions of the Option Plan 2015 remains otherwise unchanged.

 

Minutes of the EGM

 

The minutes of the EGM will be available on the Company’s website from October 5, 2023 at the latest.

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

 

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 targeting myeloid cell function. Bexmarilimab is being investigated in a Phase I/II clinical trial as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com. 

 

Forward-Looking Statements

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

 

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based. 

 
 

 

230922 Results of EGM

Faron Appoints Interim Chief Medical Officer

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

 

Faron Appoints Dr. Birge Berns, MD as Interim Chief Medical Officer

 

      Dr. Marie-Louise Fjällskog, outgoing CMO, is proposed to continue key role in bexmarilimab’s development as a Board member

 

Company announcement, September 21, 2023  

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces the appointment of Dr. Birge Berns, MD, as the Company’s interim Chief Medical Officer (CMO). Dr. Berns will be based in the UK and her appointment is effective starting September 22, 2023.

 

Dr. Berns succeeds Dr. Marie-Louise Fjällskog, who is stepping down from her current CMO role at Faron. The Board of Directors have proposed to the Extraordinary General Meeting of the Company convened for tomorrow, Friday, September 22, 2023, that Dr. Fjällskog would be nominated to the Company’s Board of Directors in a Non-Executive Director role. In this new role as a Non-Executive Director, Dr. Fjällskog would continue to play an integral role in the development of Faron’s wholly owned immunotherapy asset, bexmarilimab, providing her clinical and regulatory expertise to support the Company’s progress. 

 

Dr. Berns is a seasoned senior pharmaceuticals executive with a background in oncology, clinical medicine, rheumatology and immunology. She brings more than 25 years’ experience from senior leadership roles in global pharmaceutical companies, including Sanofi Aventis and Johnson & Johnson.

 

“I am delighted to welcome Birge to Faron as the interim Chief Medical Officer as we progress our ambitious clinical development program for bexmarilimab,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “With her extensive experience in oncology clinical development, her business acumen and broad scientific and medical knowledge, she is exceptionally well qualified to advance our plans and progress development of what we hope will be the first macrophage-targeting immunotherapy for patients with aggressive hematological malignancies.

 

“I am also very pleased that Faron will continue to benefit from the support of Marie-Louise, in her proposed new role as the Board member and would like to thank her for her great contributions to this Company’s progress, during her time as Chief Medical Officer.”

 

While at Johnson & Johnson, Dr. Berns established and led the European clinical hemato-oncology group for Centocor, the J&J Immunology group, devising early development strategies for biological molecules in a wide range of oncology indications, and writing the supporting clinical and regulatory documents. She maintains close ties with the Institute of Cancer Research/Royal Marsden Hospital in the UK where she obtained her Master’s degree in Oncology and continues to teach on this course.

Dr Berns is currently VP, Head of Clinical Development & Regulatory Strategy at tranScrip Limited, a strategic drug development partner that provides bespoke drug development services to pharma clients. She also serves as Chair of the Policy & Communication Group of the Faculty of Pharmaceutical Medicine, UK.

 

“Bexmarilimab has the potential to usher in a new era of cancer treatment for patients in relapses/refractory acute myeloid leukemia and myelodysplastic syndromes that face scant treatment options,” said Dr. Berns. “With my long-standing expertise in all aspects of early and late-stage drug development, including strategic, clinical, regulatory and market access, I am keen to apply my skillset to accelerate the development of bexmarilimab.”

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

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 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. Further information is available at www.faron.com.

 

Forward-Looking Statements

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

 

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

 

 

 

Faron Appoints Dr. Birge Berns, MD as Interim Chief Medical Officer 210923

Change in the Board of Directors

Faron Pharmaceuticals Ltd.
(“Faron” or the “Company”)

Change in the Board of Directors

Company announcement, September 8, 2023

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces that its non-executive Board member, Anne Whitaker, has notified the Company of her intention to step down from the Board of Directors from September 22, 2023, by the end of the Company’s Extraordinary General Meeting (“EGM”), due to her new executive role at another company.

Subject to the proposed election of Dr. Marie-Louise Fjällskog and Christine Roth to the Board of Directors at the forthcoming EGM and to regulatory approval, the Directors of the Company will be as follows:

  • Frank Armstrong (Chair)
  • Marie-Louise Fjällskog
  • Markku Jalkanen
  • Erik Ostrowski
  • John Poulos
  • Tuomo Pätsi
  • Christine Roth

For more information please contact:

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

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 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. Further information is available at www.faron.com.

Forward-Looking Statements

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

230907 Change in the Board of Directors FINAL

NOTICE OF FARON PHARMACEUTICALS LTD’S EXTRAORDINARY GENERAL MEETING

NOTICE OF faron pharmaceuticals LTD’s extraordinary GENERAL MEETING

Shareholders of Faron Pharmaceuticals Ltd (the “Company”) are notified of the Extraordinary General Meeting to be held on September 22, 2023 at 9:00 a.m. EEST (Finnish time) at BioCity, meeting room “Ministeri” at Tykistökatu 6, FI-20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 8:30 a.m. EEST (Finnish time).

The Board of Directors of the Company (the “Board”) has resolved to convene the Extraordinary General Meeting to resolve on the election of new members of the Board and to resolve on the amendment of the Company’s Option Plan 2015.

  1. MATTERS ON THE AGENDA OF THE EXTRAORDINARY GENERAL MEETING

 

  1. Opening of the meeting

 

  1. Calling the meeting to order

 

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

 

  1. Recording the legality of the meeting

 

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

 

  1. Resolution on the number of members of the Board 

 

The Board proposes, based on the proposal of the nomination committee, that the number of the members of the Board would be resolved to be seven (7). 

 

  1. Election of new members of the Board 

 

The Board proposes, based on the proposal of the nomination committee, that Christine Roth and Marie-Louise Fjällskog be elected as new members to the Board for a term that ends at the close of the next Annual General Meeting.

 

Christine Roth, citizen of the United States, currently serves as an Executive Vice President for Bayer Pharmaceuticals’ Global Oncology Business Unit and a member of the board of directors of Vividion Therapeutics. She is independent of the Company and its significant shareholders.

 

Marie-Louise Fjällskog, a citizen of Sweden and the United States, currently serves as Faron Pharmaceuticals Ltd’s Chief Medical Officer. She is non-independent of the Company, but she is independent of its significant shareholders.

 

Christine Roth and Marie-Louise Fjällskog have given their consent for the election. A description of both Board member candidate is available on the Company’s website at https://www.faron.com/investors/general-meetings.

 

  1. Resolution on the amendment of the Option Plan 2015 

 

The Company’s Extraordinary General Meeting has on September 15, 2015 adopted the terms and conditions of an option programme which have later been amended by the decisions of the Company’s Annual General Meetings held on May 16, 2017, May 18, 2020 and April 23, 2021 (the “Option Plan 2015”). The subscription period for shares based on options is currently scheduled to end on September 30, 2023. The Board proposes that the EGM resolves to amend the terms and conditions of the Option Plan 2015 so that the subscription period for shares based on the options is extended by two (2) years, i.e., until September 30, 2025. For the sake of clarity, it is noted that the proposal applies to all options under the Option Plan 2015 (A options, B options, C options and D options). The Board deems that the proposed amendment will enhance the usability of the options and thereby significantly increase the desired benefits of the incentivisation system for the management and personnel of the Company.

 

The consolidated terms and conditions of the Option Plan 2015, incorporating the amendments proposed herein, are attached hereto.

 

  1. Closing of the meeting

 

  1. DOCUMENTS OF THE EXTRAORDINARY GENERAL MEETING

The above-mentioned proposals to the Extraordinary General Meeting, the Company’s Annual Report 2022 including the financial statements, the Report of the Board of Directors and the Auditor’s Report, the Company’s Half-Year Financial Results January 1 – June 30, 2023, the statement by the Board of Directors on events after the preparation of the half-year financial results with a material effect on the Company and this notice are available on the Company’s website at https://www.faron.com/ as of the date of publication of this notice. The Board’s proposals and the other above-mentioned documents will also be available at the Extraordinary General Meeting. Copies of these documents will be sent to shareholders upon request. The minutes of the Extraordinary General Meeting will be available on the Company’s website from October 6, 2023 at the latest.

  1. INSTRUCTIONS FOR THE PARTICIPANTS

 

  1. The right to participate and registration

Each shareholder who on the record date of the Extraordinary General Meeting, being September 12, 2023, is registered in the Company’s shareholders register held by Euroclear Finland Oy has the right to participate in the Extraordinary General Meeting. A shareholder whose shares are registered on their personal Finnish book-entry account is registered in the Company’s shareholders register. If you do not have a Finnish book-entry account, see section C3 “Holder of nominee-registered shares (including depositary interest holders)”.

A shareholder who is registered in the Company’s shareholders register and who wants to participate in the Extraordinary General Meeting should register for the meeting by no later than 10:00 a.m. EEST (Finnish time) on Tuesday, September 19, 2023 by giving a prior notice of participation:

•          by email to general.meeting@faron.com or

•          by mail to Faron Pharmaceuticals Ltd, attn. Kaisa Kyttä, Joukahaisenkatu 6, FI-20520 Turku, Finland.

When registering, a shareholder shall state their name, personal identification number / business identity code, address, telephone number and the name of a possible proxy representative, legal representative or assistant and the personal identification number of the proxy representative or legal representative. The personal data given by shareholders to the Company are used only in connection with the Extraordinary General Meeting and the necessary processing of related registrations.

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

  1. Proxy representative and powers of attorney

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

A shareholder may participate in the Extraordinary General Meeting by means of several proxy representatives, who represent the shareholder with shares held on different book-entry accounts. In such case, the shares represented by each proxy representative shall be identified when registering for the Extraordinary General Meeting.

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

  1. Holder of nominee-registered shares (including depositary interest holders)

A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the Extraordinary General Meeting by virtue of such shares based on which the holder would be entitled to be registered in the Company’s shareholders register held by Euroclear Finland Oy on the Extraordinary General Meeting’s record date of September 12, 2023.

Additionally, participation requires that the holder of nominee-registered shares is temporarily registered in the Company’s shareholders’ register held by Euroclear Finland Oy by 10:00 a.m. EEST (Finnish time) on Tuesday, September 19, 2023. Temporary registration in the shareholders register shall be deemed to be a registration for the Extraordinary General Meeting.

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

  1. Other instructions and information

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

On the date of this notice, 1 September 2023, the total number of shares and votes in the Company is 66 246 522 of which 85 149 shares are pending registration.

The Extraordinary General Meeting shall be held in Finnish, partially translated into in English.

 

Turku, September 1, 2023

FARON PHARMACEUTICALS LTD

Board of Directors

20230830_EGM Notice ENG72

Exercise of options, Directors Dealing, Issue of equity

Faron Pharmaceuticals Ltd.

 

(“Faron”)

 

Exercise of options, Directors Dealing

Issue of equity

 

Company announcement, August 31, 2023 at 14:00 p.m. BST / 16:00 p.m. EEST

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical- stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, announces that it has received notifications from option holders to exercise 2015B options over 18,022 in the Company at an exercise price of EUR 2.90 (approx. GBP 2.48) per share, raising gross proceeds of approx. EUR 52,264 (approx. GBP   44,695)  and 2015D options over 67,127 shares in the Company at an exercise price of EUR 1.09 (approx. GBP 0.93) per share, raising gross proceeds of approx. EUR 73,168 (approx. 62,428), under the Company’s 2015 Option Plan (“New Ordinary Shares”). The terms and conditions of the 2015 Option Plan are available on the Company’s website at

consolidated-terms-and-conditions-of-the-option-plan-2015.pdf (faron.com)
 

As part of the above exercise of 2015D options, John Poulos, Non-Executive Director of the Company, has given notice to exercise options over 20,000 new ordinary shares at exercise price of EUR 1.09 (approx. GBP 0.93). Following this exercise and admission, John Poulos will be interested in 20,000 ordinary shares in the Company, representing 0.03% of the Company’s enlarged issued share capital.

 

The notification below, which has been made in accordance with the requirements of the EU Market Abuse Regulation, provides further detail.

 

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

John Poulos

2

Reason for notification

 

 

 

a.

Position/Status

Non-Executive Director

b.

Initial notification/

Amendment

Initial Notification

3

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

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

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

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

 

b.

Nature of the transaction

Exercise of options to acquire ordinary shares at an exercise price of EUR 1.09 (approx. GBP 0.93)

c.

Price(s) and volume(s)

 

 

 

 

 

 

Price(s)

Volume(s)

 

EUR 1.09 (approx. GBP 0.93)

20,000

 

 

d.

Aggregated information

 

– Aggregated Volume

 

– Price

 

 

 

N/A

e.

Date of the transaction

August 28, 2023

f.

Place of the transaction

AIM & Nasdaq First North Growth Market

 

 

Applications will be made to the London Stock Exchange and Nasdaq Helsinki to admit the New Ordinary Shares to trading on AIM and Nasdaq First North Growth Market, respectively. Admission of the New Ordinary Shares is expected to occur on or around September 11, 2023 following issue and registration of the New Ordinary Shares on or around September 12, 2023 (“Registration”). The New Ordinary Shares will rank pari passu with existing ordinary shares.

 

Faron’s enlarged issued number of shares immediately following Registration will be 66,246,522 ordinary shares with voting rights attached. The Company has no shares in treasury; therefore upon, and subject to, Registration, the total number of voting rights in Faron will be 66,246,522. 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 issued shares and votes of the Company.

 

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 

 

LifeSci Advisors 

Daniel Ferry 

Managing Director 

daniel@lifesciadvisors.com 

+1 (617) 430-7576 

  

Media Contact 

 

Faron Pharmaceuticals 

Jennifer C. Smith-Parker 

Head of Communications 

Jennifer.Smith-Parker@faron.com 

 

Cairn Financial Advisers LLP, Nomad 

Sandy Jamieson, Jo Turner 

Phone: +44 (0) 207 213 0880 

  

Peel Hunt LLP, Broker 

Christopher Golden, James Steel 

Phone: +44 (0) 20 7418 8900 

  

Sisu Partners Oy, Certified Adviser on Nasdaq First North 

Juha Karttunen 

Phone: +358 (0)40 555 4727 

Jukka Järvelä 

Phone: +358 (0)50 553 8990 

 

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 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. Further information is available at www.faron.com. 

 

2023 08 31_RNS_Exercise of options_FINAL1 (002)

Faron 2023 Half-Year Financial Results

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

 

Faron Reports Half-Year Financial Results, January 1 – June 30, 2023

 

Company Announcement, August 29, 2023

 

Summary Highlights (including post-period events)  

 

  • The US Food and Drug Administration (FDA) granted bexmarilimab Orphan Drug Designation (ODD) for the treatment of acute myeloid leukemia (AML).
  • The latest data from the Phase I/II BEXMAB study reinforces bexmarilimab’s potential to improve the therapeutic benefit for patients with aggressive hematological malignancies who do not respond to the current standard of care (SoC).   
  • Compelling data with objective responses were observed in three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort.  
  • Eight of fifteen objective responses were observed across all three doublet dosing cohorts, with one patient still on treatment after 13 months. 
  • Continued efficacy signals with the prolonged duration of responses thus far support advancement to Phase II in Q4 2023 in relapsed/refractory AML and myelodysplastic syndromes (MDS) patients failing hypomethylating agents (HMAs). 
  • New biomarker data presented at the EHA2023 Congress indicates that bexmarilimab’s mode of action in AML/MDS is supported by durable Clever-1 target engagement in the bone marrow. This mechanism results in notable increases in T and NK cells, along with enhanced antigen presentation. 
  • The Phase II BEXCOMBO protocol has been approved by the FDA.
  • The Board was strengthened with the addition of Tuomo Pätsi, and the Leadership team was enhanced with the appointment of James O’Brien, CPA, MBA, as Chief Financial Officer. 
  • Mr. Leopoldo Zambeletti stepped down from the Board to assume a business development consulting role at Faron. 
  • Cash position was strengthened through two private placements directed to institutional and other investors, successfully raising EUR 18.6 million.
  • Virtual briefing and Q&A to be held today at 08:00 am (EDT) / 13:00 pm (BST) / 15:00 pm (EEST).

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces unaudited half-year financial results for January 1 to June 30, 2023 (the “period”).

 

“I am extremely proud of the progress we made in the first half of 2023,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “We continued to execute on advancing our clinical Phase I/II BEXMAB study of bexmarilimab, our wholly-owned immunotherapy asset, in hematological malignancies. To date, we achieved strong objective responses across all three cohorts in relapsed/refractory to SoC patients, including objective responses in three of five patients receiving the high dose. Based on this compelling data, we are advancing into the Phase II portion of the study and actively preparing for regulatory submission in the first half of 2025. The recent  FDA Orphan Drug Designation for bexmarilimab in AML further reaffirms our program by offering important clinical development and commercialization benefits. We also strengthened our cash position and welcomed a former Board member as a transactional advisor. I am excited for what the future holds.”

 

Pipeline Highlights

 

Bexmarilimab – Faron’s wholly-owned, novel precision cancer immunotherapy candidate, in Phase I/II development for relapsed/refractory AML and MDS.

 

  • The FDA has granted ODD for bexmarilimab for the treatment of AML.
  • Updated data from the Phase I/II BEXMAB study showed objective responses (OR) with complete remission of blasts in the bone marrow (mCR) in three of five patients in the 6 mg/kg bexmarilimab + azacitidine cohort. In addition, one of the three patients achieved complete recovery of blood counts i.e., complete remission (CR). 
  • Eight of fifteen ORs were observed across all three doublet dosing cohorts. 
  • Four of the eight patients across the three doublet dosing cohorts (1, 3, and 6 mg/kg) had failed prior SoC hypomethylating agents (HMAs). 
  • All three patients with MDS and prior HMA failure demonstrated ORs (partial response (PR), mCR, and CR) across the dosing cohorts. 
  • Four patients out of six in the triplet dosing cohort treated with azacitidine, venetoclax, and bexmarilimab have shown objective responses. 
  • The updated BEXMAB data supports advancement to Phase II in Q4 2023 in SoC relapsed/refractory AML and MDS patients failing hypomethylating agents (HMA). 
  • Biomarker data presented at the European Hematology Association 2023 Hybrid Congress showed bexmarilimab’s mode of action in AML/MDS is supported with durable Clever-1 target engagement in the bone marrow, with increases observed in T and NK cells, and antigen presentation. 
  • The Company presented two posters at the American Association for Cancer Research Annual Meeting 2023 on its Phase I/II MATINS study of bexmarilimab in solid tumors and published a manuscript via medRxiv. The findings from MATINS, which have established strong foundations for Faron’s ongoing development program, indicate that bexmarilimab monotherapy facilitates macrophage conversion, and induces changes in the tumor microenvironment resulting in disease control and prolonged survival in late-stage cancer. Furthermore,  targeting Clever-1 with bexmarilimab is well-tolerated. A positive Phase I/II meeting with the FDA supported bexmarilimab’s development in solid tumors. 
  • Preparations are ongoing for the initiation of the Phase II BEXCOMBO trial evaluating bexmarilimab with PD-1 blockade, aimed at improving the clinical benefits from standard-of-care PD-1 blockade.  The first, proof-of-concept cohort under the investigation will be in head and neck cancer, followed by bladder and non-small cell lung cancers. Patient cohorts will comprise between 15 and 40 subjects, with the opportunity for subgroup enrichment.  

 

Corporate Highlights

  • The cash position has been strengthened through two private placements directed to institutional and other investors to raise EUR 18.6 million in January 2023 (EUR 12.0 million) and in June 2023 (EUR 6.6 million), which settled in early July 2023.
  • James O’Brien, CPA, MBA, joined as Chief Financial Officer. Mr. O’Brien is an accomplished biotech and financial executive with extensive experience in the US capital markets. His appointment highlights Faron’s progression towards becoming a global biopharmaceutical company.
  • Mr. Tuomo Pätsi joined the Board as a Non-Executive Director of the Company. Dr. Gregory B. Brown stepped down from his position as a Non-Executive Director. Mr. Pätsi was the President of the EMEA region and Worldwide Markets for Celgene Corporation, a global pharmaceutical company and currently wholly owned subsidiary of Bristol Myers Squibb, engaged primarily in the discovery, development, and commercialization of therapies for the treatment of cancer. He is an experienced biotech and pharmaceutical executive who was until recently the Executive Vice President for Seagen Inc., a US-based, cancer-focused biotechnology company.
  • Mr. Leopoldo Zambeletti, who joined Faron’s Board as a Non-Executive Director in September 2015, stepped down to take on a business development consulting role within Faron. He is a highly respected figure within the life sciences and investment banking industries and, since 2013, has been an independent strategic advisor to life science companies on mergers and acquisitions, out-licensing deals, and financing strategy.
     

Half-Year Financial Results

  • Cash balances of EUR 6.3 million on June 30, 2023 (2022: EUR 9.9 million). The Company raised EUR 6.6 million at the end of June which had not been settled until July 2023. The Company entered the third quarter with EUR 12.8 million and has funds sufficient to support operations into Q4 2023.
  • Operating loss of EUR 12.8 million for the six months ended June 30, 2023 (2022: EUR 13.4 million).
  • Net assets of EUR -9.5 million on June 30, 2023 (2022: EUR -5.2 million).
  • The cash position has been strengthened by two private placements directed to institutional and other investors to raise EUR 18.6 million.
  • On June 30, 2023, the Company had outstanding borrowings of EUR 9.8 million under a loan facility with IPF Partners which is subject to financial covenants. The Company is required to satisfy these agreed covenants including the requirement to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash runway. On June 30, 2023, and August 28, 2023, the Company was in compliance with all covenants while holding cash balances of EUR 6.3 million and EUR 9.1 million, respectively. The cash held by the Group together with known receivables will be sufficient to support the current level of activities until the year end of 2023.

Consolidated key figures, IFRS

 EUR’000

Unaudited

Unaudited     

Audited

 

1-6/2023

1-6/2022

1-12/2022

6 months

6 months

                12 months

Revenue

0

0

0

Other operating income

0

485

803

Research and Development expenses

(8 518)

(10 047)

(20 730)

General and Administrative expenses

(4 294)

(3 801)

(7 498)

Loss for the period

(13 730)

(13 121)

(28 730)

 

 

 

 

 

Unaudited

Unaudited

Audited

1-6/2023

1-6/2022

1-12/2022

6 months

6 months

                12 months

Loss per share, EUR

(0.22)

(0.25)

(0.52)

Number of shares at end of period

66 161 373

56 575 453*

59 805 383

Average number of shares

62 985 028

53 235 643

55 229 835

 

 

 

 

 EUR’000

Unaudited

Unaudited

Audited

30 Jun 2023

30 Jun 2022

31 Dec 2022

Cash and cash equivalents

6 315

9 936

6 990

Equity

(9 483)

(5 194)

(11 476)

Balance sheet total

12 836

16 729

11 271

 

* of which 1,311,800 were held in treasury

 

August 29, 2023

Faron Pharmaceuticals

Board of Directors

 

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

 

Conference call information

A virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Markku Jalkanen, Chief Executive Officer, and James O’Brien, Chief Financial Officer, today, August 29, 2023, at 8:00 am (EST) / 1:00 pm (BST) / 3:00 pm (EEST) on the day of results.

 

Webcast registration link: https://faron.videosync.fi/h1-2023

 

The half-year report, presentation, and a replay of the webcast will be available on the Company’s website at https://www.faron.com/investors.

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

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 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 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 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 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 BEXCOMBO

The Phase BEXCOMBO study will be aimed at testing bexmarilimab with PD-1 blockade. The study’s purpose is to improve standard-of-care PD-1 response rates. The indications targeted are head and neck cancer as the first cohort to gain proof-of-concept data, followed by bladder cancer and non-small cell lung cancer. Patient cohorts will number between 15 and 40 subjects, with allowed enrichment of subgroups. We see development in this space as key to addressing an unmet medical need, as clinical data show that up to 80% of cancer patients do not respond to single agent PD-1 blockade. Planning continues for trial initiation.

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 targeting myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trial as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com.

Forward-Looking Statements

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors.  Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Chairman and Chief Executive Officer’s Review

 

Introduction

The first half of 2023 has been a period of significant progress for Faron. Most notably, we continued to accelerate our ambitious bexmarilimab development program. The most recent data from the Phase I/II BEXMAB study in relapsed/refractory myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients builds upon earlier positive data. These findings set a clear trajectory for further bexmarilimab clinical and regulatory development, bringing the promise of treatment to patients who do not respond to currently approved standard-of-care treatments.

 

Bexmarilimab

Driving the clinical development of bexmarilimab continues to be Faron’s top priority. Since we recruited the first patient in our Phase I/II BEXMAB study in June 2022, we have continued to see positive data that indicates truly life-changing therapeutic potential for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients refractory to standard of care (SoC).

 

Most recently, we reported compelling data of objective responses in three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort, and eight of 15 objective responses observed in all three doublet dosing cohorts with patient still on treatment after 13 months. We intend to have additional Phase I data in Q4 2023. Yet even now, the updated data supports the advancement to the Phase II portion in the Q4 2023 focusing on SoC relapsed/refractory acute AML and MDS patients failing hypomethylating agents (HMA). Furthermore, we announced plans to file the Company’s first Biologics License Application (BLA) to the FDA in H1 2025.

 

This opportunity is so exciting because we know that certain blood cancer cells carry significant amounts of cell surface Clever-1, which may limit the body’s ability to mount an immune response. In fact, research has shown a clear survival benefit among certain blood cancer patients with low Clever-1 expression. 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. This could result in a deeper and more durable clinical benefit compared to what most patients experience with currently approved treatments.

 

The FDA has recognized the importance of addressing the unmet needs of this population and granted bexmarilimab ODD for the treatment of AML. AML is the most common leukemia among the adult population and accounts for about 80% of all cases.

 

As bexmarilimab advances and Faron expands into a global pharmaceutical company, we hired James O’Brien, CPA, MBA, as Chief Financial Officer (CFO). Mr. O’Brien is an accomplished biotech and financial executive with extensive experience in the US capital markets. Most recently, Mr. O’Brien served as the CFO of Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage biopharmaceutical company which successfully completed an IPO in October 2021, raising USD 52 million. He previously served as Executive Vice President of Finance with Enzo Biochem, Inc. (NYSE: ENZ). Earlier in his career, he held positions with increasing responsibilities at pharmaceutical companies including Actavis PLC (now AbbVie, Inc. (NYSE: ABBV)), the US subsidiary of Swiss company Nycomed, which has since been acquired by Takeda Pharmaceuticals, and Bristol Myers Squibb. 

 

In terms of other plans for bexmarilimab, we anticipate initiation of the Phase II BEXCOMBO trial evaluating bexmarilimab with PD-1 blockade. The trial is aimed at improving standard-of-care PD-1 response rates. Head and neck cancer would be the first cohort indication to gain proof-of-concept data, followed by bladder cancer and non-small cell lung cancer. Patient cohorts will number between 15 and 40 subjects, with allowed enrichment of subgroups. We see development in this space as key to addressing an unmet medical need, as clinical data show that up to 80% of cancer patients do not respond to single agent PD-1 blockade and evolving data suggest that promoting pro-inflammatory cytokines, such as IFN-gamma (ɣ), is necessary for effective responses to these agents. Because bexmarilimab induces IFN-ɣ upregulation, which is required for immune modulation in the tumor microenvironment, BEXCOMBO offers the potential to expand the population of PD-1 responders and provide meaningful benefit to more patients.  

 

 

Financial review Faron entered 2023 having completed a EUR 12.0 million equity financing in January 2023. In June, we completed our second equity financing, bringing the year-to-date total to EUR 18.6 million. The capital raised through the private placements is instrumental in advancing our bexmarilimab research and development program, accelerating the progress of our pipeline, and bringing us closer to delivering life-changing therapies to tackle aggressive hematological malignancies. Faron’s shareholders continue to be extremely supportive of our clinical development programs and achieving our objectives.

 

Faron’s recent financial performance has been marked by a strategic emphasis on capital efficiency, a key element of extending our cash runway, while having the strength and ability to advance our clinical development programs. This capital efficiency has allowed us to achieve more with our available resources, fostering a culture of innovation while maintaining a prudent financial approach. By allocating resources thoughtfully and embracing a culture of continuous improvement, we are dedicated to maximizing the impact of our efforts and achieving our mission. The balance between achieving clinical milestones and responsible fiscal management underscores our dedication to creating a sustainable, long-term value for all stakeholders.

 

During the period, nearly 70% of all spending was directly supportive of our bexmarilimab clinical development program. Faron maintained General and Administrative expenses at 2022 levels excluding one-time items and financing expenses.

 

Statement of comprehensive income

The operating loss for the six months ended June 30, 2023, was EUR 12.8 million (six months ended 30 June 2022: loss of EUR 13.4 million). No revenue was generated during the period or prior period. Research and development expenses decreased by EUR 1.5 million to EUR 8.5 million (2022: EUR 10.0 million). General and administrative expenses increased by EUR 0.5 million to EUR 4.3 million (2022: EUR 3.8 million).

 

The loss for the period was EUR 13.7 million (2022: loss of EUR 13.1 million) and the basic and diluted loss per share was EUR 0.22 (2022: loss per share of EUR 0.25).

 

Statement of financial position and cash flows

As of June 30, 2023, net assets amounted to EUR -9.5 million (June 30, 2022: EUR -5.2 million). The net cash flow for the first six months in 2023 was EUR -0.7 million (2022: EUR 3.1 million). As of June 30, 2023, total cash and cash equivalents held were EUR 6.3 million (2022: EUR 9.9 million).

 

Corporate

Faron’s Annual General Meeting (AGM) was held on March 24, 2023. The AGM adopted the financial statements of the Company and re-elected audit firm PricewaterhouseCoopers Oy (“PwC”) as the Company’s auditor. Additionally, the number of members of the Board was confirmed as seven. Frank Armstrong, John Poulos, Leopoldo Zambeletti, Markku Jalkanen, Anne Whitaker and Erik Ostrowski were re-elected to the Board and Tuomo Pätsi was elected as a new member to the Board for a term that ends at the end of the next AGM. In June 2023 Leopoldo Zambeletti stepped down from his position in Faron’s Board due to his appointment as the Company’s business development consultant.

 

 

Summary & outlook

Our focus for the remainder of 2023 continues to be the acceleration of bexmarilimab’s clinical development. Faron plans to seek FDA advice during Q3 2023 on bexmarilimab’s progress. The completion of dose escalation, readout of enrichment cohorts, and initiation of phase II BEXMAB part are expected in Q4 2023. We are committed to changing the treatment paradigm for those with limited treatment options.

 

On behalf of the Board, we would like to thank our shareholders, existing and new, for their support of Faron. We would also like to thank our employees for their continued commitment to our mission and the patients we serve. We look forward to updating the market on our progress throughout the course of the year.

 

Dr Markku Jalkanen

Chief Executive Officer

 

Dr Frank Armstrong

Chairman

 

Consolidated Income Statement, IFRS

EUR’000

Unaudited

1-6/2023

6 months

Unaudited

1-6/2022

6 months          

Audited

1-12/2022

12 months

Revenue

0

0

0

Other operating income

0

485

803

Research and development expenses

(8 518)

(10 047)

(20 730)

General and administrative expenses

(4 294)

(3 801)

(7 498)

Operating loss

(12 812)

(13 364)

(27 426)

Financial income

0

692

96

Financial expense

(918)

(430)

(1 400)

Loss before tax

(13 730)

(13 102)

(28 730)

Tax expense

0

(19)

0

Loss for the period

(13 730)

(13 121)

(28 730)

Translation difference

0 

11

17

Comprehensive loss for the period attributable to the equity holders of the Parent company

(13 730)

(13 110)

(28 713)

 

 

 

 

Loss per ordinary share

 

 

 

Basic and diluted loss per share, EUR

(0.22)

(0.25)

(0.52)

 

 

Consolidated Balance Sheet, IFRS

 

EUR’000

Unaudited

Unaudited

Audited

31 Dec 2022

30 Jun 2023

30 Jun 2022

Assets

 

 

 

Non-current assets

 

 

 

Machinery and equipment

10

17

13

Right-of-use-assets

272

98

314

Intangible assets

1 127

1 011

1 154

Prepayments and other receivables

60

53

60

Total non-current assets

1 469

1 179

1 541

 

 

 

 

Current assets

 

 

 

Prepayments and other receivables

5 052

5 614

2 740

Cash and cash equivalents

6 315

9 936

6 990

Total current assets

11 367

15 550

9 730

 

 

 

 

Total assets

12 836

16 729

11 271

 

 

 

 

 

 

 

 

 

 

 

 

EUR’000

Unaudited

Unaudited

Audited

31 Dec 2022

30 Jun 2023

30 Jun 2022

Capital and reserves attributable to the equity holders of the Parent company

 

Share capital

2 691

2 691

2 691

Reserve for invested unrestricted equity

144 778

120 839

129 544

Accumulated deficit

(156 955)

(128 726)

(143 713)

Translation difference

2

2

2

Total equity

(9 483)

(5 194)

(11 476)

 

 

 

 

Provisions

 

 

 

Other provisions

0

0

158

Total provisions

0

0

158

 

 

 

 

 

 

 

 

Non-current liabilities

 

 

 

Borrowings

10 892

12 250

11 102

Lease liabilities

163

0

163

Other liabilities

702

539

853

Total non-current liabilities

11 757

12 789

12 118

 

 

 

 

Current liabilities

 

 

 

Borrowings

2 304

0

1 851

Lease liabilities

119

106

153

Trade payables

6 002

7 791

6 014

Accruals and other current liabilities

2 137

1 238

2 453

Total current liabilities

10 562

9 135

10 471

 

 

 

 

Total liabilities

22 319

21 924

22 748

 

 

 

 

Total equity and liabilities

12 836

16 729

11 271

Consolidated Statement of Changes in Equity, IFRS

 

EUR’000

 

Share capital

Reserve for invested unrestricted equity

Translation difference

Accumulated deficit

Total equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as at
31 December 2021 (Audited)

 

2 691

116 507

-15

-116 265

2 919

 

 

 

 

 

 

 

Comprehensive loss for the last six months 2022

0

0

11

-13 121

-13 110

 

 

 

 

 

 

 

Transactions with equity holders of the Parent company

 

 

 

 

 

Issue of ordinary shares

 

0

4 332

0

0

4 332

Share-based compensation

 

0

0

0

665

665

 

 

0

4 332

0

665

4 997

 

 

 

 

 

 

 

Balance as at 30 June 2022 (Unaudited)

 

2 691

120 839

2

-128 726

-5 194

 

 

 

 

 

 

 

Comprehensive loss for the year 2022

 

0

0

17

(28 730)

(28 713)

 

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

 

Issue of ordinary shares, net of transaction costs

0

13 037

0

0

13 037

Share-based compensation

 

0

0

0

1 297

1 297

Other movements

 

0

0

0

(16)

(16)

 

 

0

13 037

17

(27 448)

(14 395)

 

 

 

 

 

 

 

Balance as at
31 December 2022 (Audited)

 

2 691

129 544

2

(143 713)

(11 476)

 

 

 

 

 

 

 

Comprehensive loss for the last six months 2023

0

0

0

(13 730)

(13 730)

 

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

 

Issue of ordinary shares, net of transaction costs

0

15 233

0

0

15 233

Share-based compensation

 

0

0

0

489

489

 

 

0

15 233

0

(13 241)

1 992

 

 

 

 

 

 

 

Balance as at 30 June 2023 (Unaudited)

 

2 691

144 778

2

(156 955)

(9 483)

 

Consolidated Cash Flow Statement, IFRS

 

 

€’000

Unaudited

1-6/2023

6 months

Unaudited

1-6/2022

6 months

    Audited

1-12/2022

12 months

Cash flow from operating activities

 

 

 

Loss before tax

(13 730)

(13 102)

(28 730)

Adjustments for:

 

 

 

Received grants

0

(415)

(803)

Depreciation and amortization

174

151

300

Change in provision

(158)

0

(158)

Financial items

918

529

1 304

Tax expense

0

(19)

0

Share-based compensation

489

665

1 297

Adjusted loss from operations before changes in working capital

(12 308)

(12 191)

(26 790)

Change in net working capital:

 

 

 

Prepayments and other receivables (increase -)

1 028

819

2 864

Trade payables (increase +)

(8)

1 211

719

Other liabilities (increase +)

(272)

(1 014)

1 183

Cash used in operations

(11 561)

(11 175)

(22 023)

Income taxes paid

0

0

0

Transaction costs related to loans and borrowings

0

0

(165)

Interest received

0

0

11

Interest paid

(782)

(108)

(816)

Net cash used in operating activities

(12 343)

(11 283)

(22 993)

 

 

 

 

Cash flow from investing activities

 

 

 

Payments for intangible assets

(68)

(167)

(385)

Payments for tangible assets

0

0

(0)

Net cash used in investing activities

(68)

(167)

(385)

 

 

 

 

Cash flow from financing activities

 

 

 

Proceeds on issue of shares

12 077

4 331

13 445

Share issue transaction cost

(648)

0

(365)

Proceeds from borrowings

64

10 389

10 389

Repayment of borrowings

0

(108)

(105)

Proceeds from grants

382

0

231

Payment of lease liabilities

(84)

(96)

(116)

Net cash from financing activities

11 791

14 516

23 478

 

 

 

 

Net increase (+) / decrease (-) in cash and cash equivalents

(675)

3 083

137

Effect of exchange rate changes

(55)

17

37

 

 

 

 

Cash and cash equivalents at 1 January

6 990

6 853

6 853

Cash and cash equivalents at the end of period

6 315

9 936

6 990

 

Notes to the interim financial report

1.   Corporate information

Faron Pharmaceuticals Ltd (the “Company”) is a clinical stage biopharmaceutical company incorporated and domiciled in Finland, with its headquarters at Joukahaisenkatu 6, 20520 Turku, Finland. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage.

 

The Company has been listed on the London Stock Exchange’s AIM market since November 17, 2015, with a ticker FARN, and since December 3, 2019, the Company has been listed on the Nasdaq First North Growth Market with a ticker FARON.

 

2.    Summary of significant accounting policies

2.1.    Basis of preparation

The unaudited H1 interim financial report has been prepared in accordance with the International Financial Reporting Standards of the International Accounting Standards Board (IASB) and as adopted by the European Union (IFRS) and the interpretations of the International Financial Reporting Standards Interpretations Committee (IFRIC).

The principal accounting policies applied in the preparation of these interim financial report is set out below. The Company has consistently applied these policies to all the periods presented, unless otherwise stated. The areas of the report involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the interim financial report, are disclosed in note 2.2.

The unaudited interim financial report incorporates the parent company, Faron Pharmaceuticals Ltd, and all subsidiaries (the “Group”).

All amounts are presented in thousands of euros, unless otherwise indicated, rounded to the nearest euro thousand.

 

2.2.         Going concern

The Group has forecasted its estimated cash requirements over the next twelve months. To make these forecasts the Group has made a number of assumptions regarding the quantity and timing of future expenditure and income as well as other key factors. Though these estimates have been made with caution and care, they continue to contain a significant amount of uncertainty. The Group also has debt obligations which carry financial covenants that could adversely impact the Group’s liquidity and operating flexibility. Based on the forecast the Group believes that it has adequate financial resources to continue its operations until the year end of 2023.  
 

The Group has taken several actions to secure further financing during the rest of the year 2023. The Directors believe that the Group can gain access to further resources to sustain operations over the next 12 months. Therefore, this unaudited financial report has been prepared on a going concern basis. At this stage the Group cannot disclose any of these options.

 

Because the additional finance is not committed at the date of issuance of this H1 2023 report, these circumstances represent a material uncertainty that may cast significant doubt on the Group’s ability to continue as a going concern. Should the Group be unable to obtain further finance such that the going concern basis of preparation were no longer appropriate, adjustments would be required, including to reduce balance sheet values of assets to their recoverable amounts, to provide for further liabilities that might arise.

 

2.3.         Financial covenants

At June 30, 2023, the Company had outstanding borrowings of EUR 9.8 million under a loan facility with IPF Partners which is subject to financial covenants. The Company is required to satisfy these agreed covenants including the requirement to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash runway. At June 30, 2023, and August 28, 2023, the Company is in compliance with all covenants while holding cash balances of EUR 6.3 million and EUR 9.1 million, respectively. The cash held by the Group together with known receivables will be sufficient to support the current level of activities until the year end of 2023.

 

3.    Subsequent events

The settlement of the second private placement during the period announced on June 29, 2023, was completed early July 2023.

In its meeting on August 28, 2023, the Board of Directors of the Company approved the publishing of this interim financial report.

Faron Reports Half-Year Financial Results January 1 – June 30 2023
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