Founders named European Inventor Award finalists

Faron Pharmaceuticals Oy

 

(“Faron” or the “Company”)

 

 

Faron founders and bexmarilimab developers selected as finalists for the European Inventor Award 2024

 

Press Release, May 16, 2024 at 9:00 (EEST) / 7:00 AM (BST) / 2:00 AM (EDT)  

 

          Dr. Markku Jalkanen and Dr. Sirpa Jalkanen, Faron’s co-founders, have been nominated as one of three finalists in the ‘SMEs’ category of prestigious European Patent Office Awards

          Nominated in recognition of research developing bexmarilimab, an investigational immunotherapy optimising clinical outcomes in cancer treatment

          Voting now open for “Popular Prize” award ahead of ceremony on July 9 via dedicated link: Sirpa Jalkanen and Markku Jalkanen | Epo.org

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces the nomination of its co-founders, Dr. Markku Jalkanen and Dr. Sirpa Jalkanen, as finalists in the ‘SMEs’ category of the European Inventor Award 2024.

 

Dr. Markku Jalkanen, co-founder, Board member and former CEO of Faron, and Dr. Sirpa Jalkanen, co-founder and member of Faron’s Scientific Advisory Board, have been nominated in recognition of their research developing Faron’s wholly owned precision cancer immunotherapy candidate, bexmarilimab. One of the most advanced myeloid cell-targeting immunotherapy candidates in development, bexmarilimab is designed to target the Clever-1 receptor present on macrophages, activating anti-tumor immunity in hematological and solid tumor microenvironments to overcome resistance and provide better patient outcomes.

 

Bexmarilimab is currently being investigated in the ongoing BEXMAB trial, evaluating the candidate’s safety and efficacy in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), an aggressive myeloid leukemia with very few treatment options.

 

In addition, every year, the public can vote for their favorite inventor: the Popular Prize goes to the shortlisted inventor with the most votes. The winners in each category, and the winner of the Popular Prize, will be announced at the online award ceremony on 9 July 2024. For further information and to vote for the Popular Prize, visit: Sirpa Jalkanen and Markku Jalkanen | Epo.org

 

Dr. Markku Jalkanen, Board member and former CEO of Faron, said: “It is an honor to be recognized by the European Patent Office and nominated for this prestigious award. The continued progress of our ambitious bexmarilimab development program and the exceptional data we are seeing in the ongoing Phase I/II BEXMAB trial, reaffirms our belief in the potential of bexmarilimab to change the treatment paradigm.  These highly significant findings provide us with continued confidence that bexmarilimab can improve the quality of life of those suffering from these aggressive hematological cancers, where there are limited options available for future therapy.”

 

Launched by the European Patent Office in 2006, the European Inventor Award is one of Europe’s most renowned innovation prizes. This award recognizes people behind successful inventions in small and medium-sized enterprises (SMEs) and honors individuals who transform their ideas into solutions to address some of the biggest challenges of our time.

 

 

For more information please contact:

 

Faron Pharmaceuticals

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

 

About Faron Pharmaceuticals Oy 

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

 

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

 

About Bexmarilimab

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

 

 

Faron confirms plans under new leadership

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

Faron confirms plans for the coming months under new leadership

 

        Initial data from ongoing Phase 2 part of BEXMAB trial anticipated next month

        Incoming CEO, Juho Jalkanen, to accelerate discussions with US regulator to coordinate plans for obtaining marketing approval for MDS patients that have failed HMA

 

Press Release, April 16, 2024 at 9:00 (EEST) / 7:00 AM (BST) / 2:00 AM (EDT)  

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces ongoing plans and activities for the coming months following the recent announcement of the proposed appointment of Dr. Juho Jalkanen as Chief Executive Officer, effective 1 May 2024.

 

Initial data from the ongoing Phase 2 part of the BEXMAB trial, evaluating the safety and efficacy of bexmarilimab in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), is expected to be announced during the week commencing 20 May 2024. This data read out will be important for ongoing partnering discussions and the major upcoming industry events that Faron will be attending, including the American Society for Clinical Oncology (ASCO) annual meeting and the Bio International Convention, taking place in June 2024.

 

Given the promising data already seen in the Phase 1 part of the trial, among HMA-failed MDS patients who have no approved treatment options, the Company plans to approach the US Food and Drug Administration (FDA) earlier than planned this year, seeking a Scientific Advice meeting regarding its registrational study plan, in order to coordinate and finalize plans that may lead to marketing approval. 

 

“2024 is set to be a pivotal year for Faron in the delivery of key milestones that will be critical to the further development of bexmarilimab,” said Dr. Juho Jalkanen, Faron’s incoming Chief Executive Officer. “In my new role as CEO I am excited to start executing on some of these key activities and to accelerating important discussions with the FDA as we map our future plans for bexmarilimab together. There is a tremendous need for an effective treatment in HMA-failed MDS patients and so we are very keen to ensure we get this treatment option to patients as soon as we can.”

 

 

For more information please contact:

 

Faron Pharmaceuticals

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

 

About Faron Pharmaceuticals Oy 

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

 

Approval of Warrant Terms and Conditions

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

 

Approval of Warrant Terms and Conditions

 

Company announcement, April 8, 2024 at 12:10 AM (EDT) / 7:10 AM (BST) / 9:10 AM (EEST)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces that the Board of Directors of Faron has approved the terms and conditions of the remaining 832,934 warrants pursuant to the terms of the warrantholder agreement (the “Warrantholder Agreement”) entered into between the Company and IPF as announced on March 28, 2024. It was previously announced that the maximum total number of warrants to be granted pursuant to the Warrantholder Agreement is 1,500,000, and the Board of the Company shall cause the registration of the remaining warrants after the Annual General Meeting 2024 of the Company, held on April 5, 2024. Each warrant entitles its holder to subscribe for one new share in the Company.

 

Further, pursuant to the terms of the Warrantholder Agreement, the number of warrants to be issued to IPF may be further increased upon (and subject to) agreed adjustment events so that the total number of new shares in the Company (issued as a result of the exercise of the increased number of warrants) multiplied by the (adjusted) subscription price per share in any subsequent share offering undertaken by the Company is equal to EUR 1,000,000 (minus any amounts already paid). The Company announced on April 4, 2024, that the Company had resolved to issue an additional 53,570 warrants to IPF based on the placement of 3,200,298 newly issued treasury shares at the issue price of EUR 1.50.

 

The strike price of the IPF warrants is currently EUR1.50 and will be adjusted to any lower subsequent subscription price of shares in any future share issue. The Company will separately publish an announcement on the issuance of any of the additional warrants.

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilimcomms.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 treatments and as a monotherapy in last line solid cancers. Further information is available at www.faron.com.

 

 

Announcement 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, NEW ZEALAND, 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 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 Placing of Newly Issued Treasury Shares to Raise EUR 4.8 Million and of

PDMR Dealings

 

Company announcement, 4 April 2024 at 7:00 a.m. BST/ 9:00 a.m. EEST

Inside information

 

Key highlights

 

          The Company has conducted a private placement directed to a limited number of institutional and other investors to raise EUR 4.8 million to secure the required and previously communicated short-term bridge financing totalling EUR 8 million (incl. the EUR 3.2 million convertible loan announced on 4 March 2024).

          Upon receipt of these proceeds, the Company continues to satisfy the required covenant levels and expects to have sufficient working capital into June 2024.

          The Placing was supported by both new and existing shareholders such as European Innovation Council (EIC Fund) and other Finnish and international investors.

          To complete the enrolment of the phase 2 of the BEXMAB study with interim and final readouts and to obtain regulatory feedback from the FDA between now and Q1/2025, the Company expects to need an additional EUR 27 million in total (accounting for the raised EUR 8 million in early March and this Placing).

          The Company continues active endeavours and preparations to secure longer term funding. The Company’s Board of Directors has proposed to the Annual General Meeting scheduled to be held on 5 April 2024 an authorization for a larger share issuance contemplated to be launched as a public offering (with planned allocation preferences to existing shareholders and bridge finance lenders) as soon as practicable once the required preparations and approvals are in place. The targeted size of the contemplated share issue is planned to be set accordingly, to meet cash runway needs for 2024.

 

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 that it has conducted a placement of 3,200,298 newly issued treasury shares (“Placing Shares“) to raise EUR 4.8 million before expenses to a limited number of institutional investors and other investors (“Placing“). Upon receipt of these proceeds, the Company continues to satisfy the required covenant levels and expects to have sufficient working capital into June 2024. Carnegie Investment Bank AB (publ), Finland Branch is acting as sole bookrunner and lead manager in the Placing.

 

The Placing was carried out as a private placement by way of a firm placement of Placing Shares to a limited number of institutional and other investors. To implement the Placing, the Board of Directors of Faron (the “Board“) has decided to issue 3,200,298 shares to Faron itself without consideration (“Treasury Shares“) and, subject to the registration of the Treasury Shares, further convey such Treasury Shares as Placing Shares to the participating investors. The subscription price per Placing Share of EUR 1.50 (the “Issue Price“) represents a 11.2 % discount to the close price on 3 April 2024 on Nasdaq Helsinki First North (“First North“). The settlement of the Placing (delivery against payment) trades is expected to complete on or around 9 April 2024. The Placing was supported by both new and existing shareholders such as European Innovation Council (EIC Fund) and other Finnish and international investors.

This fundraise will enable us to meet our immediate financing needs and continue our ambitious bexmarilimab development program, with a focus on delivering next milestones,” said Dr. Markku Jalkanen, Chief Executive Officer of the Company. “These funds are part of the larger financing plan to secure cash runway into beginning of 2025 and to complete Phase II study and receive FDA’s guidance for the pivotal study part. We would like to thank all our investors for their support in developing this novel immunotherapy, especially for myeloid leukemia with very few treatment options“.

 

 

As was announced by the Company on 4 March 2024 following its receipt of the EUR 3.2 million binding commitments for convertible loans to secure the Company’s immediate short-term financing needs until the end of March 2024 and allowing the Company to make critical payments to third parties under agreed waiver (“Waiver“) with IPF Fund II SCA, SICAV-FIAR (“IPF“), the Company has continued active endeavours to secure its short and longer-term financing needs. The now announced Placing covers the required and previously communicated short-term bridge financing totalling at least EUR 8 million (incl. the EUR 3.2 million convertible loan announced on March 4, 2024) to secure continued compliance with the cash covenants agreed in the Waiver. As part of the Waiver, the minimum cash covenant remains at the lowered level of EUR 4.5 million until 30 April 2024 and thereafter it returns to the previously agreed level (being the higher of the Company’s cash runway for the past three (3) calendar months and the Company’s expected cash runway for the following three (3) calendar months). The Company continues active endeavours and preparations to secure longer term funding.

 

As previously announced, the Board has proposed to the Annual General Meeting scheduled to be held on 5 April 2024 an authorization for a larger share issuance contemplated to be launched as a public offering (with planned allocation preferences to existing shareholders and bridge finance lenders including conversion of loans) (the “Public Offering“) as soon as practicable once the required preparations and approvals are in place. The receipt of long-term financing is necessary to secure funding for 2024 and especially the uninterrupted continuation of the Company’s BEXMAB study to full read out of the Phase II study and FDA feedback on registrational study design during 2024. The targeted size of the contemplated Public Offering is planned to be set accordingly, to meet these cash runway needs for 2024. The Company is also evaluating and continuously negotiating several business development alternatives that may result in non-dilutive funding.

 

 

USE OF PROCEEDS

 

Faron has completed an overall cost reduction plan that eliminated over 20% of operating expenses including a 25% reduction in employee-related expenditure. Cash burn for the first half of 2024 is estimated at EUR 2.5 million per month declining to approximately EUR 2.0 million per month in the second half of the year.

Key activities

  • Continuation of BEXMAB Phase 2 Study.
  • Obtaining FDA advice on registrational Study design.
  • Maintaining GMP status for manufactured bexmarilimab and preparing it for registrational Trial.
  • Short term funding needs to satisfy the IPF covenant and bridge operations into June 2024 before a long-term financing is in place.
  • Short term IPF related financing costs.

 

  

DETAILS OF THE PLACING AND SHARE ISSUES

 

The Placing is carried out within the authorization granted to the Board by shareholders at the Company’s Annual General Meeting held on 24 March 2023 to issue up to 12,500,000 new shares in aggregate in the Company, as well as the conveyance of up to the same maximum number (twelve million five hundred thousand (12,500,000)) of treasury shares in the possession of the Company, including the right to deviate from the shareholders’ pre-emptive subscription right. The Company has decided to first issue the Treasury Shares to itself without consideration and then immediately convey such Treasury Shares as Placing Shares to the participating investors against their payment of the Issue Price (delivery against payment of the Issue Price in full).

 

A total of 3,200,298 Treasury Shares (representing approximately 4.7 per cent of all the issued shares and votes in the Company immediately prior to the Placing) have been issued and registered in the Finnish Trade Register today on 4 April 2024. Following the issuance, the aggregate number of ordinary shares in the Company is 72,007,497. As a part of the Placing, the 3,200,298 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 9 April 2024. 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 (save for the Annual General Meeting scheduled to be held on 5 April 2024, the record date of which was 22 March 2024). 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 72,007,497 (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.

 

Furthermore, to align the Issue Price to the possibly lower subscription price per share to be applied in the potential Public Offering or (in the absence of the Public Offering) other equity round completed before 10 June 2024 (the “Other Equity Round“), subject to the Annual General Meeting scheduled to be held on 5 April 2024 making the required resolutions and granting the authorisation, and the Company completing such Public Offering or Other Equity Round, the Company would, in connection with (or following) the Public Offering or the Other Equity Round grant the subscribers in the Placing either new shares in the Company free of charge or other instruments to achieve the same net effect from both the Company’s and the said subscribers’ perspective. Such additional shares or other instruments would be granted as soon as practicable after the completion of the Public Offering or the Other Equity Round, estimated on or about 15 June 2024.

 

In assessing the Placing and its terms and concluding that there are weighty financial and value creation reasons for the Company to deviate from the shareholders’ pre-emptive subscription right, the Board has carefully assessed the timing, structure, size, price, participants and other terms of the Placing from the Company’s and all of its shareholders’ perspective, also in light of e.g. available alternatives, consultation and market feedback received, as well as the information, circumstances, timing, needs and planned action to secure the required short and long term financing previously and consistently announced and updated by the Company.

 

As previously announced by the Company on 28 March 2024 and 18 November 2022, respectively, the Company has issued to IPF special rights which entitle them to subscribe for new ordinary shares in the Company (“Warrants“). Pursuant to the terms and conditions of the Warrants, the subscription price per share on the exercise of a) a total of 319,944 Warrants shall be the lower of either EUR 1.85 (equivalent to issue price of the placing announced by the Company on 14 October 2022) or the subscription price per share in any subsequent share offering undertaken by the Company and b) a total of 613,496 Warrants shall be the lower of either EUR 1.63 (equivalent to the terms of a waiver received from IPF) or the subscription price per share in any subsequent share offering undertaken by the Company. As the Issue Price is EUR 1.50, the subscription price per share of the aforementioned aggregate amount of 933,440 Warrants shall be adjusted to EUR 1.50. The Company has also resolved to issue an additional 53,570 Warrants to IPF (with the same subscription price per share of EUR 1.50).

 

Further, pursuant to the terms of the warrant holder agreement entered into between the Company and IPF as announced on 28 March 2024, the number of warrants to be issued to IPF ( currently 613,496 Warrants) may be further increased upon (and subject to) agreed adjustment events so that the total number of new shares in the Company (issued as a result of the exercise of the increased number of warrants) multiplied by the (adjusted) subscription price per share in any subsequent share offering undertaken by the Company is equal to EUR 1,000,000 (minus any amounts already paid). The Company will separately publish an announcement on the issuance of the additional warrants.

 

ADMISSION

 

The Company will make applications 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 9 April 2024 (the “Admissions“).

 

RELATED PARTY AND PDMR DEALING

 

Timo Syrjälä, an existing shareholder in the Company, has subscribed for and been allocated 133,333 Placing Shares in aggregate (subscribed for by himself and through Acme Investments SPF Sarl (“Acme“), an entity wholly owned by Mr. Syrjälä), for an aggregate subscription value of approximately EUR 0.2 million at the Issue Price. Following the completion of the Placing, Mr. Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme, will be 13,432,335 shares, representing 18,65 per cent of the issued shares and votes of the Company following the Placing. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules for Companies (the “AIM Rules“). His subscription for Placing Shares pursuant to the Placing is a related party transaction for the purposes of the AIM Rules. The Directors of the Company, all of whom are independent of Mr Syrjälä, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the participation by Mr. Syrjälä in the Placing to be fair and reasonable insofar as shareholders are concerned.

 

In addition, Markku Jalkanen and Tuomo Pätsi, directors of the Company, as well as Scientific Advisor Sirpa Jalkanen have subscribed for 33,333, 13,333 and 33,333 shares respectively. Their beneficial interests in the issued shares and votes of the Company are set out below:

 

 

Before the Placing

 

Following the Placing

Director

Number of ordinary shares held

% of issued shares and votes

Number of Placing Shares subscribed for

Number of ordinary shares held

% of issued shares and votes

Markku Jalkanen

2,175,266

3.16

33,333

2,208,599

3.07

Sirpa Jalkanen

1,138,168

1.65

33,333

1,171,501

1.63

Tuomo Pätsi

11,765

0.02

13,333

25,0980

0.03

   

The participation of Markku Jalkanen and Tuomo Pätsi (“Directors’ Participation“) in the Placing constitute related party transactions for the purposes of the AIM Rules. The independent directors for the purpose of the Directors’ Participation, being Dr Frank Armstrong, John Poulos, Christine Roth, Marie-Louise Fjällskog and Erik Ostrowski, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the Directors’ Participation in the Placing to be fair and reasonable insofar as shareholders are concerned.

 

 

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

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

a)       Markku Jalkanen

b)       Sirpa Jalkanen

c)       Tuomo Pätsi

 

2

Reason for notification

 

 

 

a.

Position/Status

Directors

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

Ordinary shares

 

 

ISIN: FI4000153309
 

b.

Nature of the transaction

Purchase of ordinary shares

c.

Price(s) and volume(s)

 

 Average

 

 

 

 

Price(s)

Volume(s)

 

a)       1.50

b)       1.50

c)       1.50

 

a) 33,333

b) 33,333

c) 13,333

 

 

 

 

d.

Aggregated information

 

– Aggregated Volume

 

– Price

 

 

79,999

 

1.50

e.

Date of the transaction

3 April 2024

f.

Place of the transaction

Nasdaq First North Growth Market

 

 

 

 

 

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, Funding & 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

 

 

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 LOANS, ANY SECURITIES ISSUED UPON CONVERSION OF THE LOANS AND ANY SECURITIES ISSUED IN THE INVESTMENT ROUND (COLLECTIVELY, THE “SECURITIES”) 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 SECURITIESIN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE SECURITIES 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 BEXMAB 

The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. 

 

About Bexmarilimab

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

 

About Faron Pharmaceuticals Ltd. 

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through 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.

 

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 completion and use of proceeds from the Placing, 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.

 

 

Issue of Warrants to IPF Funding Update

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

 

Issue of Warrants to IPF

Funding Update

 

Company announcement, March 28, 2024 at 3 AM (EDT) / 7 AM (GMT) / 9 AM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces that Faron has committed to granting IPF special rights entitling to subscribe for ordinary shares of the Company against payment (“Warrants”) in addition to the warrants created on February 28, 2022.

 

IPF Warrants

 

As was announced by the Company on March 4, 2024, pursuant to the waiver regarding certain events of default (“Waiver”) under the terms of the secured debt agreement with IPF Fund II SCA, SICAV-FIAR (“IPF”) as Lender and Faron Pharmaceuticals Ltd as Borrower (“Facilities Agreement”), the Company shall issue to IPF additional special rights which entitle them to subscribe for new ordinary shares in the Company (“Warrants”), with an exercise price equal to the volume-weighted average price of the Company’s share during the three trading days preceding the date of the Waiver (“Strike Price”). The Strike Price shall be the lower of either EUR 1.63 (equivalent to the terms of the Waiver) or the subscription price per share in any subsequent share offering undertaken by the Company. The number of Warrants primarily issued to IPF is calculated by dividing 10% of the original loan amount (EUR 10 million) by the Strike Price, subject to certain adjustments in accordance to the terms of a warrantholder agreement entered into between the Company and IPF (“Warrantholder Agreement”). The Warrants are exercisable for a period of seven years.

 

In accordance with the Waiver and the Warrantholder Agreement, on March 27, 2024, the Board of Directors of the Company, based on the authorisation granted to the Board by shareholders at the Company’s Annual General Meeting held on March 24, 2023, resolved upon a warrant program directed to IPF. Pursuant to the warrant program, the Warrants are issued without consideration. The Warrants are issued as a part of the negotiated funding arrangement with IPF and therefore, from the Company’s point of view, there is a weighty financial reason for the program and the issuance of Warrants thereunder.

 

Pursuant to the Warrantholder Agreement, a preliminary amount of [613,496] warrants were issued on March 27, 2024 to IPF. The maximum total number of warrants to be granted pursuant to the Warrantholder Agreement is 1,500,000, and the Board of the Company shall cause the registration of the remaining 886,504 warrants after the Annual General Meeting 2024 of the Company, scheduled to be held on April 5, 2024. Should the Annual General Meeting 2024 of the Company resolve not to approve the proposal made to the Annual General Meeting to authorise the Board to resolve on the issuance of special rights entitling to shares in the Company, the Board shall convene an Extraordinary General Meeting of the Company to authorise the Board to issue such additional number of special rights as is required to satisfy the maximum total number of warrants to be granted pursuant to the Warrantholder Agreement. Each warrant entitles its holder to subscribe for one new share in the Company, and the number of shares in the Company may be increased by a maximum of 613,496 shares as a result of the exercise of the warrants now issued to IPF and should the maximum amount of warrants be issued to IPF, the number of shares in the Company may be increased by a maximum of 1,500,000 (when taking into account the 613,496 shares already issued) as a result of the exercise of said warrants. The warrants may be exercised for a period of seven years. Pursuant to the terms of the Warrantholder Agreement the number of warrants to be issued to IPF may be further increased upon (and subject to) agreed adjustment events so that the total number of new shares in the Company (as a result of the exercise of the exercise of the warrantes) multiplied by the (adjusted) Strike Price is equal to EUR 1,000,000 (minus any amounts already paid). The terms and conditions of the warrants are attached to this announcement and will be available on the Company’s website.

 

Funding Update

 

Further to the Company’s announcement on February 19, 2024 regarding the Events of Default with IPF, and the subsequent announcements in regards to the Company’s ongoing financial position, the Company confirms that it is in advanced negotiations with various investors in order to secure immediate funding.

 

The Company’s current cash balance is sufficient to allow the Faron to continue its operations into April 2024, however whilst the Company is in advanced negotiations to complete the remaining bridge financing of approximately EUR 5 million shortly, the Company notes that there is no guarantee that the required funds will be raised.

 

The Company will update the market in due course of any material developments as soon as practicable.

 

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consiliumcomms.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 treatments and as a monotherapy in last line solid cancers. Further information is available at www.faron.com.

 

 

Additional Positive Data from Phase 1 of BEXMAB

Faron Pharmaceuticals Ltd.

 

(“Faron” or the “Company”)

 

 

Inside Information: Additional Positive Data from the Phase 1 Part of the BEXMAB Study in Both Higher-Risk HMA-Failed MDS and r/r AML

 

 

Company announcement, 18 March 2024 at 7:00 a.m. GMT / 9:00 a.m. EET

 

Key highlights

          Latest readout of the BEXMAB study shows more responding patients and good durability of remission amongst HR HMA-failed MDS patients.

          4/5 of the initial Phase 1 HR HMA-failed MDS patients were still alive after eight months of follow-up.

          While data do not yet allow the precise estimation of median overall survival, the survival benefit seen with the current follow-up already for these 5 first patients is very encouraging. This compares favorably to what has been seen with contemporary comparators.

          3 additional HMA-failed HR MDS patients have been enrolled in Phase 1 part, leading to a total of 7 out of 8 patients responding, an overall response rate of 87.5%.

          Faron will be hosting a virtual webinar to discuss the additional data tomorrow, Tuesday, 19 March at 11.00 EET/9am GMT.

 

TURKU, Finland / BOSTON, Massachusetts – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today provided further data from patients treated during the Phase 1 part of the ongoing BEXMAB trial that has moved into Phase 2 for higher-risk (HR) myelodysplastic syndrome (MDS) patients failed on previous hypomethylating agent (HMA).

 

Previous BEXMAB study results indicated a high overall response rate (ORR) of 5/5 amongst HR HMA-failed MDS patients, for whom there is no approved treatment. The majority of the initial Phase 1 patients have now been on treatment with bexmarilimab together with azacitidine for more than six months, and only one patient has been lost due to transformation of their HR MDS into acute myeloid leukemia (AML). Out of these initial 5 patients, 4 remain alive after eight months. Normally, patients with relapsed or refractory HR MDS have a median overall survival (mOS) of fewer than six months. The mOS of patients treated in the BEXMAB trial is not yet available but, based on the current data, it is estimated to be significantly higher than traditionally seen with current standard of care (or with current approved treatments).

 

After the already reported 5 HMA-failed HR MDS patients, 3 new HMA-failed HR MDS patients were enrolled, filling the remaining Phase 1 slots. Whilst it is too early to assess these patients for survival or durability, the previously seen high ORR has been corroborated with 2/3 responders. The third patient dropped out of the study early in cycle two due to an unrelated serious adverse event (SAE), bringing the current ORR to 7/8 patients (87.5%) in the HMA-failed HR MDS population. The best responses for these 8 patients are as follows: 1 complete response (CR), 3 marrow complete remissions (mCR), 1 partial response (PR), 2 hematological improvements, and 1 stable disease (SD) that dropped out early due to an unrelated SAE.

 

Mika Kontro, MD, PhD, Associate Professor at the Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial, said: “We are continuing to see encouraging data from the BEXMAB trial with usually unresponsive patients going into remission after treatment with bexmarilimab and azacitidine. Whilst we don’t have median overall survival rates yet, it is encouraging to see that some patients are alive and, importantly, enjoying a good quality of life even up to 12+ months after treatment initiation. I continue to be very excited about the potential of bexmarilimab to considerably improve outcomes for patients suffering from these aggressive conditions.”

 

Dr. Markku Jalkanen, Chief Executive Officer of Faron, said: “These data are really remarkable and confirm our belief that we may finally have a treatment for this underserved patient population. The data are strongly supportive that a registrational trial would be positive against any contemporary comparator when the final endpoint is survival. We eagerly await completion of the Phase 2 part of the BEXMAB study so we can take these data to the FDA as soon as possible.”

 

For the 5 frontline HR MDS patients with 100% ORR previously reported at the American Society of Hematology (ASH) Annual Meeting last year, mOS has also not yet been reached. For the r/r AML patient cohort reported at ASH, which is bigger in size (n= 18) and more mature in follow-up (median follow-up six months), the mOS is currently estimated to be over 8 months (still subject to change as some patients are still ongoing). The historical mOS for this population is around six months, which means that the current data would support running a registrational trial with mOS also as the endpoint in this population.

 

Faron will be hosting a virtual webinar to discuss these data tomorrow, Tuesday, 19 March, at 11.00 EET/9am GMT.

 

There will be an opportunity to ask questions during the webcast. To register for the event visit: https://faron.videosync.fi/bexmab-study-update/ or contact the IR team for more information at investor.relations@faron.com.

 

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com  

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

 

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

 

About Bexmarilimab

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

 

About Faron Pharmaceuticals Ltd.

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

 

Forward-Looking Statements

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

 

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

 

Faron to Host BEXMAB Webcast

 

Faron Pharmaceuticals Ltd.

 

(“Faron” or the “Company”)

 

 

Faron to Host Webcast to Discuss Latest Data from Phase 1 Part of the BEXMAB Study of Bexmarilimab

 

Press Release, March 14, 2024

 

TURKU, Finland / BOSTON, Massachusetts – March 14, 2024 – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces it will host a virtual BEXMAB update event on Tuesday, March 19 at 11.00 EET/9am GMT, following the most recent data cut-off and scheduled analysis.

 

Participants of the webcast will include Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki and BEXMAB Principal Investigator; Dr. Maija Hollmen, PhD, Chief Scientific Officer at Faron, Dr Juho Jalkanen, MD, PhD, Chief Operating Officer at Faron and members of Faron’s senior management team.

 

During the event the Company will discuss latest data from the ongoing BEXMAB trial in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients, with a particular focus on the durability of remission and objective responses following treatment with bexmarilimab in combination with standard of care. This interactive event will also include an introduction to myeloid leukemia, insights into bexmarilimab’s unique mode of action and the Company’s latest understanding of the early and long-term efficacy of bexmarilimab treatment. Faron will also provide an update on bexmarilimab’s future development pathway and business opportunity. Part of the discussion will be done in Finnish and summary in English.

 

There will be an opportunity to ask questions during the webcast. To register for the event visit: https://faron.videosync.fi/bexmab-study-update/ or contact the IR team for more information at investor.relations@faron.com.

 

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com  

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

 

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

 

About Bexmarilimab

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

 

About Faron Pharmaceuticals Ltd.

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

 

Forward-Looking Statements

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

 

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

 

Binding commitments for convertible loans

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, NEW ZEALAND, 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 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: The Company has received binding commitments for convertible loans in the total amount of EUR 3.2 million enabling the Company to make critical payments and to continue preparing alternative short- and long-term financing options.

 

 

Company announcement, 4 March 2024 at 7:00 a.m. GMT / 9:00 a.m. EET

Inside information

 

Key highlights

          Binding commitments for convertible loans obtained from certain existing shareholders allowing the Company to make critical payments to third parties under agreed waivers with IPF.

          Active participation in the round by early investors of the Company.

          Receipt of the EUR 3.2 million committed funding enables the Company to secure its immediate short-term financing needs until the end of March 2024, in addition to which approximately EUR 5 million of further short-term bridge financing is required.

          The Company continues active endeavors and is in continuous discussions to secure longer term funding. In addition to the short-term bridge financing, the Board intends to propose to the Annual General Meeting an authorization for a larger share issue.

          The next BEXMAB readout will be provided to markets in mid-March. To complete the enrolment of the phase 2 of the BEXMAB study with interim and final readouts and to obtain regulatory feedback from the FDA, the Company expects to need EUR 35 million in total.

          The unaudited total cash and cash equivalents held by the Company was ca. EUR 4.3 million as of 19 February 2024. The Company further provides certain unaudited preliminary financial information in the announcement.

 

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 that it has obtained binding and irrevocable commitments amounting to a total of EUR 3.2 million (“Commitments”) from a limited number of the Company’s existing shareholders (“Investors”) to subscribe for convertible loan instruments to be issued by the Company (“Loans”).

 

As was announced by the Company on 19 February 2024, the Company was in breach of several undertakings agreed in the secured debt agreement with IPF Fund II SCA, SICAV-FIAR (“IPF”) as Lender and Faron Pharmaceuticals Ltd as Borrower (“Facilities Agreement”), and as a result of such Events of Default, IPF blocked the Company’s bank accounts which are pledged to IPF.

 

Based on the Commitments, IPF has allowed the Company to make certain critical payments and, upon the Company’s receipt of the Loan funds in full no later than 8 March 2024, agreed to waive certain Events of Default under the terms of the Facilities Agreement (“Waiver”) and to unblock the Company’s bank accounts, allowing the Company to make payments to third parties without a separate consent from IPF. The Loans are fully subordinated to the Facilities Agreement and the Company will not make any extraordinary payments to IPF other than agreed waiver fees. As part of the Waiver the minimum cash covenant will be lowered to EUR 4.5 million until 30 April 2024 and thereafter it returns to the previously agreed level. In accordance with the Waiver, the Company shall issue to IPF additional special rights which entitle them to subscribe for new ordinary shares in the Company (“Warrants”), with an exercise price equal to the volume-weighted average price of the Company’s share during the three trading days preceding the date of the Waiver (“Strike Price”). The number of Warrants is calculated by dividing 10% of the original loan amount (EUR 10 million) by the Strike Price. The Warrants are exercisable for a period of seven years and the Company will separately publish an announcement on the issuance of the Warrants. Simultaneously, the Company and IPF have agreed on certain amendments to the fee structure under the Facilities Agreement.

 

Receipt of the EUR 3.2 million pursuant to the Loans enables the Company to secure its immediate short-term financing needs until the end of March 2024. The Company continues active endeavors and is in discussions to secure its short and longer-term financing needs, including first additional bridge financing of approximately EUR 5 million, to secure publishing of the Company’s annual accounts for the year 2023 on 13 March 2024 and continued compliance with the cash covenants agreed in the Waiver.

 

Further, the Board of Directors of Faron intends to propose to the Annual General Meeting (scheduled to be held on 5 April 2024) an authorization for a larger share issue, contemplated to be launched as a public offering (with planned allocation preferences to existing shareholders and bridge finance lenders (including the Investors to enable the conversion of the Loans) and in compliance with the relevant securities markets regulation) as soon as practicable once the required preparations and approvals are in place. The receipt of long-term financing is necessary to secure funding for 2024 and especially the uninterrupted continuation of the Company’s BEXMAB study to full read out of the Phase II study and FDA feedback on registrational study design during 2024. The targeted size of the contemplated share issue is planned to be set accordingly, to meet these cash runway needs for 2024. The Company is also evaluating and continuously negotiating several business development alternatives that may result in non-dilutive funding.

 

This fundraise will enable us to meet our immediate financing needs and continue our ambitious bexmarilimab development program, with a focus on delivering next milestones,” said Dr. Markku Jalkanen, Chief Executive Officer of the Company. “These funds are part of the larger financing plan to secure cash runway for 2024 and to complete Phase II study and receive FDA’s guidance for the pivotal study part. We would like to thank support from our investors in developing this novel immunotherapy, especially for myeloid leukemia with very few treatment options”. To support the Company’s short-term financing, the Company’s CEO has agreed to give up his salary for the coming three months.

 

The Company expects to publish the next BEXMAB phase I read out in mid-March with special focus on durability of bexmarilimab efficacy on HMA-failed MDS patients known to have very short life expectancy post HMA failure. To complete the enrolment into the ongoing phase 2 of the BEXMAB study, to produce interim and final readouts from the study and to get regulatory feedback from the FDA, the Company expects to need EUR 35 million in total.

 

The unaudited total cash and cash equivalents held by the Company was ca. EUR 4.3 million as of 19 February 2024. The Company also provides the following preliminary, unaudited financial information: on 19 February 2024 the Company’s gross debts were around EUR 13.8 million and net debts around EUR 9.4 million. The Company’s financial statements bulletin for the financial year ended 31 December 2023 is planned to be published on 13 March 2024 subject to the receipt of the approximately EUR 5 million of additional bridge financing.

 

DETAILS OF THE EUR 3.2 MILLION LOAN ARRANGEMENT

 

In accordance with the Commitments from several Investors, the Company will by 8 March 2024 obtain Loans amounting to a total of approximately EUR 3.2 million which are fully subordinated to the Facilities Agreement. The Loans shall be converted to new shares in the Company as a part of (and at the subscription price of) the next investment round where shares or other equity securities are issued by the Company to existing shareholders and/or new third- party investors, with a minimum size of EUR 8 million (“Investment Round”). In the event that the subscription price in such Investment Round exceeds EUR 1.50 per share, an Investor shall have the right to postpone the conversion of the Loan until 10 June 2024 (“Due Date”). In the event that there is no Investment Round by the Due Date (or the subscription price of the Investment Round exceeds EUR 1.50 per share and the respective Investor has decided to postpone the conversion of the Loan) and the Loan has not been otherwise repaid prior to the Due Date (subject to a subordination agreement to be entered into between the Investors, the Company and IPF), then the Loan shall be at the request of the Investor converted into new shares in the Company in connection with the Due Date. In such case, the subscription price per share shall be EUR 1.50 per share. However, if then the Lender elects not to exercise its conversion right on the Due Date, (such option being only available if there has not been any Investment Round), the Due Date of the Loan will automatically be extended until 31 December 2024 (“Final Due Date”). On such Final Due Date, the Loan shall be either repaid in full in cash, subject to the terms of the subordination agreement, or converted into new shares in the Company with the subscription price of EUR 1.50 per share, subject to a valid share issue authorization being in place. In case the Loan is converted before the Due Date, each Investor is entitled to an arrangement fee of 15% of its respective Loan amount. If conversion has not taken place prior to the Due Date, the arrangement fee will be 30% of the Investor’s respective Loan amount. No interest shall be payable on the Loan if a conversion takes place before 30 May 2024, and thereafter the interest will be 12% + 3-months Euribor and paid subject to the subordination agreement.

 

RELATED PARTY TRANSACTION

 

Timo Syrjälä, an existing shareholder in the Company, has committed to participate in the Loan in the amount of EUR 600,000. 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, is on the date of this release 13,410,336 shares, representing 19.5 % of all shares and votes in the Company. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules for Companies (the “AIM Rules”). His commitment to participate in the Loan is a related party transaction for the purposes of the AIM Rules, the First North Rulebook and the Finnish Limited Liability Companies Act. The members of the Board of 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 Loan to be fair and reasonable insofar as shareholders are concerned.

 

 

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, Funding & 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

 

 

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 LOANS, ANY SECURITIES ISSUED UPON CONVERSION OF THE LOANS AND ANY SECURITIES ISSUED IN THE INVESTMENT ROUND (COLLECTIVELY, THE “SECURITIES”) 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 SECURITIESIN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE SECURITIES 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.

 

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 completion and use of proceeds from the Placing, 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.

Continued Negotiations Regarding Events of Default

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 DOES NOT CONSTITUTE AN OFFER OF ANY OF THE SECURITIES DESCRIBED HEREIN.

 

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”)

 

 

Company announcement, February 21, 2024 at 2 p.m. GMT / 4 p.m. EET

 

Inside information: the Company continues active negotiations regarding Events of Default under the terms of the Funding Agreement between IPF Fund II SCA, SICAV-FIAR and Faron Pharmaceuticals Ltd and contemplates alternative short- and long-term financing options

 

 

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 that, in relation to the Events of Default under the terms of the Funding Agreement between IPF Fund II SCA, SICAV-FIAR (“IPF”) and Faron, as announced by the Company on February 19, 2024, Faron Pharmaceuticals Ltd continues active negotiations to receive a waiver from IPF and to unblock the pledged bank accounts.

 

Faron is contemplating alternative short- and long-term financing options, and as a part of the possible long-term financing arrangements the Board of Directors of Faron intends as one of the alternatives to propose to the Annual General Meeting an authorisation for a rights issue contemplated to be launched when the required preparations and approvals are in place. The notice to the Annual General Meeting will be published separately at a later date.

 

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, Funding & 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

 

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 [RIGHTS] 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 [RIGHTS] IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES.

 

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”, ”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.

Events of Default

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”)

 

 

Company announcement, February 19, 2024 at 10:30 a.m. GMT / 12:30 p.m. EET

 

Inside information: the Company is in Events of Default under the terms of the Funding Agreement between IPF Fund II SCA, SICAV-FIAR and Faron Pharmaceuticals Ltd

 

 

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 that it is in breach of several undertakings agreed in the secured debt agreement dated February 28, 2022 between IPF Fund II SCA, SICAV-FIAR (“IPF”) as Lender and Faron Pharmaceuticals Ltd as Borrower (“Funding Agreement”) and subsequent waiver letters provided by IPF, and is therefore in several Events of Default, as defined in the Funding Agreement.

 

Faron’s bank accounts are pledged to IPF and IPF has notified Faron’s banks of the blocking of the Pledged Accounts due to the above mentioned breaches.  The Company presently does not have ability to remedy the breaches, nor make payments to third parties without separate consent from IPF.  Negotiations related to possible restructuring of the loan facility as well as waiver of covenant obligations are ongoing with IPF.  A further announcement will be made in due course.

 

The total cash and cash equivalents held by the Company is currently ca. EUR 4.3 million, which are enough to cover the company’s financing needs until the beginning of April, 2024.

 

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, Funding & 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

 

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”, ”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.

Back to top