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.

 

Appointment of Chief Financial Officer

Faron Pharmaceuticals Oy

(“Faron or the “Company”)

 

Insider Information: Appointment of Chief Financial Officer

 

Company announcement, Inside information

 

15 April 2024 at 2:00 a.m. EDT / 7:00 a.m. BST / 9:00 a.m. 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 the appointment of Yrjö Wichmann as the Company’s interim Chief Financial Officer (CFO), effective 15 April, 2024. Mr. Wichmann succeeds James O’Brien, who is leaving Faron to pursue another career opportunity.

 

Mr. Wichmann served as the Company’s CFO between 2014 and 2019 and is an accomplished biotech and financial executive with over 20 years’ experience in financing and investment banking. Most recently, Mr. Wichmann has served as Senior Vice President, Financing & IR at Faron. Prior to his roles at Faron, Mr Wichmann held a number of senior positions within the life sciences and biotechnology sector at IP Finland Oy, Biohit Oyj (NASDAQ OMX Helsinki), CapMan Oyj, FibroGen Europe Oyj (NASDAQ) and D. Carnegies & Co AB. He is a member of the Investment Committee at Dasos Timberland Fund I and II and a board member at Nordic Science Investment Oy. Mr Wichmann holds a Master’s in Economics from Helsinki University.

 

“As a former CFO of this Company and, most recently, our Senior Vice President, Financing & IR, Yrjö is well positioned to take up the role of Interim CFO whilst we look for a permanent replacement.” said Chief Executive Officer of Faron, Dr. Markku Jalkanen. “On behalf of the Board, I would like to thank Jim for his service to Faron. His contributions, during very challenging market conditions, have been considerable and very much appreciated, and we wish him all the best in his next role.”

  

Mr. Wichmann, incoming Interim Chief Financial Officer said: “As we continue to progress our ambitious program for bexmarilimab, my priority is to advance a financing plan that will secure our cash runway and enable the rapid development of this important, novel immunotherapy, which has enormous potential for patients and shareholders. I look forward to working with Markku, the Board and incoming CEO, Juho Jalkanen, to deliver on our next milestones.”

 

James O’Brien, outgoing Chief Financial Officer, said: “During my time at Faron, I have been impressed by the strength of its science and by the professionalism and unwavering commitment of the team, and I continue to believe in the potential of bexmarilimab to provide a new, safe and effective treatment option for patients suffering from aggressive cancers.  I wish the team great success for the future.”

 

 

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.

 

 

Decisions of the Board of Directors

Faron Pharmaceuticals Oy

(“Faron or the “Company”)

Decisions of the Board of Directors

Company announcement, April 8, 2024 at 9:05 (EEST) / 7:05 AM (GMT) / 12:05 AM (EDT)  

TURKU, FINLAND / BOSTON, MA – The annual general meeting (“AGM”) of Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) took place on April 5, 2024 and after the AGM, the Board of Directors (“Board”) convened.

 

Frank Armstrong and Erik Ostrowsi did not stand for re-election and thus their tenure in the Company Board of Directors ended at the end of the AGM on 5 April, 2024.

 

At the meeting of the Board held following the AGM, Tuomo Pätsi was elected as the Chair of the Board.

 

In addition, the Board elected the Chairs and other members to the Board committees from among its members as follows:

  • Markku Jalkanen was elected the Chair of the Audit Committee and Marie-Louise Fjällskog and John Poulos were elected as members of the Audit Committee.
  • Tuomo Pätsi was elected the Chair of the Nomination Committee and Markku Jalkanen and Christine Roth were elected as the other members of the Nomination Committee.
  • John Poulos was elected as the Chair of the Remuneration Committee and Tuomo Pätsi and Christine Roth were elected as the other members of the Remuneration Committee.
  • John Poulos was elected as the Chair of the Business Development Committee and Markku Jalkanen and Juho Jalkanen were elected as the other members of the Business Development Committee

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

 

 

Appointment of Chief Executive Officer

Faron Pharmaceuticals Oy

 

(“Faron or the “Company”)

 

Appointment of Chief Executive Officer

 

 

Company announcement, April 8, 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 that its Chief Executive Officer (CEO) Dr. Markku Jalkanen, who turns 70 later in 2024, has informed the Board of Directors of his wish to retire from his position as the Company’s CEO during the course of Q2 2024, while continuing in his role as Board Member.

 

As a part of its ordinary tasks and noting the age of the current CEO, the Nomination Committee of the Board has maintained preparedness for CEO succession with the help of a third-party recruitment specialist firm, and considered several options for a potential new CEO for the Company among external and internal candidates. Supported by the preparatory work conducted, the Nomination Committee has concluded that the Company’s current Chief Operating Officer, Dr. Juho Jalkanen, MD, PhD, MSc (economics), would be the best candidate to succeed Dr. Markku Jalkanen as CEO of the Company. Following information from Dr. Markku Jalkanen and the Nomination Committee’s recommendation, the Board has resolved to appoint Dr. Juho Jalkanen as CEO of the Company, effective May 1, 2024, subject to regulatory approval. Dr. Markku Jalkanen will continue as a Board Member and support in the transition of the CEO role throughout 2024.

 

“I am very happy that the AGM approved the proposals by the Board of Directors, creating an opportunity for the Company to continue efforts on fundraising for a longer-term solution. I have worked for the Company since its inception in 2006 and feel that now is the right time for me to retire as CEO of the Company and leave the operative helm,” said Dr. Markku Jalkanen, Chief Executive Officer of the Company. “The Board and I have a plan for a seamless CEO transition and now is the time to make that move. I will continue to give my support to the Company and the new CEO in my continuing role as Board Member. I also strongly believe in the promise of bexmarilimab to provide a new safe and effective cancer treatment option for a vast patient group, either as a stand-alone or combination therapy.”

 

“I am extremely honored that the Board has expressed its confidence in me as I assume the new challenge of CEO. I have enjoyed leading the development of bexmarilimab as COO and look forward to the exciting future ahead of us as I continue to work relentlessly with the Faron team to deliver results for patients and shareholders. I want to thank Markku for his leadership and mentorship as CEO,” said Dr. Juho Jalkanen, the incoming CEO.

 

 

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.

 

Results of the Annual General Meeting

Faron Pharmaceuticals Oy

(“Faron or the “Company”)

Results of the Annual General Meeting

   Change of Directors

Company announcement, 5 April 2024 at 14:00 (EEST) / 12:00 PM (BST)

TURKU, FINLAND / BOSTON, MA – The annual general meeting (“AGM”) of Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) took place at BioCity in Turku, Finland, today 5 April 2024. The AGM approved all the proposals of the Board of Directors (“Board”) and its committees, set out in the notice of the AGM published on 13 March 2024.

 

Decisions of the AGM
 

The AGM adopted the financial statements of the Company and resolved to discharge the members of the Board and the CEO of the Company from liability for the financial year 2023.

No dividend for the financial year 2023 will be paid, and the losses of the Company for the financial year, amounting to EUR 30.9 Million (IFRS), will be carried forward to the reserve for invested unrestricted equity.

Composition and remuneration of the Board

 

The number of members of the Board was confirmed as five. Tuomo Pätsi, Markku Jalkanen, John Poulos, Marie-Louise Fjällskog and Christine Roth were re-elected to the Board for a term that ends at the end of the next AGM.

The AGM resolved that the annual remuneration of the members of the Board remain unchanged and that EUR 35,000 will be paid to the Board members, in addition to which an annual remuneration of EUR 35,000 will be paid to the chair of the Board. In addition, a further annual remuneration of EUR 11,000 will be paid to the chair of the audit committee, a further annual remuneration of EUR 9,000 will be paid to the chair of the remuneration committee and a further annual remuneration of EUR 6,000 will be paid to the chair of the nomination committee. In addition, a further annual remuneration of EUR 6,000 will be paid to the audit committee members, a further annual remuneration of EUR 5,000 will be paid to the remuneration committee members and a further annual remuneration of EUR 3,000 will be paid to the nomination committee members.

Meeting fees will be paid to the Board members as follows:

  • a meeting fee of EUR 1,000 will be paid to Board members per Board meeting where the Board member was physically present, and which was held on another continent than the member’s place of residence; and
  • No meeting fees will be paid to Board members who were attending a Board meeting but not physically present or for Board meetings held on the same continent than the member’s place of residence.

In addition, all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board would be compensated.

No remuneration will be paid based on the Board membership of the CEO of the Company or a person serving the Company under a full-time employment or service agreement.

Auditor

 

Audit firm PricewaterhouseCoopers Oy (“PwC”) was re-elected as the Company’s auditor. PwC has appointed Panu Vänskä, authorized public accountant (KHT), as the key audit partner. It was decided that the auditor be remunerated in accordance with the invoice approved.

 

Resolution on the establishment of Shareholder’s Nomination Board

 

The AGM resolved to establish a Shareholders’ Nomination Board for the Company and its Charter as proposed by the Board was adopted.

 

Authorization to the Board to decide on the issuance of shares, options or other special rights entitling to shares

 

The Board was authorized to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in Chapter 10, Section 1 of the Finnish Limited Liability Companies Act, which authorization contains the right to issue new shares or dispose of the Company’s own shares in the possession of the Company. The authorization consists of up to twenty million (20,000,000) new shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately twenty nine (29) per cent of the shares and votes on the date of the AGM Notice, as well as the conveyance of up to the same maximum number (twenty million (20,000,000)) of treasury shares in the possession of the Company.

The Board was authorized to resolve on all other terms and conditions of the issuance of shares, options or other special rights entitling to shares.

The authorization is effective until 30 June 2025. This authorization does not cancel the authorization given to the Board by the Annual General Meeting on 24 March 2023 to resolve on issuances of shares, option rights or other special rights entitling to shares.

Authorization to the Board to decide on the issuance of shares

The Board was authorized to resolve on issuances of shares in connection with a larger share issuance, which authorization contains the right to issue new shares or dispose of the Company’s own shares in the possession of the Company. The authorization consists of up to thirty million (30,000,000) new shares in the aggregate, which corresponds to approximately 43,6 per cent of the shares and votes on the date of the AGM Notice, as well as the conveyance of up to the same maximum number (thirty million (30,000,000)) of treasury shares in the possession of the Company.

The Board was authorized to resolve on all other terms and conditions of the issuance of shares.

The authorization is effective until the close of the next Annual General Meeting of Shareholders to be held in 2025 and can only be used for the purposes of the contemplated public offering and the Company’s existing bridge financing needs.

The authorization does not cancel the remaining authorization given to the Board by the Annual General Meeting on 24 March 2023 to resolve on issuances of shares, option rights or other special rights entitling to shares, nor the authorization resolved by the AGM in agenda item 16.

 

Minutes of the AGM

 

The minutes of the AGM will be available on the Company’s website on 19 April 2024 at the latest.

 

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@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 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.

 

 

Faron´s Annual Report 2023

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

Faron´s Annual Report 2023

 

Company announcement, March 26, 2024

TURKU, Finland / BOSTON, Massachusetts – March 26, 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, announces today that its Annual Report for the year 2023 and audited financial statements for the accounting period January 1- December 31, 2023 in English, and its financial statements in Finnish are now available on the Company’s website: Faron Full-year results for the twelve months ended December 31, 2023 | Faron

 

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.

 

Click on, or paste the following link into your web browser, to view the associated PDF document:

https://www.faron.com/sites/faron-corp/files/Faron-Pharmaceuticals_Annual-Report-2023.pdf

 

 

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.

 

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