Board Change

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

 

Board Change

 

 

Company announcement, March 24, 2023 at 15.35 PM (EET) / 13.35 PM (GMT) / 09.35 AM (EDT)  

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers, is pleased to announce the appointment of Mr. Tuomo Pätsi as a Non-Executive Director of the Company following the passing of all resolutions put to shareholders of the Company at the Annual General Meeting held earlier today. In addition, Dr. Gregory B. Brown has today stepped down from his position as a Non-Executive Director of the Company.

 

“I am pleased to welcome Mr Pätsi to the Faron Board,” said Dr. Frank Armstrong, Chairman of the Board of Faron Pharmaceuticals. “He brings extensive experience of the commercialization and launch of new oncology products with leading cancer companies, and his expertise will be valuable as the Company continues the development of bexmarilimab. I’d also like to thank Dr. Brown for his service to the Faron Board.”

 

Mr. Pätsi was the President of the EMEA region and Worldwide Markets for Celgene Corporation, a global pharmaceutical company and currently wholly owned subsidiary of Bristol Myers Squibb, engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer. He is an experienced biotech and pharmaceutical executive who was until recently the Executive Vice President for Seagen Inc., a US-based cancer-focused biotechnology company.

 

“I am looking forward to joining the Board of Faron at this exciting time,” said Mr Pätsi. “Bexmarilimab with its innovative mechanism of action and clinical data so far holds great promise in multiple cancer indications where better treatments are desperately needed.”

 

Mr. Pätsi has over 30 years’ experience working in biotech and pharmaceuticals, with more than 10 years working at Celgene in various senior management roles, including as President of European and International Operations and President of the EMEA region and Worldwide Markets. Prior to this, he served as Vice President of Europe for Human Genome Science, a specialty pharma organization in Europe. Earlier in his career, he held roles of increasing responsibility in pharmaceutical companies, including more than ten years at Amgen Inc.  Mr. Pätsi began his career as a Biomedical Research Scientist in Finland. He is a registered pharmacist and holds an MSc in pharmacology from the School of Pharmacy, Helsinki University.

 

Additional Disclosures

 

The following information regarding the appointment of Tuomo Tapani Pätsi (aged 58), is disclosed under Schedule 2(g) of the AIM Rules for Companies and Nasdaq First North Growth Market Rulebook.

 

Current positions, directorships and/or partnerships:

 

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

 

Celgene

 

Celgene ApS

 

Celgene BV

 

Celgene Distribution BV

 

Celgene EngMab GmbH

 

Celgene Europe BV

 

Celgene Europe Limited

 

Celgene Global Holdings Sàrl

 

Celgene GmbH

 

Celgene International II Sàrl

 

Celgene International III Sàrl

 

Celgene International Sàrl

 

Celgene Limited

 

Celgene Logisitics Sarl

 

Celgene Logistics Sàrl

 

Celgene Management Sàrl

 

Celgene Netherlands BV

 

Celgene Netherlands II BV

 

Celgene Netherlands Investment BV

 

Celgene R&D Sàrl

 

Celgene Receptos Limited

 

Celgene Receptos Sàrl

 

Celgene Research SL

 

Celgene SL

 

Celgene Spółka SOO

 

Celgene sro

 

Celgene Switzerland Sàrl

 

Celgene Tri Sàrl

 

EngMab Sàrl

 

Interpharma

 

Juno Therapeutics GmbH

 

Mr. Pätsi does not have any beneficial interest in the ordinary shares or options over the ordinary shares of the Company.

 

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

 

For more information please contact:

 

Media Contact

Faron Pharmaceuticals

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880
 

Peel Hunt LLP, Broker
Christopher Golden, James Steel
Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen
Phone: +358 (0)40 555 4727
Jukka Järvelä
Phone: +358 (0)50 553 8990

 

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

 

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

Results of AGM

Faron Pharmaceuticals Oy

(“Faron or the “Company”)

Results of the Annual General Meeting and Decisions of the Board of Directors

Company announcement, March 24, 2023 at 15.30 (EET) / 13.30 PM (GMT) / 09.30 AM (EDT)  

TURKU, FINLAND / BOSTON, MA – The annual general meeting (“AGM”) of Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) took place at BioCity, meeting room “Ministeri” in Turku, Finland today, March 24, 2023. 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 March 3, 2023.

 

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 2022.

No dividend for the financial year 2022 will be paid, and the losses of the Company for the financial year, amounting to EUR 28.7 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 seven. Frank Armstrong, John Poulos, Leopoldo Zambeletti, Markku Jalkanen, Anne Whitaker and Erik Ostrowski were re-elected to the Board and Tuomo Pätsi was elected as a new member to the Board for a term that ends at the end of the next AGM.

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.

 

Amendment of the Articles of Association

 

The AGM resolved to amend the articles of association of the Company, to enable holding a General Meeting entirely without a meeting venue, as a so-called remote meeting, in addition to the Company’s domicile and London. The amended clause reads as follows:

“11§ Meeting venue

A General Meeting may in addition to the Company’s domicile be held in the city of London, United Kingdom, based on a resolution of the Board of Directors. In addition, the Board of Directors may decide that the General Meeting of the Shareholders be held without a meeting venue so that the shareholders exercise their power of decision in full in real time during the meeting using a telecommunications connection and technical means (remote meeting).”

 

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 twelve million five hundred thousand (12,500,000) new shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately twenty (20) per cent. Of the existing shares and votes 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.

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 June 30, 2024.

 

Resolution on the amendment of the option programme and authorising the Board to decide on the issuance of options or other special rights entitling to shares
 

The Board was authorized to resolve on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act, and the terms and conditions have later been amended by the decision of the Company’s AGM on May 18, 2020 (the “Share Option Plan 2019”). The AGM decided to amend the terms and conditions of the Share Option Plan 2019, so that a maximum total of four million three hundred and fifty thousand (4,350,000) options can be offered under said terms and conditions as follows:

 

  • to the chair of the Board, a maximum of two hundred and fifty thousand (250,000) options (before the amendment one hundred and eighty thousand (180,000) options);
  • to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein), a maximum of one hundred and twenty-five thousand (125,000) options (before the amendment ninety thousand (90,000) options);
  • to the Chief Executive Officer, a maximum of four hundred and ninety-five thousand (495,000) options (before the amendment three hundred and sixty thousand (360,000) options);
  • to the Chief Financial Officer, a maximum of one hundred and eighty thousand (180,000) options (before the amendment one hundred and thirty thousand (130,000) options); and
  • for any other non-employee person as determined by the Board, a maximum of seventy thousand (70,000) options (before the amendment fifty thousand (50,000) options).

Excluding the addition concerning the listing on Nasdaq Helsinki and the extension of the duration of the authorization, the terms and conditions of the option program remain otherwise unchanged.

The amendment increases the maximum total number of options under the Share Option Plan 2019 by two million three hundred and fifty thousand (2,350,000) options. This increases the aggregate per centage of shares that can be subscribed for based on options from 3.1 per cent. to 6.9 per cent. of all shares registered at the date of the AGM Notice. The maximum number of options granted to the chair of the Board increases by seventy thousand (70,000) options, representing an increase of approximately 38.9 per cent., the maximum number of options granted to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein) increases by thirty five thousand (35,000) options, representing an increase of approximately 38.9 per cent., the maximum number of options granted to the Chief Executive Officer increases by one hundred and one hundred and thirty five thousand (135,000) options, representing an increase of 37.5 per cent., the maximum number of options granted to the Chief Financial Officer increases by fifty thousand (50,000) options, representing an increase of approximately 38.5 per cent. And the maximum number of options granted to other non-employee persons as determined by the Board increases by twenty thousand (20,000) options, representing an increase of 40.0 per cent., over the current maximum totals.

The AGM authorized the Board to resolve by one or several decisions on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act. The authorization consists of up to two million four hundred seventy-three thousand and eighty-four (2 473 084) shares, options or other special rights entitling to shares in the aggregate, which corresponds to approximately 3.9 per cent. of the existing shares and votes in the Company.

The authorization does not exclude the Board’s right to decide on the issuance of options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights. The authorization will be used for implementing an option plan for the employees and directors of, and persons providing services to, the group, substantially in the form of the amended Share Option Plan 2019 attached to the Notice of the AGM available of the Company’s website. There is a weighty financial reason for issuing options, as options are an integral part of the incentivization system for the management and personnel of the Company.

The exercise of options will be subject to fulfilment of certain criteria to be resolved by the Board (the “Exercise Conditions”). Subject to fulfilment of the Exercise Conditions, the options may be exercised at the exercise price, which may not be less than the market value of a share at the grant date, as determined by the Board (the “Exercise Price”). In determining such market value, if shares are traded on Nasdaq Helsinki and/or on the AIM market of the London Stock Exchange, the Board shall have regard to the average price per share at which shares have been traded over a period of 90 days immediately preceding the grant date. The Exercise Price will be determined to create a sufficient incentive for the recipients of options. The Exercise Price shall be recorded in the Company’s reserve for invested unrestricted equity.

The Company’s Board was authorized to resolve on all other terms and conditions of the issuance of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act.

The authorization will be effective until June 30, 2026. This authorization shall not replace other authorizations granted to the Board (but for the sake of clarity, replaces the authorization granted in 2019 relating to the Share Option Plan 2019).

Decisions of the Board

 

At the meeting of the Board held following the AGM, Frank Armstrong was re-elected Chair of the Board.
 

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

  • Erik Ostrowski was elected the Chair of the Audit Committee and Leopoldo Zambeletti and Tuomo Pätsi were elected as members of the Audit Committee.
  • Frank Armstrong was elected the Chair of the Nomination Committee and Anne Whitaker and Tuomo Pätsi were elected as the other members of the Nomination Committee.
  • Anne Whitaker was elected as the Chair of the Remuneration Committee and Frank Armstrong, John Poulos and Leopoldo Zambeletti were elected as the other members of the Remuneration Committee.

 

Minutes of the AGM

 

The minutes of the AGM will be available on the Company’s website on April 6, 2023 at the latest.

For more information please contact:

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Faron Pharmaceuticals Oy 

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

 

Positive FDA Feedback to Progress Bexmarilimab

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Inside Information: Faron Announces Positive US Food and Drug Administration (FDA) Feedback to Progress Bexmarilimab as a Monotherapy in Solid Tumors

      Green light for continued clinical development after data package review

      Alignment with company’s selection of 1 mg/kg IV once-every-3-weeks (Q3W) as dose for further evaluation

      Supportive of biomarker-driven approach with CLEVER-1 staining of tumor biopsy

Company announcement, March 22, 2023 at 03:00 AM (EDT) / 07:00 AM (GMT) / 09:00 AM (EET)

Inside information

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers, announces positive FDA feedback and recommendations for the future development of bexmarilimab as a monotherapy in multiple solid tumors. The agency’s advice follows an end-of-Phase I/II meeting this month. The Phase I/II MATINS trial is investigating bexmarilimab, Faron’s wholly owned precision immunotherapy asset, in multiple cancer indications.

The official meeting minutes are consistent with the FDA’s Project Optimus initiative to reform dose optimization and the selection paradigm in oncology drug development, which MATINS sought to comply with through multiple dose and indication arms of the study.  FDA provided the following positive meeting feedback which further aligns the agency’s views on bexmarilimab with the Company’s, including:

      Completed toxicology studies are adequate to support further clinical development of single-agent (monotherapy) bexmarilimab into a registration trial

      Selection of 1 mg/kg IV Q3W as dose for further evaluation appears reasonable, although additional data are required to establish the recommended Phase II/III dose for specific cancer(s)

      Valuable feedback and guidance on further development of a simple, validated staining assay to identify patients with CLEVER-1 positive tumors for clinical trial inclusion

“We are pleased to have received these positive and supportive FDA recommendations for the continued clinical development of bexmarilimab as a monotherapy in solid tumors,” said CEO Markku Jalkanen. “As a first-in-human study for bexmarilimab, MATINS has laid the groundwork for multiple routes to market.”

Faron had previously announced a meeting with the agency would occur this quarter.

“FDA’s feedback on the MATINS study gives Faron an excellent roadmap to plot out bexmarilimab’s future strategy,” said Chief Medical Officer Marie-Louise Fjällskog. “We thank the FDA for its time and consideration of our briefing package and anticipate additional fruitful interactions.”

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

 

For more information please contact:

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

About MATINS

MATINS has demonstrated a positive safety profile in more than 200 patients treated with bexmarilimab. The study has observed an approximate 30% clinical benefit rate in several tumor types, which is associated with an interferon gamma (IFN-y) increase and leads to a significant survival benefit. Moreover, responding patients can be potentially identified using baseline IFN-y or CLEVER-1 expression. CLEVER-1 is a novel immune checkpoint, a receptor shown to promote an immunosuppressive environment.

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

Forward-Looking Statements

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

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

 

Notice of Faron Pharmaceuticals Ltd’s AGM

NOTICE OF faron pharmaceuticals LTD’s ANNUAL GENERAL MEETING

Shareholders of Faron Pharmaceuticals Ltd (the “Company”) are notified of the Annual General Meeting (the “AGM”) to be held on March 24, 2023 at 9:00 a.m. EET (Finnish time) at BioCity, meeting room “Ministeri” at Tykistökatu 6, FI-20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 8:30 a.m. EET (Finnish time).

The Company’s Annual Report 2022 is available to view and download on the Company’s website at https://www.faron.com/.

 

  1. MATTERS ON THE AGENDA OF THE ANNUAL GENERAL MEETING

 

  1. Opening of the meeting

 

  1. Calling the meeting to order

 

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

 

  1. Recording the legality of the meeting

 

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

 

  1. Presentation of the financial statements, the report of the Board of Directors and the auditor’s report for 2022

 

Review by the CEO.

 

  1. Adoption of the financial statements

 

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

 

The Board of Directors (the “Board”) proposes that no dividend for the financial year 2022 will be paid and that the losses of the Company for the financial year, amounting to EUR 28.7 million (IFRS), will be carried forward to the reserve for invested unrestricted equity.

 

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

 

  1. Resolution on the remuneration of the members of the Board

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

The Board furthermore proposes that meeting fees will be paid to the Board members as follows:

                a meeting fee of EUR 1,000 will be paid to Board members per Board meeting where the Board member was physically present, and which was held on another continent than the member’s place of residence; and

                no meeting fees will be paid to Board members who were attending a Board meeting but not physically present or for Board meetings held on the same continent as the member’s place of residence.

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

The Board also proposes, on the basis of the proposal of the remuneration committee, that no remuneration will be paid based on the Board membership of the CEO of the Company or a person serving the Company under a full-time employment or service agreement.

 

  1. Resolution on the number of members of the Board

 

The Board proposes, on the basis of the proposal of the nomination committee, that seven (7) members be elected to the Board.

 

  1. Election of members of the Board

 

The Board proposes, on the basis of the proposal of the nomination committee, that Frank Armstrong, John Poulos, Leopoldo Zambeletti, Markku Jalkanen, Anne Whitaker and Erik Ostrowski be re-elected to the Board for a term that ends at the end of the next AGM. In addition, the Board proposes, on the basis of the proposal of the nomination committee, that Tuomo Pätsi be elected as a new member to the Board for a term that ends at the end of the next AGM.

 

Tuomo Pätsi, citizen of Finland and Switzerland, holds no other board memberships at the moment. He is

independent of the Company and its significant shareholders. Information on the proposed new Board member is available on the Company’s website at https://www.faron.com/investors/general-meetings.

 

All proposed Board member candidates have given their consent for the election. The proposed Board members have informed the Company that in the event they are elected, they intend to elect Frank Armstrong as chair of the Board.

 

Information on the Board member candidates proposed to be re-elected are available on the Company’s website at https://www.faron.com/faron/leadership/board-directors.

 

  1. Resolution on the remuneration of the auditor

 

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

 

  1. Election of the auditor

 

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

 

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

 

  1. Amendment of the Articles of Association

 

The Board proposes that article 11 § of the Articles of Association of the Company (Meeting venue) be amended to enable holding a General Meeting entirely without a meeting venue as a so-called remote meeting in addition to the Company’s domicile and London. The said clause would read amended as follows:

 

“11§ Meeting venue

 

A General Meeting may in addition to the Company’s domicile be held in the city of London, United Kingdom, on the basis of a resolution of the Board of Directors. In addition, the Board of Directors may decide that the General Meeting of the Shareholders be held without a meeting venue so that the shareholders exercise their power of decision in full in real time during the meeting using a telecommunications connection and technical means (remote meeting).”

 

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

 

The proposal is based on the changes to Chapter 5 of the Finnish Companies Act, including the possibility to arrange general meetings remotely. Arranging a General Meeting as a remote meeting only, requires specific language in the Articles of Association. The legislative changes are based on the premise that, irrespective of the chosen General Meeting format, shareholders’ rights must not be compromised and that all participating shareholders can exercise their shareholder rights in full in real time, including the right to present questions and vote. The possibility to organize General Meetings remotely enables the Company to prepare for rapid changes in the Company’s operating environment and society in general, which may be caused, for example, by pandemics. It is important that the Company has the necessary means to offer its shareholders the possibility to exercise their shareholder rights and resolve on any matters that are presented in a General Meeting under any circumstances.

 

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

 

The Board proposes that the AGM authorise the Board 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 authorisation contains the right to issue new shares or dispose of the Company’s own shares in the possession of the Company. The authorisation would consist of up to twelve million five hundred thousand (12,500,000) new shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately twenty (20) per cent of the existing shares and votes 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.

 

In practise, the above authorisation includes that the Board may first resolve on one or several share issues (up to the maximum number of twelve million five hundred thousand (12,500,000) new shares) without consideration to the Company itself and then further convey such treasury shares (up to the maximum number of twelve million five hundred thousand (12,500,000) shares) against consideration.

 

The authorisation would not exclude the Board’s right to decide on the issuance of shares, options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights.

 

The authorisation is proposed to be used for material arrangements from the Company’s point of view, such as financing (including, without limitation, issuance of warrants under the funding agreement with IPF Partners announced on February 28, 2022) or implementing business arrangements, investments or for other such purposes determined by the Board in which case a weighty financial reason for issuing shares, options or other special rights entitling to shares, and possibly deviating from the shareholders’ pre-emptive rights, would exist.

 

For the sake of clarity, it is noted that in no circumstances can the total number of new shares to be registered under this authorisation exceed twelve million five hundred thousand (12,500,000) new shares in aggregate.

 

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

 

The authorisation would be effective until June 30, 2024.

 

  1. Resolution on the amendment of the option programme and authorising the Board to decide on the issuance of options or other special rights entitling to shares

The Company’s AGM has on May 28, 2019 decided to authorise the Board to resolve on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act, and the terms and conditions have later been amended by the decision of the Company’s AGM on May 18, 2020 (the “Share Option Plan 2019”). The Board proposes, on the basis of the proposal of the remuneration committee, that the AGM would resolve to amend the terms and conditions of the Share Option Plan 2019, so that a maximum total of four million three hundred and fifty thousand (4,350,000) options (previously two million (2,000,000) options) would be offered under said terms and conditions as follows:

 

• to the chair of the Board, a maximum of two hundred and fifty thousand (250,000) options (before the amendment one hundred and eighty thousand (180,000) options);

• to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein), a maximum of one hundred and twenty five thousand (125,000) options (before the amendment ninety thousand (90,000) options);

• to the Chief Executive Officer, a maximum of four hundred and ninety five thousand (495,000) options (before the amendment three hundred and sixty thousand (360,000) options);

• to the Chief Financial Officer, a maximum of one hundred and eighty thousand (180,000) options (before the amendment one hundred and thirty thousand (130,000) options); and

• for any other non-employee person as determined by the Board, a maximum of seventy thousand (70,000) options (before the amendment fifty thousand (50,000) options).

 

Excluding the addition concerning the listing on Nasdaq Helsinki and the extension of the duration of the authorisation, the terms and conditions of the option programme would remain otherwise unchanged. The consolidated rules of the Share Option Plan 2019, incorporating the amendments proposed herein, are attached hereto as Annex 1. The proposed amendments provide greater flexibility to offer competitive equity incentive awards to senior leadership and wider employees in a competitive global talent market.

 

The proposed amendment would increase the maximum total number of options under the Share Option Plan 2019 by two million three hundred and fifty thousand (2,350,000) options. This would increase the aggregate per centage of shares that can be subscribed for based on options from 3,1 per cent to 6,9 per cent of all shares registered at the date of this proposal. The maximum number of options granted to the chair of the Board would increase by seventy thousand (70,000) options, representing an increase of approximately 38.9 per cent, the maximum number of options granted to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein) would increase by thirty five thousand (35,000) options, representing an increase of approximately 38.9 per cent, the maximum number of options granted to the Chief Executive Officer would increase by one hundred and thirty five thousand (135,000) options, representing an increase of 37.5 per cent, the maximum number of options granted to the Chief Financial Officer would increase by fifty thousand (50,000) options, representing an increase of approximately 38.5 per cent and the maximum number of options granted to other non-employee persons as determined by the Board would increase by twenty thousand (20,000) options, representing an increase of 40.0 per cent, over the current maximum totals.

 

In relation to the amendment proposed above, the Board further proposes, on the basis of the proposal of the remuneration committee, that the AGM authorise the Board to resolve by one or several decisions on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act. The authorisation would consist of up to two million four hundred seventy-three thousand and eighty four (2,473.084) shares, options or other special rights entitling to shares in the aggregate, which corresponds to approximately 3.9 per cent of the existing shares and votes in the Company.

 

The authorisation would not exclude the Board’s right to decide on the issuance of options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights. The authorisation is proposed to be used for implementing an option plan for the employees and directors of, and persons providing services to, the group, substantially in the form of the amended Share Option Plan 2019 attached hereto as Annex 1. There is a weighty financial reason for issuing options, as options are an integral part of the incentivisation system for the management and personnel of the Company. The maximum numbers of options to be granted shall be as presented above. For the sake of clarity it is noted that, as described above, the new amended maximum amounts include the options already granted under the Share Option Plan 2019, which is why the proposed size of the authorisation also takes into account the options already granted based on the previous authorisation.

 

The exercise of options will be subject to fulfilment of certain criteria to be resolved by the Board (the “Exercise Conditions”). Subject to fulfilment of the Exercise Conditions, the options may be exercised at the exercise price, which may not be less than the market value of a share at the grant date, as determined by the Board (the “Exercise Price”). In determining such market value, if shares are traded on Nasdaq Helsinki and/or on the AIM market of the London Stock Exchange, the Board shall have regard to the average price per share at which shares have been traded over a period of 90 days immediately preceding the grant date. The Exercise Price will be determined to create a sufficient incentive for the recipients of options. The Exercise Price shall be recorded in the Company’s reserve for invested unrestricted equity.

 

The Company’s Board would be authorised to resolve on all other terms and conditions of the issuance of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act.

 

The authorisation will be effective until 30 June 2026. This authorisation shall not replace other authorisations granted to the Board (but for the sake of clarity, replaces the authorisation granted in 2019 relating to the Share Option Plan 2019).

 

  1. Closing of the meeting

 

 

  1. DOCUMENTS OF THE ANNUAL GENERAL MEETING

The above-mentioned proposals to the AGM, the Company’s Annual Report 2022 including the financial statements, the Report of the Board of Directors and the Auditor’s Report and this notice are available on the Company’s website at https://www.faron.com/investors as of the date of publication of this notice. The Board’s proposals and the other above-mentioned documents will also be available at the AGM. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the AGM will be available on the Company’s website from 6 April 2023 at the latest.

  1. INSTRUCTIONS FOR THE PARTICIPANTS

 

  1. The right to participate and registration

Each shareholder who on the record date of the AGM, being March 14, 2023, is registered in the Company’s shareholders’ register held by Euroclear Finland Oy has the right to participate in the AGM. A shareholder whose shares are registered on their personal Finnish book-entry account is registered in the Company’s shareholders’ register. If you do not have a Finnish book-entry account, see section C3 “Holder of nominee-registered shares (including depositary interest holders)”.

A shareholder who is registered in the Company’s shareholders’ register and who wants to participate in the AGM should register for the meeting by no later than 10:00 a.m. EET (Finnish time) on Tuesday, March 21, 2023 by giving a prior notice of participation. The notice must be received before the end of the registration period. Notice of participation can be given:

          by email to general.meeting@faron.com or

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

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

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

  1. Proxy representative and powers of attorney

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

If a shareholder participates in the AGM by means of several proxy representatives, who represent the shareholder with shares held on different book-entry accounts, the shares represented by each proxy representative shall be identified when registering for the AGM.

The Company offers the possibility for shareholders to designate Yrjö Wichmann, VP, Financing & IR, as their proxy representative, to represent them at the AGM in accordance with shareholder’s voting instructions. Authorizing the designated proxy representative will not accrue any costs for the shareholder, excluding possible postal fees for proxy documents.

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

In addition to providing proxy documents, the shareholder or their proxy representative must take care of registering for the AGM in the manner described in this notice.

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

A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the AGM by virtue of such shares based on which the holder would be entitled to be registered in the Company’s shareholders’ register held by Euroclear Finland Oy on the AGM’s record date of March 14, 2023.

Additionally, participation requires that the holder of nominee-registered shares is on the basis of such shares temporarily registered in the Company’s shareholders’ register held by Euroclear Finland Oy by 10:00 a.m. EET (Finnish time) on Tuesday, March 21, 2023. As regards nominee-registered shares, this constitutes due registration for the AGM.

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

  1. Other instructions and information

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

Changes in shareholding occurred after the record date of the AGM do not affect the right to participate in the AGM or the number of votes held by a shareholder.

On the date of this notice, March 3, 2023, the total number of shares and votes in the Company is 63,497,691.

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

 

Turku, March 3, 2023

FARON PHARMACEUTICALS LTD

Board of Directors

 

For more information please contact:

Media / Investor Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

 

Faron´s Annual Report 2022 Published

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

Faron´s Annual Report 2022 Published 

 

Company announcement, March 3, 2023 at 02:15 AM (EST) / 07:15 AM (GMT) / 09:15 AM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, announces today that its Annual Report for the year 2022 and audited financial statements for the accounting period January 1- December 31, 2022 have been published in English, and its financial statements in Finnish.

 

Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, will host a virtual briefing and Q&A session for analysts at 7:00 AM (EST) / 12:00 PM (GMT) / 2:00 PM (EET) today. Webcast link: https://faron.videosync.fi/2022-financial-statement

 

The full-year results press release for 2022, presentation, virtual briefing webcast details, audited financial statements and Annual Report 2022 is available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards.

 

For more details about the analysts’ briefing, please contact Faron@consilium-comms.com.

 

For more information please contact:
 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

About Faron Pharmaceuticals Ltd.

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

Forward-Looking Statements

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

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

Financial Statement January 1 to December 31 2022

Faron Pharmaceuticals Oy

 

Faron’s Financial Statement Release January 1 to December 31, 2022

 

Financial statement release March 3, 2023 at 09:00 AM (EET) / 07:00 AM (GMT) / 03:00 AM (EDT)  

TURKU, FINLAND / BOSTON, MA Faron Pharmaceuticals Oy (“Company”, AIM: FARN, First North: FARON) together with its subsidiaries (“Faron”), a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announced audited full-year financial results for January 1 to December 31, 2022 (the “period”) and H2 2022 and provided an overview of recent corporate developments.

 

2022 Highlights

      Faron reported that for the Phase I/II BEXMAB study of bexmarilimab, in combination with standard of care (SoC), in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), that a partial responder achieved complete remission of blasts in blood and bone marrow followed by normalization of blood counts. A second patient showed reduced blast counts.

      Bexmarilimab has been evaluated as a single agent in the Phase I/II MATINS in more than 200 patients and found to be well-tolerated.

      In MATINS, median overall survival was 14.9 months for patients who achieved stabilization of disease from bexmarilimab compared to 4.4 months for those who did not, representing a 3.4-fold increase.

      Bexmarilimab ignites the immune system by inducing IFN-y production. A high baseline level of IFN-γ in the tumor indicates that the immune system is already set to attack cancer cells and seems required for PD-1 blockade to work. Thus, adding bexmarilimab to PD-1 blockade is anticipated to enhance efficacy.  

      The Company plans to initiate the Phase II BEXCOMBO study investigating bexmarilimab in metastatic or unresectable, recurrent HNSCC, locally advanced or metastatic UCC and metastatic NSCLC where first-line PD-1 blockade is approved SoC. 

      The Company conducted two successful fundraising rounds in 2022. Combined, they raised EUR 13.4 million gross and both rounds included new and existing investors. The Company also obtained up to EUR 30.0 million debt funding from IPF Partners, drew EUR 10.0 million upon signing in February 2022, further tranches possible under certain conditions

      Virtual briefing and Q&A to be held today at 8:00 AM (EDT) / 12:00 PM (GMT) / 2:00 PM (EET)

 

Major Events After the 2022 Financial Year

      Post period in January 2023, Faron reported that three out of five patients achieved objective responses in the first doublet cohort of the Phase I/II BEXMAB study evaluating the combination of azacitidine and bexmarilimab. Two of the three responders were refractory to standard of care (SoC) azacitidine monotherapy. The addition of bexmarilimab to standard of care was well-tolerated.

      Both the 1mg/kg and 3mg/kg doublet arms are fully enrolled, and the dose-escalation meeting is planned for Q1 2023.

      The Company successfully raised a total of EUR 12.0 million gross. This fundraising round was supported by long-only institutional investors, family offices, existing shareholders, and the Leukemia & Lymphoma Society® (LLS).

      Faron will support activities in preparation of a potential clinical trial with the Fred Hutchinson Cancer Center in Seattle, Washington, to investigate intravenous (IV) interferon beta in the prevention of cytokine release syndrome (CRS) and other CAR-T therapy side effects, such as neurotoxicity.

 

“I am extremely proud of the progress we made in 2022 for the bexmarilimab program and building our corporate infrastructure, both in the US and in Europe, to support the ambitious plans we have for 2023 and beyond,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “Last year we accelerated the development of bexmarilimab in hematological malignancies and reported exciting early data that lays a solid trajectory. We also demonstrated compelling antitumor activity in heavily pretreated patients across multiple solid tumor types, setting the stage for a combination with standard of care in first-line solid tumors. We accomplished all of this while also strengthening our balance sheet, adding highly experienced team members and expanding our global footprint with a growing presence in the US.”

 

HIGHLIGHTS (including post period):

 

Pipeline Highlights

Bexmarilimab Faron’s wholly owned, novel precision cancer immunotherapy candidate, in Phase I/II development for difficult-to-treat cancers.

Hematological cancers

      Faron reported objective responses for three out of five patients enrolled in the first doublet cohort of the Phase I/II BEXMAB study investigating bexmarilimab and azacitidine in patients with hematological cancers. Notably, 2 of the 3 responders had been refractory to prior azicitidine therapy. No additional adverse events have been observed adding bexmarilimab to standard of care.

      BEXMAB’s 1mg/kg and 3mg/kg bexmarilimab doublet cohorts have fully enrolled. Faron anticipates sites in the US to be opened during Q1 2023 to speed up recruitment even further.

Advanced solid tumors

      Bexmarilimab has been evaluated as a single agent in the Phase I/II MATINS in more than 250 patients and found to be well-tolerated.

      Up to 36% of heavily pretreated patients achieved disease control in certain indications.

      Median overall survival was 14.9 months for patients who achieved stabilization of disease from bexmarilimab compared to 4.4 months for those who did not, representing a 3.4-fold increase.

      Bexmarilimab treatment in MATINS induced significant systemic interferon gamma (IFN-γ) increase, again showing the therapy’s capacity to activate immune response in cancer patients, especially in patients with immunologically “cold” tumors. As presented at ASCO2022 in Chicago, the higher baseline CLEVER-1 levels in the tumors were associated with clinical benefit and could become an essential component as a diagnostic tool for patient selection.

      An FDA meeting will take place in Q1 2023 for feedback on the recommended dosing regimen and study design for further development of single agent bexmarilimab.

 

Traumakine® – Faron’s investigational intravenous (IV) interferon beta-1a therapy, in development for the prevention of complications from cytokine release syndrome, and hyperinflammatory conditions.

 

      Faron has refocused its therapeutic strategy of Traumakine and closed its Phase II/III HIBISCUS trial investigating Traumakine in the treatment of hospitalized COVID-19 patients compared to corticosteroid treatment with dexamethasone.

      Data from the preclinical Salvage, Preservation, and Advanced Resuscitation through Endothelial Stabilization (SPARES) study was presented at the Military Health System Research Symposium (MHSRS) held in Orlando, Florida. The results further highlight the promise of IV interferon beta-1a (IFN beta-1a) therapy as a potential therapeutic for emergency and trauma patients, especially when given early on.

      The Company filed a patent to the US Patent Office and Trademark Office regarding a patient selection method in terms of steroid treatment with an identified gene mutation in the interferon beta receptor. It received positive feedback in 2022.  

      Scientific Reports published data from INFORAAA study showing Traumakine induced up-regulation of CD73 was associated with 100% survival in surgically operated ruptured abdominal aorta aneurysm (RAAA) patients. These patients are at high risk of ischemia-reperfusion injury, with expected mortality between 30-40%.

      Another patent has been filed on sequencing interferon beta and steroid treatments, so that steroids can be used once adequate levels of CD73 are reached using IV IFN beta-1a.

 

Haematokine® – An investigative AOC3 (amine oxidase copper containing 3) protein inhibitor targeting Vascular Adhesion Protein-1 (VAP-1) for the use in regenerative medicine for the expansion of hematopoietic stem cells and to treat supressed bone marrow and the production of new blood cells.

 

Corporate Highlights

      Balance sheet was strengthened by raising EUR 13.4 million gross through fundraising rounds. This included two private placements, which encompassed existing and new investors, including The Leukemia & Lymphoma Society® (LLS). In February 2022, Faron also announced a debt funding agreement with IPF Partners for up to EUR 30 million. EUR 10 million was accessed upon signing of the agreement with an additional EUR 20 million available in the future through additional tranches of EUR 5 million and EUR 15 million, subject to certain conditions being met. Post period in January 2023, Faron raised EUR 12.0 million gross from new and existing shareholders, including The Leukemia & Lymphoma Society® (LLS).

      Marie-Louise Fjällskog, M.D., Ph.D., joined Faron’s Global Management Team as Chief Medical Officer, bringing with her over 30 years of experience in clinical oncology, translational research, and drug development. Dr. Fjällskog joined Faron from Sensei Biotherapeutics (NASDAQ: SNSE). As Chief Medical Officer at Sensei, she was responsible for leading clinical and development strategy and operations. Previously, she served as Vice President, Clinical Development at Merus (NASDAQ: MRUS) and Infinity Pharmaceuticals (NASDAQ: INFI) where she led development of multiple small molecule and immuno-oncology clinical programs. She was also formerly Global Clinical Program Leader at the Novartis Institute for Biomedical Research.

      Maija Hollmén, Ph.D, joined Faron’s Global Management Team as Chief Scientific Officer. In her role, Dr. Hollmén oversees preclinical and support clinical development for Faron. Her priority will be the further development of bexmarilimab, Faron’s wholly owned, novel precision cancer immunotherapy candidate. Dr. Hollmén is the world-leading expert on CLEVER-1 biology and CLEVER-1-expressing tumor-associated macrophages. She is an Adjunct Professor of Tumor Immunology on the Faculty of Medicine at the University of Turku in Finland, as well as a Principal Investigator.

      Juho Jalkanen, M.D., Ph.D., joined Faron’s Global Management Team as as Chief Operating Officer. In his role, Dr. Jalkanen will lead business strategy and daily operations for Faron. This includes oversight of academic and industry partnerships, resource prioritization and allocation, chemistry, manufacturing and controls, supply chain and driving performance measures. Dr. Jalkanen joined Faron in 2018 as the Faron’s Chief Development Officer. He also served as Faron’s interim Chief Medical Officer in 2021 prior to the appointment of Dr. Marie-Louise Fjällskog.

      Vesa Karvonen, LL.M.  General Counsel and Juuso Vakkuri, MA, MSc, EMBA, Chief Human Resources Officer joined Faron’s Global Management Team.

      Faron appointed Erik Ostrowski as a Non-Executive Director of the Company. Mr. Ostrowski is an experienced biotech and financial executive who is currently the Chief Financial Officer of AVROBIO, Inc. (NASDAQ: AVRO). 
 

 Financial Highlights

      On December 31, 2022, Faron held cash balances of EUR 7.0 million (2021: EUR 6.9 million).

      Loss for the period for the financial year ended December 31, 2022 was EUR 28.7 million (2021: EUR 21.2 million).

      Net assets on December 31, 2022 were EUR -11.5 million (2021: EUR 2.9 million).  

      In June 2022, the Company successfully raised a total of EUR 5.0 million gross (EUR 4.8 million net) from new and existing shareholders, through issuance of a total of 3,318,421 new ordinary shares to itself without consideration. 2,006,621 of those shares were conveyed to investors. In October 2022, the Company successfully raised a total of EUR 8.4 million gross (EUR 8.2 million net) from new and existing shareholders, through issuance of a total of 3,229,930 new ordinary shares to itself. Those shares and the 1,311,800 existing treasury shares were conveyed to investors. Proceeds from both raises will be used to accelerate clinical development of Faron’s main drug candidate, continue the CMC process and US build-up and to strengthen the Company’s balance sheet.             

      In February 2022, the Company secured a debt funding agreement with IPF Partners for up to EUR 30 million. EUR 10 million was accessed upon signing of the agreement with an additional EUR 20 million available in the future though additional tranches of EUR 5 million and EUR 15 million, subject to certain conditions being met.

      Post period, in January 2023 the Company successfully raised a total of EUR 12.0 million gross through the issuance of 3,692,308 ordinary shares to itself without consideration which were conveyed to investors.

 

 

Consolidated key figures, IFRS

EUR ’000

Unaudited

7-12/2022
6 months

Unaudited

7-12/2021
6 months

1-12/2022
12 months

1-12/2021
12 months

Other operating income

318

4,927

803

6,137

Research and Development expenses

(10,683)

(8,361)

(20,730)

(17,369)

General and Administrative expenses

(3,697)

(7,250)

(7,498)

(9,876)

Loss for the period

(15,609)

(10,649)

(28,730)

(21,194)

 

 

Unaudited

7-12/2022
6 months

Unaudited

7-12/2021
6 months

1-12/2022
12 months

1-12/2021
12 months

Loss per share EUR

(0.27)

(0.21)

(0.52)

(0.42)

Number of shares at end of period

59,805,383

53,232,032

59,805,383

53,232,032

Average number of shares

57,230,625

51,836,953

55,229,835

50,723,964

 

EUR ’000

Unaudited

30 June 2022

Unaudited

30 June 2021

31 December 2022

31 December 2021

Cash and cash equivalents

9,936

6,967

6,990

6,853

Equity

(5,194)

2,813

(11,476)

2,919

Balance Sheet total

16,729

11,865

11,271

13,182

 

Board of Directors’ Proposal on the Dividend

The Company’s comprehensive loss for the period was EUR 28,924,250.82 (2021: EUR 21,270,235.71) . The Board of Directors proposes to the Annual General Meeting 2023 not to pay dividend.

March 2, 2023

Faron Pharmaceuticals Oy

Board of Directors

Webcast for investors, analysts and media

A live webcast and Q&A session for investors, analysts and media will be hosted by Dr. Markku Jalkanen, Chief Executive Officer of Faron, and Toni Hänninen, Chief Financial Officer of Faron, at 2:00 pm EET / 12:00 pm GMT / 8:00 am EDT today. The Full-year results release for 2022, presentation, webcast details, and Annual Report 2022 will be made available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards.

 

Webcast link: https://faron.videosync.fi/2022-financial-statement

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

Publication of financial information during year 2023

Faron’s financial statements for full year 2022 will be published today, March 3, 2023 and will also be available on Faron’s website at https://www.faron.com/investors/results. The half-year financial report for the period January 1 to June 30, 2023 is scheduled to be published on August 29, 2023. The Annual General Meeting is planned for March 24, 2023. A separate stock exchange notice will be issued by Faron’s Board of Directors to convene the meeting.

About Bexmarilimab

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

About Faron

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

 

Forward-Looking Statements

Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward- looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “hope”, “seek”, ”envisage”, ”estimate”, ”intend”, ”may”, ”plan”, ”potentially”, ”will” or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors’ current expectations and assumptions regarding  Faron’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 Faron. Other factors which could cause actual results to differ materially include the ability of the Faron 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 Faron 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.

 

CEO Statement

The past year 2022 has been an incredible year of transformation for Faron, in terms of development of our key asset bexmarilimab, building up a new Global Management Team with five new C-level members and the initiation of a clinical/regulatory team for US-based activities. We are excited to go into 2023 with strong clinical data behind us and clear plans to move forward.

The year 2022 started with premium recruitment when Dr. Marie-Louise Fjällskog (M.D., PhD) came on board as Chief Medical Officer, bringing over 30 years of experience in clinical oncology, translational research, and drug development. She joined Dr. Juho Jalkanen (M.D., PhD), Chief Operating Officer, as well as our new General Counsel, Vesa Karvonen. We also welcomed Juuso Vakkuri as our Chief Human Resources Officer, and most recently, Dr. Maija Hollmén, PhD, as our Chief Scientific Officer. She will spearhead further inventions around bexmarilimab, Faron’s wholly owned, novel precision cancer immunotherapy candidate.

Our first, large Phase I/II MATINS study has provided us a proper dosing regimen for bexmarilimab and demonstrated a good safety profile. Initial efficacy data on advanced solid tumors allows us to identify biomarkers predicting extended survival of these hard-to-treat cancer patients. Our teams have worked hard to build a solid data package for the FDA on the next steps forward. This feedback will significantly impact our activities in 2023.

Importantly, we have found bexamarilimab is effective for patients who are refractory to PD-1 blockade. These patients have silent immune reaction as observed in low interferon gamma (IFN-gamma) levels. This is opposite to PD-1 blockers that are usually are active in cancer patients with high IFN-gamma levels. This is understandable as their mode of action is based on activating the existing T-cells, not to generate new T-cell populations. Thus, the combination of PD-1 blockade with bexmarilimab provides a unique opportunity to stimulate immune ignition and effective T-cells.

Bexmarilimab is being evaluated for safety and efficacy in the Phase I/II BEXMAB clinical trial, in combination with standard of care (SoC), in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This study is very exciting as now we have cancer cells which express the therapy target molecule CLEVER-1 on their surfaces. This means that wherever they travel in cancer patients, they carry this immunosuppressive element with them. In December, we reported in BEXMAB a partial responder achieving complete remission of blasts in blood and bone marrow followed by normalization of blood counts. A second patient showed reduced blast counts. This is particularly noteworthy considering the population targeted in BEXMAB, such as those having AML, have high mortality rates. Post period, we reported even more positive news: that three out of five patients achieved objective responses in the first doublet cohort of the Phase I/II BEXMAB study evaluating the combination of azacitidine and bexmarilimab. Two of the three responders were refractory to standard of care (SoC) azacitidine monotherapy.

We are thrilled with the progress and are pushing ahead in opening sites at US hematological centers.

We have also been successful in obtaining continued, long-term patent protection for bexmarilimab. During 2021 the United States Patent and Trademark Office and equivalent Japanese patent office approved protection, at least through 2037, for our humanized anti-CLEVER-1 antibody (bexmarilimab) sequence. During 2022 we obtained similarly patent coverage in Europe and other territories providing Faron excellent commercial opportunity in more than 90% of pharmaceutical markets. This fact has been recognised also by our partner candidates.

We have continued background work to advance both Traumakine® and Haematokine® programs to open clinical studies for both in 2023. We decided to close the HIBISCUS study using Traumakine due to lack of steroid-free patients. Our focus now is on opportunities where steroids cannot be used, and where ischemic conditions with vascular damage is the main reason for patient death. For the latter, we will continue to collaborate with the US Department of Defense (DoD). We also understand today the molecular basis of steroid interruption of IFN-beta signalling pathway and what role some genetic alterations may cause.

The third program in our pipeline, Haematokine, an investigational Vascular Adhesion Protein 1 (VAP-1) inhibitor, has preclinical studies continuing. We believe Haematokine could have broad applicability, not just in hematological malignancies, but across the field of regenerative medicine.

Our future looks bright, with the focus for 2023 to accelerate bexmarilimab’s clinical development, especially in BEXMAB. We also aim to initiate the Phase II BEXCOMBO study investigating bexmarilimab in metastatic or unresectable, recurrent HNSCC, locally advanced or metastatic UCC and metastatic NSCLC where first-line PD-1 blockade is approved standard of care. This combination regimen has the potential to change the future of cancer care. Future interactions with the FDA will guide our path forward.

I would like to thank our shareholders for their continued support of Faron and the management team. I would also like to express my profound gratitude to every Faron team member who come to work each day committed to disrupting the current treatment landscape and fundamentally improving patient outcomes.

Markku Jalkanen

Chief Executive Officer

March 2, 2023

 

Chairman Statement

During 2022, Faron has continued to focus on bexmarilimab, our novel, wholly owned novel precision cancer immunotherapy candidate, with exciting clinical data milestones anticipated for 2023. We have also grown the Company in the US and in Finland, bringing world-class expertise into Faron to advance bexmarilimab.

We have the ongoing Phase I/II MATINS clinical trial in pretreated, late-stage cancer, and as a result have delivered on our goals to understand monotherapy bexmarilimab efficacy and safety across multiple tumor types, as well as identify a dose and potential dosing regimens. We have also undertaken substantial work on biomarkers to develop enrichment strategies to identify patients who will best respond in future trials.

Faron has published data on bexmarilimab that consistently supports earlier positive results and continues to underscore that the mechanism of action demonstrates an effect on mortality in responders. The company will be presenting a data package to the US Food and Drug Administration in the first quarter of 2023.

Faron recognises the future of cancer treatment will be in combination therapies, and as such we have reported exciting data from the Phase I/II BEXMAB study in hematological malignancies. We also plan to initiate BEXCOMBO, a Phase II study of the combination therapy bexmarilimab plus PD-1 blockade in patients that have metastatic or unresectable, recurrent HNSCC, locally advanced or metastatic UCC and metastatic NSCLC where first-line PD-1 blockade is approved standard of care.  

We continue to see bexmarilimab as the major value driver for Faron, and our goal is to deliver worldwide approvals to allow bexmarilimab to be used by cancer physicians to treat patients.

Despite Faron’s focus on bexmarilimab, we have used partnerships to develop Traumakine®, Faron’s investigational intravenous (IV) interferon (IFN) beta-1a therapy, to prevent multiorgan dysfunction.

We recognise the funding environment for European companies has been extremely challenging and despite that, we have continued to raise capital to finance Faron’s activities. In 2022, we announced Faron had entered into a secured debt agreement with IPF Partners to advance and accelerate its pipeline programs. We had two equity financing rounds and are pleased we continue to have supportive shareholders in Finland and the rest of Scandinavia. In January 2023 we completed a further financing round of EUR 12 million to support the continued development of bexmarilimab. We are delighted that The Leukemia & Lymphoma Society participated in the previous round and in the January fundraise.

In terms of building the company, Dr. Juho Jalkanen was promoted to COO and we welcomed CMO Marie-Louise Fjällskog, based in Boston, as well as a Vesa Karvonen, our new general counsel based in Turku and Juuso Vakkuri as Chief Human Resources Officer. We have developed the US team in Boston, investing in clinical and regulatory personnel. Erik Ostrowski joined the Board of Directors. He brings substantial finance experience including as the CFO of a NASDAQ-listed company. We anticipate continuing to add employees in 2023.

I’d like to thank the staff of Faron, our partner organizations, study steering and advisory committee members investigators and patients that have participated in our clinical trials. I am indebted to CEO Dr. Markku Jalkanen, CFO Toni Hänninen, COO Juho Jalkanen, CMO Marie-Louise Fjällskog, General Counsel Vesa Karvonen and CHRO Juuso Vakkuri for their contributions to Faron in 2022. We look forward to great success in 2023.

Dr Frank Armstrong

Chairman

March 2, 2023

 

Financial Review

Despite continuing challenging market conditions, the Company was able to conduct two successful fundraising rounds in 2022. Combined, they raised EUR 13.4 million gross and both rounds included new and existing investors. In our fundraising round in June we were able to attract The Leukemia & Lymphoma Society® (LLS) to support our newest bexmarilimab trial, BEXMAB. Faron became part of LLS’ Therapy Acceleration Program® (TAP). In our October fundraise we were further able to attract reputable Finnish pension funds.

Additionally, in February 2022, the Company secured a debt funding agreement with IPF Partners, one of the leading alternative financing providers focused on the healthcare sector, for up to EUR 30 million. EUR 10 million was accessed upon signing of the agreement with an additional EUR 20 million available in the future, subject to certain conditions being met. This funding agreement strengthened our financial position and gives us the flexibility to access supplemental and inexpensive capital as we continue to accelerate the development of our pipeline assets.

As a result of these fundraising efforts, the net cash from financing activities of EUR 23.5 million exceeded the net cash used in operating activities of EU 23.0 million in 2022. We were able to accomplish this while also increasing R&D and reducing G&A expenditures, as per our plan, to focus on accelerating our pipeline.

Post period in January 2023, the Company successfully raised a total of EUR 12.0 million gross. This fundraising round was supported by long-only institutional investors, family offices, existing shareholders and the Leukemia & Lymphoma Society® (LLS).

 

Revenue and Other Operating Income

Faron’s revenue was nil for the year ended December 31, 2022 (2021: EUR nil). Faron recorded other income of EUR 0.8 million that consisted of grants from the European Union and Business Finland.

 

Research and Development Costs

R&D costs increased by EUR 3.4 million from EUR 17.4 million in 2021 to EUR 20.7 million in 2022. In total, almost 90% of the R&D costs are directly attributable to advancing our clinical programs, and Faron expects this to continue as we accelerate patient recruitment. The costs of outsourced clinical trial services were increased by EUR 1.6 million from EUR 3.5 to EUR 5.1 million. The cost of employee benefits increased by EUR 1.9 million from EUR 3.3 to EUR 5.2 million, mainly driven by additional headcount in the US.

 

General and Administration Costs

Administrative expenses decreased by EUR 2.4 million from EUR 9.9 million in 2021 to EUR 7.5 million in 2022. The decrease was mainly due to the EUR 3.5 million decrease of legal expenses, that consisted in 2021 of the arbitration with Rentschler Biopharma SE, resulting in Faron’s favor. Employee benefits increased by EUR 1.1 million from EUR 3.5 million to EUR 4.5 million due to additional headcount.

 

Taxation

The Company’s tax credit for the fiscal year 2022 can be recorded only after the Finnish tax authorities have approved the tax report and confirmed the amount of tax-deductible expenses. The total amount of cumulative tax losses carried forward approved by tax authorities on December 31, 2022 was EUR 47.1 million (2021: EUR 41.0 million). The Company estimates that it can utilize most of these during the years 2023 to 2033 by offsetting them against future profits.

In addition, the Company has EUR 91.8 million of R&D costs incurred in the financial years 2010 – 2022 that have not yet been deducted from taxation. This amount can be deducted over an indefinite period at the Company’s discretion.

 

Losses

Loss before income tax was EUR 28.7 million (2021: EUR 21.2 million). Comprehensive loss for the year was EUR 28.7 million (2021: EUR 21.2 million), representing a loss of EUR 0.52 per share (2021: EUR 0.42 per share).

 

Cash Flows

Net cash flow was EUR 0.1 million positive for the year ended December 31, 2022 (2021: EUR 2.7 million positive). Cash used for operating activities increased by EUR 0.8 million to EUR 23.0 million for the year, compared to EUR 22.2 million for the year ended December 31, 2021. This increase was mostly driven by an increase in R&D investments. Net cash inflow from financing activities was EUR 23.5 million (2021: EUR 25.6 million) mainly due to the successful equity placings completed in June 2022 and October 2022 as well as the proceeds from borrowings of the loan with IPF Partners.

 

Fundraising

In June 2022, the Company successfully raised a total of EUR 5.0 million gross (EUR 4.8 million net) from new and existing shareholders, through issuance of a total of 3,318,421 new ordinary shares to itself without consideration. 2,006,621 of those shares were conveyed to investors. In October 2022, the Company successfully raised a total of EUR 8.4 million gross (EUR 8.2 million net) from new and existing shareholders, through issuance of a total of 3,229,930 new ordinary shares to itself. Those shares and the 1,311,800 existing treasury shares were conveyed to investors. Proceeds from both raises were used to accelerate clinical development of the Company’s main drug candidate, continue the CMC process and US buildup and to strengthen the Company’s balance sheet. In February 2022, the Company secured a debt funding agreement with IPF Partners for up to EUR 30 million. EUR 10 million was accessed upon signing of the agreement with an additional EUR 20 million available in the future, subject to certain conditions being met.

Post period, in January 2023, the Company successfully raised a total of EUR 12.0 million gross through and issuance of 3,692,308 ordinary shares to itself without consideration which were conveyed to investors.

 

Financial Position

As of December 31, 2022, total cash and cash equivalents held were EUR 7.0 million (2021: EUR 6.9 million).

 

Going Concern

As part of their going concern review, the Directors have followed the Finnish Limited Liability Companies Act, the Finnish Accounting Act and the guidelines published by the Financial Reporting Council entitled “Guidance on the Going Concern Basis of Accounting and Reporting on Solvency and Liquidity Risks – Guidance for directors of companies that do not apply the UK Corporate Governance Code”. Faron is subject to a number of risks similar to those of other development stage pharmaceutical companies.

These risks include, amongst others, generation of revenues in due course from the development portfolio and risks associated with research, development, testing and obtaining related regulatory approvals of its pipeline products. Ultimately, the attainment of profitable operations is dependent on future uncertain events which include obtaining adequate financing to fulfil the Faron’s commercial and development activities and generating a level of revenue adequate to support Faron’s cost structure.

Faron made a net loss of EUR 28.7 million during the year ended December 31, 2022. It had a negative equity of EUR 11.4 million including an accumulated deficit of EUR 143.7 million. As of that date, Faron had cash and cash equivalents of EUR 7.0 million.

The Directors have prepared detailed financial forecasts and cash flows looking beyond 12 months from the date of the approval of these financial statements. In developing these forecasts, the Directors have made assumptions based upon their view of the current and future economic conditions that are expected to prevail over the forecast period. The Directors estimate that the cash held by Faron together with known receivables will be sufficient to support the current level of activities into the third quarter of 2023. The Directors are continuing to explore sources of finance available to Faron and they believe they have a reasonable expectation that they will be able to secure sufficient cash inflows for Faron to continue its activities for not less than 12 months from the date of approval of these financial statements; they have therefore prepared the financial statements on a going concern basis. Because the additional finance is not committed at the date of issuance of these financial statements, these circumstances represent a material uncertainty that may cast significant doubt on Faron’s ability to continue as going concern. Should Faron be unable to obtain further finance such that the going concern basis of preparation were no longer appropriate, adjustments would be required, including to reduce balance sheet values of assets to their recoverable amounts, to provide for further liabilities that might arise.

 Headcount

Faron’s headcount at the end of year was 40 (2021: 37).

 Shares and Share Capital

During the period January 1 to December 31, 2022, the Company, using the share authorities granted at the Annual General Meeting held on April 23, 2021, issued a total of 3,318,421 new ordinary shares to itself without consideration and conveyed 2,006,621 of those shares at an issuance price of EUR 2.49 per share to investors. During the same period, the Company, using the share authorities granted at the Extraordinary General Meeting held on July 7, 2022, issued a total of 3,229,932 new ordinary shares to itself without consideration. Those shares and the existing treasury shares were conveyed to investors at an issuance price of EUR 1.85 per share.

The subscription price net of costs was credited in full to the Company’s reserve for invested unrestricted equity, and the share capital of the Company was not increased. The Company has no shares in treasury; therefore at the end of 2022 the total number of voting rights was 59,805,383.  

Toni Hänninen

Chief Financial Officer

March 2, 2023

 

Consolidated Income Statement, IFRS

 EUR ’000

Unaudited

7-12/2022
6 months

Unaudited

7-12/2021
6 months

1-12/2022
12 months

1-12/2021
12 months

Other operating income

318

4,927

803

6,137

Research and development expenses

(10,683)

(8,361)

(20,730)

(17,369)

General and administrative expenses

(3,697)

(7,250)

(7,498)

(9,876)

Operating loss

(14,062)

(10,684)

(27,426)

(21,108)

Financial income

(596)

103

96

165

Financial expense

(970)

(44)

(1,400)

(235)

Loss before tax

(15,628)

(10,625)

(28,730)

(21,178)

Tax expense

19

(9)

0

(16)

Loss for the period

(15,609)

(10,634)

(28,730)

(21,194)

 

 

 

 

 

Other comprehensive gain/loss

6

(15)

17

(15)

Total comprehensive loss for the period

(15,603)

(10,649)

(28,713)

(21,209)

 

 

 

 

 

Loss per ordinary share

 

 

 

 

Basic and diluted loss per share, EUR

(0.27)

(0.21)

(0.52)

(0.42)

 
 

Consolidated Balance Sheet, IFRS

 

 

EUR ‘000

31 December 2022

31 December 2021

Assets

 

 

Non-current assets

 

 

Machinery and equipment

13

20

Right-of-use-assets

314

187

Intangible assets

1,154

899

Prepayments and other receivables

60

53

Total non-current assets

1,541

1,159

 

 

 

Current assets

 

 

Prepayments and other receivables

2,740

5,170

Cash and cash equivalents

6,990

6,853

Total current assets

9,730

12,023

 

 

 

Total assets

11,271

13,182

 

 

 

Equity and liabilities

 

 

 

 

 

Capital and reserves attributable to the equity holders of Faron

 

 

Share capital

2,691

2,691

Reserve for invested unrestricted equity

129,544

116,507

Accumulated deficit

(143,713)

(116,265)

Translation difference

2

(15)

Total equity

(11,476)

2,919

 

 

 

Provisions

 

 

Other provisions

158

0

Total provisions

158

0

 

 

 

Non-current liabilities

 

 

Borrowings

11,102

2,918

Lease liabilities

163

16

Other liabilities

853

151

Total non-current liabilities

12,118

3,085

 

 

 

Current liabilities

 

 

Borrowings

1,851

429

Lease liabilities

153

184

Trade payables

6,014

2,229

Accruals and other current liabilities

2,453

4,336

Total current liabilities

10,471

7,178

 

 

 

Total liabilities

22,748

10,263

 

 

 

Total equity and liabilities

11,271

13,182

 

Consolidated Statement of Changes in Equity, IFRS

EUR ‘000

Share capital

Reserve for invested unrestrict-
ed equity

Trans-
lation
difference

Accumu-lated deficit

Total equity

 

 

 

 

 

 

Balance as at 31 December 2020

2,691

92,015

2

(96,557)

(1,849)

 

 

 

 

 

 

Comprehensive loss for the year 2021

0

0

(15)

(21,194)

(21,209)

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

Issue of ordinary shares, net of transaction costs

0

24,492

0

0

24,492

Share-based compensation

0

0

 0

1,487

1,487

 

0

24,492

0

1,487

25,980

 

 

 

 

 

 

Balance as at 31 December 2021

2,691

116,507

(15)

(116,265)

2,919

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss for the year 2022

0

0

17

(28,730)

(28,713)

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

 

Issue of ordinary shares, net of transaction costs

0

13,037

0

0

13,037

Share-based compensation

0

0

0

1,297

1,297

Other movements

 0

0

0

(16)

(16)

 

0

13,037

17

(27,448)

(14,395)

 

 

 

 

 

 

Balance as at 31 December 2022

2,691

129,544

2

(143,713)

(11,476)

 

Consolidated Cash Flow Statement, IFRS

EUR ‘000

Unaudited

Unaudited

1-12.2022

1-12.2021

7-12.2022

7-12.2021

12 months

12 months

6 months

6 months

 

 

Cash flow from operating activities

 

 

 

 

Loss before tax

(15,628)

-10,64

(28,730)

(21,194)

Adjustments for:

 

 

 

 

Received grant

(388)

(745)

(803)

(1,387)

Depreciation and amortization

149

165

300

307

Change in provision

(158)

0

(158)

0

Financial items

787

 

1,304

0

Interest expense

0

128

0

216

Tax expense

19

6

0

16

Unrealized foreign exchange loss (gain), net

0

434

0

153

Share-based compensation

632

644

1,297

1,487

Adjusted loss from operations before changes in working capital

(14,587)

(10,008)

(26,790)

(20,402)

Change in net working capital:

 

 

 

 

Prepayments and other receivables

2,045

(-1259)

2,864

(1,919)

Trade payables

(657)

744

719

723

Other liabilities

2,197

24

1,183

(566)

Cash used in operations

(11,001)

(10,499)

(22,023)

(22,163)

Taxes paid

0

(1)

0

(16)

Transaction costs related to loans and borrowings

0

0

(165)

0

Interest received

11

0

11

0

Interest paid

(708)

(10)

(816)

(40)

Net cash used in operating activities

(11,698)

(10,508)

(22,993)

(22,218)

 

 

 

 

 

Cash flow from investing activities

 

 

 

 

Payments for intangible assets

(218)

(76)

(385)

(461)

Payments for equipment

0

(6)

(0)

(13)

Net cash used in investing activities

(218)

(81)

(385)

(473)

 

 

 

 

 

Cash flow from financing activities

 

 

 

 

Proceeds from issue of shares

8,923

10,515

13,445

25,559

Share issue transaction cost

(174)

(405)

(365)

(1,067)

Proceeds from borrowings

(0)

145

10,389

662

Repayment of borrowings

0

0

(105)

(122)

Proceed from grants

231

750

231

750

Payment of lease liabilities

(20)

(95)

(116)

(191)

Net cash from financing activities

8,959

10,910

23,478

25,590

 

 

 

 

 

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

(2,946)

320

137

2,899

Effect of exchange rate changes on cash and cash equivalents

11

(434)

37

(153)

 

 

 

 

 

Cash and cash equivalents at 1 January / 1 July

9,936

6,967

6,853

4,108

Cash and cash equivalents at 31 December

6,990

6,853

6,990

6,853

 

 

 

 

 

 

Update to Faron’s Financial Calendar for 2023

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

 

Update to Faron’s Financial Calendar for 2023

 

Company announcement, February 6, 2023 at 1:00 PM (EST) / 6:00 PM (GMT) / 8:00 PM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces an update to its financial reporting calendar for 2023.

 

The Company’s financial statement release for the full year 2022 and Annual Report 2022, including financial statements for the full year, will now be published on Friday, March 3, 2023, at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET), rather than on Thursday, March 2, 2023, as had been previously communicated.

 

The publication date of Tuesday, August 29, 2023, for Faron’s half-year financial report for the period January 1 to June 30, 2023, remains unchanged, as does the date for the Company’s annual general meeting, which is planned to be held on Friday, March 24, 2023. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

 

Full Year Results Virtual Briefing

Following publication of Faron’s financial statement release for the full year 2022 on Friday, March 3, 2023, Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, will host a virtual briefing and Q&A session for analysts on the day at 7:00 AM (EST) / 12:00 PM (GMT) / 2:00 PM (EET).

 

The full year results press release for 2022, presentation, virtual briefing webcast details, and Annual Report 2022 will be made available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards.

 

For more details about the analyst briefing, please contact Faron@consilium-comms.com.

 

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Toni Hänninen

CFO

toni.hanninen@faron.com

Phone: +41 79 387 2643

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Faron Pharmaceuticals Ltd

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

 

Notice of 2022 Full-Year Results and Annual Report

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

Notice of 2022 Full-Year Results and Annual Report

 

Press release, February 6, 2023 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, will publish its audited full-year results for the twelve months ended December 31, 2022, on Thursday, March 2, 2023, at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET). The Annual Report 2022, including audited financial statements for the full year, will be published on the same day.

 

Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, will host a virtual briefing and Q&A session for analysts at 7:00 AM (EST) / 12:00 PM (GMT) / 2:00 PM (EET) on the day of results.

 

The full-year results press release for 2022, presentation, virtual briefing webcast details, and Annual Report 2022 will be made available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards.

 

For more details about the analysts’ briefing, please contact Faron@consilium-comms.com.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

About Faron Pharmaceuticals Ltd. 

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

 

Forward-Looking Statements

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

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

 

 

Holding(s) in Company

 

TR-1: Standard form for notification of major holdings

 

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i

 

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii:

Faron Pharmaceuticals Ltd

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

X

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

 

An acquisition or disposal of financial instruments

 

An event changing the breakdown of voting rights

X

Other (please specify) iii: (Decrease of holding due to issuance of new shares)

X

3. Details of person subject to the notification obligation iv

Name

Tom-Erik Lind

City and country of registered office (if applicable)

 

4. Full name of shareholder(s) (if different from 3.) v

Name

 

City and country of registered office (if applicable)

 

5. Date on which the threshold was crossed or reached vi:

27.01.2023

6. Date on which issuer notified (DD/MM/YYYY):

30.01.2023

7. Total positions of person(s) subject to the notification obligation

 

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights held in issuer (8.A + 8.B) vii

Resulting situation on the date on which threshold was crossed or reached

5.77%

 

5.77%

3,666,647

Position of previous notification (if

applicable)

6.13%

 

6.13%

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

3,666,647

 

5.77%

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

3,666,647

5.77%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. B 1

 

 

 

 

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

Number of voting rights

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8.B.2

 

 

 

 

 

9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii

X

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv

 

Name xv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

Tom-Erik Lind

5.77%

 

5.77%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10. In case of proxy voting, please identify:

Name of the proxy holder

 

The number and % of voting rights held

 

The date until which the voting rights will be held

 

 

11. Additional information xvi

Faron share issue per 27.01.2023

 

Place of completion

Bangkok, Thailand

Date of completion

27.01.2023

 

 

 

 

 

Holding(s) in Company

 

TR-1: Standard form for notification of major holdings

 

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i

 

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii:

Faron Pharmaceuticals Ltd

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

X

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

X

An acquisition or disposal of financial instruments

 

An event changing the breakdown of voting rights

 

Other (please specify) iii: (Increase of holding due to issuance of new shares)

X

3. Details of person subject to the notification obligation iv

Name

Varma Mutual Pension Insurance Company

City and country of registered office (if applicable)

Helsinki, Finland

4. Full name of shareholder(s) (if different from 3.) v

Name

 

City and country of registered office (if applicable)

 

5. Date on which the threshold was crossed or reached vi:

27.01.2023

6. Date on which issuer notified (DD/MM/YYYY):

27.01.2023

7. Total positions of person(s) subject to the notification obligation

 

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights held in issuer (8.A + 8.B) vii

Resulting situation on the date on which threshold was crossed or reached

4.16%

 

4.16%

2,641,503

Position of previous notification (if

applicable)

3.16%

 

3.16%

 

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

2,641,503

 

4.16%

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

2,641,503

4.16%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. B 1

 

 

 

 

B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

Number of voting rights

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8.B.2

 

 

 

 

 

9. Information in relation to the person subject to the notification obligation (please mark the

applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii

X

Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv

 

Name xv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

Varma Mutual Pension Insurance Company

4.16%

 

4.16%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10. In case of proxy voting, please identify:

Name of the proxy holder

 

The number and % of voting rights held

 

The date until which the voting rights will be held

 

 

11. Additional information xvi

Faron share issue per 27.01.2023

 

Place of completion

Helsinki, Finland

Date of completion

27.01.2023

 

 

 

 

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