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

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

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

Phase I/II Bexmarilimab Combination Study in Hematologic Malignancies

 

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

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

 

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

 

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

 

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

 

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

 

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

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

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

 

About Faron Pharmaceuticals Ltd

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

 

Forward Looking Statements

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

 

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

 

Ex Vivo Data Presented at EHA2022 Congress

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Ex Vivo Data Presented at EHA2022 Congress Suggest Critical Role for Clever-1 in

Hematological Cancer Outcome and Drug Resistance

 

  • Clever-1 is expressed in patient bone marrow blasts and monocytes in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), with the highest levels observed in M4/M5 subtypes with poor outcome
  • Blocking Clever-1 with bexmarilimab in these patients induced immune activation as observed through increased antigen presenting molecule, human leucocyte antigen DR (HLA-DR) expression and declined PD-1 expression
  • The combination of azacytidine with bexmarilimab augmented HLA-DR induction and overcame the HLA-DR suppressing effect of the bcl-2 inhibitor venetoclax

 

Press release, May 12, 2022 at 17:50 PM (EEST) / 15:50 PM (BST) / 10:50 AM (EDT)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces that preclinical data to support the Company’s upcoming clinical trials investigating the potential of bexmarilimab in combination with standard of care (SoC) in hematologic cancers will be presented at the European Hematology Association’s hybrid EHA2022 Congress in Vienna, Austria, from June 9-12, 2022. These data (Abstract ID: EHA-3535) will be presented on Friday, June 10, 2022 in a session that begins at 16:30 CEST. The abstract can be found here: EX VIVO IMMUNE ACTIVATION WITH THE MACROPHAGE-TARGETING…. EHA Library. Aakko S. Jun 10 2022; 357243 (ehaweb.org)

 

Faron’s wholly-owned novel precision cancer immunotherapy, bexmarilimab, targets Clever-1, a receptor known to be expressed on immunosuppressive tumor associated macrophages which make up nearly 50% of the tumor mass and limit the efficacy of currently approved cancer immunotherapies, including anti PD-1/L1. Faron is investigating the potential of this novel immunotherapy in combination with SoC in patients with relapsed acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CML), three hematologic cancers for which there are few treatment options.

 

The data being presented at EHA2022 profiles Clever-1 expression in blood cancer and tests bexmarilimab’s growth inhibitory and immunomodulatory potential in preclinical models, as a monotherapy and in combination with azaciditine and/or venetoclax, two standard of care treatments used as in AML, MDS and CML. Results confirmed that Clever-1 is expressed in patient-derived monocytes and blasts. Ex vivo treatment with bexmarilimab, alone or in combination with azaciditine and/or venetoclax, demonstrated increased expression of the antigen presenting molecule, human leucocyte antigen DR (HLA-DR). Enhanced antigen presentation allows the immune system to better identify and kill cancer cells

 

Furthermore, natural killer (NK) cells and CD8+ T cells showed decreased expression of PD-1 and an increase of activation markers – important predictive biomarkers for overcoming resistance to existing immunotherapies. These results help confirm bexmarilimab’s potential in hematologic malignancies.

 

“These results reinforce the strong scientific rationale behind our focus on Clever-1 and the potential of bexmarilimab, either alone or in combination with standard of care, to treat blood cancers,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “High Clever-1 expression is associated with poor survival in certain blood cancer patients and bexmarilimab provides a novel treatment approach for these patients, downregulating Clever-1 expression and igniting an effective immune response. We look forward to the imminent start of our hematology cancer clinical trial program to further explore these promising findings.”

 

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) 306-6069

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

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

 

About Faron Pharmaceuticals Ltd

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

 

Forward Looking Statements

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

 

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

 

 

Mol Cancer Ther Publishes Bexmarilimab Research

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Molecular Cancer Therapeutics Publishes Research on the Nonclinical Characterization of Bexmarilimab

 

Press release, May 9, 2022 at 02:00 AM (EDT) / 07:00 AM (BST) / 09:00 AM (EEST)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces that the American Association for Cancer Research (AACR) journal Molecular Cancer Therapeutics published research examining the discovery and preclinical development of bexmarilimab, Faron’s wholly-owned investigational precision cancer immunotherapy. The paper, titled “Nonclinical characterization of bexmarilimab, a Clever-1-targeting antibody for supporting immune defense against cancers” is available online at:  https://aacrjournals.org/mct/article/doi/10.1158/1535-7163.MCT-21-0840/696262/Nonclinical-characterization-of-bexmarilimab-a.

 

The manuscript details early research from the bexmarilimab program and explores the hypothesis that Clever-1, a protein that is highly expressed in a subset of immunosuppressive human tumor-associated macrophages and is associated with poor patient outcomes following treatment with currently approved checkpoint inhibitors, is a novel target for the development of next generation immunotherapies. Tumor-associated macrophages are one of the main contributors to an immunosuppressive tumor microenvironment and the inhibition of Clever-1 has been demonstrated to convert immunosuppressive M2 macrophages into immunostimulatory M1 macrophages. In the paper, the authors discuss the potential of Clever-1 as a therapeutic target and that downregulating Clever-1 could lead to T-cell activation and restoration of an immune response in cancer patients.

 

Reporting the humanization and nonclinical characterization steps used to determine the physicochemical properties, biological potency, and safety profile of bexmarilimab, the authors conclude that bexmarilimab could induce an immunostimulatory tumor microenvironment that leads to anti-tumor efficacy. They also state that there is a solid rationale for the continuing development of bexmarilimab for the treatment of difficult-to-treat cancers by providing permanent immune stimulation through targeting myeloid cell function.

 

“This research underlines the strength of the science behind our bexmarilimab program. It is widely known that tumor progression is profoundly influenced by interactions of the cells within the tumor microenvironment, which makes it a critical area of focus for the development of new immunotherapies,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “With bexmarilimab, targeting the Clever-1 protein on tumor-associated macrophages, we have an opportunity to switch their activity from being immunosuppressive to become immune-stimulating, enabling them to both mount an immune response of their own and activate other immune cells to infiltrate the tumor. Our ongoing clinical development program will enable us to further understand this potentially pioneering approach of harnessing the immune system to fight cancer”.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

Phone: +1 (917) 306-6069

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

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

 

About Faron Pharmaceuticals Ltd

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

 

Forward Looking Statements

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

 

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

 

Grant of options

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Grant of options

 

Company announcement, 04 May 2022 at 1:15 PM (EEST) 11:15 AM (BST) / 6:15 AM (EDT)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces that the Company’s board has confirmed the grant of a total of 497,000 options over ordinary shares in the Company (“Options”) under the Company’s Share Option Plan 2019 (including its UK and US sub plans). The Options have been allocated under the Share Option Plan 2019 and are exercisable between 24 March 2023 and 24 March 2027, vesting 25% per annum over four years. The exercise price for Options allocated under the Share Option plan and the UK sub plan is €3.09 per share (£2.57), which is calculated based on the average price per share at which the ordinary shares in the Company have been traded on AIM for 90 days preceding the allocation date of 24 March 2022. The exercise price for Options allocated under the US sub plan is €2.91 per share (£2.43), which is calculated based on the average price per share at which the ordinary shares in the Company have been traded on AIM for 30 days preceding the allocation date of 24 March 2022. The terms of the Share Option Plan 2019 are available on the Company’s website at https://www.faron.com/investors/general-meetings/2020.

 

The granted Options entitle the option holders to subscribe for a total of 497,000 new ordinary shares in the Company, if exercised in full, and represent 0.9% of the fully diluted ordinary share capital of the Company.

 

Included in the number of Options granted are the following Options which were issued to directors, other persons discharging managerial responsibilities (“PDMRs”), scientific advisory board (“SAB”) members and Company personnel:

 

Directors

Options granted

 

 

Brown Gregory

30,000

Poulos John

30,000

Whitaker Anne

30,000

 

90,000

PDMRs

 

Fjällskog Marie-Louise

 40,000

Hänninen Toni

40,000

Kyttä Kaisa

11,000

Lahtinen Maria

30,000

Total PDMRs

121,000

 

 

SAB member

 

Curiel Tyler

Jalkanen Sirpa*

10,000

10,000

Knowles Jonathan

10,000

Total SAB members

30,000

 

*Jalkanen Sirpa is a person closely associated (“PCA”) to Jalkanen Markku, Chief Executive Officer of the Company

 

 

 

Total Company personnel

256,000

 

 

 

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Faron Pharmaceuticals Oy

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

 

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

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

a) Brown Gregory

b) Fjällskog Marie-Louise

c) Hänninen Toni 

d) Kyttä Kaisa

e) Lahtinen Maria

f) Jalkanen Sirpa

g) Poulos John

h) Whitaker Anne

2

Reason for notification

 

 

 

a.

Position/Status

Person discharging managerial responsibilities/person closely associated

b.

Initial notification/

Amendment

Initial notification

3

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

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

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

a.

Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made under the Faron Share Option Plan 2019 main, UK and US sub plans exercisable at €3.09 per ordinary share and at €2.91 per ordinary share under the US sub plan.

c.

Price(s) and volume(s)

 

 

 

 

 

 

Price(s)

Volume(s)

 

 

 

 

Nil

a) 30,000

b) 40,000

c) 40,000

d) 11,000

e) 30,000

f) 10,000

g) 30,000

h) 30,000

 

 

 

 

 

d.

Aggregated information

 

– Aggregated Volume

 

– Price

 

 

 

221,000 options

 

 

Nil

 

e.

Date of the transaction

03 May 2022

f.

Place of the transaction

Turku

 

 

Board Changes

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Board Changes

 

Company announcement, April 22, 2022 at 15:01 PM (EEST) / 13:01 PM (BST) / 8:01 AM (EDT) 

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, is pleased to announce the appointment of Mr. Erik Ostrowski as a Non-Executive Director of the Company following the passing of the resolution regarding the election of members of the Board put to shareholders of the Company at the Annual General Meeting held earlier today.  Mr. Ostrowski is an experienced biotech and financial executive who is currently the Chief Financial Officer of AVROBIO, Inc. (Nasdaq: AVRO).  In addition, Matti Manner has today stepped down from his position as a Director and Vice-Chairman of the Company.

 

“We are very fortunate to welcome Erik to our Board of Directors,” said Dr. Frank Armstrong, Chairman of the Board of Faron Pharmaceuticals. “He brings deep financial and biotech experience and will provide critical guidance as we continue to interact with the capital markets and increase our presence and investor base in the US. In addition to welcoming Erik, I would like to thank Matti Manner for his service to the Faron board over the past sixteen years, first as the Chairman of the Board between 2007 – 2015 and since 2015 until today as the Vice-Chairman. His partnership and contributions have been invaluable and key to the success of our Company to date.”

 

Mr. Ostrowski has been AVROBIO’s Chief Financial Officer and Treasurer since January 2019. AVROBIO is a clinical-stage company focused on developing gene therapies to treat rare diseases. Prior to joining AVROBIO, Mr. Ostrowski served as CFO of Summit Therapeutics plc. (Nasdaq: SMMT) and vice president of finance at Organogenesis Inc. (Nasdaq: ORGO). He previously worked in investment banking, most recently as a director with Leerink Partners LLC. Mr. Ostrowski began his career as an accountant with Coopers & Lybrand (now PricewaterhouseCoopers) and received a B.S. in accounting and economics from Babson College and a M.B.A. from the University of Chicago Booth School of Business.

 

Additional Disclosures

The following information regarding the appointment of Erik John Ostrowski, aged 49, 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):

AVROBIO Securities Corporation (a 100% owned

subsidiary of AVROBIO, Inc.)

None

 

 

Mr. Ostrowski 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 Erik Ostrowski 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 / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880
 

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

 

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

 

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

 

 

About Faron Pharmaceuticals Ltd

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

Results of the AGM

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

 

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

 

Company announcement, April 22, 2022 at 15:00 PM (EEST) / 13:00 PM (BST) /  8:00 AM (EDT) 

 

TURKU, FINLAND – The annual general meeting (“AGM”) of Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON) took place at Event Venue Eliel in Helsinki, Finland today, 22 April 2022.

 

The AGM was held through exceptional meeting procedures based on the temporary legislative act (375/2021, “Temporary Act“) approved by the Finnish parliament on 7 May 2021. The shareholders of the Company and their proxy representatives could participate in the AGM and use shareholder rights only by voting in advance, by submitting counterproposals in advance and by asking questions in advance.  

 

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 2021.

 

No dividend for the financial year 2021 will be paid and the losses of the Company for the financial year, amounting to EUR 21.2 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, Gregory Brown, John Poulos, Leopoldo Zambeletti, Markku Jalkanen and Anne Whitaker were re-elected to the Board and Erik Ostrowski 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 remains unchanged.  Accordingly, an annual remuneration of 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 also remain unchanged and 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, 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, authorised public accountant (KHT), as the key audit partner. It was decided that the auditor be remunerated in accordance with the invoice presented.

 

Proposed authorisations to the Board to decide on the issuance of shares, options or other special rights entitling to shares and on the issuance of shares without consideration to the Company

The AGM did not authorize the Board to resolve on the issuances of shares, options or other special rights entitling to shares, or on a share issue without consideration to the Company itself in accordance with the proposals by the Board to the AGM.

 

The Company has an existing authorisation to resolve on issuances of shares, options or other special rights entitling to shares of up to ten million (10,000,000) shares in the aggregate, pursuant to the resolution by the Annual General Meeting on 23 April 2021, which is effective until 30 June 2022. Of the aforementioned authorization, 6,636,842 shares may still be issued by the Company.

 

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:

 

  • Leopoldo Zambeletti was elected the Chair of the Audit Committee and Gregory Brown and Erik Ostrowski were elected as the other members of the Audit Committee.
  • Frank Armstrong was elected the Chair of the Nomination Committee and Anne Whitaker and Gregory Brown 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 from 6 May 2022 at the latest.

 

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880
 

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

 

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

 

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

 

About Faron Pharmaceuticals Ltd

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

Faron Presents Results from Melanoma Cohort of MATINS Trial at 18[th] Congress of the European Association of Dermato-Oncology (EADO)

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Faron Presents Results from Melanoma Cohort of MATINS Trial at 18th Congress of the European Association of Dermato-Oncology (EADO)

 

  • Compelling 30% clinical benefit rate seen following treatment with bexmarilimab in heavily pre-treated, checkpoint inhibitor refractory patient population
  • Analysis estimates 100% overall survival at 12-months for patients who experienced clinical benefit following treatment with bexmarilimab
  • Biomarker analysis shows melanoma patients with low baseline levels of inflammatory cytokines in blood and high Clever-1 positivity in tumor are more likely to benefit from treatment with bexmarilimab and experience significant increases in serum interferon gamma (INFy) during treatment

 

Press release, April 21, 2022 at 18:30 PM (EEST) / 16:30 PM (BST) / 11:30 AM (EDT) 

 

TURKU, FINLAND / BOSTON, MA Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces that results from the melanoma cohort in the ongoing phase I/II MATINS (Macrophage Antibody to Inhibit Immune Suppression) trial, will be presented at the 18th Congress of the European Association of Dermato-Oncology (EADO), being held in Seville, Spain, April 21 to April 23, 2022.  

 

The melanoma cohort is one of the ten advanced treatment-resistant solid tumor types included in Part II (110 patients) of the MATINS study, which is investigating the potential of bexmarilimab, Faron’s wholly-owned investigational precision cancer immunotherapy, as a monotherapy. Bexmarilimab targets tumor associated macrophages, which are known to be immunosuppressive, make up nearly 50% of the tumor mass, and limit the efficacy of currently approved cancer immunotherapies, including anti PD-1/L1. As previously communicated, melanoma is among five different tumor types from the original 10 studied to have shown the strongest clinical benefit rate (CBR = partial response or stable disease) – 30% – alongside gastric cancer (30%), cholangiocarcinoma (30%), hepatocellular carcinoma (40%) and breast cancer (40%), following treatment with bexmarilimab.  

 

Data from 11 melanoma patients (including the full cohort of 10 patients in Part II and one additional patient with same dosing regimen from Part I) who were refractory to checkpoint inhibition are being presented at the congress. All patients were treated with 1mg/kg of bexmarilimab monotherapy, every three weeks. The median number of previous treatment lines was three, the median age of patients was 60.

 

  • Of the 11 patients, four experienced clinical benefit – one patient had a partial response after two cycles of bexmarilimab (tumor growth reduced by 40% from baseline) but was discontinued before a confirmatory scan was performed. Three patients had stable disease (i.e., clinical benefit rate of 30% in Part II).
     
  • Current estimates for 12-month survival in Part II melanoma cohort were 100% for the patients who experienced clinical benefit following treatment compared to 33.3% of non-CBR patients.

 

  • A preliminary biomarker analysis including the melanoma cohort showed that patients with higher intra-tumoral Clever-1 positivity and low baseline levels of serum interferon gamma (IFNy) and tumor necrosis factor alpha were more likely to experience clinical benefit following treatment with bexmarilimab. Among those patients who experienced clinical benefit, a marked rise in serum IFNy levels was seen during treatment. IFNy is a necessary pro-inflammatory cytokine for response to checkpoint inhibitors like PD-1/L1, highlighting bexmarilimab’s combination potential.

 

“This rate of clinical benefit is particularly striking when you consider these are heavily pre-treated patients, all of whom were refractory to currently approved checkpoint inhibitor therapy,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “Bexmarilimab’s ability to ignite an immune response in these patients means that it may serve as a catalyst for the immune system allowing initially checkpoint inhibitor resistant patients to become responsive to PD-1/L1 blockade.”

 

“Additionally, the biomarker analysis among melanoma patients is consistent with our broader analyses and suggests that two cytokines, which can be measured by a standard blood test as part of a patient’s routine care, could hold the key to understanding which patients will gain the greatest benefit from this novel immunotherapy. Knowing which patients are most likely to respond to treatment is key to both the development process and the successful roll out of new therapeutic approaches.”

 

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

About Bexmarilimab

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

 

About MATINS

The MATINS (Macrophage Antibody To INhibit immune Suppression) study is a first-in-human open label phase I/II clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumour cohorts – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – which are all known to host a significant number of Clever-1 positive tumour-associated macrophages (TAMs). The completed Part I of the trial dealt with tolerability, safety and dose escalation. The ongoing Part II is focused on identifying patients who show an increased number of Clever-1 positive TAMs and exploring safety and efficacy. Part III will be focused on assessing efficacy. Data from MATINS have shown that bexmarilimab has the potential to be the first macrophage immune checkpoint therapy. To date, the investigational therapy has been shown to be safe and well-tolerated, making it a low-risk candidate for combination with existing cancer therapies, and has demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options.

 

About Faron Pharmaceuticals Ltd

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

 

Forward Looking Statements

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

 

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

 

Managers’ Transactions

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

 

Managers’ transactions

 

Company announcement, 8 April 2022 at 5:45 PM (EET) / 3:45 PM (GMT) / 10:45 AM (EDT) 

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, announces today that Dr Markku Jalkanen, Chief Executive Officer of the Company, acquired 25,000 ordinary shares in Faron at a volume weighted average price of €2.8213 per share on 5 April, 2022. Following these purchases, Dr Jalkanen directly holds 2,125,565 ordinary shares in the Company, representing 3.99 per cent. of the Company’s issued share capital and has a combined interest with his spouse in 3,251,677 ordinary shares in the Company, representing 6.11 per cent of the Company’s issued share capital.

 

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

 

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

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Markku Jalkanen

2

Reason for notification

 

 

 

a.

Position/Status

Chief Executive Officer

b.

Initial notification/

Amendment

Initial Notification

3

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

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

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

a.

Description of the financial instrument, type of instrument

Identification Code

Ordinary shares

ISIN: FI4000153309
 

b.

Nature of the transaction

Purchase of ordinary shares

c.

Price(s) and volume(s)

 

 Average

 

 

 

 

Price(s)

Volume(s)

 

€2.8213

25,000

 

Transaction details

(1): Volume: 91 Unit price: 2.84 EUR

(2): Volume: 167 Unit price: 2.825 EUR

(3): Volume: 192 Unit price: 2.825 EUR

(4): Volume: 16 Unit price: 2.825 EUR

(5): Volume: 16 Unit price: 2.825 EUR

(6): Volume: 509 Unit price: 2.825 EUR

(7): Volume: 40 Unit price: 2.825 EUR

(8): Volume: 116 Unit price: 2.825 EUR

(9): Volume: 129 Unit price: 2.825 EUR

(10): Volume: 688 Unit price: 2.825 EUR

(11): Volume: 192 Unit price: 2.825 EUR

(12): Volume: 167 Unit price: 2.825 EUR

(13): Volume: 16 Unit price: 2.825 EUR

(14): Volume: 132 Unit price: 2.825 EUR

(15): Volume: 169 Unit price: 2.825 EUR

(16): Volume: 1,063 Unit price: 2.825 EUR

(17): Volume: 175 Unit price: 2.825 EUR

(18): Volume: 283 Unit price: 2.825 EUR

(19): Volume: 889 Unit price: 2.82 EUR

(20): Volume: 97 Unit price: 2.82 EUR

(21): Volume: 466 Unit price: 2.8 EUR

(22): Volume: 1,487 Unit price: 2.8 EUR

(23): Volume: 1,267 Unit price: 2.8 EUR

(24): Volume: 97 Unit price: 2.8 EUR

(25): Volume: 1,267 Unit price: 2.8 EUR

(26): Volume: 206 Unit price: 2.8 EUR

(27): Volume: 77 Unit price: 2.82 EUR

(28): Volume: 153 Unit price: 2.82 EUR

(29): Volume: 40 Unit price: 2.82 EUR

(30): Volume: 77 Unit price: 2.82 EUR

(31): Volume: 14 Unit price: 2.82 EUR

(32): Volume: 100 Unit price: 2.82 EUR

(33): Volume: 17 Unit price: 2.82 EUR

(34): Volume: 139 Unit price: 2.82 EUR

(35): Volume: 14 Unit price: 2.82 EUR

(36): Volume: 184 Unit price: 2.82 EUR

(37): Volume: 55 Unit price: 2.82 EUR

(38): Volume: 31 Unit price: 2.82 EUR

(39): Volume: 55 Unit price: 2.82 EUR

(40): Volume: 129 Unit price: 2.82 EUR

(41): Volume: 86 Unit price: 2.82 EUR

(42): Volume: 55 Unit price: 2.82 EUR

(43): Volume: 98 Unit price: 2.82 EUR

(44): Volume: 117 Unit price: 2.82 EUR

(45): Volume: 153 Unit price: 2.82 EUR

(46): Volume: 117 Unit price: 2.82 EUR

(47): Volume: 153 Unit price: 2.82 EUR

(48): Volume: 17 Unit price: 2.82 EUR

(49): Volume: 100 Unit price: 2.82 EUR

(50): Volume: 69 Unit price: 2.82 EUR

(51): Volume: 184 Unit price: 2.82 EUR

(52): Volume: 86 Unit price: 2.82 EUR

(53): Volume: 86 Unit price: 2.82 EUR

(54): Volume: 184 Unit price: 2.82 EUR

(55): Volume: 98 Unit price: 2.82 EUR

(56): Volume: 270 Unit price: 2.82 EUR

(57): Volume: 270 Unit price: 2.82 EUR

(58): Volume: 100 Unit price: 2.82 EUR

(59): Volume: 270 Unit price: 2.82 EUR

(60): Volume: 270 Unit price: 2.82 EUR

(61): Volume: 68 Unit price: 2.835 EUR

(62): Volume: 25 Unit price: 2.835 EUR

(63): Volume: 17 Unit price: 2.835 EUR

(64): Volume: 104 Unit price: 2.835 EUR

(65): Volume: 43 Unit price: 2.835 EUR

(66): Volume: 85 Unit price: 2.835 EUR

(67): Volume: 14 Unit price: 2.835 EUR

(68): Volume: 31 Unit price: 2.835 EUR

(69): Volume: 18 Unit price: 2.835 EUR

(70): Volume: 71 Unit price: 2.835 EUR

(71): Volume: 9 Unit price: 2.835 EUR

(72): Volume: 104 Unit price: 2.835 EUR

(73): Volume: 31 Unit price: 2.835 EUR

(74): Volume: 47 Unit price: 2.835 EUR

(75): Volume: 89 Unit price: 2.835 EUR

(76): Volume: 76 Unit price: 2.835 EUR

(77): Volume: 75 Unit price: 2.835 EUR

(78): Volume: 21 Unit price: 2.835 EUR

(79): Volume: 10 Unit price: 2.835 EUR

(80): Volume: 68 Unit price: 2.835 EUR

(81): Volume: 97 Unit price: 2.835 EUR

(82): Volume: 75 Unit price: 2.835 EUR

(83): Volume: 75 Unit price: 2.835 EUR

(84): Volume: 43 Unit price: 2.835 EUR

(85): Volume: 85 Unit price: 2.835 EUR

(86): Volume: 68 Unit price: 2.835 EUR

(87): Volume: 143 Unit price: 2.835 EUR

(88): Volume: 85 Unit price: 2.835 EUR

(89): Volume: 43 Unit price: 2.835 EUR

(90): Volume: 9 Unit price: 2.835 EUR

(91): Volume: 71 Unit price: 2.835 EUR

(92): Volume: 18 Unit price: 2.835 EUR

(93): Volume: 135 Unit price: 2.835 EUR

(94): Volume: 47 Unit price: 2.835 EUR

(95): Volume: 89 Unit price: 2.835 EUR

(96): Volume: 182 Unit price: 2.835 EUR

(97): Volume: 21 Unit price: 2.835 EUR

(98): Volume: 68 Unit price: 2.835 EUR

(99): Volume: 97 Unit price: 2.835 EUR

(100): Volume: 153 Unit price: 2.835 EUR

(101): Volume: 75 Unit price: 2.835 EUR

(102): Volume: 43 Unit price: 2.835 EUR

(103): Volume: 228 Unit price: 2.835 EUR

(104): Volume: 43 Unit price: 2.835 EUR

(105): Volume: 94 Unit price: 2.835 EUR

(106): Volume: 71 Unit price: 2.835 EUR

(107): Volume: 147 Unit price: 2.835 EUR

(108): Volume: 6 Unit price: 2.835 EUR

(109): Volume: 47 Unit price: 2.835 EUR

(110): Volume: 271 Unit price: 2.835 EUR

(111): Volume: 68 Unit price: 2.835 EUR

(112): Volume: 271 Unit price: 2.835 EUR

(113): Volume: 75 Unit price: 2.835 EUR

(114): Volume: 271 Unit price: 2.835 EUR

(115): Volume: 143 Unit price: 2.835 EUR

(116): Volume: 71 Unit price: 2.835 EUR

(117): Volume: 147 Unit price: 2.835 EUR

(118): Volume: 918 Unit price: 2.835 EUR

(119): Volume: 175 Unit price: 2.835 EUR

(120): Volume: 73 Unit price: 2.815 EUR

(121): Volume: 358 Unit price: 2.8 EUR

(122): Volume: 168 Unit price: 2.8 EUR

(123): Volume: 129 Unit price: 2.8 EUR

(124): Volume: 120 Unit price: 2.835 EUR

(125): Volume: 103 Unit price: 2.835 EUR

(126): Volume: 272 Unit price: 2.835 EUR

(127): Volume: 58 Unit price: 2.835 EUR

(128): Volume: 133 Unit price: 2.835 EUR

(129): Volume: 803 Unit price: 2.835 EUR

(130): Volume: 1,034 Unit price: 2.835 EUR

(131): Volume: 167 Unit price: 2.83 EUR

(132): Volume: 79 Unit price: 2.83 EUR

(133): Volume: 137 Unit price: 2.83 EUR

(134): Volume: 51 Unit price: 2.82 EUR

(135): Volume: 46 Unit price: 2.82 EUR

(136): Volume: 68 Unit price: 2.82 EUR

(137): Volume: 541 Unit price: 2.82 EUR

(138): Volume: 200 Unit price: 2.82 EUR

(139): Volume: 200 Unit price: 2.82 EUR

(140): Volume: 400 Unit price: 2.81 EUR

(141): Volume: 8 Unit price: 2.8 EUR

(142): Volume: 14 Unit price: 2.8 EUR

(143): Volume: 27 Unit price: 2.8 EUR

(144): Volume: 7 Unit price: 2.8 EUR

(145): Volume: 85 Unit price: 2.8 EUR

(146): Volume: 43 Unit price: 2.8 EUR

(147): Volume: 71 Unit price: 2.8 EUR

(148): Volume: 4 Unit price: 2.8 EUR

(149): Volume: 22 Unit price: 2.8 EUR

 

d.

Aggregated information

 

– Aggregated Volume

 

– Price

 

 

 

25,000

 

Volume weighted average price of €2.8213

e.

Date of the transaction

5 April, 2022

f.

Place of the transaction

Nasdaq First North Growth Market

 

 

For more information please contact:

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Faron Pharmaceuticals Ltd

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

 

Faron Closes HIBISCUS Trial

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Faron Closes HIBISCUS Trial Due to Low COVID-19 Infection and Hospitalization Rates in the US and Reverts Resources to the Development of Bexmarilimab

 

  • Traumakine will be re-positioned for multiple indications in organ protection together with partnerships
  • Near term value inflections are expected from the accelerated development of Bexmarilimab

 

 

Company announcement, April 05, 2022 at 09:00 AM (EET) / 07:00 AM (GMT) / 2:00 AM (EDT) 

Inside information

 

 

TURKU, FINLAND / BOSTON, MA Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announced that, due to low COVID-19 hospitalization rates and a shortage of patients not already receiving steroids, the Company is closing its Phase II/III HIBISCUS trial assessing Traumakine (Intravenous Interferon beta-1a; IFN beta-1a) as a first-line treatment for hospitalized COVID-19 patients who require low flow oxygen support. The Company’s decision was based on a recommendation from the HIBISCUS Independent Data Monitoring Committee (IDMC) to discontinue the study due to slow recruitment. The IDMC also informed the Company that there were no safety concerns related to treatment of enrolled patients.

 

“When the HIBISCUS trial was designed and initiated, infection and hospitalization rates were high across the U.S.,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “The emergence of the less severe Omicron variant and widespread vaccinations led to a significant decrease in the number of hospitalized patients requiring low flow oxygen support. While this was good news from a pandemic perspective, it, along with the widespread early use of steroids, severely limited our potential patient pool. As a result and based on a recommendation from the independent data monitoring committee, we made the decision to end patient enrollment in the HIBISCUS trial and re-focus immediate resources on the development of bexmarilimab.”

 

In January 2021, Faron announced that the US Department of Defense (DoD) had selected the HIBISCUS trial to receive $6.1 million of funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The DoD concurs with the IDMC and Faron that given the current environment the trial will not be able enroll in a timely manner and enrollment should be stopped. Faron will continue to partner with the 59th Medical Wing of the US Air Force and the DoD on preclinical studies to evaluate Traumakine’s role in preventing multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.

 

“We know that intravenous interferon beta-1a can up-regulate CD73, which reduces inflammation and prevents vascular leakage,” said Daniel S. Talmor, M.D., MPH, Chief of Anesthesia, Critical Care and Pain Medicine at Beth Israel Deaconess Medical Center and Principal Investigator of the HIBISCUS trial. “While the timing and scope of the HIBISCUS trial did not allow us to efficiently enroll patients, I believe strongly that Traumakine has the potential to become a powerful treatment option for patients who are at risk of developing major inflammation and look forward to continuing to work with Faron to advance this potentially first-in-class treatment approach in multiple settings.”

 

“We want to thank the patients, their caregivers, the investigators and everyone who participated in the HIBISCUS trial,” said Dr. Juho Jalkanen, Chief Operating Officer of Faron. “Data from this partially completed study will support our ongoing Traumakine development strategy, which we expect will include additional studies exploring its potential as a future treatment for multiple acute settings of ischemia and systemic inflammation leading to vascular dysfunction and organ damage. We expect ongoing Traumakine development efforts will be supported by both academic and industry collaborations.”

 

Traumakine is an investigational therapy developed by Faron for the potential treatment of conditions based on major inflammation and vascular dysfunction such as acute respiratory distress syndrome (ARDS), acute kidney injury, cardiac protection and ischemia reperfusion injury. The HIBISCUS trial opened enrollment and began recruiting patients at sites in the U.S. in August 2021. The trial was meant to enroll 140 patients who required low flow oxygen support, but not mechanical ventilation. Enrolled patients were randomized 1:1 across two study arms to assess the safety and efficacy of Traumakine compared to corticosteroid treatment with dexamethasone. As part of the trial protocol, corticosteroid treatment concomitantly with Traumakine was not possible in the study setting but was enabled in a sequenced manner following treatment with Traumakine. No treatment related safety concerns were reported among enrolled patients.

 

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

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

About Faron Pharmaceuticals Ltd

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

 

Forward Looking Statements

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

 

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

 

Notice of Faron Pharmaceuticals Ltd’s AGM

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

Company announcement, March 25, 2022 at 11:00 AM (EET) / 09:00 AM (GMT) / 05:00 AM (EDT) 

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 22 April 2022 at 12:00 p.m. EEST (Finnish time). The meeting venue is Event Venue Eliel, Töölönlahdenkatu 2, Helsinki, Finland. The shareholders of the Company may participate in the AGM and exercise their shareholder rights only by voting in advance, by submitting counterproposals in advance and asking questions in advance in accordance with the instructions given in this notice and otherwise by the Company. It is not possible to participate in the AGM at the meeting venue.

The Board of Directors (the “Board”) has resolved on exceptional meeting procedures based on the temporary legislative act (375/2021, “Temporary Act“) approved by the Finnish parliament on 7 May 2021. In order to prevent the spread of the COVID-19 pandemic, the AGM will be held without shareholders’ and their proxy representatives’ presence at the meeting venue. This is necessary in order to ensure the health and safety of the shareholders, employees and other stakeholders of the Company as well as to organize the AGM in a predictable way allowing equal means for shareholders to participate while also ensuring compliance with the restrictions set by the authorities from time to time. For these reasons, shareholders and their proxy representatives can participate in the AGM and use shareholder rights only by voting in advance, by submitting counterproposals in advance and by asking questions in advance. Further instructions can be found in part C of this notice (Instructions for the Participants).

 

The AGM can be followed on the Company’s website. Persons following the meeting in this manner are not considered participants in the AGM. Accordingly, shareholders will not have the possibility to address the meeting or participate in any vote, among other things, during the meeting. The webcast will be arranged only if it can be arranged in compliance with all regulatory rules and restrictions imposed by the authorities due to the COVID-19 pandemic.

 

The CEO of the Company will attend the meeting. The Chairman of the Board, the members of the Board, other management of the Company and the auditor will not attend the AGM.

 

  1. MATTERS ON THE AGENDA OF THE AGM

 

  1. Opening of the meeting

 

  1. Calling the meeting to order

Attorney-at-law Riikka Rannikko shall act as the Chairman of the meeting. If due to weighty reasons Riikka Rannikko is not able to act as Chairman, the Board shall appoint another person it deems most suitable to act as Chairman.

 

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

The Company’s Corporate Counsel Kaisa Kyttä shall scrutinize the minutes and supervise the counting of the votes. In case Kaisa Kyttä would not be able to act as the person to scrutinize the minutes and to supervise the counting of the votes due to weighty reasons, the Board shall appoint another person it deems most suitable to act in that role.

  1. Recording the legality of the meeting

 

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

The shareholders who have voted in advance and who have the right to participate in the meeting pursuant to Chapter 5, Sections 6 and 6a of the Finnish Limited Liability Companies Act (624/2006, as amended; the “Companies Act”) will be recorded to have been represented at the meeting. The list of votes will be adopted according to the information provided by Euroclear Finland Oy (“Euroclear”) and Innovatics Ltd (“Innovatics”).

  1. Presentation of the financial statements, the Board’s report and the auditor’s report for 2021

As shareholders can only participate in the AGM by voting in advance, the financial statements, the Board’s report and the auditor’s report for 2021, published by the Company on 25 March 2022 and which have been made available on the Company’s website at https://www.faron.com/investors/general-meetings, will be deemed to have been presented to the AGM.

  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 proposes that no dividend for the financial year 2021 will be paid and that the losses of the Company for the financial year, amounting to EUR 21.2 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, Gregory Brown, John Poulos, Leopoldo Zambeletti, Markku Jalkanen and Anne Whitaker 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 Erik Ostrowski be elected as a new member to the Board for a term that ends at the end of the next AGM.

Erik Ostrowski (born 1972), citizen of the U.S., 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 presented.

  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. 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 Companies Act, which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation would consist of up to ten million six hundred thousand (10,600,000) 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.

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.

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 30 June 2023.

  1. Authorising the Board to decide on the issuance of shares without consideration to the Company

The Board proposes that the AGM authorise the Board to resolve by one or several decisions on a share issue without consideration to the Company itself. The authorisation would consist of up to ten million six hundred thousand (10,600,000) shares in the aggregate, which corresponds to approximately twenty (20) 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 shares in deviation from the shareholders’ pre-emptive rights. The Board would be authorised to resolve on all other terms and conditions of the issuance of shares, including the right to issuances without consideration. Issuances without consideration require that there is an especially weighty financial reason for doing so from the Company’s point of view and observing the interests of all the shareholders of the Company.

The authorisation would be effective until 30 June 2023. The proposed authorisation does not revoke the share issue authorisations granted to the Board otherwise during this AGM.

 

  1. Closing of the meeting

 

  1. DOCUMENTS OF THE AGM

The proposals of the Board to the AGM and this notice are available on the Company’s website at https://www.faron.com/investors/general-meetings. The financial statements, the Board’s report and the auditor’s report for 2021 are available on the above-mentioned website no later than on 25 March 2022. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the AGM will be available to be viewed on the Company’s website from 6 May 2022 at the latest.

  1. INSTRUCTIONS FOR THE PARTICIPANTS

In order to prevent the spread of the COVID-19 pandemic, the AGM will be organized so that the shareholders and their proxy representatives are not allowed to be present at the meeting venue. The shareholders and their proxy representatives can participate in the meeting and use their shareholder rights only by voting in advance, by submitting counterproposals in advance and asking questions in advance in the manner described below. Proxy representatives shall also vote in advance in the manner described below.

  1. The right to participate

Each shareholder who on the record date of the AGM, being 8 April 2022, is registered in the Company’s shareholders’ register held by Euroclear 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 C.4 (Holder of nominee-registered shares (including depositary interest holders)) for all instructions on participating and voting in advance.

A shareholder may only participate in the meeting by voting in advance or by way of proxy representation and by submitting counterproposals and asking questions in advance in accordance with the instructions below.

  1. Registration and advance voting

Registration for the AGM and advance voting will begin on 4 April 2022 at 12:00 noon EEST (Finnish time) when the deadline for submitting counterproposals has passed. A shareholder entered in the Company’s shareholders’ register who wishes to participate in the AGM by voting in advance must register and vote in advance at the latest on 19 April 2022 at 10:00 a.m. EEST (Finnish time), by which time the registration shall be completed and votes need to be received.

A shareholder whose shares are registered on their Finnish book-entry account can register and vote in advance on certain items on the agenda of the AGM from 12:00 noon EEST (Finnish time) on 4 April 2022 until 10:00 a.m. EEST (Finnish time) on 19 April 2022 by the following means:

a) Through the Company’s website

The Finnish personal identity code or business ID as well as strong identification with Finnish or Swedish banking codes or mobile certificate is needed for electronic registration and advance voting. The terms and other instructions concerning electronic voting are available on the Company’s website at https://www.faron.com/investors/general-meetings.

b) By mail or email

The advance voting form and instructions relating to the advance voting will be available on the Company’s website at https://www.faron.com/investors/general-meetings no later than on 4 April 2022 at 12:00 noon EEST (Finnish time). A shareholder may send the advance voting form available on the aforementioned website or corresponding information to Innovatics by regular mail to Innovatics Ltd, Annual General Meeting / Faron Pharmaceuticals Ltd, Ratamestarinkatu 13 A, FI-00520 Helsinki, Finland or by email to agm@innovatics.fi. If the shareholder participates in the meeting by sending the votes in advance by mail or email to the above-mentioned addresses, this constitutes registration for the AGM, provided that the above-mentioned information required for registration is provided. Additional information is also available through email at general.meeting@faron.com.

In connection with the registration, a shareholder or a proxy representative is required to provide the requested personal information such as the shareholder’s name, personal ID/date of birth and email address and/or phone number. The personal data given to the Company and Innovatics by shareholders and proxy representatives is only used in connection with the AGM and with the processing of related necessary registrations.

Additional information on the registration and advance voting is available during the registration period by telephone at +358 10 2818 909 on business days during 9:00 a.m. until 12:00 noon and from 1:00 p.m. until 4:00 p.m. (EEST).

  1. Proxy representative and powers of attorney

A shareholder may participate in the AGM and exercise their rights at the meeting by way of proxy representation. Also the proxy representative of a shareholder may only participate by voting in advance in the manner instructed above. Shareholders who do not vote in advance are requested, due to the COVID-19 pandemic, to exercise shareholders’ rights through a centralized proxy representative designated by the Company by authorizing attorney-at-law Anniina Järvinen from Hannes Snellman Attorneys Ltd, or a person appointed by her, to represent them at the AGM in accordance with the shareholder’s voting instructions. Authorizing the designated proxy representative will not accrue any costs for the shareholder, excluding possible postal fees for proxy documents. Further information on the designated proxy representative is available at the following website: www.hannessnellman.com/people/all/anniina-jaervinen/.

Shareholders may also participate in the AGM and exercise their rights at the meeting by way of another proxy representative. Proxy representatives must use strong electronic authentication when registering for the meeting and voting in advance online, after which they can register and vote in advance on behalf of the shareholder they represent. A proxy representative shall present a dated proxy document or otherwise in a reliable manner demonstrate their right to represent the shareholder at the AGM. Statutory right of representation may be demonstrated by using the suomi.fi e-Authorisations service which is in use in the online registration service. When a shareholder participates in the AGM by means of several proxy representatives representing the shareholder with shares at different securities accounts, the shares by which each proxy representative represents the shareholder shall be identified in connection with the registration for the AGM.

Proxy and voting instruction templates are available on the Company’s website at https://www.faron.com/investors/general-meetings on 4 April 2022 at the latest. The proxy representative of a shareholder shall deliver duly populated and signed proxy documents together with the signed and duly populated advance voting form in accordance with the instructions set out in the form primarily as an attachment in connection with the electronic registration and advance voting or alternatively through email to general.meeting@faron.com or as originals to the address Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland before the end of the registration period, by which time the proxy documents must be received.

If a shareholder delivers a proxy to the Company in accordance with the applicable instructions before the expiry of the registration and advance-voting period, this constitutes due registration for the AGM, provided that all required information is included in the proxy documents. In addition, proxy representatives must also vote in advance in the manner described in this notice.

Further information is available on the Company’s website at https://www.faron.com/investors/general-meetings.

 

  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 maintained by Euroclear on the AGM’s record date of 8 April 2022. The right to participate in the AGM requires, in addition, that the shareholder on the basis of such shares has been registered into the temporary shareholders’ register maintained by Euroclear by 19 April 2022 at 10:00 a.m. EEST (Finnish time), at the latest. As regards nominee-registered shares this constitutes due registration for the AGM.

A holder of nominee-registered shares is advised to request necessary instructions regarding the registration in the temporary shareholders’ register of the Company, the issuing of proxy documents and registration for the AGM from their custodian bank in good time. A holder of nominee-registered shares shall note that custodian banks may apply deadlines for the registration and advance voting of holders of nominee-registered shares. The account management organisation of the custodian bank has to register a holder of nominee-registered shares into the temporary shareholders’ register of the Company at the latest by the time stated above and see to the voting in advance on behalf of a holder of nominee-registered shares.

Further information on holders of nominee-registered shares is available on the Company’s abovementioned website.

  1. Other instructions and information

Shareholders who hold at least one hundredth (1/100) of all the shares in the Company have the right to pose counterproposals concerning the matters on the agenda of the AGM to be placed for a vote. Such counterproposals shall be delivered to the Company by email to general.meeting@faron.com by no later than 1 April 2022 at 4:00 p.m. EEST (Finnish time), by which time the counterproposals must be received by the Company.

The shareholders shall in connection with the counterproposal present adequate evidence of their shareholding in the Company. The counterproposal is admissible for consideration at the AGM if the shareholders who have made the counterproposal have the right to attend the meeting and on the record date of the AGM represent at least one hundredth (1/100) of all shares in the Company. If a counterproposal will not be taken up for consideration at the AGM, the votes given in favour of the counterproposal will not be taken into account. The Company will publish possible counterproposals to be put to a vote on the Company’s website at https://www.faron.com/investors/general-meetings by no later than 4 April 2022.

A shareholder has the right to ask questions referred to in Chapter 5, Section 25 of the Companies Act with respect to the matters to be considered at the AGM. Such questions may be delivered by email to general.meeting@faron.com or by regular mail to Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland by no later than 8 April 2022, by which time the questions must have been received.

Such questions by shareholders, the Company’s management’s answers as well as other counterproposals than those admissible for voting will be available on the Company’s website at https://www.faron.com/investors/general-meetings on 13 April 2022 at the latest. In connection with asking questions, shareholders are required to provide adequate evidence of shareholding.

The AGM can be followed on the Company’s website. Persons following the meeting in this manner are not considered participants in the AGM. Accordingly, shareholders will not have the possibility to address the meeting pursuant to Chapter 5, Section 25 of the Companies Act or participate in any vote, among other things, during the meeting. The attendance list of the AGM and voting results are determined solely based on the advance votes. Shareholders cannot thus exercise their voting rights when following the meeting through the webcast, i.e., votes must be cast in advance.

Changes in the share ownership following the record date of the AGM do not have an impact on the right to participate in the AGM nor on the number of votes of the shareholder.

On the date of this notice, 25 March 2022, the total number of shares and votes in the Company is 53,232,032.

Turku, 25 March 2022

FARON PHARMACEUTICALS LTD

Board of Directors

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880
 

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

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

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

About Faron Pharmaceuticals Ltd

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

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