Faron, etusivu

Faron to Host KOL Webinar on the Potential of Clever-1 Receptor as a Target for Macrophage-Guided Immunotherapy on July 19, 2021

 Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron to Host KOL Webinar on the Potential of Clever-1 Receptor as a Target for Macrophage-Guided Immunotherapy on July 19, 2021

TURKU, FINLAND / BOSTON, MA, July 12, 2021 – Faron Pharmaceuticals Oy (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 it will host a webinar entitled ‘Clever-1 as a target for macrophage-guided immunotherapy’ on Monday 19 July 2021 at 8.30 am EDT, 13.30 pm BST,  15.30 pm EEST.

The webinar will feature a presentation by key opinion leader (KOL), Dr. Maija Hollmén, adjunct professor of tumour immunology, group leader and academy research fellow at the MediCity Research Laboratory, Institute of Biomedicine, University of Turku, Finland. Additionally, Chief Executive Officer of Faron, Dr. Markku Jalkanen, will present on the potential of bexmarilimab, Faron’s wholly-owned, novel precision cancer immunotherapy targeting Clever-1, which is currently in Phase I/II development as a potential monotherapy in patients with solid tumours who have exhausted all treatment options.

The presentation will be followed by a live Q&A session. The event can be accessed at the “Investors” section on Faron’s website at https://www.faron.com/investors. A replay will be made available on the investor section of Faron’s website shortly after the event.

 

Ends

 

 

For more information please contact:
 

Media Contact

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

+1 (610) 529-6219

 

Investor Contact

Julie Seidel

julie.seidel@sternir.com

Phone: +1 (212) 362-1200

 

Peel Hunt LLP, Broker

Dr Christopher Golden, James Steel        

Phone: + 44 (0)20 7418 8900

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone. +44 (0)20 7213 0880      

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

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 humanised 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 tumours, 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 hospitalised 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.

 

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “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.

Faron to Host KOL Webinar on the Potential of Clever-1 120721

Updated corporate presentation

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Updated corporate presentation

Company announcement, 22 June 2021 at 9.00 AM (EEST)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, has today published an updated corporate presentation on its website.

The presentation contains previously published Company information, views of Management and data from Faron’s development programmes.

Latest available data from the ongoing PhI/II MATINS trial investigating bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1, has been updated in the presentation to include positive incremental change to the previously reported disease control rate (DCR) in cutaneous melanoma patients. The previously reported DCR figure of 3/9 patients (33.3%) has, following the accumulation of new data, now increased to 4/11 patients (36.3%).

It should be noted that some information within the presentation may be presented in a different format or context to earlier versions. Readers are encouraged to read the corporate disclaimer on page two of the presentation. The Company may make additional non-material additions and updates to the presentation periodically, as deemed necessary, without making separate announcements of such updates.

The presentation is available to view in the Investors section of www.faron.com

Ends

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Peel Hunt LLP, Broker

Dr Christopher Golden, James Steel        

Phone: + 44 (0)20 7418 8900

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner,  Mark Rogers

Phone. +44 (0)20 7213 0880      

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel

Phone: +1 212 362 1200

Email: julie.seidel@sternir.com

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 humanised 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 tumours, 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 hospitalised 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.

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “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 b

Updated corporate presentation 220621

Bexmarilimab granted key US patent

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Bexmarilimab granted key US patent

 
Company announcement, 14 June 2021 at 9.00 AM (EEST)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that the United States Patent and Trademark Office has granted a new US Patent, No. 11,046,761, with claims protecting the composition of matter of bexmarilimab. The patent will be issued on 29 June, 2021.

Faron’s wholly-owned novel precision cancer immunotherapy drug candidate, bexmarilimab, targets the Clever-1 receptor, known to be expressed on immunosuppressive macrophages in the tumour microenvironment and circulating in soluble form, and which is capable of directly inhibiting T-cell activation. The reprogramming of these Clever-1 positive macrophages by bexmarilimab, from an immunosuppressive state to an immune-stimulating one, is believed to be a key immune defence against tumour growth and spread.

Bexmarilimab is currently being investigated in the ongoing Phase I/II MATINS trial as a potential monotherapy in patients with solid tumours who have exhausted all treatment options. Latest data from the trial have shown strong initial safety and tolerability, and promising anti-tumour activity in several refractory metastatic solid tumours – cutaneous melanoma, gastric cancer and cholangiocarcinoma.

The US composition of matter patent covers bexmarilimab’s binding sequences and Clever-1’s corresponding epitope – specific elements of the antibody-antigen binding site. The expiry date, not including any potential extensions, is expected to be 2037.

The same patent has been granted in Japan and applications are under review in other key territories including Europe and China.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are extremely pleased to receive this key patent approval which grants us market exclusivity up to 2037. This patent protection applies specifically to the binding process between bexmarilimab and its target, the Clever-1 receptor found on the surface of tumour associated macrophages in the tumour microenvironment. This novel binding is key to the conversion of these highly immunosuppressive macrophages to immune-stimulating ones that can target difficult-to-treat cancers, and key to the removal of soluble Clever-1 from remote locations, where it can prevent activation of immune cells. The patent is a welcome addition to our existing global IP portfolio for targeting Clever-1 and further strengthens the long-term potential of this next-generation macrophage reprogramming immunotherapy.”

 

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Peel Hunt LLP, Broker

Dr Christopher Golden, James Steel        

Phone: + 44 (0)20 7418 8900

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner,  Mark Rogers

Phone. +44 (0)20 7213 0880      

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel

Phone: +1 212 362 1200

Email: julie.seidel@sternir.com

 

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 humanised 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 tumours, 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 hospitalised 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.

 

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “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.

Faron announces bexmarilimab granted key US patent 140621

Bexmarilimab results published in CCR

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

First-in-human bexmarilimab results published in Clinical Cancer Research

– Results reveal the role of Clever-1 receptor in supressing adaptive immunity

– Bexmarilimab’s macrophage-targeting approach activates T-cells and drives anti-tumour immune responses in cold tumours that are not otherwise responsive to immunotherapy

Company announcement, 3 June 2021 at 9.00 AM (EET)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces the publication of research supporting the immunotherapeutic blockade of Clever-1 to activate anti-tumour immune responses in advanced cancer patients. The research, published in Clinical Cancer Research, a journal of the American Association for Cancer Research, analyzes the mode of action of bexmarilimab, both in vitro and in heavily pre-treated metastatic cancer patients from Part I (dose-finding) of Faron’s ongoing Phase I/II MATINS study.

Bexmarilimab is Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1 (common lymphatic endothelial and vascular endothelial receptor 1), a receptor expressed on immunosuppressive macrophages in the tumour microenvironment. The humanised monoclonal antibody is currently being investigated as a potential monotherapy in patients with solid tumours who have exhausted all treatment options. The ongoing, open label Phase I/II multicenter MATINS study has treated more than 140 patients to date. A recent and previously communicated analysis of data from patients enrolled in the completed Part I and ongoing Part II of the study identified promising anti-tumour activity in multiple advanced solid tumours.

The research published in Clinical Cancer Research was conducted by Dr. Maija Hollmén and colleagues at the University of Turku, Finland – part of Faron’s scientific network – and was supported by the investigators in the MATINS study. It explores the systemic immune signatures induced by bexmarilimab in advanced cancer patients with solid tumours and provides a mechanistic understanding of how a macrophage-targeted approach can promote robust activation of T-cells. In the cancer patients studied, it was found that administration of bexmarilimab successfully lowered the suppressive potential of macrophage precursors circulating in the blood. Treatment led to suppression of nuclear lipid signalling pathways and a proinflammatory phenotypic switch in blood monocytes. These effects were accompanied by a significant increase and activation of peripheral T-cells with indications of antitumour responses in some patients.

The researchers conclude that the therapeutic blockade of Clever-1 reveals a pathway linking the innate and adaptive immune system and that targeting macrophages can promote an immune switch, converting immunologically ignorant tumours to an immune activated state, supporting further exploration of Clever-1 as an immunotherapeutic drug target.

Commenting on the findings, Dr. Maija Hollmén, Turku University, Finland, said: “Macrophages have been proven to be critical in driving an immunosuppressive tumour microenvironment, which ultimately counteracts the effects of current T-cell targeting therapies. Successfully overcoming this suppression is critical to developing effective new cancer therapies. We have demonstrated through this research that adaptive immune activation can be achieved by modulating the behaviour of macrophages. “The notable immunological finding from this research is that anti-Clever-1 treatment can induce robust peripheral T-cell activation in patients with advanced cancer. This systemic immune activation is a promising feature of the clinical anti-tumour activity of bexmarilimab.”

The research, entitled “Systemic blockade of Clever-1 elicits lymphocyte activation alongside checkpoint molecule downregulation in patients with solid tumors” can be accessed via the link below:

 

https://clincancerres.aacrjournals.org/content/early/2021/06/01/1078-0432.CCR-20-4862

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 207 213 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

Phone: +44 (0)20 3709 5700

Email: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel, Alexa Comai

Phone: +1 (212) 362-1200

E-mail: julie.seidel@sternir.com

 

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 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 humanised 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 tumours, 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 hospitalised 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.

210603 Faron_First-in-human bexmarilimab results published in CCR FINAL

Bexmarilimab shows promising anti-tumour activity

 Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Bexmarilimab monotherapy shows promising anti-tumour activity in multiple advanced solid tumours

  • Headline data reported from patients enrolled in completed Part I and ongoing Part II of MATINS study
  • Strongest disease control rate (DCR) of 31% seen in cutaneous melanoma, gastric cancer and cholangiocarcinoma patients
  • 100% six-month survival rate observed in DCR patients compared with 31.1 % for non-DCR patients
  • Equivalent prior treatment durations for DCR and non-DCR patients suggests DCR with bexmarilimab is indicator of anti-tumour activity and survival benefit

Company announcement, 17 May 2021 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces promising new data from its ongoing bexmarilimab MATINS study, reporting combined headline data from 141 evaluable patients enrolled in the completed Part I and ongoing Part II of the study.

The open label Phase I/II MATINS clinical trial is investigating the safety and preliminary efficacy of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1, a receptor known to be expressed on immunosuppressive macrophages in the tumour microenvironment. In this trial bexmarilimab is being investigated as a potential monotherapy in patients with solid tumours who have exhausted all treatment options.

As previously communicated, the first expansion stage (Part II) of the study has progressed significantly with strong patient recruitment across the 10 different hard-to-treat solid tumours under investigation – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma. The latest data, as of the end of April, include results from 141 patients enrolled in the completed Part I (n=30) and ongoing Part II (n=111) of the study. Patients were dosed at five different levels (0.1, 0.3, 1.0, 3.0 and 10 mg/kg) and received one to 12 doses (median, three doses) of bexmarilimab every three weeks. Median follow-up was 2.1 months (range, 0.3 to 8.2 months).

Key Findings

  • Across the 141 evaluable patients, median progression-free survival (PFS) was 59 days (95% confidence interval, 57 – 60) and median overall survival (OS) was 129 days (95% confidence interval, 115 – 178).
  • Per RECIST 1.1 criteria, the DCR (partial response + stable disease rate) among responding patients was 11.4 % at cycle four of treatment across all ten solid tumour types.
  • Among responding patients, OS and PFS were improved (hazard ratio for OS 0.19; CI 0.06-0.60 and hazard ratio for PFS 0.09; CI 0.04-0.23, respectively). This improved survival in responding patients was not associated with duration of previous therapy. Six-month survival rate was 100% for DCR patients compared to 31.1 % for non-DCR patients.
  • Strongest results were observed in cutaneous melanoma (3/9 patients), gastric cancer (3/10 patients) and cholangiocarcinoma (3/10 patients) resulting in a 31.0 % DCR.
  • Most common treatment emergent adverse events (TEAEs) were fatigue (25% of patients), abdominal pain (24%) and anaemia (20%) and only 10 out of the total 145 recorded serious TEAEs (14.1% of all TEAEs) were considered related to the study drug.

Dr. Markku Jalkanen, Faron’s CEO, said: “Bexmarilimab’s ability to increase survival in patients who have exhausted all treatment options is significant and demonstrates the importance of targeting myeloid cell control in the development of next generation immunotherapies. Bexmarilimab is designed to switch immunosuppressive macrophages in the tumour microenvironment to become immune stimulating and we believe its unique mechanism of action offers broad potential across a range of hard-to-treat cancers.

“These data demonstrate strong initial safety and tolerability, and promising anti-tumour activity in several refractory metastatic solid tumours – cutaneous melanoma, gastric cancer and cholangiocarcinoma – which helps us to determine in which cancer cohorts bexmarilimab offers the most promise. Together with the additional work underway investigating higher and more frequent dosing, biomarkers of efficacy and the potential for combination with earlier lines of therapy, we are building a clear path towards the next stage of the study.”

Further detailed analysis of the data will be presented at an upcoming scientific congress.

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

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 207 213 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

Phone: +44 (0)20 3709 5700

Email: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel, Alexa Comai

Phone: +1 (212) 362-1200

E-mail: julie.seidel@sternir.com

 

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 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 humanised 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 tumours, 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 hospitalised 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.

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “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.

Faron - Bexmarilimab shows promising anti-tumour activity 170521

US rights to patent related to Traumakine

 Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron secures U.S. rights to patent related to Traumakine 

Company announcement, 14 May 2021 at 9.00 AM (EEST)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that it has signed a sub-license agreement for the rights to U.S. patent US9,376,478, which currently extends to 2033.

The agreement clarifies Faron’s intellectual property position in the U.S. ahead of any launch of Traumakine for the treatment of capillary leak and systemic inflammatory response syndromes (SIRS) including acute respiratory distress syndrome (ARDS) in the U.S. (subject to marketing approval from the U.S. Food and Drug Administration).  Faron will pay a small signing-fee, as well as single-digit standard market royalties from future sales of its intravenous (IV) IFN beta-1a (Traumakine) in the U.S.  This sub-licence specifically covers a manufacturing patent valid only in the U.S. (no corresponding patents exist in other countries) and adds to Faron’s existing comprehensive patent portfolio for Traumakine which includes use and IV formulation patents, as well as market exclusivity in Europe as an orphan medicine.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are pleased to agree this sub-licence. We continue to believe in Traumakine’s potential as a much-needed new treatment for respiratory failure and organ protection.

“Several recent publications have connected type 1 IFN with the severity of COVID-19 infections1,2. Multiple associations have been drawn across the literature including deficiency of type 1 IFN3; inborn errors of IFN-beta signalling4; and the presence of auto-antibodies that neutralise the protective effect of type 1 IFN in viral infections5. Patients who do not have an early IFN response appear to develop severe disease irrespective of the underlying reason for the deficiency2,6. The continued further evidence supports the hypothesis that COVID-19 patients may become very ill because of an impaired interferon response.

“The administration of IFN is likely to benefit patients and relieve them from the hyper-inflammatory state that leads to severe disease3,7,8. We believe intravenous administration of IFN-beta is the optimal route9 to compensate for this loss of first line viral defence and, in tandem induce CD73 a critical enzyme in organ protection during severe illness10.”

References:

  1. C. Turk et al. Eur Rev Med Pharmacol Sci 10.26355/eurrev_202008_22660 (2020)

  2. V. Feuillet et al. Trends in Immunology. 10.1016/j.it.2020.11.003 (2021)
  3. J. Hadjadj et al. Science 10.1126/science.abc6027 (2020)
  4. Q. Zhang et al. Science 10.1126/science.abd4570 (2020)
  5.  P. Bastard et al. Science 10.1126/science.asd4585 (2020)
  6. L. Walz et al. BMC Infect Dis 10.1186/s12879-020-05730-z (2020)
  7. Z. Wang et al. Sig Transduct Target Ther. 10.1038/s41392-020-00306-4 (2020)
  8. G. Schreiber et al. Front. Immunol. 10.3389/fimmu.2020.595739 (2020)
  9. J. Jalkanen et al Crit Care. 10.1186/s13054-020-03048-5
  10. Hanidziar and Robson Am J Physiol Lung Cell Mol Physiol 10.1152/ajplung.00304.2020 (2021)

For more information please contact:

 

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Peel Hunt LLP, Broker

Dr Christopher Golden, James Steel        

Phone: + 44 (0)20 7418 8900

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner,  Mark Rogers

Phone. +44 (0)20 7213 0880      

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel

Phone: +1 212 362 1200

Email: julie.seidel@sternir.com

 

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 humanised antibody, is an investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers by targeting myeloid function. This programme is currently in phase I/II clinical development as a potential therapy for patients with untreatable solid tumours. Bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint inhibitors. 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 clinical trials as a potential treatment for hospitalised 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 ischaemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “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. 

Faron secures US rights to patent related to Traumakine 140521

Holding(s) in Company

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii: Faron Pharmaceuticals Ltd
1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)
Non-UK issuer X
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights x
An acquisition or disposal of financial instruments
An event changing the breakdown of voting rights
Other (please specify)iii: (Decrease of holding due to issuance of new shares)
3. Details of person subject to the notification obligationiv
Name Timo Syrjälä
City and country of registered office (if applicable)
4. Full name of shareholder(s) (if different from 3.)v
Name
City and country of registered office (if applicable)
5. Date on which the threshold was crossed or reachedvi:  7.5.2021
6. Date on which issuer notified (DD/MM/YYYY): 10.5.2021
7. Total positions of person(s) subject to the notification obligation
% of voting rights attached to shares (total of 8. A) % of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)		 Total of both in % (8.A + 8.B) Total number of voting rights of issuervii
Resulting situation on the date on which threshold was crossed or reached  14.09% 14.09%  50,457,874
Position of previous notification (if applicable) 13.57% 13.57%
8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii
A: Voting rights attached to shares
Class/type of
sharesISIN code (if possible)		 Number of voting rightsix % of voting rights
Direct(Art 9 of Directive 2004/109/EC) (DTR5.1) Indirect(Art 10 of Directive 2004/109/EC) (DTR5.2.1) Direct(Art 9 of Directive 2004/109/EC) (DTR5.1) Indirect(Art 10 of Directive 2004/109/EC) (DTR5.2.1)
FI4000153309 2,561,402 4,550,285 5.08% 9.02%
SUBTOTAL 8. A 7,111,687 14.09%
B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))
Type of financial instrument Expiration
datex		 Exercise/
Conversion Periodxi		 Number of voting rights that may be acquired if the instrument is exercised/converted. % of voting rights
SUBTOTAL 8. B 1
B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))
Type of financial instrument Expiration
datex		 Exercise/
Conversion Period xi		 Physical or cash settlementxii Number of voting rights % of voting rights
SUBTOTAL 8.B.2
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”)
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii
Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) X
Namexv % of voting rights if it equals or is higher than the notifiable threshold % of voting rights through financial instruments if it equals or is higher than the notifiable threshold Total of both if it equals or is higher than the notifiable threshold
Timo Syrjälä (Direct) 5.08% 5.08%
Acme Investments SPF Sarl (Indirect) 9.02% 9.02%
10. In case of proxy voting, please identify:
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional informationxvi
Place of completion Luxembourg
Date of completion 10.05.2021
Faron TR-1 100521

Grant of options

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Grant of options

Company announcement, 29 April 2021 at 14.45 (EEST)

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical-stage biopharmaceutical company, announces that the Company’s board has confirmed the grant of a total of 728,333 options over ordinary shares in the Company (“Options”) under the Company’s Share Option Plan 2019. The Options have been allocated under the Share Option Plan 2019 and are exercisable between 24 March 2022 and 24 March 2026 at an exercise price of €3.99 per share (£3.47), vesting 25% per annum over four years. The exercise price 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 2021. The terms of the Share Option Plan 2019 are as attached to the notice of the Company’s 2020 annual general meeting, available on the Company’s website at https://www.faron.com/investors/general-meetings/2020.

The granted 728,333 Options entitle the option holders to subscribe for a total of 728,333 new ordinary shares in the Company, if exercised in full, and represent 1.4% 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:

Director Options granted
Armstrong Frank 60,000
Brown Gregory 30,000
Jalkanen Markku 120,000
Manner Matti 30,000
Poulos John 30,000
Whitaker Anne 30,000
Zambeletti Leopoldo 30,000
Total directors 330,000
Other PDMR
Honkasalo Pessi 12,000
Hänninen Toni 43,333
Jalkanen Juho 32,500
Karvonen Matti 32,500
Lahtinen Maria 21,000
Mandelin Jami 21,000
Total other PDMRs 162,333
SAB member
Curiel Tyler 10,000
Jalkanen Sirpa* 10,000
Knowles Jonathan 10,000
Total SAB 30,000
*Jalkanen Sirpa is a person closely associated (“PCA”) to Jalkanen Markku
Total Company personnel 206,000

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 (0) 20 7213 0880

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0) 40 555 4727

Jukka Järvelä

Phone: +358 (0) 50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0) 20 3709 5700

Email: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel, Alexa Comai

Phone: +1 (212) 362-1200

Email: julie.seidel@sternir.com

 
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 humanised 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 tumours, 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 hospitalised 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 Armstrong Frank
Brown Gregory
Honkasalo Pessi
Hänninen Toni
Jalkanen Juho
Jalkanen Markku
Jalkanen Sirpa
Karvonen Matti
Lahtinen Maria
Mandelin Jami
Manner Matti
Poulos John
Whitaker Anne
Zambeletti Leopoldo
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 exercisable at €3.99 per ordinary share
c. Price(s) and volume(s)
Price(s) Volume(s)
Nil
60,000
30,000
12,000
43,333
32,500
120,000
10,000
32,500
21,000
21,000
30,000
30,000
30,000
30,000
d. Aggregated information– Aggregated Volume– Price 502,333Nil
e. Date of the transaction 28 April 2021
f. Place of the transaction Turku

Board Change

Faron Pharmaceuticals Oy

 

(“Faron” or the “Company”)

Board Change

Company announcement, 23 April 2021 at 15:45 EET

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, is pleased to announce the appointment of Anne Whitaker as a Non-Executive Director of the Company following the passing of all resolutions put to shareholders of the Company at the AGM held earlier today. 

Anne has more than 25 years of experience in the life science industry, including senior leadership roles with large pharmaceutical, biotech and speciality pharma companies.  She is the current Chairman of the Board for Aerami Therapeutics Holdings, Inc. (formerly Dance Biopharm Holdings, Inc.), a private life science company.  Prior to taking the role of Chairman at Aerami, Anne served as the Company’s Chief Executive Officer and a Director from October 2018 to November 2020. Anne served as Chief Executive Officer of Novoclem Therapeutics, Inc. from February 2017 until April 2018. Prior to that, she served as Executive Vice President at Bausch Health overseeing its Global Branded Pharmaceutical Business and the Western European Region from May 2015 to January 2017. Previously, Anne served as President and Chief Executive Officer of Synta Pharmaceuticals.  She also served as President, North America Pharmaceuticals at Sanofi, where she oversaw all pharmaceutical and consumer healthcare operations for the region and held several commercial leadership roles at GlaxoSmithKline.

Additional Disclosures

The following information regarding the appointment of Anne Michelle Clem Whitaker, aged 53, is disclosed under Schedule 2(g) of the AIM Rules for Companies:

Current directorships and/or partnerships:

 Former directorships and/or partnerships (within the last five years):
Aerami Therapeutics, Inc. Chason Dreams, LLC
Anne Whitaker Group, LLC Cree, Inc.
Caladrius Biosciences, Inc. Novoclem Therapeutics, Inc.
Mallinckrodt plc* Vectura Group plc
UDG Healthcare plc

Ms Whitaker does not have any beneficial interest in the ordinary shares of the Company.

*Mallinckrodt plc has recently filed for bankruptcy while facing class action litigation.

Save as set out above, no further information regarding Anne Whitaker is required to be disclosed pursuant to Schedule Two, paragraph (g) of the AIM Rules for Companies.

For more information please contact:

 

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 207 213 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

Phone: +44 (0)20 3709 5700

Email: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel, Alexa Comai

Phone: +1 (212) 362-1200

E-mail: julie.seidel@sternir.com

 

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 humanised 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 tumours, 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 hospitalised 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.

Result of AGM

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

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

Company announcement, 23 April 2021 at 15:45 p.m. (EEST)

TURKU, FINLAND – The annual general meeting (“AGM”) of Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) took place at the premises of Inderes Oy in Helsinki, Finland today, 23 April 2021. The AGM approved all the proposals of the board of directors (“Board”) and its committees, set out in the notice of the AGM published on 25 March 2021.

The AGM was held through exceptional procedures in accordance with the temporary legislative act to limit the spread of the Covid-19 pandemic (677/2020). The shareholders of the Company or their proxy representatives could participate in the AGM and exercise their shareholders’ rights only by voting in advance as well as by submitting counterproposals and 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 2020. No dividend for the financial year 2020 will be paid, and the losses of the Company for the financial year, amounting to EUR 16,946,216.84 (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, Markku Jalkanen, Matti Manner, Leopoldo Zambeletti, Gregory Brown and John Poulos were re-elected to the Board and Anne Whitaker 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.
  • 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 will 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.

Amendment of the Option Plan 2015

The AGM resolved to amend the terms and conditions of the option programme adopted by the Company’s extraordinary general meeting on 15 September 2015, which has later been amended by the decision of the annual general meetings held on 16 May 2017 and 18 May 2020 (the “Option Plan 2015”) so that the subscription period for shares based on the options is extended by two (2) years, i.e., until 30 September 2023.

Amendment of the articles of association

The AGM resolved to amend the articles of association of the Company by removing article 13 (regarding the reduction of equity of the company) from the articles of association as the rules applicable to the Company are directly based on the Finnish Companies Act.

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

The Board was authorised to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act, which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation consists of up to ten million (10,000,000) 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 on the date of the AGM.

The authorisation does 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 can be used for material arrangements from the Company’s point of view, such as financing 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, exists.

The Board was authorised to resolve on all other terms and conditions of the issuance of shares, options or other special rights entitling to shares. The authorisation will be effective until 30 June 2022 and will not replace the authorisations relating to other items resolved upon in the AGM.

Decisions of the Board

At the meeting of the Board held following the AGM, Frank Armstrong was re-elected Chair of the Board and Matti Manner was re-elected Vice-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 Matti Manner and Gregory Brown were elected as the other members of the Audit Committee.
  • Matti Manner was elected the Chair of the Nomination Committee and Anne Whitaker and Frank Armstrong were elected as the other members of the Nomination Committee.
  • Frank Armstrong was elected as the Chair of the Remuneration Committee and Anne Whitaker, 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 7 May 2021 at the latest.

For more information please contact:

 

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: + 44 207 213 0880

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 40 555 4727

Jukka Järvelä

Phone: +358 50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel, Alexa Comai

Phone: +1 (212) 362-1200

E-mail: julie.seidel@sternir.com

 

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 humanised 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 tumours, 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 hospitalised 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.

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