Company announcement, 18 January 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 that the US Department of Defense (“DoD”) has selected the HIBISCUS Study to receive $6.1 million of funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Phase II/III HIBISCUS trial will assess Traumakine, Faron’s IV IFN beta-1a, for the treatment of hospitalized COVID-19 patients in the US.

The $6.1 million funding support for HIBISCUS requires final contracting between Faron and DoD’s designated military unit, the 59^th Medical Wing of the US Air Force, and is under preparation. Faron has already established a working relationship with the 59^th Medical Wing and US Army Institute of Surgical Research to explore the use of Traumakine for organ protection in combat wounds leading to multi-organ failure from ischemia and reperfusion.

Dr. Markku Jalkanen, Faron’s CEO, said: “IFN beta-1a has previously demonstrated a compelling argument as the body’s first line of defence against viral infection. Deficiency of either IFN beta or the activation of its receptor (IFNAR) have been associated with severe COVID-19 and poor outcome. This validation from the DoD represents important progress for both our science and intravenous IFN beta as a potential treatment for severe COVID-19 patients. We look forward to working with the  DoD, 59^th Medical Wing of the Air Force, University of Colorado Medical School Anschutz Campus and Harvard to fight COVID-19 and protect central organs.”

Traumakine also continues to be investigated in the ongoing global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) trial, which is evaluating potential treatments for community-acquired pneumonia, including in COVID-19 patients, and is currently ongoing across more than 200 sites and 19 countries.

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            

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500            

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. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology and organ damage. Clevegen (bexmarilimab), its investigative precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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.

Release

Company announcement, 10 December 2020 at 9.00 AM (EET)

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that two presentations at the European Society of Medical Oncology (ESMO) Immuno-Oncology Virtual Congress 2020 will showcase data from the Company’s PhI/II MATINS study and explore the role of myeloid cells in shaping the tumour microenvironment (TME).

‘CLEVER-1 a new immune checkpoint target with activity in GI cancers’, Thursday 10 December, 15.25 CET:

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy which targets Clever-1 (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) positive tumour-associated macrophages (TAMs), converting them from being highly immunosuppressive to  immune-stimulating.

Full data from Part I (dose ranging) of the MATINS trial, to be presented during an educational session by principal investigator Petri Bono, M.D., Ph.D., show bexmarilimab to be well tolerated and demonstrating immune activation and promising clinical anti-tumour activity. The first expansion stage (Part II) of the study across ten different hard-to-treat solid tumour types is ongoing and 87 percent currently recruited.

‘The role of myeloid cells in shaping TME’, Friday 11 December, 15.25 CET:

Tumour-associated myeloid cells, including TAMs, are known to promote tumour growth by favouring tumour cell proliferation and survival, thereby creating  a highly immunosuppressive microenvironment. This characteristic makes them an attractive target for new immunotherapeutic approaches. During her educational session, Professor Maija Hollmén, MediCity, Turku University, Finland, will explore opportunities to overcome the undesired effects of TAMs, including the potential of an immunotherapeutic blockade of Clever-1 to switch immunosuppressive TAMs to immune-stimulating TAMs and induce T-cell activation.

Dr. Markku Jalkanen, Faron’s CEO, said: “Our growing understanding of how the tumour microenvironment shields a cancer from the immune system and fuels its growth makes it a clear target for the next generation of immunotherapies. Everything we are learning about bexmarilimab from its rapidly advancing development programme across a broad range of cancer types gives us continued confidence in the potential of this anti-Clever-1 antibody to activate the immune system and remove T cell exhaustion.”    

For more information on the ESMO Immuno-Oncology Virtual Congress 2020  visit:

https://www.esmo.org/meetings/esmo-immuno-oncology-virtual-congress-2020

About bexmarilimab

Bexmarilimab is Faron’s investigative precision immunotherapy, a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules.

About the MATINS study

The MATINS study is the first-in-human open label Phase I/II clinical trial with an adaptive design to investigate the safety and efficacy of bexmarilimab in ten selected metastatic or inoperable solid tumours – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM).

Part I of the trial dealt with tolerability, safety and dose escalation to optimise dosing. As the trial is an open label study, the Company expects to report findings as the dosing progresses. The cohort expansion during the current Part II of the trial is focused on identifying patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. During Part III, the main focus will be on assessing the efficacy of Clevegen on study subjects who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy.

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. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology and organ damage. Clevegen (bexmarilimab), its investigative precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. Faron is based in Turku, Finland. Further information is available at www.faron.com 

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 (0)20 7213 0880       

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 (0)20 7886 2500       

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

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.

Release

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron receives €800,000 grant from Business Finland as part of Cancer IO, Finland’s leading Personalized Health Program

–      Grant will enable state-of-the-art characterization of immunological responses in MATINS trial
–      Clevegen to be studied in experimental combinations with anti-cancer molecules from other consortium members

Company announcement, 11 May 2020 at 12.00 PM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that it has joined a Finnish consortium,  Cancer IO, and received an €800,000 grant from Business Finland to conduct detailed, state-of-the-art characterization of the immunological responses seen in cancer patients in the Company’s MATINS trial.

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours.

As part of the Business Finland backed initiative, Faron will also study Clevegen in combination with other anti-cancer molecules, in experimental settings together with other consortium members. 

Cancer IO is a new cancer immunotherapy-focused €10 million top-level collaborative research and innovation project within Business Finland’s Personalized Health Program. Coordinated by the University of Helsinki, it integrates immuno-oncology (IO) activities at the universities of Helsinki and Turku, three Finnish university hospitals and one central hospital, eight Finnish SMEs, Finnish cancer patient organizations and nine of the largest IO-investing pharmaceutical companies operating in Finland. Cancer IO has been established to drive the creation of a Finnish IO ecosystem and national IO growth strategy, aiming to provide wealth and well-being through disruptive Nordic IO innovations and better care. Faron’s participation in this significant national immuno-oncology effort will include sharing clinical development expertise and samples from ongoing trials, and providing Clevegen for consortium experiments.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are very pleased to join this leading initiative, which will deepen our understanding of Clevegen’s effects during the MATINS trial, enable us to better characterize and understand the immune responses of patients receiving novel treatments, test different therapies in combination with Clevegen in a variety of laboratories and experimental settings, as well as possibly find new leads to take further into development.”

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 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

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. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company’s pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. 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.

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

Faron Pharmaceuticals Oy

Update on results of Placing

and

Issue of Equity

Capitalised terms used in this announcement have the meanings given to them in the announcement made at 4.45 p.m. BST/ 6.45 p.m. EEST on 21 April 2020 regarding the proposed placing of new ordinary shares in the Company (the “Launch Notice“) and the subsequent announcement released at 7.00 a.m. BST/ 9.00 a.m. EEST on 22 April 2020 (“Result Announcement“), unless the context provides otherwise.

Company announcement, 23 April 2020 at 1.00 p.m. BST/ 3.00 p.m. EEST

TURKU – FINLAND– Faron Pharmaceuticals Oy (“Faron” or the “Company“) (First North: FARON, AIM: FARN), the clinical stage biopharmaceutical company, is pleased to announce that following the Launch Notice and the Result Announcement, the proposed UK Placing has been subscribed for in full, in satisfaction of the UK Placee Condition. As a consequence, and conditional on, amongst other things, issue and registration of the Placing Shares, the Company has raised gross proceeds of approximately €14 million (£12.18 million) through the Placing.

The First Issue Shares (comprising 1,892,763 Placing Shares) are expected to be registered with the Finnish Trade Register today, 23 April 2020, and First Admission is expected to occur tomorrow as set out in the Result Announcement. The expected timing for issue, registration and admission to trading of the Second Issue Shares (comprising 950,000 Placing Shares) and the Third Issue Shares (comprising 657,237 Placing Shares) currently remains as set out in the Result Announcement. 

Faron’s enlarged issued number of shares immediately following registration of the First Issue Shares will be 45,183,510 Ordinary Shares with voting rights attached. The Company has no shares in Treasury; therefore upon, and subject to, registration of the First Issue Shares, the total number of voting rights in Faron will be 45,183,510 (the “Enlarged Number of Shares and Votes“). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the Enlarged Number of Shares and Votes of the Company. Faron’s enlarged issued number of shares immediately following registration of the Second Issue Shares will be 46,133,510 Ordinary Shares with voting rights attached. Faron’s enlarged issued number of shares immediately following registration of the Third Issue Shares will be 46,790,747 Ordinary Shares with voting rights attached.

Exchange rate

Unless otherwise specified, this notice contains certain translations of euros into amounts in pounds sterling for the convenience of the reader based on the exchange rate of €1 = £0.87, being the published exchange rate by the European Central Bank at the close of business on 20 April 2020 (the latest practicable date prior to the date of the Launch Notice) rounded to 2 decimal places.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Carnegie Investment Bank AB, Financial Adviser

Mika Karikoski (Corporate Finance)

Phone: +358 40 741 6959

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2892 

Consilium Strategic Communications

Mary-Jane Elliott

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 40 555 4727