Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

• Safety and efficacy results from Part I of MATINS study presented in poster at ASCO20 Virtual

• Patient recruitment for Part II in multiple cohorts progressing well  

Company announcement, 01 June 2020 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 safety and efficacy results from Part I of the MATINS trial have been presented in a poster at the virtual ASCO20 (American Society of Clinical Oncology) Annual Meeting.  Separately, the Company is also pleased to announce below an update on Part II of the MATINS trial.

ASCO Poster Presentation

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen (FP-1305), Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours.

Data were presented on all 30 patients in Part I of the trial, who had advanced solid tumours and had exhausted all standard therapeutic options. The poster included previously announced data, reporting that

• Clevegen was well tolerated without dose-limiting toxicities;

• CLEVER-1 inhibition led to immune cell activation and downregulation of several checkpoint molecules;
• Interferon gamma and chemokine CXCL10 responses were associated with clinical responses observed in target or non-target lesions.

The poster, Immune activation in fi­rst-in-human anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) phase I/II MATINS trial: Part 1 dose-escalation, safety and efficacy results, is available at the ASCO meeting library (https://meetinglibrary.asco.org) with identification code 3097.

MATINS Trial Part II update

Part II of the MATINS study has begun and the Company is pleased that patient recruitment continues to be strong, despite the COVID-19 pandemic. This Part II now contains cohorts of nine different cancers at 1.0 mg/kg dosing and three colorectal cancer (CRC) cohorts at 0.3, 1.0 and 3.0 mg/kg. Of these, the 0.3 mg/kg cohort has already recruited, with the additional two CRC cohorts expected to be recruited by mid-summer 2020. The Company intends to present data from these test cohorts (10 patients at each dosing levels) to the FDA at the end-of-phase II meeting to obtain advice ahead of expansion into the pivotal Part III stage of the trial.

Dr. Petri Bono, the Principle Investigator of the MATINS study, said:  “The MATINS trial’s Part I results have shown a  tolerable safety profile for Clevegen, as well as exciting clinical activity in the target lesions of several terminal cancer patients. Clevegen represents a novel mechanism of action and this macrophage checkpoint inhibition has already, in Part I of the trial, shown clinical response in immunologically ‘cold’ tumours traditionally not responsive to currently available checkpoint inhibitors. I very much look forward to continuing patient enrolment for Part II of the trial, which is progressing well for the selected tumour types.”

Dr. Markku Jalkanen, Faron’s CEO, said: “Despite the study patients’ very advanced stage of disease and several lines of previous therapies, including PD-1 and CTLA-4 inhibitors, the early results from this dose finding stage of the MATINS study are very encouraging for single agent efficacy.”

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 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 Clevegen in selected metastatic or inoperable solid tumours. The selected tumours under investigation are cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). All together these five target groups consist of approximately 2 million annual cases worldwide. Cancer patients with high Clever-1 expression are identified with a simple blood myeloid cell staining with Clevegen (“liquid biopsy”).

Part I of the trial deals with tolerability, safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report findings as the dosing progresses. The cohort expansion during Part II will focus on identification of patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. Colorectal cancer and ovarian cancer have been selected as the first and second expansion cohorts in Part II. 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. The treatment, if successful, may ultimately be used as a standalone therapy or in combination with other immunotherapies like PD-1 inhibitors.

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.

Company announcement, 28 May 2020 at 9.00 AM (EET)

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces plans to host a virtual R&D Day via webcast on Tuesday, 16 June 2020 at 3pm EEST, 1pm BST, 8am EDT.

The event will provide an opportunity for the Company’s management team to present its R&D strategy and provide insight into Faron’s two clinical stage programmes. Management will discuss the Company’s wholly-owned novel precision cancer immunotherapy, Clevegen, targeting Clever-1 positive tumour associated macrophages (TAMs) in selected metastatic or inoperable solid tumours, currently under development in the ongoing phase I/II MATINS clinical trial. Management will also discuss Traumakine, for the treatment of patients with Acute Respiratory Distress Syndrome (ARDS), which is currently being investigated in COVID-19 patients in the ongoing REMAP-CAP trial and the WHO’s Solidarity trial. There will be an opportunity to ask questions during the webcast.

For further information on the R&D Day, or to register for the event, please contact Consilium Strategic Communications at faron@consilium-comms.com or telephone +44 (0)20 3709 5700.

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

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that the results of its detailed analyses into the effects of glucocorticoids on intravenous (IV) interferon (IFN) beta-1a activity, which arose following the INTEREST trial in 2018, have been published in Intensive Care Medicine, a world leading journal in the field of critical care.

The results showed that the desired mechanism of action of IV IFN beta-1a in the lung vasculature – the upregulation of CD73 – is blocked by the administration of glucocorticoids. In addition, the administration of glucocorticoids with IV IFN beta-1a increases mortality in patients with acute respiratory distress syndrome (ARDS) compared to patients administered with IV IFN beta-1a alone. As previously announced, analysis from the INTEREST trial showed Day-28 mortality for patients receiving concomitant glucocorticoids with IV IFN beta-1a was 39.7% compared to 10.6% for patients receiving IV IFN beta-1a alone (p < 0.001).

Dr. Markku Jalkanen, Faron’s CEO, said: “This is a crucial publication for the critical care community,  detailing the important scientific detective work that has been undertaken since the unexpected readout from the INTEREST trial. It is especially important in these times when ICUs are filled with COVID-19 patients, many of whom may be receiving treatment with glucocorticoids. Prior clinical data have shown that glucocorticoids are harmful in viral-induced ARDS and the World Health Organization has already recommended not to use glucocorticoids in severely ill COVID-19 patients. These published and peer-reviewed data give us the mechanistic reason why and the results are without dispute. The potential lung protective effects of interferon beta through upregulation of CD73, should it be endogenous or exogenous, are lost with the administration of glucocorticoids.”

In recent weeks Faron has announced that its investigational IV IFN beta-1a (Traumakine) is being trialled in two global studies investigating potential COVID-19 treatments – the World Health Organization (WHO) Solidarity study, involving over 90 countries, and the global REMAP-CAP trial (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) underway across close to 200 sites in 14 countries. The Company continues to develop Traumakine as a treatment for ARDS patients. As previously announced, in March the U.S. Food and Drug Administration (FDA) accepted the Company’s proposed protocol design for the next Traumakine study, which will exclude the use of concomitant glucocorticoids.

“Glucocorticoids inhibit type I IFN beta signaling and the upregulation of CD73 in human lung” in Intensive Care Medicine can be found here. 

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.