Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

MATINS TRIAL UPDATE 

Ovarian cancer selected as second expansion cohort

Company announcement, 27 January 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 second expansion cohort in its phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen will be in patients with ovarian cancer.

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.

Initiation of this second expansion cohort follows approval from the MATINS trial’s data monitoring committee earlier this month to initiate the study’s first expansion cohort in patients suffering from late-stage colorectal cancer (CRC). Ovarian cancer is a tumour type known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). It presents a high unmet medical need with few available treatments for patients. Large transcript analysis of ovarian tumours indicates significant outcome differences between patients with either high or low Clever-1 expression. Patients with high Clever-1 expression have short life expectancies under current treatment options.

Dr. Markku Jalkanen, Faron’s CEO, said: “Data collected so far in the MATINS trial are highly encouraging, with Clevegen establishing itself as a potential immunotherapy capable of downregulating a range of major inhibitory immune checkpoints (PD-1, PD-L1, CTLA-4) across several cancers. Initiation of this additional expansion cohort signals our commitment to rapidly progress the development of Clevegen in patients with limited effective treatment options.”

Dr. Tyler Curiel, Professor and The Daisy M. Skinner President’s Chair in Cancer Immunology Research, UT Health San Antonio, and MATINS trial site investigator and principal investigator for USA, said: “Ovarian cancer is devastating and there remains a huge need for new treatments. Expanding the MATINS trial to include ovarian cancer patients will help us to understand this novel potential immunotherapy in a patient group where we desperately need to improve outcomes. We are very excited to join the MATINS trial and to start US recruitment.”

Existing MATINS trial sites in Europe are currently recruiting for the first expansion cohort in late-stage CRC patients and this second cohort, in a total of 10 patients with ovarian cancer, is expected to follow in the coming weeks. With good tolerability and no dose limiting toxicity signals established across all dosing levels explored in the MATINS trial to date, the dosing for this additional cohort is likely to be higher (e.g. 1 mg/kg) than for the first CRC cohort. MATINS trial sites in the US are expected to begin opening in the short term. 

Primarily intended to investigate safety and tolerability, the completed Part I of the MATINS trial has already shown that Clevegen administration promoted immune activation in all of the dosed patients to date. This would potentially make Clevegen a new and effective macrophage immune checkpoint drug for cancer patients, who frequently suffer from supressed immune capacity toward tumour elimination. Previously announced data also indicate that Clevegen can down regulate a range of major inhibitory immune checkpoints, that current immuno-oncology therapies aim to suppress.

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.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

MATINS TRIAL UPDATE 

Data monitoring committee approves initiation of expansion cohort in colorectal cancer patients

Company announcement, 13 January 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 approval from the MATINS trial’s data monitoring committee (“DMC”) to initiate the study’s first expansion cohort, Part II, in patients suffering from late-stage colorectal cancer (CRC), following a successful conclusion of the dose escalation in Part I.

The 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.

The DMC has accepted the Company’s proposal that the initial Clevegen dose for Part II of the study should be 0.3 mg/kg. This follows analysis of the data from patients in Part I of the study who received doses of 0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg and 10 mg/kg. All dose levels tested showed good tolerability with no dose limiting toxicity signals. While the dose of 0.3 mg/kg has been associated with a clinical response and has produced the strongest immune response (Natural killer cell activation, CD8+ T-cell increase), the efficacy of another Part I dose level cohort (1.0 or 3.0 mg/kg) may be tested separately during Part II following completion and final analysis of Part I.

A total of 10 late-stage CRC patients are expected to be dosed in this 0.3 mg/kg cohort, including two patients who had previously received this dose in the earlier Part I of the study. Commencement of other distinct cancer cohorts will follow the CRC cohort.

Dr. Markku Jalkanen, Faron’s CEO, said: “We continue to be impressed by the potential of Clevegen and are very pleased to have the DMC’s support for the commencement of Part II of the MATINS trial. At just 0.3 mg/kg the dose could provide an unusually high safety margin for the use of this potential therapy as a stand-alone treatment or in combination with other cancer therapies. The decline in expression of negative immune checkpoint receptors post Clevegen dosing warrants expansion of Clevegen testing in numerous cancer types and therefore we will now ensure a rapid expansion of Part II of the MATINS trial to continue investigating the safety and efficacy of Clevegen in various cancer cohorts.”

Primarily intended to investigate safety and tolerability, the completed Part I of the MATINS trial has already shown that Clevegen administration promoted immune activation in all of the dosed patients. This would potentially make Clevegen a new and effective macrophage immune checkpoint drug for cancer patients, who frequently suffer from supressed immune capacity toward tumour elimination. Previously announced data also indicate that Clevegen can down regulate a range of major inhibitory immune checkpoints, that current immuno-oncology therapies aim to suppress.

As previously announced, following approval of the Company’s Investigational New Drug (IND) application for Clevegen by the Food and Drug Administration (FDA) in November 2019, the Company is opening new MATINS trial sites in the US to facilitate its rapid expansion beyond existing and new sites in Europe. Data from Part I of the study continue to be examined to determine which different candidate cohorts will be investigated in Part II, alongside CRC. A move to Part III requires prior discussions with regulators but could take place in mid-2020.

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 (CRC) has been selected as the first expansion cohort 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.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Clevegen downregulates a range of major immuno-oncology (IO) checkpoints in MATINS cancer patients

Biomarker analysis could guide future combination therapies with Clevegen

Company announcement, 11 December 2019 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces new data from MATINS -trial patients to be presented at the ESMO Immuno-Oncology Congress 2019 in Geneva, Switzerland. Faron’s scientific network will present the data in a plenary lecture and more detailed biomarker data in a Mini Oral session.

The phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen, Faron’s wholly-owned novel precision cancer immunotherapy (Clevegen) targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours. The Company has previously announced that Clevegen administration results in an immune switch from immune suppression to immune activation.

First available set of cell surface biomarker data from a group of seven patients to be presented at the congress show that: 1) anti-Clever-1 treatment in cancer patients decreases a broad range of checkpoints including PD-1, PD-L1, CTLA-4, OX40, 41BB, LAG3 and 2) co-stimulation markers CD28 and ICOS on circulating T cell populations whereas 3) it increases the expression of activation markers CD25 (IL-2RA), CXCR3 and CD69. In addition, anti-tumour responses with anti-Clever-1 treatment are found to associate with an increase in plasma interferon gamma (IFN-gamma), which is one of the tools the immune system is using to fight against cancer.

The analysis of checkpoints (also known as exhaustion markers) and activation markers can potentially also be used to guide the best possible checkpoint inhibitor(s) combination treatment with anti-Clever-1 therapy. Cell surface markers like PD-1, PD-L1, CTLA-4, LAG3, and TIM, can then be used to monitor a patient’s response to anti-Clever-1 therapy and to evaluate the need for combination therapy in addition to anti-Clever-therapy. The present finding potentially provides a method for choosing the best combination agent(s) to initiate treatment together with anti-Clever-1 therapy after observed changes in one or more checkpoint or activation marker expression. The Company has filed a related patent to protect this method.

Commenting on these findings, Dr. Markku Jalkanen, Faron’s CEO, said: “We have always believed Clever-1 to be a master regulator of immunity, but we are very encouraged to find that Clevegen can down regulate a range of major inhibitory immune checkpoints, that current IO therapies aim to suppress. We intend to carry out further analysis of other MATINS patients and aim to understand which combination of IO therapies would build the optimal host immune activation for various cancer types or individuals. To have one single and safe treatment as early as possible would improve patient outcome. These results indicate that Clevegen treatment could potentially allow increased efficacy of other IO treatments through the biomarker analysis of patient’s blood cells post Clevegen induced immune activation, finally offering a biological rational to guide combination therapies.”  

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 two 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. The Company has already announced that colorectal cancer (CRC) has been selected as the first expansion cohort 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.

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 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

Publication of Company Description and information on Company’s cash position

Company announcement, 29 November 2019 at 9.30 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN) (“Faron” or the “Company“), the clinical stage biopharmaceutical company, announces that it has today published the company description document (the “Company Description“) that Faron is required to prepare and publish in conjunction with the applied listing of its ordinary shares on Nasdaq First North Growth Market (“Nasdaq First North“), a registered SME growth market in accordance with Directive 2014/65/EU on markets in financial instruments as implemented in the national legislation of Denmark, Finland and Sweden, operated by an exchange within the Nasdaq group. The Company Description available at https://www.faron.com/investors contains the information required under the Nasdaq First North Rulebook, and it has been approved to be published by the Board of Directors of Faron.

The information in the Company Description is either general information or information already published by the Company including the Company’s cash position on 30 September 2019. As announced the unaudited cash position of the Company as of 30 September 2019 was EUR 2,383 thousand. Since that date the cash position was strengthened with net funds of EUR 8,033 thousand raised in the placing of shares registered in the trade register maintained by the Finnish Patent and Registration Office on 12 November 2019.

If the applied listing is accepted, the first date of trading at Nasdaq First North will be 3 December 2019. The ISIN code of Faron’s ordinary shares is FI4000153309 and the trading code will be FARON.

Faron’s shares have been traded on AIM with the ticker FARN since November 2015. Trading on AIM is facilitated through depositary interests (“DIs“), which are trading securities issued by Computershare Investor Services PLC that allow share transfer and settlement for non-UK companies. Each DI represents one ordinary share in Faron.

**ENDS**

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 on AIM

Emma Earl, Freddy Crossley

Phone: +44 (0)20 7886 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

Email: faron@consilium-comms.com

Distribution:

Nasdaq Helsinki Ltd
Key media
www.faron.com

About Faron Pharmaceuticals Oy:

Faron (AIM:FARN) 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 endothelial 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 immune checkpoint molecules or other cancer standard cares. 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.

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron receives regulatory approval from FDA to expand MATINS trial for Clevegen into the USA

Company announcement, Turku, Finland, 28 November 2019 at 09 AM (EET)
Inside information

TURKU – FINLAND, 28 November 2019 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, today announces that the US Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for Clevegen® (FP-1305), enabling expansion of its ongoing MATINS trial into the US.

The phase I/II MATINS clinical trial, already underway in sites through Europe, 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. Following this US IND acceptance, and as soon as the ongoing dose optimization has been completed, Faron plans to open new study sites in the US to facilitate a rapid expansion of part II of the study, investigating the safety and efficacy of Clevegen in various cancer cohorts. Part I of the trial, to optimize dosing, is ongoing but has already provided data on the different candidate cohorts (e.g. hepatocellular cancer) indicating which should be investigated in part II, alongside colorectal cancer.

Dr Markku Jalkanen, CEO of Faron, said: “We are very pleased to receive this IND approval from the FDA, marking another milestone in the developmet of Clevegen. This approval will allow us to expand MATINS into the US using the same protocol both in Europe and in the US, accelerating our understanding of this novel precision medicine in cancer patients who are refractory to all other treatment options and streamlining the regulatory processes. With the US IND now approved, in due course, we plan to file applications for Breakthrough status in the US and Prime status in Europe,  further facilitating regulatory interactions during the development of Clevegen.“

Through the MATINS study, Clevegen has demonstrated good tolerability at all dosing levels (0.3-10 mg/kg) without dose limiting toxicity. The previously reported immune activation of MATINS patients (increased circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory T-cells (T-regs) or a substantial increase in mobile natural killer (NK) cells in the blood) will be used to optimize final dosing, as these changes are needed to activate complete adaptive immune response including an activation of B-cells to maintain cancer immunity against that particular cancer type.

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 tumour types currently 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 (TAMs). 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 investigates 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 the safety and efficacy of the FP-1305 in distinct cancer types, including the already announced colorectal cancer (CRC). During Part III, the main focus will be on assessing the efficacy of Clevegen on study subjects who with 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.

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 on AIM

Emma Earl, Freddy Crossley

Phone: +44 (0)20 7886 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

Email: faron@consilium-comms.com

Distribution:
Nasdaq Helsinki Ltd
Key media
www.faron.com

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) 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 endothelial 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 immune checkpoint molecules or other cancer standard cares. 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.