Faron Pharmaceuticals Ltd.

(“Faron or Company”)

The Board of Directors of Faron Has Resolved on a Warrant Program and an Issuance of 319,944 Warrants to IPF Partners

Company announcement, February 28, 2022 – 07:45 PM (EET) / 05:45 PM (GMT) / 12:45 PM (EST)

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, announced today, February 28, 2022, that it had entered into a secured debt agreement (the “Funding Agreement”) with IPF Partners (“IPF”). As part of the arrangement relating to the Funding Agreement, Faron has committed to granting IPF special rights entitling them to subscribe for ordinary shares of the Company against payment (“Warrants”).

In accordance with the Funding Agreement, the Board of Directors of the Company has on Monday February 28 2022, based on an authorization granted to the Board by shareholders at the Company’s Annual General Meeting held on April 23, 2021, resolved upon a warrant program directed to IPF. Pursuant to the warrant program, the Warrants are issued without consideration. The Warrants are issued as a part of Funding Agreement and therefore, from the Company’s point of view, there is a weighty financial reason for the program and the issuance of Warrants thereunder.

Pursuant to the warrant program, the Warrants are issued at the date of each drawdown under the Funding Agreement. The maximum total number of warrants to be granted under the current warrant program agreed on Monday February 28, 2022 is 600,000, under the authorization granted to the Board by shareholders at the Company’s Annual General Meeting held on April 23, 2021. Each warrant entitles its holder to subscribe for one new share in the Company. The subscription price per share on the basis of the Warrants will equal the 30-day volume-weighted average price of an ordinary share of Faron on the Nasdaq Helsinki First North exchange immediately preceding the drawdown date of the respective tranche. The Warrants may be exercised for a period of seven years following the drawdown of each tranche under the Funding Agreement, except for the first drawdown, for which the subscription period will commence on March 25, 2022 and end on the date falling seven years after such date. The terms and conditions of the Warrants will be available on the Company’s website at: https://www.faron.com/investors/aim-rule-26.

As announced on Monday February 28, 2022 , the Company has pursuant to the warrant program resolved to issue 319,944 Warrants to IPF in relation to the first tranche utilized on Monday, February 28, 2022. The subscription price per share with respect to Warrants issued in respect of the drawdown of the first tranche is, in accordance with the above, EUR 3.126 per share (subject to adjustment in accordance with the terms and conditions of the Warrants).

For more information please contact:

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

Investor.relations@faron.com

Phone: +1 (610) 529-6219

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker 

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

About Faron Pharmaceuticals Ltd

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

Forward Looking Statements

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

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

Faron Board Issues Warrants to IPF Partners 280222

Faron Pharmaceuticals Ltd.

(“Faron or Company”)

Faron Obtains Up to EUR 30 Million Debt Funding from IPF Partners to Advance and Accelerate Pipeline

• Financing of up to EUR 30 million through a loan from IPF Partners
• Initial tranche consists of EUR 10 million
• Proceeds from first tranche provide the Company with sufficient working capital through Q4 2022
• The utilization of two additional tranches of EUR 5 million and EUR 15 million, respectively, is subject to certain conditions precedent
• IPF Partners will also be granted warrants entitling them to subscribe for ordinary shares and have the right to appoint a board observer
   

Company announcement, February 28, 2022 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET)

Inside information

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, announces that it has entered into a secured debt agreement (“Funding Agreement”) with IPF Partners (“IPF”) to advance and accelerate its pipeline programs. The first tranche of EUR 10 million is agreed to be drawn today and is to be repaid quarterly over a five year term. Subject to certain conditions being met, Faron may have access to an additional EUR 20 million in funding until mid-2023 on a four and one-half year term under the Funding agreement. The Funding Agreement is subject to minimum cash and gross gearing covenants.

“This funding agreement strengthens our financial position and adds flexibility to our funding strategy by adding a debt instrument into our funding tools,” said Toni Hänninen, Chief Financial Officer of Faron. “We are excited to be working with IPF Partners, one of the leading alternative financing providers focused on the healthcare sector, and thank them for their partnership.”

The Funding Agreement is for up to EUR 30 million in three tranches. The first tranche of EUR 10 million will be drawn down on the date of this announcement. The second tranche of EUR 5 million may be drawn down on or before June 30, 2023 if Faron raises at least EUR 15 million of new gross equity, has sufficient funding until March 31, 2023 and has received an approval from the Food and Drug Administration of the U.S. Department of Health and Human Services regarding the protocol for a pivotal clinical trial of bexmarilimab in an oncology indication. The third, yet uncommitted tranche of up to EUR 15 million could be utilized after the drawdown of tranche two, subject to the IPF investment committee’s prior approval on or before June 30, 2023. Each tranche carries an annual cash interest of three-month EURIBOR + 9.00% in addition to customary structuring and legal fees. The total cash cost of the arrangement is dependent on whether the debt is repaid on each maturity date or earlier.

As part of the arrangement, IPF will also be granted special rights which entitle them to subscribe for new ordinary shares in the Company against payment (“Warrants”) for a period of seven years following the drawdown of each tranche except for the first drawdown, for which the subscription period will commence on March 25, 2022 and end on the date falling seven years after such date. The subscription price per share on the basis of these Warrants will equal the 30-day volume-weighted average price of an ordinary share of Faron on the Nasdaq Helsinki First North exchange immediately preceding the drawdown date of the respective tranche. The number of shares to be subscribed for under the Warrants will be calculated by dividing 10.0% of each tranche amount by the strike price defined above, subject to standard adjustments. For the first tranche the subscription price is calculated to be EUR 3.126 per share. Accordingly, IPF will have 319,944 Warrants giving them the right to subscribe for up to 319,944 ordinary shares in Faron following the drawdown of the first tranche. The issuance of Warrants in connection with the drawdown of the first tranche is carried out within the authorization granted to the Board by shareholders at the Company’s Annual General Meeting held on April 23, 2021. Additionally, according to the Funding Agreement, IPF has the right to appoint a board observer in Faron. 

“This year will be critical for the bexmarilimab development program as we expect updated survival and biomarker data from our Phase I/II MATINS trial, the initiation of our first hematologic Phase I/II trial, enrollment of patients in the first study evaluating bexmarilimab in combination with an anti-PD-1 molecule, and a meeting with the US FDA to discuss our data and path towards a regulatory filing,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “This financing agreement will notably help us continue to accelerate our ambitious bexmarilimab development program, which has the potential to bring the promise of immunotherapy to a much broader patient population compared to the relatively small percentage of cancer patients benefiting from checkpoint inhibitor therapies today.”

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

For more information please contact:

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

Investor.relations@faron.com

Phone: +1 (610) 529-6219

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker 

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

About Bexmarilimab

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

About MATINS

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

About Faron Pharmaceuticals Ltd

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

Forward Looking Statements

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

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

Faron Obtains Up to EUR 30 Million Debt Funding from IPF Partners to Advance and Accelerate Pipeline 280222

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Provides Update on Bexmarilimab Development Program Ahead of R&D Day
 

• Updated landmark analysis estimates nine-month overall survival rates were 70% for heavily pre-treated, late-stage cancer patients who benefited from treatment with bexmarilimab and 26% for patients who did not benefit from treatment
• Biomarker analysis showed widely available blood tests can identity which patients are likely to receive clinical benefit from treatment with bexmarilimab
• Treatment with bexmarilimab continues to be well tolerated with no treatment related adverse events resulting in a decrease or modification of dosing
• Company to host virtual R&D Day webcast today, Wednesday, February 23, at 4:00 pm EET, 2:00 pm GMT, 9:00 am EDT

Company announcement, February 23, 2022 at 09:00 AM (EET) / 07:00 AM (GMT) / 02:00 AM (EDT)

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces updated survival data from Phase I/II MATINS (Macrophage Antibody To INhibit immune Suppression) study investigating the safety and efficacy of bexmarilimab. The data will be presented at the Company’s virtual R&D Day webcast today, Wednesday, February 23, at 4:00 pm EET, 2:00 pm GMT, 9:00 am EDT. To register for Faron’s R&D Day webcast, please visit:  https://faron.videosync.fi/r-and-d-day.

The updated results from the MATINS study include patients from Part I (30 patients) and Part II (110 patients) of the trial. For all these patients, the estimated median progression free survival (PFS) is 59 days (95% confidence interval, 58-61). The estimated median overall survival (OS) is 157 days (95% confidence interval, 128-192).

Landmark OS for Part I/II patients who received three courses of treatment and had their scheduled tumor imaging at cycle four (n=92) estimated that 70% of disease control rate (DCR = partial response + stable disease rate) patients were alive at nine months after the landmark (that is, approximately 11 months from initiation of treatment) compared to 26% of non-DCR patients. The most significant disease control rate (DCR) among Part II cohorts was observed in cutaneous melanoma (30%), gastric cancer (30%), cholangiocarcinoma (30%), hepatocellular carcinoma (40%) and breast cancer (40%) patients. Treatment with bexmarilimab continues to be well tolerated with no new safety signals reported and no treatment related adverse events resulting in a decrease or modification of dosing.

As previously announced, patients with low interferon gamma (IFNy) and tumor necrosis factor alpha (TNFa) levels experienced significantly higher clinical benefit following treatment with bexmarilimab. This is the opposite to what is usually seen with checkpoint inhibitors and other T cell activating agents. Additionally, a more than 100% increase in IFNy levels was seen after the first cycle of bexmarilimab treatment among patients who experienced clinical benefit.

As part of an ongoing biomarker analysis, receiver operating characteristic (ROC) curves found that low levels of both IFNy and TNFa was highly predictive of clinical benefit (AUC 0.83, P < 0.0001). Likelihood of clinical benefit increased even higher (AUC 0.9107, P < 0.0001) when low levels of IL-6 & IL-8 were also present. These four inflammatory biomarkers can easily be identified by simple, inexpensive and readily available blood tests. The ability to have these classical pro-inflammatory cytokines measured as part of a patient’s routine clinical care could expedite treatment decisions improving patient care, which today requires costly biopsies and pathology tests.

“The updated MATINS data shows even more clearly that heavily pre-treated, late-stage cancer patients who receive clinical benefit from bexmarilimab can achieve long term survival,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “The ongoing biomarker analysis is also helping us better identify which patients are likely to respond and what happens in the tumor microenvironment when patients are treated with bexmarilimab.”

The Company will host a virtual R&D Day webcast today, Wednesday, February 23, at 4:00 pm EET, 2:00 pm GMT, 9:00 am EDT. To register to participate in the virtual webcast, please visit:  https://faron.videosync.fi/r-and-d-day.

Dr. Markku Jalkanen, Chief Executive Officer of Faron, will host the event together with members of Faron’s Global Leadership Team. In addition, the following external experts will provide additional perspectives on the immunotherapy treatment landscape and how bexmarilimab may help address the significant unmet medical need that continues to exist:

• Dr. Tyler Curiel, Professor of Medicine and Microbiology, Immunology & Molecular Genetics at The University of Texas Health Science Center at San Antonio, United States
• 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

“I look forward to hosting our virtual R&D Day and providing an update on the current treatment landscape and what we are doing to help address the significant unmet medical needs of cancer patients,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. ”Our accelerated bexmarilimab development plan, which in addition to the ongoing MATINS trial includes plans to study bexmarilimab in combination with other checkpoint inhibitors and as a treatment for hematological malignancies, is ambitious, but given the data we have seen to date and our evolving understanding of which biomarkers will predict response to treatment, we are confident that we can progress each of these programs forward and potentially have an extremely broad impact on cancer care.”

A Finnish language interview with Dr. Markku Jalkanen covering the important information shared during the R&D Day event will also take place on February 23, 2022. A link to a recording of this interview will be made available on the “Investors” section on Faron’s website at:  https://www.faron.com/investors.

For more information please contact:

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

About Bexmarilimab

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

About MATINS

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

About Faron Pharmaceuticals Ltd

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

Forward Looking Statements

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

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

220223 Faron RD Day RNS - FINAL - 2-22-22

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron announces R&D Day to be held on February 23, 2022
 

Company announcement, February 14, 2022 at 09:00 AM (EET) / 07:00 AM (GMT) / 02:00 AM (EDT)

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces plans to host a virtual R&D Day via webcast on Wednesday, February 23 at 4:00 pm EET, 2:00 pm GMT, 9:00 am EDT.

Dr. Markku Jalkanen, Chief Executive Officer, will host the event together with members of the Faron Global Management Team. In addition, the following external experts will provide additional perspectives:

• Dr. Tyler Curiel, Professor of Medicine and Microbiology, Immunology & Molecular Genetics at The University of Texas Health Science Center at San Antonio, United States
• 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

As part of the event, Faron’s new Chief Medical Officer, Dr. Marie-Louise Fjällskog, will provide an update on bexmarilimab, the Company’s wholly-owned novel precision cancer immunotherapy in Phase I/II development, targeting Clever-1, a receptor known to be expressed on immunosuppressive macrophages in the tumor microenvironment. Dr. Fjällskog will share updated survival data from the ongoing MATINS trial and provide an overview of the accelerated bexmarilimab development plan, including a review of the latest biomarker analysis and strategy. There will be an opportunity to ask questions during the webcast.

“I am delighted to be hosting this R&D Day with our invited speakers who will provide important insights into the immunotherapy approaches currently available to patients and work Faron is doing to potentially bring the promise of immunotherapy to a broader patient group,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron.  “The unfortunate reality is that currently, only a small segment of cancer patients benefit from immunotherapy and there remains an urgent clinical need to identify new treatment approaches.”

To register for Faron’s R&D Day on February 23, 2022, please visit:  https://faron.videosync.fi/r-and-d-day.

A Finnish language interview with Dr. Markku Jalkanen covering the important information shared during the R&D Day event will also take place on February 23, 2022. A link to a recording of this interview will be made available on the “Investors” section on Faron’s website at:  https://www.faron.com/investors.

For more information please contact:

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

Investor.relations@faron.com

Phone: +1 (610) 529-6219

Investor Contact

Stern Investor Relations

Julie Seidel

julie.seidel@sternir.com

Phone: +1 (212) 362-1200

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

About Bexmarilimab

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

About Faron Pharmaceuticals Ltd

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

Faron announces R&D Day to be held on February 23 2022

Faron Pharmaceuticals Ltd

(“Faron”)

Scientific Reports Publishes INFORAAA Results Showing Traumakine-Induced Up-Regulation of CD73

Prevents Death After Emergency Open Aortic Surgery

• Induction of CD73 molecule prevents death after emergency open aortic surgery

• Up-regulation of CD73 was associated with 100% survival compared to expected mortality between 30-40%

Company announcement, February 3, 2022 at 05:40 AM (EST) / 10:40 AM (GMT) / 12:40 PM (EET)

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces that the multidisciplinary journal Scientific Reports from the Nature Publishing Group published research highlighting results from Faron’s Phase II INFORAAA clinical trial. The paper, titled “Induction of CD73 prevents death after emergency open aortic surgery for a ruptured abdominal aortic aneurysm: a randomized, double-blind, placebo-controlled study” (6bc2c5da-75ff-4538-9bf8-ab69f809318c) is available online at: www.nature.com/articles/s41598-022-05771-1.

The INFORAAA study examined the effect of Traumakine (Intravenous Interferon beta-1a; IFN beta-1a) on mortality of surgically operated ruptured abdominal aorta aneurysm (RAAA) patients. These patients are at high risk of ischemia-reperfusion injury, which is tissue damage caused when blood supply returns to tissue after a period of oxygen depletion. Ischemia-reperfusion injury leads to systemic inflammation and multi-organ failure, which is the main cause of death for operated RAAA patients with expected mortality between 30-40%. Traumakine works by up-regulating CD73, a key organ protective endothelial enzyme that reduces inflammation and prevents vascular leakage.  

Twenty-nine patients were enrolled in the treatment arm of the INFORAAA study and 11 were enrolled in the control (placebo) arm. Patients in the treatment arm received Traumakine once a day for six days following surgery. Mortality was compared to the placebo arm for a period of 30 days after surgery. Analysis showed that up-regulation of CD73 was associated with 100% survival. As previously reported, approximately one-third of patients in the treatment arm were treated concomitantly with corticosteroids, which abolished a CD73 response in these patients.

“The study clearly showed that intravenous interferon beta-1a can induce CD73 when not used with steroids or in the presence of IFN beta neutralizing antibodies, and that patients who had high levels of CD73 survived this complicated and invasive surgery,” said Professor Maarit Venermo, M.D., Ph.D., Head of Vascular Surgery at Helsinki University Hospital, Secretary General of the European Society of Vascular Surgery, and one of the coordinating investigators of the INFORAAA trial. “In the absence of any drugs approved for this condition, as well as complications seen in major surgery, these exciting clinical findings warrant further research to test this drug for the prevention of acute organ injuries.”

Traumakine is an investigational therapy developed by Faron for the potential treatment of acute respiratory distress syndrome (ARDS), acute kidney injury, cardiac protection, ischemia reperfusion injury and other systemic inflammatory conditions. It is currently being investigated in the Phase II/III HIBISCUS trial as a first-line treatment for hospitalized COVID-19 patients. Additionally, investigations at the Wake Forest Institution of Regenerative Medicine by Professor Vijay S. Gorantla in association with the US Department of Defense, and ongoing work by Academician Sirpa Jalkanen, founder of Faron Pharmaceuticals, at the University of Turku continue to highlight the potential benefit of intravenous Interferon beta 1-a’s mode of action. Their research is focussed on the multiple applications of Interferon for systemic inflammatory conditions and translating this into the clinic.

“I continue to be excited by the potential of IV Interferon beta-1a for the induction of CD73,” said Professor Vijay S. Gorontla, M.D., Ph.D., Professor of Surgery at Wake Forest University and President of the International Society of Vascularized Composite Allotransplantation (a complicated transplant where multiple tissue types are transplanted at the same time, including bones, skin, vessels, and/or tendons). “CD73 is critical in removal of proinflammatory cytokines in the inflammatory process and I see it having great potential in transplantation and other conditions involving significant cytokine release, such as major operations and polytrauma.”

“These results highlight, once again, the importance of CD73 in organ protection and the ability it has to benefit patients undergoing major surgery,” said Juho Jalkanen, M.D., Ph.D., Chief Operating Officer of Faron. “We are pleased that the data was published and remain excited by the potential of Traumakine across multiple indications where there continues to be significant unmet medical need and no approved drug treatments.”

For more information please contact:

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

Investor.relations@faron.com

+1 (610) 529-6219

Investor Contact

Stern Investor Relations

Julie Seidel

julie.seidel@sternir.com

Phone: +1 (212) 362-1200

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 (0) 207 213 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

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

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 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalized patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma. Faron is headquartered in Turku, Finland with additional offices in Zürich, Switzerland and US operations in Boston, Massachusetts. Further information is available at www.faron.com.

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 - Scientific Reports Publishes INFORAAA Results 030222