Bexmarilimab KOL Event

Faron Pharmaceuticals Oy

 

(“Faron or the Company”)

 

Bexmarilimab for Hematological Malignancies KOL Event

 

Press Release, April 19, 2023

 

TURKU, FINLAND / BOSTON, MA Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON),  a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces plans to host a virtual KOL event via webcast on Tuesday, April 25 at 11.00 EST/16.00 BST/18.00 EEST with Dr. Naval Daver, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center; Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki and Faron management.

 

As part of the event, Dr. Daver will discuss the unmet medical need in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Dr. Kontro will provide an update on the most recent Phase I/II BEXMAB data in AML and MDS patients.

 

The agenda is as follows:

  • Opening remarks and introductions – Dr. Markku Jalkanen, PhD, CEO
  • Unmet medical need in r/r AML and MDS – Dr. Naval Daver, MD, Scientific Advisor for Faron
  • BEXMAB clinical data in combination with standard of care – Dr. Mika Kontro, MD, PhD
  • Next steps planned for the study – Dr. Marie-Louise Fjällskog, MD, PhD, CMO
  • Q&A session
  • Closing remarks

 

Faron reported this week updated additional positive data from its ongoing Phase I/II BEXMAB study, investigating bexmarilimab, the Company’s wholly owned immunotherapy asset, in combination with standard of care (SoC) in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The latest update included two objective responses (ORR) and two stable disease (SD) patients observed, with one having > 50% reduction of blast cells, in the second doublet cohort. Of three patients with ORR in the first doublet cohort, two remain on the study after 10 and 9 months, respectively, and the third has undergone a potentially curative transplantation.

 

During the event, Dr. Marie-Louise Fjällskog, Faron’s Chief Medical Officer, will discuss next steps planned for the BEXMAB program. There will be an opportunity to ask questions during the webcast.

 

“I am delighted to be hosting this KOL Day with Dr. Daver and Dr. Kontro,” said Dr. Markku Jalkanen, Faron’s CEO. “They will provide important insights into the immunotherapy approaches currently available to patients with hematological malignancies and the work Faron is doing to potentially bring the promise of immunotherapy to a broader patient group.”

 

To register for the webcast: https://faron.videosync.fi/kol-call-04-2023/register or contact the IR team for more information at investor.relations@faron.com.

For more information please contact:

 

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

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

David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy with the potential to provide immune stimulation for treatment-resistant cancers through targeting myeloid cell function. A novel anti-CLEVER-1 humanized antibody, bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in the tumor microenvironment, converting highly immunosuppressive M2 macrophages to immune-stimulating M1 macrophages. As an immuno-oncology therapy, bexmarilimab has therapeutic potential in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies.

 

About BEXMAB

The BEXMAB study is a first-in-human, open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplatic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacytidine) treatment and to identify the recommended Phase II dose. Directly targeting CLEVER-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. CLEVER-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

 

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigational immunotherapy with the potential to remove immunosuppression of cancers through targeting myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological and solid cancers in combination with other standard treatments including immune checkpoint molecules. Faron is headquartered 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 addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs 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.

 

 

Poster Presentations at AACR 2023

Faron Pharmaceuticals Oy

 

(“Faron” or the “Company”)

 

Faron Pharmaceuticals Announces Poster Presentations on Bexmarilimab at the American Association for Cancer Research Annual Meeting 2023

 

Press Release, April 18, 2023  

 

TURKU, FINLAND / BOSTON, MA: Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, announces the presentation of two posters at the American Association for Cancer Research Annual Meeting 2023 in Orlando, Florida.

 

Details of the poster presentations are as follows:

 

Title:

CLEVER-1/PD-L1 ratio predicts response to bexmarilimab, a novel macrophage-guided immunotherapy, in immune-deprived cancers   

Abstract ID:

Section 37, Board 9

Date/Time:

Tuesday, April 18, 9:00 a.m. EST

 

Title:

Bexmarilimab induces B-cell activation and autoantibody production   

Abstract ID:

Section 43, Board 16

Date/Time:

Monday, April 17, 9:00 a.m. EST

 

The first poster indicates a PD-L1/CLEVER-1 IHC staining ratio may be used to predict bexmarilimab response, as responding patients have a low PD-L1 and high CLEVER-1 staining, as well as low inflammatory cytokine (IFNγ, TNFα, IL-6) levels as reported previously. This finding means they are often refractory to checkpoint inhibitors and other T cell activating agents.

 

“The finding supports patient selection for planned combination studies with PD-1 blockade refractory patients,” said CEO Dr. Markku Jalkanen. Indications in the upcoming BEXCOMBO study include metastatic head and neck squamous cell carcinoma, urothelial carcinoma and non-small cell lung cancer where first-line PD-1 blockade is the approved standard of care.

 

The second poster indicates that bexmarilimab can induce activation and secondary Ig rearrangements in mature B-cells. B-cell diversity and activation is considered important for cancer immune recognition.

 

The abstracts will be available in the AACR journal Cancer Research.

 

For more information please contact:

 

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy with the potential to provide immune stimulation for treatment-resistant cancers through targeting myeloid cell function. A novel anti-CLEVER-1 humanized antibody, bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in the tumor microenvironment, converting highly immunosuppressive M2 macrophages to immune-stimulating M1 macrophages. As an immuno-oncology therapy, bexmarilimab has therapeutic potential in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies.

 

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigational immunotherapy with the potential to remove immunosuppression of cancers through targeting myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological and solid cancers in combination with other standard treatments including immune checkpoint molecules. Faron is headquartered 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 addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs 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.

 

 

 

BEXMAB study update

Faron Pharmaceuticals Oy

 

(“Faron” or the “Company”)

 

Inside Information: Encouraging Additional Data for Bexmarilimab for the Treatment of Hematological Malignancies

 

BEXMAB Study Update

 

      Two objective responses (ORR) and two stable disease (SD) patients, with one having > 50% reduction of blast cells, observed in the second doublet cohort

      Of the three patients with ORR in the first doublet cohort, two remain on the study after 10 and 9 months, respectively, and the third has undergone a potentially curative transplantation

      Second dose level in doublet well-tolerated and third cohort open for enrolment

      First dose level in triplet well tolerated and second cohort open for enrollment

      Plans to initiate the study’s Phase II in H2 2023

 

Company announcement, April 17, 2023

Inside information

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces additional positive data from the Company’s Phase I/II BEXMAB study. BEXMAB is investigating bexmarilimab, Faron’s wholly owned immunotherapy asset, in combination with standard of care (SoC) in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

 

The responses from these patients are further defined as:

 

      In the second doublet cohort (3mg/kg + azacytidine), two patients have objective responses thus far, including one complete response with incomplete blood count recovery (CRi) and one patient with hematological improvement in platelets (HI-P). There are two patients with SD, of which one has > 50% reduction in bone marrow blasts, and one patient with progressive disease.

      The first doublet cohort (1mg/kg + azacytidine) has seen a complete response with incomplete hematological recovery (CRi) in a patient with relapsed/refractory AML. The patient is still responding after 10 months. Another patient with MDS that experienced CR is still in remission after 9 months. An additional patient that achieved a partial response has undergone a possibly curative allogenic stem cell transplantation.

      No bexmarilimab-related Grade 3 or higher adverse events (AEs) or serious adverse events (SAEs) observed in the second dosing cohort and enrolment into the third cohort (6mg/kg) ongoing.

      The first triplet cohort (1mg/kg + azacytidine + venetoclax) was well-tolerated and the second cohort (3mg/kg + azacytidine + venetoclax) has opened for enrollment.

      Additional efficacy read-outs for all cohorts expected in the upcoming months.

      On a potential path to a Biologics License Application (BLA) submission, the Company plans to seek FDA advice during Q3 2023.

 

“We are extremely encouraged by the continued efficacy of bexmarilimab and the long duration of the responses seen so far,” said Chief Medical Officer Marie-Louise Fjällskog. Dr. Fjällskog noted the success of the MDS patient who did not respond to previous azacytidine therapy, but with the addition of bexmarilimab, the patient is undergoing potentially curative transplantation.

 

The primary objective of the BEXMAB study (ClinicalTrials.gov: NCT05428969) is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacytidine and venetoclax) treatment and to identify the recommended Phase II dose. Secondary objectives include characterizing preliminary efficacy as well as bexmarilimab’s pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity.

 

In January 2023, the Company announced objective responses in 3 out of 5 patients dosed in the first doublet cohort of the BEXMAB study. The Company also announced enrollment updates for the study’s cohorts, and that it had opened the first triplet cohort with bexmarilimab, azacytidine and venetoclax in newly diagnosed AML patients who are unable to tolerate chemotherapy.

 

“The latest data are a powerful indication of the therapeutic potential for bexmarilimab in hematological malignancies,” said CEO Dr. Markku Jalkanen.

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

 

 

 

For more information please contact:

 

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy with the potential to provide immune stimulation for treatment-resistant cancers through targeting myeloid cell function. A novel anti-CLEVER-1 humanized antibody, bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in the tumor microenvironment, converting highly immunosuppressive M2 macrophages to immune-stimulating M1 macrophages. As an immuno-oncology therapy, bexmarilimab has therapeutic potential in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies.

 

About BEXMAB

The BEXMAB study is a first-in-human, open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacytidine) treatment and to identify the recommended Phase II dose. Directly targeting CLEVER-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. CLEVER-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

 

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigational immunotherapy with the potential to remove immunosuppression of cancers through targeting myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological and solid cancers in combination with other standard treatments including immune checkpoint molecules. Faron is headquartered 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 addition,  other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs 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 at Canaccord Oncology Virtual Conference

Faron Pharmaceuticals Oy

 

(“Faron” or the “Company”)

 

Faron to Present at Canaccord Horizons in Oncology Virtual Conference

 

Press release, April 13, 2023

 

TURKU, FINLAND / BOSTON, MAFaron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling cancers via immunotherapy, today announces that Chief Executive Officer, Dr. Markku Jalkanen and Chief Medical Officer, Dr. Marie-Louise Fjällskog, will present at the Canaccord Genuity Horizons in Oncology Virtual Conference on April 20 at 8 AM EST.

 

Faron will present on the panel, “Boosting checkpoint inhibitors – finally two solutions?”. Dr. Jalkanen and Dr. Fjällskog will discuss the most recent data for bexmarilimab, the company’s wholly owned immunotherapy asset, for treating hematological malignancies and solid tumors.

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact 

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

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, investigational immunotherapy with the potential to provide immune stimulation for treatment-resistant 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) tumor-associated macrophages (TAMs) in the tumor microenvironment, converting highly immunosuppressive M2 macrophages to immune-stimulating M1 macrophages. As an immuno-oncology therapy, bexmarilimab has therapeutic potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies.

 

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

Appointment of Chief Financial Officer

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

 

Faron Appoints James O’Brien, CPA, MBA as Chief Financial Officer

 

Company announcement, March 29, 2023 at 09:00 AM (EEST) / 07:00 AM (BST) / 02:00 AM (EST)  

 

TURKU, FINLAND / BOSTON, MAFaron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers, is pleased to announce the appointment of James O’Brien, CPA, MBA as the Company’s new Chief Financial Officer (CFO), effective April 3, 2023. Mr. O’Brien succeeds Toni Hänninen, who is leaving Faron to pursue another career opportunity.

 

Mr. O’Brien is an accomplished biotech and financial executive with extensive experience in the US capital markets. His appointment highlights Faron’s progression towards becoming a global biopharmaceutical company.

 

“I am thrilled to welcome James to Faron considering his strong record of performance in public markets, capital raising in the US, business development and strategic planning,” said Markku Jalkanen, CEO of Faron Pharmaceuticals. “His US business acumen will be a crucial asset for our Company as we plot out the clinical development plan for our lead asset bexmarilimab.

 

“I would also like to thank Toni for his service to Faron over the years. His partnership and contributions have been invaluable and key to the success of our Company to date. We wish him the best in his next role.”

 

Most recently, Mr. O’Brien served as the CFO of Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage biopharmaceutical company which successfully completed an IPO in October 2021, raising USD 52 million. He previously served as Executive Vice President of Finance with Enzo Biochem, Inc. (NYSE: ENZ). Earlier in his career, he held positions with increasing responsibilities at pharmaceutical companies including Actavis PLC (now AbbVie, Inc. (NYSE: ABBV)), the US subsidiary of Swiss company Nycomed, which has since been acquired by Takeda Pharmaceuticals, and Bristol Myers Squibb. He spent close to a decade at PricewaterhouseCoopers and is a certified public accountant (CPA) with a Bachelor of Accountancy from George Washington University and a Master of Business Administration from Fordham University.

 

“I am pleased to join Faron, bringing my strong background in the US biotech and pharma financial sectors to drive the Company successfully forward,” said Mr. O’Brien.

 

For more information please contact:

 

Media Contact 

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

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 Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

Board Change

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

 

Board Change

 

 

Company announcement, March 24, 2023 at 15.35 PM (EET) / 13.35 PM (GMT) / 09.35 AM (EDT)  

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers, is pleased to announce the appointment of Mr. Tuomo Pätsi as a Non-Executive Director of the Company following the passing of all resolutions put to shareholders of the Company at the Annual General Meeting held earlier today. In addition, Dr. Gregory B. Brown has today stepped down from his position as a Non-Executive Director of the Company.

 

“I am pleased to welcome Mr Pätsi to the Faron Board,” said Dr. Frank Armstrong, Chairman of the Board of Faron Pharmaceuticals. “He brings extensive experience of the commercialization and launch of new oncology products with leading cancer companies, and his expertise will be valuable as the Company continues the development of bexmarilimab. I’d also like to thank Dr. Brown for his service to the Faron Board.”

 

Mr. Pätsi was the President of the EMEA region and Worldwide Markets for Celgene Corporation, a global pharmaceutical company and currently wholly owned subsidiary of Bristol Myers Squibb, engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer. He is an experienced biotech and pharmaceutical executive who was until recently the Executive Vice President for Seagen Inc., a US-based cancer-focused biotechnology company.

 

“I am looking forward to joining the Board of Faron at this exciting time,” said Mr Pätsi. “Bexmarilimab with its innovative mechanism of action and clinical data so far holds great promise in multiple cancer indications where better treatments are desperately needed.”

 

Mr. Pätsi has over 30 years’ experience working in biotech and pharmaceuticals, with more than 10 years working at Celgene in various senior management roles, including as President of European and International Operations and President of the EMEA region and Worldwide Markets. Prior to this, he served as Vice President of Europe for Human Genome Science, a specialty pharma organization in Europe. Earlier in his career, he held roles of increasing responsibility in pharmaceutical companies, including more than ten years at Amgen Inc.  Mr. Pätsi began his career as a Biomedical Research Scientist in Finland. He is a registered pharmacist and holds an MSc in pharmacology from the School of Pharmacy, Helsinki University.

 

Additional Disclosures

 

The following information regarding the appointment of Tuomo Tapani Pätsi (aged 58), is disclosed under Schedule 2(g) of the AIM Rules for Companies and Nasdaq First North Growth Market Rulebook.

 

Current positions, directorships and/or partnerships:

 

Former positions, directorships and/or partnerships (within the last five years):

 

Celgene

 

Celgene ApS

 

Celgene BV

 

Celgene Distribution BV

 

Celgene EngMab GmbH

 

Celgene Europe BV

 

Celgene Europe Limited

 

Celgene Global Holdings Sàrl

 

Celgene GmbH

 

Celgene International II Sàrl

 

Celgene International III Sàrl

 

Celgene International Sàrl

 

Celgene Limited

 

Celgene Logisitics Sarl

 

Celgene Logistics Sàrl

 

Celgene Management Sàrl

 

Celgene Netherlands BV

 

Celgene Netherlands II BV

 

Celgene Netherlands Investment BV

 

Celgene R&D Sàrl

 

Celgene Receptos Limited

 

Celgene Receptos Sàrl

 

Celgene Research SL

 

Celgene SL

 

Celgene Spółka SOO

 

Celgene sro

 

Celgene Switzerland Sàrl

 

Celgene Tri Sàrl

 

EngMab Sàrl

 

Interpharma

 

Juno Therapeutics GmbH

 

Mr. Pätsi does not have any beneficial interest in the ordinary shares or options over the ordinary shares of the Company.

 

Save as set out above, no further information regarding Mr. Pätsi is required to be disclosed pursuant to the AIM Rules for Companies or Nasdaq First North Growth Market Rulebook.

 

For more information please contact:

 

Media Contact

Faron Pharmaceuticals

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

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 Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

Results of AGM

Faron Pharmaceuticals Oy

(“Faron or the “Company”)

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

Company announcement, March 24, 2023 at 15.30 (EET) / 13.30 PM (GMT) / 09.30 AM (EDT)  

TURKU, FINLAND / BOSTON, MA – The annual general meeting (“AGM”) of Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) took place at BioCity, meeting room “Ministeri” in Turku, Finland today, March 24, 2023. The AGM approved all the proposals of the Board of Directors (“Board”) and its committees, set out in the notice of the AGM published on March 3, 2023.

 

Decisions of the AGM
 

The AGM adopted the financial statements of the Company and resolved to discharge the members of the Board and the CEO of the Company from liability for the financial year 2022.

No dividend for the financial year 2022 will be paid, and the losses of the Company for the financial year, amounting to EUR 28.7 Million (IFRS), will be carried forward to the reserve for invested unrestricted equity.

Composition and remuneration of the Board

 

The number of members of the Board was confirmed as seven. Frank Armstrong, John Poulos, Leopoldo Zambeletti, Markku Jalkanen, Anne Whitaker and Erik Ostrowski were re-elected to the Board and Tuomo Pätsi was elected as a new member to the Board for a term that ends at the end of the next AGM.

The AGM resolved that the annual remuneration of the members of the Board remain unchanged and that EUR 35,000 will be paid to the Board members, in addition to which an annual remuneration of EUR 35,000 will be paid to the chair of the Board. In addition, a further annual remuneration of EUR 11,000 will be paid to the chair of the audit committee, a further annual remuneration of EUR 9,000 will be paid to the chair of the remuneration committee and a further annual remuneration of EUR 6,000 will be paid to the chair of the nomination committee. In addition, a further annual remuneration of EUR 6,000 will be paid to the audit committee members, a further annual remuneration of EUR 5,000 will be paid to the remuneration committee members and a further annual remuneration of EUR 3,000 will be paid to the nomination committee members.

Meeting fees will be paid to the Board members as follows:

  • a meeting fee of EUR 1,000 will be paid to Board members per Board meeting where the Board member was physically present, and which was held on another continent than the member’s place of residence; and
  • No meeting fees will be paid to Board members who were attending a Board meeting but not physically present or for Board meetings held on the same continent than the member’s place of residence.

In addition, all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board would be compensated.

No remuneration will be paid based on the Board membership of the CEO of the Company or a person serving the Company under a full-time employment or service agreement.

Auditor

 

Audit firm PricewaterhouseCoopers Oy (“PwC”) was re-elected as the Company’s auditor. PwC has appointed Panu Vänskä, authorized public accountant (KHT), as the key audit partner. It was decided that the auditor be remunerated in accordance with the invoice approved.

 

Amendment of the Articles of Association

 

The AGM resolved to amend the articles of association of the Company, to enable holding a General Meeting entirely without a meeting venue, as a so-called remote meeting, in addition to the Company’s domicile and London. The amended clause reads as follows:

“11§ Meeting venue

A General Meeting may in addition to the Company’s domicile be held in the city of London, United Kingdom, based on a resolution of the Board of Directors. In addition, the Board of Directors may decide that the General Meeting of the Shareholders be held without a meeting venue so that the shareholders exercise their power of decision in full in real time during the meeting using a telecommunications connection and technical means (remote meeting).”

 

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

 

The Board was authorized to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in Chapter 10, Section 1 of the Finnish Limited Liability Companies Act, which authorization contains the right to issue new shares or dispose of the Company’s own shares in the possession of the Company. The authorization consists of up to twelve million five hundred thousand (12,500,000) new shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately twenty (20) per cent. Of the existing shares and votes in the Company, as well as the conveyance of up to the same maximum number (twelve million five hundred thousand (12,500,000)) of treasury shares in the possession of the Company.

The Board was authorized to resolve on all other terms and conditions of the issuance of shares, options or other special rights entitling to shares.

The authorization is effective until June 30, 2024.

 

Resolution on the amendment of the option programme and authorising the Board to decide on the issuance of options or other special rights entitling to shares
 

The Board was authorized to resolve on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act, and the terms and conditions have later been amended by the decision of the Company’s AGM on May 18, 2020 (the “Share Option Plan 2019”). The AGM decided to amend the terms and conditions of the Share Option Plan 2019, so that a maximum total of four million three hundred and fifty thousand (4,350,000) options can be offered under said terms and conditions as follows:

 

  • to the chair of the Board, a maximum of two hundred and fifty thousand (250,000) options (before the amendment one hundred and eighty thousand (180,000) options);
  • to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein), a maximum of one hundred and twenty-five thousand (125,000) options (before the amendment ninety thousand (90,000) options);
  • to the Chief Executive Officer, a maximum of four hundred and ninety-five thousand (495,000) options (before the amendment three hundred and sixty thousand (360,000) options);
  • to the Chief Financial Officer, a maximum of one hundred and eighty thousand (180,000) options (before the amendment one hundred and thirty thousand (130,000) options); and
  • for any other non-employee person as determined by the Board, a maximum of seventy thousand (70,000) options (before the amendment fifty thousand (50,000) options).

Excluding the addition concerning the listing on Nasdaq Helsinki and the extension of the duration of the authorization, the terms and conditions of the option program remain otherwise unchanged.

The amendment increases the maximum total number of options under the Share Option Plan 2019 by two million three hundred and fifty thousand (2,350,000) options. This increases the aggregate per centage of shares that can be subscribed for based on options from 3.1 per cent. to 6.9 per cent. of all shares registered at the date of the AGM Notice. The maximum number of options granted to the chair of the Board increases by seventy thousand (70,000) options, representing an increase of approximately 38.9 per cent., the maximum number of options granted to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein) increases by thirty five thousand (35,000) options, representing an increase of approximately 38.9 per cent., the maximum number of options granted to the Chief Executive Officer increases by one hundred and one hundred and thirty five thousand (135,000) options, representing an increase of 37.5 per cent., the maximum number of options granted to the Chief Financial Officer increases by fifty thousand (50,000) options, representing an increase of approximately 38.5 per cent. And the maximum number of options granted to other non-employee persons as determined by the Board increases by twenty thousand (20,000) options, representing an increase of 40.0 per cent., over the current maximum totals.

The AGM authorized the Board to resolve by one or several decisions on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act. The authorization consists of up to two million four hundred seventy-three thousand and eighty-four (2 473 084) shares, options or other special rights entitling to shares in the aggregate, which corresponds to approximately 3.9 per cent. of the existing shares and votes in the Company.

The authorization does not exclude the Board’s right to decide on the issuance of options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights. The authorization will be used for implementing an option plan for the employees and directors of, and persons providing services to, the group, substantially in the form of the amended Share Option Plan 2019 attached to the Notice of the AGM available of the Company’s website. There is a weighty financial reason for issuing options, as options are an integral part of the incentivization system for the management and personnel of the Company.

The exercise of options will be subject to fulfilment of certain criteria to be resolved by the Board (the “Exercise Conditions”). Subject to fulfilment of the Exercise Conditions, the options may be exercised at the exercise price, which may not be less than the market value of a share at the grant date, as determined by the Board (the “Exercise Price”). In determining such market value, if shares are traded on Nasdaq Helsinki and/or on the AIM market of the London Stock Exchange, the Board shall have regard to the average price per share at which shares have been traded over a period of 90 days immediately preceding the grant date. The Exercise Price will be determined to create a sufficient incentive for the recipients of options. The Exercise Price shall be recorded in the Company’s reserve for invested unrestricted equity.

The Company’s Board was authorized to resolve on all other terms and conditions of the issuance of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act.

The authorization will be effective until June 30, 2026. This authorization shall not replace other authorizations granted to the Board (but for the sake of clarity, replaces the authorization granted in 2019 relating to the Share Option Plan 2019).

Decisions of the Board

 

At the meeting of the Board held following the AGM, Frank Armstrong was re-elected Chair of the Board.
 

In addition, the Board elected the Chairs and other members to the Board committees from among its members as follows:

  • Erik Ostrowski was elected the Chair of the Audit Committee and Leopoldo Zambeletti and Tuomo Pätsi were elected as members of the Audit Committee.
  • Frank Armstrong was elected the Chair of the Nomination Committee and Anne Whitaker and Tuomo Pätsi were elected as the other members of the Nomination Committee.
  • Anne Whitaker was elected as the Chair of the Remuneration Committee and Frank Armstrong, John Poulos and Leopoldo Zambeletti were elected as the other members of the Remuneration Committee.

 

Minutes of the AGM

 

The minutes of the AGM will be available on the Company’s website on April 6, 2023 at the latest.

For more information please contact:

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

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 Oy 

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

 

Positive FDA Feedback to Progress Bexmarilimab

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Inside Information: Faron Announces Positive US Food and Drug Administration (FDA) Feedback to Progress Bexmarilimab as a Monotherapy in Solid Tumors

      Green light for continued clinical development after data package review

      Alignment with company’s selection of 1 mg/kg IV once-every-3-weeks (Q3W) as dose for further evaluation

      Supportive of biomarker-driven approach with CLEVER-1 staining of tumor biopsy

Company announcement, March 22, 2023 at 03:00 AM (EDT) / 07:00 AM (GMT) / 09:00 AM (EET)

Inside information

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers, announces positive FDA feedback and recommendations for the future development of bexmarilimab as a monotherapy in multiple solid tumors. The agency’s advice follows an end-of-Phase I/II meeting this month. The Phase I/II MATINS trial is investigating bexmarilimab, Faron’s wholly owned precision immunotherapy asset, in multiple cancer indications.

The official meeting minutes are consistent with the FDA’s Project Optimus initiative to reform dose optimization and the selection paradigm in oncology drug development, which MATINS sought to comply with through multiple dose and indication arms of the study.  FDA provided the following positive meeting feedback which further aligns the agency’s views on bexmarilimab with the Company’s, including:

      Completed toxicology studies are adequate to support further clinical development of single-agent (monotherapy) bexmarilimab into a registration trial

      Selection of 1 mg/kg IV Q3W as dose for further evaluation appears reasonable, although additional data are required to establish the recommended Phase II/III dose for specific cancer(s)

      Valuable feedback and guidance on further development of a simple, validated staining assay to identify patients with CLEVER-1 positive tumors for clinical trial inclusion

“We are pleased to have received these positive and supportive FDA recommendations for the continued clinical development of bexmarilimab as a monotherapy in solid tumors,” said CEO Markku Jalkanen. “As a first-in-human study for bexmarilimab, MATINS has laid the groundwork for multiple routes to market.”

Faron had previously announced a meeting with the agency would occur this quarter.

“FDA’s feedback on the MATINS study gives Faron an excellent roadmap to plot out bexmarilimab’s future strategy,” said Chief Medical Officer Marie-Louise Fjällskog. “We thank the FDA for its time and consideration of our briefing package and anticipate additional fruitful interactions.”

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

 

For more information please contact:

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

About MATINS

MATINS has demonstrated a positive safety profile in more than 200 patients treated with bexmarilimab. The study has observed an approximate 30% clinical benefit rate in several tumor types, which is associated with an interferon gamma (IFN-y) increase and leads to a significant survival benefit. Moreover, responding patients can be potentially identified using baseline IFN-y or CLEVER-1 expression. CLEVER-1 is a novel immune checkpoint, a receptor shown to promote an immunosuppressive environment.

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered 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 favorable 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 license its programs 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.

 

Notice of Faron Pharmaceuticals Ltd’s AGM

NOTICE OF faron pharmaceuticals LTD’s ANNUAL GENERAL MEETING

Shareholders of Faron Pharmaceuticals Ltd (the “Company”) are notified of the Annual General Meeting (the “AGM”) to be held on March 24, 2023 at 9:00 a.m. EET (Finnish time) at BioCity, meeting room “Ministeri” at Tykistökatu 6, FI-20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 8:30 a.m. EET (Finnish time).

The Company’s Annual Report 2022 is available to view and download on the Company’s website at https://www.faron.com/.

 

  1. MATTERS ON THE AGENDA OF THE ANNUAL GENERAL MEETING

 

  1. Opening of the meeting

 

  1. Calling the meeting to order

 

  1. Election of persons to scrutinise the minutes and to supervise the counting of votes

 

  1. Recording the legality of the meeting

 

  1. Recording the attendance at the meeting and adoption of the list of votes

 

  1. Presentation of the financial statements, the report of the Board of Directors and the auditor’s report for 2022

 

Review by the CEO.

 

  1. Adoption of the financial statements

 

  1. Resolution on the use of the profit shown on the balance sheet and the payment of dividend

 

The Board of Directors (the “Board”) proposes that no dividend for the financial year 2022 will be paid and that the losses of the Company for the financial year, amounting to EUR 28.7 million (IFRS), will be carried forward to the reserve for invested unrestricted equity.

 

  1. Resolution on the discharge of the members of the Board and the CEO of the Company from liability

 

  1. Resolution on the remuneration of the members of the Board

The Board proposes, on the basis of the proposal of the remuneration committee, that the annual remuneration of the members of the Board remain unchanged and that EUR 35,000 will be paid to the Board members, in addition to which an annual remuneration of EUR 35,000 will be paid to the chair of the Board. In addition, a further annual remuneration of EUR 11,000 will be paid to the chair of the audit committee, a further annual remuneration of EUR 9,000 will be paid to the chair of the remuneration committee and a further annual remuneration of EUR 6,000 will be paid to the chair of the nomination committee. In addition, a further annual remuneration of EUR 6,000 will be paid to the audit committee members, a further annual remuneration of EUR 5,000 will be paid to the remuneration committee members and a further annual remuneration of EUR 3,000 will be paid to the nomination committee members.

The Board furthermore proposes that meeting fees will be paid to the Board members as follows:

                a meeting fee of EUR 1,000 will be paid to Board members per Board meeting where the Board member was physically present, and which was held on another continent than the member’s place of residence; and

                no meeting fees will be paid to Board members who were attending a Board meeting but not physically present or for Board meetings held on the same continent as the member’s place of residence.

In addition, it is proposed that all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board would be compensated.

The Board also proposes, on the basis of the proposal of the remuneration committee, that no remuneration will be paid based on the Board membership of the CEO of the Company or a person serving the Company under a full-time employment or service agreement.

 

  1. Resolution on the number of members of the Board

 

The Board proposes, on the basis of the proposal of the nomination committee, that seven (7) members be elected to the Board.

 

  1. Election of members of the Board

 

The Board proposes, on the basis of the proposal of the nomination committee, that Frank Armstrong, John Poulos, Leopoldo Zambeletti, Markku Jalkanen, Anne Whitaker and Erik Ostrowski be re-elected to the Board for a term that ends at the end of the next AGM. In addition, the Board proposes, on the basis of the proposal of the nomination committee, that Tuomo Pätsi be elected as a new member to the Board for a term that ends at the end of the next AGM.

 

Tuomo Pätsi, citizen of Finland and Switzerland, holds no other board memberships at the moment. He is

independent of the Company and its significant shareholders. Information on the proposed new Board member is available on the Company’s website at https://www.faron.com/investors/general-meetings.

 

All proposed Board member candidates have given their consent for the election. The proposed Board members have informed the Company that in the event they are elected, they intend to elect Frank Armstrong as chair of the Board.

 

Information on the Board member candidates proposed to be re-elected are available on the Company’s website at https://www.faron.com/faron/leadership/board-directors.

 

  1. Resolution on the remuneration of the auditor

 

The Board proposes, on the basis of the proposal of the audit committee, that the auditor be remunerated in accordance with the invoice approved.

 

  1. Election of the auditor

 

The Board proposes, on the basis of the proposal of the audit committee, that PricewaterhouseCoopers Oy (“PwC”), a firm of authorised public accountants, continue to act as the Company’s auditor.

 

PwC has informed the Company that it will appoint Panu Vänskä, authorised public accountant (KHT), as the key audit partner.

 

  1. Amendment of the Articles of Association

 

The Board proposes that article 11 § of the Articles of Association of the Company (Meeting venue) be amended to enable holding a General Meeting entirely without a meeting venue as a so-called remote meeting in addition to the Company’s domicile and London. The said clause would read amended as follows:

 

“11§ Meeting venue

 

A General Meeting may in addition to the Company’s domicile be held in the city of London, United Kingdom, on the basis of a resolution of the Board of Directors. In addition, the Board of Directors may decide that the General Meeting of the Shareholders be held without a meeting venue so that the shareholders exercise their power of decision in full in real time during the meeting using a telecommunications connection and technical means (remote meeting).”

 

It is proposed that the Articles of Association remain unchanged in other respects.

 

The proposal is based on the changes to Chapter 5 of the Finnish Companies Act, including the possibility to arrange general meetings remotely. Arranging a General Meeting as a remote meeting only, requires specific language in the Articles of Association. The legislative changes are based on the premise that, irrespective of the chosen General Meeting format, shareholders’ rights must not be compromised and that all participating shareholders can exercise their shareholder rights in full in real time, including the right to present questions and vote. The possibility to organize General Meetings remotely enables the Company to prepare for rapid changes in the Company’s operating environment and society in general, which may be caused, for example, by pandemics. It is important that the Company has the necessary means to offer its shareholders the possibility to exercise their shareholder rights and resolve on any matters that are presented in a General Meeting under any circumstances.

 

  1. Authorising the Board to decide on the issuance of shares, options or other special rights entitling to shares

 

The Board proposes that the AGM authorise the Board to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in Chapter 10, Section 1 of the Finnish Limited Liability Companies Act, which authorisation contains the right to issue new shares or dispose of the Company’s own shares in the possession of the Company. The authorisation would consist of up to twelve million five hundred thousand (12,500,000) new shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately twenty (20) per cent of the existing shares and votes in the Company, as well as the conveyance of up to the same maximum number (twelve million five hundred thousand (12,500,000)) of treasury shares in the possession of the Company.

 

In practise, the above authorisation includes that the Board may first resolve on one or several share issues (up to the maximum number of twelve million five hundred thousand (12,500,000) new shares) without consideration to the Company itself and then further convey such treasury shares (up to the maximum number of twelve million five hundred thousand (12,500,000) shares) against consideration.

 

The authorisation would not exclude the Board’s right to decide on the issuance of shares, options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights.

 

The authorisation is proposed to be used for material arrangements from the Company’s point of view, such as financing (including, without limitation, issuance of warrants under the funding agreement with IPF Partners announced on February 28, 2022) or implementing business arrangements, investments or for other such purposes determined by the Board in which case a weighty financial reason for issuing shares, options or other special rights entitling to shares, and possibly deviating from the shareholders’ pre-emptive rights, would exist.

 

For the sake of clarity, it is noted that in no circumstances can the total number of new shares to be registered under this authorisation exceed twelve million five hundred thousand (12,500,000) new shares in aggregate.

 

The Board would be authorised to resolve on all other terms and conditions of the issuance of shares, options or other special rights entitling to shares.

 

The authorisation would be effective until June 30, 2024.

 

  1. Resolution on the amendment of the option programme and authorising the Board to decide on the issuance of options or other special rights entitling to shares

The Company’s AGM has on May 28, 2019 decided to authorise the Board to resolve on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act, and the terms and conditions have later been amended by the decision of the Company’s AGM on May 18, 2020 (the “Share Option Plan 2019”). The Board proposes, on the basis of the proposal of the remuneration committee, that the AGM would resolve to amend the terms and conditions of the Share Option Plan 2019, so that a maximum total of four million three hundred and fifty thousand (4,350,000) options (previously two million (2,000,000) options) would be offered under said terms and conditions as follows:

 

• to the chair of the Board, a maximum of two hundred and fifty thousand (250,000) options (before the amendment one hundred and eighty thousand (180,000) options);

• to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein), a maximum of one hundred and twenty five thousand (125,000) options (before the amendment ninety thousand (90,000) options);

• to the Chief Executive Officer, a maximum of four hundred and ninety five thousand (495,000) options (before the amendment three hundred and sixty thousand (360,000) options);

• to the Chief Financial Officer, a maximum of one hundred and eighty thousand (180,000) options (before the amendment one hundred and thirty thousand (130,000) options); and

• for any other non-employee person as determined by the Board, a maximum of seventy thousand (70,000) options (before the amendment fifty thousand (50,000) options).

 

Excluding the addition concerning the listing on Nasdaq Helsinki and the extension of the duration of the authorisation, the terms and conditions of the option programme would remain otherwise unchanged. The consolidated rules of the Share Option Plan 2019, incorporating the amendments proposed herein, are attached hereto as Annex 1. The proposed amendments provide greater flexibility to offer competitive equity incentive awards to senior leadership and wider employees in a competitive global talent market.

 

The proposed amendment would increase the maximum total number of options under the Share Option Plan 2019 by two million three hundred and fifty thousand (2,350,000) options. This would increase the aggregate per centage of shares that can be subscribed for based on options from 3,1 per cent to 6,9 per cent of all shares registered at the date of this proposal. The maximum number of options granted to the chair of the Board would increase by seventy thousand (70,000) options, representing an increase of approximately 38.9 per cent, the maximum number of options granted to each member of the Board (excluding the chair of the Board and the Chief Executive Officer and the Chief Financial Officer if they would be considered as members of the Company’s Board herein) would increase by thirty five thousand (35,000) options, representing an increase of approximately 38.9 per cent, the maximum number of options granted to the Chief Executive Officer would increase by one hundred and thirty five thousand (135,000) options, representing an increase of 37.5 per cent, the maximum number of options granted to the Chief Financial Officer would increase by fifty thousand (50,000) options, representing an increase of approximately 38.5 per cent and the maximum number of options granted to other non-employee persons as determined by the Board would increase by twenty thousand (20,000) options, representing an increase of 40.0 per cent, over the current maximum totals.

 

In relation to the amendment proposed above, the Board further proposes, on the basis of the proposal of the remuneration committee, that the AGM authorise the Board to resolve by one or several decisions on issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act. The authorisation would consist of up to two million four hundred seventy-three thousand and eighty four (2,473.084) shares, options or other special rights entitling to shares in the aggregate, which corresponds to approximately 3.9 per cent of the existing shares and votes in the Company.

 

The authorisation would not exclude the Board’s right to decide on the issuance of options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights. The authorisation is proposed to be used for implementing an option plan for the employees and directors of, and persons providing services to, the group, substantially in the form of the amended Share Option Plan 2019 attached hereto as Annex 1. There is a weighty financial reason for issuing options, as options are an integral part of the incentivisation system for the management and personnel of the Company. The maximum numbers of options to be granted shall be as presented above. For the sake of clarity it is noted that, as described above, the new amended maximum amounts include the options already granted under the Share Option Plan 2019, which is why the proposed size of the authorisation also takes into account the options already granted based on the previous authorisation.

 

The exercise of options will be subject to fulfilment of certain criteria to be resolved by the Board (the “Exercise Conditions”). Subject to fulfilment of the Exercise Conditions, the options may be exercised at the exercise price, which may not be less than the market value of a share at the grant date, as determined by the Board (the “Exercise Price”). In determining such market value, if shares are traded on Nasdaq Helsinki and/or on the AIM market of the London Stock Exchange, the Board shall have regard to the average price per share at which shares have been traded over a period of 90 days immediately preceding the grant date. The Exercise Price will be determined to create a sufficient incentive for the recipients of options. The Exercise Price shall be recorded in the Company’s reserve for invested unrestricted equity.

 

The Company’s Board would be authorised to resolve on all other terms and conditions of the issuance of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act.

 

The authorisation will be effective until 30 June 2026. This authorisation shall not replace other authorisations granted to the Board (but for the sake of clarity, replaces the authorisation granted in 2019 relating to the Share Option Plan 2019).

 

  1. Closing of the meeting

 

 

  1. DOCUMENTS OF THE ANNUAL GENERAL MEETING

The above-mentioned proposals to the AGM, the Company’s Annual Report 2022 including the financial statements, the Report of the Board of Directors and the Auditor’s Report and this notice are available on the Company’s website at https://www.faron.com/investors as of the date of publication of this notice. The Board’s proposals and the other above-mentioned documents will also be available at the AGM. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the AGM will be available on the Company’s website from 6 April 2023 at the latest.

  1. INSTRUCTIONS FOR THE PARTICIPANTS

 

  1. The right to participate and registration

Each shareholder who on the record date of the AGM, being March 14, 2023, is registered in the Company’s shareholders’ register held by Euroclear Finland Oy has the right to participate in the AGM. A shareholder whose shares are registered on their personal Finnish book-entry account is registered in the Company’s shareholders’ register. If you do not have a Finnish book-entry account, see section C3 “Holder of nominee-registered shares (including depositary interest holders)”.

A shareholder who is registered in the Company’s shareholders’ register and who wants to participate in the AGM should register for the meeting by no later than 10:00 a.m. EET (Finnish time) on Tuesday, March 21, 2023 by giving a prior notice of participation. The notice must be received before the end of the registration period. Notice of participation can be given:

          by email to general.meeting@faron.com or

          by mail to Faron Pharmaceuticals Ltd, attn. Kaisa Kyttä, Joukahaisenkatu 6, FI-20520 Turku, Finland.

When registering, a shareholder shall state their name, personal identification number / business identity code, address, telephone number and the name of a possible proxy representative, legal representative or assistant and the personal identification number of the proxy representative or legal representative. The personal data given by shareholders to the Company are used only in connection with the AGM and the necessary processing of related registrations.

Shareholders, and their authorised representatives or proxy representatives should, when necessary, be able to prove their identity and/or right of representation at the meeting venue.

  1. Proxy representative and powers of attorney

Shareholders may participate in the AGM and exercise their rights at the meeting by way of proxy representation. A proxy representative must present a dated power of attorney or other reliable proof of their authority to represent the shareholder.

If a shareholder participates in the AGM by means of several proxy representatives, who represent the shareholder with shares held on different book-entry accounts, the shares represented by each proxy representative shall be identified when registering for the AGM.

The Company offers the possibility for shareholders to designate Yrjö Wichmann, VP, Financing & IR, as their proxy representative, to represent them at the AGM in accordance with shareholder’s voting instructions. Authorizing the designated proxy representative will not accrue any costs for the shareholder, excluding possible postal fees for proxy documents.

Possible proxy documents should be sent by email to general.meeting@faron.com and in originals to Faron Pharmaceuticals Ltd, attn. Kaisa Kyttä, Joukahaisenkatu 6, FI-20520 Turku, Finland before the end of registration period by which time the proxy documents must be received.

In addition to providing proxy documents, the shareholder or their proxy representative must take care of registering for the AGM in the manner described in this notice.

  1. Holder of nominee-registered shares (including depositary interest holders)

A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the AGM by virtue of such shares based on which the holder would be entitled to be registered in the Company’s shareholders’ register held by Euroclear Finland Oy on the AGM’s record date of March 14, 2023.

Additionally, participation requires that the holder of nominee-registered shares is on the basis of such shares temporarily registered in the Company’s shareholders’ register held by Euroclear Finland Oy by 10:00 a.m. EET (Finnish time) on Tuesday, March 21, 2023. As regards nominee-registered shares, this constitutes due registration for the AGM.

A holder of nominee-registered shares is advised to request the necessary instructions regarding the temporary registration in the shareholders’ register, the issuing of proxy documents and registration for the AGM from their custodian bank without delay. A holder of nominee-registered shares shall note that custodian banks may apply deadlines for the registration and the providing of voting instructions of holders of nominee-registered shares. The account management organisation of the custodian bank must register a holder of nominee-registered shares who wants to participate in the AGM to be temporarily entered into the Company’s shareholders’ register by the above-mentioned time.

  1. Other instructions and information

Pursuant to Chapter 5, Section 25 of the Finnish Limited Liability Companies Act, shareholders who are present at the AGM are entitled to request information regarding the matters addressed by the meeting.

Changes in shareholding occurred after the record date of the AGM do not affect the right to participate in the AGM or the number of votes held by a shareholder.

On the date of this notice, March 3, 2023, the total number of shares and votes in the Company is 63,497,691.

The AGM shall be held in Finnish, partially translated into English.

 

Turku, March 3, 2023

FARON PHARMACEUTICALS LTD

Board of Directors

 

For more information please contact:

Media / Investor Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

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

 

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

 

Faron´s Annual Report 2022 Published

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

Faron´s Annual Report 2022 Published 

 

Company announcement, March 3, 2023 at 02:15 AM (EST) / 07:15 AM (GMT) / 09:15 AM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, announces today that its Annual Report for the year 2022 and audited financial statements for the accounting period January 1- December 31, 2022 have been published in English, and its financial statements in Finnish.

 

Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, will host a virtual briefing and Q&A session for analysts at 7:00 AM (EST) / 12:00 PM (GMT) / 2:00 PM (EET) today. Webcast link: https://faron.videosync.fi/2022-financial-statement

 

The full-year results press release for 2022, presentation, virtual briefing webcast details, audited financial statements and Annual Report 2022 is available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards.

 

For more details about the analysts’ briefing, please contact Faron@consilium-comms.com.

 

For more information please contact:
 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

About Faron Pharmaceuticals Ltd.

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered 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.

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