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.

 

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.

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.

 

Update to Faron’s Financial Calendar for 2023

Faron Pharmaceuticals Oy
(“Faron” or “Company”)

 

Update to Faron’s Financial Calendar for 2023

 

Company announcement, February 6, 2023 at 1:00 PM (EST) / 6:00 PM (GMT) / 8:00 PM (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, today announces an update to its financial reporting calendar for 2023.

 

The Company’s financial statement release for the full year 2022 and Annual Report 2022, including financial statements for the full year, will now be published on Friday, March 3, 2023, at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET), rather than on Thursday, March 2, 2023, as had been previously communicated.

 

The publication date of Tuesday, August 29, 2023, for Faron’s half-year financial report for the period January 1 to June 30, 2023, remains unchanged, as does the date for the Company’s annual general meeting, which is planned to be held on Friday, March 24, 2023. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

 

Full Year Results Virtual Briefing

Following publication of Faron’s financial statement release for the full year 2022 on Friday, March 3, 2023, Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, will host a virtual briefing and Q&A session for analysts on the day at 7:00 AM (EST) / 12:00 PM (GMT) / 2:00 PM (EET).

 

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

 

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

 

 

 

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

Faron Pharmaceuticals

Toni Hänninen

CFO

toni.hanninen@faron.com

Phone: +41 79 387 2643

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 (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 solid tumors and hematologic malignancies, 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 by 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.

 

BEXMAB Study Update

Faron Pharmaceuticals Oy

(“Faron” or “Company”)

 

Inside Information: Deepening Response of Bexmarilimab in Combination with SoC in Hematological Malignancies

BEXMAB Study Update

      Partial responder becomes complete responder with complete remission of blasts in blood and bone marrow followed by normalization of blood counts

      Second patient demonstrated a partial response

      Stable disease observed in the other treated patients

      Two patients enrolled in second cohort with increased bexmarilimab dose with azacitidine

      Enrolment initiated in the triplet cohort combining bexmarilimab with azacitidine and venetoclax

 

Company announcement, December 5, 2022 at 02:00 AM (EST) / 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 and inflammation via precision immunotherapy, today announces a further update on the Company’s Phase I/II BEXMAB study, investigating bexmarilimab, Faron’s wholly owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.

In this latest update from the ongoing, open-label clinical trial, the Company reports that:

      An azacytidine-refractory acute myeloid leukemia (AML) patient with partial responses as communicated on October 31, 2022, achieved a complete remission, with incomplete blood cell count recovery after four treatment cycles. This was followed by full blood count recovery after five treatment cycles.

      The second patient, recently diagnosed with myelodysplastic syndrome (MDS), showed early signs of efficacy, with reduced blast counts. This pattern is similar to the first patient and as such the patient could be considered a partial responder.

      The remaining patients of the first cohort have reported stable disease (SD) status.

      Bexmarilimab continues to be well-tolerated with no dose-limiting toxicities or safety concerns observed in the five patients receiving 1mg/kg weekly dosing together with azacitidine.

      Study expansion to major hematological US centers is ongoing.

The primary objective of the BEXMAB study is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine and venetoclax) treatment and to identify the recommended Phase II dose. Secondary objectives include characterizing bexmarilimabs pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity. The initial treatment efficacy is followed by measuring cancer cell blast number in blood and bone marrow.

The BEXMAB study has opened the second predefined weekly dosing level of 3mg/kg and the start of dosing in the new triplet cohort combining bexmarilimab with azacitidine and venetoclax.

“We continue to be encouraged by the promising early data observed in this trial, notably the patients who have already shown control of blast counts in blood and bone marrow,” said Dr. Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “These observations support the potential for synergy of bexmarilimab in combination with standard of care. In addition, patient recruitment has started in the first-line triplet therapy with bexmarilimab, azacitidine and venetoclax in newly diagnosed acute myeloid leukemia patients deemed unsuitable for conventional chemotherapy. “

This and other earlier data will be shared with the current BEXMAB study group and potential new US study site investigators who will convene for the 64th American Society for Hematology (ASH) meeting in New Orleans, Louisiana from December 10-13, 2022.

Further details of the BEXMAB study are available on ClinicalTrials.gov (Identifier: NCT05428969).

 

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

 

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

Faron Pharmaceuticals

Yrjö Wichmann

VP, Financing and Investor Relations

Yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979

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 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, bexmarilimabtargets 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. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

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 aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment and to identify the recommended Phase II dose. Based on initial safety data, there is potential for expansion to include a first line triplet therapy of bexmarilimab, azacitidine and venetoclax in newly diagnosed AML patients who are not able to tolerate chemotherapy. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current chemotherapy treatments to be more effective.

 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 solid tumors and hematologic malignancies, 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 by 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 Appoints Maija Hollmén PhD as CSO

 

Faron Pharmaceuticals Ltd.

(“Faron or “Company”)

 

Faron Appoints Maija Hollmén, Ph.D., as Chief Scientific Officer

 

Company announcement, December 1, 2022, at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 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 macrophage immunotherapy, today announces the appointment of Faron Co-founder Maija Hollmén, Ph.D., as Chief Scientific Officer.

 

In her new role, Dr. Hollmén will oversee preclinical and support clinical development for Faron. Her priority will be the further development of bexmarilimab, Faron’s wholly owned, novel precision cancer immunotherapy candidate. Bexmarilimab is currently being evaluated for safety and efficacy in a Phase I/II clinical trial, in combination with standard of care (SoC), in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The potential therapy has already achieved a strong safety and overall survival benefit profile in the Phase I/II MATINS trial as a monotherapy in late-stage solid tumors.

 

“Dr. Hollmén is the world-leading expert on CLEVER-1 biology and Clever-1-expressing tumor-associated macrophages,” said Marie-Louise Fjällskog, Chief Medical Officer of Faron. “Her support is essential to bexmarilimab’s development. Faron is pleased to have her on board in the Chief Scientific Officer role to bring her knowledge of the target molecule and develop it further.”

 

Dr. Hollmén is an Adjunct Professor of Tumor Immunology on the Faculty of Medicine at the University of Turku in Finland, as well as a Principal Investigator. Dr. Hollmén earned both her PhD and MSc degrees from the University of Turku.

 

“I am excited to join the team at Faron as we work to advance bexmarilimab’s development for the treatment of advanced cancers,” said Dr. Hollmén. “I am inspired by the possibility to make a difference for patients who have no other options and to be part of the pioneering work Faron is currently doing in developing next-generation immunotherapies.”

 

Dr. Hollmén’s post-doctoral studies were conducted at ETH Zurich alongside Professor Michael Detmar, focusing on tumor immunology and how cancer cells educate macrophages to support tumor growth. Dr. Hollmén returned to Turku and formed her own laboratory to develop strategies to resolve immunosuppressive cells and pathways and during this time, concentrated working on CLEVER-1.

 

 

For more information please contact:

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

Consilium Strategic Communications

David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

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, Nominated Adviser

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

 

 

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. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

 

About Faron Pharmaceuticals Oy

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 solid tumors and hematologic malignancies, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. 

 

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.

 

Amendment Terms and Conditions with IPF Partners

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Inside Information: Amendment to Terms and Conditions of Warrants and Funding Agreement with IPF Partners

 

 

Company announcement, November 18, 2022 at 11:30 AM (EST) / 4:30 PM (GMT) / 6:30 PM (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 the Company and IPF Partners (“IPF”) have agreed to amend certain terms and conditions of the warrants issued to IPF (the “Warrants”) and certain terms and conditions of the secured debt agreement with IPF (the “Funding Agreement”), each originally announced by the Company on February 28, 2022.

 

Pursuant to the amended Warrant terms and conditions, the subscription price per share on the exercise of the 319,944 Warrants issued to IPF in connection with the utilization of the first tranche under the Funding Agreement shall now be the lower of either EUR 1.85 (equivalent to issue price of the placing announced on 14 October 2022) or the subscription price per share in any subsequent share offering undertaken by the Company (the subscription price was originally EUR 3.126 per share, equal to 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 tranches, and subsequently amended to EUR 3.008 following further share issuances pursuant to the Warrant terms and conditions). The Board will separately resolve upon the Warrant terms and conditions applicable to Warrants to be issued in relation to the possible utilization of the second and third tranches under the Funding Agreement. The amendment of the Warrant terms and conditions has been resolved as a result of the Company and IPF entering into an amendment and restatement agreement dated November 18, 2022 which also  amends certain covenant, margin and fee structure provisions of the Funding Agreement. The Company’s Board of Directors has resolved on the amendments based on the authorization granted to the Board by shareholders at the Company’s Extraordinary General Meeting on July 7, 2022.

 

The amended terms and conditions of the Warrants will be available on the Company’s website at https://www.faron.com/investors/aim-rule-26.

 

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

 

 

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 Smith-Parker

Head of Communications

jennifer.smith-parker@faron.com

 

Cairn Financial Advisers LLP, Nominated Adviser

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 solid tumors and hematologic malignancies, 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 by 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.

 

 

Results of Placing

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

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”).

 

 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Announcement of the Results of Placing, the Issue Price, PDMR dealing and registration of New Shares with the Trade Register

 

Capitalised terms used in this announcement have the meanings given to them in the announcement made on 13 October 2022 regarding the proposed issue of new ordinary shares in the Company to the Company itself without consideration and placing of treasury shares in the Company (the “Launch Announcement“), unless the context provides otherwise.

 

Company announcement, 14 October 2022 at 7:00 a.m. BST / 9:00 a.m. EEST

Inside information

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), 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 today that the Bookbuild, announced on 13 October 2022, is now closed. The Placing comprises of the issuance of 3,229,930 Treasury Shares to Faron itself without consideration, which have today been registered in the Trade Register, and subsequent conveyance of these Treasury Shares together with 1,311,800 treasury shares already held by the Company, in total 4,541,730 Placing Shares, to investors at the Issue Price of EUR 1.85 per Placing Share. 4,414,460 Placing Shares are conveyed to investors in the main tranche of the Placing organised by Swedbank, and in a separate tranche without the involvement of Swedbank, 6,270 Placing Shares are conveyed by the Company directly to the Chairman of the Board and the remaining 121,000 Placing Shares to certain other investors, at the same terms and conditions as the main tranche. The Issue Price represents a 5.5 % discount to the close price on 13 October 2022 on NASDAQ Helsinki First North Growth. The payment and settlement (delivery against payment of the Issue Price in full) of the Placing Shares is expected to be completed on or about 18 October 2022.

 

The Placing Shares conveyed to investors amount to approximately 8.0 % of the issued shares and votes in the Company, immediately prior to the Placing. The Company has raised aggregate gross proceeds of EUR 8.4 million in the Placing. The Placing was supported by existing shareholders as well as new investors. With these proceeds and the current level of activities the Company has sufficient working capital further into Q1 2023.

 

“We are extremely pleased with the results of this Placing and the interest we received from investors.” said Toni Hänninen, Chief Financial Officer of Faron. “These funds allow us to accelerate our bexmarilimab pipeline further, including the continuation of our BEXMAB study, preparation for the MATINS FDA EOP (end of phase) meeting and the initiation of our BEXCOMBO study in 2023. Additionally, we are further strengthening our presence and building the team in the US as previously communicated.”

 

Use of Proceeds and registration of Treasury Shares in the Trade Register

The primary reason for conducting the Placing was to accelerate and expand the clinical development of the Company’s main drug candidate, bexmarilimab. Some of the proceeds will also be used to expand manufacturing capabilities, to support general corporate purposes and to strengthen the Company’s balance sheet.

 

A total of 3,229,930 Treasury Shares have been issued and registered in the Trade Register today on 14 October 2022. Following the issuance, the aggregate number of ordinary shares in the Company is 59,805,383. As a part of the Placing, the 3,229,930 Treasury Shares are further conveyed to investors as Placing Shares together with the 1,311,800 treasury shares already held by the Company, with payment and settlement (delivery against payment of the Issue Price in full) expected to be completed on or about 18 October 2022. The Placing Shares confer a right to dividends and other shareholder rights from the payment and settlement to investors. One Placing Share entitles to one vote in the general meeting of the Company. Following, and subject to, the completion of the settlement in full, the Company will have no shares in treasury and therefore, the total number of voting rights in Faron will be 59,805,383 (the “New Number of Shares and Votes“). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the New Number of Shares and Votes of the Company.

 

Trading in the Treasury Shares (and the Placing Shares) is expected to commence on First North and AIM latest on or about 18 October 2022.

 

Related Party Transaction and PDMR Dealing

Timo Syrjälä, an existing shareholder in the Company, has subscribed for 1,400,000 Placing Shares in aggregate, for an aggregate subscription value of EUR 2.6 million at the Issue Price. Following the Placing, Mr. Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme Investments SPF Sarl (“Acme“), an entity wholly owned by Mr. Syrjälä, will be 12,306,957 shares, representing 20.6 % of the New Number of Shares and Votes. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules for Companies (the “AIM Rules“). His subscription for Placing Shares pursuant to the Placing is a related party transaction for the purposes of the AIM Rules, the First North Rulebook and the Finnish Limited Liability Companies Act. The Directors of the Company, all of whom are independent of Mr Syrjälä, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the participation by Mr. Syrjälä in the Placing to be fair and reasonable insofar as shareholders are concerned.

 

In addition, Frank Armstrong, director of the Company has subscribed for 6,270 shares respectively to be conveyed by the Company directly in a separate tranche without the involvement of Swedbank. The beneficial interest in the issued shares and votes of the Company is set out below:

 

 

Before the Placing

 

Following the Placing

Director

Number of ordinary shares held

% of issued shares and votes

Number of Placing Shares subscribed for

Number of ordinary shares held

% of issued shares and votes

Frank Armstrong

64,792

0.1

6,270

71,062

0.1

    

The participation of Frank Armstrong (“Director Participation”) in the Placing constitutes a related party transaction. The independent directors for the purpose of the Director Participation, being all other members of the Board, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the Director Participation in the Placing to be fair and reasonable insofar as shareholders are concerned.

 

 

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Frank Armstrong

 

2

Reason for notification

 

 

 

a.

Position/Status

Directors

b.

Initial notification/

Amendment

Initial Notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Ordinary shares

ISIN: FI4000153309
 

b.

Nature of the transaction

Purchase of ordinary shares

c.

Price(s) and volume(s)

 

 Average

 

 

 

 

Price(s)

Volume(s)

 

1.85

6 270

 

 

 

 

d.

Aggregated information

 

– Aggregated Volume

 

– Price

 

 

 

6 270

 

1.85

e.

Date of the transaction

14 October 2022

f.

Place of the transaction

Nasdaq First North Growth Market

 

 

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

Eric Van Zanten

VP, Communications

eric.vanzanten@faron.com

Phone: +1 (610) 529-6219

 

Swedbank AB (publ), Financial Adviser

Mika Karikoski

Phone: + 358 (0)40 7416959

 

Cairn Financial Advisers LLP, Nominated Adviser

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

 

THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF REGULATION 2017/1129/EU AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON BEING REFERRED TO AS A “RELEVANT PERSON”). ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

 

THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO INTENTION TO REGISTER THE PLACING SHARES IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE PLACING SHARES IN THE UNITED STATES WAS MADE SOLELY TO “QUALIFIED INSTITUTIONAL BUYERS” AS DEFINED IN RULE 144A IN RELIANCE ON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT.

 

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 in both solid tumors and hematologic malignancies. 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 solid tumors and hematologic malignancies, 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 by 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.

IMPORTANT INFORMATION

 

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

 

This announcement contains inside information for the purposes of Article 7 of MAR and Article 7 of UK MAR.

 

MiFID II

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offer.

 

Caution regarding forward-looking statements

Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward-looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, ”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 licence its programmes, 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.

Top-Line Data on Bexmarilimab Dose Variation

Faron Pharmaceuticals Ltd

(“Faron or Company”)

 

Faron Pharmaceuticals Announces Top-Line Data on Bexmarilimab Dose Variation from MATINS Advanced Solid Tumor Patients

 

  • Bexmarilimab was well tolerated in patients receiving higher dose levels or frequency of administration
  • Treatment induced significant systemic interferon (IFN) gamma increase – again showing the capacity of bexmarilimab to activate immune response in cancer patients, especially in patients with immunologically “cold” tumors
  • Higher baseline Clever-1 levels in the tumors was associated with increased clinical benefit and could become an essential component as a diagnostic tool for patient selection
  • Median overall survival based on patients from Part I and II (n=138) was 14.9 months for patients who benefited from treatment with bexmarilimab compared to 4.4 months for those who did not, representing a 3.4-fold increase
  • Clinical benefit was observed across all dosing regimens
  • New data, together with recent scientific advisory board recommendations and pharmacokinetic modelling, allow Faron to file the end of Phase I/II package with the US Food and Drug Administration later this year
  • Company to host Bexmarilimab Development Update webcast today, Tuesday, September 20, at 02:00 pm EEST, 12:00 pm BST, 7:00 am EST

 

Company Announcement, September 20, 2022 at 02:00 AM (EST) / 07:00 AM (BST) / 09:00 AM (EEST)

 

Insider 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, today announces further dose escalation data from its Phase I/II MATINS (Macrophage Antibody To INhibit immune Suppression) study investigating the safety and efficacy of bexmarilimab monotherapy in ten different hard-to-treat metastatic or inoperable solid tumor cohorts. The latest progress with the MATINS study was focused on higher dose levels and frequencies to finalize the dose for future study designs as a single agent or in combination with other anti-cancer treatments, including PD-1 blocking agents. Higher doses, up to 30mg/kg, were well tolerated as was more frequent dosing of 1-3 mg/kg administered every week to every other week.  

 

Despite the relatively rapid clearance of bexmarilimab from circulation, the majority of evaluated dosing regimens produced significant Clever-1 occupancy in circulating monocytes and reduced the presence of soluble Clever-1 in blood. This data suggests that bexmarilimab dosing can be effective across several dosing regimens. Currently, the highest clinical benefit (25-30% of the test cohort) was observed at 1 mg/kg and seen with weekly and three-weekly administration. Additional pharmacokinetic / pharmacodynamic (PK/PD) and clinical efficacy data is expected shortly and should together with pharmacokinetic modelling enable Faron to present an acceptable data package to the US Food and Drug Administration (FDA) for determination of the recommended dosing regimen(s) for future studies.

 

As previously reported, low IFN-gamma levels predict clinical benefit as measured by extended overall survival (Part I data). Additionally, Part II patients with low baseline IFN-gamma levels experienced a five-fold increase IFN-gamma levels in their blood, which was not seen in patients with high baseline IFN-gamma levels. The regression analysis of this correlation was highly significant (p=0.007) and indicates that bexmarilimab has the capacity to ignite immunity in heavily pre-treated, last line cancer patients who either did not respond to or were ineligible for treatment with currently approved immunotherapy drugs.  

 

The data also showed that the lower the pre-existing IFN-gamma response is, the higher the IFN-gamma levels will increase with bexmarilimab treatment. This highlights the importance of the patient phenotype that benefits from bexmarilimab, i.e., the characteristics of the tumor are critical when determining whether a patient is likely to benefit from treatment, making a biomarker strategy extremely important for the future development of bexmarilimab. The key tumor characteristics have now been clearly identified and Faron is well placed to drive a biomarker strategy forward to guide patient selection.

 

“Bringing the promise of immunotherapy to more cancer patients starts with the ability to identify which patients are likely to benefit from specific treatments,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “We now have a clear understanding of which patients benefit from bexmarilimab treatment and can identify them using a validated staining antibody, which can be widely accessible and adapted to routine practice. In addition, we have blood-based cytokine profiles to support our biological approach, and even further strengthen our biomarker development strategy.”

 

An updated survival analysis including 138 patients from Part I and Part II of the MATINS trial showed median overall survival was 14.9 months for patients who benefited from treatment with bexmarilimab compared to 4.4 months for those who did not, representing a 3.4-fold increase. This corresponds to a hazard ratio estimated using a Cox model of 0.33 (95% confidence interval from 0.18 to 0.61).

 

The Company plans to compile the end of Phase I/II package, which will include additional PK/PD and clinical efficacy data, and file it with the FDA to obtain regulatory advice for further clinical development of bexmarilimab, as a stand-alone last line treatment and in earlier line combinations.

 

”The fact that bexmarilimab treatement was well tolerated at all dosing levels and frequencies is significant,” said Petri Bono, MD, PhD., Chief Medical Officer, Terveystalo Finland and Principal Investigator of the MATINS trial. “One of the big challenges we have seen with immuno-therapy drugs to date, particularly when used in combination, is dose limiting toxicity. Bexmarilimab’s safety profile in a monotherapy setting suggests combination therapy with an anti-PD-1 would also be well tolerated.”

 

“We have made steady progress with our MATINS trial and following a detailed evaluation of this latest data, expect to submit a full data package to the FDA and request an end of Phase I/II meeting,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “We look forward to sharing all of our MATINS data, including the updated dosing and survival data, with the FDA and discussing the best possible way to bring this new treatment option forward to patients.”

 

Faron thanks the patients and investigators who are participating in the MATINS clinical trial and SAB members for their advice.

 

To register for the Bexmarilimab Development Update webcast on September 20, 2002, please visit: https://faron.videosync.fi/2022-bexmarilimab-development-update.

 

A Finnish language interview with Dr. Markku Jalkanen covering the important information shared during the event will also take place on September 20, 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.

 

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

 

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

Eric Van Zanten

VP, Communications

eric.vanzanten@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 in both solid tumors and hematologic malignancies. 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 solid tumors and hematologic malignancies, 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 by 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.

Registration of New Shares

 

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

 

 

Faron Pharmaceuticals Ltd

 

(“Faron” or the “Company”)

Registration of New Shares with the Trade Register

 

Capitalised terms used in this announcement have the meanings given to them in the announcement made at 09.00 a.m. EEST / 07.00 a.m. BST on 28 June 2022 regarding the issue and placing of new ordinary shares in the Company (the “Placing Announcement), unless the context provides otherwise.

 

Company announcement, 28 June 2022 at 15:45 EEST / 13.45 BST

 

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, has, as announced earlier today, conducted the Placing of 2,006,621 shares in the Company.

 

A total of 3,318,421 Treasury Shares have been issued and registered in the Trade Register today on 28 June 2022. Following the issuance, the aggregate number of ordinary shares in the Company is 56,575,453. As a part of the Placing, 2,006,621 of such Treasury Shares are further conveyed to investors as Placing Shares. The trades of the Placing Shares are printed in two parts, 1,806,621 million Placing Shares were printed today on 28 June and the remaining Placing shares will be printed on 1 July, with settlement of trades against payment of the Issue Price expected to be completed on or around 30 June 2022 and 5 July 2022, respectively. The Placing Shares confer a right to dividends and other shareholder rights from the registration with the Trade Register. One Placing Share entitles to one vote in the general meeting of the Company. Following, and subject to, the completion of the settlement in full, the Company will hold a total of 1,311,800 Treasury Shares. The number of shares in issue (excluding Treasury Shares), and the figure to be used as the denominator for calculations of interests in the Company’s voting rights, is 55,263,653.

 

Trading in the Placing Shares (and the remaining Treasury Shares) is expected to commence on First North and AIM latest on or around 29 June 2022.

 

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

Eric Van Zanten

VP, Communications

eric.vanzanten@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

 

THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF REGULATION 2017/1129/EU AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON BEING REFERRED TO AS A “RELEVANT PERSON”). ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

 

THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO INTENTION TO REGISTER THE PLACING SHARES IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE PLACING SHARES IN THE UNITED STATES WAS MADE SOLELY TO “QUALIFIED INSTITUTIONAL BUYERS” AS DEFINED IN RULE 144A IN RELIANCE ON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT.

 

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 solid tumors and hematologic malignancies, 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 by 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.

 

IMPORTANT INFORMATION

 

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

 

MiFID II

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offer.

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