Positive Phase 2 Interim Results from BEXMAB Trial

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Inside Information: Faron Announces Positive Phase 2 Interim Results from BEXMAB Trial to be presented at ASH

Company announcement, Inside Information , 27 November 2024

Key highlights

–      Interim Phase 2 read-out from the BEXMAB Trial confirms earlier positive Phase 1 & 2 findings in MDS patients with prior HMA failure

–      In Phases 1 & 2, 20 MDS patients who are refractory or relapsed on HMA (r/r MDS) and have no effective treatment options, continue to show high objective response rate (ORR) at 80%

–      The BEXMAB Phase 1 & 2 MDS patients with prior HMA failure are experiencing an estimated median overall survival (mOS) of approximately 13.4 months currently, compared to the 5-6 months that would typically be expected under standard of care historically

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today provides Interim Phase 2 results of the ongoing BEXMAB trial in myelodysplastic syndrome (MDS) patients that have failed a hypomethylating agent (HMA), also known as relapsed/refractory MDS (r/r MDS). Full analysis of the data will be presented at the 66th American Society of Hematology (ASH) Annual Meeting on 9 December 2024 in San Diego, US .

The initial BEXMAB Phase 2 results have already indicated a high ORR of 79% (11/14) amongst HMA-failed MDS patients treated with a combination of bexmarilimab + azacitidine. There is now a total of 20 HMA-failed MDS patients evaluable for read-out with this novel combination. The treatment has been well tolerated, without any dose-limiting toxicity. The ORR in this otherwise untreatable population is 80% (16/20). Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions. The estimated median overall survival of the 20 r/r MDS patients remains 13.4 months.


In summary, the updated BEXMAB results show very encouraging efficacy and robust treatment benefit for the r/r MDS patients. The detailed efficacy, safety and biomarker results of the 20 r/r MDS patients treated in the BEXMAB trial will be presented at the 66th American Society of Hematology Annual Meeting. The BEXMAB trial is continuing to enroll patients as planned with the next efficacy data readout for the fully recruited BEXMAB trial patients expected around the end of Q1 2025.

Dr. Petri Bono, Chief Medical Officer of Faron, said: “r/r MDS is a life-threatening haematological malignancy with limited treatment options and high unmet medical need. Our updated trial results in r/r MDS further enforces bexmarilimab’s ability to overcome treatment leading to clinically meaningful deep responses. We look forward to sharing the detailed results with the haematology community and discussing these data with health authorities in H1 2025.”

Dr. Juho Jalkanen, Chief Executive Officer of Faron, said: “It is remarkable seeing the ORR continuing to be so strong even as the patient population grows, as it would typically be expected to settle at a lower level. For patients, I believe these results are truly exciting as we take another step closer to providing an additional option for their poorly met treatment needs. With our repeatedly strong data, we are very much looking forward to our continuing discussions with regulatory agencies and partner candidates.”

Faron will be hosting a virtual webinar to discuss the full analysis of data on Tuesday, December 10, 2024 at 16.00 EET/9am ET.

To register for the event visit:  BEXMAB Study Update

The ASH Annual Meeting will take place from 7-10 December 2024, in San Diego, California and virtually. The poster will contain updated clinical data from the trial.

Poster presentation details:

Title:                            Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study

Session Time :                   Monday, 9 December 2024, 6:00 PM – 8:00 PM PST

Session Title:                 Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III

Location:                      San Diego Convention Center, Halls G-H

Lead Authors:               Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki; Dr. Naval Daver, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center

Abstract Number:         4265

The full poster will be available on the Company’s website at https://www.faron.com/investors once presented at ASH.

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an 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 (azacitidine) treatment. 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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.

Shareholders’ Nomination Board

(“Faron” or “the Company”)

 Composition of Faron Pharmaceutical’s Shareholders’ Nomination Board

Company Announcement, 5 November 2024

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces that the following members have been appointed by a meeting of the Company’s five largest shareholders to Faron Pharmaceuticals Oy’s Shareholders’ Nomination Board:

·    Timo Syrjälä, representing himself (Chair)

·    Erkka Kohonen, representing Varma Mutual Pension Insurance Company , and

·    Joonas Haakana, representing UMO Capital

Faron’s Shareholders’ Nomination Board consists of three members, which represent the Company’s shareholders. The Chair of Faron’s Board of Directors, Mr. Tuomo Pätsi, will serve as an expert in the Nomination Board without being a member.

The Shareholders’ Nomination Board prepares and presents proposals to the Annual General Meeting on the number, composition and remuneration of the members of the Board as well as the Chair of the Board of Directors.

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@icrhealthcare.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

About BEXMAB

The BEXMAB study is an 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 (azacitidine) treatment. 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com .

Faron’s Capital Markets Day 2024

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

 Faron’s Capital Markets Day 2024 – BEXMAB follow-up data and update on drug development pipeline, partnering discussions and introducing new Scientific Advisory Board

Company Announcement, 22 October 2024

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherap ies , will host a Capital Markets Day for investors, analysts and media today, Tuesday, 22 October 2024 at 08:00 am (EDT) / 13:00 pm (BST) / 15:00 pm (EEST). Speakers are Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki, Mr. Ralph Hughes, MSc, BSc, Senior Vice President at PharmaVentures and Faron’s senior management members.

BEXMAB Follow Up Data Continue to Indicate High Overall Response Rate

The BEXMAB Phase I/II trial results have already indicated a high overall response rate (ORR) of 79% (11 out 14) amongst relapsed and refractory myelodysplastic syndrome (r/r MDS) patients treated with a combination of bexmarilimab + azacitidine. Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions.

Previously estimated median overall survival (mOS) was approximately 13.4 months with 14 r/r MDS patients and subject to change with longer follow up. Now, after median follow up of 275 days (doubled since May 2024), t he mOS among these 14 r/r MDS patients remains strong at 13.4 months, which is significantly longer than the 5-6 months typically expected with standard care, as reported in the literature. Median time on treatment for r/r MDS in the BEXMAB trial at the moment is 7.9 months, exceeding any prior expectations in this field. The treatment remains well tolerated according to the latest safety follow up.

Previously there were two (2/14) patients who moved on to receive bone marrow transplant and there are now a total of three patients (3/14) who have moved to bone marrow transplant which is seen as the only possibility for curative treatment of r/r MDS.

Business Update / Partnering Discussions


In June 2024, Faron completed a fully subscribed EUR 30.7 million share offering and published its focus areas for 2024:

1.    To obtain regulatory feedback from the USA Food and Drug Administration ( FDA) regarding measures required to obtain regulatory approval in the U.S.

2.    Aim to complete BEXMAB Phase II enrolment.

3.    Aim to conclude a global partnership deal to fund Phase III clinical research and to commercialize bexmarilimab.

4.    To have sufficient funding until the latter half of March 2025, allowing the Company to pursue readiness to move to Phase III in drug development, and in compliance with the financial covenants of the IPF Fund II SCA, SICAV-FIAR’s Facilities Agreement.

In July, Faron obtained positive feedback from the FDA regarding the registrational study plan for bexmarilimab in relapsed and refractory high risk MDS (HR MDS). In August 2024, the FDA granted Fast Track Designation (FTD) for bexmarilimab for the treatment of r/r MDS. Based on the FDA’s guidance, Faron made the decision to recruit additional frontline MDS patients. Full BEXMAB enrolment will include 32 r/r MDS patients and also 20 frontline HR MDS patients. According to the latest enrolment estimate, the BEXMAB trial (including also 20 frontline HR MDS patients) will be fully recruited in January 2025.

Since the fundraise completed in June 2024, Faron has been in dialogue with several partner candidates to fund Phase III development and to commercialize bexmarilimab. These discussions have progressed according to Faron’s expectations. To date, the Company has chosen not yet to enter into a partnership agreement or grant exclusivity to any negotiating party. Faron continues to discuss and evaluate the received terms and their impact diligently. To enable more flexibility in pursuing the best commercial outcome for the Company and its shareholders in continued compliance with the financial covenants and to facilitate availability of high-quality Phase II BEXMAB efficacy data (also observing patient enrolment for full Phase II readout), Faron may, subject to market conditions, consider strengthening its financial position before concluding discussions concerning partnering.

Scientific Advisory Board Renewed

Faron has renewed its Scientific Advisory Board (SAB) to better correspond with the Company’s current drug development pipeline. The new Scientific Advisory Board consists of prestigious and internationally recognized clinical scientists with broad anti-cancer clinical development expertise within haematological neoplasms and solid tumors. The SAB will assist Faron’s management in making significant scientific judgements related to translational activities as well as its clinical portfolio. The members of Faron’s SAB are Dr. Toni Choueiri, Dr. Tom Powles, Dr. Amer Zeidan, Dr. Naval G. Daver, Dr. Mika Kontro and Dr. Christophe Massard.

Toni Choueiri, MD is the Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School, Boston, MA, the Director of the Lank Center for Genitourinary (GU) Oncology and co-leader of the Kidney Cancer Program at Dana-Farber/Harvard Cancer Center. He serves on the US National comprehensive cancer network (NCCN) expert panel. He has over 800 PubMed-indexed publications and is the lead investigator in multiple international phase 1-3 clinical trials in genitourinary cancers. In a series of NEJM articles on which Dr Choueiri was either first or last author, he has made seminal observations leading to multiple FDA and EMA approvals.

Tom Powles, MBBS, MRCP, MD is a professor of urology cancer at the University of London and the Director of Barts Cancer Centre which is one of the UKs largest Cancer Centres. Prof Powles is also editor-in-chief of Annals of Oncology, the leading European oncology scientific journal. He has had a major role in the development of biomarkers and new drug strategies leading to multiple FDA and EMA approvals. He has authored 10 NEJM or Lancet publications with two first author NEJM publications and two first author Nature publications. He was named in December 2023 in TIME’s list among the most influential people in global health.

Amer Zeidan, MD, MBBS, MHS is an Associate Professor of Medicine, Chief of Hematologic Malignancies Division, Director of Hematology Early Therapeutics Research, and leader of the clinical program and the Clinical Research Team for Leukemia and Myeloid Malignancies at Yale Cancer Center. Dr. Zeidan specializes in the management of myeloid malignancies especially MDS and acute myeloid leukemia (AML). His research and clinical care focus on targeting therapies to a patient’s diagnosis and working with their own immune system to counter the malignancies. He has published over 330 peer-reviewed publications and is the principal investigator on numerous phase II and III clinical trials in the areas of acute myeloid leukemia and myelodysplastic syndromes.

Naval G. Daver, MD is a Professor and Director of the Leukemia Research Alliance Program in the Department of Leukemia at MD Anderson Cancer Center (MDACC) in Houston, TX. He is a clinical investigator with a focus on molecular and immune therapies in acute myeloid leukemia (AML) and myeloid disease and is principal investigator on more than 25 ongoing institutional, national, and international clinical trials in these diseases, including multiple registration and label enabling trials. Prof. Daver has published over 400 peer-reviewed manuscripts and is on the editorial board of numerous hemalotology journals.

Mika Kontro, MD, PhD is an adjunct professor and a consultant in clinical hematology at the Helsinki University Hospital Comprehensive Cancer Center. Dr. Mika currently works as K. Albin Johannson Cancer Research Fellow (Finnish Cancer Institute) and as a group leader in Finnish Institute of molecular medicine, FIMM. He has a strong background in running clinical trials and he currently chairs the Finnish AML group and is a board member of the Nordic AML Group.

Christophe Massard, MD, PhD is professor and a Head of Cancer Research at Gustave-Roussy, the first leading cancer hospital in Europe and in the top four in the world.  Dr. Christophe is a member of ESMO, ASCO and AACR and has participated in over 130 trials in the past five years. He has been the principal investigator over the last 10 years of 50 phase 1 trials and co-investigator in more than 100 trialsHis research focuses on early clinical trials and precision medicine. He has published over 100 peer-reviewed publications.

Development Plan for Solid Tumors Progressing

Faron has made significant progress with its development plan regarding bexmarilimab’s future potential in treating solid tumors. In today’s CMD, Faron will present its oncology pipeline for solid tumors to illustrate bexmarilimab’s potential as a first-in-class macrophage reprogrammer in various anti-cancer treatments. In addition, an update on the innovative approaches in improving recognition of tumor cells and preventing immunosuppression will be presented.

Dr. Juho Jalkanen, CEO of Faron, comments:

“As previously communicated, everything is progressing as planned and our focus is to ensure that we are armed with adequate resources to be able to meet our objectives of completing Phase II of the BEXMAB trial and optimizing the outcome of partnering with Phase II data.  The next business decision we make will be   crucial in how the value and future of bexmarilimab is divided. There is more than two decades of hard work behind the development of bexmarilimab, and our job is to see that the maximum potential of bexmarilimab comes to life for both patients and investors.”


Dr. Petri Bono, CMO of Faron, comments:

“We’ve continued to see extremely encouraging data from our ongoing BEXMAB trial, and I am very pleased to see that the data encourage us systematically as we go forward in our solid tumor development pipeline. Our purpose is to establish bexmarilimab as a cornerstone drug for cancers where Clever-1 macrophages are a source of treatment resistance and cancer progression. Now we’ve a world-leading Scientific Advisory Board supporting us, the likes of which I have never seen before, and I am very excited about what future holds.”

Presentation Materials and Webcast

The Capital Markets Day presentation material will be available at https://www.faron.com/investors . The CMD webcast can be followed online at https://faron.videosync.fi/cmd-2024

For more information please contact:

ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an 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 (azacitidine) treatment. 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com .

Forward-Looking Statements

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Faron Appoints Dr. Petri Bono as new CMO

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Faron Appoints Dr. Petri Bono as new CMO

Company announcement, 6 August 2024 at 8:30 a.m. BST / 10:30 a.m. EEST

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in treatment resistant hematological malignancies and solid tumors, is pleased to announce the appointment of Dr. Petri Bono (M.D., Ph.D.) as the new Chief Medical Officer (CMO) starting the 15th of August.

Previously Dr. Bono has served as the Chief Medical Officer and member of the Group executive team of Terveystalo, the largest private healthcare service provider in Finland. Prior to Terveystalo he was the Chief Medical Officer at Helsinki University Hospital. In addition to being Associate Professor of Cancer Biology at University of Helsinki, Dr. Bono has held various leadership positions within Helsinki University Hospital, including as the Director and Physician-in-Chief of the Comprehensive Cancer Center. Dr. Bono has participated in numerous oncology trials from Phase 1 to 3, including early phase immuno-oncological trials and published 102 peer reviewed papers in international journals including New England Journal of Medicine, Lancet Oncology, JAMA as well as Cancer Cell.

Dr. Bono’s own research has been focusing on molecular and immunological oncology. Given his translational and clinical studies in targeted therapies and applied immunology, he is uniquely suited to support Faron’s immuno-oncology program to tackle cancers via novel myeloid cell targeting immunotherapies that will bring the promise of immunotherapy to much broader patient populations, especially in the solid tumors space. 

Bexmarilimab is an exceptional asset. It is an industry-leading agent in macrophage re-programming and has wide applicability in the treatment of a variety of cancers. Macrophages remain a key source of treatment resistance in solid tumors and in many instances bexmarilimab has shown it can induce responses and overcome this resistance. I am thrilled to develop further Faron’s novel and innovative immunotherapy program, and make bexmarilimab a cornerstone of future cancer care”, says Dr. Bono the in-coming CMO of Faron.

“We are delighted to have such an experienced and proactive oncologist join us as the new CMO”, says Dr. Juho Jalkanen, CEO of Faron . “This especially strengthens us in respect to our up-coming expansion plans into solid tumors, as we expect to benefit from the experience and broader shoulders of a partner for late-stage development in hematology. This means maximizing our expertise and development capabilities in both solid tumors and hematological malignancies using a mix of internal know-how and strategic partnerships to generate broader value for both patients and investors.”

Dr. Birge Berns, the acting CMO seconded from tranScrip Ltd. will continue her role as part of the medical leadership involved in developing bexmarilimab. “We are very grateful for tranScrip and Dr. Berns’ services and look forward to continuing this partnership. Dr. Berns has had a vital role in our success with the FDA and bringing Bexmarilimab to where it is today., She will continue to have an important role in shaping our development and regulatory strategy as we go forward”, continues Dr. Jalkanen.

For more information please contact:

Investor Contact

Faron Pharmaceuticals
E-mail: investor.relations@faron.com

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 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 (azacitidine) treatment. 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 Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com .

Forward-Looking Statements

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully license its programs within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Faron Announces Positive FDA Feedback

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Inside Information: Faron Announces Positive FDA Feedback

Company announcement, Inside Information, 11 July 2024 at 7:00 a.m. BST / 9:00 a.m. EEST

Key highlights

–       Faron had a formal meeting with the FDA to discuss the registrational clinical development plan for bexmarilimab in the treatment myelodysplastic syndrome (MDS).

–       The FDA acknowledged the difficulties of running a randomized study with a comparator in the relapsed / refractory setting (r/r) and instead proposed that Faron conduct a confirmatory Phase III study in frontline high-risk MDS (HR MDS), that would not require a separate Phase III in r/r MDS.

–      This FDA guidance is part of Project Frontrunner, an initiative intended to bring promising new cancer treatments as early as possible to a broader patient population.

–       The Phase III suggested by the FDA targets a significantly larger patient population with potential for faster approval earlier than anticipated, speeding up and increasing our sales forecast for bexmarilimab.

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today provides information on the result of its formal Type D Scientific Advice Meeting with the USA Food and Drug Administration (the FDA) regarding the registrational study plan for its drug candidate bexmarilimab in relapsed and refractory high risk MDS (r/r MDS).

Given the previously reported promising results of treating r/r MDS using a combination of bexmarilimab + azacitidine to overcome primary or developed resistance to azacitidine, Faron had proposed to move into a randomized registrational Phase III study for the treatment of r/r MDS using bexmarilimab + azacitidine against the investigator’s choice of a hypomethylating agent (HMA). Instead, given the encouraging efficacy already seen in both frontline and r/r HR MDS and the well-established safety profile of bexmarilimab, the FDA proposed that after the ongoing Phase II BEXMAB study in r/r MDS, Faron should move directly into a registrational blinded randomized frontline HR MDS study investigating bexmarilimab + azacitidine against placebo + azacitidine. The FDA noted that given the relatively modest efficacy of single agent azacitidine and the current response rates with bexmarilimab that the size of such a frontline study may not have to be substantially larger than the proposed study in the r/r setting.

Further, the FDA suggested such a frontline study could be seen in the context of FDA’s Project Frontrunner. Project FrontRunner is an FDA Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to develop and seek approval of promising new cancer drugs for advanced diseases in an earlier clinical setting, rather than the usual approach to develop and seek approval of a new drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. The FDA guidelines give different possible approval strategies to sponsors, including the conduct of a frontline trial supporting an accelerated approval in the r/r settings. Project FrontRunner | FDA

Subject to continued positive results, the FDA’s feedback means that a separate Phase III in r/r MDS would not be required and Faron’s ongoing BEXMAB Phase II study could be the registrational trial for patients with r/r MDS, given that the benefit of bexmarilimab + azacitidine against azacitidine alone will be confirmed in an interim read-out of the response rate from a Phase III in frontline HR MDS study. Accelerated approval for frontline HR MDS would come from the response rate of this single Phase III study and the full approval from the survival read-out of the same study.

“Faron is now adjusting its development plan accordingly”, says Dr. Juho Jalkanen, Chief Executive Officer of Faron . “This is very positive feedback and exceeds our expectations. The FDA’s proposal significantly reduces development costs and timelines to bring bexmarilimab therapy to all HR MDS patients. This feedback underlines that the FDA sees the high unmet need in HR MDS, a condition for which new treatment options are urgently needed. The FDA’s proposal has provided Faron with clear guidance on the path to approval that will confirm the highly encouraging results bexmarilimab has already obtained in overcoming resistance to azacitidine. We are extremely grateful for this feedback and will work hard to deliver on this recommendation.”

“The suggested Phase III targets a significantly bigger patient population sooner than anticipated, speeding up and increasing our sales forecast for bexmarilimab. This does not significantly impact our ongoing activities and cash runway, as the Phase II in r/r MDS continues as planned. In addition, we will enroll more frontline HR MDS patients into the Phase I part of BEXMAB to better understand the effect size, which will enable us to successfully power and design the proposed frontline Phase III study. We believe we can offset this additional clinical investment through other savings, so that it will not have a significant impact on our cash runway. The only deviation from the original plan is that instead of a Phase III in r/r MDS, we will start preparations for a Phase III in frontline HR MDS, which is a remarkable achievement.”, continues Dr. Jalkanen.

Faron will be hosting a virtual webinar to discuss the FDA feedback and updated clinical development plans July 15th, at 15.00 EEST / 13.00 BST.

To register for the event visit: https://faron.videosync.fi/fda-feedback-update or contact the IR team for more information at investor.relations@faron.com .

For the purposes of MAR and UK MAR, the person responsible for arranging for the release of this announcement on behalf of Faron is Juho Jalkanen, Chief Executive Officer.

For more information please contact:

Investor Contact
Faron Pharmaceuticals
E-mail: investor.relations@faron.com

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 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 (azacitidine) treatment. 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 Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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.

New shares registered with Finnish Trade Register

Faron Pharmaceuticals Ltd

(“Faron” or the “Company“)

New shares of Faron registered with the Finnish Trade Register

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND OR THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO ACQUIRE ANY SECURITIES. PLEASE SEE THE IMPORTANT NOTICES AT THE END OF THIS ANNOUNCEMENT.

Company announcement, 20 June 2024 at 3pm (EEST) / 1pm (BST) / 8am (EDT)

TURKU, FINLAND  – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, announced earlier today results of the share offering (the “Offering“) and the issuance of a total of 30,709,056 newly issued treasury shares and new shares in the Company in the Offering, as well as the issuance of 308,158 new shares to certain subscription guarantors in the Offering and the issuance of 1,600,153 new shares to investors who participated in the private placement announced on 4 April 2024 (together the “New Shares“), as well as the registration of the first part of the New Shares, i.e. a total of 20,727,359 shares to Faron itself without consideration, to be further conveyed to institutional investors and in the UK offerings.

Faron announces that also the remaining 11,890,008 New Shares have now been registered with the Trade Register maintained by the Patent and Registration Office. These New Shares are issued to private individuals and legal entities in Finland in the public offering, to lenders of the convertible capital loans, and to subscription guarantors.

Following the completion of the registrations, the total number of registered shares in Faron is 104,624,864. The New Shares together account for approximately 45.3 per cent of the Company’s outstanding shares and votes prior to the Offering and 31.2 per cent following the Offering.

As previously announced, the New Shares will be recorded on investors’ book-entry accounts on or about 24 June 2024. The first part of the New Shares has been registered first as treasury shares of the Company and will be recorded upon their conveyance on investors’ book-entry accounts (delivery against payment) and, as applicable, settled as DIs in the UK open offer and the REX retail offer on or about 24 June 2024. No shares will be held in treasury.

Applications will be made for the admission to trading of the New Shares on the Nasdaq First North Growth Market Finland (“First North“) maintained by Nasdaq Helsinki Ltd (“Nasdaq Helsinki“) under the current trading code “FARON”, and on AIM (“AIM“), the market of that name operated by London Stock Exchange plc under the trading code “FARN”. Trading in the New Shares is expected to commence on or around 10:00 a.m. EEST / 8:00 a.m. BST on 24 June 2024 subject to the admission of the New Shares to trading on First North and AIM.

Faron Pharmaceuticals Ltd

For more information please contact:

ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an 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 (azacitidine) treatment. 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) state, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com .

Important notice

This announcement is not an offer of securities for sale into the United States. The Offer 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 Offer Shares in the United States or to make a public offering in the United States. Any sale of the Offer Shares in the United States will be made solely to a limited number of “qualified institutional buyers” or accredited investors, each as defined in Rule 144A in reliance on an exemption from the registration requirements of the Securities Act.

The distribution of this release may be restricted by law and persons into whose possession any document or other information referred to herein comes should inform themselves about and observe any such relevant legal restrictions. The information contained herein is not for publication or distribution, directly or indirectly, in or into the United States, Australia, Canada, Japan, New Zealand or the Republic of South Africa. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such aforementioned jurisdiction. This release is not directed to, and is not intended for distribution to or use by, any person or entity that is a citizen, resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would violate law or regulation or which would require any registration or licensing within such jurisdiction.

In any European Economic Area Member State, other than Finland, this release is only addressed to and is only directed at “qualified investors” in that Member State within the meaning of Article 2(e) of Regulation (EU) 2017/1129 (the “Prospectus Regulation“).

In the United Kingdom, this release is only being distributed to and is only directed at “qualified investors” within the meaning of Article 2(e) of the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation“) who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order“) or (ii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “UK Relevant Persons“). Any investment activities to which this announcement relates will only be available to and will only be engaged in with UK Relevant Persons. Any person who is not a UK Relevant Person should not act or rely on this release or any of its contents.

This release does not constitute a prospectus as defined in either the Prospectus Regulation or the UK Prospectus Regulation and, as such, it does not constitute or form part of, and should not be construed as, an offer to sell, or a solicitation or invitation of any offer to buy, acquire or subscribe for, any securities or an inducement to enter into investment activity in relation to any securities.

No part of this release, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. The information contained in this release has not been independently verified. No representation, warranty or undertaking, expressed or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein. The Company or any of its respective affiliates, advisors or representatives or any other person, shall have no liability whatsoever (in negligence or otherwise) for any loss, however arising from any use of this release or its contents or otherwise arising in connection with this release. Each person must rely on their own examination and analysis of the Company, its subsidiaries, its securities and the transactions, including the merits and risks involved.

Carnegie Investment Bank AB, Finland Branch and Peel Hunt LLP are acting as lead managers (the “Lead Managers“) and bookrunners for the Offering. The Lead Managers are acting exclusively for the Company and no one else in connection with the Offering. They will not regard any other person as their respective client in relation to the Offering. The Lead Managers will not be responsible to anyone other than the Company for providing the duties afforded to their respective clients, nor for giving advice in relation to the Offering or any transaction or arrangement referred to herein.

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 Company’s current expectations and assumptions regarding the completion and use of proceeds from the Offering, 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 Company’s current beliefs and assumptions and are based on information currently available to the Company.

A number of factors could cause actual results to differ materially from the results and expectations dis-cussed 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 Company believes 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.

Proposed REX Retail Offer

THIS ANNOUNCEMENT IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR WITHIN THE UNITED STATES OR THE DISTRICT OF COLUMBIA (COLLECTIVELY THE “UNITED STATES”), AUSTRALIA, CANADA, NEW ZEALAND, SOUTH AFRICA OR JAPAN, OR ANY MEMBER STATE OF THE EUROPEAN ECONOMIC AREA (THE “EEA”), OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

 

THIS ANNOUNCEMENT AMOUNTS TO A FINANCIAL PROMOTION FOR THE PURPOSES OF SECTION 21 OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (“FSMA”) AND HAS BEEN APPROVED BY PEEL HUNT LLP WHICH IS AUTHORISED AND REGULATED BY THE FINANCIAL CONDUCT AUTHORITY (FRN 530083). THIS IS A FINANCIAL PROMOTION AND IS NOT INTENDED TO BE INVESTMENT ADVICE.

 

 

Faron Pharmaceuticals Ltd

 

(“Faron” or the Company“)

 

Proposed REX Retail Offer

 

Company announcement, 5 June 2024 at 10:00 a.m. (EEST) / 8:00 a.m. (BST) / 3:00 a.m. (EDT)

 

Key Highlights

 

  • Faron will conduct an offer to retail investors in the United Kingdom on the “REX” platform. The REX Offer (as defined below) is part of an Offering (as defined below) raising approximately EUR 30.7 million. Details of the Offering can be found in the Company’s announcement dated 4 June 2024 and available on the Company’s website at www.faron.com/investors/publicoffer.

 

TURKU, FINLAND – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces its intention to raise funds by means of a proposed retail offer via the Retail Capital Markets ‘REX’ portal (the “REX Offer“) of ordinary shares (“Ordinary Shares“) in the capital of the Company (the “REX Offer Shares“).

 

The Company is conducting the Offering to raise approximately EUR 30.7 million in total through the issue of up to 30,714,592 Ordinary Shares (the “Offer Shares“) at a subscription price of EUR 1 per Offer Share (or GBP 0.85 per Offer Share in respect of the UK Open Offer and the REX Offer) by way of:

  • a public offering of Offer Shares to private individuals and legal entities in Finland (the “Public Offering“);
  • an institutional offering of Offer Shares to institutional investors in the European Economic Area and, in accordance with applicable laws, internationally (the “Institutional Offering“);
  • an open offer to qualifying holders of depositary interests in the United Kingdom (the “UK Open Offer“); and
  • the REX Offer (together with the Public Offering, the Institutional Offering and the UK Open Offer, the “Offering“).

The price of the REX Offer Shares is 85 pence per REX Offer Share (the “Offer Price“), which is the same issue price as for the UK Open Offer and is equivalent to the EUR 1 subscription price of the Public Offering and the Institutional Offering based on an exchange rate of GBP 1 : EUR 1.1714 on 31 May 2024. The Offer Price represents a 54 per cent. discount to the closing price of the Ordinary Shares on 31 May 2024 (being the latest practicable date prior to the announcement of the Offering dated 4 June 2024). The aggregate gross proceeds of the REX Offer and the UK Open Offer shall not exceed £6.8 million (the GBP equivalent of EUR 8 million based on an exchange rate of GBP 1 : EUR 1.1714 on 31 May 2024).

 

For the avoidance of doubt, the REX Offer is not part of the Public Offering, Institutional Offering or the UK Open Offer.

 

REX Offer

 

The REX Offer is conditional upon, among other things:

 

  1. completion of the Public Offering, Institutional Offering and the UK Open Offer;

 

  1. the REX Offer Shares being admitted to trading on AIM, the market of that name operated by London Stock Exchange plc, and Nasdaq First North Growth Market Finland of Nasdaq Helsinki Ltd (Admission“). Admission is expected to take place at or around 8.00 a.m. on 24 June 2024.

  

The Company values its retail shareholder base in the United Kingdom and believes that it is appropriate to provide retail investors in the United Kingdom the opportunity to participate in the current fundraising.

 

Therefore, the Company is making the REX Offer open to eligible investors in the United Kingdom following release of this announcement through certain financial intermediaries.

 

Investors should contact their broker or wealth manager to participate in the REX Offer.

 

The REX Offer is expected to close at or around 7:30 a.m. on 19 June 2024. Investors should note that financial intermediaries may have earlier closing times.

 

At the time of this announcement the following intermediaries have confirmed their participation in the REX Offer:

 

  • AJ Bell
  • interactive investor

 

Retail brokers wishing to participate in the REX Offer on behalf of retail investors, should contact info@rexretail.com.

 

To be eligible to participate in the REX Offer, applicants must be a customer of a participating intermediary, which may include individuals aged 18 years or over, companies and other bodies corporate, partnerships, trusts, associations and other unincorporated organisations.

  

There is a minimum subscription of £50 per investor. The terms and conditions on which investors subscribe will be provided by the relevant financial intermediaries, including relevant commission or fee charges.

 

The Company reserves the right in its absolute and sole discretion to: (i) scale back any order under the REX Offer; and (ii) reject any application for subscription under the REX Offer without giving any reason for such rejection.

 

Allocations under the REX Offer are expected to be in keeping with the principle of soft pre-emption, subject to the Company’s discretion.

 

It is vital to note that once an application for REX Offer Shares has been made and accepted via an intermediary, it cannot be withdrawn.

 

The REX Offer Shares, when issued, will be credited as fully paid and will rank pari passu in all respects with the Company’s then existing Ordinary Shares, including the right to receive all dividends and other distributions declared, made or paid in respect of such shares after the date of issue.

 

It is a term of the REX Offer that the aggregate total value of the Offer Shares to be allotted and issued pursuant to the REX Offer and the UK Open Offer does not exceed £6.8 million (the GBP equivalent of EUR 8 million based on an exchange rate of GBP 1 : EUR 1.1714 on 31 May 2024). Allocations under the REX Offer will be scaled back, as necessary, to ensure that the total aggregate consideration under the REX Offer and the UK Open Offer will not exceed this amount.

 

The REX Offer is being made in the United Kingdom under the exemption from the requirement to publish a prospectus in section 86(1)(e) of FSMA. As such, there is no need for publication of a prospectus pursuant to the Prospectus Regulation Rules of the Financial Conduct Authority, or for approval of the same by the Financial Conduct Authority. The REX Offer is not being made into any jurisdiction other than the United Kingdom.

 

No offering document, prospectus or admission document has been or will be prepared or submitted to be approved by the Financial Conduct Authority (or any other authority) in relation to the REX Offer, and investors’ commitments will be made solely on the basis of the information contained in this announcement and information that has been published by or on behalf of the Company prior to the publication of this announcement by notification to a Regulatory Information Service in accordance with the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules, the Market Abuse Regulation (EU Regulation No. 596/2014) (“MAR“) and MAR as assimilated into United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 (as amended).

  

Investors should make their own investigations into the merits of an investment in the Company. Nothing in this announcement amounts to a recommendation to invest in the Company or amounts to investment, taxation or legal advice. In relation to the Public Offering, the Institutional Offering and the UK Open Offer, please refer to Company’s announcement on 4 June 2024, published at 7:00 a.m (BST), and materials available on the Company’s website www.faron.com/investors/publicoffer 

It should be noted that a subscription for REX Offer Shares and investment in the Company carries a number of risks. Investors should take independent advice from a person experienced in advising on investment in securities such as the REX Offer Shares if they are in any doubt.

 

An investment in the Company will place capital at risk. The value of your investment in the Company and any income from it is not guaranteed and can fall as well as rise due to stock market and currency movements. When you sell your investment, you may get back less than the amount originally invested.

 

Neither past performance nor any forecasts should be considered a reliable indicator of future results.

 

For Further Information

 

Investor Contact

 

ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.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

 

 

 

REX Retail

 

 

Info@rexretail.com

 

Further information on the Company can be found on its website at www.faron.com.

 

The Company’s LEI is 7437009H31TO1DC0EB42.

 

This announcement should be read in its entirety. In particular, the information in the “Important Notices” section of this announcement should be read and understood.

 

Important Notices

 

The content of this announcement has been prepared by and is the sole responsibility of the Company.

 

 

THIS ANNOUNCEMENT IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR WITHIN THE UNITED STATES OR THE DISTRICT OF COLUMBIA (COLLECTIVELY THE UNITED STATES), AUSTRALIA, CANADA, NEW ZEALAND, SOUTH AFRICA OR JAPAN, OR ANY MEMBER STATE OF THE EUROPEAN ECONOMIC AREA (THE EEA), OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

 

No action has been taken by the Company or any person acting on its behalf or any of its or their affiliates that would permit an offer of the REX Offer Shares or possession or distribution of this announcement or any other offering or publicity material relating to such REX Offer Shares in any jurisdiction where action for that purpose is required. Persons into whose possession this announcement comes are required to inform themselves about, and to observe, such restrictions.

 

This announcement is not for publication or distribution, directly or indirectly, in or into the United States of America.  The REX Offer Shares have not been and will not be registered under the US Securities Act of 1933, as amended (the “US Securities Act“) or under the applicable state securities laws of the United States and may not be offered or sold directly or indirectly in or into the United States, except pursuant to an applicable exemption from registration. No public offering of the REX Offer Shares is being made in the United States. The REX Offer Shares are being offered and sold outside the United States in “offshore transactions”, as defined in, and in compliance with, Regulation S under the US Securities Act (“Regulation S“). In addition, the Company has not been, and will not be, registered under the US Investment Company Act of 1940, as amended.

 

The REX Offer has not been approved or disapproved by the US Securities and Exchange Commission, any state securities commission in the United States or any United States regulatory authority, nor have any of the foregoing authorities passed upon or endorsed the merits of the Institutional Offering, the UK Open Offer, the Public Offering or REX Offer, or the accuracy or adequacy of this announcement. Any representation to the contrary is a criminal offence in the United States.

 

This announcement or any part of it does not constitute an offer to sell or issue or a solicitation of an offer to buy or subscribe for REX Offer Shares in the United States, Australia, Canada, New Zealand, Japan, the Republic of South Africa, any member state of the EEA or any other jurisdiction in which such offer or solicitation is or may be unlawful. No public offer of the REX Offer Shares referred to herein is being made in any such jurisdiction.

 

The distribution of this announcement may be restricted by law in certain jurisdictions and persons into whose possession any document or other information referred to herein comes should inform themselves about and observe any such restriction. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction.

 

REX is a proprietary technology platform owned and operated by Peel Hunt LLP (registered address at 7th Floor, 100 Liverpool Street, London EC2M 2AT; FRN 530083). Peel Hunt LLP (“Peel Hunt“) is authorised and regulated in the United Kingdom by the Financial Conduct Authority, is acting exclusively for the Company and for no-one else and will not regard any other person (whether or not a recipient of this announcement) as its client in relation to the REX Offer and will not be responsible to anyone other than the Company for providing the protections afforded to its clients, nor for providing advice in connection with the REX Offer, Admission and the other arrangements referred to in this announcement.

 

The value of Ordinary Shares and the income from them is not guaranteed and can fall as well as rise due to stock market and currency movements. When you sell your investment, you may get back less than you originally invested. Figures refer to past performance and past performance is not a reliable indicator of future results. Returns may increase or decrease as a result of currency fluctuations.

 

Certain statements in this announcement are forward-looking statements which are based on the Company’s expectations, intentions and projections regarding its future performance, anticipated events or trends and other matters that are not historical facts. These forward-looking statements, which may use words such as “aim”, “anticipate”, “believe”, “intend”, “estimate”, “expect” and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks, assumptions and uncertainties that could cause the actual results of operations, financial condition, liquidity and dividend policy and the development of the industries in which the Company’s businesses operate to differ materially from the impression created by the forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Given those risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements.

 

These forward-looking statements speak only as at the date of this announcement and cannot be relied upon as a guide to future performance. The Company and Peel Hunt expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein to reflect actual results or any change in the assumptions, conditions or circumstances on which any such statements are based unless required to do so by the Financial Conduct Authority, the London Stock Exchange plc or applicable law.

 

The information in this announcement is for background purposes only and does not purport to be full or complete. Neither Peel Hunt nor any of its affiliates, accepts any responsibility or liability whatsoever for, or makes any representation or warranty, express or implied, as to this announcement, including the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to the Company or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of the announcement or its contents or otherwise arising in connection therewith. Peel Hunt and its affiliates, accordingly disclaim all and any liability whether arising in tort, contract or otherwise which they might otherwise be found to have in respect of this announcement or its contents or otherwise arising in connection therewith.

 

Any indication in this announcement of the price at which the Ordinary Share have been bought or sold in the past cannot be relied upon as a guide to future performance. Persons needing advice should consult an independent financial adviser. No statement in this announcement is intended to be a profit forecast and no statement in this announcement should be interpreted to mean that earnings or target dividend per share of the Company for the current or future financial years would necessarily match or exceed the historical published earnings or dividends per share of the Company.

 

Neither the content of the Company’s website (or any other website) nor the content of any website accessible from hyperlinks on the Company’s website (or any other website) is incorporated into or forms part of this announcement. The REX Offer Shares to be issued or sold pursuant to the REX Offer will not be admitted to trading on any stock exchange other than the AIM market of the London Stock Exchange plc.

Faron commences a share offering

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Inside Information: Faron commences a share offering of preliminarily a maximum of 30,714,592 Offer Shares at a subscription price of EUR 1.00 per Offer Share and publishes a prospectus

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND OR THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

 

THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO ACQUIRE ANY SECURITIES. PLEASE SEE THE IMPORTANT NOTICES AT THE END OF THIS ANNOUNCEMENT.

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS IT FORMS PART OF DOMESTIC LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”). IN ADDITION, MARKET SOUNDINGS (AS DEFINED IN MAR AND UK MAR) WERE TAKEN IN RESPECT OF THE TRANSACTION WITH THE RESULT THAT CERTAIN PERSONS BECAME AWARE OF INSIDE INFORMATION (AS DEFINED IN MAR AND UK MAR), AS PERMITTED BY MAR AND UK MAR. THIS INSIDE INFORMATION IS SET OUT IN THIS ANNOUNCEMENT. THEREFORE, THOSE PERSONS THAT RECEIVED INSIDE INFORMATION IN A MARKET SOUNDING ARE NO LONGER IN POSSESSION OF SUCH INSIDE INFORMATION RELATING TO THE COMPANY AND ITS SECURITIES.

 

Company announcement, 4 June 2024 at 9:00 (EEST) / 7:00 (BST) / 2:00 AM (EDT)

Inside information

 

Key highlights

 

  • Faron announces an offering of approximately EUR 30.7 million in total by offering for subscription preliminarily a maximum of 30,714,592 new and/or treasury shares (the “Offer Shares”) at a subscription price of EUR 1.00 per Offer Share (the “Subscription Price”) (the “Offering”).
  • The Offering will be conducted as a directed share issue by way of (i) a public offering to private individuals and legal entities in Finland (the “Public Offering”) and (ii) an institutional offering to institutional investors in the European Economic Area and, in accordance with applicable laws, internationally (the “Institutional Offering”). Moreover, there will be  (a) a separate open offer to qualifying holders of depositary interests in the United Kingdom and elsewhere (the “UK Open Offer”); and (ii) a separate retail offer to retail investors in the United Kingdom on the “REX” platform (the “REX Retail Offer”), through which a part of the amount of proceeds sought by the Company in the Offering may be raised.
  • The objective of the Offering is to strengthen the Company’s cash position so that the Company would have sufficient funding to reach its key milestones for the year 2024, i.e. a significant commercial partnership agreement and to finance the Company’s product development costs until the latter half of March 2025, that mainly include the production and research costs in respect of the Company’s lead program bexmarilimab. If the Company succeeds in completing the Offering of approximately EUR 30.7 million, the Company believes it would have sufficient resources to execute its core business and deliver on its key milestones of the year 2024 under the current business plan and in compliance with the financial covenants of the facilities agreement entered into with IPF FUND II SCA, SICAV-FIAR (“IPF”) (the “IPF Facilities Agreement”) until the latter half of March 2025.
  • The Offering is conditional upon the Company raising at least EUR 15 million in gross proceeds. The Company has obtained:
    • binding subscription commitments in the aggregate amount of approximately EUR 6.2 million (the “Subscription Commitments”); and
    • binding subscription guarantee undertakings whereby the subscription guarantors have undertaken to subscribe for any new shares of the Company not subscribed for in the Offering in an aggregate amount of up to EUR 8.8 million, as described below (the “Subscription Guarantee Undertakings”). The Subscription Guarantee Undertakings are limited to cover any unsubscribed new shares in the Company up to the minimum gross proceeds of the Offering of EUR 15 million.
  • Based on the binding Subscription Commitments and Subscription Guarantee Undertakings received by the Company, the condition of raising at least EUR 15 million in gross proceeds has been fulfilled.
  • The subscription period for the Offer Shares will commence on 5 June 2024 at 10:00 a.m. Finnish time and end on 18 June 2024 at 4:00 p.m. Finnish time for the Public Offering and on 19 June 2024 at 9:30 a.m. Finnish time for the Institutional Offering (the “Subscription Period”).
  • The Subscription Price in the Offering has been determined on market terms, based on feedback received from the market in advance and investors’ price indications, and it includes a significant discount to the market price of the Company’s shares prior to the announcement of the Offering. No subscription rights will be issued in the Offering, and therefore cannot be subject to public trading. The Offering dilutes current shareholders’ ownership share in the Company, unless the current shareholders subscribe for the Offer Shares in the Offering. 
  • The Offering can be completed even if it is not subscribed in full, in which case the Company’s funding would not be sufficient to deliver on the Company’s key milestones of the year 2024 in accordance with the current business plan and it would have to adjust and reduce its operations and negotiate changes to its terms of payment or negotiate new amendments to its financial covenants and seek additional funding earlier than currently planned.
  • Carnegie Investment Bank AB, Finland Branch (“Carnegie”) and Peel Hunt LLP (“Peel Hunt”) are acting as lead managers (the “Lead Managers”) and bookrunners for the Offering. Carnegie is not participating in arranging the UK Open Offer or the REX Retail Offer and Peel Hunt is not participating in arranging the UK Open Offer.
  • The Company has prepared a Finnish language prospectus, which will be available on the Company’s website at www.faron.com/osakeanti and on Nordnet Bank AB’s website at www.nordnet.fi/faron no later than 4 June 2024. An unofficial English language translation of the prospectus will be available on the Company’s website at www.faron.com/publicoffer no later than 4 June 2024.

 

TURKU, FINLAND – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces that it will commence a share offering. The aim of the Company is to strengthen its cash position so that the Company would have sufficient funding to reach its key milestones for the year 2024, i.e. to reach a significant commercial partnership agreement and to finance its product development costs until the latter half of March 2025, that mainly include the production and research costs in respect of the Company’s lead program bexmarilimab.

 

Based on the authorisations granted at the annual general meetings of the Company on 5 April 2024 and 24 March 2023, the Board of Directors of the Company has resolved on 3 June 2024 on terms for the Offering of approximately EUR 30.7 million in total by offering for subscription preliminarily up to 30,714,592 Offer Shares. The Board of Directors of the Company may, in the event of an oversubscription, increase the number of Offer Shares offered in the Offering by a maximum of 8,000,000 Offer Shares (the “Upsize Option”). If the Upsize Option is used in full, the number of Offer Shares offered shall amount up to 38,714,592 shares of the Company in aggregate.

 

 

The Offering in brief:

 

  • The Company is offering for subscription preliminarily up to 30,714,592 Offer Shares in the Offering comprising the Public Offering and the Institutional Offering.
  • The Subscription Price, EUR 1.00 per Offer Share, has been determined on market terms, based on feedback received from the market in advance and investors’ price indications, and it includes a significant discount to the market price prior to the announcement of the Offering. The Company’s Board of Directors has confirmed the Subscription Price based on negotiations between the Company, the Lead Managers, and several potential investors regarding the investors’ prerequisites to participate in the Offering in a manner enabling its completion, and the pricing of the Offering, taking into account the Company’s financial situation and the uncertainty regarding the continuation of the Company’s operations.
  • The Subscription Price corresponds to a discount of approximately 58 per cent compared to the closing price of the Company’s current share EUR 2.36, a discount of approximately 61 per cent compared to EUR 2.57, i.e. the 30 days volume-weighted average trading price of the Company’s share, and a discount of approximately 49 per cent compared to EUR 1.98, i.e. the 90 days volume-weighted average trading price of the Company’s share on the First North marketplace on the trading day immediately preceding the decision on the Offering 31 May 2024.
  • In the Public Offering, the Subscription Price shall be paid in euros. In the Institutional Offering, the Subscription Price shall be paid in euros and/or by way of setting off the principal, any accrued interest and any unpaid arrangement fees relating to convertible capital loan instruments issued by the Company to certain investors in March 2024 (the “Capital Loans”).
  • Based on the binding Subscription Commitments and Subscription Guarantee Undertakings received by the Company, the condition of gross proceeds of at least EUR 15 million has been fulfilled.
  • In the Public Offering, the minimum subscription is 750 Offer Shares and the maximum subscription is 99,999 Offer Shares. The minimum subscription in the Institutional Offering is 100,000 Offer Shares. Multiple subscriptions by the same investor shall be combined into one single subscription, subject to the aforementioned maximum and minimum subscription amounts.
  • In the Public Offering, Offer Shares are offered for subscription to individuals and legal entities in Finland. Investors whose permanent address or domicile is in Finland and who subscribe Offer Shares in Finland may participate in the Public Offering.

 

  • The Company aims to raise through the Offering a total of approximately EUR 30.7 million, of which amount, approximately EUR 3.7 million will be paid by converting the Company’s Capital Loans and related arrangement fees and interests into shares in the Company, gross proceeds of approximately EUR 27 million, and net proceeds of approximately EUR 23 million.
  • If the Company succeeds in completing the Offering of approximately EUR 30.7 million, the Company believes it would have sufficient resources to execute its core business and deliver on its key milestones for the year 2024 under the current business plan and in compliance with the financial covenants of IPF’s Facilities Agreement until the latter half of March 2025.
  • The Company will likely complete the Offering even though its targeted amount would not be reached. In such situation, the Company’s funding would not be sufficient to deliver on all of the Company’s key milestones for the year 2024 in accordance with the current business plan and the Company would have to seek additional funding earlier than currently planned to fulfil its current financing needs and financial covenants included in the IPF Facilities Agreement. The financial scenarios have been described below in more detail (see “Reasons for the Offering and use of proceeds; Scenarios for the outcome of the Offering”).
  • The structure of the Offering as a directed share issue rather than a rights issue is due to the challenges involved due to the admission of the Company’s Shares to trading on AIM and the post-Brexit regulatory environment. The structure and reasons for it have been described in the notice of the Annual General Meeting 2024 when seeking the share issue authorisation for the Board.  No subscription rights will be issued in the Offering, and therefore cannot be subject to public trading due to which the current shareholders of the Company cannot receive compensation typical of a rights issue for the sale of subscription rights in the Offering.
  • For the Company to be able to strengthen its financial position, secure the continuation of its operations and create preconditions for delivering on its key milestones for the year 2024 described above in accordance with its current business plan, the Board of Directors of the Company considers that there is a weighty financial reason for the Company to deviate from the shareholders’ pre-emptive subscription right.
  • The Offer Shares issued in the Offering (without the Upsize Option) amount to approximately 42.7 per cent of the shares and votes in the Company prior to the Offering and approximately 29.9 per cent of the shares and votes in the Company following the Offering. The number of outstanding shares in the Company may be increased by a maximum of 41,371,666 shares (i.e. to a total maximum of 113,379,163 shares) when the Upsize Option is exercised in full, the Free Shares (as defined below) are issued as a result of the completion of the Offering as well as assuming that all subscription guarantors would decide to receive their subscription guarantee fee in Shares instead of euros. This would result in approximately 36.5 per cent dilution of the total shareholding of current shareholders.
  • The lenders of the Capital Loans have agreed, pursuant to the terms of the Capital Loans, to convert principal, any accrued interest and any unpaid arrangement fees relating to Capital Loans in the total aggregate amount of EUR 3.7 million into Offer Shares in the Offering, corresponding to approximately 3,714,592 Offer Shares and representing approximately 12 per cent of the aggregate number of the Offer Shares (assuming that the Upsize Option is not used).
  • The Company has committed to issue investors who participated in the private placement announced on 4 April 2024 new shares primarily through a free issue (“Free Shares”), so that the subscription price of the private placement (EUR 1.50 per share) would be equal to the subscription price of a public offer or other share issue that may have been completed with a lower subscription price (or that it will make a corresponding compensation in another way). As the Subscription Price in the Offering is EUR 1.0 per Offer Share, the Company would issue 1,600,153 Free Shares in total.
  • The Board of Directors decides on the procedures to be followed in case of under- or oversubscription and may also decide to not complete the Offering (or the UK Offering). The Board of Directors of the Company may, in the event of an oversubscription, increase the number of Offer Shares offered in the Offering by a maximum of 8,000,000 Offer Shares. If the Upsize Option is used in full, the number of Offer Shares offered shall amount up to 38,714,592 shares of the Company in aggregate. In case of oversubscription of the Offering or when the aggregate number of subscriptions for the Offering and the UK Offering exceed EUR 30.7 million, the Board of Directors of the Company may reduce subscriptions. The Board of Directors has the right to reduce large subscriptions relatively more than small subscriptions. In case of oversubscription, the Board of Directors of the Company may prioritise the allocation of Offer Shares to: (i) first to lenders of the Capital Loans; (ii) secondly to subscribing shareholders of the Company who are registered in the shareholder register of the Company maintained by Euroclear Finland Oy as at 6 June 2024, to whom, based on their ownership as at the date mentioned, a pro rata allocation is intended to be provided, and thereafter to (iii) investors who have committed to subscribe. In any event, valid applications by qualifying holders of DIs will be satisfied in full up to their basic open offer entitlements under the UK Open Offer.
  • The Company’s Board of Directors will decide, on or about 19 June 2024 (unless the Subscription Period is extended) on the completion of the Offering, on the final number of Offer Shares to be issued (including on the exercise of the Upsize Option) and on the acceptance of subscriptions made in the Offering in full or in part. The Company’s Board of Directors decides on the allocation of the Offer Shares between the Public Offering and the Institutional Offering
  • An application will be made for the admission to trading of the Offer Shares on the First North under the current trading code “FARON”, and under the trading code “FARN” on AIM. Trading in the Offer Shares is expected to commence on or about 24 June 2024, unless the Subscription Period (as defined below) is extended and subject to the admission of the Offer Shares to trading on First North and AIM.

 

 

Open Offer and REX Retail Offer in brief

 

  • In the separate share offering in the United Kingdom, the Company may raise up to approximately GBP 6.8 million (equated to EUR 8.0 million based on an exchange rate of 1.1714 on 31 May 2024) through (i) an open offer of up to approximately 5.8 million new shares of the Company (the “UK Open Offer Shares”) to qualifying holders of depositary interests (“DIs”) representing entitlements to shares in the Company in the United Kingdom and elsewhere on the relevant record date (“Qualifying DI Holders”) at a UK subscription price of GBP 0.85 per share (the “UK Open Offer”) and (ii) an offer of new shares of the Company to retail investors in the United Kingdom through intermediaries using Peel Hunt LLP’s Retail Capital Markets Platform at a UK subscription price of GBP 0.85 per share (the “REX Retail Offer” and together with the UK Open Offer, the “UK Offering”). The total consideration under the UK Offering cannot exceed the GBP equivalent of EUR 8 million, and excess allocations under the UK Open Offer and allocations under the REX Retail Offer shall be scaled back accordingly to ensure this. The subscription price for shares in the UK Offering is equivalent to the EUR 1.00 Subscription Price of the Offering based on an exchange rate of 1.1714 on 31 May 2024. The UK Open Offer is governed by separate terms and conditions to be included in a circular published by the Company (the “UK Open Offer Circular”) and does not form part of the Offering. The REX Retail Offer is governed by separate terms and conditions to be included in the announcement of the REX Retail Offer and does not form part of the Offering. Further details of the UK Open Offer are set out below under “Details of the UK Open Offer”. Further details of the REX Retail Offer will be set out in a separate announcement.
  • The issue price of GBP 0.85 per share (the “UK Issue Price”) in the UK Offering corresponds to a discount of approximately 54 per cent compared to the closing price of the Company’s ordinary shares of GBP 1.85, and a discount of approximately 61 per cent compared to GBP 2.18, i.e. the 30 days volume-weighted average trading price of the Company’s ordinary shares, and a discount of approximately 52 per cent compared to GBP 1.78, i.e. the 90 days volume-weighted average trading price of the Company’s Share on AIM on the trading day immediately preceding the resolution on the Offering 31 May 2024.

 

 

Dr. Juho Jalkanen, CEO of Faron, comments:

 

“Years of hard work and dedication are finally expected to come to life over the next nine months as we seek to complete Phase II of our BEXMAB trial in patients with relapsed or refractory higher-risk myelodysplastic syndrome (r/r MDS), obtain regulatory feedback regarding measures required to obtain regulatory approval in the U.S. and complete a partnership agreement for the last stages of development and commercialization of bexmarilimab. With the unmet need in r/r MDS, current competitive landscape, untapped market opportunity and exceptional Phase I and initial Phase II read-outs we feel we could possibly offer a unique opportunity for value inflection. Join us in transforming the care of r/r MDS patients that have very limited treatment options and extremely poor prognosis.

 

Many of you may not know, that r/r MDS is as lethal as pancreatic cancer. We can possibly change this, which would be truly remarkable. For me it also gives great pleasure that we can offer this investment opportunity to the general public with the same terms and discounts as we do to institutional investors. Now everyone can take part and share the excitement of the upcoming year.”

 

Tuomo Pätsi, Chairman of the Board of Faron, comments:

 

“Faron is currently at a very interesting stage. The preliminary results from the Phase II study of our bexmarilimab drug candidate have been excellent and confirmed the previous positive Phase I results. Now, our goal is to bring bexmarilimab to market as quickly as possible, as patients are waiting for such new treatment options. The planned share issue is therefore crucial so that we would have sufficient funding to finance our product development and to sign a significant commercial partnership agreement by the end of 2024.”

 

Background to the Offering and Deviation from the Shareholders’ Pre-emptive subscription right

 

The Company announced on 4 March 2024 that it expects to require EUR 35 million in financing to complete the enrolment of patients for the BEXMAB Phase II trial with interim and final readouts and to obtain regulatory feedback from the FDA regarding path to regulatory approval in the U.S. Earlier this year, the Company has raised financing totalling EUR 8 million (including the EUR 3.2 million convertible Capital Loans announced on 4 March 2024, and paid to the Company on 8 March 2024, and the EUR 4.8 million directed share issue, the completion of which was announced on 4 April 2024), to secure continued compliance with the minimum cash covenant agreed in the waiver with IPF. Thereafter, the Company has assessed preconditions for arranging a larger financing round and now the Company aims, based on the investigations of various alternatives, to conclude the Offering.

 

Due to the admission of the Company’s shares to trading on AIM and the number of DIs (representing shares in the Company) held by DI holders in the United Kingdom, arranging a rights issue in a post-Brexit regulatory environment would involve separate regulatory approval processes in Finland and the UK. Arranging a rights issue in the UK would be challenging, time consuming and expensive and not feasible in the Company’s current financial situation. On 5 April 2024, the Company’s Annual General Meeting granted an authorisation for a directed share issue with broad discretion for the Board of Directors to allow flexibility for the Company to arrange the contemplated offering in a manner involving the Company’s shareholders, in a timely manner and at the most beneficial terms available. Hence, the now contemplated financing round is structured as (i) a public offering of shares in Finland with private placements in the EEA and elsewhere (i.e. the Public Offering and the Institutional Offering), and (ii) a separate UK Offering, the aggregate amount of which shall always be less than EUR 8 million. In the Offering, the current shareholders of the Company do not receive subscription rights, but they have the right to participate in the Offering and subscribe for the Offer Shares in accordance with the terms and conditions of the Offering.

 

The Company has applied for and received a statement from the Market Practice Board of the Finnish Securities Market Association (Decision Recommendation 1/2024) on the compliance of the Offering with good securities market practice. In its decision recommendation, the Market Practice Board has concluded that, in the circumstances described in the application, the planned directed share issue described in the application is in accordance with good securities market practice, provided that the subscription price in the share issue is determined on market terms. The Market Practice Board has in its recommendation also noted that the issuer shall, when disclosing information on the directed share issue, thoroughly and clearly describe information on the directed share issue, the reason for deviating from the shareholders’ pre-emptive subscription right and the determination of the subscription price. When disclosing information on the share issue and marketing, the issuer may not create a misleading understanding that the share issue would be based on the shareholders’ pre-emptive subscription right.

 

Reasons for the Offering and use of proceeds; Scenarios for the outcome of the Offering

 

The objective of the Offering is to strengthen the Company’s cash position so that the Company would have sufficient funding to reach its key milestones for the year 2024, i.e. a significant commercial partnership agreement and to finance its product development costs described below until the latter half of March 2025. The product development costs mainly include the production and research costs in respect of the Company’s lead program bexmarilimab, i.e. costs related to the completion of enrolment of the patients for the BEXMAB Phase II trial, treatment of patients and publication of readouts as well as obtaining regulatory feedback from the FDA regarding measures required to obtain regulatory approval in the U.S. By the end of 2024, the Company is also aiming to conclude a global partnership agreement to fund Phase III clinical research and to commercialise bexmarilimab, and it believes that the better the Company is financed the better its position is to conclude a partnership. If the Company succeeds in completing the Offering of approximately EUR 30.7 million, the Company believes it would have sufficient resources to execute its core business and deliver on its key milestones of the year 2024 under the current business plan and in compliance with the financial covenants of the IPF Facilities Agreement until the latter half of March 2025. The reasons for the UK Offering are the same as described above.

 

The Company estimates to use approximately two-thirds of the net proceeds of the Offering towards product development costs included in its key milestones for the year 2024, i.e. the continuation of the BEXMAB Phase II trial, including site and patient enrolment expenses and the drug’s CMC (Chemistry, Manufacturing, and Controls) related drug product costs, which result from its preparations for Phase III. The Company will also incur costs from an investigator-initiated study to generate data with anti-PD-1 combinations in solid tumors. The balance of the net proceeds will be used for financing costs and repayments of its existing financing agreements (IPF Facilities Agreement, loan agreement with Business Finland and the Company’s lease agreements), general and administrative expenses, working capital and general corporate purposes of the Company. The Company intends to use approximately EUR 3 million in total of the net proceeds towards repayments under the financing agreements mentioned above during the period between June 2024 and February 2025.

 

The Company will likely complete the Offering even though its targeted amount would not be reached. In such situation, the Company’s funding would not be sufficient to deliver on all of the Company’s key milestones for the year 2024 in accordance with the current business plan and the Company would have to seek additional funding earlier than currently planned to fulfil its current financing needs and financial covenants included in the IPF Facilities Agreement. The following is an estimate of the sufficiency of the gross proceeds to be received from the Offering (including the UK Offering) in different situations. The Offering is conditional upon the Company raising at least EUR 15 million in gross proceeds and the Subscription Guarantee Undertakings received by the Company are limited to this minimum amount of the Offering:

 

  • With the EUR 15 million gross proceeds, the Company’s funding could be sufficient until it receives regulatory feedback from the FDA regarding measures required to obtain regulatory approval in the U.S. The Company would have some more time to obtain further clinical results from the current patients as well as recruit some additional patients. The Company would target and focus primarily on achieving a licensing or partnership agreement as soon as possible. With the EUR 15 million gross proceeds (approximately EUR 12 million net proceeds) the Company expects that it is able to comply with its current financial covenants until the end of September 2024. If the Company conducts negotiations with the vendors of accounts payable and achieves a favourable outcome, and agrees on changes to the payment schedules, the Company would be able to comply with its current financial covenants until the end of the year 2024.

 

  • If the gross proceeds received from the Offering would be at least EUR 23 million, the Company would pursue the completion of Phase II of the BEXMAB clinical trial and the Company estimates that it would be able to comply with its current financial covenants until the beginning of January 2025. The Company would have the opportunity to devote more time and resources to negotiating and concluding a licensing or partnership agreement before the beginning of January 2025.

 

  • If the gross proceeds received from the Offering would be EUR 27 million, the Company would pursue readiness to proceed to Phase III clinical trial, which would, in the Company’s opinion, improve its negotiating position in future partnership negotiations, and the Company estimates that it would be able to comply with its current financial covenants until the latter half of March 2025. The Company could have sufficient clinical results and time to improve its negotiating position significantly in negotiating and concluding a commercial partnership agreement.

 

If the Company succeeds in raising more funds through the Offering than the aimed total amount of EUR 27 million in gross proceeds, the Company could achieve the above-mentioned objectives and it would have a stronger balance sheet to conduct commercial negotiations. The proceeds received with the potential Upsize Option would be used to strengthen the Company’s balance sheet, as well as to preparation for the Phase III clinical trial.

 

Subscription Commitments and Subscription Guarantee Undertakings

 

Certain current shareholders of the Company and other investors have, each separately, committed to subscribe for Offer Shares in the Offering for a total of EUR 6.2 million and to pay the Subscription Price for such Offer Shares (the “Subscription Commitments”). The Subscription Commitments cover subscription of the Offer Shares for a total value of approximately EUR 6.2 million, which corresponds to approximately 6,238,724 Offer Shares, and represent approximately 20 per cent of the total number of the Offer Shares (assuming the Upsize Option is not used).

 

The Subscription Commitments are binding, irrevocable and subject only to the fulfilment of the following conditions: (i) the subscription price per new share of the Company in the Offering shall not exceed EUR 1.0, (ii) the Board of Directors of the Company having no later than 30 June 2024 resolved to commence the Offering and (iii) the Company raises gross proceeds totalling at least EUR 15 million in the Offering and the UK Offering (taking into account the binding Subscription Commitments and Subscription Guarantee Undertakings received by the Company).

 

In addition, certain investors (the “Subscription Guarantors”) have entered into Subscription Guarantee Undertakings (“Subscription Guarantee Undertakings”) with the Company, according to which the Subscription Guarantors have undertaken, subject to certain conditions, to subscribe for any new shares of the Company that may not be subscribed for in the Offering for a maximum amount of EUR 8.8 million. The Subscription Guarantees are limited to cover any unsubscribed new shares of the Company only up to the minimum amount of the Offering (EUR 15 million). The Subscription Guarantees do not cover the UK Offering.

 

The Subscription Guarantee Undertakings are binding, irrevocable and subject only to the fulfilment of the following conditions: (i) the subscription price per new share of the Company in the Offering shall not exceed EUR 1.0, (ii) the Board of Directors of the Company having no later than 30 June 2024 resolved to commence the Offering and (iii) the Company raises gross proceeds totalling at least EUR 15 million in the Offering and the UK Offering (taking into account the binding Subscription Commitments and Subscription Guarantee Undertakings received by the Company).

 

Based on the binding Subscription Commitments and Subscription Guarantee Undertakings received by the Company, the condition of EUR 15 million in gross proceeds described above has been fulfilled.

 

Placing Agreement

 

On 3 June 2024, the Company and the Lead Managers have entered into a placing agreement (the “Placing Agreement”), which sets out Carnegie’s and Peel Hunt’s duties as the Lead Managers of the Offering.

The Placing Agreement contains customary terms and conditions, according to which the Lead Managers have the right to terminate the Placing Agreement in certain circumstances and subject to certain conditions. Such circumstances include, but are not limited to, significant adverse changes in the business, financial or other position or operating result of the Company, and certain other changes in, among other things, national or global political or economic conditions. Furthermore, Faron has given customary representations to the Lead Managers in the Placing Agreement regarding, among other things, the business and legal compliance of the Company, the Shares of the Company, and the contents of the Prospectus. In addition, Faron has agreed to indemnify the Lead Managers against certain liabilities in connection with the Offering.

 

Restriction on the Issue or Transfer of Shares (Lock-up)

 

The Company has undertaken not to issue new Shares or securities entitling to Shares or rights attached to them without the written consent of the Lead Managers, for a period that falls 90 days from the completion of the Offering, with the exception of the Offer Shares, the Free Shares, the Shares issued to the lenders of the Capital Loans in connection with the conversion of the Capital Loans, the Shares issued under the warrants granted to IPF, and the Shares to be issued in accordance with the terms of the Company’s current incentive schemes, as well as certain other customary exceptions. In the event that the Offering will not be completed in the targeted amount of appr. EUR 30.7 million, the Lead Managers have agreed not to unreasonably withhold their consent regarding issuance of any equity securities or any securities exchangeable for or convertible into or exercisable for equity securities proposed by the Company within the limits of the currently existing share issuance authorisations granted to the Board.

 

Publication of the prospectus

 

The Company has prepared a Finnish language prospectus regarding the Offering (the “Prospectus”), which the Finnish Financial Supervisory Authority has approved on 3 June 2024. The Prospectus will be available in Finnish on the Company’s website at www.faron.com/osakeanti and on Nordnet Bank AB’s website at www.nordnet.fi/faron on 4 June 2024, at the latest. An unofficial English-language translation of the Prospectus is expected to be available on the Company’s website at www.faron.com/publicoffer on or about 4 June 2024.

 

Important Dates for the Offering

 

  • The Subscription period for the Offering commences on 5 June 2024 at 10:00 a.m. (Finnish time)
  • The allocation preference of the Company’s shareholders is determined in the Offering on 6 June 2024 after 6:00 p.m. (Finnish time)
  • The Subscription period for the Public Offering ends on 18 June 2024 at 4:00 p.m. (Finnish time)
  • The Subscription period for the Institutional Offering ends on 19 June 2024 at 9:30 a.m. (Finnish time)
  • Announcement of the results of the Offering on 20 June 2024 (estimate) 
  • The Offer Shares are registered in the Finnish Trade Register on 20 June 2024 (estimate)
  • The Offer Shares subscribed for in the Offering are recorded in the book-entry accounts of investors on 24 June 2024 (estimate)
  • Trading in the Offer Shares commences on First North Growth Market Finland and AIM on 24 June 2024 (estimate)
  • The Offer Shares subscribed for in the Institutional Offering are ready for delivery against payment on 24 June 2024 (estimate)

 

Details of the UK Open Offer

 

The Company is proposing to raise up to approximately GBP 4.9 million before expenses by the issue of up to 5,765,368 UK Open Offer Shares under the UK Open Offer at the UK Issue Price of GBP 0.85 per share, payable in full on acceptance. Any entitlements to UK Open Offer Shares not subscribed for by Qualifying DI Holders will be available to Qualifying DI Holders under an excess application facility (the “Excess Application Facility”) that allows Qualifying DI Holders to apply for UK Open Offer Shares in excess of their entitlement to UK Open Offer Shares pro rata to their holding of Existing DIs (as defined below) (“UK Open Offer Entitlement”).

 

Qualifying DI Holders should note that the UK Open Offer is not a rights issue and therefore the UK Open Offer Shares which Qualifying DI Holders do not apply for will not be sold in the market for the benefit of Qualifying DI Holders who do not apply for UK Open Offer Shares.

 

Qualifying DI Holders may apply for UK Open Offer Shares under the UK Open Offer at the UK Issue Price pro rata to their holdings of existing DIs on the record date of the UK Open Offer (the “Existing DIs”) on the basis of:

 

3 UK Open Offer Shares for every 7 Existing DIs held

 

Entitlements of Qualifying DI Holders will be rounded down to the nearest whole number of UK Open Offer Shares. Fractional entitlements which would otherwise arise will not be issued to Qualifying DI Holders but will be aggregated and made available under the Excess Application Facility. Not all holders of DI will be Qualifying DI Holders. Shareholders who are located in, or are citizens of, or have a registered office in, the United States, Australia, Canada, Japan, New Zealand, the Republic of South Africa or any jurisdiction the extension or availability of the UK Open Offer would breach any applicable laws or regulations will not qualify to participate in the UK Open Offer.

 

Subject to availability, the Excess Application Facility enables Qualifying DI Holders to apply for UK Open

Offer Shares in addition to their UK Open Offer Entitlement (“Excess Shares”) up to the maximum number of UK Open Offer Shares available less their UK Open Offer Entitlement.

 

Valid applications by Qualifying DI Holders will be satisfied in full up to their UK Open Offer Entitlements. Applicants can apply for less or more than their entitlements under the UK Open Offer, but the Company cannot guarantee that any application for Excess Shares under the Excess Application Facility will be satisfied, as this will depend, in part, on the extent to which other Qualifying DI Holders apply for less than or more than their own UK Open Offer Entitlements. The Company may satisfy valid applications for Excess Shares in whole or in part but reserves the right not to satisfy any application above any UK Open Offer Entitlement. The Board may scale back applications made in excess of UK Open Offer Entitlements on such basis as it reasonably considers to be appropriate.

 

Application has been made for the UK Open Offer Entitlements and the entitlement to apply for UK Open

Offer Shares pursuant to the Excess Application Facility (“Excess CREST UK Open Offer Entitlements”) to be admitted to CREST. It is expected that such UK Open Offer Entitlements and Excess CREST UK Open Offer Entitlements will be credited to CREST on 5 June 2024. The UK Open Offer Entitlements and Excess CREST UK Open Offer Entitlements will be enabled for settlement in CREST until 11.00 a.m. on 18 June 2024. Applications through the CREST system may only be made by the Qualifying DI Holders originally entitled or by a person entitled by virtue of bona fide market claims. The UK Open Offer Shares must be paid in full on application. The latest time and date for receipt of CREST applications by Qualifying DI Holders and payment in respect of the UK Open Offer is 11.00 a.m. on 18 June 2024.

 

Qualifying DI Holders will receive a credit of UK Open Offer Entitlements and Excess CREST UK Open Offer Entitlements to their CREST stock account.

 

The UK Open Offer Shares will be issued free of all liens, charges and encumbrances and will, when issued and fully paid, rank pari passu in all respects with the existing shares of the Company and the Offer Shares, including the right to receive all dividends and other distributions declared, made or paid after the date of their issue.

 

Application will be made to the London Stock Exchange for the admission of the UK Open Offer Shares to trading on AIM and to Nasdaq Helsinki Ltd for the UK Open Offer Shares to be admitted to trading on First North. It is expected that admission of the UK Open Offer Shares to trading on AIM will occur, and that dealings in the UK Open Offer Shares subscribed for pursuant to the UK Open Offer on AIM will commence, at 8.00 a.m. on 24 June 2024, at which time it is also expected that the UK Open Offer Shares will be enabled for settlement in CREST.

 

Qualifying DI Holders should refer to the UK Open Offer Circular for more information on, and full details of, the UK Open Offer and the terms and conditions on which it is being made.

 

Important Dates for the UK Open Offer

 

Record Date for the UK Open Offer

Close of business on 3 June 2024

Announcement of the UK Open Offer

 4 June 2024

Ex-entitlement Date of the UK Open Offer

8:00 a.m. on 4 June 2024

UK Open Offer Entitlements credited to CREST
stock accounts of Qualifying DI Holders

8:00 a.m. on 5 June 2024

Latest time and date for acceptance of the
UK Open Offer by Qualifying DI holders through CREST

11:00 a.m. on 18 June 2024

Announcement of the result of the UK Open Offer

20 June 2024

Admission of the UK Open Offer Shares to trading on First North and commencement of dealings

8:00 a.m. on 24 June 2024

Admission of the UK Open Offer Shares to trading on AIM and commencement of dealings

8:00 a.m. on 24 June 2024

Expected date for CREST accounts to be credited in respect of UK Open Offer Shares in uncertificated form

24 June 2024

Notes

(1)     Each of the times and dates set out in the above timetable and mentioned in this document is subject to change by the Company, in which event details of the new times and dates will be notified to the London Stock Exchange and the Company will make an appropriate announcement via a Regulatory Information Service.

(2)     References to times in this document are to London time unless otherwise stated.

 

Publication of the UK Open Offer Circular

 

The terms and conditions of the UK Open Offer will be set out in the UK Open Offer Circular to be sent to Qualifying DI Holders in the United Kingdom and elsewhere. It is expected that the UK Open Offer Circular will be dispatched on or around 4 June 2024, and will also be available at this time on the Company’s website at www.faron.com/investors.

 

Webinars

 

Faron will be hosting two virtual webinars for investors and analysts on 6 June 2024. The webinar beginning at 5:30 p.m. (EEST) / 2:30 p.m. (GMT) / 10:30 a.m. (EDT) will be held in Finnish and the webinar beginning at 7:00 p.m. (EEST) / 4:00 p.m. (GMT) / 12 noon (EDT) will be held in English. Dr. Juho Jalkanen, CEO of Faron, and Yrjö Wichmann, Interim CFO of Faron, will be presenting at the webinars.

 

Questions may be presented during the webinar. To register for the webinar, please visit https://faron.videosync.fi/yritysesittely_2024. Contact the IR team for more information at investor.relations@faron.com.

 

Carnegie Investment Bank AB, Finland Branch and Peel Hunt LLP are acting as the Lead Managers of the Offering and as the subscription places in the Institutional Offering. Carnegie is not participating in arranging the UK Open Offer or the REX Retail Offer and Peel Hunt is not participating in arranging the UK Open Offer. In addition, Nordnet Bank AB acts as the subscription place in the Public Offering and as a subscription place in the Institutional Offering for its own customers.

 

Related party and PDMR filing

 

Christine Roth, a director of the Company, has committed to subscribe for 46,075 Offer Shares. Her interests in the issued shares and votes of the Company are set out below:

 

 

Before the Offering

 

Following the Offering

Director

Number of ordinary shares held

% of issued shares and voting rights

Number of Offer Shares committed to subscribe for

Number of ordinary shares held

% of issued shares and votes

Christine Roth

0

0

46,075

46,075

0.04

 

The participation of Christine Roth (“Director Participation”) in the Offering constitutes a related party transaction for the purposes of the AIM Rules, the First North Rulebook and the Finnish Limited Liability Companies Act. 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 Offering 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

Christine Roth

2

Reason for notification

 

 

 

a.

Position/Status

Member of the Board

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

Share

ISIN: FI4000153309
 

b.

Nature of the transaction

Subscription of shares

c.

Price(s) and volume(s)

 

 Average

 

 

 

 

Price(s)

Volume(s)

 

1.00

46,075

 

 

 

 

d.

Aggregated information

 

– Aggregated Volume

 

– Price

 

 

 

46,075

 

1.00

e.

Date of the transaction

20 June 2024

f.

Place of the transaction

Outside of trading venue

 

 

The terms of the Offering are available at http://www.faron.com/investors/publicoffer 

For the purposes of MAR and UK MAR, the person responsible for arranging for the release of this

announcement on behalf of Faron is Juho Jalkanen, Chief Executive Officer.

 

Faron Pharmaceuticals Ltd

 

 

For more information please contact:

ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.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

 

About BEXMAB

 

The BEXMAB study is an 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 (azacitidine) treatment. 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 bexmarilimab

 

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

 

About Faron Pharmaceuticals Ltd

 

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com.

 

Important notice

 

This announcement is not an offer of securities for sale into the United States. The Offer 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 Offer Shares in the United States or to make a public offering in the United States. Any sale of the Offer Shares in the United States will be made solely to a limited number of “qualified institutional buyers” or accredited investors, each as defined in Rule 144A in reliance on an exemption from the registration requirements of the Securities Act.

 

The distribution of this release may be restricted by law and persons into whose possession any document or other information referred to herein comes should inform themselves about and observe any such relevant legal restrictions. The information contained herein is not for publication or distribution, directly or indirectly, in or into the United States, Australia, Canada, Japan, New Zealand or the Republic of South Africa. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such aforementioned jurisdiction. This release is not directed to, and is not intended for distribution to or use by, any person or entity that is a citizen, resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would violate law or regulation or which would require any registration or licensing within such jurisdiction.

 

In any EEA Member State, other than Finland, this release is only addressed to and is only directed at “qualified investors” in that Member State within the meaning of Article 2(e) of Regulation (EU) 2017/1129 (the “Prospectus Regulation”).

 

In the United Kingdom, this release is only being distributed to and is only directed at “qualified investors” within the meaning of Article 2(e) of the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”) who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (ii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “UK Relevant Persons”). Any securities mentioned herein are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, in the United Kingdom, UK Relevant Persons. Any person who is not a UK Relevant Person should not act or rely on this release or any of its contents. The UK Open Offer is only available to persons in the United Kingdom falling within Article 43 of the Order.

 

This release does not constitute a prospectus as defined in either the Prospectus Regulation or the UK Prospectus Regulation and, as such, it does not constitute or form part of, and should not be construed as, an offer to sell, or a solicitation or invitation of any offer to buy, acquire or subscribe for, any securities or an inducement to enter into investment activity in relation to any securities.

 

No part of this release, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. The information contained in this release has not been independently verified. No representation, warranty or undertaking, expressed or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein. The Company or any of its respective affiliates, advisors or representatives or any other person, shall have no liability whatsoever (in negligence or otherwise) for any loss, however arising from any use of this release or its contents or otherwise arising in connection with this release. Each person must rely on their own examination and analysis of the Company, its subsidiaries, its securities and the transactions, including the merits and risks involved.

 

The Lead Managers are acting exclusively for the Company and no one else in connection with the Offering. They will not regard any other person as their respective client in relation to the Offering. The Lead Managers will not be responsible to anyone other than the Company for providing the duties afforded to their respective clients, nor for giving advice in relation to the Offering or any transaction or arrangement referred to herein.

 

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 Company’s current expectations and assumptions regarding the completion and use of proceeds from the Offering, 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 Company’s current beliefs and assumptions and are based on information currently available to the Company.

 

A number of factors could cause actual results to differ materially from the results and expectations dis-cussed 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 Company believes 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.

Initial positive data from Phase 2 of BEXMAB

Faron Pharmaceuticals Ltd.

 

(“Faron” or the “Company”)

 

 

Inside Information: Faron Reports Initial Positive Phase 2 Read-out in HMA-resistant MDS

 

Company announcement, Inside Information, 20 May 2024 at 7:00 a.m. BST / 9:00 a.m. EEST

 

Key highlights

          Initial preliminary phase 2 read-out from the BEXMAB Trial confirms earlier positive Phase 1 findings in MDS patients with prior HMA failure

          In Phases 1 & 2, 14 MDS patients who are refractory or relapsed on HMA (r/r MDS) and have no effective treatment options, show an objective response rate (ORR) of 79%

          The BEXMAB Phase 1 MDS patients with prior HMA failure are experiencing an estimated median overall survival (mOS) of approximately 13 months currently, compared to the 5-6 months that would typically be expected under standard of care historically

 

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today provided first data from patients treated during the Phase 2 part of the ongoing BEXMAB trial in myelodysplastic syndrome (MDS) patients that have failed a hypomethylating agent (HMA), also known as relapsed/refractory MDS (r/r MDS). There are limited viable treatment options for r/r MDS and the mOS for these patients is only 5.6 months historically (Prebet et al. 2011).

 

The BEXMAB Phase 1 results have already indicated a high overall response rate (ORR) of 87.5% (7/8) amongst HMA-failed MDS patients treated with a combination of bexmarilimab + azacitidine. There are now a total of 14 HMA-failed MDS patients treated in both Phase 1 & 2 with this novel combination. The treatment has been well tolerated, without any dose-limiting toxicity.  The ORR in this otherwise untreatable population is 79% (11/14). The current true remission rate is 64% (9/14). Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions.

 

The best responses for these 14 patients are as follows: 1 complete response (CR), 7 marrow complete remissions (mCR), 1 partial response (PR), 2 hematological improvements, 2 stable diseases (SD) and 1 progressive disease (PD). Two patients have moved on to receive bone marrow transplantation for a possibility of curative treatment. This is seldom seen in this population because patients usually cannot be brought to remission. For Phase 1 patients with adequate follow-up available the estimated mOS is currently 13.4 months, but still subject to change.

 

Dr. Amer Zeidan, Associate Professor of Medicine, Chief of Hematologic Malignancies Division, Director of  Hematology Early Therapeutics Research, and leader of the clinical program and the Clinical Research Team for Leukemia and Myeloid Malignancies at Yale Cancer Center, who is also a leading investigator on the trial, said: “Management of patients with higher risk MDS after HMA failure is very challenging and with very limited options, and is currently considered one of the most urgent unmet clinical needs in MDS. Bexmarilimab is a promising agent that works by modulating the immune system and in early data from the ongoing clinical trial in MDS appears to have a very good safety profile and promising clinical activity, especially in median survival after HMA failure. While these are early data and in a small number of patients, if these findings continue to hold up, they would position bexmarilimab to potentially fill a very important clinical gap in the management of  MDS patients”.

 

Dr. Juho Jalkanen, Chief Executive Officer of Faron, said: “This is a significant milestone for Faron. Many of us have recognized the grave need for new treatment options in r/r MDS. With these first results from the Phase 2 continuing the positive results already seen in Phase 1, we are committed to rapidly advancing Bexmarilimab to market, because patients are waiting for treatment options like this”.

 

Faron will be hosting a virtual webinar to discuss these data the day after tomorrow, Wednesday, May 22nd, at 17.00 EEST/15.00 BST

 

To register for the event visit: https://faron.videosync.fi/bexmab-study-update-may2024 or contact the IR team for more information at investor.relations@faron.com.

 

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.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

 

 

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 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 (azacitidine) treatment. 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 Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

 

 

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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.

 

Issuance of warrants

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Issuance of warrants

Company Announcement, 17 May 2024 at 18:00 (EEST) / 16:00 (BST) / 11:00 AM (EDT)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces that it has issued to its lender IPF Fund II SCA, SICAV-FIAR (“IPF”) 333,333 warrants (“Warrants”) in accordance  with the announcement released on 30 April 2024 in relation to a waiver extension. The strike price is 1.50 euros for these Warrants and it will be adjusted to any lower subsequent subscription price of shares in any future share issue. Each Warrant entitles its holder to subscribe for one new share in the Company, and the Warrants may be exercised for a period of seven years.

 

Pursuant to the terms of the restated warrant holder agreement entered into between the Company and IPF on 17 May 2024, the number of the Warrants to be issued to IPF may be further increased upon (and subject to) agreed adjustment events so that the total number of new shares in the Company (as a result of the exercise of the Warranties) multiplied by the (adjusted, if applicable) strike price is equal to EUR 500,000 (minus any amounts already paid). For that purpose, the Board of Directors of Faron has approved the terms and conditions for 750,000 Warrants of which the 333,333 Warrants are now issued. The terms and conditions of the Warrants are available on the Company’s website. Any further issuances will be announced separately.

 

On the date of this announcement, IPF holds 1,320,343 warrants, which entitle them to subscribe for the same number of shares in the Company using strike price EUR 1.50, representing 1.8% of the current number of shares in the Company (72,007,497).

 

 

For more information please contact:

Faron Pharmaceuticals

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.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

 

 

About Faron Pharmaceuticals Oy 

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, 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 cancers in combination with other standard treatments and as a monotherapy in last line solid cancers. Further information is available at www.faron.com.

 

 

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