Annuncio • Jul 13
Faron Pharmaceuticals Oy Provides Update on Investigator-Initiated Trial Portfolio for Bexmarilimab Faron Pharmaceuticals Oy provided an update on its portfolio of Investigator-Initiated Trials (IITs) evaluating bexmarilimab, its wholly owned anti-Clever-1 immunotherapy, in multiple oncology indications. The update covers five IITs in solid tumors and hematological malignancies, reflecting both advances and adjustments across the program. The investigators of the BLAZE IIT, led by The Institute of Cancer Research (ICR) and conducted at The Royal Marsden NHS Foundation Trust in London, UK, as well as other UK hospitals, have updated the trial’s anti-PD-1 combination drug to nivolumab (Opdivo®), a fully approved, globally used standard-of-care anti-PD-1 inhibitor. The trial has received the necessary regulatory and ethical approvals and is advancing towards first patient enrolment. The BLAZE trial is a Phase 1/2 evaluating bexmarilimab in combination with nivolumab in patients with metastatic non-small cell lung cancer (NSCLC) or melanoma who have developed resistance to prior anti-PD-1-based immunotherapy. The trial investigates a sequential approach: patients first receive a run-in dose of bexmarilimab to reprogram the immunosuppressive tumor microenvironment, followed by the combination of bexmarilimab and nivolumab, with the aim of resensitizing tumors to checkpoint inhibition. Using nivolumab as the combination backbone is scientifically meaningful, because its efficacy is well characterized. Therefore, clinical activity observed in the combination treatment can be better understood. The BEXAR trial has received the necessary regulatory and ethical approvals and is advancing towards first patient recruitment. BEXAR is a randomized Phase 1b/2 IIT sponsored by MEDSIR and conducted at six Spanish hospitals and led by Dr. Cesar Serrano at the University Hospital Vall d'Hebron in Barcelona, Spain. The trial evaluates bexmarilimab in combination with standard-of-care doxorubicin in patients with first-line metastatic soft-tissue sarcoma. The expression of bexmarilimab’s target, Clever-1, in soft-tissue sarcomas is among the highest observed across tumor types, providing a strong biological rationale for the use of bexmarilimab in this setting. Additionally, bexmarilimab's observed effects on hematopoiesis in the bone marrow may help offset the myelosuppressive effects of doxorubicin. The trial design includes exploratory endpoints to further evaluate this hypothesis in the sarcoma setting. The FINPROVE trial is an ongoing national, investigator-initiated precision medicine study sponsored by Helsinki University Hospital, designed to evaluate targeted treatment approaches across multiple tumor types. Following a regulatory review by the Finnish Medicines Agency (Fimea), the proposed bexmarilimab cohort was considered incompatible with the FINPROVE platform trial, which focuses primarily on marketed therapies with established and approved patient selection strategies. This outcome does not impact Faron’s broader development program for bexmarilimab. Two further IITs continue to advance through active protocol development and regulatory submission preparations. The BEAM-X trial, led by the Nordic AML Group, will evaluate bexmarilimab in patients with measurable residual disease-positive acute myeloid leukemia (AML) following allogeneic stem cell transplantation. In parallel, the IIT sponsored by City of Hope National Medical Center in the United States, is planned to evaluate bexmarilimab and orally administered decitabine-cedazuridine (Inqovi®) in relapsed or refractory myelodysplastic syndromes (r/r MDS). Further updates on both IITs will be provided in due course. 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. Board Change • May 20
High number of new and inexperienced directors There are 7 new directors who have joined the board in the last 3 years. The company's board is composed of: 7 new directors. 3 experienced directors. 2 highly experienced directors. Non- Executive Director Markku Jalkanen is the most experienced director on the board, commencing their role in 2006. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Annuncio • Mar 10
Faron Pharmaceuticals Oy has filed a Follow-on Equity Offering in the amount of €40 million. Faron Pharmaceuticals Oy has filed a Follow-on Equity Offering in the amount of €40 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 80,000,000
Price\Range: €0.5
Transaction Features: Regulation S; Rights Offering; Rule 144A Annuncio • Feb 24
Faron Pharmaceuticals Ltd. Announces Data from Its Phase I/II Bexmab Trial Evaluating Bexmarilimab in Combination with Azacitidine for the Treatment of Higher-Risk Myelodysplastic Syndromes Faron Pharmaceuticals Ltd. announced that data from its Phase I/II BEXMAB trial evaluating bexmarilimab in combination with azacitidine for the treatment of higher-risk myelodysplastic syndromes (MDS) have been accepted for presentation at the 66th Annual Scientific Meeting of the British Society for Haematology (BSH), taking place 19-21 April 2026 in Liverpool, UK. The abstract, titled "Bexmarilimab Plus Azacitidine in Higher Risk Myelodysplastic Syndrome: Updated Results from the BEXMAB Study," has been selected for poster presentation (Poster P02.10) under the theme Myeloid Malignancies and Bone Marrow Failure Syndromes. The acceptance supports Faron's consistent scientific presence at major hematology and oncology meetings. While the BSH poster contains updated figures from the latest data cut, the dataset itself is previously reported. Bexmarilimab is Faron's wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments by targeting Clever-1, a receptor on immunosuppressive macrophages and malignant blasts. By inhibiting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response. 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. Annuncio • Jun 30
Faron Pharmaceuticals Ltd. Announces Publication of New Study in the Peer-Reviewed Journal Theranostics Faron Pharmaceuticals Ltd. announced the publication of a new study in the peer-reviewed journal Theranostics. The research identified a secreted, truncated form of the Clever-1 receptor (sClever-1) as a key immunosuppressive mediator in cancer that impaired T-cell responses and was associated with resistance to anti-programmed cell death protein -1 (PD-1) immunotherapies. The study, supported by Faron Pharmaceuticals and grants from leading international funding bodies, including Cancer Research UK (CRUK), the NIHR Birmingham Biomedical Research Centre, the Research Council of Finland, and the Sigrid Juselius Foundation, provided significant new insights into the biology of Clever-1, the target of Faron's wholly owned, first-in-class immunotherapy asset, bexmarilimab. Clever-1 is an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). In this study, researchers analyzed plasma samples from breast cancer patients (n=139) and bexmarilimab-treated clinical trial participants (n=193) as well as healthy donors and discovered that a secreted form of Clever-1 or sClever-1 was significantly enriched in the plasma of cancer patients compared to healthy individuals. sClever-1, released by macrophages and endothelial cells, was found to bind to activated T cells, impairing their signaling and promoting the differentiation of suppressive T cells, contributing to tumor immune evasion. This adds to the growing body of evidence supporting bexmarilimab's development as a potential cornerstone of immunotherapy for patients with aggressive cancers. This provides also a very intriguing basis of using soluble Clever-1 to inactivate T-cells in conditions where they are attacking their own body, i.e. in a wide range of auto-immune and inflammatory conditions. Annuncio • Jun 03
Faron Pharmaceuticals Presents Phase II Data from BEXMAB Study at ASCO 2025 Faron Pharmaceuticals Ltd. presented phase II data from its ongoing BEXMAB study evaluating bexmarilimab in high-risk myelodysplastic syndromes (HR-MDS) as a part of a Rapid Oral Abstract Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from 30 May to 3 June 2025, in Chicago, Illinois, USA. As per the new IWG 2023 criteria, the composite CR (cCR) rate in frontline HR-MDS was 56%, while historically up to 20-25% can be expected with azacitidine alone. This supports moving on to a confirmatory registrational frontline HR-MDS trial comparing bexmarilimab + azacitidine against placebo + azacitidine according to previously received guidance from the FDA. This and the proposed primary endpoint cCR which is strongly linked to survival will be discussed in an upcoming end-of-phase II meeting with the Agency. Annuncio • May 30
Faron Pharmaceuticals Ltd Announces Publication of full Phase I BEXMAB study data in Lancet Haematology Faron Pharmaceuticals Ltd. announced the publication of the results of its Phase I BEXMAB study in the prestigious Lancet Haematology which reinforced the safety and efficacy of the treatment in patients with high-risk myelodysplastic syndrome (HR-MDS) and relapsed/refractory (r/r) acute myeloid leukemia (AML). A total of 33 patients across six centres in the US and Finland were treated with increasing doses of bexmarilimab (1, 3, and 6 mg/kg once a week in a 28-day cycle) in combination with azacitidine (as per label). Out of these, five were patients with HR-MDS, nine were hypomethylating agents (HMA)-failed MDS patients, and 19 were relapsed/refractory AM (r/r AML) patients (unresponsive to earlier treatments). The combination therapy was effective with objective responses observed in 45% of patients across all the studied indications. The majority of treatment-emergent adverse events (TEAE) were mild to moderate, and only 6% of them were related to bexmarilimab. The treatment was well-tolerated, and no dose-limiting toxicities were observed. Among the patients studied in BEXMAB, the estimated median overall survival (mOS) was 8.1 months in patients with r/r AML, and 13.4 months in patients with HMA-failed MDS. Generally, in these relapsed or refractory patients’ remissions are rare and median overall survival is only 5-6 months. The mOS of 13.4 months for patients with HMA-failed MDS is notable and this indication was advanced into Phase 2. Moreover, two HMA-failed MDS patients received a hematopoietic stem cell transplantation (HSCT). Also, a reduction in bone marrow blast cells (immature cells) was seen in 64% of all patients across all doses of bexmarilimab. The study also evaluated the immune response in the bone marrow and found that some biomarkers (human leukocyte antigen-DR isotype or HLA-DR molecules and CD4+ T cells) involved in the immune response increased by nearly three-fold versus baseline after treatment with bexmarilimab and azacitidine. Interestingly, an increase in HLA-DR molecules was seen even in 67% of patients with HMA-failed MDS indicating increased antigen presentation. Annuncio • May 27
Faron Pharmaceuticals Ltd. Announces the Publication of A New Peer-Reviewed Preclinical Study in Scientific Reports Faron Pharmaceuticals Ltd. announced the publication of a new peer-reviewed preclinical study in Scientific Reports, validating the immune-reprogramming and anti-leukemic potential of its investigational macrophage CLEVER-1 inhibitor, bexmarilimab, in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The study, conducted in collaboration with leading Finnish and Danish academic research centers, examined AML cell lines and bone marrow samples from patients with AML (n = 34) and MDS (n = 4) and showed that CLEVER-1 is highly expressed on malignant myeloid cells, especially in AML with monocytic differentiation. Addition of bexmarilimab helped overcome venetoclax-resistance in 33-40% of ex vivo AML samples, without adding to lymphocyte toxicity. Moreover, the triplet of bexmarilim AB, azacitidine, and venetoclax showed enhanced cytotoxicity in ex vivo models of treatment-resistant AML; suggesting that bexmarilimab increases the susceptibility to venetoclax and/or azacitidine induced cell death. The ongoing BEXMAB clinical study is currently evaluating bexmarilimab in combination with azacitidine in relapsed/refractory AML and MDS patients. The trial's most recent phase II data, to be presented at ASCO and EHA 2025, showed promising response rates in pretreated populations. 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 myelodyingplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilim ab in combination with SoC (azacitidine) in combination with SoC. Annuncio • May 12
Faron Pharmaceuticals Ltd. Presents Promising Phase 1/2 Data from BEXMAB Study at MDS 2025 plenary Session Faron Pharmaceuticals Ltd. presented updated data from its ongoing BEXMAB Phase 1/2 trial at plenary oral session at the 18th International Congress on Myelodysplastic Syndromes (MDS 2025) on May 10, 2025, in Rotterdam, Netherlands. The presentation, led by Dr. Amer Zeidan, MBBS, MHS, focused on the preliminary efficacy, safety, and immune biomarker data from 20 first patients with relapsed or refractory high-risk myelodysplastic syndromes (r/r MDS) who had failed prior hypomethylating agent (HMA) therapies. 90% of the patients were very high/high risk at baseline and 50% had tp53 mutations. These patients represent a population with extremely limited treatment options and aggressive and difficult-to-treat disease. The BEXMAB Phase 1 & 2 MDS patients with prior HMA failure experienced an estimated median overall survival (mOS) of approximately 13.4 months, compared to the 5-6 months that would typically be expected under standard of care historically. The BEXMAB study evaluated bexmarilimab (1, 3, or 6 mg/kg weekly in 28-day cycles), a first-in-class monoclonal antibody targeting the Clever-1 receptor, in combination with azacitidine, a standard-of-care HMA. By blocking Clever-1, bexmarilimab reprograms macrophages in the bone marrow, enhancing anti-tumor immunity. The combination was well tolerated, with no Grade 3-5 adverse events attributed to bexmarilimab and no treatment discontinuations due to related toxicity. Clinically, the combination of bexmarilimab & azacitidine demonstrated encouraging efficacy in patients with r/r MDS. A reduction of 50% or more in bone marrow blast counts was observed in 55% of patients, indicating clinically significant disease control. Additionally, 21% of patients who were transfusion dependent at baseline achieved transfusion independence, reflecting a potential improvement in quality of life and a reduced need for supportive care. Importantly, four patients were able to proceed to hematopoietic stem cell transplantation, the only potentially curative treatment, suggesting that this regimen may serve as an effective bridge to transplant. Biomarker analysis revealed that treatment with bexmarilimab plus azacitidine was associated with a rise in immune activation markers in the bone marrow, suggesting that Clever-1 blockade enhances immune activation and engagement. Additionally, despite all patients being Clever-1 positive responding patients had higher pre-treatment Clever-1 expression on monocytes/macrophages than non-responding patients confirming the importance of Clever-1 as a target and the mode of action of bexmarilim AB as a target and the mode the mode of action of bexmarilimab in the treatment of MDS patients. Annuncio • Apr 05
Faron Pharmaceuticals Oy announced that it expects to receive €35 million in funding Faron Pharmaceuticals Oy enters into a convertible bond arrangement with Heights Capital Management, Inc to issue Convertible bonds for gross proceeds of EUR 15 million on April 3, 2025. two additional tranches of similar convertible bonds, each with a principal amount of EUR 10 million. Bondholders have the option to convert the bonds into shares at an initial conversion price of EUR 2.94 per share. Annuncio • Jan 31
Faron Pharmaceuticals Ltd. Announces Final Patient Has Been Identified for the BEXMAB Phase II Study Faron Pharmaceuticals Ltd. announced that the final patient has been identified for the BEXMAB Phase II dose optimization study inrefractory or relapsed myelodysplastic syndrome(r/r MDS), as well as the BEXMAB Phase I/II study in frontline high risk (HR) MDS. The topline response rate read out is thus expected to become available in April 2025. Detailed data will be presented later at upcoming major medical conferences. The reportable data set will consist of approximately 35 r/r MDS patients and 20 frontline HR MDS patients. The r/r MDS population will consist of 32 patients treated with either 3mg/kg or 6mg/kg dose of bexmarilimab per the U.S. Food and Drug Administration (FDA) Project Optimus guidance, and three r/r MDS patients treated with 1mg/kg dose of bexmarilimab in Phase I. A similar split between doses will be reported concerning the frontline HR MDS population. The BEXMAB Phase II Interim Results presented at the 66th American Society of Hematology (ASH) Annual Meeting on December 2024 showed a high objective response rate (ORR) at 80% (16/20). Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions. Previouslyreportedestimated median overall survival of the 20 r/r MDS patients were 13.4 months compared to the 5-6 months that would typically be expected under standard of care historically. The BEXMAB trial will continue enrolling CMML patients and there is also the possibility to expand the enrollment of r/r MDS patients under the current protocol. The Company is assessing expanding the enrollment of r/r MDS patients in order to have this treatment option available for patients and to strengthen the data set for upcoming regulatory purposes. Annuncio • Dec 10
Faron Pharmaceuticals Ltd. Presents Full Analysis of Positive Phase 2 Interim Data from BEXMAB Trial at the 66th American Society of Hematology (ASH) Annual Meeting Faron Pharmaceuticals Ltd. announced full analysis of the positive Phase 2 interim readout presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. Dr. Mika Kontro, MD, PhD, Associate Professor at the Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial, said: "Addressing MDS remains a considerable therapeutic challenge due to the limited efficacy of the current standard of care, particularly in TP53 mutated and HMA- failed MDS patient populations. The data presented at ASH are highly promising, showing notable improvements in overall response rate and overall survival. These findings highlight the meaningful strides Faron is making in improving treatment outcomes for r/r MDS." The BEXMAB study is a multicenter study, taking place in Finland, UK and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with standard of care in patients with aggressive myeloid leukemias. The BEXMAB trial is a multicenter study, take place in Finland, UK and The U.S., evaluating the Safety and efficacy of bexmarILimab, a novel anti -Clever-1 humanized antibodies, with standard of care in patient with aggressive myeloid le Dukemias. The BEX MAB study is a multicenter studies, taking place in Finland,UK and the U.S., evaluate the safety and efficacy of be xmarilimab, a new anti-Clever-1 Humanized antibody, with standard of Care in patients with aggressive myeloids leukemias. The ASH Annual Meeting takes place from 7-10 December 2024, in San Diego, California and virtually. Annuncio • Dec 02
Faron Pharmaceuticals Ltd. Announces Positive Update on Recent Interactions with Uk Regulatory Authorities Regarding Bexmarilimab and Expanding the Bexmab Study to the Uk Faron Pharmaceuticals Ltd. announced that the BEXMAB Study may proceed in the UK and bexmarilimab has received an Innovation Passport, under the Innovative Licensing and Access Pathway (ILAP) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA), for the treatment of relapsed/refractory Myelodysplastic Syndrome (r/r MDS). The ILAP was introduced by the MHRA in 2021 to give patients quicker access to cutting-edge treatments and therapies for life-threatening or seriously debilitating conditions, or conditions for which there is a significant patient or public health need. The benefits of the ILAP include enhanced regulatory support from the MHRA and provides collaborative opportunities with health technology assessment bodies and other stakeholders, with the aim of accelerating the development, and improving patient access to promising new medicines. The decision to award the Innovation Passport to bexmarilimab was made by the ILAP Steering Group, which is comprised of representatives from the MHRA, NICE, AWTTC and SMC, and provides further regulatory verification of bexmarilimab's potential to address significant unmet medical needs and positions the therapy for faster development and potentially earlier access for patients. In addition, Faron announced that it has received regulatory approval from the MHRA to conduct the BEXMAB trial in the UK. This approval will allow Faron to recruit UK haematology patients directly, accelerating its research efforts by increasing recruitment and enhancing the study's diversity and scope by expanding the participant pool. Annuncio • Nov 27
Faron Pharmaceuticals Provides Positive Phase 2 Interim Results from BEXMAB Trial Faron Pharmaceuticals Ltd. 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 on9 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 first quarter of 2025. Annuncio • Nov 11
Faron Pharmaceuticals Ltd. Announces the Filing of A Patent Application Around the Use of Soluble Clever-1 for Inactivating T-Cells and the Treatment of Autoimmune Diseases and Inflammatory Disorders Faron Pharmaceuticals Ltd. announced the filing of a patent application around the use of soluble Clever-1 for inactivating T-cells and the treatment of autoimmune diseases and inflammatory disorders. The key highlights of these findings are the following: Clever-1-positive macrophages and endothelial cells secrete a soluble form of Clever-1; Soluble Clever-1 binds activated T-cells and impairs their differentiation into anti-tumor effectors; The Company and its researchers have identified the part of Clever-1 that binds to T-cells andinactivates them; and The submitted patent application covers use of soluble Clever-1 or fragments of it to inactivate T-cells for the treatment of autoimmune diseases and inflammatory disorders. The nextphasefor the Company is to take the identified part of soluble Clever-1 and design the optimal drug composition with the desired characteristics for treating autoimmune diseases. The Company will in due course elucidate this new addition to its pipeline in more detail to expand the pipeline beyond hematological cancers and solid tumor oncology. Annuncio • Aug 26
Faron Pharmaceuticals Ltd. Announces FDA Grants Fast Track Designation for Bexmarilimab Faron Pharmaceuticals Ltd. announced that their lead candidate bexmarilimab has been granted Fast Track Designation for the treatment of relapsed or refractory myelodysplastic syndrome (r/r MDS) in combination with azacitidine by the USA Food and Drug Administration (the FDA). Fast Track Designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application. Given the previously reported promising results in both Phase 1 and 2 of Faron's BEXMAB trial when treating r/r MDS patients using a combination of bexmarilimab and azacitidine to overcome primary or developed resistance to azacitidine, bexmarilimab has been granted Fast Track Designation subsequent to the accelerated development plan proposed by the FDA in July 2024. "This news highlights the urgency for new treatment options besides HMAs for the treatment of higher-risk MDS and solidifies the company's case that bexmarilimab can overcome resistance to HMAs", says Dr. Juho Jalkanen CEO of Faron. Relapsed or refractory myelodysplastic syndrome is an aggressive and deadly form of blood cancer, for which there is very limited treatment option and a median survival of only 5-6 months. The standard of care for higher-risk MDS is azacitidine or another hypomethylating agent (HMA). Unfortunately, the majority of patients eventually relapse or are non-responsive to HMAs, which then leads to r/r MDS. Currently around 180,000 - 510,000 people globally live with an MDS diagnosis. Annuncio • Aug 08
Faron Pharmaceuticals Ltd. Appoints Yrjö Wichmann as Permanent Chief Financial Officer Faron Pharmaceuticals Ltd. announced the appointment of Yrjö Wichmann, Faron's current interim Chief Financial Officer (CFO, int.), as the Company's permanent Chief Financial Officer (CFO). Mr. Wichmann has served as Faron's interim CFO since April 2024, having previously served as the Company's CFO between 2014 and 2019 and as Senior Vice President, Financing & IR 2019 to April 2024. He is an accomplished biotech and financial executive with over 20 years' experience in financing and investment banking. Prior to his roles at Faron, Mr. Wichmann held a number of senior positions within the life sciences and biotechnology sector at IP Finland Oy, Biohit Oyj (NASDAQ OMX Helsinki), CapMan Oyj, FibroGen Europe Oyj (NASDAQ) and D. Carnegies & Co AB. He is a member of the Investment Committee at Dasos Timberland Fund I and II and a board member at Nordic Science Investment Oy investment fund. Mr. Wichmann holds a Master's in Economics from Helsinki University. Annuncio • Aug 06
Faron Pharmaceuticals Ltd. Announces Changes to Management Team, August 15, 2024 Faron Pharmaceuticals Ltd. announced the appointment of Dr. Petri Bono (M.D., Ph.D.) as the new Chief Medical Officer (CMO) starting the 15th of August, 2024. Previously Dr. Bono has served as the Chief Medical Officer and member of the Group executive team of Terveystalo. 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. Dr. Birge Berns, the acting CMO seconded from tranScrip Ltd. will continue her role as part of the medical leadership involved in developing bexmarilimab. Annuncio • Jul 11
Faron Pharmaceuticals Ltd. Announces Positive FDA Feedback Faron Pharmaceuticals Ltd. provided 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. Annuncio • Apr 17
Faron Pharmaceuticals Oy Announces Chief Financial Officer Changes Faron Pharmaceuticals Oy announced the appointment of Yrjö Wichmann as the Company's interim Chief Financial Officer (CFO), effective 15 April, 2024. Mr. Wichmann succeeds James O'Brien, who is leaving Faron to pursue another career opportunity. Mr. Wichmann served as the Company's CFO between 2014 and 2019 and is an accomplished biotech and financial executive with over 20 years' experience in financing and investment banking. Most recently, Mr. Wichmann has served as Senior Vice President, Financing & IR at Faron. Prior to his roles at Faron, Mr. Wichmann held a number of senior positions within the life sciences and biotechnology sector at IP Finland Oy, Biohit Oyj, CapMan Oyj, FibroGen Europe Oyj and D. Carnegies & Co AB. He is a member of the Investment Committee at Dasos Timberland Fund I and II and a board member at Nordic Science Investment Oy. Mr. Wichmann holds a Master's in Economics from Helsinki University. Annuncio • Apr 16
Faron Pharmaceuticals Oy Confirms Plans for the Coming Months Faron Pharmaceuticals Oy announced that incoming CEO, Juho Jalkanen, to accelerate discussions with US regulator to coordinate plans for obtaining marketing approval for MDS patients that have failed HMA. Initial data from the ongoing Phase 2 part of the BEXMAB trial, evaluating the safety and efficacy of bexmarilimab in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), is expected to be announced during the week commencing 20 May 2024. This data read out will be important for ongoing partnering discussions and the major upcoming industry events that Faron will be attending, including the American Society for Clinical Oncology (ASCO) annual meeting and the Bio International Convention, taking place in June 2024. Given the promising data already seen in the Phase 1 part of the trial, among HMA-failed MDS patients who have no approved treatment options, the Company plans to approach the US Food and Drug Administration (FDA) earlier than planned this year, seeking a Scientific Advice meeting regarding its registrational study plan, in order to coordinate and finalize plans that may lead to marketing approval. Annuncio • Apr 09
Faron Pharmaceuticals Ltd. Announces Chief Executive Officer Changes Faron Pharmaceuticals Ltd. announced that its chief executive officer (CEO) Dr. Markku Jalkanen, who turns 70 later in 2024, has informed the board of directors of his wish to retire from his position as the company's CEO during the course of second quarter 2024, while continuing in his role as board member. As a part of its ordinary tasks and noting the age of the current CEO, the Nomination Committee of the Board has maintained preparedness for CEO succession with the help of a third-party recruitment specialist firm, and considered several options for a potential new CEO for the company among external and internal candidates. Supported by the preparatory work conducted, the Nomination Committee has concluded that the company's current Chief Operating Officer, Dr. Juho Jalkanen,MD, PhD, MSc (economics),would be the best candidate to succeed Dr. Markku Jalkanen as CEO of the company. Following information from Dr. Markku Jalkanen and the Nomination Committee's recommendation, the board has resolved to appoint Dr. Juho Jalkanen as CEO of the company, effective May 1, 2024, subject to regulatory approval. Dr. Markku Jalkanen will continue as a board member and support in the transition of the CEO role throughout 2024. Annuncio • Mar 20
Faron Pharmaceuticals Ltd. Announces Additional Positive Data from the Phase 1 Part of the Bexmab Study in Both Higher-Risk HMA-Failed MDS and r/r AML Faron Pharmaceuticals Ltd. provided further data from patients treated during the Phase 1 part of the ongoing BEXMAB trial that has moved into Phase 2 for higher-risk (HR) myelodysplastic syndrome (MDS) patients failed on previous hypomethylating agent (HMA). Previous BEXMAB study results indicated a high overall response rate (ORR) of 5/5 amongst HR HMA- failed MDS patients, for whom there is no approved treatment. The majority of the initial Phase 1 patients have now been on treatment with bexmarilimab together with azacitidine for more than six months, and only one patient has been lost due to transformation of their HR MDS into acute myeloid leukemia (AML). Out of these initial 5 patients, 4 remain alive after eight months. For the 5 frontline HR MDS patients with 100% ORR previously reported at the American Society of Hematology (ASH) Annual Meeting last year, mOS has also not yet been reached. For the r/r AML patient cohort reported at ASH, which is bigger in size (n= 18) and more mature in follow-up (median follow-up six months), the mOS is currently estimated to be over 8 months (still subject to change as some patients are still ongoing). Annuncio • Mar 13
Faron Pharmaceuticals Oy Announces Board Changes Faron Pharmaceuticals Oy announced Frank Armstrong and Erik Ostrowski have informed the Board that they are not available for re-election at the Annual General Meeting to be held on 5 April 2024. Annuncio • Mar 06
Faron Pharmaceuticals Oy announced that it expects to receive €3.2 million in funding Faron Pharmaceuticals Oy entered into binding and irrevocable commitments with a limited number of the Company's existing shareholders to subscribe for convertible loan instruments to be issued by the Company for a proceeds of €3,200,000 on March 4, 2024. The Loans shall be converted to new shares in the Company as a part of the next investment round where shares or other equity securities are issued by the Company to existing shareholders and/or new third- party investors, with a minimum size of €8 million. The loan will bear no interest rate if a conversion takes place before 30 May 2024, and thereafter the interest will be 12% + 3-months Euribor and paid subject to the subordination agreement. The transaction is expected to close on March 8, 2024. The transaction will include participation from Timo Syrjälä for a proceeds of €600,000. Annuncio • Feb 20
Faron Pharmaceuticals Ltd Announces Events of Default Faron Pharmaceuticals Ltd. announced that it is in breach of several undertakings agreed in the secured debt agreement dated February 28, 2022 between IPF Fund II SCA, SICAV-FIAR ("IPF") as Lender and Faron Pharmaceuticals Ltd. as Borrower ("Funding Agreement") and subsequent waiver letters provided by IPF, and is therefore in several Events of Default, as defined in the Funding Agreement. Faron's bank accounts are pledged to IPF and IPF has notified Faron's banks of the blocking of the Pledged Accounts due to the above mentioned breaches. The Company presently does not have ability to remedy the breaches, nor make payments to third parties without separate consent from IPF. Negotiations related to possible restructuring of the loan facility as well as waiver of covenant obligations are ongoing with IPF. A further announcement will be made in due course. Annuncio • Jan 25
Faron Pharmaceuticals Ltd. Provides Details from Its Further Analysis of Data from the Completed Phase 1 Part of the Ongoing Bexmab Trial Faron Pharmaceuticals Ltd. provided details from its further analysis of data from the completed Phase 1 part of the ongoing BEXMAB trial. Patients are currently being enrolled in the Phase 2 of the BEXMAB trial, which is evaluating the safety and efficacy of investigational immunotherapy bexmarilimab at two dose levels (Project Optimus part), in combination with standard of care (SoC), in patients with hypomethylating agents (HMAs)-refractory or -relapsed myelodysplastic syndrome (MDS), an aggressive myeloid leukemia with very few treatment options. The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways. In the HMA-failed MDS patient group: Patients had been previously treated with azacitidine monotherapy or combinations of up to four therapies that included azacitidine or decitabine + magrolimab, venetoclax and sabatolimab, 3 of the 5 patients were refractory to previous HMA-therapy, with progressive disease (PD) or stable disease (SD) being the best responses achieved from that therapy, 2 out of the 5 patients had relapsed after treatment with azacitidine or an azacitidine/venetoclax combination. Annuncio • Jan 09
Faron Pharmaceuticals Ltd. Announces First HMA-failed MDS Patient Dosed with Bexmarilimab as part of Phase 2 of BEXMAB Trial Faron Pharmaceuticals Ltd. announced that the first patient has been dosed in Phase 2 of the BEXMAB trial that evaluates the safety and efficacy of bexmarilimab, in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), an aggressive myeloid leukemia with very few treatment options. The ongoing, randomized parallel-assigned Phase 2 part is enrolling 32 HMA-failed MDS patients at 3 mg/kg and 6 mg/kg dose levels of bexmarilimab. Dose levels have been selected in accordance with the FDA's Project Optimus initiative, which aims to reform the paradigm of dose optimization and selection in oncology drug development. Patients are being randomized 1:1 between the doses before moving into a Phase 2/3 study expansion. As previously detailed, data from the first 20 patients (10 per dose group) will be reviewed for exposure-to-benefit to compare the two selected dose levels. Post selection of final dosing, Faron intends to discuss a potential registrational study plan with the FDA. Faron is currently opening additional sites to speed up the trial's rapid recruitment, ahead of a future registrational study. The Company's key focus is to pursue an accelerated path to approval in refractory higher risk MDS, where no treatment option exists. Given the positive results to date, the Company will also explore the immunotherapy's potential in low risk MDS as well as chronic myelomonocytic leukaemia (CMML) patients, who are currently treated with HMA-based therapies treatment upon worsening of disease and consider further development and expansion opportunities with bexmarilimab in hematological cancers in the form of partnerships. Annuncio • Dec 23
Faron Pharmaceuticals Oy, Annual General Meeting, Mar 22, 2024 Faron Pharmaceuticals Oy, Annual General Meeting, Mar 22, 2024. Annuncio • Dec 12
Faron Pharmaceuticals Ltd. Presents Phase 1 Data from BEXMAB in Myeloid Malignancies Trial at the 65th American Society of Hematology Annual Meeting Faron Pharmaceuticals Ltd. announced very positive Phase 1 data from the ongoing BEXMAB study in myeloid Malignancies, being presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place until December 12, 2023, in San Diego, California, and virtually. The BEXMAB study is a multicenter study, taking place in Finland and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with standard of care in patients with aggressive myeloid leukemias. The data presented at ASH are promising, demonstrating a higher ORR and prolonged response duration in this trial compared to published historical benchmarks. These findings underscore the future potential of this combination in advancing the treatment of higher-risk and HMA- failed MDS patient populations. Annuncio • Dec 07
Faron Pharmaceuticals Oy Announces Publication of Full Analysis from Phase 1/2 MATINS Trial of Bexmarilimab in Solid Tumors in Cell Reports Medicine Faron Pharmaceuticals Ltd. announced the publication of the full safety and anti-tumor efficacy results from the first-in-human Phase 1/2 MATINS trial of bexmarilimab in patients with treatment-refractory late-stage solid tumors in Cell Reports Medicine. Clever-1 is highly expressed by the most immunosuppressive macrophages and contributes to impaired antigen presentation and suppression of anti-tumor immunity. Bexmarilimab is a humanized monoclonal anti-CLEVER-1 antibody that activates the immune system and evokes anti-tumor responses. The Phase 1/2 first-in-human MATINS trial evaluated the safety and efficacy of CLEVER-1 blockade with bexmarilimab in patients with treatment-refractory solid tumors. The monotherapy showed no dose-limiting toxicities and exhibited excellent safety and tolerability in over 200 patients. Observed disease control rates were associated with improved survival and were consistent with higher pre-treatment intratumoral CLEVER-1 levels and low baseline IFN? signaling that then increased during treatment. Transcriptomics profiling of the tumors demonstrated that bexmarilimab activates intra-tumoral macrophages and stimulates IFN? and T-cell receptors in a proportion of patients, which then leads to disease control and prolonged survival. New Risk • Nov 14
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: €29m Forecast net loss in 3 years: €8.6m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Negative equity (-€9.5m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€8.6m net loss in 3 years). Shareholders have been diluted in the past year (15% increase in shares outstanding). Annuncio • Nov 07
Faron Pharmaceuticals Initiates Phase 2 Part of BEXMAB Study of Bexmarilimab in HMA-Failed MDS Faron Pharmaceuticals Ltd. announced that based on guidance from the U.S. Food and Drug Administration (FDA), hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndromes (MDS) has been selected as the initial indication to advance to Phase 2 in the BEXMAB study investigating bexmarilimab in combination with standard of care (SoC). The BEXMAB study is a multicenter study, taking place in Finland and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with SoC in patients with aggressive myeloid leukemias. The Phase 2 part of the BEXMAB trial will enroll a total of 32 patients with HMA-failed MDS. Patients will be randomized 1:1 between the selected recommended doses for expansion (RDE) of 3 mg/kg or 6 mg/kg bexmarilimab before moving into a Phase 2/3 extension of the study. Data from the first 20 patients (10 per group) will be reviewed for exposure benefit for the two selected dose levels. Post selection of final dosing Faron intends to discuss a potential registrational study plan with the FDA. Data from the Phase 1 part of the study have demonstrated that optimal target engagement can be achieved with 3 mg/kg dosing. The highest immune activation, as observed in the accumulation of activated immune cells in patients’ bone marrow, was observed in both 3 mg/kg and 6 mg/kg cohorts. Both dose levels have been safe and well tolerated to date. The 3 mg/kg and 6 mg/kg doses were selected in accordance with the FDA’s Project Optimus initiative, which aims to reform the paradigms of dose optimization and selection in oncology drug development. Faron recently reported updated, positive data from the Phase 1 part of the BEXMAB trial. Bexmarilimab produced a 50% remission rate in doublet dose cohorts (11 out of 22 patients.) Eight out of 11 patients achieved complete remission in the bone marrow with or without blood count recovery. The highest overall response rate (ORR) of 80% was observed among the previously failed HMA MDS group (4 out of 5 patients). The bexmarilimab /SoC combination continues to be well-tolerated at all tested dose levels with no dose-limiting toxicities. Faron expects to open additional sites in the U.S. and Europe to keep up with the increased recruitment speed. Annuncio • Oct 28
Faron Pharmaceuticals Oy has completed a Follow-on Equity Offering in the amount of €7.102194 million. Faron Pharmaceuticals Oy has completed a Follow-on Equity Offering in the amount of €7.102194 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 2,491,998
Price\Range: €2.85
Transaction Features: Subsequent Direct Listing New Risk • Oct 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€24m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€24m free cash flow). Share price has been highly volatile over the past 3 months (10% average weekly change). Negative equity (-€9.5m). Revenue is less than US$1m. Minor Risk Shareholders have been diluted in the past year (11% increase in shares outstanding). Annuncio • Oct 11
Faron Announces Positive BEXMAB Study Update Faron Pharmaceuticals Ltd. announced updated data from the Phase 1/2 BEXMAB study investigating bexmarilimab in combination with standard of care (SoC) in relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients having failed hypomethylating agents (HMAs). The updated data are consistent with the high objective response rate observed in the previous results. The most recent data includes read outs from a total of 22 patients (r/r AML with 12 patients, MDS frontline and MDS HMA-failed patients with five patients each) who have completed at least two or more treatment cycles. Eight of 11 patients achieved complete remission in the bone marrow with or without blood count recovery. The highest single indication-specific ORR was observed among HMA-failed MDS patients (4 out of 5 patients; 80%). The combined study ORR continues to be high (11 out of 22 patients; 50%) across all patient groups having received two or more treatment cycles in the doublet. In most patients (75%), blast reduction was observed. A total of 29 patients have been recruited into the doublet cohort as of October 5, 2023. Bexmarilimab continues to be well-tolerated at all tested dose levels as no dose-limiting toxicity has been observed. A total of 18 drug-related events were observed with the majority below Grade 3. Five drug-related events were reported as Grade 3 and above, including immune-related events (capillary leak syndrome, hemophagocytic lymphohistiocytosis and cryptogenic organizing pneumonia), as well as one event of increased liver enzymes. Faron plans to initiate the Phase 2 part of the BEXMAB study in HMA-failed MDS and r/r AML patients in Fourth Quarter 2023. Consistent with the FDA's Project Optimus initiative, the planned Phase 2 will start with dose optimization and is expected to enroll 28-32 patients randomized between two selected doses. Faron plans to increase the number of US clinical sites from two to five sites to accelerate study recruitment. For more information on BEXMAB, please visit ClinicalTrials.gov and reference Identifier NCT05428969. Board Change • Sep 27
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Erik Ostrowski was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • Sep 23
Faron Pharmaceuticals Ltd. Announces Board Changes Faron Pharmaceuticals Ltd. announced the appointment of Ms. Christine Roth and Dr. Marie-Louise Fjällskog as Non-Executive Directors of the Company with immediate effect following the passing of all resolutions put to shareholders of the Company at the Extraordinary General Meeting held on September 22, 2023. Christine Ann Roth - Non-Executive Director: Ms. Christine Roth is a pharmaceutical executive with over three decades of experience in the industry. She has played key roles in the development and launch of several therapies, including the first immune-oncology therapy and intentionally designed targeted therapy combinations. Her career includes leadership positions at major pharmaceutical companies, such as Novartis, Bristol-Myers Squibb, GlaxoSmithKline (GSK), and most recently, Bayer AG, where she serves as the Executive Vice President of the Oncology Strategic Business Unit focussing on precision molecular oncology, next-generation immuno-oncology medicines, and radioligand therapies.AtGSK, she was responsible for the rebuild of the oncology business, including the integration of assets following the acquisition of Tesaro. Ms. Roth's expertise extends across various therapy areas, including Oncology, Cardiovascular, Metabolic, and Infectious Diseases. She is actively involved in industry associations, such as the American Society of Clinical Oncology and the American Society of Hematology. She holds a Bachelor's degree in Chemistry from the University of North Carolina at Chapel Hill. Dr. Marie-Louise Helena Fjällskog - Non-Executive Director: Dr. Marie-Louise Fjällskog is a professional with extensive experience in the pharmaceutical and biopharmaceutical industry, particularly in the field of clinical oncology, translational research, and drug development. She holds an MD degree and a Ph.D. from Uppsala University, Sweden, and is an Associate Professor of Oncology at the same institution. With over 25 years of clinical experience, Dr. Fjällskog has made significant contributions to the development of targeted therapies for cancer. She has held key roles in various pharmaceutical companies, such as Sensei Biotherapeutics, Merus, and Infinity Pharmaceuticals, where she led clinical development programs and played instrumental roles in their success, including Sensei's $152 million IPO in 2021. Her extensive expertise and leadership have also earned her a position on the board of Biovica International AB, a prominent biotech company in Sweden and in the US, respectively. She is also on the board of Norwegian company Lytix Biopharma. In January 2022, Dr. Fjällskog assumed the role of Chief Medical Officer at Faron where she lead Faron's clinical development programs, particularly the bexmarilimab program. Dr. Fjällskog stepped down from the CMO role on September 21, 2023. Annuncio • Sep 21
Faron Pharmaceuticals Ltd Appoints Birge Berns as Interim Chief Medical Officer Faron Pharmaceuticals Ltd. announced the appointment of Dr. Birge Berns, MD, as the Company's interim Chief Medical Officer (CMO). Dr. Berns will be based in the UK and her appointment is effective starting September 22, 2023. Dr. Berns succeeds Dr. Marie-Louise Fjällskog, who is stepping down from her current CMO role at Faron. The Board of Directors have proposed to the Extraordinary General Meeting of the Company convened for tomorrow, September 22, 2023, that Dr. Fjällskog would be nominated to the Company's Board of Directors in a Non-Executive Director role. In this new role as a Non-Executive Director, Dr. Fjällskog would continue to play an integral role in the development of Faron's wholly owned immunotherapy asset, bexmarilimab, providing her clinical and regulatory expertise to support the Company's progress. Dr. Berns is a seasoned senior pharmaceuticals executive with a background in oncology, clinical medicine, rheumatology and immunology. She brings more than 25 years' experience from senior leadership roles in global pharmaceutical companies, including Sanofi Aventis and Johnson & Johnson. Dr Berns is currently VP, Head of Clinical Development & Regulatory Strategy at tranScrip Limited, a strategic drug development partner that provides bespoke drug development services to pharma clients. She also serves as Chair of the Policy & Communication Group of the Faculty of Pharmaceutical Medicine, UK. Annuncio • Sep 08
Faron Pharmaceuticals Oy Announces Change in the Board of Directors Faron Pharmaceuticals Ltd. announces that its non-executive Board member, Anne Whitaker, has notified the Company of her intention to step down from the Board of Directors from September 22, 2023, by the end of the Company's Extraordinary General Meeting ("EGM"), due to her new executive role at another company. Subject to the proposed election of Dr. Marie-Louise Fjällskog and Christine Roth to the Board of Directors at the forthcoming EGM and to regulatory approval, the Directors of the Company will be as follows: Frank Armstrong (Chair), Marie-Louise Fjällskog, Markku Jalkanen, Erik Ostrowski, John Poulos, Tuomo Pätsi, Christine Roth. Annuncio • Jul 21
Faron Pharmaceuticals Ltd. Announces New Positive Clinical Data from the Ongoing Phase I/II BEXMAB Study Faron Pharmaceuticals Ltd. announced new positive clinical data from the Company's ongoing Phase I/II BEXMAB study. The BEXMAB study (ClinicalTrials.gov: NCT05428969) investigates bexmarilimab, Faron's wholly owned immunotherapy asset, in combination with standard of care (SoC) in the aggressive hematological malignancies of relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The data reported here builds on earlier positive results presented on June 9, 2023 at the European Hematology Association (EHA) 2023 Hybrid Congress. BEXMAB Phase I Study Update: Three of five patients in 6 mg/kg bexmarilimab + azacitidine doublet dosing cohort showed an objective response (OR) of complete remission of blasts in the bone marrow (mCR). In the three out of five patients in the 6 mg/kg + azacitidine doublet cohort, one patient also achieved a complete recovery of blood counts (CR). Eight of 15 ORs were observed across all three doublet dosing cohorts. Four of the eight patients across the three doublet dosing cohorts (1, 3 and 6 mg/kg) failed SoC hypomethylating agents (HMAs). All three patients with MDS and prior HMA failure demonstrated ORs (partial response (PR), mCR and CR) across dosing cohorts. Four patients out of six in the triplet dosing cohort treated with azacitidine, venetoclax and bexmarilimab have shown objective response. Faron plans to seek FDA advice during the Third Quarter 2023. It also expects to advance to the Phase II part of BEXMAB in the H2 2023 in patients who are refractory to SoC in AML and have failed HMAs in MDS. Annuncio • Jun 09
Faron Pharmaceuticals Oy Announces New Biomarker Data from BEXMAB Study at EHA2023 Faron Pharmaceuticals Oy announced the release of new biomarker data from the ongoing Phase I/II BEXMAB study of bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The data will feature in a poster presentation at the European Hematology Association (EHA) 2023 Hybrid Congress on June 9, 2023. In BEXMAB patients, a high Clever-1 expression in leukemic blasts is associated with lower levels of antigen presentation. The proposed mode of action of bexmarilim AB in AML/MDS is now supported by the biomarker data, which suggests durable Clever-1 target engagement in the bone marrow tumor microenvironment with increases observed in key cell types limiting cancer growth and spread, namely T and NK cells (up to 2-3-fold). In addition, bexmarilimab treatment increased HLA-DR expression by leukemic blasts, indicating improved immune recognition and eradication of the malignant cells. Bexmarilimab, a humanized IgG4 monoclonal antibody, binds common lymphatic endothelial and vascular endothelial receptor-1 (Clever-1), a novel macrophage checkpoint. Clever-1 alters the function of macrophages, a type of white blood cell that surrounds and kills micro-organisms. High Clever-1 expression is associated with therapeutic resistance and poor outcomes. Ex vivo treatment of AML bone marrow cells with bexmarilimab alone or in combination with azacitidine/venetoclax increases antigen presentation, induces secretion of proinflammatory cytokines (signaling proteins that help control inflammation in the body) and increases activation of white blood cells called T cells, which allows cancer to be targeted and eliminated. The BEXMAB study is a first-in-human, open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacytidine) treatment and to identify the recommended Phase II dose. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. Annuncio • Jun 05
Faron Pharmaceuticals Oy Announces Executive Changes Faron Pharmaceuticals Oy announced that Mr. Leopoldo Zambeletti is to take on a business development consulting role within Faron. Due to this new operational position, it is agreed that he will relinquish his Non-Executive Director board seat. Mr. Zambeletti joined Faron's Board as a Non-Executive Director in September 2015. He is a highly respected figure within the life sciences and investment banking industries and, since 2013, has been an independent strategic advisor to life science companies on mergers and acquisitions, out-licensing deals, and financing strategy. Mr. Zambeletti led the European Healthcare Investment team at JP Morgan for eight years before serving in the same role at Credit Suisse for an additional five years. He is a Non-Executive Director of Nogra Pharma, Philogen, Touchlight, LenioBio, Adler Ortho, Meatless Farm and Nogra Pharma Invest Sarl. Breakeven Date Change • Apr 18
Forecast to breakeven in 2025 The 4 analysts covering Faron Pharmaceuticals Oy expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €1.50m in 2025. Average annual earnings growth of 48% is required to achieve expected profit on schedule. Annuncio • Dec 24
Faron Pharmaceuticals Oy to Report Fiscal Year 2022 Results on Mar 02, 2023 Faron Pharmaceuticals Oy announced that they will report fiscal year 2022 results on Mar 02, 2023