Faron Pharmaceuticals Oy

Dr. Markku Jalkanen and Dr. Sirpa Jalkanen, Faron’s co-founders, have been nominated as one of three finalists in the ‘SMEs’ category of prestigious European Patent Office AwardsNominated in recognition of research developing bexmarilimab, an investigational immunotherapy optimising clinical outcomes in cancer treatmentVoting now open for “Popular Prize” award ahead of ceremony on July 9 via dedicated link: Sirpa Jalkanen and Markku Jalkanen | Epo.org TURKU, Finland and BOSTON, May 16, 2024 (GLOBE NEWSWIRE) -- 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 the nomination of its co-founders, Dr. Markku Jalkanen and Dr. Sirpa Jalkanen, as finalists in the ‘SMEs’ category of the European Inventor Award 2024. Dr. Markku Jalkanen, co-founder, Board member and former CEO of Faron, and Dr. Sirpa Jalkanen, co-founder and member of Faron’s Scientific Advisory Board, have been nominated in recognition of their research developing Faron’s wholly owned precision cancer immunotherapy candidate, bexmarilimab. One of the most advanced myeloid cell-targeting immunotherapy candidates in development, bexmarilimab is designed to target the Clever-1 receptor present on macrophages, activating anti-tumor immunity in hematological and solid tumor microenvironments to overcome resistance and provide better patient outcomes. Bexmarilimab is currently being investigated in the ongoing BEXMAB trial, evaluating the candidate’s safety and efficacy 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. In addition, every year, the public can vote for their favorite inventor: the Popular Prize goes to the shortlisted inventor with the most votes. The winners in each category, and the winner of the Popular Prize, will be announced at the online award ceremony on 9 July 2024. For further information and to vote for the Popular Prize, visit: Sirpa Jalkanen and Markku Jalkanen | Epo.org Dr. Markku Jalkanen, Board member and former CEO of Faron, said: “It is an honor to be recognized by the European Patent Office and nominated for this prestigious award. The continued progress of our ambitious bexmarilimab development program and the exceptional data we are seeing in the ongoing Phase I/II BEXMAB trial, reaffirms our belief in the potential of bexmarilimab to change the treatment paradigm. These highly significant findings provide us with continued confidence that bexmarilimab can improve the quality of life of those suffering from these aggressive hematological cancers, where there are limited options available for future therapy.” Launched by the European Patent Office in 2006, the European Inventor Award is one of Europe’s most renowned innovation prizes. This award recognizes people behind successful inventions in small and medium-sized enterprises (SMEs) and honors individuals who transform their ideas into solutions to address some of the biggest challenges of our time. For more information please contact: Faron PharmaceuticalsInvestor ContactLifeSci AdvisorsDaniel FerryManaging Directordaniel@lifesciadvisors.com+1 (617) 430-7576 ICR ConsiliumMary-Jane Elliott, David Daley, Lindsey NevillePhone: +44 (0)20 3709 5700E-mail: faron@consilium-comms.com Cairn Financial Advisers LLP, NomadSandy Jamieson, Jo TurnerPhone: +44 (0) 207 213 0880 Peel Hunt LLP, BrokerChristopher Golden, James SteelPhone: +44 (0) 20 7418 8900 Sisu Partners Oy, Certified Adviser on Nasdaq First NorthJuha KarttunenPhone: +358 (0)40 555 4727Jukka JärveläPhone: +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. About BEXMABThe 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 BexmarilimabBexmarilimab 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.

Initial data from ongoing Phase 2 part of BEXMAB trial anticipated next monthIncoming CEO, Juho Jalkanen, to accelerate discussions with US regulator to coordinate plans for obtaining marketing approval for MDS patients that have failed HMA TURKU, Finland and BOSTON, April 16, 2024 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (“Faron” or the “Company”) (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 ongoing plans and activities for the coming months following the recent announcement of the proposed appointment of Dr. Juho Jalkanen as Chief Executive Officer, effective 1 May 2024. 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 readout 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. “2024 is set to be a pivotal year for Faron in the delivery of key milestones that will be critical to the further development of bexmarilimab,” said Dr. Juho Jalkanen, Faron’s incoming Chief Executive Officer. “In my new role as CEO, I am excited to start executing on some of these key activities and accelerating important discussions with the FDA as we map our future plans for bexmarilimab together. There is a tremendous need for an effective treatment in HMA-failed MDS patients, and so we are very keen to ensure we get this treatment option to patients as soon as we can.” For more information please contact: Faron PharmaceuticalsInvestor ContactLifeSci AdvisorsDaniel FerryManaging Directordaniel@lifesciadvisors.com+1 (617) 430-7576 ICR ConsiliumMary-Jane Elliott, David Daley, Lindsey NevillePhone: +44 (0)20 3709 5700E-mail: faron@consilium-comms.com Cairn Financial Advisers LLP, NomadSandy Jamieson, Jo TurnerPhone: +44 (0) 207 213 0880 Peel Hunt LLP, BrokerChristopher Golden, James SteelPhone: +44 (0) 20 7418 8900 Sisu Partners Oy, Certified Adviser on Nasdaq First NorthJuha KarttunenPhone: +358 (0)40 555 4727Jukka JärveläPhone: +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.

Initial data from ongoing Phase 2 part of BEXMAB trial anticipated next month Incoming CEO, Juho Jalkanen, to accelerate discussions with US regulator to coordinate plans for obtaining marketing approval for MDS patients that have failed HMA TURKU, Finland and BOSTON, April 16, 2024 (GLOBE NEWSWIRE) -- Faron Pharmaceuticals Ltd. (“Faron” or the “Company”) (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 ongoing plans and activities for the coming months following the recent announcement of the proposed appointment of Dr. Juho Jalkanen as Chief Executive Officer, effective 1 May 2024. 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 readout 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. “2024 is set to be a pivotal year for Faron in the delivery of key milestones that will be critical to the further development of bexmarilimab,” said Dr. Juho Jalkanen, Faron’s incoming Chief Executive Officer. “In my new role as CEO, I am excited to start executing on some of these key activities and accelerating important discussions with the FDA as we map our future plans for bexmarilimab together. There is a tremendous need for an effective treatment in HMA-failed MDS patients, and so we are very keen to ensure we get this treatment option to patients as soon as we can.” 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 .