View Future GrowthBioSenic 과거 순이익 실적과거 기준 점검 0/6BioSenic은 연평균 7.8%의 비율로 수입이 증가해 온 반면, Biotechs 산업은 연평균 17%의 비율로 증가했습니다. 매출은 연평균 189.6%의 비율로 감소했습니다.핵심 정보7.84%순이익 성장률204.22%주당순이익(EPS) 성장률Biotechs 산업 성장률-3.59%매출 성장률-189.57%자기자본이익률n/a순이익률167.41%최근 순이익 업데이트30 Jun 2025최근 과거 실적 업데이트공시 • Apr 26+ 1 more updateBioSenic S.A. to Report Fiscal Year 2023 Results on Jun 06, 2024BioSenic S.A. announced that they will report fiscal year 2023 results on Jun 06, 2024모든 업데이트 보기Recent updatesNew Risk • May 17New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2025. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€24m). Revenue is less than US$1m. Market cap is less than US$10m (€1.44m market cap, or US$1.67m). Minor Risk Latest financial reports are more than 6 months old (reported June 2025 fiscal period end).Board Change • Feb 13High number of new and inexperienced directorsThere are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. 7 experienced directors. No highly experienced directors. Interim CEO & Director Jean-Luc Vandebroek is the most experienced director on the board, commencing their role in 2022. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model.New Risk • Sep 30New major risk - Financial data availabilityThe company's latest financial reports are more than a year old. Last reported fiscal period ended June 2024. This is considered a major risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. In the worst case scenario, it may be facing other major going concern issues jeopardizing its viability as a listed company. Currently, the following risks have been identified for the company: Major Risks Latest financial reports are more than 1 year old (reported June 2024 fiscal period end). Share price has been highly volatile over the past 3 months (9.2% average weekly change). Negative equity (-€20m). Shareholders have been substantially diluted in the past year (160% increase in shares outstanding). Market cap is less than US$10m (€1.63m market cap, or US$1.92m). Minor Risk Revenue is less than US$5m (€2.7m revenue, or US$3.1m).New Risk • Apr 17New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Negative equity (-€20m). Shareholders have been substantially diluted in the past year (200% increase in shares outstanding). Market cap is less than US$10m (€989.4k market cap, or US$1.12m). Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Revenue is less than US$5m (€2.9m revenue, or US$3.3m).공시 • Oct 28BioSenic S.A. Announces Executive ChangesBioSenic S.A. announced that In October 2024, Carole Nicco stepped down from her roles as Chief Scientific and Operations Officer of BioSenic to focus on the subsidiary Medsenic SAS.공시 • Sep 17Véronique Pomi-Schneiter Step Down as BioSenic's Deputy CEOBioSenic announced that Véronique Pomi-Schneiter resignes for personal reasons as Deputy CEO of BioSenic. Véronique Pomi-Schneiter will fully assist in the transition process and continue to serve as non-executive member of the board of directors of BioSenic, as well as an executive member of the board of directors (i.e., the strategic committee) of its subsidiary, Medsenic SAS.공시 • Aug 14+ 1 more updateMedsenic, Subsidiary of Biosenic Receives the Intention to Grant Key European Patent from European Patent OfficeBioSenic announced that the European Patent Office has granted an important new EU patent to its subsidiary Medsenic entitled: Method For Treating Relapsing-Remitting Multiple Sclerosis Using Arsenic Trioxide (EP18722530, priority date May 4, 2018). Medsenic had earlier sponsored a preclinical study showing that a well-known and accepted mouse model of multiple sclerosis, which exhibits inflammatory and degenerative features reminiscent of human RRMS, could delay the onset of the disease or treat it. This preclinical model (Experimental Allergic Encephalomyelitis: EAE) is induced by MOG35-55/CFA immunization and pertussis toxin injection in C57BL/6 mice and allows to study the effects of ATO on the inflammatory processes active in early MS development (RRMS), thus focusing on the early manifestations of RRMS. These data had previously supported the granting of a USPTO patent (US10716807), protecting the same application in the US. The present extension will facilitate projects to license and develop phase 2-3 clinical trials for the most prevalent form of Multiple Sclerosis, RRMS. BioSenic has also recently published data on the mechanism of action of arsenic trioxide (ATO), which gives further grounds to understand its immunomodulatory effects on inflammation. These data, published in peer-reviewed international journals in 2022 and 2023, now allow Medsenic to develop the use of various formulations of Arsenic trioxide, including new innovating combinations with excipients or APIs, opening a wider field of applications, particularly in the fields of autoimmunity, infectious diseases and cancer. The expected EU patent allows the specific application of Medsenic's arsenic platform to the key human health indication, Multiple Sclerosis. This patent is part of Medsenic/BioSenic's extensive efforts to conduct international clinical trials in pathologies with clear unmet medical needs, using all the potential of ATO based treatments.공시 • Jul 18Biosenic Releases New In-Depth Analysis of Its Positive Phase 2 Clinical Data for Optimal Administration Scheme for Its Next Late-Stage Trial of Arsenic Trioxide (Ato) Targeting CgvhdBioSenic S.A. announced the final results of a new, detailed post-hoc analysis of the Company's previous Phase 2 clinical trial of ATO for the first-line curative treatment of cGvHD. The analysis will be used to determine the optimal posology of therapeutic oral ATO administration for BioSenic's upcoming clinical trial(s) and will be submitted for peer review prior to preparation of the necessary regulatory filings for trial approvals. BioSenic's new in-depth post-hoc clinical analysis of the Phase 2 clinical data now shows that in the group of patients who did not respond after first so-called induction cycle, more patients (20%) responded after a consolidation cycle of treatment. As a result, BioSenic will continue to use this 2-cycle, time-limited regimen. This will consist of a double four-week course. In addition, BioSenic has determined that an increase in the number of weekly injections over a four-week course could significantly increase the positive effect of the treatment on the biological and cellular parameters of the disease, consistent with a full effect of the drug at levels determined to be very safe for patients. BioSenic's goal is to finally select the best conditions for administering effective and safe doses of arsenic trioxide to achieve a convincing curative treatment of cGvHD, for which there is currently no alternative effective long-term therapy. In the field of oncology, intravenous (IV) ATO has been accepted as a first-line treatment for acute promyelocytic leukemia (APL) since 2002, with demonstrated safety and long-term remissions. Until now, ATO in APL has been administered daily by IV infusion for up to or more than one hundred cumulative doses. IV administration requires hospitalization, is inconvenient for patients, results in reduced quality of life and is expensive. The anticipated introduction of an oral formulation of ATO in 2 cycles of four full weeks each, corresponding to an optimal dosing regimen, will significantly improve patient quality of life and compliance while reducing healthcare costs. This will be the next achievement in BioSenic's broader goal to contribute improved and potentially curative treatments for an autoimmune disease for which there are currently no satisfactory medical solutions.New Risk • May 16New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 73% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks No financial data reported. Share price has been highly volatile over the past 3 months (11% average weekly change). Shareholders have been substantially diluted in the past year (73% increase in shares outstanding). Market cap is less than US$10m (€3.16m market cap, or US$3.43m).공시 • Apr 26+ 1 more updateBioSenic S.A. to Report Fiscal Year 2023 Results on Jun 06, 2024BioSenic S.A. announced that they will report fiscal year 2023 results on Jun 06, 2024공시 • Mar 12Biosenic S.A. Releases Details of Optimized Administration Approach Ahead of Planned Phase 3 Trial of OATO for Chronic Graft-Versus-Host DiseaseBioSenic S.A. announces the publication of an open-access article describing an optimized schedule for administration of oral arsenic trioxide (OATO) treatment for chronic graft-versus-host disease (cGvHD), based on an earlier post-hoc analysis of Phase 2 data. The schedule will play an important role in the protocol for BioSenic’s forthcoming pivotal Phase 3 clinical trial. GvHD is a common occurrence following allogeneic hematopoietic stem cell transplantation, used to treat a range of blood and immune diseases, including several leukaemias and lymphomas. Standard treatment begins with corticosteroids, with mixed outcomes, and those with a chronic form of GvHD may need to continue treatment for years, highlighting the clear unmet need for better treatment. BioSenic previously conducted a Phase 2 clinical trial of intravenous ATO in cGvHD treatment following stem cell transplant, with results showing that the first-line use of ATO and corticosteroids in patients with moderate to severe disease is associated with both a high clinical response rate and less need for corticosteroids. Last year, BioSenic announced the results of an additional, observational post-hoc analysis of the full set of clinical data from the Phase 2 trial, improving the overall understanding of clinical response, safety (SAE/AE related to ATO) and cGVHD severity evolution after short cycle(s) of ATO treatment. It shows that the risk of loss of overall response over time is greater in patients who received only one cycle of ATO since they are in partial or complete remission at week 6 post-treatment compared to patients who received two cycles of second-line treatment. The use of 2 cycles of 4 weeks each, separated by a rest period of 4 weeks on ATO at 0.15mg/kg/day, should be optimal for the future treatment of cGvHD patients. The therapeutic schedule of the upcoming Phase 3 trial will be adapted thanks to a recent advance that allowed for an oral ATO formulation that can be taken at home. BioSenic is committed to exploiting the immune modulating potential of ATO in new ways for a range of diseases. In oncology, intravenous treatment with ATO has made acute promyelocytic leukaemia (APL) the most curable blood cancer since 20021,2. The company is now introducing an oral formulation of ATO under an exclusive licensing agreement from its partner Phebra for use in a one-month cycle treatment, repeated twice, which will significantly improve patient quality of life and compliance while reducing healthcare costs. BioSenic aims to better address the unmet medical need in cGvHD with this oral, take-at-home formulation, proven in earlier studies on APL patients to be safe and bioavailable compared to an intravenous delivered formulation. In addition, the company is developing other formulations to expand its potential applications into other immune-related disease areas.공시 • Jan 30BioSenic S.A. Patent Granted in Canada for Broader Protection of ATO Therapeutic PlatformBioSenic S.A. patent granted in Canada for broader protection of its ATO therapeutic platform; Composition-of-matter patent covers the therapeutic use of arsenic salts and metal ions through various routes of administration; Enriched IP portfolio protects arsenic trioxide (ATO) use combined with copper ions delivery, which has demonstrated increased therapeutic potential for indications ranging from immune to cancer and infectious diseases. The second is in oncology, where ATO has already demonstrated exceptional results for patients, including complete remission in acute promyelocytic leukaemia. These patents will support BioSenic's plans for international clinical trials in pathologies with unmet medical needs, toward the company's long-term goal of seeking market access approvals for its various formulations, optimizing the original properties of arsenic salts - alone or in combination. The expected availability of an oral formulation that combines arsenic and copper puts BioSenic in a unique position to build on clinical successes in its fields of applications. As a result, BioSenic will be able to continue clinical development with proprietary original formulations containing arsenic and new active ingredients such as metal ions, increasing the potency of its products, and minimizing secondary side effects. The Canadian patent, corresponding to Application 3,138,472, was granted to Medsenic, a subsidiary of BioSenic.공시 • Jan 25BioSenic Presents New Phase 3 Data on JTA-004 to Treat Severe Osteoarthritis Pain at the 2024 OARSI World CongressBioSenic announced that it will for the first time share post hoc data on its late-clinical asset JTA-004 at the Osteoarthritis Research Society International (OARSI) World Congress 2024. The post hoc analysis of a Phase 3 study found that a single injection of JTA-004 was safe and efficacious for patients with a newly characterized severe inflammatory subtype of knee osteoarthritis (OA). The data will be presented by Yves Henrotin, Ph.D, a professor at University of Liege in Belgium (musculoSKeletal Innovative research Lab, mSKIL), Center for Interdisciplinary Research on Medicine, CIRM), as well as Founder and the Chairman of the Board of Artialis, which performed the analysis. JTA-004 is an innovative intra-articular viscosupplement treatment for knee OA, composed of hyaluronic acid, plasmatic proteins, and clonidine. BioSenic recently filed an additional patent application to support further development of JTA-004 for severe OA. The initial results in a broad pool including patients with several subtypes were inconclusive. However, BioSenic was inspired to reevaluate the previous data following the publication of a study that identified biomarkers to stratify OA phenotypes, including a disease subtype characterized by systemic inflammation and the most severe symptoms. The conclusion of the post hoc analysis is that JTA-004 is safe and effective for successfully treating symptoms in this inflammatory-driven subgroup. BioSenic recently filed an additional patent application to support further development of JTA-004 for severe OA.공시 • Jan 23BioSenic Files for Additional Patent Protection Following New Clinical Evidence of Efficacy for JTA-004 in OABioSenic announced the filing of a U.S. patent for JTA-004, a viscosupplement in late-stage clinical development, following new evidence of its efficacy in a recently defined subtype of osteoarthritis (OA). There are several types of OA. In 2022, outside investigators published findings that defined three subtypes based on biomarkers - including a severe form marked by high levels of pain, of certain biomarkers and persistent and progressive inflammation. The rights were initially acquired from Bone Therapeutics following a reverse merger with Medsenic SAS to form BioSenic. As BioSenic develops a new clinical plan, this position will support steps toward commercializing JTA-004 for patients experiencing severe pain from knee OA. JTA-004 differs from other hyaluronic acid-based products for OA in its inclusion of clonidine, an alpha-2 adrenergic inhibitor, as an active pharmacological component. Its analgesic properties have been known for decades, and more recent data has demonstrated prolonged local anti-inflammatory activity, as well as a normalizing effect on cell differentiation of chondrocytes. New findings publishedii this month in Nature further connect chondrocytes to degeneration in knee OA, providing further potential explanation for JTA-004's positive clinical results in reducing symptoms of pain and inflammation in severe cases.공시 • Jan 10Biosenic S.A. and Its Subsidiary Medsenic SAS Announces the Promotion of Carole Nicco to Chief Operating OfficerBioSenic S.A. and its subsidiary Medsenic SAS announces the promotion of Dr. Carole Nicco to Chief Operating Officer (COO) in addition to her position as Chief Scientific Officer (CSO). Dr. Carole Nicco will be involved in the strategic planning, decision-making and management of key initiatives, as well as overseeing and enhancing the strategic development of BioSenic's pipelines, targeting treatments with its visco supplementation, cell therapy and arsenic trioxide platforms. She will work closely with BioSenic's CEO, Prof. François Rieger, to further oversee and enhance BioSenic's strategic decisions. Dr. Nicco has already begun to meet and interact with key global players interested in the development of the global BioSenic project or targeted therapeutic innovations. BioSenic wishes her all due success in her new commitments in company.New Risk • Oct 25New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €8.49m (US$8.98m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks No financial data reported. Share price has been highly volatile over the past 3 months (43% average weekly change). Market cap is less than US$10m (€8.49m market cap, or US$8.98m).공시 • Sep 28BioSenic S.A. Performs Further Analysis of Its Phase 2 Clinical Trial Data, Leading to an Optimal Administration Scheme for Its Next Late-Stage Trial of Arsenic Trioxide in cGvHDBIOSENIC announced the completion of a post-hoc analysis of its phase 2 clinical trial of ATO, finding the best scheme for administration of an efficient treatment of cGvHD. The analysis will be used to decide on the best oral ATO’s posology for BioSenic’s forthcoming phase 3 clinical trial. BioSenic phase 2 clinical trial entitled ‘Treatment of Chronic Graft Versus Host Disease with Arsenic Trioxide (GvHD-ATO)’ was conducted from 2016 to 2020 (ClinicalTrials.gov ID NCT02966301 - GMED16-001). The first results were originally published in 2022 in the peer-reviewed journal Transplantation and Cellular Therapy under the title ‘High Response Rate and Corticosteroid (CS) Sparing with Arsenic Trioxide-Based First-Line Therapy in Chronic Graft-versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation’. These collated results demonstrated that the first-line use of ATO and corticosteroids is associated with a high clinical response rate and rapid CS sparing in moderate to severe cGvHD following allo-HSCT (current standard treatment for several types of leukaemias). The primary endpoint of the phase 2 trial was preliminary efficacy based on the overall response rate (ORR; complete response [CR] or partial response [PR]) at 6 months, after 1 or 2 cycles of intravenous (IV) ATO treatment. At 6 months, the ORR was 75.0%, with a CR rate of 35% and PR of 40%. BioSenic’s new post-hoc analysis of the full set of clinical data gained during the phase 2 trial shows that among the group of patients who did not achieved complete remission after the first course, a significant one-fifth of these patients had a positive primary endpoint following a second cycle of treatment. As a result, BioSenic will further use this 2-cycle treatment in its forthcoming trials. This will involve the administration of a double four-week course, separated by a rest period, resulting in a two-to-four times higher total dose of ATO. BioSenic expects thus to get closer to the optimal conditions for a curative treatment for cGvHD, for which there is currently no satisfactory therapy. In the field of oncology, IV ATO is used as a first-line treatment for acute promyelocytic leukemia (APL) since 2003, with demonstrated safety and long-term remissions. Until now, in APL, ATO was administered daily by IV infusions for up to, or more than, a hundred accumulated doses. IV administration, because it requires hospitalization, is not practical for patients, results in lower quality of life, and is very expensive. The introduction of an oral formulation of ATO during 2 short cycles, presently BioSenic’s optimal design of administration, will greatly improve patient quality of life and compliance, while reducing healthcare costs. This is a significant achievement in BioSenic’s aim to contribute improved and potentially curative treatment for an autoimmune disease, with no current satisfactory medical solutions.공시 • Sep 20BioSenic Publishes New Evidence of Beneficial Effects of Arsenic Treatment Supporting Clinical Trial for Systemic SclerosisBIOSENIC announced the publication of data providing additional key indications of its lead API (Active Pharmaceutical Ingredient) arsenic trioxide (ATO) to treat systemic sclerosis (SSc) in a peer-reviewed international journal. The new data, in a third valuable preclinical model, show a significant reduction in inflammatory infiltration and a strong improvement in vascular remodeling, mediated by an immune status improvement, particularly involving T-cells. These findings represent a substantial advancement in understanding of the complex interplay between inflammation-driven fibrosis and the pathophysiology of SSc. These results give ground to the proposed clinical relevance of ATO treatment in SSc, and more generally in autoimmune pathologies, where lung is often impacted by fibrosis and vascular remodeling. In oncology, ATO is now recognized as a first-line treatment for acute promyelocytic leukaemia, with demonstrated safety and long-term remission. BioSenic had recently further demonstrated the safety and efficacy of ATO treatment in successful clinical programs targeting chronic Graft-versus-Host Disease, in a phase 2 and Systemic Lupus Erythematosus (SLE), in a phase 2a trial. BioSenic believes that the clinical data it has helped to generate over the past decade, together with its ongoing efforts to understand the cellular pathways that are controlled by ATO administration at the right dose and time, now allow for further expansion of clinical trials targets. This applies to new indications in autoimmunity and inflammatory diseases. This is a reason why BioSenic specifically selected SSc for a systematic clinical approach to testing ATO as a novel first-in-class therapy.New Risk • Jul 17New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €8.52m (US$9.57m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks No financial data reported. Share price has been highly volatile over the past 3 months (13% average weekly change). Market cap is less than US$10m (€8.52m market cap, or US$9.57m).공시 • Jun 19BioSenic S.A. Puts Phase IIb Allob Trial on HoldBioSenic announced the decision to suspend its interventional trial on fracture healing, using the ex-Bone-Therapeutics lead product, ALLOB. This decision follows negative results obtained for the primary endpoint in the exploratory Phase IIb trial (ALLOB IIb), which focused on safety and treatment timing efficacy. The aim of this Phase IIb study was to evaluate the efficacy of administering ALLOB (derived from mesenchymal stem cells) a couple of days after a bone fracture to accelerate fracture healing. In contrast to the previous successful Phase IIa, where ALLOB was administered after 3.5 to 7 months, in 21 long bone fractures with documented delayed- or non-union, early application of ALLOB did not accelerate the fracture healing process. BioSenic, through the Medsenic company autoimmune disease platform had completed a successful phase II trial targeting cGVHD (chronic Graft vs Host Disease), with a demonstrated efficacy of more than 75% on the Full Study Population and 84% on the Per Protocol Population. A phase III study is now in the starting blocks to reach the market as quickly as possible, through the framework of an expedite 505(b)(2) FDA regulatory pathway.공시 • Jan 27BioSenic S.A. Appoints Yves Sagot as Independent DirectorBioSenic announced the appointment of Yves Sagot as a Member of the Board and Independent Director. Yves co-founded Relief Therapeutics in 2013 to develop a clinical asset acquired from Merck Serono. In 2016, Relief Therapeutics went public on the Swiss stock exchange (SIX) after a reverse merger with THERAMetrics. Whilst maintaining his activities as Chief Scientific Officer at Relief Therapeutics, Yves created MBS Sagot Consulting in 2018 to provide to the life science market senior expertise covering research and early clinical development. Subsequently, after leaving Relief Therapeutics, he is a private investor in biotechnology via MBS Invest & Consult Sàrl. He is also one of the ambassadors of the Léon Bérard Cancer Center. He has authored 25 papers that have been published in international peer-reviewed journals, holds three granted patents and received the Serono CEO Award in 2001 and the Merck Serono Reward and Recognition Award in 2008. Yves Sagot replaces Terry Sadler as an Independent Director and Member of the Board at BioSenic.Yves Sagot has been appointed to the BioSenic Board for his experience and achievements for Relief Therapeutics SA and a number of specific aspects that mirror recent BioSenic developments.공시 • Jan 18BioSenic Appoints Dr. Carole Nicco as Chief Scientific OfficerBioSenic announced it is strengthening its scientific team with the appointment of Dr. Carole Nicco, as Chief Scientific Officer (CSO). Dr. Carole Nicco will be responsible for managing the company’s scientific research and development. She will work closely with the company’s CEO, Prof. François Rieger, to further supervise and enhance the company’s strategic pipeline development, targeting treatments with its cell therapy and autoimmune disease platforms. Dr. Nicco brings more than two decades of expertise in cancer biology and immunology, inflammation, immunity, new target identification and drug discovery. Prior to joining the company, Dr. Nicco has actively conducted programs from research all the way through to preclinical trials in collaboration with renown pharma companies (Vertex, BOIRON, IPRAD/GYNOV, Medsenic). Additionally, she has directed dozens of preclinical studies for pathologies ranging from cancer to endometriosis, as well as in autoimmune diseases (SLE, SSc, cGVHD) or pathologies implicating the immune system, including wound healing, uveitis, sepsis, hepatitis and endometriosis. From 2005 to 2023, Carole was one of the principle investigators and the lab manager of the research team Pathogeny andinnovative treatments for chronic fibro-inflammatory diseases at Cochin Institute, a biomedical research center affiliated with INSERM (Unit 1016), CNRS (UMR 8104) and Paris Cité University. She was also head of the conventional preclinical structure of the Cochin Institute for the 10 last years. Since 2016, Dr. Nicco is a member of the scientific committee and advisory board of four international congresses: Paris Redox, Targeting Mitochondria, Targeting Microbiota and Skin Challenges. In 2023, Dr. Nicco becomes President of the international non-profit organization Redox Medecine Society (previous International Society of Antioxidants in Nutrition and Health). She is the author of 110 articles published in international scientific journals in the fields of autoimmune disorders, inflammation and cancer. Dr. Nicco holds a Ph.D. in human physiology and physiopathology from Denis Diderot University of Paris, France.공시 • Dec 03BioSenic S.A. Appoints Michel Wurm as Interim Chief Medical OfficerBioSenic announced it has appointed Michel Wurm, MD, as interim Chief Medical Officer (CMO), responsible for the development of both of BioSenic’s cell therapy and autoimmune disease platforms. Michel Wurm replaces Anne Leselbaum as interim CMO and as an independent consultant. His appointment will commence with immediate effect. Both Michel and Anne worked and collaborated closely together alongside the medical and scientific teams throughout the processes of the merger between Bone Therapeutics and Medsenic, from when the discussions between the two companies started in May 2022. Michel will serve as CMO whilst BioSenic selects a permanent CMO from the list of candidates it is currently compiling. The new CMO will be selected for his/her expertise and experience in both autoimmunity and cell therapy. Michel has been selected as interim CMO primarily for his previous achievements for MedSenic. He has acquired considerable knowledge of clinical development, specifically in phase II and III. In Michel’s career, he has designed and managed over 50 international phase II and III clinical studies and has extensive experience in working within clinical guidelines for, and interacting with regulatory agencies including the FDA and EMA. Michel has also acquired experience in a number of therapeutic target areas including cardiovascular diseases, inflammation and auto-immunity. Michel has also gained wider expertise in innovative drug development, including launching start-ups, filing patents, and raising funds for both private and public companies. Michel wrote the French adaption of ‘The Investigator's Guide to Clinical Research’, a manual for investigators and health professionals involved in conducting clinical research, investigator financial disclosure, noncompliance issues, the FDA audit process and data collection technologies. As Michel has been instrumental in bringing together the clinical pipelines of Bone Therapeutics and Medsenic during the merger process, he has gained full working knowledge of the current clinical progress of the cell therapy platform ALLOB and has extensive working knowledge of the autoimmune platform using arsenic trioxide (ATO), and specifically its clinical development in cGvHD (chronic Graft vs Host Disease). Michel will be immediately responsible for continued progression of both BioSenic assets: The ALLOB MSC platform using cells with immune privilege, anti-inflammatory properties and the ability to differentiate into bone tissues when injected into the specific bone sites to be regenerated or repaired. The phase IIb trial of ALLOB, a randomized, double-blind, placebo-controlled study in patients with high-risk tibial fractures, is still ongoing and set to report important interim results in H1 2023. Michel will progress this trial to the intermediary analysis stage. This includes overall responsibility for liaising with the CRO nominated for the trial, and liaising with investigators in the thirty-five trial centers across seven EU countries. For the autoimmune ATO platform using ATO, Michel will also be focused on the start of the phase III trial in cGvHD, and will oversee the commencement of recruitment for the trial in a US center, to be selected shortly.Board Change • Nov 16Less than half of directors are independentFollowing the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 5 non-independent directors. Independent Director Terry Sadler 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.공시 • Nov 08BioSenic SA provides update on its autoimmune disease platform based on ATO (arsenic trioxide)BioSenic S.A. announced an update on its systemic autoimmune disease platform, originally designed by Medsenic. The update follows the announcement of the merger between Bone Therapeutics and Medsenic, and the listing on Euronext Brussels and Paris. The BioSenic autoimmune platform has been constructed to target systemic autoimmune diseases using arsenic trioxide (ATO). This uses ATO’s first-in-class mechanism of action as an active anti-inflammatory and immunomodulatory agent. The unique efficacy of ATO to create long-lasting remission of a rare cancer condition, acute promyelocytic leukemia (APL), has been previously recognized by both FDA and EMA, with market approvals. BioSenic is now further actively clinically testing ATO as a main therapeutic asset for autoimmune diseases. There are two mechanisms of action of arsenic trioxide for counteracting autoimmunity and inflammatory chronic diseases. The first is a significant increase in oxidative stress of activated immune cells leading to their death. The second inhibits the synthesis and/or release of proinflammatory cytokines. By combining the mechanisms of action, inflammation and active autoimmunity is drastic decreased. These immunomodulatory properties have important and long-lasting effects on the immune pathology in a number of autoimmune diseases. This has been extensively previously demonstrated in adequate animal models by Medsenic and other organizations. BioSenic assets now comprise two platforms: The ALLOB MSC platform uses cells with immune privilege, anti-inflammatory properties and the ability to differentiate into bone tissues when injected into the specific bone sites to be regenerated or repaired. The phase IIb trial of ALLOB, a randomized, double-blind, placebo-controlled study in patients with high-risk tibial fractures, is still ongoing and set to report important interim results in first half 2023; The autoimmune disease platform using ATO has completed a phase IIb trial with positive results on safety and efficacy in 20 patients for cGVHD (chronic Graft vs Host Disease). A headline result for this corticosteroid-controlled trial was that patient’s corticosteroids levels decreased as soon as six weeks following the start of the treatment with ATO, to reach minimal levels. The acquired clinical results and expected results from both platforms enable BioSenic to move forward into confirmatory Phase III studies prior to Market Access procedures with regulatory agencies in US and Europe. The phase III study of the autoimmune disease platform in cGvHD (Chronic Graft vs Host Disease) has been designed to reach the market as quickly as possible through the framework of an expedite 505b2 FDA regulatory pathway. In addition to cGVHD, BioSenic is also preparing a randomized placebo-controlled phase IIb study with ATO in Systemic Lupus Erythematosus. This disease has a high prevalence - the worldwide prevalence of SLE can reach 108 per 100,000 inhabitants and its incidence 5.14 per 100,000 inhabitants per year (Tian et al, 2022, Ann Reum. Dis.). As a result, this disease is potentially a strategic target for BioSenic. In addition, promising preclinical data gathered by Medsenic has provided clinical data to support a phase II clinical trial with ATO targeting systemic sclerosis. As a result, BioSenic expects key value creation milestones in first half 2023 with the interim phase IIb results of ALLOB and the start of the phase III study with ATO in cGvHD. BioSenic will start the process to engage with industrial partners to co-develop late-stage clinical projects and to look at other segments of interest in autoimmune diseases and cancer.Board Change • Nov 02Less than half of directors are independentFollowing the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 5 non-independent directors. Independent Director Terry Sadler 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.매출 및 비용 세부 내역BioSenic가 돈을 벌고 사용하는 방법. 최근 발표된 LTM 실적 기준.순이익 및 매출 추이ENXTBR:BIOS 매출, 비용 및 순이익 (EUR Millions)날짜매출순이익일반관리비연구개발비30 Jun 25-2-42131 Mar 25-1-42131 Dec 240-53230 Sep 241-63330 Jun 243-73331 Mar 242-184431 Dec 230-294430 Sep 230-263430 Jun 231-223331 Mar 230-122231 Dec 220-22131 Dec 210-111양질의 수익: BIOS 은(는) 현재 수익성이 없습니다.이익 마진 증가: BIOS는 현재 수익성이 없습니다.잉여현금흐름 대비 순이익 분석과거 순이익 성장 분석수익추이: BIOS는 수익성이 없지만 지난 5년 동안 연평균 7.8%의 속도로 손실을 줄였습니다.성장 가속화: 현재 수익성이 없어 지난 1년간 BIOS의 수익 성장률을 5년 평균과 비교할 수 없습니다.수익 대 산업: BIOS은 수익성이 없어 지난 해 수익 성장률을 Biotechs 업계(45%)와 비교하기 어렵습니다.자기자본이익률높은 ROE: BIOS의 부채가 자산을 초과하여 자본 수익률을 계산하기 어렵습니다.총자산이익률투하자본수익률우수한 과거 실적 기업을 찾아보세요7D1Y7D1Y7D1YPharmaceuticals-biotech 산업에서 과거 실적이 우수한 기업.View Financial Health기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/05/22 11:30종가2026/05/22 00:00수익2025/06/30연간 수익2024/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스BioSenic S.A.는 1명의 분석가가 다루고 있습니다. 이 중 0명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Stephanie LefebvreGilbert Dupont
공시 • Apr 26+ 1 more updateBioSenic S.A. to Report Fiscal Year 2023 Results on Jun 06, 2024BioSenic S.A. announced that they will report fiscal year 2023 results on Jun 06, 2024
New Risk • May 17New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2025. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€24m). Revenue is less than US$1m. Market cap is less than US$10m (€1.44m market cap, or US$1.67m). Minor Risk Latest financial reports are more than 6 months old (reported June 2025 fiscal period end).
Board Change • Feb 13High number of new and inexperienced directorsThere are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. 7 experienced directors. No highly experienced directors. Interim CEO & Director Jean-Luc Vandebroek is the most experienced director on the board, commencing their role in 2022. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model.
New Risk • Sep 30New major risk - Financial data availabilityThe company's latest financial reports are more than a year old. Last reported fiscal period ended June 2024. This is considered a major risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. In the worst case scenario, it may be facing other major going concern issues jeopardizing its viability as a listed company. Currently, the following risks have been identified for the company: Major Risks Latest financial reports are more than 1 year old (reported June 2024 fiscal period end). Share price has been highly volatile over the past 3 months (9.2% average weekly change). Negative equity (-€20m). Shareholders have been substantially diluted in the past year (160% increase in shares outstanding). Market cap is less than US$10m (€1.63m market cap, or US$1.92m). Minor Risk Revenue is less than US$5m (€2.7m revenue, or US$3.1m).
New Risk • Apr 17New minor risk - Financial data availabilityThe company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Negative equity (-€20m). Shareholders have been substantially diluted in the past year (200% increase in shares outstanding). Market cap is less than US$10m (€989.4k market cap, or US$1.12m). Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Revenue is less than US$5m (€2.9m revenue, or US$3.3m).
공시 • Oct 28BioSenic S.A. Announces Executive ChangesBioSenic S.A. announced that In October 2024, Carole Nicco stepped down from her roles as Chief Scientific and Operations Officer of BioSenic to focus on the subsidiary Medsenic SAS.
공시 • Sep 17Véronique Pomi-Schneiter Step Down as BioSenic's Deputy CEOBioSenic announced that Véronique Pomi-Schneiter resignes for personal reasons as Deputy CEO of BioSenic. Véronique Pomi-Schneiter will fully assist in the transition process and continue to serve as non-executive member of the board of directors of BioSenic, as well as an executive member of the board of directors (i.e., the strategic committee) of its subsidiary, Medsenic SAS.
공시 • Aug 14+ 1 more updateMedsenic, Subsidiary of Biosenic Receives the Intention to Grant Key European Patent from European Patent OfficeBioSenic announced that the European Patent Office has granted an important new EU patent to its subsidiary Medsenic entitled: Method For Treating Relapsing-Remitting Multiple Sclerosis Using Arsenic Trioxide (EP18722530, priority date May 4, 2018). Medsenic had earlier sponsored a preclinical study showing that a well-known and accepted mouse model of multiple sclerosis, which exhibits inflammatory and degenerative features reminiscent of human RRMS, could delay the onset of the disease or treat it. This preclinical model (Experimental Allergic Encephalomyelitis: EAE) is induced by MOG35-55/CFA immunization and pertussis toxin injection in C57BL/6 mice and allows to study the effects of ATO on the inflammatory processes active in early MS development (RRMS), thus focusing on the early manifestations of RRMS. These data had previously supported the granting of a USPTO patent (US10716807), protecting the same application in the US. The present extension will facilitate projects to license and develop phase 2-3 clinical trials for the most prevalent form of Multiple Sclerosis, RRMS. BioSenic has also recently published data on the mechanism of action of arsenic trioxide (ATO), which gives further grounds to understand its immunomodulatory effects on inflammation. These data, published in peer-reviewed international journals in 2022 and 2023, now allow Medsenic to develop the use of various formulations of Arsenic trioxide, including new innovating combinations with excipients or APIs, opening a wider field of applications, particularly in the fields of autoimmunity, infectious diseases and cancer. The expected EU patent allows the specific application of Medsenic's arsenic platform to the key human health indication, Multiple Sclerosis. This patent is part of Medsenic/BioSenic's extensive efforts to conduct international clinical trials in pathologies with clear unmet medical needs, using all the potential of ATO based treatments.
공시 • Jul 18Biosenic Releases New In-Depth Analysis of Its Positive Phase 2 Clinical Data for Optimal Administration Scheme for Its Next Late-Stage Trial of Arsenic Trioxide (Ato) Targeting CgvhdBioSenic S.A. announced the final results of a new, detailed post-hoc analysis of the Company's previous Phase 2 clinical trial of ATO for the first-line curative treatment of cGvHD. The analysis will be used to determine the optimal posology of therapeutic oral ATO administration for BioSenic's upcoming clinical trial(s) and will be submitted for peer review prior to preparation of the necessary regulatory filings for trial approvals. BioSenic's new in-depth post-hoc clinical analysis of the Phase 2 clinical data now shows that in the group of patients who did not respond after first so-called induction cycle, more patients (20%) responded after a consolidation cycle of treatment. As a result, BioSenic will continue to use this 2-cycle, time-limited regimen. This will consist of a double four-week course. In addition, BioSenic has determined that an increase in the number of weekly injections over a four-week course could significantly increase the positive effect of the treatment on the biological and cellular parameters of the disease, consistent with a full effect of the drug at levels determined to be very safe for patients. BioSenic's goal is to finally select the best conditions for administering effective and safe doses of arsenic trioxide to achieve a convincing curative treatment of cGvHD, for which there is currently no alternative effective long-term therapy. In the field of oncology, intravenous (IV) ATO has been accepted as a first-line treatment for acute promyelocytic leukemia (APL) since 2002, with demonstrated safety and long-term remissions. Until now, ATO in APL has been administered daily by IV infusion for up to or more than one hundred cumulative doses. IV administration requires hospitalization, is inconvenient for patients, results in reduced quality of life and is expensive. The anticipated introduction of an oral formulation of ATO in 2 cycles of four full weeks each, corresponding to an optimal dosing regimen, will significantly improve patient quality of life and compliance while reducing healthcare costs. This will be the next achievement in BioSenic's broader goal to contribute improved and potentially curative treatments for an autoimmune disease for which there are currently no satisfactory medical solutions.
New Risk • May 16New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 73% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks No financial data reported. Share price has been highly volatile over the past 3 months (11% average weekly change). Shareholders have been substantially diluted in the past year (73% increase in shares outstanding). Market cap is less than US$10m (€3.16m market cap, or US$3.43m).
공시 • Apr 26+ 1 more updateBioSenic S.A. to Report Fiscal Year 2023 Results on Jun 06, 2024BioSenic S.A. announced that they will report fiscal year 2023 results on Jun 06, 2024
공시 • Mar 12Biosenic S.A. Releases Details of Optimized Administration Approach Ahead of Planned Phase 3 Trial of OATO for Chronic Graft-Versus-Host DiseaseBioSenic S.A. announces the publication of an open-access article describing an optimized schedule for administration of oral arsenic trioxide (OATO) treatment for chronic graft-versus-host disease (cGvHD), based on an earlier post-hoc analysis of Phase 2 data. The schedule will play an important role in the protocol for BioSenic’s forthcoming pivotal Phase 3 clinical trial. GvHD is a common occurrence following allogeneic hematopoietic stem cell transplantation, used to treat a range of blood and immune diseases, including several leukaemias and lymphomas. Standard treatment begins with corticosteroids, with mixed outcomes, and those with a chronic form of GvHD may need to continue treatment for years, highlighting the clear unmet need for better treatment. BioSenic previously conducted a Phase 2 clinical trial of intravenous ATO in cGvHD treatment following stem cell transplant, with results showing that the first-line use of ATO and corticosteroids in patients with moderate to severe disease is associated with both a high clinical response rate and less need for corticosteroids. Last year, BioSenic announced the results of an additional, observational post-hoc analysis of the full set of clinical data from the Phase 2 trial, improving the overall understanding of clinical response, safety (SAE/AE related to ATO) and cGVHD severity evolution after short cycle(s) of ATO treatment. It shows that the risk of loss of overall response over time is greater in patients who received only one cycle of ATO since they are in partial or complete remission at week 6 post-treatment compared to patients who received two cycles of second-line treatment. The use of 2 cycles of 4 weeks each, separated by a rest period of 4 weeks on ATO at 0.15mg/kg/day, should be optimal for the future treatment of cGvHD patients. The therapeutic schedule of the upcoming Phase 3 trial will be adapted thanks to a recent advance that allowed for an oral ATO formulation that can be taken at home. BioSenic is committed to exploiting the immune modulating potential of ATO in new ways for a range of diseases. In oncology, intravenous treatment with ATO has made acute promyelocytic leukaemia (APL) the most curable blood cancer since 20021,2. The company is now introducing an oral formulation of ATO under an exclusive licensing agreement from its partner Phebra for use in a one-month cycle treatment, repeated twice, which will significantly improve patient quality of life and compliance while reducing healthcare costs. BioSenic aims to better address the unmet medical need in cGvHD with this oral, take-at-home formulation, proven in earlier studies on APL patients to be safe and bioavailable compared to an intravenous delivered formulation. In addition, the company is developing other formulations to expand its potential applications into other immune-related disease areas.
공시 • Jan 30BioSenic S.A. Patent Granted in Canada for Broader Protection of ATO Therapeutic PlatformBioSenic S.A. patent granted in Canada for broader protection of its ATO therapeutic platform; Composition-of-matter patent covers the therapeutic use of arsenic salts and metal ions through various routes of administration; Enriched IP portfolio protects arsenic trioxide (ATO) use combined with copper ions delivery, which has demonstrated increased therapeutic potential for indications ranging from immune to cancer and infectious diseases. The second is in oncology, where ATO has already demonstrated exceptional results for patients, including complete remission in acute promyelocytic leukaemia. These patents will support BioSenic's plans for international clinical trials in pathologies with unmet medical needs, toward the company's long-term goal of seeking market access approvals for its various formulations, optimizing the original properties of arsenic salts - alone or in combination. The expected availability of an oral formulation that combines arsenic and copper puts BioSenic in a unique position to build on clinical successes in its fields of applications. As a result, BioSenic will be able to continue clinical development with proprietary original formulations containing arsenic and new active ingredients such as metal ions, increasing the potency of its products, and minimizing secondary side effects. The Canadian patent, corresponding to Application 3,138,472, was granted to Medsenic, a subsidiary of BioSenic.
공시 • Jan 25BioSenic Presents New Phase 3 Data on JTA-004 to Treat Severe Osteoarthritis Pain at the 2024 OARSI World CongressBioSenic announced that it will for the first time share post hoc data on its late-clinical asset JTA-004 at the Osteoarthritis Research Society International (OARSI) World Congress 2024. The post hoc analysis of a Phase 3 study found that a single injection of JTA-004 was safe and efficacious for patients with a newly characterized severe inflammatory subtype of knee osteoarthritis (OA). The data will be presented by Yves Henrotin, Ph.D, a professor at University of Liege in Belgium (musculoSKeletal Innovative research Lab, mSKIL), Center for Interdisciplinary Research on Medicine, CIRM), as well as Founder and the Chairman of the Board of Artialis, which performed the analysis. JTA-004 is an innovative intra-articular viscosupplement treatment for knee OA, composed of hyaluronic acid, plasmatic proteins, and clonidine. BioSenic recently filed an additional patent application to support further development of JTA-004 for severe OA. The initial results in a broad pool including patients with several subtypes were inconclusive. However, BioSenic was inspired to reevaluate the previous data following the publication of a study that identified biomarkers to stratify OA phenotypes, including a disease subtype characterized by systemic inflammation and the most severe symptoms. The conclusion of the post hoc analysis is that JTA-004 is safe and effective for successfully treating symptoms in this inflammatory-driven subgroup. BioSenic recently filed an additional patent application to support further development of JTA-004 for severe OA.
공시 • Jan 23BioSenic Files for Additional Patent Protection Following New Clinical Evidence of Efficacy for JTA-004 in OABioSenic announced the filing of a U.S. patent for JTA-004, a viscosupplement in late-stage clinical development, following new evidence of its efficacy in a recently defined subtype of osteoarthritis (OA). There are several types of OA. In 2022, outside investigators published findings that defined three subtypes based on biomarkers - including a severe form marked by high levels of pain, of certain biomarkers and persistent and progressive inflammation. The rights were initially acquired from Bone Therapeutics following a reverse merger with Medsenic SAS to form BioSenic. As BioSenic develops a new clinical plan, this position will support steps toward commercializing JTA-004 for patients experiencing severe pain from knee OA. JTA-004 differs from other hyaluronic acid-based products for OA in its inclusion of clonidine, an alpha-2 adrenergic inhibitor, as an active pharmacological component. Its analgesic properties have been known for decades, and more recent data has demonstrated prolonged local anti-inflammatory activity, as well as a normalizing effect on cell differentiation of chondrocytes. New findings publishedii this month in Nature further connect chondrocytes to degeneration in knee OA, providing further potential explanation for JTA-004's positive clinical results in reducing symptoms of pain and inflammation in severe cases.
공시 • Jan 10Biosenic S.A. and Its Subsidiary Medsenic SAS Announces the Promotion of Carole Nicco to Chief Operating OfficerBioSenic S.A. and its subsidiary Medsenic SAS announces the promotion of Dr. Carole Nicco to Chief Operating Officer (COO) in addition to her position as Chief Scientific Officer (CSO). Dr. Carole Nicco will be involved in the strategic planning, decision-making and management of key initiatives, as well as overseeing and enhancing the strategic development of BioSenic's pipelines, targeting treatments with its visco supplementation, cell therapy and arsenic trioxide platforms. She will work closely with BioSenic's CEO, Prof. François Rieger, to further oversee and enhance BioSenic's strategic decisions. Dr. Nicco has already begun to meet and interact with key global players interested in the development of the global BioSenic project or targeted therapeutic innovations. BioSenic wishes her all due success in her new commitments in company.
New Risk • Oct 25New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €8.49m (US$8.98m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks No financial data reported. Share price has been highly volatile over the past 3 months (43% average weekly change). Market cap is less than US$10m (€8.49m market cap, or US$8.98m).
공시 • Sep 28BioSenic S.A. Performs Further Analysis of Its Phase 2 Clinical Trial Data, Leading to an Optimal Administration Scheme for Its Next Late-Stage Trial of Arsenic Trioxide in cGvHDBIOSENIC announced the completion of a post-hoc analysis of its phase 2 clinical trial of ATO, finding the best scheme for administration of an efficient treatment of cGvHD. The analysis will be used to decide on the best oral ATO’s posology for BioSenic’s forthcoming phase 3 clinical trial. BioSenic phase 2 clinical trial entitled ‘Treatment of Chronic Graft Versus Host Disease with Arsenic Trioxide (GvHD-ATO)’ was conducted from 2016 to 2020 (ClinicalTrials.gov ID NCT02966301 - GMED16-001). The first results were originally published in 2022 in the peer-reviewed journal Transplantation and Cellular Therapy under the title ‘High Response Rate and Corticosteroid (CS) Sparing with Arsenic Trioxide-Based First-Line Therapy in Chronic Graft-versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation’. These collated results demonstrated that the first-line use of ATO and corticosteroids is associated with a high clinical response rate and rapid CS sparing in moderate to severe cGvHD following allo-HSCT (current standard treatment for several types of leukaemias). The primary endpoint of the phase 2 trial was preliminary efficacy based on the overall response rate (ORR; complete response [CR] or partial response [PR]) at 6 months, after 1 or 2 cycles of intravenous (IV) ATO treatment. At 6 months, the ORR was 75.0%, with a CR rate of 35% and PR of 40%. BioSenic’s new post-hoc analysis of the full set of clinical data gained during the phase 2 trial shows that among the group of patients who did not achieved complete remission after the first course, a significant one-fifth of these patients had a positive primary endpoint following a second cycle of treatment. As a result, BioSenic will further use this 2-cycle treatment in its forthcoming trials. This will involve the administration of a double four-week course, separated by a rest period, resulting in a two-to-four times higher total dose of ATO. BioSenic expects thus to get closer to the optimal conditions for a curative treatment for cGvHD, for which there is currently no satisfactory therapy. In the field of oncology, IV ATO is used as a first-line treatment for acute promyelocytic leukemia (APL) since 2003, with demonstrated safety and long-term remissions. Until now, in APL, ATO was administered daily by IV infusions for up to, or more than, a hundred accumulated doses. IV administration, because it requires hospitalization, is not practical for patients, results in lower quality of life, and is very expensive. The introduction of an oral formulation of ATO during 2 short cycles, presently BioSenic’s optimal design of administration, will greatly improve patient quality of life and compliance, while reducing healthcare costs. This is a significant achievement in BioSenic’s aim to contribute improved and potentially curative treatment for an autoimmune disease, with no current satisfactory medical solutions.
공시 • Sep 20BioSenic Publishes New Evidence of Beneficial Effects of Arsenic Treatment Supporting Clinical Trial for Systemic SclerosisBIOSENIC announced the publication of data providing additional key indications of its lead API (Active Pharmaceutical Ingredient) arsenic trioxide (ATO) to treat systemic sclerosis (SSc) in a peer-reviewed international journal. The new data, in a third valuable preclinical model, show a significant reduction in inflammatory infiltration and a strong improvement in vascular remodeling, mediated by an immune status improvement, particularly involving T-cells. These findings represent a substantial advancement in understanding of the complex interplay between inflammation-driven fibrosis and the pathophysiology of SSc. These results give ground to the proposed clinical relevance of ATO treatment in SSc, and more generally in autoimmune pathologies, where lung is often impacted by fibrosis and vascular remodeling. In oncology, ATO is now recognized as a first-line treatment for acute promyelocytic leukaemia, with demonstrated safety and long-term remission. BioSenic had recently further demonstrated the safety and efficacy of ATO treatment in successful clinical programs targeting chronic Graft-versus-Host Disease, in a phase 2 and Systemic Lupus Erythematosus (SLE), in a phase 2a trial. BioSenic believes that the clinical data it has helped to generate over the past decade, together with its ongoing efforts to understand the cellular pathways that are controlled by ATO administration at the right dose and time, now allow for further expansion of clinical trials targets. This applies to new indications in autoimmunity and inflammatory diseases. This is a reason why BioSenic specifically selected SSc for a systematic clinical approach to testing ATO as a novel first-in-class therapy.
New Risk • Jul 17New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €8.52m (US$9.57m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks No financial data reported. Share price has been highly volatile over the past 3 months (13% average weekly change). Market cap is less than US$10m (€8.52m market cap, or US$9.57m).
공시 • Jun 19BioSenic S.A. Puts Phase IIb Allob Trial on HoldBioSenic announced the decision to suspend its interventional trial on fracture healing, using the ex-Bone-Therapeutics lead product, ALLOB. This decision follows negative results obtained for the primary endpoint in the exploratory Phase IIb trial (ALLOB IIb), which focused on safety and treatment timing efficacy. The aim of this Phase IIb study was to evaluate the efficacy of administering ALLOB (derived from mesenchymal stem cells) a couple of days after a bone fracture to accelerate fracture healing. In contrast to the previous successful Phase IIa, where ALLOB was administered after 3.5 to 7 months, in 21 long bone fractures with documented delayed- or non-union, early application of ALLOB did not accelerate the fracture healing process. BioSenic, through the Medsenic company autoimmune disease platform had completed a successful phase II trial targeting cGVHD (chronic Graft vs Host Disease), with a demonstrated efficacy of more than 75% on the Full Study Population and 84% on the Per Protocol Population. A phase III study is now in the starting blocks to reach the market as quickly as possible, through the framework of an expedite 505(b)(2) FDA regulatory pathway.
공시 • Jan 27BioSenic S.A. Appoints Yves Sagot as Independent DirectorBioSenic announced the appointment of Yves Sagot as a Member of the Board and Independent Director. Yves co-founded Relief Therapeutics in 2013 to develop a clinical asset acquired from Merck Serono. In 2016, Relief Therapeutics went public on the Swiss stock exchange (SIX) after a reverse merger with THERAMetrics. Whilst maintaining his activities as Chief Scientific Officer at Relief Therapeutics, Yves created MBS Sagot Consulting in 2018 to provide to the life science market senior expertise covering research and early clinical development. Subsequently, after leaving Relief Therapeutics, he is a private investor in biotechnology via MBS Invest & Consult Sàrl. He is also one of the ambassadors of the Léon Bérard Cancer Center. He has authored 25 papers that have been published in international peer-reviewed journals, holds three granted patents and received the Serono CEO Award in 2001 and the Merck Serono Reward and Recognition Award in 2008. Yves Sagot replaces Terry Sadler as an Independent Director and Member of the Board at BioSenic.Yves Sagot has been appointed to the BioSenic Board for his experience and achievements for Relief Therapeutics SA and a number of specific aspects that mirror recent BioSenic developments.
공시 • Jan 18BioSenic Appoints Dr. Carole Nicco as Chief Scientific OfficerBioSenic announced it is strengthening its scientific team with the appointment of Dr. Carole Nicco, as Chief Scientific Officer (CSO). Dr. Carole Nicco will be responsible for managing the company’s scientific research and development. She will work closely with the company’s CEO, Prof. François Rieger, to further supervise and enhance the company’s strategic pipeline development, targeting treatments with its cell therapy and autoimmune disease platforms. Dr. Nicco brings more than two decades of expertise in cancer biology and immunology, inflammation, immunity, new target identification and drug discovery. Prior to joining the company, Dr. Nicco has actively conducted programs from research all the way through to preclinical trials in collaboration with renown pharma companies (Vertex, BOIRON, IPRAD/GYNOV, Medsenic). Additionally, she has directed dozens of preclinical studies for pathologies ranging from cancer to endometriosis, as well as in autoimmune diseases (SLE, SSc, cGVHD) or pathologies implicating the immune system, including wound healing, uveitis, sepsis, hepatitis and endometriosis. From 2005 to 2023, Carole was one of the principle investigators and the lab manager of the research team Pathogeny andinnovative treatments for chronic fibro-inflammatory diseases at Cochin Institute, a biomedical research center affiliated with INSERM (Unit 1016), CNRS (UMR 8104) and Paris Cité University. She was also head of the conventional preclinical structure of the Cochin Institute for the 10 last years. Since 2016, Dr. Nicco is a member of the scientific committee and advisory board of four international congresses: Paris Redox, Targeting Mitochondria, Targeting Microbiota and Skin Challenges. In 2023, Dr. Nicco becomes President of the international non-profit organization Redox Medecine Society (previous International Society of Antioxidants in Nutrition and Health). She is the author of 110 articles published in international scientific journals in the fields of autoimmune disorders, inflammation and cancer. Dr. Nicco holds a Ph.D. in human physiology and physiopathology from Denis Diderot University of Paris, France.
공시 • Dec 03BioSenic S.A. Appoints Michel Wurm as Interim Chief Medical OfficerBioSenic announced it has appointed Michel Wurm, MD, as interim Chief Medical Officer (CMO), responsible for the development of both of BioSenic’s cell therapy and autoimmune disease platforms. Michel Wurm replaces Anne Leselbaum as interim CMO and as an independent consultant. His appointment will commence with immediate effect. Both Michel and Anne worked and collaborated closely together alongside the medical and scientific teams throughout the processes of the merger between Bone Therapeutics and Medsenic, from when the discussions between the two companies started in May 2022. Michel will serve as CMO whilst BioSenic selects a permanent CMO from the list of candidates it is currently compiling. The new CMO will be selected for his/her expertise and experience in both autoimmunity and cell therapy. Michel has been selected as interim CMO primarily for his previous achievements for MedSenic. He has acquired considerable knowledge of clinical development, specifically in phase II and III. In Michel’s career, he has designed and managed over 50 international phase II and III clinical studies and has extensive experience in working within clinical guidelines for, and interacting with regulatory agencies including the FDA and EMA. Michel has also acquired experience in a number of therapeutic target areas including cardiovascular diseases, inflammation and auto-immunity. Michel has also gained wider expertise in innovative drug development, including launching start-ups, filing patents, and raising funds for both private and public companies. Michel wrote the French adaption of ‘The Investigator's Guide to Clinical Research’, a manual for investigators and health professionals involved in conducting clinical research, investigator financial disclosure, noncompliance issues, the FDA audit process and data collection technologies. As Michel has been instrumental in bringing together the clinical pipelines of Bone Therapeutics and Medsenic during the merger process, he has gained full working knowledge of the current clinical progress of the cell therapy platform ALLOB and has extensive working knowledge of the autoimmune platform using arsenic trioxide (ATO), and specifically its clinical development in cGvHD (chronic Graft vs Host Disease). Michel will be immediately responsible for continued progression of both BioSenic assets: The ALLOB MSC platform using cells with immune privilege, anti-inflammatory properties and the ability to differentiate into bone tissues when injected into the specific bone sites to be regenerated or repaired. The phase IIb trial of ALLOB, a randomized, double-blind, placebo-controlled study in patients with high-risk tibial fractures, is still ongoing and set to report important interim results in H1 2023. Michel will progress this trial to the intermediary analysis stage. This includes overall responsibility for liaising with the CRO nominated for the trial, and liaising with investigators in the thirty-five trial centers across seven EU countries. For the autoimmune ATO platform using ATO, Michel will also be focused on the start of the phase III trial in cGvHD, and will oversee the commencement of recruitment for the trial in a US center, to be selected shortly.
Board Change • Nov 16Less than half of directors are independentFollowing the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 5 non-independent directors. Independent Director Terry Sadler 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.
공시 • Nov 08BioSenic SA provides update on its autoimmune disease platform based on ATO (arsenic trioxide)BioSenic S.A. announced an update on its systemic autoimmune disease platform, originally designed by Medsenic. The update follows the announcement of the merger between Bone Therapeutics and Medsenic, and the listing on Euronext Brussels and Paris. The BioSenic autoimmune platform has been constructed to target systemic autoimmune diseases using arsenic trioxide (ATO). This uses ATO’s first-in-class mechanism of action as an active anti-inflammatory and immunomodulatory agent. The unique efficacy of ATO to create long-lasting remission of a rare cancer condition, acute promyelocytic leukemia (APL), has been previously recognized by both FDA and EMA, with market approvals. BioSenic is now further actively clinically testing ATO as a main therapeutic asset for autoimmune diseases. There are two mechanisms of action of arsenic trioxide for counteracting autoimmunity and inflammatory chronic diseases. The first is a significant increase in oxidative stress of activated immune cells leading to their death. The second inhibits the synthesis and/or release of proinflammatory cytokines. By combining the mechanisms of action, inflammation and active autoimmunity is drastic decreased. These immunomodulatory properties have important and long-lasting effects on the immune pathology in a number of autoimmune diseases. This has been extensively previously demonstrated in adequate animal models by Medsenic and other organizations. BioSenic assets now comprise two platforms: The ALLOB MSC platform uses cells with immune privilege, anti-inflammatory properties and the ability to differentiate into bone tissues when injected into the specific bone sites to be regenerated or repaired. The phase IIb trial of ALLOB, a randomized, double-blind, placebo-controlled study in patients with high-risk tibial fractures, is still ongoing and set to report important interim results in first half 2023; The autoimmune disease platform using ATO has completed a phase IIb trial with positive results on safety and efficacy in 20 patients for cGVHD (chronic Graft vs Host Disease). A headline result for this corticosteroid-controlled trial was that patient’s corticosteroids levels decreased as soon as six weeks following the start of the treatment with ATO, to reach minimal levels. The acquired clinical results and expected results from both platforms enable BioSenic to move forward into confirmatory Phase III studies prior to Market Access procedures with regulatory agencies in US and Europe. The phase III study of the autoimmune disease platform in cGvHD (Chronic Graft vs Host Disease) has been designed to reach the market as quickly as possible through the framework of an expedite 505b2 FDA regulatory pathway. In addition to cGVHD, BioSenic is also preparing a randomized placebo-controlled phase IIb study with ATO in Systemic Lupus Erythematosus. This disease has a high prevalence - the worldwide prevalence of SLE can reach 108 per 100,000 inhabitants and its incidence 5.14 per 100,000 inhabitants per year (Tian et al, 2022, Ann Reum. Dis.). As a result, this disease is potentially a strategic target for BioSenic. In addition, promising preclinical data gathered by Medsenic has provided clinical data to support a phase II clinical trial with ATO targeting systemic sclerosis. As a result, BioSenic expects key value creation milestones in first half 2023 with the interim phase IIb results of ALLOB and the start of the phase III study with ATO in cGvHD. BioSenic will start the process to engage with industrial partners to co-develop late-stage clinical projects and to look at other segments of interest in autoimmune diseases and cancer.
Board Change • Nov 02Less than half of directors are independentFollowing the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 5 non-independent directors. Independent Director Terry Sadler 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.