Board Change • May 20
High number of new and inexperienced directors There 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. Duyuru • Oct 28
BioSenic S.A. Announces Executive Changes BioSenic 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. Duyuru • Sep 17
Véronique Pomi-Schneiter Step Down as BioSenic's Deputy CEO BioSenic 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. Duyuru • Jul 18
Biosenic 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 Cgvhd BioSenic 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 16
New major risk - Shareholder dilution The 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 (75% 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). Duyuru • Mar 12
Biosenic S.A. Releases Details of Optimized Administration Approach Ahead of Planned Phase 3 Trial of OATO for Chronic Graft-Versus-Host Disease BioSenic 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. Duyuru • Jan 30
BioSenic S.A. Patent Granted in Canada for Broader Protection of ATO Therapeutic Platform BioSenic 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. Duyuru • Jan 25
BioSenic Presents New Phase 3 Data on JTA-004 to Treat Severe Osteoarthritis Pain at the 2024 OARSI World Congress BioSenic 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. Duyuru • Jan 23
BioSenic Files for Additional Patent Protection Following New Clinical Evidence of Efficacy for JTA-004 in OA BioSenic 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. Duyuru • Jan 10
Biosenic S.A. and Its Subsidiary Medsenic SAS Announces the Promotion of Carole Nicco to Chief Operating Officer BioSenic 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 25
New major risk - Market cap size The 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 (58% average daily change). Market cap is less than US$10m (€8.49m market cap, or US$8.98m). Duyuru • Sep 28
BioSenic 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 cGvHD BIOSENIC 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. Duyuru • Sep 20
BioSenic Publishes New Evidence of Beneficial Effects of Arsenic Treatment Supporting Clinical Trial for Systemic Sclerosis BIOSENIC 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 18
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.52m (US$9.56m) 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 (16% average weekly change). Market cap is less than US$10m (€8.52m market cap, or US$9.56m). Duyuru • Jun 19
BioSenic S.A. Puts Phase IIb Allob Trial on Hold BioSenic 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. Duyuru • Jan 27
BioSenic S.A. Appoints Yves Sagot as Independent Director BioSenic 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. Duyuru • Jan 18
BioSenic Appoints Dr. Carole Nicco as Chief Scientific Officer BioSenic 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. Board Change • Nov 16
Less than half of directors are independent Following 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. Board Change • Nov 02
Less than half of directors are independent Following 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. 