PRESS RELEASE - PRIVILEGED INFORMATION
In view of the restructuring plan announced on April 11, 2024, BioSenic has decided to postpone the publication of its 2023 annual report as well as its annual general meeting of shareholders, so that the Enterprise Court of Nivelles can make a decision before the completion of the annual formalities. The Company believes that this postponement is preferable to ensure that the financial statements can be prepared on a going concern basis.
Mont-Saint-Guibert, Belgium, 24 April 2024, 7:00 am CET – BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases, today announces the postponing of the publication of its 2023 annual report, as well as the annual general meeting of its shareholders, so that the Enterprise Court of Nivelles can provide a decision before the closing of the annual formalities.
In light of the above, the publication of the full year results and the 2023 annual report is postponed to Thursday 6 June 2024 and the annual general meeting to Thursday 12 July 2024. The financial calendar on the company's website will be adapted in consequence. BioSenic can however not exclude to postpone further if circumstances oblige.
Regarding the key financial figures in 2023, the total operating income amounted to € 0.54 million, which is a slight increase compared to the same period in 2022 (i.e., € 0.27 million). The operating loss for the 2023 period amounted to € 6.36 million, compared to € 2.32 million in the 2022 period. BioSenic ended 2023 with € 0.12 million in cash and cash equivalents. Net cash used for the 2023 period amounted to € 1.73 million, while the cash position in 2022 increased of € 1.09 million. It should be noted that the financial figures reflected in the present press release are not yet audited.
François Rieger, PhD, President of the Board and CEO of the BioSenic Group, said: "BioSenic is in the process of finalizing the details of its restructuring plan to be submitted to the Enterprise Court of Nivelles. In order to offer a valid continuity perspective to all shareholders, we have agreed to wait for the Court's decision and to publish in due course - as soon as possible - the annual data and analyses necessary to fully inform the market. We should then be able to work most efficiently on the core of our mission, which is to address unmet medical needs in the autoimmune field"
About BioSenic
BioSenic is a leading biotech company specializing in the development of clinical assets issued from its Medsenic’s arsenic trioxide (ATO) platform. Key target indications for the autoimmune platform include graft-versus-host-disease (GvHD), systemic lupus erythematosus (SLE), and now systemic sclerosis (SSc).
Following the merger in October 2022, BioSenic combined the strategic positionings and strengths of Medsenic and Bone Therapeutics. The merger specifically enables Medsenic/Biosenic to develop an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/oral ATO (OATO).
BioSenic is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.biosenic.com.
About the main Medsenic/BioSenic technology platform
The ATO platform provides derived active products with immunomodulatory properties and fundamental effects on the activated cells of the immune system. One direct application is its use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in its chronic, established stage. cGvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Medsenic has been successful in a phase 2 trial with its intravenous formulation, Arscimed®, which has orphan drug designation status by FDA and EMA. The company is heading towards an international phase 3 confirmatory study, with its new, IP-protected, OATO formulation. Another selected target is moderate-to-severe forms of systemic lupus erythematosus (SLE), using the same oral formulation. ATO has shown good safety and significant clinical efficacy on several affected organs (skin, mucosae, and the gastrointestinal tract). Systemic sclerosis is now full part of the clinical pipeline of Medsenic/BioSenic. This serious chronic disease badly affects skin, lungs, or vascularization, and has no current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a phase 2 clinical protocol, using new immunomodulatory formulations of APIs recognized to be active on the immune system.
The company is currently focusing its present R&D and clinical activities on a selective, accelerated development of its autoimmune platform.
Note: The allogeneic cell therapy platform-originating from the previous listed company Bone Therapeutics company, may be of renewed interest by using isolated and purified differentiated bone marrow Mesenchymal Stromal Cells (MSCs) as a starting material for further isolation of passive or active biological subcellular elements. Indeed, these cells may provide new subcellular vesicles potentially able to deliver a unique and proprietary approach to organ repair. BioSenic is now involved in determining new patentable approaches in this complex area of cell therapy.
For further information, please contact:
BioSenic SA
François Rieger, PhD, CEO
Tel: +33 (0)671 73 31 59
investorrelations@biosenic.com
International Media Enquiries:
IB Communications
Michelle Boxall
Tel: +44 (0)20 8943 4685
michelle@ibcomms.agency
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the company or, as appropriate, the company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
