Press Release – Regulatory Information
Mont Saint-Guibert, Belgium, May 24, 2024, 17:00 CET Bioscenic (Euronext Brussels and Paris: BIOS)a clinical-stage company focused on treating serious autoimmune and inflammatory diseases and cell therapies, today announced an update on its financial results for the first quarter ended March 31, 2024.
Key highlights
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In January 2024, BioSenic entered into an initial subscription agreement for a convertible note facility of up to €1.2 million arranged by ABO Securities through its affiliate Global Tech Opportunities 15.
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In January 2024, Dr. Carol Nicco was promoted to Chief Operating Officer (COO) in addition to her role as Chief Scientific Officer (CSO).
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In January 2024, Medsenic SAS, a subsidiary of BioSenic, signed a binding term sheet with Phebra PTY Ltd. in connection with the License Agreement and amendment to the MDA entered into in May 2021.
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In January 2024, Bioscenic filed a U.S. patent for JTA-004, a viscosupplement in clinical development, following new evidence of efficacy in recently defined subtypes of osteoarthritis (OA).
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In January 2024, BioScenic received a patent from the Canadian Intellectual Property Office expanding the scope of protection for its arsenic trioxide (ATO) platform. The patent, entitled “Use of Metal Ions to Enhance the Therapeutic Effect of Arsenic,” covers the use of the ATO platform in combination with metal ions, such as copper.
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In February 2024, BioSenic raised €500,000 through a private placement.
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In March 2024, BioSenic published 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 a post-hoc analysis of phase II data.
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In April 2024, BioSenic submitted its global restructuring plan for 2024 to 2030 to the Nivelle Corporate Court.
Financial Highlights
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Net cash at end of March 2024 is €380,000 (1).
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Operating cash burn for the full year 2024 is in the range of €4.5 million to €5.5 million, with financial cash burn of approximately €800,000. BioSenic expects to have sufficient cash to pursue its operational objectives through the third quarter of 2024, assuming, among other things, a debt restructuring in line with the plan it has filed with the Nivelles Corporate Court.
Outlook for the rest of 2024
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A detailed analysis of Medsenic's Phase 2 clinical trial with arsenic trioxide as first-line treatment for cGvHD has been completed, bringing new and valuable details to the upcoming trial. These results help justify the clinically significant selection of an upcoming Phase 3 trial with oral arsenic trioxide as first-line treatment for cGvHD, for which Medsenic previously received a positive pre-IND response from the FDA. A Phase 2a clinical trial in systemic lupus erythematosus (SLE) has already established safety in autoimmune patients and efficacy during the course of autoimmune disease. Recent positive preclinical studies provide sufficient justification for a Phase 2 clinical trial in systemic sclerosis (SSc). Phase 2b clinical trials in SLE and SSc are in the planning stages, and protocols for both trials are being prepared.
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BioSenic is currently preparing a convertible bond and equity financing, which the BioSenic Group intends to actively deploy in its Phase 3 clinical trials for cGvHD by the end of 2024. As a result, if BioSenic Group is successful in entering into solid partnerships with biopharmaceutical companies or licensing parts of its technology, it will be able to initiate Phase 2b clinical trials for SLE and SSc.
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The Court's ruling on the submitted global restructuring plan for 2024-2030 is expected shortly.
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Disciplined cost and cash management remains a key priority and the cash position is actively and closely monitored.
(1) Unaudited figures
About Bioscenic
BioSenic is a leading biotechnology company focused on the development of clinical assets. From MedCenic's Arsenic Trioxide (ATO) platform. Primary target indications for the autoimmune platform include graft-versus-host disease (GvHD), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc).
Following the merger in October 2022, BioScenic will combine the strategic positioning and strengths of MedScenic and Bone Therapeutics. The merger will, among other things, Medsenic/Biosenic will exploit the immunomodulatory properties of ATO/oral ATO (OATO) to develop an entirely new arsenal of different anti-inflammatory and anti-autoimmune formulations.
BioSenic is based at the Louvain-la-Neuve Science Park in Mont Saint-Guibert, Belgium. For more information, please visit http://www.biosenic.com.
About Medsenic/BioSenic's Key Technology Platforms
of ATO Platform It offers derived active products with immunomodulatory properties and fundamental effects on activated cells of the immune system. One of the direct applications is in tumor immunology to treat GvHD (graft-versus-host disease) in its chronic established phase. cGvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT).
MedCenic has successfully completed Phase 2 trials of its intravenous formulation. Alcimed®, It has received orphan drug designation from the FDA and EMA. The company is heading towards an international phase 3 confirmatory trial with a new IP-protected OATO formulation. Moderate to severe systemic lupus erythematosus (SLE), with the same oral formulation, is another target chosen. ATO has shown a good safety profile and remarkable clinical efficacy on several affected organs (skin, mucous membranes, gastrointestinal tract). Systemic scleroderma is now part of Medisenic/BioSenic's clinical pipeline. This serious chronic disease severely affects the skin, lungs or angiogenesis and currently has no effective treatment. Preclinical studies with relevant animal models are positive, giving sufficient justification to start a phase 2 clinical protocol with a new immunomodulatory formulation of API recognized as active on the immune system.
The company is currently focusing its research, development and clinical activities on the selective and rapid development of its autoimmune platform.
NOTE: The allogeneic cell therapy platform originating from the previously publicly traded Bone Therapeutics company may gain renewed interest by using isolated and purified differentiated bone marrow mesenchymal stromal cells (MSCs) as starting material for further isolation of passive or active biological subcellular elements. Indeed, these cells may provide novel intracellular vesicles that could potentially provide a unique and original approach to organ repair. BioSenic is currently working on determining new patentable approaches in this complex field of cell therapy.
For further information, please contact:
Bioscenic SA
Dr. François Rieger, CEO
Phone: +33 (0)671 73 31 59
Investor Relations
Certain statements, beliefs and opinions contained in this press release are forward-looking and reflect the current expectations and projections of the Company or, where appropriate, the Company's directors regarding 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 in the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. Many factors, including, but not limited to, changes in demand, competition and technology, may cause actual events, performance or results to differ materially from expected developments. Forward-looking statements contained in this press release regarding past trends or activities are not intended to represent that such trends or activities will continue in the future. The Company therefore expressly disclaims any obligation or undertaking to update or revise any forward-looking statements in this press release as a result of any change in expectations, or as a result of changes in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company, its advisors, agents, its subsidiaries, nor any of their respective directors or employees guarantee that the assumptions on which the forward-looking statements are based will be free from errors, and they do not assume any responsibility for the future accuracy of the forward-looking statements contained in this press release, or for the actual occurrence of the forecasted developments. Undue reliance should not be placed on forward-looking statements, which speak only as of the date of this press release.
