BioSenic Releases Q1 2024 Business Update

Mont-Saint-Guibert, Belgium, May 24, 2024 – BioSenic, a company traded on Euronext Brussels and Paris (BIOS), specializing in severe autoimmune and inflammatory conditions and cell therapy, has disclosed its business updates for the first quarter ending on March 31, 2024.

Key Developments

In January 2024, BioSenic secured a new subscription agreement for up to EUR 1.2 million in convertible bonds, organized by ABO Securities via its associated entity Global Tech Opportunities 15. Dr. Carole Nicco was promoted to Chief Operating Officer (COO) while continuing as Chief Scientific Officer (CSO). BioSenic's subsidiary, Medsenic SAS, also entered a binding term sheet with Phebra PTY Ltd., modifying their License Agreement and MDA from May 2021.

BioSenic filed a U.S. patent application for JTA-004, a viscosupplement under clinical development for a specific type of osteoarthritis, and was granted a patent by the Canadian Intellectual Property Office. The new patent extends protection of their arsenic trioxide (ATO) platform, titled "Use of metal ions to potentiate the therapeutic effects of arsenic."

In February, BioSenic raised EUR 500,000 through a private placement. By March, they published an open-access article on an optimized schedule for oral arsenic trioxide (OATO) treatment for chronic graft-versus-host disease (cGvHD), based on prior Phase II data analysis. In April, the company submitted a global restructuring plan for 2024-2030 to the enterprise Court of Nivelles.

Financial Overview

As of the end of March 2024, BioSenic's net cash stood at EUR 0.38 million. The company projects an operational cash burn of EUR 4.50-5.50 million for the entire year, with a financing cash burn of around EUR 0.80 million. The current funds are expected to support operations until Q3 2024, contingent on successful debt restructuring as per the submitted plan.

Future Outlook for 2024

BioSenic has completed detailed analysis of the Medsenic Phase 2 clinical study using arsenic trioxide for first-line treatment of cGvHD. The findings will inform the upcoming Phase 3 study, for which Medsenic received positive pre-IND responses from the FDA. A Phase 2a trial for systemic lupus erythematosus (SLE) previously demonstrated safety and efficacy, supporting plans for a Phase 2 trial in systemic sclerosis (SSc). Phase 2b trials for both SLE and SSc are currently being planned.

BioSenic is also preparing a fundraising initiative involving convertible debt and equity, aimed at advancing into the Phase 3 trial for cGvHD by the end of 2024. This timeline also targets the commencement of Phase 2b trials for SLE and SSc, provided a solid partnership with a biopharmaceutical company is established or successful out-licensing of some technologies is achieved. The court's decision on the restructuring plan is anticipated soon. BioSenic will continue close monitoring and disciplined management of costs and cash flow.

About BioSenic

BioSenic is a biotech firm focused on developing clinical assets from Medsenic’s arsenic trioxide (ATO) platform. Key indications include graft-versus-host-disease (GvHD), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc). Following a merger in October 2022, BioSenic is leveraging the strengths of Medsenic and Bone Therapeutics to create new treatments using the immunomodulatory properties of ATO/OATO.

The company is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium.

Medsenic/BioSenic Technology Platform

The ATO platform provides products with immunomodulatory properties, targeting chronic GvHD and autoimmune diseases. Medsenic has conducted a successful Phase 2 trial with its intravenous formulation, Arscimed®, which has orphan drug designation by the FDA and EMA. An international Phase 3 confirmatory study using a new OATO formulation is planned. Additionally, the company aims to treat systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) with ATO, having shown promising results in preclinical studies.

BioSenic is also exploring the use of Mesenchymal Stromal Cells (MSCs) from bone marrow for potential organ repair applications.BioSenic remains focused on advancing its autoimmune platform through targeted R&D and clinical activities.

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