Mont-Saint-Guibert, Belgium, October 28, 2024 – BioSenic (Euronext Brussels and Paris: BIOS), a clinical-stage company dedicated to the treatment of serious autoimmune and inflammatory diseases, has published its business update for the third quarter ending September 30, 2024. The report highlights significant progress and strategic initiatives as the company navigates a crucial phase in its development.
Key Developments
In July 2024, BioSenic entered into global licensing, supply, and commercialization agreements with Phebra Pty Ltd., modifying an earlier agreement made in May 2021, which established Phebra as a minority shareholder in Medsenic SAS. This partnership aims to strengthen the company’s market position.
The same month saw BioSenic file a continuation patent application (US 18/763,376) with the United States Patent & Trademark Office (USPTO) to protect the application of arsenic trioxide (ATO) in preventing and treating sepsis syndrome. Furthermore, BioSenic shared promising new analysis from its Phase II clinical data concerning optimal administration strategies for an upcoming late-stage trial targeting chronic graft-versus-host disease (cGvHD).
In August 2024, BioSenic secured vital patent protections for its ATO platform, with the Japan Patent Office granting a key patent and the European Patent Office (EPO) awarding a significant EU patent related to a method for treating relapsing-remitting multiple sclerosis with arsenic trioxide.
The company also underwent changes in leadership during this quarter, with Véronique Pomi-Schneiter resigning as Deputy CEO in September, followed by Carole Nicco stepping down from her roles as Chief Scientific and Operations Officer to concentrate on Medsenic SAS.
Additionally, BioSenic announced the initiation of a search for new assets through a merger and acquisition (M&A) process. This includes assessing the interests of Medsenic SAS shareholders, implementing cost reductions, engaging in creditor discussions regarding asset sales, and reshaping its board of directors. The company has amended its convertible bond agreement with GTO 15 to secure an additional €1.5 million in financing.
Financial Overview
As of September 30, 2024, BioSenic reported net cash reserves of €0.52 million. The company anticipates receiving €210,000 from its existing convertible bonds program with GTO15, which will ensure sufficient cash flow to support its operations through the end of the year. However, additional funding will be necessary in 2025, prompting BioSenic to evaluate various financing options.
Future Outlook
Following a homologation judgment on June 13, 2024, BioSenic plans to implement its approved strategy, which includes relinquishing rights to the JTA and ALLOB technologies to the Walloon Region and ceasing all activities related to these technologies.
The company recently completed its Phase II clinical study of arsenic trioxide for first-line treatment of cGvHD, yielding positive results. A Phase III study is expected to commence in 2024, following favorable pre-IND feedback from the FDA. Previous trials have established the safety and efficacy of arsenic trioxide in treating systemic lupus erythematosus (SLE), and promising preclinical results support a Phase II trial for systemic sclerosis (SSc). However, the initiation of these trials hinges on BioSenic’s ability to secure a strong partnership with a biopharmaceutical company or successfully out-license its technologies, with clinical trials not anticipated before 2025.
Cost reduction and disciplined cash management will remain paramount as the company actively monitors its financial situation. Concurrently, BioSenic will pursue new asset opportunities through M&A processes and initiate negotiations with creditors regarding potential sales of its interests in Medsenic and other intellectual properties as part of its ongoing debt restructuring efforts.
About BioSenic
BioSenic is a prominent biotechnology firm focusing on the clinical development of therapies derived from its Medsenic’s arsenic trioxide (ATO) platform. The company targets various autoimmune conditions, including graft-versus-host disease (GvHD), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc).
Following its merger with Bone Therapeutics in October 2022, BioSenic has unified its strategic resources to develop a diverse range of anti-inflammatory and anti-autoimmune formulations utilizing the immunomodulatory properties of ATO and oral ATO (OATO).
Based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium, BioSenic continues to lead in innovative biotechnology solutions. For more information, please visit www.biosenic.com.
Forward-Looking Statements
This press release contains forward-looking statements that reflect BioSenic’s expectations and projections regarding future events. These statements involve risks, uncertainties, and assumptions that could cause actual results to differ materially. Factors such as changes in demand, competition, and technological advancements may impact outcomes. BioSenic disclaims any obligation to update or revise these forward-looking statements following any changes in expectations or circumstances.
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