421 0 Kommentare BioSenic provides First Quarter 2023 Business Update - Seite 2

In April 2023, BioSenic received a key European patent from EPO, for further therapeutic development in cancer, infectious and immune diseases. The patent covers the therapeutic use of a new composite formulation of anti-inflammatory compounds with unique advantages. This new formulation lowers the dosage of arsenic trioxide by combining it with copper salts to maintain therapeutic efficacy, with the potential of administration through multiple routes, including intravenous, oral and other novel routes of administration.

In May 2023, BioSenic identified key biomarkers for cGvHD and submitted patent to EPO. The technology covered by the patent applies to a method and kit for diagnosing and monitoring cGvHD in an individual who has undergone an allogeneic hematopoietic stem cell transplantation. The patent describes biomarkers to be used to determine if the condition of a patient worsens or improves following standard or new treatments for cGvHD. This international patent could allow the development of an industrial biomarker analysis kit which could generate a turnover of 30 to 40 million euros globally.

In May 2023, BioSenic announced it reacquired global IP rights for JTA-004 and provided update on JTA-004 development. BioSenic is looking for an industry partner to submit its results to the regulatory bodies in order to find the best and fastest way to obtain a Marketing Authorization (MA). This partnership will jointly conduct a small-scale additional Phase III trial targeting the most severe form of knee OA, prior to the MA with global regulators. The Marketing Authorization Application (MAA) could be submitted as soon as three years after the start of the Phase III trial, and as a result JTA could reach the market in 2027.

Financial highlights

Net cash at the end of March 2023 amounted to €1.45 million ⁽¹⁾.
Disciplined cost and cash management will remain a key priority. The operating cash burn for the full year 2023 is in the range of €8-10 million and a financing cash burn of approximately EUR 1.7 million. The situation will be actively and closely monitored. BioSenic anticipates having sufficient cash to carry out its business objectives until end of June 2023, assuming (amongst other) issuance of the eighth tranche of the Convertible Bonds and the renegotiation of the terms of the ongoing loans that will otherwise fall due in June 2023.