(AOF) – BioSenic expects to have sufficient cash flow to achieve its commercial objectives until October 2023. This company specializing in clinical trials in serious autoimmune and inflammatory diseases and cell therapy ended the first half of 2023 with 0.52 million euros in cash and cash equivalents. Its operating loss for the period amounted to 3.90 million euros, compared to 3.96 million euros in the first half of 2022, for a total operating profit of 0.37 million euros, a slight increase over one year.
BioSenic is currently preparing a fundraising which will be organized in the third or fourth quarter of 2023. BioSenic Group plans for 2024 to use the proceeds of future anticipated fundraising as a priority to advance its phase 3 clinical trial against the chronic disease of the graft versus host (cGvHD). The start of phase 2 clinical trials on SLE (systemic lupus erythematosus) and SSc (systemic sclerosis) is therefore not envisaged before 2024.
It will only be possible if the company manages to enter into a solid partnership with a biopharmaceutical company or manages to license some of its technologies.
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Biotechs put to the test
These companies are suffering from a much less favorable economic cycle, which is reflected in particular by a drop in venture capital financing of start-ups. These companies are therefore obliged to carry out redundancy plans. Added to this is a much more restrictive regulatory framework. First, in the United States, the measures linked to the Inflation Reduction Act (IRA) could have a strong impact on the margins of the participants. Indeed, from 2026, the federal Medicare program will be able to renegotiate the price of drugs marketed for nine years (chemical) or 13 years (biological), with discounts that could range from 35 to 60% for biotechs. Similarly, in Europe, with the new drug regulations presented in Brussels in April, the duration of patent protection will be reduced if the innovative treatment is not marketed in all member countries within two years.