New Risk • Mar 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of French stocks, typically moving 8.7% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 48% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€40m net loss in 3 years). Share price has been volatile over the past 3 months (8.7% average weekly change). Revenue is less than US$5m (€4.1m revenue, or US$4.7m). Announcement • Mar 27
ABIONYX Pharma Achieves Major Milestone in ApoA-I Biomanufacturing with Breakthrough in Synthetic Sphingomyelin Production ABIONYX Pharma announced a significant technological and industrial breakthrough combining high-performance apoA-I bioproduction with exclusive mastery of ultra-pure synthetic sphingomyelin, paving the way for a new class of sepsis therapeutics. As part of its strategy to enable large-scale industrial production of CER-001, ABIONYX Pharma has developed a new manufacturing process allowing: A threefold increase in sphingomyelin production yield, one of the two key components of CER-001; A synthetic component with exceptional purity and structural quality, meeting the most stringent pharmaceutical standards. All synthesis processes for this component are based on fully proprietary patents, providing ABIONYX Pharma with a major technological and competitive barrier. Sphingomyelin is a strategic lipid widely recognized for its structural and functional properties. Within the CER-001 biomedicine, it plays a central role: It stabilizes the ApoA-I protein in its optimal functional conformation; It gives CER-001 biological and therapeutic properties fully comparable to natural HDL found in the human body; It exhibits high intrinsic stability in pure form without added stabilizers—unlike conventional sphingomyelins—strengthening manufacturing robustness and pharmaceutical-grade quality. Sphingomyelin is also used as a key ingredient in other pharmaceutical applications, including advanced cosmetics, due to its ability to stabilize and protect biological structures. The use of 100% synthetic sphingomyelin, replacing traditional sources (egg or bovine), eliminates: Any risk of contamination; Variability in raw materials; Allergenic risks. With this achievement, the Company overcomes a major technological barrier in the control and production of CER-001. ABIONYX Pharma is advancing its platform in sepsis, a global medical emergency characterized by severe systemic dysregulation and a substantial unmet therapeutic need. The combination of highly purified apoA-I, proprietary synthetic sphingomyelin and optimized formulation technologies positions the company to deliver differentiated therapeutic approaches aimed at restoring essential biological functions in sepsis patients. This breakthrough in synthetic sphingomyelin production will also directly benefit the manufacturing of the two validation batches required ahead of Marketing Authorization (MAA) in LCAT deficiency. By ensuring high purity, reproducibility, and secured supply, this innovation significantly de-risks the production process and supports timely execution of these critical batches. These validation lots represent a key milestone for the Company, as they are essential to advancing CER-001 toward regulatory approval. This milestone reinforces ABIONYX Pharma’s positioning as a leader in advanced biomanufacturing within the biotech sector. The company demonstrates its ability to: Manufacture complex, high-value therapeutic proteins at scale; Control critical lipid components at an unprecedented level of purity; Integrate these elements into differentiated, functional drug formulations. This achievement validates the industrial scalability of the apoA-I platform, strengthens supply chain security, and supports upcoming clinical and regulatory milestones. It also creates new opportunities for strategic partnerships with global industry players. Reported Earnings • Mar 15
Full year 2025 earnings released Full year 2025 results: Revenue: €4.10m (down 9.9% from FY 2024). Net loss: €5.50m (loss widened 26% from FY 2024). Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 50% growth forecast for the Biotechs industry in France.