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Simulations Plus Extends U.S. FDA and NIEHS Collaborations to Advance AI-Powered Computational Toxicity Models for Food and Chemical Safety Assessment

Simulations Plus, Inc. (Nasdaq: SLP), a global leader in model-informed and AI-accelerated drug development, has announced the extension of two key research collaborations with the U.S. Food and Drug Administration (FDA) and the National Institute of Environmental Health Sciences (NIEHS). The extensions support ongoing federal efforts to develop and validate new approach methodologies (NAMs) and computational tools for assessing the safety of food and chemical substances. The expanded partnership with the FDA’s Human Foods Program will continue research into AI-driven computational models designed to evaluate the safety of chemicals found in food. Following the successful completion of earlier objectives, the FDA has extended the collaboration to further refine and expand the use of machine learning and in silico models in regulatory science. Additional federal funding for food and chemical safety modernization will provide access to curated toxicological datasets, enabling enhanced training, validation, and benchmarking of Simulations Plus’ AI/ML platforms. The NIEHS collaboration focuses on advancing computational approaches for environmental and exposure-related chemical safety assessments. This work supports NIEHS’s mission to understand how environmental factors affect human health by evaluating a wide range of chemicals and exposure scenarios. The project will continue leveraging Simulations Plus’ software engines to design, validate, and benchmark new experimental systems under evaluation, contributing to a national shift toward non-animal testing methods. Viera Lukacova, Chief Scientific Officer of Simulations Plus, highlighted the importance of the extended partnerships. She noted that the research addresses critical challenges in safety assessment and praised the company’s role in advancing AI-enabled, in silico solutions that support regulatory decision-making. Shawn O’Connor, Chief Executive Officer, emphasized Simulations Plus’ long-standing commitment to scientific innovation. With over three decades of experience in model-informed development, the company has helped establish foundational methods now widely adopted by regulators and industry. He expressed pride in continuing to lead the evolution of science-based tools for pharmaceutical development, food safety, and chemical risk assessment. The extensions underscore growing federal interest in computational and AI-based approaches to replace or reduce reliance on animal testing. Simulations Plus remains at the forefront of this transformation, combining deep scientific expertise with advanced software and data analytics to support safer, faster, and more efficient safety evaluations. For more information about Simulations Plus, visit www.simulations-plus.com. Forward-looking statements in this release involve risks and uncertainties, including regulatory acceptance of AI tools, market conditions, customer adoption, and the company’s ability to execute its strategic vision. Actual results may differ materially due to factors such as changes in regulatory standards, economic conditions, and competition. Detailed risk factors are outlined in the company’s filings with the U.S. Securities and Exchange Commission. No regulatory authority has endorsed, approved, or validated the company’s products or AI-related methodologies.

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