Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced that the U.S. Food and Drug Administration’s (FDA) Cosmetics Regulatory Science Branch has licensed ADMET Predictor® to support its computational research for modern cosmetic safety assessment. The contract expands the use of Simulations Plus technology within the FDA, underscoring the growing importance of predictive modeling and mechanistic science in advancing regulatory research.

The ADMET Predictor platform provides researchers with advanced artificial intelligence and machine learning (AI/ML) technology, novel descriptors, premium data, and predictive models to rapidly predict endpoint properties and systemic exposure in animals and humans.

By coupling high-throughput pharmacokinetic (HTPK) modeling with predictive ADMET and toxicity assessments, ADMET Predictor provides FDA researchers in the Cosmetic Regulatory Science Branch with tools to evaluate both potential exposure and intrinsic hazard within a unified computational framework. The development of modern, science-based approaches to cosmetic safety assessment supports the FDA’s ongoing research into New Approach Methodologies (NAMs).

The announcement builds on Simulations Plus’ work in computational safety assessment beyond pharmaceuticals. In 2024, the Company announced a research collaboration with the International Collaboration on Cosmetics Safety (ICCS) to evaluate physiologically based kinetic (PBK) modeling approaches that support animal-free safety assessment of cosmetics and other non-pharmaceutical ingredients. Together, these initiatives help to reinforce the expanding role of Simulations Plus technologies in advancing predictive science across regulated industries.

“We are proud that ADMET Predictor is trusted by researchers working in industry, academia, and regulatory agencies globally,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “The FDA’s adoption of ADMET Predictor within its Cosmetics Regulatory Science Branch expands our relationship with one of the world’s leading regulatory organizations and reflects growing confidence in predictive modeling and mechanistic science as essential components supporting NAMs and advancing the future of regulatory science. We believe it also highlights the versatility of our technology beyond pharmaceutical research and reinforces our leadership in computational solutions for non-pharmaceutical markets.”

About Simulations Plus, Inc.

Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com.

Forward-Looking Statements

Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “will”, “can”, “expect,” “anticipate,” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions, or circumstances) mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Forward-looking statements include but are not limited to regarding the anticipated use, capabilities and potential applications of ADMET Predictor®, the role of predictive modeling, mechanistic science and New Approach Methodologies in regulatory research, the Company’s expansion into non-pharmaceutical markets, and the potential benefits and applications of the Company’s software and technologies. These forward-looking statements are based on current assumptions and expectations that involve risks and uncertainties that could cause the actual results to differ materially from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our internal operational structure, our ability to maintain our competitive advantages and commercialize AI and cloud-enabled solutions, evolving regulatory and data privacy standards governing AI technologies, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual, and current reports and filed with the U.S. Securities and Exchange Commission. No regulatory authority has endorsed, approved, or validated the Company’s products, platforms, or AI-related approaches.

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