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FDA Purchases Bundle of ADMET Predictor® Licenses

LANCASTER, Calif.--(BUSINESS WIRE)--

Center for Tobacco Products incorporates machine learning platform to assist toxicology research

Simulations Plus, Inc. (SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has received an order from the U.S. Food and Drug Administration (FDA) for a 15-user license to its ADMET Predictor® software suite. The purchase was made by the Center for Tobacco Products to support research projects aimed at informing regulatory decision making.

John DiBella, Lancaster division president for Simulations Plus, said: “For many years, the FDA has utilized our software across various departments, including the Office of Clinical Pharmacology, Office of Generic Drugs, and Office of Pharmaceutical Quality. We are thrilled to now see the Center for Tobacco Products incorporate our machine learning technology to support their risk assessment activities as they evaluate tobacco products and ingredients. We look forward to interactions with the FDA staff to understand model performance on their chemicals and identify future advances to ADMET Predictor’s functionality and workflow.”

Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organizations imply endorsement by the United States Government.

About Simulations Plus, Inc.

Simulations Plus, Inc. is a premier developer of drug discovery and development software as well as a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injury, drug-induced kidney injury, and nonalcoholic fatty liver disease. The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical, biotechnology, and chemical agents. Our software is licensed to and used in the conduct of drug research by major pharmaceutical, biotechnology, chemical, and consumer goods companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation. For more information, visit our website at www.simulations-plus.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that 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. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, 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, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

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