U.S. FDA Renews DILIsym® Software Licenses for 7th Year

Predicting DILI risk supports informed decision-making regarding drug evaluations and approvals

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that the U.S. FDA has renewed its licenses to the DILIsym® software platform. DILIsym is the industry gold standard for quantitative systems toxicology (QST) software designed for the prediction and investigation of drug-induced liver injury (DILI). The one-year renewal provides the FDA with continued access to the DILIsym platform for authorized employees across all FDA divisions.

DILIsym predicts the potential for DILI risk in new molecules and provides deeper insight into the mechanisms responsible for observed DILI responses at various stages of the development process. This allows pharmaceutical development teams to understand their compounds and tailor proposed dosing strategies for efficacy and safety. It also allows the FDA to evaluate the potential DILI risk across multiple populations, which supports informed decision-making regarding drug approvals.

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, said, “It is now known what properties to avoid to minimize liver toxicity in a new drug candidate -- but these same properties are often necessary to have therapeutic efficacy. By predicting safe dosing regimens of such drugs, DILIsym is now enabling successful development of important therapies that might otherwise be abandoned.”

“By incorporating disease pathophysiology, clinical presentation, and clinical outcomes into a unified framework, quantitative systems pharmacology (QSP) and toxicology (QST) models are powerful tools for evaluating therapies,” said Dr. Brett A. Howell, President of Quantitative Systems Pharmacology Solutions at Simulations Plus. “It’s exciting to see the FDA incorporate these methodologies and our software platform as part of their review process for submissions.”

For the last 14 years, Simulations Plus has coordinated the DILI-sim Initiative, which is a public-private partnership that guides the development of the DILIsym platform. DILIsym is available to the pharmaceutical and chemical industries for direct use to predict and understand liabilities via membership in the DILI-sim Initiative consortium and/or commercial licenses. Simulations Plus also routinely uses DILIsym for comprehensive consulting services on safety-related issues. Companies interested in a free trial version of the DILIsym software can request it here.

About Simulations Plus, Inc.

Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube.

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Forward-Looking Statements

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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