Simulations Plus Releases DILIsym® 11

Newest version of the quantitative systems toxicology (QST) software supports drug-induced liver injury (DILI) prediction for pediatric patient populations

Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced the release of DILIsym^® 11, the latest version of its flagship quantitative systems toxicology (QST) platform.

“Advancing toxicology research and improving the prediction of drug-induced liver injury (DILI) are essential to developing safer treatments,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “DILIsym continues to set the standard by enabling researchers to assess potential liver safety risks, as well as explore dosing strategies that optimize patient safety. We are proud to support innovation that directly impacts patient health and drug development success.”

“The addition of pediatric representation is an important milestone in predictive toxicology,” said Dr. Scott Q. Siler, Chief Scientific Officer of QSP Solutions of Simulations Plus. “By advancing the evaluation of potential liver safety risks in children, DILIsym 11 will support the development of safer and more effective therapies for children across the globe. We are proud of our role in developing leading-edge modeling tools that help bring better treatment options to vulnerable patient populations.”

DILIsym is a software platform designed to predict potential DILI hazards and provide insight into the mechanisms responsible for observed DILI responses. It is the most widely used QST modeling software for DILI prediction and is utilized as a source of QST modeling-based data assessed by the U.S. Food and Drug Administration’s (FDA) DILI team.

DILIsym 11 offers new pediatric representation for exploratory predictions regarding liver safety to children, and a new T-cell model that allows for better understanding of putative contributions of CD8+ T-cell mediated hepatocellular injury. It also includes improved representation of bile acid and cholestatic liver injury, updated antioxidant adaptation mechanisms, and more.

Learn more about DILIsym 11 and request your evaluation license.

About Simulations Plus, Inc.

With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading 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

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,” “believe,” “expect,” “anticipate” and similar expressions (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 contained in this press release include, but are not limited to, statements about expectations for the second half of 2025 and anticipated projections for fiscal year 2025. Factors that could cause or contribute to such differences include, but are not limited to: our ability to integrate our ALI and MC business units, our ability to meet our stated guidance, 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, 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.

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