Simulations Plus Releases DILIsym® X

Updated quantitative systems toxicology (QST) software investigates and predicts drug-induced liver injury (DILI)

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

“Modeling and predictions regarding drug efficacy are critical in the drug development process—but so are predictions regarding safety,” said Dr. Brett Howell, President of Quantitative Systems Pharmacology (QSP) Solutions at Simulations Plus. “We know there is often a gap between preclinical and clinical research toxicology results, but DILIsym is designed to help researchers identify potential DILI risks and, when appropriate, design dosing strategies that can mitigate or eliminate possible hazards. With the enhanced processing speed and improved user interface offered by DSX, clients get crucial insight into the safety of their drug candidate faster and more easily than ever before.”

Branded as DSX™, the software is designed to support key drug development decisions by predicting potential drug-induced liver injury (DILI) risks. These predictions can guide go/no-go decisions, or the need to modify dosages, which are vital to avoiding costly failed clinical trials.

Dr. Scott Q. Siler, Chief Scientific Officer of QSP Solutions at Simulations Plus, added, “DSX will greatly enhance our clients’ and our consulting group’s ability to quickly generate population-level liver safety results that impact drug development decisions. This faster turnaround time means fewer delays between critical safety decision points, ensuring safe new drugs get to patients as rapidly as possible while unsafe drug candidates can be discarded earlier in the costly development process.”

DSX offers a completely redesigned interface, tested by clients and consultants, that includes both command line and graphical interface options as well as a licensing option that enables scale-up on local or cloud cluster configurations. Four new exemplar compounds are included in this version of the software, as well as two new simulated populations that include variability in susceptibility to liver injury and biomarker-related parameters (ALT and bilirubin).

Learn more about DSX 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 (PBPK), quantitative systems pharmacology/toxicology (QSP/QST), 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.

Environmental, Social, and Governance (ESG)

We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our 2023 ESG update.

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,” “expect” and “anticipate” 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. Factors that could cause or contribute to such differences include, but are not limited to: our ability to successfully integrate the recently acquired Pro-ficiency business with our own, as well as expenses we may incur in connection therewith, to maintain our competitive advantages, acceptance of new software and improved versions of our existing software, the general economics of the pharmaceutical industry, market conditions, macroeconomic factors, 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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Simulations Plus Investor Relations Renee Bouche 661-723-7723 renee.bouche@simulations-plus.com

Financial Profiles Lisa Fortuna 310-622-8251 slp@finprofiles.com

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