Simulations Plus Releases GastroPlus® X, The Next Generation PBPK/PBBM Modeling & Simulation Software

Redesigned platform offers ease-of-use, enhanced software engineering, and significant productivity gains for users

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced the release of GastroPlus® X.

Branded as GPX™, this new platform represents the next generation of physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM) modeling and simulation software. Utilizing proven top-rated science, advanced models, refined algorithms and integrated machine learning (ML) technology, GPX offers an entirely updated user experience with an intuitive interface, streamlined workflows, and faster processing.

“GPX is truly a culmination of a long-term collaboration with our partners to understand how we can better support their program needs and enable critical scientific thinking,” said Neil Miller, Vice President of Simulation Sciences at Simulations Plus. “Our development process included significant external user testing and we sought partners’ feedback throughout the entire development cycle. This resulted in a completely redesigned, intuitive, flexible platform that follows our customers’ research and thought processes instead of requiring them to fit their processes to the software.”

“For more than 25 years, we have remained laser-focused on providing the best science and algorithms on the market. Our commitment to continuous innovation and improvement is why GastroPlus remains the preferred platform for predicting a wide array of applications, including gastrointestinal absorption for oral products, first-in-human outcomes, and food effects,” said John DiBella, President of PBPK Solutions at Simulations Plus. “GPX offers increased functionality that other programs cannot provide, such as true polypharmacy simulations mimicking real-world scenarios. We believe the intuitive design, workflows, and data handling will help us expand our addressable market globally by significantly shortening the learning curves for new users, improving the productivity of experienced modelers, and enhancing critical communication with health authorities. As our clients consider the implications of the FDA’s newly established Quantitative Medicine Center of Excellence, GPX will provide robust support for their regulatory interactions. GPX is truly the most exciting development in PBPK science to launch in many years.”

GPX is designed to be a comprehensive PBPK/PBBM modeling and simulation platform, allowing users to handle everything from early discovery high-throughput PK simulations and drug-drug interactions (DDIs) to population predictions and more all in the same place. Utilization of a single PBPK/PBBM platform, with reusable assets and templates, reduces the time spent on tedious tasks like model setup, importing and exporting data, and reformatting plotted modeling results.

GPX offers flexible deployment options, allowing for both local installation and seamless integration with cloud environments, providing users with the freedom to choose the best setup for their needs.

GPX is available for licensing now.

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.

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

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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Simulations Plus Investor Relations Renee Bouche 661-723-7723 [e-mail]

Financial Profiles Lisa Fortuna 310-622-8251 [e-mail]