Simulations Plus Upgrades Flagship GastroPlus

LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has released version 9.7 of its flagship physiologically based pharmacokinetic (PBPK) modeling platform, GastroPlus^®.

Key improvements in this version include:

• Ability to add lysosomal trapping effects to PBPK tissues for more accurate systemic calculations
• New mechanistic pregnancy PBPK model with integrated population settings
• Options to define multiple solubility inputs for different drug forms
• Expanded fed state simulation conditions based on defined meal types
• Validated models of standard compounds added to the drug-drug interaction (DDI) Module
• PK/PD model extensions added to the PDPlus™ Module
• Improved population groups for extensive, intermediate, and poor metabolizers based on specific genotypes
• Updates to the dermal absorption (TCAT™) model through the Cosmetics Europe collaboration
• Novel effects of immune response added to the intramuscular injection models
• And more...

“Special populations modeling continues to be a key component of GastroPlus with numerous companies applying the results to support regulatory interactions,” said Dr. Viera Lukacova, director of Simulation Sciences for Simulations Plus. “With this release, we have added several new groups, including a validated mechanistic pregnancy model, which will greatly enhance the understanding of drug exposure and assist with dose selection decisions. Special thanks to the dedicated scientific team at Simulations Plus and our collaboration partners for all their outstanding efforts.”

John DiBella, Lancaster division president for Simulations Plus, added: “GastroPlus continues to provide researchers, including chemists, DMPK scientists, pharmaceutical developers, and clinical pharmacologists, a proven and flexible PBPK software to support safety and efficacy decisions, first-in-human estimations, formulation optimization, and drug-drug interaction assessments. For over twenty years, Simulations Plus has been dedicated to improving our state-of-the-art tools, and the significant enhancements that are integrated in version 9.7 are just a preview of exciting advancements that will be the foundation for next year’s entirely new platform release of GastroPlus.”

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 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 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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