Simulations Plus Releases GastroPlus® Version 9.8

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 9.8 of the preeminent platform for physiologically based biopharmaceutics (PBBM) / pharmacokinetic (PBPK) modeling, GastroPlus®. Since 1998, Simulations Plus has been dedicated to expanding the understanding and use of state-of-the-art in silico modeling and simulation software tools to make model informed drug development a reality.

"We have been very fortunate to partner with numerous companies, and several regulatory agencies, over the past 18 months to drive enhancements and further validate the unique models within this version,” said Dr. Viera Lukacova, Chief Scientist at Simulations Plus. "Two of the many key improvements coming out of these collaborations include the industry’s first mechanistic model for intra-articular delivery and a revamped virtual bioequivalence trial simulation engine to address many of the requirements published in the U.S. FDA’s new regulatory guidance document on PBBM applications.”

Dr. Michael Bolger, Founding Scientist at Simulations Plus, added: "We also focused substantial resources to improve the platform’s capabilities in clinical pharmacology. Extensive documentation and updated GastroPlus model files for our drug-drug interaction (DDI) standards database that can be used for regulatory submissions has been scientifically reviewed for several compounds, with many more models to be added soon. Additionally, we have incorporated new approaches for accurate handling of parent molecules and metabolites which allow for mechanistically correct enterohepatic circulation calculations, improving the accuracy of DDI simulations for complex perpetrators like gemfibrozil and substrates like atorvastatin.”

John DiBella, Lancaster division president, said: "The global pandemic has highlighted, in a demonstrative way, the ‘need for speed and safety’ in drug development. GastroPlus continues to provide researchers the capability to evaluate repurposing existing drugs, predict drug-drug interactions, and perform virtual bioequivalence assessment with a growing variety of dosing routes. We continue to welcome collaborations with our customers to advance the science of drug development, reduce the time and cost of research, and to improve patient wellness.”

About Simulations Plus, Inc.

Simulations Plus, Inc. is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer solutions which bridge 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, chemical, consumer goods companies and regulatory agencies worldwide. 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 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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