Simulations Plus Releases GastroPlus™ Version 9.6

Significant improvements support internal research activities through regulatory interactions

Simulations Plus, Inc. SLP, the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, and chemicals industries, today announced that it has released version 9.6 of its flagship PBPK modeling program, GastroPlus™.

Key improvements include:

• New dynamic intestinal fluid options added to the #1-ranked ACAT™ oral absorption model
• New population physiologies for obesity and renal impairment disease states
• Expanded enzyme/transporter distribution information for easier extrapolation across species
• Additional compound model files for standard drug-drug interaction (DDI) substrates and inhibitors
• Upgraded capabilities to all major mechanistic absorption routes, including dermal, pulmonary, ocular, and subcutaneous/intramuscular injections
• Enhanced deconvolution methods for generation of mechanistic in vitro-in vivo correlations (IVIVCs)
• Improved output/reporting functions in all simulation modes to facilitate communication across departments and with regulatory agencies
• Significant simulation speed improvements
• Custom template generation for seamless use of GastroPlus to drive DILIsym® SimPops™ liver injury predictions
• And more...

Dr. Viera Lukacova, director – simulation sciences, said: "This version of GastroPlus provides new features that users have requested and will appreciate. It is the product of ongoing input and collaboration with the U.S. FDA, industry, academics, and by our talented Simulations Plus and DILIsym® Services scientific teams."

John DiBella, president – Lancaster division, added: "GastroPlus continues to be the mostly widely used commercial PBPK software worldwide, and this new release is the most feature-rich and user-friendly in our history. With the ever-increasing emphasis on PBPK modeling from regulatory agencies globally, the client base for GastroPlus continues to expand. For over 20 years, our company has invested to improve our software tools and attract the most talented scientists, and this will continue as we look to meet the unprecedented demand for PBPK modeling support and new functionality requests."

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 to 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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