Simulations Plus Releases GastroPlus® Version 9.8.3

New update expands the library of virtual populations and enhances connections between software platforms

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced the release of version 9.8.3 of its flagship physiologically based biopharmaceutics (PBBM) / pharmacokinetics (PBPK) modeling platform, GastroPlus^®.

Key enhancements include:

• Improved reporting templates for the Monolix™ software to support the statistical analysis of virtual PBPK population results
• New validated nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH) disease populations with options to inform the NAFLDsym^® software
• New validated swine PBPK model to drive pharmaceutical and veterinary medicine research
• New enzyme and transporter expression levels across species to expand the virtual population databases
• Flexible handling of dose regimens to allow for administration of any Additional Dosage Routes model during simulations

Dr. Haiying Zhou, director of Simulation Technologies, said: “Our goals with this release of GastroPlus were twofold: to advance the ways in which our software programs communicate with each other across the Simulations Plus universe and to provide the flexibility our users require to simulate the scenarios they need. We succeeded in this effort through our close collaborations with our partners in industry, academia, and government agencies and by working in harmony with the product development teams of our company.”

“We continue to push the boundaries for how PBBM/PBPK modeling should be integrated with machine learning, quantitative systems pharmacology/toxicology (QSP/QST), and population PK/PD approaches,” added Daniel O’Connor, director of Business Development. “Our leadership in this space is reflected through the growing number of companies applying GastroPlus to support candidate selection, first-in-human dose selection, formulation optimization, drug-drug interaction assessments, and more – all within a single software environment. We are excited to release this new version to our user community and continue to support and educate researchers worldwide by providing the best and most innovative science.”

About Simulations Plus

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 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 | Twitter | YouTube.

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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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