• New version delivers on FDA collaborations and user feedback for expansion of non-oral delivery route models

LANCASTER, Calif. / Jan 30, 2024 / Business Wire / 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® 9.9, the latest version of its flagship physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM) modeling and simulation software.

Key enhancements include:

• Expanded the ocular (OCAT™), oral cavity (OCCAT™), and dermal (TCAT™) models by adding new formulation and PK/PD mechanisms to better capture local and systemic exposure levels in animals and humans
• Extended the ACAT™ model to enhance the evaluation of formulation approaches for local gastrointestinal (GI) disease states
• Improved Biologics Module features to mimic study designs and refine dose optimization simulations for clinical trial success
• Upgraded with ADMET Predictor® version 11 models, enhancing our First in Human Simulator

“Our software updates reflect the needs our customers communicate to us, and GastroPlus 9.9 is no exception,” said Neil Miller, Vice President of Simulation Sciences at Simulations Plus. “We incorporated feedback from more than 100 companies into these latest enhancements, ensuring they truly provide the improved functionality our customers require. And as we do with every software release, we also updated our models with the latest scientific research, leveraging more than 30 peer-reviewed papers to improve the predictive capabilities of our software platform.”

“For many years, we have worked on collaborative projects with the FDA and other regulatory agencies to improve the technology available to the pharmaceutical industry and increase the safety of animal and human trials,” said Dr. Haiying Zhou, Sr. Director of Simulation Technologies at Simulations Plus. “This is one reason our clients know they can rely on data generated with GastroPlus to inform their program design and support regulatory submissions. In GastroPlus 9.9 specifically, our updates to the Additional Dosage Routes (ADR) Module were built with FDA involvement and funding from three separate FDA grants, and these enhancements are now available for the global GastroPlus user community to apply to their research programs to accelerate the development of new therapies to help patients worldwide.”

GastroPlus 9.9 is available now for licensing and download.

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 | Twitter | 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 2022 ESG update.

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.