Simulations Plus Enters New Collaboration to Advance DDDPlus™ Software

Funded partnership with large pharmaceutical company will enhance mechanistic dissolution models for injectable formulations

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced a new funded collaboration with a large pharmaceutical company to expand and validate the mechanistic in vitro dissolution models for intravitreal injectable formulations within the DDDPlus™ software.

James Mullin, Senior Principal Scientist and lead programmer on DDDPlus, said: “The DDDPlus software is being utilized by numerous companies and regulatory agencies around the globe to support oral drug product development. Recent enhancements to the tool have focused on improvements to the in vitro analysis of precipitation kinetics and functionality to help establish drug product specification limits. Through this new collaboration, we will expand into the injectable product space and apply our novel approaches to capture dissolution kinetics within in vitro systems designed by our industry partner. We look forward to the fruitful interactions.”

“Our team of scientists and programmers have designed unique workflows between DDDPlus and GastroPlus® to advance innovative in vitro-in vivo extrapolation (IVIVE) methods for dissolution and precipitation modeling,” added Haiying Zhou, Director of Simulation Technologies. “Turning our attention to injectable products, and the special in vitro systems used to measure formulation performance, opens new market opportunities for our IVIVE workflows. Like other collaborations, Simulations Plus will own all improvements made to our software programs, and we look forward to sharing these exciting developments with all users to advance model-informed drug development.”

About Simulations Plus

Serving clients worldwide for 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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