Simulations Plus Supported Development of Every FDA-Approved Drug in 2024

Simulations Plus

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Simulations Plus, Inc. (Nasdaq: SLP) ("Simulations Plus”), a leading provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today highlighted its impact on the pharmaceutical industry through supporting the development of 100% of the drugs approved by the U.S. Food and Drug Administration (FDA) in 2024.

"For more than 25 years, our clients have entrusted us to provide the mission-critical software and services needed to develop therapies that are changing the landscape of healthcare,” said Shawn O’Connor, Chief Executive Officer at Simulations Plus. "We are proud that our advanced modeling and simulation software and consulting services supported the development of every drug approved by the FDA in 2024. This achievement underscores the increasing role that innovative technologies and collaborative expertise plays in accelerating the drug development process. As global health challenges grow, we remain committed to delivering solutions which help advance life-saving therapies that improve patient outcomes worldwide.”

Simulations Plus offers software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. SLP’s suite of solutions leverage artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/physiologically based biopharmaceutics (PBPK/PBBM), quantitative systems pharmacology/quantitative systems toxicology (QSP/QST), and population PK/PD modeling approaches, as well as adaptive learning and medical communications tools.

About Simulations Plus, Inc.

With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | 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 2023 ESG update.

Forward-Looking Statements

Except for historical information, the matters discussed in this press release are forward-looking statements that involve 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 successfully integrate the Pro-ficiency business with our own, as well as expenses we may incur in connection therewith, the efficiency and effectiveness of our internal business restructuring and leadership changes, 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, market conditions, macroeconomic factors, 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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