Co-development initiatives to advance next-generation workflows, accelerate adoption, and expand the role of AI within model-informed drug development

Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced strategic collaboration programs with three large pharmaceutical companies to advance artificial intelligence (AI) workflows across the drug development lifecycle.

These programs apply AI within scientifically grounded modeling workflows and define how next-generation workflows are deployed at scale. The close collaboration between Simulations Plus and leading pharmaceutical organizations will provide direct insight into how AI will be integrated into real-world environments—informing product direction, workflow standardization, and future commercial models. The programs will utilize Simulations Plus’ major software platforms, including GastroPlus®, MonolixSuite™, ADMET Predictor®, and Thales™.

“Our approach to AI is grounded in how it operates within a complete system, not as a standalone capability,” said Jonathan Chauvin, Co-Chief Product & Technology Officer at Simulations Plus. “These collaborations will allow us to work alongside our partners, leveraging real-time scientific feedback and company data to continuously refine how workflows are orchestrated across our tools, ensuring AI-driven efficiencies translate into reproducible, traceable outcomes. The insights we gain will directly shape how we evolve our platform and deliver value at scale.”

Participating companies will integrate the Company’s internally developed AI agents directly into model-informed drug development (MIDD) workflows, enabling natural language interaction, automation of data processing, coordination of simulations across multiple modeling engines, and generation of interpretable outputs from complex, multi-step pipelines.

Importantly, the collaborations will also serve as a foundation for broader enterprise adoption, including direct alignment with information technology teams to define how AI-enabled capabilities are deployed, governed, and integrated within existing systems. This includes defining standards together for transparency, reproducibility, and governance as AI becomes more deeply embedded in drug development processes.

“As highlighted at our Investor Day presentation in January, AI will only fulfill its potential in drug development when it is delivered responsibly, grounded in validated science, and integrated into real workflows,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Our customers are choosing to work with us because of the strength of our validated scientific engines and depth of our teams who apply them daily within real workflows, enabling us to translate AI into practical, deployable solutions. These strategic collaboration programs represent an important step in moving us and our partners beyond experimentation and into practical implementation as we advance our software and services into a unified modeling ecosystem.”

Companies interested in learning about using AI-enabled workflows in their modeling can request additional information.

About Simulations Plus, Inc.

Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com.

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,” “will”, “can”, “expect,” “anticipate,” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions, or circumstances) 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. Forward-looking statements include but are not limited to statements regarding our fiscal year 2026 guidance, revenue growth, anticipated margins and profitability, demand to software and services, the impact of pricing actions, client spending levels, market conditions, the development, capabilities, regulatory acceptance, regulatory compliance and commercialization of AI-enabled and could-based solutions, the timing and content of product initiatives discussed at Investor Day, and our ability to execute our long-term strategic vision. These forward-looking statements are based on current assumptions and expectations that involve risks and uncertainties that could cause the actual results to differ materially from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our internal operational structure, our ability to maintain our competitive advantages and commercialize AI and cloud-enabled solutions, evolving regulatory and data privacy standards governing AI technologies, 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, annual, and current reports and filed with the U.S. Securities and Exchange Commission. No regulatory authority has endorsed, approved, or validated the Company’s products, platforms, or AI-related approaches.

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