Simulations Plus Announces Extensions of U.S. FDA and NIEHS Research Collaborations

Extended projects support ongoing research into computational approaches and new approach methodologies for food and chemical safety assessment

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–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 the extension of two separate research collaborations with the U.S. Food and Drug Administration (FDA) and the National Institute of Environmental Health Sciences (NIEHS). The extended projects support ongoing federal research efforts focused on the development of new approach methodologies (NAMs) and advancing computational approaches for food and chemical safety assessments.

Recent guidance from the FDA and other regulatory agencies encourages the use of non-animal based research, including in silico, mechanistic, and data-driven methods intended to support food and chemical safety evaluations. The extended collaborations align with these broader federal initiatives by supporting research into the application, evaluation, and refinement of computational toxicity models.

“We appreciate the opportunity to continue our collaborations with the FDA and NIEHS,” said Viera Lukacova, Chief Scientific Officer of Simulations Plus. “The research being conducted through these projects addresses important challenges, and we are pleased to contribute our scientific engines in support of federal research efforts. We look forward to continued collaboration to advance the scientific foundation for food and chemical safety assessment through AI-enabled and in silico approaches.”

FDA Research Collaboration

The extended agreement with the FDA’s Human Foods Program allows scientists to continue research involving computational models to support chemical safety assessments for food-related substances.

Following the completion of earlier project objectives, the FDA elected to extend the collaboration with Simulations Plus to further expand and refine AI-based safety models for use in regulatory research. New federal funding dedicated to food and chemical safety modernization will provide this collaboration with expanded access to curated toxicological datasets for further training, validation, and benchmarking of Simulations Plus’ AI/ML models.

NIEHS Research Collaboration

The extended collaboration with NIEHS focuses on computational approaches relevant to environmental and exposure-related chemical safety research. This work addresses a broad range of chemicals and exposure scenarios, consistent with NIEHS’s mission to support research on environmental influences on human health.

NIEHS’ collaboration with Simulations Plus is part of a national effort to modernize chemical safety assessment through AI-powered new approach methodologies and will continue the application of the company’s software engines to help with the design, validation, and benchmarking of new experimental systems under evaluation.

Advancing NAM Research

The extensions reflect continued federal interest in evaluating computational and AI-based approaches, areas in which Simulations Plus has longstanding technical expertise.

“For 30 years, our company has helped lay the scientific foundation for what is now known as model-informed drug development,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Our experts helped standardize methods that are now widely accepted by industry and regulators alike, and we are proud to continue pioneering the science and technology that support better-informed decisions across pharmaceutical development, food safety research and chemical risk assessment.”

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.

Contacts

Investor Relations Contact:
Lisa Fortuna
Financial Profiles
310-622-8251
slp@finprofiles.com