Simulations Plus Highlights Platform Innovation and Strategic Direction at 2026 Investor Day

Key Terms

model-informed drug development (MIDD) medical

Model-informed drug development uses computer-based math models and simulations of how a drug behaves in the body and how patients respond to guide decisions across research and clinical trials. Like a flight simulator for drug programs, it helps teams test scenarios, pick better doses, design smarter trials and reduce surprises, which can lower costs, shorten timelines and de-risk programs—information investors use to judge a drug’s chances and capital efficiency.

non-animal methodologies (NAMs) medical

Non-animal methodologies (NAMs) are laboratory and computer-based approaches—such as cell cultures, human tissue models, organ-on-a-chip systems, and computer simulations—used instead of live animal testing to evaluate safety and effectiveness of drugs, chemicals or consumer products. They matter to investors because NAMs can lower development time and costs, reduce regulatory and ethical risks, and improve chances of market approval by providing human-relevant data faster—like using a flight simulator instead of trial flights to spot problems early.

in silico medical

In silico means using computer models, simulations, or data analysis to study biological, chemical, or financial processes instead of physical experiments. For investors, in silico work can speed up research, lower costs and highlight promising opportunities or risks early—like using a flight simulator to test maneuvers before flying a real plane—while still requiring real-world testing to confirm results.

u.s. food and drug administration (fda) regulatory

The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.

european medicines agency’s (ema) regulatory

The European Medicines Agency is the European Union agency that evaluates, approves, and monitors medicines and vaccines for use across member countries. Its decisions act like a gatekeeper for the continent’s drug market—determining which treatments can be sold, restricted, or withdrawn—so investors watch EMA rulings closely to assess a product’s market access, revenue potential, regulatory risk, and timelines for commercialization.

mechanistic modeling medical

Mechanistic modeling is a mathematical simulation that maps how a drug or product interacts with the body’s underlying systems, using known biological processes as the blueprint. For investors it matters because these models turn lab knowledge into testable predictions—like a flight simulator for a drug—helping estimate likely effectiveness, optimal dosing, and clinical trial chance of success, which reduces uncertainty and guides valuation and funding decisions.

ai-assisted workflows technical

AI-assisted workflows are business processes where software using artificial intelligence helps people complete tasks faster, more accurately, or with less manual effort — like a smart assistant that suggests next steps, flags problems, or automates routine work. For investors this matters because such workflows can lower operating costs, speed product or service delivery, and scale a company’s output without a matching jump in headcount, all of which can improve margins and competitive position.

cloud-enabled execution technical

Cloud-enabled execution means running a company’s core operations, software and automated tasks on remote internet servers instead of only on local computers. For investors, it matters because this approach can lower upfront hardware costs, speed up rollouts, improve reliability and let a business scale more quickly—like renting a commercial kitchen that can expand on demand rather than building your own—while introducing dependence on outside providers and variable ongoing costs.

Showcases platform momentum, strategic priorities, and long-term value creation outlook

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 hosted its 2026 Virtual Investor Day, outlining how the Company is advancing an integrated, AI-enabled platform to support the evolving needs of the drug development industry and its regulators.

The Investor Day presentation focused on how Simulations Plus is driving innovation and leading meaningful change across the drug development lifecycle—pairing its long-standing scientific reputation with modern cloud and AI capabilities, while maintaining clear strategic direction.

“Our industry is at an inflection point,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Scientific complexity is increasing, regulatory expectations are evolving, and our clients are under pressure to move faster without compromising rigor. Our strategy is intended to address these challenges by combining trusted science with modern, integrated technology—so teams can make better decisions with confidence.”

Executive leadership discussed industry dynamics shaping pharmaceutical R&D, including increasing scientific complexity, rising expectations for in silico evidence, and regulatory momentum around model-informed drug development (MIDD), non-animal methodologies (NAMs), and responsible use of AI. The Company highlighted its alignment with emerging regulatory guidance, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency’s (EMA) shared principles for good AI practice in medicine development, emphasizing transparency, traceability, and scientific accountability.

“Drug development is entering a new phase—one where scale, integration, and scientific trust matter more than isolated tools,” said Jonathan Chauvin, Co-Chief Product & Technology Officer of Simulations Plus. “Our focus is on evolving our software and services into a unified modeling ecosystem that connects validated science, AI-assisted workflows, and enterprise-ready infrastructure in a way our clients and regulators can rely on.”

“At the core of our approach is grounded intelligence,” said Erik Guffrey, Co-Chief Product & Technology Officer of Simulations Plus. “We are following the FDA and EMA guiding principles of good AI practice in drug development—using AI to augment, not replace, mechanistic modeling, and ensuring outputs remain explainable, auditable, and anchored in validated science.”

The central theme of the event was Simulations Plus’ evolution from a portfolio of best-in-class tools into an orchestrated ecosystem spanning discovery, development, clinical operations, and commercialization. The Company outlined how cloud-enabled execution, reusable workflow patterns, and AI-assisted capabilities are being developed to hopefully improve productivity while supporting regulator-ready documentation and reproducibility.

The Investor Day broadcast is available for replay on the Simulations Plus website.

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 cloud-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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Investor Relations Contact:

Lisa Fortuna

Financial Profiles

310-622-8251

slp@finprofiles.com

Source: Simulations Plus, Inc.