Simulations Plus Positioned to Capitalize on FDA’s Streamlined Nonclinical Safety Guidance with Advanced Mechanistic and Model-Informed Solutions

Key Terms

monoclonal antibodies medical

Monoclonal antibodies are lab-made proteins designed to bind a single, specific target on cells or viruses, like identical keys cut to fit one lock. They are used as medicines, tests, or targeted delivery tools and can precisely block or mark disease processes. Investors care because they can become high-value drugs with large sales, long patent protection, and binary risks tied to clinical trial results, regulatory approval, manufacturing scale and pricing.

pharmacokinetics medical

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

physiologically based pharmacokinetics (PBPK) medical

A physiologically based pharmacokinetic (PBPK) model is a computer simulation that uses a virtual map of the body—organs, blood flow and basic biology—to predict how a drug is absorbed, distributed, broken down and eliminated. For investors, PBPK models help estimate dosing, safety and interactions earlier and cheaper than some lab or patient tests, which can reduce development cost, shorten timelines and lower the risk around a drug program.

quantitative systems toxicology medical

A method that uses computer models and real biological measurements to predict how a drug or chemical will affect the body across organs and over time, like creating a virtual ‘test run’ of safety instead of relying only on lab tests. For investors, it matters because better predictions reduce the chance of costly late-stage failures, speed development decisions, and provide clearer safety signals that influence regulatory approval and valuation.

quantitative systems pharmacology medical

A modeling approach that uses math, biology and drug data to create virtual simulations of how a medicine interacts with the body and disease. Think of it like a weather forecast for a drug: it tests different doses, patient types and timelines on a computer before or alongside real trials. Investors care because these models can lower development risk, help predict clinical success and guide cheaper, faster trial design and dosing decisions.

clinical pharmacokinetics (PK) medical

Clinical pharmacokinetics (PK) is the study of how a drug moves through and is processed by the human body—how it is absorbed, distributed to tissues, broken down, and eliminated. For investors, PK data show whether a drug can reach effective levels safely, what dose and schedule are practical, and how likely it is to clear regulatory hurdles and succeed commercially; think of it as the logistics and timing data that determine whether a delivery system actually works in the real world.

antibody-drug conjugates medical

A class of targeted cancer medicines that combine a lab-made antibody (which finds and sticks to specific markers on tumor cells) with a powerful cell-killing drug linked together so the toxic payload is delivered directly to the tumor. Think of it like a guided missile that reduces collateral damage compared with traditional chemotherapy; for investors, success or failure of these drugs drives clinical, regulatory and commercial value and can sharply affect a biotech company’s prospects and stock price.

AI copilots technical

AI copilots are software assistants powered by artificial intelligence that work alongside people to help with tasks such as writing, analyzing data, suggesting actions, and automating routine workflows; think of them as a helpful co-pilot who shares the workload and offers recommendations while a human remains in control. For investors, they matter because they can increase productivity, lower operating costs, enable new products and services, and change competitive dynamics, while also introducing risks around accuracy, implementation costs, and regulation that can affect profits and valuation.

Validated engines and AI-orchestrated ecosystem align with the emerging regulatory framework

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 responded to the U.S. Food and Drug Administration’s draft guidance on streamlined nonclinical safety studies for monospecific monoclonal antibodies. The guidance encourages reduced reliance on animal studies and elevates mechanistic understanding, pharmacokinetics, and integrated weight-of-evidence (WoE) assessments for nonclinical decision-making.

“The FDA’s draft guidance signals a clear regulatory mandate towards mechanistic, model-informed science, and Simulations Plus is uniquely positioned to help clients respond with confidence,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Our scientific engines, workflows, and cross-disciplinary capabilities have supported these integrated approaches for years.”

Mechanistic WoE Approaches Already Embedded in Simulations Plus’ Practice

Simulations Plus enables clients to integrate physiologically based pharmacokinetics (PBPK), quantitative systems toxicology/pharmacology (QST/QSP), clinical pharmacokinetics (PK), and mechanistic insights to support WoE assessments aligned with FDA-recommended approaches. This includes PBPK modeling in GastroPlus® to project human exposure and guide dose selection, mechanistic toxicity assessment in BIOLOGXsym™, and population modeling in MonolixSuite® to connect preclinical and clinical understanding.

Case studies published in the International Journal of Molecular Sciences, Pharmaceutics, and elsewhere show how combining PBPK and QST can strengthen the scientific rationale for streamlined nonclinical strategies for monospecific antibodies, including determining when extended non-human primate toxicology studies may not be warranted.

Ecosystem-Level Alignment with the New Regulatory Paradigm

The Simulations Plus ecosystem aligns with the FDA’s focus on mechanistic, model-informed evidence. Its validated scientific engines—including GastroPlus, MonolixSuite, ADMET Predictor®, and QSP platforms—provide the transparency, traceability and cross-domain mechanistic reasoning regulators expect. Supporting this scientific core is an AI-orchestrated framework that enables reproducible multi-engine workflows and guided decision support through AI copilots, all grounded in validated methods.

Continued investment in biologics modeling, including planned enhancements to GastroPlus and BIOLOGXsym, will expand support for monoclonal antibodies, antibody-drug conjugates, and immune-related pathways highlighted in recent FDA guidances.

“The draft guidance gives the industry a clear direction, and as model-informed safety and toxicology become essential disciplines, a new growth frontier opens for Simulations Plus in areas of our customer organization which have historically been underpenetrated,” said O’Connor. “Our mission is to help innovators navigate this transition with clarity, rigor, and confidence.”

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.

Environmental, Social, and Governance

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.

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”, “believe”, “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. 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 new 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251209477071/en/

Investor Relations Contact:

Lisa Fortuna

Financial Profiles

310-622-8251

slp@finprofiles.com

Source: Simulations Plus, Inc.