Simulations Plus, Inc. (SLP) Business

ITEM 1 –BUSINESS

As used in this Report, each of the terms “we,” “us,” “our,” the “Company,” and “Simulations Plus” refers to Simulations Plus, Inc. and its wholly owned subsidiaries (both current and previous, as applicable).

Simulations Plus, Inc. was incorporated in California on July 17, 1996. The Company is a global leader and premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery and development, clinical trial operations, and commercialization. The Company supports its clients across the drug development lifecycle from early discovery through all phases of clinical research and development (“R&D”), including clinical operations, to product commercialization. The Company serves clients as a strategic partner throughout the entire drug development lifecycle, offering solutions that integrate scientific software platforms, artificial intelligence-augmented insights, and expert consulting. This optimizes efficiency, costs, and time-to-market for our clients, thereby enhancing our competitive position.

Our clients face many challenges. Developing new therapies is time-consuming and expensive, requiring an average of 10-15 years at an average cost of $2.2 billion to develop a single drug according to Drug Discovery Today. Drug sponsors must prioritize not only the safety and efficacy of the drug, but also navigate issues such as drug-drug interactions, inclusion of diverse populations, evolving regulatory policies, increasing compliance during clinical trials, and achieving commercial success.

Our model-informed drug development (“MIDD”) software and services solutions allow clients to use modeling and simulation to accelerate the drug development timeline, minimize animal testing, reduce the costs of R&D, comply with regulatory guidance and best practices, and increase confidence in the safety and efficacy of their drugs. Our clinical operations solutions support the success of clinical trials by enhancing participant diversity and retention of participants and driving competency and compliance with trial protocols. Meanwhile, our commercialization solutions provide support in obtaining regulatory approval and post-regulatory commercialization of new treatments.

Through these offerings, we fulfill our mission to create value for our clients by accelerating and reducing the costs of R&D through innovative science-based software and consulting solutions that optimize treatment options and improve patient lives.

At the beginning of the fourth quarter of fiscal year 2025, the Company reorganized its internal structure to create a more integrated and cohesive operating platform based on product and service solutions. This reorganization reflects a shift from a business unit to a function-based organizational structure including:

•Services;

•Operations;

•Product and Technology;

•Research and Development;

•Sales and Marketing; and

•General and Administrative

The Company's U.S. headquarters is in Research Triangle Park, NC and its European office is in Paris, France. Our common stock has traded on the Nasdaq Global Select Market under the symbol “SLP” since May 13, 2021, prior to which it traded on the Nasdaq Capital Market under the same symbol.

SOLUTIONS

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We provide end-to-end offerings across the drug development lifecycle, including guiding early drug discovery, establishing pre-clinical protocols, contributing to the design of clinical programs, enabling clinical trial operations, facilitating regulatory submissions for product approval, and supporting commercial market launches. We are a premier developer of modeling and simulation software for drug discovery and development, including the prediction of properties of molecules utilizing both artificial intelligence (“AI”) and machine-learning ("ML") technologies. Our software and consulting services are provided to major pharmaceutical, biotechnology, agrochemical, cosmetics, and food industry companies and academic and regulatory agencies worldwide for use in conducting industry-based research. Our clients use our software programs and scientific consulting services during the drug discovery and development stages to enhance their understanding of the properties of potential new therapies and to use emerging data to improve formulations, select and justify dosing regimens, support generic pharmaceutical product development, optimize clinical trial designs, and simulate outcomes in special populations, such as elderly and pediatric patients. Our clients also leverage our software and consulting services to optimize their clinical trial operations and commercial market launches.

SOFTWARE

General

We currently offer software products for discovery, development, clinical operations, and commercialization, as follows:

Discovery

•Two biosimulation products that predict and analyze static properties of chemicals utilizing both AI and ML technologies:

◦ADMET Predictor® : AI/ML software for absorption, distribution, metabolism, excretion, and toxicity (ADMET) modeling, with extended capabilities for data analysis, extensive metabolism predictions, AI-driven drug design, integrated HT-PBPK simulations, and rapid mechanistic liver safety risk assessments.

◦MedChem Designer™: free chemical sketching software tool that combines innovative molecule drawing features with some of the fast and accurate ADMET property predictions from ADMET Predictor.

Development

•Three biosimulation products that provide time-dependent results based on solving large sets of mechanistic differential equations:

◦

◦GastroPlus®: mechanistically based simulation software that predicts absorption, biopharmaceutics, pharmacokinetics, and pharmacodynamics in humans and animals.

◦DDDPlus™: software for modeling the in vitro dissolution of active pharmaceutical ingredients (APIs) and formulation excipients under various experimental conditions.

◦MembranePlus™: software for in vitro permeability and hepatocyte modeling.

•Eight biosimulation products that are based on mechanistic, mathematical models and differential equations:

◦DILIsym®: software for predicting potential drug-induced liver injury (DILI) hazards and providing insight into mechanisms responsible for observed DILI responses.

◦NAFLDsym®: software for predicting efficacy for treatment modalities developed for metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as nonalcoholic fatty liver disease (NAFLD), and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH).

◦ILDsym™: software for predicting efficacy of treatment modalities developed for interstitial lung disease (ILD) associated with systemic sclerosis (SSc).

◦IPFsym®: software for predicting efficacy of treatment modalities developed for idiopathic pulmonary fibrosis (IPF) and other lung diseases.

◦RENAsym®: software for predicting the likelihood of renal injury and providing insight into the biological mechanisms behind observed renal safety signals.

◦MITOsym®: software focused on representing in vitro experimental assessment of mitochondrial function.

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◦OBESITYsym™: software for predicting drug efficacy for weight loss and nausea side effects.

◦Thales™: end-to-end quantitative systems pharmacology (QSP) software for building models, optimizing simulated populations to reported clinical efficacy, and visualizing and analyzing simulation results.

•One biosimulation product designed for modeling and simulation that supports clinical trial simulations and trial design, as well as population analyses, rapid clinical trial data analyses, and regulatory submissions:

◦MonolixSuite™ (the combination of Monolix®, PKanalix®, and Simulx®).: fully interoperable software suite for a modeling workflow that includes data visualization, non-compartmental analysis, and population modeling and simulations.

Clinical Operations

•One product for education, training, and compliance monitoring:

◦Pro-ficiency®: adaptive learning/simulation-based training software supporting protocol compliance during clinical trials.

Commercialization

•One product for key opinion leader (“KOL”) research in the medical community:

◦Panorama KOL Insights: an easy-to-use dashboard for accessing current information about key opinion leaders (KOLs) based on filters including but not limited to therapeutic expertise, geographic location, affiliations, publications, and clinical trials.

Our software business represented 58% of our total revenue during the fiscal year ended August 31, 2025, primarily generated by the following products:

ADMET Predictor®

ADMET Predictor is a top-ranked, chemistry-based computer program that takes molecular structures as inputs and uses AI/ML technology to predict more than 175 different properties for them. This capability allows chemists to generate estimates for many important molecular properties without the need to synthesize and test the molecules. A chemist can then assess the likely success of many existing molecules in a company’s chemical library, as well as generate new ideas for virtual molecules still being designed.

The optional ADMET Modeler™ Module in ADMET Predictor enables scientists to use their own experimental data to quickly create proprietary high-quality predictive models using the same powerful AI engine we use to build our top-ranked property predictions.

Version 13 of ADMET Predictor was released in June 2025, which added many new features, including:

•New Models: New models offer increased accuracy and granularity of our clients' predictions, including areas such as liver microsomal and hepatocyte intrinsic clearance for monkeys and dogs, plasma protein binding (Fup) for monkeys and dogs, melting point, Gibbs free energy of self-solvation and hydration, and more.

•Enhanced Models: Updates to our trusted models offer improved understanding around aqueous solubility, volume of distribution, blood-brain barrier (BBB) penetration, and more.

•Updated Modules: The high-throughput pharmacokinetic ("HTPK") and Artificial Intelligence-driven Drug Design ("AIDD") modules have been expanded to provide more detail to our clients' predictions and promote novelty and synthetic feasibility.

•Expanded Representation State Transfer ("REST") API: The latest version of our REST API supports image generation in Linux, easier property prioritization, and more.

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•General Usability and Informatics Improvements

We have made significant investments in three key areas with recent versions: improving integration of our top-ranked ADMET Predictor and GastroPlus models to leverage our novel HTPK simulation approaches for chemists and safety researchers, enhancing our best-in-class AI/ML engine to assist with drug discovery, and advancing our innovative AIDD Module to apply generative AI technology to design, optimize, and evaluate up to 10 million lead molecules overnight for any combination of properties.

Recent collaborations include:

•Validation of ADMET Predictor models with enhanced AI drug design: in July 2025 and with the Institute of Medical Biology of the Polish Academy of Sciences (IMB PAS), we announced the publication of results that showed the validation of our models and on the ADMET Predictor platform. With IMB PAS, we used our models to design and optimize molecules for RORγ/RORγT ligand potency, in vivo absorption, synthesizability, and ADMET risk; the vast majority of compounds tested had strong potency for the target.

•Development of new AI drug discovery offering: in October 2024 and in partnership with the University of Southern California (USC) Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, we were awarded a research grant from the National Institutes of Health ("NIH") to evaluate and integrate novel computational methods that account for water-ligand interactions into the AIDD module for a first-of-its-kind ligand-based virtual screening solution.

GastroPlus®

In May 2024, GastroPlus version 10 (branded as GPX™) was released. This version was the culmination of a long-term collaboration with our scientific partners to understand how we can better support their needs, and resulted in a completely redesigned platform that incorporated the proven top-rated science, advanced models, refined algorithms, and integrated ML technology that has been validated over 27 years. In September 2025, GastroPlus version 10.2 (branded as GPX.2) was released with new and expanded models, as well as new AI and automation functionality designed to support complex simulations and workflows.

Because of the extent of the use of GastroPlus, we have been able to enter both funded and unfunded collaborations with industry and government agencies to drive advances in modeling and simulation science. In all such collaborations, we own the intellectual property developed within the GastroPlus program, and updates are integrated into future versions and made available to all clients. Recent collaborations include:

•Enhancement of advanced compartmental absorption and transit (ACAT™) model: in January 2025, we partnered with the Enabling Technologies Consortium to enhance the predictive capabilities of our ACAT model to support the development of immediate-release oral drug products.

•Expansion of mechanistic modeling approaches for long-acting injectables: in November 2024 and in partnership with the University of Connecticut’s School of Pharmacy, Department of Pharmaceutical Sciences, we were awarded a funded grant from the U.S. Food and Drug Administration (FDA) to use Physiologically Based Pharmacokinetics ("PBPK") approaches in GastroPlus to build and validate mechanistic in vitro-in vivo correlations for long-acting injectables.

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DILIsym®

DILIsym is the leading quantitative systems toxicology ("QST") platform for predicting and explaining drug-induced liver injury ("DILI"). It is designed for use during drug development to provide an indication of the potential DILI hazard posed by individual molecules as well as to provide deeper insight into the mechanisms responsible for observed DILI responses at various stages of the development process.

It is the most widely used software for DILI prediction and is utilized as a source of QST modeling-based data assessed by the FDA’s DILI team.

In May 2025, DILIsym version 11 was released with new and enhanced models, as well as the addition of new pediatric and post-menopausal women (PMW) simulated populations.

Thales™

Thales is an end-to-end quantitative systems pharmacology (QSP) platform for building models, optimizing simulated populations to reported clinical efficacy, and visualizing and analyzing simulation results. It is designed to support scientists in developing models to understand biological complexities, evaluate drug candidates for clinical efficacy and/or toxicity potential, and guide clinical trial designs and optimal dosing protocols. Licensable models are available in the areas of metabolism, oncology, inflammation, and immunology.

MonolixSuite™

MonolixSuite is a specialized solution for modeling and simulation for pharmaceutical companies, biotechnology enterprises, and hospitals. It supports nonparametric analyses, population analyses and modeling, and clinical trial simulation. The extended MonolixSuite contains three main products: PKanalix®, Monolix®, and Simulx®. Monolix 2024R1 was released in March 2024, which combines the most advanced algorithms with a unique ease of use. The products are used by pharmaceutical companies across the globe at each step of drug development, from preclinical to first-in-human, clinical, and post-approval.

Pro-ficiency®

Pro-ficiency is an adaptive learning/simulation-based training platform that delivers bespoke education underpinned by a proprietary software foundation that allows for rapid content development with multi-language and cultural adaptability, with insights derived from learned behavior that highlight performance/execution risk areas and allow them to be addressed before trials or projects begin.

SERVICES

General

Our scientists and engineers have extensive expertise, including, but not limited to initial molecule design using molecular design tools, and AI and ML; modeling pharmacokinetics, pharmacodynamics, drug-drug interactions, dosing paradigms, exposure-response, and potential toxicity; developing and conducting effective site/investigator training and compliance monitoring; and medical communications and commercialization strategies. We partner with clients who have complex problems and recognize our expertise in solving them.

Our services business represented 42% of our total revenue during the fiscal year ended August 31, 2025, primarily generated by the following service offerings:

Development

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PBPK: In 2014, the FDA began to emphasize the need to encourage mechanistic PBPK modeling and simulation in clinical pharmacology, with final guidance documents completed in 2018. Draft guidance documents from the FDA, which were released in October 2020, focused on additional biopharmaceutics applications for oral drug product development, manufacturing changes, and controls. Other global agencies, including the European Medicines Agency (“EMA”), Japan’s Pharmaceutical and Medical Devices Agency (“PMDA”), the Chinese National Medical Products Administration (“NMPA”), and Health Canada, have all published their own guidance, or extended existing ones, over the past several years. This has resulted in an increased need for our scientific consulting staff to draw upon its extensive experience across multiple therapeutic areas of modeling and simulation to provide consulting-related services utilizing these sophisticated techniques. We support PBPK modeling throughout the entire product lifecycle, from discovery through translational research and clinical development, when an organization lacks the time or resources to use our software directly. More specifically, our clients seek out our consulting services to acquire scientific, therapeutic-area-related modeling and simulation expertise that they do not have in-house.

QSP: We provide creative and insightful consulting services to support our quantitative systems pharmacology (“QSP”) modeling focused on liver and kidney safety, metabolic and cardiac conditions, inflammatory disease, and immuno-oncology, as well as other areas.

PKPD: Our clinical-pharmacology-based consulting services span the entire clinical development phase, and includes population pharmacokinetic and pharmacodynamic (“PKPD”) modeling, exposure-response analyses, clinical trial simulations, data programming, and technical writing services in support of regulatory submissions. In addition to modeling and simulation consulting services, we provide expertise and assistance with development-related decision-making and support for regulatory interactions related to dose selection, clinical trial design, and understanding of the determinants of safety and efficacy for new medicines.

Clinical Operations

Our training development consulting services provide a unique blend of instructional design and clinical operations expertise, designing simulation-based programs that allow learners to practice complex concepts from clinical trial protocols in a risk-free virtual environment, thereby facilitating and accelerating study launch, and that provide Sponsors with performance-based analytics to mitigate risk and optimize study and project quality.

Commercialization

Our experienced medical communications consultants provide strategy, positioning, messaging, and tactical support for our clients in support of their market intelligence and commercial endeavors.

Below is a summary of percentage of total revenues for each of our software and services businesses for the fiscal years ended August 31:

SALES AND MARKETING

We market our software and services globally through attendance and presentations at scientific meetings, exhibits at trade shows, seminars at pharmaceutical companies and government agencies, online presentations, our website, and various communication channels to our database of prospects and clients. At various scientific meetings worldwide, research accomplishments using our software are reported through numerous presentations and posters. Many of these presentations are from industry and FDA scientists; while others are from our staff. Numerous peer-reviewed scientific journal articles are published, and conference presentations are delivered each year using our software, primarily by our clients, further supporting its use in a wide range of preclinical and clinical studies.

Our sales and marketing efforts are handled primarily internally by our sales and marketing staff, with our scientific team and several senior management staff assisting with trade shows, seminars, and client training both online and on-site. We also have independent distributors in Japan, China, India, South Korea, and Brazil, who sell and market our products with support from our scientists and engineers.

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During the fourth quarter of fiscal year 2025, the Company pivoted to an account-based solution selling business model, where the focus is on identifying and solving client pain points across the drug development lifecycle rather than selling discrete products or services. This is an opportunity to align business development activities with the Company reorganization and design the sales organization for strategic growth, client-centricity, and scalability.

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COMPETITION

We compete against a number of established companies; some of our competitors provide screening, testing, and research services, and products that are not based on biosimulation software. Other competitors provide both consulting services and biosimulation software. There are also software companies whose products do not compete directly with ours but are sometimes closely related. Our competitors in this field include some companies with financial, personnel, research, and marketing resources that are larger than ours.

Major pharmaceutical companies conduct drug discovery and development efforts through their internal development staff and outsourcing. Smaller companies generally need to outsource a greater percentage of this effort. Thus, we compete not only with other software suppliers, scientific consulting service providers, and contract research organizations ("CROs"), but also with in-house development and scientific consulting teams at some of the larger pharmaceutical companies. Our competitors include, but are not limited to, Optibrium, Certara, ICON, Metrum Research Group, Veeva, and WCG.

Based on our technical knowledge and expertise, we believe that we are strategically positioned to offer competitive modeling and simulation consulting services to companies. Our clients seek out our services for multiple reasons including: (i) to acquire scientific, therapeutic-area-related modeling expertise that they do not have in-house, (ii) to address a need for modeling and simulation efforts beyond the capacity of in-house resources, (iii) to fulfill their modeling requirements more efficiently than they could do in-house, and (iv) to utilize our software when they do not have the in-house expertise to do so. We apply our software and assist companies in such areas as AIDD, MIDD, PKPD, PBPK, and QSP.

We believe the key factors in our ability to successfully compete in this field are our ability to: (i) continue to invest in research and development, and develop and support industry-leading simulation and modeling software and related products and services, (ii) develop and maintain a proprietary database of results of physical experiments that serve as a basis for simulated studies and empirical models, (iii) continue to attract and retain a highly-skilled scientific and engineering team, (iv) aggressively promote our products and services to the global market, and (v) develop and maintain collaborative relationships with research and development departments of pharmaceutical companies, universities, and government agencies.

In addition, we are actively seeking strategic acquisitions to expand both our pharmaceutical software portfolio and services offerings.

TRAINING AND TECHNICAL SUPPORT

Client training and technical support are important factors in client satisfaction for our modeling and simulation products in discovery and development, and we believe we are an industry leader in providing strong client training and technical support in our business areas. We provide in-house seminars at clients’ and potential clients’ sites, as well as at selected universities to train students who will soon be industry scientists. These seminars often serve as initial training in the event the potential clients decide to license or evaluate our software. Technical support is provided after the sale of any software in the form of on-site training (at the client’s expense), web meetings, and e-mail assistance to the clients’ users during the clients’ license periods.

Technical support for our software is provided by our sales operations and support staff. We have found that most clients need minimal technical support for our software products.

RESEARCH AND DEVELOPMENT

The development of our software is focused on the convergence of AI, cloud computing, and our validated science to expand our product portfolio and integrate existing and new products into our principal software architecture and platform technologies. We intend to continue to offer regular updates to our products and to continue to look for opportunities to expand our existing suite of products and services.

To date, we have developed products internally, sometimes also licensing or acquiring products, or portions of products, from third parties. We intend to continue to license or otherwise acquire technology or products from third parties when we believe that it makes business sense to do so.

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Our software products are designed and developed by our product and technology team in close partnership with other departments. Our products and services are delivered electronically and deployed through on-premise and cloud-hosted models.

INTELLECTUAL PROPERTY AND OTHER PROPRIETARY RIGHTS

We primarily protect our intellectual property through trademarks, copyrights, trade secrets, and through contractual measures. Our intellectual property consists primarily of source code for computer programs, online platforms, and data files for various applications of those programs and platforms for use by pharmaceutical businesses. The expertise of our staff is a considerable asset closely related to intellectual property and attracting and retaining highly qualified scientists and engineers is essential to our business.

CLIENTS

Our clients include companies involved in pharmaceuticals, biotechnology, agriculture, and consumer goods, as well as universities, hospitals, and government research and regulatory agencies. We concentrate on serving the needs of our clients in drug discovery, development, clinical trials, post-patent generic formulation development, and post-approval drug commercialization. Our current client base is highly fragmented, and we did not derive a material portion of our revenues from any single client for the fiscal year ended August 31, 2025.

SEASONALITY

Our revenues exhibit seasonal fluctuations, with the first and fourth fiscal quarters generally having the lowest revenues. This is due to pharmaceutical industry buying patterns, consulting service slowdowns due to summer vacations in the previous quarter, and lower client and employee conference attendance in those periods. Revenues for any quarter are not necessarily indicative of revenues for any future period; however, because our pharmaceutical software is licensed on an annual basis, renewals are usually within the same quarter year after year, even though there are certain instances in which the license renewal term may not immediately follow the initial license term, and therefore result in a shift of certain client revenues to a subsequent quarter.

ENVIRONMENTAL REGULATORY MATTERS

We believe we are in compliance in all material respects with all applicable environmental laws. Presently, we do not anticipate that efforts to maintain such compliance will have a material effect on capital expenditures, earnings, or competitive position with respect to any of our operations.

HUMAN CAPITAL

We are dedicated to our people and foster a culture of engagement, empowerment, and equity. Over 99% of our global workforce is full-time, with more than 70% having life sciences software, services, and R&D backgrounds. Due to the specialized nature of our work, we recruit candidates with advanced education and skills-over 60% of our technical and scientific staff hold advanced degrees with focuses inclusive of mathematics, chemistry, biomedical engineering, or pharmaceutical sciences.

As of August 31, 2025, we employed 213 people, including 212 full-time and one part-time employee.

Culture

Our continued success depends on attracting and retaining top talent. To support this, we focus on a comprehensive total rewards program encompassing compensation, benefits, wellness, training, time off, recognition, and travel support. In 2025, according to employee feedback collected by the workplace-culture platform Comparably, the Company was included on that site's lists for Best Company for Diversity, Best Company for Women, Best Company for Leadership, and Best Company for Benefits. Our voluntary turnover rate was under 6% in fiscal year 2024, reflecting strong continued employee engagement.

In fiscal 2025, we hosted an all-company summit that brought our global team together to align on company strategy, strengthen in-person connections, and give back to the community. As part of the event, employees volunteered to assemble and donate over 100 STEM backpacks to support a local underserved community.

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We are committed to fostering an inclusive environment where all employees feel valued, respected, and supported in reaching their full potential. Our goal is to ensure that everyone has equal access to opportunities and is empowered to contribute meaningfully to our shared success. In terms of gender equity, women currently comprise 46% of our workforce and 47% of our scientific staff. Through our ADP Workforce Now platform, we actively monitor workforce trends and hiring data to guide continuous improvements in our policies and practices. We regularly review these metrics to align our recruitment efforts and refine benefits to support all employees. We offer paid parental leave for all employees, whether for birth or adoption, and maintain a flexible time-off and remote-first work culture that enables collaboration across the globe and allows us to hire the best talent, regardless of location.

Compensation, Training, and Awareness Programs

We continue to refine our career paths across all functions, using grade-level benchmarking to guide internal development, promotion, and recruitment. These structured pathways ensure transparency and consistency while supporting employee growth and organizational excellence. Our ADP Workforce Now platform further enhances performance management, goal tracking, and succession planning.

In the coming year, we intend to place greater emphasis on identifying and growing future leaders by strengthening leadership development and succession planning. We continue to provide company-funded opportunities for employees to advance their technical, leadership, and professional skills. Our ongoing cross-specialty training program—featuring monthly presentations by expert modelers from different departments—fosters collaboration, expands shared knowledge, and builds a unified, innovative workforce.

Health & Safety

We place a high value on maintaining a clean, safe, and healthy environment for our employees. Our Human Rights Policy confirms our commitment to basic human rights worldwide and our Code of Conduct requires our employees and vendors to work within our established principles of ethics.

The well-being of our employees, whether they are working in our offices or remotely from home offices, is one of our highest priorities. We believe that we are substantially in compliance with all applicable laws, regulations, and standards, and we make every reasonable effort to be attentive and responsive to our employees’ needs. We continue to provide very competitive health and wellness benefits, and each year we host a wellness challenge for all employees with monetary incentives to encourage a healthy and less sedentary lifestyle. We also host regular "coffee breaks" and other virtual engagement opportunities to encourage, even in a remote environment, interacting and sharing with colleagues outside of work meetings or topics.

We also consider open and transparent channels of communication to be a critical component of our employee health and wellness program. Toward this end, on a quarterly basis, we hold a company-wide virtual meeting to keep our employees engaged, informed, and apprised of activities occurring at the Company and within each business unit, including quarterly financial results, future goals, and notable milestones.

GOVERNMENT REGULATION

We believe that our operations are substantially in compliance with all applicable laws and regulations and that we hold all necessary permits to operate our business in each jurisdiction in which our facilities are located. Laws and government regulations are subject to change and interpretation. Our pharmaceutical software products and platforms are tools used in research and/or development and are neither approved nor approvable by the FDA or other government agencies.

No significant pollution or other types of hazardous emissions result from our operations and it is not anticipated that our operations will be materially affected by federal, state, or local provisions concerning environmental controls. Our costs of complying with environmental, health, and safety requirements have not been material. Furthermore, compliance with federal, state, and local requirements regulating the discharge of materials into the environment, or otherwise relating to the protection of the environment, has not had, nor are they expected to have, any material effect on the capital expenditures, earnings, or competitive position of the Company.

ENVIRONMENTAL, SOCIAL, GOVERNANCE

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We are committed to creating sustainable and excellent returns to our shareholders, all while maintaining a strong sense of good corporate citizenship that places a high value on the welfare of our employees, the communities in which we operate, and the world as a whole. We believe that effectively prioritizing and managing our Environmental, Social, and Governance (“ESG”) factors will help create long-term value for our investors. We also believe that transparently disclosing the goals and relevant metrics related to our ESG programs will allow our stakeholders to be informed about our progress.

The topics covered in this section are identified through third-party ESG reporting frameworks, standards, and metrics, such as the Sustainability Accounting Standards Board (“SASB”), and United Nations Sustainable Development Goals ("SDGs"). More information regarding our key ESG programs, goals and commitments, and key metrics can be found on the ESG Reports and Updates section of our website.

Our ESG highlights include the following:

Environmental Matters

Our electronic waste is sent to approved local e-waste recycling centers. We have a policy of using IT hardware vendors that embrace environmental sustainability. We continue in our commitment to remote work, with most employees working from home, which reduces emissions from commuting to workplaces. As part of our ongoing commitment to environmentally sustainable business operations, we recently consolidated the servers in our U.S. offices into our existing colocation facility to reduce energy usage and our carbon footprint. As a result, our energy usage was reduced by 75% compared to the prior year.

Greenhouse Gas Emission:

Scope:

Scope 1: Scope 1 covers direct greenhouse gas (“GHG”) emissions that occur from sources that are controlled or owned by an organization (e.g., emissions associated with fuel combustion in boilers, furnaces, and vehicles).

Scope 1 is not applicable to our organization as it does not own or control any sources that produce direct GHG emissions.

Scope 2: Guidance standardizes how corporations measure emissions from purchased or acquired electricity, steam, heat, and cooling (called “scope 2 emissions”).

We have identified electricity as our source that produces GHG scope 2 emissions.

Scope 3: Scope 3 encompasses emissions that are not produced by the company itself and are not the result of activities from assets owned or controlled by it, but by those entities with which it engages up and down its value chain. An example of this is when we buy, use, and dispose of products from suppliers. Scope 3 emissions include all sources not within the scope 1 and 2 boundaries.

We believe that we do not produce GHG emissions that fall within Scope 3.

We believe we are in compliance in all material respects with all applicable environmental laws. Presently, we do not anticipate that such compliance will have a material effect on capital expenditures, earnings, or competitive position with respect to any of our operations.

Social Impact and Supporting Our Communities

Our People

•Our commitment to our people lies in our continued efforts to support and value our most important asset - our employees.

•We maintain a remote-first philosophy that supports the needs and priorities our employees have outside of work and contributes to work-life balance.

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•We have a paid parental leave program to support working parents and a recognition system to encourage peer- to-peer and leader-to-employee recognition.

•We also ensure that all our employees have the opportunity to attend in-person employee events to collaborate face-to-face with their colleagues around the globe.

•We continue to provide supplemental benefits to our health benefit offerings and have increased our focus on physical and mental wellness with all our teams through an online wellness challenge hosted by the Company.

•We continue to engage with our employees and listen to their feedback in order to work toward building a culture of trust, collaboration, and transparency.

Client Privacy & Data Security

•We value client privacy, and we endeavor to collect data only to the extent needed to deliver company information, software products, and consulting services. Our website includes a copy of our comprehensive Privacy Notice, which details what and how data are collected, how data are used and stored, and the options for controlling personal data, including opting out, accessing, updating, or deleting it.

•In recognition of the critical importance of data security to our operations, including cybersecurity, data protection, and client privacy, our leadership team conducts a thorough examination of all elements of data security. Our objective is to ensure the security, confidentiality, and privacy of our systems and information assets, and to follow and be compliant with all applicable laws, regulations, and guidelines, including, but not limited to:

◦U.S. and State data privacy laws

◦The EU’s General Data Protection Regulation (the "EU GDPR")

◦The UK Data Protection Act 2018 (the "UK GDPR")

◦Pharmaceutical Good Practice Quality Guidelines, including FDA 21 CFR Part 11

◦The Sarbanes-Oxley Act

◦The Personal Information Protection Law of the People’s Republic of China ("PIPL")

•Our corporate-level IT department provides consistency, efficiency, and functional IT support across all business units. Our IT department is responsible for centralizing business unit-driven data processing, storage, and backup capabilities at each of our geographical locations. Our Quality and Compliance department is also responsible for ensuring that corporate IT policies are aligned and compliant with all applicable regulatory provisions and current best practices.

•Margaret Richardson, Executive Director of Quality and Compliance, is the Data Protection Officer (“DPO”) for the Company. The DPO is responsible for ensuring that we have a Personal Data Protection program in place that is compliant with data privacy laws such as the EU GDPR, UK GDPR, China’s PIPL, and data privacy laws enacted at the state level, as applicable to SLP. Our corporate Personal Data Protection program includes policies, practices, and training directed to protecting personal data.

Business Ethics

•From the Company’s inception, we have placed a strong emphasis on conducting our business with honesty and integrity. High ethical standards are expected of management and employees alike, and we continuously strive to create a corporate culture of honesty, integrity, and trust. Throughout our operations and in our dealings with our stakeholders, we endeavor to engender the confidence that the Company’s conduct is beyond reproach.

•The policies we have developed are intended to:

◦Define and disseminate our core values and the legal requirements applicable to good business conduct and ethical behavior.

◦Offer guidance in understanding Company policies, interpreting laws, and handling Company-related issues and situations.

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◦Foster clear, ethical behaviors and conduct to create an atmosphere of respect, trust, cooperation, and collaboration throughout the Company and its activities.

◦Provide clear and well-defined procedures by which employees can easily obtain information, ask questions, and, if necessary, report any suspected violations of any of our Business Ethics policies.

•In addition to abiding by all applicable laws, all management and employees are required to comply fully with our Code of Conduct, which sets forth the Company’s values, business culture, and practices. The Code of Conduct also governs conduct between our employees and our clients and vendors with whom we do business. Because many of our clients are companies in the pharmaceutical and biotech industries, we have incorporated into our Code of Conduct the principles of the Pharmaceutical Supply Chain Initiative, including Leadership, Partnering, Presence, Consistency & Quality, Learning, and Innovation & Discovery.

Human Rights

•The Company was founded on the belief that our software technologies could lead to important advances in healthcare, thereby improving patient outcomes, advancing and improving global health, and bettering the lives of humankind. This objective cannot be accomplished without a commitment to human rights, and we are committed to ensuring that, in our day-to-day business practices, in our business relationships, and in matters of employment, we will uphold our own principles as delineated in our Code of Conduct. Furthermore, we support the principles set forth in the United Nations International Bill of Human Rights, specifically the Universal Declaration of Human Rights, and the ILO Declaration on Fundamental Principles and Rights at Work and have a written Human Rights Policy to uphold these commitments. As we evolve this policy, we will look to the UN Guiding Principles on Business and Human Rights ("UNGPs") for guidance.

Governance

We are committed to ensuring strong corporate governance practices on behalf of our shareholders and other stakeholders. We believe strong corporate governance provides the foundation for financial integrity and shareholder confidence. Our Board of Directors is responsible for the oversight of risks facing the Company, while our management is responsible for the day-to-day management of risk. The Board has three committees: Audit Committee, Compensation Committee, and Nominating & Corporate Governance Committee. The Board, as a whole, directly oversees our strategic and business risk, including risks related to financial reporting, compensation practices, cybersecurity, ESG, and product developments. In addition, all our employees, contractors, and vendors are required to follow our Code of Conduct as a part of our good governance practice. Our Board of Directors is gender and racially diverse. Our ESG steering committee oversees and executes matters related to ESG. More information about our corporate governance features will be included in our Proxy Statement for the 2026 Annual Meeting of Shareholders (the "Proxy Statement"), which we intend to file with the Securities and Exchange Commission within 120 days after August 31, 2025, the close of our fiscal year covered by this Report.

These ESG initiatives reflect our approach to managing long-term operational and reputational risks. They are not intended to imply that we have adopted, or are required to comply with, any particular third-party standard. We will continue to evaluate our ESG disclosures as regulatory expectations evolve.

COMPANY WEBSITE

We maintain a corporate website at: www.simulations-plus.com.

The contents of this website, including without limitation any documents, web pages or other information accessible through our website (whether or not referred to in this Report), are not incorporated in or otherwise to be regarded as part of this Report. We file reports with the SEC, which are available on our website free of charge. These reports include annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements, and other related filings, each of which is provided on our website as soon as reasonably practical after we electronically file such materials with or furnish them to the SEC. Our officers and directors also file “Section 16” filings on Form 3, Form 4, and Form 5 with the SEC, which filings are also accessible on our website as soon as reasonably practicable after they are filed with the SEC. In addition, the Securities and Exchange Commission maintains a website (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC, including the Company.