Board Change • May 20
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 3 highly experienced directors. Independent Director Sharlene Evans was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. 공시 • Apr 24
Simulations Plus, Inc. Announces Collaboration with Lonza Group Ag and U.S. Food and Drug Administration to Advance Predictive Frameworks for Complex Oral Drug Products Simulations Plus, Inc. had announced a funded research collaboration with Lonza Group AG and the U.S. Food and Drug Administration to develop and validate a mechanistic, predictive framework for assessing the in vivo performance of amorphous solid dispersion drug products. Mechanistic modeling approach and experimental integration designed to improve early risk identification, strengthen regulatory confidence, and expand AI-enabled workflows connecting data to decision-making. The collaboration evaluates whether advanced in vitro dissolution systems—particularly those incorporating dynamic gastrointestinal physiology—combined with mechanistic physiologically based biopharmaceutics modeling, can reliably predict key in vivo outcomes, including food effects and the impact of elevated gastric pH conditions. By establishing and validating these predictive capabilities, the collaboration aims to provide a scientific foundation for reducing reliance on certain clinical bioequivalence studies while maintaining the rigor and transparency required by regulators. Lonza will lead experimental work, including in vitro dissolution testing under fasted, fed, and elevated gastric pH conditions using advanced systems such as Controlled Transfer Dissolution, as well as the characterization and, where needed, manufacturing of amorphous solid dispersion formulation variants. Simulations Plus will lead the development and validation of in vitro–in vivo extrapolation frameworks using its DDDPlus® and GastroPlus® platforms, translating experimental data into predictions of in vivo pharmacokinetics and supporting virtual bioequivalence assessments. At the same time, it creates new opportunities to extend these capabilities into grounded AI-enabled workflow environments, where data, mechanistic models, and simulation outputs will be more directly connected. The Company will also contribute to interpretation within a regulatory context, ensuring alignment with evolving expectations for model-informed drug development. This work is supported in part through FDA funding and includes ongoing engagement with FDA scientists to directly align with regulatory priorities to advance model-informed drug development, modernize bioequivalence assessment for complex products, and reduce unnecessary reliance on human studies. By combining regulatory collaboration with open, non-proprietary data and validated methods based on real-world, FDA-approved amorphous solid dispersion products, the initiative is intended to inform future regulatory approaches and support broader adoption of science-based alternatives. 공시 • Apr 21
Simulations Plus Inc Announces Completion of 2026 Spring School Global Training Initiative Simulations Plus, Inc. announced the successful completion of its 2026 Spring School, a global training initiative designed to expand access to model-informed drug development (MIDD) and strengthen the scientific foundation of the industry’s future workforce. More than 1,400 scientists from industry, academia, and regulatory agencies from over 65 countries participated in the week-long program, reflecting the high demand for expert-led training as modeling and simulation increasingly become standard for drug development strategy, regulatory engagement, and clinical execution. Held from March 23 to 27, 2026, the Spring School program offered two tracks: GastroPlus Spring School: From PBPK Basics to Biopharmaceutics Applications, and MonolixSuite Spring School: High-Impact Pharmacometrics Case Studies. Both tracks included interactive lectures, hands-on exercises, and live Q&A sessions led by Simulations Plus experts. Simulations Plus has a long-standing commitment to education. In addition to its Spring School, the Company has previously offered Summer and Autumn Schools focused on PK/PD modeling. The most recent Autumn School was the first program to offer a second track focused on PBPK modeling. In addition to these programs, Simulations Plus is widely known for its University+ program, which provides free academic access to modeling and simulation software for thousands of students and educators worldwide. Together, these initiatives form a cornerstone of the Company’s global educational outreach—helping expand the adoption of model-informed approaches and strengthening the pipeline of scientists equipped to apply these methods across the drug development lifecycle. 공시 • Mar 27
Simulations Plus, Inc. to Report Q2, 2026 Results on Apr 09, 2026 Simulations Plus, Inc. announced that they will report Q2, 2026 results After-Market on Apr 09, 2026 공시 • Jan 09
Simulations Plus, Inc. Reaffirms Earnings Guidance for Fiscal 2026 Simulations Plus, Inc. reaffirmed earnings guidance for Fiscal 2026. For the period, the company expects Revenue to be in the range of $79 Million to $82 Million. 공시 • Dec 30
Simulations Plus, Inc., Annual General Meeting, Feb 12, 2026 Simulations Plus, Inc., Annual General Meeting, Feb 12, 2026. 
