Lixoft Expands MonolixSuite™ in Version 2020R1

Lixoft, a Simulations Plus company (Nasdaq: SLP), a leading provider of population PKPD modeling solutions for pharmacometricians and biostatisticians, today announced that it has released version 2020R1 of its MonolixSuite™.

Key advancements in MonolixSuite version 2020R1 include:

• An enhanced Simulx module with a graphical user interface (GUI) featuring:
  • An exploration section allowing simulation of a typical individual and an interactive exploration of parameters and treatments
  • A simulation section allowing simulations of populations and clinical trials, post-processing to outcomes and endpoints, and replicates for uncertainty assessment. In addition, results and plots are built in.
• Data set filters
• A tumor growth inhibition (TGI) library
• Trend lines (mean and sd) in plots of observed data
• More flexibility for non-compartmental analysis (NCA) (e.g., units, parameter selection, stratification of results)
• A more flexible interface (e.g., dark theme, font size)
• Improved performance for data, libraries, and algorithms
• And more…

The advanced Simulx module is a powerful and flexible simulator for clinical trial pharmacometrics with an easy-to-use interface. In addition, it allows for a complete modeling and simulation workflow from data analysis and non-compartmental analysis, to population modeling and simulation with fully interoperable applications. It provides users with a fast, easy-to-use, and powerful suite of applications for pharmacometrics analysis, modeling, and simulation.

Jonathan Chauvin, Lixoft deputy general manager, said: "This is a significant breakthrough for the platform, especially for simulation purposes. These changes are a combination of features requested by industry and academic scientists and our own beliefs that extend the power of the MonolixSuite in important ways for modeling and simulation of both preclinical and clinical data. It clearly represents our vision to design products with advanced user experience, advanced statistical methods and computational performance.”

About Lixoft

Lixoft products are designed to save pharmacometricians and biostatisticians valuable time and energy. By providing the modeling and simulation community with breakthrough advances in user-friendly tools, Lixoft’s technologies bridge the preclinical/clinical/vigilance divides in modeling and simulation, allowing all stages of drug development to share information and synthesize the results. The MonolixSuite is a unique population PKPD modeling solution for pharmacometricians. Lixoft was founded in Paris, France, in 2011. More information is available on Lixoft’s website at www.lixoft.com.

About Simulations Plus, Inc.

Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer solutions which bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like "believe,” "expect,” and "anticipate” mean that these are our best estimates as of this writing, but that 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. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, 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, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports and filed with the U.S. Securities and Exchange Commission.

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