Simulations Plus Releases GastroPlus® Version 9.8.3

Rhea-AI Summary

Simulations Plus (NASDAQ: SLP) has announced the launch of version 9.8.3 of its GastroPlus software, enhancing its physiologically based biopharmaceutics modeling capabilities. Key updates include improved reporting templates for Monolix, new validated disease populations for NAFL and NASH, a swine PBPK model for veterinary research, and flexible dosing regimen handling. The company aims to strengthen software interoperability and provide researchers with advanced simulation tools. This release reflects the company's ongoing commitment to integrating machine learning and quantitative systems pharmacology in drug development.

Positive

• Enhanced software capabilities with version 9.8.3 launch.
• New validated NAFL and NASH disease populations improve research options.
• Addition of swine PBPK model supports veterinary medicine research.
• Improved reporting templates for Monolix enhance data analysis.

Negative

• None.

New update expands the library of virtual populations and enhances connections between software platforms

LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced the release of version 9.8.3 of its flagship physiologically based biopharmaceutics (PBBM) / pharmacokinetics (PBPK) modeling platform, GastroPlus^®.

Key enhancements include:

• Improved reporting templates for the Monolix™ software to support the statistical analysis of virtual PBPK population results
• New validated nonalcoholic fatty liver (NAFL) and nonalcoholic steatohepatitis (NASH) disease populations with options to inform the NAFLDsym^® software
• New validated swine PBPK model to drive pharmaceutical and veterinary medicine research
• New enzyme and transporter expression levels across species to expand the virtual population databases
• Flexible handling of dose regimens to allow for administration of any Additional Dosage Routes model during simulations

Dr. Haiying Zhou, director of Simulation Technologies, said: “Our goals with this release of GastroPlus were twofold: to advance the ways in which our software programs communicate with each other across the Simulations Plus universe and to provide the flexibility our users require to simulate the scenarios they need. We succeeded in this effort through our close collaborations with our partners in industry, academia, and government agencies and by working in harmony with the product development teams of our company.”

“We continue to push the boundaries for how PBBM/PBPK modeling should be integrated with machine learning, quantitative systems pharmacology/toxicology (QSP/QST), and population PK/PD approaches,” added Daniel O’Connor, director of Business Development. “Our leadership in this space is reflected through the growing number of companies applying GastroPlus to support candidate selection, first-in-human dose selection, formulation optimization, drug-drug interaction assessments, and more – all within a single software environment. We are excited to release this new version to our user community and continue to support and educate researchers worldwide by providing the best and most innovative science.”

About Simulations Plus

Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that 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, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.

Environmental, Social, and Governance (ESG)

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 to read our ESG Report.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221012005025/en/

Simulations Plus Investor Relations

Ms. Renee Bouche

661-723-7723

renee.bouche@simulations-plus.com

Hayden IR

Mr. Brian Siegel

346-396-8696

brian@haydenir.com

Source: Simulations Plus, Inc.

FAQ

What are the new features in Simulations Plus' GastroPlus version 9.8.3?

The new features include enhanced reporting templates, new validated disease populations for NAFL and NASH, a swine PBPK model, and flexible handling of dose regimens.

How does GastroPlus 9.8.3 improve research for NAFL and NASH?

It introduces validated disease populations that allow for better simulation and analysis of these conditions.

What is the significance of the new swine PBPK model in GastroPlus?

The swine PBPK model drives research in pharmaceutical and veterinary medicine, expanding research capabilities.

When was version 9.8.3 of GastroPlus released?

Version 9.8.3 was released on October 12, 2022.

Is Simulations Plus focused on integrating machine learning in their software?

Yes, the company is focused on integrating machine learning and quantitative systems pharmacology in their PBBM/PBPK modeling.