Simulations Plus Enters New Funded Collaboration to Improve Lung Exposure Models for Pulmonary Infection Treatments

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has entered into a new funded collaboration with a large pharmaceutical company to develop machine learning models and enhance physiologically based pharmacokinetics / pharmacodynamics (PBPK/PD) approaches for potential treatments of pulmonary infections.

"Significant investments have been made by our partner to identify new oral and/or intravenous therapies for the lung, which will make our technology a centerpiece of their research strategy and enable accurate first-in-human predictions based on in silico, in vitro, and preclinical data,” said Dr. Viera Lukacova, chief scientist at Simulations Plus. "We will apply the ADMET Predictor® platform to build machine learning models for key endpoints to serve two purposes: to aid scientists in discovery as they screen candidate libraries, and to inform the mechanistic GastroPlus® models as lead compounds progress through development. Additionally, the innovative GastroPlus PBPK/PD models will be validated in specific populations (e.g., disease, geriatric) and published to increase regulatory understanding and acceptance.”

"This new collaboration highlights the uniqueness of working with Simulations Plus,” added John DiBella, Lancaster division president for the company. "We can take our validated, best-in-class machine learning and PBPK modeling platforms and customize them to our client’s specifications as their research priorities are defined. Our expert modelers will also support our partner’s teams as they apply the software to their research. The proactive engagement channels we have with our clients globally continues to pay dividends, and we welcome and invite future collaborations across our entire suite of software programs.”

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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