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Simulations Plus Releases RENAsym® Version 1A Software for Kidney Injury

New RENAsym platform helps drug developers avoid kidney injury side effects

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that its DILIsym Services division has released RENAsym® version 1A, the first version of its novel quantitative systems toxicology (QST) software for predicting and investigating drug-induced kidney injury.

Dr. Brett Howell, president of the DILIsym Services division, remarked: “DILIsym continues to be used for high impact applications in the liver safety space. RENAsym, our newest QST platform, will allow us to help companies developing new therapeutics understand and avoid potential kidney injury issues as well, thereby expanding the reach of our software and associated consulting services into an important area.”

Dr. Jeffrey Woodhead, Principal Scientist and lead on the RENAsym program, added: “RENAsym includes various mechanisms by which therapeutics can injure the kidneys of preclinical species and humans, as well as important biomarkers of kidney injury and function. It will greatly enhance our capabilities on the QST side, allowing us to solve a broader array of problems and client challenges. We look forward to iterating on this first version and meeting with new prospective users and clients regarding its capabilities.”

RENAsym modeling supports key drug development decisions by predicting potential kidney injury risk of new drug candidates. The modeling also identifies the biochemical events that lead to injury caused by a drug and can thereby predict certain subgroups of patients at increased risk for DILI from that drug. The information from RENAsym modeling will help guide go/no-go decisions on drug development projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances of a path to FDA approval. RENAsym was developed with SBIR funding from the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases division, grant R44DK118981.

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About Simulations Plus, Inc.

Serving clients worldwide for 25 years, Simulations Plus, Inc. is a leading provider of modeling and simulation 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, chemical, consumer goods companies, and regulatory agencies worldwide. For more information, visit our website at Follow us on Twitter | Read our Environmental, Social, and Governance (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.


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