U.S. FDA Renews Licenses of DILIsym Software

FDA Renewal Allows for Evaluation of DILIsym Submissions by Sponsors

Simulations Plus, Inc. SLP, a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that its DILIsym Services (DSS) division has renewed licenses to its DILIsym^® software platform, its flagship quantitative systems toxicology (QST) software for predicting and investigating drug-induced liver injury (DILI), for use by the U.S. Food and Drug Administration (FDA). The renewal ensures continued DILIsym software access to FDA employees across all FDA divisions at the FDA's discretion through an unlimited licensing package.

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, remarked, "It is not surprising that the FDA continues to see value in maintaining access to the DILIsym software in-house, as they are now frequently seeing results from the software in regulatory submissions, including NDA applications. It's clear that results for DILIsym modeling can be an important part of the weight of evidence supporting the liver safety of new drug candidates."

Dr. Brett Howell, president of the DILIsym Services division, added: "DILIsym is helping drug developers better predict and understand liver injury. There are now several public examples of this, including work focused on ubrogepant, lixivaptan, tolvaptan, remdesivir, pexidartinib, solithromycin, entolimod, acetaminophen, and GGF2. Many other examples are ongoing or completed but not yet public. It is, therefore, great to see the FDA maintaining DILIsym access to potentially evaluate the DILIsym submissions received and to potentially do further analyses."

Simulations Plus will host a panel discussion on April 29, 2021, featuring key leaders in the drug development and liver safety spaces. Dr. Lorenzo Pellegrini, COO of Palladio Biosciences, Dr. Vlad Coric, CEO of Biohaven Pharmaceuticals, and Dr. Paul B. Watkins, a world-renowned DILI expert consultant and Distinguished Professor at the University of North Carolina, will join the panel to take questions regarding the use of QST tools (such as DILIsym) within drug development. Register for the FREE webinar here.

DILIsym modeling supports key drug development decisions by predicting potential DILI risk of new drug candidates. The modeling also identifies the biochemical events that lead to DILI caused by a drug and can thereby predict certain subgroups of patients at increased risk for DILI from that drug. The information from DILIsym modeling serves to help guide go/no-go decisions on major drug development projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that DILI will not be an insurmountable obstacle to regulatory approval. For the past 10 years, the DILIsym Services division has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym software package. DILIsym is available to the pharmaceutical and chemical industries for direct use to predict and understand liabilities via membership in the DILI-sim Initiative consortium and/or commercial licenses. The DILIsym Services division also routinely uses DILIsym for comprehensive consulting services on safety-related issues.

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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. Follow us on Twitter | Read our Environmental, Social, and Governance (ESG) Report.

The DILIsym Services division of Simulations Plus has developed DILIsym® and NAFLDsym® QSP software, and is developing IPFsym™ and RENAsym™ QSP software, to provide the pharmaceutical industry with the tools and resources to efficiently develop safe and effective drug therapies. DILIsym and RENAsym are designed to address drug-induced liver injury (DILI) and drug-induced acute kidney injury, respectively. NAFLDsym and IPFsym are designed for target or compound evaluation of therapeutic efficacy in nonalcoholic fatty liver disease (NAFLD or NASH) and idiopathic pulmonary fibrosis (IPF), respectively.

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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