Press release

DILIsym Services Partners with Large Pharmaceutical Company to Begin QSP Model Development for Heart Failure

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DILIsym Services Inc. (DSS), a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical efficacy and safety, today announced that it is developing a new component for a QSP model focused on treating heart failure, such as can occur after myocardial infarction. As with other QSP efforts by the company, the development of this new QSP software component is being sponsored by a large pharmaceutical company partner and will be widely available via licensing and consulting for the broader pharmaceutical industry upon completion.

This new venture represents the company’s first project focused on QSP for heart failure. DSS expects the resulting IP to enable a pipeline of heart failure-related consulting and licensing revenue in the future, expanding the company’s addressable market. More importantly, the project illustrates the willingness of DSS to partner with its clients to provide custom solutions to their modeling and simulation needs in the areas of both efficacy and safety.

Scott Siler, Chief Scientific Officer of DSS, noted: “This QSP modeling effort builds on our existing competencies in developing models of fibrosis and companion pathophysiologies. Simulating the mechanisms contributing to the development of cardiac fibrosis and its contributions to heart failure will enable us to support the pharmaceutical industry in the development of therapeutics to treat heart failure by predicting efficacy before real-world patients are administered potential drugs.”

Brett Howell, President of DSS, added: “We are well suited to serve the full spectrum of our clients’ QSP needs, such as the development of a custom heart failure-related application in this case. The pharmaceutical industry’s use of QSP modeling approaches to improve development decision making and outcomes is increasing rapidly. Building upon our success in developing DILIsym®, the industry standard for liver safety modeling, we have applied our QSP expertise in an expanding array of therapeutic areas including NASH, pulmonary fibrosis, and now heart failure.”

About DILIsym Services Inc.

DILIsym Services Inc. was founded in 2015 in Research Triangle Park, North Carolina, and is the leading provider of drug-induced liver injury simulation software and related consulting services to the pharmaceutical industry. The company spun out of the former Hamner Institutes, acquiring all of the intellectual property, software, documentation, and other materials for the DILIsym software. The company’s other products include MITOsym®, for simulating in vitro mitochondrial function; NAFLDsym®, for the study of nonalcoholic fatty liver disease – a worldwide disease with few available treatment options; and future tools RENAsym™ for predicting drug-induced kidney injury and IPFsym™ for predicting the efficacy of drugs being developed to treat idiopathic pulmonary fibrosis (IPF). More information is available on the company’s website at

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery and development software as well as a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injury and nonalcoholic fatty liver disease. The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical, biotechnology, and chemical agents. Our software is licensed and used in the conduct of drug research by major pharmaceutical, biotechnology, chemical, and consumer goods companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation. For more information, visit our website at

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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