U.S. FDA Renews Annual DILIsym Software Licenses

FDA Maintains Access to Leading Liver Injury Software Program

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical safety and efficacy, today announced that the U.S. Food and Drug Administration (FDA) has again renewed its multi-seat license for the company’s leading quantitative systems toxicology (QST) modeling software, DILIsym®. The renewal continues to provide DILIsym software access to FDA employees across all FDA divisions at the FDA’s discretion.

DILIsym supports key management decisions by providing information about potential drug-induced liver injury (DILI) risk in upcoming clinical studies and/or post-marketing situations, as well as mechanistic rationale for the underlying biochemical events that could cause liver toxicity. The information from such studies serves to guide go/no-go decisions on major projects, potentially avoiding the disastrous financial effects of failed clinical trials, or better, providing assurances that drug-induced liver injury will not be an insurmountable obstacle to establishing the safety of a new compound or dose. A new therapeutic illustrates one such example where a potential blockbuster drug recently approved by the FDA, ubrogepant, was analyzed by DILIsym utilizing SimPops. DILIsym is the product of an ongoing public-private partnership (the DILI-sim Initiative) that involves scientists from the pharmaceutical industry and academia.

Dr. Paul Watkins, founder of the DILI-sim Initiative and chair of the DILI-sim Scientific Advisory Board, said: “Over the last year, DILIsym software has been used increasingly across the Pharma industry to assess the liver safety of new drug candidates, and the modeling results have frequently been shared with regulators. For example, DILIsym modeling predicted the liver safety of ubrogepant relative to the first two drugs in class which failed in clinical trials due to liver safety concerns. The modeling results were part of the weight of evidence supporting approval of ubrogepant. I am pleased to see that the FDA continues to see value in maintaining access to this software.”

Dr. Brett Howell, president of DILIsym Services, also chimed in: “Our pharmaceutical partners continue to see the value of DILIsym for predicting and understanding their liver injury issues. We are glad the FDA does as well, and we look forward to continuing to work with them to ensure they have access to our tools as they conduct their important work of reviewing new drug applications.”

Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organizations imply endorsement by the United States Government.

About DILIsym Service, Inc.

DILIsym Services, Inc. was founded in 2015 in Research Triangle Park, North Carolina, and 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. Thus, DILIsym and RENAsym may be applied to address drug safety across therapeutic areas, while NAFLDsym and IPFsym may be applied to support the development of efficacious drugs in these therapeutic areas. DILIsym Services makes these tools available to small, mid-size and large pharmaceutical organizations and regulatory agencies through its licensing programs. In addition to performing consulting services using the modeling software, the expert scientific team engages clients from initial program design through data input and “results” interpretation. The company’s mission is to apply its modeling and simulation expertise to support the development of safe and efficacious drug therapies. More information is available on the company’s web page.

About Simulations Plus, Inc.

Simulations Plus, Inc.,
is the premier developer of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen Corporation, DILIsym Services, and Lixoft, we offer #1-ranked, easy-to-use software to bridge data mining and compound library screening with QSAR models, PBPK/TK modeling and simulation in animals and humans following administration around the body, and quantitative systems pharmacology approaches. Our technology is now licensed and used by major pharmaceutical and biotechnology 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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Contacts

Simulations Plus Investor Relations
Ms. Renee Bouche

661-723-7723

renee@simulations-plus.com

Hayden IR
Mr. Cameron Donahue

651-653-1854

slp@haydenir.com

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