DILIsym Services Presents Important DILIsym and NAFLDsym Software Applications at the Virtual AASLD Liver Meeting

DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) and a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that important applications of their software programs were presented in poster form at the 2020 AASLD virtual Liver Meeting. Liver safety research conducted with the DILIsym software platform was reported for the COVID-19 drug remdesivir in a poster presented by Dr. Kyunghee Yang. The research helped to characterize the liver safety profile of the important anti-viral treatment. Quantitative systems pharmacology (QSP) work was presented by Dr. Zack Kenz focused on a NAFLDsym software application for the agonist anti-FGFR1/KLB bispecific antibody, BFKB8488A. The role of adiponectin in the reduction of liver fat (steatosis) in non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) patients was investigated as a key point of emphasis, and the results suggested adiponectin may play a major role in the mechanism.

DILIsym modeling supports key drug development decisions by predicting potential drug-induced liver injury (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. DILIsym is the product of an ongoing public-private partnership (the DILI-sim Initiative) that involves scientists from the pharmaceutical industry and academia.

NAFLDsym is QSP modeling software designed to support the development of treatments for NAFLD and NASH. The platform enables users to predict efficacy for novel treatment approaches, with the ability to evaluate compounds with various mechanisms of action. These mechanisms include fibrosis, steatosis, lipotoxicity, and inflammation. NAFLDsym also allows users to predict efficacy in NASH patients for combinations of treatments.

Dr. Scott Q. Siler, Chief Scientific Officer of DILIsym Services, said: “Our 2020 virtual Liver Meeting posters on remdesivir and BFKB8488A show our continued commitment to great science and important collaborations, even in the midst of the turbulent year of 2020. Kyunghee and Zack should be commended for their excellent work.”

Dr. Brett A. Howell, President of DILIsym Services, added: “These applications in both safety and efficacy are critical examples of our many great partnerships with the pharmaceutical industry. Both posters relate very closely to diseases where treatments are critically needed.”

About DILIsym Services, 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, DILIsym Services, and Lixoft, we offer #1-ranked, intuitive 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/toxicology approaches. Our technology is now licensed and used 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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