DILIsym Services Inc., a Simulations Plus Company, Releases DILIsym® Version 6A

Significant update of liver safety program includes performance and capability enhancements

Research Triangle Park, NC, August 8, 2017 – 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 it has released Version 6A of its flagship QSP (quantitative systems pharmacology) modeling program, DILIsym.

Dr. Paul Watkins, chair of the DILI-sim Scientific Advisory Board, said: “We are excited to release DILIsym v6A to the members of the DILI-sim Initiative so they can continue using the software to improve the efficiency of the drug development process. The important updates and new features included are the direct result of feedback from our member companies and the oversight of the Scientific Advisory Board. We look forward to continuing this process of developing DILIsym for optimal use through the DILI-sim Initiative as we enter Stage 3 of the consortium over the next three years.”

Dr. Brett Howell, President of DILIsym Services, added, “This new release of DILIsym is the result of many months of intense effort by our talented modeling and simulation team and the support of our member companies. It reflects the priorities of the pharmaceutical liver safety community, as represented by the member companies of the DILI-sim Initiative, and we are excited to make this new product available to the members.”

A sample of the enhancements include:

  • New validation compounds (ambrisentan, sitaxsentan, phenformin, nelfinavir)
  • New simulated population focused on biomarker variability, SimPops™ (v6A-1), with variability in alanine aminotransferase (ALT) parameters
  • New capability for population-level PK data input (for enhanced compatibility with Simulations Plus’ GastroPlus™ and other PBPK programs)
  • Substantial improvements in the PBPK submodel
  • Addition of TNF-α-mediated survival and regeneration for better representation of pleiotropic functionality
  • Updated DILIsym documentation resources, now embedded within the software

Walt Woltosz, chairman and chief executive officer of parent company Simulations Plus, said, “This major release follows our first two months of operations with DILIsym Services, and we are very pleased with the operation and organization of our new division. I like to say that we sell productivity for drug development, and simulation and modeling software provides a tremendous bang for the buck. The DILIsym software provides important information to pharmaceutical companies regarding the potential for drug-induced liver injury from new and existing compounds, and this information synergizes well with GastroPlus and other modeling solutions from Simulations Plus. Project managers can make more informed decisions with respect to taking new compounds forward or switching to alternate compounds based on the insight gained through DILIsym into the likelihood of liver toxicity prior to conducting expensive and time-consuming clinical trials.”

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 and a newer product called NAFLDsymfor the study of nonalcoholic fatty liver disease – a worldwide disease with few available treatment options.  More information is available on the company’s Web site at https://www.dilisym.com.

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. The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents. Our software is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology 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 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 as filed with the U.S. Securities and Exchange Commission.

CONTACT:

Simulations Plus Investor Relations                             Hayden IR
Ms. Renee Bouche                                                    Mr. Cameron Donahue
661-723-7723                                                            651-653-1854
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Simulations Plus, Inc.
42505 10th Street West
Lancaster, CA 93534-7059

Companies Supporting DILIsym® Software Development

2016 04 DILIsim Consortium 2