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Simulations Plus Forms Scientific Advisory Board for RENAsym Consortium

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RENAsym SAB to Provide Insights and Guidance for Development of Kidney Injury Software

Simulations Plus, Inc. (Nasdaq: 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 formed a Scientific Advisory Board (SAB) to provide guidance and direction for development of its RENAsym quantitative systems toxicology (QST) kidney injury software platform.

The SAB has been formed within the RENAsym Consortium, and consists of the following experts:

  • Dr. Lauren Aleksunes, Professor of Pharmacology and Toxicology at the Rutgers University Ernest Mario School of Pharmacy;

  • Dr. Zheng Dong, Regents’ Professor and Leon H. Charbonnier Endowed Chair at the Medical College of Georgia of Augusta University and the Director of Research & Development at the Charlie Norwood VA Medical Center;

  • Dr. K. Melissa Hallow, Associate Professor at the University of Georgia School of Chemical, Materials, and Biomedical Engineering;

  • Dr. Ravindra Mehta, Professor at the University of California at San Diego School of Medicine;

  • Dr. Frank D. Sistare, Former Scientific Associate Vice President at Merck Research Laboratories and Captain in the U.S. Public Health Service at the Food and Drug Administration’s Center for Drug Evaluation and Research;

  • Dr. Paul B. Watkins, RENAsym and DILI-sim SAB Chair, Howard Q. Ferguson Distinguished Professor and Director of the Institute for Drug Safety Sciences at the University of North Carolina.

For the past 10 years, DSS has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym® software package. The RENAsym Consortium was recently launched in a similar fashion for the development of the RENAsym® software program, which uses properties of drugs to predict their risk of causing kidney injury in patients. RENAsym version 1A will be released in the latter half of 2021 for drug developers to use in-house or engage via consulting. The combined liver and kidney safety capabilities of DILIsym and RENAsym will allow DSS to address a larger portion of the safety issues facing drug developers.

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the RENAsym Consortium, remarked: "Given the tremendous success of the DILIsym® software in predicting liver injury due to drugs, many stakeholders urged the team to take on kidney toxicity and we are delighted to see this happening. The members of the Scientific Advisory Board are internationally recognized scientists with expertise spanning basic kidney biology, novel new tests to detect kidney injury, and the various ways drugs can harm kidneys in patients. I am very excited to be working with this team."

Newly appointed SAB member, Dr. Frank Sistare, commented: "I am honored to be part of this effort. Drug safety toolboxes are expanding in areas of region-specific translational kidney safety biomarkers, advanced in vitro kidney models, and mechanistic molecular tissue biomarkers. It makes perfect sense to work collaboratively to expand mathematical modeling capabilities that can pull these data streams together to provide more accurate perspectives on kidney effects at target clinical exposures and improve drug development decision making."

Dr. Brett A. Howell, president of DILIsym Services, added, "All of our new RENAsym SAB members are extremely knowledgeable and distinguished scientific leaders. Our establishment of this new SAB under the RENAsym Consortium umbrella is just another example of our commitment to top level science within our products and services."

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. More information is available on the company’s web page.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210316005399/en/

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