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Simulations Plus Receives $1.7 Million Grant for BIOLOGXsym™ Macromolecule Safety Software

SLP will partner with the University of Pittsburgh and its Liver-on-a-Chip platform

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that it has received a Phase II SBIR NIH grant for the further development and validation of its novel BIOLOGXsym™ platform, which is quantitative systems toxicology (QST) software focused on complex macromolecule liver safety. The grant provides approximately $1.7 million for both software development and wet lab work, which will be accomplished via a partnership with the University of Pittsburgh Drug Discovery Institute (UPDDI). The UPDDI will utilize its human vascularized Liver Acinus MicroPhysiology System (vLAMPS), a next-generation organ-on-a-chip system that allows for comparison of liver toxicity in liver cells collected from healthy versus liver-diseased donors, to screen for signals related to liver safety mechanisms and provide that as input data for BIOLOGXsym simulations. Principal Investigator (PI) on this project is Dr. Kyunghee Yang. The combined in vitro laboratory data plus software offering will be available commercially following the 2-year development and testing period.

Dr. Paul Watkins, the Director of the Institute for Drug Safety Sciences at University of North Carolina and consultant for the project, said: “The liver QST software provided by Simulations Plus, DILIsym®, is now used to improve the safety of many drugs in development. BIOLOGXsym will serve a similar purpose for large molecules and will incorporate the novel information that can be obtained from vLAMPS. This collaboration with UPDDI will expand the spectrum of drugs in development that will benefit from QST to include therapeutic proteins, monoclonal antibodies, and potentially viruses used in gene therapy. Importantly, it will pioneer application of QST software to the evolving ‘human-on-a-chip’ systems.”

Dr. D. Lansing Taylor, the Director of the University of Pittsburgh Drug Discovery Institute and Co-PI on the project, stated: “The integration of testing biologics in human liver microphysiology systems containing four or more liver cell types organized to mimic the liver acinus, coupled through the BioSystics™ Analytics Platform (formerly the Microphysiology Systems Database) to the BIOLOGXsym computational modeling and simulation software creates a powerful QST platform. Dr. Lawrence Vernetti, a Co-PI on the project, will lead the project at the UPDDI.”

Brett Howell, President of the DILIsym Services division of Simulations Plus, added, “We are excited to receive this NIH grant, one of the largest ever procured by SLP, which validates our plan for focusing on the liver safety of complex molecules as an important market need, and also allows us to expand our software and services offerings to a rapidly growing side of therapeutic development.”

Funding for this collaboration is made possible by the National Institutes of Health through grant R44TR003535. 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 organization imply endorsement by the United States Government.

About Simulations Plus

Serving clients worldwide for 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that 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, and regulatory agencies worldwide. For more information, visit our website at Follow us on Twitter | LinkedIn.

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We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our ESG Report.

About the University of Pittsburgh Drug Discovery Institute (UPDDI)

The University of Pittsburgh Drug Discovery Institute (UPDDI) brings together collaborations with Pitt faculty, other academic centers, corporations and government agencies to focus on the application of quantitative systems pharmacology (QSP) as a complementary approach to drug discovery and development. The UPDDI works in multiple disease areas including metastatic cancers, liver diseases and neurodegenerative diseases, as well as drug safety. We apply QSP by integrating human, biomimetic microphysiology systems (MPS) to generate physiological and pathophysiological experimental and computational models to create a new paradigm for the development of repurposed and novel therapeutics. BioSystics, Inc was spun-off as a bioanalytics company to measure, model and understand data from patients and biomimetic MPS to create patient digital twins for precision medicine.

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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