DILIsym Services was awarded a Phase II $1.5M NIH SBIR grant to continue development of RENAsym, software for predicting drug-induced kidney injury.

Phase II Award of NIH Fast Track SBIR Grant for Drug-induced Kidney Injury Software, RENAsym™, Funds Development Over Next 20 Months

Contacts

DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) developing in silico modeling software, resources, and information for assisting the pharmaceutical industry to more efficiently develop safe and effective drug therapies, today announced it has been awarded $1.5 million from Phase II of its previously announced Fast-Track Small Business Innovation Research (SBIR) grant by the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK). The second phase of the grant funding will support DILIsym Services’ continued development, validation, and testing of its RENAsym software for predicting drug-induced kidney injury. Drug-induced kidney injury can be costly, and may require multiple interventions, including hospitalization. The development of the RENAsym software will provide a tool that can be used in drug development efforts to predict a drug’s potential to cause drug-induced kidney injury, as well as assess and improve the understanding of mechanisms of drug-induced kidney injury.

Brett Howell, Ph.D., president of DILIsym Services, commented: “Our success with Phase I of this Fast-Track NIH grant demonstrates our commitment to help modernize drug development and reduce the time and costs associated with developing new therapies. With this continued NIH grant funding support, we will produce the first commercial version of RENAsym. Our team is dedicated to the development of commercial versions of RENAsym for use by the pharmaceutical industry, academic centers, and government agencies for investigation and screening of possible drug-induced kidney damage.”

In parallel with, and at the conclusion of the grant funding, the RENAsym Consortium is being formed to unite the world’s leading biopharmaceutical companies within a pre-competitive arena to collaborate, share ideas, and guide future development of RENAsym. This new consortium is patterned after DILIsym Services’ highly successful DILI-sim Initiative, which has developed tools to predict and understand drug-induced liver injury. RENAsym will utilize the PBPK module from GastroPlus®, the industry leading PBPK modeling software, and eventually be offered as a module integrated into the GastroPlus platform (as well as in a standalone format).

Contact us to join the RENAsym Consortium today!

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, a platform for predicting drug-induced liver injury. The company’s other products include MITOsym®, for simulating in vitro mitochondrial function, and NAFLDsym® for the study of nonalcoholic fatty liver disease – a worldwide disease with few available treatment options. More information is available on the company’s website 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 and filed with the U.S. Securities and Exchange Commission.