FDA Purchases Bundle of ADMET Predictor® Licenses

Center for Tobacco Products incorporates machine learning platform
to assist toxicology research

LANCASTER, Calif.–(BUSINESS WIRE)–Simulations Plus, Inc. (Nasdaq:SLP), the leading provider of modeling
and simulation solutions for the pharmaceutical, biotechnology,
chemicals, and consumer goods industries, today announced that it has
received an order from the U.S. Food and Drug Administration (FDA) for a
15-user license to its ADMET Predictor^® software suite. The
purchase was made by the Center
for Tobacco Products to support research projects aimed at informing
regulatory decision making.

John
DiBella, Lancaster division president for Simulations Plus, said:
“For many years, the FDA has utilized our software across various
departments, including the Office of Clinical Pharmacology, Office of
Generic Drugs, and Office of Pharmaceutical Quality. We are thrilled to
now see the Center for Tobacco Products incorporate our machine learning
technology to support their risk assessment activities as they evaluate
tobacco products and ingredients. We look forward to interactions with
the FDA staff to understand model performance on their chemicals and
identify future advances to ADMET Predictor’s functionality and
workflow.”

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 organizations
imply endorsement by the United States Government.

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 and quantitative
systems pharmacology models for drug-induced
liver injury, drug-induced
kidney injury, and nonalcoholic
fatty liver disease. The company is a global leader focused on
improving the ways scientists use knowledge and data to predict the
properties and outcomes of pharmaceutical, biotechnology, and chemical
agents. Our software is licensed to and used in the conduct of drug
research by major pharmaceutical, biotechnology, chemical, and consumer
goods 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.

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Contacts

Simulations Plus Investor Relations
Ms.
Renee Bouche
661-723-7723
[email protected]

Hayden IR
Mr. Cameron Donahue
651-653-1854
[email protected]