U.S. FDA Renews DILIsym Software Licenses

U.S. FDA Remains Committed to Streamline & Accelerate Drug
Development using Model-Informed Drug Development (MIDD) technology

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–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 the U.S. Food and Drug
Administration has renewed its multi-seat license for the company’s
flagship quantitative systems toxicology (QST) modeling software, DILIsym®.
The renewal provides DILIsym access to FDA employees across all FDA
divisions.

DILIsym prospectively supports key management decisions by providing
information about potential drug-induced liver injury (DILI) risk in
upcoming experimental or clinical study designs, as well as mechanistic
rationale for the underlying biochemical events that could cause liver
toxicity. The information from such studies serves to guide go/no-go
decisions on major projects, potentially avoiding the disastrous
financial effects of failed clinical trials, or better, providing
assurances that drug-induced liver injury will not be an insurmountable
obstacle to establishing the safety of a new compound or dose. DILIsym
is the product of an ongoing public-private partnership (the DILI-sim
Initiative
) that involves scientists from the pharmaceutical
industry and academia.

Dr.
Paul Watkins
, chair of the DILI-sim Scientific Advisory Board, said:
“DILI remains a major problem for drug developers and regulators.
DILIsym modeling software is helping to address this challenge. We’re
excited to see the DILI-sim Initiative QST platform continue to be
available to the FDA, especially as sponsor submissions with DILIsym
results are ever increasing.”

Dr.
Brett Howell
, president of DILIsym Services, added: “The cost of
developing new drugs continues to rise, and liver safety is an important
component of this cost. If not adequately addressed during the drug
development process, this issue can either force companies to run
unrealistically large clinical trials to support safety or to abandon
their molecule after expensive large trials and even drug approval in
some cases. DILIsym is now helping companies address these concerns
through the use of QST, and we are delighted to see that the FDA remains
engaged in this process through the renewal of its license package for
DILIsym.”

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 DILIsym Service, Inc.

DILIsym Services, Inc. was founded in 2015 in Research Triangle Park,
North Carolina, and 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. Thus, DILIsym and
RENAsym may be applied to address drug safety across therapeutic areas,
while NAFLDsym and IPFsym may be applied to support the development of
efficacious drugs in these therapeutic areas. DILIsym Services makes
these tools available to small, mid-size and large pharmaceutical
organizations and regulatory agencies through its licensing programs. In
addition to performing consulting services using the modeling software,
the expert scientific team engages clients from initial program design
through data input and “results” interpretation. The company’s mission
is to apply its modeling and simulation expertise to support the
development of safe and efficacious drug therapies. More information is
available on the company’s web page at www.dilisymservices.com.

About Simulations Plus, Inc.

Simulations
Plus, Inc.
is the premier developer of modeling and
simulation software and consulting services supporting drug discovery,
development research, and regulatory submissions. With our subsidiaries,
Cognigen Corporation and DILIsym Services, we offer #1-ranked,
easy-to-use software to bridge data mining and compound library
screening with QSAR models, PBPK/TK modeling and simulation in animals
and humans following administration around the body, and quantitative
systems pharmacology approaches. Our technology is now licensed and used
by major pharmaceutical and biotechnology companies and regulatory
agencies worldwide. 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]

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