Market Overview

Simulations Plus Subsidiary DILIsym Awarded Grant for up to $1.7 Million For Model Development


Novel in silico Drug-induced Kidney Injury Model

Services, Inc.
, a Simulations Plus company (NASDAQ:SLP) developing in
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 a
Fast-Track Small Business Innovation Research (SBIR) grant by the
National Institutes of Diabetes and Digestive and Kidney Diseases
(NIDDK). The grant, coauthored by Dr.
Brett Howell
(Principal Investigator) and Dr.
Bud Nelson
, is entitled "Software for predicting a drug's potential
to cause acute kidney injury." The total award for this Fast Track SBIR
grant is up to $1.7 million over the next 18-24 months. The initial
award is for Phase I, at a level of $225,000, with Phase II beginning in
January 2019, subject to successful completion of Phase I. Drug-induced
kidney injury can be costly, and may require multiple interventions,
including hospitalization. The goal of this project is to provide
software 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

Brett Howell, Ph.D., president of DILIsym Services, commented: "We are
thrilled to see that the NIH supports our mission to help modernize drug
development and reduce the time and costs associated with developing new
therapies. This large research grant will provide the funding we need to
produce the first version of RENAsym™, which will be marketed to the
pharmaceutical industry for investigation and screening of possible
drug-induced kidney damage. Our team had already begun development of
RENAsym, and we will now ramp up to accelerate the process."

Walt Woltosz, chairman of Simulations Plus, added: "This is a major
accomplishment by the DILIsym team, representing the largest federal
grant in Simulations Plus' history. Building on our expertise in
drug-induced liver injury and nonalcoholic fatty liver disease, RENAsym
will expand our Quantitative
Systems Pharmacology (QSP)
offerings to include potential damage to
the kidney. Identifying the potential for kidney damage as early as
possible in a drug development program can avoid costly failures later
on in expensive clinical trials. It's worth noting that RENAsym, like DILIsym®
and NAFLDsym®,
will require target tissue concentrations generated by physiologically
based pharmacokinetics (PBPK) software, and the eventual tight
integration of all three products with our industry-leading GastroPlus™
PBPK platform will seamlessly provide the required information to each

About DILIsym Services, Inc.

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. The
company's other products include MITOsym®
for simulating in vitro mitochondrial function and a newer
product called NAFLDsym®
for the study of nonalcoholic fatty liver disease – a worldwide disease
with few available treatment options.

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
for regulatory submissions and quantitative systems
pharmacology/toxicology models for drug-induced
liver 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 research
by major pharmaceutical, biotechnology, chemical, consumer goods
companies, and regulatory agencies worldwide. Our innovations in
integrating new and existing science in medicinal chemistry,
computational chemistry, artificial intelligence, pharmaceutical
science, biology, and physiology into our software have made us the
leading software provider for molecular property prediction from
structure and physiologically
based pharmacokinetic modeling and simulation
. For more information,
visit our website at

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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