Simulations Plus Offers Rapid Response COVID-19 Research Initiative

“As a company, we are adjusting our standard business priorities and schedule to prepare to provide immediate support for pharmaceutical research and development efforts,” said Dan O’Connor, Director of Business Development for Simulation Sciences. “Our scientists are eager to help teams expedite solutions to address the COVID-19 virus.”

As part of this initiative, each division of Simulations Plus will provide specialized expertise which will contribute to developing safe and effective treatments. Integrated solution offerings include:

• Mechanistic GastroPlus® pulmonary simulations to investigate alternative dosing modalities (inhalation, oral, and various parenteral routes) and optimize dosing to target lung exposure
• Application of GastroPlus modeling and simulation data in regulatory reports to support repurposing strategies or drug product quality claims (e.g., safe prescribing of higher strength medications)
• Utilization of the quantitative systems toxicology (QST)/pharmacology (QSP) models from DILIsym to predict potential liver toxicity risk, efficacy potential for pulmonary injury-related pathophysiology, or efficacy potential for cardiac injury-related pathophysiology of drug candidate treatments for COVID-19
• Semi-mechanistic drug and disease modeling and simulation support, including implementation of state-of-the-art viral dynamics models developed at Cognigen, for clinical and strategic decision making and regulatory submissions
• Comprehensive Clinical Pharmacology consulting for drug development and regulatory interaction

Shawn O’Connor, Chief Executive Officer of Simulations Plus, added: “Working together with pharmaceutical companies, universities, and government agencies, we can speed the virtual candidate evaluation pipeline and/or drug repurposing assessments to improve predictions of clinical outcomes, drive research priorities, and accelerate regulatory approval. We stand ready to help in any way useful to effectively solve this pandemic.”

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery/development software and 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. Our software is used to conduct drug 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, pharmaceutical science, biology, and physiology into our software have made us the leading provider for physiologically based pharmacokinetic modeling and simulation. Visit us online 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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