Simulations Plus Releases GastroPlus Version 9.5

Significant update of top-rated program contains enhancements to several modules

LANCASTER, Calif.--(BUSINESS WIRE)--Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling & simulation solutions for the pharmaceutical, biotechnology, and chemicals industries, today announced that it has released version 9.5 of its flagship PBPK modeling program, GastroPlus™.

“This new version of GastroPlus is the result of many months of intense work by our talented simulation technologies team, and we are excited about the final outcome. A small sample of the many enhancements includes”

Dr. Viera Lukacova, team leader and GastroPlus product manager, said: “This new version of GastroPlus is the result of many months of intense work by our talented simulation technologies team, and we are excited about the final outcome. A small sample of the many enhancements includes:

• New PBPK models for antibody-drug conjugates (extension to the Biologics Module)
• New models for subcutaneous and intramuscular injection formulations (extension to the Additional Dosage Routes Module)
• Revamped workflows for building in vitro-in vivo correlations (IVIVCs) and performing virtual bioequivalence trial simulations (extension to the IVIVCPlus™ Module)
• Several new physiology models, including Chinese and hepatic impairment population groups
• Improved reporting capabilities, making it easier for companies wishing to submit results to regulatory agencies.”

John DiBella, vice president for marketing and sales for Simulations Plus, added: “GastroPlus has served as the industry’s workhorse software for oral drug development activities for many years, and we have invested heavily to extend the utility of the program to serve other research functions. We have also been fortunate to enter into several funded collaborations with industry and secure multiple grant awards from the U.S. FDA, which has resulted in the ongoing development of the Additional Dosage Routes Module that is now being licensed by numerous organizations. Version 9.5 has a mix of important new features that users across companies and departments will appreciate, and we expect this to drive further adoption of GastroPlus within the different markets we serve.”

Walt Woltosz, chairman and chief executive officer of Simulations Plus, said, “The cost and time to develop new drugs continues to increase, and simulation and modeling software is one of the most powerful productivity tools available to offset these rising costs. As a result of the recently released draft guidance documents focused on PBPK modeling from the U.S. FDA and the European Medicines Agency supporting the need for tools like GastroPlus to assist with pharmaceutical research and development, we believe adoption will only increase. Our focus on improving the reporting capabilities in this new version should allow sponsor companies to more effectively communicate results to regulatory authorities and, ultimately, to assist with the drug approval process.”

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 as filed with the U.S. Securities and Exchange Commission.

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