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Simulations Plus Enters New Funded Collaboration to Enhance Top-Rated GastroPlus® ACAT™ Model for Oral Absorption of Peptides

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New modeling approaches will accelerate the evaluation of innovative formulation strategies

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has entered into a new funded collaboration with a large pharmaceutical company to add novel mechanisms for oral peptide formulations within the top-rated GastroPlus® Advanced Compartmental Absorption and Transit (ACAT™) mechanistic model.

"Our partner, a frequent user of the GastroPlus platform across multiple research sites worldwide, has a growing portion of their development pipeline focused on therapeutic peptides and proteins," said Dr. Viera Lukacova, chief scientist at Simulations Plus. "Part of their strategy involves designing oral delivery systems which can safely and efficiently complement the traditional invasive routes for these biomolecules. In this new collaborative effort, we will expand the applicability of GastroPlus to simulate intestinal absorption of larger molecules and the effect of permeation enhancers within oral formulations. The novel approaches and workflows will be validated through unique data provided to us by our partner, with the results serving as the foundational elements for peer-reviewed journal manuscripts describing the exciting improvements."

"What a great way to kick off 2021," added John DiBella, Lancaster division president for Simulations Plus. "Over the past several years, we have driven advances in modeling and simulation science for injectable formulations of both small and large molecules. With the market for oral delivery of therapeutic peptides and proteins expected to increase significantly over the next several years, it was important for us to partner with experts and embrace a leadership role to expand oral absorption modeling beyond small molecules. Like other funded collaborations, we will own all improvements made to our software programs, and our entire user community can access these new capabilities to accelerate research timelines and develop better medicines for the patients we all serve. We continue to welcome and invite future collaborations across our entire suite of software programs."

About Simulations Plus, Inc.

Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer solutions which bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods 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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View source version on businesswire.com: https://www.businesswire.com/news/home/20210105005260/en/

Contacts

Simulations Plus Investor Relations
Ms. Renee Bouche
661-723-7723
renee@simulations-plus.com

Hayden IR
Mr. Cameron Donahue
651-653-1854
slp@haydenir.com