Industry partners to provide funding and data to support ACAT™ model improvements

Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a leading provider of biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, today announced that it has entered a new funded collaboration with the Enabling Technologies Consortium (ETC). This partnership is aimed at advancing in vitro-in vivo correlation (IVIVC) approaches for oral drug delivery and expanding the functionality of the GastroPlus platform.

The collaboration focuses on enhancing the predictive capabilities of the GastroPlus advanced compartmental absorption and transit (ACAT™) model to support the development of immediate release (IR) oral drug products. Using data gathered from public sources and members of the ETC, physiologically based pharmacokinetics (PBPK) and biopharmaceutics modeling (PBBM) experts and software engineers at Simulations Plus will look to complete key objectives as defined by the partnership. These advancements, including implementation of novel product-particle size distribution (P-PSD) methodologies and enhanced food effect modeling features, will provide researchers with powerful tools to improve drug product development, reduce reliance on animal studies, and streamline regulatory submissions.

“We are honored to collaborate with ETC, a consortium representing leaders in pharmaceutical innovation who recognize the critical role GastroPlus already plays in drug development,” said Dr. Xavier Pepin, Vice President of PBPK R&D at Simulations Plus and principal investigator for this project. “This partnership reflects the trust and confidence the industry places in our platform and the desire to support its continued evolution. By advancing cutting-edge capabilities, we are not only reaffirming our commitment to innovation but also empowering researchers to solve complex biopharmaceutical challenges with even greater precision and efficiency.”

The collaboration leverages the combined expertise of Simulations Plus and ETC’s Participating Members, which include leading pharmaceutical and biotechnology companies. Throughout the project, Simulations Plus will deliver beta versions of the enhanced GastroPlus platform to ETC members for testing. Upon completion, the updated software will be accessible to the broader user community. Consistent with all collaborations that Simulations Plus enters, the Company will retain ownership of intellectual property developed through this partnership, ensuring that future enhancements to its platform continue to reflect Simulations Plus’ leadership in PBPK/PBBM science.

About the Enabling Technologies Consortium

The Enabling Technologies Consortium (ETC) serves as a dynamic platform for pharmaceutical and biotechnology companies to exchange ideas, share knowledge, and collaborate on pioneering new technologies that enhance drug development and manufacturing processes. With a mission centered on advancing pre-competitive enabling technologies, ETC fosters partnerships between its member companies and external collaborators. Pre-competitive initiatives are defined as joint efforts among multiple pharmaceutical organizations and third parties to develop tools, methodologies, or refinements that drive efficiencies in drug development. These outcomes are made widely accessible through publication, product commercialization, or other dissemination methods.

By uniting industry leaders under a shared vision, ETC is driving progress and empowering pharmaceutical companies to tackle common challenges with innovative, enabling technologies. For more information about ETC and its initiatives, please visit https://www.etconsortium.org/.

About Simulations Plus, Inc.

With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube.

Environmental, Social, and Governance (ESG)

We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our 2023 ESG update.

Forward-Looking Statements

Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “expect,” and “anticipate” mean that these are our best estimates as of this writing, but 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 successfully integrate the Pro-ficiency business with our own, as well as expenses we may incur in connection therewith, the efficiency and effectiveness of our internal business restructuring and leadership changes, 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, market conditions, macroeconomic factors, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250122083173/en/