Simulations Plus Launches New Integrated Pulmonary Software and Services Package to Streamline Drug Development and Improve Patient Outcomes

LANCASTER, Calif. – Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced the release of a new integrated pulmonary software and services package. This targeted package will support pharmaceutical companies by streamlining their pulmonary drug development processes, enabling them to make better-informed decisions and bring therapies to market faster.

“Developing molecules intended to treat interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) is a daunting challenge; they are serious conditions with no known cures”

The pulmonary package offered by Simulations Plus is founded on the industry leading GastroPlus® modeling and simulation platform, which can be used to predict localized exposure in the lungs. That localized exposure data is then utilized to inform the ILDsym™ or IPFsym™ platforms for efficacy predictions. As client ventures launch and progress, Simulations Plus scientists will leverage their 40+ years of combined experience in pulmonary exposure and efficacy modeling to train in-house client experts on how to use the software and create models to accurately predict the exposure and efficacy of their pulmonary assets.

“Developing molecules intended to treat interstitial lung disease (ILD) and idiopathic pulmonary fibrosis (IPF) is a daunting challenge; they are serious conditions with no known cures,” explained Dr. Brett A. Howell, President of the DILIsym Services division at Simulations Plus. “We anticipate that the use of our targeted pulmonary package could lead to an acceleration in the development of treatments to slow or even halt progression of these diseases. By integrating the industry-leading platforms for PBPK/PCAT™, quantitative systems pharmacology (QSP), and the expertise of our scientists, along with the training of in-house scientists, we believe we can help our clients develop therapies that will improve and even extend the lives of patients worldwide.”

“Hiring and retaining skilled modelers is difficult, which is why many companies develop talent from within,” noted Vice President of Business Development Josh Fohey. “While we are always pleased to assist with our clients’ drug development programs as an extension of their team, we also want to empower them to engage with their models and data beyond what is typical with consulting relationships. As part of our Pulmonary Package, client teams benefit from a customized learning package using the tools in their program, implemented with support and guidance from our experts. Together, we can better understand lung absorption and efficacy, and find new treatments for respiratory disease.”

Learn more about the newly released pulmonary package: https://www.simulations-plus.com/breatheeasy

About Simulations Plus

Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/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, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com.

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 ESG Report.

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.