Simulations Plus Releases IPFsym version 1A, State-of-the-Art Quantitative Systems Pharmacology (QSP) Software for Idiopathic Pulmonary Fibrosis (IPF)

IPFsym will enable new software and services revenue by aiding development of IPF therapies

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that it has released IPFsym version 1A, quantitative systems pharmacology modeling software to support the development of treatments for idiopathic pulmonary fibrosis. IPF is the most common type of pulmonary fibrosis, a disease that causes scarring (fibrosis) of the lungs. The development effort leading up to this release was sponsored by a leading pharmaceutical company that is also utilizing the software for evaluation of several IPF treatment options.

Dr. Scott Q Siler, chief scientific officer of the DILIsym Services division, said, “Finding treatments that provide maximal benefit to IPF patients has proven challenging thus far. We believe that IPFsym can contribute by using the predictive power of the software to accelerate the development of new treatments or combinations of treatments that could halt disease progression and reduce mortality rates for IPF patients.”

Shawn O’Connor, chief executive officer of Simulations Plus, added, “Drug development spending on IPF candidates has increased significantly in response to the current global IPF treatment market size estimated to be in excess of $2 billion and growing. The combination of IPFsym and our scientific consulting expertise is positioned to support our clients in this important field.”

Features of IPFsym v1A include:

• Representations of key IPF elements, such as:
  • lung fibrosis, lung alveolar epithelial injury, inflammation, and lung function tests;
  • clinically distinct regions of the lungs, including honeycombed regions, fibroblastic foci, and normal alveolar parenchyma;
• A virtual IPF population (SimPops^®) of greater than 700 subjects with heterogeneity, including variability in disease progression rates;
• Important biomarkers or endpoints, including:
  • forced vital capacity (FVC);
  • diffusing capacity of the lungs for carbon monoxide (DLCO);
  • high-resolution computed tomography (HRCT) of the lungs;
• Standard of care treatments for IPF patients, including:
  • OFEV^® (nintedanib)
  • Esbriet^® (pirfenidone)

Simulations Plus will host a webinar introducing the mechanistic underpinnings of IPFsym and the exploration of treatments within SimPops. You can register for the webinar here: IPFsym Webinar.

IPFsym is applied within comprehensive consulting services on drug development decisions, and is also available for licensing. Contact us to schedule a conversation today!

About Simulations Plus, Inc.

Serving clients worldwide for 25 years, 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. Follow us on Twitter | 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.

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