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Simulations Plus Releases GastroPlus® X, The Next Generation PBPK/PBBM Modeling & Simulation Software

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Simulations Plus has launched GastroPlus® X (GPX™), marking a significant upgrade in PBPK/PBBM modeling and simulation software. This new platform offers advanced models, refined algorithms, and integrated machine learning, alongside an intuitive interface and streamlined workflows. GPX is designed to enhance productivity through ease-of-use and faster processing. The development involved extensive user testing and feedback, resulting in a flexible platform that supports diverse research needs. Notably, GPX includes unique features like true polypharmacy simulations and flexible deployment options, including cloud integration. Available for licensing now, GPX aims to expand Simulations Plus's global market reach.

Positive
  • GPX offers advanced models, refined algorithms, and integrated machine learning, enhancing software performance.
  • Extensive user testing and feedback contributed to the development of an intuitive, flexible platform.
  • GPX includes unique features like true polypharmacy simulations, mimicking real-world scenarios.
  • The platform supports diverse research needs, from early discovery PK simulations to population predictions.
  • Flexible deployment options, including local installation and cloud integration, provide user convenience.
  • Availability for licensing now could potentially boost Simulations Plus's market reach and revenue.
Negative
  • No detailed financial impact or revenue projections were provided.
  • The press release lacks specific data on how GPX’s benefits translate into measurable business outcomes.
  • Potential high cost of licensing GPX could be a barrier for smaller companies.

Insights

GastroPlus® X (GPX) represents a significant advancement in the field of physiologically based pharmacokinetics (PBPK) and biopharmaceutics modeling (PBBM). The introduction of advanced models, refined algorithms and machine learning technology is pivotal. For stakeholders, the integration of machine learning offers the potential for more accurate and faster predictions, reducing the risk of costly errors in drug development and regulatory submissions.

The usability improvements, such as an intuitive interface and streamlined workflows, will likely reduce training time and increase productivity for both new and experienced users. This could lead to higher adoption rates and user satisfaction. Moreover, the flexible deployment options, including local and cloud integrations, provide users with choice and scalability, addressing diverse operational needs.

In the short-term, these advancements could boost the company's market position and drive revenue growth through new licenses. Long-term benefits include strengthened client relationships and expanded market reach, especially as regulatory bodies like the FDA emphasize quantitative methods. However, investors should consider the potential for increased competition as other firms might develop similar capabilities.

The launch of GPX can have a substantial impact on Simulations Plus' financial performance. By enhancing existing capabilities and introducing new features, the company stands to attract a broader client base. The mention of features like true polypharmacy simulations and improved productivity tools indicates a strong value proposition, which could translate to higher revenues from licensing agreements.

Enhanced user experience and ease of adoption might reduce churn rates among existing customers and support premium pricing strategies. The potential to align with industry trends, like the FDA’s Quantitative Medicine Center of Excellence, positions GPX as an essential tool for pharmaceutical and biotech companies aiming to adhere to new regulatory standards.

In the short-term, attention should be on subscription and licensing growth rates, while long-term considerations include the potential for recurring revenue from continued software usage and updates. Investors should also watch for operational costs associated with maintaining and updating the platform.

Redesigned platform offers ease-of-use, enhanced software engineering, and significant productivity gains for users

LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced the release of GastroPlus® X.

Branded as GPX™, this new platform represents the next generation of physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM) modeling and simulation software. Utilizing proven top-rated science, advanced models, refined algorithms and integrated machine learning (ML) technology, GPX offers an entirely updated user experience with an intuitive interface, streamlined workflows, and faster processing.

“GPX is truly a culmination of a long-term collaboration with our partners to understand how we can better support their program needs and enable critical scientific thinking,” said Neil Miller, Vice President of Simulation Sciences at Simulations Plus. “Our development process included significant external user testing and we sought partners’ feedback throughout the entire development cycle. This resulted in a completely redesigned, intuitive, flexible platform that follows our customers’ research and thought processes instead of requiring them to fit their processes to the software.”

“For more than 25 years, we have remained laser-focused on providing the best science and algorithms on the market. Our commitment to continuous innovation and improvement is why GastroPlus remains the preferred platform for predicting a wide array of applications, including gastrointestinal absorption for oral products, first-in-human outcomes, and food effects,” said John DiBella, President of PBPK Solutions at Simulations Plus. “GPX offers increased functionality that other programs cannot provide, such as true polypharmacy simulations mimicking real-world scenarios. We believe the intuitive design, workflows, and data handling will help us expand our addressable market globally by significantly shortening the learning curves for new users, improving the productivity of experienced modelers, and enhancing critical communication with health authorities. As our clients consider the implications of the FDA’s newly established Quantitative Medicine Center of Excellence, GPX will provide robust support for their regulatory interactions. GPX is truly the most exciting development in PBPK science to launch in many years.”

GPX is designed to be a comprehensive PBPK/PBBM modeling and simulation platform, allowing users to handle everything from early discovery high-throughput PK simulations and drug-drug interactions (DDIs) to population predictions and more all in the same place. Utilization of a single PBPK/PBBM platform, with reusable assets and templates, reduces the time spent on tedious tasks like model setup, importing and exporting data, and reformatting plotted modeling results.

GPX offers flexible deployment options, allowing for both local installation and seamless integration with cloud environments, providing users with the freedom to choose the best setup for their needs.

GPX is available for licensing now.

About Simulations Plus, Inc.

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. 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

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.

Simulations Plus Investor Relations

Renee Bouche

661-723-7723

renee.bouche@simulations-plus.com

Financial Profiles

Lisa Fortuna

310-622-8251

slp@finprofiles.com

Source: Simulations Plus, Inc.

FAQ

What is GastroPlus® X (GPX™)?

GPX is the next generation of PBPK/PBBM modeling and simulation software by Simulations Plus, offering advanced models, refined algorithms, and integrated machine learning.

When was GastroPlus® X released?

GastroPlus® X was announced in a press release by Simulations Plus.

What are the key features of GastroPlus® X?

GPX features an intuitive interface, streamlined workflows, advanced models, refined algorithms, integrated machine learning, and true polypharmacy simulations.

How does GPX improve productivity?

GPX enhances productivity through ease-of-use, faster processing, reusable assets, and templates, reducing time spent on model setup, data import/export, and reformatting results.

How can users deploy GastroPlus® X?

GPX can be deployed locally or integrated with cloud environments, providing flexible deployment options.

Is GastroPlus® X available for licensing?

Yes, GastroPlus® X is available for licensing now.

Simulations Plus, Inc.

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