Simulations Plus Releases DILIsym® X

Rhea-AI Summary

Simulations Plus (Nasdaq: SLP) has released DILIsym® version X (DSX), an updated quantitative systems toxicology (QST) platform. DSX is designed to predict drug-induced liver injury (DILI) risks, supporting critical drug development decisions. The software features:

- Enhanced processing speed
- Improved user interface
- Command line and graphical interface options
- Licensing for scale-up on local or cloud clusters
- Four new exemplar compounds
- Two new simulated populations

DSX aims to help researchers identify potential DILI risks, design mitigating dosing strategies, and make faster go/no-go decisions. This can lead to more efficient drug development processes, potentially reducing costly failed clinical trials and accelerating safe drug delivery to patients.

Positive

• Release of updated DILIsym® version X (DSX) with enhanced features
• Improved processing speed and user interface for faster insights
• Potential to reduce costly failed clinical trials
• New licensing option for scale-up on local or cloud cluster configurations
• Addition of four new exemplar compounds and two new simulated populations

Negative

• None.

Biotechnology Analyst

The release of DILIsym® X (DSX™) by Simulations Plus represents a significant advancement in drug development technology, particularly in the critical area of drug safety assessment. This updated quantitative systems toxicology (QST) platform addresses a important pain point in the pharmaceutical industry: the gap between preclinical and clinical toxicology results.

Key features of DSX™ that stand out:

• Enhanced processing speed: This allows for faster generation of population-level liver safety results, potentially accelerating the drug development timeline.
• Improved user interface: The redesigned interface, including both command line and graphical options, suggests improved usability and potential for wider adoption.
• Scalability: The new licensing option for scale-up on local or cloud cluster configurations indicates the software's ability to handle larger, more complex simulations.
• Expanded database: The addition of four new exemplar compounds and two new simulated populations enhances the software's predictive capabilities.

From an investor's perspective, this release could strengthen Simulations Plus's market position in the biosimulation sector. The ability to predict DILI risks more accurately and efficiently could lead to increased demand from pharmaceutical companies looking to reduce the risk of costly failed clinical trials. Moreover, by potentially shortening the drug development timeline, DSX™ could indirectly contribute to faster time-to-market for new drugs, a critical factor in the pharmaceutical industry.

However, it's important to note that while this software update is promising, its real-world impact will depend on its adoption rate and proven efficacy in predicting DILI risks accurately. Investors should monitor future announcements for any data on the software's performance in actual drug development scenarios.

Financial Analyst

The release of DILIsym® X (DSX™) by Simulations Plus (Nasdaq: SLP) is a positive development that could potentially drive growth for the company. Here's why:

• Market Opportunity: The global biosimulation market is projected to grow significantly, driven by the increasing cost and complexity of drug development. DSX™ addresses a critical need in this market.
• Competitive Advantage: The enhanced features of DSX™, particularly its improved speed and user interface, could give Simulations Plus an edge over competitors in the biosimulation space.
• Revenue Potential: If DSX™ gains traction, it could lead to increased software license sales and consulting services, potentially boosting Simulations Plus's revenue streams.
• Cost Savings for Clients: By helping to identify potential DILI risks early, DSX™ could save pharmaceutical companies significant amounts in avoided failed clinical trials. This value proposition could drive adoption.

However, investors should also consider potential risks:

• Adoption Rate: The success of DSX™ will depend on its adoption by pharmaceutical companies, which can be a slow process in this conservative industry.
• Competition: The biosimulation market is competitive and other companies may develop similar technologies.
• Regulatory Environment: Changes in drug development regulations could impact the demand for biosimulation software.

In terms of financial impact, while specific revenue projections for DSX™ aren't provided, its potential to accelerate drug development timelines and reduce costly failures could make it an attractive offering. Investors should monitor future earnings reports for indications of DSX™'s contribution to Simulations Plus's financial performance.

Updated quantitative systems toxicology (QST) software investigates and predicts drug-induced liver injury (DILI)

LANCASTER, Calif.--(BUSINESS WIRE)-- 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, has released the latest version of its flagship quantitative systems toxicology (QST) platform, DILIsym® version X.

“Modeling and predictions regarding drug efficacy are critical in the drug development process—but so are predictions regarding safety,” said Dr. Brett Howell, President of Quantitative Systems Pharmacology (QSP) Solutions at Simulations Plus. “We know there is often a gap between preclinical and clinical research toxicology results, but DILIsym is designed to help researchers identify potential DILI risks and, when appropriate, design dosing strategies that can mitigate or eliminate possible hazards. With the enhanced processing speed and improved user interface offered by DSX, clients get crucial insight into the safety of their drug candidate faster and more easily than ever before.”

Branded as DSX™, the software is designed to support key drug development decisions by predicting potential drug-induced liver injury (DILI) risks. These predictions can guide go/no-go decisions, or the need to modify dosages, which are vital to avoiding costly failed clinical trials.

Dr. Scott Q. Siler, Chief Scientific Officer of QSP Solutions at Simulations Plus, added, “DSX will greatly enhance our clients’ and our consulting group’s ability to quickly generate population-level liver safety results that impact drug development decisions. This faster turnaround time means fewer delays between critical safety decision points, ensuring safe new drugs get to patients as rapidly as possible while unsafe drug candidates can be discarded earlier in the costly development process.”

DSX offers a completely redesigned interface, tested by clients and consultants, that includes both command line and graphical interface options as well as a licensing option that enables scale-up on local or cloud cluster configurations. Four new exemplar compounds are included in this version of the software, as well as two new simulated populations that include variability in susceptibility to liver injury and biomarker-related parameters (ALT and bilirubin).

Learn more about DSX and request your evaluation license.

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 (PBPK), quantitative systems pharmacology/toxicology (QSP/QST), 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 recently acquired Pro-ficiency business with our own, as well as expenses we may incur in connection therewith, to maintain our competitive advantages, acceptance of new software and improved versions of our existing software, the general economics of the pharmaceutical industry, 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.

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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 the purpose of Simulations Plus' DILIsym® X (DSX) software?

DILIsym® X (DSX) is designed to predict drug-induced liver injury (DILI) risks, supporting key drug development decisions by helping researchers identify potential hazards and design mitigating dosing strategies.

How can DSX impact the drug development process for SLP?

DSX can potentially reduce costly failed clinical trials by enabling faster go/no-go decisions and more efficient drug development processes, which could accelerate the delivery of safe drugs to patients.

What are the key improvements in the new version of DILIsym® (DSX) released by SLP?

The new version features enhanced processing speed, an improved user interface, command line and graphical interface options, new licensing for scale-up, four new exemplar compounds, and two new simulated populations.

How does DILIsym® X address the gap between preclinical and clinical research toxicology results?

DILIsym® X is designed to help researchers identify potential DILI risks and design dosing strategies that can mitigate or eliminate possible hazards, bridging the gap between preclinical and clinical research toxicology results.