SLP Advances Predictive Toxicology With DILIsym 11: Shares to Benefit?

Simulations Plus, Inc. SLP bolstered its flagship quantitative systems toxicology (QST) platform with the launch of DILIsym 11. This new release advances drug-induced liver injury (DILI) prediction, with cutting-edge features like pediatric representation and an enhanced T-cell model, solidifying Simulations Plus’s commitment to improving drug safety and patient outcomes.

DILIsym 11 introduces several powerful enhancements to extend its predictive reach and improve simulation accuracy. The enhanced version empowers researchers to evaluate potential liver safety concerns and investigate dosing strategies that improve patient safety.

One of the most standout additions is pediatric representation, allowing researchers to evaluate liver toxicity risk in children. Simulating DILI risk in pediatric populations is a breakthrough in predictive toxicology. This capability aligns with growing regulatory and societal pressure to include pediatric considerations earlier in drug development.

DILIsym is already the most widely used QST platform for DILI prediction. Its outputs have been reviewed by the U.S. Food and Drug Administration’s (“FDA”) DILI team, making it not just a research tool but a regulatory-grade simulation platform. This reflects not only the robustness of the platform but also its ability to generate clinically relevant insights, especially when addressing certain populations like pediatrics.

Simulations Plus, Inc. Price and Consensus

Simulations Plus, Inc. price-consensus-chart | Simulations Plus, Inc. Quote

In addition, it introduces enhanced pediatric modeling to support exploratory predictions of liver safety in children, along with a new T-cell module that provides deeper insight into the potential role of CD8+ T-cell-mediated liver cell damage. The update also features improved simulation of bile acid-related and cholestatic liver injuries, refined antioxidant response mechanisms and several additional advancements.

Simulations Plus continues to evolve DILIsym based on cutting-edge science and industry feedback. The addition of pediatric models, improved immune mechanisms and enhanced cholestasis simulation reflects a deep commitment to addressing the evolving needs in toxicology and risk assessment. As the biopharmaceutical industry continuously seeks to improve drug safety and accelerate time-to-market, platforms like DILIsym are likely to gain healthy traction, elevating SLP’s financial and share price performance.

SLP Banks on Unique Portfolio Amid Macro Uncertainty

Simulations Plus is committed to continuous innovation in biosimulation and predictive modeling.  Proliferating adoption of its premium GastroPlus, MonolixSuite and ADMet Predictor aids top-line momentum. In the last reported quarter, its revenues surged 23% year over year to $22.4 million, driven by increasing demand across its software and services business segments. The Adaptive Learning & Insights (“ALI”) and Medical Communications (“MC”) business units, acquired through the Pro-ficiency buyout in June 2024, contributed $3.3 million in the fiscal second quarter.

Nonetheless, the wider biopharmaceutical sector is still facing financial strain and difficulties in securing funding, which in turn is negatively impacting investment in research and development as well as the adoption of new software solutions. It expects to build momentum in the second half of fiscal 2025.

SLP anticipates revenues to be between $90 million and $93 million for fiscal 2025. This indicates an increase of 28-33% from fiscal 2024 revenues. In addition, the Pro-ficiency acquisition is expected to contribute an additional $15-$18 million to revenues in the year.

SLP’s Zacks Rank & Stock Price Performance

Currently, Simulations Plus carries a Zacks Rank #3 (Hold). Shares of the company have lost 37% in the past year against the Zacks Computer - Software industry's growth of 9.6%.

Stocks to Consider

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