Simulations Plus Inc Stock Price, News & Analysis

Simulations Plus (Nasdaq: SLP) and the Institute of Medical Biology of the Polish Academy of Sciences (IMB PAS) have published successful results of their artificial intelligence-driven drug design (AIDD) collaboration in ACS Medical Chemistry Letters. The partnership, initiated in 2023, focused on designing novel RORγ/RORγT ligands using ADMET Predictor®.

The results showed that 70% of the 27 tested compounds demonstrated significant RORγT inhibition. The lead compound, featuring a novel indolizine scaffold, showed potent inverse agonist activity, strong efficacy in cellular assays, no significant cytotoxicity, and effectively suppressed proinflammatory Th17 cytokines in human T cells. The compound also displayed favorable drug-like properties as predicted by ADMET Predictor.

Simulations Plus (Nasdaq: SLP) has announced a $1 million investment in Nurocor, a cloud-based software platform provider for clinical development. The investment, made through SLP's Corporate Development Initiative launched in 2024, aims to accelerate innovations in biopharma development.

Nurocor's technology, founded in 2017, focuses on improving efficiency and automation in clinical trials through digitalization. The clinical trial technology sector, valued at $25.7 billion in 2024, is expected to grow at a CAGR of 15.5% from 2025 to 2030. This strategic investment aligns with SLP's mission to expedite drug development and enhance clinical trial processes.

Simulations Plus (Nasdaq: SLP), a provider of biosimulation and cheminformatics solutions, reported Q3 fiscal 2025 results with total revenue increasing 10% to $20.4 million. The quarter saw software revenue grow 6% to $12.6 million and services revenue rise 17% to $7.7 million.

The company recorded a net loss of $67.3 million ($3.35 per share) due to a one-time non-cash impairment charge of $77.2 million. Adjusted EBITDA reached $7.4 million, representing 37% of total revenue. The company implemented a strategic reorganization, transitioning to a functionally-driven operating model.

Management updated FY2025 guidance with revenue expected between $76-80 million and adjusted diluted EPS of $0.93-$1.06. The company is focusing on new AI-driven initiatives across product lines to drive innovation and growth.

[ "Total revenue increased 10% to $20.4 million in Q3 2025", "Services revenue grew 17% to $7.7 million", "Software revenue increased 6% to $12.6 million", "Adjusted EBITDA improved to $7.4 million (37% of revenue) from $5.6 million", "Adjusted diluted EPS increased to $0.45 from $0.27 year-over-year", "Implementation of new AI-driven initiatives across product lines" ]

Simulations Plus (Nasdaq: SLP) has rescheduled its Q3 FY2025 earnings release and conference call from July 2 to July 14, 2025, after market close. The company, which transitioned from a large accelerated filer to a non-accelerated filer, is utilizing the maximum time allowed by regulations before releasing results. SLP reaffirmed its preliminary Q3 revenue guidance of $19-20 million and full-year FY2025 revenue guidance of $76-80 million. The preliminary figures are unaudited and subject to adjustment in the final Form 10-Q, expected to be filed by July 15, 2025. The company provides cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry.

Simulations Plus (Nasdaq: SLP), a provider of cheminformatics, biosimulation, and medical communications solutions for the biopharma industry, announced its participation in the upcoming Citizens Medical Devices and Healthcare Services Forum in Boston. CEO Shawn O'Connor will conduct one-on-one meetings with institutional investors on June 17, 2025. The company's presence at this forum provides an opportunity for institutional investors to engage directly with senior management and learn more about SLP's business strategy and operations.

Simulations Plus (Nasdaq: SLP) announced preliminary Q3 FY2025 revenue expectations of $19-20 million and updated full-year FY2025 revenue guidance to $76-80 million. CEO Shawn O'Connor cited significant market headwinds affecting pharmaceutical and biotech clients, including budget reductions, project cancellations, and delays. While the software segment remains relatively stable, services have been more impacted by market volatility. The company recently implemented a strategic reorganization, shifting from business units to a functionally driven operating model, aimed at streamlining operations and enhancing client engagement. The reorganization represents the final phase of a multi-year transformation focused on operational efficiency and sustainable growth. The company will report detailed Q3 FY2025 results on July 2, 2025.

Simulations Plus (Nasdaq: SLP) has launched ADMET Predictor 13, an enhanced version of its machine learning modeling platform for drug discovery. The new release features three major improvements: (1) Enhanced high-throughput PBPK simulations powered by GastroPlus combined with an upgraded AI-driven drug design engine, (2) An expanded suite of next-generation ADMET models with improved accuracy built using updated AI science and premium datasets, and (3) Extended enterprise capabilities including APIs, Python scripting support, and IT-friendly deployment features. The platform aims to streamline the design, optimization, and selection of new molecules during drug discovery stages, offering improved automation and scalability for R&D teams.

Simulations Plus (Nasdaq: SLP) has released DILIsym® 11, the latest version of its quantitative systems toxicology (QST) platform. This flagship software is designed to predict drug-induced liver injury (DILI) risks and is widely used by the FDA's DILI team. The key enhancement in version 11 is the addition of pediatric representation, enabling researchers to evaluate liver safety risks in children.

The new version also features a T-cell model for understanding CD8+ T-cell mediated hepatocellular injury, improved bile acid and cholestatic liver injury representation, and updated antioxidant adaptation mechanisms. These advancements aim to support the development of safer treatments and optimize patient safety in drug development.

Simulations Plus (Nasdaq: SLP) announces support for FDA's new roadmap to reduce animal testing in preclinical safety studies through new approach methodologies (NAMs). The company introduces NAMVantage™, a comprehensive package combining PBPK and QSP professional services with regulatory strategy and training.

The company's software platforms, including GastroPlus, MonolixSuite™, ADMET Predictor®, DILIsym®, and OBESITYsym™, are designed to support this initiative by enabling researchers to reduce or eliminate animal testing during non-clinical development. These platforms utilize modeling, simulation, and AI/ML technologies to predict drug efficacy and safety.

Having collaborated with FDA on over 15 projects in the past decade, Simulations Plus offers expertise in PBPK, QSP/QST, clinical pharmacology, and pharmacometrics to help pharmaceutical companies align with NAMs and accelerate development timelines.