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Simulations Plus, Inc. provides model-informed and AI-accelerated drug development software, training, and consulting services for biopharmaceutical research. News about the company centers on its software and services segments, scientific modeling engines, ADMET and other modeling workflows, and financial results tied to software renewals, services bookings, and customer activity.
Recurring developments also include collaborations with pharmaceutical companies, technology providers, and regulatory or public-health agencies. These updates cover GPU-accelerated simulation, AI-assisted modeling, predictive frameworks for complex oral drug products, computational toxicology, new approach methodologies, and education programs that expand use of model-informed drug development practices.
Simulations Plus, Inc. (NASDAQ: SLP) will report its financial results for Q1 FY 2022, ending November 30, 2021, on January 6, 2022, after market close. A conference call is scheduled for the same day at 5:00 PM ET, where all interested individuals can join by registering online or via phone. The company, a leader in simulation software for drug discovery and development, has been serving clients for 25 years, providing solutions to major pharmaceutical and regulatory firms globally. More information will be available on their website.
Simulations Plus has announced an extension of its distributor agreement in Japan with Northern Science Consulting for its Monolix software. This partnership builds on existing agreements for GastroPlus and ADMET Predictor, enhancing the company's presence in the Japanese pharmaceutical market. The collaboration aims to boost awareness of Monolix and strengthen relationships with local businesses and universities, reflecting a growing user community in the region.
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Simulations Plus, Inc. (Nasdaq: SLP) has appointed Sharlene Evans to its Board of Directors, replacing retiring board member David L. Ralph. Evans brings over 25 years of experience in operations and human resources, previously serving as Chief People Officer at Myrtle Consulting Group. She will participate in the Audit and Compensation committees and stand for election at the company’s Annual General Meeting in February 2022. This leadership change aims to strengthen talent management as the company seeks continued growth in the modeling and simulation software sector.
Simulations Plus (Nasdaq: SLP) presented findings at The Liver Meeting that connect yo-yo dieting to increased placebo response rates in clinical trials for non-alcoholic steatohepatitis (NASH). The research suggests that minor dietary changes can significantly reduce fibrosis scores, a critical measure for treatment efficacy. This insight could aid in addressing the perplexing high placebo response rates observed in numerous clinical trials, potentially improving the viability of various treatment candidates for NASH.
Simulations Plus (Nasdaq: SLP) has launched RENAsym version 1A, a quantitative systems toxicology software aimed at predicting drug-induced kidney injuries. This new platform expands the company's capabilities beyond liver safety, enhancing its consulting services for drug developers. RENAsym helps identify risks associated with new therapeutics and key biochemical events related to kidney injury, supporting critical go/no-go decisions in drug development. The platform was developed with funding from the National Institutes of Health.
Simulations Plus, Inc. (Nasdaq: SLP) has launched version 9.8.2 of its GastroPlus software, enhancing its modeling and simulation capabilities in the pharmaceutical sector. Key updates include new enzyme expression levels, improved solubility models, and physiology models for better dosing translation. The enhancements aim to streamline workflows and improve user experience, reflecting feedback from the GastroPlus User Group and partnerships with industry leaders. The company emphasizes its commitment to innovation in drug development tools over its 25-year history.
Simulations Plus, Inc. (NASDAQ: SLP) has been awarded a funded contract by the FDA in collaboration with the University of Connecticut. This contract aims to enhance mechanistic in vitro/in vivo correlation (IVIVC) methods for long-acting injectable (LAI) formulations. Dr. Diane Burgess and her lab will generate data for marketed LAI products, while Simulations Plus will develop physiologically based models to establish bioequivalence, potentially reducing regulatory burden. This collaboration marks a significant step in advancing modeling and simulation technology in drug development.
Simulations Plus, Inc. (Nasdaq: SLP) reported a 12% year-over-year revenue increase to $46.5 million for fiscal 2021, with software revenue rising 28% to $27.7 million. In Q4, total revenue was $9.8 million, a 3% increase, while software revenue grew 14% to $5.4 million. Despite a 7% decline in services revenue, gross profit was $7.1 million with a 72% gross margin. For fiscal 2022, the company projects total revenue between $51 million and $53 million, indicating 10% to 15% growth.