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Simulations Plus, Inc. (NASDAQ: SLP) is a leading developer of modeling and simulation software and consulting services that support drug discovery, development research, and regulatory submissions. The company collaborates with pharmaceutical organizations to implement a data-driven, strategic modeling methodology that begins in early discovery stages, extends through preclinical and clinical development, and continues into clinical trials and post-approval phases.
Simulations Plus, through its subsidiaries Cognigen Corporation and DILIsym Services, offers a suite of top-ranked, user-friendly software solutions. These include GastroPlus™, ADMET Predictor™, KIWI™, DILIsym®, NAFLDsym®, PKPlus™, and more. These tools bridge data mining and compound library screening with QSAR models and PBPK/TK modeling and simulation in both animals and humans. The company's quantitative systems pharmacology approaches are widely recognized and licensed by regulatory agencies globally.
In addition to software development, Simulations Plus provides consulting and contract research services to the pharmaceutical industry. The company’s operations are divided into two primary segments: software and services. The software segment generates the majority of the company’s revenue.
Over the past 20 years, Simulations Plus has consistently partnered with clients to reduce costs and accelerate research timelines. The company’s innovative technology and methodologies have earned it a reputation as a reliable partner in the pharmaceutical industry.
Latest News: Simulations Plus continues to make headlines with its innovative solutions and strategic partnerships. Stay updated with the latest developments and achievements of Simulations Plus on our news section.
Simulations Plus has received a cooperative agreement from the FDA, providing $250,000 annually for two years to enhance its GastroPlus® platform. This funding aims to improve the Transdermal Compartmental Absorption and Transit (TCAT™) model for better simulations of dermal formulations. The project will involve collaboration with leading pharmaceutical and research organizations, focusing on developing innovative strategies for regulatory assessments. This initiative strengthens the company's position in drug modeling and simulation, particularly in dermatology.
Simulations Plus, Inc. (Nasdaq: SLP) announced the release of version 10.3 of its ADMET Predictor platform, now marketed as APX.3. This update introduces enhanced AI capabilities, including a new AI-driven Drug Design Module that integrates third-party calculations for compound optimization. Key improvements include an updated CYP metabolism model and the MedChem Studio™ accessibility for all users, designed to bolster data visualization and analysis. The features aim to expand the client base and maintain double-digit revenue growth as the company enters its 2022 fiscal year.
Simulations Plus, Inc. (Nasdaq: SLP) announced that CEO Shawn O’Connor will present at the BofA Securities 2021 Tech Solutions for Drug Discovery Conference on September 20, 2021, at 10:00 a.m. ET, and at the Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit on September 22, 2021, at 9:55 a.m. ET. One-on-one meetings will also be held at both events. Live webcasts and presentations will be accessible via the Investors page of the Simulations Plus website for 90 days.
Simulations Plus (Nasdaq: SLP) announced promising results from the second phase of a collaborative research project with a major pharmaceutical company. Nearly 30% of the 19 synthesized molecules demonstrated activity below 50 nM, indicating strong therapeutic potential. The predictive errors in rat and human microsomal clearance were improved by three-fold, showcasing advancements in the Artificial Intelligence-driven Drug Design (AIDD) Module of ADMET Predictor. The company plans to present further details in the coming months, along with functional updates to be released this fall.
Simulations Plus, Inc. (Nasdaq: SLP) has received a significant order from China's National Medical Products Administration (NMPA) to add licenses for its GastroPlus® software. This development underscores the growing adoption of physiologically based biopharmaceutics modeling in drug development. Division president John DiBella highlighted the expanding relationships with the NMPA and the positive impact on over 20 domestic Chinese pharmaceutical companies. The initiative aims to enhance regulatory review processes, potentially reducing time to market for new medicines, benefiting both companies and patients.
Simulations Plus, Inc. (Nasdaq: SLP) reported its third quarter fiscal 2021 results with total revenue of $12.8 million, up 4% year-over-year. Software revenue surged 21% to $8.3 million, while services revenue dropped 18% to $4.5 million. Gross profit rose 7% to $10.3 million, and net income increased 29% to $3.8 million. For the year-to-date, total revenue grew 14% to $36.6 million, bolstered by a 32% rise in software revenue. Despite project delays in services, the company anticipates full-year revenue growth of 5-10%.
Simulations Plus, Inc. (Nasdaq: SLP) announced it will release its financial results for Q3 of fiscal year 2021, ending May 31, 2021, on July 12, 2021, after market close. A conference call is scheduled for the same day at 4:15 p.m. Eastern Time, where stakeholders can register to participate. Simulations Plus has been a leader in modeling and simulation software for drug development and has served clients for over 25 years, providing solutions to major pharmaceutical and regulatory agencies globally.
Simulations Plus (Nasdaq: SLP) announced the release of IPFsym version 1A, a quantitative systems pharmacology software aimed at developing treatments for idiopathic pulmonary fibrosis (IPF). The software, sponsored by a leading pharmaceutical company, aims to enhance treatment options in a market worth over $2 billion. Key features include a virtual population of over 700 subjects and important biomarkers like forced vital capacity and high-resolution computed tomography. The company will also host a webinar for further insights on IPFsym.
Simulations Plus, Inc. (Nasdaq: SLP) announced that CEO Shawn O’Connor will participate in the Craig-Hallum 18th Annual Institutional Investor Conference on June 2, 2021. The conference will be virtual, featuring over 150 public companies and allowing institutional clients to engage in one-on-one 30-minute meetings. Attendance is by invitation only. Simulations Plus has been a leading provider of simulation software and consulting services for drug discovery for 25 years, serving clients across the globe.