Simulations Plus Inc Stock Price, News & Analysis

Simulations Plus (NASDAQ: SLP) has launched a Concierge Program aimed at fostering strategic partnerships with pharmaceutical companies and contract research organizations. This initiative is designed to enhance customer support through regular communication and collaboration, helping clients to expedite their development programs. Notable successes have been reported, including tailored training for regulatory scientists and customized software solutions across North America, Europe, and South America. The program demonstrates SLP's commitment to understanding clients' evolving needs in the pharmaceutical landscape.

Simulations Plus, Inc. (Nasdaq: SLP) reported a 17% total revenue growth for Q3 fiscal 2022, reaching $15.0 million. The software revenue rose by 16% to $9.7 million, while services revenue grew by 19% to $5.3 million. Diluted EPS increased by 11% to $0.20, with a net income of $4.1 million. The company reiterated its full-year revenue guidance of $52-53 million and announced a quarterly dividend of $0.06 per share, payable August 1, 2022.

Simulations Plus, Inc. (Nasdaq: SLP) reported record attendance at the 2022 Pharmacometrics Spring School, with 936 participants from over 50 countries. The event featured workshops on model-informed drug development and clinical trial simulations using the MonolixSuite and PKanalix platforms, both offered free to attendees. Dr. Jonathan Chauvin highlighted strong community interest which supports the company's position as a leader in modeling and simulation software. The company aims to continue these workshops in 2023.

Simulations Plus, Inc. (NASDAQ: SLP) revealed its Cognigen division's collaboration with a major pharmaceutical firm to enhance the development of a COVID-19 therapy. This partnership facilitated modeling and simulation activities, significantly contributing to regulatory submissions. The project focused on real-time data processing, improving insights on pharmacokinetics and efficacy throughout clinical trials. Cognigen division president Jill Fiedler-Kelly emphasized the essential role of these services in optimizing drug development efficiency.

Simulations Plus (SLP) will report its third-quarter financial results for fiscal year 2022, ending May 31, 2022, after market close on July 6, 2022. A conference call will be held at 5:00 PM ET on the same day, allowing stakeholders to engage with company representatives. Interested parties can join the call by registering here or by calling 1-201-389-0879.

Simulations Plus (NASDAQ: SLP) has published simulation results utilizing its DILIsym software, featured in Toxicological Sciences. These results illustrate the liver safety differences between small molecule CGRP receptor antagonists, addressing past failures in this drug class like telcagepant. DILIsym has effectively predicted the safety of newer candidates, contributing to the FDA approval of rimegepant in 2021. This research, co-authored by Jeffrey Woodhead, reinforces DILIsym's role in guiding drug development with an emphasis on safety.

Simulations Plus (NASDAQ: SLP) has released version 10.4 of its flagship ADMET Predictor machine learning platform, enhancing capabilities for pharmaceutical modeling. Key features include new 3D conformer generation, expanded mouse models for the HTPK Simulation Module, and improved Ames mutagenicity models for reliability. The enhancements are aimed at improving drug discovery processes. The company is focused on advancing artificial intelligence in drug design and has noted increased adoption of its technologies in recent years.

Simulations Plus has announced the renewal of its DILIsym software licenses by the FDA, ensuring uninterrupted access for FDA employees across all divisions. This one-year renewal reflects the FDA's continued reliance on DILIsym for evaluating drug-induced liver injury (DILI) risks, which is critical for drug development decisions. The software aids in predicting DILI risks and identifying patient subgroups vulnerable to such injuries, thereby mitigating financial losses from failed clinical trials.

Simulations Plus, Inc. (NASDAQ: SLP) announced the completion of a project funded by the U.S. FDA and the Center for Research on Complex Generics. The collaboration, involving the Lixoft and Cognigen divisions, aims to demonstrate bioequivalence for long-acting injectables (LAI) using a novel model-integrated design. This method could alleviate the challenges of low power and prolonged duration in bioequivalence trials. The results were presented at an FDA workshop on Nov. 30, 2021.