Simulations Plus, Inc. - SLP STOCK NEWS

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.

Simulations Plus (Nasdaq: SLP) has announced a funded partnership with a major pharmaceutical company to enhance mechanistic dissolution models for injectable formulations using their DDDPlus™ software. This collaboration aims to improve in vitro analysis of drug product specifications and capture dissolution kinetics more effectively. Senior scientists expressed enthusiasm about expanding market opportunities in injectables, while the company retains ownership of all software improvements. Simulations Plus continues to support global pharmaceutical development through innovative biosimulation solutions.

Simulations Plus, a leader in modeling and simulation software for pharmaceutical safety, announced participation in the Berenberg Discover AI Seminar on April 26, 2022, in Boston, Massachusetts. CEO Shawn O’Connor will hold one-on-one meetings during the event. For details on the seminar, the slide presentation will be accessible on the Simulations Plus Investors page. With 25 years of experience, Simulations Plus supports drug discovery and regulatory submissions through advanced software solutions licensed by major pharmaceutical companies and regulatory agencies worldwide.

Simulations Plus, Inc. (Nasdaq: SLP) reported a 13% increase in total revenue for Q2 FY2022, reaching $14.8 million. Software revenue grew by 25% to $9.8 million, now comprising 66% of total revenue. The company’s diluted EPS rose 40% to $0.21, with net income at $4.4 million.

Despite a 5% decline in services revenue, strong performance in the software sector, particularly MonolixSuite®, which saw 43% growth, boosted overall results. The Board declared a quarterly dividend of $0.06 per share.

Simulations Plus (SLP) has announced a partnership with the University of Pittsburgh to develop and validate its BIOLOGXsym™ platform, focused on quantitative systems toxicology for liver safety. A Phase II SBIR NIH grant of approximately $1.7 million will fund software development and lab work over two years. The collaboration aims to enhance drug safety assessments, particularly for large molecules, and will utilize the university's advanced organ-on-a-chip technology for testing. This initiative is seen as a pivotal step in expanding SLP's offerings in the growing therapeutic development market.