Simulations Plus, Inc. - SLP STOCK NEWS

Simulations Plus, Inc. (NASDAQ: SLP), a leader in modeling software for pharmaceutical safety, will present at the Raymond James 44th Annual Institutional Investors Conference from March 5-8, 2023, in Orlando, Florida. CEO Shawn O’Connor is scheduled to speak on March 7, 2023, at 1:40 p.m. Eastern Time and will host one-on-one meetings. Interested parties can access a live webcast and presentation on the company's Investors page post-event. Attendance is by invitation only. Simulations Plus has been serving the biosimulation market for over 25 years, offering solutions for drug discovery and regulatory submissions.

Simulations Plus (Nasdaq: SLP) has entered a new collaboration with a leading agrochemicals company to enhance the ADMET Predictor platform. This partnership aims to improve the accuracy of predicting ionization constants (pK_a) for chemical compounds by utilizing the partner's proprietary data. Dr. Robert Fraczkiewicz highlighted that this collaboration will expand chemical coverage and drive next-generation safety assessments, particularly important due to global regulations limiting animal testing. The enhancements will benefit clients across multiple industries, including chemicals and cosmetics.

Simulations Plus (NASDAQ: SLP) has launched NAFLDsym v2B Beta, a new version of its quantitative systems pharmacology modeling software aimed at enhancing treatment development for nonalcoholic steatohepatitis (NASH). This release features a faster and more intuitive interface, developed using the Julia programming language, which significantly increases simulation speeds for large datasets. Key updates include a modern GUI, integration with the Julia toolkit, and a results viewer for previously exported files. A tech talk webinar on this release is scheduled for March 14, 2023, at 11:00 a.m. Eastern Time.

Simulations Plus (Nasdaq: SLP) has launched the beta version of its DILIsym^® version X (DSX), a significant update to its quantitative systems toxicology software aimed at predicting drug-induced liver injury (DILI). This new version enhances speed and user-friendliness, supporting wider adoption among pharmaceutical companies, regulators, and academics. Key updates include a software redesign, new exemplar compounds, and improved biomarker parameters. The DILIsym modeling approach is crucial for guiding drug development decisions and avoiding costly clinical trial failures.

Simulations Plus (NASDAQ: SLP) has initiated an accelerated share repurchase (ASR) program to buy back $20 million of its common shares, part of a larger $50 million share repurchase plan approved in December 2022. This move is aimed at enhancing shareholder value and aligns with the company's updated capital allocation strategy. Funding for the ASR will come from available cash balances, and the final settlement is expected by Q3 2023. Post-ASR, $30 million will remain for additional repurchases.

Simulations Plus reported Q1 fiscal 2023 total revenue of $12 million, consistent with guidance, and diluted EPS of $0.06. Software revenue decreased 17% to $6.1 million, while services revenue increased 17% to $5.9 million. The company announced a $50 million share repurchase program and continues to invest in its workforce. Fiscal 2023 guidance projects revenue growth of 10-15% and diluted EPS growth of 5-10%. A cash dividend of $0.06 per share was declared for February 6, 2023.

Simulations Plus (NASDAQ: SLP) will announce its first-quarter fiscal 2023 financial results, covering the period ended November 30, 2022, after market close on January 4, 2023. The company will host a conference call at 5 p.m. EST to discuss these results. Interested participants can register via the company's website. Simulations Plus has provided biosimulation solutions for over 25 years, supporting drug discovery and regulatory submissions across major pharmaceutical and biotech sectors.

Simulations Plus has been awarded a grant by the U.S. FDA to develop a modeling framework aimed at assessing bioequivalence for locally-acting drugs targeting the gastrointestinal tract. This collaboration with the University of Bath will enhance the GastroPlus® platform, aiming to reduce reliance on animal and human studies. The project focuses on generating in vitro data for various GI conditions, potentially providing innovative solutions for drug development and regulatory processes.

Simulations Plus has announced the appointment of Gustavo Mendes Lima Santos to its Regulatory Affairs team for a one-year fellowship. He will collaborate with global health regulatory agencies and academia to enhance pharmacometric strategies. Santos, who previously served as General Manager at Anvisa, brings extensive expertise in drug evaluation and regulatory processes. His work is expected to boost drug development programs, particularly in Latin America, by leveraging modeling and simulation techniques.