Simulations Plus, Inc. - SLP STOCK NEWS

Simulations Plus (Nasdaq: SLP) and the University of Connecticut have received a new FDA grant to expand mechanistic modeling for long-acting injectable (LAI) technologies. The collaboration will use GastroPlus® PBPK platform to investigate relationships between LAI formulation and physiological factors at injection sites. The project aims to develop models that could serve as alternatives to in vivo studies for establishing bioequivalence. Dr. Diane Burgess's lab will generate vital data for marketed LAI suspension products, while Simulations Plus will develop PBPK models for validation. The initiative seeks to reduce development time and costs while streamlining regulatory processes for both innovator and generic formulations.

Simulations Plus (Nasdaq: SLP), a leading biosimulation and medical communications solutions provider for the biopharma industry, announced its participation in the Stephens Annual Investment Conference in Nashville. CEO Shawn O'Connor will engage in a fireside chat on November 20, 2024, at 12:00 p.m. Eastern Time and conduct one-on-one investor meetings throughout the day. The presentation will be available via live audio webcast, with a 90-day replay accessible on the company's Investors page.

Simulations Plus (Nasdaq: SLP) has secured a new FDA grant in partnership with the University of Strathclyde and InnoGI Technologies. The collaboration aims to improve understanding of amorphous solid dispersion (ASD) formulations and predict food and pH-dependent drug-drug interactions through in vitro testing and simulation. The project will utilize GastroPlus® platform for physiologically based pharmacokinetic modeling to link in vitro dissolution with in vivo data. The research is expected to accelerate formulation adjustments, reduce costs, and speed up time-to-market for both innovator and generic ASD products.

Simulations Plus (Nasdaq: SLP) reported strong fiscal 2024 results with total revenue growing 18% to $70.0 million. Software revenue increased 12% to $41.0 million (59% of total), while services revenue rose 26% to $29.0 million (41% of total). The company reported net income of $10.0 million with diluted EPS of $0.49. The acquisition of Pro-ficiency in June doubled their total addressable market to $8 billion. For fiscal 2025, the company provides revenue guidance of $90-93 million (+28-33%) and adjusted diluted EPS guidance of $1.07-1.20.

Simulations Plus (Nasdaq: SLP) has announced its upcoming fourth quarter and fiscal 2024 financial results release, scheduled for Wednesday, October 23, 2024, after the market close. The company will host a conference call and live webcast on the same day at 5:00 p.m. Eastern Time to discuss the results.

Interested parties, including investment professionals and shareholders, can join the webcast by registering online. Alternatively, participants can dial in using 1-877-451-6152 (domestic) or 1-201-389-0879 (international) numbers. A 'Call me' link is also available for those requesting a return call.

The webcast will be accessible on the Simulations Plus investor relations page, where it will remain available for replay approximately one hour after the call concludes.

Simulations Plus and the University of Southern California have secured an NIH grant to develop new AI drug discovery offerings. The partnership aims to advance ligand-based virtual screening by incorporating water-ligand interactions into drug design and optimization activities.

The project will integrate USC's WATGEN algorithm for predicting water positions with Simulations Plus's ADMET Predictor platform. Machine learning approaches will be applied to predict pharmacophore features for 3D shape and feature matching. The goal is to create a first-of-its-kind LBVS solution that enhances current methods and accelerates the discovery of more effective drugs.

The team will validate the technology by designing drugs against defined targets, synthesizing and testing selected compounds experimentally. This collaboration between industry and academia aims to reduce the Design-Make-Test-Analyze cycle of drug discovery significantly.

Simulations Plus (Nasdaq: SLP), a leading provider of biosimulation and medical communications solutions for the biopharma industry, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. The event will take place on September 6, 2024, at the Marriott Marquis in New York.

CEO Shawn O'Connor will represent the company, hosting one-on-one and small group meetings throughout the day. This prestigious conference is expected to feature over 200 companies and attract a prominent group of investors, including chief investment officers, portfolio managers, and analysts.

The conference provides an excellent opportunity for Simulations Plus to showcase its innovative solutions and network with key industry players and investors. For those interested in learning more about the event, additional information can be found on the Morgan Stanley conference website.

Simulations Plus (Nasdaq: SLP) has announced a strategic restructuring of its business units and leadership to support future growth following recent acquisitions. The company is forming two new business units: Adaptive Learning & Insights and Medical Communications, while transitioning Regulatory Strategies into a Center of Excellence. This reorganization aims to enhance customer engagement, accelerate cross-selling opportunities, and maximize growth potential.

Key leadership changes include:

• Steven Chang promoted to President, Quantitative Systems Pharmacology
• Jenna Rouse promoted to President of Adaptive Learning & Insights
• Murry Alper promoted to President of Medical Communications
• Sandra Suarez-Sharp transitioning to President, Regulatory Strategies Center of Excellence

Simulations Plus (Nasdaq: SLP) has released DILIsym® version X (DSX), an updated quantitative systems toxicology (QST) platform. DSX is designed to predict drug-induced liver injury (DILI) risks, supporting critical drug development decisions. The software features:

- Enhanced processing speed
- Improved user interface
- Command line and graphical interface options
- Licensing for scale-up on local or cloud clusters
- Four new exemplar compounds
- Two new simulated populations

DSX aims to help researchers identify potential DILI risks, design mitigating dosing strategies, and make faster go/no-go decisions. This can lead to more efficient drug development processes, potentially reducing costly failed clinical trials and accelerating safe drug delivery to patients.