Simulations Plus Inc Stock Price, News & Analysis

Simulations Plus, Inc. (NASDAQ: SLP) announced the renewal of FDA licenses for its DILIsym® software, a leading tool in predicting drug-induced liver injury (DILI). This one-year renewal allows FDA employees continued access to DILIsym across all divisions. Dr. Paul B. Watkins emphasized that this endorsement underscores DILIsym's value in assessing liver safety during drug development, especially after the FDA Modernization Act 2.0 signing. Dr. Brett A. Howell remarked on the growing importance of simulation technologies to enhance drug development efficiency amid rising healthcare costs. DILIsym's predictive modeling aids crucial decisions in drug development by identifying potential DILI risks and guiding go/no-go decisions. Simulations Plus has provided biosimulation solutions for over 25 years, employed by major stakeholders in the pharmaceutical industry.

Simulations Plus, a leader in pharmaceutical modeling software, reported Q2 fiscal 2023 revenues of $15.8 million, a 6% increase year-over-year. Software revenue rose 7% to $10.5 million, while services revenue saw a 4% increase to $5.3 million. Gross profit grew 10% to $13.1 million, achieving an impressive gross margin of 83%. However, net income decreased to $4.2 million with diluted EPS at $0.20, down from $4.4 million or $0.21 last year. Year-to-date, revenues climbed 2% to $27.7 million, with diluted EPS at $0.26, down from $0.36. The company maintains its full-year revenue guidance of $59.3 - $62.0 million and diluted EPS of $0.63 - $0.67.

Simulations Plus recently hosted a virtual panel discussion focused on advancing gender equity for women in science, attended by over 150 participants. The session, part of the Model-Informed Drug Development (MIDD+) conference, featured a diverse group of speakers emphasizing the importance of male involvement in the conversation. Jill Fiedler-Kelly, President of Cognigen, highlighted the need for policy changes to support women, including flexible hours and parental leave. Current statistics show that 52% of Simulations Plus scientists are women, but more work is needed for equity, particularly for women of color in STEM. The panel emphasized creating supportive environments and critically examining existing policies.

Simulations Plus (NASDAQ: SLP) has partnered with the Sino-American Cancer Foundation to enhance drug discovery focused on the MTHFD2 target, a key area in cancer treatment. This collaboration will utilize Simulations Plus’ Artificial Intelligence-driven Drug Design technology and ADMET Predictor® software to develop novel inhibitors. The initiative includes creating quantitative structure-activity relationship (QSAR) models and optimizing lead compounds for efficacy. The SACF will provide funding and support throughout the project, expected to yield valuable compounds for cancer therapy.