Financial Data and Key Metrics Changes - Revenue for Q1 2025 totaled $70,000, a decline from $334,000 in Q1 2024, primarily due to an 81% decrease in unit sales linked to a 92% reduction in advertising spend [10][11] - Cost of sales decreased to $20,000 from $167,000 in the prior year, resulting in an increase in gross margins from 50% to 72% [11] - Operating expenses remained flat at $1,600,000 for Q1 2025 compared to the same period in 2024, with a net loss of $1,500,000 remaining unchanged year-over-year [11][12] - Cash and cash equivalents were $669,000 at the end of Q1 2025, down from $2,000,000 at the end of 2024, with working capital at $520,000 [12] Business Line Data and Key Metrics Changes - The company transitioned from a single product focus to a diversified immunotherapeutics company, emphasizing a clinical pipeline targeting immune system dysregulation [4][5] - Significant investment was made in securing and operationalizing biopharmaceutical assets, particularly in the licensing agreement with Staterra for entelimod and its derivative [8][14] Market Data and Key Metrics Changes - The market for neutropenia treatment is projected to reach $20 billion by 2029, indicating a significant opportunity for the company’s new drug candidates [33] - The company is positioned to address diseases caused by both underactive and overactive immune systems, which is a unique market opportunity [40] Company Strategy and Development Direction - The strategic focus is on enhancing shareholder value by prioritizing assets with the greatest potential for substantial returns, including the advancement of entelimod and the vagus nerve stimulation program [8][9] - The company aims to transition into high-value markets while managing capital to minimize dilution for investors [7][8] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of the licensing agreement with Staterra as a significant strategic shift, providing a foundation for growth and value creation [16][18] - The FDA granted Fast Track and orphan drug status to entelimod, with potential for accelerated pathways and emergency use designations [35] Other Important Information - The company has entered into an $8,400,000 tranche funding agreement to support its transformation and has secured a $25,000,000 equity line of credit [7][12] - The company is committed to advancing its non-invasive vagus nerve stimulation program, with ongoing clinical studies expected to yield results in the near future [39][40] Q&A Session Summary Question: What is the company's strategy regarding the new licensing agreement? - The licensing agreement with Staterra is seen as a major opportunity to accelerate value creation and leverage the company’s commercial infrastructure for long-term growth [14][16] Question: How does the company plan to address the decline in revenue? - The company intentionally reduced advertising spend to focus on capital resources for biopharmaceutical assets, which impacted revenue but is expected to lead to greater long-term value [10][11] Question: What are the expected milestones for entelimod? - The company is focused on validating the manufacturing process for entelimod and preparing for the biological licensing application with the FDA, with significant confidence in the collaboration for successful outcomes [36][40]