Tivic Health Systems (TIVC) Conference Summary Company Overview - Tivic Health Systems is a late-stage diversified immunotherapeutics company focused on harnessing the immune system to fight diseases and restore health [3][4] - The company has transitioned from a single product company to a diversified portfolio, including a program in vagus nerve stimulation and a phase three immunotherapy program [5][6] Key Developments - Tivic has licensed a phase three immunotherapy program involving two molecules, with significant prior funding of approximately $140 million from agencies like DARPA and DOD [5][12] - The company is positioned in a $183 billion market segment with multiple commercial and clinical catalysts expected in the next 18 months [7] Product Pipeline - The newly licensed asset, Entelimod, is engineered to activate specific receptors in the immune system, showing promising results in treating acute radiation syndrome [11][12] - The acute radiation syndrome treatment has demonstrated a threefold increase in survival rates in mouse trials after radiation exposure [16][17] - The company is also exploring applications for neutropenia, a condition with a current market of approximately $10 billion, expected to grow to over $20 billion by 2032 [21][22] Competitive Advantage - Tivic's approach combines bioelectronic and biologic therapies, targeting both overactive and underactive immune systems [8][30] - The company’s bioelectronic portfolio aims to modulate the vagus nerve non-invasively, presenting a compelling alternative to existing surgical solutions [32][40] Market Opportunities - The acute radiation syndrome indication is seen as a significant opportunity for stockpiling orders, potentially ranging from $25 million to $250 million [20] - The G-CSF market, which currently stands at $7.2 billion, is expected to grow to $14.5 billion, providing a substantial opportunity for Tivic’s products [26] Clinical Trials and Regulatory Pathways - All trials for acute radiation syndrome have been completed, and the company is looking to start new trials for neutropenia [42] - Tivic has initiated GMP manufacturing processes and is in discussions with the FDA for potential expedited pathways to market [19][15] Financial Position - The company has maintained a clean cap table with no debt and good trading volumes, regaining NASDAQ minimum bid compliance as of March 31 [6][44] - An $8.4 million financing has been signed, with plans for a shareholder meeting to approve announced financings [46] Conclusion - Tivic Health is at a pivotal point with a diversified portfolio and significant market opportunities, particularly in immunotherapy and bioelectronic medicine, positioning itself for potential growth and investment [3][48]

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 [11][12] - 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% [12] - 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 for both quarters [12][13] - Cash and cash equivalents were $669,000 as of March 31, 2025, down from $2,000,000 at the end of 2024 [13] 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 biopharmaceutical assets and supporting clinical research in non-invasive vagus nerve stimulation [9] Market Data and Key Metrics Changes - The treatment market for neutropenia is expected to reach $20 billion by 2029, indicating a substantial growth opportunity for the company [36] Company Strategy and Development Direction - The company is focused on enhancing shareholder value by prioritizing assets with the greatest potential for substantial returns, including the licensing agreement for entelimod [9][10] - A strategic shift towards immunotherapeutics is underway, with plans to advance both late and early-stage treatments in the pipeline [42] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the high economic uncertainty and the impact of reduced advertising on revenue, but emphasized the importance of capital management for future returns [10] - The company views 2025 as a year of tremendous opportunity with several key milestones expected in the second half of the year [44] Other Important Information - The FDA granted Fast Track status and orphan drug status for entelimod, with potential for accelerated pathways and emergency use designations [37] - The company has secured an $8.4 million tranche funding agreement to support its transformation [8] Q&A Session Summary - No specific questions and answers were provided in the content, as the call was pre-recorded and questions were submitted in advance.

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]

Financial Data and Key Metrics Changes - Revenue net of returns totaled $0.8 million compared to $1.2 million a year ago, a decline primarily due to a 41% decrease in unit sales associated with reductions in overall marketing spend [59] - Cost of sales decreased 12% to $0.8 million from $0.9 million in the prior year, with an inventory reserve of $354,000 in 2024 compared to $32,000 in 2023 [60] - Net loss for the year decreased to $5.7 million from $8.2 million for 2023 [63] - Cash and cash equivalents at December 31, 2024, totaled $2 million compared with $3.4 million at December 31, 2023 [64] Business Line Data and Key Metrics Changes - Gross profit was $2,000 compared with $287,000 for the prior year, primarily due to the inventory reserves recorded in 2024 [62] - Total operating expenses were $5.7 million compared to $8.5 million for 2023, with plans to increase research and development investments in the Vagus nerve platform and clinical applications [63] Company Strategy and Development Direction - The company has acquired worldwide exclusive rights to a phase three immunomodulatory drug candidate, Intellimod, which is positioned to fill a critical gap in treatments for acute radiation syndrome [7][15] - The strategic transformation aims to build a biopharmaceutical capacity within the company, combining biologic and bioelectronic medicine to focus on immune dysrhythmias [9][11] - The company is developing a noninvasive cervical stimulation device for vagus nerve activation, targeting conditions caused by overactive immune systems [36][40] Management's Comments on Operating Environment and Future Outlook - Management views 2025 as a year of growth and progress, focusing on achieving key milestones associated with Intellimod commercialization and advancing VNS programs [68] - The company has reshaped itself into a diversified therapeutics organization, moving from a single product company to a robust immunotherapy pipeline [56][57] Other Important Information - The company received approval for a compliance plan from NASDAQ and traded above a dollar for ten consecutive days, expecting to be in compliance with continued listing requirements [54] - An equity line of credit in the amount of $25 million has been closed, providing flexible funding for development stages [55] Q&A Session Summary Question: What are the key milestones for Intellimod commercialization? - Management highlighted the importance of moving into manufacturing validation and filing a biologics license application with the FDA, with potential marketing opportunities within about two years [27][28] Question: How does the company plan to address the decline in revenue? - The company is exploring new opportunities to increase cash flow generated by the ClearUp business and has deployed a new e-commerce web infrastructure to improve user experience [61][62]