Financial Data and Key Metrics Changes - The company reported net sales of $11,200,000 for Q2 2025, representing a 52% increase compared to Q2 2024 and a 22% sequential gain over Q1 2025 [8][21] - Gross margin for the quarter was 84%, down from 88% in 2024, primarily due to lower manufacturing efficiency associated with newly launched products [22] - Operating losses for Q2 2025 were $7,300,000, an improvement from $8,200,000 in 2024 [25] - Adjusted EBITDA loss for Q2 2025 was $5,300,000, compared to $6,700,000 in 2024, attributed to increased sales and reduced R&D expenses [26] Business Line Data and Key Metrics Changes - The company launched the TriNavFlex infusion system and reported strong initial sales exceeding internal projections [12] - The number of unique ordering accounts increased by 28% year over year, with a 10% increase quarter over quarter [21][42] - The TriNav product portfolio is expanding, with new devices aimed at addressing complex clinical scenarios [10][12] Market Data and Key Metrics Changes - The company gained further penetration in the complex liver embolization market, supported by the issuance of HCPCS code C8004, which allows for reimbursement of simulation or mapping procedures using TriNav [11] - The company is focusing on expanding its market opportunity through new clinical applications and partnerships [10] Company Strategy and Development Direction - The strategic priorities include driving adoption of the Pressure Enabled Drug Delivery (PEDD) platform, advancing new clinical applications, and improving operational performance [10][20] - The company is transitioning to a partnership-focused approach for nalotolimod, which will eliminate development-related expenses while preserving long-term value [14] - The company aims to become cash flow positive by early 2026, with a focus on device innovation and expanding the clinical body of evidence [26][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 50% revenue growth for the year, emphasizing the importance of operational performance and strategic investments [19] - The company is optimistic about the growing momentum across its programs and the potential for TriNav to become the standard of care in liver embolization [13][20] Other Important Information - The company completed a $22,000,000 private placement, strengthening its balance sheet and providing resources for further investment in its commercial strategy [8][26] - The exchange offer and consent solicitation for preferred stock were successfully completed, simplifying the capital structure [27] Q&A Session Summary Question: Discussion on the new mapping code and its market reception - Management highlighted the importance of the new mapping code for reimbursement, which has increased physician confidence in using the technology for both mapping and treatment [30][32] Question: Operating expense outlook - Management indicated a focus on reducing operating expenses, particularly in general and administrative costs, while maintaining investment in sales and marketing [36][38] Question: Unique ordering accounts and commercial organization investments - Unique ordering accounts were up 28% year over year, with a focus on increasing utilization per account through enhanced sales strategies [42][46] Question: Contribution of new products to revenue - The TriNav Large product contributed approximately 10% to 15% to revenue, while the newly launched TriNav Flex is exceeding expectations [49][50] Question: Impact of thyroid data publication on adoption - The publication of data on thyroid procedures is generating significant interest among physicians, with expectations for increased adoption in the coming years [54][56] Question: Third quarter revenue expectations - Management expressed confidence in achieving low double-digit growth in the next two quarters, aligning with the overall guidance of 50% revenue growth for the year [56][58]

Financial Data and Key Metrics Changes - Trisalis Life Sciences reported net sales of $9.2 million for Q1 2025, representing a 42% increase compared to Q1 2024 and an 11% sequential gain over Q4 2024 [9][23] - The company achieved a gross margin of 84% in Q1 2025, slightly down from 85% in Q1 2024, attributed to decreased factory volumes during a clean room expansion [24] - Operating losses for Q1 2025 totaled $7.3 million, a decrease from $11.7 million in Q1 2024, primarily due to increased sales and reduced R&D expenses [25] - Adjusted EBITDA losses for Q1 2025 were $5.5 million, compared to losses of $10.4 million in Q1 2024 [27] Business Line Data and Key Metrics Changes - The company maintained strong momentum in the liver embolization market, increasing the number of unique ordering accounts by 39% year-over-year, adding 32 new accounts in Q1 2025 [11][12] - The launch of TriNav Large and TriGuide expanded the PEDD technology into larger vessels, supporting deeper penetration in the liver market [15] Market Data and Key Metrics Changes - Trisalis has achieved a market share of 10% in liver taste and tear procedures, reflecting growth driven by the adoption of TriNav in new accounts and increased utilization [23] - The Centers for Medicare and Medicaid Services issued a new HCPCS code C8004, providing coverage for mapping procedures using TriNet, effectively doubling the reimbursable use of the technology [12] Company Strategy and Development Direction - The company is focusing on deepening penetration in the liver embolization market, advancing TriNav Flex and TriNav Large, and generating new health economic and outcome research data [19][20] - A shift to a partnership-focused strategy for nalotolimod is expected to eliminate development expenses while preserving long-term value [9][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving at least 50% revenue growth for 2025, despite not anticipating being EBITDA positive or cash flow positive in the year [20] - The company is optimistic about the momentum built from recent strategic initiatives and the potential for new clinical applications [19][21] Other Important Information - Trisalis raised approximately $22 million in gross proceeds through a private placement, strengthening its balance sheet for future investments [18][27] - The company is implementing an exchange offer to convert preferred shares to common stock, simplifying its capital structure [18] Q&A Session Summary Question: What should be looked for in the PERIO three readout? - Management highlighted the focus on the device's functionality and safety profile, as well as the potential to stimulate the innate environment of pancreatic tumors [36] Question: Is there interest in nalotolimod independently or in conjunction with TriNav? - Management clarified that nalotolimod's optimal delivery is through their technology, and they expect to partner with pharmaceutical companies for combined trials [40] Question: Feedback on TriNav Large and its adoption? - Initial adoption is strong among larger tumors and uterine fibroid embolization, with positive results reported by physicians [46] Question: Impact of clean room expansion on gross margins? - The clean room expansion was completed in March, and gross margins are expected to improve in the upcoming quarters [50] Question: How will the sales force expansion impact growth rates? - The company plans to add sales resources to accelerate growth, with the most significant impact expected in 2026 [55] Question: Feedback on the new mapping code? - Early feedback is favorable, with physicians using the device more consistently due to full reimbursement [58] Question: Commercial organization expansion and account numbers? - The company currently has around 300 accounts and aims to expand its sales force to 60-70 representatives over the next 18 months [79]

Financial Data and Key Metrics Changes - Trisalis Life Sciences reported net sales of $9.2 million for Q1 2025, representing a 42% increase compared to Q1 2024 and an 11% sequential gain over Q4 2024 [8][22] - The company achieved a gross margin of 84% in Q1 2025, slightly down from 85% in Q1 2024, attributed to decreased factory volumes during a clean room expansion [23] - Operating losses for Q1 2025 totaled $7.3 million, a decrease from $11.7 million in Q1 2024, primarily due to increased sales and reduced R&D expenses [24] - Adjusted EBITDA losses for Q1 2025 were $5.5 million, down from $10.4 million in Q1 2024, reflecting improved sales and reduced expenses [25] Business Line Data and Key Metrics Changes - The company maintained strong momentum in the liver embolization market, increasing the number of unique ordering accounts by 39% compared to Q1 2024, adding 32 new accounts [10] - The TriNav device's market share in liver procedures reached 10%, with a compound annual growth rate of approximately 50% since its launch in 2020 [22] Market Data and Key Metrics Changes - The Centers for Medicare and Medicaid Services issued a new HCPCS code C8004, providing coverage for mapping procedures using TriNav, effectively doubling the reimbursable use of the technology [11] - The company is expanding its technology into new clinical settings, including a multicenter registry evaluating PEDD for patients with thyroid nodules [13] Company Strategy and Development Direction - The company is focusing on deepening penetration in the liver embolization market, advancing TriNav technology, and preparing nalotolimod for pharmaceutical partnerships [7][18] - Strategic priorities include driving adoption of PEDD across solid tumors, improving manufacturing and gross margins, and expanding the product portfolio [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving at least 50% revenue growth for 2025, despite not anticipating being EBITDA positive or cash flow positive in the year [19] - The company is entering the rest of 2025 with strong tailwinds and plans to invest in strategic areas to drive long-term value [19][20] Other Important Information - The company raised approximately $22 million in gross proceeds through a private placement, strengthening its balance sheet for further investments [16] - The completion of Phase I trials for nalotolimod allows the company to shift to a partnership-focused strategy, reducing development expenses [15] Q&A Session Summary Question: What should be looked for in the PERIO three readout? - Management highlighted the focus on the device's functionality and safety profile, as well as the potential to stimulate the innate environment of pancreatic tumors [30][34] Question: Is there interest in nalotolimod independently or in conjunction with TriNav? - Management indicated that nalotolimod's performance is optimized through their technology, and they expect to partner with pharmaceutical companies for combined development [35][38] Question: Feedback on TriNav Large and its adoption? - Initial adoption is strong among physicians treating larger tumors, with positive results reported [41][43] Question: Impact of clean room expansion on gross margins? - The clean room expansion was completed in March, and gross margins are expected to improve in the upcoming quarters [45][46] Question: How will the sales force expansion impact growth rates? - The company plans to add sales resources to accelerate growth, with the most significant impact expected in 2026 [50][51] Question: Feedback on the new mapping code? - Early feedback is favorable, with physicians using the device more consistently due to full reimbursement [52][54] Question: What is the current number of accounts and future goals? - The company has around 300 accounts and aims to increase its sales force to cover more hospitals [73][76]