Summary of TriSalus Life Sciences Conference Call Company Overview - **Company**: TriSalus Life Sciences (TLSI) - **Industry**: MedTech, Life Science Tools, and Diagnostics - **Technology**: Microcatheter technology designed to enhance drug delivery to solid tumors, particularly in the liver and other areas Key Points and Arguments 1. **Technology and Market Opportunity**: - TriSalus's technology addresses the challenge of delivering drugs to solid tumors, where less than 1% of drugs can penetrate due to high internal pressure [3][4] - The company has expanded its market opportunity from approximately $400 million to nearly $2.5 billion, primarily targeting liver metastases and primary liver cancer [8] 2. **Growth and Financial Performance**: - The company reported a 50% growth in the first half of 2025 compared to the first half of 2024, with a 22% sequential growth from Q1 to Q2 [9] - New product launches, including a more trackable version of their technology and a product for uterine fibroids, are expected to drive growth [10] 3. **Reimbursement Strategy**: - TriSalus has developed its own embolization procedural code for Pressure-Enabled Drug Delivery, which is favorable for hospitals and saves over $8,000 per patient for CMS [12] - The reimbursement model is designed to be cash positive for hospitals, enhancing the adoption of their technology [12] 4. **Sales and Market Penetration**: - The company focuses on existing accounts for growth, with a strategy to expand usage among multiple physicians within hospitals [13][14] - TriSalus targets high-volume interventional radiology accounts, with 57 out of 100 identified accounts performing well [21] 5. **Education and Adoption Challenges**: - The primary barrier to adoption is the lack of education regarding intratumoral pressure and the tumor microenvironment among physicians [22][25] - The company is focused on training and registry studies to support the adoption of their technology [26][30] 6. **Future Developments**: - Upcoming milestones include data releases on various applications, including uterine fibroids and genicular artery procedures [36] - The company is also looking to partner for the advancement of nelitolimod, targeting liver and pancreatic indications [32][33] 7. **Financial Outlook**: - The company aims for near-term cash flow breakeven, with opportunities for cost savings and efficiency improvements [34][35] - The focus remains on scaling sales and marketing efforts while leveraging clinical evidence from registry studies to enhance market presence [35] Additional Important Content - The technology allows for a non-invasive procedure for thyroid embolization, which avoids risks associated with traditional methods [28][29] - The company is committed to educating physicians about the new methodologies and ensuring proper training for interventional radiologists [25][30]

分组1 - TriSalus Life Sciences, Inc. reported a quarterly loss of $0.27 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.22, and compared to a loss of $0.21 per share a year ago, indicating an earnings surprise of -22.73% [1] - The company posted revenues of $11.21 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 5.52%, and this represents an increase from year-ago revenues of $7.36 million [2] - TriSalus Life Sciences, Inc. shares have declined approximately 28.7% since the beginning of the year, contrasting with the S&P 500's gain of 8.4% [3] 分组2 - The earnings outlook for TriSalus Life Sciences, Inc. is uncertain, with current consensus EPS estimates of -$0.16 on $11.38 million in revenues for the coming quarter and -$0.86 on $44.31 million in revenues for the current fiscal year [7] - The Zacks Industry Rank indicates that the Medical - Products sector is currently in the bottom 42% of over 250 Zacks industries, suggesting that the industry outlook could significantly impact the stock's performance [8]

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]

Special Note Regarding Forward-Looking Statements [Forward-Looking Statements Overview](index=4&type=section&id=Forward-Looking%20Statements%20Overview) This section cautions readers that the report contains forward-looking statements, which are not guarantees of performance and are subject to known and unknown risks, uncertainties, and assumptions - Forward-looking statements are not guarantees of performance and are based on current expectations and projections about future events[9](index=9&type=chunk) - Actual results, levels of activity, performance, or achievements may be materially different due to known and unknown risks, uncertainties, and assumptions[10](index=10&type=chunk)[11](index=11&type=chunk) - Key risk factors include the ability to raise future financing, commercialize product candidates, achieve regulatory approvals, manage clinical trial outcomes, retain key personnel, execute business strategy, protect intellectual property, manage growth, maintain Nasdaq listing, and navigate unfavorable industry or global economic conditions[12](index=12&type=chunk) PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets show a significant increase in total assets from **$23,971 thousand** at December 31, 2024, to **$41,317 thousand** at June 30, 2025, primarily driven by an increase in cash and cash equivalents | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :--------------------------- | :------------------------------- | :-------------------- | | Cash and cash equivalents | $26,490 | $8,525 | +$17,965 | | Total current assets | $38,084 | $20,669 | +$17,415 | | Total assets | $41,317 | $23,971 | +$17,346 | | Total current liabilities | $9,324 | $10,228 | -$904 | | Long-term debt, net | $32,274 | $22,084 | +$10,190 | | Total liabilities | $60,740 | $49,865 | +$10,875 | | Total stockholders' deficit | $(19,423) | $(25,894) | +$6,471 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, revenue increased by **52.3%** year-over-year, leading to a **45.9%** increase in gross profit | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | YoY Change | | :---------------------------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :--------- | | Revenue | $11,213 | $7,364 | +52.3% | | Gross profit | $9,411 | $6,452 | +45.9% | | Research and development | $3,923 | $4,666 | -15.9% | | Sales and marketing | $7,163 | $6,004 | +19.3% | | General and administrative | $5,657 | $3,956 | +43.0% | | Loss from operations | $(7,332) | $(8,174) | -10.3% | | Interest expense | $(1,423) | $(877) | +62.3% | | Change in fair value of contingent earnout liability | $700 | $13,689 | -94.9% | | Net loss available to common stockholders | $(8,288) | $(4,332) | +91.3% | | Net loss per common share, basic and diluted | $(0.27) | $(0.21) | +28.6% | | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | YoY Change | | :---------------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :--------- | | Revenue | $20,380 | $13,821 | +47.5% | | Gross profit | $17,083 | $11,938 | +43.1% | | Research and development | $7,219 | $10,510 | -31.3% | | Sales and marketing | $13,897 | $12,691 | +9.5% | | General and administrative | $10,628 | $8,583 | +23.8% | | Loss from operations | $(14,661) | $(19,846) | -26.1% | | Interest expense | $(2,632) | $(880) | +199.1% | | Change in fair value of contingent earnout liability | $(120) | $9,701 | -101.2% | | Net loss available to common stockholders | $(18,663) | $(17,538) | +6.4% | | Net loss per common share, basic and diluted | $(0.65) | $(0.81) | -19.7% | [Condensed Consolidated Statements of Stockholders' Deficit](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Deficit) The total stockholders' deficit improved from **$(25,894) thousand** at December 31, 2024, to **$(19,423) thousand** at June 30, 2025 | Item | Six Months Ended June 30, 2025 (in thousands) | | :-------------------------------- | :-------------------------------------------- | | Balance at December 31, 2024 | $(25,894) | | Exercise of options | $279 | | Stock-based compensation | $1,620 | | Preferred stock conversion | $0 | | Net loss (Q1 2025) | $(10,375) | | Exercise of options | $56 | | Stock-based compensation | $2,517 | | Proceeds from sale of common stock | $20,662 | | Preferred stock conversion | $0 | | Net loss (Q2 2025) | $(8,288) | | Balance at June 30, 2025 | $(19,423) | - Proceeds from the sale of common stock contributed **$20,662 thousand** to additional paid-in capital for the **six months** ended June 30, 2025[23](index=23&type=chunk) - Net loss for the **six months** ended June 30, 2025, totaled **$(18,663) thousand**[23](index=23&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the **six months** ended June 30, 2025, the company experienced a net increase in cash, cash equivalents, and restricted cash of **$17,965 thousand**, reaching **$26,840 thousand** | Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(11,819) | $(24,289) | | Net cash used in investing activities | $(621) | $(126) | | Net cash provided by financing activities | $30,405 | $29,119 | | Increase in cash, cash equivalents and restricted cash | $17,965 | $4,704 | | Cash, cash equivalents and restricted cash, end of period | $26,840 | $16,831 | - Financing activities in H1 2025 included **$22,211 thousand** from the issuance of common stock and **$10,000 thousand** from the issuance of debt[29](index=29&type=chunk) - Operating cash outflow significantly reduced from **$(24,289) thousand** in H1 2024 to **$(11,819) thousand** in H1 2025[29](index=29&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [(1) Nature of Business](index=13&type=section&id=(1)%20Nature%20of%20Business) TriSalus Life Sciences, Inc. completed a merger on August 10, 2023, with Legacy TriSalus being the accounting acquirer, and is an oncology-focused medical technology business developing PEDD™ infusion systems and nelitolimod - TriSalus Life Sciences, Inc. completed a merger on **August 10, 2023**, with Legacy TriSalus deemed the accounting acquirer[31](index=31&type=chunk) - The company is an oncology-focused medical technology business developing Pressure Enabled Drug Delivery (PEDD™) infusion systems and investigational immunotherapeutic nelitolimod to transform solid tumor treatment[32](index=32&type=chunk)[33](index=33&type=chunk) - Key products include TriNav™ (launched **2020**) and TriNav LV Infusion System (launched **2024**), with new HCPCS codes (C9797 effective Jan 1, 2024, and C8004 effective April 1, 2025) providing reimbursement clarity[34](index=34&type=chunk)[217](index=217&type=chunk) - As of **June 30, 2025**,

Financial Performance - Generated $11.2 million in net sales, a 52% increase year-over-year, and a 22% sequential growth over Q1 2025[5] - Gross margins were 84% in Q2 2025, down from 88% in the same period of 2024, primarily due to lower manufacturing efficiency associated with newly launched products[5] - Operating losses were $7.3 million, an improvement from $8.2 million in the same period in 2024[10] - Net loss attributable to common stockholders was $9.0 million, compared to $5.1 million for the same period in 2024[10] - The basic and diluted loss per share was $0.27, compared to $0.21 for the same period in 2024[10] - Net loss available to common stockholders for Q2 2025 was $8,288 million, compared to a loss of $4,332 million in Q2 2024, indicating a deterioration of 91.5%[18] - Adjusted EBITDA for Q2 2025 was $(5,275) million, an improvement from $(6,705) million in Q2 2024, showing a reduction in losses of 21.3%[18] Expenses - Research and Development (R&D) expenses were approximately $3.9 million, down from $4.7 million in the same quarter of the prior year[5] - Sales and Marketing (S&M) expenses increased to approximately $7.2 million in Q2 2025, compared to $6.0 million in the same quarter of 2024[5] - Interest expense for Q2 2025 was $1,423 million, compared to $877 million in Q2 2024, reflecting an increase of 62.2%[18] Guidance and Market Response - The company reaffirmed full-year revenue growth guidance of at least 50% due to continued commercial momentum[2] - The successful launch of TriNav® FLX is expected to enhance navigability through tortuous vessels, with early market response surpassing internal projections[5] Assets and Liabilities - As of June 30, 2025, cash and cash equivalents totaled $26.5 million, providing sufficient runway to reach positive adjusted EBITDA in the first half of 2026[10] - Total assets increased to $41,317 million as of June 30, 2025, up from $23,971 million at December 31, 2024, representing a growth of 72.2%[15] - Current assets rose to $38,084 million, a significant increase from $20,669 million, reflecting a growth of 84.3%[15] - Long-term debt increased to $32,274 million as of June 30, 2025, up from $22,084 million at December 31, 2024, marking a rise of 46.2%[15] - Total liabilities reached $60,740 million, up from $49,865 million, representing an increase of 21.8%[15] - Cash and cash equivalents significantly increased to $26,490 million from $8,525 million, a growth of 210.5%[15] - Stockholders' deficit improved to $(19,423) million as of June 30, 2025, compared to $(25,894) million at December 31, 2024, indicating a reduction of 24.9%[15] Non-GAAP Financial Measures - The company emphasizes the importance of non-GAAP financial measures to provide additional insights into its operational performance[16]

Company Overview - TriSalus Life Sciences, Inc. held its Q1 2025 Earnings Conference Call on May 15, 2025, featuring key participants including the President and CEO, CFO, and Medical Director [1][3][4]. Financial Results - The company released its financial results for the quarter ended March 31, 2025, which were discussed in detail during the call [4]. Strategic Direction - The President and CEO provided an overview of the company's first quarter results and outlined the strategy for the remainder of the year [4].

Company Performance - TriSalus Life Sciences, Inc. reported a quarterly loss of $0.33 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.20, representing an earnings surprise of -65% [1] - The company posted revenues of $9.17 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 1.04%, but showing an increase from $6.46 million in the same quarter last year [2] - Over the last four quarters, the company has not surpassed consensus EPS estimates and has topped consensus revenue estimates only once [2] Stock Performance - TriSalus Life Sciences, Inc. shares have declined approximately 2.2% since the beginning of the year, while the S&P 500 has gained 0.2% [3] - The current Zacks Rank for the stock is 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.17 on revenues of $10.69 million, and for the current fiscal year, it is -$0.60 on revenues of $44.3 million [7] - The outlook for the Medical - Products industry, to which TriSalus belongs, is currently in the bottom 28% of over 250 Zacks industries, which may impact the stock's performance [8]

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]

Revenue and Sales Performance - TriSalus reported a revenue increase driven primarily by sales of its PEDD infusion systems, particularly the TriNav, with a gross margin that allows for substantial funding of growth and R&D [227][230]. - Revenue increased by $2.7 million, or 42.0%, for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to increased sales of TriNav [239]. Product Development and Clinical Trials - The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter in 2024, expanding its PEDD device portfolio to optimize therapeutic delivery for larger vessels [215][216]. - A registry study called PROTECT aims to enroll 100 patients and is expected to expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity [217]. - The company completed Phase I clinical trials for nelitolimod and is exploring partnerships for further development, with data expected in 2025 [218]. - The MDACC Agreement was modified and extended to include a sixth year, enhancing collaboration for ongoing clinical studies [222]. Financial Position and Cash Flow - Cash and cash equivalents were approximately $13.0 million at March 31, 2025, with a minimum cash requirement increased from $5.0 million to $10.0 million [250]. - Net cash used in operating activities was $4.5 million for the three months ended March 31, 2025, compared to $10.9 million for the same period in 2024 [251]. - Net cash provided by financing activities was $9.7 million for the three months ended March 31, 2025, primarily from the First Delayed draw under the OrbiMed Credit Agreement [256]. Expenses and Losses - Gross profit increased by $2.2 million, or 39.8%, for the three months ended March 31, 2025, with gross margin decreasing to 83.7% from 85.0% [241]. - Research and development expenses decreased by $2.5 million, or 43.6%, for the three months ended March 31, 2025, primarily due to reduced clinical trial expenses [242]. - General and administrative expenses increased by $0.3 million, or 7.4%, for the three months ended March 31, 2025, mainly due to professional services related to filing and audit expenses [245]. - Net loss available to common stockholders was $10.4 million for the three months ended March 31, 2025, compared to a net loss of $13.2 million for the same period in 2024 [238]. Funding and Capital Requirements - TriSalus secured a $10 million loan under the OrbiMed Credit Agreement, contingent on achieving a $30 million revenue base [221]. - The company anticipates gross proceeds of approximately $22 million from a private placement of 5.5 million shares at $4.00 per share, closing on May 2, 2025 [225]. - The company expects to finance its cash needs through a combination of securities offerings, debt financings, collaborations, strategic alliances, and licensing arrangements [260]. - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2025, due to its reliance on generating sufficient cash flows or obtaining additional capital [263]. - If the company is unable to raise additional capital, it may have to delay or terminate product development efforts [261]. - The company may face dilution of existing ownership interests if it raises additional capital through equity or convertible debt securities [260]. Regulatory and Compliance Matters - TriSalus received a permanent HCPCS code for the TriNav Infusion System effective January 1, 2024, which may enhance reimbursement clarity and support sales [214]. - The expiration of the TPT payment program in December 2023 poses a risk to maintaining current pricing and gross margins for TriNav [219]. - The company is subject to affirmative and restrictive covenants under the OrbiMed Credit Agreement, which may limit its operational flexibility [260]. - The company does not currently have any off-balance sheet financing arrangements or relationships with unconsolidated entities [266]. - The company’s critical accounting policies have not changed significantly during the three months ended March 31, 2025, compared to the previous year [267]. Other Financial Liabilities - The fair value of the SEPA, warrant, and revenue base redemption liabilities changed by $3.4 million, resulting in a loss of $0.8 million for the three months ended March 31, 2025 [247]. - The company has paid Dynavax $12.0 million as of March 31, 2025, with potential additional payments of up to $158 million upon achieving certain milestones related to nelitolimod [265]. - The company may be required to pay up to $80 million upon achieving certain commercial milestones for nelitolimod, subject to obtaining marketing approval [265].