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].

[Securities Purchase Agreement](index=1&type=section&id=SECURITIES%20PURCHASE%20AGREEMENT) This Securities Purchase Agreement outlines the terms for a private placement of 5,500,000 common shares at $4.00 each, totaling $22,000,000, between TriSalus Life Sciences, Inc. and investors [Definitions](index=1&type=section&id=1.%20Definitions) This section defines key terms like "Material Adverse Effect" and "Transaction Agreements" for precise interpretation of the agreement - Defines **"Material Adverse Effect"** as a significant adverse impact on the Company's business, financial condition, or ability to fulfill its obligations under the agreement[34](index=34&type=chunk) - Defines **"Transaction Agreements"** to include this Securities Purchase Agreement and the associated Registration Rights Agreement[53](index=53&type=chunk) [Purchase and Sale of Shares](index=5&type=section&id=2.%20Purchase%20and%20Sale%20of%20Shares) This section outlines the core transaction terms, including the sale of common stock at a fixed price and closing logistics Transaction Details | Metric | Value | | :--- | :--- | | Price per Share | $4.00 | | Total Shares Sold | 5,500,000 | | Total Purchase Price | $22,000,000.00 | - The closing of the purchase and sale is scheduled to occur remotely no later than the **fifth business day** after the agreement date[55](index=55&type=chunk) - At closing, investors will pay the aggregate purchase amount via wire transfer, and the Company will issue the shares in book-entry form, free of most restrictive legends[55](index=55&type=chunk) [Representations and Warranties of the Company](index=6&type=section&id=3.%20Representations%20and%20Warranties%20of%20the%20Company) The Company provides extensive representations and warranties to investors, covering SEC filings, capitalization, and compliance, forming a factual baseline - The Company warrants that its **SEC filings** are accurate, compliant with regulations, and do not contain any material misstatements or omissions[66](index=66&type=chunk) - The Company confirms its Common Stock is listed on the **Nasdaq Global Market** under the symbol "TLSI" and it is in compliance with all listing requirements[80](index=80&type=chunk) - The Company represents that it has not engaged in general solicitation for this offering and that the transaction is exempt from registration under the Securities Act, assuming the accuracy of investor representations[88](index=88&type=chunk) - The Company represents it has entered into Support Agreements with holders of more than **50%** of its outstanding Preferred Stock, related to a planned Exchange Offer[100](index=100&type=chunk) [Representations and Warranties of Each Investor](index=17&type=section&id=4.%20Representations%20and%20Warranties%20of%20Each%20Investor) Each investor represents their status as an accredited investor, acknowledging investment risks and intent to hold shares for investment - Each Investor represents that it is an **"accredited investor"** or **"qualified institutional buyer"** with the financial knowledge to evaluate the investment[107](index=107&type=chunk) - Investors acknowledge that the shares are not registered under the Securities Act and are subject to transfer restrictions, understanding they must be held indefinitely unless registered or an exemption is available[112](index=112&type=chunk) - Investors confirm they are not purchasing shares as a result of any general solicitation or public advertising[117](index=117&type=chunk) [Covenants](index=22&type=section&id=5.%20Covenants) This section outlines ongoing obligations, including the Company's commitment to file Form 8-K, maintain Nasdaq listing, and adhere to equity sale restrictions - The Company must file a Current Report on **Form 8-K** by 9:00 a.m. New York City time on the first business day following the agreement to disclose the transaction and any material non-public information[124](index=124&type=chunk) - For **60 days** after closing, the Company agrees not to issue additional shares of Common Stock or equivalents, with certain exceptions such as for employee compensation plans or the planned Exchange Offer[137](index=137&type=chunk) - The Company agrees to indemnify and hold harmless the Investors from losses arising from any breach of its representations, warranties, or covenants in the agreement[133](index=133&type=chunk) [Conditions of Closing](index=26&type=section&id=6.%20Conditions%20of%20Closing) This section specifies conditions for closing, including accurate Company representations, absence of material adverse effects, and receipt of the full purchase price - A key condition for the Investors' obligation to close is that no event constituting a **Material Adverse Effect** has occurred since the agreement date[142](index=142&type=chunk) - The Company must deliver a legal opinion from its counsel, **Cooley LLP**, to the Investors and the Placement Agent at closing[150](index=150&type=chunk) - The Company's obligation to close is conditioned upon receiving the **full purchase price** from each Investor via wire transfer[155](index=155&type=chunk) [Termination](index=28&type=section&id=7.%20Termination) This section outlines circumstances for agreement termination prior to closing, including mutual consent or if closing does not occur within **five business days** - The agreement can be terminated by either the Company or an Investor if the Closing does not occur on or prior to the **fifth business day** following the date of the agreement[156](index=156&type=chunk) - Termination is also possible by **mutual written consent** of the Company and the Investor Majority[155](index=155&type=chunk)[157](index=157&type=chunk) [Miscellaneous Provisions](index=29&type=section&id=8.%20Miscellaneous%20Provisions) This section contains standard legal clauses governing agreement interpretation and enforcement, covering governing law, jurisdiction, and several investor obligations - The agreement is governed by the laws of the **State of New York**, and the parties submit to the jurisdiction of courts in Manhattan, waiving the right to a jury trial[165](index=165&type=chunk)[167](index=167&type=chunk) - The obligations of each Investor are **several and not joint**, meaning no Investor is responsible for the performance of any other Investor[181](index=181&type=chunk) - The Placement Agent (**Canaccord Genuity LLC**) is an intended third-party beneficiary of certain representations and warranties made by the Company and the Investors[38](index=38&type=chunk)[179](index=179&type=chunk) [Exhibits](index=61&type=section&id=Exhibits) The exhibits provide supplementary information, including investor commitments in Exhibit A and the Registration Rights Agreement in Exhibit B Investor Commitments (Exhibit A) | Investor Name | Shares | Aggregate Purchase Price | | :--- | :--- | :--- | | Alyeska Master Fund, LP | 557,500 | $2,230,000.00 | | Broadfin Holdings LLC | 125,000 | $500,000.00 | | Lytton-Kambara Foundation | 400,000 | $1,600,000.00 | | Nantahala Capital Partners LP | 457,086 | $1,828,344.00 | | Blackwell Partners LLC – Series A | 817,614 | $3,270,456.00 | | Pinehurst Partners, L.P. | 500,000 | $2,000,000.00 | | Special Situations Funds (Aggregate) | 1,250,000 | $5,000,000.00 | | ... (Other Investors) | ... | ... | | **TOTAL:** | **5,500,000** | **$22,000,000.00** | - Exhibit B confirms that a **Registration Rights Agreement** will be executed, providing investors with rights to have their shares registered with the SEC for future public sale[243](index=243&type=chunk)[3](index=3&type=chunk)

Part I [Business Overview](index=7&type=section&id=Item%201.%20Business) TriSalus Life Sciences is an oncology-focused medical technology company leveraging its Pressure-Enabled Drug Delivery (PEDD™) technology and investigational immunotherapeutic nelitolimod, with its TriNav® system generating $29.4 million in 2024 revenue [Overview and Business Strategy](index=7&type=section&id=Overview%20and%20Business%20Strategy) TriSalus is an oncology company focused on transforming solid tumor treatment through its PEDD™ technology and investigational immunotherapeutic nelitolimod, with TriNav® revenue reaching $29.4 million in 2024 - TriSalus is an oncology company focused on transforming solid tumor patient outcomes by integrating its innovative **PEDD™ delivery technology** with therapies, including its investigational immunotherapeutic, **nelitolimod**[22](index=22&type=chunk) - The company's strategy aims to overcome high intratumoral pressure and immunosuppressive tumor microenvironments, key barriers in solid tumor treatment[22](index=22&type=chunk) - The commercial **TriNav® PEDD™ device** generated **$29.4 million in revenue** in 2024, marking **59.0% year-over-year growth** in interventional radiology procedures[24](index=24&type=chunk) - The company is developing **nelitolimod**, a class C TLR9 agonist, in **Phase 1/1b trials** for various cancers to reactivate the immune system within tumors[25](index=25&type=chunk)[27](index=27&type=chunk) [PEDD Delivery Technology and TriNav Device](index=8&type=section&id=PEDD%20Delivery%20Technology%20and%20TriNav%20Device) The PEDD™ technology and TriNav® device are designed to overcome intratumoral pressure, enhancing therapeutic delivery and improving patient outcomes in procedures like TARE and TACE - The **Pressure-Enabled Drug Delivery (PEDD™) technology** is designed to overcome high intratumoral pressure, increasing therapeutic delivery into tumors while minimizing systemic exposure[29](index=29&type=chunk) - The **TriNav® device** features a SmartValve™ that works with the cardiac cycle to intermittently occlude blood vessels, enhancing therapeutic perfusion into tumors and reducing reflux[30](index=30&type=chunk) - Clinical studies show PEDD devices improve tumor targeting, increase therapeutic dose delivery, and enhance patient response rates in Transarterial Radioembolization (TARE) and Transarterial Chemoembolization (TACE) procedures[31](index=31&type=chunk)[33](index=33&type=chunk)[35](index=35&type=chunk) - A Health Economic and Outcome Research (HEOR) study indicated TriNav use in complex patients resulted in comparable or better outcomes, including reduced post-procedure fatigue and fewer inpatient visits[34](index=34&type=chunk)[36](index=36&type=chunk)[42](index=42&type=chunk) [Market Opportunity and Growth](index=10&type=section&id=Market%20Opportunity%20and%20Growth) TriSalus estimates a current U.S. market opportunity of $494.0 million for TriNav in liver cancer, with potential expansion into new applications exceeding $1.6 billion annually - The current U.S. market opportunity for **TriNav** in liver cancer embolization procedures (TACE/TARE) is estimated at approximately **62,000 units annually**, representing about **$494.0 million**[39](index=39&type=chunk) - The company expanded its portfolio with **TriNav LV** for larger vessels, targeting new applications like uterine fibroid embolizations (UFEs), potentially adding approximately **$160.0 million** to the market opportunity[40](index=40&type=chunk)[41](index=41&type=chunk) - TriSalus is exploring additional PEDD technology applications, including multinodular goiters, pancreatic cancer, and prostate embolization, projecting a total U.S. addressable market exceeding **$1.6 billion annually**[43](index=43&type=chunk)[44](index=44&type=chunk)[46](index=46&type=chunk) [Commercial Operations](index=11&type=section&id=Commercial%20Operations) TriNav received a unique HCPCS code for 2025 with a $17,957 payment rate, and the company utilizes a direct sales model targeting high-volume medical centers - **TriNav** received a unique and permanent **HCPCS code (C9797)** from CMS, effective for 2025, with a payment rate of **$17,957** for hospital outpatient and ambulatory surgery center settings[50](index=50&type=chunk)[52](index=52&type=chunk) - The company utilizes a direct sales model targeting hospitals and major academic medical centers with high volumes of TACE and TARE procedures, with a sales and marketing team of **53 professionals** as of December 31, 2024[56](index=56&type=chunk)[57](index=57&type=chunk) - TriNav's primary competition is the standard microcatheter, which lacks pressure and flow modulation, with other competitors including Embolix's Sniper and Merit Medical's Swift NINJA[60](index=60&type=chunk)[61](index=61&type=chunk) [Nelitolimod Therapeutic Program](index=14&type=section&id=Nelitolimod%20Therapeutic%20Program) TriSalus acquired nelitolimod, a TLR9 agonist, and is conducting three Phase 1/1b PERIO clinical trials to address immunosuppression in liver and pancreatic cancers - In July 2020, TriSalus acquired **nelitolimod**, a class C TLR9 agonist, from Dynavax to address immunosuppression in the tumor microenvironment of liver and pancreas cancers[70](index=70&type=chunk) - The company initiated three **Phase 1/1b PERIO clinical trials** to test nelitolimod delivered via PEDD in combination with systemic checkpoint inhibitors for uveal melanoma, ICC, HCC, and pancreatic carcinoma[74](index=74&type=chunk)[79](index=79&type=chunk) - The addressable market for the **nelitolimod/PEDD platform** is estimated at over **80,000 patients annually** in the U.S. across liver and pancreatic cancers[84](index=84&type=chunk) - A **5-year alliance** with MD Anderson Cancer Center, initiated in March 2021, supports the PERIO clinical programs, with TriSalus committing **$10.0 million** in collaboration funding[92](index=92&type=chunk) [Manufacturing and Intellectual Property](index=19&type=section&id=Manufacturing%20and%20Intellectual%20Property) TriNav devices are manufactured in-house, while nelitolimod production is outsourced, supported by a robust intellectual property portfolio of 79 registered patents - **TriNav devices** are manufactured at the company's facility in Westminster, Colorado, while **nelitolimod** manufacturing is outsourced to third-party contract manufacturers (CMOs)[101](index=101&type=chunk)[102](index=102&type=chunk) - As of December 31, 2024, the company's intellectual property portfolio includes at least **79 registered patents** expiring between 2030 and 2040, with an additional **86 pending patent applications**[104](index=104&type=chunk) - For the **TriNav device**, the company owns five granted U.S. patents expiring between 2031 and 2038, along with foreign patents and pending applications[105](index=105&type=chunk) - For **nelitolimod**, the company jointly owns two granted U.S. patents and 14 granted foreign patents with Merck Sharp & Dohme LLC, expiring in 2036[107](index=107&type=chunk) [Government Regulation and Healthcare Reform](index=20&type=section&id=Government%20Regulation%20and%20Healthcare%20Reform) The company is subject to extensive FDA regulation for its medical devices and drug candidates, alongside U.S. healthcare reforms and fraud and abuse laws - The company is subject to extensive regulation by the **FDA** and other agencies, covering testing, manufacturing, labeling, and promotion of its medical device and drug products[112](index=112&type=chunk) - Medical devices like **TriNav** are regulated as **Class II devices**, requiring 510(k) clearance from the FDA to demonstrate substantial equivalence to a predicate device[115](index=115&type=chunk)[116](index=116&type=chunk) - Drug candidates like **nelitolimod** require a more rigorous **New Drug Application (NDA) approval process**, involving extensive preclinical studies and multi-phase clinical trials to demonstrate safety and efficacy[129](index=129&type=chunk)[139](index=139&type=chunk) - The company's business is affected by U.S. healthcare reforms, such as the **Affordable Care Act (ACA)** and the **Inflation Reduction Act (IRA)**, which influence drug pricing, reimbursement, and market access[162](index=162&type=chunk)[163](index=163&type=chunk)[165](index=165&type=chunk) - The company is subject to federal and state healthcare fraud and abuse laws, including the **Anti-Kickback Statute** and the **False Claims Act**, regulating relationships with healthcare providers and payors[173](index=173&type=chunk)[174](index=174&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a limited operating history with substantial losses, high dependence on TriNav revenue, early-stage drug development uncertainty, material weaknesses in internal controls, and intellectual property challenges - The company has a history of significant losses, with a net loss of **$30.0 million** in 2024 and an accumulated deficit of **$279.5 million**, raising substantial doubt about its ability to continue as a going concern without additional capital[183](index=183&type=chunk)[184](index=184&type=chunk) - Revenue is primarily generated from sales of the **TriNav device**, making the company highly dependent on its continued market acceptance and favorable reimbursement[205](index=205&type=chunk) - The pharmaceutical candidate, **nelitolimod**, is in early-stage clinical development, a lengthy and expensive process with an uncertain outcome, and failure to advance it would materially harm business prospects[220](index=220&type=chunk)[221](index=221&type=chunk) - Management has identified several **material weaknesses** in its internal control over financial reporting, which could affect its ability to accurately and timely report financial results[415](index=415&type=chunk)[416](index=416&type=chunk) - The company faces risks related to intellectual property, including patent expiration, potential infringement claims, and challenges in protecting trade secrets globally[355](index=355&type=chunk)[368](index=368&type=chunk)[374](index=374&type=chunk) [Unresolved Staff Comments](index=82&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the Securities and Exchange Commission - None[451](index=451&type=chunk) [Cybersecurity](index=82&type=section&id=Item%201C.%20Cybersecurity) The company's cybersecurity risk management program, overseen by the Senior Director of Operations and the Audit Committee, has not materially affected business operations to date - The company's cybersecurity risk management is led by the Senior Director of Operations, with assistance from a third-party IT support firm, and is integrated into overall enterprise risk management[451](index=451&type=chunk)[452](index=452&type=chunk) - The Audit Committee of the Board of Directors has primary oversight responsibility for cybersecurity risk, receiving comprehensive updates at least annually[457](index=457&type=chunk)[458](index=458&type=chunk) - As of the report date, the company states that no cybersecurity threats have had a material effect, or are reasonably likely to have a material effect, on its business, operations, or financial condition[459](index=459&type=chunk) [Properties](index=84&type=section&id=Item%202.%20Properties) The company's principal office, manufacturing, and warehouse facility is a leased 21,000 sq ft space in Westminster, Colorado, with additional leased office and laboratory spaces - The main facility is a **21,000 sq. ft. leased space** in Westminster, CO, used for office, manufacturing, and warehousing, with the lease expiring on December 31, 2031[462](index=462&type=chunk) - Additional leased facilities include office space in Bannockburn, Illinois, and laboratory space at Rhode Island Hospital in Providence, Rhode Island[462](index=462&type=chunk) [Legal Proceedings](index=84&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any pending or threatened legal proceedings expected to have a material adverse effect on its business - The company is not currently involved in any material legal proceedings[463](index=463&type=chunk) [Mine Safety Disclosures](index=84&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not Applicable[464](index=464&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=85&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock and public warrants trade on Nasdaq, with 113 holders of record as of March 31, 2025, and no cash dividends paid to date - Common stock trades under the symbol **"TLSI"** and public warrants trade under **"TLSIW"** on the Nasdaq exchange[466](index=466&type=chunk) - As of March 31, 2025, there were **113 holders of record** of common stock[467](index=467&type=chunk) - The company has never declared or paid cash dividends and does not anticipate doing so, intending to retain earnings for business growth[468](index=468&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=85&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For FY2024, TriSalus reported $29.4 million revenue (59.0% growth), a narrowed net loss of $30.0 million, and addressed going concern doubts with new financing agreements [Results of Operations](index=91&type=section&id=Results%20of%20Operations) In 2024, revenue increased by 59.0% to $29.4 million, gross profit grew by 59.2% to $25.3 million, and net loss narrowed to $30.0 million Consolidated Statements of Operations Summary (in thousands) | | 2024 | 2023 | $ Change | % Change | |:---|---:|---:|---:|---:| | **Revenue** | **$29,431** | **$18,511** | **$10,920** | **59.0%** | | Cost of goods sold | 4,103 | 2,605 | 1,498 | 57.5% | | **Gross profit** | **25,328** | **15,906** | **9,422** | **59.2%** | | Research and development | 17,688 | 29,835 | (12,147) | (40.7)% | | Sales and marketing | 25,839 | 17,034 | 8,805 | 51.7% | | General and administrative | 17,966 | 23,512 | (5,546) | (23.6)% | | **Loss from operations** | **(36,165)** | **(54,475)** | **18,310** | **33.6%** | | **Net loss available to common stockholders** | **$(30,045)** | **$(59,363)** | **$29,318** | **49.4%** | - Revenue increased by **59.0%** to **$29.4 million** in 2024, driven by higher sales volumes of the TriNav device[512](index=512&type=chunk) - Research and development expenses decreased by **40.7%** to **$17.7 million** in 2024, primarily due to the completion of certain clinical studies for nelitolimod[515](index=515&type=chunk) - Sales and marketing expenses increased by **51.7%** to **$25.8 million** in 2024, mainly from increased headcount and professional services to support TriNav growth[516](index=516&type=chunk) [Liquidity and Capital Resources](index=94&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash position of $8.5 million raises going concern doubts, addressed by a $50.0 million credit agreement with OrbiMed and a $30.0 million equity purchase agreement - The company had cash and cash equivalents of **$8.5 million** as of December 31, 2024, down from **$11.8 million** at the end of 2023[527](index=527&type=chunk) - Management concluded there is substantial doubt about the company's ability to continue as a going concern, as existing cash is insufficient to fund operations for the next 12 months[529](index=529&type=chunk)[544](index=544&type=chunk) - To fund operations, the company entered into a credit agreement with OrbiMed for up to **$50.0 million** in debt and a Standby Equity Purchase Agreement (SEPA) with Yorkville for up to **$30.0 million** in equity[528](index=528&type=chunk) Cash Flow Summary (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | |:---|---:|---:| | Net cash used in operating activities | $(40,843) | $(50,578) | | Net cash used in investing activities | (345) | (1,588) | | Net cash provided by financing activities | 37,936 | 54,629 | [Critical Accounting Policies and Estimates](index=97&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Key accounting policies involve revenue recognition upon shipment, fair value measurement of warrant and contingent earnout liabilities, and expensing research and development costs as incurred - Revenue is recognized when control of products transfers to the customer, typically upon shipment, with reserves established for variable consideration like rebates[549](index=549&type=chunk)[550](index=550&type=chunk)[553](index=553&type=chunk) - Warrant liabilities are measured at fair value each reporting period, with changes recognized in the statement of operations[556](index=556&type=chunk)[557](index=557&type=chunk)[558](index=558&type=chunk) - The contingent earnout liability related to sponsor shares is measured at fair value using a Monte Carlo simulation, with changes recorded in earnings[559](index=559&type=chunk)[560](index=560&type=chunk) - Research and development costs are expensed as incurred, with estimates used for obligations under vendor and contract research organization agreements based on work progress[563](index=563&type=chunk)[564](index=564&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=100&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable as the company qualifies as a "smaller reporting company" - Not Applicable for a "smaller reporting company"[571](index=571&type=chunk) [Financial Statements and Supplementary Data](index=101&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The consolidated financial statements for 2024 and 2023 are presented, with the auditor's report highlighting a going concern uncertainty due to recurring losses and an accumulated deficit [Report of Independent Registered Public Accounting Firm](index=102&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor's report for 2024 expresses substantial doubt about the company's ability to continue as a going concern due to a $33.2 million loss and a $279.5 million accumulated deficit - The auditor's report for the 2024 financial statements includes a paragraph expressing substantial doubt about the company's ability to continue as a going concern, citing its loss of **$33.2 million** for the year and an accumulated deficit of **$279.5 million**[578](index=578&type=chunk) [Consolidated Financial Statements](index=104&type=section&id=Consolidated%20Financial%20Statements) Key consolidated financial data for 2024 includes total assets of $24.0 million, total liabilities of $49.9 million, a stockholders' deficit of $25.9 million, and a net loss of $30.0 million Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | |:---|---:|---:| | Cash and cash equivalents | $8,525 | $11,777 | | Total current assets | $20,669 | $20,862 | | **Total assets** | **$23,971** | **$24,598** | | Total current liabilities | $10,228 | $14,687 | | Long-term debt, net | $22,084 | $— | | **Total liabilities** | **$49,865** | **$51,663** | | **Total stockholders' deficit** | **$(25,894)** | **$(27,065)** | Consolidated Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | |:---|---:|---:| | Revenue | $29,431 | $18,511 | | Gross profit | $25,328 | $15,906 | | Loss from operations | $(36,165) | $(54,475) | | **Net loss available to common stockholders** | **$(30,045)** | **$(59,363)** | Consolidated Statement of Cash Flows Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | |:---|---:|---:| | Net cash used in operating activities | $(40,843) | $(50,578) | | Net cash used in investing activities | $(345) | $(1,588) | | Net cash provided by financing activities | $37,936 | $54,629 | [Changes in and Disagreements with Accountants on Accounting and Financial Disclosures](index=151&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosures) On April 12, 2024, the company dismissed KPMG LLP, with no disagreements on accounting principles, though KPMG's reports included a going concern paragraph - On April 12, 2024, the Audit Committee dismissed **KPMG LLP** as the company's independent registered public accounting firm[812](index=812&type=chunk) - There were no disagreements with KPMG on any matter of accounting principles or practices, though KPMG's audit reports for 2022 and 2023 included a paragraph about the company's ability to continue as a going concern[813](index=813&type=chunk) [Controls and Procedures](index=151&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of December 31, 2024, due to material weaknesses in internal control over financial reporting, with a remediation plan underway - Management concluded that disclosure controls and procedures were **not effective** as of December 31, 2024, due to **material weaknesses** in internal control over financial reporting[814](index=814&type=chunk)[816](index=816&type=chunk) - Material weaknesses were identified in areas including insufficient trained resources for complex accounting, controls over the Business Combination, valuation of derivative liabilities, stock-based compensation, and IT security[819](index=819&type=chunk) - A remediation plan is in progress, involving hiring additional experienced personnel and engaging external experts to address identified control deficiencies[820](index=820&type=chunk) [Other Information](index=153&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[823](index=823&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=154&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders - Information regarding directors, executive officers, and corporate governance is incorporated by reference from the forthcoming 2025 Proxy Statement[825](index=825&type=chunk) [Executive Compensation](index=154&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders - Information regarding executive compensation is incorporated by reference from the forthcoming 2025 Proxy Statement[827](index=827&type=chunk) [Security Ownership of Certain Beneficial Owner and Management and Related Stockholder Matters](index=154&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owner%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders - Information regarding security ownership is incorporated by reference from the forthcoming 2025 Proxy Statement[828](index=828&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=154&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders - Information regarding related transactions and director independence is incorporated by reference from the forthcoming 2025 Proxy Statement[829](index=829&type=chunk) [Principal Accounting Fees and Services](index=154&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders - Information regarding principal accounting fees and services is incorporated by reference from the forthcoming 2025 Proxy Statement[830](index=830&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=155&type=section&id=Item%2015.%20Exhibits,%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the Form 10-K, with audited consolidated financial statements included in Item 8 and no financial statement schedules filed - The audited Consolidated Financial Statements are filed under Part II, Item 8 of the report[832](index=832&type=chunk) - No financial statement schedules are filed with this report[832](index=832&type=chunk) [Form 10-K Summary](index=161&type=section&id=Item%2016.%20Form%2010-K%20Summary) No Form 10-K summary is provided - None[838](index=838&type=chunk)

Company Overview - TriSalus Life Sciences, Inc. (TLSI) shares increased by 6.6% to close at $5.49, with trading volume significantly higher than usual, reflecting a 10.5% gain over the past four weeks [1][2] Financial Performance - The company reported a 44% year-over-year revenue growth in Q4 and a 59% growth for the full year 2024, primarily driven by the TriNav Infusion System [2] - Expected sales growth for 2025 is projected to exceed 50%, with gross margins anticipated to surpass 87% and a pathway to positive EBITDA and cash flow in the second half of 2025 [2] Market Sentiment - Investor sentiment is bolstered by the commercial launch of TriNav LV, expansion through the DELIVER program, and a strong cash position supported by anticipated funding from OrbiMed [2] - The consensus EPS estimate for the upcoming quarter is a loss of $0.20 per share, reflecting a year-over-year change of +63%, with revenues expected to reach $9.26 million, up 43.4% from the previous year [3] Earnings Estimates - Over the last 30 days, the consensus EPS estimate for TriSalus has been revised 2% lower, indicating a negative trend in earnings estimate revisions, which typically does not correlate with price appreciation [4] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a cautious outlook [4] Industry Comparison - TriSalus operates within the Zacks Medical - Products industry, where Abbott (ABT) has a Zacks Rank of 2 (Buy) and reported a 0.7% decline in its last trading session [4][5]

Group 1 - The article expresses consistent optimism about TriSalus Life Sciences (TLSI) and outlines the expected course for the company [1] - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies, emphasizing the importance of understanding the science behind investments [1] Group 2 - There are no disclosed stock or derivative positions in any mentioned companies, indicating an unbiased perspective [2] - The article reflects the author's personal opinions and is not influenced by compensation from any company [2]

Financial Data and Key Metrics Changes - TriSalus achieved $29.4 million in net sales for 2024, reflecting a 59.4% growth over 2023, marking it as one of the fastest-growing med tech companies [12][27] - Revenue for Q4 2024 reached $8.3 million, representing a 44% increase compared to Q4 2023 and a 12% sequential increase from Q3 2024 [27] - Operating losses for Q4 2024 totaled $7.6 million, compared to losses of $14.2 million in Q4 2023, with year-to-date losses in 2024 amounting to $36.2 million compared to $54.5 million in 2023 [32] Business Line Data and Key Metrics Changes - The number of unique ordering accounts increased by 43% year-over-year from 199 to 284, with account utilization improving as average units sold per ordering account rose 10% from 12.3 to 13.5 units [13][14] - The launch of the TriNav LD infusion system and TriGuide guiding catheter expanded the PEDD portfolio, optimizing therapeutic delivery and improving procedural efficiency [18] Market Data and Key Metrics Changes - TriSalus captured 9% of the liver, TACE, and TARE procedures market in 2024, with 103 new hospital accounts opened year-to-date [28] - The PROTECT registry study is evaluating TriNav for non-malignant thyroid goiters and nodules, representing a market of approximately 50,000 annual procedures and a $400 million incremental opportunity [15] Company Strategy and Development Direction - The company prioritized its pressure-enabled drug delivery technology, aiming for EBITDA positivity by mid-2025 and cash flow positivity by year-end 2025 [10][22] - Strategic partnerships are being sought to advance the nelitolimod program in uveal melanoma liver metastases, with a focus on expanding reimbursement for radioembolization mapping [19][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% revenue growth in 2025, alongside positive full-year EBITDA and cash flow in the second half of 2025 [22][29] - The company aims to deepen penetration in the complex liver embolization market and enhance health economic and outcome research data [21][23] Other Important Information - TriSalus secured up to $50 million in debt financing from OrbiMed to support growth initiatives, with $35 million accessed to date [20] - The company filed a Form 12b-25 notification of late filing with the SEC due to errors identified in stock-based compensation and clinical trial-related R&D expenses [25][26] Q&A Session Summary Question: Where is the uptake for the launch of TriNav large vessels? - Management noted that TriNav is primarily being used in TARE more than TACE, particularly for larger vessel applications [36][38] Question: Can you provide insight on current mapping with TARE? - Management confirmed that the new CMS code allows for mapping and treatment in Medicare patients, which opens up about 25% of the market [41][46] Question: What should be expected in the PERIO-03 data? - Management clarified that the Phase I study is not to be compared to systemic chemotherapy, focusing instead on the technology's safety and efficacy [49][50] Question: Can you provide more color on account openings? - Management indicated a deliberate strategy to focus on driving utilization in existing accounts rather than aggressively opening new ones [63][65] Question: What is the attachment rate of mapping cases today in commercial? - Management believes the attachment rate is close to one-to-one on the commercial side, as mapping with the same technology yields better outcomes [80][81] Question: What is the status of the 10-K filing delay? - Management is working through the audit process and is hopeful that the numbers will not change significantly [90][92]

Financial Data and Key Metrics Changes - TriSalus achieved $29.4 million in net sales for 2024, reflecting a 59.4% growth over 2023, marking it as one of the fastest-growing med tech companies [12][27] - Revenue for Q4 2024 reached $8.3 million, representing a 44% increase compared to Q4 2023 and a 12% sequential increase from Q3 2024 [27] - Operating losses for Q4 2024 totaled $7.6 million, a decrease from $14.2 million in Q4 2023, with year-to-date losses amounting to $36.2 million compared to $54.5 million in 2023 [32] Business Line Data and Key Metrics Changes - The company reported a 44% growth in Q4 and 59% operational growth for the full year, driven by the success of the TriNav device [11][27] - The number of unique ordering accounts increased by 43% year-over-year, from 199 to 284, with account utilization improving by 10% [13][14] - The launch of new products, including the TriNav LD infusion system and TriGuide guiding catheter, expanded the PEDD portfolio [18] Market Data and Key Metrics Changes - TriSalus captured 9% of the liver, TACE, and TARE procedures market in 2024, with 103 new hospital accounts opened [28] - The company reported a robust gross margin profile of 85% in Q4 2024, down from 90% in Q4 2023, but maintained an overall gross margin of 86% for the full year [29] Company Strategy and Development Direction - The company is focusing on expanding its PEDD technology into new clinical applications while reducing R&D expenses to achieve EBITDA positivity by mid-2025 [10][11] - Strategic partnerships are being sought to advance the nelitolimod program, particularly in uveal melanoma liver metastases [19] - The company aims to deepen penetration in the complex liver embolization market and enhance health economic and outcome research data [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% revenue growth in 2025, alongside positive EBITDA and cash flow in the second half of the year [22][23] - The company acknowledged the challenges posed by the economic environment but emphasized strong commercial momentum and a clear path to growth [10][11] Other Important Information - TriSalus secured up to $50 million in debt financing from OrbiMed to support growth initiatives, with $35 million accessed to date [20] - The company filed a Form 12b-25 notification of late filing with the SEC due to errors in stock-based compensation and R&D expense timing [25][26] Q&A Session Summary Question: Uptake of TriNav large vessels in TACE and TARE procedures - Management noted increased use in TARE more than TACE, particularly for larger vessel applications [37][39] Question: Current mapping with TARE and new CMS code impact - The new CMS code allows for mapping and treatment in Medicare patients, opening up about 25% of the market previously not accessible [46][72] Question: Insights on PERIO-03 data - The Phase I study is focused on safety and technology success, with results expected mid-2025 [50][52] Question: Guidance for Q1 and year cadence - Management indicated that while growth may not be uniform, they remain optimistic about achieving the 50% growth target for the year [61][98] Question: Account openings and utilization strategy - The company is shifting focus from opening new accounts to driving utilization in existing accounts, with a balanced approach moving forward [65][66] Question: Mapping attachment rate in commercial cases - Management believes the mapping attachment rate is close to one-to-one in commercial cases, emphasizing better outcomes with the same technology [81][82] Question: Next steps for pancreatic trials - A Phase II or III trial is likely, with potential for partnership, pending data from ongoing studies [88] Question: Status of 10-K filing delay - The audit is ongoing, and management is committed to transparency regarding any changes in financial results [91][92]

Core Insights - TriSalus Life Sciences, Inc. reported a quarterly loss of $0.35 per share, consistent with the Zacks Consensus Estimate, and an improvement from a loss of $1.56 per share a year ago [1] - The company generated revenues of $8.26 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 1.24% and up from $5.72 million year-over-year [2] - The stock has increased approximately 11.4% since the beginning of the year, contrasting with a -2.9% decline in the S&P 500 [3] Financial Performance - The company has not surpassed consensus EPS estimates over the last four quarters [1] - Current consensus EPS estimate for the upcoming quarter is -$0.22 on revenues of $9.4 million, and for the current fiscal year, it is -$0.60 on revenues of $44.55 million [7] Industry Context - The Medical - Products industry, to which TriSalus belongs, is currently ranked in the bottom 31% of over 250 Zacks industries, indicating potential challenges ahead [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact investor sentiment [5] Future Outlook - The sustainability of the stock's price movement will largely depend on management's commentary during the earnings call [3] - The estimate revisions trend for TriSalus is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6]