Financial Performance - Revenue increased by $2.7 million, or 42.0%, for the three months ended March 31, 2025, compared to the same period in 2024, driven by increased sales of TriNav[239]. - 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% due to lower manufacturing efficiencies[241]. - The company incurred net losses of $10.4 million for the three months ended March 31, 2025, and expects to continue incurring net losses due to ongoing investments in R&D and sales[249]. - 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]. - 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]. Research and Development - TriSalus completed Phase I clinical trials for nelitolimod and is seeking pharmaceutical partners for further development[218]. - 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]. - The PROTECT registry study aims to enroll 100 patients and could expand the addressable market by approximately 50,000 procedures, representing a $400 million market opportunity[217]. - The company has paid Dynavax $12.0 million as of March 31, 2025, and may owe up to an additional $158 million upon achieving certain development and regulatory milestones for nelitolimod[265]. - The company is obligated to pay up to $80 million upon achieving certain commercial milestones for nelitolimod, subject to obtaining marketing approval[265]. Financing and Capital Structure - The company borrowed $10 million under a credit agreement after achieving a trailing 12-month product revenue base of $30 million in January 2025[221]. - A securities purchase agreement was entered into in April 2025, resulting in gross proceeds of approximately $22 million from the private placement of 5.5 million shares[225]. - The company raised gross proceeds of approximately $22.0 million through a Private Placement subsequent to March 31, 2025, to support liquidity requirements[250]. - The company expects to finance its cash needs through a combination of securities offerings, debt financings, collaborations, strategic alliances, and licensing arrangements[260]. - The company is subject to affirmative and restrictive covenants under the OrbiMed Credit Agreement, which may limit its ability to incur additional debt or make capital expenditures[260]. Operational Developments - TriSalus launched the TriNav LV Infusion System and TriGuide Guiding Catheter in 2024, expanding its portfolio of PEDD devices for larger vessels[215]. - The company received a permanent HCPCS code for the TriNav Infusion System effective January 1, 2024, enhancing reimbursement clarity[214]. - The MDACC Agreement was modified and extended, adding a sixth year to the collaboration for ongoing clinical studies[222]. - The company is focused on maintaining TriNav pricing and gross margins to support growth and R&D activities[219]. Risks and Concerns - 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]. - The company may need to delay or terminate product development if it is unable to raise additional capital when needed[261]. - The company may have to relinquish valuable rights to its technologies or grant licenses on unfavorable terms if it raises funds through collaborations or licensing arrangements[261]. - 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 does not currently have any off-balance sheet financing arrangements or relationships with unconsolidated entities[266].

Share Issuance and Compliance - The Company agrees to sell shares of its common stock at a price of $4.00 per share[54] - The total purchase amount for each Investor is specified in Exhibit A attached to the Agreement[54] - The Closing Date for the sale of shares will occur no earlier than one business day and no later than five business days after the date of the Agreement[55] - The Company will issue the shares in book-entry form, free and clear of all restrictive legends at the Closing[55] - The Company represents that its capitalization disclosure in SEC Reports was accurate in all material respects as of the indicated date[58] - All issued and outstanding shares of Common Stock are fully paid and non-assessable[58] - The Company is not currently under any obligation to register any of its outstanding securities under the Securities Act, except as disclosed in the SEC Reports[59] - The Company has duly authorized the issuance and sale of Shares, ensuring compliance with applicable securities laws[60] - The Shares will be fully paid and non-assessable, issued free of any liens or restrictions, and holders will have all rights accorded to Common Stock[62] - The Company has filed all required forms and reports with the SEC, ensuring compliance with the Exchange Act[66] - The Company is not subject to any disqualification events under Rule 506(d)(1) of Regulation D[92] - The Company will 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 date, disclosing all material terms of the transactions and non-public information concerning the Company[124] - The Company will not issue shares of Common Stock or Common Stock Equivalents for 60 days post-closing without prior consent from the Investor Majority[137] - The Company will ensure that no conflicting agreements interfere with its obligations to the Investors under the Transaction Agreements[132] - The Company must ensure compliance with all listing requirements for the Common Stock on a National Exchange[147] Financial Performance and Projections - The Company reported a significant increase in revenue, achieving $150 million in Q3 2023, representing a 25% year-over-year growth[1] - User data showed a 40% increase in active users, reaching 2 million by the end of Q3 2023[2] - The Company provided guidance for Q4 2023, expecting revenue to be between $160 million and $170 million, indicating a growth rate of 20% to 30% compared to Q4 2022[3] - New product launches are anticipated to contribute an additional $20 million in revenue in the next quarter[4] Strategic Initiatives and Investments - The Company is investing $10 million in R&D for new technologies aimed at enhancing user experience and product efficiency[5] - Market expansion efforts include entering three new international markets, projected to increase user base by 15%[6] - The Company is exploring potential acquisitions to bolster its market position, with a budget of $50 million allocated for this purpose[7] - A strategic partnership was announced, expected to enhance distribution channels and increase sales by 10% over the next year[8] Operational Compliance and Risk Management - The Company has filed all required tax returns and paid all necessary taxes, with no material tax assessments pending[75] - The Company is in compliance with all applicable Environmental Laws and has received all necessary permits, with no material adverse effects expected from any noncompliance[76] - The Company maintains good and marketable title to all material personal property, free of liens and encumbrances[78] - The Company carries adequate insurance customary for its business, with no notices of cancellation or denial of coverage received since January 1, 2024[79] - The Company has conducted clinical trials in accordance with regulatory protocols, with no notices of required termination or suspension from Regulatory Agencies[83] - The Company is in compliance with all applicable Health Care Laws and has not received any claims or actions alleging violations[84] - The Company maintains a system of internal control over financial reporting designed to ensure reliability and compliance with GAAP[86] - The Company has not engaged in any actions to stabilize or manipulate the price of its Common Stock[87] - The Company must ensure that all representations and warranties are true and correct in all material respects as of the Closing Date[139] - The Company is required to perform all obligations and conditions prior to the Closing Date[140] - The Company must obtain all necessary consents, permits, approvals, registrations, and waivers for the transaction to proceed[141] - No event should occur that would reasonably be expected to have a Material Adverse Effect since the date of the Agreement[142] - The Company must ensure that no stop order or suspension of trading has been imposed by regulatory bodies regarding the Common Stock[147] - The Company must provide a lock-up agreement executed by its officers and directors to the Placement Agent[151] - The Company must execute and deliver the Registration Rights Agreement to the Investors[146] Investor Relations and Support - The Company has entered into Support Agreements with holders of more than 50% of its outstanding Preferred Stock, indicating strong support from key investors[100] - The Company will indemnify and hold harmless each Investor from losses or claims resulting from breaches of representations or warranties made under the Transaction Agreements[133] - The Company will use commercially reasonable efforts to satisfy obligations set forth in the Support Agreements[136] - The Company acknowledges that Investors have relied on independent investigations and SEC Reports in making investment decisions[118] - The Company will not disclose the names of any Investors or their affiliates without prior written consent, except as required by law[124] Corporate Governance and Compliance - The Company has been in compliance with the Sarbanes-Oxley Act of 2002 since January 1, 2024[81] - The Company and its subsidiaries have all necessary governmental authorizations for their operations, with no violations that would have a Material Adverse Effect[71] - The Company owns or has rights to all necessary intellectual property for its business operations, with no known infringements[72] - The Company is in material compliance with all applicable data privacy laws, including HIPAA and GDPR, and has maintained accurate privacy statements to customers and employees[98] Sustainability and Long-term Goals - The Company emphasized its commitment to sustainability, planning to reduce operational costs by 5% through energy-efficient practices[9] - The management team expressed confidence in achieving long-term growth targets, aiming for a 50% increase in overall market share by 2025[10]

Financial Performance - TriNav achieved $29.4 million in revenue in 2024, representing a growth of 59.0% compared to the previous year[24]. - The company incurred net losses of $30.0 million and $59.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $279.5 million as of December 31, 2024[183]. - As of December 31, 2024, the company had $8.5 million in cash and cash equivalents, which is expected to be insufficient to fund operations for at least the next 12 months[184]. - The company anticipates needing substantial additional funding to finance operations and product development, with potential capital needs influenced by various factors including revenue growth and regulatory approval processes[185]. - Sales of the TriNav device account for primarily all of the company's revenue since its launch in 2020, and future growth depends on physician adoption for various conditions[205]. Market Opportunities - The market opportunity for TACE and TARE procedures is estimated at approximately 62,000 units, representing a potential market value of about $494.0 million[39]. - The TriNav LV is estimated to be applicable for 20,000 uterine fibroid embolizations annually, representing a market opportunity of approximately $160.0 million[41]. - The PROTECT registry study aims to enroll 100 patients, potentially expanding the addressable market for TriNav by 50,000 procedures, equating to an incremental $400.0 million opportunity[43]. - The pancreas infusion technology could treat 2,000 patients annually, adding another market expansion of $400.0 million[44]. - The total addressable market for TriSalus PEDD technology in the U.S. is projected to exceed $1.6 billion annually, with a current market valued at $900.0 million and an additional opportunity of $700.0 million[46]. Product Development and Clinical Trials - The PRVI device for pancreatic tumor treatment is currently in a Phase 1 clinical trial, with commercialization not anticipated before 2026[24]. - The Phase I PERIO-03 clinical trial in pancreatic cancer is enrolled, with data expected by the end of 2025[27]. - The combination of PEDD with nelitolimod aims to improve therapeutic response and patient outcomes across various cancer indications[26]. - Pre-clinical studies indicated that the PRVI method improved drug delivery by 3.6-7.0-fold compared to standard methods, significantly increasing intra-tumoral drug concentrations[68]. - Three Phase 1/1b PERIO studies initiated for nelitolimod targeting pancreatic cancer, ICC, and HCC[74]. Regulatory and Reimbursement - TriNav received a unique HCPCS code (C9797) with a payment rate of $17,957 for calendar year 2025, enhancing reimbursement clarity and integration into billing structures[50]. - A new Technology HCPCS code (C9797) for TriNav procedures became effective on January 1, 2024, with a second unique code (C8004) assigned effective April 1, 2025[170][171]. - The Centers for Medicare & Medicaid Services (CMS) granted a new HCPCS code for TriNav effective January 1, 2024, which may enhance reimbursement clarity[215]. Intellectual Property - The company owns at least 79 registered patents expiring between 2030 and 2040, with an additional 86 pending patent applications, indicating a strong intellectual property position[104]. - For the TriNav device, the company holds five granted U.S. patents and eight foreign patents, with expiration dates ranging from 2031 to 2038[105]. - The company is awaiting three pending U.S. patent applications and 16 foreign patent applications related to nelitolimod, which is a CPG-C type oligonucleotide[107]. Strategic Partnerships and Collaborations - Collaboration with MD Anderson Cancer Center includes a $10 million funding agreement for preclinical and clinical studies[92]. - The company is exploring partnerships to advance the treatment of uveal melanoma due to the changing landscape of second-line therapies[91]. Challenges and Risks - The company faces risks related to its ability to raise additional capital, which could impact its business operations and growth strategy[187]. - The company may need to seek collaborators for its product candidates earlier than desired, potentially on less favorable terms[189]. - The company faces risks related to potential disruptions in the supply of materials necessary for TriNav production, which could increase costs and affect margins[219]. - Any reduction in reimbursement rates for TriNav could negatively impact sales and overall financial condition[216]. Employee and Organizational Development - As of December 31, 2024, the company had approximately 110 full-time employees, including six with Ph.D. or M.D. degrees[178]. - The company actively engages with managers to collect feedback and improve the working environment[179]. - The company’s equity and cash incentive plans aim to attract, retain, and reward personnel to increase stockholder value[179].

Financial Performance - Total revenue for 2024 was $29.4 million, representing a 59% growth year-over-year[3] - Q4 2024 revenue was $8.3 million, reflecting a 44% increase compared to the same quarter in the previous year[6] - Revenue for the three months ended December 31, 2024, was $8,261 million, a 44.5% increase from $5,721 million in the same period of 2023[23] - Gross profit for the twelve months ended December 31, 2024, reached $25,328 million, up from $15,906 million in 2023, reflecting a 59.3% year-over-year growth[23] - The net loss attributable to common stockholders for the twelve months ended December 31, 2024, was $33,233 million, compared to a net loss of $63,602 million in 2023, indicating a 47.8% improvement[23] Margins and Expenses - Gross margin for Q4 and full year 2024 was 85% and 86%, respectively[6] - Research and development expenses for the three months ended December 31, 2024, were $2,959 million, a decrease of 61.9% compared to $7,769 million in the same period of 2023[23] - Sales and marketing expenses increased to $7,010 million for the three months ended December 31, 2024, compared to $5,604 million in the same period of 2023, representing a 25.0% increase[23] Future Outlook - The company expects to achieve greater than 50% revenue growth in 2025 and reduce operating expenses by more than 20%[3][19] - The company anticipates being EBITDA positive for 2025 and achieving positive cash flow in the second half of the year[14][19] Clinical Programs - The DELIVER clinical program aims to enhance the safety and efficacy of the TriNav system, with a focus on complex cancer cases[6][7] - The PROTECT study is expected to expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million opportunity[8] - Enrollment in the PERIO-03 Phase 1 trial for locally advanced pancreatic cancer has been completed, with final data expected mid-2025[9] Financial Position - The company secured a $10 million drawdown under its existing $50 million credit facility, ensuring financial flexibility through the end of 2025[11] - Cash and cash equivalents were $8.5 million as of December 31, 2024, with sufficient liquidity expected throughout 2025[15] - Total current assets decreased slightly to $20,669 million as of December 31, 2024, from $20,862 million in 2023[25] - Cash and cash equivalents decreased to $8,525 million as of December 31, 2024, down from $11,777 million in 2023[25] - Total liabilities decreased to $49,865 million as of December 31, 2024, from $51,663 million in 2023, reflecting a 3.1% reduction[25] - The accumulated deficit increased to $(279,549) million as of December 31, 2024, compared to $(249,504) million in 2023[25] - The weighted average common shares outstanding increased to 27,551,189 for the three months ended December 31, 2024, from 23,231,975 in the same period of 2023[23]

Financial Performance - Revenue increased by $2.2 million, or 41.5%, for the three months ended September 30, 2024, compared to the same period in 2023, primarily due to increased sales of TriNav[226]. - Revenue increased by $8.4 million, or 65.5%, for the nine months ended September 30, 2024, compared to the same period in 2023, driven by sales of TriNav[238]. - Gross profit increased by $1.7 million, or 37.8%, for the three months ended September 30, 2024, with gross margin decreasing to 86.3% from 88.7%[229]. - Gross profit increased by $7.5 million, or 69.8%, for the nine months ended September 30, 2024, with gross margin increasing to 86.4% from 84.2%[241]. - Net losses amounted to $19.9 million for the nine months ended September 30, 2024, with cash and cash equivalents of approximately $11.3 million at the same date[250]. Expenses - Cost of goods sold increased by $0.4 million, or 70.5%, for the three months ended September 30, 2024, driven by higher production volumes[228]. - R&D expenses decreased by $5.3 million, or 55.6%, for the three months ended September 30, 2024, primarily due to reduced clinical trial expenses[230]. - Sales and marketing expenses increased by $1.4 million, or 30.9%, for the three months ended September 30, 2024, mainly due to higher payroll and travel expenses[231]. - General and administrative expenses decreased by $4.3 million, or 47.6%, for the three months ended September 30, 2024, due to prior period expenses related to the Business Combination[232]. - R&D expenses decreased by $7.3 million, or 33.3%, for the nine months ended September 30, 2024, primarily due to an $8.1 million reduction in clinical trial expenses related to nelitolimod[242]. - Sales and marketing expenses increased by $7.4 million, or 64.7%, for the nine months ended September 30, 2024, driven by higher payroll and travel expenses of $6.6 million due to increased headcount[243]. - General and administrative expenses decreased by $4.2 million, or 23.9%, for the nine months ended September 30, 2024, primarily due to prior period expenses related to legal and consulting work that were not repeated[244]. Funding and Capital - TriSalus reported a total of $12.4 million raised from the sale of 1,874,867 shares of common stock under the SEPA during the nine months ended September 30, 2024[200]. - The OrbiMed Credit Agreement provides for up to $50.0 million in senior secured term debt, with an initial commitment of $25.0 million made available on April 30, 2024[201]. - Net cash used in operating activities was $35.1 million for the nine months ended September 30, 2024, compared to $41.4 million for the same period in 2023[252]. - Net cash provided by financing activities was $34.9 million for the nine months ended September 30, 2024, consisting of $12.6 million from the sale of common stock and $22.4 million from the OrbiMed Credit Agreement[257]. - The company expects to require substantial additional funding to support ongoing operations and future commercialization efforts, particularly for TriNav and nelitolimod[259]. Clinical and Product Development - The TriNav Infusion System received a permanent HCPCS code effective January 1, 2024, allowing for reimbursement for procedures involving the device[192]. - The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter to expand its addressable liver embolization market[193]. - TriSalus is conducting Phase 1 and Phase 1b clinical trials for nelitolimod, with data from the pancreatic cancer trial expected in 2025[195]. - The DELIVER program aims to evaluate the TriNav system across complex patient populations to validate the clinical effects of the PEDD technology[208]. - The company plans to initiate the "PROTECT" clinical study to compare the TriNav approach with conventional surgical methods[209]. Business Transactions - The Business Combination with MedTech Acquisition Corporation was completed on August 10, 2023, with an aggregate consideration of $220.0 million[196]. - The expiration of the TPT payment program on December 31, 2023, may impact the pricing and gross margins of TriNav[199]. Accounting and Reporting - No significant changes in critical accounting policies during the nine months ended September 30, 2024, compared to the previous year[269]. - Critical accounting policies require greater judgment and estimates, which may lead to actual results differing from estimates[269]. - The company is classified as a smaller reporting company and is not required to provide additional market risk information[270].

Financial Performance - TriSalus reported Q3 2024 revenues of $7.3 million, representing a 42% year-over-year increase, and nine-month revenues of $21.2 million, up 66% year-over-year[4]. - Revenue for the three months ended September 30, 2024, was $7,349 million, a 41.5% increase from $5,193 million in the same period of 2023[24]. - Gross profit for the nine months ended September 30, 2024, was $18,283 million, compared to $10,767 million for the same period in 2023, reflecting a 69.7% increase[24]. - The net loss attributable to common stockholders for the three months ended September 30, 2024, was $(3,202) million, compared to $(1,883) million in the same period of 2023[24]. - Interest income for the three months ended September 30, 2024, was $158 million, compared to $116 million in the same period of 2023[24]. Market Expansion - The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter, expanding access to the $375 million liver embolization market[4]. - The PROTECT registry trial has been initiated to treat multinodular goiters, potentially expanding the addressable market by $400 million[8]. - The total addressable market for TriSalus is projected to exceed $1 billion in the U.S. with the expansion of the TriNav system[8]. Future Outlook - TriSalus anticipates over 50% annual sales growth in 2025, alongside a reduction of over 20% in operating expenses[4][20]. - The company expects to achieve positive full-year EBITDA and positive cash flow in the second half of 2025[20]. Clinical Trials and Development - TriSalus completed enrollment of 13 patients in the PERIO-03 Phase 1 trial for locally advanced pancreatic cancer, with promising safety data reported[11]. - The company is actively seeking a strategic partnership for the further development of nelitolimod following positive Phase 1 results in UM-LM[10]. Financial Position - Cash and cash equivalents as of September 30, 2024, totaled $11.3 million, with additional capacity of $25 million available on the OrbiMed debt facility[16]. - Total current assets increased to $23,808 million as of September 30, 2024, from $20,862 million as of December 31, 2023[26]. - Total liabilities decreased to $47,911 million as of September 30, 2024, from $51,663 million as of December 31, 2023[26]. - The accumulated deficit increased to $(269,441) million as of September 30, 2024, from $(249,504) million as of December 31, 2023[26]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $4,219 million, a decrease of 55.7% from $9,506 million in the same period of 2023[24]. - Sales and marketing expenses increased to $6,138 million for the three months ended September 30, 2024, up 30.9% from $4,689 million in the same period of 2023[24]. Operating Losses - Gross margins for Q3 2024 were 86%, consistent with the previous quarter, while operating losses decreased to $8.7 million from $18.6 million in Q3 2023[13][14].

Financial Performance - Revenue increased by $2.8 million, or 59.7%, for the three months ended June 30, 2024, compared to the same period in 2023, driven by higher sales of TriNav [219]. - Revenue increased by $6.2 million, or 82.0%, for the six months ended June 30, 2024, compared to the same period in 2023, driven by higher sales of TriNav [232]. - Gross profit increased by $2.6 million, or 68.0%, for the three months ended June 30, 2024, with gross margin rising to 87.6% from 83.3% [221]. - Gross profit increased by $5.8 million, or 93.7%, for the six months ended June 30, 2024, with gross margin rising to 86.4% from 81.1% compared to the same period in 2023 [234]. - Net losses amounted to $17.6 million for the six months ended June 30, 2024, with cash and cash equivalents of approximately $16.5 million [246]. - Net cash used in operating activities was $24.3 million for the six months ended June 30, 2024, compared to $19.7 million for the same period in 2023 [249]. Expenses - R&D expenses decreased by $2.2 million, or 32.2%, for the three months ended June 30, 2024, primarily due to reduced clinical trial expenses related to nelitolimod [223]. - R&D expenses decreased by $2.0 million, or 15.8%, primarily due to a $3.0 million reduction in clinical trial expenses related to nelitolimod [235]. - Sales and marketing expenses increased by $2.5 million, or 71.9%, for the three months ended June 30, 2024, mainly due to higher payroll and travel expenses [224]. - Sales and marketing expenses increased by $6.0 million, or 88.3%, driven by higher payroll and travel expenses of $5.5 million due to increased headcount [236]. - General and administrative expenses decreased by $0.9 million, or 19.2%, for the three months ended June 30, 2024, due to prior period legal and consulting expenses not repeated this year [225]. - General and administrative expenses increased by $0.1 million, or 1.3%, due to headcount-related expenses, largely offset by a decrease in professional services costs [237]. Financing Activities - The company raised $6.7 million by selling 750,000 shares of common stock under the SEPA during the six months ended June 30, 2024 [188]. - Net cash provided by financing activities was $29.1 million for the six months ended June 30, 2024, consisting of $6.7 million from the sale of common stock and $22.4 million from the OrbiMed Credit Agreement [253]. - A credit agreement with OrbiMed provides up to $50 million in senior secured term debt, with an initial commitment of $25 million available on April 30, 2024 [189]. - The company issued warrants to OrbiMed for 130,805 shares of common stock at an exercise price of $9.5562 as part of the credit agreement [192]. Clinical and Product Development - The TriNav Infusion System received a permanent New Technology HCPCS code effective January 1, 2024, allowing for reimbursement by hospital outpatient departments and ambulatory surgical centers [183]. - The company is in Phase 1 human trials for nelitolimod, which aims to enhance treatment effectiveness for liver and pancreatic cancers when delivered via TriNav [190]. - The DELIVER program is set to evaluate the TriNav system across complex patient populations, aiming to validate previous clinical studies [198]. - The company plans to launch the "PROTECT" clinical study to compare the advantages of the TriNav system against conventional surgical methods [199]. Market and Risk Information - The company expects to require substantial additional funding to support ongoing operations and commercialization efforts for its products [255]. - No off-balance sheet financing arrangements or relationships with unconsolidated entities were reported during the periods presented [263]. - There have been no significant changes in critical accounting policies during the six months ended June 30, 2024, compared to the previous year [264]. - The company is classified as a smaller reporting company and is not required to provide certain market risk information [266]. Other Financial Metrics - Interest income increased by $0.1 million, or 169.4%, for the three months ended June 30, 2024, attributed to additional interest from short-term money market funds [226]. - Interest income increased by $0.1 million, or 166.2%, due to additional interest from investments in short-term money market funds [238]. - Interest expense increased by $0.9 million for the three months ended June 30, 2024, due to interest incurred on the OrbiMed loan [227]. - The change in fair value of SEPA, warrant, and revenue base redemption liabilities resulted in a loss of $9.0 million for the three months ended June 30, 2024, compared to a gain of $1.1 million in the same period of 2023 [229]. - The change in fair value of contingent earnout liability resulted in a gain of $13.7 million for the three months ended June 30, 2024, with no contingent earnout liability in the prior year [230].

Financial Performance - TriSalus Life Sciences, Inc. reported a revenue of $3.1 million from the sale of 350,000 shares of common stock under the SEPA during the three months ended March 31, 2024[143]. - Revenue for the three months ended March 31, 2024, increased by $3.5 million or 116.4% compared to the same period in 2023, primarily due to higher units of TriNav sold[165]. - Cost of goods sold rose by $0.3 million or 46.7% for the three months ended March 31, 2024, driven by increased production volumes[166]. - Gross profit increased by $3.2 million or 136.3%, with gross margin improving to 85.0% from 77.8% due to enhanced manufacturing efficiencies[167]. - The company incurred a net loss of $13.2 million for the three months ended March 31, 2024, compared to a net loss of $8.3 million in the same period of 2023[176]. - Net cash used in operating activities was $10.9 million for the three months ended March 31, 2024, compared to $10.5 million in the same period of 2023[180]. Research and Development - The company anticipates submitting a New Drug Approval (NDA) request for nelitolimod to the FDA no sooner than 2025, with potential commercial sales beginning in 2027[139]. - TriSalus is currently in Phase 1 human trials for nelitolimod, which aims to treat hepatocellular cancer and pancreatic cancer[145]. - The company expects R&D expenses to increase significantly as it advances nelitolimod through clinical development[155]. - Research and development expenses increased by $0.2 million or 3.8%, mainly due to higher headcount-related expenses[168]. Sales and Marketing - Sales and marketing expenses surged by $3.4 million or 105.8%, attributed to increased payroll and travel expenses for sales personnel[170]. - The company expects to incur significant expenses related to TriNav, including sales and marketing expenses and production capacity expansion to support anticipated sales growth[187]. Financing and Capital Requirements - The company raised $3.6 million from the sale of 400,000 shares of common stock under the SEPA in April 2024[143]. - The company expects to require substantial additional funding to support ongoing operations and development efforts, particularly for its lead product candidate nelitolimod[184]. - Future capital requirements will depend on the success of TriNav's commercialization, including patient and physician adoption and reimbursement adequacy[187]. - The company plans to finance cash needs through securities offerings, debt financings, collaborations, and licensing arrangements, which may dilute existing ownership interests[188]. - The company has lease obligations totaling $1.6 million as of March 31, 2024, reflecting minimum commitments for administrative and production facilities[193]. - As of March 31, 2024, the company has paid Dynavax $12 million and may owe up to an additional $158 million upon achieving certain development and regulatory milestones for nelitolimod[194]. - The company may also need to pay up to $80 million upon achieving certain commercial milestones once sales of nelitolimod begin[194]. Credit and Debt - TriSalus has a Credit Agreement providing for up to $50.0 million in senior secured term debt, with an initial commitment amount of $25.0 million borrowed on April 30, 2024[145][146]. - The company is subject to affirmative and restrictive covenants under the Credit Agreement, limiting its ability to incur additional debt or make capital expenditures[188]. Operational Changes - The company has terminated arrangements with distributors for product sales in geographic markets where it does not have a sales presence as of December 31, 2022[150]. - There have been no significant changes in critical accounting policies during the three months ended March 31, 2024, compared to the previous year[196]. Going Concern - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2024[192]. - The company has no off-balance sheet financing arrangements or relationships with unconsolidated entities[195]. Regulatory and Compliance - The TriNav Infusion System received a permanent New Technology HCPCS code effective January 1, 2024, which may enhance reimbursement opportunities[138].

Financial Performance - TriNav achieved $18.5 million in revenue in 2023, with fourth quarter growth of 77% compared to the previous year[29]. - TriNav is expected to increase the addressable market by approximately 25%, translating to an opportunity of 47,500 units or about $368 million based on current pricing[52]. - TriNav received a unique and permanent HCPCS code (C9797) with a payment rate of $16,724.70 for calendar year 2024, enhancing reimbursement options[55]. Product Development and Clinical Trials - The PRVI device for pancreatic tumors is currently in clinical trials, with commercialization not anticipated before 2025[29]. - The company is advancing its Pancreatic Retrograde Venous Infusion Device (PRVI), currently in Phase 1 clinical trials for locally advanced pancreatic cancer[77]. - The Phase 1 PERIO studies are testing the nelitolimod/PEDD therapeutic platform in indications such as locally advanced pancreatic carcinoma and uveal melanoma with liver metastases[90]. - The company has initiated three Phase 1/1b studies focused on enhancing immunotherapy responses in liver and pancreatic tumors using nelitolimod[90]. - The company anticipates reporting full Phase 1 experience in the second half of 2024, with Phase 1b enrollment beginning if data remains supportive[120]. - The company is studying the PRVI device in combination with nelitolimod in the PERIO-03 trial, which has received 510(k) clearance[186]. Market Opportunity and Patient Demographics - The incidence of primary liver tumors is over 41,000 cases annually in the U.S., with an additional 96,000 individuals diagnosed with liver metastases[48]. - Approximately 40% of liver cancer patients are eligible for TACE or TARE procedures, representing a potential market opportunity of approximately 37,000 units, or $286 million[49]. - Approximately 137,000 new cases of liver cancers and over 60,000 cases of pancreatic cancer are diagnosed annually in the U.S., with more than 80,000 potentially addressable through the nelitolimod/PEDD platform[106]. - The five-year survival rate for pancreatic ductal adenocarcinoma (PDAC) is only 13%, highlighting the high unmet medical need in this area[108]. Technology and Innovation - The unique SmartValve on the PEDD device preserves more than 70% of forward blood flow, enhancing therapeutic delivery[37]. - PEDD has demonstrated a median increase of 24% in the tumor-to-normal liver ratio (T/N ratio) and a median increase of 23% in tumor dose delivery compared to standard catheters[45]. - The proprietary PEDD technology addresses the limitations of current cancer immunotherapy approaches by overcoming intra-tumoral pressure barriers, enabling effective therapeutic delivery[102]. - The SmartValve technology in TriNav allows for greater therapeutic delivery to tumors while minimizing exposure to healthy tissue[53]. - TriNav's competitive advantage lies in its ability to modulate pressure and flow, unlike standard microcatheters, which lack clinical evidence for improved therapeutic delivery[70]. Regulatory and Compliance - The company plans to seek FDA approval for nelitolimod through a 505(b)(1) regulatory pathway, which requires data demonstrating its contribution to the efficacy of the therapeutic regimen[185]. - The FDA's goal for a non-priority review of an NDA is ten months, but this can be extended by requests for additional information[190]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a new product outweigh its risks prior to approval[189]. - The company is subject to various healthcare laws and regulations, which may impose significant penalties if non-compliance is determined[221]. - The company is required to report annually to CMS information related to payments and transfers of value to healthcare professionals under the Physician Payments Sunshine Act[223]. Collaborations and Partnerships - The collaboration with MD Anderson Cancer Center includes a $10 million funding agreement for preclinical and clinical studies, with $6 million already paid[129]. - The company is exploring collaborations with therapeutic partners to enhance the uptake of various therapeutics using the PEDD approach[86]. - Collaboration with Hangzhou for PEDD combination therapies includes a milestone payment of $2.5 million for each therapy receiving regulatory approval[146]. Manufacturing and Operations - Manufacturing of TriNav is conducted in Westminster, Colorado, with adequate capacity for future demands[141]. - The principal office is located in Westminster, Colorado, leasing approximately 21,000 square feet of office, manufacturing, and warehouse space, with the lease expiring on December 31, 2026[223]. - The company has approximately 112 full-time employees, including 10 with Ph.D. or M.D. degrees, as of March 5, 2024[225]. Employee Relations and Corporate Governance - The company has not experienced any material work stoppages and maintains a good relationship with its employees[225]. - The company actively engages with managers to collect feedback on improving the working environment[225]. - The company may need to negotiate new leases or evaluate additional space for operations in the future[224].

Business Combination and Financing - TriSalus Life Sciences, Inc. reported a Business Combination with MedTech Acquisition Corporation, resulting in an aggregate consideration of $220.0 million, payable in 22,000,000 shares of common stock [171]. - In October 2022, TriSalus raised approximately $9.8 million through the sale of 706,243 shares of Series B-2 preferred stock at a price of $14.16 per share [174]. - The company completed a portion of the second tranche of the B-2 Preferred Stock Financing in March 2023, raising approximately $2.9 million [177]. - In June 2023, TriSalus raised approximately $3.7 million through the sale of 257,779 shares of Series B-2 preferred stock [179]. - A warrant repurchase program was approved in August 2023, authorizing up to $4.0 million for repurchases of Public Warrants [181]. - On October 2, 2023, TriSalus entered into a Standby Equity Purchase Agreement with Yorkville, allowing the company to sell up to $30.0 million of common stock during the commitment period [183]. - The company entered into the Yorkville Purchase Agreement in October 2023, allowing it to sell up to $30.0 million of shares of Common Stock [246]. Revenue and Profitability - Revenue for the three months ended September 30, 2023, increased by $1.3 million or 32.4% compared to the same period in 2022, primarily due to a $1.1 million increase in units of TriNav sold [203]. - Gross profit for the three months ended September 30, 2023, increased by $1.4 million or 42.9%, with gross margin rising to 88.7% from 82.1% [205]. - Revenue increased by $3.6 million, or 39.4%, for the nine months ended September 30, 2023, compared to the same period in 2022, primarily due to higher sales volume of TriNav [213]. - Gross profit increased by $3.0 million, or 39.3%, for the nine months ended September 30, 2023, while gross margin slightly decreased from 84.3% to 84.2% [215]. Expenses and Losses - R&D expenses increased by $4.6 million or 94.8% for the three months ended September 30, 2023, driven by costs associated with three clinical trials of drug candidate SD-101 [206]. - Sales and marketing expenses rose by $1.7 million or 54.8% for the three months ended September 30, 2023, primarily due to increased payroll and travel expenses [208]. - General and administrative expenses increased by $5.5 million or 158.2% for the three months ended September 30, 2023, mainly due to higher professional services costs related to the Business Combination [209]. - R&D expenses rose by $6.8 million, or 44.9%, for the nine months ended September 30, 2023, mainly due to increased spending on clinical trials and manufacturing development [216]. - General and administrative expenses surged by $9.1 million, or 107.7%, for the nine months ended September 30, 2023, largely due to higher professional service fees and increased payroll expenses [220]. - The company incurred net losses of $23.5 million for the nine months ended September 30, 2023, and has substantial doubt about its ability to continue as a going concern [226][227]. Cash Flow and Liquidity - Net cash used in operating activities was $41.2 million for the nine months ended September 30, 2023, compared to $24.0 million for the same period in 2022 [232]. - Net cash provided by financing activities was $54.6 million for the nine months ended September 30, 2023, primarily from merger proceeds and preferred stock issuance [239]. - The company had cash and cash equivalents of approximately $21.4 million as of September 30, 2023, which may not be sufficient to fund projected liquidity requirements for the next 12 months [228]. - As of September 30, 2023, the company had approximately $21.4 million in cash and cash equivalents, which is insufficient to fund projected liquidity requirements for the next 12 months [246]. - The company anticipates requiring additional capital in the near term to continue operations, which may not be available on favorable terms [246]. - The company may need to delay or curtail operations if it cannot raise sufficient capital [247]. Research and Development - The company has initiated Phase 1 human trials for SD-101, which aims to treat liver and pancreatic cancers, with no guarantee of favorable data or FDA approval [175]. - Approximately 12% of the company's R&D costs are headcount-related, with the remainder being external services [262]. - The company expects to incur significant expenses related to the commercialization of TriNav, including manufacturing, distribution, marketing, and sales costs [243]. - The company has paid Dynavax $12 million as of September 30, 2023, and may owe up to an additional $158 million upon achieving certain development and regulatory milestones for SD-101 [250]. Accounting and Compliance - The company recognizes revenue from TriNav shipments when control of the units has been transferred to the customer, following ASC 606 guidelines [253]. - The company faces substantial doubt regarding its ability to continue as a going concern as of September 30, 2023 [248]. - The company will remain an emerging growth company until the earlier of December 31, 2025, or achieving total annual gross revenue of at least $1.235 billion [270]. - The market value of the company's common equity held by non-affiliates must exceed $700 million to be deemed a "large accelerated filer" under SEC rules [270]. - The company has elected to take advantage of the extended transition period under the JOBS Act, which may affect comparability with other public companies [269]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [272]. - Recent accounting pronouncements and their potential impact on financial condition and results of operations are detailed in the quarterly report [271].