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].

Table of Contents As filed with the U.S. Securities and Exchange Commission on June 14, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 3841 | 85-3009869 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Cl ...

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].

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Table of Contents As filed with the U.S. Securities and Exchange Commission on December 15, 2023. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Mary Szela Chief Executive Officer 6272 W. 91st Ave. Westminster, Colorado 80031 (888) 321-5212 (Name, address, including zip code, and telephone number, including area code, of agent for service) Copy to: TRISALUS LIFE SCIENCES, INC. (Exact name of regis ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on December 14, 2023. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) 3841 (Primary Standard Industrial Delaware (State or other jurisdiction of incorporation or organization) Classification Code Number) 6272 W. 91st Ave. Westminster, Colorado ...

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].

TABLE OF CONTENTS As filed with the U.S. Securities and Exchange Commission on October 18, 2023. Registration No. 333-274292 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Mary Szela Chief Executive Of ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on September 1, 2023. Registration No. 333-274292 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) 3841 Delaware (State or other jurisdiction of incorporation or organization) Westminster, Colorado 80031 (888) 321-5212 (Address, including zip co ...