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[147]. - Revenue for the three months ended March 31, 2024, increased by $3.5 million or 116.4% compared to the same period in 2023, driven by higher sales of the TriNav product[169]. - Gross profit rose by $3.2 million or 136.3%, with gross margin improving to 85.0% from 77.8% due to increased manufacturing efficiencies[171]. - The net loss available to common stockholders for the three months ended March 31, 2024, was $13.2 million, compared to a net loss of $8.3 million in the same period of 2023[180]. - Cash and cash equivalents were approximately $4.0 million as of March 31, 2024, with net cash used in operating activities amounting to $10.9 million[180][183]. - Interest income increased by $0.1 million or 162.9% for the three months ended March 31, 2024, due to investments in short-term money market funds[176]. - Net cash provided by financing activities decreased to $3.1 million in Q1 2024 from $7.9 million in Q1 2023, reflecting a significant reduction in capital raised[183][187]. Capital and Funding - The company raised $3.6 million from the sale of 400,000 shares of common stock under the SEPA in April 2024[147]. - The company anticipates needing to raise additional capital to fund operations and execute its long-term business strategy, including potential commercialization expenses[180][190]. - The company may need to raise funds through securities offerings, debt financings, collaborations, or licensing arrangements, which may not be available on favorable terms[194]. - The company has a Credit Agreement with OrbiMed providing for up to $50.0 million in senior secured term debt, with an initial commitment of $25.0 million available on the closing date[149]. - Future capital requirements will depend on factors such as the success of TriNav commercialization, regulatory approval costs for nelitolimod, and the ability to maintain adequate reimbursement for TriNav[191]. - The company has paid Dynavax $12 million as of March 31, 2024, and may owe up to an additional $158 million upon achieving certain development and regulatory milestones for nelitolimod[198]. - Upon obtaining marketing approval for nelitolimod, the company will be required to pay up to $80 million upon achieving certain commercial milestones once sales begin[198]. Research and Development - The company expects R&D expenses to increase significantly as it advances nelitolimod through clinical development[159]. - The company is currently in Phase 1 human trials for nelitolimod, which aims to treat liver and pancreatic cancers[149]. - The company has transformed from solely selling infusion systems to marketing medical devices alongside pharmaceutical drugs[143]. Operational Challenges - Operating expenses increased significantly, with R&D expenses rising by $0.2 million (3.8%), sales and marketing expenses up by $3.4 million (105.8%), and general and administrative expenses increasing by $1.1 million (30.3%) compared to the prior year[172][174][175]. - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2024, due to reliance on generating sufficient cash flows or obtaining additional capital[196]. - The company is subject to affirmative and restrictive covenants under its Credit Agreement, which may limit its ability to incur additional debt or make capital expenditures[192]. Regulatory and Market Developments - 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[143]. - The TriNav Infusion System received a permanent New Technology HCPCS code effective January 1, 2024, which may facilitate reimbursement for the device[142]. - A loss of $4.0 million was recorded due to changes in the fair value of earnout liabilities, attributed to an increase in the market price of the underlying common stock[178].

Financial Performance - Reported revenues of $6.5 million in Q1 2024, representing a 116% increase compared to Q1 2023[7] - Gross margin improved to 85% in Q1 2024, up from 78% in Q1 2023, due to increased factory volumes and operational efficiency[9] - Operating losses were $11.7 million in Q1 2024, compared to $10.1 million in Q1 2023, driven by increased investments in sales, marketing, and R&D[10] - Net losses available to common stockholders were $13.2 million in Q1 2024, compared to $8.3 million in Q1 2023[11] - Full-year sales growth is expected to exceed 50%[7] Financing and Cash Position - Secured up to $50 million in debt financing with OrbiMed to support growth initiatives for the TriNav® Infusion System[4] - Cash and cash equivalents were $3.97 million as of March 31, 2024, down from $11.78 million at the end of 2023[21] - The company expects sufficient cash runway to fund operations through the end of 2025, assuming revenue targets are met[5] Corporate Governance - The company appointed Liselotte Hyveled to its Board of Directors, bringing over two decades of experience in pharmaceutical innovation[6] Shareholder Information - The weighted average common shares outstanding increased to 23,323,045 in Q1 2024 from 16,166,581 in Q1 2023[12]

Revenue and Profitability - Revenue for the year ended December 31, 2023, was $18,511,000, representing a 49% increase from $12,398,000 in 2022[640] - Gross profit increased to $15,906,000 in 2023, up from $10,140,000 in 2022, reflecting a gross margin improvement[640] - The net loss attributable to common stockholders for 2023 was $63,277,000, compared to a loss of $50,016,000 in 2022, highlighting ongoing financial challenges[640] - The company reported a loss from operations of $54,150,000 in 2023, compared to a loss of $36,439,000 in 2022, reflecting increased operational costs[640] - Net loss for 2023 was $59,038, compared to a net loss of $47,187 in 2022, representing a 25.5% increase in losses year-over-year[645] Expenses and Investments - Research and development expenses rose to $29,510,000 in 2023, compared to $21,358,000 in 2022, indicating a focus on innovation[640] - The company reported a significant increase in share-based compensation expense, rising to $1,402 in 2023 from $368 in 2022, a 280.4% increase[645] - Advertising expenses for the years ended December 31, 2023 and 2022 were $1.346 million and $2.201 million, respectively[681] Financial Position - Total assets increased to $25,725,000 in 2023 from $21,995,000 in 2022, showing growth in the company's financial position[638] - Cash and cash equivalents at year-end 2023 were $11,777,000, up from $9,414,000 in 2022, indicating improved liquidity[638] - Total liabilities increased significantly to $51,663,000 in 2023 from $34,319,000 in 2022, raising concerns about financial leverage[638] - The company has an accumulated deficit of $248,377 as of December 31, 2023, indicating ongoing financial challenges[653] Cash Flow and Financing - Cash flows from operating activities resulted in a net cash used of $50,045 in 2023, up from $32,313 in 2022, indicating a 54.8% increase in cash outflow[645] - Management estimates that existing cash and cash equivalents will be insufficient to fund projected liquidity requirements for the next 12 months without additional financing[653] - The company has indicated a need to raise additional equity or debt to fund operations, raising substantial doubt about its ability to continue as a going concern[632] - The company raised $36,854 in cash from the Business Combination, contributing to a total of $164,364 raised from preferred stock since inception[651] Business Combination and Shareholder Equity - The business combination with TriSalus Life Sciences was completed on August 10, 2023, with proceeds totaling $42,854, including $40,150 from PIPE Financing[694][697] - Following the business combination, there were 26,316,681 shares of common stock outstanding and options/RSUs for 2,816,224 shares[699] - The company issued 4,015,002 shares of Series A Convertible Preferred Stock for $40,150, with an original issue price of $10.00 and cumulative dividends accruing at a rate of 8.00% per annum[755] - The total convertible preferred stock decreased from $164,006 as of December 31, 2022, to $0 as of December 31, 2023, due to conversions and retirements[768] Stock and Warrant Information - The total number of warrants outstanding decreased from 15,819,000 in 2022 to 14,215,112 in 2023, a reduction of approximately 10.1%[730] - The fair value of the Series B-3 Warrants as of August 10, 2023, was estimated at $9.31 per share, based on an enterprise value of $220,000 allocated to all outstanding shares[774] - The Company repurchased 51,493 Public Warrants for a total of $20 under a warrant repurchase program authorized for up to $4,000[739] Lease and Tax Information - Total lease liabilities as of December 31, 2023, amounted to $1,431 for operating leases and $164 for finance leases[804] - The total lease expense for the year ended December 31, 2023, was $489, compared to $463 in 2022[802] - The Company has established a valuation allowance equal to 100% of net deferred tax assets due to the lack of historical taxable income[741] Future Plans and Strategic Initiatives - The company is undergoing a strategic transformation to market its medical devices alongside pharmaceutical drugs, which will increase operating expenses in the short term[653] - The Employee Stock Purchase Plan (ESPP) will become active in 2024, with 1,396,252 shares reserved for issuance and an automatic annual increase of 2% of the total shares of Fully Diluted Common Stock[797]

Financial Data and Key Metrics Changes - TriSalus achieved $5.7 million in revenue for Q4 2023, representing a 77% increase compared to Q4 2022 and a 10% sequential increase from Q3 2023 [61] - Full year revenues reached $18.5 million in 2023, a 49% increase from 2022 [62] - Gross margin for Q4 2023 was 90%, up from 75% in Q4 2022, and full year gross margin was 86%, compared to 82% in 2022 [45] - Operating losses for Q4 2023 totaled $14.1 million, compared to $11.4 million in Q4 2022, with year-to-date losses amounting to $54.2 million in 2023, up from $36.4 million in 2022 [47][48] Business Line Data and Key Metrics Changes - The company reported a 49% operational growth for the year, driven by the adoption of the TriNav device in new accounts and increased utilization in existing accounts [14][62] - The sales team expanded from 10 representatives at the beginning of 2023 to 28 by the end of Q4 2023, along with the addition of seven clinical specialists [63] Market Data and Key Metrics Changes - TriSalus captured 7% market share in liver TACE and TARE procedures in 2023, with expectations for growth exceeding 50% in 2024 [38] - A health, economic, and outcome research study covering 300 million patient data sets demonstrated that TriNav patients achieved comparable clinical results to those with lower disease burdens [20][25] Company Strategy and Development Direction - The company aims to position TriNav as the standard-of-care for complex patients requiring liver embolization, focusing on educational initiatives and comprehensive reimbursement support [29] - TriSalus plans to advance its pipeline with nelitolimod and is investigating its use in combination with systemic checkpoint inhibitors [30][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in TriSalus's potential for breakout growth in 2024 due to permanent reimbursement and robust clinical evidence for TriNav [22] - The company anticipates a decrease in clinical costs in 2024 as it completes patient follow-up and analyzes trial data [64] Other Important Information - TriSalus filed a Form 12b-25 Notification of Late Filing with the SEC due to data errors related to non-cash stock compensation expense [8][9] - The company raised $61 million in 2023, including a $41 million PIPE to support going public, and ended the year with $11.8 million in cash and cash equivalents [48] Q&A Session Summary Question: Inclusion of clinical specialists for TriNav sales - The company currently has seven clinical specialists who support sales representatives in training physicians and expanding adoption [51] Question: Next steps for pancreatic work to larger Phase 2 trial - The company is completing enrollment in the Phase 1 single agent nelitolimod experience to establish safety and feasibility before moving to Phase 1b [70][71]

Exhibit 99.1 TriSalus Reports Q4 and Full Year 2023 Financial Results and Business Update TriSalus Life Sciences Inc., (Nasdaq: TLSI), today announced its financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update. "2023 was a critical year for TriSalus, underscored by significant growth in TriNav revenue, a landmark achievement of permanent reimbursement, and disciplined progress within our technology and clinical pipelines," said Mary Szela, Chief Execut ...

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 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 (State or other jurisdiction of incorporation or organization) 3841 (Primary Standard Industrial Classification Code Number) 85-3009869 (I.R.S. Employer Identific ...

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 ...

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 Mary Szela Chief Executive Officer 6272 W. 91st Ave. Westminster, Colorado 80031 (888) 321-5212 (Name, address, including zip code, and tele ...

Company Overview - TriSalus Life Sciences, Inc. focuses on innovative drug delivery technology and immune-oncology therapeutics, particularly for liver and pancreatic cancer [172]. - The company has developed two product lines: Pressure Enabled Drug Delivery (PEDD) infusion systems and the investigational agent SD-101, aimed at enhancing immune response in treating solid tumors [172]. Financial Performance - 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 an increase in units of TriNav sold [208]. - 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% in the same period last year [210]. - 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 [218]. - 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% [220]. Expenses - R&D expenses increased by $4.6 million or 94.8% for the three months ended September 30, 2023, driven by costs associated with clinical trials for drug candidate SD-101 [211]. - 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 [213]. - 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 [214]. - 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 [221]. - 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 [225]. Cash Flow and Financing - 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 [239]. - Net cash provided by financing activities was $54.6 million for the nine months ended September 30, 2023, primarily from the merger proceeds and issuance of preferred stock [245]. - The company anticipates requiring additional capital in the near term to fund operations, which may not be available on favorable terms or at all [252]. - The company has entered into the Yorkville Purchase Agreement, allowing it to sell up to $30.0 million of shares of Common Stock [252]. Losses and Concerns - 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 [231]. - The company may face substantial doubt regarding its ability to continue as a going concern due to insufficient cash flow and liquidity [254]. - The company may need to delay or curtail operations if it cannot secure sufficient capital to capitalize on business opportunities [253]. Business Developments - The company completed a Business Combination on August 10, 2023, with an aggregate consideration of $220 million, resulting in the exchange of approximately 890 million shares of TriSalus common stock for about 22 million shares of MTAC common stock [175][177]. - In October 2022, TriSalus raised approximately $9.8 million through the sale of 706,243 shares of Series B-2 preferred stock at $14.16 per share [179]. - In August 2023, the Board approved a warrant repurchase program with an expenditure of up to $4 million, having repurchased 28,502 Public Warrants for $9.9 thousand by October 31, 2023 [185]. - On October 2, 2023, TriSalus entered into a Standby Equity Purchase Agreement with Yorkville, allowing the sale of up to $30 million of Common Stock during the commitment period [186][187]. Regulatory and Compliance - TriSalus applied for a new technology Ambulatory Payment Classifications code with CMS on June 1, 2023, to ensure continued reimbursement for the TriNav device starting January 1, 2024 [173]. - The company recognizes revenue from TriNav shipments when control of the units has been transferred to the customer, following ASC 606 guidelines [259]. - The company has no off-balance sheet financing arrangements or relationships with unconsolidated entities [257]. Future Outlook - The company expects R&D expenses to increase significantly in future periods as it advances its manufacturing technologies and seeks regulatory approvals for drug candidates [196]. - The company expects to incur significant expenses related to the commercialization of TriNav, including manufacturing, distribution, marketing, and sales costs [249]. - Approximately 12% of the company's R&D costs are headcount-related, with the remainder being external services for pre-clinical and clinical activities [268]. - 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 [276]. - 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 [276]. - The company has elected to take advantage of the extended transition period under the JOBS Act, which may affect comparability with other public companies [275]. - Recent accounting pronouncements may impact the company's financial condition and results of operations, as detailed in the quarterly report [277].