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, primarily due to increased sales of TriNav[175]. - 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% in the same period last year[176]. - Revenue increased by $6.2 million, or 82.0%, for the six months ended June 30, 2024, compared to the same period in 2023, primarily due to increased sales of TriNav[188]. - Gross profit increased by $5.8 million, or 93.7%, for the six months ended June 30, 2024, with gross margin percentage rising to 86.4% from 81.1%[188]. - The net loss attributable to common stockholders was $5.1 million for the three months ended June 30, 2024, compared to a net loss of $15.996 million in the same period of 2023[173]. - The company incurred net losses of $17.6 million for the six months ended June 30, 2024, and expects to continue incurring losses due to ongoing investments in R&D and marketing[195]. Research and Development - The DELIVER program aims to evaluate the TriNav system across complex patient populations, with the first clinical study named "PROTECT" focusing on thyroid disease[154][155]. - TriSalus is currently in Phase 1 human trials for nelitolimod, with no guarantee of favorable data or FDA approval[144]. - R&D expenses decreased by $2.2 million, or 32.2%, for the three months ended June 30, 2024, mainly due to reduced clinical trial expenses related to nelitolimod[178]. - R&D expenses decreased by $2.0 million, or 15.8%, primarily due to a reduction in clinical trial expenses related to nelitolimod[189]. Capital and Financing - TriSalus reported a total consideration of $220.0 million for the Business Combination, payable in approximately 22,000,000 shares of MTAC common stock[142]. - The OrbiMed Credit Agreement provides for up to $50.0 million in senior secured term debt, with an initial commitment of $25.0 million borrowed on April 30, 2024[146][147]. - The company raised $6.7 million from the sale of 750,000 shares of common stock under the SEPA during the six months ended June 30, 2024[196]. - The company anticipates needing additional capital to fund operations and execute its long-term business strategy, with substantial doubt regarding its ability to continue as a going concern as of June 30, 2024[206]. Expenses - Sales and marketing expenses increased by $2.5 million, or 71.9%, for the three months ended June 30, 2024, driven by higher payroll and travel expenses due to increased headcount[179]. - General and administrative expenses decreased by $0.9 million, or 19.2%, for the three months ended June 30, 2024, primarily due to prior period legal and consulting expenses not repeated this year[180]. - Sales and marketing expenses increased by $6.0 million, or 88.3%, driven by higher payroll and travel expenses due to increased headcount[189]. Liabilities and Obligations - As of June 30, 2024, the company has lease obligations totaling $1.5 million for its principal administrative and production facility and other office spaces[207]. - The company has paid Dynavax $12 million as of June 30, 2024, with potential additional payments of up to $158 million upon achieving certain development and regulatory milestones for nelitolimod[208]. - Subject to marketing approval for nelitolimod, the company may also pay up to $80 million upon achieving certain commercial milestones[208]. - The Dynavax Agreement includes low double-digit royalties based on future net sales of products containing nelitolimod, with potential reductions of up to 50% under certain circumstances[208]. Other Financial Information - The expiration of the TPT payment program on December 31, 2023, may impact TriNav sales and revenue generation[144]. - The company has yet to generate sufficient revenues to drive positive cash flows from operations[141]. - Interest income increased by $0.1 million, or 169.4%, for the three months ended June 30, 2024, attributed to additional interest from investments in short-term money market funds[181]. - Interest expense increased by $0.9 million for the three months ended June 30, 2024, due to interest incurred on the OrbiMed loan[182]. - 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 last year[184]. - 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, due to the lower market price of the underlying common stock[185]. - A gain of $9.7 million was recorded for the change in fair value of earnout liabilities for the six months ended June 30, 2024, due to a lower market price of the underlying common stock[193]. - There are no off-balance sheet financing arrangements or relationships with unconsolidated entities as of the reporting period[209]. - There have been no significant changes in critical accounting policies during the six months ended June 30, 2024, compared to the previous year[210].

Core Viewpoint - TriSalus Life Sciences, Inc. (TLSI) is a device manufacturer focused on organ-targeted therapy delivery mechanisms, with ongoing efforts to develop its own drug to complement its devices, presenting a potential investment opportunity as the market cap has declined significantly [1][13]. Pipeline Updates - TLSI's platform aims to improve tumor uptake of chemotherapy agents in organ-restricted cancers, particularly liver and pancreatic cancers, with optimism surrounding its use in liver metastases from uveal melanoma [2]. - The company is developing nelitolimod (formerly SD-101), a TLR9 activator, which is being evaluated in various solid tumors, including liver metastases and primary liver cancers [3]. Clinical Data - At the Annual Meeting of the Society of Interventional Radiology, the PERIO-03 study demonstrated the feasibility of delivering nelitolimod via pancreatic retrograde venous infusion in 5 patients without immediate complications [4]. - The ASCO Annual Meeting presented more promising data from the PERIO-02 study, where nelitolimod achieved disease control in all 3 patients treated, with no safety concerns noted across 23 patients [5]. Financial Overview - As of the latest quarterly filing, TLSI reported $13.2 million in current assets, including $4.0 million in cash, with a net loss of $13.2 million after operational expenses of $11.7 million [7]. - The company secured $50 million in financing from OrbiMed, extending its cash runway to just over one year, with an additional potential $25 million based on revenue targets [8]. Strengths and Risks - TLSI has seen rapid sales growth from its approved devices, which supports ongoing drug development efforts and provides some financial stability [9]. - Early clinical data for nelitolimod is encouraging, with no major safety concerns reported, although caution is advised due to the small patient cohorts [10]. - Despite securing financing, TLSI's cash runway remains a concern, with quarterly sales doubling year-over-year but still facing significant cash burn [11][12]. Bottom Line Summary - TLSI's market cap has dropped to around $150 million, making it appear more attractive given its two marketed devices generating growing sales, although cash concerns persist [13].

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. 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 (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 ...

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 Data and Key Metrics Changes - Company reported a remarkable 116% growth in revenues, reaching $6.5 million, driven solely by the success of the TriNav device in the U.S. This represents the highest quarterly sales in the company’s history [9][15]. - Gross margin improved to 85% in Q1 2024, up from 78% in Q1 2023, attributed to increased factory volumes and operational efficiencies [17][25]. - Operating losses for Q1 2024 totaled $11.7 million, compared to $10.1 million in Q1 2023, primarily due to higher operating expenses in sales and marketing, R&D, and general administrative expenses [37]. Business Line Data and Key Metrics Changes - The growth in revenue was entirely from the sale of TriNav, with the company capturing 32 net new hospital accounts, exceeding internal projections due to pent-up demand [15][16]. - Account utilization increased to 14.5 units per account compared to 11.2 units in Q1 2023, indicating stronger adoption of the TriNav device [16]. Market Data and Key Metrics Changes - The company has achieved a compound annualized growth rate of approximately 50% since the launch of the TriNav product in 2020, with expectations for continued growth over 50% in 2024 [26]. Company Strategy and Development Direction - The company is positioning TriNav to become the standard-of-care for complex patients and is implementing educational and reimbursement support programs to facilitate adoption [12]. - The launch of TriNav Large is anticipated in the second half of the year, with ongoing clinical trials for nelitolimod expected to yield promising results [12][13]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% top-line revenue growth and advancing the pipeline, supported by recent positive developments in reimbursement and robust clinical data [14]. - The company is focused on pursuing indications with low competitive environments and significant treatment effects, with a comprehensive evaluation of clinical data expected in the third quarter [27]. Other Important Information - The company closed a debt financing facility in April, borrowing $25 million with an additional $25 million available, which is expected to provide sufficient runway to fund operations through the end of 2025 [38]. - General and administrative expenses increased by 30% compared to Q1 2023, primarily due to costs associated with becoming a public company [20]. Q&A Session Summary Question: Upcoming data readouts for nelitolimod and their impact on future decisions - Management is waiting for recently enrolled patients to reach the six-month mark for a comprehensive evaluation, with plans to pursue indications based on competitive environment and treatment effect [27]. Question: Preparation efforts for the commercial launch of TriNav Large - The company has conducted extensive market evaluations and validated the need for a larger size of TriNav, with plans to launch in the fourth quarter [34][42].

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 ...