tlsi-20250331

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


x			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025


o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______

Commission file number 001-39813

TRISALUS LIFE SCIENCES, INC.

(Exact name of registrant as specified in its charter)


Delaware			85-3009869
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)

6272 W 91st Ave, Westminster, CO			80031
(Address of Principal Executive Offices)			(Zip Code)

(888) 321-5212

Registrant's telephone number, including area code

N/A (Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, $0.0001 par value	TLSI	Nasdaq Global Market
Warrants, each whole warrant exercisable for one share of registrant's common stock at an exercise price of $11.50 per share	TLSIW	Nasdaq Global Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,”

“accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):


Large accelerated filer	o	Accelerated filer	o
Non-accelerated filer	x	Smaller reporting company	x
		Emerging growth company	x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No x

The registrant had 37,838,962 shares of common stock outstanding as of May 9, 2025.

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TABLE OF CONTENTS


		Page
	Special Note Regarding Forward-Looking Statements	2

PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements	4
	Condensed Consolidated Balance Sheets	4
	Condensed Consolidated Statements of Operations	5
	Condensed Consolidated Statements of Stockholders’ Deficit	6
	Condensed Consolidated Statements of Cash Flows	7
	Notes to Condensed Co nsolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	35
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	43
Item 4.	Controls and Procedures	43

PART II.	OTHER INFORMATION	45
Item 1.	Legal Proceedings	45
Item 1A.	Risk Factors	45
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	45
Item 3.	Defaults Upon Senior Securities	45
Item 4.	Mine Safety Disclosures	45
Item 5.	Other Information	45
Item 6.	Exhibits	46

Signatures		47

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form10-Q (the "Quarterly Report") contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. We have based these forward-looking statements on our current expectations and projections about future events. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “approximately,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words or phrases.

These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. Except as otherwise required by applicable law, we disclaim any duty to update any forward-looking statements, all of which are expressly qualified by the statements in this section, to reflect events or circumstances after the date of this Quarterly Report.

We caution you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond our control. Some factors that could cause actual results to differ include:

•our ability to raise financing in the future;

•our ability to service our indebtedness and to access additional delayed draws that may in the future become available to us;

•changes in applicable laws or regulations;

•our ability to retain or recruit, or changes required in, our officers, key employees or directors;

•our ability to successfully commercialize any product candidates that we successfully develop and that are approved by applicable regulatory authorities;

•our expectations for the timing and results of data from clinical trials and regulatory approval applications;

•our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

•our business, operations and financial performance including:

◦our history of operating losses and expectations of significant expenses and continuing losses for the foreseeable future;

◦our ability to execute our business strategy, including the growth potential of the markets for our products and our ability to serve those markets;

◦our ability to grow market share in our existing markets or any new markets we may enter;

◦our ability to develop and maintain our brand and reputation;

◦our ability to partner with other companies;

◦the size of the addressable markets for our product candidates;

◦our expectations regarding our ability to obtain and maintain intellectual property protection and not infringe on the rights of others;

◦our ability to manage our growth effectively;

◦our ability to maintain the listing of our securities in the Nasdaq Global Market, and the potential liquidity and trading of such securities;

◦the outcome of any legal proceedings that may be instituted against us; and

◦unfavorable conditions in our industry, the global economy or global supply chain, including financial and credit market fluctuations, international trade relations, pandemics, political turmoil, natural catastrophes, warfare and terrorist attacks.

Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Should one or more of the risks or uncertainties described in this Quarterly Report occur, or should underlying

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assumptions prove incorrect, actual results and plans could differ materially from those expressed in any forward-looking statements. For a further discussion of these and other factors that could cause our future results, performance or transactions to differ significantly from those expressed in any forward-looking statement, please see the section titled “Risk Factors.”

Except to the extent required by applicable law, we are under no obligation (and expressly disclaim any such obligation) to update or revise their forward-looking statements whether as a result of new information, future events, or otherwise. You should read this Quarterly Report completely and with the understanding that our actual future results, levels of activity and performance as well as other events and circumstances may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

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Part I - Financial Information

Item 1. Financial Statements

TRISALUS LIFE SCIENCES, INC.

Condensed Consolidated Balance Sheets

(unaudited, in thousands except share and per share data)


	March 31, 2025		December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	13,000	$	8,525
Accounts receivable, net	5,453		5,087
Inventory, net	4,162		4,048
Prepaid expenses	2,481		3,009
Total current assets	25,096		20,669
Property and equipment, net	1,968		1,669
Right-of-use assets	1,137		1,210

Other assets	424		423
Total assets	$	28,625	$	23,971
Liabilities and Stockholders’ Deficit
Current liabilities:
Trade payables	$	2,806	$	2,274
Accrued liabilities	8,403		7,355
Short-term lease liabilities	118		216
Other current liabilities	426		383
Total current liabilities	11,753		10,228
Long-term debt, net of unamortized discount and debt issuance costs	31,699		22,084
Revenue base redemption liability	564		507
Long-term lease liabilities	1,299		1,329
Contingent earnout liability	8,221		7,401
Warrant and SEPA liabilities	9,459		8,316
Total liabilities	62,995		49,865
Commitments and contingencies
Stockholders’ deficit:
Preferred Stock, Convertible Series A, $0.0001 par value per share, $10.00 liquidation value per share. Authorized 10,000,000 shares at March 31, 2025 and December 31, 2024, respectively; issued and outstanding, 3,620,002 and 3,985,002 shares at March 31, 2025, and December 31, 2024, respectively.	—		—
Common stock, $0.0001 par value per share. Authorized 400,000,000 shares at March 31, 2025 and December 31, 2024, respectively; issued and outstanding, 32,272,462 and 31,279,264 shares at March 31, 2025, and December 31, 2024, respectively.	3		3
Additional paid-in capital	255,551		253,652
Accumulated deficit	(289,924)		(279,549)
Total stockholders’ deficit	(34,370)		(25,894)
Total liabilities and stockholders’ deficit	$	28,625	$	23,971

See accompanying notes to unaudited condensed consolidated financial statements.

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TRISALUS LIFE SCIENCES, INC.

Condensed Consolidated Statements of Operations

(unaudited, in thousands except share and per share data)


	Three Months Ended March 31,
	2025		2024
Revenue	$	9,167	$	6,457
Cost of goods sold	1,495		971
Gross profit	7,672		5,486
Operating expenses:
Research and development	3,296		5,844
Sales and marketing	6,734		6,687
General and administrative	4,971		4,627
Loss from operations	(7,329)		(11,672)
Other income (expense):
Interest income	74		92
Interest expense	(1,209)		(3)
Change in fair value of SEPA, warrant, and revenue base redemption liabilities	(835)		2,521
Change in fair value of contingent earnout liability	(820)		(3,988)
Other expense, net	(251)		(153)
Loss before income taxes	(10,370)		(13,203)
Income tax expense	(5)		(3)
Net loss available to common stockholders	$	(10,375)	$	(13,206)
Undeclared dividends on Series A preferred stock	$	(712)	$	(801)
Net loss attributable to common stockholders	$	(11,087)	$	(14,007)
Net loss per common share, basic and diluted	$	(0.39)	$	(0.60)
Weighted average common shares outstanding, basic and diluted	28,527,453		23,323,045

See accompanying notes to unaudited condensed consolidated financial statements.

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TRISALUS LIFE SCIENCES, INC.

Condensed Consolidated Statements of Stockholders’ Deficit

Three months ended March 31, 2025 and 2024

(unaudited, in thousands except share data)


	Three months ended March 31, 2025
	Preferred stock			Common stock				Additional paid-in capital		Accumulated deficit		Total
	Shares	Amount		Shares		Amount
At December 31, 2024	3,985,002	$	—	31,279,264		$	3	$	253,652	$	(279,549)	$	(25,894)
Exercise of options	—	—		215,369		—		279		—		279
Stock-based compensation	—	—		—		—		1,620		—		1,620
Preferred stock conversion	(365,000)	—		777,829		—		—		—		—
Net loss	—	—		—		—		—		(10,375)		(10,375)
At March 31, 2025	3,620,002	—		32,272,462		$	3	$	255,551	$	(289,924)	$	(34,370)

















	Three months ended March 31, 2024
	Preferred stock			Common stock				Additional paid-in capital		Accumulated deficit		Total
	Shares	Amount		Shares		Amount
At December 31, 2023	4,015,002	$	—	26,413,213		$	2	$	222,437	$	(249,504)	$	(27,065)
Exercise of options	—	—		(4,941)	(1)	—		7		—		$	7
Stock-based compensation	—	—		—		—		1,086		—		$	1,086
Proceeds from sale of common stock	—	—		350,000		—		3,141		—		$	3,141
Net loss	—	—		—		—		—		(13,206)		(13,206)
At March 31, 2024	4,015,002	—		26,758,272		$	2	$	226,671	$	(262,710)	$	(36,037)

(1) Amount reflects 2,906 shares issued for option exercises and 7,847 shares returned from options exercised in 2023 to correct clerical error.

See accompanying notes to unaudited condensed consolidated financial statements.

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TRISALUS LIFE SCIENCES, INC.

Condensed Consolidated Statements of Cash Flows

Three months ended March 31, 2025 and 2024

(unaudited, in thousands)


	Three Months Ended March 31,
	2025		2024
Cash flows from operating activities:
Net loss available to common stockholders	$	(10,375)	$	(13,206)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	172		175
Reduction in the carrying amount of right-of-use assets	173		76
Change in fair value of warrants and SEPA liabilities	758		(2,521)
Change in fair value of OrbiMed Warrants and revenue base redemption liabilities	77		—
Change in fair value of contingent earnout liability	820		3,988
Non-cash interest expense	266		—



Stock-based compensation expense	1,620		1,086
Allowance for credit losses	39		—
Loss on disposal of property and equipment	117		18
Amortization of debt issuance costs	235		—

Changes in operating assets and liabilities:
Accounts receivable	(366)		(723)
Inventory, net	(114)		(368)
Prepaid expenses	511		955
Deposits	—		43
Operating lease liabilities	(56)		(85)

Trade payables and accrued liabilities	1,624		(305)
Net cash used in operating activities	(4,499)		(10,867)
Cash flows from investing activities:
Purchases of property and equipment	(754)		(66)

Proceeds from the disposal of property and equipment	40		—
Net cash used in investing activities	(714)		(66)
Cash flows from financing activities:

Proceeds from the issuance of common stock	—		3,141



Debt issuance costs	(520)		—
Proceeds from the issuance of debt	10,000		—
Payments on finance lease liabilities	(71)		(22)
Proceeds from the exercise of stock options for common stock	279		7
Net cash provided by financing activities	9,688		3,126
Increase (decrease) in cash, cash equivalents and restricted cash	4,475		(7,807)
Cash, cash equivalents and restricted cash, beginning of period	8,875		12,127
Cash, cash equivalents and restricted cash, end of period	$	13,350	$	4,320

Supplemental disclosures of cash flow information:
Interest paid	$	709	$	3
Income taxes	$	1	$	—
Supplemental disclosures of non-cash items:
Right-of-use assets obtained in exchange for new operating lease liabilities	$	—	$	90
Fixed asset purchase through exchange of finance lease right-of-use asset	$	85	$	—
Derecognition of finance lease right-of-use asset	$	(85)	$	—
Fixed asset purchases included in trade payables and accrued expenses	$	87	$	—
Fair value of warrants issued related to OrbiMed debt	$	366	$	—
Non-cash interest expense	$	266	$	—

See accompanying notes to unaudited condensed consolidated financial statements.

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TriSalus Life Sciences, Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share data)

(Unaudited)

(1) Nature of Business

On August 10, 2023 (the "Closing Date"), TriSalus Life Sciences, Inc., a Delaware corporation (the “Company,” “TriSalus,” “we,” “us”), formerly known as MedTech Acquisition Corporation (“MTAC”), consummated the previously announced merger pursuant to the Agreement and Plan of Merger, dated as of November 11, 2022, as amended by that certain First Amendment to Agreement and Plan of Merger, dated as of April 4, 2023, the Second Amendment to Agreement and Plan of Merger, dated as of May 13, 2023, and the Third Amendment to Agreement and Plan of Merger, dated as of July 5, 2023 (as amended, the “Merger Agreement”), by and between MTAC Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of MTAC (“Merger Sub”) and TriSalus Operating Life Sciences, Inc. (formerly known as TriSalus Life Sciences, Inc.), a Delaware corporation (“Legacy TriSalus”), whereby Merger Sub merged with and into Legacy TriSalus with the separate corporate existence of Merger Sub ceasing (the “Merger” and, together with the other transactions contemplated by the Merger Agreement, the “Business Combination”) and TriSalus Life Sciences, Inc. becoming the surviving company. The closing of the Business Combination is herein referred to as “the Closing.” In connection with the consummation of the Merger, on August 10, 2023, Legacy TriSalus changed its name from TriSalus Life Sciences, Inc. to TriSalus Operating Life Sciences, Inc., and MTAC changed its name from MedTech Acquisition Corporation to TriSalus Life Sciences, Inc., the surviving company. As further described in Note (3) Business Combination, Legacy TriSalus was deemed to be the accounting acquirer and predecessor company in the Business Combination.

We are a growing, oncology focused medical technology business seeking to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies, and with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 (“TLR9”) agonist, for a range of different therapeutic and technology applications. Our ultimate goal is to transform the treatment paradigm for patients battling solid tumors. We have developed an innovative technology designed to overcome two significant challenges that prevent optimal delivery and performance of therapeutics in these difficult-to-treat diseases: (i) high intratumoral pressure caused by tumor growth and collapsed vasculature restricting the delivery of oncology therapeutics and (ii) off target delivery. Nelitolimod, specifically, combined with our technology, aims to address the immunosuppressive properties of tumor immune cells in liver, pancreas and other solid tumors. By systematically addressing these barriers, we aim to improve response to therapies and to enable improved patient outcomes.

We market our cutting-edge Pressure Enabled Drug Delivery (PEDD™) infusion systems, which optimize delivery of embolics and therapeutics for the treatment of various solid tumors. Our PEDD with SmartValve™ is the only technology designed to work in synchrony with the cardiac cycle to open collapsed open collapsed arterial vessels to enable deeper perfusion and improve therapeutic drug delivery in tumors with high intratumoral pressure. In multiple preclinical models and certain prospective and retrospective clinical studies, PEDD with SmartValve has been shown in certain prospective and retrospective clinical studies and in multiple pre-clinical models to improve therapy uptake and tumor response. Additionally, we have conducted Phase I clinical trials of a novel product candidate, nelitolimod (a TLR9 agonist), which has the potential to enhance immune system response, when delivered via PEDD, in the treatment of locally-advance pancreatic adenocarcinoma (LA-PDAC) and primary and secondary liver tumors. The combination of our PEDD technology with nelitolimod is focused on solving the two main barriers in the tumor microenvironment that inhibits the success of systemic therapies. The first barrier (mechanical) is comprised of high intratumoral pressure within tumors that limits drug uptake and the second barrier (biological) is intratumoral immunosuppression. Nelitolimod has a dual mechanism of action in solid tumors: the alteration of the tumor microenvironment by reducing immunosuppressive myeloid derived suppressor cells and simultaneous activation of immune response and recruiting T-cells to the tumor, which may allow checkpoint inhibitors to work more effectively.

TriNav™ is the newest therapy delivery device with SmartValve technology for the proprietary PEDD approach. Current sales consist of the TriNav Infusion System, introduced in 2020, and TriNav LV Infusion System, introduced in 2024. In 2020, we gained transitional pass-through payments (“TPT”) approval from the Centers for Medicare & Medicaid Services (“CMS”), which allows hospitals to cover the cost of using TriNav. The approval expired at the end of 2023. On June 1, 2023, we applied for a new technology Ambulatory Payment Classification ("APC") code with CMS. In December 2023, CMS granted a New Technology Healthcare Common Procedure Coding System ("HCPCS") code for both mapping and therapeutic procedures involving TriNav. This code, HCPCS C9797, has been assigned to the APC code 5194 - Level 4 Endovascular procedures. The code became effective on January 1, 2024, and may be reported by hospital outpatient departments and ambulatory surgical centers. Effective April 1, 2025, TriNav received a second unique and permanent HCPCS code from CMS, C8004, which has been assigned to APC 5193 (Level 3 Endovascular Procedures). This new code provides reimbursement clarity for mapping procedures conducted prior to transarterial radioembolization ("TARE").

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In 2021, we entered into a 5-year Alliance Program (the “MDACC Agreement”) with the University of Texas MD Anderson Cancer Center (“MDACC”) to serve as the lead clinicians for the PERIO-01, PERIO-02, and PERIO-03 studies. The term of the agreement was for the later of (i) five years or (ii) until the applicable studies are completed. Prior to the expiration of the term of the MDACC Agreement, either party may terminate the MDACC Agreement if the other party commits a material breach of the agreement and fails to cure such breach within 30 days of receiving notice of such breach. Effective February 25, 2025, we modified and extended the MDACC Agreement payment terms with MDACC and added a sixth year. Effective February 25, 2025, we modified and extended our strategic collaboration agreement terms with The University of Texas M.D. Anderson Cancer Center.

Liquidity

As of March 31, 2025, we had cash, cash equivalents and restricted cash of $13.4 million. The Company is still in its early stage, has a history of recurring operating losses, has yet to generate revenues sufficient to create positive cash flow and has an accumulated deficit of $289.9 million as of March 31, 2025. Without additional financing and based on our sales, operations and research and development plans, our management estimates that our existing cash and cash equivalents will be insufficient to fund our projected liquidity requirements for the next 12 months.

In accordance with ASC Topic 205-40, Presentation of Financial Statements, Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, we are required to evaluate whether there is substantial doubt about our ability to continue as a going concern each reporting period. In evaluating our ability to continue as a going concern, management projected our cash flow sources and needs and evaluated that conditions and events have raised substantial doubt about our ability to continue as a going concern within one year after the date that these condensed consolidated financial statements were issued. Management’s plans to address the conditions and events have considered our current projections of future cash flows, current financial condition, sources of liquidity and debt obligations for at least one year from the date of issuance of these condensed consolidated financial statements in considering whether we have the ability to fund future operations and meet our obligations as they become due in the normal course of business.

Our ability to fund future operations and to continue the execution of our long-term business plan and strategy will require that we raise additional capital through a combination of collaborations, strategic alliances and licensing arrangements, and issuance of additional equity and/or debt. We have funded operations resulting in the cumulative net losses of $289.9 million, as of March 31, 2025, principally with proceeds from the sale of preferred stock, from the issuance of debt and convertible debt, and the closing of the Business Combination.

For the three months ended March 31, 2025, we issued $0.3 million of common stock for cash from the exercise of stock options. As described in Note (13) Standby Equity Purchase Agreement, we have the right but not the obligation, to sell up to $30.0 million of our Common Stock at our request under the Standby Equity Purchase Agreement, which we entered into with YA II PN, Ltd. ("Yorkville") on October 2, 2023 (the "SEPA"), subject to terms and conditions specified in the agreement. For the three months ended March 31, 2025, we sold no shares of common stock under the SEPA.

On April 30, 2024 (the "OrbiMed Closing Date"), we entered into the OrbiMed Credit Agreement (the "Credit Agreement") with OrbiMed Royalty & Credit Opportunities IV, LP ("OrbiMed"), a healthcare investment firm. Under the terms of the OrbiMed Credit Agreement, we may borrow up to $50.0 million, of which we immediately drew $25.0 million, before expenses. The remaining debt is available in two increments of $10.0 million and $15.0 million, subject to the achievement of certain revenue targets. On February 18, 2025, we drew the $10.0 million increment before expenses. As part of the First Amendment To Credit Agreement and Registration Rights Agreement, effective March 20, 2025, we received a waiver for the prior default events related to the Series A Convertible Preferred Stock conversions and the Agreement was amended to allow for these conversions going forward. In addition, we received a waiver on March 31, 2025 to extend the timing for the required audited financial statements to occur on or before April 15, 2025. Effective on April 30, 2025, the Second Amendment To Credit Agreement allows for the Company accelerate payment of the Series A Preferred Stock dividends in cash payments in lieu of fractional shares upon conversion of the Preferred Stock shares. See Note (13) Debt for further discussion.

On April 30, 2025, we also entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional and accredited investors named therein (the “Purchasers”) pursuant to which the Company agreed to issue and sell to the Purchasers in a private placement (the “Private Placement”) an aggregate of 5,500,000 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), at a purchase price of $4.00 per share.

The Purchase Agreement contains customary representations, warranties and agreements by the Company and the Purchasers, indemnification rights and other obligations of the parties. In connection with the Private Placement, the Company and the Purchasers has entered into a registration rights agreement (the “Registration Rights Agreement”) at the closing, pursuant to which the Company will grant certain registration rights to the Purchasers with respect to their Shares (as further described below). In addition, the Company has committed to use commercially reasonable efforts to

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satisfy all of its obligations set forth in the Support Agreements (as defined below). The Company and its directors and officers have agreed, for a period of 60 days after the date of the Purchase Agreement, to customary lock-up and clear market provisions, as applicable, subject to certain exceptions.

The Private Placement closed on May 2, 2025. The Company received aggregate gross proceeds from the Private Placement of approximately $22.0 million, before deducting estimated offering fees and expenses payable by the Company.

Outside of these agreements, there can be no assurance that we will be able to raise such additional financing or, if available, that such financing can be obtained on satisfactory terms. If adequate capital resources are not available on a timely basis, we intend to consider limiting our operations substantially. This limitation of operations could include a hiring freeze, reductions in our workforce, reduction in cash compensation, deferring clinical trials and capital expenditures, and reducing other operating costs.

Our current operating plan, which is in part determined based on our most recent results and trends, along with the items noted above, causes substantial doubt to exist about our ability to continue as a going concern and management’s plans do not alleviate the existence of substantial doubt. Our financial statements have been prepared assuming we will continue as a going concern, which contemplates the continuity of normal business activities and realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments that might be necessary should we be unable to continue as a going concern.

We are subject to various risks and uncertainties frequently encountered by companies in the early stages of growth, particularly companies in the rapidly evolving market for medical technology-based and pharmaceutical products and services. Such risks and uncertainties include, but are not limited to, a limited operating history, need for additional capital, a volatile business and technological environment, the process to test and obtain approval to market nelitolimod, an evolving business model, and demand for our products. To address these risks, we must, among other things, gain access to capital in sufficient amounts and on acceptable terms, maintain and increase our customer base, implement and successfully execute our business strategy, develop nelitolimod, continue to enhance our technology, provide superior customer service, and attract, retain, and motivate qualified personnel. There can be no guarantee that we will succeed in addressing such risks.

(2) Summary of Significant Accounting Policies

Basis of Presentation

The accompanying interim unaudited condensed consolidated financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). The interim unaudited condensed consolidated financial statements are comprised of the condensed financial statements of the Company. In management’s opinion, the interim financial data presented includes all adjustments necessary for a fair presentation. All intercompany accounts and transactions have been eliminated. Certain information required by GAAP has been condensed or omitted in accordance with rules and regulations of the SEC. Operating results for the three months ended March 31, 2025, are not necessarily indicative of the results that may be expected for any future period or for the year ending December 31, 2025. The accompanying interim unaudited condensed consolidated financial statements should be read in conjunction with the Annual Report on Form 10-K for the year ended December 31, 2024. The December 31, 2024, Condensed Consolidated Balance Sheet is derived from the audited balance sheet included in the Annual Report on Form 10-K for the year ended December 31, 2024. A summary of our significant accounting policies is included in Note 2 to our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024. Certain of our accounting policies are considered critical, as these policies are the most important to the depiction of our financial statements and require significant, difficult or complex judgments by us, often employing the use of estimates about the effects of matters that are inherently uncertain. Such policies are summarized below.

SEC Form 10-Q filed by TriSalus Life Sciences Inc.