tlsi-20240331

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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, 2024


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 27,159,327 shares of common stock outstanding as of May 8, 2024.

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TABLE OF CONTENTS


		Page
	Special Note Regarding Forward-Looking Statements	1

	Summary Risk Factors	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	23
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	31
Item 4.	Controls and Procedures	31

PART II.	OTHER INFORMATION	33
Item 1.	Legal Proceedings	33
Item 1A.	Risk Factors	33
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	83
Item 3.	Defaults Upon Senior Securities	83
Item 4.	Mine Safety Disclosures	83
Item 5.	Other Information	83
Item 6.	Exhibits	84

Signatures		86

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;

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•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 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.

RISK FACTOR SUMMARY

Below is a summary of material factors that make an investment in our securities speculative or risky. Importantly, this summary does not address all of the risks and uncertainties that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found in the more detailed discussion in Item 1A in this Quarterly Report, and the below summary is qualified in its entirety by that more complete discussion of such risks and uncertainties. You should carefully consider the risks and uncertainties described herein as part of your evaluation of an investment in our securities:

•We have a limited operating history, have incurred significant losses since our inception and anticipate incurring increasing expenses and continuing losses for the foreseeable future.

•The Asset Purchase Agreement dated July 31, 2020, which TriSalus Operating Life Sciences, Inc. (formerly known as TriSalus Life Sciences, Inc.) entered into with Dynavax Technologies Corporation (“Dynavax”) in connection with the purchase of nelitolimod requires us to make potentially significant payments to Dynavax before we will have regulatory approval of nelitolimod and be able to generate revenue from sales of nelitolimod.

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•Until we are able to generate significant revenues or achieve profitability through product sales, we will require substantial additional capital to finance our operations and continue development of our product candidates. We cannot be certain that such additional financing will be available on terms favorable to us, or at all, which could limit our ability to grow and jeopardize our ability to continue our business operations.

•We may not be able to generate sufficient cash to service our indebtedness or borrow additional funds pursuant to our Loan Facility.

•Our revenue is primarily generated from sales of our TriNav device and we are therefore highly dependent on it for our success. Failure to achieve continued market acceptance of TriNav for any reason will harm our business and future prospects.

•TriNav is currently subject to an uncertain reimbursement environment, and any change to TriNav’s reimbursement status that reduces our level of reimbursement could cause TriNav sales to materially decline and impede market adoption.

•We currently have a limited marketing, sales and distribution organization. If we are unable to successfully grow our marketing, sales and distribution capabilities, then our product revenues related to TriNav, our results of operations and financial condition will suffer.

•We are early in our pharmaceutical development efforts, and we have only one pharmaceutical product candidate, nelitolimod, in early clinical development. If we are unable to advance our product candidates, including nelitolimod, in clinical development for any reason (including due to lack of funding), obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business, results of operations, financial condition, and prospects may be materially adversely affected.

•Clinical development is a lengthy and expensive process with an uncertain outcome. In addition, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials. Failure can occur at any stage of clinical development.

•Changes in existing third-party coverage or our inability to maintain and secure favorable reimbursement may impact our ability to sell our products, which would materially and adversely impact our business, results of operations, financial condition and prospects.

•The business and industry in which we participate are highly competitive. If we are unable to compete effectively, we will not be able to establish our products in the marketplace or maintain or grow our products’ market share in the marketplace, and as a result, our business and results of operations will be adversely impacted.

•We are subject to numerous complex regulatory requirements, and failure to comply with these regulations, or the cost of compliance with these regulations, may harm our business.

•The complexity of a combination product that includes a drug and a medical device presents additional, unique development and regulatory challenges, which may adversely impact our development plans and our ability to obtain regulatory approval or clearance of our product candidates.

•Failure to obtain, adequately protect, maintain or enforce our intellectual property rights could substantially harm our business and results of operations.

•The expiration or loss of patent protection may adversely affect our future revenues.

•We have limited experience operating as a United States public company and may not be able to adequately develop and implement the governance, compliance, risk management and control infrastructure and culture required for a public company, including compliance with the Sarbanes Oxley Act.

•Our management has identified material weaknesses in its internal control over financial reporting and we may identify additional material weaknesses in the future. If we fail to remediate the material weaknesses or if we otherwise fail to establish and maintain effective control over financial reporting, it may adversely affect our ability to accurately and timely report our financial results and may adversely affect investor confidence and business operations.

•The price of our securities has been and may continue to be volatile.

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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, 2024		December 31, 2023
Assets
Current assets:
Cash and cash equivalents	$	3,970	$	11,777
Accounts receivable	4,277		3,554
Inventory, net	2,913		2,545
Prepaid expenses	2,031		2,986
Total current assets	13,191		20,862
Property and equipment, net	1,965		2,091
Right-of-use assets	1,196		1,179
Intangible assets, net	1,113		1,127
Other assets	424		466
Total assets	$	17,889	$	25,725
Liabilities and Stockholders’ Deficit
Current liabilities:
Trade payables	$	2,348	$	3,391
Accrued liabilities	11,423		10,556
Short-term lease liabilities	363		351
Other current liabilities	260		389
Total current liabilities	14,394		14,687
Long-term lease liabilities	1,218		1,244
Contingent earnout liability	22,620		18,632
Warrant and SEPA liabilities	14,580		17,100
Total liabilities	52,812		51,663
Stockholders’ deficit:
Preferred stock, Series A, $0.0001 par value per share, $10.00 liquidation value per share. Authorized 10,000,000 shares at March 31, 2024 and December 31, 2023, respectively; issued and outstanding, 4,015,002 shares at March 31, 2024 and December 31, 2023, respectively.	—		—
Common stock, $0.0001 par value per share. Authorized 400,000,000 shares at March 31, 2024 and December 31, 2023, respectively; issued and outstanding, 26,758,272 and 26,413,213 shares at March 31, 2024, and December 31, 2023, respectively.	2		2
Additional paid-in capital	226,671		222,437
Accumulated deficit	(261,596)		(248,377)
Total stockholders’ deficit	(34,923)		(25,938)
Total liabilities and stockholders’ deficit	$	17,889	$	25,725

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,
	2024		2023
Revenue	$	6,457	$	2,984
Cost of goods sold	971		662
Gross profit	5,486		2,322
Operating expenses:
Research and development	5,857		5,642
Sales and marketing	6,687		3,249
General and administrative	4,627		3,552
Loss from operations	(11,685)		(10,121)
Other income (expense):
Interest income	92		35
Interest expense	(3)		(5)
Loss on equity issuance	—		(1,465)
Extinguishment of tranche liability	—		881
Change in fair value of SEPA and warrant liabilities	2,521		2,421
Change in fair value of contingent earnout liability	(3,988)		—
Other expense, net	(153)		(19)
Loss before income taxes	(13,216)		(8,273)
Income tax (expense) benefit	(3)		5
Net loss available to common stockholders	$	(13,219)	$	(8,268)
Deemed dividend related to Series B-2 preferred stock down round provision	$	—	$	(959)
Undeclared dividends on Series A preferred stock	$	(801)	$	—
Net loss attributable to common stockholders	$	(14,020)	$	(9,227)
Net loss per common share, basic and diluted	$	(0.60)	$	(0.57)
Weighted average common shares outstanding, basic and diluted	23,323,045		16,166,581

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, 2024 and 2023

(unaudited, in thousands except share data)


	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	$	(248,377)	$	(25,938)
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	—	—		—		—		—		(13,219)		(13,219)
At March 31, 2024	4,015,002	$	—	26,758,272		$	2	$	226,671	$	(261,596)