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What changed in TriSalus Life Sciences, Inc.'s 10-K2022 vs 2023

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Paragraph-level year-over-year comparison of TriSalus Life Sciences, Inc.'s 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+1495 added413 removedSource: 10-K (2024-04-11) vs 10-K (2023-03-22)

Top changes in TriSalus Life Sciences, Inc.'s 2023 10-K

1495 paragraphs added · 413 removed · 8 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

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Biggest changeOn December 29, 2022, the Consolidated Appropriations Act of 2023 (H.R. 2617) was signed into law and includes an extension to the TPT payment status for certain devices, including the TriNav™ Infusion System, through December 31, 2023, which satisfied the Payment Condition.
Biggest changeFor example, CMS awarded TPT payments for TriNav for the two-year period through December 31, 2022. On December 29, 2022, the Consolidated Appropriations Act of 2023 (H.R. 2617) was signed into law and includes an extension of TPT status for certain devices, including TriNav, through December 31, 2023.
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Item 1. Business. We are an early stage blank check company formed on September 11, 2020 as a Delaware corporation for the purpose of effecting an initial business combination. Since our initial public offering (as described below), we have focused our search for an initial business combination on businesses that may provide significant opportunities for attractive investor returns.
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Item 1. Business Overview We are a growing, oncology focused medical technology business bringing disruptive drug delivery technology with the goal of improving therapeutic delivery to liver and pancreatic tumors. Additionally, we are exploring the integration of our technology with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of liver and pancreatic indications.
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Our efforts to identify a prospective target business are not limited to a particular industry or geographic region, although we have focused on finding businesses primarily operating in the healthcare sector in the United States and we entered into a business combination agreement with TriSalus on November 11, 2022.
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Our ultimate goal is to transform the treatment paradigm for patients battling liver and pancreatic tumors.
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Initial Public Offering and Extension of our Combination Period On December 22, 2020, we consummated our initial public offering of 25,000,000 units.
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We have developed an innovative organ-specific platform that is designed to overcome two of the most 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) the immunosuppressive properties of liver and pancreatic tumor immune cells.
Removed
Each unit consists of one share of Class A common stock and one-third of one redeemable warrant of the Company, with each whole warrant entitling the holder thereof to purchase one share of Class A common stock for $11.50 per share. The units were sold at a price of $10.00 per unit, generating gross proceeds to the Company of $250,000,000.
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By systematically addressing these barriers, we aim to improve response to therapies and to enable improved patient outcomes. Background Liver and pancreatic cancers are among the world’s most lethal diseases. Depending on the disease stage, many patients have no curative treatment options and have poor outcomes, with 5-year survival rates ranging from 8-20% for patients with advanced disease.
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Simultaneously with the closing of the initial public offering, we completed the private sale of an aggregate of 4,933,333 warrants to our sponsor at a purchase price of $1.50 per private placement warrant, generating gross proceeds of $7,400,000.
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While immunotherapy represents one of the greatest advancements in cancer treatment over the past 50 years, patients with primary or secondary tumors in the liver or pancreas are less likely to respond to treatment relative to most other cancer types that do not involve these sites of disease.
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A total of $250,000,000 of the proceeds from the initial public offering and the sale of the private placement warrants was placed in the trust account maintained by Continental, acting as trustee. We originally had up to 24 months from the closing of our initial public offering, or until December 22, 2022, to consummate an initial business combination.
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These patients need new treatment options designed to address the unique challenges specific to liver and pancreatic tumors that limit the success of immunotherapy.
Removed
However, at the Extension Special Meeting held on December 12, 2022, the Company’s stockholders approved an amendment to our amended and restated certificate of incorporation to extend the date by which we must consummate our initial business combination from December 22, 2022 to June 22, 2023 (or such earlier date as determined by our board of directors).
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We have developed a platform approach to address the unique challenges of treating tumors in the liver and pancreas by integrating our innovative drug delivery technology with our investigational immunotherapeutic agent, nelitolimod, formerly known as SD-101, with the goal of overcoming the two primary barriers that inhibit treatment success: intratumoral pressure and immunosuppression, both of which limit therapeutic delivery and efficacy.
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In connection with the Extension Special Meeting, stockholders holding 23,046,578 public shares exercised their right to redeem their shares for a pro rata portion of the funds in the trust account.
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PEDD & TriNav- Device Business with Potential for Growth: Our delivery method — Pressure-Enabled Drug Delivery (PEDD TM ) (“PEDD”) — modulates pressure and flow within blood vessels to improve intravascular therapeutic delivery into tumors and is designed to increase the likelihood of tumor response in comparison to conventional delivery technologies.
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As a result, approximately $232.37 million (approximately $10.08 per public share) was removed from the trust account and paid to such holders and approximately $19.70 million remained in the trust account. Following the redemptions, the Company had 1,953,422 public shares outstanding.
Added
Our on-market, 510(k) cleared PEDD device, the TriNav Infusion System (“TriNav”) is currently being used for a number of interventional radiology procedures, most commonly transarterial radioembolization (“TARE”) and transarterial chemoembolization (“TACE”) in patients with either primary liver cancer and in patients with liver metastases.
Removed
In connection with the approval of the Extension, the Company issued the 2022 Extension Note to the sponsor, and the sponsor (or one or more of its affiliates, members or third-party designees) provided the Extension Funds to the Company. The 2022 Extension Note does not bear interest and matures upon the closing of the Company’s initial business combination.
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TriNav is a highly innovative, novel technology, FDA-cleared drug delivery device that has undergone peer-reviewed studies at multiple clinical sites. The PEDD method has now been used in over 18,000 procedures, primarily TACE and TARE. TriNav achieved $18.5 million in revenue in 2023 with fourth quarter growth of 77% vs. the previous year.
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In the event that the Company does not consummate a business combination, the 2022 Extension Note will be repaid only from amounts remaining outside of the trust account, if any. The proceeds from the initial payment under the Extension Contributions have been deposited in the trust account in connection with the Extension.
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We also have developed a separate 510(k) cleared PEDD device for infusions into the pancreas (Pancreatic Retrograde Venous Infusion (PRVI) device) to treat pancreatic tumors.
Removed
It is the job of our sponsor and management team to complete our initial business combination. Our management team is led by Karim Karti, our Chairman, Christopher C. Dewey, our Chief Executive Officer and director, David J. Matlin, our Chief Financial Officer and director, and Robert H. Weiss, our Chief Administrative Officer and Secretary.
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TriSalus developed a novel way to access the pancreas via the venous vasculature where the vessels are larger, easier to access and PRVI is designed to address many of the limitations inherent to arterial infusions in the pancreas. The PRVI device is currently being studied in a clinical trial for nelitolimod delivery into pancreatic tumors.
Removed
We must complete our initial business combination within the Combination Period. If our initial business combination with TriSalus or another target company is not consummated within the Combination Period, then our existence will terminate, and we will distribute all amounts in the trust account.
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Although FDA-cleared, the PRVI device has not yet been commercialized and commercial sale is not anticipated before 2025.
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Termination of Memic Business Combination Agreement On August 12, 2021, we entered into the Memic Business Combination Agreement with Memic and Memic Merger Sub.
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We are currently studying the ability of nelitolimod, an investigational class C toll-like receptor 9 (“TLR9”) agonist, to reactivate the immune system within the liver and pancreas by broadly reprogramming immune cells and reducing myeloid derived suppressor cells (“MDSCs”), cells which cause immunosuppression, to enable more durable responses to immune checkpoint inhibitors (“CPIs”), thereby improving patient outcomes.
Removed
On March 9, 2022, we convened and then adjourned, without conducting any other business, a special meeting of stockholders relating to the proposed business combination with Memic and the other transactions contemplated by the Memic Business Combination Agreement.
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Nelitolimod has previously been shown in both clinical and non-clinical studies to broadly induce interferon production, dendritic cell activation, and B cell activation.
Removed
On March 10, 2022, we entered into the Termination Agreement with Memic and Memic Merger Sub, under which the parties agreed to mutually terminate the Memic Business Combination Agreement.
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Through pre-clinical experiments and early clinical experience in patients with liver and pancreatic tumors, we have demonstrated that nelitolimod reduces MDSCs, which are important mediators of immunosuppression in these tumor types, while recruiting T cells which are the target of CPIs.
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The termination of the Memic Business Combination Agreement became effective as of March 9, 2022. 1 Table of Contents As a result of the termination of the Memic Business Combination Agreement, the Memic Business Combination Agreement, along with any Transaction Agreement (as defined in the Memic Business Combination Agreement) entered into in connection therewith, are void and there is no liability under either of the Memic Business Combination Agreement or any Transaction Agreement on the part of any party thereto (including, without limitation, under the SPAC Sponsor Letter Agreement by and among Memic, the sponsor, and the other parties signatory thereto dated August 12, 2021).
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We believe that the combination of PEDD with nelitolimod creates a platform approach with the potential to address common therapeutic barriers across numerous cancer indications affecting the liver and pancreas and that this approach 1 Table of Contents could provide a meaningful benefit to patients.
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Pursuant to the Termination Agreement, subject to certain exceptions, the Company, Memic and Memic Merger Sub have also agreed, on behalf of themselves and their respective related parties, to a release of claims relating to the proposed business combination.
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There is also the potential that this platform may not only enable CPIs, but other classes of immunotherapy as well, such as cell therapeutics. Currently we are completing phase 1 clinical trials for four indications, in leading academic oncology centers across the United States (“U.S.”).
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TriSalus Business Combination TriSalus Merger Agreement On November 11, 2022, the Company entered into the TriSalus Merger Agreement with Merger Sub, and TriSalus under which Merger Sub will merge with and into TriSalus, with TriSalus surviving the TriSalus Merger as a wholly-owned subsidiary of the Company.
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In these trials, PEDD devices are used to administer our investigational immunotherapy candidate, nelitolimod, through a regional intravascular approach for patients with liver and pancreatic tumors.
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The TriSalus Business Combination is subject to certain closing conditions as summarized below under “Conditions to Closing.” Upon consummation of the TriSalus Business Combination, the Company will be renamed “TriSalus Life Sciences, Inc.” Capitalized terms not defined herein, but otherwise used in the following description have the meanings ascribed to them in the TriSalus Merger Agreement.
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We believe this approach will maximize TLR9 stimulation within the liver and pancreas and eliminate immunosuppressive cells to broadly reprogram the tumor microenvironment (“TME”) with the goal of enabling improved efficacy of systemic immunotherapies like CPIs or cell therapy while maintaining a tolerable safety profile.
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Merger Consideration The aggregate consideration payable to the stockholders of TriSalus at the closing of the TriSalus Business Combination (the “Closing”) is $220,000,000, payable solely in shares of the Company’s common stock, valued at $10.00 per share (the “Closing Merger Consideration”).
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We are currently evaluating data from these trials and determining which indication we intend to advance. Overcoming Barriers to Effective Drug Delivery with PEDD Systemic delivery of cancer therapeutics presents two critical challenges for patients with liver tumors. First, based on the normal distribution of cardiac output, the liver will receive only a small fraction of the dose.
Removed
Immediately prior to the Closing, the shares of Class A common stock and the warrants to purchase shares of Class A common stock issued to the public stockholders that comprise each issued and outstanding unit will be automatically separated, if not already separated prior to such time, and the holder thereof shall be deemed to hold one share of Class A common stock and one-third of one warrant to purchase Class A common stock; provided that any fractional warrants issuable to a holder upon the separation of the units will be rounded down to the nearest whole number of warrants.
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Second, intratumoral solid stresses compress the interior of the tumor and deform blood vessels, inhibiting therapeutic delivery into the tumor tissue. In particular, vessel leakiness together with vascular compression causes elevated interstitial fluid pressure that hinders delivery of therapeutic agents and limits efficacy.
Removed
Following the separation of the units but prior to the Closing, the Class B common stock will automatically convert into Class A common stock, and pursuant to the proposed amended and restated certificate of incorporation to be effective immediately prior to the Closing, if approved by the Company’s stockholders, Class A common stock and Class B common stock will be reclassified into a single class of common stock.
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The end result of these factors creates barriers to the systemic administration of chemotherapeutic agents and nanomedicines to tumors, reducing treatment efficacy. PEDD Delivery Technology is a technological solution to this intratumoral pressure barrier that can enable more effective delivery of therapeutic agents to liver and pancreatic tumors.
Removed
Immediately prior to the Closing, each share of TriSalus’ issued and outstanding preferred stock will automatically convert into shares of TriSalus common stock (the “Preferred Conversion”), and all in-the-money TriSalus warrants that would be exercised or otherwise exchanged in full in accordance with their terms by virtue of the occurrence of the TriSalus Business Combination will be exercised for shares of TriSalus common stock, such that the holders thereof will receive Closing Merger Consideration as holders of TriSalus common stock.
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PEDD devices are engineered to overcome high intratumoral pressure through creation of a favorable pressure gradient, causing increased blood flow to the tumor while constricting blood flow to normal tissue minimizing systemic exposure and decreasing toxicity.
Removed
TriSalus warrants that are out-of-the-money will be cancelled for no consideration immediately prior to the Closing. At the time of the TriSalus Business Combination, the outstanding options for shares of TriSalus common stock under TriSalus’ equity plan will be assumed by the Company and converted into options to purchase common stock (the “Assumed Equity”).
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The unique valve on the PEDD device, referred to as SmartValve, works in sync with the cardiac cycle and preserves more than 70% of forward blood flow with a pulsative response (vs. total occlusion) due to its intermittently occlusive design.
Removed
Representations, Warranties and Covenants The TriSalus Merger Agreement contains customary representations, warranties and covenants by the parties thereto, including, among other things, covenants with respect to the conduct of the Company and TriSalus during the period between execution of the TriSalus Merger Agreement and the Closing, including the parties’ agreement not to solicit or enter into any inquiry, proposal or offer, or any indication of interest in making an offer or proposal for an alternative competing transactions.
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This physiologically and traumatically increases local vascular pressure at the target location close to the tumor, infusing therapeutics into resistive tumor vessels to enable deeper perfusion and to improve therapeutic delivery. The SmartValve also provides a fixed centro-luminal catheter position, unlike a standard microcatheter where the position of the catheter is in a random, off-centered position.
Removed
The representations, warranties and covenants made under the TriSalus Merger Agreement will not survive the Closing; provided, however, that any covenants that are to be performed at or after the Closing shall survive until such covenant has been performed or satisfied pursuant to their terms.
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This more reproducible catheter positioning has been associated with a more homogeneous particle distribution in an in vivo hepatic arterial model. The SmartValve has also been shown to reduce or eliminate reflux and has been shown in clinical studies to reduce delivery of therapeutics to non-target tissues.
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Each of the Company and TriSalus have agreed to use their commercially reasonable efforts to cause the TriSalus Business Combination to be consummated as soon as practicable. 2 Table of Contents Post-Closing Board of Directors Prior to the Closing, the parties shall use all commercially reasonable efforts to designate and nominate to the Company’s board of directors nine directors, which shall include seven directors designated by TriSalus (with at least a majority of the authorized number of such directors to qualify as “independent directors” pursuant to Nasdaq listing standards) (the “TriSalus Directors”), and two directors as non-executive directors designated solely by the Company (the “Company Directors”).
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In independent clinical studies, the PEDD method of delivery has demonstrated the ability to overcome the infusion barriers of the TME and to improve therapeutic delivery.
Removed
Following the Closing, the board of directors will be a classified board with three classes of directors. No Solicitation of Acquisition Proposals Each party also agreed, during the period between the execution of the TriSalus Merger Agreement and continuing until the earlier of its Closing or termination, not to solicit or enter into any alternative competing transactions.
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Additionally, in a recent large Health Economics and Outcome Research ("HEOR") study, (a 300 million patient dataset covering over 98% of US patients), capturing real-world safety and clinical outcomes for TriNav in its launch phase (2020-2022), demonstrated that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results that were comparable to patients with a lower disease burden.
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Conditions to Closing The Closing is subject to certain conditions, including, among others, that (i) the stockholders of TriSalus and the stockholders of the Company approve the TriSalus Business Combination, (ii) Nasdaq approves for listing the common stock to be issued in connection with the TriSalus Business Combination, (iii) the Company has at least $60,000,000 in Available Closing Acquiror Cash (as defined in the TriSalus Merger Agreement), which amount includes any proceeds or committed amounts from private equity or debt sources, the remaining balance in the Company’s trust account (after taking into account stockholder redemptions), minus the payment of up to $6,000,000 of the Company’s transaction expenses (subject to potential increases as further described in the TriSalus Merger Agreement) (such amount, the “Company Transaction Expenses Cap”), (iv) for the calendar year ending December 31, 2023, either (a) by legislation or application regulatory action, the Transitional Pass through Payment (“TPT”) provision applicable to TriSalus’ TriNav™ Infusion System will have been extended or a permanent reimbursement code will have been assigned to the TriNav™ Infusion System as specified in the TriSalus Merger Agreement or (b) use of existing reimbursement codes with respect to the TriNav™ Infusion System will provide adequate profitability to TriSalus (the “Payment Condition”), and (v) the Company has $5,000,001 or more in net tangible assets at the Closing.
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The study also demonstrated that: • In TACE procedures, interventional radiologists were able to deliver significantly more chemotherapeutic to the tumor when using TriNav vs. the amount delivered using standard catheters, a critical treatment goal. • TriNav patients had fewer 30-day inpatient visits post-procedure vs. non-TriNav patients in matched cohort comparison. • TriNav HCC patients were more likely to have a liver transplant in matched cohort comparison. • TriNav TARE patients with liver metastases had fewer clinical complications post-procedure vs. non-TriNav patients in matched cohort comparison. ◦ TriNav TARE patients with liver metastases had lower rates of post-procedure fatigue vs. non-TriNav patients.
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Termination The TriSalus Merger Agreement may be terminated prior to the Closing under certain circumstances, including, among others, (i) by written consent of TriSalus and the Company, (ii) by written notice from either the Company or TriSalus, if (A) the Closing has not occurred on or before December 22, 2022, as such date may be extended to match any extension to the Company’s last date to consummate an initial business combination under its certificate of incorporation (currently June 22, 2023) obtained by approval of the Company’s stockholders (the “Outside Date”), unless the terminating party’s failure to comply in any material respect with its obligations under the TriSalus Merger Agreement shall have contributed to the failure of the Closing to have occurred on or prior to the Outside Date, (B) the consummation of the TriSalus Business Combination is permanently enjoined, (C) the Company does not obtain stockholder approval of the TriSalus Business Combination at the special meeting at which such approval shall be voted upon, or (D) by March 31, 2023, the Company shall not have obtained commitments for private financing of at least $40,000,000 in support of the TriSalus Business Combination, (iii) by written notice from either the Company or TriSalus, in the event that the other party breaches any of its representations, warranties, covenants or other agreements under the TriSalus Merger Agreement that would result in the failure of the conditions to the Company’s or TriSalus’ obligation to consummate the TriSalus Business Combination and such breach has not been cured by the breaching party within 30 days after receiving notice of such breach, (iv) by TriSalus at any time prior to the approval of the TriSalus Business Combination by the Company’s public stockholders, if the board of directors of the Company has made a change in recommendation to its stockholders regarding the TriSalus Business Combination, and (v) by written notice to TriSalus from the Company, if TriSalus does not obtain stockholder approval within 25 days after delivering an information statement regarding the TriSalus Business Combination to its stockholders. 3 Table of Contents Amended and Restated Registration Rights Agreement On the day of Closing, the Company will enter into an amended and restated registration rights agreement (the “A&R RRA”) with the sponsor, and certain TriSalus stockholders (the “Requisite Stockholders,” and together with the sponsor, collectively, the “Investors”), which, among other things, amends and restates the registration rights agreement entered into by and among the Company and the sponsor at the time of the Company’s initial public offering.
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The results from this HEOR study suggests that TriNav is preferentially selected to treat patients with higher burden of disease than patients treated with standard catheters, yet these patients show comparable results post-treatment when compared to patients with lower disease burden. In matched cohort comparisons, TriNav patients showed meaningful trends towards better outcomes, including an increased rate of liver transplant.
Removed
Pursuant to the terms of the A&R RRA, among other things, the Company will be obligated to file, within 45 days of the Closing, a registration statement covering re-sale of the shares of common stock issued or issuable to the Investors.
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These results also demonstrate how real-world data complement traditional clinical trials to provide a more robust and timely understanding of the benefits realized by patients. TriSalus is committed to updating this data set continuously, and to continue reinforcing the benefit TriNav and the PEDD approach have been shown to provide to patients, providers, and payers.
Removed
Subject to certain requirements and customary conditions, the A&R RRA also provides the Investors with piggyback registration rights and demand registration rights. The A&R RRA provides that the Company will pay certain expenses relating to such registration and indemnify the Investors against certain liabilities.
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Treatment of Liver Tumors with Transarterial Radioembolization (TARE) 2 Table of Contents TARE is an image guided, locoregional therapy that involves hepatic artery embolization with intra-arterial infusion of Yttrium-90 (" 90 Y") microspheres for treatment of hepatocellular cancer as well as patients with certain metastatic liver cancers.
Removed
Lock-up Agreement In connection with the entry into the TriSalus Merger Agreement, on November 11, 2022, the Requisite Stockholders entered into lock-up agreements (the “Lock-up Agreements”) with the Company, pursuant to which the Requisite Stockholders will not transfer shares of common stock held by them prior to the earliest of (x) three hundred and sixty-five (365) days after the Closing, (y) the date on which the last sales price of common stock equals or exceeds $12.00 per share, subject to adjustment as provided therein, for any 20 trading days within any 30-consecutive-day trading period commencing at least 150 days after the Closing, and (z) the date following Closing on which the Company consummates a liquidation, merger, tender offer, or similar transaction resulting in all the Company stockholders having the right to exchange their shares of common stock for cash, securities, or other property.
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The aim of the treatment is to target tumor cells with a high dose of radiation while limiting exposure to healthy tissue. The PEDD approach is designed to provide a reliable method to maximize the tumor to normal liver ratio (“T/N ratio”).
Removed
Sponsor Support Agreement In connection with the entry into the TriSalus Merger Agreement, on November 11, 2022, the sponsor entered into a support agreement (the “Sponsor Support Agreement”) with the Company and TriSalus, pursuant to which the sponsor agreed, among other things, to vote or cause to be voted (or express consent or dissent in writing, as applicable) all its shares of common stock that are entitled to vote to approve and adopt the TriSalus Merger Agreement and the TriSalus Business Combination.
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PEDD devices are designed to not only increase therapeutic delivery to target tumors but also to provide anti-reflux protection to minimize off-target delivery of radioactive micro spheres and the potential complications associated with undesired normal tissue exposure.
Removed
The sponsor also agreed (i) not to sell or transfer any of its shares of Common Stock or the Company warrants prior to the Closing, except to affiliates of the sponsor who execute a joinder to the Sponsor Support Agreement or by private sales or transfers made in connection with any forward purchase agreement or similar arrangement or in connection with the consummation of the TriSalus Business Combination, (ii) to assume the transaction expenses of the Company which exceed the Company Transaction Expenses Cap, (iii) to forfeit 2,187,500 shares of common stock (which represents 35% of the sponsor’s shares of the Company as of November 11, 2022), and (iv) to subject 3,125,000 of its shares of common stock (which represents 50% of the sponsor’s shares of the Company as of November 11, 2022) to certain vesting restrictions as set forth in the Sponsor Support Agreement (it being understood that the undertakings in the foregoing clauses (iii) and (iv) shall be null and void in the event that the Sponsor Support Agreement or TriSalus Merger Agreement is terminated).
Added
A pilot study of a PEDD catheter not only demonstrated reduced hepatic nontarget embolization but also found a significant increase in tumor deposition of 99m Tc-MAA by a factor of 1.68 (range 1.33 to 1.90, p In patients undergoing TARE, augmenting the T/N ratio for the delivery of therapeutic micro spheres has the potential to increase therapeutic response as a direct positive relationship between absorbed dose and tumor response.
Removed
Stockholder Support Agreements In connection with the entry into the TriSalus Merger Agreement, on November 11, 2022, the Company, TriSalus, and the Requisite Stockholders executed and delivered support agreements (the “Stockholder Support Agreements”), pursuant to which each Requisite Stockholder agreed to, among other things, (i) consent to, and vote to approve and adopt, the TriSalus Merger Agreement and the TriSalus Business Combination, (ii) waive any dissenters’ or approval rights under applicable law in connection with the TriSalus Business Combination, and (iii) not transfer, subject to certain permitted exceptions, any of such stockholder’s TriSalus shares prior to the Closing.
Added
In addition to the potential for improved response, an increased T/N ratio reduces radiation exposure to normal liver parenchyma and reduces the risk of associated liver toxicity.
Removed
Raymond James Agreements Raymond James & Associates, Inc. (“Raymond James”) was originally engaged by the Company to act as sole manager for the IPO and would be entitled to a deferred underwriting fee of $8,750,000 upon the consummation of a business combination.
Added
Treatment of Liver Tumors with Transarterial Chemoembolization (TACE) TACE is an image-guided, locoregional therapy that involves hepatic artery embolization with intra-arterial infusion of a chemotherapeutic agent and is used most commonly for treatment of HCC and hepatic metastases of colorectal and neuroendocrine tumors in the U.S.
Removed
In connection with the entry into the TriSalus Merger Agreement, on November 11, 2022, the Company and Raymond James amended that certain Underwriting Agreement, dated December 17, 2020, pursuant to which, Raymond James agreed to waive the foregoing deferred underwriting fee in its entirety if the TriSalus Business Combination is consummated.
Added
As with TARE, the goal of TACE procedures is to deliver chemotherapeutic agents (in either an emulsion or as part of a drug-eluting bead system) with the goal of complete tumor coverage while avoiding delivery of therapeutic or embolic beads to normal tissue.
Removed
Raymond James was separately engaged by the Company to act as its investment banking advisor in connection with a business combination, and will receive customary fees for its 4 Table of Contents services in that role if the TriSalus Business Combination is consummated.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAny of these factors could result in a significant or material adverse effect on our results of operations or financial condition. Additional risks could arise that may also affect our business or ability to consummate an initial business combination.
Biggest changeAny of these sanctions could have a material adverse effect on our reputation, business, results of operations and financial condition.
Removed
Item 1A. Risk Factors. As a smaller reporting company under Rule 12b-2 of the Exchange Act, we are not required to include risk factors in this Report.
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Item 1A. Risk Factors Investing in our securities involves a high degree of risk.
Removed
However, below is a partial list of material risks, uncertainties and other factors that could have a material effect on the Company and its operations: ● we are a blank check company with no revenue or basis to evaluate our ability to select a suitable business target; ● we may not complete our initial business combination, including the TriSalus Business Combination, or select and complete our initial business combination with an appropriate alternative target business or businesses in the prescribed time frame; ● our expectations around the performance of a prospective target business or businesses, including TriSalus, may not be realized; ● we may not be successful in retaining or recruiting required officers, key employees or directors following our initial business combination; ● our officers and directors may have difficulties allocating their time between the Company and other businesses and may potentially have conflicts of interest with our business or in approving our initial business combination; ● we may not be able to obtain additional financing to complete our initial business combination or reduce the number of stockholders requesting redemption; ● we may issue our shares to investors in connection with our initial business combination at a price that is less than the prevailing market price of our shares at that time; ● you may not be given the opportunity to choose the initial business target or to vote on the initial business combination; ● trust account funds may not be protected against third party claims or bankruptcy; ● an active market for our public securities’ may not develop and you will have limited liquidity and trading; ● our financial performance following a business combination with an entity may be negatively affected by their lack an established record of revenue, cash flows and experienced management; ● because we intend to seek a business combination with a target business in the healthcare industry, we expect our future operations to be subject to risks associated with this industry. ● changes in the market for directors and officers liability insurance could make it more difficult and more expensive for us to negotiate and complete an initial business combination; ● there may be more competition to find an attractive target for an initial business combination, which could increase the costs associated with completing our initial business combination; ● we may engage one or more of our underwriters or one of their respective affiliates to provide additional services to us after the initial public offering, which may include acting as a financial advisor in connection with an initial business combination or as placement agent in connection with a related financing transaction.
Added
Before you make a decision to buy our securities, in addition to the risks and uncertainties discussed above under “Special Note Regarding Forward-Looking Statements,” you should carefully consider the risks and uncertainties described below together with all of the other information contained in this Annual Report , including the accompanying financial statements and related notes, and in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” If any of the following events or developments described as risks were to occur, either alone or taken together, our business, financial condition, results of operations and future growth prospects would likely be materially and adversely affected.
Removed
Our underwriters are entitled to receive deferred underwriting commissions that will be released from the trust account only upon a completion of an initial business combination.
Added
In these circumstances, the market price of our securities could decline, and you could lose all or part of your investment. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently believe to be immaterial may also adversely affect our business.
Removed
These financial incentives may cause them to have potential conflicts of interest in rendering any such additional services to us after the initial public offering, including, for example, in connection with the sourcing and consummation of an initial business combination; 23 Table of Contents ● we may attempt to complete our initial business combination with a private company, such as TriSalus, about which little information is publicly available, which may result in a business combination with a company that is not as profitable as we suspected, if at all; ● our warrants are accounted for as derivative liabilities and are recorded at fair value upon issuance with changes in fair value each period reported in earnings, which may have an adverse effect on the market price of our common stock or may make it more difficult for us to consummate an initial business combination; ● since our initial stockholders will lose their entire investment in us if our initial business combination is not completed (other than with respect to any public shares they may acquire during or after the initial public offering), and because our sponsor, officers and directors may profit substantially even under circumstances in which our public stockholders would experience losses in connection with their investment, a conflict of interest may arise in determining whether a particular business combination target is appropriate for our initial business combination; ● changes in laws or regulations or how such laws or regulations are interpreted or applied, or a failure to comply with any laws or regulations, may adversely affect our business, including our ability to negotiate and complete our initial business combination, and results of operations; ● the value of the founder shares following completion of our initial business combination is likely to be substantially higher than the nominal price paid for them, even if the trading price of our common stock at such time is substantially less than $10.00 per share; ● resources could be wasted in researching acquisitions that are not completed, which could materially adversely affect subsequent attempts to locate and acquire or merge with another business.
Added
RISKS RELATED TO OUR BUSINESS Risks Related to Our Financial Condition 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. Our independent registered public accountants and management have expressed substantial doubt as to our ability to continue as a going concern.
Removed
If we have not completed our initial business combination within the Combination Period, our public stockholders may receive only approximately $10.00 per share , or less than such amount in certain circumstances, on the liquidation of our trust account and our warrants will expire worthless; ● the SEC has recently issued proposed rules relating to certain activities of SPACs.
Added
We are a commercial-stage medical device and Phase I clinical-stage pharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We have incurred significant losses since inception, including net losses of $59.0 million and $47.2 million for the years ended December 31, 2023, and 2022, respectively.
Removed
Certain of the procedures that we, a potential business combination target, or others may determine to undertake in connection with such proposals may increase our costs and the time needed to complete our initial business combination and may constrain the circumstances under which we could complete an initial business combination.
Added
As of December 31, 2023, we had an accumulated deficit of $248.4 million. We anticipate incurring increasing research and development and general and administrative expenses related to our operations and transition into a public company for the foreseeable future.
Removed
The need for compliance with such proposals may cause us to liquidate the funds in the trust account or liquidate the Company at an earlier time than we might otherwise choose; ● if we are deemed to be an investment company for purposes of the Investment Company Act, we would be required to institute burdensome compliance requirements and our activities would be severely restricted.
Added
Losses will likely continue and may increase in the future as we continue to incur significant expenses 30 Table of Contents related to drug development. We may find that these efforts are more expensive than we currently anticipate or that these efforts may not result in revenues, which would further increase our losses.
Removed
As a result, in such circumstances, unless we are able to modify our activities so that we would not be deemed an investment company, we may abandon our efforts to complete an initial business combination and instead liquidate the Company; ● to mitigate the risk that we might be deemed to be an investment company for purposes of the Investment Company Act, in December 2022, we instructed the trustee to liquidate the investments held in the trust account and instead to hold the funds in the trust account in a demand deposit account until the earlier of the consummation of our initial business combination or our liquidation.
Added
In addition, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by clinical-stage pharmaceutical companies.
Removed
As a result, we will likely receive less interest on the funds held in the trust account, which will reduce the dollar amount our public stockholders will receive upon any redemption or liquidation of the Company; ● we may not be able to complete an initial business combination with certain potential target companies if a proposed transaction with the target company may be subject to review or approval by regulatory authorities pursuant to certain U.S. or foreign laws or regulations, including the Committee on Foreign Investment in the United States; ● recent increases in inflation and interest rates in the United States and elsewhere could make it more difficult for us to consummate an initial business combination; ● military conflict in Ukraine or elsewhere may lead to increased price volatility for publicly traded securities, which could make it more difficult for us to consummate an initial business combination; 24 Table of Contents ● a 1% U.S. federal excise tax may be imposed on us in connection with our redemptions of shares in connection with a business combination or other stockholder vote pursuant to which stockholders would have a right to submit their shares for redemption; and ● there is substantial doubt about our ability to continue as a “going concern”. ​ For the complete list of risks relating to our operations, see the section titled “Risk Factors” contained in our (i) IPO Registration Statement, (ii) our Annual Report on Form 10-K/A for the fiscal year ended December 31, 2020 filed with the SEC on June 28, 2021,and December 13, 2021, (iv) our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed with the SEC on March 3, 2022, (iv) our quarterly report on Form 10-Q/A for the quarter ended September 30, 2021, filed with the SEC on December 13, 2021 and (v) our quarterly reports on Form 10-Q for the quarters ended, March 31, 2022, June 30, 2022 and September 30, 2022 filed with the SEC on May 16, 2022, August 10, 2022 and November 10, 2022, respectively, and (vi) our Definitive Proxy Statement filed with the SEC on November 7, 2022.
Added
If we are unable to achieve and/or sustain profitability, or if we are unable to achieve the growth that we expect from these efforts, it could have a material adverse effect on our business, financial condition or results of operations. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.
Removed
We may disclose changes to such risk factors or disclose additional risk factors from time to time in our future filings with the SEC.
Added
In addition, the Report of Independent Registered Public Accounting Firm to our December 31, 2023, financial statements includes an explanatory paragraph that expressed substantial doubt about our ability to continue as a going concern.
Removed
For risk factors relating to the TriSalus Business Combination, see the section titled “Risk Factors” contained in the TriSalus Registration Statement initially filed with the SEC on January 6, 2023 (File No. 333-269138), as amended. ​ Item 1B. Unresolved Staff Comments. Not applicable. ​
Added
Additionally, our management has independently determined that there is substantial doubt about our ability to continue as a going concern because we have incurred significant operating losses and expect to continue incurring losses for the foreseeable future.
Added
Our financial statements were prepared assuming that we will continue as a going concern and do not include any adjustments that may result from the outcome of this uncertainty.
Added
Without additional financing and based on our sales, operations and research and development plans, our management estimates that our existing cash and cash equivalents as of December 31, 2023, will be insufficient to fund our projected liquidity requirements for the next 12 months, creating substantial doubt about our ability to continue as a going concern, and we may be unable to realize assets and discharge liabilities in the ordinary course of operations.
Added
If we are unable to obtain sufficient funding, we may be forced to delay, scale back, or eliminate some or all of our research and development activities, our financial condition and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern.
Added
Future financial statements may include similar qualifications about our ability to continue as a going concern.
Added
If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern; investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms or at all.
Added
The Dynavax Agreement, entered into by Legacy TriSalus in connection with its 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.
Added
Pursuant to the Dynavax Agreement, as of the date of this Annual Report, we have paid Dynavax $12 million to date and we may be required to pay Dynavax up to an additional $158 million upon the achievement of certain development and regulatory milestones with respect to nelitolimod.
Added
We will also be required to pay up to $80 million upon achieving certain commercial milestones once sales of nelitolimod have begun. The Dynavax Agreement also obligates us to pay royalties based on potential future net sales of products containing nelitolimod compound on a product-by-product and country-by-country basis during the applicable royalty term.
Added
Such royalties are subject to reduction by up to 50% in certain circumstances. Our failure to satisfy these payment obligations or other obligations under the Dynavax Agreement could result in penalties or litigation, which could have a material adverse effect on our business, financial condition, and results of operations.
Added
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.
Added
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.
Added
Based on our sales, operations, and research and development plans, we expect that our existing cash and cash equivalents as of December 31, 2023, will be sufficient to fund operations into the second quarter of 2024.
Added
We expect to incur significant expenses and operating losses for the foreseeable future as we continue to invest in the commercialization of TriNav, clinical trials and other development, manufacturing and regulatory activities for TriNav, nelitolimod and our other product candidates, and discovery research and development.
Added
Based on our history of losses, we do not expect that we will be able to fund our longer-term capital and liquidity needs through our cash balances and operating cash flow alone.
Added
Until we can generate a sufficient amount of revenue, we will need to finance our operations through strategic alliance and licensing arrangements and/or public or private debt and equity financings.
Added
We expect to need to obtain substantial additional funding in connection with our continuing operations and planned activities, including to continue the clinical development of, and seek regulatory approval for, nelitolimod in any indication, to expand our business, to respond to competitive pressure and to make acquisitions.
Added
The amount of capital we will need may change depending on, among other things, the success of our efforts to grow revenue, our efforts to continue to effectively manage expenses, the results of our research and development and clinical trials for product candidates, and costs arising from seeking regulatory approvals. 31 Table of Contents We may not succeed in raising additional funds in a timely manner.
Added
The timing of our need for additional funds will depend on many factors, which are difficult to predict or may be outside of our control, including: ◦ the revenue received from sales of TriNav; ◦ the costs and timing of research and development programs, including for additional Pressure- Enabled Drug Delivery (“PEDD”) devices; ◦ the scope, progress, results, resources, time and costs of preclinical development, laboratory testing and clinical trials for our current and future product candidates; ◦ the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; ◦ our ability to establish collaborations on favorable terms, if at all; ◦ the costs, timing and outcome of the regulatory review and approval of nelitolimod and any future product candidate; ◦ the timing of any milestone payments or royalties due to Dynavax; and ◦ the costs of operating as a public company.
Added
If our estimates and predictions relating to any of these factors are incorrect, we may need to modify our business plans.
Added
Conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve product sales for nelitolimod or any of our product candidates. In addition, nelitolimod and any future product candidates, if approved, may not achieve commercial success.
Added
Our ability to raise additional capital in the equity and debt markets, should we choose to do so, will depend upon many factors, including but not limited to, the market demand for our Common Stock, which itself is subject to a number of development and business risks and uncertainties, as well as investor perception of our creditworthiness and prospects.
Added
It will also depend on a number of factors, including market conditions, interest rates, our operating performance and our credit rating. If we are unable to raise funds on acceptable terms, we may not be able to execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated requirements.
Added
This may seriously harm our business, financial condition and results of operations. If we are not able to continue operations, investors may suffer a complete loss of their investments in our securities.
Added
If we raise additional funds through future issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities we issue could have rights, preferences and privileges superior to those of holders of Common Stock.
Added
Any debt financing that we may secure in the future could involve significant fixed payment obligations and restrictive covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue business opportunities, including potential acquisitions.
Added
We may not be able to obtain additional financing on terms favorable to us, if at all.
Added
If we are unable to obtain adequate financing or financing on terms satisfactory to us when needed, we may need to delay, reduce the scope of or put on hold one or more research and development programs or commercialization efforts while we seek strategic alternatives, and our ability to continue to support our business growth and to respond to business challenges and opportunities could be significantly impaired.
Added
We may also need to seek collaborators for nelitolimod and any future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or license on unfavorable terms our rights to nelitolimod and any future product candidates in markets where we otherwise would seek to pursue development or commercialization ourselves.
Added
Any of the above events could significantly harm our business, prospects, financial condition, and results of operations and cause the price of Common Stock to decline.
Added
Further, our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions, and the continued disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical events, including the wars in Ukraine and the Middle East, and disruptions to the U.S. banking system due to bank failures, particularly in light of the recent events that have occurred with respect to Silicon Valley Bank, Signature Bank, and First Republic Bank.
Added
Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry, or the financial services industry generally, or concerns or rumors about any events of these kinds, have in the past and may in the future lead to market-wide liquidity problems.
Added
If we are unable to raise sufficient additional capital, we could be forced to curtail our planned operations and the pursuit of our growth strategy and business development efforts, which could jeopardize our ability to continue our business operations. 32 Table of Contents Our future capital needs may require us to sell additional equity or debt securities that may dilute our stockholders, adversely affect the market price of our Common Stock or introduce covenants that may restrict our operations.
Added
We may seek additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships and licensing arrangements.
Added
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of existing stockholders will be diluted, such offerings may reduce the market price of the Common Stock, and the terms may include a preference on liquidating distributions or a preference on dividend payments liquidation or other preferences that adversely affect the rights of existing stockholders.
Added
Thus, existing holders of our Common Stock bear the risk of our future offerings reducing the market price of our Common Stock and diluting their shareholdings in us.
Added
For instance, in October 2023, we entered into a standby equity purchase agreement (the “SEPA”) with YA II PN, LTD., a Cayman Islands exempt limited partnership (“Yorkville”), whereby we have the right, but not the obligation, to sell to Yorkville up to $30.0 million of our Common Stock at our request, subject to terms and conditions specified in the SEPA.
Added
We have, and in the future may continue to, sell shares of our Common stock to Yorkville under the SEPA.
Added
In addition, the incurrence of indebtedness would result in increased fixed or variable payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business, including grants of security interests in our intellectual property.
Added
If we raise additional capital through future collaborations, strategic alliances or third-party licensing arrangements, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us.
Added
Because our decision to issue additional equity or debt securities in any future offering or to enter into any strategic partnership or licensing arrangement will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing, nature or success of our future capital raising efforts or partnership and licensing arrangements.
Added
In addition, a significant decline in the trading price of our Common Stock could potentially impact our ability to use equity securities as consideration in acquisitions.
Added
If we are unable to raise additional capital when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization efforts, or grant rights to develop and market products or product candidates that we would otherwise develop and market ourselves. We may issue additional Common Stock from time to time under our equity incentive plans.
Added
Any such issuances would dilute the interest of our stockholders and likely present other risks. We may issue additional Common Stock from time to time under our equity incentive plans.
Added
Common Stock reserved for future issuance under our equity incentive plans will become eligible for sale in the public market once those shares are issued, subject to provisions relating to time-based and performance-based vesting conditions, lock-up agreements and, in some cases, limitations on volume and manner of sale applicable to affiliates under Rule 144, as applicable.
Added
We have filed a registration statement on Form S-8 under the Securities Act to register additional shares we may issue pursuant to our 2023 Equity Incentive Plan (the “2023 Plan”) and 2023 Employee Stock Purchase Plan.
Added
In addition, we may file one or more registration statements on Form S-8 under the Securities Act to register additional Common Stock or securities convertible into or exchangeable for Common Stock issued pursuant to our equity incentive plans. Any future Form S-8 registration statements will automatically become effective upon filing.
Added
Accordingly, Common Stock registered under such registration statements may be immediately available for sale in the open market. If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders if we issue equity securities, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
Added
We may evaluate various acquisitions and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights, technologies, or businesses.
Added
Any potential acquisition or strategic partnership may entail numerous risks, including: • increased operating expenses and cash requirements; • the assumption or occurrence of additional indebtedness or contingent liabilities; • the issuance of our equity securities; • assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integration; • the diversion of our management’s attention from our existing product programs and initiatives in pursuing such an acquisition or strategic partnership; 33 Table of Contents • retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships; • risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and related regulatory approvals; and • our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.
Added
In addition, if we undertake acquisitions, we may incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense. Moreover, we may not be able to locate suitable acquisition opportunities, which could impair our ability to grow or obtain access to technology or products that may be important to the development of our business.
Added
Risks Related to TriNav 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.
Added
We began selling TriNav in 2020 in the United States, and sales of TriNav accounted for substantially all of revenue for the years ended December 31, 2023, and 2022. Sales of TriNav are expected to continue to account for primarily all of our revenue going forward.
Added
Our ability to execute our growth strategy and become profitable will therefore depend upon the adoption of TriNav by physicians and hospitals, among others. TriNav is a relatively new drug delivery platform designed to overcome the barriers of the high pressure tumor microenvironment. As a result, physician awareness of TriNav, and experience with TriNav, is limited.
Added
A number of factors that are outside of our control may contribute to fluctuations in our financial results, including: • physician experience and hospital demand for our products and the extent of adoption of TriNav, including the rate at which physicians recommend TriNav for use on their patients; • delays in, or failure to supply product, component and material deliveries by our third-party suppliers; • positive or negative media coverage, or public, patient and/or physician perception, of TriNav or competing products and procedures; • any safety or effectiveness concerns that arise regarding TriNav; • the extent of reimbursement by CMS for purchases of TriNav; and • introduction of new products or procedures for delivering drugs into the tumor microenvironment that compete with TriNav.
Added
There is no assurance that TriNav will achieve broad market acceptance among physicians and hospitals. Any failure of TriNav to satisfy physician or hospital demand or to achieve meaningful market acceptance will harm our business and future prospects. Further, to the extent broad market acceptance is achieved in the future, there is no assurance that such acceptance will be sustained.
Added
Our business is dependent upon the continued adoption of TriNav by hospitals and physicians. Our future growth and profitability largely depend on our ability to increase physician awareness and adoption of TriNav and on the willingness of physicians to recommend the device to more of their patients.
Added
Physicians may not use our products unless they are able to determine, based on experience, clinical data, medical society recommendations and other analyses, that our product provides a safe and effective treatment alternative for drug delivery.

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Item 2. Properties

Properties — owned and leased real estate

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Removed
Item 2. Properties. Our executive offices are located at 48 Maple Avenue, Greenwich, CT 06830, and our telephone number is (908) 391-1288. The cost for our use of this space is included in the $10,000 per month fee we accrue for office space, administrative and shared personnel support services payable to our sponsor.
Added
Item 2. Properties Our principal office is located in Westminster, Colorado, where we lease approximately 21,000 square feet of office, manufacturing, and warehouse space pursuant to a lease that expires on December 31, 2026. The lease includes two extension options, each for five years. We have not yet determined if we will exercise the extension options.
Removed
We consider our current office space adequate for our current operations. ​
Added
We lease office facilities in Bannockburn, Illinois, and Cranston, Rhode Island. We also lease laboratory space at Rhode Island Hospital in Providence, Rhode Island. We believe our facilities are adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations.
Added
We believe appropriate alternative space will be readily available on commercially reasonable terms.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Removed
Item 3. Legal Proceedings. To the knowledge of our management team, there is no litigation currently pending or contemplated against us, any of our officers or directors in their capacity as such or against any of our property. ​ Item 4. Mine Safety Disclosures. Not applicable. ​ 25 Table of Contents PART II
Added
Item 3. Legal Proceedings From time to time, we may be subject to legal proceedings. We are not currently a party to or aware of any pending or threatened legal proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations.
Added
Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. Item 4. Mine Safety Disclosures Not Applicable. 83 Table of Contents Part II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeIn addition, our board of directors is not currently contemplating and does not anticipate declaring any stock dividends in the foreseeable future. Further, if we incur any indebtedness in connection with our initial business combination, our ability to declare dividends may be limited by restrictive covenants we may agree to in connection therewith.
Biggest changeThe payment of any cash dividends will be within the discretion of our board of directors at such time. In addition, our board of directors is not currently contemplating and does not anticipate declaring any stock dividends in the foreseeable future.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities. (a) Market Information Our units, public shares and public warrants are each traded on Nasdaq under the symbols “MTACU,” “MTAC,” and “MTACW,” respectively.
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common shares and public warrants are each traded on Nasdaq under the symbols “TLSI,” and “TLSIW,” respectively. Our common shares and public warrants commenced separate public trading on February 8, 2021.
The payment of cash dividends in the future will be dependent upon our revenues and earnings, if any, capital requirements and general financial condition subsequent to completion of our initial business combination. The payment of any cash dividends subsequent to our initial business combination will be within the discretion of our board of directors at such time.
We currently intend to retain all available funds and any future earnings to support our operations and finance the growth and development of our business. The payment of cash dividends in the future will be dependent upon our revenues and earnings, if any, capital requirements and general financial condition.
(c) Dividends We have not paid any cash dividends on our common stock to date and do not intend to pay cash dividends prior to the completion of our initial business combination.
Holders of Record On April 3, 2024, there were 136 holders of record of our shares of Common Stock, 147 holders of record of our shares of Series A preferred stock, and 17 holders of record of our warrants. Dividends We have not declared or paid any cash dividends on our Common Stock to date.
Removed
Our units commenced public trading on December 18, 2020, and our public shares and public warrants commenced separate public trading on February 8, 2021.
Added
Further, if we incur any indebtedness, our ability to declare dividends may be limited by restrictive covenants we may agree to in connection therewith. Securities Authorized for Issuance Under Equity Compensation Plans. Information about our equity compensation plans in Item 12 of Part III of this Annual Report is incorporated herein by reference.
Removed
(b) Holders On March 22, 2023, there was one holder of record of our units, one holder of record of our shares of Class A common stock, one holder of record of our shares of Class B common stock, and two holders of record of our warrants.
Added
Recent Sales of Unregistered Securities As previously disclosed, in October 2023, we entered the SEPA with Y orkville , whereby we have the right, but not the obligation, to sell to Yorkville up to $30.0 million of our Common Stock at our request, subject to terms and conditions specified in the SEPA.
Removed
(d) Securities Authorized for Issuance Under Equity Compensation Plans. None. (e) Recent Sales of Unregistered Securities None.
Added
As of the filing of this Annual Report, we have issued and sold 350,000 shares of Common Stock to Yorkville for gross proceeds of approximately $3.1 million .
Removed
(f) Use of Proceeds from the Initial Public Offering For a description of the use of the proceeds generated in our initial public offering, see Part II, Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 as filed with the SEC on March 31, 2021, as amended on June 28, 2021.
Added
The shares issued to Yorkville were unregistered, but, pursuant to the Registration Statement on Form S-1 (File No. 333-276070) that we filed with the SEC on December 15, 2023, and which was declared effective on December 26, 2023, the shares issued to Yorkville have been registered for resale.
Removed
There has been no material change in the planned use of proceeds from our initial public offering and private placement as described in the IPO Registration Statement. ​ (g) Purchases of Equity Securities by the Issuer and Affiliated Purchasers In connection with the Extension Special Meeting, stockholders holding 23,046,578 public shares exercised their right to redeem their shares for a pro rata portion of the funds in the trust account.
Added
The securities issued to Yorkville were issued and sold in reliance on the exemption from registration requirements thereof provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder as a transaction by an issuer not involving a public offering. Purchases of Equity Securities by the Issuer and Affiliated Purchasers None Item 6. [Reserved]
Removed
As a result, approximately $232.37 million (approximately $10.08 per public share) was removed from the trust account and paid to such holders and approximately $19.70 million remained in the trust account.
Removed
Following the redemptions, we had 1,953,422 public shares outstanding. ​ 26 Table of Contents The following table contains monthly information about the repurchases of our equity securities for the three months ended December 31, 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ (d) Maximum ​ ​ ​ ​ ​ ​ ​ ​ ​ number (or ​ ​ ​ ​ ​ ​ ​ (c) Total number ​ approximate dollar ​ ​ (a) Total ​ ​ ​ ​ of shares (or ​ value) of shares (or ​ ​ number of ​ ​ ​ ​ units) purchased ​ units) that may yet ​ ​ shares (or ​ (b) Average price ​ as part of publicly ​ be purchased under ​ ​ units) ​ paid per share (or ​ announced plans ​ the plans or Period purchased unit) or programs programs October 1 – October 31, 2022 ​ — ​ ​ — ​ — ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ November 1 – November 30, 2022 ​ — ​ ​ — ​ — ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 1 – December 31, 2022 ​ 23,046,578 ​ $ 10.08 ​ — ​ — ​ ​ Item 6. [Reserved.] ​

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changePursuant to the Termination Agreement, subject to certain exceptions, the Company, Memic and Memic Merger Sub have also agreed, on behalf of themselves and their respective related parties, to a release of claims relating to the proposed business combination. 27 Table of Contents TriSalus Business Combination On November 11, 2022, the Company entered into the TriSalus Merger Agreement with Merger Sub, and TriSalus under which Merger Sub will merge with and into TriSalus, with TriSalus surviving the TriSalus Merger as a wholly owned subsidiary of the Company.
Biggest changeThe Business Combination On November 11, 2022, Legacy TriSalus entered into an Agreement and Plan of Merger (the “Merger Agreement”) with MedTech Acquisition Corporation (“MTAC”) and MTAC Merger Sub, Inc., a wholly owned subsidiary of MTAC (“Merger Sub”), pursuant to which, Legacy TriSalus would merge with and into Merger Sub, with Legacy TriSalus surviving the merger and becoming a wholly owned subsidiary of MTAC (the “Business Combination”).
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the financial statements and the notes thereto contained elsewhere in this Report.
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis of the financial condition and results of operations of TriSalus Life Sciences, Inc.
Removed
Overview We are a blank check company formed under the laws of the State of Delaware on September 11, 2020 for the purpose of effecting an initial business combination.
Added
(for purposes of this section, the “Company,” “TriSalus” “we,” “us” and “our”) should be read together with TriSalus’ audited consolidated financial statements as of and for the fiscal years ended December 31, 2023 and 2022, together with the related notes thereto, included elsewhere in this Annual Report.
Removed
We intend to effectuate our an initial business combination using cash from the proceeds of the initial public offering and the sale of the private placement warrants, our capital stock, debt or a combination of cash, stock and debt. We expect to continue to incur significant costs in the pursuit of our acquisition plans.
Added
Some of the information contained in this discussion and analysis includes forward-looking statements that involves risks and uncertainties.
Removed
We cannot assure you that our plans to complete an initial business combination will be successful. Termination of Memic Business Combination Agreement On August 12, 2021, we entered into the Memic Business Combination Agreement with Memic and Memic Merger Sub.
Added
You should review the sections titled “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” for a discussion of forward-looking statements and important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Removed
On March 9, 2022, we convened and then adjourned, without conducting any other business, a special meeting of stockholders relating to the proposed business combination with Memic and the other transactions contemplated by the Memic Business Combination Agreement.
Added
Overview We are engaged in the research, development, and sales of innovative drug delivery technology and immune-oncology therapeutics to improve outcomes in difficult to treat liver and pancreatic cancer. Our technology is utilized in the delivery 84 Table of Contents of our therapeutics and administered by interventional radiologists.
Removed
On March 10, 2022, we entered into the Termination Agreement with Memic and Memic Merger Sub, under which the parties agreed to mutually terminate the Memic Business Combination Agreement. The termination of the Memic Business Combination Agreement became effective as of March 9, 2022.
Added
We are developing and marketing two product lines: Pressure Enabled Drug Delivery (“PEDD”) infusion systems, in use today, and an investigational agent, called nelitolimod which shows potential to enhance immune system response in the treatment of hepatocellular cancer, pancreatic cancer and other solid tumors in the liver.
Removed
As a result of the termination of the Memic Business Combination Agreement, the Memic Business Combination Agreement, along with any Transaction Agreement (as defined in the Memic Business Combination Agreement) entered into in connection therewith, are void and there is no liability under either of the Memic Business Combination Agreement or any Transaction Agreement on the part of any party thereto (including, without limitation, under the SPAC Sponsor Letter Agreement by and among Memic, the sponsor, and the other parties signatory thereto dated August 12, 2021).
Added
The combination of our PEDD technology with nelitolimod, is focused on solving the two main barriers in the tumor micro environment that inhibits the success of immunotherapy. The first barrier (mechanical) is comprised of high intratumoral pressure within tumors that limits drug uptake and the second barrier (biological) is the reversal of intratumoral immunosuppression.
Removed
The TriSalus Business Combination is subject to certain closing conditions as summarized below under “Conditions to Closing.” Upon consummation of the TriSalus Business Combination, the Company will be renamed “TriSalus Life Sciences, Inc.” For a full description of the TriSalus Merger Agreement and the proposed TriSalus Business Combination, please see “Item 1.
Added
In 2020, we launched TriNav™, which is our newest liver therapy delivery device with SmartValve technology for our proprietary PEDD approach. Current sales consist of the TriNav Infusion System, introduced in 2020. 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.
Removed
Business.” Results of Operations We have neither engaged in any operations nor generated any revenues to date. Our only activities from September 11, 2020 (inception) through December 31, 2022 were organizational activities, those necessary to prepare for the initial public offering, and identifying a target company for an initial business combination, including TriSalus.
Added
The approval began in January 2020 and expired at the end of 2023. On December 14, 2023, CMS created a permanent New Technology Healthcare Common Procedure Coding System (HCPCS) code for procedures involving the TriNav® Infusion System.
Removed
We do not expect to generate any operating revenues until after the completion of our initial business combination. Until the Extension Special Meeting, we generated non-operating income in the form of interest income on cash and investments held in the trust account.
Added
This new code became effective on January 1, 2024, and may be reported by hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs) for the Company to obtain reimbursement for TriNav device. We are currently in our early stage of development and have yet to generate revenues sufficient to drive positive cash flows from operations.
Removed
After the Extension Special Meeting, the funds are now held in the trust account is in a demand deposit account held by Continental Stock Transfer & Trust Company and no longer contains marketable securities.
Added
Beginning in 2020, we began a strategic transformation from a company focused solely on the sale of our infusion systems to a therapeutic company whereby our medical devices are marketed alongside the pharmaceutical drugs and other treatments that the devices deliver to patients.
Removed
We incur expenses as a result of being a public company (for legal, financial reporting, accounting and auditing compliance) as well as identifying and evaluating targets for an initial business combination.
Added
This transformation led us to acquire our first immune-oncology drug, nelitolimod, in July 2020, and to begin clinical development of nelitolimod for the treatment of liver and pancreatic cancers.
Removed
For the year ended December 31, 2022, we had a net income of $5,539,079, which consists of a change in fair value of warrant liabilities of $5,837,332 and interest income on cash and investments held in the trust account of $3,018,726, offset by general and administrative expenses of $2,746,125 and provision for income taxes of $570,854.
Added
If our clinical trials are successful, we anticipate submitting a New Drug Approval (“NDA”) request to the FDA no sooner than 2025, and assuming we receive FDA approval, commercial sales would begin thereafter, possibly in 2027.
Removed
For the year ended December 31, 2021, we had a net income of $4,767,283, which consists of a change in fair value of warrant liabilities of $7,744,000 and interest income on cash and investments held in the trust account of $63,997, offset by general and administrative expenses of $3,040,714.
Added
The aggregate consideration payable to the stockholders of Legacy TriSalus was $220.0 million, payable in approximately 22,000,000 shares of MTAC common stock. On August 8, 2023, the stockholders of MTAC approved the Business Combination, and the Business Combination closed on August 10, 2023.
Removed
Liquidity and Going Concern On December 22, 2020, we consummated the initial public offering of 25,000,000 Units at $10.00 per unit, generating gross proceeds of $250,000,000.
Added
Pursuant to the Merger Agreement, 890,020,482 shares of Legacy TriSalus common stock (after conversion of all outstanding shares of Legacy TriSalus preferred stock and all in-the-money warrants) were exchanged for approximately 22,000,000 shares of MTAC common stock, reflecting an exchange ratio of approximately 0.02471853.
Removed
Simultaneously with the closing of the initial public offering, we consummated the sale of 4,933,333 private placement warrants at a price of $1.50 per private placement warrant in the private placement, generating gross proceeds of $7,400,000.
Added
All share and per share amounts of our common and preferred stock have been retrospectively adjusted for the exchange ratio in the following discussion. Following the consummation of the Business Combination, we were deemed the accounting acquirer and are accounting for the Business Combination as a reverse recapitalization.
Removed
Following the initial public offering, the partial exercise of the over-allotment option, and the sale of the private placement warrants, a total of $250,000,000 was placed in the trust account. We incurred $14,161,525 in initial public offering related costs, including $5,000,000 of underwriting fees and $8,750,000 of deferred underwriting fees and $411,525 of other offering costs.
Added
Factors Affecting Our Performance We believe that our performance and future success depend on several factors that present significant opportunities for us but also pose risks and challenges, including those discussed below and in the section of this Annual Report titled “ Risk Factors .” In particular, our performance is affected by: • The continued acceptance and growth of TriNav in the marketplace .
Removed
For the year ended December 31, 2022, cash used in operating activities was $2,736,994. Net income of $5,539,079 was affected by a change in fair value of warrant liabilities of $5,837,332 and interest earned on cash and investments held in the trust account of $3,018,726. Changes in operating assets and liabilities provided $579,985 of cash for operating activities.
Added
While we believe TriNav to be a superior technology for the delivery of therapies to tumors, particularly high-density tumors, there are other technologies with which we compete.
Removed
For the year ended December 31, 2021, cash used in operating activities was $1,738,114. Net income of $4,767,283 was affected by a change in fair value of warrant liabilities of $7,744,000 and interest earned on cash and investments held in the trust account of $63,998. Changes in operating assets and liabilities provided $1,302,600 of cash for operating activities.
Added
Our ability to grow TriNav sales depends on the skills of our sales force and the willingness of the marketplace to use TriNav. • Our ability to maintain our current TriNav pricing and gross margins to help fund the rest of our activities.
Removed
As of December 31, 2022, we had investments held in the trust account of $19,827,884. Interest income on the balance in the trust account may be used by us to pay taxes.
Added
Our current pricing allows us to generate a substantial gross margin, which provides funds to support our growth and our research and development (“R&D”) for both TriNav and nelitolimod. TriNav sells at a significant premium to competitive products. Our higher price was previously supported by the TPT payment program from CMS; however, the TPT authorization expired on December 31, 2023.
Removed
During the year ended December 31, 2022, the Company withdrew $905,000 of interest income from the trust account to pay for taxes and $232,371,273 in connection with redemption of public shares in connection with the Extension Special Meeting. 28 Table of Contents We intend to use substantially all of the funds held in the trust account, including any amounts representing interest earned on the trust account (less income taxes payable), to complete our business combination.
Added
In December 2023, CMS granted a New 85 Table of Contents Technology HCPCS for procedures involving TriNav. This new code, HCPCS C9797, has been assigned to the Ambulatory Payment Classification (APC) 5194 - Level 4 Endovascular Procedures.
Removed
To the extent that our capital stock or debt is used, in whole or in part, as consideration to complete our business combination, the remaining proceeds held in the trust account will be used as working capital to finance the operations of the target business or businesses, make other acquisitions and pursue our growth strategies.
Added
The new code became effective on January 1, 2024, and may be reported by hospital outpatient departments and ambulatory surgical centers, but there can be no assurance that continuing reimbursement will be available at similar reimbursement rates or at all.
Removed
As of December 31, 2022, we had cash of $153,563.
Added
Any reduction in the amount of the reimbursement for TriNav will negatively impact the revenue we are able to generate from the sale of TriNav and may hinder our ability to recoup our total investment in TriNav notwithstanding regulatory approval of the product.
Removed
We intend to use the funds held outside the trust account primarily to perform business due diligence on prospective target businesses, travel to and from the offices, plants or similar locations of prospective target businesses or their representatives or owners, review corporate documents and material agreements of prospective target businesses, and structure, negotiate and complete an initial business combination, including the TriSalus Business Combination.
Added
If we are unable to promptly obtain coverage and profitable payment rates from hospital budgets or government-funded and private purchasers for TriNav or any future products, we may sell fewer units or need to sell them at a lower price.
Removed
In order to fund working capital deficiencies or finance transaction costs in connection with an initial business combination, the Sponsor, or certain of our officers and directors or their affiliates may, but are not obligated to, loan us funds as may be required. If we complete an initial business combination, we would repay such loaned amounts.
Added
Such changes in revenues would have a material adverse effect on our operating results and our overall financial condition. • The success and cost of our clinical trials of nelitolimod . Nelitolimod is in Phase 1 human trials to determine if, when delivered via TriNav, it is safe and effective in treating certain cancers.
Removed
In the event that an initial business combination does not close, we may use a portion of the working capital held outside the trust account to repay such loaned amounts but no proceeds from our trust account would be used for such repayment.
Added
As with all drug candidates, the cost of operating clinical trials can be substantial, with no guarantee that the trials will result in favorable data. • Obtaining FDA approval of nelitolimod for sale .
Removed
Up to $1,500,000 of such loans may be convertible into warrants at a price of $1.50 per warrant, at the option of the lender. The warrants would be identical to the private placement warrants. On December 30, 2021, we issued the 2021 Promissory Note to the sponsor, pursuant to which we borrowed an aggregate principal amount of $544,000.
Added
Our clinical trials are still in early stages, and there is no certainty that we will generate favorable data or that, upon review, the FDA will approve nelitolimod for sale.
Removed
The 2021 Promissory Note is non-interest bearing and matures upon the closing of our initial business combination. As of December 31, 2022 and 2021, there was $544,000 outstanding under the 2021 Promissory Note. On January 28, 2022, we issued the 2022 Promissory Note, of which $400,000 was funded by the sponsor during the year ended December 31, 2022.
Added
Recent Developments Preferred Stock Financing In October 2022, we sold 706,243 shares of Legacy TriSalus Series B-2 preferred stock in a private financing, primarily to existing stockholders, at a price of $14.16 per share (raising approximately $9.8 million, net of issuance costs) (the “Initial Preferred Stock Financing”).
Removed
The 2022 Promissory Note does not bear interest and matures upon closing of our initial business combination. As of December 31, 2022 and 2021, there was $400,000 and $0 outstanding under the 2022 Promissory Note, respectively.
Added
For each share sold, we also issued a warrant to purchase four shares of Series B-3 preferred stock for no additional consideration (warrants to purchase an aggregate of 2,824,974 shares of Series B-3 preferred stock were issued in the Initial Preferred Stock Financing). The strike price of the warrants issued was $2.03 per share.
Removed
On May 24, 2022, we issued the 2022 Convertible Promissory Note in the principal amount of up to $1,500,000 to the sponsor for working capital requirements and payment of certain expenses in connection with our initial business combination.
Added
The Initial Preferred Stock Financing included, at the unilateral option of the Legacy TriSalus's Audit Committee, a second tranche for to the sale of up to 518,854 shares of Series B-2 preferred stock for approximately $7.3 million (which could be increased up to an aggregate of 706,243 shares of Series B-2 preferred stock for approximately $10.0 million), with each such share of Series B-2 preferred stock accompanied by a warrant to purchase four shares of Series B-3 preferred stock at a strike price of $2.03 per share (warrants to purchase up to an aggregate of 2,075,417 shares of Series B-3 preferred stock may be issued in closings of the second tranche of the Initial Preferred Stock Financing assuming the full $10.0 million is sold); and a third tranche, at the unilateral election of investors who participated in the second tranche, for the sale of up to 306,053 shares of Series B-2 preferred stock, for approximately $4.3 million (which could be increased up to an aggregate of 353,121 shares of Series B-2 preferred stock for approximately $5.0 million), with each such share of Series B-2 preferred stock accompanied by a warrant to purchase eight shares of Series B-3 preferred stock at a strike price of $2.03 per share (warrants to purchase up to an aggregate of 2,824,974 shares of Series B-3 preferred stock may be issued in the third tranche closing assuming the full $5.0 million is sold).
Removed
The 2022 Convertible Promissory Note is non-interest bearing and matures upon the closing of a business combination (in which case we will repay the 2022 Convertible Promissory Note note out of the proceeds of the trust account released to us) or upon our liquidation (in which case we may only repay the 2022 Convertible Promissory Note out of working capital funds held outside the trust account).
Added
In March 2023, we effectuated closings (“Second Tranche Closings”) of a portion of the second tranche of the B-2 Preferred Stock Financing whereby (i) 207,541 shares of Series B-2 preferred stock and accompanying warrants to purchase 830,167 shares of Series B-3 preferred stock, representing 40.0% of the shares committed in the second tranche, were sold for an aggregate purchase price of approximately $2.9 million, net of execution costs, and (ii) 17,656 shares of Series B-2 preferred stock and accompanying warrants to purchase 70,624 shares of Series B-3 preferred stock, none of which were shares committed in the second tranche, were sold for an aggregate purchase price of $250 thousand.
Removed
At the election of the sponsor, all or a portion of the unpaid principal amount of the 2022 Convertible Promissory Note may be converted into that number of warrants at a price of $1.50 per warrant, each exercisable for one share of Class A common stock.
Added
As a result of the closings of a portion of the second tranche of the B-2 Preferred Stock Financing described above, in accordance with the anti-dilution rights in the Legacy TriSalus’s certificate of incorporation, the conversion prices of the Legacy TriSalus's preferred stock were adjusted.
Removed
As of December 31, 2022 and 2021, there was $1,341,000 and $0 outstanding under the 2022 Convertible Promissory Note.
Added
The conversion prices were further adjusted as a result of the June 2023 exercise of a portion of the second tranche of the B-2 Preferred Stock Financing described below, which represent the conversion prices in effect on the Closing Date.
Removed
On December 16, 2022, we issued the 2022 Extension Note in the principal amount of up to $468,821 to the sponsor pursuant to which the sponsor agreed to loan to us and deposit into the trust account the Extension Funds for the public shares that were not redeemed in connection with the Extension.
Added
In June 2023, Legacy TriSalus effectuated closings of a portion of the second tranche of the B-2 Preferred Stock Financing whereby (i) 257,779 shares of Series B-2 preferred stock and accompanying warrants to purchase 1,031,116 shares of Series B-3 preferred stock, representing approximately 49.7% of the shares committed in the second tranche, were sold for an aggregate purchase price of approximately $3.7 million, and (ii) 165,967 shares of Series B-2 preferred stock and accompanying warrants to purchase 663,868 shares of Series B-3 preferred stock, none of which were shares committed in the second tranche, were sold for an aggregate purchase price of $2.4 million.
Removed
The 2022 Extension Note does not bear interest and is repayable in full upon the date of the consummation of an initial business combination. As of December 31, 2022 and 2021, there was $39,068 and $0 outstanding under the 2022 Extension Note, respectively.
Added
As a result of the closings of a portion of the second tranche of the B-2 Preferred Stock Financing described above, in accordance with the anti-dilution 86 Table of Contents rights in the Legacy TriSalus’s certificate of incorporation, the conversion prices of the Legacy TriSalus’s preferred stock (i) were adjusted to $38.84 for Series A-1 preferred stock, $12.14 for Series A-2 preferred stock, $13.36 for Series A-3 preferred stock, $12.55 for Series A-4 preferred stock, $13.36 for Series A-5 preferred stock, $14.97 for Series A-6 preferred stock, $9.71 for Series B preferred stock, and $10.93 for Series B-1 preferred stock and (ii) remained the same for Series B-2 preferred stock $14.16 and Series B-3 preferred stock $2.03, which correlate to approximate (in each case rounded to three decimals) exchange ratios of 1.275 to 1 for Series A-1 preferred stock, 1.290 to 1 for Series A-2 preferred stock, 1.303 to 1 for Series A-3 preferred stock, 1.277 to 1 for Series A-4 preferred stock, 1.333 to 1 for Series A-5 preferred stock, 1.351 to 1 for Series A-6 preferred stock, 1.250 to 1 for Series B preferred stock, 1.296 to 1 for Series B-1 preferred stock, 1 to 1 for Series B-2 preferred stock and 1 to 1 for Series B-3 preferred stock.
Removed
On December 16, 2022, we issued the 2022 Promissory Note III, an unsecured promissory note in the principal amount of up to $1,000,000 to the sponsor for working capital purposes, which may be drawn down from time to time upon our request.
Added
These conversion prices remained in effect at the Closing Date.
Removed
The 2022 Promissory Note III does not bear interest and the principal amount will not be payable if we fail to complete our initial business combination within the required time period as set forth our amendment and restated certificate of incorporation, as amended from time to time.
Added
Any portion of the Series B-3 Warrants that remained unexercised at the time the Business Combination is consummated were automatically net settled for shares of Legacy TriSalus Common Stock immediately prior to the closing of the Business Combination (see Note 3) and exchanged into shares of our Common Stock at the Closing Date.
Removed
As of December 31, 2022 and 2021, there was no outstanding balance under 2022 Promissory Note III, respectively. In connection with our assessment of going concern considerations in accordance with FSB ASU Topic 2014-15, “Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern,” we have until June 22, 2023, to consummate an initial business combination.
Added
In July 2023, holders of warrants to purchase 2,239,309 shares of Series B-3 preferred stock exercised their purchase rights for proceeds of approximately $4.5 million. Components of Results of Operations The following discussion sets forth certain components of our consolidated statements of operations as well as factors that impact those items.
Removed
It is uncertain that we will be able to consummate an initial business combination by this time. If an initial business combination is not consummated by this date, there will be a mandatory liquidation and subsequent dissolution of the Company.
Added
Revenue We currently operate in one reportable segment and revenue is generated primarily from sales of PEDD infusion systems to our customers, principally related to TriNav.
Removed
Management has determined that the liquidity condition and mandatory liquidation, should an initial business combination 29 Table of Contents not occur, and potential subsequent dissolution raises substantial doubt about our ability to continue as a going concern. Management plans to consummate a business combination prior to the mandatory liquidation date.
Added
Revenue is recognized when control of the promised goods or services is transferred to the customer in an amount that reflects the consideration to which we expect to be entitled in exchange for those products or services. The primary end-user customers for our products are hospitals, clinics and physicians.

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