Nelitolimod

WESTMINSTER, Colo.--(BUSINESS WIRE)-- TriSalus Life Sciences® Inc. (“TriSalus” or the “Company”) (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, announced today the expiration and results of its previously announced exchange offer (the “Offer”) and consent solicitation (the “Consent Solicitation”) relating to its warrants (the “Warrants”) identified in the Prospectus/Offer to Exchange that forms a part of the Registration Statement (as defined below). The Offer and Consent Solicitation expired one minute after 11:59 p.m., Eastern Standard Time, on June 25, 2024. Pursuant to the Offer, the Company offered all holders of each class of its Warrants, consisting of (i) its publicly traded Warrants (the “Public Warrants”), (ii) certain Warrants issued in a private placement transaction occurring simultaneously with the closing of the initial public offering of the Company (the “Private Placement Warrants”) and (iii) certain Warrants issued for working capital requirements and payment of certain expenses of the Company (“Working Capital Warrants”), the opportunity to receive 0.30 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”), in exchange for each Warrant tendered by the holder and exchanged pursuant to the Offer. As previously disclosed, parties representing approximately 34.8% of the Public Warrants agreed to tender their Public Warrants in the Offer and to consent to the Warrant Amendment (as defined below) in the Consent Solicitation pursuant to tender and support agreements. The Company did not receive tender and support agreements with respect to the Private Placement Warrants or Working Capital Warrants. The Offer and Consent Solicitation expired at one minute after 11:59 p.m., Eastern Standard Time, on June 25, 2024. The Company has been advised that the Warrants tendered were comprised of 6,533,614 Public Warrants (including 9,185 Public Warrants tendered through guaranteed delivery), 504,685 Private Placement Warrants, and 0 Working Capital Warrants, which represents approximately 78.89%, 10.23% and 0.00% of the outstanding Warrants of each respective class, were validly tendered and not validly withdrawn prior to the expiration of the Offer and Consent Solicitation. The Company expects to accept all validly tendered Warrants for exchange and settlement on or before July 1, 2024. In addition, pursuant to the Consent Solicitation, the Company received the approval of approximately 78.89% of the outstanding Public Warrants to amend the warrant agreement that governs the Warrants (the “Warrant Amendment”), which represents a majority of the outstanding Public Warrants required to effect the Warrant Amendment with respect to the Public Warrants. Pursuant to the Consent Solicitation, the Company did not receive the requisite approval to effect the Warrant Amendment with respect to either the Private Placement Warrants or Working Capital Warrants. Accordingly, the Company and Continental Stock Transfer & Trust Company entered into the Warrant Amendment, dated June 26, 2024, with respect to the Public Warrants but not the Private Placement Warrants or Working Capital Warrants. The Company also announced that its Registration Statement on Form S-4 (Registration No. 333- 279691), filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 24, 2024 (the “Registration Statement”), registering shares of Common Stock issuable in the Offer and pursuant to the Warrant Amendment was declared effective by the SEC on June 25, 2024. Oppenheimer & Co. Inc. served as the Dealer Manager and Solicitation Agent for the Offer and Consent Solicitation. Morrow Sodali LLC served as the Information Agent for the Offer and Consent Solicitation, and Continental Stock Transfer & Trust Company served as the Exchange Agent. About TriSalus Life Sciences TriSalus Life Sciences® is an oncology focused medical technology business providing disruptive drug delivery technology with the goal of improving therapeutics delivery to liver and pancreatic tumors. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via PEDD may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by PEDD are commonly present as well. Nelitolimod delivered by PEDD will be studied across several indications in an effort to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas. In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn. No Offer or Solicitation This press release shall not constitute an offer to exchange or the solicitation of an offer to exchange or the solicitation of an offer to purchase any securities, nor shall there be any exchange or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The Registration Statement filed with the SEC registering shares of Common Stock issuable in the Offer and pursuant to the Warrant Amendment was declared effective by the SEC on June 25, 2024. Forward-Looking Statements Certain statements made in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby under the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “expect,” “will” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements may include, but are not limited to, statements regarding the Company’s acceptance of all validly tendered Warrants for exchange of shares of Common Stock in the Offer and settlement thereof. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including, without limitation: the Company’s ability to successfully accept all validly tendered Warrants for exchange of shares of Common Stock; the uncertainty as to whether the Company will exercise its right to force exchange the Public Warrants pursuant to the Warrant Amendment in the future; risks related to future market adoption of the Company’s offerings; risks related to the Company’s marketing and growth strategies; risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, the effects of competition on the Company’s future business; the risks discussed in the Company’s quarterly report on Form 10-Q for the period ended March 31, 2024 under the heading “Risk Factors”; and the risks discussed in the Company’s Registration Statement, under the heading “Risk Factors” and other documents of the Company or to be with the SEC. If any of these risks materialize or any of the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company presently does not know of or that the Company currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect the Company’s expectations, plans or forecasts of future events and views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by applicable law. These forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. View source version on businesswire.com: Contacts For Media and Investor Inquiries: Argot Partners 212.600.1902 TriSalus@argotpartners.com Source: TriSalus Life Sciences View this news release online at:

Hepatic arterial infusion (HAI) of nelitolimod has been well tolerated and associated with encouraging immunologic activity in patients with HCC and ICC 4 mg dose demonstrated 3 of 3 patients achieving disease control, with one complete response in the liver (5L ICC), one partial response (-31%), and one stable disease (SD) when combined with checkpoint inhibition Follow up of patients is ongoing to determine next steps in the program Poster presentation on Saturday, June 1, 2024, at 9:00 a.m. to 12 p.m. CT DENVER--(BUSINESS WIRE)-- TriSalus Life Sciences, Inc. (Nasdaq: TLSI), an oncology company integrating its novel Pressure Enabled Drug Delivery™ (PEDD™) technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, today announced that data from its Phase 1b PERIO-02 clinical trial was presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, taking place May 31-June 4, 2024, in Chicago, Illinois. The PEDD approach is a proprietary delivery mechanism developed by TriSalus that aims to overcome challenges of the tumor microenvironment (TME) by modulating pressure and flow to enhance local drug concentrations in tumors by improving intravascular therapeutic delivery. The PERIO-02 clinical trial is the hepatic arterial infusion (HAI) of nelitolimod with the PEDD method to enhance tumor response in combination with intravenous checkpoint inhibition in adults with Hepatocellular Carcinoma (HCC) or Intrahepatic Cholangiocarcinoma (ICC). “The PEDD approach represents a promising new delivery method that addresses the limitations of intravenous infusions or needle injections to deliver therapeutics such as nelitolimod to immune cells throughout and surrounding the tumor microenvironment,” said Mary Szela, Chief Executive Officer and President of TriSalus. “The findings from the PERIO-02 clinical trial demonstrate the potential of the PEDD method to treat patients with HCC and ICC and provide initial clinical validation that HAI of nelitolimod is well tolerated with encouraging immunologic activity. We look forward to presenting these data and engaging with the medical community at ASCO.” Key Findings from the Phase 1b PERIO-02 Clinical Trial At the 4 mg dose in cohort C, three of three patients had disease control as best on-treatment response, with one complete response (CR) in the liver (5L ICC), one partial response (PR) (-31%), and one stable disease (SD). For patient 101-017, investigators noted decreases in the target liver lesion (31.3 to 17.5 mm), non-target liver lesion, and extra-hepatic lymph nodes on days 53 and 84 with CR of target liver lesions and stability of extra-hepatic nodal lesions reported on day 154. Median progression-free survival (PFS) in the Cohort C 4 mg dose level is > 120 days. Median overall survival (OS) for this group has not been reached (range 120-170 days). Immune effects of nelitolimod included increases in liver tumor CD4 and CD8 T cells and an increase in the CD8 T cell:MDSC ratio. Gene expression changes revealed increased Th1 programming as well as increased expression of granzyme A, IFNγ, and CXCL10 in both liver tumor and surrounding normal liver. Changes among plasma marker levels included increased IL-2R and CXCL10 expression, with decreased IL-17A, IDO, and NT5E (CD73). “The PERIO-02 data presented by Dr. Sunyoung Lee from the University of Texas MD Anderson Cancer Center illustrate that SD-101 is well tolerated when given by the PEDD method in patients who often have underlying liver disease, in association with encouraging biologic activity. The effects noted in PERIO-02 patients, including liver myeloid derived suppressor cell depletion and broad tumor microenvironment immune stimulation, are consistent with previously reported data in metastatic liver tumors (PERIO-01) and locally advanced pancreatic adenocarcinoma (PERIO-03),” said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. PERIO-02 is an open-label phase 1 trial of nelitolimod given by the PEDD method in HCC and ICC. The study consists of dose-escalation cohorts of nelitolimod alone (Cohort A), with IV pembrolizumab (Cohort B), or IV nivolumab + ipilimumab (Cohort C). Nelitolimod is delivered over two cycles, with three weekly doses per cycle. Blood, liver tumor, and normal liver biopsies are collected for correlative studies. Details about the presentation can be found below and on the ASCO website. Additionally, a copy of the poster will be available on the publications page of the TriSalus website. Title: PERIO-02: Phase 1b Pressure Enabled Regional Immuno-oncology Trial of nelitolimod (SD-101), a Class C TLR9 agonist, delivered via hepatic artery infusion +/- checkpoint inhibition in intrahepatic cholangiocarcinoma and hepatocellular carcinoma Presenter: Dr. Sunyoung Lee, associate professor of Gastrointestinal (GI) Medical Oncology at the University of Texas MD Anderson Cancer Center Date: Saturday, June 1, 2024 Session Time: 9:00-12:00 p.m. CT/10:00-1:00 p.m. ET Poster Session: Developmental Therapeutics—Immunotherapy Abstract: 2622 About TriSalus Life Sciences TriSalus Life Sciences® is an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via PEDD may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by PEDD are commonly present as well. Nelitolimod delivered by PEDD will be studied across several indications in an effort to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas. In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn. Forward-Looking Statements Statements made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company’s PEDD drug delivery technology and nelitolimod investigational immunotherapy, the Company’s ability to achieve the revenue milestones under the credit facility, the Company’s expectations about its cash runway, and the Company’s ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward-looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with the credit facility, including the Company’s ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, and other risks described in the Company’s filings with the Securities and Exchange Commission under the heading "Risk Factors." All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law. View source version on businesswire.com: Contacts For Media Inquiries: Stephanie Jacobson Argot Partners 610.420.3049 TriSalus@argotpartners.com For Investor Inquiries: James Young SVP-Investor Relations/Treasurer 847.337.0655 james.young@trisaluslifesci.com Source: TriSalus Life Sciences View this news release online at: