On April 30, 2025 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology focused medical technology business seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications, reported preliminary financial results for Q1 2025 and that it has entered into a securities purchase agreement with certain investors for shares of its common stock to raise approximately $22.0 million in gross proceeds (Press release, TriSalus Life Sciences, APR 30, 2025, View Source [SID1234652403]). Additionally, as further described below, the Company committed to commence an exchange offer with respect to its outstanding Series A Convertible Preferred Stock (the "Preferred Stock"), which is intended to simplify the Company’s capital structure.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Preliminary Unaudited First Quarter 2025 Financial Results

Full financial results for the quarter ended March 31, 2025 are in the process of being finalized, however, initial and preliminary results show revenue, driven solely by the TriNav Infusion System, of approximately $9.2 million for the first quarter of 2025. This represents growth of approximately 42% versus the first quarter of 2024.

Private Placement

The private placement is being led by Nantahala Capital and includes investments by Broadfin Holdings and additional healthcare-focused institutional investors. Canaccord Genuity is acting as the sole placement agent for the private placement.

The Company will issue an aggregate of 5,500,000 shares of its common stock at a purchase price of $4.00 per share. The private placement is expected to close on or about May 2, 2025, subject to satisfaction of customary closing conditions. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued in the private placement and intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

Simplifying the Capital Structure

In connection with the private placement, TriSalus has entered into a Tender and Support Agreement with certain holders representing approximately 55% of outstanding shares of Preferred Stock. The Company has agreed to:

Launch a registered exchange offer pursuant to a registration statement on Form S-4 to be filed with the SEC to offer all preferred holders the opportunity to exchange their shares of Preferred Stock into a number of shares of common stock calculated based on a fixed value of $10.00 per share of Preferred Stock plus accrued dividends that would have accrued through August 10, 2027, divided by $4.00 per share; and
Convene a special meeting of stockholders to, among other things, vote on an amendment to the Certificate of Designations for the Preferred Stock that would (i) allow TriSalus to call and convert outstanding shares of Preferred Stock under specific terms and (ii) eliminate the conversion price reset provision currently scheduled for July 2027.
The Company expects to launch the exchange offer by the end of the second quarter of 2025 and to hold the special meeting in the third quarter of 2025. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

About Preliminary Financial Results

The preliminary results set forth above are unaudited, are based on management’s initial review of the Company’s results for the quarter ended March 31, 2025, and are subject to revision based upon the Company’s quarter-end closing procedures. Actual results may differ materially from these preliminary unaudited results following the completion of quarter-end closing procedures, final adjustments or other developments arising between now and the time that the Company’s financial results are finalized. In addition, these preliminary unaudited results are not a comprehensive statement of the Company’s financial results for the quarter ended March 31, 2025, should not be viewed as a substitute for full, unaudited financial statements for the quarter ended March 31, 2025, and are not necessarily indicative of the Company’s results for any future period.

On April 30, 2025 PanGIA Biotech, a company advancing urine-based, AI-driven diagnostics for early cancer detection, reported that an abstract co-authored by researchers from PanGIA Biotech, Entopsis Inc., and Genetics Institute of America has been accepted for presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place May 30–June 3, 2025, in Chicago, Illinois (Press release, PanGIA Biotech, APR 30, 2025, View Source [SID1234652402]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The abstract, titled Development and validation of an AI-enabled prediction of prostate cancer (PCa) using urine-based liquid biopsy (Abstract #3080), has been accepted for presentation in the poster session titled Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology.

The presentation highlights collaborative research contributing to PanGIA’s AI-driven, urine-based diagnostic platform. The work integrates biomolecular pattern analysis and machine learning to support the development of scalable, non-invasive solutions in cancer care.

ASCO 2025 Presentation Details

Date: June 2, 2025
Time: 1:30 – 4:30 p.m. CDT
Location: McCormick Place, Chicago, IL
"This presentation reflects our focus on developing non-invasive, scalable diagnostics rooted in the promise of liquid biopsy innovation," said Holly Magliochetti, CEO of PanGIA Biotech. "We remain committed to advancing technologies that may support earlier cancer detection and improve access to care globally."

Co-authors on the abstract include researchers from PanGIA Biotech, Entopsis Inc., and the Genetics Institute of America.

On April 30, 2025 Ingenium Therapeutics, a clinical-stage biotechnology company advancing allogeneic natural killer (NK) cell therapies, reported that it has received positive regulatory feedback from the U.S. Food and Drug Administration (FDA) following a Pre-Investigational New Drug (Pre-IND) meeting (Press release, Ingenium Therapeutics, APR 30, 2025, View Source [SID1234652401]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ingenium has conducted multiple investigator-initiated trials in South Korea, enrolling over 140 patients with acute myeloid leukemia (AML), including a Phase 2 randomized clinical trial with long-term overall survival follow-up. These studies have generated robust non-clinical and clinical data supporting the safety and efficacy profile of Gengleucel.

Based on its review of these data, the FDA has provided positive feedback on Ingenium’s proposal to initiate a Phase 2 trial of Gengleucel in the United States without a preceding Phase 1 study. This regulatory milestone may streamline Gengleucel’s clinical development pathway and may accelerate access for patients with measurable residual disease-positive (MRD+) AML.

The planned multicenter study will be conducted at leading cancer centers across the United States, including a world-renowned institution in Texas. Gengleucel is positioned to become the first NK cell therapy in AML to use MRD negativity as a primary endpoint, underscoring its potential to improve outcomes by eradicating minimal residual disease and reducing relapse risk.

"We are thrilled with the FDA’s guidance, which reflects the rigor of our clinical research and the significant therapeutic potential of Gengleucel, especially in targeting minimal residual disease," said Kevin Koh, CEO of Ingenium Therapeutics. "Launching our U.S. Phase 2 trial at premier cancer centers marks a major milestone in our mission to deliver novel immunotherapies to AML patients with MRD."

The trial is expected to begin in early 2026 and will evaluate Gengleucel’s ability to achieve MRD negativity and reduce relapse and mortality. To ensure reliable clinical operations and product supply, Ingenium is transferring its manufacturing technology to a Texas-based manufacturing facility.

About Gengleucel

Gengleucel is a non-engineered, allogeneic NK cell therapy composed of memory NK cells with enhanced activating receptor expression and increased secretion of IFN-gamma, granzyme, and perforin. These features drive potent anti-cancer activity and sustained in vivo persistence. Clinical trials have demonstrated Gengleucel’s favorable safety, tolerability, and efficacy in high-risk AML and MDS populations. Gengleucel has been granted Orphan Drug Designation by the U.S. FDA for the treatment of AML.

On April 30, 2025 J INTS BIO, a company specializing in anticancer and orphan drugs, reported its research findings for the next-generation EGFR-TKI therapeutic ‘JIN-A02’ (clinical Phase 1/2 results) and the ovarian cancer treatment candidate ‘JIN-001’ (preclinical results) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025, held in Chicago from April 25 to 30 (Press release, J INTS BIO, APR 30, 2025, View Source [SID1234652400]). In this presentation, J INTS BIO demonstrated its innovative drug development capabilities on a global stage, attracting significant attention from both academia and the industry.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

‘JIN-A02’: New Hope for Overcoming Resistance – 4th Generation EGFR-TKI Clinical Results

Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases worldwide, and among these, EGFR mutations are considered a major therapeutic target. JIN-A02, introduced at AACR (Free AACR Whitepaper) 2025, showed outstanding therapeutic efficacy in patients who developed resistance to existing third-generation EGFR-TKIs. In particular, JIN-A02 demonstrated remarkable antitumor activity in patients with EGFR C797S mutation—currently a mutation for which no approved targeted therapies exist—thus opening a new avenue for treatment options.

In the clinical trial, a patient in the 300 mg cohort showed complete clearance of circulating tumor DNA (ctDNA) harboring either the C797S or Ex19del mutation, and ctDNA carrying the T790M mutation was reduced by over 90%. Clinically, a partial response (PR) was observed, with tumor size reductions of up to 39.7%, and notable shrinkage of intracranial metastatic lesions. These findings are particularly important for NSCLC patients, in whom brain metastases are common. Furthermore, no dose-limiting toxicities (DLTs) or serious adverse events were observed up to the 300 mg dose, highlighting the excellent safety profile of JIN-A02. This safety profile is expected to be particularly beneficial for patients requiring long-term treatment and combination therapies.

Currently, JIN-A02 is undergoing multinational clinical trials in Korea, the United States, Thailand, and other countries, and it is being closely watched as a potential groundbreaking treatment option for EGFR-mutant NSCLC patients.

‘JIN-001’: An Innovative New Drug Targeting Refractory Ovarian Cancer

Also presented was ‘JIN-001,’ J INTS BIO’s second-generation synthetic HSP90 inhibitor, developed as a new strategy to overcome resistance to existing ovarian cancer treatments. Ovarian cancer remains one of the deadliest gynecological malignancies, as it is often diagnosed at an advanced stage when effective treatment options are extremely limited.

The preclinical study demonstrated that JIN-001, when combined with the chemotherapeutic agent cisplatin, significantly enhanced tumor suppression compared to cisplatin alone. Notably, even at low concentrations (≤0.1 μM), JIN-001 enhanced the antitumor activity of cisplatin against both cisplatin-sensitive and cisplatin-resistant ovarian cancer cells, compared to cisplatin alone. Moreover, the combination therapy significantly reduced the expression of key signaling proteins related to cisplatin resistance, contributing to a sustained antitumor effect.

Based on these promising results, J INTS BIO is planning additional preclinical studies and aims to rapidly advance JIN-001 into clinical trials, with the goal of establishing a new standard of care for the treatment of refractory and multidrug-resistant ovarian cancer.

Led by the presentation at AACR (Free AACR Whitepaper) 2025, J INTS BIO aims to further strengthen its competitiveness in the global oncology market and solidify its position as a frontrunner in next-generation anticancer drug development. The company also outlined its vision to continue delivering innovative therapies through ongoing research and development efforts, offering new hope to cancer patients worldwide.

On April 30, 2025 Genocury Biotech reported groundbreaking clinical data from its noval in vivo CD19 CAR-T therapy in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), a notoriously aggressive blood cancer (Press release, Shenzhen Genocury Biotech, APR 30, 2025, View Source [SID1234652399]). In an investigator-initiated trial (IIT) led by the Hematology Department at Tongji Hospital, a heavily pretreated relapsed/refractory (R/R) patient with advanced DLBCL achieved complete remission (CR) after 1 month of the in vivo CAR-T treatment, with durable response sustained over three months. Notably, the treatment eliminated the need for lymphodepletion, a standard yet toxic preconditioning step in traditional CAR-T protocols.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Clinical Breakthrough: Redefining Safety, Efficacy, and Speed

Key trial findings:

1. Rapid and Deep Response:

A relapsed DLBCL male patient achieved complete hematological remission (CR) within 28 days following a single dose of Genocury’s CD19 in vivo CAR-T without lymphodepletion. Flow cytometric analysis revealed significant CAR-T cell expansion kinetics, with sustained therapeutic efficacy confirmed through 90-day follow-up monitoring.

2. Unprecedented Safety Profile:

Unlike conventional CAR-T, which carries a ~50% risk of cytokine release syndrome (CRS) and neurotoxicity, this novel therapeutic approach demonstrated complete absence of:

Cytokine release syndrome (CRS)
Immune effector cell-associated neurotoxicity syndrome (ICANS)
Lymphodepletion-related complications – typically associated with increased infection risk- further underscores the therapy’s safety profile.
Reimagining CAR-T: In Vivo Engineering Breakthroughs

Genocury’s in vivo CAR-T platform overcomes two critical roadblocks in current CAR-T therapy:

Eliminates Ex Vivo Manipulation: Traditional CAR-T requires 3-4 week vein-to-vein timeline by harvesting, modifying, and expanding a patient’s T cells outside the body, and $400K price tag stems from this time-consuming process. Genocury’s proprietary in vivo CAR-T vector delivers CAR payload directly into circulating T cells in vivo, enabling functional CAR-T generation.
Lymphodepletion-Free Protocol: Current protocols require the harsh preconditioning chemotherapy for immune reset – a leading cause of hospitalization. Genocury’s lymphodepletion-free approach reduces treatment-related complications and logistical burdens, as well as enabling significant CAR-T cell expansion.
Statement from Prof. Jia Wei , M.D., Ph.D.

PI (principal investigator), Tongji Hospital Hematology Department (Wuhan)
"In this groundbreaking case, we observed the patient treated with Genocury’s CD19 in vivo CAR-T achieved complete remission through 90-day follow-up – achieved without any lymphodepletion, which fundamentally challenges current cellular therapy dogma" said Dr. Jia Wei, "This therapy combines the benefits of autologous CAR-T with the accessibility of universal therapies, potentially ending the era of unaffordable cancer treatments. This could democratize access to CAR-T globally, we are very excited to advance this paradigm-shifting approach."