On March 19, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported its business update and financial results for the quarter ended December 31, 2025.

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Operational Highlights

TakeAim Lymphoma

Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute in Boston, presented a poster with updated clinical data in Primary CNS Lymphoma (PCNSL) at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) in November 2025. The poster, titled Preliminary Safety and Efficacy of Emavusertib (CA-4948) in Combination with Ibrutinib in Relapsed/Refractory Primary Central Nervous System Lymphoma Patients, showed results for 24 patients who have received treatment with emavusertib and ibrutinib, a BTK inhibitor (BTKi), for at least 1 cycle (28 days):
5 of 5 BTKi-naïve patients achieved objective response (100% ORR)
7 of 19 BTKi-experienced patients achieved objective response (37% ORR)
Median treatment duration for the 12 responders was 123 days (44 – 798 days)
9 additional patients were unable to complete 1 cycle of treatment; reasons for discontinuing treatment included adverse events unrelated to treatment, disease progression, and transition to hospice care.
Cecilia Merrigan, DNP, Mayo Clinic in Rochester, presented a poster with initial clinical data in Secondary CNS Lymphoma (SCNSL) at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) in November 2025. The poster, titled Promising Efficacy Signal in Secondary CNS Lymphoma Patients Treated with Emavusertib and Ibrutinib, showed results for 2 patients who had previously progressed on a BTKi. Adding emavusertib to their ibrutinib treatment resulted in 1 complete response (CR) and 1 stable disease (SD) with a 38% reduction in disease burden.
Curis continues to enroll PCNSL patients in the Company’s TakeAim Lymphoma study of emavusertib in combination with ibrutinib which, as a result of discussions with FDA and EMA, is intended to support filings for accelerated approval in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both FDA and EMA in PCNSL.
TakeAim CLL

Curis initiated an open label Phase 2 clinical study of emavusertib in combination with zanubrutinib, a BTKi, in patients with Chronic Lymphocytic Leukemia (CLL). The goal of combining emavusertib with a BTKi is to enable a dual blockade of NF-kB, a key driver of disease in CLL and NHL, by inhibiting both the TLR and BCR pathways. The current standard of care is BTKi, which blocks the BCR pathway and can deliver high response rates, though typically only partial responses. Previous clinical studies have shown that adding emavusertib, which blocks the TLR pathway, to a BTKi regimen can enable patients with NHL to achieve deeper responses, including complete remission or undetectable minimal residual disease (MRD) and the potential for time-limited treatment, outcomes which represent the potential for a paradigm shift in the management of CLL.
AML

Christina Papayannidis, MD, IRCCS Azienda Ospedaliero Universitaria di Bologna, presented a poster with initial clinical data in frontline AML at the 67th ASH (Free ASH Whitepaper) Annual Meeting in December. The AML triplet study (CA-4948-104) is evaluating the addition of emavusertib to the combination of azacitidine and venetoclax (aza-ven) in AML patients who have achieved complete remission on aza-ven but remain MRD-positive (MRD+). The first two cohorts in the study evaluate patients who received emavusertib for either 7 or 14 days in a 28-day cycle, in addition to their aza-ven treatment. The poster, titled Preliminary Pharmacokinetic and MRD Results from AML Patients Treated with 7- and 14-Day Dosing Schedule of Emavusertib added to Combination Therapy with Azacitidine and Venetoclax, showed results for 4 patients in the 7-day cohort and 6 patients in the 14-day cohort:
8 patients had central MRD samples
5 of 8 patients (62.5%) achieved MRD conversion (MRD+ to undetectable).
Corporate

On January 9, 2026, the Company announced the closing of a private placement (the "January 2026 PIPE Financing") with gross proceeds of up to $80.8 million, including initial gross proceeds of approximately $20.2 million with three series of warrants (A, B, and C) which can be exercised for up to $20.2 million each according to the terms and conditions of the financing agreement. All three series of warrants are currently exercisable at $0.75 per share and have the following termination conditions:

Series A warrants terminate on January 8, 2031
Series B warrants terminate 30 days after the Company announces dosing of the fifth patient in the Phase 2 clinical trial in CLL, subject to conditions defined in the financing agreement
Series C warrants terminate on January 8, 2027.
Fourth Quarter 2025 Financial Results

For the year ended December 31, 2025, Curis reported a net loss of $7.6 million, or $0.58 per share on both a basic and diluted basis, as compared to a net loss of $43.4 million, or $6.88 per share on both a basic and diluted basis in 2024. For the fourth quarter of 2025, Curis reported net income of $19.4 million or $1.23 per share on both a basic and diluted basis as compared to a net loss of $9.6 million or $1.25 on both a basic and diluted basis for the same period in 2024.

Revenues, net were $9.4 million and $10.9 million for the years ended December 31, 2025 and 2024, respectively. Revenues are comprised of royalty revenues related to Genentech and Roche’s net sales of Erivedge. Revenues were $1.1 million and $3.3 million for the fourth quarters of 2025 and 2024, respectively. As previously announced, on November 6, 2025, the Company sold to TPC Investments Royalty LLC, a limited liability company managed by Oberland, its interest in Curis Royalty LLC. The sale included the Erivedge intellectual property, other assets associated with Erivedge and the License Agreement with Genentech ("Erivedge"), in exchange for upfront consideration of $2.5 million and a release of the Company’s liability related to sale of future royalties to Oberland. In connection with such transaction, the Company transferred to Curis Royalty all rights to Curis Technology, Inventions and Joint Patents (each as defined in the License Agreement) and assigned the Company’s rights, duties and obligations under the License Agreement to Curis Royalty. Following the sale, the Company is no longer entitled to revenues under the License Agreement.

Research and development expenses were $28.3 million and $38.6 million for the years ended December 31, 2025 and 2024, respectively. The decrease was primarily attributable to lower employee-related, clinical, manufacturing and consulting costs. Research and development expenses were $5.8 million and $9.0 million for the fourth quarters of 2025 and 2024, respectively.

General and administrative expenses were $14.0 million and $16.8 million for the years ended December 31, 2025 and 2024, respectively. The decrease was primarily attributable to lower employee-related and legal costs. General and administrative expenses were $2.9 million and $3.4 million for the fourth quarters of 2025 and 2024, respectively.

Gain on release of liability related to sale of future royalties associated with sale of assets was the result of the sale of Erivedge. In the fourth quarter 2025, the Company recognized a non-cash $27.2 million gain and the liability related to sale of future royalties was extinguished.

Other expense, net was $1.9 million for the year ended December 31, 2025 and other income, net was $1.2 million for the year ended December 31, 2024. The increase was partially attributable to an increase in expense related to the sale of future royalties and a decrease in interest income. Other expense, net was $0.3 million and $0.6 million for the fourth quarters of 2025 and 2024, respectively.

As of December 31, 2025, Curis’s cash and cash equivalents totaled $5.1 million, and the Company had approximately 12.9 million shares of common stock outstanding.

Cash Runway Guidance

Curis believes its cash and cash equivalents as of December 31, 2025, together with initial gross proceeds of $20.2 million received in January 2026 and expected gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE Financing Series B Warrants upon the public announcement of dosing the 5th CLL patient in our TakeAim CLL study expected later this year, should enable the Company’s planned operations into the second half of 2027.

Conference Call Information

Curis management will host a conference call today, March 19, 2026, at 4:30 p.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial (800)-836-8184 from the United States or (646)-357-8785 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed here on the Curis website in the Investors section.

(Press release, Curis, MAR 19, 2026, View Source [SID1234663747])

On March 19, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") reported financial results for the fourth quarter and fiscal year 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. (the "Acquirer") and the Former Parent’s concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials.

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Upcoming Milestones

ozekibart (INBRX-109)
We expect to submit the Biologics License Application ("BLA") for ozekibart for the treatment of unresectable or metastatic conventional chondrosarcoma to the U.S. Food and Drug Administration ("FDA") early in the second quarter of 2026;
We plan to announce progression-free survival ("PFS") data for the Phase 1/2 colorectal cancer expansion cohort in the second quarter of 2026; and
We plan to meet with the FDA to discuss accelerated approval for Ewing Sarcoma and fourth line colorectal cancer in the second half of 2026.
INBRX-106
We plan to announce interim objective response rate ("ORR") data from the randomized Phase 2/3 trial in head and neck squamous cell carcinoma ("HNSCC") in combination with KEYTRUDA (pembrolizumab) in the second quarter of 2026; and
We plan to announce PFS data from the randomized Phase 2/3 trial in HNSCC in combination with pembrolizumab in the fourth quarter of 2026 at the European Society for Medical Oncology ("ESMO") 2026 Congress.
Financial Results

Cash and Cash Equivalents. As of December 31, 2025, Inhibrx had cash and cash equivalents of $124.2 million. On March 18, 2026, the Company entered into the First Amendment to the Loan and Security Agreement with Oxford Finance, LLC and received gross proceeds of $75.0 million.

R&D Expense

Research and development expenses were $25.3 million during the fourth quarter of 2025 as compared to $33.4 million during the fourth quarter of 2024. This decrease during the fourth quarter of 2025 was primarily due to a decrease in expense related to lower clinical trial costs in our ozekibart registration-enabling trial for the treatment of unresectable or metastatic conventional chondrosarcoma as the trial approached completion of enrollment ahead of our data readout in October 2025, as well as a decrease in contract manufacturing expenses;
Research and development expenses were $113.0 million during the fiscal year 2025 as compared to $203.7 million during the fiscal year 2024. This decrease during the fiscal year 2025 was primarily due to the following factors:
a decrease in clinical trial expense primarily related to lower clinical trial costs in our ozekibart registration-enabling trial for the treatment of unresectable or metastatic conventional chondrosarcoma as discussed above;
a decrease in contract manufacturing expense primarily attributable to decreased expenses incurred at our contract development and manufacturing organizations for our ozekibart program and INBRX-106 program, as well as decreased expenses following the 101 Transaction; and
increased personnel-related expense during the fiscal year 2024 related to the recognition of $25.9 million upon the acceleration of outstanding options in connection with the closing of the 101 Transaction.
G&A Expense

General and administrative expenses were $5.6 million during the fourth quarter of 2025, compared to $16.7 million during the fourth quarter of 2024. This decrease during the fourth quarter of 2025 was primarily due to an increase in legal services incurred in the prior period in connection with legal proceedings, which have since concluded, finding the Company not liable for damages.
General and administrative expenses were $23.3 million during the fiscal year 2025, compared to $127.9 million during the fiscal year 2024. This decrease during the fiscal year 2025 was primarily due to the following factors:
one-time expenses incurred during the fiscal year 2024 related to the 101 Transaction, including $68.1 million of legal, advisory, and consulting services, and the recognition of $15.2 million in stock option expense upon the acceleration of outstanding options in connection with the closing of the 101 Transaction; and
increased expense during the fiscal year 2024 related to legal services incurred in connection with the Company’s legal proceedings as discussed above.
Other Income (Expense)

Other expense was $1.9 million during the fourth quarter of 2025, compared to other income of $2.1 million during the fourth quarter of 2024. Other expense in the current period consisted of $3.2 million of interest expense on the Company’s $100.0 million outstanding debt balance, offset in part by other income. Other income during each period consisted of interest income earned on the Company’s sweep and money market account balances. During the fourth quarter of 2024, the Company did not incur any interest expense following the extinguishment of all outstanding debt in connection with the 101 Transaction.
Other expense was $5.0 million during the fiscal year 2025, compared to other income of $2.0 billion during the fiscal year 2024. Other expense in the current period consisted of $12.2 million of interest expense on the Company’s $100.0 million outstanding debt balance, offset in part by other income. Other income during each period consisted of interest earned on the Company’s sweep and money market account balances. During the fiscal year ended 2024, as noted above, other income also included the gain recorded in connection with the completion of the 101 Transaction. This gain consisted of (i) the consideration paid by the Acquirer for all outstanding common stock, warrants, and stock options, (ii) the extinguishment of the Company’s outstanding debt which was assumed by the Acquirer, (iii) assets and liabilities related to the Inhibrx 101 Business, which were assumed by the Acquirer, and (iv) transaction costs paid for by the Acquirer.
Net Income (Loss)

Net loss was $32.8 million during the fourth quarter of 2025, or $2.11 per share, basic and diluted, compared to a net loss of $47.9 million during the fourth quarter of 2024, or $3.09 per share, basic and diluted.
Net loss was $140.1 million during the fiscal year 2025, or $9.04 per share, basic and diluted, compared to a net income of $1.7 billion during the fiscal year 2024, or earnings per share $114.01 basic and $112.62 diluted.

(Press release, Inhibrx, MAR 19, 2026, View Source [SID1234663765])

On March 19, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the initiation of new clinical sites in the US.

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The Phase III clinical trial has recently been activated at City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States – specifically at its network sites in Los Angeles and Orange counties, Arizona, Atlanta, and Illinois. Principal investigator at City of Hope, Hope S. Rugo, M.D., continues her participation on the Steering Committee. Her prior site at University of California San Francisco, where she is Professor Emeritus, is still participating in the study.

Dr. Rugo is division chief of breast medical oncology and a professor in the Department of Medical Oncology & Therapeutics Research at City of Hope. She also serves as director of the Women’s Cancers Program for City of Hope’s national network of cancer centers. A world-renowned expert in breast cancer and clinical trial design and execution, Dr. Rugo oversees women’s cancer research initiatives and clinical care at City of Hope. She is focused on expanding breast cancer clinical trials, advancing translational research, and standardizing care to improve patient outcomes. She is deeply committed to improving access to innovative new therapies for breast cancer patients everywhere and takes a compassionate, collaborative approach in her work.

Dr. Rugo has been directly involved in numerous projects that have established new standards of care for breast cancer. She has served on the steering committees of multiple clinical trials that led to the approval of agents such as PARP inhibitors, CDK4/6 inhibitors, PI3K inhibitors, checkpoint inhibitors, and antibody-drug conjugates, among others. Additionally, Dr. Rugo has led several studies aimed at minimizing therapy-related toxicity. She also served as co-chair of the Triple Negative Working Group of the Translational Breast Cancer Research Consortium, where she spearheaded groundbreaking multicenter clinical trials in collaboration with researchers, pharmaceutical companies, and clinical providers. As a physician-scholar with more than 500 peer-reviewed publications, Dr. Rugo served on the editorial board of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Education Committee, which included co-chairing the creation of new guidelines for the hormonal treatment of metastatic breast cancer.

Dr. Rugo commented, "I am excited to open this important trial across our City of Hope sites, expanding treatment opportunities for our patients with high-risk early stage HER2 positive breast cancer. It is truly an honor to now represent City of Hope on the Steering Committee. This study aligns with City of Hope’s interest in and the importance of harnessing the host immune system to reduce the risk of breast cancer recurrence."

Last year City of Hope launched a national clinical trials model that includes clinical sites across the United States in order to accelerate cancer research.

Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "We are honored to have Dr. Rugo, a globally recognized leader in breast cancer, now participating in FLAMINGO-01 through her leadership at City of Hope. Her site’s expertise and commitment to advancing patient care, which I personally experienced when training these sites, is invaluable as we continue to study GLSI-100. The four City of Hope locations also strengthen our study footprint in some regions of the US where we were not previously covered, providing the study with access to additional population centers."

CEO Snehal Patel commented, "We started working with Dr. Rugo when she was the breast cancer leader at UCSF and joined our Phase III study and Steering Committee. We quickly benefited from her recommendations as the study was starting up and expanding into Europe. Her extensive experience in developing novel therapies, while minimizing toxicities, will guide us through the development of GLSI-100 as an effective and safe vaccine to prevent metastatic breast cancer in high-risk breast cancer survivors. With the addition of these new sites at City of Hope, planned expansion of US Oncology/Sarah Cannon sites, addition of sites in new countries, including potentially the United Kingdom and Canada, the total sites participating in FLAMINGO-01 could increase from the current 160 sites to up to 190-200 sites."

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, MAR 19, 2026, View Source [SID1234663748])

On March 19, 2026 Ractigen Therapeutics, a pioneering clinical-stage biotechnology company developing innovative small activating RNA (saRNA) therapeutics, reported that China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved its Investigational New Drug (IND) application to initiate a Phase II clinical trial of RAG-01 for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

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This significant milestone makes RAG-01 the second saRNA therapeutic to receive IND approval in China, both of which were developed by Ractigen. This approval not only solidifies Ractigen’s global leadership in saRNA technology but also serves as a critical clinical validator for the company’s broader RNA activation (RNAa) platform and its LiCOTM delivery technology.

RAG-01 is a novel saRNA therapeutic designed to upregulate p21, a key regulator of cell cycle arrest and cellular senescence, to inhibit the abnormal proliferation of bladder cancer cells. This innovative saRNA therapeutic aims to treat NMIBC by increasing p21 mRNA and protein levels.

The progression of RAG-01 into Phase II clinical development follows highly encouraging Phase I data from Australia, which demonstrated clear target engagement (p21 protein upregulation), a favorable safety profile, and promising complete response (CR) signals.

"We are very pleased to receive IND approval from the China NMPA CDE for the Phase II trial of RAG-01," said Dr. Long-Cheng Li, Founder and CEO of Ractigen Therapeutics. "This approval is an important validation of both the RAG-01 program and the broader potential of saRNA therapeutics. RAG-01 reflects our innovation strategy of activating endogenous disease-relevant genes that have long been considered difficult to drug. We believe this differentiated mechanism, together with local bladder delivery, may offer a meaningful new treatment option for patients with NMIBC. We look forward to working closely with investigators and regulatory authorities to advance this program."

The Phase II study is a randomized, controlled, multi-center trial designed to evaluate the efficacy and safety of RAG-01 as monotherapy and in combination with chemotherapy in patients with intermediate- and high-risk NMIBC. The China study builds on encouraging preliminary data from the ongoing Phase I clinical trial in Australia, where RAG-01 has demonstrated favorable safety, clear target engagement, and anti-tumor activity.

About RAG-01

RAG-01 is a pioneering saRNA therapeutic candidate designed to activate the tumor suppressor gene p21 via RNA activation (RNAa). The product is administered through intravesical instillation using Ractigen’s proprietary LiCO delivery technology. In the Phase I clinical trial conducted in Australia, RAG-01 has shown encouraging preliminary safety, target engagement, and efficacy data. In 2024, RAG-01 received IND clearance from the U.S. Food and Drug Administration (FDA) and was granted Fast Track designation.

About NMIBC

Non-muscle invasive bladder cancer (NMIBC) is a common malignancy confined to the lining of the bladder. The standard first-line treatment is transurethral resection of the bladder tumor (TURBT) followed by intravesical BCG or chemotherapy. However, a significant proportion of patients experience treatment failure or multiple recurrences, highlighting the need for new and effective treatment options.

About RNAa

RNA activation is a clinically validated platform technology developed by Dr. Long-Cheng Li and his team. It utilizes saRNAs to target gene regulatory domains, activating gene expression and restoring therapeutic protein levels. This innovative technology holds vast potential for developing therapeutic drugs across various diseases, particularly where traditional methods fall short.

(Press release, Ractigen, MAR 19, 2026, View Source [SID1234663766])

On March 18, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported the publication of preclinical research evaluating Pressure-Enabled Drug Delivery (PEDD) of nelitolimod in liver tumor models in Frontiers in Oncology.

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The study evaluated the delivery and biologic activity of nelitolimod, an investigational Toll-like receptor 9 (TLR9) agonist, when administered using PEDD, compared with conventional delivery approaches. The research examined therapeutic distribution in a porcine liver tumor model and anti-tumor activity in murine liver metastasis models.

Key findings from the study include:

Improved intratumoral delivery: PEDD administration with the TriNav Infusion System resulted in significantly greater distribution of nelitolimod within and around tumors compared with delivery through a conventional microcatheter in an Oncopig model of hepatic tumors
Evidence of enhanced immune activity: Treatment using PEDD was associated with reduced levels of immunosuppressive myeloid-derived suppressor cells (MDSCs) and increased infiltration of cytotoxic CD8+ T cells within the tumor microenvironment.
Reduced tumor growth: In a murine liver metastasis model, nelitolimod delivered using PEDD significantly reduced tumor growth compared with systemic administration at key time points during the study.
Potential impact of delivery on immunotherapy performance: The findings support the concept that improving therapeutic distribution within tumors may influence both immune activation and anti-tumor activity.

"This study highlights the critical role that delivery plays in determining how effectively therapies engage the tumor microenvironment, particularly for immunotherapies designed to activate local immune responses," said Mary Szela, President and Chief Executive Officer of TriSalus Life Sciences. "By combining PEDD-enabled delivery with nelitolimod, we observed improved distribution within tumors along with encouraging signals of immune activation and anti-tumor activity in these preclinical models. Importantly, these findings illustrate the broader potential of PEDD as a delivery platform capable of enhancing the intratumoral delivery of multiple therapeutic modalities while limiting exposure healthy tissue. We believe this approach may help unlock the full potential of immunotherapies and other agents for patients with difficult-to-treat solid tumors, including those in the liver."

For TriSalus Life Sciences, the data reinforces the Company’s strategy of combining PEDD-enabled delivery with locoregional immunotherapy approaches. The TriNav Infusion System is designed to temporarily overcome elevated intratumoral pressure and reopen collapsed microvasculature to promote distribution of therapeutics within tumors and surrounding tissue and increasing the level of the therapeutic in the tumor.

Nelitolimod is being investigated by TriSalus for use as an immunotherapy intended to stimulate immune responses within tumors. This study’s findings support continued investigation of approaches that combine targeted drug delivery with immune activation in solid tumors.

(Press release, TriSalus Life Sciences, MAR 18, 2026, View Source [SID1234663722])