On March 27, 2025 Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, reported the analytical validation of NavDx+Gyn, an important extension of the NavDx blood test. NavDx+Gyn is a cell-free DNA-based fragmentomic profiling assay that enhances the detection and monitoring of human papillomavirus (HPV)-driven gynecologic cancers (Press release, Naveris, MAR 27, 2025, View Source [SID1234651549]).

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Leveraging the robust foundation of the NavDx test, which has been validated in over 35 peer-reviewed publications and utilized in nearly 100,000 patient-physician encounters, NavDx+Gyn expands detection capabilities to include fourteen high-risk HPV types associated with cervical, vaginal, and vulvar cancers. This new blood test has been rigorously validated to provide exceptional analytical specificity and sensitivity, setting a new standard for early detection and monitoring of these cancers.

The analytical validation, published in the Journal Diagnostics, confirms that NavDx+Gyn achieves outstanding limits of detection and quantitation, ensuring dependable detection of HPV types at very low concentrations. The assay’s performance was extensively tested across multiple analytical metrics including accuracy, precision, and linearity, with results underscoring its high-quality standards.

"NavDx+Gyn is a significant enhancement in the non-invasive surveillance of HPV-associated gynecologic cancers," said Dr. Piyush B. Gupta, PhD, Executive Chairman, Chief Science & Technology Officer, and Founder of Naveris. "Early detection is vital for effective management and treatment of these cancers."

The development of NavDx+Gyn comes at a critical time, addressing the pressing need for advanced diagnostic tools in the face of the global burden of HPV-related cancers and the limitations of current diagnostic methods. By offering a reliable, non-invasive testing option, NavDx+Gyn aims to change the landscape of cancer surveillance and offer new hope to thousands of women worldwide.

"Naveris is committed to advancing healthcare equity and improving outcomes for cancer patients through state-of-the-art diagnostics," added Dr. Barry M. Berger, MD, Chief Medical Officer of Naveris. "NavDx+Gyn embodies our dedication to harnessing innovation to improve patient care through early detection."

Hutcheson J., Conway D., Kumar S., Wiseman C., Chakraborty S., Skrypkin E., Horan M., Gunning A., Williams C.K., Kuperwasser C., Naber S.P., and Gupta P.B. Analytical Validation of NavDx+Gyn, a cfDNA-Based Fragmentomic Profiling Assay for HPV-Driven Gynecologic Cancers. Diagnostics 2025, 15(7), 825. View Source

On March 27, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported a clinical programs update and announced financial results for the full year ended December 31, 2024 (Press release, PDS Biotechnology, MAR 27, 2025, View Source [SID1234651534]).

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"We are pleased with the progress made over the past year and in recent weeks, culminating with the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating Versamune HPV in recurrent/metastatic ("R/M") HPV16-positive head and neck squamous carcinoma ("HNSCC")," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Patients with HPV16-positive HNSCC represent a large and rapidly growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. Considering the strength and durability of the clinical responses observed in our VERSATILE-002 study, we are excited that this registrational trial is underway and are confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care. In the coming weeks, we expect to continue activating additional clinical sites, and look forward to the progression of this registrational trial."

Clinical Strategy Summary

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Phase 3 VERSATILE-003 Trial in HPV16-positive first-line recurrent and/or metastatic HNSCC

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Announced activation of the first site in March 2025

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Trial designed to include approximately 350 patients

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PDS Biotech is aligned with the U.S. Food and Drug Administration ("FDA") on the design of the registrational trial and clinical endpoints.

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Two-arm controlled trial with 2:1 randomization

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Median overall survival is primary endpoint

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Design based on strong and durable responses seen in the VERSATILE-002 trial

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Interim readouts included in study design

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The Company received Fast Track designation from the FDA for the combination of Versamune HPV and pembrolizumab in R/M HNSCC.

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For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966)

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In March 2025, announced FDA Clearance of Investigational New Drug ("IND") application for the combination of Versamune MUC1 and PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma.

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Phase 1/2 clinical trial evaluating the proprietary combination to be run under PDS Biotech’s Cooperative Research and Development Agreement with the National Cancer Institute

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Second Versamune platform candidate targets MUC1-positive solid tumors

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In October 2024, updated results from the IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune HPV and chemoradiotherapy were presented at the 66th American Society for Radiation Oncology (ASTRO) Annual Meeting.

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In October 2024, the rationale and design of a recurrent prostate cancer trial combining Xtandi + PDS01ADC vs. Xtandi were presented at the 12th Annual Meeting of the International Cytokine and Interferon Society (Cytokines 2024).

Full Year 2024 Financial Results

Net loss for the year ended December 31, 2024, was approximately $37.6 million, or $1.03 per basic and diluted share, compared to a net loss of $42.9 million, or $1.39 per basic and diluted share, for the year ended December 31, 2023. The reduced net loss was primarily the result of decreased operating expenses, partially offset by increased net interest expense.

Research and development expenses for the year ended December 31, 2024, were $22.6 million, compared to $27.8 million for the year ended December 31, 2023. The decrease of $5.2 million was primarily attributable to decreases in clinical costs of $4.1 million, personnel costs of $1.0 million and professional fees of $0.1 million.

General and administrative expenses for the year ended December 31, 2024, were $13.8 million, compared to $15.3 million for the year ended December 31, 2023. The $1.5 million decrease was primarily attributable to decreases in professional fees of $1.3 million and facilities costs of $0.2 million.

Total operating expenses for the year ended December 31, 2024, were $36.3 million, compared to $43.0 million for the year ended December 31, 2023.

Net interest expense was $2.2 million for the year ended December 31, 2024, compared to $1.3 million for the year ended December 31, 2023. The change was due to increased debt interest and lower interest income on the Company’s cash balances.

On February 27, 2025, the Company announced an up to $22 million registered direct offering. The securities purchase agreements with new and existing healthcare focused institutional investors included $11 million of upfront gross proceeds, with up to an additional $11 million of aggregate gross proceeds upon cash exercise in full of warrants issued to the investors.

The Company’s cash balance as of December 31, 2024, was $41.7 million.

Conference Details

Date: March 27, 2025
Time: 8:00 a.m. Eastern Time
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
Webcast Registration: Click Here
Call MeTM Registration: Click Here (Available 15 minutes prior to call)

On March 27, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported the 2024 annual results as of 31 December 2024 (Press release, InnoCare Pharma, MAR 27, 2025, View Source [SID1234651550]).

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Financial Highlights

Revenue of Orelabrutinib increased by 49.1% to RMB 1,000.4 million1 in 2024, mainly driven by rapid growth of marginal zone lymphoma (MZL) indication and strong commercial execution. Total revenue increased by 36.7% to RMB 1,009.4 million in 2024.
Gross Profit increased by 42.8% to RMB 871.0 million in 2024, with a gross profit margin of 86.3%, representing an increase of 3.7 percentage points, mainly due to the reduction in the unit cost of sales.
Research and Development Expenses increased by 8.4% to RMB 814.0 million in 2024, primarily due to increased investment in advanced technology platforms and heightened spending on global clinical trials.
The Loss decreased by 29.9% to RMB 452.9 million in 2024.
Cash and Related Accounts Balance2 stood at approximately RMB 7.8 billion as of 31 December 2024. This robust cash position provides InnoCare with flexibility to expedite clinical development and invest in a competitive pipeline.
Accelerating Globalization

China’s innovative drugs have become a new focus of the global pharmaceutical industry, and its innovation capabilities are increasingly recognized worldwide. In January 2025, InnoCare Pharma and KeyMed Biosciences entered into an exclusive license agreement with Prolium Bioscience (Prolium) for the development and commercialization of ICP-B02 (CM355), a CD20xCD3 bispecific antibody. Under the terms of the agreement, Prolium will have the exclusive right to develop, register, manufacture and commercialize ICP-B02 in the non-oncology field globally and in the oncology field in ex-Asia regions. InnoCare and KeyMed will receive aggregate payments of up to US$ 520 million, including upfront and near-term payments and other payments subject to the achievement of certain clinical, regulatory and commercial milestones, as well as a minority equity stake in Prolium. InnoCare and KeyMed are also eligible to receive tiered royalties on future net sales of any product resulting from the collaboration.

InnoCare will continue to strengthen the globalization of its other promising pipeline assets. As part of its BD strategy, the Company has been actively exploring collaboration and licensing opportunities for key assets, with a focus on expanding its presence outside of China. The Company remains committed to accelerating the global reach of its products through strategic partnerships, as well as strengthening regulatory and clinical capabilities in key markets.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare, said, "2024 marks the first year of the rapidly evolving InnoCare 2.0. Our commercial growth continued to accelerate, our R&D pipelines achieved key milestones, and our internationalization efforts gained momentum. 2025 marks our 10th anniversary. We will continue to pursue original innovation, advance multiple new molecules into clinical development, and accelerate multiple Phase III registration clinical studies in China and around the world. We will further strengthen our market expansion and establish a long-term successful commercial strategy, and further advance our globalization to bring more innovative projects to the global stage."

Building A Leading Franchise in Hemato-Oncology

With orelabrutinib as the backbone therapy, it plays a central role in InnoCare’s extensive pipeline in hemato-oncology. Alongside orelabrutinib, tafasitamab’s BLA was accepted, and ICP-248 (mesutoclax) entered into a Phase III clinical trial in combination with orelabrutinib for the fixed-duration treatment of 1L CLL/SLL in the first quarter of 2025. Together, orelabrutinib, tafasitamab and ICP-248 form a robust product combination that will establish a solid foundation in hematology-oncology. With this powerful combination and ongoing developments from both internal and external sources, InnoCare is dedicated to becoming a leading player in hemato-oncology both in China and worldwide. The Company remains committed to addressing major diseases, such as NHL, leukemia and multiple myeloma, through both monotherapies and combination therapies to provide effective solutions for patients globally.

Orelabrutinib

All three approved indications, including relapsed and refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (r/r CLL/SLL), r/r mantle cell lymphoma (r/r MCL) and r/r marginal zone lymphoma (r/r MZL), have been covered in the National Reimbursement Drug List while maintaining stable pricing. Orelabrutinib has been approved as the first and only BTK inhibitor for r/r MZL in China. Meanwhile, commercial capabilities have undergone significant enhancement. The dedicated commercial team has been optimized to operate with heightened efficiency and strategic focus, ensuring effective execution of the market initiatives. All of the above factors resulted in an 49.1% increase in orelabrutinib’s revenue in 2024.

The new drug application (NDA) of orelabrutinib for the first-line treatment of CLL/SLL was accepted in China.
In Australia, the NDA of orelabrutinib for r/r MCL was submitted.
In Singapore, the NDA of orelabrutinib for r/r MZL was submitted.
The Company is accelerating a global Phase III study of orelabrutinib for the first-line treatment of MCL, and a Phase III confirmatory study of orelabrutinib for MZL.
Tafasitamab

The NMPA accepted and granted priority review to the Biologics License Application (BLA) for tafasitamab in combination with lenalidomide for adult patients with r/r diffuse large B-cell lymphoma (DLBCL) who are not eligible for Autologous Stem Cell Transplant.
Based on a single arm, open label Phase II registrational trial of tafasitamab in combination with lenalidomide in patients with r/r DLBCL, the overall response rate (ORR) was 73.1%, with 34.6% of patients achieving complete response.
The result of a five-year study from L-MIND shows that tafasitamab provided prolonged, durable responses in patients with r/r DLBCL.
Tafasitamab in combination with lenalidomide was approved in the region of Hong Kong, Macau and Taiwan, and approved for use in Bo’ao and Greater Bay Area with first prescription issued respectively.
Mesutoclax (ICP-248)

The first patient has been dosed in the Phase III clinical trial of ICP-248 in combination with orelabrutinib as a first line therapy for the treatment of CLL/SLL patients in China.
As of the latest update, 42 patients with treatment-naïve (TN) CLL/SLL were enrolled and treated with ICP-248 in combination with orelabrutinib, with no clinical or laboratory evidence of tumor lysis syndrome (TLS) observed. At a median combination therapy duration of 5.5 months, the ORR and uMRD (undetectable minimal residual disease) rate were 100% and 46.2% respectively (MRD check point: 12 weeks after initiation of combo treatment).
The Company is applying for registrational trial of BTKi-treated r/r MCL in China.
The clinical trials of ICP-248 for the first line treatment of acute myeloid leukemia (AML) are ongoing in both China and globally.
ICP-248 is a novel, orally bioavailable BCL2 selective inhibitor, developed as monotherapy or in combination with orelabrutinib for the treatment of CLL/SLL, MCL, AML and other NHLs.
ICP-490

ICP-490 is a proprietary, orally available small molecule that modulates the immune system and other biological targets through multiple mechanisms of action. Phase I/II dose escalation and expansion studies with MM and NHL patients are underway in China.
ICP-490 in combination with dexamethasone was well tolerated and the preliminary efficacy has been confirmed at the dose levels of 1.0mg + of ICP-490 in combination with dexamethasone in MM patients
Developing B-cell and T-cell Pathways in Autoimmune Diseases

Autoimmune diseases can affect almost every organ in the body and may arise at any stage of life. The global market for autoimmune disease therapeutics anticipated to reach $185 billion by 20293. The Company has fortified its powerful discovery engine on cutting-edge global targets for the development of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments to address the massive unmet clinical needs and strong market potential in China and globally.

Orelabrutinib

MS: In September 2024, the Company and the FDA reached an agreement to initiate a Phase III study of orelabrutinib in patients with Primary Progressive Multiple Sclerosis (PPMS). In February 2025, the FDA also approved the Phase III trial protocol of orelabrutinib in the Secondary Progressive Multiple Sclerosis (SPMS). The Company is accelerating the initiation of the Phase III studies for PPMS and SPMS, demonstrating its ongoing commitment to developing innovative and effective treatments to address unmet medical needs in patients with progressive multiple sclerosis (PMS).
The Phase II results of orelabrutinib for the treatment of MS were presented at the 10th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS). The study showed that orelabrutinib was highly effective in treating patients with relapsing-remitting multiple sclerosis (RRMS). The 80 mg once daily (QD) dose showed the best efficacy and safety profile, thus was selected for Phase III studies in progressive MS.
ITP: The Company is accelerating patient enrolment in the Phase III registrational trial of orelabrutinib for the treatment of Immune Thrombocytopenia (ITP) and expects to submit the NDA application in the first half of 2026. By leveraging the BTK inhibitor’s advantage in ITP, such as decreased macrophage-mediate platelet destruction and reduced production of pathogenic autoantibodies, orelabrutinib is well positioned to become a preferred BTK inhibitor in the field of ITP.
SLE: The Phase IIa trial for systemic lupus erythematosus (SLE) demonstrated positive results, with remarkable SLE Responder Index (SRI)-4 response rates observed in a dose dependent manner, along with trends indicating a reduction in proteinuria levels. The Phase IIb clinical trial for orelabrutinib in SLE has completed patient enrollment in 2024, with data readout expected in the fourth quarter of 2025. Orelabrutinib is the first and only BTK inhibitor globally, to have ever demonstrated efficacy in Phase II SLE trials.
Soficitinib (ICP-332)

The company is accelerating patient enrollment in the Phase III trial of ICP-332 for atopic dermatitis (AD), with over 110 patients enrolled to date.
The Phase II/III trial for vitiligo was initiated in China, and the Company is planning the Phase II global trial for prurigo nodularis.
In the U.S., the Phase I trial of ICP-332 was completed, and the Company will engage with the FDA regarding the subsequent clinical development plan.
Data on ICP-332 for the treatment of patients with moderate-to-severe AD has been released at the 2024 American Academy of Dermatology (AAD) Annual Meeting as a late-breaking oral presentation.
ICP-332 demonstrated an outstanding efficacy and safety profile. ICP-332 achieved multiple efficacy endpoints in the 80 mg QD and 120 mg QD dosing groups respectively, including the percentage change in Eczema Area and Severity Index (EASI) score from baseline, EASI 50, EASI 75, EASI 90 (improvement of at least 50%, 75% and 90% in EASI score from baseline), Investigator’s Global Assessment (IGA) 0/1 (score of 0 ‘clear’ or 1 ‘almost clear’) with >= 2 points improvement, and Pruritus Numerical Rating Scale (NRS) score from baseline, etc.
The mean percentage change from baseline of the EASI 50 score reached 78.2% and 72.5% at the 80 mg QD and 120 mg QD groups respectively, both with a highly significant P value, compared to 16.7% for the patients receiving placebo. The percentages of patients achieving at least 75% improvement in EASI 75 were significantly higher in the ICP-332 80 mg QD (64.0%) and 120 mg QD (64.0%) groups than that of placebo (8.0%). These results exceed the reported efficacies of multiple approved innovative drugs after 12 or 16 weeks of treatment (not a head-to-head comparison).
ICP-332 was safe and well tolerated in AD patients. The overall incidence rates of adverse events (AEs) and AEs related to infections and infestations in the two treatment groups were comparable to that of the placebo group.
ICP-332 is a novel tyrosine kinase 2 (TYK2) inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders.
ICP-488

The first patient has been dosed in the Phase III registrational trial of ICP-488 for the treatment of moderate-to-severe plaque psoriasis in China.
Data on ICP-488 for the treatment of patients with moderate-to-severe plaque psoriasis has been released at the 2025 AAD Annual Meeting as a late-breaking oral presentation. The study results demonstrated that ICP-488 is highly effective in treating psoriasis at both the 6 mg QD and 9 mg QD doses. Moreover, ICP-488 exhibited favorable safety and tolerability profiles, reinforcing its potential as a valuable treatment option for moderate-to-severe psoriasis patients.
At week 12, the percentage of patients achieving PASI 75 was significantly superior in the ICP-488 6 mg QD group (77.3%) and the 9 mg QD group (78.6%) than that of the placebo group (11.6%); the percentages of subjects achieving PASI 90 and sPGA of 0 (clear) or 1 (almost clear) were also significantly higher in the ICP-488 6 mg QD group (36.4%, 70.5%) and 9 mg QD group (50.0%, 71.4%) compared to the placebo group (0%, 9.3%).
All treatment emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) were mild or moderate.
ICP-488 is a potent and selective TYK2 allosteric inhibitor that binds to the pseudo kinase JH2 domain of TYK2 and blocks IL-23, IL12, type 1 IFN, and other cytokine receptors.
IL-17 Small Molecule

IL-17 (Interleukin-17) is a pro-inflammatory cytokine that plays a critical role in the pathogenesis of several autoimmune and inflammatory diseases, such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis. Oral small molecules targeting IL-17 represent a new and promising class of therapeutics, offering the potential for easier administration, flexible dosing, and broader patient access. InnoCare identified a novel, orally available, small molecule that can potently block the binding of both IL-17AA and IL-17AF to IL-17R, thereby modulating immune responses and reducing inflammation.
Building Innovative Solid Tumor Assets

With ongoing efforts to address the growing needs in solid tumors, InnoCare is committed to building a competitive drug portfolio aimed at treating a broad range of solid tumor indications. The Company is expanding the scope of its pipeline through a combination of targeted therapies, immune-oncology approaches, and cutting-edge ADC technology. The R&D team is focused on discovering and developing novel platforms that target various solid tumors, utilizing innovative technologies to identify and advance potential drug candidates that offer significant clinical benefits. InnoCare’s proprietary ADC technology platform, alongside promising precision medicine candidates like ICP-723, positions the Company to establish a strong presence in the field of solid tumor treatment.

Zurletrectinib (ICP-723)

The Company has completed the Phase II registrational trial for ICP-723 in adult and adolescent patients (12+ years of age) with advanced solid tumors harboring NTRK gene fusions. The NDA is expected to be submitted at the end of March 2025.
Zurletrectinib was shown to overcome acquired resistance to the first generation TRK inhibitors, bringing hope for patients who failed prior TRKi therapy.
Zurletrectinib demonstrated outstanding efficacy with a good safety profile, achieving an ORR of 85.5%.
Registrational trial for pediatric patients (2 to 12) ongoing, targeting NDA submission in later 2025
ICP-189

The Company has completed the Phase 1b dose finding study of ICP189 combined with firmonertinib, with no DLTs observed. The dose expansion study is currently ongoing, and the Phase 1b data readout is expected in 2025.
InnoCare and ArriVent reached a clinical development collaboration to evaluate the anti-tumor activity and safety of the combination of InnoCare’s novel SHP2 allosteric inhibitor, ICP-189, with ArriVent’s third generation EGFR inhibitor firmonertinib in patients with advanced non-small cell lung cancer (NSCLC). Currently, the combination study is underway. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases4.
In-House Developed Antibody-Drug Conjugate (ADC) Platform

The Company has developed a cutting-edge ADC platform with proprietary linker-payload (LP) technologies, aimed at the delivery of potent and targeted therapies for cancer treatment. This platform allows for the creation of highly differentiated ADCs with improved efficacy and safety profiles. Key features of the platform include:
Novel connector: Irreversible connector to avoid linker detachment caused by instability.
Hydrophilic linker: enhancing ADC stability and achieving high drug-to-antibody ratio (DAR).
Novel payload: incorporating highly potent cytotoxic payloads with strong bystander killing effect.
The platform is expected to deliver ADCs with strong tumor-killing efficacy and an adequate therapeutic window, thereby broadening treatment options for cancer patients and improving their clinical outcomes. As the platform continues to evolve, the Company is poised to expand its portfolio with multiple differentiated ADC candidates, further advancing precision medicine in oncology.
ICP-B794: A Novel B7-H3 Targeted ADC for Solid Tumors

ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to in-house developed potent payload (a novel topoisomerase 1 inhibitor) via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, etc. The company will submit an IND application for ICP-B794 in the first half of 2025.
ICP-B794 has demonstrated superior anti-tumor activity in animal model compared to other ADCs, and exhibited significant tumor-killing effect even in large tumors.
Leveraging AI to Drive Innovation and Enhance Efficiency

InnoCare is committed to harnessing the power of artificial intelligence (AI) to accelerate drug discovery, optimize research and development (R&D) processes, and improve operational efficiency. AI-driven technologies enable to analyze vast datasets, identify promising drug candidates with greater precision, and streamline clinical trial design. By integrating AI into various aspects of the operations, the Company will enhance decision-making, reduce development timelines, and increase the probability of success in bringing novel therapies to patients. Moving forward, InnoCare will continue to explore AI’s potential to drive innovation and create transformative treatment solutions.

To know more about the detailed financial data and business updates of InnoCare 2024 annual results, please log in to View Source

Conference Call Information

InnoCare will host a conference call at 8:30 p.m. Beijing time on March 27 in English and at 9:00 a.m. Beijing time in Chinese on March 28, 2024. Participants must register in advance of the conference call. Details are as follows:

For English conference call, please register through the below link:
View Source

For Chinese conference call, please register through the below link:
View Source

On March 27, 2025 Portage Biotech Inc. (NASDAQ: PRTG), a clinical-stage immuno-oncology company with a portfolio of innovative therapeutics, reported new preclinical data for PORT-7 (TT-4), a selective Adenosine A2B receptor inhibitor, generated by Dr. Luciano Mutti, Gruppo Italiano Mesotelioma e Oncologia Ambientale, at the 2025 European Lung Cancer Congress (ELCC), held in Paris, France March 26-29 (Press release, Portage Biotech, MAR 27, 2025, View Source [SID1234651535]). The new data demonstrate both single agent activity for PORT-7, and a dramatic >90% inhibition of tumor growth when PORT-7 was combined with an anti-PD1 antibody in a murine model of mesothelioma. Immunohistochemistry of the tumors revealed a significant infiltration of both CD3 and CD45 positive immune effector cells. Mesothelioma is an aggressive cancer with limited treatment options in need of novel approaches to overcome immune resistance. To our knowledge, this is the first report of antitumor activity against mesothelioma using a selective A2B receptor inhibitor. Portage is making preparations to commence a first-in-human clinical trial with PORT-7.

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Combining PORT-6 and PORT-7 for a More Comprehensive Immunotherapy Approach

In parallel, Portage is advancing the dose escalation of PORT-6, a potent and selective inhibitor of the A2A adenosine receptor. Portage’s plan is to ultimately co-administer PORT-6 with PORT-7 in the ongoing ADPORT-601 trial. This will mark the first time two highly selective A2A and A2B antagonists are combined in patients, with the aim of achieving a complete blockade of adenosine-induced immunosuppression in the tumor microenvironment. This innovative approach is designed to fully neutralize adenosine-mediated immune suppression, enhance anti-tumor responses, and broaden the impact of immunotherapy in solid tumors.

On March 27, 2025 TriSalus Life Sciences Inc., (Nasdaq: TLSI), oncology focused medical technology business seeking to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies, and with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications, reported its financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, TriSalus Life Sciences, MAR 27, 2025, View Source [SID1234651551]).

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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

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"We achieved commercial and clinical progress throughout 2024, and positioning TriSalus for greater success in 2025," said Mary Szela, President and Chief Executive Officer of TriSalus Life Sciences. "We achieved $29.4 million in total revenue, marking 59% growth year-over-year, and continue to expect to deliver greater than 50% revenue growth in 2025. Additionally, we anticipate reducing operating expenses by more than 20%, achieving positive EBITDA for the full year, and achieving positive cash flow in the second half of the year."

"We were also pleased to strengthen our Board of Directors with the additions of William Valle and Dr. Gary Gordon. Additionally, we want to sincerely thank Sean Murphy for his leadership in guiding the Company through the process of going public, a milestone that would not have been possible without his dedication and expertise. We are thrilled to welcome him back to the Board of Directors and look forward to his continued contributions to our success," concluded Ms. Szela.

Clinical and Commercial Advancements

Expanded Product Portfolio

In the second half of 2024, TriSalus expanded its portfolio of PEDD devices with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter to optimize therapeutic delivery for patients with larger vessels. The TriNav LV is suitable for patients with vessels sized between 3.5 and 5.0mm. The TriGuide Guiding Catheter is equipped with a larger inner diameter, lubricious inner lining, and reverse curve design to support femoral access for the TriNav LV.

These new products are eligible for the same HCPCS reimbursement codes as existing TriNav products, which should enable seamless integration into current billing structures. The Company believes these expanded features will allow physicians to address more complex cases, enhance procedural efficiency, meaningfully expand its addressable market, and provide full access to the $375 million liver embolization market.

Expanding the DELIVER Clinical Program

The Company continues to advance its DELIVER clinical program, a series of Investigator Initiated Trials (IITs) designed to further underscore the impact of PEDD technology by demonstrating enhanced safety and efficacy of the TriNav system across a broad spectrum of complex, difficult-to-treat patients. A key focus of the DELIVER program is to investigate the potential of combining use of the TriNav system with other therapies to enhance effectiveness and address resistance mechanisms in challenging cancers.

The first IIT is a registry study called PROTECT (Pressure Enabled Retrograde Occlusive Therapy with Embolization for Control of Thyroid Disease). The PROTECT study has been initiated and intends to enroll 100 patients across five leading academic sites. It is estimated that approximately 5% of adults have multinodular goiters, prevalence in adults over 50 is estimated to be up to 50%. The Company estimates that this may expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity and putting the Company’s total addressable market at more than $1 billion.

Advancing Pancreatic Cancer Treatment – Enrollment was completed in the PERIO-03 Phase 1 trial investigating nelitolimod in locally advanced pancreatic cancer. Final data are expected mid-2025, with next steps to be determined based on results.

Clinical Progress in Immunotherapy – In November 2024, we presented positive Phase 1 results from our PERIO-01 trial at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), demonstrating promising clinical benefits and durable survival in heavily pretreated uveal melanoma liver metastases (UM-LM) patients. We are actively seeking strategic partnerships to advance this program.

Strengthened Board and Financial Position

New Board Members – Industry veterans William Valle and Dr. Gary Gordon joined the Board of Directors, bringing deep expertise in medical devices and oncology. Additionally, Sean Murphy retired from the management team and rejoined the Board.

Extended Cash Runway – TriSalus secured a $10 million drawdown under its existing $50 million credit facility with OrbiMed, ensuring financial flexibility through the end of 2025.

Unaudited Financial Results for Fourth Quarter and Full Year 2024

The Company will file a Form 12b-25, Notification of Late Filing, with the SEC related to the Company’s Annual Report on Form 10-K for fiscal year 2024. The Company’s need to request a 15-day extension is primarily due to errors identified in determining the Company’s stock-based compensation and clinical trial related research and development expense timing in 2024. The Company is working diligently to evaluate the materiality of the errors to determine whether any corrections for previously issued quarterly financial statements are required and to complete the Company’s year end 2024 financial statements. As a result, the results below and elsewhere in this press release are unaudited and subject to change pending the completion of the Company’s financial statement as of and for the year ended December 31, 2024.

Full year 2024 revenue was $29.4 million, representing growth of approximately 59% versus the full year 2023. Momentum in revenue growth is expected to continue in 2025 and, consistent with previously announced guidance, is expected to grow in excess of 50% in 2025.

Operating Cash Flow in the fourth quarter of 2024 was ($5.7) million, reflecting a notable improvement compared to the previous quarter amount of ($10.8) million. Consistent with previously announced guidance, the Company expects to achieve positive full year EBITDA in 2025 and positive cash flow during the second half of 2025.

Cash and Cash Equivalents were $8.5 million as of December 31st, 2024. The Company expects existing liquidity sources and the $15 million of available capacity on the OrbiMed debt facility to provide sufficient cash runway throughout 2025.

2025 Guidance

The company is reaffirming previously issued guidance for 2025, including:

Sales are expected to grow by more than 50% in 2025, driven by further market share increases in TriNav, the commercial launch of TriNav LV, and the TriNav target market expansion driven by the DELIVER program and the new HCPCS reimbursement code for TriNav simulation angiograms —commonly known as mapping procedures—conducted prior to transarterial radioembolization (TARE) from Centers for Medicare & Medicaid Services (CMS).
Gross margins are expected to exceed 87%.
Operating expenses are expected to decline greater than 20% in 2025 due to reductions in R&D associated with the completion of the PERIO phase 1b trials and reductions in G&A expenses due to the non-recurrence of certain costs related to becoming a public Company in 2024.
The company expects to be EBITDA positive for 2025 and achieve positive cash flow by the second half of 2025, extending total cash runway beyond 2025.
Conference Call

The company will host a conference call and webcast on March 27, 2025, at 8:00 a.m. ET to discuss financial results for the fourth quarter and full year ended December 31, 2024, and provide a business update. A press release detailing the fourth quarter and full year results will be issued prior to the call. To register for the webcast, click here.