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TriSalus Life Sciences Announces Preliminary Fourth Quarter and Full-Year 2025 Results and 2026 Revenue Guidance

On January 12, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) ("TriSalus" or the "Company"), an oncology focused medical technology company advancing novel drug delivery technologies alongside standard-of-care therapies to improve outcomes for patients with solid tumors, reported preliminary unaudited financial results for the fourth quarter and full year ended December 31, 2025.

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The Company anticipates fourth quarter 2025 revenues of approximately $13.2 million and full-year 2025 revenues of approximately $45.2 million. As of December 31, 2025, TriSalus estimates cash and cash equivalents of approximately $20.4 million.

"TriSalus continued to deliver strong commercial performance in the fourth quarter and exceeded our 2025 guidance of 50% annual revenue growth, underscoring the meaningful clinical adoption of our TriNav product suite and proprietary PEDD platform across a broad range of solid tumor indications," said Mary Szela, President and Chief Executive Officer of TriSalus. "We are pleased not only with our commercial execution but also with the sustained progress on our strategic initiatives, including expansion of the TriNav platform across multiple indications beyond the liver and deepening our engagement within the interventional radiology community. Looking ahead to 2026, we expect full-year revenues to be in a range of approximately $60 million to $62 million."

Projected Unaudited 2025 Fourth Quarter and Full-Year Financial Results

Preliminary revenue for the fourth quarter of approximately $13.2 million, compared to $8.3 million in the prior year, representing approximately 60% growth year-over-year and sequential quarterly growth of approximately 14%.
Preliminary revenue for the year of approximately $45.2 million for the year, compared to $29.4 million in the prior year, representing approximately 53% growth year-over-year.
Year-end cash and cash equivalents of approximately $20.4 million, compared to $22.7 million at the start of the fourth quarter, a reduction in cash and cash equivalents for the fourth quarter of 2025 of $2.3 million. This reflects continued strong revenue growth and focus on operational efficiency.
The preliminary financial results set forth above are unaudited, are based on management’s initial review of TriSalus Life Science’s results as of and for the year ended December 31, 2025, and are subject to revisions based upon TriSalus Life Science’s year-end closing procedures and the completion of the external audit of TriSalus Life Science’s year-end financial statements. Actual results may differ materially from these preliminary unaudited results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that TriSalus Life Science’s financial results are finalized. In addition, these preliminary unaudited results are not a comprehensive statement of TriSalus Life Science’s financial results for the year ended December 31, 2025, should not be viewed as a substitute for full, audited financial statements, prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period. Accordingly, investors are cautioned not to place undue reliance on these preliminary unaudited results.

TriSalus Life Sciences expects to announce full-year 2025 financial results its during earnings conference call in March 2026.

(Press release, TriSalus Life Sciences, JAN 12, 2026, View Source [SID1234662003])

Ono to Participate in the 44th Annual J.P. Morgan Healthcare Conference

On January 12, 2026 Ono Pharmaceutical Co., Ltd. (TSE:4528) reported that Toichi Takino, President and COO, will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 11:15 a.m. PST / 2:15 p.m. EST.

A live webcast of the event will be available here and accessible for 30 days following the presentation.

(Press release, Ono, JAN 12, 2026, View Source [SID1234662002])

Novocure Announces Preliminary Full Year and Fourth Quarter 2025 Performance and Provides Company Update

On January 12, 2026 Novocure (NASDAQ: NVCR) reported preliminary unaudited financial and operational results for the quarter and full year ended December 31, 2025. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

"Novocure exits 2025 having achieved record annual revenue, providing the financial strength to execute on the exciting growth opportunities we have in 2026," said Frank Leonard, CEO, Novocure. "We have built the team and capabilities to support multiple product launches in the coming year while ensuring the company is on a clear path to profitability."

Financial updates for the year and fourth quarter ended December 31, 2025*:

Total preliminary net revenues for the year were $655.4 million, an increase of 8% compared to the prior year.
Total preliminary net revenues for the fourth quarter were $174.4 million, an increase of 8% compared to the same period in 2024.
The U.S., Germany, France and Japan contributed $101.6 million, $21.6 million, $20.5 million and $10.2 million in net revenue, respectively, with other active markets contributing $15.8 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.6 million.
Recognized revenue from Optune Lua in the quarter was $3.5 million, including $2.4 million from non-small cell lung cancer (NSCLC) and $1.1 million from malignant pleural mesothelioma (MPM).
Cash, cash equivalents and short-term investments were $448.3 million as of December 31, 2025, after repayment of $561 million of convertible notes at maturity in November 2025.
Operational updates for the year and fourth quarter ended December 31, 2025:

As of December 31, 2025, there were 4,620 total active patients on TTFields therapy globally.
Optune Gio
1,609 Optune Gio prescriptions for the treatment of glioblastoma (GBM) were received in the quarter, an increase of 6% from the same period in 2024. The U.S., Germany, France and Japan contributed 950; 178; 197 and 139 prescriptions, respectively, with the remaining 145 prescriptions received from other active markets.
As of December 31, 2025, there were 4,464 active Optune Gio patients on therapy, an increase of 9% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,251; 623; 509 and 542 Optune Gio active patients, respectively, with the remaining 539 active patients contributed by other active markets.
Optune Lua
145 total prescriptions for Optune Lua were received in the quarter.
118 Optune Lua prescriptions were received for the treatment of NSCLC. The U.S., Germany and France contributed 87; 29 and 1 prescriptions, respectively, with the remaining 1 prescription received from other active markets.
27 Optune Lua prescriptions were received for the treatment of MPM. The U.S. and Germany contributed 10 and 16 prescriptions, respectively, with the remaining 1 prescription received from other active markets.
As of December 31, 2025, there were 122 active Optune Lua patients on therapy for the treatment of NSCLC. The U.S. and Germany contributed 102 and 19 active patients, respectively, with the remaining 1 active patient contributed by other active markets.
As of December 31, 2025, there were 34 active Optune Lua patients on therapy for the treatment of MPM. The U.S. and Germany contributed 8 and 24 active patients, respectively, with the remaining 2 active patients contributed by other active markets.
In Q1 2026, Novocure intends to stop reporting new prescriptions received in indications which have been commercially available for more than one year (GBM, MPM and NSCLC). Novocure will continue to report active patients on therapy segmented by product (Optune Gio, Optune Lua) and material market.
Fourth quarter and recent updates and achievements:

In December, Novocure announced the appointment of Frank Leonard as Chief Executive Officer. Mr. Leonard previously served as Novocure’s President.
In December, Novocure submitted the final module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for TTFields therapy use for the treatment of brain metastases from NSCLC.
Anticipated clinical and regulatory milestones:

Topline data from the Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (Q1 2026).
Topline data from the Phase 3 TRIDENT clinical trial in newly diagnosed GBM (Q2 2026).
Decision by the U.S. FDA on the PMA application for the use of TTFields therapy for the treatment of locally advanced pancreatic cancer (Q2 2026).
Decision by the U.S. FDA on the PMA application for the use of TTFields therapy for the treatment of brain metastases from NSCLC (Q4 2026).
Complete enrollment in Phase 3 KEYNOTE D58 clinical trial in newly diagnosed GBM (Q4 2026).
Active Patients on Therapy

December 31,

2025

2024

Optune Gio

Optune Lua

Total

Optune Gio

Optune Lua

Total

Active patients at period end1

United States

2,251

110

2,361

2,161

2,192

International markets:

Germany

623

666

564

575

France

509

—

509

426

—

426

Japan

542

—

542

420

—

420

Other international

539

542

506

513

International markets – Total

2,213

2,259

1,916

1,934

4,464

156

4,620

4,077

4,126

Fourth quarter and full year 2025 financial results conference call:

Novocure will host a conference call and webcast to discuss full year and fourth quarter 2025 financial results at 8:00 a.m. EST on Thursday, February 26, 2026. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

*The unaudited financial results and other data in this press release are preliminary and subject to the completion of the Company’s annual independent audit and final review and, therefore, are subject to adjustment.

(Press release, NovoCure, JAN 12, 2026, View Source [SID1234662001])

ConcertAI and Foundation Medicine Integrate Genomic and Clinical Data to Transform Translational Research and Efficient Drug Development

On January 12, 2026 ConcertAI, a leading oncology real-world evidence data and AI SaaS technology company, and Foundation Medicine, a global, patient-focused precision medicine company, reported a collaboration to combine their data assets for life sciences research. The collaboration brings Foundation Medicine’s expansive de-identified multimodal dataset derived from its genomic testing portfolio together with ConcertAI’s high-quality clinical data, to support more efficient drug development and real-world evidence research. With the addition of Foundation Medicine’s data, ConcertAI now offers the largest and most comprehensive clinically-linked dataset with nearly half a million patients.

The collaboration comes as oncology drug programs face rising trial complexity and tighter budgets, which puts more weight on high-quality data that can guide early decisions. Pairing Foundation Medicine and ConcertAI’s data captures the full journey of cancer patients from pre-diagnosis through treatment and outcomes, allowing life science researchers and biopharmaceutical developers to reduce guesswork in early research, tighten trial plans, and bring new therapies to patients faster, while ensuring the rigor of their research.

"Drug developers are increasingly pushed to accelerate their research pipelines but require more robust insights into both early genomic signals and patient outcomes to make this a reality," said Eron Kelly, CEO of ConcertAI. "By combining the largest and deepest set of clinical data with genomic insights, including whole slide imaging, we can help teams set a clearer plan and speed up their projects. Our collaboration with Foundation Medicine complements our full suite of partnerships aimed at advancing the development of vital therapies."

Foundation Medicine has U.S Food and Drug Administration-approved companion diagnostic indications for all four major classes of genomic alterations and for multiple genomic signatures. Detection of these major classes of alterations provide partners with a comprehensive view of their cohort’s genomic landscape, including difficult-to-detect alterations, such as MTAP loss, that are not detected well by all next-generation sequencing tests.1

In addition to genomic data, the combined dataset includes gene expression data, immunohistochemistry (IHC) results, and whole-slide images, alongside one of the most diverse clinical datasets from ConcertAI, whether measured by socioeconomic diversity, ethnic diversity, or rural vs. urban communities. By connecting these views, researchers can better study how cancers act in real life and how patients respond to treatments over time.

"By integrating our high-quality genomic data with ConcertAl’s electronic health data, we have created one of the most powerful new real-world data sets that enables insights to be turned into strategic decisions at critical milestones for our partners," said Dan Malarek, CEO of Foundation Medicine. "AI is the future and through our Al-driven analytical capabilities via FoundationInsights, our biopharmaceutical and research partners can access the right data when they need it and uncover answers faster. This accelerates development and helps patients benefit sooner from advances in precision medicine."

(Press release, Foundation Medicine, JAN 12, 2026, View Source [SID1234662000])

U.S. FDA Grants RMAT Designation to ECT204, an ARTEMIS® CAR (AbTCR) T-Cell Therapy for Advanced Hepatocellular Carcinoma

On January 12, 2026 Eureka Therapeutics, Inc., a clinical-stage biotechnology company advancing next-generation T-cell therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to ECT204, a GPC3-targeting ARTEMIS CAR T-cell therapy, for the treatment of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer.

The RMAT designation followed the FDA’s review of data from the completed Phase I cohort, together with additional clinical data, from Eureka’s ongoing Phase I/II ARYA-3 trial evaluating ECT204, an autologous ARTEMIS CAR T-cell therapy based on the AbTCR (Antibody-T Cell Receptor) architecture, in adult patients with GPC3-positive advanced HCC. RMAT designation, granted based on preliminary clinical evidence of potential to address unmet medical needs, provides the benefits of Breakthrough Therapy designation for regenerative medicines, including enhanced FDA interaction, alignment on development and manufacturing strategy, discussion of surrogate or intermediate clinical endpoints that may support accelerated approval, and eligibility for priority review of a future biologics license application (BLA).

"This represents an important inflection point for Eureka and for cell therapy in solid tumors," said Dr. Cheng Liu, Founder and Chief Executive Officer of Eureka Therapeutics. "ARTEMIS was designed to overcome the limitations of conventional CAR T-cell therapies in solid tumors, and early clinical observations with ECT204 in liver cancer reinforce our belief that the ARTEMIS architecture can meaningfully expand the therapeutic reach of cell therapy."

HCC is among the most biologically resistant solid tumors in oncology, characterized by an immunosuppressive tumor microenvironment that has posed significant challenges to the effectiveness of cell-based therapies. Unlike conventional CAR T cells that rely on a synthetically fused CD3-zeta (ζ) signaling domain linked to co-stimulatory molecules, which may contribute to constitutive activation and limited persistence in solid tumors, ARTEMIS CAR T cells were engineered using the AbTCR architecture and incorporate dual receptors that leverage human gamma delta (γ/δ) T cell receptor (TCR) signaling with co-stimulation delivered through separate receptors. This more natural TCR signaling design combines the precision of antibody-redirected tumor targeting with balanced and sustained T-cell activation, which may explain the improved tumor infiltration, persistence, and functional activity of the engineered T cells in hostile solid tumor environments.

The advantages of ARTEMIS CAR T cells over conventional CAR T cells have been validated by independent research conducted in collaboration with the National Cancer Institute, including NCI-led, peer-reviewed studies published in Cell Reports Medicine. In preclinical solid tumor models, ARTEMIS CAR T cells demonstrated significantly greater tumor infiltration and anti-tumor activity than conventional CAR T cells using the same antigen-binding domain, including in low antigen density settings that typically limit conventional CAR T efficacy.

ECT204 previously received FDA Orphan Drug Designation (ODD) in January 2022, reflecting the significant unmet need in advanced HCC. With RMAT designation in place, Eureka will work closely with the FDA to advance ECT204 through the ongoing ARYA-3 trial while continuing to build on the broader applicability of the ARTEMIS platform across different cancer indications.

About ECT204

ECT204 is an autologous T-cell therapy engineered with Eureka’s proprietary ARTEMIS CAR platform. Unlike conventional CAR T cells, ARTEMIS T cells are designed to mimic the natural biological regulation of T-cell activation, potentially improving safety, tumor infiltration, and persistence in solid tumors. ECT204 targets GPC3 (Glypican-3), an oncofetal antigen found on more than 70% of HCC cells but rarely on healthy tissues. The GPC3 protein is also expressed in other solid tumors, including ovarian and lung cancer. ECT204 is currently being investigated in Eureka’s ongoing ARYA-3 study, an open-label, dose escalation, multi-center Phase I/II clinical trial in adult patients with GPC3-positive HCC.

(Press release, Eureka Therapeutics, JAN 12, 2026, View Source [SID1234661999])