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Natera Announces Clinical Collaboration with Incyte on Interventional Phase II Study in Colorectal Cancer

On November 10, 2026 Natera, Inc. (Nasdaq:NTRA), a global leader in cell-free DNA and precision medicine, reported that it has entered into a clinical collaboration agreement with Incyte (Nasdaq:INCY) for a new phase II study in colorectal cancer (CRC).

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The trial will evaluate INCA33890, Incyte’s investigational bispecific immunotherapy, in patients with stage 2/3 CRC who have completed surgery and adjuvant chemotherapy (ACT), incorporating Signatera as both a primary and secondary endpoint. Following ACT, patients will undergo longitudinal testing with Signatera for up to 12 months, and those who test Signatera MRD-positive and have no evidence of radiographic disease may be eligible for enrollment and treatment in the study.

Natera’s clinical and real-world evidence, along with its expertise in MRD-guided clinical trial strategy and design, helped inform the study. Through the collaboration, Natera will also provide trial matching services to help identify patients for enrollment based on their Signatera MRD status and other eligibility criteria.

"We are excited by Incyte’s vision for this innovative trial, leveraging both our extensive real-world evidence and proven MRD capabilities," said Eric Matthews, General Manager, BioPharma, Natera. "Across a growing portfolio of TOMR studies, Signatera has been shown to enable early identification of patients at elevated risk of recurrence and supports enrollment into trials with treatment strategies that may alter the course of disease before radiographic progression occurs."

"Patients with colorectal cancer who remain MRD-positive after surgery and chemotherapy represent a population with substantial unmet need and a significantly elevated risk of recurrence," said Lois Erskine, Vice President and INCA 33890 Global Program Head, Incyte. "We look forward to the valuable insights this collaboration will enable as we work to advance this promising treatment and aim to improve outcomes for patients with CRC."

(Press release, Natera, NOV 10, 2026, View Source [SID1234674592])

TriSalus Life Sciences Reports Third Quarter 2026 Results

On November 10, 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 financial results for the quarter ended September 30, 2026, and provided an operational update.

"The third quarter marked an important period of growth and expansion for TriSalus – we drove double-digit year-over-year growth and received FDA clearance for TriNav Advance, which enables Pressure-Enabled Drug Delivery to small distal vessels through the microcatheter of the physician’s choice. This clearance allows us to address the full range of vessels encountered in liver embolization procedures going forward," said Mary Szela, President and Chief Executive Officer of TriSalus.

"Looking ahead, we believe we are well positioned for 2027. We more than doubled our commercial footprint over the first half of the year, and although our team productivity has ramped slightly slower than anticipated, our representatives continue to educate and drive further TriNav utilization as they build and strengthen relationships with interventional radiologists. Combined with the launch of TriNav Advance, expanded access to office-based labs through the new G-code, and continued cost discipline, we believe we have laid the foundation for continued growth in 2027 and beyond."

Recent Business Highlights

Received FDA clearance for TriNav Advance, which enables PEDD to small distal vessels through the microcatheter of the physician’s choice.
In the calendar year 2027 Hospital Outpatient Prospective Payment System ("OPPS") final rule, the Centers for Medicare & Medicaid Services ("CMS") finalized the reassignment of HCPCS code C8004 from APC 5193 to APC 5194, aligning it with C9797, which is already assigned to APC 5194. Based on the final rule, the national Medicare payment rate for procedures billed under C8004 will increase from approximately $11,794 to approximately $20,910, effective January 1, 2027.
Additionally, CMS published its calendar year 2027 Physician Fee Schedule final rule, establishing national payment for HCPCS code G0577, vascular embolization using a pressure-generating catheter in the office-based lab setting. Effective January 1, 2027, the total national office payment is approximately $13,800 per procedure, extending reimbursement for PEDD.
Achieved the enrollment cutoff required for the interim analysis of the PROTECT registry in thyroid artery embolization; the Company remains on track to deliver the first multi-center U.S. data on thyroid artery embolization in the first quarter of 2027.
Financial Results for Q3 2026

Revenue from the sale of the TriNav system was $12.9 million for the three months ended September 30, 2026, an increase of 11.3% compared to the same period in 2025. The increase in revenue was primarily due to an increase in TriNav units sold.
Gross margins were 86.2% for the three months ended September 30, 2026, compared to 83.5% for the same period in 2025. The year-over-year increase in gross margin was primarily due to a reduction in cost per TriNav unit.
Operating losses were $7.7 million for the three months ended September 30, 2026, compared to losses of $9.0 million for the same period in 2025. The decrease in operating losses was primarily driven by improved gross margins, lower research and development expenses and lower general and administrative expenses, partially offset by higher sales and marketing expenses related to our investment in marketing and our sales organization expansion.
Net loss attributable to common stockholders was $8.9 million for the three months ended September 30, 2026, compared to a net loss of $41.3 million for the same period in 2025. This change is primarily driven by the conversion of our preferred stock to common stock during the third quarter of 2025, resulting in approximately $30.5 million of net loss attributable to common stockholders. The current period includes $0.1 million of non-cash net gains related to changes in the fair value of various derivatives for the three months ended September 30, 2026, compared to net losses of $0.4 million for the same period in 2025. The basic and diluted loss per share for the three months ended September 30, 2026 was $0.15, compared to $0.96 for the same period in 2025.
The non-GAAP measure of adjusted EBITDA is shown in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were $4.7 million for the three months ended September 30, 2026, compared to losses of $5.4 million for the same period in 2025. The decrease in adjusted EBITDA losses were primarily driven by improved gross margins, lower research and development and lower general and administrative expenses, partially offset by increased sales and marketing expenses.
On September 30, 2026, cash and cash equivalents totaled $41.1 million. The Company raised $46.0 million in gross proceeds in the first quarter from an equity offering.
2026 Financial Guidance

The Company is updating its full-year 2026 revenue guidance to $46 million to $48 million, representing growth of approximately 2% to 6% compared to full year 2025.

Conference Call & Webcast

The Company will host a conference call and webcast today at 8:30 AM eastern time to discuss its financial results for the quarter ended September 30, 2026. Those interested in listening should register online by visiting investor relations section of TriSalus’ website. Participants are encouraged to register more than 15 minutes before the start of the call. A replay will also be available on the website following the event.

(Press release, TriSalus Life Sciences, NOV 10, 2026, View Source [SID1234674591])

Lantern Pharma Announces Peer-Reviewed Publication of Phase 1a LP-184 Data in Recurrent Glioblastoma, Supporting a Phase 1b/2a Combination Trial with Spironolactone

On November 10, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage AI-driven precision oncology company, and its wholly owned subsidiary Starlight Therapeutics reported the publication of Phase 1a clinical data for LP-184 (zirdafulven) in patients with recurrent GBM. LP-184 is being developed as STAR-001 for central nervous system (CNS) cancers. The paper appears in the October 2026 issue of Cancer Research Communications, a peer-reviewed journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The work was led by investigators at Johns Hopkins University School of Medicine, the Sidney Kimmel Comprehensive Cancer Center and the Hugo W. Moser Research Institute at Kennedy Krieger, together with Lantern scientists.

The study shows that LP-184 is generally well tolerated in patients with recurrent GBM and defines the path forward. Plasma levels at the RDE reached projected effective systemic exposures. However, only about 20% of systemic drug is expected to reach brain tumors, so single-agent concentrations of LP-184 in the brain tumor are not projected to remain at therapeutic levels for a sustained period. Spironolactone is an FDA-approved, brain-penetrant drug used primarily to treat hypertension and as a diuretic. It also triggers degradation of ERCC3, a key protein in the DNA repair pathway GBM cells use to survive DNA-damaging agents like LP-184. In preclinical models, spironolactone lowers the concentration of LP-184 needed to kill GBM cells 3- to 6-fold. Together, these findings provide the dosing basis for the planned Phase 1b/2a trial in GBM at first recurrence.

Key Findings from the Phase 1a GBM Cohort

Patient population: All 16 patients had IDH wild-type, WHO grade 4 GBM previously treated with surgery, radiation and temozolomide (TMZ), with a median of two prior lines of therapy. Of the 14 with known status, 8 (57%) had an unmethylated MGMT promoter, a common driver of TMZ resistance.
Safety and tolerability: The safety profile in patients with GBM was consistent with the broader solid tumor population, and no adverse events occurred only in patients with GBM. Nausea was grade 1 to 2 in all affected patients, and severe thrombocytopenia and transaminitis were infrequent. The two grade 3 to 4 liver enzyme elevations both occurred at the highest dose level tested, above the RDE.
Recommended dose for expansion: The RDE is 0.39 mg/kg, given intravenously on days 1 and 8 of each 21-day cycle. It was established based on the totality of safety and pharmacokinetic data.
PTGR1 biomarker: Lantern developed an RT-qPCR assay to measure PTGR1, the enzyme that activates LP-184 inside tumor cells, and defined an expression threshold associated with LP-184 sensitivity. Six of eight (75%) available pretreatment tumor samples exceeded that threshold, consistent with published reports of PTGR1 overexpression in more than 70% of GBM.
Clinical observations: Consistent with the projected limited brain exposure of LP-184 as a single agent, no objective radiographic responses were observed. One patient with MGMT-methylated GBM at first recurrence received LP-184 for six months. That patient has remained clinically and radiographically stable for more than 22 months after enrollment, including more than 17 months off treatment, without further therapy.
Rationale for the LP-184 Plus Spironolactone Combination

Treatment failure in GBM is driven by two problems: too little drug reaching the tumor, and DNA repair that lets tumor cells survive the drug that does. The combination is designed to address both.

A mechanism that bypasses MGMT. LP-184 alkylates DNA at a different site than TMZ or lomustine. The resulting lesions are not repaired by MGMT, the main cause of TMZ resistance. They are instead resolved primarily through transcription-coupled nucleotide excision repair (TC-NER).
Spironolactone shuts down that repair pathway. Spironolactone, a widely used FDA-approved medicine that crosses the blood-brain barrier, triggers degradation of ERCC3 (XPB), a core TC-NER protein. Across multiple patient-derived GBM cell models, spironolactone lowers the concentration of LP-184 needed to kill tumor cells 3- to 6-fold.
A defined dosing schedule. In orthotopic GBM xenografts, tumor ERCC3 reached its lowest level 8 hours after a dose of spironolactone. Three daily doses reduced tumor ERCC3 by approximately 80%, compared with 49% to 57% after one or two doses. Spironolactone did not reduce ERCC3 in the liver, suggesting the effect is concentrated in tumor tissue.
Greater tumor cell killing. Giving LP-184 8 hours after the third daily dose of spironolactone approximately doubled tumor cell death, measured by cleaved caspase-3, compared with LP-184 alone.
A bridge from patient pharmacokinetics to tumor exposure. Pharmacokinetic modeling used plasma data from 11 patients treated at the RDE. It projects that adding spironolactone will bring intratumoral LP-184 to approximately 2- to 3-fold above the concentration needed to kill GBM cells.
The combination was identified with support from Lantern’s RADR AI platform. RADR also points to DNA damage repair deficiencies and EGFR alterations, both common in GBM, as predictors of LP-184 sensitivity.

"Glioblastoma is especially difficult to treat because a therapy must both reach the brain at effective levels and overcome the tumor’s ability to repair the damage," said Reginald Ewesuedo, M.D., MBA, Vice President of Clinical Development at Lantern Pharma. "This study shows LP-184 is well tolerated in patients with recurrent GBM and points directly to how we can improve its activity in the tumor. By removing a key DNA repair protein with spironolactone, we aim to make the LP-184 that reaches the tumor considerably more effective."

"Limited brain exposure is why many drugs fail in glioblastoma, and this paper is direct about that challenge and specific about the answer," said Panna Sharma, President and CEO of Lantern Pharma. "Rather than push the dose higher, we used patient pharmacokinetic data, insights from our RADR AI platform and our collaborators’ models at Johns Hopkins to design a combination that makes the drug reaching the tumor work harder. We now have a defined dose and schedule to carry into the planned Phase 1b/2a study with our CNS-focused subsidiary, Starlight Therapeutics."

Next Steps

The planned Phase 1b/2a study (NCT07431216) is sponsored by Starlight Therapeutics under an FDA-cleared Investigational New Drug application. It is designed to evaluate the safety, pharmacokinetics and objective response of LP-184 (STAR-001) plus spironolactone in patients with supratentorial GBM at first recurrence after standard TMZ-based therapy. The completed Phase 1a study is registered as NCT05933265.

Lantern Pharma funded the clinical trial and preclinical studies.

About the Publication

Schreck KC, Lal B, Zhou J, Lopez-Bertoni H, Holdhoff M, Ewesuedo R, Bhatia K, Chamberlain M, Laterra J. "Phase Ia Evaluation of LP-184 in Recurrent Glioblastoma: Safety, Pharmacokinetics, and Translational Optimization of CNS Exposure." Cancer Research Communications. 2026;6(10):2519–2528. DOI: 10.1158/2767-9764.CRC-26-0518.

About LP-184 (STAR-001)

LP-184 (zirdafulven) is a novel small molecule acylfulvene prodrug designed to damage DNA selectively in tumor cells. It is activated by PTGR1, an enzyme overexpressed in many solid tumors, including GBM. It is especially active in tumors with deficiencies in DNA damage repair. The DNA lesions LP-184 creates are independent of MGMT status. LP-184 has received FDA Fast Track Designation for GBM and triple-negative breast cancer (TNBC). It has also received FDA Orphan Drug Designations, including for malignant gliomas and atypical teratoid rhabdoid tumors (ATRT). LP-184 is being developed as STAR-001 for CNS cancers through Starlight Therapeutics.

(Press release, Lantern Pharma, NOV 10, 2026, View Source [SID1234674590])

PRECISION Study Published in ESMO Open Highlights Utility of Guardant360® Liquid and Guardant Reveal® to Assess Recurrence Risk After Surgery for Colorectal Cancer Metastases

On November 10, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that ESMO (Free ESMO Whitepaper) Open has published results from PRECISION, a prospective multicenter observational study in Japan that enrolled 130 patients and evaluated complementary blood-based approaches for assessing recurrence risk in patients undergoing curative-intent surgery for colorectal cancer metastases.

The study paired pretreatment comprehensive genomic profiling (CGP) using Guardant360 Liquid with postoperative MRD detection using Guardant Reveal approximately four weeks after surgery. The paired assessment identified three groups with markedly different outcomes, showing that information about tumor mutations before treatment and residual circulating tumor DNA (ctDNA) detection after surgery together provide improved prognostic stratification.

"The application of ctDNA analysis has evolved dramatically in this decade. However, the clinical utility of preoperative CGP and postoperative MRD testing for guiding perioperative treatment decisions for resectable colorectal oligometastases (CRM) has been unclear," said Shin Kobayashi, MD., PhD., Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Kashiwa, Japan, a principal investigator of the PRECISION study. "PRECISION suggests that combining pretreatment tumor genomic profiling with postoperative MRD assessment may provide complementary prognostic information. This could help patients and their care teams better understand the post-surgery risk of recurrence and inform the future development of more personalized treatment strategies, although these findings should be prospectively verified in an interventional study."

Key findings included:

Pretreatment blood-based profiling was feasible in nearly all eligible patients. Guardant360 Liquid detected genomic alterations in 97% of patients, 64% of whom had genomic profiles that were associated with greater than 4-fold higher hazard of recurrence or death.
Postoperative blood-based MRD detection was evaluable in 99% of patients who underwent surgery. MRD was detected in 31% of patients and also significantly associated with worse outcomes (4.7-fold increase in hazard of recurrence or death).
Combining pretreatment genomic profiling with postoperative MRD testing identified three distinct risk groups, with estimated two-year recurrence-free survival of 78% among patients with neither adverse feature, 40% among those with one, and 9% among those with both.
Establishing the feasibility of preoperative liquid-based CGP paired with postoperative liquid-based MRD testing is especially meaningful, as tissue-based testing is often infeasible due to limited biopsy accessibility pretreatment and longer turnaround times post-surgery.

"These findings illustrate how Guardant’s liquid biopsy tests can provide a comprehensive view of cancer—informing meaningful outcomes that can benefit clinical practice," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "The study also affirms our commitment to supporting patients throughout the care continuum."

Globally, colorectal cancer (CRC) is the third most common type of cancer and the second leading cause of cancer-related mortality. These findings indicate the potential of a dual approach to ctDNA analysis to identify reliable biomarkers and inform the development of personalized perioperative chemotherapy for the advanced stages of CRC.

About Guardant360 Liquid

Guardant360 Liquid is a blood-based test that analyzes tumor DNA fragments circulating in the blood (cfDNA) to identify genetic mutations in advanced solid tumors, helping oncologists find targeted therapies. It offers an alternative to tissue biopsies, providing CGP to guide personalized treatment for a wide range of solid cancers including lung, breast, colorectal, and prostate cancer. Guardant360 Liquid is guideline-complete across all advanced solid tumors, and has been clinically validated in more than 1,500 publications and research abstracts.

About Guardant Reveal

Guardant Reveal is a tissue-free liquid biopsy test that detects MRD and monitors recurrence in early-stage colorectal, breast, and lung cancers, helping oncologists guide treatment decisions. In addition to MRD detection, Reveal can be used for late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights.

The first clinical-validation study of pan-cancer chemotherapy monitoring published in The Journal of Liquid Biopsy showed that Guardant Reveal predicts long-term patient benefit up to 18 months earlier than standard clinical measures.

(Press release, Guardant Health, NOV 10, 2026, View Source [SID1234674589])

Rallybio Announces Reverse Stock Split of Common Stock in Connection with the Proposed Merger with Avenzo

On November 10, 2026 Rallybio Corporation (Nasdaq: RLYB) reported that it will effect a one-for-two reverse stock split of its issued and outstanding common stock in connection with the transactions contemplated by the Agreement and Plan of Merger and Reorganization, dated as of May 31, 2026, among Rallybio, Avenzo Therapeutics, Inc. ("Avenzo") and Farmington Merger Sub, Inc., a wholly owned subsidiary of Rallybio (the "Merger Agreement"). At Rallybio’s Annual Meeting of Stockholders held on November 4, 2026, stockholders approved an amendment to Rallybio’s Amended and Restated Certificate of Incorporation to effect a reverse stock split at a ratio ranging from one-for-two to one-for-nine, inclusive, with the final ratio to be mutually determined by Rallybio and Avenzo. On November 8, 2026, Rallybio’s Board of Directors, with Avenzo’s mutual agreement, approved a one-for-two reverse stock split of Rallybio’s issued and outstanding common stock. The reverse stock split is expected to become effective at 12:01 a.m., Eastern Time, on November 20, 2026, prior to the anticipated completion of the merger contemplated by the Merger Agreement (the "Merger"). Following the satisfaction of applicable Nasdaq approvals and the closing of the Merger, Rallybio plans to change its name to Avenzo Therapeutics, Inc. and to trade on the Nasdaq Capital Market under the new trading symbol "AVZO" and the new CUSIP number 053928 107.

At the effective time of the reverse stock split, every two issued and outstanding shares of Rallybio’s common stock will automatically be combined into one share of common stock. The reverse stock split will reduce the number of issued and outstanding shares of Rallybio’s common stock from approximately 5.6 million to approximately 2.8 million (prior to giving effect to the closing of the Merger). The reverse stock split will not change the authorized number of shares of Rallybio’s common stock.

The par value of Rallybio’s common stock will remain unchanged at $0.0001 per share after the reverse stock split. The reverse stock split will affect all stockholders uniformly and, by itself, will not alter any stockholder’s percentage interest in Rallybio’s equity, except to the extent that the reverse stock split results in some stockholders receiving cash in lieu of any fractional shares as described below.

Proportionate adjustments will be made to the number of shares underlying outstanding pre-funded warrants, equity awards and, where applicable, their exercise prices, and to the number of shares reserved for issuance under Rallybio’s equity incentive plans, in each case in accordance with the terms of the applicable pre-funded warrants, awards and plans.

No fractional shares will be issued in connection with the reverse stock split. Stockholders who would otherwise be entitled to receive a fractional share will instead receive a cash payment equal to the fair market value of that fractional share based on the closing price of Rallybio’s common stock on the effective date of the reverse stock split.

Computershare Trust Company, N.A. ("Computershare") is acting as the exchange agent and transfer agent for the reverse stock split. Stockholders holding their shares electronically in book-entry form are not required to take any action to receive post-split shares. Computershare will provide instructions to stockholders holding physical certificates regarding the process for exchanging their pre-split stock certificates for the appropriate number of post-split shares in book-entry form and receiving payment in lieu of any fractional shares. Stockholders holding shares through a bank, broker or other nominee will have their positions adjusted to reflect the reverse stock split and will receive payment in lieu of any fractional shares in accordance with their respective bank’s, broker’s or nominee’s procedures. Additional information regarding the reverse stock split can be found in Rallybio’s proxy statement/prospectus, included in its registration statement on Form S-4, which was declared effective by the Securities and Exchange Commission on October 15, 2026 (the "Proxy Statement/Prospectus").

(Press release, Avenzo Therapeutics, NOV 10, 2026, View Source [SID1234674588])