On February 12, 2026 SURGE Therapeutics (SURGE), a clinical-stage oncology company pioneering intraoperative immunotherapy, reported the final patient has been dosed in its Phase 1 clinical trial of SRG-514, an investigational therapy for breast cancer patients undergoing surgery. The treatment was generally well tolerated in the Phase 1 dose-escalation study, and there were no treatment-related dose-limiting toxicities or treatment-related serious adverse events to date. Based on the data generated to date and discussions with the FDA, the company is preparing to advance SRG-514 directly into a registrational trial.

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SRG-514 is designed to deliver immunotherapy intraoperatively, directly into the resection cavity during the time of tumor removal. The therapy aims to reprogram the local inflammatory response from immunosuppressive to immunostimulatory, with the goal of generating a durable, systemic anti-tumor immune response when tumor burden is at its lowest.

"Intraoperative immunotherapy represents a fundamentally different approach to treating cancer," said Michael Goldberg, Ph.D., CEO & Founder, SURGE Therapeutics. "With SRG-514, we are targeting primary drivers of cancer mortality – post-surgical recurrence and metastasis – by improving how, when, and where immunotherapy is delivered. We are encouraged by the data generated to date and by the broader potential of our programs to serve as pipelines-in-a-product."

"One of the most persistent challenges in oncology is that microscopic disease can remain even after successful tumor removal and later drive cancer recurrence, both locally and distally," said Robert Langer, Sc.D., Institute Professor at MIT and Chair of SURGE’s Scientific Advisory Board. "Applying established principles of drug delivery in the intraoperative setting creates a powerful opportunity to influence immune responses where and when intervention may have the greatest impact."

SRG-514 is a novel thermosensitive formulation of ketorolac, a non-steroidal anti-inflammatory drug commonly used perioperatively. By intervening during surgery, the therapy is designed to provide extended, localized release directly at the tumor resection site and may counteract surgery-induced immune suppression, a biological process that can promote recurrence and metastasis.

Post-surgical recurrence remains one of the most significant unmet needs in oncology, as 90% of cancer-related deaths are driven by local recurrence and metastasis. Each year, approximately 9 million cancer patients worldwide undergo surgical tumor resection, yet an estimated 40% of patients experience disease recurrence within five years. While surgery triggers acute inflammation, standard post-operative therapies are typically not administered until several weeks after surgery, allowing residual cancer cells time to develop strategies to evade immune surveillance.

SURGE’s proprietary SURGERx platform uses an injectable, biodegradable hydrogel optimized for intraoperative administration to deliver a drug in a highly concentrated manner.

The company expects to initiate a registrational trial of SRG-514 in triple-negative breast cancer this year, with potential expansion into additional breast cancer and solid tumor indications. In parallel, the company is advancing two additional intraoperative immunotherapy programs – STM-416 and STM-416p, utilizing the TLR7/8 agonist resiquimod, in bladder cancer and prostate cancer, respectively. Both programs are expected to enter Phase 2 clinical trials this year.

These programs highlight SURGE’s mission to transform surgery from a purely physical intervention into a therapeutic modality to deliver localized immunotherapy to potentially improve patient outcomes.

(Press release, SURGE Therapeutics, FEB 12, 2026, View Source [SID1234662656])

On February 12, 2026 J INTS BIO, Inc. reported that research findings on its investigational fourth-generation EGFR tyrosine kinase inhibitor (TKI), JIN-A02, have been published in Clinical Cancer Research, a leading oncology journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper). According to the most recent Journal Citation Reports (2025), the journal has an Impact Factor of 10.2, reflecting its influence in translational and clinical cancer research.

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The study presents a therapeutic strategy designed to overcome EGFR C797S, a major resistance mutation that commonly emerges following treatment with the third-generation EGFR inhibitor Tagrisso. By integrating comprehensive preclinical findings with early clinical observations, the research outlines a potential new treatment approach for patients with EGFR-mutant non–small cell lung cancer (NSCLC) who have limited options after Tagrisso failure.

EGFR-mutant NSCLC is driven by aberrant activation of EGFR signaling, and while EGFR-targeted therapies have dramatically improved outcomes over the past decade, acquired resistance remains inevitable for most, if not all patients. In particular, the C797S mutation is known as a representative resistance mechanism that emerges, preventing existing third-generation EGFR targeted therapies from working effectively. Currently, there are no approved treatments targeting the C797S mutation. JIN-A02 was developed as an orally available, fourth-generation EGFR inhibitor engineered to selectively target resistance-associated EGFR mutations, including C797S and T790M, while minimizing activity against wild-type EGFR. In preclinical models derived from patients with EGFR E19del/T790M/C797S mutant NSCLC that are resistant to Tagrisso, JIN-A02 demonstrated marked antitumor activity, achieving a maximum tumor growth inhibition (TGI) of 168.2%, substantially exceeding the effects observed with Tagrisso under the same conditions and indicating tumor regression. This means that it was observed that administration of JIN-A02 could reduce tumor size beyond simple growth inhibition.

Tumor tissue analyses showed significant reductions in phosphorylated EGFR (p-EGFR) and the proliferation marker Ki-67 following JIN-A02 treatment, confirming effective inhibition of EGFR-driven signaling at the molecular level. In intracranial tumor models reflecting brain metastases, JIN-A02 produced rapid and sustained reductions in tumor burden, suggesting the ability to achieve therapeutically meaningful exposure across the blood–brain barrier (BBB).

The publication also reports early clinical observations from an ongoing Phase 1/2 trial (NCT05394831) in patients with EGFR-mutant NSCLC who progressed after prior EGFR-targeted therapies and chemotherapy. As of the data cutoff, 23 patients had been treated with JIN-A02, with partial responses and stable disease observed in multiple cases. Notably, one patient in the 300 mg dose cohort achieved a partial response, with a 39.7% reduction in lung lesion size observed at the start of the third treatment cycle. This response was sustained through the seventh cycle, reaching a maximum reduction of 44.9%. In addition, the patient’s brain metastatic lesions decreased by 25% at the fifth treatment cycle, with the response maintained throughout the seventh cycle.

In addition, blood-based circulating tumor DNA (ctDNA) analysis in this patient showed complete clearance of the EGFR C797S mutation and the exon 19 deletion, along with a reduction of more than 90% in the T790M mutation. These findings are interpreted as evidence that the molecular-level target inhibition achieved by JIN-A02 translated into a meaningful clinical response.

Professor Sun Min Lim of the Division of Medical Oncology at Severance Hospital, the corresponding author of the study, stated, "JIN-A02 has demonstrated meaningful preclinical activity and early clinical signals targeting C797S-mediated resistance, for which treatment options have been extremely limited following the failure of third-generation EGFR-targeted therapies. In particular, the observed activity in brain metastases, along with a reduction in EGFR mutations detected in plasma ctDNA, provides important support for its further clinical development."

J INTS BIO plans to further accelerate the clinical development of JIN-A02, focusing on dose optimization, expansion of clinical data in patients with brain metastases, and further validation of molecular response biomarkers, with the goal of establishing a new treatment option for patients with EGFR-mutant NSCLC who have exhausted current standard therapies.

(Press release, J INTS BIO, FEB 12, 2026, View Source [SID1234662655])

On February 12, 2026 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported that Dr. James Bianco, President and Chief Executive Officer of TuHURA Biosciences, will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference.

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Date: February 26, 2026
Time: 3:20 pm ET
Links: To register and view presentation, click HERE

A live and archived webcast of the presentation will be available through the investors page of TuHURA’s corporate website at View Source

(Press release, TuHURA Biosciences, FEB 12, 2026, View Source [SID1234662654])

On February 12, 2026 10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, reported financial results for the fourth quarter and full year ended December 31, 2025 and provided its outlook for 2026.

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Recent Updates

Revenue was $166.0 million for the fourth quarter of 2025, representing a 1% increase over the corresponding period of 2024. Revenue was $642.8 million for the full year of 2025. Excluding $44.1 million of non-recurring revenue related to patent litigation settlements, full-year revenue was $598.7 million, representing a 2% decrease from the full year of 2024.
Announced partnerships with the Cancer Research Institute and PharosAI to build some of the world’s largest AI-ready datasets for cancer research, leveraging our Chromium and Xenium platforms to transform thousands of clinical samples into high-resolution multimodal insights for drug discovery and diagnostics.
Entered into a collaboration with Dana-Farber Cancer Institute to analyze patient tumor samples, marking the beginning of a multi-year research initiative to incorporate single cell and spatial tumor analysis into potential diagnostic workflows to support cancer patient care.
Launched a study with Brigham & Women’s Hospital aimed at identifying single cell blood-based signatures of autoimmune disease activity and treatment response to support clinical care.
Ended the year with $523.4 million of cash and cash equivalents and marketable securities, an increase of $130.0 million over the prior year.
"In 2025, our team executed with discipline through a challenging environment while continuing to strengthen the fundamentals of the business," said Serge Saxonov, Co-founder and CEO of 10x Genomics. "As we look to 2026, I am excited by the expanding impact of our platforms, driven by new product innovations and strategic partnerships. We are well positioned to execute across multiple growth vectors in the business, especially AI-driven demand, translational research and emerging clinical opportunities."

Fourth Quarter 2025 Financial Results

Revenue was $166.0 million for the three months ended December 31, 2025, a 1% increase from $165.0 million for the corresponding prior year period.

Gross margin was 68% for the fourth quarter of 2025, as compared to 67% for the corresponding prior year period. The increase in gross margin was primarily due to lower inventory write-downs, lower royalty costs and lower warranty costs, partially offset by higher manufacturing costs.

Operating expenses were $132.6 million for the fourth quarter of 2025, an 18% decrease from $160.8 million for the corresponding prior year period. The decrease was primarily driven by lower outside legal expenses and personnel expenses.

Operating loss was $19.5 million for the fourth quarter of 2025, as compared to an operating loss of $49.8 million for the corresponding prior year period. This includes $25.2 million of stock-based compensation for the fourth quarter of 2025, as compared to $32.5 million for the fourth quarter of 2024.

Net loss was $16.3 million for the fourth quarter of 2025, as compared to a net loss of $49.0 million for the corresponding prior year period.

Full Year 2025 Financial Results

Revenue was $642.8 million for the year ended December 31, 2025, a 5% increase from $610.8 million for 2024. Excluding $44.1 million related to patent litigation settlements, full-year revenue was $598.7 million, a 2% decrease from the prior year.

Gross margin was 69% for full year 2025, as compared to 68% for 2024. The increase in gross margin was primarily due to higher license and royalty revenue and lower royalties and warranty costs, partially offset by an increase in inventory write-downs and higher manufacturing costs.

Operating expenses were $504.9 million for full year 2025, as compared to $609.0 million for 2024, a decrease of 17%. The decrease was primarily driven by a $49.9 million gain on litigation settlements, lower outside legal expenses and personnel expenses.

Operating loss was $61.0 million for full year 2025, as compared to an operating loss of $194.6 million for 2024. This includes $108.8 million of stock-based compensation for full year 2025, as compared to $140.7 million for full year 2024.

Net loss was $43.5 million for full year 2025, as compared to a net loss of $182.6 million for 2024.

Cash and cash equivalents and marketable securities were $523.4 million as of December 31, 2025.

2026 Financial Guidance

10x Genomics expects full year 2026 revenue to be in the range of $600 million to $625 million. Excluding the non-recurring license and royalty revenue related to patent litigation settlements in 2025, this represents 0% to 4% growth over full year 2025.

Webcast and Conference Call Information

10x Genomics will host a conference call to discuss the fourth quarter and full year 2025 financial results, business developments and outlook after market close on Thursday, February 12, 2026 at 1:30 PM Pacific Time / 4:30 PM Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 45 days after the event.

(Press release, 10x Genomics, FEB 12, 2026, View Source [SID1234662653])

On February 12, 2026 Innovent Biologics, Inc. ("Innovent",HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the first participant has been successfully dosed in the pivotal Phase 3 clinical study (HeriCare-Breast01). The trial is evaluating the company’s developed IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) as a first-line treatment for patients with unresectable locally advanced or metastatic HER2-positive breast cancer. IBI354 has two pivotal Phase 3 trials ongoing (HeriCare-Ovarian01, HeriCare-Breast01), which holds potential to deliver a new generation of ADC therapies characterized by "high potency and low-toxicity".

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HeriCare-Breast01 (NCT07377643) is a multicenter, randomized, open-label, active-controlled study designed to evaluate the safety and efficacy of IBI354, with or without pertuzumab, compared with the current standard-of-care, paclitaxel plus trastuzumab and pertuzumab (THP). The primary endpoint is progression-free survival (PFS).

Previously, in a multicenter Phase 1/2 study in participants with advanced solid tumors, a total of 88 participants with HER2-positive breast cancer were enrolled（the median prior treatment lines was 4) and were treated with 6-15 mg/kg doses of IBI354.

As of March 24, 2025, the overall confirmed objective response rate (cORR) was 59.1% and the disease control rate (DCR) was 90.9%.
Among them, ORR reached 72.4% and DCR reached 89.7% in 29 breast cancer participants treated with 9mg/kg Q3W.
The median follow-up time of 9mg/kg Q3W dose group was 13.6 months as of the cut-off date, and progression-free survival (PFS) was 14.1 month (95%CI: 8.3, NC). The data were presented at the ASCO (Free ASCO Whitepaper) 2025[Link].
IBI354 also demonstrated an excellent safety profile in this Phase 1/2 clinical study (n=368).

No DLT was occurred up to 18mg/kg dose group.
The overall incidence of grade 3 or higher treatment-related adverse events (TRAEs) in 9mg/kg Q3W dose group was 21.0%, the incidence of TRAEs leading to dose interruption was 9.9%, the incidence of TRAEs leading to dose reduction was 1.2%, the overall incidence of TRAEs leading to discontinuation was 1.2%, and no TRAE leading to death reported.
The most common TRAEs are white blood cell count decreased, nausea and anemia. The incidence of interstitial lung disease was only 1.2%, all were grade 1.
The Principal Investigator of the HeriCare-Breast01 study, Binghe Xu, academician of the Chinese Academy of Engineering from Cancer Hospital Chinese Academy of Medical Sciences, stated, "We are pleased to complete the first patient enrollment for the HeriCare-Breast01 study at our center. Although first-line treatment for HER2-positive advanced breast cancer has improved substantially—with the THP regimen delivering durable responses for many patients—important clinical challenges remain. These include treatment discontinuation driven by toxicity and limited tolerability of currently available ADCs, particularly among older patients and those with comorbid conditions. As a next-generation HER2-targeted ADC, IBI354 has shown compelling antitumor activity in Phase 1/1b studies, achieving class-leading ORR and DCR, alongside a notably favorable safety profile. In particular, IBI354 has demonstrated reduced incidence of key adverse events such as interstitial lung disease (ILD), peripheral neuropathy, and neutropenia. This "high-efficacy, low-toxicity" therapeutic window may allow a broader range of patients to achieve sustained, high-quality treatment outcomes. We look forward to the Phase 3 HeriCare-Breast01 study to further validate this potential and advancing IBI354 toward becoming a new standard of care in the first-line treatment for HER2-positive advanced breast cancer. "

Dr. Zhou Hui, Chief R&D Officer (Oncology) of Innovent, stated, "The initiation of the pivotal Phase 3 HeriCare-Breast01 trial in China marks a significant milestone in the clinical translation of Innovent’s ADC pipeline. Leveraging the world’s leading antibody engineering and differentiated linker-payload technologies, Innovent has established a highly competitive and innovative TOPO1i ADC technology platform SoloTx. IBI354 has demonstrated a compelling safety and efficacy profile in early-stage studies, strongly validating the strengths of our SoloTx ADC platform. IBI354 holds strong potential to offer a new first-line treatment option for patients with HER2-positive advanced breast cancer—one that combines durable antitumor activity with favorable long-term tolerability. Looking ahead, Innovent will continue to advance innovation of next-generation IO+ADC, with a steadfast commitment to delivering improved therapeutic outcomes for cancer patients."

About Breast Cancer

Breast cancer is one of the most common cancers among women worldwide. Approximately 1.3 million women are diagnosed with breast cancer each year, and about 30% of them develop locally advanced or metastatic breast cancer. The clinical proportion of HER2-positive breast cancer is approximately 20%[1]. Previous studies have demonstrated that overexpression of this HER2 gene plays a significant role in the occurrence and development of invasive breast cancer and is associated with an increased recurrence rate and poor prognosis [2]. At present, no ADC targeting HER2 has been fully approved for first-line treatment of advanced breast cancer in China. There is an urgent need for new drugs to improve the prognosis of patients.

About IBI354

IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent’s proprietary SoloTx ADC platform. Based on this platform, Innovent is promoting clinical trial studies multiple self-developed ADC molecules, which have shown promising safety and efficacy signals.

With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors.

Starting from the urgent clinical needs, in addition to the Phase 3 studies (HeriCare-Breast01 and HeriCare-Ovarian01) already initiated in BC and PROC, Innovent will explore IBI354 in multiple solid tumor indications.

(Press release, Innovent Biologics, FEB 12, 2026, View Source [SID1234662651])