Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

On March 16, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara1, Floretyrosine F 18 or 18F-FET), an investigational PET2 imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

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Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter3.

Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug4 and Fast Track5 designations by the FDA. PET imaging with 18F-FET is already included in international clinical practice guidelines for the imaging of gliomas6, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, "We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool."

Maggie Haynes, Executive Director, Head for the Cure Foundation, added: "Our community is encouraged by the FDA’s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it."

About TLX101-Px

TLX101-Px is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as LAT1 and LAT27. This enables TLX101-Px to be potentially utilized as a companion diagnostic agent to TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study8.

About gliomas in the U.S.

Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors9. In the U.S., there are six cases of gliomas diagnosed per 100,000 people every year10. GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.11. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients12, with an expected survival duration of 12-15 months from diagnosis.

(Press release, Telix Pharmaceuticals, MAR 16, 2026, View Source [SID1234663549])

Akeso Announces Global First-in-Class Trispecific Antibody AK150 Enters Clinical Trials: A Triple-Target Approach to Overcome Immunotherapy Resistance

On March 15, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that its proprietary first-in-class trispecific antibody, AK150 (ILT2/ILT4/CSF1R), has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) for clinical trials in patients with advanced solid tumors.

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AK150 is currently the only ILT2/ILT4/CSF1R trispecific antibody under development globally and is also Akeso’s first trispecific molecule to enter the clinical stage. Engineered via Akeso’s leading AI-driven drug discovery platform and its proprietary Tetrabody technology, AK150 stands as a global first-in-class innovation, once again demonstrating the company’s deep expertise and strong R&D capabilities in the field of multispecific antibody therapeutics.

ILT2, ILT4, and CSF1R exhibit high expression levels in various solid tumors, particularly prominent in tumor types with significant immunosuppressive microenvironments, including non-small cell lung cancer, hepatocellular carcinoma, pancreatic cancer, and some refractory breast cancers. Although current single- or dual-target therapies against macrophage related targets (such as those targeting ILT2, ILT4, or CSF1R) have shown some potential globally, they still fall short of fully breaking the immunosuppressive network of the tumor microenvironment. This underscores an urgent need for multi-target synergistic innovative therapies capable of multi-dimensional immune remodeling to improve anti-tumor efficacy—especially to overcome the clinical challenge of traditional immunotherapy’s insensitivity to "cold tumors".

By simultaneously targeting ILT2, ILT4, and CSF1R, AK150 enables synergistic anti-tumor activity through coordinated modulation of both innate and adaptive immune systems. It holds high therapeutic potential not only for hot tumors but also for converting "cold tumors" into "hot tumors", thereby fundamentally improving tumor responsiveness to immunotherapy.

CSF1R, ILT2, and ILT4 each play important immunomodulatory roles in the tumor microenvironment, together constructing a complex immunosuppressive network. The synergistic blockade of these three targets can relieve immune suppression at multiple levels. AK150 depletes immunosuppressive myeloid cells by CSF1R blockade, while simultaneously releasing the "molecular brakes" on remaining myeloid populations by ILT2 and ILT4 blockade. Meanwhile, ILT2 blockade by AK150 also has the potential to activate CD8+ T cells and Natural Killer (NK) cells, enhancing the anti-tumor immune response. This innovative design holds promise for addressing key challenges in solid tumor drug development.

About AK150
AK150 is a proprietary, humanized anti-CSF1R, ILT2, and ILT4 trispecific antibody developed by Akeso. By binding to CSF1R, AK150 blocks the interaction between CSF1R and CSF1/IL-34, thereby inhibiting CSF1R-dependent survival of myeloid cells, eliminating M2-like TAMs; By binding to ILT2/ILT4, AK150 blocks the interaction between ILT2/ILT4 and HLA-A/B/C/E/G, relieving immunosuppression of myeloid cells, and restoring the activity and function of NK cells and CD8+ T cells. Therefore, by synergistically blockade CSF1R/ILT2/ILT4, AK150 achieves multi-pathway blockade of both innate and adaptive immunity, enabling multi-dimensional relief of immunosuppression in the tumor microenvironment and overcoming the limitations of poor clinical efficacy by single-target drugs. . Preclinical animal models have demonstrated that AK150 exhibits dose-dependent tumor inhibition across all tested dosage groups.

(Press release, Akeso Biopharma, MAR 15, 2026, View Source [SID1234663548])

Junshi Biosciences Announces 2025 Full Year Financial Results and Provides Corporate Updates

On March 13, 2026 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported its financial results for the full year of 2025 and provided corporate updates.

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FINANCIAL HIGHLIGHTS

Total revenue of Junshi Biosciences was approximately RMB2,498 million in 2025, representing an increase of approximately 28% compared to 2024, which was mainly due to the increase in revenue from sales of pharmaceutical products, in particular the domestic sales revenue of the company’s core product, toripalimab, was approximately RMB2,068 million, representing an increase of approximately 38% compared to 2024.
Total research and development ("R&D") expenses of the company were approximately RMB1,384 million in 2025, representing an increase of approximately 9% compared to 2024. The increase in R&D expenses was mainly due to the company’s focus on more competitive and innovative R&D pipelines and accelerated clinical development in 2025.
Net cash inflow from financing activities was approximately RMB2,232 million, which fully covered the cash outflows in operating and investing activities, leading to an increase in bank balances and cash. A successful placing of new H shares on 20 June 2025 generated a net cash inflow of approximately RMB940 million for the company.
As of the end of 2025, the company’s aggregate balance of bank balances and cash and financial products was approximately RMB3,195 million, providing a relatively sufficient cash position to support the company’s development.
BUSINESS HIGHLIGHTS

During 2025, our commitment to addressing "unmet medical needs" has driven original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and drugs through accelerating international development. Here are the notable achievements and milestones:

Advancements in the pipeline: Junshi Biosciences’ innovative R&D field has expanded from monoclonal antibodies to the research and development of various drug modalities, including small molecule drugs, polypeptide drugs, antibody drug conjugates (ADC), bi-specific or multi-specific antibodies, bispecific antibody drug conjugates, fusion protein, nucleic acid drugs and vaccines, as well as the exploration of next-generation innovative therapies, including those for cancer and autoimmune diseases. A total of four drugs have been commercialized, a number of products are undergoing phase 3 clinical studies or in the stage of marketing application, and various innovative drugs that are competitive in the international market are undergoing accelerated clinical trials.

In January 2025, the indication of toripalimab for the treatment of unresectable or metastatic melanoma after failure of standard systemic therapy was approved by the National Medical Products Administration of China (the "NMPA") for conversion from conditional approval to regular approval.
In January 2025, the investigational new drug ("IND") application for JS212 [a recombinant humanized epidermal growth factor receptor ("EGFR") and human epidermal growth factor receptor 3 ("HER3") bispecific ADC] was accepted by the NMPA. It was approved by the NMPA in March 2025. The IND application of JS212 multi-cohort combined drug application was approved by the NMPA in November 2025. In December 2025, the IND application for JS212 for the treatment of advanced solid tumors was approved by the U.S. Food and Drug Administration ("FDA").
In January 2025, the indication of VV116/JT001 (MINDEWEI) for the treatment of adult patients with mild to moderate coronavirus disease 2019 ("COVID-19") was approved by the NMPA for conversion from conditional approval to regular approval.
In January 2025, the New Chemical Entity ("NCE") application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma ("NPC") and toripalimab, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy was approved by the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the "TGA"). Toripalimab became the first immuno-onocology treatment for NPC in Australia.
In February 2025, the IND application for JS213 (a PD-1 and interleukin-2 ("IL-2") bifunctional antibody fusion protein) was approved by the NMPA.
In March 2025, the supplemental new drug application (the "sNDA") for toripalimab in combination with bevacizumab for the first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma ("HCC") was approved by the NMPA.
In March 2025, the new drug application (the "NDA") for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC was approved by the Singapore Health Sciences Authority (the "HSA"). Toripalimab became the first approved immuno-oncology treatment for NPC in Singapore.
In April 2025, the sNDA for toripalimab for the first-line treatment of unresectable or metastatic melanoma was approved by the NMPA. This is the 12th indication of toripalimab approved in Chinese Mainland.
In May 2025, the two sNDAs for the ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA) for: 1) adult patients with heterozygous familial hypercholesterolemia ("HeFH"); 2) alone or in combination with ezetimibe, in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are statin-intolerant or statins contraindicated, were approved by the NMPA. Ongericimab became the first domestic PCSK9-targeted drug approved for statin-intolerant patients.
In June 2025, the IND application for the JT118 injection ("JT118") was accepted. It was approved by the NMPA in September 2025. JT118 is a "two-in-one" recombinant protein vaccine composed of a tandem fusion of monkeypox virus antigens A35 (an extracellular enveloped virus antigen) and M1 (an intracellular mature virus antigen), and is intended mainly for the prevention of monkeypox virus infection.
In June 2025, the indications of toripalimab for the first-line treatment of NPC and the first-line treatment of esophageal squamous cell carcinoma ("ESCC") were officially approved for marketing in the United Arab Emirates (the "UAE") and Kuwait.
In August 2025, the sNDA for toripalimab in combination with disitamab vedotin as the treatment of HER2-expressing (HER2 expression is defined as HER2 immunohistochemistry results of 1+, 2+, or 3+) locally advanced or metastatic UC was accepted by the NMPA.
In September 2025 and October 2025, the two indications for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced NPC, and toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy were approved for marketing in Pakistan and Canada, respectively.
In October 2025, the IND application for an open-label, two-arm, randomized, active-controlled, phase 2/3 clinical study comparing JS207 (recombinant humanized anti-PD-1/VEGF bispecific antibody), to nivolumab for the neoadjuvant treatment of patients with stage 2/3, resectable, actionable genomic aberration (AGA)-negative, non-small cell lung cancer ("NSCLC") was approved by the FDA.
In November 2025, a new indication of toripalimab in combination with chemotherapy as first-line treatment of ESCC was approved in Hong Kong SAR, China.
In November 2025, the multi-center, open-label, randomized controlled phase 3 clinical study comparing JS001sc (toripalimab injection for subcutaneous use) to toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic non-squamous NSCLC met its primary endpoints.
In December 2025, the NDA for JS005 (roconkibart injection, a recombinant humanized anti-IL-17A monoclonal antibody injection), for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy was accepted.
In December 2025, toripalimab, with two new indications, and JUNSHIDA was successfully included in Category B of the National Drug List for Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance (Year 2025) (the "NRDL").
In December 2025, the indications of toripalimab for the first-line treatment of NPC and the first-line treatment of ESCC were approved for marketing in Bahrain.
Update on external collaborations

In January 2025, TopAlliance Biosciences Inc. ("TopAlliance"), a wholly-owned subsidiary of the company, entered into a distribution and marketing agreement with LEO Pharma A/S ("LEO Pharma"). TopAlliance will grant LEO Pharma the exclusive right to store, distribute, promote, market and sell toripalimab in all current member states and any future member states of the European Union (the "EU") and the European Economic Area (the "EEA"), Switzerland as well as the United Kingdom (the "UK") (the "Territory"). LEO Pharma shall pay TopAlliance an upfront payment of EUR15 million, milestone payment(s) for any subsequent approved indication(s) for toripalimab in the Territory, and a revenue share of a double-digit percentage on the net sales of toripalimab throughout the Territory.
Update on business operations

In June 2025, Suzhou Union Biopharm Biosciences Co., Ltd. ("Suzhou Union"), a wholly-owned subsidiary of the company, underwent and passed an unannounced inspection (i.e., an inspection conducted without prior notification during routine operations) in respect of Current Good Manufacturing Practice ("CGMP") by the FDA.
In June 2025, the company completed the placing of new H shares under general mandate (the "Placing"), pursuant to which an aggregate of 41,000,000 H shares (the "Placing Shares") were successfully allotted and issued at HK$25.35 per H share. The net proceeds (after deduction of commissions and estimated expenses) amounted to approximately HK$1,026 million, which shall be used for innovative drug development and general corporate purposes such as replenishment of working capital.
In September 2025, the 2025 A Share Option Incentive Scheme and the 2025 H Share Option Incentive Scheme and related resolutions were considered and approved at a general meeting held by the company.

(Press release, Shanghai Junshi Bioscience, MAR 13, 2026, View Source [SID1234663542])

Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate-risk non-muscle-invasive bladder cancer

On March 13, 2026 Johnson & Johnson (NYSE:JNJ) reported results from an open-label, multicenter Phase 1 study evaluating an investigational intravesical drug-releasing system with erdafitinib (Erda-iDRS) in patients with intermediate-risk and high-risk non–muscle-invasive bladder cancer (NMIBC) whose tumors harbor select fibroblast growth factor receptor (FGFR) alterations. The study met its primary safety endpoint and demonstrated complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease. These findings support continued development of this targeted approach with ongoing Phase 2 and Phase 3 studies evaluating Erda-iDRS across risk settings. Data were presented during a late-breaking oral session at the European Association of Urology (EAU) 2026 Annual Meeting (Abstract #LB26-0083).1

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FGFR alterations are common in early-stage bladder cancer, occurring in approximately 70 percent of intermediate-risk and 40 percent of high-risk non–muscle-invasive bladder cancer tumors.2,3 Because these changes may drive tumor growth, they represent an important therapeutic target in this setting. Erda-iDRS is designed to provide prolonged release of erdafitinib, an oral kinase inhibitor, directly into the bladder via intravesical administration over a three-month period, and may enable localized treatment while aiming to minimize systemic exposure and the risk of adverse events associated with oral administration.

"Intermediate-risk non–muscle-invasive bladder cancer is defined by recurrences, and many patients undergo repeated procedures as their tumors return," said Antoni Vilaseca Cabo,* M.D., adjunct physician of the Urology Service at Hospital Clínic de Barcelona in Spain, and presenting author. "In this study, treatment with Erda-iDRS led most patients with FGFR-altered disease to achieve a complete response by the end of the second treatment cycle, and many of those responses were sustained over time. Achieving and maintaining a complete response is particularly meaningful in this setting, where recurrence is common and requires repeated surgical intervention."

"For patients with FGFR-altered non–muscle-invasive bladder cancer, care has historically not been guided by precision-based approaches," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson. "The high and durable complete responses demonstrated with Erda-iDRS highlight the opportunity to deliver a targeted therapy to these patients. Bringing a biology-based approach into earlier stages of this disease has the potential to change how these patients are treated."

Detailed Study Results

In this Phase 1 study, Erda-iDRS was evaluated in patients with non–muscle-invasive bladder cancer harboring select FGFR alterations identified by urine and/or tissue testing. As of November 3, 2025, 62 patients with recurrent intermediate-risk non–muscle-invasive bladder cancer and 26 patients with recurrent, Bacillus Calmette-Guérin (BCG)-experienced, high-risk non–muscle-invasive bladder cancer had received treatment. The primary endpoint was safety, with the secondary endpoints assessing complete response rate and duration of CR in the intermediate-risk cohort and recurrence-free survival in the high-risk cohort.1

In the intermediate-risk cohort, Erda-iDRS was evaluated as a non-surgical treatment for visible tumors. The complete response rate was 89 percent (95 percent confidence interval [CI], 78-95), based on tumor assessments during the initial treatment period. Among responders, the median duration of complete response was 18 months (95 percent CI, 14-25), with a median follow-up of 18 months (range, 15-21), indicating prolonged responses over time. Forty-nine percent of patients remain in follow-up.1

In the high-risk cohort, patients treated with Erda-iDRS had a median recurrence-free survival of 20 months (95 percent CI, 15-30), with a 12-month recurrence-free survival rate of 83 percent (95 percent CI, 62-93). With a median recurrence-free survival follow-up of 24 months (range, 15-30), 31 percent of patients remain in follow-up.1

Treatment was generally well tolerated, as evidenced by the absence of dose-limiting toxicities and a safety profile characterized by predominantly local adverse events. In the combined cohorts, the most frequent treatment-related adverse events (TRAEs) were hematuria (32 percent) and dysuria (22 percent). Grade 3 or higher TRAEs occurred in four patients (5 percent). Eight patients (9 percent) discontinued treatment due to adverse events, and two patients (2 percent) experienced serious TRAEs. Pharmacokinetic analyses demonstrated prolonged drug levels in the urine, with limited systemic exposure and no observed hyperphosphatemia.1

Continued Development

Phase 2 and Phase 3 studies are ongoing to evaluate Erda-iDRS in intermediate- and high-risk non–muscle-invasive bladder cancer. The MoonRISe program includes the Phase 3 MoonRISe-1 study (NCT06319820) in intermediate-risk disease in the adjuvant setting (after tumor resection), the Phase 2 MoonRISe-2 study (NCT05316155) in intermediate-risk disease in the ablative setting (evaluating treatment of visible tumors without surgery), and the Phase 3 MoonRISe-3 study (NCT06919965) in patients with high-risk papillary non–muscle-invasive bladder cancer who received prior BCG therapy, including those with BCG-unresponsive disease, in the adjuvant setting.4,5,6

About Erdafitinib Intravesical Drug-Releasing System (Erda-iDRS)

Erda-iDRS is an investigational intravesical drug delivery system designed to deliver prolonged, localized erdafitinib, an oral kinase inhibitor, directly to the bladder. The safety and efficacy of Erda-iDRS are being evaluated in a Phase 1 study in patients with non–muscle-invasive bladder cancer (NMIBC), including those with high-risk, BCG-unresponsive disease and intermediate-risk disease with visible tumors. Additional Phase 2 and Phase 3 studies are ongoing to further assess Erda-iDRS across intermediate- and high-risk NMIBC.

In 2008, Janssen Pharmaceuticals entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize erdafitinib.

About Non–Muscle-Invasive Bladder Cancer

Non–muscle-invasive bladder cancer (NMIBC) is an early stage of bladder cancer confined to the lining of the bladder. It accounts for approximately 75 percent of newly diagnosed bladder cancer cases. NMIBC is categorized as low-, intermediate-, or high-risk based on tumor characteristics and likelihood of recurrence or progression.7

Patients with intermediate-risk NMIBC experience frequent tumor recurrences that often require repeated procedures and ongoing monitoring. High-risk NMIBC carries a greater likelihood of progression to muscle-invasive disease, which may require radical cystectomy.8,9,10 Despite available treatments, recurrence and progression remain common across intermediate- and high-risk disease, underscoring the need for durable bladder treatment options.

(Press release, Johnson & Johnson, MAR 13, 2026, View Source;johnson-highlights-promising-first-in-human-erda-idrs-formerly-tar-210-results-in-intermediate-risk-nonmuscle-invasive-bladder-cancer-302713590.html [SID1234663541])

Xenetic Biosciences, Inc. Reports Full Year 2025 Financial Results

On March 13, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported its financial results for the year ended December 31, 2025.

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Recent Highlights

Expanded and presented preclinical and translational evidence supporting neutrophil extracellular traps (NETs) as drivers of cancer progression and highlighting the therapeutic potential of Deoxyribonuclease (DNase) -based interventions;

Progressed investigator-initiated exploratory studies in Israel evaluating DNase I in combination with standard-of-care and immunotherapy platforms, including:

Ongoing pancreatic ductal adenocarcinoma (PDAC) study;

Proposed large B-cell lymphoma (LBCL) study in combination with Chimeric Antigen Receptor (CAR) T cell therapy;

Advanced clinical manufacturing activities for DNase I toward Investigational New Drug (IND) application;

Current focus on mechanism-of-action and translational research studies supported by encouraging CAR-T proof-of-concept studies with Scripps Research; and

Pursuing strategic alternatives to maximize shareholder value.

"During 2025, we continued to advance our DNase-based technology toward Phase 1 clinical development while making steady progress across scientific, operational and strategic fronts," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "We strengthened the evidence linking NETs to cancer progression and the therapeutic promise of DNase-based strategies, advanced multiple investigator-initiated studies and progressed toward IND-enabling activities. We believe these efforts position the Company well as we move through 2026, while remaining disciplined in our use of capital and focused on creating long-term shareholder value."

Xenetic continues to advance its DNase-based technology toward Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. During 2025, the Company completed preclinical studies evaluating DNase I in combination with chemotherapy, immunotherapies and CAR-T approaches across both solid and hematologic cancer models. Data generated from these studies are informing ongoing translational work and manufacturing activities as the Company progresses toward U.S. IND submission.

Summary of Financial Results for Fiscal Year 2025
Net loss for the year ended December 31, 2025 was approximately $2.7 million, reflecting investment in the Company’s most promising scientific programs. Royalty revenue from the Company’s sublicense with Takeda Pharmaceuticals Co. Ltd increased approximately 19% to $3.0 million in the year ended December 31, 2025 from $2.5 million for the year ended December 31, 2024 primarily due to royalty payments received from certain countries. Research and development expenses for the year ended December 31, 2025 decreased by approximately $0.2 million, or 7%, to $3.1 million from $3.3 million in the prior year period. Research and development costs for the year ended December 31, 2024 included a $0.7 million impairment charge that did not reoccur in 2025. This decrease was substantially offset by increased spending in connection with the Company’s DNase process development efforts. General and administrative expenses for the year ended December 31, 2025 were $2.7 million, decreasing by approximately $0.7 million, or 20%, compared to the prior year. This decrease was primarily due to certain severance and benefits expensed during the year ended December 31, 2024 in connection with a separation agreement entered into during the second quarter of 2024 with our former Chief Executive Officer.

The Company ended the year with approximately $7.9 million of cash, representing an increase of approximately $1.7 million compared to the prior year-end, primarily due to net proceeds of approximately $4.0 million from an underwritten public offering completed in October 2025.

(Press release, Xenetic Biosciences, MAR 13, 2026, View Source [SID1234663539])