On March 23, 2026 Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) reported its audited consolidated results for the year ended 31 December 2025 (the "Reporting Period").

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Kelun-Biotech is leveraging its core strengths and proprietary OptiDC technology platform to continue deepening its presence in the ADC and novel DC drug field. The company is actively advancing cutting-edge modalities including bispecific ADCs, RDCs, iADCs, and DACs, building a differentiated pipeline with strong global competitiveness. At the same time, Kelun-Biotech is steadily advancing product commercialization, achieving transformational growth across its business. To date, the company has four products with eight indications approved for marketing in China, including Sacituzumab Tirumotecan (佳泰莱), Trastuzumab Botidotin (舒泰莱), Tagitanlimab (科泰莱), and Cetuximab N01 (达泰莱). Among them, three products with five indications have been included in the 2025 National Reimbursement Drug List (NRDL), establishing a fully integrated drug development ecosystem that spans R&D through commercialization.

As of now, the company has built a robust pipeline of more than 30 drug candidates, with over 10 in the clinical stage, and are gradually expanding into broader non-oncology therapeutic areas such as autoimmune diseases and metabolic disorders. Looking ahead, the company will leverage its innovative and differentiated pipeline to deliver high-quality therapeutic solutions for major unmet medical needs worldwide.

Core ADC Products’ Commercialization Realized to Solidify Long-term Performance Foundation

Sac-TMT (sacituzumab tirumotecan, TROP2 ADC) (also known as SKB264/MK-2870) (佳泰莱)

TNBC:

The Company received marketing authorization in China from the NMPA for sac-TMT in adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting).
The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus ICC for 1L advanced TNBC.
HR+/HER2- BC:

In February 2026, a new indication application for sac-TMT for the treatment of adult patients with HR+/HER2- BC who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting has been approved for marketing by the NMPA.
A Phase 3 registrational study of sac-TMT versus ICC for treatment of patients with HR+/HER2- BC who received prior ET is in progress.
EGFR-mutant NSCLC:

In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. This is the first TROP2 ADC drug approved for marketing in LC globally.
In October 2025, the company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC who progressed after treatment with EGFR-TKI therapy. This is the first ADC globally to show an OS benefit compared with platinum doublet chemotherapy and be approved for advanced NSCLC following progression on only TKI therapy (2L).
The Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of EGFR-mutant NSCLC and a Phase 2 study of sac-TMT monotherapy or in combination with osimertinib as neoadjuvant therapy for EGFR-mutant NSCLC are in progress.
EGFR-wild type NSCLC:

The Phase 3 registrational study of sac-TMT in combination with KEYTRUDA[1] (pembrolizumab) versus pembrolizumab as first-line treatment of PD-L1 positive NSCLC met its primary endpoint. This is the first Phase 3 clinical trial of ADC combined with immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC.
In January 2026, sac-TMT in combination with pembrolizumab for the first-line treatment of PD-L1 positive NSCLC were granted Breakthrough Therapy Designation by the NMPA.
The Phase 3 registrational study of sac-TMT in combination with pembrolizumab as first-line treatment of PD-L1 negative NSCLC is in progress.
Other indications: The company is actively exploring the potential of sac-TMT both as a monotherapy and in combination with other therapies for treating other solid tumors, including GC, EC, CC, OC, UC, CRPC, HNSCC, and TC, etc.

Trastuzumab botidotin (HER2 ADC, also known as A166, 舒泰莱)

In October 2025, trastuzumab botidotin was approved for marketing by the NMPA for adult patients with HER2+ BC who have received one or more prior anti-HER2 therapy. This is the first domestically developed HER2 ADC approved for 2L+ HER2+ BC in China.
An open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ BC that previously received a topoisomerase inhibitor ADC is in progress.
Key Clinical Data Highlighted at International Academic Conferences and in Top Journals

Results from the Phase 3 study of sac-TMT for the treatment of 2L EGFR-mutant NSCLC were selected for LBA and presented as an oral report in the Presidential Symposium session at the 2025 ESMO (Free ESMO Whitepaper) Congress. Sac-TMT achieved statistically significant and clinically meaningful improvements in ORR, PFS, and OS compared to chemotherapy. The study findings were published simultaneously online at the New England Journal of Medicine and in the first issue of 2026.
Results from the study of sac-TMT for the treatment of 3L EGFR-mutant NSCLC were presented as an oral report at the ASCO (Free ASCO Whitepaper) Annual Meeting and published at the British Medical Journal. The final OS analysis of this study will be selected for LBA and presented as a mini oral report at the 2026 ELCC.
Results from the Phase 3 study of sac-TMT for the treatment of 2L+ HR+/HER2-BC were selected for LBA and presented as an oral report at the 2025 ESMO (Free ESMO Whitepaper) Congress.
Results from the Phase 3 study of trastuzumab botidotin for the treatment of 2L+ HER2+ BC were selected for LBA and presented as an oral report at the 2025 ESMO (Free ESMO Whitepaper) Congress.
Sustained Value Release of ADCs Under Development with Tiered Advancement of Innovation Pipeline

Phase 2 clinical stage

SKB315 (CLDN18.2 ADC):

The Phase 1b clinical trial of SKB315 is in progress, for the treatment of GC/GEJC/PDAC, etc.
Results of a Phase 1 study of SKB315 in patients with advanced solid tumors including GC/GEJC were presented at 2025 ESMO (Free ESMO Whitepaper) Congress in October 2025.
SKB410/MK-3120 (Nectin-4 ADC):

Its partner MSD has launched 4 global Phase 1/2 clinical trial of SKB410/MK-3120 in advanced solid tumor including bladder cancer, etc.
SKB571/MK-2750 (novel bsADC): The Phase 2 clinical trial in China is ongoing.

SKB518 (novel ADC with a potential FIC target): The Phase 2 clinical trials are ongoing in China.

SKB500 (novel ADC): The Phase 2 study is ongoing in China.

Phase 1 clinical stage

SKB107 (RDC)[2]: The Phase 1 study is ongoing.

SKB535/MK-6204 (novel ADC with potential FIC target): The Phase 1 clinical trial for SKB535 is ongoing in China.

SKB445 (novel ADC with potential FIC target): The Phase 1 clinical trials for SKB445 is ongoing in China.

SKB105/CR-003 (ITGB6 ADC): In January 2026, an IND application was approved by the CDE of NMPA for the treatment of advanced solid tumor. A Phase 1/2 trial is ongoing in China.

Strategic Layout of Non-DC Assets with Focus on Combination Therapy & Indication Expansion

Drug candidates for oncology

Tagitanlimab (PD-L1 mAb, also known as A167) (科泰莱): In January 2025, the Company received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of NPC from NMPA. Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC.
In May 2025, the results of a Phase 3 clinical study of tagitanlimab in combination with cisplatin and gemcitabine for the first-line treatment of NPC were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting.
Cetuximab N01 (EGFR mAb, also known as A140) (达泰莱):

In February 2025, the Company received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC.
Lunbotinib Fumarate Capsules (RET inhibitor, also known as A400/EP0031)(宁泰莱)[3]：

An NDA was accepted for review by the CDE of the NMPA of China for the 1L+ treatment of RET-fusion positive NSCLC.
The company is also conducting a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China.
Ellipses Pharma is progressing their phase 2 clinical study globally outside of China.
In May 2025, results from the Phase 1 study of Lunbotinib Fumarate Capsules in patients with advanced RET-mutant MTC were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting.
SKB118/CR-001 (PD-1/VEGF bsAb):

In January 2026, Crescent Biopharma announced the regulatory clearance of the IND application for SKB118 by FDA to initiate its global ASCEND Phase 1/2 clinical trial for the treatment of advanced solid tumors, and the first patient has been dosed in February, 2026.
The company is planning to initiate the Phase 1/2 clinical study for SKB118 in China in the first half of 2026.
Drug candidates for autoimmune diseases

SKB378/WIN378 (TSLP mAb):

In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA.
Its collaboration partner, Windward Bio, has launched the Phase 2 POLARIS global trial in patients with asthma.
SKB575 (TSLP/undisclosed target bsAb): In March 2026, an IND application for SKB575 for the treatment of atopic dermatitis was approved by the NMPA.

Drug candidates for other non-oncology diseases

SKB336 (FXI/FXIa mAb): The company completed Phase 1 clinical trial in China.

Multiple Products First Included in National Reimbursement Drug List with Accelerated Market Coverage

In 2025, the Company witnessed an explosive growth in the commercialization of its innovative achievements. The Company has also filed an NDA for Lunbotinib Fumarate Capsules and expects to commence its commercialization in the second half of 2026 or the first half of 2027, subject to regulatory communications and marketing approval. To date, the company’s initial commercial product portfolio, consisting of five products, has taken shape.

Supported by national innovation policies, the Company has successfully secured the first-time inclusion of three of its commercialized products, namely 佳泰莱, 科泰莱 and 达泰莱, in the National Reimbursement Drug List (國家醫保藥品目錄), which officially took effect on January 1, 2026, and is expected to benefit more patients faster and better.

Steady Advancement of Global Collaboration and Comprehensive Strength Authoritatively Recognized

Collaboration with MSD: As at the date of this announcement, MSD is evaluating initiated 17 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer, including BC, LC, gynecological cancers, GI cancer and GU cancer. In addition to sac-TMT, the company is also collaborating with MSD on certain ADC assets to continuously explore favorable ADC pipeline portfolios.

Collaboration with Ellipses Pharma: The Company has deepened its collaboration with Ellipses Pharma on A400/EP0031, which has cleared by the FDA to progress into Phase 2 clinical development. As at December 31, 2025, a total of 39 clinical sites in the United States, Europe and UAE were set up for Lunbotinib Fumarate Capsules.

Collaboration with Windward Bio: In January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). Windward Bio has launched the Phase 2 POLARIS global trial in patients with asthma.

Collaboration with Crescent Biopharma. In December 2025, the company and Crescent Biopharma entered into a strategic collaboration for SKB105/CR-003 and SKB118 (a PD1 x VEGF bsAb, also known as CR-001). Under the collaboration, the company granted Crescent Biopharma exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside of Greater China. In return, the compamy obtained exclusive rights from Crescent Biopharma to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China.

In January 2026, Crescent Biopharma announced the regulatory clearance of the IND application for SKB118 by FDA to initiate its global ASCEND Phase 1/2 clinical trial for the treatment of advanced solid tumors, and the first patient has been dosed in February, 2026.

Continuous Improvement of ESG Capabilities to Consolidate the Foundation for Sustainable Development

Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability and ensures the Company’s sustainable development. In May 2025, the company was awarded "Best ESG" by Extel. In March 2026, the Company had received a rating of "AA" in the MSCI ESG Rating Assessment.

Outlook

In 2026, Kelun-Biotech will continue to drive innovation and strengthen its operational capabilities, steadily advancing towards becoming a world-class biopharmaceutical company. Specifically, the Company will implement the following development strategies: advancing differentiated pipelines targeting indications with significant medical needs; innovating on and optimizing payload-linker strategies and novel DC designs and structures, while expanding applications in non-oncology diseases; enhancing its end-to-end drug development and commercialization capabilities; expanding business landscape and strategic partnerships and improve our capabilities for the development, registration and commercialization of our products in ex-China market; and optimizing its operational systems with the aim of becoming a leading global biopharmaceutical company.

(Press release, Kelun, MAR 23, 2026, View Source [SID1234663840])

On March 23, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) announced today it has entered into a definitive agreement to acquire Ouro Medicines, a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases.

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The acquisition adds OM336 (gamgertamig), a clinical‑stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio. OM336 is designed to enable rapid and deep B cell depletion following a limited subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, OM336 has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies in 2027.

"This acquisition underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases," said Dietmar Berger, MD, PhD, Chief Medical Officer of Gilead. "BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases. BCMA targeted T cell engagers represent a differentiated approach with the potential to induce durable disease control. This novel framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative science that may redefine standards of care."

BCMA‑targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA‑expressing plasma cells, clinical data suggests these agents may reduce inflammation, improve organ‑level disease, and, in some cases, enable an immune reset marked by durable, drug‑free remission without ongoing immunosuppression. T cell engagers represent an important modality for patients alongside Gilead’s portfolio of CAR-T assets.

"From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases," said Jaideep Dudani, PhD, CoFounder and Chief Executive Officer of Ouro Medicines. "Since then, we’ve taken meaningful steps to advance that vision, with multiple trials now underway. With support from Gilead and Galapagos, we can build on the strong early foundation—leveraging a proven track record in late stage development, launch, and commercialization to accelerate our programs and help deliver on the promise gamgertamig holds for patients with immune-mediated diseases, following our initial collaboration with Keymed Biosciences."

Terms of the Transaction

Under the terms of the agreement Gilead will acquire all of the outstanding equity of Ouro Medicines for a total of $1,675 million in upfront cash consideration, subject to customary adjustments, which is payable at closing, and up to $500 million in contingent milestone payments. Closing of the transaction is subject to expiration or termination of certain regulatory filings and other customary conditions.

Strategic Collaboration with Galapagos

Gilead is currently in advanced discussions with Galapagos with respect to a potential research and development collaboration on the acquired Ouro Medicines assets. The arrangement between Gilead and Galapagos is contemplated to include the following key terms:

Galapagos would pay 50% of the upfront consideration and 50% of any contingent milestone payments payable to Ouro Medicines’ shareholders.
Galapagos would absorb substantially all of Ouro Medicines’ operating assets and retain its employees.
Gilead and Galapagos would collaborate on the development of OM336, with Galapagos responsible for development costs through initiation of registrational studies. Registrational study costs would be shared equally between the parties.
Gilead would retain sole worldwide commercialization rights (other than in Greater China where Keymed Biosciences has existing commercialization rights) and Gilead would pay Galapagos royalties of 20%-23% of net sales.
Amended legacy Galapagos Option License and Collaboration Agreement ("OLCA") to allow for up to $500 million of Galapagos’ current cash to be used freely by Galapagos, including up to $150 million for potential share repurchases.
Centerview Partners LLC and TD Cowen are acting as financial advisors to Gilead. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Ouro Medicines. Morgan Stanley & Co., LLC is acting as financial advisor to Galapagos. Covington & Burling LLP, Mayer Brown LLP, and Arnold & Porter Kaye Scholer LLP are serving as legal counsel to Gilead. Goodwin Procter LLP is serving as legal counsel to Ouro Medicines. Paul Weiss LLP and Linklaters LLP are serving as legal counsel to Galapagos.

About OM336

OM336 is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibodies driven immune-mediated disease. OM336 has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration for certain autoimmune diseases. OM336 is under an open IND in the U.S. and is expected to enter registrational studies in 2027. OM336 is in-licensed by Ouro Medicines from Keymed Biosciences, which owns the rights to develop the program in Greater China.

On March 23, 2026 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported the outcomes of a recent Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC).

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The FDA provided general agreement with Theriva’s proposed design for a Phase 3 clinical trial, which closely tracks the design of the successful VIRAGE Phase 2 trial. As announced in 2025, the VIRAGE trial met its primary endpoints, with metastatic PDAC patients receiving VCN-01 with SoC chemotherapy having improved overall survival (OS), progression free survival (PFS) and Duration of Response (DoR) compared to SoC chemotherapy alone. Greater improvements in OS and PFS were observed in patients who received two doses of VCN-01, leading Theriva to plan the Phase 3 trial to include repeat dosing and an adaptive design aimed to optimize the trial’s timelines and outcomes. .

Consistent with scientific advice previously received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the FDA advised that a potential biologics licensing application (BLA) for VCN-01 in metastatic PDAC could be supported by Theriva’s proposed Phase 3 clinical trial (if successful) comprising a single, high-quality, randomized, double-blinded, study comparing VCN-01 plus gemcitabine/nab-paclitaxel SoC to gemcitabine/nab-paclitaxel SoC plus placebo. The FDA further agreed on the proposed dosing of VCN-01 and gemcitabine/nab-paclitaxel in repeated "macrocycles" (enabling more than 2 doses of VCN-01 to be administered in the Phase 3 trial), the proposed inclusion/exclusion criteria, the primary endpoint (overall survival), key secondary endpoints (including progression free survival), and the use of an adaptive design. The FDA also clarified statistical expectations regarding the proposed interim analyses and the quality of data required for potential sample size re-estimation or a demonstration of early efficacy.

"We are very pleased to align with the FDA on the key elements of our proposed pivotal Phase 3 trial evaluating VCN-01 plus gemcitabine/nab-paclitaxel SoC in metastatic PDAC patients," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Data from our VIRAGE Phase 2b study demonstrated improved outcomes in PDAC patients treated with 2 doses of VCN-01 and we believe that administering multiple macrocycles of VCN-01 and gemcitabine/nab-paclitaxel that may further improve patient outcomes. The combined feedback from the FDA and the EMA now enables us to finalize the protocol for a pivotal Phase 3 clinical trial and pursue development funding and/or partnerships, which, if successful, may deliver a novel and effective treatment option for patients with this difficult to treat solid tumor cancer."

About Pancreatic Ductal Adenocarcinoma

Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma ("PDAC") accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About VCN-01

VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in Company- and investigator-sponsored clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.

(Press release, , MAR 23, 2026, View Source [SID1234663838])

On March 23, 2026 Oncotelic Therapeutics, Inc. (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or "Our"), a leader in RNA-based therapeutics, reported that its subsidiary Sapu Nano will present new data on everolimus toxicology, focusing on tissue concentration-driven effects, at the upcoming Society of Toxicology (SOT) 2026 Annual Meeting and ToxExpo, taking place March 22-25, 2026, in San Diego, California.

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The presentation will be featured during the Poster Session: ADME/Toxicokinetics I:

Date: Monday, March 23, 2026
Time (Author Attended): 1:45 PM – 4:15 PM
Display Time: 9:00 AM – 4:30 PM
Location: Exhibit Hall B, San Diego Convention Center
Abstract #: 3539
Poster Board #: K692
Presentation Title:
"Everolimus Toxicology: Tissue Concentration Effects"

Authors:
W. Chang, N. Chang, T. Hoque, and C. Lee
Sapu Nano, San Diego, CA

This poster presents new findings that elucidate the relationship between tissue-level exposure of everolimus and organ-specific toxicological outcomes, advancing understanding beyond traditional plasma pharmacokinetics.

"These data underscore the importance of tissue pharmacokinetics in determining toxicity profiles for mTOR inhibitors such as everolimus," said Wen-Han Chang PhD, Sr. Manager Nanomedicine. "Our findings provide a foundation for developing improved delivery strategies, including intravenous and nanoparticle-based formulations that better control biodistribution."

The SOT Annual Meeting and ToxExpo is the leading international forum for toxicology, bringing together scientists from academia, industry, and regulatory agencies to present cutting-edge research in safety science and drug development.

Sapu Nano’s participation highlights its continued leadership in nanomedicine and advanced drug delivery, with a focus on enhancing therapeutic index through precise control of drug distribution at the tissue level.

For more information about the meeting, visit:
www.toxicology.org/2026 | #2026SOT | #ToxExpo

(Press release, Oncotelic, MAR 23, 2026, View Source [SID1234663837])

On March 23, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the fourth quarter and full year ended December 31, 2025.

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"As we enter 2026, we are well-positioned to leverage our clinically validated masking technology to continue advancing our next generation of multi-specific I-O therapies toward the clinic," said René Russo, Pharm.D., president and chief executive officer of Xilio. "We are encouraged by the progress the field has recently made with masked T cell engagers for prostate cancer, and we are excited to be advancing a potential first-in-class multi-specific masked T cell engager targeting both PSMA and STEAP1 with built-in co-stimulatory signaling designed to enhance potency and durability of response. We believe that targeting both PSMA and STEAP1, which are the most prevalent tumor-associated antigens expressed in prostate cancer, will minimize resistance due to antigen escape. In addition, this quarter we continued to make strong progress advancing XTX501, our potential best-in-class bispecific PD-1 / masked IL-2, toward a planned IND submission mid-year."

Pipeline Progress and Business Updates

XTX501: bispecific PD-1 / masked IL-2

XTX501 is a novel bispecific PD-1 / masked IL-2 designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function. XTX501 incorporates masking and is designed to overcome IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents. In preclinical studies, XTX501 demonstrated robust monotherapy activity (including in settings insensitive to PD-1 therapy) and tumor-selective pharmacodynamics consistent with its intended mechanism of action.

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Xilio is currently advancing XTX501 through investigational new drug (IND)-enabling studies and plans to submit an IND application for XTX501 in the middle of 2026.
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Xilio plans to initiate a Phase 1 trial for XTX501 in the second half of 2026 and report initial Phase 1 data in the second half of 2027, subject to clearance of the IND by the U.S. Food and Drug Administration.
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Xilio plans to initially evaluate XTX501 in patients with metastatic non-small cell lung cancer before expanding development to other solid tumor types, including tumors that are insensitive to PD-1 therapy. The company believes XTX501 also has the potential to be a foundational "backbone" therapy for combination treatment with other agents.

Masked T Cell Engager Programs

Xilio is leveraging its proprietary, clinically-validated masking technology to advance two wholly-owned programs for masked T cell engagers, as well as an additional program in collaboration with AbbVie Group Holdings Limited (AbbVie).

Xilio’s masked T cell engagers include molecules with one or more tumor-associated antigen (TAA) binding domains and a CD3 targeting domain, which are designed to release a potent, short half-life T cell engager upon tumor-selective activation (ATACR format), and molecules that include a co-stimulatory domain designed to further enhance potency and durability of the T cell response (SEECR format). Depending on the desired properties that Xilio is seeking to achieve for a particular molecule and TAA(s), Xilio’s modular architecture for its masked T cell engagers enables optionality to: include multiple TAA binding domains; add a co-stimulatory domain; and/or mask the CD3 targeting domain, TAA binding domain(s) and/or the co-stimulatory signaling domain.

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Xilio is advancing a wholly-owned masked T cell engager program targeting CLDN18.2 (ATACR format). Xilio’s modular design architecture for T cell engagers also enables flexibility to evaluate designs that incorporate masking of the CLDN18.2 binding domain and/or add a co-stimulatory domain (SEECR format) in parallel with advancing the current molecule design. CLDN18.2 is expressed in gastrointestinal cancers (including gastric, pancreatic and esophageal) and lung cancer.
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Xilio plans to present new preclinical data for its CLDN18.2 program in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 17-22, 2026 (abstract number: 1619).
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Xilio is advancing a wholly-owned multi-specific, masked T cell engager program targeting PSMA and STEAP1 with built-in co-stimulatory signaling (SEECR format). Xilio anticipates nominating a development candidate in the second quarter of 2026. PSMA and STEAP1 are expressed in most prostate cancer tumors, and targeting both of these TAAs has the potential to address tumor heterogeneity while minimizing the potential for resistance due to antigen escape.
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Xilio plans to advance these masked T cell engager programs into IND-enabling studies and submit IND applications for each of these programs in 2027.

Efarindodekin alfa: masked IL-12

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Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors and expects to deliver an option data package to Gilead Sciences, Inc. (Gilead) in the first half of 2027.

Recent Corporate Updates

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In January 2026, Xilio announced the appointment of Sara Bonstein as chair of the board of directors.
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In January 2026, Xilio announced the receipt of $35.8 million in gross proceeds from the exercise of Series B warrants, before deducting underwriting discounts and commissions and any offering expenses, including the full exercise of Series B warrants held by Coastlands Capital, Frazier Life Sciences and Gilead. The Series B warrants were issued in connection with a follow-on offering in June 2025.
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In January 2026, Xilio announced the achievement of a development milestone related to the masked antibody-based immunotherapy program under the company’s collaboration, license and option agreement with AbbVie.

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In February 2026, Xilio closed a follow-on offering of prefunded warrants for $40.0 million in gross proceeds, before deducting underwriting discounts and commissions and any offering expenses. The offering was led by existing investor Coastlands Capital and included participation from OrbiMed, Perceptive Advisors and Gilead, as well as other new and existing institutional investors.

Year-End and Fourth Quarter 2025 Financial Results

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Cash Position: Cash and cash equivalents were $137.5 million as of December 31, 2025, compared to $55.3 million as of December 31, 2024. In the fourth quarter of 2025, Xilio received $35.8 million in gross proceeds from Series B warrant exercises and a $17.5 million development milestone payment under its license agreement with Gilead.
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Collaboration and License Revenue: Collaboration and license revenue was $13.7 million for the quarter ended December 31, 2025, compared to $1.7 million for the quarter ended December 31, 2024. Collaboration and license revenue was $43.8 million for the year ended December 31, 2025, compared to $6.3 million for the year ended December 31, 2024. The year-over-year increase was primarily driven by collaboration and license revenue recognized under the collaboration, license and option agreement and stock purchase agreement that Xilio entered into in February 2025 with AbbVie and an increase in collaboration and license revenue recognized under the license agreement with Gilead due to the achievement of a $17.5 million development milestone during the third quarter of 2025.
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Research & Development (R&D) Expenses: R&D expenses were $18.1 million for the quarter ended December 31, 2025, compared to $8.8 million for the quarter ended December 31, 2024. R&D expenses were $56.0 million for the year ended December 31, 2025, compared to $41.2 million for the year ended December 31, 2024. The year-over-year increase was primarily driven by manufacturing activities related to IND-enabling studies and preclinical development activities for XTX501, increased clinical development activities related to efarindodekin alfa, increased costs related to masked T cell engager programs and indirect research and development and increased personnel-related costs, which were partially offset by a decrease in costs related to vilastobart and XTX202.
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General & Administrative (G&A) Expenses: G&A expenses were $7.4 million for the quarter ended December 31, 2025, compared to $6.5 million for the quarter ended December 31, 2024. G&A expenses were $29.7 million for the year ended December 31, 2025, compared to $24.8 million for the year ended December 31, 2024. The year-over-year increase was primarily driven by an increase in professional and consulting fees, including legal fees and other professional costs, and an increase in personnel-related costs, which were partially offset by a decrease in costs related to directors’ and officers’ liability insurance.
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Net Income (Loss): Net income was $10.4 million for the quarter ended December 31, 2025, compared to a net loss of $13.1 million for the quarter ended December 31, 2024. Net loss was $35.0 million for the year ended December 31, 2025, compared to $58.2 million for the year ended December 31, 2024. The year-over-year decrease in net loss was primarily driven by increased collaboration and license revenue for the year ended December 31, 2025.

Cash Runway

Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents will be sufficient to enable it to fund its operating expenses and capital expenditure requirements through the end of 2027.

This estimate excludes any potential future milestone payments, option-related fees or other contingent payments under Xilio’s collaboration and partnership agreements with AbbVie and Gilead and excludes up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price.

(Press release, Xilio Therapeutics, MAR 23, 2026, View Source [SID1234663836])