On March 25, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported its financial results for the year ended December 31, 2025, and highlighted late-stage clinical progress for Plinabulin and strategic developments related to its equity interest in SEED Therapeutics ("SEED").

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2025: Clinical and Operational Progress
"2025 was a year of important clinical and operational progress for BeyondSpring and SEED Therapeutics," said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer of BeyondSpring. "We advanced our Phase 3 Plinabulin program, generated meaningful clinical data, and strengthened our strategic and financial position."

"BeyondSpring made meaningful progress advancing Plinabulin in Phase 3 NSCLC, while SEED Therapeutics reached a critical milestone — initiating its first clinical trial following IND clearance in both the U.S. and China — and strengthened its leadership team and capital resources."

Positioned for 2026 and Beyond
"With a solid scientific and clinical foundation and clear regulatory pathways, we believe BeyondSpring and SEED are well positioned for the next stage of development," Dr. Huang concluded. "As we enter 2026, we remain focused on advancing the DUBLIN-4 confirmatory trial for Plinabulin in non-squamous EGFR wild-type NSCLC post immune checkpoint inhibitors, supporting SEED’s Phase 1a clinical program for ST-01156 in solid tumors, and creating long-term value for our shareholders."

Recent Clinical and Business Updates
Plinabulin Demonstrates Overall Survival Benefit in Phase 3 NSCLC Study; Confirmatory Trial Planned
There is a significant unmet need in EGFR wild-type NSCLC following immune checkpoint inhibitor (ICI) therapy, where numerous Phase 3 studies have failed to improve overall survival over standard of care docetaxel.

BeyondSpring reported positive Phase 3 results from the DUBLIN-3 study evaluating plinabulin in combination with docetaxel in second- and third-line (2/3L) EGFR wild-type non-small cell lung cancer (NSCLC). The study demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to docetaxel alone (ITT, n=559), with results published in The Lancet Respiratory Medicine.

At IASLC North America and ESMO (Free ESMO Whitepaper) Asia in December 2025, BeyondSpring presented updated data from the mechanism-targeted non-squamous NSCLC population (n=332; 24-month after database lock), in which the combination achieved:

OS hazard ratio (HR) of 0.72 (p=0.0078)
Median OS improvement of 2.5 months vs. docetaxel
Doubling of 2-year and 3-year survival rates
Favorable safety profile, reducing grade 4 neutropenia from >30% to 5% (p<0.0001)
To date, over 700 patients have been treated with plinabulin across clinical studies, supporting the characterization of its safety and tolerability profile.

Based on these findings and discussions with the U.S. FDA, BeyondSpring plans to initiate the global Phase 3 DUBLIN-4 confirmatory study, focusing on a mechanism-enriched patient population of EGFR wild-type non-squamous NSCLC progressed on prior PD-1/L1 inhibitors with overall survival as the primary endpoint (NCT07361484).

Plinabulin Shows Potential to Overcome PD-1/PD-L1 Resistance
Emerging clinical data suggests plinabulin may help address acquired resistance to PD-1/PD-L1 therapies — a major challenge affecting approximately 60% of patients, with limited therapies for these progressed patients. With PD-1/PD-L1 therapies representing a multi-billion-dollar market, addressing resistance remains one of the most significant opportunities in oncology.

Presentations at ASCO (Free ASCO Whitepaper) 2025 and SITC (Free SITC Whitepaper) 2025 on multiple early-stage and investigator-initiated studies of Plinabulin combinations:

Plinabulin + pembrolizumab + docetaxel (303 study, NCT05599789): A Phase 2 study conducted at Peking Union Hospital in China in metastatic NSCLC patients progressing on PD-1/PD-L1 inhibitors (n=47) demonstrated:
Median progression-free survival (PFS) of 7.0 months
Disease control rate (DCR) of 85% and overall response rate (ORR) of 18.2%
Median OS not reached with 24-month overall survival rate of 66%
Whole blood analysis indicated higher proportions of activated CD4+/CD8+ T-cells post treatment

Plinabulin + PD-1 inhibitor + radiation (NCT04902040): A Phase 1 study conducted at MD Anderson Cancer Center across eight tumor types resistant to checkpoint inhibitors showed:
DCR of 54% and ORR of 23%
Mechanistic evidence of dendritic cell maturation and immune activation
Identification of a potential predictive biomarker (GEF-H1 immune signature)
These findings, published in Med 2025 (Cell Press), support plinabulin’s proposed immune-priming mechanism and its potential role in combination strategies to restore tumor sensitivity to immunotherapy
BeyondSpring Business Update

In January 2025, BeyondSpring entered into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED for gross proceeds of approximately $35.4 million to advance late-stage clinical development of Plinabulin. First closing of approximately $7.35 million was completed in February 2025.
SEED Therapeutics (Reported as Discontinued Operations) Advances First Clinical Program and Strengthens Organization
SEED Therapeutics continued to make progress in 2025 and early 2026, advancing its targeted protein degradation platform and pipeline.

Key highlights include:

ST-01156, a novel oral RBM39 degrader:
Received U.S. FDA Orphan Drug and Rare Pediatric Disease Designations
Achieved IND clearance in both the U.S. and China
Dosed first patient in a Phase 1a study in January 2026
ST-01156 Phase 1a enrolling at leading U.S. cancer centers: Dana-Farber, Massachusetts General Hospital, Memorial Sloan Kettering, MD Anderson Cancer Center, Hoag, and City of Hope
Presentation at AACR (Free AACR Whitepaper) 2025 on ST-01156 mechanism and preclinical studies including complete tumor regression in Ewing sarcoma and other cancer models; new degrader approaches in KRAS G12D degradation
SEED Business Update

Completed a $30 million Series A-3 financing
Appointed Dr. Bill Desmarais as Chief Financial Officer and Chief Business Officer
Named a finalist for the 2025 Prix Galien USA "Best Start-Up" Award
Full-Year 2025 Financial Resultsˆ
Continuing operations:

R&D expenses: $4.4 million (vs. $2.6 million in 2024), driven by increased drug manufacturing, NSCLC data management, Plinabulin combination research, regulatory consulting, and personnel costs
G&A expenses: $4.6 million (vs. $6.1 million in 2024), driven by lower personnel costs, reduced consulting expenses, and lower corporate overhead
Net loss: $8.7 million (vs. $8.9 million in 2024)
Cash, cash equivalents, and short-term investments: $12.6 million as of December 31, 2025
Discontinued operations:

Net loss: $5.5 million (vs. $7.8 million in 2024)
Current assets: $8.0 million as of December 31, 2025
Note 1. As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes.

(Press release, BeyondSpring Pharmaceuticals, MAR 25, 2026, View Source [SID1234663898])

On March 25, 2026 Boehringer Ingelheim reported about key launches in its Human Pharma business in 2025, bringing two medicines with FDA Breakthrough Therapy designation for lung cancer and pulmonary fibrosis to market in the second half of 2025. Group net sales rose by 7.3%* to EUR 27.8 billion for the full year, supported by both the Human Pharma and Animal Health business. In 2025, Boehringer increased Research and Development (R&D) investments to EUR 6.4 billion, representing 22.9% of group net sales. The company reached 70 million patients in 2025, delivering innovative medicines to more patients than ever before.

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"2025 reinforced the strength of our pipeline and underscored the impact of our long-term investment in R&D. With two newly launched medicines in oncology and respiratory, we are addressing high unmet medical needs of patients, while also driving the renewal of our portfolio. Our pipeline positions us well to continue to make a real difference across important disease areas, and to bring innovative therapies to more patients than ever," said Shashank Deshpande, Chairman of the Board of Managing Directors and responsible for Human Pharma. "As 2026 unfolds with pivotal Phase III programs and readouts as well as new launches ahead, we strive to improve the lives of patients, animals, and communities worldwide."

Frank Hübler, Member of the Board of Managing Directors responsible for Finance, added: "In volatile markets and amid regional challenges, our business proved resilient as we focused on what we do best: bringing more medicines to patients and animals. We are investing more than ever in innovation, which reflects our ambition for the next years."

Human Pharma: JARDIANCE (empagliflozin) and OFEV (nintedanib) continue to grow; HERNEXEOS and JASCAYD launched

Human Pharma sales rose 7.4%* to EUR 22.7 billion, supported by strong performance in its core brands. JARDIANCE, for the treatment of chronic kidney disease, type 2 diabetes and heart failure, grew 8.7%* to EUR 8.8 billion. Sales for OFEV, used to treat idiopathic pulmonary fibrosis and other progressive fibrosing interstitial lung diseases, increased 5.4%* to EUR 3.8 billion.

Boehringer Ingelheim expanded its portfolio with the launch of two innovative therapies in 2025: HERNEXEOS, an oral treatment for HER2-mutant advanced non-small cell lung cancer, was launched in the U.S. in August 2025. The company also launched JASCAYD, which was approved in the U.S. and China for idiopathic pulmonary fibrosis (IPF) in October 2025, and for progressive pulmonary fibrosis (PPF) in December 2025. JASCAYD represents the first new innovative therapy for IPF coming to market in more than a decade.

Human Pharma R&D investments came in at EUR 5.8 billion or 27.4% of the unit’s net sales. The company continued to advance its pipeline across cardiovascular, renal and metabolic diseases (CRM), oncology, respiratory and immunology, mental health, and eye health. The pipeline today includes more than 80 projects, representing over 50 new molecular entities. Ongoing advances in Boehringer’s growing mid‑ and late‑stage pipeline are building towards a sustained wave of potential launches, positioning the company to deliver transformative impact for patients in the years to come.

Animal Health: preventing the spread of transboundary animal diseases

In 2025, the Animal Health business demonstrated resilience and impact, with sales rising 6.5%* to EUR 4.9 billion. Growth was driven by pet parasiticides and therapeutics, poultry, and ruminant segments, with NEXGARD growing 8.5%* to EUR 1.4 billion, cementing its position as the industry’s top-selling parasiticide brand.

The company worked side by side with farmers, veterinarians, and governments, to help combat livestock diseases such as avian influenza, foot-and-mouth disease, and bluetongue virus. Boehringer received EU Marketing Authorization under Exceptional Circumstances for two poultry vaccines, supporting producers in keeping their poultry flocks healthy and increasing preparedness for avian influenza outbreaks. In addition to the VAXXINACT H5 avian influenza vaccine, VAXXITEK HVT+IBD+H5 is a new trivalent vaccine protecting chickens and turkeys against Marek’s disease, Infectious Bursal Disease and H5 avian influenza.

Outlook

In 2026, Boehringer expects to build on the momentum of recent years with continued progress across the Animal Health and Human Pharma pipelines and critical inflection points particularly in CRM, oncology and eye health.

(Press release, Boehringer Ingelheim, MAR 25, 2026, View Source [SID1234663883])

On March 25, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the signing of a large-scale Manufacturing Supply Agreement for copper-64 with Theragenics.

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The agreement relates to Theragenics’ 134,000 square foot production facility with a fleet of 14 cyclotrons close to Atlanta, Georgia, a major US transport hub, for centralised, large-scale copper-64 (Cu-64 or 64Cu) production ahead of anticipated 64Cu-SAR-bisPSMA commercial launch upon successful completion of Clarity’s Phase III registrational trials with this product, AMPLIFY1 and CLARIFY2, and subsequent US Food and Drug Administration (FDA) New Drug Application (NDA) approval.

Theragenics have substantial cyclotron expertise with 40 years of routine radiometal production and considerable experience in production of radioisotopes for medical use. Combined with a sizeable fleet of high-current cyclotrons, this constitutes an opportunity for large-scale copper-64 manufacturing at the site. Theragenics have capacity to produce around 100Ci (3.7 TBq) of copper-64 per day on a single cyclotron, which translates into around 2,000 patient doses per day on each cyclotron at 200 MBq per dose with a 48-hour shelf life. Together with Clarity’s existing copper-64 supply agreements with SpectronRx and Nusano, this agreement with Theragenics further enhances Clarity’s broad network of high-volume copper-64 manufacturers in distinct US geographies. The network is designed to support commercial-scale demand across multiple large oncology indications with secure, seamless and abundant supply of this diagnostic isotope, made possible with the 12.7-hour half-life of copper-64, which is unique in the radiopharmaceutical commercial space.

Mark Pugh, CEO of Theragenics, commented, "We are excited to enter into this Manufacturing Supply Agreement for copper-64 with Clarity. Having a current commercial sales force in prostate cancer, we have a deep insight into this field and have seen the excitement from key opinion leaders around 64Cu-SAR-bisPSMA. This agreement continues our expansion into the contract manufacturing organisation (CMO) isotope market, and we see Clarity as an ideal partner to advance this vision. Clarity is in a unique position with two diagnostic Phase III trials nearing completion, three Fast Track Designations (FTDs) from the US FDA and impressive data generated to date. With our core expertise and experience in producing radiometals for commercial medical purposes at Theragenics, together we can expand access to radiopharmaceuticals and bring a next-generation platform to patients in need of better diagnostics in the US."

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "Clarity is closer than ever to commercialisation of 64Cu-SAR-bisPSMA, with outstanding data recently released from the head-to-head Co-PSMA investigator-initiated trial3 and our announcement on achieving our target number of participants in the Phase III AMPLIFY trial just months since imaging the first patient4.

"The growing body of scientific evidence, along with the FTDs from the FDA are providing great momentum for 64Cu-SAR-bisPSMA. Building out a secure, reliable and abundant supply and manufacturing strategy is now coming into play, ensuring a solid base for our commercial launch and accelerated market expansion, subject to FDA approval. Our team is committed to continue working closely with our vendors, clinicians, participating clinical trial sites, regulatory agencies and supply and manufacturing facilities to get 64Cu-SAR-bisPSMA to patients in need as soon as possible, at scale to meet the future demand.

"The longer half-life of copper-64 (12.7 hours vs. less than 2 hours for the radionuclides currently used in prostate-specific membrane antigen [PSMA] positron emission tomography [PET], i.e. gallium-68 and fluorine-18) translates into a shelf-life of up to 48 hours for 64Cu-SAR-bisPSMA. As such, copper-64 offers greater flexibility for supply and scheduling of patients, overcoming various limitations of the short half-life isotopes currently used in radiodiagnostics. This represents a unique opportunity to implement a multi-tiered service approach comprising of large, local, centralised manufacturing with broad geographic distribution. Importantly, we have the opportunity to avoid the excessive costs, waste and inefficiencies associated with the supply and manufacture of short half-life isotopes. Our goal is to take the industry in a new direction of scalability and profitability while delivering universal access to radiodiagnostics for physicians and the patients they serve.

"Theragenics has decades of experience in the commercial production of radiometals for medical purposes and valuable insight into the prostate cancer field based on their existing brachytherapy business. We look forward to working with them as we prepare to take the next steps in our development."

The Manufacturing Supply Agreement is effective as of 25 March 2026. Cancellation and extension provisions are aligned with industry standard rates.

(Press release, Clarity Pharmaceuticals, MAR 25, 2026, View Source [SID1234663861])

On March 24, 2026 WuXi Biologics (Cayman) Inc. ("WuXi Biologics" or "the Group", stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions for biologics discovery, development and manufacturing, reported audited results for the year ended December 31, 2025 ("Reporting Period").

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Financial Highlights

Revenue: Revenue increased 16.7% YoY to RMB21.8 billion, driven by continued execution of the Group’s "Follow and Win the Molecule" strategy, rising demands for complex biologics modalities including bispecific antibodies and ADCs, growing Research Services partnerships, and higher utilization of existing and newly expanded manufacturing capacity, including the ramp-up of the Group’s European facility.

Gross Profit and Gross Profit Margin: IFRS gross profit increased 30.9% YoY to RMB10.0 billion, with gross margin expanding 500 bps to 46.0%. Adjusted gross profit rose 25.5% YoY to RMB10.6 billion, with adjusted gross margin of 48.8%. Margin expansion was primarily driven by favorable business mix, higher capacity utilization, and efficiency gains from WBS and digitalization initiatives.

EBITDA and EBITDA Margin: EBITDA grew 38.1% YoY to RMB9.0 billion, while adjusted EBITDA increased 22.8% YoY to RMB9.8 billion. EBITDA margin reached 41.5%, with adjusted EBITDA margin expanding to 45.1%.

Net Profit and Net Profit Attributable to Owners of the Company: IFRS net profit rose 45.3% YoY to RMB5.7 billion, while net profit attributable to owners of the Company grew 46.3% to RMB4.9 billion. These increases were primarily driven by the higher gross profits and the gains from the Group’s investment portfolio.

Adjusted Net Profit and Adjusted Net Profit Attributable to Owners of the Company: Adjusted net profit increased 22.0% YoY to RMB6.6 billion, while adjusted net profit attributable to owners of the Company rose 17.9% YoY to RMB5.6 billion.

Earnings Per Share (EPS): Basic EPS rose 48.8% to RMB1.22 (2024: RMB0.82). Diluted EPS advanced 48.7% to RMB1.16 (2024: RMB0.78)

Adjusted Earnings Per Share (Adjusted EPS): Adjusted basic EPS increased 19.7% to RMB1.40 (2024: RMB1.17), while adjusted diluted EPS reached RMB1.33, up 18.8% from RMB1.12 in the prior year.

Business Highlights

Integrated Project Adds
The Group added a record-high of 209 new integrated projects in 2025, bringing the total pipeline to 945 programs. Approximately half of the new additions originated from U.S. clients, reflecting strong momentum from the U.S. biopharma sector. With 74 late-stage and 25 commercial projects, the Group is well positioned to drive sustained manufacturing revenue growth.

Of the 209 new additions, 23 programs were post-IND wins under the Group’s "Win-the-Molecule" strategy, including 6 late-stage programs, bringing total "Win-the-Molecule" projects to 112 since 2018.

Research
Research Services delivered another phenomenal year in 2025, generating record-high upfront and total payments, and securing potential milestone and royalties over US$4 billion.

CD3 T-cell engager (TCE) partnerships continued to expand during the year, reflecting growing industry adoption of the Group’s leading CD3 platform. The platform has been adopted by many leading biopharma companies, including Vertex, Merck, GSK and Sino Biopharmaceutical.

As of year-end 2025, Research Services supported 50+ active programs eligible for milestone payments and sales royalties, providing a growing base of high-margin long-term revenue potential.

Development
The Group supported 156 IND filings in 2025, and expanded capacity to 200 INDs and 20 BLAs/MAAs annually. It also added a record number of new development projects in 2025. Bispecifics and ADCs accounted for 2/3 of new additions, with each modality growing by approximately 30% to 196 and 252 programs, respectively. Complex modalities now represent more than half of the entire project portfolio, reflecting sustained momentum in next-gen biologics and the Group’s leading market position.

Leveraging its integrated R-D-M capabilities, bi- & multi-specifics have emerged as the Group’s fastest growing modality, contributing nearly 20% of total revenue in 2025 and delivering 120%+ YoY growth. To support continued pipeline growth, the Group has expanded regulatory submission capacity to support approximately 200 INDs and 20 BLAs/MAAs annually.

During the Reporting Period, the Group introduced WuXia TrueSite, a targeted-integration CHO cell line platform that enables 6-month DNA-to-IND timelines, while delivering 8+ g/L mAb titers and >99% expression stability across 60 generations. The Group also expanded its high-dose drug delivery capabilities for clinical and commercial applications, including WuXiHighTM high-throughput formulation development, hyaluronidase co-formulation, and large-volume device solutions, further broadening their addressable commercial opportunities.

Manufacturing
In 2025, the Group supported 74 Phase III projects and 25 commercial manufacturing projects, completed 28 PPQs (process performance qualification), and has 34 PPQs scheduled for 2026 based on contracts as of Dec 31, 2025. The Group maintained a 100% PPQ campaign success rate, demonstrating consistent execution and a robust large-scale manufacturing quality system.

To support the expanding commercial pipeline and enhance global supply resilience, the Group continues to advance its "Global Dual Sourcing" strategy, scaling integrated CRDMO capabilities across geographies, while expanding its manufacturing footprint globally.

U.S.: Construction of MFG11 in Worcester, MA is progressing. Upon completion, the facility will feature six 6,000L single-use bioreactors, a dedicated downstream line, and extensive automation. MFG18 in Cranbury, NJ is also being upgraded to add commercial manufacturing capabilities in response to the strong local demands.
Singapore: Construction of a new modular drug product (DP) facility has commenced and is expected to be one of the largest modular biologics DP facilities globally, significantly enhancing the Group’s end-to-end DP service capabilities. The design of a modular drug substance (DS) facility is also underway. In addition, WuXi XDC’s Singapore site achieved mechanical completion in June 2025.
Qatar: In December 2025, the Group signed a MOU with the Qatar Free Zones Authority (QFZ), advancing plans to establish the Qatar site as a strategic hub within its global CRDMO network and extend its geographic presence into the Middle East.

Backlog
As of December 31, 2025, total backlog stood at US$23.7 billion, including US$11.5 billion service backlog and US$12.2 billion potential milestones. Backlog within 3 years reached US$4.5 billion, providing strong visibility into near-term revenue growth.

Quality
The Group maintains a comprehensive global quality management system to support clients’ regulatory and compliance requirements. From 2017 to 2025, the Group has completed 46 regulatory inspections by major national authorities, including 22 by the U.S. FDA and EU EMA, with no critical issues and zero data integrity findings.

As of December 31, 2025, the Group maintains a 100% pass rate for FDA Pre-License Inspection (PLI) and has passed more than 1,800 client GMP audits, including 230+ conducted by EU Qualified Persons, demonstrating consistent quality and compliance standards across global operations.

(Press release, WuXi Biologics, MAR 24, 2026, View Source [SID1234669264])

On March 24, 2026 Callio Therapeutics, a biotherapeutics company advancing dual-payload antibody-drug conjugates (ADCs) with a targeted, multi-mechanism approach to cancer treatment, reported that the first patient has been dosed in a Phase I clinical trial evaluating CLIO-8221 in patients with advanced HER2-expressing solid tumors. CLIO-8221 is a novel, first-in-class dual-payload ADC targeting HER2, engineered for targeted delivery of two payload classes: a topoisomerase 1 (Topo1) inhibitor and an ATR inhibitor, to HER2-expressing tumors.

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The Phase I clinical trial (NCT07300943) is ongoing in Australia and the U.S., with Callio Therapeutics having received IND clearance from the U.S. Food and Drug Administration (FDA) this month. The IND is also under review by the China National Medical Products Administration (NMPA), and the trial is expected to expand to multiple sites in China.

"Dosing the first patient in the Phase I trial in Australia and receiving IND clearance from the U.S. FDA are significant steps in our commitment to advancing dual-payload ADCs for patients with cancer," said Piers Ingram, Ph.D., Chief Executive Officer of Callio Therapeutics. "CLIO-8221 is the first program from Callio’s dual-payload ADC pipeline to enter the clinic, achieved in just a year from our launch. We believe this dual-payload ADC approach represents a promising new modality for multi-mechanism targeted cancer treatment."

"CLIO-8221 uses a potent combination of two complementary anti-cancer payloads to address a common mechanism that causes resistance to single-payload ADCs. In preclinical models, CLIO-8221 demonstrated compelling anti-tumor activity, with a single dose leading to tumor regression in both Topo1 inhibitor-insensitive and -refractory models and was significantly more effective than single-payload ADCs," said Jerome Boyd-Kirkup, Ph.D., Chief Scientific Officer of Callio Therapeutics. "Callio is actively developing a pipeline of promising dual-payload ADCs with rationally selected payload combinations. We are excited to move this pipeline into clinical trials in the upcoming months."

"We are committed to improving treatment options for patients and are excited to take this step with CLIO-8221," said Naomi Hunder, M.D., Chief Medical Officer of Callio Therapeutics. "CLIO-8221 represents a major advance in ADC technology, combining the validated cytotoxic payload exatecan with an ATR inhibitor payload. For patients whose cancers have become resistant or do not respond to existing Topo1 inhibitor-based ADCs, this dual-payload approach offers a new potential treatment option. Patients may also benefit from improved safety, as our next-generation linker platform is designed to reduce toxicities, consistent with the broad therapeutic window observed in preclinical studies."

About CLIO-8221

HER2 is a clinically validated target for antibody-drug conjugates (ADCs), with multiple approved therapies demonstrating meaningful benefit across tumor types, however, most patients eventually progress on treatment despite retaining HER2 expression. Mechanistic resistance to cytotoxic payloads has emerged as a key reason for treatment failure. CLIO-8221 is a novel, first-in-class dual-payload ADC targeting HER2, designed to address this challenge.

CLIO-8221 delivers two mechanistically complementary payloads, a topoisomerase 1 (Topo1) inhibitor and an ATR inhibitor, directly to HER2-expressing tumors. While Topo1 inhibitors have shown strong clinical activity, activation of the DNA damage response following Topo1 inhibitor-induced replication stress represents a potential major driver of resistance. By simultaneously inhibiting Topo1 and blocking the DNA damage response through ATR inhibition, CLIO-8221 is engineered to overcome payload insensitivity and sensitize tumors to Topo1 inhibition. Developed using proprietary linker and ADC platform technologies, CLIO-8221 aims to maximize anti-tumor activity while reducing systemic toxicity, offering the potential for deeper and more durable responses in patients who have progressed on existing HER2-targeted therapies.

(Press release, Callio Therapeutics, MAR 24, 2026, View Source [SID1234663888])