What changed in this filing

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Item 1. Business

2026-03-31 compared with 2025-03-31 · 112 added, 82 removed, 530 unchanged (27% of the section changed)

Connect Biopharma, headquartered in San Diego, California, is a clinical-stage biopharmaceutical company focused on advancing rademikibart, a potentially best-in-class next generation anti-interleukin-4-receptor alpha (“IL-4Rα”) antibody, to transform acute and chronic care in asthma and chronic obstructive pulmonary disease (“COPD”).

Connect Biopharma, headquartered in San Diego, California, is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and chronic obstructive pulmonary disease (“COPD”).

The Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target interleukin-4-receptor alpha (“IL-4Rα”).

Significant Unmet Need and Market Opportunity in Asthma

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Approximately 50% of asthma patients who visit emergency departments meet treatment failure criteria within four weeks of an exacerbation.

Approximately 20% of such patients require a re-visit to the emergency department.

Approximately 20% of such patients require a re-visit to the emergency department and an additional approximately 30% require medical care from another source, such as urgent care or medical clinics.

Current standard of care treatment for these patients includes fast-acting inhaled bronchodilators and oral or intravenous (“IV”) corticosteroids.

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Blockade of the IL-4 and IL-13 binding to the IL-4R a results in inhibition of both the IL-4 and IL-13 signaling.

Rademikibart binds to a region of the IL-4Rα that is

associated with high binding affinity and potency for IL-4Rα, which we believe may lead to an improved clinical response and possible differentiating safety profile for this class of medication.

We are focused on advancing rademikibart for treatment of eosinophilic driven respiratory diseases supported by results of the completed global asthma trial CBP-201-WW002 (see the Asthma Global Phase 2b Trial Results section below for further details on this trial ) .

Although no head-to-head trials have been conducted, and data from unrelated clinical trials cannot reliably be compared due to differences in trial designs, site locations, subject characteristics and other factors, in cross-study comparisons rademikibart demonstrated greater Forced Expiratory Volume in One Second (“FEV 1 ”) response than seen in clinical trials of currently approved biologics using the initial protocol-specified baseline eosinophils > 150 cells/µL.

Rademikibart binds to a region of the IL-4Rα that is associated with high binding affinity and potency for IL-4Rα, which we believe may lead to an improved clinical response and possible differentiating safety profile within this class of medication.

We are focused on advancing rademikibart for treatment of eosinophilic driven respiratory diseases with a specific focus on treatment of acute exacerbations of asthma and COPD.

To address this unmet need, in May 2025 we initiated two Phase 2 trials of rademikibart for the treatment of acute exacerbations of asthma and COPD.

The Phase 2 acute asthma trial, Seabreeze STAT ASTHMA , and the acute COPD trial, Seabreeze STAT COPD , are evaluating rademikibart plus Standard of Care (“SoC”) compared to SoC plus placebo in patients with asthma or COPD and Type 2 inflammation who are having an acute exacerbation.

The primary endpoint of these two trials is treatment failure over 28 days after randomization.

Treatment failure includes:

death (any cause), (re)admission to the hospital, an urgent visit to an outpatient or emergency department provider for symptoms that are worsening, or the necessity to intensify pharmacologic treatment.

Key secondary efficacy endpoints of these trials include the rate of new exacerbations, time to the first new exacerbation, change in symptoms, and change in lung function in the 28 days after randomization.

Exploratory endpoints include time-to-discharge in hospitalized patients and disease-specific patient-reported outcomes.

We expect to report topline data for our ongoing Phase 2 acute exacerbation studies in mid-2026.

In April 2025, we announced feedback from our Type C meeting with the FDA, Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation.

We obtained the FDA’s alignment on the design of our two parallel Phase 2 trials evaluating rademikibart in patients experiencing an acute exacerbation of asthma or COPD.

This treatment setting is of particular interest because available SoC therapy in the acute setting shows insufficient long-term treatment effect on symptoms and lung function, with frequent exacerbations leading to re-visits by patients to the acute care setting for respiratory critical care treatment.

Preventing and delaying recurrent exacerbations in the first 28 days following an exacerbation is a significant unmet medical need and a crucial therapeutic goal in asthma and COPD.

Despite current guideline recommendations, treatment with systemic corticosteroids and antibiotics is not wholly adequate.

In January 2026, we announced new in vitro and preclinical mechanism of action data providing mechanistic support for rademikibart’s potentially differentiated efficacy and safety profile, compared to what has been observed for dupilumab, and providing a potential basis for the large and rapid improvement in Forced Expiratory Volume in One Second (“FEV 1 ”) observed in the Company’s previously completed Phase 2b global chronic asthma study.

In March 2026, the Company announced positive topline data from its Phase 1 clinical pharmacology study of IV rademikibart in patients with stable asthma or COPD.

Rademikibart administered as a single 300 mg 2-minute IV push to asthma and COPD patients produced rapid improvement in FEV 1 with many patients experiencing improvements in airway function of ≥200 mL as early as 15 minutes post-dosing.

The rapid improvement in FEV 1 demonstrated with IV rademikibart in this study provides clinical confirmation of preclinical observations that rademikibart has a unique beneficial effect on bronchodilation.

Mean FEV 1 improvements of ~200 - 400 mL were maintained through Day 29 in asthma and COPD patients.

Rademikibart was generally well-tolerated in asthma and COPD patients.

Our current development plan is supported by the results from the completed global asthma trial CBP-201-WW002 (see the Asthma Global Phase 2b Trial Results section below for further details on this trial ) .

Although no head-to-head trials have been conducted, and data from unrelated clinical trials cannot reliably be compared due to differences in trial designs, site locations, subject characteristics and other factors, in cross-study comparisons rademikibart demonstrated greater FEV 1 response than seen in clinical trials of currently approved biologics using the initial protocol-specified baseline eosinophils > 150 cells/µL.

The prespecified analysis of patients with baseline eosinophils > 300 cells/µL showed greatest clinical response.

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alone who visit an emergency department for acute exacerbations annually.

Millions more patients experience exacerbations, but are treated in the outpatient setting.

In our completed Phase 2 asthma clinical trial, rademikibart has demonstrated encouraging efficacy and safety data, as well as rapid onset of action in less than 24 hours.

As described above, approximately 50% of both asthma and COPD patients who are treated with Standard of Care (“SoC”) will meet the criteria for treatment failure within four weeks of an exacerbation and approximately 11%-20% will return for emergency care.

To address this unmet need, during the first half of 2025, we plan to initiate two Phase 2 trials of rademikibart for the treatment of acute exacerbations of chronic respiratory disease, including asthma and COPD.

The Phase 2 acute asthma trial, Seabreeze ASTHMA STAT , and the acute COPD trial, Seabreeze COPD STAT will evaluate rademikibart plus SoC compared to SoC plus placebo in patients with asthma and COPD and Type 2 inflammation who are having an acute exacerbation.

The primary endpoint of these two trials is treatment failure over 28 days after randomization.

Treatment failure includes:

The key secondary efficacy endpoints of these trials are the rate of new exacerbations, the time to the first new exacerbation, change in symptoms, and change in lung function in the 28 days after randomization.

Exploratory endpoints of these trials include time-to-discharge in hospitalized patients, and disease-specific patient-reported outcomes.

more patients experience exacerbations, but are treated in the outpatient setting.

In our completed Phase 2 asthma clinical trial, rademikibart has demonstrated encouraging long-term (6 month) efficacy and safety data, as well as rapid onset of action in less than 24 hours.

The ability to treat from acute to chronic administration is important because as described above, approximately 50% of both asthma and COPD patients who are treated with SoC will meet the criteria for treatment failure within four weeks of an exacerbation and approximately 11%-20% will return for emergency care.

We have also undertaken a study to determine differences in the atomic-resolution three dimensional (“3D”) structures of rademikibart and dupilumab, that may potentially lead to an understanding of the differences in efficacy and safety between the two drugs.

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These data provide a molecular and structural rationale for the enhanced IL-4Rα inhibition by rademikibart over dupilumab and may provide an insight into the different safety profile.

In 2024, the initial manufacturing process for rademikibart was successfully transferred to a U.S.

contract manufacturing organization (“CMO”).

In 2023, we entered into an exclusive License and Collaboration Agreement (the “License Agreement”), with Simcere Pharmaceutical Co., Ltd (“Simcere”) to develop and commercialize rademikibart in Greater China.

Under the terms of the License Agreement, Simcere has been granted exclusive rights to develop, manufacture and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau and Taiwan, while Connect retains the rights in all other markets.

Under the License Agreement, Simcere will be responsible for

rademikibart’s BLA for Atopic Dermatitis (“AD”) and asthma in China and will also conduct and be responsible for the costs of all future clinical studies in all additional disease indications for rademikibart Simcere pursues in Greater China.

Under the License Agreement, Simcere will be responsible for rademikibart’s BLA for Atopic Dermatitis (“AD”) and asthma in China and will also conduct and be responsible for the costs of all future clinical studies in all additional disease indications for rademikibart Simcere pursues in Greater China.

As of December 31, 2025, we had received the full upfront payment of $21 million, as well as $6.5 million for the achievement of certain development milestones and cost reimbursements.

We remain eligible for additional significant milestone payments and royalties under the License Agreement.

In July 2025, Simcere submitted its New Drug Application for rademikibart to the NMPA of China for the treatment of AD in adults and adolescents.

As a part of the License Agreement, we are eligible to receive remaining milestone payments up to an aggregate amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones.

We are also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China.

The AD market in China represents considerable opportunity, with an estimated 70 million patients with AD.

In March 2026, the Company announced the results of a Phase 3 study of rademikibart in moderate-to-severe AD conducted by Simcere.

In this study, rademikibart achieved rapid, durable efficacy results across all key endpoints through 52 weeks, with near-maximal responses achieved in ~90% of patients.

Rademikibart was well tolerated with safety similar to placebo at 16 weeks and lower conjunctivitis than other agents in the class.

Simcere presented the data in the Late-Breaking Research session at the 2026 American Academy of Dermatology Annual Meeting.

In March 2025, we announced the publication of positive data from our global Phase 2 trial of rademikibart in patients with moderate-to-severe uncontrolled asthma in the American Journal of Respiratory and Critical Care Medicine .

These data highlight rademikibart’s potential as a novel biologic treatment option for patients with asthma and Type 2 inflammation, demonstrating rapid onset of action, sustained improvement in FEV 1 and clinically important reductions in annual exacerbation rates.

During the second quarter of 2025, we presented clinical and preclinical data supporting the development of rademikibart at the American Thoracic Society 2025 International Conference and the European Academy of Allergy and Clinical Immunology 2025 Annual Congress.

In this data analysis, rademikibart was observed to significantly improve airway function, as measured by FEV 1 , within a day and significantly reduce acute exacerbations in patients with inflammation-mediated chronic asthma, which we believe strongly supports ongoing Phase 2 acute exacerbation studies in asthma and COPD described above.

In addition, we believe that the preclinical data presented demonstrates rademikibart’s differentiated structural and molecular dynamics, including potentially enhanced IL-4Rα inhibition compared to dupilumab.

These findings provide a molecular basis for the distinct efficacy and safety data observed with rademikibart.

During the third quarter of 2025, we presented data supporting the development of rademikibart at the European Respiratory Society Congress 2025.

Rapid and significant improvement in lung function and asthma control was observed across a broad range of type 2 inflammatory markers with the greatest improvements observed in those with elevated

baseline levels of blood eosinophil counts of ≥300 cells/μL and fractional exhaled nitric oxide levels of > 25 ppb.

We believe this data supports our ongoing Phase 2 acute exacerbations studies in asthma and COPD described above.

In September 2025, the results from a one-year AD study with rademikibart was published in the British Journal of Dermatology.

In addition to producing significant improvement in all key measures of AD, the study also showed that administration of rademikibart every 4-weeks was equivalent to every 2-week administration during the maintenance period out to 52-weeks.

Asthma Global Phase 2b Trial Results

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Atopic Dermatitis Clinical Trial Results

Although Connect has decided to not currently pursue further development of rademikibart for AD, the results of the completed Phase 2, randomized, placebo-controlled studies in participants with AD provides support for the chronic asthma and COPD programs and the opportunity to potentially use rademikibart in a Q4W regimen.

AD is a chronic inflammatory skin condition that affects millions of patients worldwide.

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We completed a global Phase 2 trial (CBP-201-WW001) of rademikibart in adult patients with moderate-to-severe AD conducted at 46 sites in 4 countries (U.S., Australia, New Zealand, and China), designed to assess efficacy and safety with various rademikibart doses and dosing schedules.

A total of 226 patients were enrolled (1:1:1:1) with rademikibart groups receiving one loading dose of 600 mg followed by 150 mg every two weeks (“Q2W”), 300 mg Q2W or 300 mg every four weeks (“Q4W”) for 16 weeks.

A total of 226 patients were enrolled (1:1:1:1) with rademikibart groups receiving one loading dose of 600 mg followed by 150 mg every two weeks (“Q2W”), 300 mg Q2W or 300 mg Q4W for 16 weeks.

The placebo group received a matching placebo loading dose followed by placebo Q2W.

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The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary and novel products and product candidates.

While we believe that our technology, the expertise of our executive and scientific team, research, clinical capabilities, development experience,

scientific knowledge and intellectual property provide us with competitive advantages, we face increasing competition from many different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and provide research institutions.

While we believe that our

technology, the expertise of our executive and scientific team, research, clinical capabilities, development experience, scientific knowledge and intellectual property provide us with competitive advantages, we face increasing competition from many different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and provide research institutions.

Our competitors have developed, are developing or may develop products or product candidates competitive with our Product Candidates.

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Our policy is to seek to protect our proprietary position by, among other methods, filing patent applications in the U.S., the PRC and in other jurisdictions outside of the U.S.

related to our proprietary technology, inventions, improvements and Product Candidates that are important to the development and implementation of our business.

We also rely on trade secrets and know-how

relating to our proprietary technology and Product Candidates, and we may in the future rely on in-licensing opportunities, to develop, strengthen and maintain our proprietary position in our field.

related to our proprietary technology, inventions, improvements and Product Candidates

that are important to the development and implementation of our business.

We also rely on trade secrets and know-how relating to our proprietary technology and Product Candidates, and we may in the future rely on in-licensing opportunities, to develop, strengthen and maintain our proprietary position in our field.

Our success depends in part on our ability to obtain and maintain patent, trade secret, trademark and other intellectual property and proprietary protection for our Product Candidates, proprietary technologies and their uses, as well as our ability to operate without infringing upon, misappropriating or otherwise violating the intellectual property and proprietary rights of others.

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patents, one pending U.S.

patent application, over 10 foreign patents issued in such jurisdictions as China, Israel, Korea, Singapore, and others, and over five foreign patent applications pending in such jurisdictions as Europe, Canada, and Brazil.

patent application, over 28 foreign patents issued in such jurisdictions as China, Israel, Korea, Singapore, and others, and over seven foreign patent applications pending in such jurisdictions as Europe, Canada, and Brazil.

Not accounting for any patent term adjustment or extensions or terminal disclaimers, and assuming that all applicable annuity and/or maintenance fees are paid timely, the issued patents, and, if granted, the pending patent applications in this family, are expected to expire in 2037.

We also own a patent family with claims directed to formulations of rademikibart that includes a pending U.S.

patent application, at least five foreign patents issued in such jurisdictions as China, Taiwan, and South Africa, and over 15 foreign patent applications pending in such jurisdictions as Europe, Canada, Brazil, and others.

patent application, at least nine foreign patents issued in such jurisdictions as China, Taiwan, and South Africa, and over 17 foreign patent applications pending in such jurisdictions as Europe, Canada, Brazil, and others.

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The PCT searching authority performs a patentability search and issues a non-binding patentability opinion which can be used to evaluate the chances of success for the national or regional applications prior to having to incur the filing fees and prosecution costs.

Although a PCT application does not issue as a patent, it allows the applicant to seek protection in any of the member states through national/regional-phase applications.

At the end of the period of two and a half years from the

first priority date of the patent application, separate patent applications can be pursued in any of the PCT member states either by direct national filing or, in some cases by filing through a regional patent organization, such as the European Patent Organisation.

Although a PCT application does not issue as a patent, it allows the applicant to seek protection in any of

the member states through national/regional-phase applications.

At the end of the period of two and a half years from the first priority date of the patent application, separate patent applications can be pursued in any of the PCT member states either by direct national filing or, in some cases by filing through a regional patent organization, such as the European Patent Organisation.

The PCT system delays expenses, allows a limited evaluation of the chances of success for national/regional patent applications and enables substantial savings where applications are abandoned within the first two and a half years of filing.

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Regulation of Drugs and Biologics

In the U.S., the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and its implementing regulations, and biologics under the FDCA and the Public Health Service Act (“PHSA”), and its implementing regulations.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.

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generally involves the following:

• completion of extensive preclinical laboratory tests and preclinical animal studies, certain of which must be performed in accordance with Good Laboratory Practice (“GLP”) regulations and other applicable requirements;

• completion of extensive preclinical laboratory tests and preclinical animal studies, certain of which must be performed in accordance with Good Laboratory Practice regulations and other applicable requirements;

• submission to the FDA of an investigational new drug application (“IND”), which must become effective before human clinical studies may begin;

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• a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;

• satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the proposed product is produced to assess compliance with current Good Manufacturing Practices (“cGMP”), and potential FDA inspection of nonclinical study and clinical trial sites that generated the data in support of the NDA or BLA to ensure compliance with GCP;

• satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the proposed product is produced to assess compliance with cGMP, and potential FDA inspection of nonclinical study and clinical trial sites that generated the data in support of the NDA or BLA to ensure compliance with GCP;

• FDA review and approval of an NDA or BLA prior to any commercial marketing or sale of the drug in the U.S.

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Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed.

Regulatory authorities, such as the FDA, may impose a partial or full clinical hold, or the IRB or the

sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives.

Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to some data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy.

Regulatory authorities, such as the FDA, may impose a partial or full clinical hold, or the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives.

Some studies also include oversight

by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to some data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy.

There are also requirements governing the reporting of ongoing preclinical studies and clinical trials and clinical study results to public registries.

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Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of the product, or from a number of alternative sources, including studies initiated and sponsored by investigators.

submission of an NDA or BLA requires payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.

The submission of an NDA or BLA requires payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.

In addition, under the Pediatric Research Equity Act (“PREA”), an NDA or BLA or supplement to an NDA or BLA must contain data to assess the safety and effectiveness of the biological product candidate for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is deemed safe and effective.

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For example, the fast track program is intended to expedite or facilitate the process for reviewing product candidates that meet specific criteria.

Specifically, product candidates are eligible for fast track designation if they are intended to treat a serious

or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

Specifically, product candidates are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

Fast track designation applies to the combination of the product candidate and the specific indication for which it is being studied.

The sponsor of a fast track product candidate has opportunities for more frequent interactions with the review team during product development and, once an NDA or BLA is submitted, the application may be eligible for priority review.

The sponsor of a fast track product candidate has opportunities for more frequent interactions with the

review team during product development and, once an NDA or BLA is submitted, the application may be eligible for priority review.

A fast track product candidate may also be eligible for rolling review, where the FDA may consider for review sections of the NDA or BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA or BLA, the FDA agrees to accept sections of the NDA or BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA or BLA.

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The orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including a full NDA or BLA, to market the same drug or biologic for the same disease or condition for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or

condition for which the drug or biologic was designated.

Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition.

If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including a full NDA or BLA, to market the same drug or biologic for the same approved indication or use within such disease or condition for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity in the relevant indication or if the FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs relating to the approved indication or use of patients with the disease or condition for which the drug or biologic was designated.

Orphan drug exclusivity does not prevent the FDA from approving a different drug or

biologic for the same indication or use, or the same drug or biologic for a different indication or use.

Among the other benefits of orphan drug designation are tax credits for some research and a waiver of the NDA or BLA application user fee.

A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation.

A designated orphan drug may not receive orphan drug exclusivity if it is approved for an indication or use that is broader than the disease or condition for which it received orphan designation.

In addition, exclusive marketing rights in the U.S.

may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

Post-Approval Requirements

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In addition to regulations in the U.S., we may be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our products.

For example, clinical trials conducted in the European Union must be done under an Investigational Medicinal Product Dossier, and the oversight of an Ethics Committee.

For example, clinical trials conducted in the European Union (“EU”) must be done under an Investigational Medicinal Product Dossier, and the oversight of an Ethics Committee.

If we market our products in foreign countries, we also will be subject to foreign regulatory requirements governing marketing approval for pharmaceutical products.

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In December 2021, Regulation ((EU) 2021/2282) on HTA (“HTA Regulation”) was adopted.

While the HTA Regulation entered into force in January 2022, it currently only applies for oncology and advanced therapy medicinal product therapies, and it will begin to apply as from January 13, 2028 for orphan medicinal products and January 13, 2030 for other medicinal products.

The HTA Regulation entered into force in January 2022 and has been applicable since January 2025, with phased implementation based on the type of product, i.e., oncology and advanced therapy medicinal product therapies as of 2025, from January 13, 2028 for orphan medicinal products and January 13, 2030 for all other new medicinal products.

It particularly replaces the current system based on the voluntary network of national authorities, and the new framework covers joint clinical assessments, joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation for the national authorities.

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Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted legislation designed, among other things, to bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for pharmaceutical products.

In addition, individual states in the U.S.

have also become increasingly active in implementing regulations designed to address pharmaceutical product pricing, such as transparency measures that require the disclosure of prices, including price or patient reimbursement constraints, discounts, restrictions on specific product access and changes, marketing cost disclosure and transparency measures and, in some cases, mechanisms to encourage importation from other countries and bulk purchasing costs, and research costs, among others.

Furthermore, there has been increased interest by third party payors and governmental authorities as to pricing systems and publication of discounts and list prices for drug spending.

In August 2022, former President Biden signed into law the Inflation Reduction Act of 2022 (the “IRA”), which implements substantial changes to the Medicare program, including drug pricing reforms and changes to the Medicare Part D benefit design.

In August 2022, the Inflation Reduction Act of 2022 (the “IRA”) was signed into law, which implements substantial changes to the Medicare program, including drug pricing reforms and changes to the Medicare Part D benefit design.

Among other reforms, the IRA imposes inflation rebates on drug and biological product manufacturers for products reimbursed under Medicare Parts B and D if the prices of those products increase faster than inflation which began in 2023;

implements changes to the Medicare Part D benefit that, which began in 2025, will cap benefit annual out-of-pocket spending at $2,000, with new discount obligations for pharmaceutical manufacturers;

and, beginning in 2026, establishes a “maximum fair price” for a fixed number of pharmaceutical and biological products covered under Medicare Parts B and D following a price negotiation process with the Centers for Medicare and Medicaid Services.

implements changes to the Medicare Part D benefit that cap benefit annual out-of-pocket spending at $2,000, with new discount obligations for pharmaceutical manufacturers, which began in 2025;

and establishes a “maximum fair price” for a fixed number of pharmaceutical and biological products covered under Medicare Parts B and D following a price negotiation process with the CMS, which began in 2026.

The IRA permits the Secretary of the Department of Health and Human Services (“HHS”) to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

CMS has published the negotiated prices for the initial ten drugs, which will first be effective in 2026, and the list of the subsequent 15 drugs that will be subject to negotiation, although the drug price negotiation program is currently subject to legal challenges.

CMS published the negotiated prices for the initial ten drugs, which went into effect in 2026, and the subsequent 15 drugs, which will first be effective in 2027, as well as the next set of 15 drugs that will be subject to negotiation, although the drug price negotiation program is currently subject to legal challenges.

For that and other reasons, it is currently unclear how the IRA will be effectuated.

In July 2025, the One Big Beautiful Bill Act (the “OBBBA”) was enacted, which imposes significant reductions in the funding of the Medicaid program and restrictions for certain groups to access the ACA Marketplace.

These changes are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, and may result in an increase in the number of individuals who are unable to access health insurance benefits and medical care, either of which could adversely affect our sales of any product candidate that we commercialize.

The Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S.

President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S.

to the lowest price in a group of other countries.

In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government.

The Trump administration is also pursuing traditional regulatory pathways to impose drug pricing policies, and published two proposed regulations in December 2025, referred to as Globe and Guard.

If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing.

While the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant.

Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S.

pharmaceutical sector and our business.

In addition, pharmaceutical pricing and marketing has long been the subject of considerable discussion in Congress and among policymakers, and it is possible that Congress could enact additional laws that negatively affect the pharmaceutical industry.

In addition, individual states in the U.S.

have also become increasingly active in implementing regulations designed to address pharmaceutical product pricing, such as transparency measures that require the disclosure of prices, including price or patient reimbursement constraints, discounts, restrictions on specific product access and changes, marketing cost disclosure, drug price reporting and other transparency measures and, in some cases, mechanisms to encourage importation from other countries and bulk purchasing costs, and research costs, among others.

Some states have enacted legislation creating so-called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states.

Furthermore, there has been increased interest by third party payors and governmental authorities as to pricing systems and publication of discounts and list prices for drug spending.

We expect that the healthcare reform measures that have been adopted and may be adopted in the future, may, among other things, result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product.

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We have a policy against using Company funds for political purposes, and we incurred no costs associated with legal or regulatory fines or settlements associated with violations of bribery, corruption or anti-competitive standards.

Patient Privacy and Data Security

We are required to comply, as applicable, with numerous federal and state laws, including state security breach notification laws, state health and personal information privacy laws and federal and state consumer protection laws, and to govern the collection, use and disclosure of personal information.

Numerous states have adopted data privacy and security laws and regulations, which govern the privacy, processing and protection of consumer health-related information and other personal information.

Data Privacy and Security

Numerous state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and security of health-related and other personal information, and could apply now or in the future to our operations or the operations of our partners.

For example, in the U.S., there are federal and state laws, including data breach notification laws, health information privacy and security laws and consumer protection laws, that govern the collection, use and disclosure of personal information.

In addition, certain foreign laws govern the privacy and security of personal data, including health-related data.

Such laws and regulations are subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners.

For example, the California Consumer Privacy Act of 2018 (the “CCPA”) went into effect on January 1, 2020 and was amended by the California Privacy Rights Act on January 1, 2023 (as amended, the “CPRA”).

The CPRA creates individual privacy rights for California consumers and increases the privacy and security obligations of entities handling specific personal information.

It also provides a private right of action for data breaches which has increased the likelihood of, and risks associated with, data breach litigation and creates a statutory damages framework.

In addition, the CPRA created a new state agency to oversee implementation and enforcement efforts.

Additional compliance investment and potential business process changes may be required as the CPRA evolves and is enforced.

Similar laws have passed in several other states, and have been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the U.S.

The enactment of such laws could have potentially conflicting requirements that would make compliance challenging.

In addition, most healthcare providers who may utilize our products we may sell in the future are subject to privacy and security requirements under HIPAA and HITECH.

We are not a HIPAA covered entity, do not intend to become one, and we do not operate as a business associate to any covered entities.

Therefore, these privacy and security requirements do not apply to us.

However, we could be subject to civil and criminal penalties if we knowingly obtain individually identifiable or protected health information from a covered entity in a manner that is not authorized or permitted by HIPAA or for aiding and abetting the violation of HIPAA.

The legislative and regulatory landscape for privacy and data protection

continues to evolve, and there has been an increasing amount of focus on privacy and data protection issues with the potential to affect our business, including through affecting our customers.

The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing amount of focus on privacy and data protection issues with the potential to affect our business, including through affecting our customers.

These laws could create liability for us or increase our cost of doing business, and any failure to comply could result in harm to our reputation, and potentially fines and penalties.

In addition, state laws govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Environmental, Health and Safety Laws

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Regulations on Company Establishment and Foreign Investment

The establishment, operation and management of corporate entities in the PRC are governed by the Company Law of the PRC (the “PRC Company Law”), which was promulgated by the Standing Committee of the National People’s Congress (the “NPC”) in December 1993 and further amended in December 1999, August 2004, October 2005, December 2013, October 2018 and July 2024, respectively.

According to the PRC Company Law, companies are generally classified into two categories:

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Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others.

We are subject to a variety of financial disclosure and securities trading regulations as a public company, including laws relating to the oversight activities of the SEC and the regulations of The Nasdaq Global Market, on which our ADSs are traded.

We are also subject to various laws, regulations and recommendations relating to safe working conditions, laboratory practices and the experimental use of animals.

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The recognition and enforcement of foreign judgments are provided for under the PRC Civil Procedures Law.

PRC courts may recognize and enforce foreign judgments in accordance with the requirements of the PRC Civil Procedures Law and other applicable laws and regulations based either on treaties between the PRC and the country where the judgment is made or on principles of reciprocity between jurisdictions.

reciprocity between jurisdictions.

The PRC does not have any treaties or other form of reciprocity with the U.S.

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or in the Cayman Islands.

jurisdiction, and meet other procedural requirements, including, among others, the plaintiff must have a direct interest in the case, and there must be a concrete claim, a factual basis and a cause for the suit.

Under the PRC Civil Procedures Law, foreign shareholders may originate actions based on PRC law against a company in the PRC for disputes if they can establish sufficient nexus to the PRC for a PRC court to have jurisdiction, and meet other procedural requirements, including, among others, the plaintiff must have a direct interest in the case, and there must be a concrete claim, a factual basis and a cause for the suit.

It may be, however, difficult for U.S.

shareholders to originate actions against us in the PRC in accordance with PRC laws because we are incorporated under the laws of the Cayman Islands and it may be difficult for U.S.

shareholders, by virtue only of holding our ADSs or ordinary shares, to establish sufficient connection to the PRC for a PRC court to have jurisdiction as required under the PRC Civil Procedures Law.

shareholders, by virtue only of holding our ordinary shares, to establish sufficient connection to the PRC for a PRC court to have jurisdiction as required under the PRC Civil Procedures Law.

We have appointed Connect Biopharm LLC, as our agent upon whom process may be served in any action brought against us under the securities laws of the U.S.

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Our principal executive offices are located at 3580 Carmel Mountain Road, Suite 200, San Diego, California 92130, and our telephone number is (877) 245-2787.

Our website address is www.connectbiopharm.com .

Our website address is www.connectbiopharma.com .

We make our periodic and current reports available on our website, free of charge, as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC.

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Additional information regarding the Company, including our audited financial statements and descriptions of our business, is contained in the documents incorporated by reference in this Annual Report on Form 10-K.

Our American Depositary shares are traded on The Nasdaq Global Market, under the symbol “CNTB.”

Our ordinary shares are traded on The Nasdaq Global Market, under the symbol “CNTB.”

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business