What changed in this filing

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Item 1A. Risk Factors

2026-03-25 compared with 2025-03-27 · 56 added, 135 removed, 1581 unchanged (11% of the section changed)

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For the years ended December 31, 2025 and 2024, we reported a consolidated net loss of $14.2 million, and $16.7 million, respectively, and had an accumulated deficit of $408.4 million and $407.4 million as of December 31, 2025 and 2024, respectively.

Substantially all of our operating losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Substantially all of our operating losses have resulted from costs incurred in connection with our research and development programs and from general and administrative expenses associated with our operations.

We expect to continue to incur losses for the foreseeable future as we continue our development of, and seek regulatory approvals for, our product candidates, and begin to commercialize approved drugs, if any.

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We have financed the operations of SEED through the issuance of ordinary and preferred shares and through collaboration payments from Eli Lilly.

Through December 31, 2024, we have raised approximately $299.0 million in equity financing, $10.2 million of issuance of noncontrolling interests, $34.0 million from the sale of preferred shares of SEED, $2.1 million from bank loans, of which $0.6 million has been forgiven in July 2021 and $1.5 million has been repaid in March 2022, $2.5 million in third party loans, of which $1.0 million has since been converted into an equity investment and $1.5 million has been repaid, and $14.4 million in shareholder loans, of which $6.0 million has been repaid and $8.4 million was assumed by Wanchun Biotech, the former holding company of our U.S.

Through December 31, 2025, we have raised approximately $301.0 million in equity financing, $10.2 million of issuance of noncontrolling interests, $37.0 million from the sale of preferred shares of SEED in connection with its Series A-2/A-3 financings and $7.4 million from the sale of preferred shares of SEED by the Company to third-party investors, $2.1 million from bank loans, of which $0.6 million has been forgiven in July 2021 and $1.5 million has been repaid in March 2022, $2.5 million in third party loans, of which $1.0 million has since been converted into an equity investment and $1.5 million has been repaid, and $14.4 million in shareholder loans, of which $6.0 million has been repaid and $8.4 million was assumed by Wanchun Biotech, the former holding company of our U.S.

subsidiary, on July 20, 2015 pursuant to our internal restructuring, $10.0 million upfront payment to SEED from Eli Lilly, and approximately $31.0 million upfront payment to our partially owned subsidiary, Wanchunbulin, from Hengrui.

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Changes in funding or staffing for the FDA and other government agencies could hinder new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, payment of user fees and reauthorization of user fee programs and ability to hire and retain key personnel, as well as statutory, regulatory and policy changes, and average review times at the FDA have fluctuated in recent years as a result.

In addition, funding of other government agencies that support research and development activities that pertain to FDA review, such as research to understand new technologies or establish new standards, is subject to the political process, which is inherently fluid and unpredictable.

The current Trump administration has implemented policies that may affect the FDA review process, including efforts to downsize the federal workforce, remove job elimination protections for federal workers, limit certain communications, and potentially interfere with user fee reauthorization.

Such policy shifts, including, for example, the recent efforts to downsize the federal workforce by restructuring the U.S.

Department of Health and Human Services (HHS) and eliminating positions at the FDA and other federal agencies, including senior and mid-level leaders as well as teams critical to the FDA's ability to conduct regular inspections, reviews and other regulatory activities, such as issuing regulations and guidance for industry, may affect the timelines, conclusions, completeness or duration of the FDA review process.

In addition, HHS may change the user fee reauthorization process or fail to reauthorize user fee programs.

As a result, average review times at the FDA may fluctuate, and the outcome of any such review process may be impacted.

If political considerations or global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

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The newly revised Provisions for Drug Registration reiterate the duties owed by the market authorization holder as stipulated in the PRC Drug Administration Law and further provide that the drug approved conditionally shall be declared in the form of a supplementary application after the relevant post-marketing clinical research is accomplished.

The draft protocol and its policy interpretations provide for strengthened post-marketing supervisions for conditionally approved drugs, and state that if a drug has been conditionally approved, clinical trial applications targeting at conditional approval of similar drugs with the same mechanism, target, or indications in principle will not be approved.

The NMPA solicited comments until September 25, 2023, and as of the date of this Annual Report, there is no timeline for its enactment.

On August 24, 2023, the NMPA issued the revised draft Protocol for Review and Approval of Conditional Approval of Drugs Marketing Applications (Trial) and the policy interpretations for such protocol for public comments，and on July 7, 2025, the NMPA issued the revised draft Protocol for Review and Approval of Conditional Approval of Drugs Marketing Applications (Trial) and the policy interpretations for such protocol for public comments again.

The draft protocol and its policy interpretations provide for strengthened post-marketing supervisions for conditionally approved drugs.

The NMPA solicited comments until August 7,2025, and as of the date of this Annual Report, there is no timeline for its enactment.

Based on positive results in our two clinical trials, PROTECTIVE-1 and PROTECTIVE-2, we submitted an NDA for approval in China for the use of Plinabulin in combination with G-CSF for the prevention of CIN in March 2021.

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Plinabulin is currently being developed in combination with standard of care (SOC) agents for multiple cancer indications.

It is currently being studied in two clinical developmental programs.

It has finished in two phase 3 clinical developmental programs.

The first program is an anti-cancer therapy for second- and third- line NSCLC with EGFR wild type;

we have completed the Phase 3 trial (DUBLIN-3) with the final data published in Lancet Respiratory Medicine in September 2024.

we have completed the randomized global Phase 3 trial (DUBLIN-3) with the final data of significant benefit in OS and neutropenia reduction compared to SOC docetaxel, published in Lancet Respiratory Medicine in September 2024.

We plan to use our best efforts to file an NDA with the NMPA and potentially other regulatory agencies as soon as possible.

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A Category 1 designation also does not increase the likelihood that our product candidates will receive regulatory approval.

In August 2015, the State Council issued the Opinions on Reforming the Review and Approval Process for Drugs and Medical Devices, that contained several potential policy changes that could benefit the pharmaceutical industry:

A plan to accelerate innovative drug approval with a special review and approval process, with a focus on areas of high unmet medical needs, including innovative drugs for HIV, malignant tumors, serious infectious diseases and orphan diseases;

drugs sponsored by national science and technology major projects and national major research and development plans;

innovative drugs to be manufactured locally in China;

children’s drugs;

drugs using advanced formulation technology, using innovative treatment methods, or having distinctive clinical benefits.

A plan to adopt a policy which would allow institutions of drugs research and development to act as the marketing authorization holder.

A plan to improve the review and approval of clinical trials, and to allow the new drugs which have not been marketed in abroad to conduct clinical trials at the same time as they are being conducted in other countries and encourage domestic clinical trial institutions to participate in international multi-center clinical trials.

In November 2015, the CFDA released the Circular concerning Several Policies on Drug Registration Review and Approval, which further clarified the following policies potentially simplifying and accelerating the approval process of clinical trials:

A one-time umbrella approval procedure allowing approval of all phases of a new drug’s clinical trials at once, rather than the current phase-by-phase approval procedure, will be adopted for new drugs’ clinical trial applications.

A fast track drug registration or clinical trial approval pathway will be available for the following applications:

(1) registration of innovative new drugs treating and preventing HIV, malignant tumors, serious infectious diseases and orphan diseases, etc.;

(2) registration of pediatric drugs;

(3) registration of geriatric drugs and drugs treating China-prevalent diseases in elders;

(4) registration of drugs sponsored by national science and technology major projects and national major research and development plans;

(5) registration for drugs with urgent clinical need using advanced technology, using innovative treatment methods, or having distinctive clinical benefits;

(6) registration of foreign innovative drugs to be manufactured locally in China;

(7) concurrent applications for new drug clinical trials which are already approved in the U.S.

or European Union or concurrent drug registration applications for drugs which have applied for marketing authorization and passed onsite inspections in the U.S.

or European Union and are manufactured with the same production line in China;

and (8) clinical trial applications for drugs with urgent clinical need and patent expiry within three years, and marketing authorization applications for drugs with urgent clinical need and patent expiry within one year.

In December 2017, the CFDA released the Opinions on Encouraging Drug Innovations and Implying the Prioritized Review and Approval System, which further clarified the following policies potentially accelerating the approval process of certain clinical trials or drug registrations which may benefit us:

A fast-track drug registration or clinical trial approval pathway is available for the following drug registration applications with distinctive clinical benefits:

(1) registration of innovative drugs not sold within or outside China;

(2) registration of innovative drug transferred to be manufactured in China;

(3) registration of drugs using advanced technology, using innovative treatment methods, or having distinctive clinical treatment advantages;

(4) clinical trial applications for drugs with patent expiry within three years, and marketing authorization applications for drugs with patent expiry within one year;

(5) concurrent applications for new drug clinical trials which are already approved in the U.S.

or European Union, or concurrent drug registration applications for drugs which have applied for marketing authorization and passed onsite inspections in the U.S.

or European Union and are manufactured using the same production line in China;

(6) traditional Chinese medicines (including ethnic medicines) with clear position in prevention and treatment of serious diseases;

and (7) registration of new drugs sponsored by national science and technology major projects, national major research and development plans and registration for drugs with clinical trials conducted by national clinical medical research centers and recognized by the administration department of the such centers.

A fast-track drug registration approval pathway is available for the drug registration applications with distinctive clinical benefits for the prevention and treatment of the following diseases:

HIV, pulmonary tuberculosis, viral hepatitis, orphan diseases, malignant tumors, pediatric diseases, and geriatric diseases.

In March 2016, the CFDA released the Reform Plan, as mentioned above, outlining the re-classifications of chemical medicine applications.

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According to such rule, Category 5.1 are innovative chemical drugs and improved new chemical drugs while Category 5.2 are generic chemical drugs, all of which shall have been already marketed abroad but not yet approved in China.

In November 2015, the Standing Committee of the National People’s Congress issued the Decision on Authorizing the State Council to Conduct the Pilot Program of the System of the Marketing Authorization Holder in Several Regions and the Relevant Issues, which authorized the State Council to conduct the pilot program of the system of the marketing authorization holder in Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan, and authorized the State Council to conduct reforms of registration category for drugs.

In May 2016, the General Office of the State Council issued Circular 41, which signals that the drug marketing authorization holder system is finally put into implementation.

Circular 41 allows institutions of drugs research and development and research specialist staff in Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan, to act as the applicant of drugs registration and to submit applications for drug clinical trials and drug marketing.

For those drugs newly registered after the effective date of Circular 41, applicants are allowed to submit applications for becoming a drug marketing authorization holder at the same time as they submit applications for drug clinical trials or drug marketing.

In July 2016, the CFDA issued Circular on Conducting Works Regarding the Pilot Program for the Drug Marketing Authorization Holder System, which provides further details on the application procedures stipulated in Circular 41.

In August 2017, the CFDA issued the Circular on the Matters Relating to Promotion of the Pilot Program for the Drug Marketing Authorization Holder System.

This circular is issued, among other things, to advance implementation of a system pilot program for holders of drug marketing authorization, to delineate the rights and obligations of such holders, to enhance the quality control system for the drug manufacturing process and to improve the responsibility system over drug manufacturing and marketing supply chains.

In October 2018, the Standing Committee of the National People’s Congress issued the Decisions on Extending the Term of the Pilot Program for the Drug Marketing Authorization Holder System in Several Regions, which extended the expiration date of the pilot program from November 4, 2018 to November 4, 2019.

On December 1, 2019, the newly revised PRC Drug Administration Law came into effect, which formally adopts and signals the nationwide implementation of the drug marketing authorization holder system.

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In China, we have entered into an exclusive commercialization and co-development agreement in Greater China with Hengrui to commercialize Plinabulin for the treatment of NSCLC and the prevention of CIN and any additional indications, if approved for sale.

Business—Commercialization.” Plinabulin has been granted Breakthrough Therapy Designation by the NMPA.

Additionally, Plinabulin has achieved status as a 2017 National Science and Technology Major Project in China, or the 2017 Grant.

Business—Commercialization.” Plinabulin has achieved status as a 2017 National Science and Technology Major Project in China, or the 2017 Grant.

As a result of the 2017 Grant, Plinabulin has been included in the National Drug Priority Review List in China.

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Legislative and regulatory measures have been enacted or proposed to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

We cannot be sure whether additional legislative changes will be enacted, whether President Trumps administration will propose other initiatives, or whether FDA regulations, guidance or interpretations will be changed, and if so, what the impact of such changes on the regulatory approvals or commercialization of our product candidates, if any, may be.

We cannot be sure whether additional legislative changes will be enacted, whether President Trump’s administration will propose other initiatives, or whether FDA regulations, guidance or interpretations will be changed, and if so, what the impact of such changes on the regulatory approvals or commercialization of our product candidates, if any, may be.

In addition, increased scrutiny of the FDA’s approval process by the U.S.

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expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance;

a Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices;

extension of manufacturers’ Medicaid rebate liability;

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since the Affordable Care Act was enacted could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain marketing approval and may affect our overall financial condition and ability to develop or commercialize product candidates.

For example, the Bipartisan Budget Act of 2018, among other things, amended the Affordable Care Act, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, and also increase beginning in 2019 the percentage that a drug manufacturer must discount the cost of the prescription drugs from 50% under current law to 70%.

We expect that the Affordable Care Act and other laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved drug.

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For example, the Inflation Reduction Act of 2022, or IRA, enacted on August 16, 2022, seeks to reduce prescription drug costs by, among other provisions, allowing Medicare to negotiate prices for certain high-cost prescription drugs in Medicare Parts B and D, imposing an excise tax on pharmaceutical manufacturers that refuse to negotiate pricing with Medicare, requiring inflation rebates to limit annual drug price increases in Medicare, and redesigning the Medicare Part D formula.

These provisions began taking effect progressively starting in fiscal year 2023, including an initial group of drugs that HHS selected for the first cycle of Medicare drug price negotiations in 2024 and a second group of drugs selected for price negotiations in 2025;

These provisions began taking effect progressively starting in fiscal year 2023, including the selection of certain drugs by HHS for Medicare drug price negotiation cycles which began in 2024;

our revenues may be significantly impacted if one or more of our products are eventually selected for evaluation under this program.

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The IRA is currently subject to legal challenges and it is unclear how the IRA will be effectuated or changed under the Trump administration, but it is possible that the IRA could have a material adverse effect on our business, financial condition, results of operations and cash flows in the future.

President Trump and the U.S.

Congress have taken additional actions to limit or change healthcare policies.

For example, President Trump rescinded an executive order issued by former President Biden, pursuant to which the CMMI created three drug pricing experiments, and it is unclear whether CMMI will continue to pursue some or any of these models.

Likewise, it remains unclear whether the Trump administration will continue an initiative announced by the Biden administration to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act.

Further, a budget resolution passed by the U.S.

House of Representatives in February 2025 proposed significant spending reductions for Medicaid and other federal programs, which, if enacted as part of a future U.S.

federal budget, could impact our future business prospects.

The current U.S.

administration is focused on lowering prescription drug costs.

For example, on May 12, 2025, the current administration published an executive order that expressed support for equalizing the prices paid for drugs in the United States and other developed countries by employing a “most favored nations” (MFN) approach to drug pricing.

The May 12 executive order directs the HHS Secretary to communicate MFN price targets to pharmaceutical manufacturers, which the Secretary announced on May 20, 2025.

If significant progress towards MFN pricing targets is not delivered, the executive order directs the Secretary to propose a rulemaking plan to impose MFN pricing.

On September 25, 2025 and October 2, 2025, the Centers for Medicare & Medicaid Services (CMS) submitted proposed rules for CMMI models, called the Global Benchmark for Efficient Drug Pricing (GLOBE) Model and Guarding U.S.

Medicare Against Rising Drug Costs (GUARD) Model, to the White House for review.

These models, if implemented, may allow CMS to pursue formalized approaches to MFN pricing for prescription drugs.

In addition, on November 6, 2025, CMS published a request for applications for another CMMI model, the GENEROUS (GENErating cost Reductions fOr U.S.

Medicaid) Model.

This is a voluntary model that tests the effect of supplemental rebate agreements between manufacturers and CMS, which align Medicaid prices with a defined MFN price.

Likewise, the Trump administration has taken steps indicating that it will continue an initiative announced by the Biden administration to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act.

Further, budget reconciliation legislation enacted in 2025 provided for significant spending reductions for Medicaid and other federal programs, which could impact our future business prospects.

At the state level, individual states are becoming increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure and transparency measures, as well as, in some cases, measures designed to encourage importation from other countries and bulk purchasing.

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These and similar laws may be subject to amendment or reinterpretation, and implementing regulations may be revised or reinterpreted, in ways that may significantly affect our business.

For example, the former Trump administration issued final rules in late 2020 that, among other things, made changes to certain Anti-Kickback Statute safe harbors;

however, implementation of these rules has been and may continue to be affected by subsequent legislative and regulatory action or litigation delaying or challenging these rules.

Additionally, we may be subject to state and non-U.S.

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Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our future business activities could be subject to challenge under one or more of such laws.

In addition, recent health care reform legislation has strengthened these laws.

In addition, certain health care reform legislation has strengthened these laws.

For example, the Affordable Care Act, among other things, amends the intent requirement of the federal Anti-Kickback Statute and criminal healthcare fraud statutes.

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As of December 31, 2025, we owned 19 issued U.S.

patents directed to Plinabulin synthesis, Plinabulin use in the treatment of various disorders including lung cancer, polymorphic forms of Plinabulin, Plinabulin compositions, and Plinabulin analogs.

In addition, we had counterpart granted patents in 32 foreign jurisdictions, including Japan, South Korea, China, European countries, and other countries.

patents directed to Plinabulin use in the treatment of various disorders, polymorphic forms of Plinabulin, Plinabulin compositions, and Plinabulin analogs.

In addition, we had granted patents in 34 foreign jurisdictions, including Japan, South Korea, China, European countries, and other countries.

patents are scheduled to expire between 2033 and 2042, excluding any patent term restorations.

We had 16 families of pending patent applications directed to use of Plinabulin in neutropenia reduction, use of Plinabulin for treating RAS mutant tumors and brain tumors, polymorphic forms of Plinabulin, use of Plinabulin in combination with checkpoint inhibitors, use of Plinabulin in reduction of immunotherapy related adverse events, use of Plinabulin in the treatment of thrombocytopenia, use of Plinabulin in combination with G-CSF therapy, use of Plinabulin for treating EGFR mutant tumors, use of Plinabulin in combination with an immune checkpoint inhibitor and a farnesyl pyrophosphate synthase inhibitor for treating cancer, use of Plinabulin in treating immune checkpoint inhibitor-resistant patients, Plinabulin impurities, use of Plinabulin as a monotherapy in treating certain cancers, and kits and methods for providing and administering Plinabulin.

We had 20 families of pending patent applications directed to use of Plinabulin in neutropenia reduction, use of Plinabulin for treating RAS mutant tumors and brain tumors, polymorphic forms of Plinabulin, use of Plinabulin in combination with checkpoint inhibitors, use of Plinabulin in reduction of immunotherapy related adverse events, use of Plinabulin in the treatment of thrombocytopenia, use of Plinabulin in combination with G-CSF therapy, use of Plinabulin for treating EGFR mutant tumors, use of Plinabulin in combination with an immune checkpoint inhibitor and a farnesyl pyrophosphate synthase inhibitor for treating cancer, use of Plinabulin in treating immune checkpoint inhibitor-resistant patients, Plinabulin impurities, use of Plinabulin as a monotherapy in treating certain cancers, kits and methods for providing and administering Plinabulin, use of Plinabulin in combination with a PARP inhibitor, Plinabulin micelle compositions, use of Plinabulin in combination with a cyclin-dependent kinase inhibitor, and use of biomarkers for Plinabulin therapy.

If these applications were to issue, they would nominally expire between 2033 and 2044.

We had four pending PCT, patent applications directed use of Plinabulin in combination with a PARP inhibitor, Plinabulin micelle compositions, use of Plinabulin in combination with a cyclin-dependent kinase inhibitor, and use of biomarkers for Plinabulin therapy.

If applications claiming priority to these PCT applications were to issue, they would nominally expire between 2043 and 2044.

We had three pending PCT patent applications directed to use of Plinabulin in combination with ADCs, use of Plinabulin in a combination therapy for treating small-cell lung cancer, and use of Plinabulin in a combination therapy for treating non-small cell lung cancer in patients who have failed first-line immune checkpoint inhibitor therapy.

If applications claiming priority to these PCT applications were to issue, they would nominally expire in 2045.

With respect to issued patents in certain jurisdictions, for example, the U.S.

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The granted U.S.

patents directed to Plinabulin synthesis, use, compositions, and polymorphic forms are scheduled to expire between 2025 and 2039, excluding any potential patent term restoration.

patents directed to Plinabulin use, compositions, and polymorphic forms are scheduled to expire between 2033 and 2042, excluding any potential patent term restoration.

Upon the expiration of our issued patents or patents that may issue from our pending patent applications, we will not be able to assert such patent rights against potential competitors and our business and results of operations may be adversely affected.

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Registered share capital and capital reserve accounts are also restricted from withdrawal in China.

As of December 31, 2024, these restricted net assets were nil.

As of December 31, 2025, these restricted net assets were approximately $12 thousand.

In August 2021, Wanchunbulin entered into an exclusive commercialization and co-development agreement with Hengrui to further develop and commercialize Plinabulin in Greater China.

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If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

We previously identified two material weaknesses in our internal control over financial reporting, both of which have been remediated.

Nevertheless, if we fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our ordinary shares.

If we fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our ordinary shares.

As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such internal controls.

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We do not expect our independent registered public accounting firm to attest to our management report on internal control over financial reporting for so long as we are a non-accelerated filer.

In connection with the audit of our consolidated financial statements as of December 31, 2023 and for the year ended December 31, 2023, we identified two material weaknesses in our internal control over financial reporting.

The material weaknesses related to lack of adequate and timely review of reconciliations and consolidations, resulting in material adjustments, and significant post-closing adjustments;

and lack of adequate review of journal entries, resulting in material post-closing adjustments.

After identifying the material weaknesses, we implemented measures designed to improve our internal control over financial reporting to remediate the material weaknesses, including the following:

(i) we continue to establish effective monitoring and oversight controls for non-recurring and complex transactions to ensure the accuracy and completeness of our consolidated financial statements and related disclosures, (ii) we have obtained accounting and advisory services from professional accounting consultants with U.S.

GAAP and SEC reporting experience, and (iii) we continue to conduct accounting and financial reporting training for our employees.

We concluded the previously reported material weaknesses have been remedied as of December 31, 2024.

While we believe we have remediated this material weakness, we may identify additional material weaknesses or significant deficiencies in our internal control over financial reporting in the future.

Our management evaluated, with the participation of our Chief Executive Officer and Chief Financial Officer, the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of the end of the period covered by this report and has concluded that our disclosure controls and procedures were effective as of December 31, 2025.

We have identified material weaknesses in our internal control over financial reporting in the past and may identify additional material weaknesses or significant deficiencies in our internal control over financial reporting in the future.

More generally, if we are unable to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, if we are unable to assert that our internal control over financial reporting is effective, or when required in the future, if our independent registered public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our ordinary shares could be adversely affected, and we could become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities, which could require additional financial and management resources.

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Our investments are subject to risks that could result in losses.

Our continuing operations had cash, cash equivalents and restricted cash of $2.9 million and $15.3 million at December 31, 2024 and 2023, respectively.

In February 2025, we received approximately $7.35 million in cash as consideration for the first closing of the sale of a portion of our equity interests in SEED, as further described under “Item 1.

Business—SEED’s Targeted Protein Degradation (TPD) Platform and Pipeline.” We may invest our cash in a variety of financial instruments, principally short-term investment grade, interest-bearing instruments.

Our continuing operations had cash and cash equivalents of $7.8 million and $2.9 million at December 31, 2025 and 2024, respectively.

We may invest our cash in a variety of financial instruments, principally short-term investment grade, interest-bearing instruments.

Our continuing operations had short-term investments of $4.8 million and nil at December 31, 2025 and 2024, respectively.

All of these investments are subject to credit, liquidity, market and interest rate risk.

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The current tensions in international economic relations may negatively affect the process of our clinical trials, the cost of our operations and the growth of our business.

In recent years, there have been heightened tensions in international economic relations, such as between the U.S.

Since July 2018, including after the “Phase 1” agreement was signed between the U.S.

and China, the U.S.

government has imposed new or higher tariffs on certain products imported from China, and China has responded by imposing new or higher tariffs on certain products imported from the U.S.

Since January 2025, the United States has announced significant new tariffs on imports from a wide range of countries, including China, which was followed by retaliatory tariffs by China and a number of countries and a cycle of further retaliatory tariff announcements and trade actions.

Certain of the tariffs have been and may be delayed, but others have taken or may take effect.

Further, tariffs announced or imposed by the United States could be altered or delayed through presidential action, bilateral negotiations, judicial orders or congressional action, and tariffs announced or imposed by other countries can be affected by similar developments.

It is not clear what impact these tariff negotiations may have or what further actions the governments may take.

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Furthermore, Chinese government have indicated an intent to increase the government’s oversight and control over offerings of companies with significant operations in China that are to be conducted in foreign markets.

For example, in July 2021, the Chinese government provided new guidance on China-based companies raising capital outside of China, including through arrangements called variable interest entities, or VIEs.

On February 17, 2023, the CSRC promulgated Trial Administrative Measures of the Overseas Securities Offering and Listing by Domestic Companies, or the Overseas Listing Trial Measures and relevant five guidelines, which became effective on March 31, 2023.

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Any unfavorable government policies on cross-border relations and/or international trade, including increased scrutiny on companies with significant China-based operations, capital controls or tariffs, may affect the hiring of scientists and other research and development personnel, the import or export of raw materials in relation to drug development, our ability to raise capital, or the market price of our ordinary shares.

Furthermore, the SEC has issued statements primarily focused on companies with significant China-based operations.

For example, on July 30, 2021, Gary Gensler, former Chairman of the SEC, issued a Statement on Investor Protection Related to Recent Developments in China, pursuant to which Chairman Gensler stated that he has asked the SEC staff to engage in targeted additional reviews of filings for companies with significant China-based operations.

For example, in 2021, the Chairman of the SEC, issued a Statement on Investor Protection Related to Recent Developments in China, pursuant to which he stated that he has asked the SEC staff to engage in targeted additional reviews of filings for companies with significant China-based operations.

The statement also addressed risks inherent in companies with VIE structures.

We do not have a VIE structure and are not in an industry that is subject to foreign ownership limitations by China.

However, it is possible that the Company’s periodic reports and other filings with the SEC may be subject to enhanced review by the SEC and this additional scrutiny could affect our ability to effectively raise capital in the United States.

In response to the SEC’s July 30, 2021 statement, the CSRC announced on August 1, 2021, that “it is our belief that Chinese and U.S.

regulators shall continue to enhance communication with the principle of mutual respect and cooperation, and properly address the issues related to the supervision of China-based companies listed in the U.S.

so as to form stable policy expectations and create benign rules framework for the market.” While the CSRC will continue to communicate “closely with relevant departments to further coordinate and handle the relationships among investors, and relevant authorities and to further promote transparency and certainty of policies and implementing measures,” it emphasized that it “has always been open to companies’ choices to list their securities on international or domestic markets in compliance with relevant laws and regulations.”

There have also been Congressional legislative proposals to discourage contracting with Chinese companies on the development or manufacturing of pharmaceutical products.

For example, the BIOSECURE Act was passed as part of the National Defense Authorization Act for Fiscal Year 2026 and prohibits U.S.

government contracts, loans and grants being made to any “biotechnology company of concern” or to any entity that uses biotechnology equipment or services from a “biotechnology company of concern”, including certain entities in China involved in the manufacturing, distribution, provision, or procurement of a biotechnology equipment or service.

If our suppliers or our customers were to be designated under the BIOSECURE Act, this could potentially harm our business and could severely restrict our ability to purchase services or products from, or otherwise collaborate with “biotechnology companies of concern” without losing the ability to contract with, or otherwise receive funding from, the U.S.

If any new legislation, executive orders, tariffs, laws and/or regulations are implemented, if existing trade agreements are renegotiated, if the U.S.

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In addition, registered share capital and capital reserve accounts are also restricted from withdrawal in China.

As of December 31, 2024, these restricted net assets were nil.

As of December 31, 2025, these restricted net assets were approximately $12 thousand.

The EIT Law, and its implementation rules, both of which became effective on January 1, 2008 and have been amended certain times thereafter, provide that China-sourced income of foreign enterprises, such as dividends paid by a Chinese subsidiary to its equity holders that are non-Chinese resident enterprises, will normally be subject to Chinese withholding tax at a rate of 10%, unless any such foreign investor’s jurisdiction of incorporation has a tax treaty with China that provides for a different withholding arrangement.

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On December 15, 2022, the PCAOB removed mainland China and Hong Kong from the list of jurisdictions where it is unable to inspect or investigate completely registered public accounting firms.

Our current auditor since January 5, 2024, Marcum LLP, or Marcum, as an auditor of companies that are traded publicly in the United States and a firm registered with the PCAOB, is subject to laws in the United States pursuant to which the PCAOB conducts regular inspections to assess its compliance with the applicable professional standards.

Marcum is headquartered in Manhattan, New York.

Marcum was not included in the list of PCAOB Identified Firms in the PCAOB Determination Report issued in December 2021, and was inspected by the PCAOB on a regular basis.

Our current auditor since April 9, 2025, CBIZ CPAs P.C., or CBIZ, as an auditor of companies that are traded publicly in the United States and a firm registered with the PCAOB, is subject to laws in the United States pursuant to which the PCAOB conducts regular inspections to assess its compliance with the applicable professional standards.

CBIZ is headquartered in Cleveland, Ohio.

CBIZ was not included in the list of PCAOB Identified Firms in the PCAOB Determination Report issued in December 2021, and was inspected by the PCAOB on a regular basis.

For this reason, we do not expect to be identified as a Commission-Identified Issuer under the HFCAA.

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Regulatory authorities in China have implemented and are considering a number of legislative and regulatory proposals concerning data protection.

For example, the Cyber Security Law of the PRC, or the Cyber Security Law, which became effective in June 2017, created China’s first national-level data protection regime for “network operators,” which may include all organizations in China that provide services over the internet or another information network.

For example, the Cyber Security Law of the PRC, or the Cyber Security Law, which became effective in June 2017 and amended in October 2025, created China’s first national-level data protection regime for “network operators,” which may include all organizations in China that provide services over the internet or another information network.

We do not maintain, nor do we intend to maintain in the future, personally identifiable health information of patients in China.

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With China’s growing emphasis of its sovereignty over data derived from China, the outbound transmission of de-identified or pseudonymized health data for clinical trials may be subject to the new national security legal regime, including the Cyber Security Law, the Data Security Law (as defined below), the Personal Information Protection Law (as defined below), and various implementing regulations and standards.

Under the Cyber Security Law and the Measures on Standard, Safety and Service of the National Medical Care Big Data (Tentative), or the Measures on Health and Medical Big Data, the transmission of certain personal information, important data and health and medical care big data outside of China is only permitted upon the completion of a security assessment conducted by or as determined by the Chinese government.

On July 7, 2022, the CAC promulgated the Security Assessment Measures for Outbound Data Transfer, effective from September 1, 2022, or the Security Assessment Measures, to regulate outbound data transfer activities, protect the information rights and interests of individuals, safeguard national security and social public interests, and promote the safe and free cross-border flow of data.

On March 22, 2024, the CAC promulgated the Provisions on Facilitating and Regulating Cross-border Data Flow, effective on the same date.

The provisions intend to replace the rules set forth in the Security Assessment Measures that are inconsistent with the new provisions, and provide for, among others, circumstances that are exempted from and circumstances that require application for security assessment for outbound data transfer, execution of a standard contract for personal information outbound transfer and passing of the certification for personal information protection.

In addition, the SCNPC, promulgated the Data Security Law of the People’s Republic of China, or the Data Security Law, on June 10, 2021, which became effective on September 1, 2021.

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The security assessment mechanism was also included in the Personal Information Protection Law, or the Personal Information Protection Law, which was promulgated in August 2021 and became effective on November 1, 2021, for the Chinese government to supervise certain cross-border transfers of personal information.

The Personal Information Protection Law provides a comprehensive set of data privacy and protection requirements that apply to the processing of personal information and expands data protection compliance obligations to cover the processing of personal information of persons by organizations and individuals in China, and the processing of personal information of persons in China outside of China if such processing is for purposes of providing products and services to, or analyzing and evaluating the behavior of, persons in China.

The Personal Information Protection Law also provides that critical information infrastructure operators and personal information processing entities who process personal information meeting a volume threshold to be set by Chinese cyberspace regulators are also required to store in China personal information generated or collected in China, and to pass a security assessment administered by Chinese cyberspace regulators for any export of such personal information.

Lastly, the Personal Information Protection Law contains proposals for significant fines for serious violations of up to RMB 50 million or 5% of annual revenues from the prior year and may also be ordered to suspend any related activity by competent authorities.

We do not maintain, nor do we intend to maintain in the future, personally identifiable health information of patients in China.

We do, however, collect and maintain de-identified or pseudonymized health data for clinical trials in compliance with local regulations.

Under the Cyber Security Law and Data Security Law, we are required to establish and maintain a comprehensive data and network security management system that will enable us to monitor and respond appropriately to data security and network security risks.

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The potential conflicts in legal obligations could have adverse impact on our operations in and outside of China.

Recently, the CAC has taken action against several Chinese internet companies in connection with their initial public offerings on U.S.

securities exchanges, for alleged national security risks and improper collection and use of the personal information of Chinese data subjects.

According to the official announcement, the action was initiated based on the National Security Law, the Cyber Security Law and the Cybersecurity Review Measures, which are aimed at “preventing national data security risks, maintaining national security and safeguarding public interests.” In addition, on December 28, 2021, the CAC and several other PRC government authorities jointly issued the newly revised Cybersecurity Review Measures, according to which, among others, if an internet platform operator has personal information of over one million users and intends to be listed on a foreign stock exchange, it must be subject to the cybersecurity review.

The newly revised Cybersecurity Review Measures became effective on February 15, 2022.

On September 24, 2024, the State Council published the Administrative Regulations on the Internet Data Security, effective from January 1, 2025, or the Data Security Measures.

The Data Security Measures further stipulates on personal information protection, the security of important data, the cross-border security management of network data, and the obligations of network platform service providers.

The national security legal regime imposes stricter data localization requirements on personal information and human health-related data and requires us to undergo cybersecurity or other security review, obtain government approval or certification, or put in place certain contractual protections before transferring personal information and human health-related data out of China.

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We plan to closely monitor legal and regulatory developments in this area to see how scientific data is interpreted, and we may be required to comply with additional regulatory requirements for sharing clinical study data with our licensors or foreign regulatory authorities, although the scope of such requirements, if any, is currently unknown.

On July 7, 2022, the CAC promulgated the Security Assessment Measures, to regulate outbound data transfer activities, protect the information rights and interests of individuals, safeguard national security and social public interests, and promote the safe and free cross-border flow of data.

Furthermore, the Security Assessment Measures provide that the security assessment for outbound data transfers shall follow principles of the combination of pre-assessment and continuous supervision and the combination of risk self-assessment and security assessment, so as to prevent the security risks arising from outbound data transfers and ensure the orderly and free flow of data according to the law.

For outbound data transfers activities that have been carried out prior to the implementation of the Security Assessment Measures, and not in compliance with the Security Assessment Measures, rectification shall be completed within 6 months from the implementation of the Security Assessment Measures.

The Security Assessment Measures further provide that a data processor intending to implement outbound data transfer under the following circumstances shall apply for security assessment to the CAC:

(a) a data processor intending to provide critical data abroad;

(b) a critical information infrastructure operator or a data processor processing the personal information of more than one million individuals intending to provide personal information abroad;

(c) a data processor, who has cumulatively provided personal information of 100,000 individuals or sensitive personal information of 10,000 individuals abroad since January 1st of the previous year, intending to provide personal information abroad;

and (d) other circumstances prescribed by the CAC for which application for security assessment for outbound data transfers is required.

On March 22, 2024, the CAC promulgated the Provisions on Facilitating and Regulating Cross-border Data Flow, effective on the same date.

The provisions intend to replace the rules set forth in the Security Assessment Measures that are inconsistent with the new provisions.

Pursuant to the Provisions on Facilitating and Regulating Cross-border Data Flow, a data processor intending to implement outbound data transfer under the following circumstances shall apply for security assessment to the CAC:

(a) a critical information infrastructure operator intending to provide personal information or important data abroad;

or (b) a data processor, that is not a critical information infrastructure operator, intending to provide important data abroad, or has since January 1st of the current year cumulatively provided personal information (excluding sensitive personal information) of over one million individuals, or sensitive personal information of over 10,000 individuals, abroad.

For any data processors other than critical information infrastructure operators who have since January 1st of the current year cumulatively provided personal information (excluding sensitive personal information) of over 100,000 and less than one million individuals, or sensitive personal information of less than 10,000 individuals abroad, should execute a standard contract for outbound transfer of personal information with the recipient abroad or pass the certification for personal information protection.

In addition, certain industry-specific laws and regulations affect the collection and transfer of personal data in China.

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See “Item 1A.

Risk Factors—Risks Related to Our Industry, Business and Operation—We previously identified two material weaknesses in our internal control over financial reporting, both of which have been remediated.

Risk Factors—Risks Related to Our Industry, Business and Operation—If we fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our ordinary shares.”

In addition, as of January 1, 2025, we have lost our status as a “foreign private issuer,” as defined in the SEC’s rules and regulations and, consequently, we are now subject to all of the disclosure requirements applicable to public companies organized within the U.S.

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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 1A. Risk Factors