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Item 1. Business

2026-03-25 compared with 2025-03-27 · 137 added, 141 removed, 1191 unchanged (19% of the section changed)

We are a clinical stage global biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs.

Our first-in-class lead asset, Plinabulin, which has been administered to over 700 cancer patients with generally good tolerability, is being developed as a potential “pipeline in a drug” in various cancer indications as a direct anti-cancer agent.

Our first-in-class lead asset, Plinabulin is a novel brain-penetrant microtubule modulator with dendritic cell maturation and vasculature modulation mechanism, which has the potential to help mitigate “acquired resistance” from prior immune checkpoint inhibitors (ICI) treatment in cancer patients.

Plinabulin has been administered to over 700 cancer patients with generally good tolerability and is being developed as a potential “pipeline in a drug” in various cancer indications as a direct anti-cancer agent with safety benefit of reducing chemotherapy-induced neutropenia (CIN).

After a successful phase 3 study (DUBLIN-3) in NSCLC, Plinabulin regimen is in a confirmatory global phase 3 study in second- and third-line NSCLC with epidermal growth factor receptor (EGFR) wild type after progression on prior immune checkpoint inhibitors, a severe unmet medical need.

We are also developing three small molecule immune agents, which are currently in pre-clinical stages.

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SEED is utilizing a proprietary Targeted Protein Degradation (TPD) drug discovery platform, or “molecular glue” technology, to develop innovative therapeutic agents from internal research and development efforts and with our collaborators on currently undruggable protein targets.

SEED has advanced its wholly owned lead oncology asset, a novel RBM39 degrader into phase 1 clinical studies in January 2026.

SEED is partnering with Eli Lilly and Co., or Eli Lilly, and Eisai Co., Ltd., or Eisai, to discover and develop new chemical entities through this proprietary TPD platform which could produce therapeutic benefits to patients suffering from oncology and central nervous system (CNS) disease, among others.

Through our 15-year research and development efforts to progress our lead asset Plinabulin, we discovered that Plinabulin has novel mechanisms of action.

Plinabulin binds in a unique pocket in tubulin which is different from other tubulin binders such as taxane, vinca, and colchicine, and releases an immune defense protein GEF-H1, which produces the potent effect of maturing immune dendritic cells, leading to T-cell activation for a potential durable anti-cancer benefit.

Therefore, we believe Plinabulin’s mechanism stimulates both innate and adaptive immunity.

We are applying these insights to our current clinical studies to target mechanism-based patient populations.

Plinabulin’s unique binding site has also led to clinical findings that have repeatedly shown significant reductions in CIN, which may provide added clinical and safety benefits to cancer patients.

Plinabulin is being studied as an anti-cancer agent in a number of company-sponsored studies and investigator-initiated studies.

We completed a randomized global Phase 3 study of Plinabulin in combination with docetaxel compared with docetaxel alone for second- and third- line treatment of NSCLC, epidermal growth factor receptor, or EGFR, wild type (DUBLIN-3 Phase 3 registration study).

The DUBLIN-3 study enrolled 559 patients at 58 clinical sites globally and the final results from the study showed that the Plinabulin and docetaxel combination had statistically significant and clinically meaningful overall survival benefit compared to standard of care docetaxel alone.

Key secondary endpoints were also achieved with additional clinically significant benefits in progression free survival (PFS) and objective response rate (ORR), coupled with a significant reduction in grade 4 neutropenia, with over 80% reduction.

Plinabulin is a differentiated microtubule modulator with different binding and kinetics from other microtubule stabilizing or depolymerizing agents.

By depolymerizing microtubule, it activates the immune defense protein GEF-H1, which leads to induction of innate and adaptive immunity via dendritic cell (DC) maturation.

In June 2025, we published in Cell Press “Med” Plinabulin’s DC maturation benefit to responding patients in eight cancers, based on our multi-year collaboration with The University of Texas MD Anderson Cancer Center, or MD Anderson.

In January 2026, our research collaborator Dr.

Steinmetz group published in “Cell” on the structural basis of microtubule-mediated signal transduction, which suggests the important role of microtubule as signal sensors to regulate cellular function, further supporting Plinabulin’s unique biological function.

With this unique immune mechanism, Plinabulin is being studied as an anti-cancer agent in a number of company-sponsored studies and investigator-initiated studies in late-line and first-line cancer treatments, including targeting patients progressed on checkpoint inhibitors in NSCLC with EGFR wild type, which we believe presents a severe unmet medical need.

The current standard of care for first-line EGFR wild type NSCLC is PD-1/PD-L1 antibodies with or without platinum doublet.

However, over 60% patients progress on these therapies, defined as “acquired resistance” due to “T cell exhaustion” and/or “antigen presenting cell (APC) pathway mutation” (Memon et al., Cancer Cell 2024).

Once patients progress on these regimens, docetaxel, a drug approved over 25 years ago, is recommended in the second- and third-line, but it has modest clinical benefit and high severe neutropenia.

Recently, 11 phase 3 studies, with agents including PD-1/PD-L1 antibodies combinations or Antibody Drug Conjugate (ADC) have failed to surpass docetaxel in overall survival (OS) in this population.

We believe that Plinabulin’s mechanism of DC maturation could help mitigate ICI acquired resistance, as DC is the most potent APC and it can prime T cells.

To address the significant unmet need in this population, we have been conducting multiple studies on Plinabulin combinations.

First, we completed a randomized global Phase 3 study of Plinabulin in combination with docetaxel compared with docetaxel alone for second- and third-line treatment of NSCLC, with EGFR wild type (DUBLIN-3 Phase 3 registration study).

It has more pronounced overall survival benefit in plinabulin-mechanism targeted non-squamous patients (OS HR 0.72 after additional 2-year follow-up, p=0.0078).

The finding was published in LANCET Respiratory Medicine journal in September 2024, and at the same time we made an oral presentation at the International Association for the Study of Lung Cancer (IASLC) conference.

We plan to use our best efforts to file an NDA with the NMPA as soon as possible.

The current standard of care for first-line NSCLC without driver mutations is chemotherapy plus PD-1/PD-L1 antibodies, with 60% patients progress on these therapies.

Once patients progress on these regimens, docetaxel is the recommended in the second line, but it has modest clinical benefit and high severe neutropenia.

To address the significant unmet need in this population, our collaborators at Peking Union Medical College Hospital in China are conducting an investigator-initiated Phase 2 study (Study 303):

Because DUBLIN-3 study had over 80% patients from Asia, we plan to initiate a confirmatory global phase 3 study in second- and third-line non-squamous NSCLC with epidermal growth factor receptor (EGFR) wild type after progression on prior immune checkpoint inhibitors, based on productive discussion with US regulatory agency.

In addition, we are conducting a number of investigator-initiated study (IIT) on Plinabulin in ICI progressed cancers, including NSCLC, head-and-neck cancer and Hodgkin’s Lymphoma, and first line ES-SCLC.

We provide financial support for these various investigator-initiated clinical trials as well as the drug supply of Plinabulin.

First, our collaborators at Peking Union Medical College Hospital in China are conducting an investigator-initiated Phase 2 study (Study 303) with the completion of all 47 patients enrolled:

Plinabulin in combination with Keytruda® (pembrolizumab), a PD-1 antibody, and docetaxel for the treatment of NSCLC patients who progressed from PD-1/PD-L1 antibodies.

We presented the early data of disease control rate and prolonged PFS from this study at European Society for Medical Oncology (ESMO) 2024 and Society for Immunotherapy of Cancer (SITC) 2024.

Plinabulin is also being studied in a Phase 2 investigator-initiated study (Study 302) in combination with Keytruda®, etoposide and platinum for the first-line treatment of extensive-stage small cell lung cancer, or ES-SCLC, patients at Wuhan Union Hospital in China, where the current standard of care has limited median progression free survival.

Additional investigator initiated studies with Plinabulin include:

We presented clinically meaningful data of high disease control rate of 80% and prolonged PFS from this study at European Society for Medical Oncology (ESMO) 2024, Society for Immunotherapy of Cancer (SITC) 2024, and American Society of Clinical Oncology (ASCO) 2025.

Second, our collaborators at MD Anderson Cancer Center have completed a phase 1 IIT study in Plinabulin combination with PD-1 or PD-L1 antibodies and radiation for the treatment of patients in eight cancers who progressed from PD-1/PD-L1 antibodies, with disease control rate of 54%.

This paper was published in Cell Press “Med” in June 2025.

Plinabulin’s rapid DC maturation biomarker analysis was observed in responding patients.

Third, Plinabulin is being studied in a Phase 2 IIT study (Study 302) in combination with Keytruda®, etoposide and platinum for the first-line treatment of extensive-stage small cell lung cancer, or ES-SCLC, patients at Wuhan Union Hospital in China, where the current standard of care has limited median PFS.

Additional completed investigator initiated studies with Plinabulin include:

1) in combination with nivolumab, a PD-1 antibody, for the treatment of NSCLC at the University of California San Diego, or UCSD, and the University of Washington (Phase 1 completed);

2) in combination with nivolumab and ipilimumab, a CTLA-4 antibody, for the treatment of ES-SCLC at the Rutgers University and other U.S.

2) in combination with nivolumab and ipilimumab, a CTLA-4 antibody, for the treatment of second line ES-SCLC at the Rutgers University and other U.S.

clinical centers (both Phase 1 and Phase 2 completed).

and 3) in combination with PD-1 or PD-L1 antibodies and radiation for the treatment of patients with various cancers who progressed from PD-1/PD-L1 antibodies at The University of Texas MD Anderson Cancer Center, or MD Anderson (Phase 1 completed and presented at SITC 2023).

We expect each of these studies to benefit from our previous investigation of Plinabulin as an agent that has been studied in two randomized, controlled Phase 3 clinical studies to have demonstrated a statistically significant reduction in CIN.

In total, over 700 patients have been treated with Plinabulin, where improvements in CIN have been repeatedly observed.

Our principal executive offices are located in New Jersey, and we also have offices in Beijing, China and Dalian, China.

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Plinabulin is a first-in-class, novel small molecule derived from a natural compound found in marine microorganisms.

It is a Selective Immunomodulating Microtubule-Binding Agent, which may provide multiple therapeutic opportunities.

It is a Selective Immunomodulating Microtubule-Binding Agent (SIMBA), which may provide multiple therapeutic opportunities.

As a low molecular weight small molecule, Plinabulin is relatively simple to manufacture.

An advantage of natural products and their derivatives, such as Plinabulin, is that it may be difficult for others to discover structurally distinct molecules possessing a similar array of activities.

By depolymerizing tubulin, Plinabulin triggers the release of the immune defense protein, GEF-H1, which activates RhoA/ROCK (Rho-associated protein kinases) pathway and leads to two distinct effects:

By binding to a distinct pocket and depolymerizing tubulin, Plinabulin triggers the release of the immune defense protein, GEF-H1, which activates RhoA/ROCK (Rho-associated protein kinases) pathway and leads to two distinct effects:

1) a durable anti-cancer benefit due to the maturation of dendritic cells resulting in activation of tumor antigen-specific T-cells to target cancer cells and 2) early-onset action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells, or HSPCs.

Effects on HSPCs could explain the potential for Plinabulin not only to prevent CIN but also to increase circulating CD34+ cells in patients.

As a potential “pipeline in a drug,” Plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and potentially allow patients who progressed on PD-1/PD-L1 antibodies to respond to PD-1/PD-L1 combination with Plinabulin.

The elucidation of this mechanism was a multi-year collaborative effort among us, University of Basel, Massachusetts General Hospital, and MD Anderson.

As a potential “pipeline in a drug,” Plinabulin is being broadly studied in combination with chemotherapy, radiation, or various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and potentially allow patients who progressed on PD-1/PD-L1 antibodies to respond to Plinabulin regimen.

The elucidation of Plinabulin’s unique mechanism was a multi-year collaborative effort among us, University of Basel, Massachusetts General Hospital, and MD Anderson.

In aggregate, as of the date of this Annual Report on Form 10-K, Plinabulin has been administered to over 700 patients with advanced cancer and thus far is generally well-tolerated.

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Lung cancer is typically diagnosed relatively late in its clinical course after it has metastasized to other tissues in the body.

In these advanced cases, treatment is not curative, and patients are generally treated with systemic therapies.

Initial first-line therapy is often based on broad chemotherapy drugs such as cisplatin with or without PD-1/PD-L1 inhibitors.

Most patients, however, do not obtain a long-term overall survival benefit.

For patients who failed first-line therapies and with no driver mutation, the current standard of care is still docetaxel-based therapies, with limited survival benefit of around 9 months and high severe neutropenia rate of over 40%.

Seven recent Phase 3 studies in patients with EGFR wild-type NSCLC who were previously treated with immune checkpoint inhibitors failed to show overall survival (OS) benefit compared with docetaxel (SAPPHIRE, LEAP-008, CONTACT01, EVOKE-01, CARMEN-LC03, and CANOPY-2, and TROPION-Lung01).

No new drug has been approved in this hard-to-treat indication in the last decade.

Therefore, we believe new treatments for advanced and metastatic NSCLC with EGFR wild-type after platinum therapy progression are urgently needed.

In these advanced cases, treatment is not curative, and patients with EGFR wild type (around 85% western patients and 50-70% Asian patients) are generally treated with first-line therapies including platinum doublet with or without PD-1/PD-L1 inhibitors.

However, over 60% patients could progress on these therapies and with docetaxel as the SOC after progression.

Recently 11 phase 3 trials failed to show OS benefit of new agents compared to docetaxel in patients with advanced and metastatic NSCLC after progression on ICI-based therapy.

These studies evaluated PD-(L)1 inhibitor combination with tyrosine kinase inhibitor (LEAP-008, SAPPHIRE, CONTACT-01), PD-L1 inhibitor with ATR inhibitor (LATIFY), PD-L1 inhibitor with VEGFR-2 antibody (PRAGMATICA-LUNG) , PD-1 inhibitor combined with Docetaxel with or without TIM3 inhibitor (COSTAR Lung), or novel bispecific antibodies (PD-L1x4-1BB, ABBIL1TY), or antibody-drug conjugates (TROPION-Lung01, EVOKE-1, CARMEN-LC03.

Therefore, docetaxel, a drug approved 25 years ago, with limited survival benefit of around 9 months and high severe neutropenia rate of over 40%, remains the standard of care, highlighting a significant unmet medical need.

Plinabulin in advanced and metastatic NSCLC

Plinabulin is a Selective Immunomodulating Microtubule-Binding Agent, which activates immune defense protein GEF-H1, and leads to dendritic cell maturation and T-cell activation (La Sala 2019;

Plinabulin is a Selective Immunomodulating Microtubule-Binding Agent (SIMBA), which activates immune defense protein GEF-H1, and leads to dendritic cell maturation and T-cell activation (La Sala 2019;

Kashyap 2019) for anti-cancer benefit.

High GEF-H1 immune signature patients in anti-cancer studies live much longer than the ones who have lower GEF-H1 immune signature (Kashyap 2019).

In addition, Plinabulin has the benefit in tumor vasculature modulation (Clinical Cancer Research 2010).

Phase 1/2 in advanced and metastatic NSCLC (Study 101)

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The patients who received Plinabulin plus docetaxel also had a duration of response, the initial response until documented tumor progression, of 12.7 months compared to only one month for the patients who received docetaxel monotherapy (p=0.049).

This subset analysis was presented as an oral presentation at 2017 American Society of Clinical Oncology—Society for Immunotherapy of Cancer, or ASCO-SITC, conference and was selected as one of five highlights of the meeting.

This subset analysis was presented as an oral presentation at 2017 ASCO-SITC conference and was selected as one of five highlights of the meeting.

Phase 3 in advanced and metastatic NSCLC (Study 103 or DUBLIN-3)

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OS HR=0.81 in the ITT population, with better OS benefit in the non-squamous subset (OS HR=0.72, p=0.0078).

For the non-squamous subset patients, median OS (mOS) in Plinabulin/docetaxel arm was 11.4 months vs.

8.8 months in the docetaxel arm, with mOS benefit of 2.6 months.

For the Plinabulin mechanism targeted non-squamous subset patients, median OS (mOS) in Plinabulin/docetaxel arm was 11.4 months vs.

8.8 months in the docetaxel arm, with mOS benefit of 2.6 months (OS HR 0.72, p=0.0078):

mOS 11.2 months in DP (n=154) vs.

mOS 8.8 months in D (n=178).

Improved OS benefit with more cycles of treatment (≥ 4, 6, 8, 10, or 12 cycles):

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While PD-1/PD-L1 inhibitors are highly effective in a subset of tumors, there are multiple pathways that tumors rely upon to evade the immune system allowing many tumors to continue to proliferate.

The global market size of PD-1 and PD-L1 inhibitors/ immune checkpoint inhibitors was estimated at $52.3 billion in 2024.

It is estimated at $63.7 billion in 2025 and $145.6 billion by 2030 at a compound annual growth rate (CAGR) of 18.0% (Modor Intelligence Research and Advisory 2024).

Around 60% of the patients who receive such treatment progressed from PD-1/PD-L1 antibodies in NSCLC (Cancer Cell 2024).

The global market size of PD-1 and PD-L1 inhibitors/ immune checkpoint inhibitors was around $60 billion in 2025 and is projected to reach $135.55 billion by 2031 at a compound annual growth rate (CAGR) of 13.88% (Mordor Intelligence 2025).

Around 60% of the cancer patients who receive such treatment progressed from PD-1/PD-L1 antibodies, including in NSCLC (Cancer Cell 2024).

As with the treatment of most cancers, combination treatments are often required to increase efficacy.

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In addition, cancer patients who progressed from PD-1/PD-L1 antibodies could potentially benefit from Plinabulin and PD-1/PD-L1 combination and chemotherapy/radiation.

Current investigator-initiated studies on these Plinabulin combinations aim to help design an optimum registrational study for these indications for patients who failed PD-1/PD-L1 inhibitors, especially in NSCLC.

Current investigator-initiated studies on these Plinabulin combinations aim to help design an optimum registrational study for these indications for patients who progressed on PD-1/PD-L1 inhibitors, especially in NSCLC.

Preclinical study data supporting Plinabulin in immuno-oncology

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Plinabulin triple combination significantly increased dendritic cell MHC-II expression and T-cell infiltration in the tumor.

We believe that the activation of dendritic cells is a key to unlocking the next boost to the efficacy of immuno-oncology agents.

Activated dendritic cells, which are the most potent antigen presenting cells, present foreign tumor antigens to T-cells to induce cancer-directed immune attacks.

We believe that the maturation of dendritic cells is a key to unlocking the next boost to the efficacy of immuno-oncology agents.

Matured dendritic cells, which are the most potent antigen presenting cells, present foreign tumor antigens to T-cells to induce cancer-directed immune attacks.

Thus, adding this critical step of dendritic cell activation in the immune cascade to the established effects of immune checkpoint inhibition therapies is expected to increase overall anti-cancer efficacy in the clinic and has the potential to re-sensitize patients who progress on prior immunotherapies.

Even with the current PD-1 and PD-L1 antibody annual sales exceeding $50 billion, with most sales coming from lung cancer, around 60% of lung cancer patients could develop acquired resistance to PD-1 and PD-L1 antibody, and these patients currently have limited treatment options (Tamon et al Cancer Cell 2024).

Our anti-cancer strategy is to combine Plinabulin with checkpoint inhibition and immune activation from radiotherapy.

We believe the data strongly indicates that this triple combination has potential to help patients who failed or have progressed on anti-PD-1/PD-L1 targeted therapy, which represents a high unmet medical need.

Even with the current PD-1 and PD-L1 antibody annual sales at around $60 billion, with most sales coming from lung cancer, around 60% of lung cancer patients could develop acquired resistance to PD-1 and PD-L1 antibody, and these patients currently have limited treatment options (Tamon et al Cancer Cell 2024).

Our anti-cancer strategy is Plinabulin combination regimen.

We believe the data strongly indicates that this combination has potential to help patients who failed or have progressed on anti-PD-1/PD-L1 targeted therapy, which represents a high unmet medical need.

Investigator-initiated studies in Plinabulin in immuno-oncology

We have explored and plan to continue to explore the role of Plinabulin in stimulating the activity of other immuno-oncology agents in clinical programs:

Plinabulin + Pembrolizumab + Docetaxel in 2L NSCLC who progressed on PD-1/PD-L1 (Study 303)

Docetaxel remains the standard of care for second-line and third-line treatments of patients with NSCLC without targetable alterations who progress on immune checkpoint inhibitors with and without standard chemotherapy.

Plinabulin + Pembrolizumab + Docetaxel in 2L NSCLC who progressed on PD-1/PD-L1 inhibitors (Study 303)

Docetaxel remains the standard of care for second-line and third-line treatments of patients with EHFR wild type NSCLC who progress on immune checkpoint inhibitors with and without standard chemotherapy.

In the recent TROPION Lung-01 Phase 3 studies, a similar patient population had an overall response rate (ORR) of 12.8% and median PFS (mPFS) of 3.7 months with docetaxel.

The study intends to enroll 47 patients and is funded by Merck’s Investigator Studies Program with provision of study drug and financial support.

This investigator-initiated, single-arm, open-label, Phase 2 study (KeyPelms-004 or Study 303) evaluates the efficacy and safety of a triple combination regimen of pembrolizumab plus Plinabulin/docetaxel (NCT05599789) in metastatic EGFR wild type NSCLC who progressed on prior PD-1/L1 inhibitor in combination with or without platinum doublet.

The study has completed enrollment of all 47 patients and is funded by Merck’s Investigator Studies Program with provision of study drug and financial support.

The study is ongoing at Peking Union Medical College Hospital, Beijing, China with the principal investigator Dr.

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In March 2023, the first patient was enrolled.

At the database lock on August 29, 2024, 36 patients were enrolled, 30 patients are evaluable.

Prior to entry, all patients had experienced disease progression after initial clinical benefit with immune checkpoint inhibitors.

Of the 30 treated patients (median age at 68.0 years;

ranged 50-77 years), 73.3% were male and 26.7% were female;

The data of 47 patients was presented at SITC 2025.

Median follow-up was 14.3 months at the data cut-off date of Sep 30, 2025.

Median age was 67 (44-83) with 80.9% male and 19.1% female.

72.3% were current or former smokers.

Histology included 57% patients (n=17) with non-squamous cell carcinoma and 43% (n=13) with squamous cell carcinoma.

The median follow-up was 11.5 months.

Histology included 63.8% with non-squamous cell carcinoma, 36.2% with squamous cell carcinoma.

In 42 patients who completed blood sampling on C1D0 and C3D0, the proportions of CD4+ and CD8+ T cells remained stable (p>0.05) while Ki67+CD8+ T cells were significantly increased (p=0.004).

The frequencies of CD38+HLA-DR+CD4+T cells and CD38+HLA-DR+CD8+T cells were dramatically elevated (p<0.0001).

The combination was generally well tolerated.

46.7% of patients experienced grade 3 or higher treatment-related adverse effects, or AEs.

Most common AE is myelosuppression (13.3%), gastrointestinal side effect (13.3%), and transient hypertension (6.7%).

53.2% of patients experienced grade 3 or higher treatment-related adverse effects, or TEAEs.

Most common grade 3 or higher TEAE is myelosuppression (17.0%), gastrointestinal side effect (14.9%), and transient hypertension (17.0%).

There were no treatment-related deaths.

Table below is the summary of the efficacy study of 30 patients presented at SITC conference in November 2024, which is consistent with the data reported on the first 19 patients in Study 303 at ESMO in September 2024.

Table below is the summary of the efficacy study of 47 patients presented at SITC conference in November 2025.

Primary Endpoint

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(Overall Survival)

(Duration of Response)

Disease Control Rate

(Partial Response + Stable Disease > 4 months)

(25/28 – 2 patients withdrew after first dose)

12 months OS Rate

24 months OS Rate

partial response:

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Phase 1 portion of this study has been completed.

The study was published in Med 2025.

Plinabulin + PD-1 antibody in 2/3L NSCLC

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Patients with low neutrophil counts are more susceptible to bacterial infections and sepsis, which are a significant cause of morbidity and mortality in cancer patients.

Chemotherapy is still the standard of care for cancer patients with or without combination with PD-1/PD-L1 antibodies in a number of cancer indications.

Chemotherapy is still the standard of care for cancer patients with or without combination with PD-1/PD-L1 antibodies in a number of cancer indications, including NSCLC, SCLC, Triple negative breast cancer, gastric cancer, esophageal cancer, head and neck cancer, cervical cancer, endometrial cancer, bladder cancer, and biliary tract cancer.

Neutropenia represents a key limitation associated with most chemotherapies.

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SEED is establishing a growing pipeline of novel drug candidates for internal development and in R&D collaboration with Eli Lilly and Eisai on a path to potential clinical and commercial success.

SEED’s wholly owned lead oncology asset, a novel RBM39 degrader (ST-01156), has entered clinical study with first patient dose in January 2026 in the US.

RBM39 degrader has the potential to target mechanism-based indications, including Ewing Sarcoma, Neuroblastoma, liver cancer, and colon cancer.

ST-01156 has received Orphan Drug and Rare Pediatric Disease designations from the FDA for Ewing sarcoma.

We believe SEED is an established leader in overcoming the significant scientific challenges to discovering “molecular glue”, which enables the development of a new class of drugs with the potential to treat many previously untreatable medical conditions through the targeting of disease-causing proteins that are resistant to inhibition with traditional drug discovery methods.

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In August 2024, SEED completed the first close of its Series A-3 financing, where SEED sold an aggregate of 5,647,059 of its Series A-3 Preferred Shares to Eisai and certain other third-party investors, for an aggregate purchase price of $24.0 million, each at a cash purchase price of $4.25 per share.

In September 2025, SEED completed the second close of its Series A-3 financing, where SEED sold an aggregate of 1,411,761 of its Series A-3 Preferred Shares to a related party and certain third-party investors, for an aggregate purchase price of $6.0 million, each at a cash purchase price of $4.25 per share.

See “Item 13.

Certain Relationships and Related Transactions, and Director Independence— Purchase of SEED’s Preferred Shares.”

In January 2025, we entered into definitive agreements to sell a portion of our Series A-1 Preferred Shares of SEED for $35.4 million, or $4.25 per share, to certain third-party investors in three installments.

The first closing of approximately $7.35 million occurred in February 2025.

The second closing of approximately $13.19 million and the third closing of approximately $14.88 million are expected to occur no later than December 15, 2025 and 2026, respectively.

The second closing of approximately $13.19 million is expected to be completed in 2026.

Under the terms of the definitive agreements, the third closing of approximately $14.88 million is scheduled to occur no later than December 15, 2026.

Each agreement contains specified termination rights for us and each purchaser, including a mutual termination right in the event a closing shall not have occurred by such specified date as set forth in each agreement.

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Additional programs are in development for anti-aging applications.

SEED’s internal lead program is a novel RBM39 degrader for multiple solid tumors, targeting IND filing around mid-2025.

RBM39 is an RNA splicing factor implicated in multiple mechanism-targeted solid tumor indications.

In July 2024, the FDA granted Rare Pediatric Disease and Orphan Drug designations to SEED’s IND candidate ST-01156.

SEED’s lead candidate, ST-01156, is a brain-penetrant RBM39 degrader entering clinical development for Ewing sarcoma and other RBM39-dependent cancers.

In July 2024, ST-01156 received Orphan Drug and Rare Pediatric Disease designations from the FDA for Ewing sarcoma.

The IND application was cleared by the FDA and the NMPA in August 2025 and November 2025, respectively.

In January 2026, the first patient was dosed in the Phase 1a dose-escalation study of ST-01156.

The following table summarizes the current status of Plinabulin’s and our other immuno-oncology product candidates’ indication in development.

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We are exploring the potential of Plinabulin in combination with immuno-oncology agents and other synergistic standards of care to target severe unmet medical needs in oncology.

Plinabulin is a first-in-class small molecule, which is a unique tubulin binder with mechanism to induce dendritic cell maturation and T-cell activation, and targets tumor vasculature based on its differentiated binding to tubulin.

We believe that its unique mechanism supports the improved anti-cancer efficacy potential in combination with checkpoint inhibitors and tumor antigen generators, including chemotherapy or radiation.

Plinabulin is a first-in-class small molecule, which is a unique microtubule modulator and GEF-H1 agonist with mechanism to induce dendritic cell maturation and T-cell activation, and tumor vasculature modulation.

We believe that its unique mechanism supports the improved anti-cancer efficacy potential in combination with tumor antigen generators, including chemotherapy or radiation, with or without checkpoint inhibitors.

We have multiple ongoing investigator-initiated studies with PD-1 antibodies provided by Merck and BMS, and these studies were conducted at leading institutions including MD Anderson, Rutgers University, and Peking Union Medical College Hospital in Beijing, China.

The goal of these studies is to advance Plinabulin in clinical trials to investigate its therapeutic potential immuno-oncology agent in multiple cancers, especially in PD-1/PD-L1 antibody progressed patients, which we believe represent high unmet medical needs.

Advance Plinabulin through global clinical trials and obtain regulatory approvals in select geographies.

Advance Plinabulin through global clinical trials and obtain regulatory approvals in select geographies in second- and third-line non-squamous EGFR wild type NSCLC.

We have treated over 700 cancer patients with Plinabulin with good tolerability.

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this regimen represents a potential positive benefit/risk ratio for these very sick patient population.

In plinabulin-mechanism based non-squamous population, the overall survival benefit is more pronounced in plinabulin and docetaxel combination.

We plan to use our best efforts to file an NDA with the NMPA as soon as possible.

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All of our clinical trials have been conducted globally by working with leading global contract research organizations, or CROs, such as ICON and Covance (now Labcorp) to assure the quality of the data.

In addition, we plan to initiate a confirmatory global phase 3 study for Plinabulin+docetaxel vs.

docetaxel alone in second- and third-line NSCLC with epidermal growth factor receptor (EGFR) wild type after progression on prior immune checkpoint inhibitors, a severe unmet medical need.

We believe that our global development strategy has provided significant advantages, including the ability to conduct trials in China with timely and cost-effective enrollment.

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We believe Plinabulin, if approved, could have significant commercial potential in the U.S.

and globally as an anti-cancer agent across several substantial solid tumor patient populations, such as NSCLC and ES-SCLC, among others.

and globally as an anti-cancer agent across several substantial solid tumor patient populations, such as NSCLC, head and neck cancer, and ES-SCLC, among others.

Additionally, our early clinical results in immune-oncology indicate that Plinabulin may play an important role in triple combination immunotherapy with chemotherapy to improve or expand effectiveness of current immune-oncology therapeutic regimens and reduce chemotherapy induced neutropenia.

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Further, SEED has since reached three R&D milestones under the Collaboration Agreement with Eli Lilly, which we believe demonstrates the team’s execution capabilities.

Furthermore, SEED currently has a robust pipeline with nine programs (six internal and three with Eli Lilly and Eisai) in diverse indications including oncology, neurodegeneration, immunology and anti-viral, with a lead internal oncology asset RBM39 degrader expected to file IND around mid-2025.

Furthermore, SEED currently has a robust pipeline with nine programs (six internal and three with Eli Lilly and Eisai) in diverse indications including oncology, neurodegeneration, immunology and anti-viral, with a lead clinical candidate, ST-01156, a brain-penetrant RBM39 degrader.

With over 600 E3 ligases in the cell, TPD has the potential to develop drugs for over 70% of undruggable targets with novel discovery agents in multiple disease areas.

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We also owned 13 pending U.S.

non-provisional patent applications as well as corresponding patent applications pending in other jurisdictions and four pending U.S.

non-provisional patent applications as well as corresponding patent applications pending in other jurisdictions and two pending U.S.

provisional patent applications.

In addition, we owned four pending international patent applications related to Plinabulin filed under the Patent Cooperation Treaty, or PCT, which we plan to file nationally in the U.S.

and in other jurisdictions directed to 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.

In addition, we owned three pending international patent applications related to Plinabulin filed under the Patent Cooperation Treaty, or PCT, which we plan to file nationally in the U.S.

and in other jurisdictions directed to combination therapies using plinabulin.

Our patent portfolio as of December 31, 2025 included 19 issued U.S.

patents directed to Plinabulin synthesis, polymorphic forms of Plinabulin, Plinabulin compositions, Plinabulin analogs, and Plinabulin use in the treatment of various disorders including docetaxel-induced neutropenia and certain other CIN, various cancers such as lung cancer, breast cancer, melanoma, prostate cancer, RAS mutant tumors, and brain tumors, and use of Plinabulin in combination with gemcitabine to reduce thrombocytopenia.

patents directed to polymorphic forms of Plinabulin, Plinabulin compositions, Plinabulin analogs, and Plinabulin use in the treatment of various disorders including docetaxel-induced neutropenia and certain other CIN, RAS mutant tumors, and brain tumors, and use of Plinabulin in combination with gemcitabine to reduce thrombocytopenia, and in combination with a PD-1 or PD-L1 inhibitor to treat cancer resistant to or progressed after prior treatment with one or more immune checkpoint inhibitor.

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

The patent portfolio also contained counterpart patents granted in 32 foreign jurisdictions including Japan, South Korea, China, European countries, and other countries.

The patent portfolio also contained patents granted in 34 foreign jurisdictions including Japan, South Korea, China, European countries, and other countries.

The term of individual patents may vary based on the countries in which they are obtained.

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Our industry is highly competitive and subject to rapid and significant change.

While we believe that our development and commercialization experience, commercial strategy, Breakthrough Therapy Designation status, scientific knowledge and industry relationships provide us with competitive advantages, we face competition from pharmaceutical and biotechnology companies, including specialty pharmaceutical companies, and generic drug companies, academic institutions, government agencies and research institutions.

While we believe that our development and commercialization experience, commercial strategy, scientific knowledge and industry relationships provide us with competitive advantages, we face competition from pharmaceutical and biotechnology companies, including specialty pharmaceutical companies, and generic drug companies, academic institutions, government agencies and research institutions.

There are a number of large pharmaceutical and biotechnology companies that currently market and sell drugs or are pursuing the development of drugs for the treatment of cancer for which we are developing our product candidates.

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Plinabulin effectively activates GEF-H1, an immune defense protein, which is shown to prolong patient survival in a number of cancers.

The immune mechanism of Plinabulin can effectively add more T-cells, or “hit the gas” to kill cancer cells, while PD-1/PD-L1 antibodies are known to let T-cells “see” cancer cells, or “release the break.” Thus, combining Plinabulin, PD-1/PD-L1 antibodies, and chemotherapy or radiation have the potential to elevate the anti-cancer benefit and re-sensitize patients who progressed on immunotherapies.

The immune mechanism of Plinabulin can effectively add more T-cells, or “hit the gas” to kill cancer cells, while PD-1/PD-L1 antibodies are known to let T-cells “see” cancer cells, or “release the break.” Thus, combining Plinabulin, and chemotherapy or radiation, with or without PD-1/PD-L1 antibodies have the potential to elevate the anti-cancer benefit and re-sensitize patients who progressed on immunotherapies.

While we are investigating an alternative approach to disease treatment by using molecular glue technology to tag dysfunctional proteins with ubiquitin ligase and destroy such proteins, there are a number of companies who are also working on using such technology to target and destroy dysfunctional proteins.

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Government authorities in the U.S.

at the federal, state and local level extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing, export and import of drug products such as those we are developing.

at the federal, state and local levels extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing, export and import of drug products such as those we are developing.

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

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Senate and federal and state prosecutors.

In May 2018, President Trump released the “American Patients First” Blueprint which, along with related drug pricing proposals, could cause significant operational and reimbursement changes for the pharmaceutical industry.

Although a number of these and other proposed measures will require authorization through additional legislation to become effective, Congress and the current Trump administration have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs.

Although a number of proposed measures will require authorization through additional legislation to become effective, Congress and the current Trump administration have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs.

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.

However, it is unclear how the IRA will be effectuated or changed under the current Trump administration or the degree of impact that the IRA will ultimately have upon our business.

Further, a budget resolution passed by the 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.

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.

However, it is unclear if or how these or other measures may be effectuated or changed under the current administration or the degree of impact any of them may ultimately have upon our business.

Adoption of government controls and measures, and tightening of restrictive policies in jurisdictions with existing controls and measures, could limit payments for pharmaceuticals including our product candidates, if any achieve approval.

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

For example, in November 2020 the U.S.

Department of Health and Human Services issued rules that amended the regulations to the federal Anti-Kickback Statute;

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.

Many states have adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, not only the Medicare and Medicaid programs.

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The applicable civil penalties are subject to an annual increase based on inflation;

for 2025, the penalties are between $14,308 and $28,619 for each separate false claim.

for 2025, the penalties were between $14,308 and $28,619 for each separate false claim.

In addition, although the federal False Claims Act is a civil statute, conduct that results in a False Claims Act violation may also implicate various federal criminal statutes.

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The Affordable Care Act expanded the types of entities eligible to receive discounted 340B pricing.

The Affordable Care Act imposed a requirement on manufacturers of branded drugs to provide a 50% discount off the negotiated price of branded drugs dispensed to Medicare Part D patients in the coverage gap (i.e., the “donut hole”).

The Affordable Care Act imposed an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their market share in certain government healthcare programs, although this fee does not apply to sales of certain products approved exclusively for orphan indications.

In addition to these provisions, the Affordable Care Act established a number of bodies whose work may have a future impact on the market for certain pharmaceutical products.

These include the Patient-Centered Outcomes Research Institute, established to oversee, identify priorities in, and conduct comparative clinical effectiveness research and the Center for Medicare and Medicaid Innovation within the Centers for Medicare and Medicaid Services, to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

However, the current administration has taken action to limit or change certain U.S.

healthcare policies.

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

These include the Patient-Centered Outcomes Research Institute, established to oversee, identify priorities in, and conduct comparative clinical effectiveness research and the Center for Medicare and Medicaid Innovation (CMMI) within the Centers for Medicare and Medicaid Services, to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

The Affordable Care Act has been subject to challenges, as well as numerous ongoing efforts by the U.S.

Congress and the administrations of President Trump to repeal or amend the Affordable Care Act in whole or in part.

For example, a case challenging the Affordable Care Act’s requirement that private insurers cover certain preventative services is currently pending before the U.S.

District Court for the Northern District of Texas.

In March 2023, the judge struck down the requirement and, on appeal, in June 2024 the U.S.

For example, in March 2023, the U.S.

District Court for the Northern District of Texas struck down the Affordable Care Act’s requirement that private insurers cover certain preventative services.

On appeal, in June 2024 the U.S.

Court of Appeals for the Fifth Circuit held, among other things, that the Affordable Care Act’s requirement that group health plans and health insurance issuers cover certain preventative services without cost-sharing is unconstitutional.

The parties have petitioned to appeal the case to the U.S.

Supreme Court, which granted certiorari in January 2025.

The parties appealed the case to the U.S.

Supreme Court, which granted certiorari in January 2025 and upheld the constitutionality of the requirement in June 2025.

Although we cannot predict the full effect on our business of the implementation of existing legislation or the enactment of additional legislation pursuant to healthcare and other legislative reform, we believe that legislation or regulations that would reduce reimbursement for, or restrict coverage of, our products could adversely affect how much or under what circumstances healthcare providers will prescribe or administer our product candidates if we gain approval for any of them.

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The NMPA’s primary responsibility includes evaluating, registering and approving new drugs, generic drugs, imported drugs and traditional Chinese medicines;

approving and issuing permits for the manufacture, export and import of pharmaceutical products and medical appliances;

approving the establishment of enterprises for pharmaceutical manufacture and distribution;

formulating administrative rules and policies concerning the supervision and administration of cosmetics, pharmaceuticals and medical equipment.

and handling significant accidents involving these products.

The local provincial drug administrative authorities are responsible for supervision and administration of drugs within their respective administrative regions.

The PRC Drug Administration Law, promulgated by the Standing Committee of the National People’s Congress in 1984, as amended in 2001, 2013, 2015 and 2019, respectively, and the Implementing Measures of the PRC Drug Administration Law promulgated by the State Council in 2002, as amended in 2016, 2019 and 2024, respectively, set forth the legal framework for the administration of pharmaceutical products, including the research, development and manufacturing of drugs.

The PRC Drug Administration Law, promulgated by the Standing Committee of the National People’s Congress in 1984, as amended in 2001, 2013, 2015 and 2019, respectively, and the Implementing Measures of the PRC Drug Administration Law promulgated by the State Council in 2002, as amended in 2016, 2019 , 2024 and 2026 respectively and the most recently revised version shall take effect on May 15, 2026, set forth the legal framework for the administration of pharmaceutical products, including the research, development and manufacturing of drugs.

The PRC Drug Administration Law was revised to strengthen the supervision and administration of pharmaceutical products and to ensure the quality and safety of those products for human use.

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Good Clinical Trial Practice

To improve the quality of clinical trials, the CFDA amended the Administration Rules of Quality of Drug Clinical Practice in April 2020.

To improve the quality of clinical trials, the CFDA promulgated the Administration Rules of Quality of Drug Clinical Practice in August 2003.

According to the Administration Rules of Quality of Drug Clinical Practice, clinical trial means systematical investigation of drugs conducted on human subjects (patients or healthy volunteers) to prove or reveal the function, adverse reactions and/or absorption, distribution, metabolism and excretion of the drug being investigated.

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(i) the applicant may submit an application for communication to the CDE during the key phase of the clinical trial of drugs, and the CDE shall arrange for review officers to communicate with the applicant;

(ii) the applicant may submit research materials in phases to the CDE;

and (iii) the CDE shall, based on the available research materials, give opinions or recommendations pertaining to the next step of the research scheme and feedback to the applicant.

On December 10, 2020, the NMPA issued the revised Administration Measures for the Communication of Drug Development and Technical Review which stipulated detailed procedural rules of the communication.

(ii) the applicant may submit research materials in phases to the CDE, and the CDE shall, based on the available research materials, give opinions or recommendations pertaining to the next step of the research scheme and feedback to the applicant.

On December 10, 2020, the CDE issued the revised Administration Measures for the Communication of Drug Development and Technical Review which stipulated detailed procedural rules of the communication.

Pursuant to the revised Provisions for Drug Registration, the following drugs with significant clinical value may enjoy a priority procedure for drug marketing authorization:

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On July 8, 2020, the NMPA issued Protocol for the Review of Breakthrough Therapeutic Drugs (Trial), Protocol for Review and Approval of Conditional Approval of Drugs Marketing Applications (Trial) as well as Protocol for Prioritized Review and Approval of Drugs Marketing Certificates (Trial), which stipulated detailed procedural rules for the breakthrough therapeutic drug procedure and priority procedure, procedural rules for drugs that meet the conditions for conditional approval for marketing, and procedures and detailed conditions of the priority review and approval, respectively.

Plinabulin has been granted Breakthrough Therapy Designation by the NMPA, may enable us to pursue a more expedited path to approval in China and bring therapies to patients more quickly.

The Advantages of Category 1 New Drugs over Category 5 Drugs

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Compared with the application for Category 5 drugs, the application for Category 1 domestic new drugs has a more straight-forward registration pathway.

According to the Administration Measures for the Communication of Drug Development and Technical Review issued by NMPA on December 10, 2020, where breakthrough therapeutic drug procedure and priority procedure is granted, the application for clinical trial and marketing will be handled with priority and with enhanced communication with the CDE.

According to the Administration Measures for the Communication of Drug Development and Technical Review issued by CDE on December 10, 2020, where breakthrough therapeutic drug procedure and priority procedure is granted, the application for clinical trial and marketing will be handled with priority and with enhanced communication with the CDE.

In comparison, according to Provisions for Drug Registration promulgated by the SAMR in 2020, the registration pathway for Category 5 drugs is complicated and evolving.

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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 one-time umbrella approval procedure allowing approval of all phases of a new drug’s clinical trials at once, rather than the 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:

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On July 8, 2020, the NMPA issued Protocol for Review and Approval of Conditional Approval of Drugs Marketing Applications (Trial) which stipulated procedures and detailed conditions of the conditional approval.

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 trials application 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.

On March 12, 2021, the National People’s Congress issued the Fourteenth Five-Year Plan, which provides that the accelerated evaluation and approval mechanism shall be improved for innovative drugs, vaccines, medical devices.

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The environment and facilities for the animals’ living and propagating must meet state requirements;

The animals’ feed and water must meet state requirements;

The animals’ feed must meet state requirements;

The animals’ feeding and experimentation must be conducted by professionals, specialized and skilled workers, or other trained personnel;

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In July 2015, the Ministry of Science and Technology issued the Service Guide for the Examination and Approval of Sampling, Collecting, Trading, Exporting Human Genetic Resources, which provides that foreign entities that collect and use patients’ human genetic resources in clinical trials shall be required to file for an advance approval with the Human Genetic Resources Administration Office, or the HGRAO through its online system.

In October 2017, the Ministry of Science and Technology issued the Circular on Optimizing the Administrative Examination and Approval of Human Genetic Resources, which simplified the approval process for collecting and using human genetic resources for the purpose of seeking marketing authorization of drugs in China.

In May 2019, the State Council issued the Human Genetic Resources Regulation, or the HGR Regulation and revised in March 2024, which stipulates the approval requirements pertinent to research collaborations between Chinese and foreign-owned entities.

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In October 2020, the Standing Committee of the National People’s Congress of the PRC, or the SCNPC, promulgated the China Biosecurity Law, which became effective on April 15, 2021 and was amended on April 26, 2024.

The China Biosecurity Law reaffirms the regulatory requirements stipulated by the HGR Regulation while potentially increasing the administrative fines significantly in cases in which foreign entities are alleged to have collected, preserved or exported Chinese human genetic resources.

The China Biosecurity Law reaffirms the regulatory requirements stipulated by the HGR Regulation.

In May 2023, the Ministry of Science and Technology promulgated the Implementing Rules of the Regulation on the Administration of Human Genetic Resources, which became effective on July 1, 2023.

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Any organization or individual that needs to obtain personal information of others shall obtain such information legally and ensure the safety of such information, and shall not illegally collect, use, process or transmit personal information of others, or illegally purchase or sell, provide or make public personal information of others.

In November 2016, the SCNPC promulgated the Cyber Security Law, which became effective in June 2017.

In November 2016, the SCNPC promulgated the Cyber Security Law, which became effective in June 2017 and was amended in October 2025.

The Cyber Security Law requires network operators to perform certain functions related to cybersecurity protection and strengthen the network information management.

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Any individual or organization may neither acquire personal information by stealing or through other illegal ways, nor illegally sell or provide personal information to others.

On September 12, 2022, the Cyberspace Administration of China, or CAC, issued the proposed amendment to the Cyber Security Law for public comment.

The amendment included adjusting the types and ranges of administrative penalties for violations endangering network operation security and strengthening the responsibility of critical information infrastructure operations.

The amendment also seeks to improve the legal liability systems of network information security and personal information protection.

In July 2018, the National Health Commission promulgated the Measures on Standards, Security and Services of National Healthcare Big Data (for Trial Implementation), which set out the guidelines and principles for standards management, security management and services management of health and medical big data.

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The Data Security Measures 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.

Additional regulations, guidelines, and measures relating to data privacy and data protection are expected to be adopted, including the Measures for Security Assessment for Cross-border Transfer of Personal Information and Important Data (Draft for Comment), published in 2017, the Measures for Security Assessment for Cross-border Transfer of Personal Information (Draft for Comment), published in 2019, each of which indicates a trend of more stringent compliance requirements, and, if adopted or effective, would require security assessment and review before transferring personal health information out of China.

Since our subsidiaries are located in China, we are required to comply with the requirements of China’s network and data protection regime.

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The Enterprise Income Tax Law of the PRC, or the EIT Law, and its implementation rules permit certain high and new technologies enterprises, or HNTEs, to enjoy a preferential enterprise income tax rate subject to these HNTEs meeting certain qualification criteria.

One of our Chinese subsidiaries enjoys such preferential tax treatment.

On March 23, 2016, the Ministry of Finance and the State Administration of Taxation, or SAT, issued the Circular on Comprehensively Promoting the Pilot Program of the Collection of Value-added Tax in Lieu of Business Tax.

Effective from May 1, 2016, the PRC tax authorities collect VAT in lieu of business tax in all regions and industries.

VAT is applicable at a rate of 6% in lieu of business taxes for certain services and 17%, as adjusted to 16% between May 1, 2018 and March 31, 2019 and as adjusted to 13% starting from April 1, 2019, for the sale of goods and provision of tangible property lease services not listed in Article 2 Sub-article 2 of the Provisional Regulations on Value Added Tax of the PRC promulgated by the State Council in December 1993 and further amended in 2008, 2016 and 2017, respectively.

VAT payable on goods sold or taxable services provided by a general VAT taxpayer for a taxable period is the net balance of the output VAT for the period after crediting the input VAT for the period.

In accordance with the Value-Added Tax Law of the PRC, promulgated by the SCNPC and effective as of January 1, 2026, entities and individuals (including individual industrial and commercial households) that sell goods, services, intangible assets, real estate, and import goods within the territory of China are regarded as value-added tax payers and shall pay value-added tax in accordance with said Law.

The term “selling goods, services, intangible assets, and real estate” refers to the transfer of ownership of goods and real estate for consideration, the provision of services, and the transfer of ownership or the right to use intangible assets.

The value-added tax rates are set at 13%, 9%, 6%, and 0%, depending on the nature of the transactions.

The tax rate applicable under the simplified tax calculation method is 3%.

Regulations Relating to Intellectual Property Rights

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Under the Patent Law of the PRC, the term of patent protection starts from the date the patent was filed.

Patents relating to utility-models and designs are effective for ten years from the initial date the patent application was filed, patents relating to designs are effective for fifteen years from the initial date the patent application was filed, and patents relating to invention are effective for twenty years from the initial date the patent application was filed.

Patents relating to utility-models are effective for ten years from the initial date the patent application was filed, patents relating to designs are effective for fifteen years from the initial date the patent application was filed, and patents relating to invention are effective for twenty years from the initial date the patent application was filed.

The Patent Law of the PRC adopts the principle of “first to file,” which means where more than one person files a patent application for the same invention, a patent will be granted to the person who first filed the application.

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The compensation period shall not exceed five years, and the total validity term of patent rights since the new drug approved to be marketed shall not exceed 14 years.

Compared with the Patent Law of the PRC revised in 2008, changes in the 2020 revised Patent Law mainly include:

(i) clarifying the incentive mechanism for inventor or designer relating to service inventions;

(ii) extending the duration of design patent;

(iii) establishing a new system of “open licensing”;

(iv) strengthening the joint liability of internet service providers for network patent infringement;

(v) improving the distribution of burden of proof in patent infringement cases;

(vi) increasing the compensation for patent infringement;

and (vii) patent term adjustment to compensate delays of the China National Intellectual Property Administration, or CNIPA, or the CNIPA in the review of patent applications.

Existing patents can become invalid or unenforceable due to a number of factors, including lack of novelty, and/or lack of inventive step in technology, and deficiencies in patent application.

In China, a patent must have novelty, inventive step and practical applicability.

Under the Patent Law of the PRC, novelty means that before a patent application is filed, no identical invention or utility model has been publicly disclosed in any publication in China or abroad or has been publicly used or made known to the public by any other means, whether in or outside of China, nor has any other person filed with the patent authority an application that describes an identical invention or utility model and is recorded in patent application documents or patent documents published after the filing date.

Under the Patent Law of the PRC, novelty means that an invention or a utility model does not fall under the prior art;

and no organisation or individual has submitted an application to the patent administrative department under the State Council for an identical invention or utility model prior to the filing date, and record shall be made in the announced patent application documents or promulgated patent documents after the filing date.

Inventive step means, compared with existing technology, an invention has prominent substantial features and represents notable progress, and a utility model has substantial features and represents any progress;

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When a dispute arises as a result of infringement of the patent owner’s patent right, Chinese law requires that the parties first attempt to settle the dispute through consultation between them.

However, if the dispute cannot be settled through consultation, the patent owner, or an interested party who believes the patent is being infringed, may either file a civil legal suit or file an administrative complaint with the relevant patent administration authority.

Where the parties concerned are not willing to negotiate or the negotiation is unsuccessful, the patent owner, or an interested party who believes the patent is being infringed, may either file a civil legal suit or file an administrative complaint with the relevant patent administration authority.

A Chinese court may issue a preliminary injunction upon the patent owner’s or an interested party’s request before instituting any legal proceedings or during the proceedings.

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Any person who uses the relevant patents solely for the purposes of scientific research and experimentation;

Any person who manufactures, uses or imports patented drugs or patented medical equipment for the purpose of providing information required for administrative approval, or manufactures, uses or imports patented drugs or patented medical equipment for the abovementioned person.

Any person who manufactures, uses or imports patented drugs or patented medical equipment for the purpose of providing information required for administrative approval, or manufactures or imports patented drugs or patented medical equipment for the abovementioned person.

However, even if patented drugs are utilized on the ground of exemptions for unlicensed manufacture, use, sell or import of patented drugs prescribed in Patent Law of the PRC, such patented drugs cannot be manufactured, used, sold or imported for any commercial purposes without authorization granted by the patent owner.

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Trade Secrets

According to the Law Against Unfair Competition of the PRC promulgated in September 1993 and amended in November 2017 and April 23, 2019, respectively, the term “trade secrets” refers to technical information, business operation information and other commercial information that are not known to the public and have commercial value and for which corresponding confidentiality measures have been taken by their rights holders.

According to the Law Against Unfair Competition of the PRC promulgated in September 1993 and amended in November 2017, April 2019 and June 2025, respectively, the term “trade secrets” refers to technical information, business operation information and other commercial information that are not known to the public and have commercial value and for which corresponding confidentiality measures have been taken by their rights holders.

Under this law, business persons are prohibited from employing the following methods to infringe trade secrets:

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In contrast, approval from or registration with appropriate government authorities is required when RMB is to be converted into a foreign currency and remitted out of China to pay capital expenses such as the repayment of foreign currency-denominated loans.

In November 2012, SAFE promulgated and revised in May 2015 the Circular of Further Improving and Adjusting Foreign Exchange Administration Policies on Foreign Direct Investment, which substantially amends and simplifies the current foreign exchange procedure.

Pursuant to this circular, the opening of various special purpose foreign exchange accounts, such as pre-establishment expenses accounts, foreign exchange capital accounts and guarantee accounts, the reinvestment of RMB proceeds by foreign investors in China, and remittance of foreign exchange profits and dividends by a Foreign Investment Enterprise, or FIE, to its foreign shareholders no longer require the approval or verification of SAFE, and multiple capital accounts for the same entity may be opened in different provinces, which was not previously possible.

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The proportion of such discretionary settlement is temporarily determined as 100%.

The RMB converted from the foreign exchange capital will be kept in a designated account, and if an FIE needs to make further payment from such account, it still must provide supporting documents and go through the review process with the banks.

Furthermore, SAFE Circular 19 stipulates that the use of capital by FIEs must adhere to the principles of authenticity and self-use within the business scope of enterprises.

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The proportion of such discretionary settlement is temporarily determined as 100%.

The RMB converted from relevant foreign exchange will be kept in a designated account, and if a domestic enterprise needs to make further payment from such account, it still must provide supporting documents and go through the review process with the banks.

Furthermore, SAFE Circular 16 reiterates that the use of capital by domestic enterprises must adhere to the principles of authenticity and self-use within the business scope of enterprises.

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Regulation of Dividend Distribution

The principal laws, rules and regulations governing dividend distribution by FIEs in China are the Company Law of the PRC, which was most recently amended on December 29, 2023 and will become effective on July 1, 2024, the Foreign Investment Law, which took effect on January 1, 2020, and its implementation regulations, which took effect on January 1, 2020.

The principal laws, rules and regulations governing dividend distribution by FIEs in China are the Company Law of the PRC, which was most recently amended on December 29, 2023 and became effective on July 1, 2024, the Foreign Investment Law, which took effect on January 1, 2020, and its implementation regulations, which took effect on January 1, 2020.

Under these laws and regulations, FIEs may pay dividends only out of their accumulated profit, if any, as determined in accordance with Chinese accounting standards and regulations.

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Furthermore, according to the Overseas Listing Trial Measures, if a domestic company fails to complete the filing procedure or conceals any material fact or falsifies any major content in its filing documents, such domestic company may be subject to administrative penalties, such as order to rectify, warnings, fines, and its controlling shareholders, actual controllers, the person directly in charge and other directly liable persons may also be subject to administrative penalties, such as warnings and fines.

However, since the Overseas Listing Trial Measures was newly promulgated, the interpretation, application and enforcement of Overseas Listing Trial Measures remain unclear.

On February 17, 2023, CSRC also issued the Notice on Administration for the Filing of Overseas Offering and Listing by Domestic Companies, which, among others, provided that (1) the domestic companies that have already been listed overseas on or before the effective date of the Overseas Listing Trial Measures (i.e.

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if domestic companies fail to complete the overseas listing within such six-month transition period, they shall file with the CSRC according to the requirements.

and (4) the CSRC will solicit opinions from relevant regulatory authorities and complete the filings of the overseas listing of companies with contractual arrangements which duly meet the compliance requirements, and support the development and growth of these companies by enabling them to utilize two markets and two kinds of resources.

On February 24, 2023, the CSRC, together with other authorities, jointly issued the Provisions on Strengthening the Confidentiality and Archives Administration Related to the Overseas Securities Offering and Listing by Domestic Enterprises, or the Confidentiality and Archives Administration Provisions, which came into effect on March 31, 2023.

63 unchanged sentences

These include our annual reports on Form 10-K, our quarterly reports on Form 10-Q, and our current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act.

We announce material information to the public about the Company, the progress and results of its clinical trials and research and development programs, and other matters through a variety of means, including filings with the SEC, press releases, public webcasts and presentations, the Company’s website (www.beyondspringpharma.com), and/or social media, including its LinkedIn account (https://www.linkedin.com/company/beyondspring-pharmaceuticals/) and X account (@BeyondSpringInc), in order to achieve broad, non-exclusionary distribution of information to the public.

We announce material information to the public about the Company, the progress and results of its clinical trials and research and development programs, and other matters through a variety of means, including filings with the SEC, press releases, public webcasts and presentations, the Company’s website (www.beyondspringpharma.com), and/or social media, including its LinkedIn account (www.linkedin.com/company/beyondspring-pharmaceuticals/) and X account (@BeyondSpringInc), in order to achieve broad, non-exclusionary distribution of information to the public.

We encourage investors and others to review the information we make public in these locations, as such information could be deemed to be material information.

2 unchanged sentences

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