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federal income tax purposes.
−Removed: Notwithstanding the foregoing, as discussed elsewhere in this Annual Report on Form 10-K, for purposes of U.S.
−Removed: federal securities law, we have become a domestic issuer for purposes of U.S.
+Added: Notwithstanding the foregoing, in 2025, we became a domestic issuer for purposes of U.S.
federal securities law.
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We are a clinical stage global biopharmaceutical company focused on developing innovative therapies to improve clinical outcomes for patients with high unmet medical needs.
−Removed: 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.
+Added: 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 ICI treatment in cancer patients.
+Added: 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 CIN.
We are also developing three small molecule immune agents, which are currently in pre-clinical stages.
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Business—SEED’s Targeted Protein Degradation (TPD) Platform and Pipeline—SEED’s relationship with BeyondSpring” for additional information.
−Removed: 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.
+Added: SEED is utilizing a proprietary 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.
+Added: 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 Eisai to discover and develop new chemical entities through this proprietary TPD platform which could produce therapeutic benefits to patients suffering from oncology and CNS disease, among others.
Plinabulin is being studied as an anti-cancer agent in a number of company-sponsored studies and investigator-initiated studies.
−Removed: 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, EGFR wild type (DUBLIN-3 Phase 3 registration study).
−Removed: 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.
+Added: 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.
+Added: 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 with doubling 2-year and 3-year OS rate.
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.
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We plan to use our best efforts to file an NDA with the NMPA as soon as possible.
−Removed: 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.
−Removed: Once patients progress on these regimens, docetaxel is the recommended in the second line, but it has modest clinical benefit and high severe neutropenia.
+Added: 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.
+Added: The current standard of care for first-line EGFR wild type NSCLC is PD-1/PD-L1 antibodies with or without platinum doublet.
+Added: However, over 60% patients progress on these therapies, defined as “acquired resistance” due to “T cell exhaustion” and/or “APC pathway mutation” (Memon et al., Cancer Cell 2024).
+Added: 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.
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):
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.
−Removed: We presented the early data of disease control rate and prolonged PFS from this study at ESMO 2024 and SITC 2024.
+Added: We presented clinical meaningful data of high disease control rate and prolonged PFS from this study at ESMO 2024, SITC 2024, and ASCO 2025.
+Added: In addition, 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%.
+Added: This paper was published in Cell Press “Med” in June 2025.
+Added: Plinabulin’s rapid DC maturation biomarker analysis was observed in responding patients.
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 ES-SCLC patients at Wuhan Union Hospital in China, where the current standard of care has limited median PFS.
−Removed: Additional investigator initiated studies with Plinabulin include:
+Added: Additional completed investigator initiated studies with Plinabulin include:
1) in combination with nivolumab, a PD-1 antibody, for the treatment of NSCLC at UCSD and the University of Washington (Phase 1 completed);
−Removed: 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.
+Added: and 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.
clinical centers (Phase 1 completed, Phase 2 completed for patients who progressed on PD-1/PD-L1 antibodies).
−Removed: 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 MD Anderson (Phase 1 completed and presented at SITC 2023).
−Removed: We provide financial support for these various investigator-initiated clinical trials as well as the drug supply of Plinabulin.
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.
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We have financed our operations with a combination of equity financings, shareholder and third-party loans, including bank loans, sale of subsidiary interests and collaboration arrangements.
−Removed: Through December 31, 2024, we have raised approximately $299.0 million in equity financings, $10.2 million of issuance of non-controlling 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.
+Added: Through December 31, 2025, we have raised approximately $301.0 million in equity financings, $10.2 million of issuance of non-controlling 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 Wanchunbulin from Hengrui.
As of December 31, 2025, our continuing operations had cash and cash equivalents of $7.8 million.
−Removed: 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.
−Removed: Business—SEED’s Targeted Protein Degradation (TPD) Platform and Pipeline.”
Since inception we have incurred operating losses.
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As of December 31, 2025 and 2024, we had an accumulated deficit of $408.4 million and $407.4 million, respectively.
−Removed: Substantially all of our losses have resulted from funding our preclinical studies, clinical trials, manufacturing our drug product, our research and development programs and from general and administrative costs associated with our operations.
+Added: Substantially all of our losses have resulted from funding our preclinical studies, clinical trials, manufacturing our drug product, our research and development programs and from general and administrative expenses associated with our operations.
We expect to continue to incur significant expenses and operating losses for the foreseeable future.
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Adequate funding may not be available to us on acceptable terms, or at all.
−Removed: In particular, inflation and high interest rates across the global economy, governments’ monetary policy in response to inflation concerns, concerns around tariffs and a possible recession, the ongoing hostilities between Russia and Ukraine and the current war between Israel and Hamas have caused, and may continue to cause, market volatility, and under such market conditions, we may not be able to obtain funding on reasonable terms or at all.
+Added: In particular, inflation and high interest rates across the global economy, governments’ monetary policy in response to inflation concerns, concerns around tariffs and a possible recession, the ongoing hostilities between Russia and Ukraine and escalating geopolitical tensions and military conflicts in the Middle East, including conflicts involving Israel, Hamas, Iran and other regional actors, have caused, and may continue to cause, market volatility, and under such market conditions, we may not be able to obtain funding on reasonable terms or at all.
Discontinued Operations
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The first closing of 1,730,454 shares for approximately $7.35 million occurred in February 2025.
−Removed: The second closing of 3,103,055 shares for approximately $13.19 million and the third closing of 3,500,128 shares for approximately $14.88 million are expected to occur no later than December 15, 2025 and 2026, respectively.
+Added: The second closing of 3,103,055 shares for approximately $13.19 million is expected to be completed in 2026.
+Added: Under the terms of the definitive agreements, the third closing of 3,500,128 shares for 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.
+Added: In September 2025, SEED entered into share purchase agreements with certain third-party investors to sell an aggregate of 1,411,761 of its Series A-3 Preferred Shares for an aggregate purchase price of $6 million at a cash purchase price of $4.25 per share.
As of the date of this Annual Report on Form 10-K, the BYSI Entities own approximately 38.03% of the outstanding equity interest in SEED, and are expected to own approximately 26.56% and 13.62% of the outstanding equity interest in SEED after the second and third closings, respectively, in each case calculated on an as-converted basis (excluding any shares that may be reserved under an employee stock ownership plan, or similar arrangement), and assuming there is no other change to SEED’s share capital prior to such closings.
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We reclassified the financial results of SEED to Discontinued Operations in the Consolidated Statements of Comprehensive Loss for all periods presented.
+Added: In connection with the first closing described above, we recorded a gain on sale of subsidiary interests of $7.0 million.
We also reclassified the related assets and liabilities as current and noncurrent assets and liabilities of discontinued operations on the accompanying Consolidated Balance Sheets as of December 31, 2025 and 2024.
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The TPD platform segment was comprised of SEED’s operations.
−Removed: As a result of SEED’s operations being reclassified as discontinued operations, the TPD platform segment is excluded from the Company’s continuing operations at year end 2024.
+Added: As a result of SEED’s operations being reclassified as discontinued operations, the TPD platform segment is excluded from the Company’s continuing operations.
See Note 14 (Segment reporting and geographic information) to our consolidated financial statements for additional information.
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costs associated with protecting intellectual property;
−Removed: share-based compensation to employees, directors and non-employee consultants;
other expenses, which include direct and allocated expenses for rent, insurance and other supplies used in research and development activities.
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Other Income (Expenses)
−Removed: Other income consists primarily of government grants received and interest income earned on our cash and cash equivalents.
+Added: Other income consists primarily of foreign exchange gains and interest income earned on our cash and cash equivalents.
Other expenses consist primarily of foreign exchange losses.
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Other income (expense)
−Removed: Foreign exchange loss, net
+Added: Foreign exchange gain (loss), net
Interest income
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Loss from discontinued operations
+Added: Gain on sale of subsidiary interests
Income tax expenses
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Research and development (R&D) expenses were $4.4 million for the year ended December 31, 2025 compared to $2.6 million for the year ended December 31, 2024.
−Removed: The $4.7 million decrease was primarily due to lower clinical development expense, lower professional services expense, lower personnel costs and lower facility and other expenses, as results of completion of DUBLIN-3, PROTECTIVE-1 and PROTECTIVE-2 studies.
+Added: The $1.8 million increase was primarily due to expanded drug manufacturing activities to prepare for potential future study initiation, increased data management efforts related to NSCLC study data cleaning and validation, increased Plinabulin combination therapy research supporting strategic business development and partnership initiatives, higher regulatory affairs related professional service expenses, and higher personnel costs.
The following table summarizes the research and development expenses for the years ended December 31, 2025 and 2024:
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General and administrative (G&A) expenses were $4.6 million for the year ended December 31, 2025, compared to $6.1 million for the year ended December 31, 2024.
−Removed: The $1.7 million decrease was primarily due to lower professional services costs.
−Removed: There were also decreases in costs in facilities, financial operations and miscellaneous items such as travel and entertainment, as results of process optimization and workflow streamlining.
+Added: The $1.5 million decrease was primarily attributable to lower personnel costs resulting from reduced headcount, decreased professional service expenses related to business development and partnership consulting, and lower corporate overhead including D&O insurance premiums and investor marketing advisory expenses.
Other Income (Expenses)
+Added: Other income for the year ended December 31, 2025 consisted primarily of foreign exchange gains and interest income earned on our cash and cash equivalents.
Other income for the year ended December 31, 2024 consisted primarily of foreign exchange losses, offset by interest income.
−Removed: Other income for the year ended December 31, 2023 consisted primarily of $0.8 million of cash government grants received for R&D expenses incurred in the past and $0.3 million of interest income.
Non-Accelerated Filer
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Since inception, we have incurred net losses and negative cash flows from our operations.
−Removed: Substantially all of our negative cash flows have resulted from funding our research and development programs and general and administrative costs associated with our operations.
+Added: Substantially all of our negative cash flows have resulted from funding our research and development programs and general and administrative expenses associated with our operations.
We incurred consolidated net losses of $14.2 million and $16.7 million for the years ended December 31, 2025 and 2024, respectively.
As of December 31, 2025 and 2024, we had an accumulated deficit of $408.4 million and $407.4 million, respectively.
−Removed: Our primary use of cash is to fund research and development costs and for general and administrative costs.
+Added: Our primary use of cash is to fund research and development costs and for general and administrative expenses.
Our operating activities used $19.8 million and $16.4 million of cash, including $12.3 million and $7.7 million used in discontinued operating activities, during the years ended December 2025 and 2024, respectively.
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As of December 31, 2025, our continuing operations had cash and cash equivalents of $7.8 million.
−Removed: 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.
−Removed: Business—SEED’s Targeted Protein Degradation (TPD) Platform and Pipeline.”
Our liquidity is affected by financing activities, our clinical trials, and research and development and general and administrative expenses.
−Removed: We will need, among other things, additional capital resources.
We anticipate that our current financial resources will allow us to meet our operational expenses and capital expenditures in the next 12 months after the date of this Annual Report on Form 10-K.
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Net cash used in operating activities
−Removed: Net cash used in investing activities
+Added: Net cash provided by (used in) investing activities
Net cash provided by financing activities
Net effect of foreign exchange rate changes
−Removed: Net decrease in cash, cash equivalents and restricted cash
+Added: Net decrease in cash and cash equivalents
The following table provides information regarding cash flows of discontinued operations for the years ended December 31, 2025 and 2024:
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Net cash used in discontinued operating activities
−Removed: Net cash used in discontinued investing activities
+Added: Net cash provided by (used in) discontinued investing activities
Net cash provided by discontinued financing activities
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The cash used in operating activities for the years ended December 31, 2025 and 2024 resulted primarily from our net losses of $14.2 million and $16.7 million, respectively, adjusted for non-cash charges and changes in components of working capital.
−Removed: During 2024, these non-cash charges mainly consisted of $2.3 million of non-cash share-based compensation and $0.7 million of non-cash operating lease expenses.
+Added: During 2025, these non-cash charges mainly consisted of $7.0 million of gain on sale of subsidiary interests, $0.7 million of non-cash share-based compensation and $0.7 million of non-cash operating lease expenses.
Net cash used in operating activities was $19.8 million for the year ended December 31, 2025, compared to $16.4 million for the year ended December 31, 2024.
−Removed: There were no major changes to the scale of operating activities on a consolidated basis.
−Removed: The primary use of our cash in the periods presented was to fund the development of our research and development, regulatory and other clinical trial costs and related administrative costs.
+Added: The $3.4 million increase was primarily due to increase of operating cash expenditures by our discontinued operations to fund their own R&D activities.
+Added: The primary use of our cash in the periods presented was to fund our research and development, regulatory and other clinical trial costs and related administrative expenses.
Our advances to suppliers and other current assets, accounts payable and accrued expense balances in all periods presented were affected by the timing of vendor invoicing and payments.
−Removed: Net Cash Used in Investing Activities
−Removed: Net cash used in investing activities for the year ended December 31, 2024 and 2023 was $12.0 million and $0.1 million, respectively.
+Added: Net Cash Provided by (Used in) Investing Activities
+Added: Net cash provided by investing activities for the year ended December 31, 2025 was $10.8 million.
+Added: Net cash used in investing activities for the year ended December 31, 2024 was $12.0 million.
+Added: During 2025, net cash was primarily provided by maturity of time deposits, partially offset by cash used in acquiring structured deposits.
During 2024, net cash was primarily used for acquiring time deposits.
−Removed: During 2023, net cash was primarily used for acquiring property and equipment.
Net Cash Provided by Financing Activities
−Removed: Net cash provided by financing activities for the year ended December 31, 2024 was $26.8 million.
−Removed: Net cash provided by financing activities for the year ended December 31, 2023 was $4.0 thousand.
+Added: Net cash provided by financing activities for the year ended December 31, 2025 and 2024 was $5.0 million and $26.8 million, respectively.
During 2025, we received aggregate net cash proceeds of $2.0 million from the issuance of our equity securities.
−Removed: SEED received $20.0 million from the issuance of its Series A-3 Preferred Shares.
−Removed: During 2023, net cash was primarily provided by the proceed of employees’ exercise of share options issued by SEED.
+Added: SEED received $3.0 million from the sale of its Series A-3 Preferred Shares.
+Added: During 2024, we received aggregate net cash proceeds of $3.0 million from the issuance of our equity securities.
+Added: SEED received $20.0 million from the sale of its Series A-3 Preferred Shares.
Future Liquidity and Material Cash Requirements
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Payments under the lease are expensed on a straight-line basis over the period of the lease.
−Removed: As of December 31, 2024, we occupied office space in Dalian, China, under a rent-free arrangement with the local government.
−Removed: This space, measuring 860.12 square meters, remained in use throughout 2024 while our formal application for rent exemption was under review.
−Removed: The local government office has since approved the rent-free subsidy for the 2024 lease, and as of March 1, 2025, the subsidy is pending disbursement by the government’s finance department.
−Removed: Upon the lease’s expiration on December 31, 2024, we transitioned to a new office space in Dalian, China, under a lease agreement with a different landlord.
−Removed: The new office, effective January 1, 2025, measures 210.65 square meters, with a monthly rent of $1,404.
+Added: We lease office space in Dalian, China, with total space of 210.65 square meters and a monthly rent of RMB 10,252 (approximately $1,466).
The lease is set to expire on December 31, 2027.
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Certain of these estimates are considered critical as they involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our consolidated financial statements.
−Removed: Our critical accounting estimates are summarized below.
+Added: Our critical accounting estimate is summarized below.
For a summary of significant accounting policies and the effect on our financial statements, see Note 2 to our consolidated financial statements included in this Annual Report.
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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.