BeyondSpring Inc.

Previous wording

Plinabulin binds in a unique pocket of tubulin and activates the immune defense protein GEF-H1, which leads to induction of innate and adaptive immunity via dendritic cell maturation. It 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, with epidermal growth factor receptor (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. 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.

Current wording

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, a drug approved over 25 years ago, is recommended in the second- and third-line, but it has modest clinical benefit and results in high severe neutropenia. 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 epidermal growth factor receptor (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. 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. In addition, 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. We presented clinically meaningful data of high disease control rate 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.

Previous wording

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 PFS.

Current wording

In addition, Plinabulin is 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 PFS.

Previous wording

Additional 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 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. 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 (Phase 1 completed and presented at SITC 2023). We provide financial support for these various investigator-initiated clinical trials as well as the drug supply of Plinabulin.

Current wording

Additional 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 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. 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 in eight cancers who progressed from PD-1/PD-L1 antibodies at The University of Texas MD Anderson Cancer Center (Phase 1 completed and presented at SITC 2023, based on which we published Plinabulin’s DC maturation benefit to such patients in Cell Press “Med” in June 2025). We provide financial support for these various investigator-initiated clinical trials as well as the drug supply of Plinabulin.

Previous wording

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 strategy is to develop Plinabulin in multiple indications with the potential for Plinabulin to be an important component of the triple-agent combination with chemotherapy or radiation to release real-time tumor antigen, supported by Plinabulin’s potent dendritic cell maturation mechanism to present real-time tumor antigen to T cells, and immune checkpoint inhibitor regimens to elevate the anti-cancer benefit for cancer patients or to re-sensitize patients who failed prior immunotherapies. To implement our strategy, we use a highly efficient business model that integrates clinical resources in the U.S. and China. We work with global contract research organizations, or CROs, such as ICON and Covance (now Labcorp), to ensure data quality with studies conducted under U.S. Good Clinical Practice requirements. Our drug development capabilities are facilitated by interest from clinical investigators in the U.S. and China, as well as by our understanding of the pharmaceutical industry, clinical resources and regulatory system in China.

Current wording

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 chemotherapy induced neutropenia (CIN) as an additional safety benefit. In total, over 700 patients have been treated with Plinabulin, where improvements in CIN have been repeatedly observed. Recent publication in Cancer Cell (Memon et al. 2024) suggested the mechanism for “acquired resistance” to immunotherapies could be due to “T cell exhaustion” and/or “antigen presenting cell (APC) pathway mutation”, which Plinabulin’s mechanism of DC maturation, with DC as the most potent APC, could potential target. Our strategy is to develop Plinabulin in multiple indications with the potential for Plinabulin to be an important component of the combination with chemotherapy or radiation to release real-time tumor antigen, with or without PD-1/L1 inhibitor, to re-sensitize patients who failed prior immunotherapies. To implement our strategy, we use a highly efficient business model that integrates clinical resources in the U.S. and China. We work with global contract research organizations, or CROs, such as ICON and Covance (now Labcorp), to ensure data quality with studies conducted under U.S. Good Clinical Practice requirements. Our drug development capabilities are facilitated by interest from clinical investigators in the U.S. and China, as well as by our understanding of the pharmaceutical industry, clinical resources and regulatory system in China.

Previous wording

Through March 31, 2025, 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 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 March 31, 2025, our continuing operations had no outstanding debt and held $6.5 million in cash and cash equivalents. We expect to receive $28.07 million in tranches from the sale of our Series A-1 Preferred Shares of SEED as described under “—Discontinued Operations.”

Current wording

Through June 30, 2025, 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 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 June 30, 2025, our continuing operations had no outstanding debt and held $9.5 million in cash and cash equivalents. We expect to receive $28.07 million in tranches from the sale of our Series A-1 Preferred Shares of SEED as described under “—Discontinued Operations.”

Previous wording

Our consolidated net loss was $3.3 million for the three months ended March 31, 2024 and our consolidated net income was $1.2 million for the three months ended March 31, 2025. The consolidated net income for the three months ended March 31, 2025 includes a gain of $7.0 million on the sale of preferred shares of SEED by the Company to third-party investors. As of December 31, 2024 and March 31, 2025, we had an accumulated deficit of $407.4 million and $402.9 million, respectively. 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. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses may increase in connection with our ongoing activities, as we:

Current wording

Our consolidated net loss was $4.1 million and $7.4 million for the three and six months ended June 30, 2024, respectively. Our consolidated net loss was $4.6 million and $3.5 million for the three and six months ended June 30, 2025, respectively. As of December 31, 2024 and June 30, 2025, we had an accumulated deficit of $407.4 million and $404.8 million, respectively. 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. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses may increase in connection with our ongoing activities, as we:

Previous wording

To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future. For the three months ended March 31, 2025, our discontinued operations generated $0.5 million of revenue through SEED’s research collaboration and license agreement with Eli Lilly and our continuing operations did not generate any revenue. The RMB 200 million (approximately $31 million) upfront payment received by Wanchunbulin from Hengrui is recorded as deferred revenue and will be recognized as revenue over time after product approval using unit of delivery measure of progress. In the future, we may generate revenue from a combination of product sales, reimbursements, upfront payments, milestone payments and royalties in connection with existing and future collaborations. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval, we will not generate revenue from product sales in the future.

Current wording

To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future. For the three and six months ended June 30, 2025, our discontinued operations generated $0.5 million and $1.0 million of revenue, respectively, through SEED’s research collaboration and license agreement with Eli Lilly and our continuing operations did not generate any revenue. The RMB 200 million (approximately $31 million) upfront payment received by Wanchunbulin from Hengrui is recorded as deferred revenue and will be recognized as revenue over time after product approval using unit of delivery measure of progress. In the future, we may generate revenue from a combination of product sales, reimbursements, upfront payments, milestone payments and royalties in connection with existing and future collaborations. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval, we will not generate revenue from product sales in the future.

Previous wording

Research and development (R&D) expenses were $0.9 million for the three months ended March 31, 2025 compared to $0.7 million for the three months ended March 31, 2024. The $0.2 million increase was primarily due to higher personnel costs primarily attributable to a non-cash adjustment for 2024 incentive compensation recognized in 2025, and higher Plinabulin combination therapy research related costs to support strategic business development and partnership initiatives.

Current wording

Research and development (R&D) expenses were $1.0 million for the three months ended June 30, 2025 compared to $0.8 million for the three months ended June 30, 2024. The $0.2 million increase was primarily due to higher professional service fees in regulatory and CMC activities and higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.

Previous wording

Since inception, we have incurred negative cash flows from our operations. 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. We incurred consolidated net losses of $3.3 million for the three months ended March 31, 2024 and had consolidated net income of $1.2 million for the three months ended March 31, 2025. The consolidated net income for the three months ended March 31, 2025 includes a gain on sale of subsidiary interests of $7.0 million. As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of $402.9 million and $407.4 million, respectively. Our primary use of cash is to fund research and development costs and for general and administrative costs. Our operating activities used $4.2 million and $5.3 million of cash, including $2.5 million and $1.5 million used in discontinued operating activities, during the three months ended March 31, 2025 and 2024, respectively. We have financed our operations with a combination of equity offerings, shareholder and third-party loans, including bank loans, sale of subsidiary interests and collaboration arrangements. In February 2025, we received approximately $7.4 million in cash as consideration for the first closing of the sale of a portion of our equity interests in SEED. As of March 31, 2025, our continuing operations had cash and cash equivalents of $6.5 million.

Current wording

Since inception, we have incurred negative cash flows from our operations. 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. We incurred consolidated net losses of $7.4 million and $3.5 million for the six months ended June 30, 2024 and 2025, respectively. As of June 30, 2025 and December 31, 2024, we had an accumulated deficit of $404.8 million and $407.4 million, respectively. Our primary use of cash is to fund research and development costs and for general and administrative costs. Our operating activities used $10.1 million and $12.3 million of cash, including $5.8 million and $6.9 million used in discontinued operating activities, during the six months ended June 30, 2025 and 2024, respectively. We have financed our operations with a combination of equity offerings, shareholder and third-party loans, including bank loans, sale of subsidiary interests and collaboration arrangements. In February 2025, we received approximately $7.4 million in cash as consideration for the first closing of the sale of a portion of our equity interests in SEED. As of June 30, 2025, our continuing operations had cash and cash equivalents of $9.5 million.

Previous wording

The following table provides information regarding our consolidated cash flows for the three months ended March 31, 2025 and 2024:

Current wording

The following table provides information regarding our consolidated cash flows for the six months ended June 30, 2025 and 2024:

Previous wording

The following table provides information regarding cash flows of discontinued operations for the three months ended March 31, 2025 and 2024:

Current wording

The following table provides information regarding cash flows of discontinued operations for the six months ended June 30, 2025 and 2024:

Previous wording

The cash used in operating activities for the three months ended March 31, 2025 and 2024 reflects adjustments to our net income of $1.2 million and net loss of $3.3 million, respectively, for non-cash gains and charges, and changes in components of working capital. During the three months ended March 31, 2025, these non-cash adjustments mainly consisted of $7.0 million on gain of sale of subsidiary interests, $0.2 million of non-cash share-based compensation and $0.2 million of non-cash operating lease expenses. Net cash used in operating activities was $4.2 million for the three months ended March 31, 2025, compared to $5.2 million for the three months ended March 31, 2024. The $1.0 million decrease was primarily due to a decrease of operating cash expenditures during the quarter, partially offset by $0.2 million of cash proceeds from sale of short-term investments classified as trading securities.

Current wording

The cash used in operating activities for the six months ended June 30, 2025 and 2024 reflects adjustments to our net loss of $3.5 million and $7.4 million, respectively, for non-cash gains and charges, and changes in components of working capital. During the six months ended June 30, 2025, these non-cash adjustments mainly consisted of $7.0 million of gain on sale of subsidiary interests, $0.4 million of non-cash share-based compensation and $0.4 million of non-cash operating lease expenses. Net cash used in operating activities was $10.1 million for the six months ended June 30, 2025, compared to $12.3 million for the six months ended June 30, 2024. The $2.2 million decrease was primarily due to a decrease of operating cash expenditures during the quarter, partially offset by $0.3 million of cash proceeds from sale of short-term investments classified as trading securities.

Previous wording

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. 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.

Current wording

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 costs. 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.

Previous wording

Net cash provided by investing activities for the three months ended March 31, 2025 was 6.3 million, consisting primarily of $7.4 million cash consideration received in February 2025 for the first closing of the sale of a portion of our equity interests in SEED, offset by $1.0 million used to purchase time deposits. There were no cash provide by or used in investing activities for the three months ended March 31, 2024.

Current wording

Net cash provided by investing activities for the six months ended June 30, 2025 was $17.2 million, consisting primarily of $14.9 million cash proceeds from maturity of time deposits, $7.4 million cash consideration received in February 2025 for the first closing of the sale of a portion of our equity interests in SEED, offset by $5.0 million used to purchase time deposits. There were no cash provided by or used in investing activities for the six months ended June 30, 2024.

Previous wording

There were no cash provided by financing activities for the three months ended March 31, 2025 and 2024.

Current wording

There were no cash provided by financing activities for the six months ended June 30, 2025. Net cash provided by financing activities for the six months ended June 30, 2024 was the aggregate net cash proceeds of $3.0 million from the issuance of our equity securities.

Previous wording

We currently lease office space in New Jersey, with total space of 9,727 square feet. The lease expires in February 2027. Our current rent is $25,939 per month. Starting in August 2025, our annual rent will increase by $0.50 per square foot leased. We additionally pay for the cost of utilities, as well as our share of building real estate taxes and building operating expenses. Payments under the lease are expensed on a straight-line basis over the period of the lease.

Current wording

We currently lease office space in New Jersey, with total space of 9,727 square feet. The lease expires in February 2027. Our current rent is $26,344 per month. Starting in August 2026, our annual rent will increase by $0.50 per square foot leased. We additionally pay for the cost of utilities, as well as our share of building real estate taxes and building operating expenses. Payments under the lease are expensed on a straight-line basis over the period of the lease.

Previous wording

We lease office space in Dalian, China, with total space of 210.65 square meters and a monthly rent of $1,404. The lease is set to expire on December 31, 2027. Payments under the lease are expensed on a straight-line basis over the period of the lease. We are entitled to receive rent subsidy in the amount of RMB 220,000 (approximately $30,000) from the local government office of Dalian, China, with respect to our prior office lease in Dalian, China.

Current wording

We lease office space in Dalian, China, with total space of 210.65 square meters and a monthly rent of $1,404. The lease is set to expire on December 31, 2027. Payments under the lease are expensed on a straight-line basis over the period of the lease. We are entitled to receive rent subsidy in the amount of RMB 220,000 (approximately $31,000) from the local government office of Dalian, China, with respect to our prior office lease in Dalian, China.

Previous wording

See Note 2 to our condensed consolidated financial statements included in this Annual Report for recent accounting pronouncements.

Current wording

See Note 2 to our condensed consolidated financial statements included in this Quarterly Report for recent accounting pronouncements.