ST-01156

Nov. 12, 2025 -- SEED Therapeutics, Inc. (“SEED”), a clinical-stage biotechnology company pioneering rational molecular glue degraders for historically undruggable disease drivers, today announced that China’s National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for ST-01156. This clearance enables the inclusion of Chinese clinical sites in SEED’s planned global expansion study, which will follow the completion of the ongoing first-in-human dose-escalation trial of ST-01156 in patients with advanced solid tumors. SEED’s proprietary RITE3™ platform rationally identifies the optimal E3 ligase to target disease-causing proteins and enables the discovery of drug-like molecular glues for multiple indications. ST-01156 is SEED’s first clinical candidate and has received Orphan Drug and Rare Pediatric Disease designations from the U.S. FDA for Ewing sarcoma, a rare pediatric malignancy with no new approved therapies in over 30 years. “The NMPA’s clearance of our IND for ST-01156 marks an important step in SEED’s global development strategy,” said Dr. Lan Huang, Co-Founder, Chairman, and CEO of SEED. “With our dose-escalation study now underway, we are laying the groundwork for an expansion study focused on RBM39 mechanism-targeted cancers. The ability to include China as part of this program will broaden access to diverse patient populations and accelerate our understanding of ST-01156’s therapeutic potential.” “We are excited to expand the upcoming ST-01156 study into China,” said Dr. James Tonra, President and Chief Scientific Officer of SEED. “Our preclinical data show complete tumor regression in multiple xenograft models and strong target engagement, providing a compelling rationale to evaluate ST-01156 across RBM39-dependent tumors such as Ewing sarcoma, hepatocellular carcinoma, and KRAS-mutant cancers.” ST-01156 induces selective degradation of RBM39, a key regulator of RNA splicing and transcription that is overexpressed and required for survival in a broad range of cancers. In preclinical models, ST-01156 achieved complete tumor regression in xenografts of Ewing sarcoma, neuroblastoma, and KRAS-mutant colon cancer. Patient-derived models have identified additional RBM39-dependent tumors that will help inform enrollment in the expansion study, which will include sites in the United States, Europe, China, and other regions. SEED Therapeutics is a clinical-stage biotechnology company pioneering rationally designed molecular glue degraders to treat diseases driven by undruggable proteins. Its proprietary RITE3™ platform enables targeted protein degradation with small-molecule precision. SEED’s lead candidate, ST-01156, is an RBM39 degrader entering clinical development for Ewing sarcoma and other RBM39-dependent cancers. SEED was co-founded by four scientific leaders: Nobel Laureate Prof. Avram Hershko, discoverer of the ubiquitin-proteasome system Dr. Lan Huang, solved the first E3 Ligase structure and a serial biotech entrepreneur Prof. Ning Zheng (University of Washington, HHMI Investigator), pioneer of RING-finger E3 Ligase structures and coined the term “molecular glue” Prof. Michele Pagano (NYU Grossman School of Medicine, HHMI Investigator), a preeminent expert on E3 ligase biology Eli Lilly and Eisai are cornerstone investors and collaborators, supporting SEED’s mission to unlock undruggable disease targets. The company’s pipeline includes nine molecular glue programs across oncology, neurodegeneration, immunology, and virology. The content above comes from the network. if any infringement, please contact us to modify.

Two SITC 2025 presentations: First-in-class dendritic cell (DC) maturation agent Plinabulin drives immune re-sensitization in metastatic NSCLC patients who had progressed after PD-1/L1 inhibitors with disease control rate of 85% in combination with docetaxel and Keytruda. Mechanism studies with MD Anderson collaborators showed DC maturation and M1 macrophage polarization via a Plinabulin specific GEF-H1 dependent mechanism in responding patients with Plinabulin, PD-1 inhibitor and radiation. SEED, co-founded by BeyondSpring with 38% equity share, successfully completed its $30 million Series A-3 financing, alongside U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for its lead program targeting RBM39.SEED Named Finalist for 2025 Prix Galien USA “Best Start-Up” Award FLORHAM PARK, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, today reported Q3 2025 financial results alongside clinical and corporate milestones. “With over 700 patients treated, Plinabulin continues to demonstrate a favorable safety profile and meaningful potential as an immune-modulating therapy with unique mechanism of dendritic cell (DC) maturation and T cell priming,” said Dr. Lan Huang, Co-Founder, Chair and Chief Executive Officer of BeyondSpring. “With DC bridging innate and adaptive immunity, Plinabulin offers new hope for patients with NSCLC and other cancers whose disease progresses after checkpoint inhibitors, presented at recent SITC conference. In addition, results from our global Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine, showed that Plinabulin in combination with docetaxel achieved durable survival benefits and reduced chemotherapy-induced neutropenia, reinforcing its potential to advance the standard of care and drive long-term value creation.” Dr. Huang added, “At SEED, which we co-founded with Lilly five years ago, we are excited that our RBM39 molecular-glue degrader has received IND clearance from both the US FDA and China NMPA. It is such an honor to be the only target protein degradation company nominated by the Prix Galien Foundation, recognizing our commitment to developing transformative medicine for patients. We are also grateful for the support of our investors and collaborators, including Lilly and Eisai, and clinicians from leading US institutions, as we work together to advance molecular glue development to address undruggable targets for patients with unmet medical needs.” Key Milestones: Two SITC 2025 Presentations on Plinabulin Anti-cancer Clinical Benefit: Resensitize NSCLC Patients Who Progressed on Prior PD-1/L1 Inhibitors with Disease Control Rate of 85% in Phase 2 Clinical Study: New data from a phase 2 investigator-initiated study (NCT05599789, Peking Union Hospital China) evaluating Plinabulin, docetaxel, and pembrolizumab in metastatic NSCLC patients who progressed on prior PD-1/L1 inhibitors (n=47), showed encouraging efficacy and safety data. The combination demonstrated median progression-free survival (PFS) of 7.0 months, confirmed objective response rate (ORR) of 18.2%, duration of response (DOR) of 7.2 months, disease control rate (DCR) of 85%, and 12-month overall survival (OS) rate at 79%, and 24-month OS rate at 66% (median OS not reached).Resensitize Patients with Eight Cancer Types Who Failed Prior PD-1/L1 Inhibitors with Disease Control Rate of 54% through DC Maturation and M1 Macrophage Polarization via GEF-H1-dependent Mechanism in Phase 1 Clinical Study: This phase 1 investigator-initiated study (NCT04902040, MD Anderdon Cancer Center) shows that in addition to potent DC maturation for a systemic immune response, plinabulin combined with radiation and PD-1 inhibitor promotes proinflammatory monocytes and M1 macrophage polarization via a Plinabulin specific GEF-H1-dependent mechanism with the potential of overcoming acquired resistance to immune checkpoint inhibitors from pro-tumor macrophages. SEED, Co-founded by BeyondSpring with 38% Equity Share, Secured Financial Position and Achieved IND Clearance: SEED completed its $30 million Series A-3 financing and received U.S. FDA and China NMPA clearance of its Investigational New Drug (IND) application for its lead RBM39 degrader program. SEED was also named a finalist for the 2025 Prix Galien USA “Best Start-Up” Award and co-hosted a targeted protein degradation symposium at NYU Grossman School of Medicine honoring Co-Founder and Nobel Laureate Prof. Avram Hershko, with leading thought leaders in the TPD field as presenters. Third Quarter Financial Results1Continuing operations: Research and development (R&D) expenses were $1.0 million for the quarter ended September 30, 2025 compared to $0.6 million for the quarter ended September 30, 2024. The $0.4 million increase was primarily due to higher drug manufacturing expenses, higher professional service expenses in regulatory affairs and higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.General and administrative (G&A) expenses were $0.8 million for the quarter ending September 30, 2025 compared to $1.7 million for the quarter ended September 30, 2024. The $0.9 million decrease was primarily due to lower professional service costs in consulting for business development and partnership initiatives, and lower salary expenses driven by decrease in administrative headcount.Net loss: $1.7 million for the quarter ended September 2025, compared to $2.2 million for the quarter ended September 2024Cash and cash equivalents: $12.5 million as of September 30, 2025, compared to $2.9 million as of December 2024 Discontinued operations: Net loss: $3.2 million for the quarter ended September 2025, compared to $2.4 million for the quarter ended September 2024Current assets: $11.4 million as of September 2025, compared to $25.3 million as of December 2024 Year to Date Financial Results1Continuing Operations: Research and development (R&D) expenses were $2.9 million for the nine months ended September 30, 2025 compared to $2.2 million for the nine months ended September 30, 2024. The $0.7 million increase was primarily due to higher drug manufacturing expenses, higher professional service expenses in regulatory affairs, and higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.General and administrative (G&A) expenses were $3.4 million for the nine months ended September 30, 2025, compared to $4.9 million for the nine months ended September 30, 2024. The $1.5 million decrease was primarily due to lower salary expenses resulting from decrease in administrative headcount, lower professional services in consulting for business development and partnership initiatives, and lower company overhead expenses mainly due to decrease in investor relations services and D&O insurance related costs.Net loss: $6.2 million for the nine months ended September 2025, compared to $6.9 million for the nine months ended September 2024 Discontinued operations: Net loss: $2.2 million for the nine months ended September 2025, compared to $5.0 million for the nine months ended September 2024 Note 1: Accounting UpdateFollowing definitive agreements in January 2025 to sell the majority of its Series A-1 Preferred Shares in SEED Therapeutics, BeyondSpring now reports SEED’s financial results as discontinued operations under ASC 205-20. BeyondSpring currently owns approximately 38% of SEED and upon completion of the future sale transactions BeyondSpring would own approximately 14% of SEED’s outstanding shares. About BeyondSpringBeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies addressing high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and other indications. Plinabulin’s novel mechanism as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors resistant to checkpoint inhibitors. Learn more at beyondspringpharma.com. About SEED TherapeuticsSEED Therapeutics is a clinical-stage biotechnology company pioneering rationally designed molecular glue degraders to treat diseases driven by undruggable proteins. Its proprietary RITE3™ platform enables targeted protein degradation with small-molecule precision. SEED’s lead candidate, ST-01156, is a brain-penetrant RBM39 degrader entering clinical development for Ewing sarcoma and other RBM39-dependent cancers. SEED’s investors and collaborators include Eli Lilly and Eisai, both of whom have been instrumental in supporting SEED’s mission to unlock undruggable disease targets. The company’s pipeline includes nine programs across oncology, neurodegeneration, immunology, and virology. Learn more at seedtherapeutics.com. Cautionary Note Regarding Forward-Looking StatementsThis press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet the Company’s expectations regarding the potential safety, the ultimate efficacy or clinical utility of the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq’s continued listing requirements, and other risks described in BeyondSpring’s most recent Form 10-K on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. ContactsInvestor Relations: ir@beyondspring.comMedia: pr@beyondspringpharma.com BEYONDSPRING INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) As of December 31, 2024 September 30, 2025 $ $ (Unaudited) Assets Current assets: Cash and cash equivalents 2,922 12,483 Short term investments - 141 Advances to suppliers 240 250 Prepaid expenses and other current assets 68 131 Current assets of discontinued operations 25,347 11,406 Total current assets 28,577 24,411 Noncurrent assets: Property and equipment, net 239 184 Operating right-of-use assets 513 368 Other noncurrent assets 213 219 Noncurrent assets of discontinued operations 4,773 4,302 Total noncurrent assets 5,738 5,073 Total assets 34,315 29,484 Liabilities and equity Current liabilities: Accounts payable 295 304 Accrued expenses 840 990 Current portion of operating lease liabilities 282 313 Other current liabilities 780 676 Current liabilities of discontinued operations 8,813 10,608 Total current liabilities 11,010 12,891 Noncurrent liabilities: Operating lease liabilities 307 93 Deferred revenue 27,400 28,094 Other noncurrent liabilities 3,686 3,840 Noncurrent liabilities of discontinued operations 6,197 4,376 Total noncurrent liabilities 37,590 36,403 Total liabilities 48,600 49,294 Commitments and contingencies Shareholders’ deficit Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 40,316,320 and 40,322,320 shares issued and outstanding as of December 31, 2024 and September 30, 2025, respectively) 4 4 Additional paid-in capital 373,185 373,602 Accumulated deficit (407,425) (406,294)Accumulated other comprehensive income 1,336 913 Total BeyondSpring Inc.’s shareholders’ deficit (32,900) (31,775)Noncontrolling interests 18,615 11,965 Total shareholders’ deficit (14,285) (19,810) Total liabilities and shareholders’ deficit 34,315 29,484 BEYONDSPRING INC.CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)(Unaudited) Three months ended September 30, Nine months ended September 30, 2024 2025 2024 2025 $ $ $ $ Revenue - - - - Operating expenses Research and development (622) (1,039) (2,172) (2,915)General and administrative (1,736) (751) (4,882) (3,434) Loss from operations (2,358) (1,790) (7,054) (6,349)Foreign exchange gain, net 128 24 45 100 Interest income 15 19 55 64 Other income, net - 30 8 48 Loss before income tax (2,215) (1,717) (6,946) (6,137)Income tax expenses - (26) - (68) Net loss from continuing operations (2,215) (1,743) (6,946) (6,205) Discontinued operations Loss from discontinued operations (2,358) (3,201) (5,004) (9,204)Gain on sale of subsidiary interests - - - 6,986 Income tax expenses - - - - Net loss from discontinued operations (2,358) (3,201) (5,004) (2,218) Net loss (4,573) (4,944) (11,950) (8,423)Less: Net income (loss) attributable to noncontrolling interests from continuing operations (83) 41 (198) (106)Less: Net loss attributable to noncontrolling interests from discontinued operations (2,358) (3,445) (2,358) (9,448)Net income (loss) attributable to BeyondSpring Inc. (2,132) (1,540) (9,394) 1,131 Earnings (loss) per share, basic and diluted Continuing operations (0.05) (0.04) (0.17) (0.15)Discontinued operations - - (0.07) 0.18 Basic and diluted earnings (loss) per share (0.05) (0.04) (0.24) 0.03 Weighted-average shares outstanding Basic and diluted 40,300,350 40,317,266 39,539,494 40,316,639 Other comprehensive loss, net of tax of nil: Foreign currency translation adjustment loss from continuing operations (905) (166) (318) (660)Foreign currency translation adjustment gain (loss) from discontinued operations 4 (17) (7) (51)Comprehensive loss (5,474) (5,127) (12,275) (9,134)Less: Comprehensive loss attributable to noncontrolling interests from continuing operations (408) (19) (311) (343)Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations (2,354) (3,462) (2,354) (9,499)Comprehensive income (loss) attributable to BeyondSpring Inc. (2,712) (1,646) (9,610) 708