ASCO 2026 Knowledge Veil Prolonged-term Survival Earnings of Plinabulin/Docetaxel and Pembrolizumab in Metastatic NSCLC Following Development on First-Line Immune Checkpoint Inhibitor (ICI) Therapy
AACR 2026 Preclinical Knowledge Present the Scientific Rationale for Plinabulin as a Doubtless Backbone Agent to Mix with Antibody-Drug Conjugate (ADC) Regimens to Enhance Efficacy, Survival and Tolerability
Management Transition Efficient July 1, 2026 Aligns the Organization Around Focused Advancement of the Confirmatory DUBLIN-4 Program in NSCLC Put up-ICI and Prolonged-Term Sign Creation
FLORHAM PARK, N.J., Aug. 14, 2026 (GLOBE NEWSWIRE) — BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Firm”), a clinical-stage firm increasing transformative therapies for the treatment of cancer and various diseases, on the present time announced its financial results for the quarter ended June 30, 2026, and equipped a corporate change highlighting clinical progress for Plinabulin and the Firm’s leadership transition.
“The 2d quarter used to be marked by extra clinical and scientific make stronger for continuing Plinabulin pattern,” said Min Qiu, Chief Government Officer of BeyondSpring. “Updated Portion 2 knowledge presented at ASCO 2026 continued to repeat an encouraging 58% two-year OS price in metastatic NSCLC patients whose illness stepped forward after first-line immune checkpoint inhibitor (ICI) treatment. This encouraging prospective OS knowledge strengthens our conviction in the DUBLIN-4 explore, a confirmatory Portion 3 explore with OS because the foremost endpoint in non-squamous NSCLC publish-ICI with out a driver mutation, a extreme unmet medical need with docetaxel because the identical outdated of care. With our leadership transition now efficient, our priorities are determined: advancing the regulatory, operational and financing preparations mandatory to provoke DUBLIN-4.”
Mr. Qiu continued, “The DUBLIN-4 explore represents our lead clinical pattern precedence for a doubtless route in direction of future regulatory submissions. We predict regarding the revealed DUBLIN-3 leads to The Lancet Respiratory Treatment, recent ASCO 2026 clinical knowledge, and the AACR 2026 ADC aggregate findings collectively toughen Plinabulin’s differentiated doubtless as a potent dendritic cell maturation agent to crimson meat up survival advantages while mitigating treatment-limiting excessive-grade neutropenia in NSCLC and beyond.”
Recent Clinical and Company Highlights of Plinabulin
ASCO 2026 (Portion 2 knowledge): Plinabulin aggregate demonstrated durable response and survival support in publish-ICI metastatic NSCLC
- Presented updated efficacy and safety results from the investigator-initiated Portion 2 303 Gaze evaluating Plinabulin/docetaxel and pembrolizumab in 47 patients with metastatic NSCLC and bought resistance following first-line immune checkpoint inhibitor treatment.
- As of the February 28, 2026 knowledge cutoff, median progression-free survival used to be 7.0 months, median duration of response used to be 9.3 months, illness encourage watch over price used to be 79.5%, and confirmed aim response price used to be 18.2%.
- The 12-month and 24-month overall survival charges were 78.1% and 58.0%, respectively, with median overall survival no longer reached after a median apply-up of 28.8 months.
- The aggregate demonstrated a veritably manageable safety profile and proof of immune activation, alongside side increased frequencies of activated CD4+ and CD8+ T cells as neatly as increased white blood cell, neutrophil, and platelet counts.
AACR 2026 (preclinical knowledge): Improved entire response price, overall survival and tolerability of sure antibody-drug-conjugates (ADCs)
- Presented preclinical knowledge displaying that Plinabulin in aggregate with the accredited topoisomerase I inhibitor (TOP1)-primarily based completely ADCs enhanced entire tumor regression charges and/or survival of TROP-2-directed datopotamab deruxtecan or HER2-directed trastuzumab deruxtecan, with or with out PD-1/PD-L1 inhibition.
- Plinabulin improved tolerability in the preclinical aggregate devices and increased the CD8+ T-cell-to-Treg ratio, supporting an immune-mediated mechanism for the enhanced anticancer project.
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The findings make stronger Plinabulin’s doubtless to tackle restricted durability and treatment-limiting hematologic toxicity linked to ADC-primarily based completely treatment and develop the scientific rationale for future ADC aggregate stories.
DUBLIN-4 Confirmatory Portion 3 Program
- DUBLIN-4 is the Firm’s deliberate, randomized, double-blind, 442-patient confirmatory Portion 3 explore of Plinabulin plus docetaxel in non-squamous, EGFR wild-kind NSCLC patients who’ve stepped forward on PD-1/PD-L1 inhibitor-containing therapies.
- The program is designed to prospectively ascertain the survival and tolerability advantages observed in the DUBLIN-3 Portion 3 explore, which used to be revealed in The Lancet Respiratory Treatment in 2024.
BeyondSpring Management Transition and Company Execution
- Efficient July 1, 2026, Min Qiu used to be appointed Chief Government Officer with a mandate pondering about advancing DUBLIN-4, extending Plinabulin’s scientific optionality, and constructing BeyondSpring’s world partner and investor negative. Dr. Jiangwen (Jen) Majeti used to be appointed Vice Chairman, strengthening Board-stage governance continuity and strategic depth. Na Li used to be appointed Chief Monetary Officer to boost financial self-discipline, public-firm reporting, financing activities, and capital markets engagement.
- Dr. Lan Huang stays Co-Founder and Chairman of BeyondSpring, offering strategic vision and Board leadership, while devoting her executive point of curiosity to SEED Therapeutics, the effect she serves as Co-Founder, Chairman, and Chief Government Officer.
Second Quarter Monetary Results
Continuing operations:
- Analysis and pattern (R&D) fees were $1.0 million for the quarter ended June 30, 2026, when put next to $1.0 million for the quarter ended June 30, 2025. R&D fees remained relatively flat, as a $0.3 million lengthen in drug manufacturing activities to prepare for doubtless future explore initiation used to be considerably offset by lower patent-linked skilled companies and products and personnel fees.
- Overall and administrative (G&A) fees were $0.8 million for the quarter ended June 30, 2026, when put next to $0.9 million for the quarter ended June 30, 2025. The $0.1 million lower used to be primarily attributable to lower appropriate and consulting fees linked to accounting advisory and replace pattern.
- Compile loss used to be $1.8 million for the quarter ended June 30, 2026, when put next to $1.9 million for the quarter ended June 30, 2025.
- Money, money equivalents, and non eternal investments were $6.5 million as of June 30, 2026, when put next to $12.6 million as of December 31, 2025.
Year-to-Date Monetary Results
Continuing operations:
- Analysis and pattern (R&D) fees were $2.0 million for the six months ended June 30, 2026, when put next to $1.9 million for the six months ended June 30, 2025. The $0.1 million lengthen used to be primarily attributable to increased drug manufacturing fees, partially offset by lower patent-linked skilled companies and products, regulatory submitting advisory and personnel fees.
- Overall and administrative (G&A) fees were $1.9 million for the six months ended June 30, 2026, when put next to $2.7 million for the six months ended June 30, 2025. The $0.8 million lower used to be primarily attributable to lower incentive compensation and share-primarily based completely compensation and lower skilled companies and products fees linked to appropriate advisory matters.
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Compile loss used to be $4.1 million for the six months ended June 30, 2026, when put next to $4.5 million for the six months ended June 30, 2025.
About BeyondSpring
BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical firm increasing first-in-class therapies for cancers with excessive unmet wants. Its lead asset, Plinabulin, has been studied in over 700 cancer patients and is in unhurried-stage pattern across extra than one cancer indications, with results revealed in The Lancet Respiratory Treatment. Plinabulin’s recent mechanism as a GEF-H1 agonist with dendritic cell maturation support helps each and every anticancer project and immune modulation, offering a determined components to re-sensitizing tumors proof against checkpoint inhibitors. To boot, it has the functionality to synergize with chemotherapy, antibody-drug conjugates (ADCs), radiation, and checkpoint inhibitors. Learn extra at beyondspringpharma.com.
Investor Contact: [email protected]
Media Contact: [email protected]
Cautionary Veil With regards to Forward-Taking a see Statements
This press originate entails forward-attempting statements which can maybe maybe maybe be no longer historic facts. Phrases equivalent to “will,” “demand,” “rely on,” “notion,” “consider,” “invent,” “might well maybe,” “future,” “estimate,” “predict,” “aim,” “aim,” or diversifications thereof and the same expressions are supposed to title such forward-attempting statements. Forward-attempting statements are in step with BeyondSpring’s most modern info, beliefs, and expectations regarding doubtless future events and are self-discipline to risks, uncertainties, and assumptions. True results and the timing of events might well maybe maybe vary materially from those anticipated in these forward-attempting statements due to the a enormous selection of factors, alongside side, however no longer restricted to, difficulties elevating the anticipated amount wanted to finance the Firm’s future operations on terms acceptable to the Firm, if in any admire; sudden results from preclinical stories or clinical trials; the possibility that preclinical results is maybe no longer predictive of clinical results; delays in, or failure to originate, regulatory approvals; results that stay no longer meet the Firm’s expectations regarding the safety, efficacy, clinical utility, or regulatory pathway of the Firm’s product candidates; increased competition in the market; the Firm’s ability to meet Nasdaq’s continued itemizing requirements; and various risks described in BeyondSpring’s hottest Procure 10-Okay and subsequent filings with the U.S. Securities and Switch Commission. All forward-attempting statements made herein focus on most productive as of the date of this originate, and BeyondSpring undertakes no responsibility to interchange publicly such forward-attempting statements to accept as true with subsequent events or circumstances, other than as otherwise required by law.
Monetary Tables to Note
|
BEYONDSPRING INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Quantities in thousands of U.S. Dollars (“$”), other than for form of shares and per share knowledge) |
||||||||
| As of | ||||||||
|
December 31, 2025 |
June 30, 2026 |
|||||||
| $ | $ | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Recent property: | ||||||||
| Money and money equivalents | 7,786 | 2,697 | ||||||
| Momentary investments | 4,775 | 3,832 | ||||||
| Advances to suppliers | 227 | 247 | ||||||
| Pay as you fling fees and various most modern property | 71 | 273 | ||||||
| Recent property of discontinued operations | 8,023 | 2,852 | ||||||
| Complete most modern property | 20,882 | 9,901 | ||||||
| Noncurrent property: | ||||||||
| Property and equipment, fetch | 166 | 138 | ||||||
| Working appropriate-of-employ property | 305 | 174 | ||||||
| Varied noncurrent property | 224 | 128 | ||||||
| Noncurrent property of discontinued operations | 4,356 | 4,265 | ||||||
| Complete noncurrent property | 5,051 | 4,705 | ||||||
| Complete property | 25,933 | 14,606 | ||||||
| Liabilities and equity | ||||||||
| Recent liabilities: | ||||||||
| Accounts payable | 363 | 790 | ||||||
| Amassed fees | 938 | 1,390 | ||||||
| Recent allotment of working lease liabilities | 320 | 171 | ||||||
| Varied most modern liabilities | 822 | 1,055 | ||||||
| Recent liabilities of discontinued operations | 11,133 | 10,787 | ||||||
| Complete most modern liabilities | 13,576 | 14,193 | ||||||
| Noncurrent liabilities: | ||||||||
| Deferred earnings | 28,600 | 29,476 | ||||||
| Varied noncurrent liabilities | 3,981 | 4,420 | ||||||
| Noncurrent liabilities of discontinued operations | 3,766 | 2,542 | ||||||
| Complete noncurrent liabilities | 36,347 | 36,438 | ||||||
| Complete liabilities | 49,923 | 50,631 | ||||||
| Shareholders’deficit | ||||||||
| Extraordinary shares ($0.0001 par rate; 500,000,000 shares authorized; 41,122,320 and 41,119,820 shares issued and illustrious as of December 31, 2025 and June 30, 2026, respectively) | 4 | 4 | ||||||
| Further paid-in capital | 375,664 | 375,814 | ||||||
| Amassed deficit | (408,431 | ) | (411,439 | ) | ||||
| Amassed assorted comprehensive earnings | 602 | 55 | ||||||
| Complete BeyondSpring Inc.’s shareholders’ deficit | (32,161 | ) | (35,566 | ) | ||||
| Noncontrolling pursuits | 8,171 | (459 | ) | |||||
| Complete shareholders’ deficit | (23,990 | ) | (36,025 | ) | ||||
| Complete liabilities and shareholders’deficit | 25,933 | 14,606 | ||||||
|
BEYONDSPRING INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Quantities in thousands of U.S. Dollars (“$”), other than for form of shares and per share knowledge) (Unaudited) |
||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2026 | 2025 | 2026 | |||||||||||||
| $ | $ | $ | $ | |||||||||||||
| Earnings | – | – | – | – | ||||||||||||
| Working fees | ||||||||||||||||
| Analysis and pattern | (1,002 | ) | (973 | ) | (1,876 | ) | (2,049 | ) | ||||||||
| Overall and administrative | (947 | ) | (758 | ) | (2,683 | ) | (1,914 | ) | ||||||||
| Loss from operations | (1,949 | ) | (1,731 | ) | (4,559 | ) | (3,963 | ) | ||||||||
| Foreign alternate invent, fetch | 47 | 61 | 76 | 111 | ||||||||||||
| Ardour earnings | 28 | 4 | Forty five | 12 | ||||||||||||
| Varied earnings, fetch | 18 | 16 | 18 | 31 | ||||||||||||
| Loss sooner than earnings tax | (1,856 | ) | (1,650 | ) | (4,420 | ) | (3,809 | ) | ||||||||
| Earnings tax fees | (22 | ) | (100 | ) | (42 | ) | (292 | ) | ||||||||
| Compile loss from continuing operations | (1,878 | ) | (1,750 | ) | (4,462 | ) | (4,101 | ) | ||||||||
| Discontinued operations | ||||||||||||||||
| Loss from discontinued operations | (2,771 | ) | (3,950 | ) | (6,003 | ) | (8,273 | ) | ||||||||
| Keep on sale of subsidiary pursuits | – | – | 6,986 | – | ||||||||||||
| Earnings tax fees | – | – | – | – | ||||||||||||
| Compile earnings (loss) from discontinued operations | (2,771 | ) | (3,950 | ) | 983 | (8,273 | ) | |||||||||
| Compile loss | (4,649 | ) | (5,700 | ) | (3,479 | ) | (12,374 | ) | ||||||||
| Less: Compile loss attributable to noncontrolling pursuits from continuing operations | (72 | ) | (841 | ) | (147 | ) | (973 | ) | ||||||||
| Less: Compile loss attributable to noncontrolling pursuits from discontinued operations | (2,771 | ) | (4,010 | ) | (6,003 | ) | (8,393 | ) | ||||||||
| Compile earnings (loss) attributable to BeyondSpring Inc. | (1,806 | ) | (849 | ) | 2,671 | (3,008 | ) | |||||||||
| Earnings (loss) per share, overall and diluted | ||||||||||||||||
| Continuing operations | (0.04 | ) | (0.02 | ) | (0.11 | ) | (0.08 | ) | ||||||||
| Discontinued operations | – | – | 0.18 | – | ||||||||||||
| Overall and diluted earnings (loss) per share | (0.04 | ) | (0.02 | ) | 0.07 | (0.08 | ) | |||||||||
| Weighted-moderate shares illustrious | ||||||||||||||||
| Overall and diluted | 40,316,320 | 41,119,820 | 40,316,320 | 41,119,820 | ||||||||||||
| Varied comprehensive loss, fetch of tax of nil: | ||||||||||||||||
| Foreign forex echange translation adjustment loss from continuing operations | (343 | ) | (471 | ) | (494 | ) | (850 | ) | ||||||||
| Foreign forex echange translation adjustment loss from discontinued operations | (27 | ) | (70 | ) | (34 | ) | (117 | ) | ||||||||
| Entire loss | (5,019 | ) | (6,241 | ) | (4,007 | ) | (13,341 | ) | ||||||||
| Less: Entire loss attributable to noncontrolling pursuits from continuing operations | (194 | ) | (1,007 | ) | (324 | ) | (1,276 | ) | ||||||||
| Less: Entire loss attributable to noncontrolling pursuits from discontinued operations | (2,798 | ) | (4,080 | ) | (6,037 | ) | (8,510 | ) | ||||||||
| Entire earnings (loss) attributable to BeyondSpring Inc. | (2,027 | ) | (1,154 | ) | 2,354 | (3,555 | ) | |||||||||
