Announcement • Apr 24

BeyondSpring Inc Reports Compelling New Data on Plinabulin Advances Both the Anticancer Efficacy and Safety of Adc Drugs

BeyondSpring Inc. reported new preclinical data at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) demonstrating that Plinabulin has the potential to enhance both the efficacy and tolerability of ADC therapy — potentially boosting anticancer responses while keeping patients on treatment long enough to benefit. Antibody-drug conjugates — a form of targeted chemotherapy that delivers cancer-killing agents directly to tumor cells, known as ADCs — have emerged as one of oncology’s most important new treatment classes. But two persistent clinical barriers limit their full potential: they do not always produce durable responses, and neutropenia (a dangerous drop in white blood cell counts) can force dose reductions or treatment delays that cut treatment short. New AACR data show that Plinabulin directly and simultaneously addresses both. The data show why the combination works. Plinabulin, when added to two approved ADCs — T-DXd (trastuzumab deruxtecan) and Dato-DXd (datopotamab deruxtecan) — produced three significant results that neither drug achieved alone: Complete tumor regressions were more frequent and animals survived significantly longer — in both two-drug (ADC+ Plinabulin) and three-drug (ADC+ Plinabulin + PD-1 inhibitor) combinations. Plinabulin reduced animal death in both two-drug and three-drug combinations. In 6 prior clinical studies, Plinabulin measurably reduced chemotherapy-induced neutropenia, the white blood cell toxicity that commonly forces ADC dose reductions or treatment delays — potentially allowing patients to remain on treatment long enough to benefit from the drug’s anticancer activity. Analysis showed that Plinabulin enhanced the body’s own cancer-fighting T-cells, significantly increasing CD8+ T cell/Treg ratio — providing a biological explanation for why the combination outperforms either drug alone. Plinabulin activates a protein called GEF-H1 that simultaneously matures immune cells (dendritic cells) to attack tumors, signals the body to replenish cancer-fighting blood cells, and disrupts the blood supply feeding tumors. These are precisely the biological pathways that ADCs do not activate — which is why the two work better together than either does alone. In BeyondSpring’s pivotal Phase 3 DUBLIN-3 study (The Lancet Respiratory Medicine, 2024), Plinabulin combined with docetaxel chemotherapy doubled two- and three-year survival rates in second- and third-line EGFR wild-type NSCLC patients — and simultaneously reduced docetaxel-limiting grade 4 neutropenia from 33% to 5%, keeping patients on therapy longer for the drug to work. The new AACR data extend that same combination logic into the ADC setting, broadening Plinabulin’s reach across the treatment landscape. BeyondSpring’s planned DUBLIN-4 program — a 442-patient FDA-aligned confirmatory Phase 3 trial building directly on the DUBLIN-3 results — is the defined next clinical step. AACR data further strengthen the scientific rationale for Plinabulin’s combination potential and point toward future ADC combination studies beyond the confirmatory program. ADCs are increasingly being tested in earlier lines of cancer treatment and in combination with immunotherapy. However, recent large Phase 3 studies — TROPION-Lung01 and EVOKE-01 — showed that ADCs failed to outperform older chemotherapy, such as docetaxel, in certain lung cancer settings, underscoring the need for an agent that can improve the efficacy and tolerability of ADC-based combinations. Plinabulin’s ability to simultaneously boost efficacy and reduce toxicity positions it as a potential backbone agent across the ADC landscape — a role no other drug currently fills. AACR data open the door to ADC combination studies as a natural next chapter in Plinabulin’s clinical development, alongside the ongoing DUBLIN-4 confirmatory program. BeyondSpring’s China operations have been a strategic engine in building the ADC partnerships that support Plinabulin’s global development. BeyondSpring’s AACR 2026 Presentation Title: Plinabulin Boosts Antitumor Efficacy of Topoisomerase Inhibitor-Based Antibody-Drug Conjugates Without or With Immune Checkpoint Inhibitor Presenters: Yingjuan June Lu, Xiaoyan He, Weiwei Cheng, Zhengyan Zhang, James Tonra, Lan Huang Session: T Cell Engagers 2 /Antibody-Drug Conjugates 1 (Immunology Track) Poster Number: 5597 Plinabulin is a late-stage Phase 3 anticancer agent and first-in-class GEF-H1 (guanine nucleotide exchange factor H1) agonist. Its multifunctional mechanism — encompassing dendritic cell maturation, tumor microenvironment modulation, anti-angiogenesis, and chemotherapy-induced neutropenia (CIN) mitigation — activates biological pathways that standard chemotherapy and ADCs do not. Over 700 cancer patients have been treated with good tolerability and durable anticancer benefit in rational combination settings. DUBLIN-3 Phase 3 results in NSCLC were published in The Lancet Respiratory Medicine in 2024. In the DUBLIN-3 Phase 3 study of 2L/3L EGFR wild-type NSCLC (Lancet Respiratory Medicine, 2024), Plinabulin plus docetaxel significantly outperformed docetaxel monotherapy (n=559, 1:1 randomization), with improvements in OS, PFS, and ORR; doubling of 2- and 3-year survival rates; and reduction of docetaxel-induced grade 4 neutropenia from 33% to 5%.

Announcement • Jun 11

BeyondSpring Announces Final Positive Data from the PROTECTIVE-1 Phase 3 CIN Program of Plinabulin as a Single Agent Compared to Pegfilgrastim at the American Society of Clinical Oncology (ASCO) Annual Meeting

BeyondSpring Inc. announced presentation of data from the PROTECTIVE-1 Phase 3 clinical study of plinabulin for prevention of chemotherapy-induced neutropenia (CIN) at the American Society of Clinical Oncology (ASCO) Annual Meeting being held on June 4 - 8, 2021. Data further supports plinabulin’s fast onset of action and CIN prevention benefit in week 1 following chemotherapy with results including clinically meaningful endpoints for reduction of febrile neutropenia (FN), hospitalization and bone pain. The Company has submitted New Drug Applications (NDA) for plinabulin in combination with pegfilgrastim for the prevention of CIN, in both the U.S. and China. The U.S. FDA accepted the NDA with Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2021. Plinabulin, BeyondSpring’s lead drug, is a selective immunomodulating microtubule-binding agent (SIMBA). It is a novel, intravenous infused, patent-protected drug that is NDA filed for CIN prevention in the U.S. and China and has a fully enrolled pivotal Phase 3 anti-cancer study for non-small cell lung cancer (NSCLC). Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received breakthrough designation from both U.S. and China FDA for CIN prevention indication. As a “pipeline in a drug,” plinabulin is being broadly studied in various immuno-oncology regimens to determine if it can boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody resistant patients. The Plinabulin and G-CSF combination NDA program is comprised of four studies: PROTECTIVE-1 Phase 2 and Phase 3 and PROTECTIVE-2 Phase 2 and Phase 3. PROTECTIVE-1 Phase 2 (4arm randomized study, NSCLC, docetaxel, n=55): Plinabulin single agent (5 mg/m2, 10 mg/m2, or 20 mg/m2, day 1 dose), pegfilgrastim (6 mg, day 2 dose). Plinabulin 20 mg/m2 was selected as the Phase 3 dose. PROTECTIVE-1 Phase 3 (2 arm randomized, double-blind study, NSCLC, breast cancer, prostate cancer, docetaxel, n=105 patients): Plinabulin single agent (40 mg fixed dose – equivalent to 20 mg/m2, day 1 dose) vs. pegfilgrastim (6 mg, day 2 dose). Primary endpoint DSN cycle is met with non-inferiority. Plinabulin showed week 1 early onset of action and was effective in prevention of clinical outcomes, such as FN and hospitalization, and chemo dose reduction and delay. PROTECTIVE-2 Phase 2 (7 arm randomized study, breast cancer, TAC, n=115 patients): Plinabulin single agent (10 mg/m2, 20 mg/m2, or 30 mg/m2, day 1 dose) – 20 mg/m2 selected; Plinabulin (20 mg/m2, day 1 dose) + pegfilgrastim (1.5 mg, 3 mg, or 6 mg, day 2 dose); pegfilgrastim (6 mg, dose 2 dose). Plinabulin (20 mg/m2) and pegfilgrastim (6 mg) was selected to be Phase 3 dose. PROTECTIVE-2 Phase 3 (2 arm randomized, double-blind study, breast cancer, TAC, 221 patients – Pivotal study): Plinabulin (40 mg fixed dose – equivalent to 20 mg/m2, day 1 dose) + pegfilgratstim (6 mg, day 2 dose) vs. pegfilgrastim (6 mg, day 2 dose). The combination is superior to pegfilgrastim alone, which met primary endpoint of prevention of grade 4 neutropenia and key secondary endpoints, with superior benefit in reducing the incidence and severity of febrile neutropenia (FN) and hospitalization, with better quality-of-life (QoL) CIN remains a severely unmet medical need and is the primary cause for the 4D’s (Decrease, Delay, Discontinue dose and Downgrade regimen) that compromise carefully selected cancer treatment regimens. Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen was approved in 1991. The main benefit of G-CSF treatment, however, is in Week 2 after chemotherapy. Week 1 after chemotherapy is considered the “neutropenia vulnerability gap” where over 75% of CIN-related clinical complications occur, including febrile neutropenia, infection, hospitalization and death. Plinabulin is the first drug seeking FDA approval that has the potential to fill this gap. Combining plinabulin and G-CSF may maximize the protection of patients for the full cycle of chemotherapy, as demonstrated in the PROTECTIVE-2 Phase 3 registration study. Each year in the U.S., 110,000 patients receiving chemotherapy are hospitalized after developing CIN, a severe side effect that increases the risk of infection with fever (also called FN). Due to the COVID-19 pandemic, the updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, including pegfilgrastim, from high-risk patients only (chemo FN rate >20%), to include intermediate-risk patients (FN rate between 10-20%), to reduce the number of hospital/ER visits related to CIN. The revision of the NCCN guidelines effectively increases the addressable market of patients to approximately 467,500 cancer patients in the U.S. annually.

Total Shareholder Yield	-3.4%
Future Dividend Yield	n/a
Dividend Growth	n/a
Next dividend pay date	n/a
Ex dividend date	n/a
Dividend per share	n/a
Payout ratio	n/a

Segment	Dividend Yield
Company (BYSI)	n/a
Market Bottom 25% (US)	1.4%
Market Top 25% (US)	4.2%
Industry Average (Biotechs)	2.5%
Analyst forecast (BYSI) (up to 3 years)	n/a

Data	Last Updated (UTC time)
Company Analysis	2026/05/06 06:32
End of Day Share Price	2026/05/06 00:00
Earnings	2025/12/31
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Joel Beatty	Baird
Jason Matthew Gerberry	BofA Global Research
Joshua Schimmer	Evercore ISI

BeyondSpring Dividends and Buybacks

Dividend criteria checks 0/6

Key information

Recent dividend and buyback updates

Recent updates

Can BeyondSpring (NASDAQ:BYSI) Afford To Invest In Growth?

BeyondSpring Inc Reports Compelling New Data on Plinabulin Advances Both the Anticancer Efficacy and Safety of Adc Drugs

New major risk - Financial position

BeyondSpring Announces ESMO Asia Presentation on Plinabulin + Docetaxel Improving Survival in Large Phase 3

Beyondspring Inc. Announces New Post-Hoc Analyses from Its Global Phase 3 Dublin-3Study

BeyondSpring Inc. has completed a Follow-on Equity Offering in the amount of $2 million.

BeyondSpring Inc. has filed a Follow-on Equity Offering in the amount of $2 million.

We Think BeyondSpring (NASDAQ:BYSI) Needs To Drive Business Growth Carefully

Insufficient new directors

BeyondSpring Inc. Publishes Human Clinical Study in Med (Cell Press) Showing Plinabulin-Driven Dendritic Cell Maturation and Tumor Response After Prior Checkpoint Inhibitor Failure

BeyondSpring Inc., Annual General Meeting, Sep 15, 2025

New major risk - Share price stability

Here's Why BeyondSpring (NASDAQ:BYSI) Must Use Its Cash Wisely

BeyondSpring Inc. Presents Efficacy/Safety Data from a Phase 2 Study of Pembrolizumab Plus Plinabulin/Docetaxel in Metastatic NSCLC After Progressing on First-Line Immune Checkpoint Inhibitors at 2025 ASCO Annual Meeting

New minor risk - Share price stability

New major risk - Revenue size

New minor risk - Financial data availability

BeyondSpring Presents Updated Efficacy Results from a Phase 2 IIT Study of Triple IO Combo of Pembrolizumab plus Plinabulin/Docetaxel in Metastatic NSCLC after Progressing on Prior Immune Checkpoint Inhibitors at the 39th SITC Annual Meeting

BeyondSpring Inc. Presents Final Data Analysis of DUBLIN-3 Phase 3 Study in 2L/3L EGFR Wild-Type NSCLC at NSCLC Congress 2024

First half 2024 earnings released: US$0.19 loss per share (vs US$0.33 loss in 1H 2023)

New minor risk - Shareholder dilution

New minor risk - Market cap size

BeyondSpring Regains Compliance with Nasdaq Minimum Bid Price Rule

First half 2023 earnings released: US$0.33 loss per share (vs US$0.47 loss in 1H 2022)

New major risk - Revenue and earnings growth

BeyondSpring Inc. Announces New Data That Translates Preclinical Proof-Of-Concept to Clinical Evidence of Plinabulin’s Immunomodulating Activity

New minor risk - Financial data availability

BeyondSpring Regains Compliance with Nasdaq Minimum Bid Price Requirement

New major risk - Share price stability

BeyondSpring Receives Nasdaq Notice Regarding Minimum Bid Price Requirements

BeyondSpring Inc. Announces Retirement of Yanbin Xie as Board of Director

Here's Why We're Watching BeyondSpring's (NASDAQ:BYSI) Cash Burn Situation

BeyondSpring Inc. Announces New Data from Phase 1 Investigator Initiated Study Plinabulin’s Ability to Reduce Infectious Neutropenic Fever for Multiple Myeloma Patients Undergoing AHCT

Full year 2022 earnings: EPS exceeds analyst expectations while revenues lag behind

BeyondSpring Receives Notifications from Nasdaq Regarding Compliance With Listing Rules

BeyondSpring Inc. Announces the Resignation of Christine Ying Zhao from the Board of Directors, Effective January 1, 2023

BeyondSpring Receives Nasdaq Notice Regarding Minimum Bid Price Requirements

Price target decreased to US$2.30

BeyondSpring Inc. Presents New Clinical Evidence of Plinabulin Protection of Granulocyte-Monocyte Progenitor Stem Cells for the Prevention of Chemotherapy-Induced Neutropenia at the ESMO Congress 2022

BeyondSpring Inc. Announces Board Appointments

BeyondSpring Inc.(NasdaqCM:BYSI) dropped from Russell 2000 Dynamic Index

BeyondSpring Inc. Announces Executive Resignations, with Effect from June 9, 2022

BeyondSpring Inc. Announces Resignation of Gordon L. Schooley as Chief Regulatory Officer

Price target decreased to US$6.10

Elizabeth Czerepak Resigns as Executive Vice President of BeyondSpring Inc

Consensus forecasts updated

Price target increased to US$13.67

BeyondSpring Inc. to Report Q4, 2021 Results on Apr 14, 2022

BeyondSpring, Beyond Salvage

BeyondSpring Pharmaceuticals Announces Organizational Streamlining

Consensus revenue estimates fall by 90%

BeyondSpring Pharmaceuticals Announces New Clinical Data Confirming Plinabulin’s Fast Onset Mechanism of Action in Prevention of Chemotherapy-Induced Neutropenia at 63rd ASH Annual Meeting and Exposition

Consensus forecasts updated

BeyondSpring Pharmaceuticals Receives Complete Response Letter from the FDA for Plinabulin New Drug Application for Prevention of Chemotherapy-Induced Neutropenia (CIN)

No longer forecast to breakeven

Circling Back On BeyondSpring

Price target decreased to US$58.60

Upcoming News For BeyondSpring's Plinabulin Tees Up Big Potential Returns

BeyondSpring: Poor Trial Conduct And Lack Of Transparency Create Substantial Downside Risk

Price target increased to US$67.25

BeyondSpring's Plinabulin: Upcoming PDUFA And Positioning In The CIN Space

Consensus forecasts updated

BeyondSpring Inc.(NasdaqCM:BYSI) dropped from Russell Microcap Value Index

Consensus forecasts updated

BeyondSpring Announces Final Positive Data from the PROTECTIVE-1 Phase 3 CIN Program of Plinabulin as a Single Agent Compared to Pegfilgrastim at the American Society of Clinical Oncology (ASCO) Annual Meeting

BeyondSpring Announces First Patient Dosed in a Triple Combination Study with Plinabulin, PD-1/PD-L1 Inhibitor and Radiotherapy for the Reversal of Resistance to PD-1/PD-L1 Inhibitors in Patients with Advanced Solid Tumors

BeyondSpring Inc. Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Plinabulin and G-CSF Combination for the Prevention of Chemotherapy-Induced Neutropenia

BeyondSpring Announces Five Presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting

Chief Scientific Officer has left the company

BeyondSpring Inc. Announces Management Changes

Price target lowered to US$36.00

How Much Of BeyondSpring Inc. (NASDAQ:BYSI) Do Insiders Own?

BeyondSpring Announces the Appointment of Dr. Jeffrey Vacirca to its Board of Directors

BeyondSpring Announces New Positive PROTECTIVE-2 Phase 3 Registrational Trial Results at the 2020 San Antonio Breast Cancer Symposium

BeyondSpring Inc. has completed a Follow-on Equity Offering in the amount of $75 million.