On August 14, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported its financial results for the quarter ended June 30, 2026, and provided a corporate update highlighting clinical progress for Plinabulin and the Company’s leadership transition.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter was marked by additional clinical and scientific support for continuing Plinabulin development," said Min Qiu, Chief Executive Officer of BeyondSpring. "Updated Phase 2 data presented at ASCO (Free ASCO Whitepaper) 2026 continued to demonstrate an encouraging 58% two-year OS rate in metastatic NSCLC patients whose disease progressed after first-line immune checkpoint inhibitor (ICI) therapy. This encouraging prospective OS data strengthens our conviction in the DUBLIN-4 study, a confirmatory Phase 3 study with OS as the primary endpoint in non-squamous NSCLC post-ICI with no driver mutation, a severe unmet medical need with docetaxel as the standard of care. With our leadership transition now effective, our priorities are clear: advancing the regulatory, operational and financing preparations necessary to initiate DUBLIN-4."

Mr. Qiu continued, "The DUBLIN-4 study represents our lead clinical development priority for a potential path toward future regulatory submissions. We believe the published DUBLIN-3 results in The Lancet Respiratory Medicine, recent ASCO (Free ASCO Whitepaper) 2026 clinical data, and the AACR (Free AACR Whitepaper) 2026 ADC combination findings collectively reinforce Plinabulin’s differentiated potential as a potent dendritic cell maturation agent to improve survival benefits while mitigating treatment-limiting high-grade neutropenia in NSCLC and beyond."

Recent Clinical and Corporate Highlights of Plinabulin

ASCO 2026 (Phase 2 data): Plinabulin combination demonstrated durable response and survival benefit in post-ICI metastatic NSCLC

Presented updated efficacy and safety results from the investigator-initiated Phase 2 303 Study evaluating Plinabulin/docetaxel and pembrolizumab in 47 patients with metastatic NSCLC and acquired resistance following first-line immune checkpoint inhibitor therapy.
As of the February 28, 2026 data cutoff, median progression-free survival was 7.0 months, median duration of response was 9.3 months, disease control rate was 79.5%, and confirmed objective response rate was 18.2%.
The 12-month and 24-month overall survival rates were 78.1% and 58.0%, respectively, with median overall survival not reached after a median follow-up of 28.8 months.
The combination demonstrated a generally manageable safety profile and evidence of immune activation, including increased frequencies of activated CD4+ and CD8+ T cells as well as higher white blood cell, neutrophil, and platelet counts.
AACR 2026 (preclinical data): Improved complete response rate, overall survival and tolerability of certain antibody-drug-conjugates (ADCs)

Presented preclinical data showing that Plinabulin in combination with the approved topoisomerase I inhibitor (TOP1)-based ADCs enhanced complete tumor regression rates and/or survival of TROP-2-directed datopotamab deruxtecan or HER2-directed trastuzumab deruxtecan, with or without PD-1/PD-L1 inhibition.
Plinabulin improved tolerability in the preclinical combination models and increased the CD8+ T-cell-to-Treg ratio, supporting an immune-mediated mechanism for the enhanced anticancer activity.
The findings support Plinabulin’s potential to address limited durability and treatment-limiting hematologic toxicity associated with ADC-based therapy and broaden the scientific rationale for future ADC combination studies.
DUBLIN-4 Confirmatory Phase 3 Program

DUBLIN-4 is the Company’s planned, randomized, double-blind, 442-patient confirmatory Phase 3 study of Plinabulin plus docetaxel in non-squamous, EGFR wild-type NSCLC patients who have progressed on PD-1/PD-L1 inhibitor-containing therapies.
The program is designed to prospectively confirm the survival and tolerability benefits observed in the DUBLIN-3 Phase 3 study, which was published in The Lancet Respiratory Medicine in 2024.
BeyondSpring Leadership Transition and Corporate Execution

Effective July 1, 2026, Min Qiu was appointed Chief Executive Officer with a mandate focused on advancing DUBLIN-4, extending Plinabulin’s scientific optionality, and building BeyondSpring’s global partner and investor base. Dr. Jiangwen (Jen) Majeti was appointed Vice Chairman, strengthening Board-level governance continuity and strategic depth. Na Li was appointed Chief Financial Officer to support financial discipline, public-company reporting, financing activities, and capital markets engagement.
Dr. Lan Huang remains Co-Founder and Chairman of BeyondSpring, providing strategic vision and Board leadership, while devoting her executive focus to SEED Therapeutics, where she serves as Co-Founder, Chairman, and Chief Executive Officer.
Second Quarter Financial Results

Continuing operations:

Research and development (R&D) expenses were $1.0 million for the quarter ended June 30, 2026, compared to $1.0 million for the quarter ended June 30, 2025. R&D expenses remained relatively flat, as a $0.3 million increase in drug manufacturing activities to prepare for potential future study initiation was substantially offset by lower patent-related professional services and personnel expenses.
General and administrative (G&A) expenses were $0.8 million for the quarter ended June 30, 2026, compared to $0.9 million for the quarter ended June 30, 2025. The $0.1 million decrease was primarily due to lower legal and consulting expenses related to accounting advisory and business development.
Net loss was $1.8 million for the quarter ended June 30, 2026, compared to $1.9 million for the quarter ended June 30, 2025.
Cash, cash equivalents, and short-term investments were $6.5 million as of June 30, 2026, compared to $12.6 million as of December 31, 2025.
Year-to-Date Financial Results

Continuing operations:

Research and development (R&D) expenses were $2.0 million for the six months ended June 30, 2026, compared to $1.9 million for the six months ended June 30, 2025. The $0.1 million increase was primarily due to higher drug manufacturing expenses, partially offset by lower patent-related professional services, regulatory filing advisory and personnel expenses.
General and administrative (G&A) expenses were $1.9 million for the six months ended June 30, 2026, compared to $2.7 million for the six months ended June 30, 2025. The $0.8 million decrease was primarily due to lower incentive compensation and share-based compensation and lower professional services expenses related to legal advisory matters.
Net loss was $4.1 million for the six months ended June 30, 2026, compared to $4.5 million for the six months ended June 30, 2025.

(Press release, BeyondSpring Pharmaceuticals, AUG 14, 2026, View Source [SID1234670120])

On August 14, 2026 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported advances across its Actimab-A program, including recently acquired patents adding to a broad suite of IP, and expansion of the Company’s manufacturing capacity, as the program approaches clinical milestones from the fourth quarter of 2026 and into 2027. The Company also provided an update on the status of its NYSE American listing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Actiniums holds a broad IP portfolio covering the manufacture of Actimab-A, as well as its use alone and in combination with other therapies in the treatment of myeloid hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in addition to solid tumor cancers via targeting of tumor-resident myeloid-derived suppressor cells (MDSCs). Actimab-A patent portfolio activity in the last twelve months:

Actimab-A targeting of myeloid-derived suppressor cells (MDSCs) for the treatment of solid tumors: Two United States patents issued — US 12,491,274 for the treatment of sarcoma, expiring 15 October 2043, and US 12,539,340 for the treatment of solid tumors generally, alone or with checkpoint therapy, expiring 31 October 2043. Together they extend the anti-CD33 franchise beyond hematologic malignancy into solid tumors by targeting the immunosuppressive myeloid cells of the tumor microenvironment rather than the tumor cells themselves. Applications remain pending in the United States, Canada and Europe.

Actimab-A treatment of low peripheral blast AML: US 12,410,249 issued, with a term to 12 October 2039, and Canadian application 3,022,802 entered pre-grant status, with a term to 25 May 2037. Additional patents in this family have already issued in the United States and Japan; applications remain pending in the United States and Europe.

Actimab-A venetoclax (BCL-2 inhibitor) combination therapy for the treatment of AML: Canadian application 3,059,752 entered pre-grant status, with a term to 26 April 2038, covering the use of Actimab-A together with venetoclax in AML. Three patents have already issued in the United States and one in Mexico; applications remain pending in the United States, Europe, Japan and China.

Actimab-A CLAG-M combination therapy for the treatment of AML: Canadian application 3,087,346 was allowed, with a term to 8 January 2039. A counterpart patent has already issued in Japan; applications remain pending in the United States, Europe and Japan.

Actinium has amended its Investigational New Drug (IND) application to add an additional manufacturer. The additional manufacturer will supply studies conducted under the Company’s Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), together with additional Company-sponsored studies, which carry clinical milestones expected from the second half of 2026 and throughout 2027. Establishing an additional manufacturing source is intended to expand capacity and supply flexibility as Actimab-A advances into a broader set of studies across hematologic malignancies and solid tumors.

NYSE American Listing Update

Actinium also announced today that NYSE Regulation has accepted the Company’s plan submitted June 18, 2026, to regain compliance with the NYSE American continued listing standards and granted the Company a plan period through November 27, 2027 (the "Plan Period") – the maximum period available under Section 1009 of the NYSE American Company Guide (the "Company Guide").

The Company’s common stock continues to be listed and traded on NYSE American under the symbol ATNM during the Plan Period, subject to the Company’s compliance with the terms of the compliance plan and the other continued listing standards of the NYSE American Company Guide. NYSE Regulation staff will periodically review the Company’s compliance with the initiatives outlined in the compliance plan.

As previously disclosed, the Company is not currently in compliance with Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide, and its listing is being continued pursuant to an extension through November 27, 2027.

(Press release, Actinium Pharmaceuticals, AUG 14, 2026, View Source [SID1234670119])

On August 13, 2026 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the second quarter ended June 30, 2026, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our patient focus has driven achievement of important milestones and strong demand for our TransCon products as Ascendis continues to transform into a leading biopharma company," said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. "This focus on addressing unmet medical needs continues to drive a growing pipeline of innovative TransCon programs, further positioning Ascendis for durable, long-term growth in rare endocrine diseases and new therapeutic areas."

(Press release, Ascendis Pharma, AUG 13, 2026, https://investors.ascendispharma.com/news-releases/news-release-details/ascendis-pharma-reports-second-quarter-2026-financial-results?utm_source=chatgpt.com [SID1234670719])

On August 13, 2026 Evotec reported Half-Year Interim Report 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Presentation, Evotec, AUG 13, 2026, View Source [SID1234670282])

On August 13, 2026 Baylink Biosciences, Inc. ("Baylink"), a biotechnology company focused on developing next-generation antibody-drug conjugates (ADCs) for the treatment of solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BLB101, a novel CLDN6/CLDN9 dual-targeting ADC for the treatment of patients with advanced solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BLB101 is Baylink’s lead ADC program and is designed to selectively deliver the highly potent topoisomerase I inhibitor Exatecan to tumor cells expressing CLDN6 and/or CLDN9. The molecule incorporates Baylink’s proprietary BL001 hydrophilic cleavable linker. It uses cysteine-maleimide conjugation approach with a drug-to-antibody ratio (DAR) of 8.

"FDA clearance of the BLB101 IND is an important milestone for Baylink and validates the progress of our ADC development platform," said Alice Chen, CSO of Baylink Biosciences. "BLB101 represents our differentiated approach to ADC development, combining dual CLDN6/CLDN9 targeting, a TOP1 inhibitor payload that is insensitive to efflux pump, and our proprietary hydrophilic linker technology. We look forward to advancing BLB101 into clinical development and evaluating its potential to provide a new treatment option for patients with advanced solid tumors."

Designed for Broader Tumor Targeting

CLDN6 is a tight-junction protein with highly restricted expression in most normal adult tissues and aberrant expression in some solid tumors. CLDN9, a closely related Claudin family member, is also expressed in a range of solid tumors and may provide complementary tumor coverage.

BLB101 incorporates Baylink’s proprietary 2D5S antibody, which binds both CLDN6 and CLDN9. This dual-targeting strategy is designed to expand the potential patient population and address tumor heterogeneity associated with expression of individual tumor antigens.

Preclinical studies have demonstrated specific binding to CLDN6 and CLDN9, internalization of BLB101 into target-positive tumor cells, and potent cytotoxic activity in relevant tumor models.

Exatecan Payload and Proprietary BL001 Linker

BLB101 uses Exatecan, a highly potent Topoisomerase I inhibitor that is insensitive to efflux pump, as its cytotoxic payload. Following internalization and intracellular processing of the ADC, Exatecan is released and induces DNA damage through stabilization of the TOP1-DNA cleavage complex, ultimately leading to tumor cell death.

Baylink’s proprietary BL001 linker was designed to improve the overall physicochemical properties and stability of high-DAR ADCs while supporting efficient intracellular payload release. BL001 incorporates hydrophilic structural elements and a cleavable Val-Ala sequence and supports a high drug-to-antibody ratio of 8. BL001 linker was also designed to reduce non-specific internalization by non-cancer cells which is expected to further reduce side effects.

Advancing Toward Clinical Proof of Concept

Baylink has completed key preclinical, CMC, and IND-enabling activities for BLB101, including GLP toxicology studies, pharmacokinetic and toxicokinetic characterization, analytical development, drug substance and drug product manufacturing, formulation development, and stability studies.

The FDA clearance of the BLB101 IND enables Baylink to initiate clinical development of BLB101 in patients with advanced solid tumors.

"The IND clearance is the result of the tremendous effort of the Baylink team," said Patrick Zweider-McKay, MD/PhD, Baylink’s Clinical Advisor. "We are excited to bring this program into the clinic and generate clinical data that will help determine the therapeutic potential of CLDN6/CLDN9 dual targeting."

(Press release, Baylink Biosciences, AUG 13, 2026, View Source [SID1234670159])