On August 9, 2026 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, reported that its wholly owned Taiwan subsidiary has entered into a strategic collaboration with the research team led by Professor Sung-Liang Yu of National Taiwan University, a key participating team in the Taiwan Cancer Moonshot Program (TCMP). The collaboration has been formalized through a memorandum of understanding signed by HanchorBio Taiwan and Professor Yu’s team.

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HanchorBio Chairman Scott Liu (left) and Professor Sung-Liang Yu (right), Chair of the Department of Clinical Laboratory Sciences and Medical Biotechnology at National Taiwan University, signed a Memorandum of Understanding (MOU) today to establish a joint research and development collaboration.
HanchorBio Chairman Scott Liu (left) and Professor Sung-Liang Yu (right), Chair of the Department of Clinical Laboratory Sciences and Medical Biotechnology at National Taiwan University, signed a Memorandum of Understanding (MOU) today to establish a joint research and development collaboration.

This strategic collaboration represents an important step in HanchorBio’s evolution from a clinical-stage immunotherapy company toward a precision immunotherapy platform integrating patient-derived biological insights, biomarker strategies, proprietary therapeutic engineering, and global clinical development capabilities.

By combining TCMP’s internationally recognized cancer multi-omics and translational research capabilities with HanchorBio’s FBDB (Fc-Based Designer Biologics) platform and clinical-stage pipeline, the parties aim to accelerate the development of biomarker-driven immunotherapies and improve the precision of clinical development strategies.

Connecting Discovery, Biomarkers, and Clinical Development

The Taiwan Cancer Moonshot is an Academia Sinica-led precision-oncology research program that brings together investigators from Academia Sinica, National Taiwan University, and leading clinical institutions to characterize the molecular biology of cancers affecting Taiwanese and broader Asian populations.

The project has established capabilities in cancer genomics, proteomics, integrated multi-omics analysis, clinically annotated patient-derived datasets, and biomarker discovery. The project has also contributed to international cancer proteogenomics research involving the U.S. National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) and the International Cancer Proteogenome Consortium. These efforts have generated important insights into cancer biology across different populations, including landmark studies of major cancers in Taiwan, lung adenocarcinoma published in Cell 2020, a cross-population analysis of lung adenocarcinoma across Asian, North American, and Eastern European cohorts, published in Cancer Cell 2025, gastric cancer published in Gut 2026 and breast cancer published in Molecular Cancer 2026.

Strengthening Clinical Development and Through Biological Precision

As immunotherapy advances beyond single checkpoint inhibition, understanding which patients are most likely to benefit and why has become increasingly important.

Through this collaboration, HanchorBio and Professor Yu’s team will explore how integrated molecular and immune profiling can support next-generation immunotherapy development, including:

Identification of potential biomarkers associated with treatment response, resistance, and patient selection;
Understanding how tumor biology influences innate and adaptive immune responses;
Evaluating the relationship between macrophage-mediated immune regulation, T-cell functional states, and therapeutic outcomes;
Integrating patient-derived molecular insights with clinical development strategies for HanchorBio’s pipeline.
These capabilities may help improve clinical trial design, enhance translational understanding, and support more precise development approaches for next-generation immunotherapies.

Building a Differentiated Precision Immunotherapy Platform

"The Taiwan Cancer Moonshot has established internationally recognized excellence in cancer proteogenomics, multi-omics, and patient-derived translational research, particularly in Asian cancer populations," said Scott Liu, PhD, Founder and Chairman of HanchorBio. "The significance of this strategic collaboration is that it brings TCMP’s capabilities directly into the drug-development process. By connecting Professor Yu’s expertise and the TCMP’s resources with HanchorBio’s clinical-stage portfolio and FBDB platform, we aim to answer specific development questions: which patients are most likely to benefit, what biology drives response or resistance, and how biomarker strategies can make clinical development more precise. This includes understanding how tumor-intrinsic biology, macrophage-mediated immune regulation, and adaptive immune responses, including T-cell functional states, contribute to treatment response, resistance, and durability. Our goal is to translate patient-derived molecular insights into better development strategies and ultimately better therapies."

From Patient-Derived Discovery to Precision Immunotherapy

Chair and Professor Sung-Liang Yu of Department of Clinical Laboratory Sciences and Medical Biotechnology, National Taiwan University said:

"The Taiwan Cancer Moonshot has generated extensive molecular and clinical insights through the systematic study of cancers affecting Taiwanese and East Asian populations. Collaboration with a clinical-stage biotechnology company creates an important opportunity to evaluate these discoveries in the context of defined therapeutic mechanisms and active drug-development programs. By combining patient-derived research and multi-omics analysis with HanchorBio’s drug-development capabilities, we aim to shorten the path from scientific discovery to biomarkers, patient-selection strategies, and potential clinical applications."

Together, the parties aim to establish a translational model:

PATIENT-DERIVED DISCOVERY → MOLECULAR & IMMUNE INSIGHT → BIOMARKER-GUIDED CLINICAL DEVELOPMENT → PRECISION IMMUNOTHERAPY

Strategic Significance of HanchorBio

This collaboration strengthens three strategic pillars of HanchorBio’s long-term value creation:

Improving clinical development precision
By integrating patient-derived molecular data and immune profiling, HanchorBio aims to improve understanding of treatment response, resistance mechanisms, and patient selection strategies.
Expanding platform differentiation
The combination of discovery capabilities, biomarker strategies, FBDB therapeutic engineering, and clinical development creates a differentiated precision immunotherapy ecosystem beyond individual drug candidates.
Supporting global innovation from Taiwan
The collaboration connects Taiwan’s internationally recognized cancer research capabilities with a globally oriented clinical-stage biotechnology company, supporting the translation of Taiwan-originated scientific innovation into global therapeutic development.

(Press release, Hanchor Bio, AUG 9, 2026, View Source [SID1234669886])

On August 9, 2026 Innovent Biologics, Inc. (01801.HK) and Daiichi Sankyo (TSE: 4568), reported to have entered into an exclusive agreement for the commercialization of Vanflyta (quizartinib) in China.

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Under the terms of the agreement, Daiichi Sankyo will be responsible for the development, manufacturing and supply of Vanflyta while Innovent Biologics holds sole commercialization rights for Vanflyta in China, leading market promotion.

VANFLYTA was approved in China in June 2026 for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an adequate validated diagnostic test, based on the results from the QuANTUM-First trial1.

"This collaboration with Daiichi Sankyo represents an exciting milestone for our hematology franchise. Innovent has continued to expand its product footprint in this field, building a diversified portfolio and strong market presence including TYVYT (sintilimab injection), HALPRYZA (rituximab injection), olverembatinib, FUCASO (Equecabtagene Autoleucel Injection), Jaypirca (pirtobrutinib), and the addition of VANFLYTA will further enhance our synergistic offerings," said Vivian Zhang, Executive Director, Chief Commercial Officer, Innovent Biologics. "Vanflyta (quizartinib) will be the 20th product in Innovent’s commercialized product portfolio. Through collaborative efforts, we aim to bring forward innovative medicines to benefit patients with cancer and further strengthen our leadership in oncology."

"The partnership with Innovent Biologics reflects our commitment to delivering innovation to patients in China," said Michio Hayashi, China President, Daiichi Sankyo. "By combining our research and development capabilities with Innovent’s commercial capabilities in China, we believe this collaboration can accelerate access to VANFLYTA for patients with newly diagnosed FLT3-ITD-positive AML and ultimately help improve outcomes in this high-risk patient population."

About FLT3-ITD Positive Acute Myeloid Leukemia
More than 487,000 new cases of leukemia were reported globally in 2022, with more than 305,000 deaths.2 AML accounts for 23.1% of total leukemia cases worldwide and is most common in adults.3,4 In China, nearly 82,000 people were diagnosed with leukemia in 2022 and more than 50,000 people died from the disease, making it the tenth deadliest cancer.5 AML is a common and aggressive subtype, accounting for approximately 50% of leukemia cases in China.6

A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the most common.7 Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and contribute to particularly unfavorable prognosis, including increased risk of relapse and shorter overall survival. 7,8 FLT3-ITD mutations occur in about 25% of all AML cases.9

About Vanflyta
Vanflyta (quizartinib) is an oral, highly potent type II FLT3 inhibitor that targets FLT3-ITD mutations.

(Press release, Innovent Biologics, AUG 9, 2026, https://www.prnewswire.com/news-releases/innovent-biologics-and-daiichi-sankyo-enter-exclusive-agreement-for-vanflyta-commercialization-in-china-302846648.html [SID1234669885])

On August 7, 2026 Oncolys BioPharma reported Non-consolidated Financial Results for the Six Months Ended June 30, 2026.

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(Press release, Oncolys BioPharma, AUG 7, 2026, View Source [SID1234670812])

On August 7, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, reported its financial results and provided an update on recent corporate developments for the second quarter ended June 30, 2026.

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"During the quarter, we executed well across the business," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics’ President and Chief Executive Officer. "We continued to advance the scientific rationale for (Z)-endoxifen’s potential in rare pediatric diseases, such as Duchenne Muscular Dystrophy and McCune-Albright Syndrome, while also strengthening its clinical and scientific foundation in breast cancer, all through new data presented at important industry conferences, including ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper), as well as publications in well-regarded peer-reviewed journals, Degenerative Neurological and Neuromuscular Disease and npj Breast Cancer."

Dr. Quay continued, "These accomplishments, together with additional capital from our registered direct offering, underscore the breadth of potential we see for (Z)-endoxifen, and investors’ support in our ability to continue advancing our programs."

Second Quarter 2026 & Recent Highlights

Rare Diseases

Atossa Participated at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference in Cancer Research: Cancer Evolution

In a poster presentation titled, "Dual estrogen receptor and PKC-β signaling modulation by (Z)-Endoxifen: A mechanism-driven therapeutic strategy for estrogen-driven pathology in McCune-Albright Syndrome," the Company discussed a dual mechanism of action for (Z)-endoxifen in estrogen-driven pathology relevant to McCune-Albright Syndrome-associated Peripheral Precocious Puberty (MAS-PPP).

The dual mechanism includes the blockade of estrogen receptor (ER)-mediated transcription downstream of autonomous estrogen production and suppression of PKC-β/AKT-associated proliferative and cell-cycle signaling.

This multi-pathway profile may address a key therapeutic gap in MAS-PPP, where estrogen suppression alone may not fully mitigate downstream proliferative signaling.

The Company previously received Rare Pediatric Disease (RPD) designation for (Z)-endoxifen from the U.S. Food and Drug Administration (FDA) for (Z)-endoxifen for the treatment of McCune-Albright Syndrome (MAS).

The Company Announced Acceptance of Manuscript Highlighting the Utrophin-Modulation Potential of (Z)-Endoxifen in Duchenne Muscular Dystrophy (DMD)

A paper details how (Z)-endoxifen may support the expression of utrophin, a paralog of dystrophin. (Z)-Endoxifen therefore represents a potential dystrophin mutation-agnostic treatment for DMD. The paper citation is: Remmel HL, Hammer SS, Blackburn SM, Quay SC. (Z)-Endoxifen as a Potential Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy: A Mechanistic and Transcriptomic Perspective. Degener Neurol Neuromuscular Dis. 2026;16:574524 View Source

The results support further investigation of (Z)-endoxifen in dystrophin-deficient models, as well as biomarker development. These data also build upon the Company’s previously published manuscript, "A Hypothesized Therapeutic Role of (Z)-Endoxifen in Duchenne Muscular Dystrophy," also published in Degenerative Neurological and Neuromuscular Disease.

The Company previously received Orphan Drug Designation (ODD) and RPD designation for (Z)-endoxifen from the FDA for the treatment of DMD.
Oncology

The Company Published Manuscript Highlighting the Anti-cancer Activity of (Z)-Endoxifen-related Compounds

In the peer-reviewed journal, npj Breast Cancer, the Company published an article titled, "Novel (Z)-endoxifen-related new chemical entities exhibit potent anti-cancer activity in ERα+ breast cancer."

The investigators evaluated five previously uncharacterized compounds generated during the synthesis of (Z)-endoxifen, alongside (Z)-endoxifen in a broad panel of laboratory assays, as well as in combination with the CDK4/6 inhibitor abemaciclib.

The publication reported anti-estrogenic and anti-cancer activity across multiple ER-positive (ER+) breast cancer models, including models harboring clinically relevant activating mutations in ESR1.

In certain experimental settings and models, selected compounds combined with abemaciclib demonstrated additive to synergistic activity that was comparable to or greater than the activity observed with abemaciclib plus (Z)-endoxifen.

The authors concluded that select compounds warrant further in vivo safety evaluation, as well as efficacy studies, including as potential second- or third-line approaches for recurrent disease.

Atossa Participated in the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

In a poster presentation titled, "A Phase 2 Clinical Trial in Progress of (Z)-Endoxifen Plus Goserelin as Neoadjuvant Therapy in Premenopausal Women With ER+/HER2- Breast Cancer (EVANGELINE)," the Company described EVANGELINE (NCT05607004), an ongoing, multicenter, open-label Phase 2 study evaluating daily 40 mg (Z)-endoxifen plus goserelin administered every 28 days as neoadjuvant therapy in premenopausal women with ER+/human epidermal growth factor receptor 2 negative (HER2-), cT2-3, cN0-1 breast cancer. Enrollment in this study was completed as of June 30, 2026.

In an online publication titled, "Effect of (Z)-endoxifen Demonstrates Robust Estrogen Receptor Signaling Inhibition Across Clinically Relevant ESR1 Mutations," the Company highlighted new preclinical data demonstrating that (Z)-endoxifen delivers robust ER inhibition across clinically relevant estrogen receptor alpha gene (ESR1) mutations. ESR1 mutations are a major mechanism of acquired endocrine resistance in ER-positive breast cancer and remain associated with limited treatment options despite the emergence of next-generation endocrine therapies. These data support the ongoing clinical development of (Z)-endoxifen, as well as its potential as a promising treatment option for breast cancer patients with limited therapeutic alternatives.
Corporate

Atossa Strengthened its Balance Sheet with a Registered Direct Offering, Potentially Providing Up to $16.5 Million in Gross Proceeds

The Company entered into a securities purchase agreement with institutional investors, which provided for the issuance and sale by the Company, in a registered direct offering of (i) 1,363,637 shares of the Company’s common stock and (ii) Series A warrants to purchase up to 1,363,637 shares of common stock and short-term Series B warrants to purchase up to 1,363,637 shares of common stock, raising $4.5 million in upfront gross proceeds, with the potential to receive up to an additional $12 million, assuming the full cash exercise of the warrants. Net proceeds are designated to support the clinical development of (Z)-endoxifen and for general corporate working capital.
Financial Results for the Second Quarter Ended June 30, 2026

Operating Expenses. Total operating expenses were $8.7 million and $18.6 million for the three and six months ended June 30, 2026, respectively, which was a decrease of $0.3 million and an increase of $2.1 million from total operating expenses for the three and six months ended June 30, 2025 of $9.0 million and $16.5 million, respectively. Factors contributing to the changes in operating expenses during the three and six months ended June 30, 2026 are explained below.

Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and six months ended June 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended June 30,

For the Six Months Ended June 30,

2026

2025

Increase (Decrease)

% Increase (Decrease)

2026

2025

Increase (Decrease)

% Increase (Decrease)

Research and Development Expense

Clinical and non-clinical trials

$

3,525

$

4,089

$

(564)

(14) %

$

7,243

$

6,836

$

407

6 %

Compensation

954

856

98

11 %

1,888

1,736

152

9 %

Professional fees and other

418

557

(139)

(25) %

545

1,087

(542)

(50) %

Research and Development Expense Total

$

4,897

$

5,502

$

(605)

(11) %

$

9,676

$

9,659

$

17

0 %

As (Z)-endoxifen is our only product candidate for which we currently incur R&D expenses, we have not further disaggregated R&D expenses by product candidate:

Clinical and non-clinical trial expenses decreased $0.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily due to a decrease of $1.0 million in spend on preclinical trials that concluded in the prior period, partially offset by an increase in expense due to higher enrollment in clinical trials of $0.2 million and an increase in drug development costs of $0.3 million in the current period. Clinical and non-clinical trial expenses increased $0.4 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, due to an increase in expense related to clinical trial enrollments of $1.5 million and an increase in drug development costs of $0.7 million, partially offset by a $1.8 million decrease in expenses related to preclinical work completed in 2025.
The increase in R&D compensation expenses of $0.1 million and $0.2 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to increases in non-cash stock-based compensation expense of $0.1 million.
The decrease in R&D professional fees and other of $0.1 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was primarily attributable to a decrease in regulatory consulting fees in the 2026 periods related to our (Z)-endoxifen program as compared to the same periods in the prior year.
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three and six months ended June 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended June 30,

For the Six Months Ended June 30,

2026

2025

Increase (Decrease)

% Increase
(Decrease)

2026

2025

Increase (Decrease)

% Increase
(Decrease)

General and Administrative Expense

Compensation

$

1,248

$

1,564

$

(316)

(20) %

$

2,559

$

3,026

$

(467)

(15) %

Professional fees and other

2,549

1,974

575

29 %

6,329

3,769

2,560

68 %

General and Administrative Expense
Total

$

3,797

$

3,538

$

259

7 %

$

8,888

$

6,795

$

2,093

31 %

The decrease in G&A compensation expenses of $0.3 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to a decrease in headcount in the current year periods compared to the same periods in the prior year.
The increase in G&A professional fees and other of $0.6 million and $2.6 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to higher legal fees of $0.7 million and $2.5 million, for the three and six months ended June 30, 2026, respectively, related to our patent litigation matters, which have now been settled, as well as fees associated with management of our intellectual property portfolio and legal costs related to our SEC compliance and other stock administration matters incurred during the current year periods.
Interest Income. Interest income was $0.2 million and $0.5 million for the three and six months ended June 30, 2026, respectively, and decreased $0.4 million and $0.8 million compared to the three and six months ended June 30, 2025, respectively. The decrease was due primarily to lower average cash balances invested in our money market account during the current year periods relative to the same periods in the prior year.

(Press release, Atossa Therapeutics, AUG 7, 2026, View Source [SID1234669882])

On August 7, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that the U.S. Food and Drug Administration’s (FDA) Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on Sept. 23, 2026 to review the Premarket Approval (PMA) application for the Galleri multi-cancer early detection (MCED) blood test.

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The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening today. When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings.

"Today, the status quo in cancer screening is simply unacceptable. Many cancers are detected too late, after symptoms appear and the disease is too advanced for effective or curative-intent treatments. In fact, 70-80% of cancer deaths occur due to cancers we are not screening for at all. GRAIL has pioneered a breakthrough technology, the Galleri test, designed to transform cancer screening by detecting more cancers before symptoms appear, including many of the deadly cancers that lack recommended screenings today. The Galleri technology is unique in how it is designed to examine the methylome using proprietary technology and artificial intelligence. We have generated extensive data in multiple studies to evaluate the impact of adding Galleri to standard of care screening with positive results showing evidence of increases in screen detected cancers, a low false positive rate and high signal origin prediction accuracy. Adding Galleri to recommended screening could result in a more effective and efficient cancer screening program in the U.S.," said Josh Ofman, MD, MSHS, CEO at GRAIL. "Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations. We appreciate the FDA’s leadership in advancing the review of the first premarket approval application for an MCED, and we look forward to discussing Galleri’s clinical data and the opportunity for multi-cancer early detection to address a significant unmet public health need, with the Advisory Committee."

GRAIL submitted its PMA application for Galleri to the FDA on Jan. 29, 2026. The FDA designated Galleri as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants with one year of follow up in the US-based PATHFINDER 2 study as well as data from over 70,000 participants from the intervention arm of the prevalent screening round (first year) of the NHS-Galleri trial, the largest and only randomized, controlled trial of an MCED test in an intended use population. The submission is also supported by an analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval.

(Press release, Grail, AUG 7, 2026, View Source [SID1234669881])