AB Science announces today the successful completion of capital increases of a total gross amount of EUR 14.2 million

On August 10, 2026 AB Science S.A. (the "Company" or "AB Science", Euronext – FR0010557264 – AB) reported the successful completion of capital increases of a total gross amount of EUR 14.2 million subscribed by a limited number of investors (the "Private Placement").

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The capital increase was subscribed for EUR 12 million by an existing long-term investor who expressed its intention to accompany the development of the Company.

Stéphane Ledermann, the Chief Executive Officer of the Company, also contributed to the round of financing, and indicated "My personal financial investment in this capital increase, alongside long-standing, long-term shareholders whom I thank, provides a lasting foundation for our new governance. This stability is necessary to pursue the transformation of the Company initiated four weeks ago.

This exceptional, non-recurring financing covers our working capital requirements for the months to come without any additional funding and secures the implementation of our new growth priorities, which are currently being finalized. The value-creation strategies for our employees and shareholders will be approved in the coming weeks and announced during September."

The Private Placement is not subject to a prospectus requiring an approval from the French Financial Market Authority (Autorité des Marchés Financiers – the "AMF"). In accordance with Article 1.5.(ba) of the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the "Prospectus Regulation"), the Company file with the AMF a document containing the information set out in Appendix IX of the Prospectus Regulation (the "Information document"), copies of which will be available free of charge on the Company’s website at www.ab-science.com and on the AMF’s website at www.amf-france.org.

Use of proceeds

The Company intends to use the net proceeds from the Private Placement to fund its research and development programs, with primary focus on:

AB8939 development in acute myeloid leukemia;
Masitinib development in amyotrophic lateral sclerosis; and
Nearer-term value-creation projects that are expected to be finalized and disclosed in September.

This transaction strengthens the Company’s cash position and enables it to cover its financing needs beyond the next 12 months.

Terms and conditions of the Private Placement

The Private Placements, for a total amount of EUR 14.2 million (including share issue premium), was carried out through the issuance, without preferential subscription rights and without a priority subscription period, of:

(i) 3,606,560 new ordinary shares of the Company (the "New Shares"), each with one share warrant attached (a "BSA-1" and, together with the New Share to which it is attached, an "ABSA-1") – five BSA-1 entitle their holder to subscribe to three new ordinary shares of the Company at a price of EUR 1.00 per ordinary share; and

(ii) 19,672,132 New Shares, each with one share warrant attached (a "BSA-2" and, together with the New Share to which it is attached, an "ABSA-2") – four BSA-2 entitle their holder to subscribe to seven new ordinary shares of the Company at a price of EUR 1.00 per ordinary share.

The total of 23,278,692 New Shares (ABSA-1 and ABSA-2) are collectively called the "ABSA". The total of 23,278,692 warrants attached (BSA-1 and BSA-2) are collectively called the "BSA".

The issuance of the ABSA was conducted through share capital increases with cancellation of shareholders’ preferential subscription rights for the benefit of investors within the category of persons defined by the 15th resolution of the Combined General Meeting of the Company’s shareholders of June 30, 2026 (the "General Meeting"), in accordance with article L. 225-138 of the French commercial code.

The issue of the ABSA, representing approximately 29.09% of the Company’s share capital, on a non-diluted basis, before completion of the Private Placement, and 22.53% of the Company’s share capital, on a non-diluted basis, after completion of the Private Placement, was decided on August 9, 2026 by the Chief Executive Officer, pursuant to the delegation of competence granted to him by the board of directors dated August 8, 2026, pursuant to the delegation of competence granted to it under the 15th resolution of the General Meeting.

The issue price of one ABSA is EUR 0.61 (including share issue premium), representing a facial discount of 24.87% (i.e. EUR 0.2019) to the volume-weighted average price of the AB Science shares on the regulated market of Euronext Paris ("Euronext Paris") over the three trading days preceding the setting of such issue price, i.e. August 5, 6 and 7, 2026, i.e. EUR 0.8119 (the "3-day VWAP").

The issue price of:

one ABSA-1, including the theoretical value of the BSA-1 attached to it (as described below, together with the issue price of the new ordinary shares issued upon exercise of the BSA-1) represents a total 22.11% discount per AB Science share to the 3-day VWAP, consistent with the maximum discount authorized by the General Meeting pursuant to its 15th resolution; and

one ABSA-2, including the theoretical value of the BSA-2 attached to it (as described below, together with the issue price of the new ordinary shares issued upon exercise of the BSA-2) represents a total 20.19% discount per AB Science share to the 3-day VWAP, consistent with the maximum discount authorized by the General Meeting pursuant to its 15th resolution.

Terms and conditions of the BSA

One BSA is attached to each New Share.

Five BSA-1 entitle their holder to subscribe to three new ordinary shares of the Company at a price of EUR 1.00 per ordinary share.

Four BSA-2 entitle their holder to subscribe to seven new ordinary shares of the Company at a price of EUR 1.00 per ordinary share.

The BSAs may be exercised at any time within 60 months of their issuance. In the event all BSAs are exercised, a total number of 36,590,166 additional ordinary shares of the Company will be issued, representing additional total proceeds of approximately EUR 36 million.

The theoretical value of each BSA, assuming a volatility of 32.088%1, based on closing price as of August 7, 2026 and using Black & Scholes model, is equal to:

EUR 0.1982 by BSA-1; and

EUR 0.5780 by BSA-2.

The BSAs will be immediately detached (détachés) from the New Shares upon issuance and will not be listed.

Impact of the Private Placement on the Company’s shareholding

Following the issuance of the ABSAs, the Company’s total share capital will be EUR 1,033,083.57 (and EUR 1,265,870 in the event of exercise of all BSAs). It will be comprised of 96,530,683 ordinary shares (and of 133,120,849 ordinary shares in the event of exercise of all BSAs) with a par value of EUR 0.01. There will be no change on the number of preferred shares.

To the Company’s knowledge, immediately prior to completion of the Private Placement and after completion of the Private Placement, the breakdown of the Company’s share capital is as follows:

Before the capital increase After the capital increase (before exercising the warrants) After the capital increase and exercise of the warrant
Number of shares ( 1) % Diluted base ( 2) Number of shares ( 1) % Diluted base ( 2) Number of shares ( 1) % Diluted base ( 2)
Investors above 5% 25 315 344 31,63% 32,54% 44 987 476 43,55% 41,72% 79 413 707 56,77% 53,10%
Single Private Investor 6 259 910 7,82% 6,85% 25 932 042 25,10% 20,56% 60 358 273 43,14% 36,54%
Subtotal concert A. Moussy 19 055 434 23,81% 25,69% 19 055 434 18,45% 21,16% 19 055 434 13,62% 16,56%
A. Moussy 6 782 434 8,47% 14,38% 6 782 434 6,57% 11,84% 6 782 434 4,85% 9,27%
AMY SAS (3) 12 273 000 15,34% 11,31% 12 273 000 11,88% 9,31% 12 273 000 8,77% 7,29%
Other Investors 54 714 321 68,37% 67,46% 58 320 881 56,45% 58,28% 60 484 816 43,23% 46,90%
Total 80 029 665 100,00% 100,00% 103 308 357 100,00% 100,00% 139 898 523 100,00% 100,00%
(1) All classes of shares are affected. The number of ordinary shares amounts to 73,251,991 before the Private Placement, 96,530,683 after the Private Placement (but before exercise of the BSAs), and 133,120,849 after the Private Placement and exercise of the BSAs.
(2) The diluted basis takes into account the exercise of all instruments giving access to the capital, the definitive allocation of all free shares and the conversion of all preferred shares into ordinary shares (aiming for the highest theoretical dilution).
(3) AMY SAS is a company controlled by A. Moussy.

On the basis of the share capital of the Company immediately after completion of the Private Placement, the interest of a shareholder who held 1.00% of the Company’s share capital prior to the above-mentioned capital increase and who did not subscribe to it now stands at 0.7747% on a non-diluted basis and 0.6072% on a diluted basis.

Admission to trading of the New Shares

The New Shares are expected to be admitted to trading on the regulated market of Euronext Paris on August 14, 2026.

The New Shares will be subject to the provisions of the Company’s by-laws and will be assimilated to existing shares upon final completion of the Private Placement. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company’s existing shares under the same ISIN code FR0010557264 – AB.

The BSAs will not be admitted to trading on any market.

The new ordinary shares issued upon exercise of the BSAs will be, when issued, subject to the provisions of the Company’s by-laws and will be assimilated to existing shares. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company’s existing shares under the same ISIN code FR0010557264 – AB.

Lock-up commitments

The Company has signed a lock-up commitment (to the benefit of the investors) pursuant to which it has agreed to a lock-up period of 30 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

The directors and officers of the Company have signed a lock-up commitment (to the benefit of the investors) pursuant to which they have agreed to a lock-up period of 30 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

Indicative timetable

August 8, 2026 Decisions of the Board of Directors deciding the principle of the Private Placement.
August 9, 2026 Decisions of the Chief Executive Officer setting the terms and conditions of the Private Placement (including the subscription price of the ABSAs and the gross amount of the Private Placement).
August 10, 2026 Publication of this press release.
Publication of the Information Document
August 12, 2026 Settlement-delivery of the ABSAs – Detachment of the BSA
August 14, 2026 Start of trading of the New Shares on Euronext Paris.
Risk factors

AB Science draws the attention of the public to the risk factors relating to the Company and its business described in its annual management reports and press releases, which are available free of charge on the Company’s website (www.ab-science.com).

In addition, the main risks specific to securities are as follows:

The existing shareholders who do not participate in the Private Placement will see their shareholding in the share capital of AB Science diluted, and this shareholding may also be diluted in the event of exercise of the BSA, as well as in the event of new securities transactions.

The volatility and liquidity of AB Science shares could fluctuate significantly. The market price of the Company’s shares may fluctuate and fall below the subscription price of the shares issued in the context of the Private Placement. The sale of Company shares may occur on the secondary market, after the Private Placement, and have a negative impact on the Company share price.

About masitinib

Masitinib is a novel oral tyrosine kinase inhibitor that is being developed to target mast cells and macrophages, key immune cells, through inhibition of a limited number of kinases. Through its activity on mast cells and microglial cells and therefore its inhibitory effect on the activation of the inflammatory process, masitinib may have an effect on the course of central nervous system diseases.

About AB8939

AB8939 is a new synthetic microtubule-destabilizing drug candidate. Preclinical data suggests that AB8939 has broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome P-glycoprotein (Pgp) and myeloperoxidase (MPO) mediated drug resistance. Development of drug resistance often restricts the clinical efficacy of microtubule-targeting chemotherapy drugs (for example, taxanes and vinca alkaloids); thus, AB8939 has the potential to be developed in numerous oncology indications.

(Press release, AB Science, AUG 10, 2026, View Source [SID1234669898])

HanchorBio and Taiwan Cancer Moonshot Project-NTU Subteam Led by Professor Sung-Liang Yu Establish Strategic Collaboration to Advance Precision Oncology

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])

Innovent Biologics and Daiichi Sankyo Enter Exclusive Agreement for VANFLYTA® Commercialization in China

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])

Atossa Therapeutics Reports Second Quarter 2026 Financial Results and Provides a Corporate Update

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])

GRAIL Announces FDA Advisory Committee Meeting to Review Premarket Approval Application for the Galleri® Multi-Cancer Early Detection Test

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])