Atossa Therapeutics Reports Second Quarter 2025 Financial Results and Strategic Insights

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company focused on innovative breast cancer therapies, recently announced its financial results for the second quarter ended June 30, 2025. The company also provided updates on its research initiatives and pipeline developments.

Key Highlights of the Financial Results

For the second quarter of 2025, Atossa reported total operating expenses of $9.0 million, an increase from $7.1 million in the same period of 2024. This increase is attributed to higher research and development expenses, which reached $5.5 million, primarily due to significant investment in clinical trials for (Z)-endoxifen, Atossa's leading drug candidate in breast cancer treatment. The increase in operating expenses reflects the company’s commitment to advancing its clinical programs effectively.

According to Dr. Steven Quay, Chairman and CEO of Atossa, the company is positioned well for future milestones, including the anticipated submission of an Investigational New Drug (IND) application for (Z)-endoxifen later in 2025.

Positive Regulatory Feedback from FDA

A significant development highlighted in the announcement is the positive feedback from the U.S. Food and Drug Administration (FDA) regarding the (Z)-endoxifen program. The FDA acknowledged the scientific rationale behind Atossa's proposed dose-optimization trial for estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer. The agency confirmed that existing data would suffice to initiate the trial's monotherapy arm, thereby eliminating the need for additional toxicology studies.

These developments indicate that Atossa's strategy is on course, emphasizing its potential impact on metastatic breast cancer treatment. Dr. Quay expressed confidence that the upcoming IND submission would bolster the company’s clinical programs and reflect the scientific rigor characteristic of Atossa.

Clinical Trial Progress and Efficacy Data

Atossa’s recent updates also highlighted promising results from the I-SPY2 trial. The study's Phase 2 monotherapy pilot demonstrated a notable 95% completion rate of planned dosing among participants. More impressively, the median Ki-67 levels, a crucial biomarker for cancer cell proliferation, dropped significantly from 10.5% at baseline to 5% after three weeks of administering the low-dose (Z)-endoxifen. This result aligns with the previous findings in the POETIC trial, suggesting that early reductions in Ki-67 can predict better patient outcomes.

In ongoing trials, Atossa has also witnessed encouraging patient recruitment rates. As of late July 2025, 41 patients were enrolled in the I-SPY2 trial to study the combination of (Z)-endoxifen with Eli Lilly's abemaciclib. The company continues to explore (Z)-endoxifen in two additional Phase 2 trials focusing on ductal carcinoma in situ (DCIS) and ER+/HER2- breast cancer patients.

Enhancements in Intellectual Property Portfolio

In mid-May, Atossa secured issuance of U.S. Patent No. 12,281,056, encompassing 58 claims associated with the oral formulations of (Z)-endoxifen. The company remains confident in its extensive intellectual property portfolio, which protects its innovations in breast cancer treatments and ensures future revenue streams from potential patent licensing.

Despite facing challenges regarding two of its patents, Atossa believes these challenges are standard in the pharmaceutical space and asserts its capability to defend these patents robustly while continuing to innovate.

Strategic Outlook: Looking Ahead

Atossa has laid out a clear roadmap for the future, focusing on several key milestones. The company plans to announce selected Contract Research Organizations (CROs) for execution of the metastatic dose-ranging study and disclosing the trial design in alignment with FDA feedback. The anticipated IND submission targets Q4 2025, coinciding with a broader strategic aim of exploring additional breast cancer indications.

Overall, Atossa Therapeutics aims to solidify its position in the breast cancer treatment landscape while delivering substantial value to its stakeholders. The commitment to scientific innovation, patient-focused solutions, and careful financial planning underscores Atossa’s pursuit of excellence in combating breast cancer.