Atossa Therapeutics Advances Breast Cancer Treatments with Positive Q2 Earnings

Atossa Therapeutics reported Q2 earnings with a net loss of $8.4 million, driven by increased research and development costs. The company made progress in its breast cancer treatments, receiving positive feedback from the FDA for its (Z)-endoxifen development strategy and strong results from the I-SPY2 trial. Atossa is poised to continue its strategic execution in breast cancer treatment, with plans to submit an IND application in Q4 2025.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported its second-quarter financial results, ending June 30, 2025, with a net loss of $8.4 million. The loss was primarily driven by increased research and development (R&D) costs, which totaled $9.0 million for the quarter. The company's financial performance was impacted by higher expenses related to its (Z)-endoxifen trials, including drug development costs, and an increase in headcount and consulting fees [1].

Despite the financial challenges, Atossa made significant progress in its breast cancer treatment pipeline. The company received highly constructive written feedback from the U.S. Food and Drug Administration (FDA) supporting its proposed dose optimization trial for (Z)-endoxifen in estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) metastatic breast cancer. The FDA agreed that existing clinical and nonclinical data are sufficient to initiate the monotherapy arm (Part A) of the study and indicated that no additional general toxicity or neurotoxicity studies are required. This development paves the way for Atossa to file an Investigational New Drug (IND) application with the FDA, which is expected in Q4 2025 [1].

The company also announced strong results from the I-SPY 2 trial, where (Z)-endoxifen demonstrated efficacy in treating breast cancer. The trial showed promising results for both monotherapy and combination therapy arms, further validating the compound's potential in breast cancer treatment [1].

Atossa continues to evaluate (Z)-endoxifen in two other Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and one in women with ER+/HER2- breast cancer. The company is also working on regulatory strategies to expand its breast cancer indications beyond metastatic breast cancer, including treating women in the adjuvant setting, patients with DCIS, and reducing the incidence of breast cancer in high-risk women [1].

Atossa's strategic outlook remains focused on executing its breast cancer development strategy. Key upcoming deliverables include the announcement of a Contract Research Organization (CRO) selected to execute the metastatic dose ranging study and the disclosure of the trial design, including patient selection criteria and combination treatment backbone. The company is also targeting an IND submission in Q4 2025 [1].

In summary, while Atossa Therapeutics reported a net loss for the second quarter, the company made significant strides in its breast cancer treatment pipeline. The positive FDA feedback and strong trial results for (Z)-endoxifen position the company well to continue its strategic execution and potentially make a meaningful impact in breast cancer treatment.

References:
[1] https://finance.yahoo.com/news/atossa-therapeutics-announces-second-quarter-123000374.html