Key Highlights

  • Third quarter loss per share was USD 0.56, narrower than the estimated USD 0.86 loss, with no Revenue reported.
  • Net loss was USD 5.6 million for the quarter and USD 23.7 million for the nine months.
  • Cash was USD 20.6 million, and the filing states conditions raise substantial doubt about continuing as a going concern.
  • Durability data from the Karisma trial are scheduled for the San Antonio Breast Cancer Symposium in December 2026.

Atossa Therapeutics (NASDAQ:ATOS), a clinical-stage biopharmaceutical company focused on its proprietary oral (Z)-endoxifen, reported a third quarter 2026 loss of USD 0.56 per share, narrower than the USD 0.86 estimated loss. The company had no revenue or cost of revenue in the three- and nine-month periods. Net loss was USD 5.6 million for the quarter and USD 23.7 million for the nine months, and operations used USD 24.7 million of cash over the nine months.

The accumulated Deficit was USD 270.3 million. Cash and cash equivalents were USD 20.6 million at September 30, with Working Capital of USD 20.5 million.

Going Concern and Funding

The filing states that conditions evaluated by management raise substantial doubt about the company's ability to continue as a going concern. During the nine months the company received net proceeds of USD 4.0 million from a registered direct offering, and USD 21,000 from selling 4,300 shares under its at-the-market program.

Endoxifen Programs

The company reports (Z)-endoxifen is being investigated in four Phase 2 trials, including the completed Karisma trial. Karisma evaluated the candidate to reduce mammographic breast density, a recognized risk Factor for breast cancer. It enrolled 240 participants in Stockholm, randomized to six months of daily oral dosing with placebo, 1 mg or 2 mg. The 24-month record review concluded March 31, 2026, final durability data were received in the third quarter, and the company is presenting them at the San Antonio Breast Cancer Symposium in December 2026.

In the I-SPY 2 Endocrine Optimization Pilot, the candidate is being evaluated as a neoadjuvant therapy for early ER-positive, HER2-negative breast cancer, alone and with other drugs. Enrollment in all arms of the expanded study is complete and select data are to be presented at the same symposium in December. The filing reports biologic activity across multiple measures, including reductions in the Ki-67 proliferation index, a median MRI functional tumor Volume reduction of about 72% and clearance of circulating tumor DNA in a majority of patients who were positive at baseline.

EVANGELINE is a Phase 2 study of the candidate plus ovarian function suppression as neoadjuvant therapy in premenopausal women with ER-positive, HER2-negative breast cancer, with enrollment complete.

The filing states the company is not presently a party to any legal proceedings it believes would have a material adverse effect. It also states the company holds Patent protection for its endoxifen through at least November 17, 2038 in oncology, endocrine dysfunction and muscular dystrophy-related areas.

Items to Follow

The December symposium presentations, the cash balance against quarterly spending of about USD 5.6 million and any further financing are the figures to follow.