Atossa Therapeutics, Inc. (ATOS)

Changes are expected to reduce future study costs, accelerate objective readouts, and extend operating runway under current plans SEATTLE , Oct. 6, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS; "Atossa" or the "Company), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, announces an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer. The amended, non-registrational design is expected to accelerate objective readouts while reducing projected future study costs, consistent with Atossa's focus on extending operating runway and deploying capital where it is most impactful.

Veteran development leader with successful regulatory approvals record returns to lead late-stage clinical and regulatory programs to address multiple unmet clinical needs SEATTLE , Oct. 1, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS; "Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, announces the appointment of Janet R. Rea, MSPH to its newly created position Senior Vice President, R&D.

SEATTLE, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS; “Atossa” or the “Company”), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, today announces it has appointed CORE IR, a strategic investor relations, public relations, and corporate advisory firm, to support the Company's ongoing investor relations and communications initiatives.

Type C FDA Meeting Requested, Update Expected by Year-End 2025 SEATTLE , Sept. 8, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS; "Atossa" or the "Company") announced today it has requested a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss a regulatory strategy aimed at accelerating development of low-dose (Z)-endoxifen for breast cancer risk reduction.

Monotherapy Phase 2 study designed with FDA input; IND expected in Q4 2025 Topline results anticipated in 2026  Positions Atossa for transition into registrational Phase 3 development SEATTLE , Aug. 20, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, announced today it has selected PSI, a leading global contract research organization (CRO), to operationalize and manage its planned (Z)-endoxifen monotherapy dose-ranging study in women with metastatic breast cancer (mBC). The study was designed following guidance from the U.S. Food and Drug Administration (FDA) and is intended to directly inform a subsequent Phase 3 trial.

FDA Provides Positive Feedback, Clears Path for Atossa to File IND for (Z)-Endoxifen in Metastatic Breast Cancer; FDA Indicates No Additional Toxicity Studies Required Strong I-SPY2 Results Reinforce Efficacy of Atossa's Monotherapy at 3-weeks SEATTLE , Aug. 12, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the second quarter ended June 30, 2025 and provided an update on recent company developments. "Atossa continues to make meaningful and measurable progress across our pipeline, underscored by recent, highly constructive interactions with the FDA that further support our (Z)-endoxifen development strategy in metastatic breast cancer," stated Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics.

SEATTLE , July 29, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, today announced positive written feedback from the U.S. Food and Drug Administration (FDA) regarding the company's proposed dose optimization trial of (Z)-endoxifen for the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer. With the FDA's feedback, Atossa is energized and moving quickly to advance (Z)-endoxifen in metastatic breast cancer.

SEATTLE , June 2, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced that Dr. Steven Quay, M.D., Ph.D., President and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 7:35 a.m.

SEATTLE, WASHINGTON / ACCESS Newswire / May 20, 2025 / Atossa Therapeutics, Inc. (Nasdaq:ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, is pleased to invite investors to a webinar on May 22, 2025, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature Dr. Steven Quay, CEO of Atossa Therapeutics.

Here is how Atossa Genetics Inc. (ATOS) and Clover Health Investments, Corp. (CLOV) have performed compared to their sector so far this year.

Feasibility endpoint achieved; rapid Ki‑67 suppression and substantial MRI‑confirmed tumor shrinkage observed with favorable safety profile SEATTLE , May 14, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today reported full results from the Phase 2 Endocrine Optimization Pilot (EOP) sub‑study within the I‑SPY 2 TRIAL evaluating low‑dose oral (Z)‑endoxifen (10 mg daily) as a neoadjuvant treatment in 20 women with stage II/III estrogen‑receptor–positive (ER+), HER2‑negative breast cancer. Key Findings: Primary feasibility goal surpassed – 95 percent of participants (19/20) completed at least 75 percent of planned dosing, far exceeding the predefined 75 percent threshold.

Announced strategic plan to advance (Z)-endoxifen for metastatic breast cancer indication  Enhanced (Z)-endoxifen intellectual property portfolio with three new U.S. patents, expanding IP portfolio to more than 200 patent claims related to (Z)-endoxifen Ended first quarter 2025 with $65.1 million in cash and cash equivalents and no debt SEATTLE , May 13, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the first quarter ended March 31, 2025 and provided an update on recent company developments. First Quarter 2025 Highlights: Announced Strategic Decision to Pursue Metastatic Breast Cancer Indication: Atossa announced plans to target metastatic breast cancer as its lead program for (Z)-endoxifen.

SEATTLE, April 30, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced that the United States Patent and Trademark Office (USPTO) has granted a new patent (U.S. Patent No. 12,281,056) directed to highly pure and stable enteric oral formulations comprising (Z)-endoxifen as well as therapeutic methods of using those oral formulations.

SEATTLE, April 29, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today outlined a framework for a pioneering Phase 3 clinical study titled SMART 2.0. The proposed trial would investigate the potential of oral (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition, to significantly reduce interval breast cancer in women identified as high-risk through advanced mammographic screening techniques. The proposed SMART 2.0 study was presented at the American Association for Cancer Research (AACR) Annual Meeting and represents a future research program and potential partnership opportunity to advance this critical initiative for women at high risk of breast cancer.

SEATTLE, April 22, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced that the United States Patent and Trademark Office (USPTO) has granted a new patent (U.S. Patent No. 12,275,684) directed to enteric oral formulations comprising (Z)-endoxifen as well as methods of treating subjects with those oral formulations.