Atossa Therapeutics Inc Stock Price, News & Analysis

Atossa Therapeutics (NASDAQ:ATOS) will host a live investor webinar and Q&A session on May 22, 2025, at 4:15 p.m. ET. The event, hosted by RedChip Companies, will feature CEO Dr. Steven Quay discussing the company's lead clinical candidate, (Z)-endoxifen, a next-generation SERM targeting metastatic breast cancer. The presentation will cover multiple ongoing Phase 2 studies showing strong clinical activity, improved tolerability, and favorable safety profiles. Investors will learn about recent progress, upcoming milestones, and how Atossa's differentiated science and capital-efficient model aim to create clinical impact and shareholder value.

Atossa Therapeutics (NASDAQ: ATOS) has reported full results from its Phase 2 Endocrine Optimization Pilot sub-study within the I-SPY 2 TRIAL, evaluating low-dose oral (Z)-endoxifen for treating stage II/III ER+, HER2-negative breast cancer. The study achieved its primary feasibility goal with 95% of participants completing at least 75% of planned dosing. Key findings showed median Ki-67 reduction from 10.5% to 5% by Week 3, and median functional tumor volume decreased 77.7%. The treatment demonstrated a favorable safety profile with mostly Grade 1 adverse events.

However, no participants achieved pathologic complete response (pCR), with residual cancer burden classes showing moderate to extensive residual disease. This was expected due to the intentionally low 10mg dose. Atossa is now enrolling participants for additional I-SPY 2 cohorts testing higher doses (40mg) of (Z)-endoxifen, both alone and combined with abemaciclib, with top-line data expected in 2026.

Atossa Therapeutics (NASDAQ: ATOS) reported its Q1 2025 financial results and corporate updates. The company announced a strategic shift to focus on (Z)-endoxifen for metastatic breast cancer treatment. Atossa strengthened its intellectual property portfolio with three new U.S. patents, expanding to over 200 patent claims related to (Z)-endoxifen. The company ended Q1 2025 with $65.1 million in cash and no debt. Financial highlights show total operating expenses of $7.4 million, up $0.4 million from Q1 2024. R&D expenses increased 11% to $4.16 million, while G&A expenses remained relatively flat at $3.26 million. Interest income decreased to $0.7 million from $1.1 million in the previous year. The company reported no revenue for the quarter.

Atossa Therapeutics (Nasdaq: ATOS) has secured a significant patent victory with the issuance of U.S. Patent No. 12,281,056 by the USPTO. The patent includes 58 claims covering (Z)-endoxifen formulations and therapeutic methods for their use.

The new patent specifically protects highly pure and stable enteric oral formulations of (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM). This development strengthens Atossa's intellectual property portfolio in breast cancer treatment innovation.

Led by CEO Steven Quay, M.D., Ph.D., the company continues to expand its patent estate, which now includes multiple U.S. patents with over 200 patent claims related to (Z)-endoxifen formulations and clinical applications. This strategic protection reinforces Atossa's position in developing targeted therapies for hormone receptor-positive breast cancer.

Atossa Therapeutics has proposed a groundbreaking Phase 3 clinical study called SMART 2.0 at the AACR 2025 Annual Meeting. The study aims to investigate (Z)-endoxifen, a Selective Estrogen Receptor Modulator (SERM), for reducing interval breast cancer in high-risk women.

Key highlights:

• The study targets interval breast cancers, which occur between regular mammography screenings and are typically more aggressive
• Low-dose (1mg) Z-endoxifen reduced mammographic density by nearly 20% at six months in Phase 2 KARISMA trial
• Side effects were not statistically different from placebo
• The proposed trial will use AI Risk modeling to identify and randomize participants
• Primary endpoint: measuring reduction in interval breast cancer incidence over two years

This research represents a potential advancement in breast cancer prevention, offering a safer alternative to existing treatments like tamoxifen.

Atossa Therapeutics (NASDAQ: ATOS) has been granted a new U.S. Patent (No. 12,275,684) by the USPTO for enteric oral formulations of (Z)-endoxifen and related treatment methods. The patent specifically covers formulations and their use in treating hormone-dependent breast and reproductive tract disorders.

This development strengthens Atossa's intellectual property portfolio for its proprietary (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM). The company's patent estate now includes multiple U.S. patents with over 100 claims related to (Z)-endoxifen formulations and clinical applications, reinforcing their position in developing targeted therapies for hormone receptor-positive breast cancer.

Nona Biosciences and Atossa Therapeutics (Nasdaq: ATOS) have announced a research collaboration to develop next-generation therapeutic antibodies for breast cancer. The partnership will utilize Nona's proprietary H2L2 Harbour Mice® platform, which generates fully human monoclonal antibodies without requiring additional engineering or humanization.

The platform combines transgenic mice technology with single B cell cloning, offering an efficient approach to therapeutic antibody development. The Harbour Mice® platform has been implemented in over 250 drug discovery programs across multiple therapeutic areas and has gained widespread recognition from global partners.

Atossa Therapeutics (NASDAQ: ATOS) has released its full year 2024 financial results, ending with $71.1 million in cash and no debt. The company announced a strategic shift to focus on metastatic breast cancer for its lead program, (Z)-endoxifen.

Key highlights include positive data from the Phase 2 EVANGELINE trial, showing tumor suppression rates above 85% across dose levels. The trial will continue with amended protocol comparing 40mg (Z)-endoxifen with OFS to exemestane plus OFS. The Phase 2 KARISMA-Endoxifen study demonstrated significant mammographic breast density reduction, with 1mg and 2mg doses achieving 17.3 and 23.5 percentage point reductions respectively.

Financial results show total operating expenses decreased by $3.8 million to $27.6 million in 2024, compared to $31.4 million in 2023. Interest income was $4.1 million, down $0.2 million from the previous year.

Atossa Therapeutics (NASDAQ: ATOS), a clinical-stage biopharmaceutical company focused on breast cancer medicines, has scheduled its fourth quarter and full year 2024 financial results conference call for Tuesday, March 25, 2025, at 8:30 a.m. ET.

The company will host both a conference call and live audio webcast to discuss corporate and financial results. Investors can access the webcast through the investor relations section of Atossa's website. For telephone access, U.S. callers should dial 1-800-836-8184, while international participants can dial 1-646-357-8785. The conference call name is 'Atossa Therapeutics Business Update'. A 30-day replay will be available on the company's website following the call.