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ATOSNasdaq

ATOSSA THERAPEUTICS, INC.

Biopharma developer (SEC filing verified)·Phase 2·Seattle, WA, United States·CEO: Dr. Steven C. Quay FCAP, M.D., Ph.D.
OncologyReproductive

ATOS evidence brief

What we can confirm

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What it means

The company data is ready for cross-source review; unsupported conclusions remain unknown.

What to watch

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BioSniper AIPage evidence connected

Prepared research question

What matters most for ATOS—catalysts, financial risk and supporting evidence?

Run cited research

Traceable citations · Unknowns marked

BioSniper AI · ATOS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing (Z)-endoxifen, a selective estrogen receptor modulator/degarder, primarily for breast cancer and other breast conditions.

Key risk: Going concern uncertainty

5.4/10

BioSniper Score

Based on 4 of 6 signals

Market Cap

$25.7M

Cash Runway

8.6 mo

Lead Asset

-endoxifen (Phase 2)

Next Catalyst

Financial data as of Jun 30, 2026.

Tracking 1 pipeline candidate · 2 clinical trials for ATOSSA THERAPEUTICS, INC..

AI OverviewAI overview is shown in English only.

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing (Z)-endoxifen, a selective estrogen receptor modulator/degarder, primarily for breast cancer and other breast conditions.

  • Lead drug candidate is oral (Z)-endoxifen, a selective estrogen receptor modulator (SERM)/selective estrogen receptor degrader (SERM/D) [sec_mda · as of 2026-03-25].
  • Cash and equivalents of $26.1 million as of 2026-06-30 [sec].
  • Net loss of $8.5 million for the quarter ended 2026-06-30 [sec].
  • Shareholders' equity of $57.7 million as of 2026-06-30 [sec].
  • Expects existing resources will be insufficient to fund planned operations for the next twelve months, raising substantial doubt about going concern [sec_mda · as of 2026-08-07].

What works

  • (Z)-endoxifen is the most active metabolite of Tamoxifen, an FDA-approved drug for breast cancer, and is substantially more potent [sec_mda · as of 2026-08-07].
  • Patent protection for (Z)-endoxifen extends through at least November 2038 in key areas [sec_mda · as of 2026-08-07].
  • Company has completed a Phase 2 trial of (Z)-endoxifen for mammographic density reduction (NCT05068388) [catalyst].

What to weigh

  • Company has no revenue and expects to incur ongoing operating losses for the foreseeable future [sec_mda · as of 2026-08-07].
  • Existing cash is likely insufficient to fund operations for the next twelve months, creating substantial doubt about going concern [sec_mda · as of 2026-08-07].
  • Additional capital may not be available on acceptable terms or at all, and the company could be forced to cease or curtail operations [sec_mda · as of 2026-08-07].

From the filings

Quoted directly from source documents.

  • Lead drug candidate is (Z)-endoxifen, a SERM/SERD for breast cancer.

    Our lead drug candidate is oral (Z)-endoxifen, a selective estrogen receptor modulator (SERM)/ selective estrogen receptor degrader (SERM/D)

    SEC MD&A · March 25, 2026

  • Company expects existing resources will be insufficient for the next twelve months.

    As of the date of filing this Quarterly Report, we expect our existing resources will likely be insufficient to fund our planned operations for the next twelve months, and additional capital resources will be needed to fund operations longer-term.

    SEC MD&A · August 7, 2026

  • (Z)-endoxifen is the most active metabolite of Tamoxifen and is substantially more potent.

    (Z)-endoxifen is the most active metabolite of Tamoxifen, an FDA approved drug to treat and prevent breast cancer in high-risk women, and it is substantially more pot

    SEC MD&A · August 7, 2026

Catalyst timeline

  • 2021-12-21 · Phase 2 Start: A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose-Response Study of Oral (Z)-Endoxifen - NCT: NCT05068388This Phase 2 trial of (Z)-endoxifen for mammographic density reduction has been completed.
  • 2023-02-14 · Phase 2 Start: A Phase 2 Trial of (Z)-Endoxifen + Goserelin as Neoadjuvant Treatment for Premenopausal Women With E - NCT: NCT05607004This Phase 2 trial of (Z)-endoxifen in combination with goserelin is active but not recruiting.
Risks & what to watch (3)

Key risks

  • Going concern uncertaintyExisting cash likely insufficient for 12 months; may need to cease or curtail operations [sec_mda · as of 2026-08-07].
  • No revenue or profitabilityNo revenue anticipated until regulatory approval and commercialization; ongoing operating losses [sec_mda · as of 2026-08-07].
  • Capital access riskAdditional funding may not be available on acceptable terms due to market conditions [sec_mda · as of 2026-08-07].

What to watch

  • Ability to raise additional capital to fund operations beyond the next twelve months [sec_mda · as of 2026-08-07].
  • Progress of ongoing Phase 2 trial of (Z)-endoxifen + goserelin in premenopausal women (NCT05607004) [catalyst].
  • Any new clinical data or regulatory milestones for (Z)-endoxifen [sec_mda · as of 2026-08-07].

Sources: Catalysts · SEC filings · SEC MD&A · Generated August 27, 2026 · How we verify sources →

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Evidence & data

Score breakdownBased on 4 of 6 signals · derived from public data

Cash Runway2.4

8.6 months

Financial Health9.7

D/E 0.20 · 0% dilution

Pipeline Maturity6.0

Lead: Phase 2

Pipeline Breadth3.3

1 candidate

Catalyst MomentumN/A

No upcoming catalysts tracked

Insider SignalN/A

No insider transactions in the last 180 days

Runway

Pipeline

Regulatory

Financials

Institutional Holdings

Source: SEC Form 13F · as of Mar 2026

Institutional holders

31

Total value held

$8.2M

Showing top 10 of 31 institutional holders of ATOSSA THERAPEUTICS, INC.. Open the full 13F history after sign-in.

Short Interest

as of May 20, 2026
% of float
3.9%
Days to cover
6.2
Shares short
337,509
Daily short volume
-

Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →

ATOS short interest

Governance

Frequently asked questions

What is the AI investment thesis for ATOSSA THERAPEUTICS, INC.?

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing (Z)-endoxifen, a selective estrogen receptor modulator/degarder, primarily for breast cancer and other breast conditions.

What is ATOSSA THERAPEUTICS, INC.'s lead drug candidate?

ATOSSA THERAPEUTICS, INC.'s most advanced tracked candidate is -endoxifen (Phase 2) for Breast Neoplasms.

Who is the CEO of ATOSSA THERAPEUTICS, INC.?

Dr. Steven C. Quay FCAP, M.D., Ph.D. is the chief executive officer of ATOSSA THERAPEUTICS, INC. (ATOS).

Where is ATOSSA THERAPEUTICS, INC. headquartered?

ATOSSA THERAPEUTICS, INC. (ATOS) is headquartered in Seattle, WA, United States.

What therapeutic areas does ATOSSA THERAPEUTICS, INC. focus on?

ATOSSA THERAPEUTICS, INC. develops therapies across Oncology, Reproductive.

925 companies232,681 SEC filings21,419 clinical trials100% citation-verification pass rate (7d)How we verify →

The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.