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Atossa Therapeutics (ATOS)
NASDAQ:ATOS

Atossa Therapeutics (ATOS) AI Stock Analysis

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ATOS

Atossa Therapeutics

(NASDAQ:ATOS)

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Neutral 43 (OpenAI - 5.2)
Rating:43Neutral
Price Target:
$5.50
▲(3.97% Upside)
The score is held down primarily by weak financial performance (no revenue, ongoing losses, and rising TTM cash burn) and a strongly bearish technical setup (price far below key moving averages with negative MACD). Positive FDA-related corporate milestones provide some support, but valuation is difficult to justify with negative earnings and no dividend.
Positive Factors
Zero debt balance sheet
A zero-debt capital structure materially lowers financial risk for a cash-burning clinical-stage biotech. Over the next several months it preserves flexibility to structure non-dilutive funding, access debt if needed, or prioritize strategic partnerships without immediate lender constraints.
FDA 'Study May Proceed' clearance
Regulatory clearance to initiate a metastatic ER+/HER2- trial is a structural de-risking event: it enables execution of a pivotal clinical program, generates prospective clinical data, and materially advances the pathway toward approval or partnering opportunities over the coming 2-6 months.
Orphan drug designation for DMD
Orphan designation provides regulatory incentives and potential marketing exclusivity that strengthen long-term commercial and partnership economics. This structural benefit improves the program’s attractiveness to collaborators and can materially raise the expected value of a successful DMD indication.
Negative Factors
Pre-revenue with persistent operating losses
As a pre-revenue clinical-stage company, lack of product sales means continued reliance on financing to fund R&D. Persistent multi‑million operating losses limit runway, amplify execution risk, and mean business viability depends on future trial success or sustained capital access over the next several months.
Shrinking shareholders' equity and negative ROE
Material erosion of equity and persistently negative returns on capital signal dilution and capital inefficiency. Over a medium-term horizon this constrains financing options, weakens the balance sheet buffer for clinical setbacks, and raises the probability of dilutive capital raises.
Weak cash generation; elevated cash burn
Sustained negative operating cash flow implies the company must raise capital to sustain trials and operations. Elevated burn increases dilution risk and can force prioritization of a single program or milestone-driven strategy, reducing optionality and stressing long-term R&D plans.

Atossa Therapeutics (ATOS) vs. SPDR S&P 500 ETF (SPY)

Atossa Therapeutics Business Overview & Revenue Model

Company DescriptionAtossa Therapeutics, Inc. operates as a clinical-stage biopharmaceutical company that develops medicines in the areas of unmet medical need in oncology for women breast cancer and other conditions in the United States. The company's lead drug candidate is oral (Z)-endoxifen, an active metabolite of tamoxifen, which is in Phase II clinical trials to treat and prevent breast cancer. It also develops immunotherapy/chimeric antigen receptor therapy programs. The company was formerly known as Atossa Genetics Inc. and changed its name to Atossa Therapeutics, Inc. in January 2020. Atossa Therapeutics, Inc. was founded in 2008 and is based in Seattle, Washington.
How the Company Makes MoneyAtossa Therapeutics primarily generates revenue through strategic partnerships and collaborations with other pharmaceutical companies, licensing agreements, and potential milestone payments related to the development and commercialization of its drug candidates. As a clinical-stage company, revenue is also contingent upon successful clinical trial results and subsequent regulatory approvals. Additionally, Atossa may engage in fundraising activities to support its ongoing research and development efforts.

Atossa Therapeutics Earnings Call Summary

Earnings Call Date:Mar 25, 2025
(Q4-2024)
|
% Change Since: |
Next Earnings Date:Apr 01, 2026
Earnings Call Sentiment Positive
The earnings call presented a generally positive outlook with notable reductions in operating costs and promising clinical advancements for (Z)-endoxifen, particularly in metastatic breast cancer. However, the financial impact of a write-off and decreased interest income offset some of these positives.
Q4-2024 Updates
Positive Updates
Reduced Operating Expenses
Total operating expenses for the year were $27.6 million, down from $31.4 million in 2023, a decrease of $3.8 million, reflecting disciplined spending in both R&D and G&A.
R&D Cost Reduction
R&D expenses declined by $3.2 million from $17.3 million in 2023 to $14.1 million in 2024, driven by a reduction in clinical and preclinical spending on (Z)-endoxifen trials and drug development.
Strong Cash Position
The company closed the year with $71.1 million in cash and cash equivalents, providing a healthy runway to advance (Z)-endoxifen and other research initiatives.
(Z)-endoxifen Clinical Progress
(Z)-endoxifen showed promising results in Phase I and Phase II studies, demonstrating robust plasma concentration, a 26% clinical benefit rate in difficult-to-treat settings, and significant reduction in mammographic breast density.
Metastatic Breast Cancer Focus
The company is prioritizing the advancement of (Z)-endoxifen in metastatic breast cancer, aiming for a potential expedited approval and faster time to market.
Negative Updates
Investment Write-off
A write-off of $1.7 million was recorded as Dynamic Cell Therapies ceased operations in the fourth quarter of 2024.
Decreased Interest Income
Interest income was $4.1 million for the year, a slight decrease compared to 2023 due to a lower average invested balance in 2024.
G&A Expense Details
Professional fees increased by $1.8 million year-over-year, primarily due to higher legal and investor relation costs, along with accounting fees tied to public company expenses.
Company Guidance
In their recent earnings call, Atossa Therapeutics provided guidance highlighting several key metrics. Operating expenses for 2024 decreased to $27.6 million, down from $31.4 million in 2023, due to disciplined spending in R&D and G&A. R&D expenses fell by $3.2 million to $14.1 million, driven by a $2.6 million reduction in spending on (Z)-endoxifen trials. G&A expenses decreased slightly to $13.5 million, with a $1.9 million reduction in compensation costs. The company reported a net loss of $25.5 million or $0.20 per share, compared to $30.1 million or $0.24 per share in the previous year. Atossa closed the year with $71.1 million in cash and cash equivalents, providing a strong financial position to advance their lead program, (Z)-endoxifen, particularly in metastatic breast cancer settings. Additionally, a Phase I study demonstrated a clinical benefit rate of approximately 26% in patients with previous progression on multiple therapies, and a related Phase II study suggested nearly a five-month improvement in progression-free survival for certain subgroups. The company plans to focus on the U.S. FDA process for a streamlined path to market, with further guidance expected as they engage with key opinion leaders and regulatory authorities.

Atossa Therapeutics Financial Statement Overview

Summary
Development-stage profile with zero revenue, persistent net losses, and worsening TTM cash burn (operating cash flow -$26.3M). A key offset is a zero-debt balance sheet, but shrinking equity and negative ROE highlight ongoing funding and dilution risk.
Income Statement
18
Very Negative
Results remain pre-revenue (total revenue is 0 across annual periods and TTM (Trailing-Twelve-Months)), with persistent operating losses. Losses are sizable and have not meaningfully improved: net loss was -$25.5M in 2024 and -$30.2M in TTM (Trailing-Twelve-Months), indicating continued heavy R&D/operating spend relative to the current revenue base. While annual net loss narrowed versus 2023 (-$30.1M), the latest TTM (Trailing-Twelve-Months) shows deterioration again, highlighting volatility and limited earnings visibility.
Balance Sheet
62
Positive
The balance sheet is conservatively levered with zero total debt in recent years (and minimal debt in 2020), which lowers financial risk and supports funding flexibility. However, equity has been shrinking meaningfully over time (stockholders’ equity fell from ~$138.1M in 2021 to ~$71.5M in 2024 and ~$49.8M in TTM (Trailing-Twelve-Months)), consistent with ongoing losses and cash burn. Returns on equity are negative across the period (e.g., -35.7% in 2024; -42.8% in TTM), underscoring that capital is not currently generating profits.
Cash Flow
28
Negative
Cash generation remains weak with consistently negative operating cash flow and free cash flow, reflecting a business still in investment/burn mode. Operating cash flow was -$21.0M in 2024 and worsened to -$26.3M in TTM (Trailing-Twelve-Months), implying an elevated ongoing cash need. A positive note is that free cash flow broadly tracks net losses (free cash flow to net income ~1.0), suggesting limited non-cash earnings distortion, but the overall trajectory still points to sustained cash consumption and potential future funding requirements.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit-16.00K-17.00K-23.00K-8.00K-23.00K-46.60K
EBITDA-32.28M-27.60M-31.35M-27.68M-20.50M-14.56M
Net Income-30.18M-25.50M-30.09M-26.96M-20.61M-17.83M
Balance Sheet
Total Assets58.01M76.44M96.25M123.53M141.26M42.84M
Cash, Cash Equivalents and Short-Term Investments51.84M71.08M88.46M110.89M136.38M39.66M
Total Debt0.000.000.000.000.0018.05K
Total Liabilities8.22M4.97M5.24M5.57M3.13M15.68M
Stockholders Equity49.79M71.48M91.02M117.96M138.14M27.17M
Cash Flow
Free Cash Flow-26.29M-21.05M-20.95M-20.79M-16.48M-11.58M
Operating Cash Flow-26.27M-21.03M-20.94M-20.76M-16.47M-11.57M
Investing Cash Flow-16.00K-19.00K-14.00K-4.73M-9.00K-9.37K
Financing Cash Flow3.37M3.67M-1.48M0.00113.30M38.55M

Atossa Therapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price5.29
Price Trends
50DMA
9.98
Negative
100DMA
11.72
Negative
200DMA
12.10
Negative
Market Momentum
MACD
-1.15
Positive
RSI
23.26
Positive
STOCH
7.90
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ATOS, the sentiment is Negative. The current price of 5.29 is below the 20-day moving average (MA) of 8.62, below the 50-day MA of 9.98, and below the 200-day MA of 12.10, indicating a bearish trend. The MACD of -1.15 indicates Positive momentum. The RSI at 23.26 is Positive, neither overbought nor oversold. The STOCH value of 7.90 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for ATOS.

Atossa Therapeutics Risk Analysis

Atossa Therapeutics disclosed 48 risk factors in its most recent earnings report. Atossa Therapeutics reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Atossa Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
54
Neutral
$100.98M-1.28-25.74%13.77%-4.76%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
$114.73M-0.60-328.45%-10.36%42.36%
47
Neutral
$192.67M-60.06%946.61%-11.30%
45
Neutral
$98.28M-1.30-33.41%81.19%
43
Neutral
$45.55M-1.51-48.89%-9.42%
41
Neutral
$56.51M-1.58-234.46%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ATOS
Atossa Therapeutics
5.29
-6.78
-56.19%
AGEN
Agenus
2.89
-0.85
-22.73%
INO
Inovio Pharmaceuticals
1.67
-0.33
-16.50%
OVID
Ovid Therapeutics
1.48
0.78
112.34%
SEER
Seer
1.75
-0.58
-24.89%
TVGN
Tevogen Bio Holdings
0.28
-1.14
-80.28%

Atossa Therapeutics Corporate Events

Shareholder MeetingsStock Split
Atossa Therapeutics Sets 15-for-1 Reverse Stock Split
Neutral
Jan 26, 2026

On December 19, 2025, Atossa Therapeutics stockholders approved an amendment to the company’s Certificate of Incorporation authorizing a reverse stock split of its common stock at a ratio between 5:1 and 20:1, with 33.7 million votes in favor, 27.9 million against and a small number of abstentions. Following this approval, the board of directors set a 15:1 reverse stock split to take effect at 12:01 a.m. Eastern Time on February 2, 2026, after which every 15 existing shares will be automatically combined into one new share, the stock will begin trading on a split-adjusted basis under a new CUSIP while retaining the ATOS ticker, fractional shares will be cashed out based on the January 30, 2026 closing price, and proportional adjustments will be made to equity awards, share reserves and preferred stock conversion terms, effectively reducing the share count and consolidating the company’s capital structure for existing shareholders.

The most recent analyst rating on (ATOS) stock is a Buy with a $7.00 price target. To see the full list of analyst forecasts on Atossa Therapeutics stock, see the ATOS Stock Forecast page.

Business Operations and StrategyRegulatory Filings and Compliance
Atossa Therapeutics outlines strategy for lead (Z)-Endoxifen program
Neutral
Jan 9, 2026

In a recent Form 8-K, Atossa Therapeutics furnished a corporate presentation outlining its development and regulatory strategy for its lead program, (Z)-Endoxifen, including potential breast cancer indications and anticipated milestones, while specifying that the materials are not deemed filed with the SEC for liability purposes. The company cautioned that these plans are subject to significant risks and uncertainties, citing factors such as the unpredictability of preclinical and clinical results, timing and likelihood of regulatory approvals, macroeconomic conditions, capital-raising needs, and the firm’s ability to remain in compliance with Nasdaq listing standards and protect its intellectual property.

The most recent analyst rating on (ATOS) stock is a Hold with a $0.64 price target. To see the full list of analyst forecasts on Atossa Therapeutics stock, see the ATOS Stock Forecast page.

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
Atossa Wins FDA Clearance to Advance (Z)-Endoxifen Trial
Positive
Jan 6, 2026

On January 6, 2026, Atossa Therapeutics announced that the U.S. Food and Drug Administration issued a “Study May Proceed” letter for the company’s investigational new drug application to study its lead candidate (Z)-Endoxifen in metastatic ER+/HER2- breast cancer. The regulatory clearance marks a key milestone that allows Atossa to advance clinical investigation of (Z)-Endoxifen, which has shown a favorable safety profile and distinct pharmacology from tamoxifen, and may offer a treatment option for tumors resistant to other endocrine therapies, potentially strengthening the company’s position in the oncology pipeline and enhancing the strategic value of its intellectual property around (Z)-Endoxifen.

The most recent analyst rating on (ATOS) stock is a Hold with a $0.64 price target. To see the full list of analyst forecasts on Atossa Therapeutics stock, see the ATOS Stock Forecast page.

Business Operations and StrategyRegulatory Filings and Compliance
Atossa Completes FDA Meeting on Regulatory Strategies
Positive
Dec 4, 2025

On December 4, 2025, Atossa Therapeutics announced the completion of a Type C meeting with the FDA on November 17, 2025, to discuss regulatory strategies for advancing (Z)-endoxifen. The FDA provided feedback on potential expedited pathways for metastatic, neoadjuvant, and risk-reduction breast cancer settings, which Atossa believes will help accelerate its clinical development and regulatory review processes. This meeting marks a significant milestone for Atossa’s programs, as it aims to shorten regulatory timelines and enhance its development strategy across multiple breast cancer indications.

The most recent analyst rating on (ATOS) stock is a Buy with a $7.00 price target. To see the full list of analyst forecasts on Atossa Therapeutics stock, see the ATOS Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Feb 03, 2026