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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 45 (OpenAI - 5.2)
Rating:45Neutral
Price Target:
$0.64
▲(7.00% Upside)
The score is primarily constrained by weak financial performance (no revenue, ongoing losses and cash burn, shrinking equity) and bearish technical signals (below key moving averages with negative MACD). Positive FDA-related pipeline events provide an offset, but valuation remains pressured due to negative earnings and no dividend support.
Positive Factors
Regulatory Progress
FDA allowing the metastatic ER+/HER2- IND to proceed materially lowers regulatory execution risk for the lead program. This enables clinical data generation, supports strategic pathway clarity across indications, and strengthens the company’s ability to de-risk value drivers over coming months.
Intellectual Property
A newly issued U.S. patent with broad claims on manufacturing and enteric formulations provides durable exclusivity and formulation control. This supports lifecycle management, potential licensing or partnering, and protects commercial upside if clinical development succeeds.
Conservative Leverage
Having no meaningful debt reduces fixed obligations and lowers bankruptcy risk for a cash-burning clinical-stage biotech. This balance-sheet conservatism preserves strategic flexibility to raise equity or pursue partnerships without servicing debt, aiding multi-indication development plans.
Negative Factors
Pre-Revenue Cash Burn
Sustained negative operating cash flow and zero product revenue create a persistent financing requirement. Over 2-6 months this constrains program pacing, increases likelihood of dilutive capital raises, and can limit the company’s ability to fund multiple INDs or expansion without external financing.
Eroding Equity / Dilution Risk
Steady erosion of equity indicates cumulative losses and prior financing, implying further dilution risk to fund operations. Persistent declines reduce capital buffer, making future rounds likelier and potentially constraining long-term shareholder value if clinical milestones are delayed or unmet.
Pipeline Concentration
Heavy dependence on a single lead asset concentrates binary clinical and regulatory risk: setbacks in pivotal trials or tolerability/efficacy issues could materially impair the company’s prospects. Limited commercial diversification and a small team further heighten execution and scale-up challenges.

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

Atossa Therapeutics Business Overview & Revenue Model

Company DescriptionAtossa Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on the discovery and development of medicines in the areas of oncology and infectious diseases. The company's lead program is Endoxifen, an active metabolite of tamoxifen, which is in Phase II clinical trials to treat and prevent breast cancer. It is also developing AT-H201, an inhalation therapy to improve lung function in severely ill and hospitalized COVID-19 patients; AT-301, a proprietary drug candidate for nasal administration in patients diagnosed with COVID-19; and immunotherapy/chimeric antigen receptor therapy programs for the treatment of breast cancer. It has a research agreement with Dana-Farber Cancer Institute, Inc. to support research of cytokine-coated nanoparticles for the treatment of breast cancer. 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 headquartered 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
Atossa Therapeutics faces significant financial challenges, reflected in its inability to generate revenue and ongoing operational losses. While the company benefits from a debt-free balance sheet and strong equity, its cash flow situation is concerning, with negative cash flow metrics indicating reliance on external financing. The overall financial health is weak, necessitating strategic changes to improve revenue generation and operational efficiency.
Income Statement
18
Very Negative
Atossa Therapeutics has consistently reported zero revenue over the years, with increasing net losses, reflecting challenges in achieving profitability. The TTM (Trailing-Twelve-Months) data shows a worsening net loss, indicating further financial strain. The absence of revenue growth and negative profit margins highlight significant operational challenges.
Balance Sheet
62
Positive
The company maintains a strong equity position with no debt, which is a positive financial indicator. However, the consistent net losses and decreasing equity over time raise concerns about the sustainability of its financial position. The equity ratio remains high, suggesting financial stability despite operational losses.
Cash Flow
28
Negative
Atossa Therapeutics exhibits negative operating and free cash flow, indicating cash burn due to ongoing operational expenses without revenue generation. The company relies on financing activities to support operations, which may not be sustainable in the long term without revenue growth. The cash flow ratios indicate inefficiency in converting cash flow into profits, raising concerns over liquidity.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit-8.00K0.000.000.000.000.00
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 Price0.60
Price Trends
50DMA
0.74
Negative
100DMA
0.82
Negative
200DMA
0.81
Negative
Market Momentum
MACD
-0.04
Negative
RSI
35.99
Neutral
STOCH
44.83
Neutral
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 0.6 is below the 20-day moving average (MA) of 0.66, below the 50-day MA of 0.74, and below the 200-day MA of 0.81, indicating a bearish trend. The MACD of -0.04 indicates Negative momentum. The RSI at 35.99 is Neutral, neither overbought nor oversold. The STOCH value of 44.83 is Neutral, 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
$107.11M-1.41-25.74%13.77%-4.76%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$117.50M-3.23-60.06%946.61%-11.30%
46
Neutral
$112.67M-0.63-328.45%-10.36%42.36%
45
Neutral
$77.76M-2.57-48.89%-9.42%
41
Neutral
$159.16M-2.20-33.41%81.19%
41
Neutral
$63.16M-1.78-234.46%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ATOS
Atossa Therapeutics
0.60
-0.25
-29.18%
AGEN
Agenus
4.68
1.53
48.57%
INO
Inovio Pharmaceuticals
1.64
-0.27
-14.14%
OVID
Ovid Therapeutics
1.65
0.92
126.03%
SEER
Seer
1.92
-0.39
-16.88%
TVGN
Tevogen Bio Holdings
0.32
-0.89
-73.80%

Atossa Therapeutics Corporate Events

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.

Business Operations and StrategyExecutive/Board Changes
Atossa Therapeutics Appoints New Chief Financial Officer
Positive
Oct 14, 2025

On October 14, 2025, Atossa Therapeutics announced the appointment of Mark Daniel as Chief Financial Officer, succeeding Heather Rees. Daniel’s extensive experience in finance and capital markets is expected to support Atossa’s transition from clinical development to commercialization, particularly for its (Z)-endoxifen product. His expertise in revenue forecasting, financial discipline, and capital strategy is anticipated to enhance Atossa’s operational readiness and market entry strategy.

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: Jan 06, 2026