Atossa Therapeutics narrows Q3 loss to $5.64M
Any CVR payment depends on monetization of Atossa’s first qualifying FDA voucher; IND clearances are anticipated by early 2027.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Atossa Therapeutics, Inc. (ATOS) reported a third-quarter 2026 net loss of $5.638 million, versus $8.692 million a year earlier. Operating expenses were $5.899 million, down from $9.251 million. Nine-month net loss was $23.718 million, compared with $23.833 million. Cash and cash equivalents were $20.574 million as of September 30, 2026, versus $41.299 million as of December 31, 2025.
The board declared one contingent value right (CVR) for each common share outstanding as of October 19, 2026, and issued thereafter. CVRs remain attached to shares and will not trade separately unless the board elects to detach them. Holders collectively are entitled to 25% of net proceeds from sale or other monetization of Atossa’s first qualifying FDA priority review voucher, subject to a $50 million aggregate payment cap. No voucher has been awarded, and no payment is assured.
Atossa anticipates FDA clearance of investigational new drug applications for (Z)-endoxifen in Duchenne muscular dystrophy and McCune-Albright syndrome by early 2027, with Phase 2 trial initiation expected in 2027. Topline data from the Phase 2 EVANGELINE study are anticipated in the second quarter of 2027. Karisma follow-up and selected I-SPY2 data are to be presented at the San Antonio Breast Cancer Symposium in December 2026.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointQuarterly net loss: $5.638 million versus $8.692 million in 2025.
Negative
- None.
Filing Explained
At September 30, cash equaled 342.9 days of the last reported quarterly operating cash use at that quarter’s rate.
This 8-K reports Atossa’s results for the quarter ended
Because the reported share count increased, existing holders’ percentage ownership is lower absent offsetting changes. At
Sources and calculations
- Atossa Therapeutics Form 8-K and attached press release (2026-11-10)
- Atossa Therapeutics third-quarter 2026 fundamentals (2026Q3)
- Dilution definition (undated)
- Available liquidity against the last reported quarterly operating outflow, in days at that rate $20,574,000 / ($5,520,000 / 92) = 342.9 days
8-K Event Classification
Key Figures
Key Terms
Stapled Contingent Value Rights financial
Priority Review Voucher regulatory
Investigational New Drug (IND) application regulatory
Selective Estrogen Receptor Modulator/Degrader medical
Earnings Snapshot
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What was ATOS’s net loss in the third quarter of 2026?
What do ATOS CVR holders receive if the company monetizes a priority review voucher?
When does ATOS expect FDA clearance and Phase 2 trials for (Z)-endoxifen?
When does ATOS expect topline data from the EVANGELINE study?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
N/A |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 10, 2026, Atossa Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2026 and providing a Company update. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in Items 2.02 and 9.01 of this report, including Exhibit 99.1 attached hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
|
|
|
Exhibit No. |
|
Description |
99.1 |
|
Press Release dated November 10, 2026 |
|
|
|
104 |
|
Cover page Interactive Data File (embedded within the Inline XBRL document) |
* * *
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
Atossa Therapeutics, Inc. |
|
|
|
|
Date: |
November 10, 2026 |
By: |
/s/ Mark J. Daniel |
|
|
|
Mark J. Daniel (Principal Financial and Accounting Officer) |
Exhibit 99.1
Atossa Therapeutics Reports Third Quarter 2026 Financial Results and Provides a Corporate Update
SEATTLE, WASHINGTON, November 10, 2026 — Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announced its financial results for the third quarter ended September 30, 2026 and provided an update on recent corporate developments.
“In recent weeks, we took meaningful steps to enable shareholders to participate in potential future value from our rare disease programs,” stated Steven C. Quay, M.D., Ph.D., Atossa's Chairman, President and Chief Executive Officer. “Our recently announced contingent value rights agreement entitles holders to share in 25% of the net proceeds, up to $50 million, from the sale of the first priority review voucher awarded to Atossa from its rare disease development programs. At the same time, we continued to advance (Z)-endoxifen toward several near-term milestones, including anticipated FDA clearance of our IND applications in Duchenne Muscular Dystrophy and McCune-Albright Syndrome in early 2027. In December 2026, presentations at the San Antonio Breast Cancer Symposium will include Karisma follow-up results and selected data from the ongoing I-SPY2 study evaluating (Z)-endoxifen in combination with other therapies.”
Third Quarter 2026 & Recent Highlights
Anticipated Milestones
Financial Results for the Third Quarter Ended September 30, 2026
Operating Expenses. Total operating expenses were $5.9 million and $24.5 million for the three and nine months ended September 30, 2026, respectively, which represented a decrease of $3.4 million and $1.2 million from total operating expenses for the three and nine months ended September 30, 2025, which were $9.3 million and $25.7 million, respectively. Factors contributing to the changes in operating expenses during the three and nine months ended September 30, 2026, are explained below.
Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and nine months ended September 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
|
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
||||||||||||||||||||||||
|
|
|
2026 |
|
|
2025 |
|
|
Increase (Decrease) |
|
|
% Increase (Decrease) |
|
2026 |
|
|
2025 |
|
|
Increase (Decrease) |
|
|
% Increase (Decrease) |
||||||
Research and Development Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
Clinical and non-clinical trials |
|
$ |
2,483 |
|
|
$ |
4,318 |
|
|
$ |
(1,835 |
) |
|
(42)% |
|
$ |
9,726 |
|
|
$ |
11,154 |
|
|
$ |
(1,428 |
) |
|
(13)% |
|
Compensation |
|
|
741 |
|
|
|
723 |
|
|
|
18 |
|
|
2% |
|
|
2,629 |
|
|
|
2,459 |
|
|
|
170 |
|
|
7% |
|
Professional fees and other |
|
|
154 |
|
|
|
329 |
|
|
|
(175 |
) |
|
(53)% |
|
|
699 |
|
|
|
1,416 |
|
|
|
(717 |
) |
|
(51)% |
|
Research and Development Expense Total |
|
$ |
3,378 |
|
|
$ |
5,370 |
|
|
$ |
(1,992 |
) |
|
(37)% |
|
$ |
13,054 |
|
|
$ |
15,029 |
|
|
$ |
(1,975 |
) |
|
(13)% |
As (Z)-endoxifen is our only product candidate for which we currently incur R&D expenses, we have not further disaggregated R&D expenses by product candidate.
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three and nine months ended September 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
|
|
|
For the Three Months Ended September 30, |
|
For the Nine Months Ended September 30, |
||||||||||||||||||||||||
|
|
|
2026 |
|
|
2025 |
|
|
Increase (Decrease) |
|
|
% Increase (Decrease) |
|
2026 |
|
|
2025 |
|
|
Increase (Decrease) |
|
|
% Increase (Decrease) |
||||||
General and Administrative Expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
|
Compensation |
|
$ |
1,119 |
|
|
$ |
1,453 |
|
|
$ |
(334 |
) |
|
(23)% |
|
$ |
3,678 |
|
|
$ |
4,479 |
|
|
$ |
(801 |
) |
|
(18)% |
|
Professional fees and other |
|
|
1,402 |
|
|
|
2,428 |
|
|
|
(1,026 |
) |
|
(42)% |
|
|
7,731 |
|
|
|
6,197 |
|
|
|
1,534 |
|
|
25% |
|
General and Administrative Expense Total |
|
$ |
2,521 |
|
|
$ |
3,881 |
|
|
$ |
(1,360 |
) |
|
(35)% |
|
$ |
11,409 |
|
|
$ |
10,676 |
|
|
$ |
733 |
|
|
7% |
Interest Income. Interest income was $0.2 million and $0.7 million for the three and nine months ended September 30, 2026, respectively, and decreased $0.4 million and $1.2 million compared to the three and nine months ended September 30, 2025, respectively. The decrease was due primarily to lower average cash balances invested in our money market account during the current year periods relative to the same periods in the prior year.
About Atossa Therapeutics
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company developing innovative medicines in oncology and other areas of significant unmet need. The Company’s lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings.
(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms of interest. Atossa is evaluating its potential applications in oncology and rare diseases. The Company’s proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition. Atossa’s (Z)-endoxifen is not approved for any indication.
Atossa has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for (Z)-endoxifen for the treatment of DMD, as well as Rare Pediatric Disease (RPD) designation for (Z)-endoxifen for the treatment of both DMD and MAS. Upon approval of a qualifying marketing application, drugs with RPD designation may be eligible for a Priority Review Voucher (PRV), which can be used to obtain priority review for a future application or may be sold or transferred to another sponsor. In the last 18–24 months, disclosed PRV sales have ranged from $100–$220 million.
Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide.
More information is available at https://atossatherapeutics.com.
Forward-Looking Statements
This press release contains certain “forward-looking statements” within the meaning of applicable securities laws, including but not limited to, our full year 2026 outlook; our expectations regarding the Company’s development and regulatory strategy and related milestones, including the timing of data; the potential indications that the Company may pursue for (Z)-endoxifen; the potential role of (Z)-endoxifen and (Z)-endoxifen-related compounds in endocrine therapies; the potential for (Z)-endoxifen to receive regulatory approval to commence clinical trials for DMD and MAS and the timing thereof; the Company's progress across its pipeline and potential commercialization; the strength of the Company's patent portfolio; the Company’s potential eligibility for, the value of, and the Company's ability to monetize a Rare Pediatric Disease PRV; potential payments under the CVR Agreement; and the potential market and growth opportunities for the Company. Words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “believe,” “design,” “predict,” “future,” or other similar expressions or statements regarding intent, belief or current expectations, are forward-looking statements.
Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes to differ materially from those projected or anticipated, including, without limitation, risks and uncertainties associated with: our ability to successfully execute our strategy to shorten our clinical development timelines and pursue a DMD or MAS indication or other indications for our lead program, (Z)-endoxifen; expected timing, completion and results of our preclinical studies, clinical trials, and research and development programs; the potential clinical significance of preclinical data and the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; the outcome or timing of necessary regulatory approvals; our ability to receive orphan-drug exclusivity for (Z)-endoxifen for MAS; our ability to receive a PRV from the FDA; changes to, or the expiration of, the Rare Pediatric Disease PRV program; our ability to monetize any PRV we may receive and our expectations around any PRV’s potential future value; the number of outstanding CVRs, our ability to make a payment to CVR holders, and the expected timing of such payment, if any; our ability to maintain compliance with Nasdaq listing requirements; our ability to establish and maintain intellectual property rights covering our products; the impact of general macroeconomic conditions on our business; our ability to raise capital; and other risks and uncertainties detailed from time to time in Atossa’s filings with the SEC, including, without limitation, its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.
The market value of a PRV is variable and subject to a number of factors beyond our control and reported past PRV sale amounts are not necessarily indicative of PRV sale amounts in the future.
Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements.
Investor and Media Contacts
Investors: WaterSeid Partners, Inc. — ATOS@waterseid.com
Media: Elev8 New Media — atossa@elev8newmedia.com
ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
||
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
Assets |
|
|
|
|
|
|
||
Current assets |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
20,574 |
|
|
$ |
41,299 |
|
Restricted cash |
|
|
110 |
|
|
|
110 |
|
Prepaid materials |
|
|
3,014 |
|
|
|
3,081 |
|
Prepaid expenses and other current assets |
|
|
1,483 |
|
|
|
1,128 |
|
Total current assets |
|
|
25,181 |
|
|
|
45,618 |
|
Other assets |
|
|
1,267 |
|
|
|
1,990 |
|
Total assets |
|
$ |
26,448 |
|
|
$ |
47,608 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
||
Current liabilities |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
1,501 |
|
|
$ |
4,293 |
|
Accrued expenses |
|
|
1,296 |
|
|
|
1,307 |
|
Payroll liabilities |
|
|
1,167 |
|
|
|
1,558 |
|
Other current liabilities |
|
|
745 |
|
|
|
1,097 |
|
Total current liabilities |
|
|
4,709 |
|
|
|
8,255 |
|
Total liabilities |
|
|
4,709 |
|
|
|
8,255 |
|
Commitments and contingencies |
|
|
— |
|
|
|
— |
|
Stockholders' equity |
|
|
|
|
|
|
||
Convertible preferred stock - $0.001 par value; 10,000,000 shares authorized; 577 shares issued and outstanding as of September 30, 2026 and December 31, 2025. |
|
|
— |
|
|
|
— |
|
Common stock - $0.18 par value; 350,000,000 shares authorized; 9,979,298 and 8,611,361 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively |
|
|
1,796 |
|
|
|
1,550 |
|
Additional paid-in capital |
|
|
291,698 |
|
|
|
285,840 |
|
Treasury stock, at cost; 88,003 shares of common stock at September 30, 2026 and December 31, 2025 |
|
|
(1,475 |
) |
|
|
(1,475 |
) |
Accumulated deficit |
|
|
(270,280 |
) |
|
|
(246,562 |
) |
Total stockholders' equity |
|
|
21,739 |
|
|
|
39,353 |
|
Total liabilities and stockholders' equity |
|
$ |
26,448 |
|
|
$ |
47,608 |
|
ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
(Unaudited)
|
|
For the Three Months Ended September 30, |
|
|
|
For the Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
|
2026 |
|
|
2025 |
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
3,378 |
|
|
$ |
5,370 |
|
|
|
$ |
13,054 |
|
|
$ |
15,029 |
|
General and administrative |
|
|
2,521 |
|
|
|
3,881 |
|
|
|
|
11,409 |
|
|
|
10,676 |
|
Total operating expenses |
|
|
5,899 |
|
|
|
9,251 |
|
|
|
|
24,463 |
|
|
|
25,705 |
|
Operating loss |
|
|
(5,899 |
) |
|
|
(9,251 |
) |
|
|
|
(24,463 |
) |
|
|
(25,705 |
) |
Interest income |
|
|
209 |
|
|
|
570 |
|
|
|
|
745 |
|
|
|
1,935 |
|
Other income (expense), net |
|
|
52 |
|
|
|
(11 |
) |
|
|
|
— |
|
|
|
(63 |
) |
Loss before income taxes |
|
|
(5,638 |
) |
|
|
(8,692 |
) |
|
|
|
(23,718 |
) |
|
|
(23,833 |
) |
Income tax benefit |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
Net loss |
|
|
(5,638 |
) |
|
|
(8,692 |
) |
|
|
|
(23,718 |
) |
|
|
(23,833 |
) |
Net loss per share of common stock - basic and diluted |
|
$ |
(0.56 |
) |
|
$ |
(1.01 |
) |
|
|
$ |
(2.58 |
) |
|
$ |
(2.76 |
) |
Weighted average shares outstanding used to compute net loss per share - basic and diluted |
|
|
9,990,226 |
|
|
|
8,622,289 |
|
|
|
|
9,178,686 |
|
|
|
8,622,289 |
|