ATOS 8-K
Atossa Therapeutics, Inc. (ATOS)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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:
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Securities registered pursuant to Section 12(b) of the Act:
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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 August 7, 2026, Atossa Therapeutics, Inc. (the “Company”) issued a press release announcing the second quarter ended June 30, 2026 financial results 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
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Exhibit No. |
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Description |
99.1 |
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104 |
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Cover page Interactive Data File (embedded within the Inline XBRL document) |
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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.
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Atossa Therapeutics, Inc. |
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Date: |
August 7, 2026 |
By: |
/s/ Mark J. Daniel |
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Mark J. Daniel (Principal Financial and Accounting Officer) |
Atossa Therapeutics Reports Second Quarter 2026 Financial Results and Provides a Corporate Update
SEATTLE, WASHINGTON, August 7, 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 and provided an update on recent corporate developments for the second quarter ended June 30, 2026.
“During the quarter, we executed well across the business,” stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics’ President and Chief Executive Officer. “We continued to advance the scientific rationale for (Z)-endoxifen’s potential in rare pediatric diseases, such as Duchenne Muscular Dystrophy and McCune-Albright Syndrome, while also strengthening its clinical and scientific foundation in breast cancer, all through new data presented at important industry conferences, including ASCO and AACR, as well as publications in well-regarded peer-reviewed journals, Degenerative Neurological and Neuromuscular Disease and npj Breast Cancer.”
Dr. Quay continued, “These accomplishments, together with additional capital from our registered direct offering, underscore the breadth of potential we see for (Z)-endoxifen, and investors’ support in our ability to continue advancing our programs.”
Second Quarter 2026 & Recent Highlights
Rare Diseases
Oncology
Corporate
Financial Results for the Second Quarter Ended June 30, 2026
Operating Expenses. Total operating expenses were $8.7 million and $18.6 million for the three and six months ended June 30, 2026, respectively, which was a decrease of $0.3 million and an increase of $2.1 million from total operating expenses for the three and six months ended June 30, 2025 of $9.0 million and $16.5 million, respectively. Factors contributing to the changes in operating expenses during the three and six months ended June 30, 2026 are explained below.
Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and six months ended June 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
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For the Three Months Ended June 30, |
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For the Six Months Ended June 30, |
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2026 |
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2025 |
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Increase (Decrease) |
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% Increase (Decrease) |
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2026 |
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2025 |
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Increase (Decrease) |
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% Increase (Decrease) |
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Research and Development Expense |
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Clinical and non-clinical trials |
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$ |
3,525 |
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$ |
4,089 |
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$ |
(564 |
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(14)% |
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$ |
7,243 |
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$ |
6,836 |
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$ |
407 |
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6% |
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Compensation |
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954 |
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856 |
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98 |
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11% |
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1,888 |
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1,736 |
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152 |
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9% |
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Professional fees and other |
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418 |
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557 |
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(139 |
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(25)% |
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545 |
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1,087 |
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(542 |
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(50)% |
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Research and Development Expense Total |
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$ |
4,897 |
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$ |
5,502 |
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$ |
(605 |
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(11)% |
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$ |
9,676 |
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$ |
9,659 |
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$ |
17 |
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0% |
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 six months ended June 30, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
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For the Three Months Ended June 30, |
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For the Six Months Ended June 30, |
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2026 |
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2025 |
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Increase (Decrease) |
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% Increase (Decrease) |
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2026 |
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2025 |
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Increase (Decrease) |
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% Increase (Decrease) |
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General and Administrative Expense |
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Compensation |
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$ |
1,248 |
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$ |
1,564 |
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$ |
(316 |
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(20)% |
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$ |
2,559 |
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$ |
3,026 |
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$ |
(467 |
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(15)% |
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Professional fees and other |
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2,549 |
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1,974 |
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575 |
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29% |
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6,329 |
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3,769 |
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2,560 |
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68% |
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General and Administrative Expense Total |
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$ |
3,797 |
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$ |
3,538 |
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$ |
259 |
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7% |
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$ |
8,888 |
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$ |
6,795 |
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$ |
2,093 |
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31% |
Interest Income. Interest income was $0.2 million and $0.5 million for the three and six months ended June 30, 2026, respectively, and decreased $0.4 million and $0.8 million compared to the three and six months ended June 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 Duchenne Muscular Dystrophy, as well as Rare Pediatric Disease (RPD) designation for (Z)-endoxifen for the treatment of both Duchenne Muscular Dystrophy and McCune-Albright Syndrome. 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 2026 outlook and our expectations regarding the Company’s development and regulatory strategy and related milestones, 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 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 and the value of a Rare Pediatric Disease PRV, 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 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 & Media Contact
Investors: WaterSeid Partners, Inc. — [email protected]
Media: Elev8 New Media — [email protected]
ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
(Unaudited)
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June 30, 2026 |
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December 31, 2025 |
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Assets |
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Current assets |
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Cash and cash equivalents |
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$ |
26,094 |
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$ |
41,299 |
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Restricted cash |
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110 |
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110 |
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Prepaid materials |
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3,013 |
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3,081 |
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Prepaid expenses and other current assets |
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1,793 |
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1,128 |
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Total current assets |
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31,010 |
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45,618 |
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Other assets |
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1,271 |
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1,990 |
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Total assets |
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$ |
32,281 |
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$ |
47,608 |
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Liabilities and stockholders' equity |
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Current liabilities |
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Accounts payable |
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$ |
1,976 |
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$ |
4,293 |
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Accrued expenses |
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1,380 |
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1,307 |
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Payroll liabilities |
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972 |
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1,558 |
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Other current liabilities |
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1,123 |
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1,097 |
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Total current liabilities |
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5,451 |
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8,255 |
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Total liabilities |
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5,451 |
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8,255 |
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Commitments and contingencies |
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— |
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— |
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Stockholders' equity |
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Convertible preferred stock - $0.001 par value; 10,000,000 shares authorized; 577 shares issued and outstanding as of June 30, 2026 and December 31, 2025 |
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— |
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— |
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Common stock - $0.18 par value; 350,000,000 shares authorized; 9,979,298 and |
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1,796 |
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1,550 |
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Additional paid-in capital |
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291,151 |
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285,840 |
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Treasury stock, at cost; 88,003 shares of common stock at June 30, 2026 and |
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(1,475 |
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(1,475 |
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Accumulated deficit |
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(264,642 |
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(246,562 |
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Total stockholders' equity |
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26,830 |
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39,353 |
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Total liabilities and stockholders' equity |
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$ |
32,281 |
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$ |
47,608 |
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ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
(Unaudited)
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For the Three Months Ended June 30, |
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For the Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses |
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Research and development |
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$ |
4,897 |
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$ |
5,502 |
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$ |
9,676 |
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$ |
9,659 |
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General and administrative |
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3,797 |
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3,538 |
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8,888 |
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6,795 |
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Total operating expenses |
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8,694 |
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9,040 |
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18,564 |
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16,454 |
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Operating loss |
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(8,694 |
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(9,040 |
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(18,564 |
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(16,454 |
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Interest income |
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227 |
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645 |
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536 |
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1,365 |
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Other expense, net |
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(24 |
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(28 |
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(52 |
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(52 |
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Loss before income taxes |
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(8,491 |
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(8,423 |
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(18,080 |
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(15,141 |
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Income tax benefit |
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— |
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— |
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— |
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— |
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Net loss |
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(8,491 |
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(8,423 |
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(18,080 |
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(15,141 |
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Net loss per share of common stock - basic and diluted |
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$ |
(0.95 |
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$ |
(0.98 |
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$ |
(2.06 |
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$ |
(1.76 |
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Weighted average shares outstanding used to compute |
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8,908,511 |
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8,622,289 |
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8,766,191 |
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8,622,289 |
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