ATOS Atossa Therapeutics Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 11, 2025

 

 

Atossa Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-35610	26-4753208
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
10202 5th Avenue NE, Suite 200
Seattle, Washington				98125
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (206) 588-0256

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check th e 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:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.18 par value		ATOS		The Nasdaq Capital Market

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. ☐
 

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Item 8.01 Other Events

On March 11, 2025, Atossa Therapeutics, Inc. issued a press release announcing its strategic decision to pursue metastatic breast cancer indication for (Z)-endoxifen and continued engagement with the FDA on additional indications. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit Number		Description of Exhibit
99.1		Press release, dated March 11, 2025
104		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.

			Atossa Therapeutics, Inc.
Date:	March 12, 2025	By:	/s/ Heather Rees
			Chief Financial Officer

 

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Exhibit 99.1

 

 

 

 

Atossa Therapeutics Announces Plans to Pursue Metastatic Breast Cancer Indication for (Z)-Endoxifen and Continued Engagement with FDA on Additional Indications

SEATTLE, March 11, 2025 – Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the prevention and treatment of breast cancer, today announced its strategic decision to pursue a metastatic breast cancer indication for (Z)-endoxifen. Atossa believes that pursuing a metastatic indication may offer a more efficient regulatory pathway to deliver (Z)-endoxifen to women in urgent need and simultaneously plans to work with the FDA to advance additional indications, such as breast cancer prevention and neoadjuvant therapy, that often require larger and longer clinical trials.

Addressing the High Unmet Need in Metastatic Breast Cancer

Metastatic breast cancer remains a significant area of unmet medical need, with current treatment options often providing limited durability of response and substantial side effects. (Z)-endoxifen, a potent and well-tolerated selective estrogen receptor modulator (SERM), has shown encouraging signals in previous clinical trials, which we believe supports its potential to fill this critical gap in treatment.

 

Promising Data from Early-stage Clinical Trials

(Z)-endoxifen has shown encouraging results in early-stage trials, which we believe reinforces its potential as a transformative therapy for breast cancer. Key findings from early clinical programs include:

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Dr. Steven Quay, Chairman and Chief Executive Officer of Atossa Therapeutics, stated: “Our decision to advance (Z)-endoxifen into a metastatic breast cancer indication underscores our unwavering commitment to developing a best-in-class therapy for women facing this devastating disease. The encouraging clinical data that has been generated to date supports the potential of (Z)-endoxifen to provide a meaningful benefit to patients who have exhausted other treatment options. By pursuing this strategy, we believe we are not only addressing an urgent medical need but also fortifying the path forward for expanding (Z)-endoxifen’s role across the full spectrum of breast cancer prevention and treatment. We look forward to providing future updates as we execute this plan.”

The Strategic Advantage of a Metastatic Indication

We believe that pursuing an initial approval in metastatic breast cancer provides an efficient regulatory and clinical path to market, potentially allowing Atossa to more rapidly bring (Z)-endoxifen to patients who need it most. This approach can also strengthen the foundation for the expansion of (Z)-endoxifen into earlier-stage disease settings, where (Z)-endoxifen has already shown significant promise in reducing tumor proliferation and preventing recurrence.

Advancing Additional Indications in Prevention and Early-Stage Disease

Beyond metastatic disease, Atossa remains committed to demonstrating the broad clinical utility of (Z)-endoxifen across the breast cancer treatment paradigm. Since the release of compelling data at the end of 2024, the Company is actively engaging with the FDA to further define a regulatory path forward for additional indications, including in:

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Atossa Therapeutics remains dedicated to accelerating the development of (Z)-endoxifen with the goal of helping patients across all stages of breast cancer to benefit from its therapeutic potential.

About Atossa Therapeutics

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company’s lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit atossatherapeutics.com.

FORWARD LOOKING STATEMENTS

This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as “expect,” “potential,” “continue,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate,” “believe,” “design,” “predict,” “future,” or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, benefits of the Company’s strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, and the potential market and growth opportunities for the Company, 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 risks and uncertainties associated with: our ability to obtain patent coverage for our product candidates; macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our

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ability to regain compliance or maintain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa’s filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. 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, whether as a result of new information, future events or circumstances or otherwise.

Investor and Media Contact:

Michael Parks
VP, Investor and Public Relations
484-356-7105
michael.parks@atossainc.com

 

 

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v3.25.0.1

Document And Entity Information	Mar. 11, 2025
Document Information [Line Items]
Entity Registrant Name	Atossa Therapeutics, Inc.
Document Type	8-K
Document Period End Date	Mar. 11, 2025
Entity Incorporation, State or Country Code	DE
Entity File Number	001-35610
Entity Tax Identification Number	26-4753208
Entity Address, Address Line One	10202 5th Avenue NE,
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	Seattle
Entity Address, State or Province	WA
Entity Address, Postal Zip Code	98125
City Area Code	206
Local Phone Number	588-0256
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Title of 12(b) Security	Common Stock
Trading Symbol	ATOS
Security Exchange Name	NASDAQ
Amendment Flag	false
Entity Central Index Key	0001488039

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