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Atossa Therapeutics (Nasdaq: ATOS) details Q2 loss and up to $16.5M financing

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Atossa Therapeutics, a clinical-stage biopharmaceutical company focused on its lead candidate (Z)-endoxifen, reported financial results and a corporate update for the second quarter ended June 30, 2026. Total operating expenses were $8.7 million for the quarter and $18.6 million for the first half of 2026.

In Q2 2026, research and development expense was $4.9 million and general and administrative expense was $3.8 million. Net loss was $8,491 thousand for the quarter and $18,080 thousand year-to-date, with a basic and diluted net loss per share of $0.95 and $2.06, respectively. Cash and cash equivalents were $26,094 thousand at June 30, 2026.

Atossa highlighted new preclinical and clinical data supporting (Z)-endoxifen in McCune‑Albright Syndrome, Duchenne Muscular Dystrophy, and ER+ breast cancer, and completed enrollment in the EVANGELINE Phase 2 neoadjuvant breast cancer trial. A registered direct offering raised $4.5 million upfront and could provide up to an additional $12 million in gross proceeds to support (Z)-endoxifen development and general working capital.

Positive

  • None.

Negative

  • None.

Filing Explained

The offering’s immediate effect is issued-share dilution, with additional dilution dependent on warrant exercise.

The August 7 Form 8-K records that Atossa completed the upfront part of its registered direct offering: 1,363,637 common shares were issued and sold, alongside warrants for up to 1,363,637 additional shares. The issued shares immediately increase the share count and reduce existing holders’ percentage ownership absent offsets; the warrant shares remain contingent capacity, not an issuance disclosed as completed.

Although the release calls the offering balance-sheet strengthening, cash and equivalents were $26,094 thousand at June 30, 2026, versus $41,299 thousand at December 31, 2025; the filing therefore establishes financing proceeds but not a higher period-end cash balance.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Total operating expenses Q2 2026 $8.7 million For the three months ended June 30, 2026; decrease of $0.3 million from $9.0 million in 2025
Total operating expenses H1 2026 $18.6 million For the six months ended June 30, 2026; increase of $2.1 million from $16.5 million in 2025
Net loss Q2 2026 $8,491 thousand For the three months ended June 30, 2026; amounts in thousands; net loss per share basic and diluted $0.95
Net loss H1 2026 $18,080 thousand For the six months ended June 30, 2026; amounts in thousands; net loss per share basic and diluted $2.06
Cash and cash equivalents $26,094 thousand Cash and cash equivalents as of June 30, 2026; amounts in thousands
Total stockholders' equity $26,830 thousand Stockholders’ equity as of June 30, 2026; amounts in thousands
Registered direct offering potential proceeds $16.5 million Includes $4.5 million upfront gross proceeds and up to $12 million upon full cash exercise of warrants
Common shares outstanding 9,979,298 shares Common stock issued and outstanding as of June 30, 2026
registered direct offering financial
"The Company entered into a securities purchase agreement with institutional investors, which provided for the issuance and sale ... in a registered direct offering"
A registered direct offering is a way for a company to sell new shares of its stock directly to select investors with regulatory approval. This method allows the company to raise funds quickly and efficiently without needing a public auction, similar to offering exclusive access to a limited number of buyers. For investors, it often provides an opportunity to purchase shares at a favorable price, while giving the company immediate access to capital.
Orphan Drug Designation regulatory
"The Company previously received Orphan Drug Designation (ODD) and RPD designation for (Z)-endoxifen from the FDA for the treatment of DMD."
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
Rare Pediatric Disease (RPD) designation regulatory
"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"
A rare pediatric disease (RPD) designation is a regulatory status given to a drug or therapy aimed at treating a serious, uncommon disease that primarily affects children. It matters to investors because the label often brings development incentives—such as faster review, reduced fees, financial support, or market advantages—that lower risk and can speed a product to market, similar to giving a small project a fast pass and extra funding to reach customers sooner.
Priority Review Voucher (PRV) regulatory
"drugs with RPD designation may be eligible for a Priority Review Voucher (PRV), which can be used to obtain priority review"
A priority review voucher (PRV) is a transferable regulatory 'fast pass' that speeds up a government agency’s review of a drug or medical product, shortening the time it takes to get approval. For investors, a PRV is a valuable asset because it can both accelerate a product’s path to market—potentially bringing revenue sooner—and be sold to other companies, creating a direct one-time or strategic financial benefit.
Selective Estrogen Receptor Modulator/Degrader (SERM/D) medical
"(Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms"
A selective estrogen receptor modulator/degrader (SERM/D) is a drug that both adjusts how cells respond to estrogen and can remove or disable the receptor proteins that let estrogen act, combining a “dimmer switch” effect with a “take out the battery” action. Investors care because these compounds target diseases driven by estrogen signals—so clinical trial results, approvals, or setbacks can rapidly change a drugmaker’s revenue outlook and stock value, similar to how a new, more efficient tool can disrupt an entire market.
Total operating expenses Q2 2026 $8.7 million Decrease of $0.3 million from $9.0 million for the three months ended June 30, 2025
Total operating expenses H1 2026 $18.6 million Increase of $2.1 million from $16.5 million for the six months ended June 30, 2025
Research and development expense Q2 2026 $4,897 thousand Research and Development Expense Total decreased from $5,502 thousand in Q2 2025 (amounts in thousands)
General and administrative expense Q2 2026 $3,797 thousand General and Administrative Expense Total increased from $3,538 thousand in Q2 2025 (amounts in thousands)
Net loss Q2 2026 $8,491 thousand Compared with net loss of $8,423 thousand for the three months ended June 30, 2025 (amounts in thousands)
Cash and cash equivalents June 30, 2026 $26,094 thousand Compared with $41,299 thousand as of December 31, 2025 (amounts in thousands)

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FAQ

What were Atossa Therapeutics (ATOS) operating expenses in Q2 2026?
Atossa reported total operating expenses of $8.7 million for Q2 2026, down from $9.0 million in Q2 2025. The quarter included $4.9 million in research and development and $3.8 million in general and administrative expenses.

How much cash did Atossa Therapeutics (ATOS) have as of June 30, 2026?
As of June 30, 2026, Atossa held $26,094 thousand in cash and cash equivalents. Total current assets were $31,010 thousand and total assets were $32,281 thousand, with total stockholders’ equity of $26,830 thousand and total liabilities of $5,451 thousand.

What was Atossa Therapeutics (ATOS) net loss and EPS for Q2 and first half 2026?
Atossa recorded a Q2 2026 net loss of $8,491 thousand and a six-month 2026 net loss of $18,080 thousand. Net loss per share, basic and diluted, was $0.95 for Q2 and $2.06 for the first six months of 2026.

What are the terms of Atossa Therapeutics (ATOS) 2026 registered direct offering?
Atossa entered a registered direct offering issuing 1,363,637 common shares plus Series A and short-term Series B warrants for up to 2,727,274 shares. The deal raised $4.5 million upfront and could add up to $12 million upon full cash exercise of the warrants.

Which clinical programs is Atossa Therapeutics (ATOS) advancing for (Z)-endoxifen?
Atossa is advancing (Z)-endoxifen in oncology and rare diseases, including the EVANGELINE Phase 2 neoadjuvant trial in premenopausal ER+/HER2- breast cancer. The company is also exploring use in Duchenne Muscular Dystrophy and McCune‑Albright Syndrome through preclinical and mechanistic studies.

What regulatory designations has (Z)-endoxifen received for Atossa Therapeutics (ATOS)?
Atossa has Orphan Drug Designation for (Z)-endoxifen in Duchenne Muscular Dystrophy and Rare Pediatric Disease (RPD) designation for both Duchenne Muscular Dystrophy and McCune‑Albright Syndrome. RPD designation may qualify a Priority Review Voucher; recent disclosed PRV sales ranged from $100–$220 million.

How did research and development spending at Atossa Therapeutics (ATOS) change in Q2 2026?
Q2 2026 research and development expense was $4,897 thousand, compared with $5,502 thousand in Q2 2025. Clinical and non-clinical trial expenses fell by $0.6 million, reflecting lower preclinical spending, partly offset by higher clinical enrollment and drug development costs.
0001488039false00014880392026-08-072026-08-07

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): August 7, 2026

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.)

1448 NW Market Street, Suite 500

Seattle, Washington

98107

(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 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:


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. ☐


 

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

 

 

 

Exhibit No.

 

Description

99.1

 

Press Release dated August 7, 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:

August 7, 2026

By:

/s/ Mark J. Daniel

Mark J. Daniel
Chief Financial Officer

(Principal Financial and Accounting Officer)

img248274862_0.jpg

 

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

•
Atossa Participated at the 2026 American Association for Cancer Research (AACR) Special Conference in Cancer Research: Cancer Evolution

 

o
In a poster presentation titled, “Dual estrogen receptor and PKC-β signaling modulation by (Z)-Endoxifen: A mechanism-driven therapeutic strategy for estrogen-driven pathology in McCune-Albright Syndrome,” the Company discussed a dual mechanism of action for (Z)-endoxifen in estrogen-driven pathology relevant to McCune-Albright Syndrome-associated Peripheral Precocious Puberty (MAS-PPP).

 

o
The dual mechanism includes the blockade of estrogen receptor (ER)-mediated transcription downstream of autonomous estrogen production and suppression of PKC-β/AKT-associated proliferative and cell-cycle signaling.

 

o
This multi-pathway profile may address a key therapeutic gap in MAS-PPP, where estrogen suppression alone may not fully mitigate downstream proliferative signaling.

 

o
The Company previously received Rare Pediatric Disease (RPD) designation for (Z)-endoxifen from the U.S. Food and Drug Administration (FDA) for (Z)-endoxifen for the treatment of McCune-Albright Syndrome (MAS).

 

•
The Company Announced Acceptance of Manuscript Highlighting the Utrophin-Modulation Potential of (Z)-Endoxifen in Duchenne Muscular Dystrophy (DMD)

 

o
A paper details how (Z)-endoxifen may support the expression of utrophin, a paralog of dystrophin. (Z)-Endoxifen therefore represents a potential dystrophin mutation-agnostic treatment for DMD. The paper citation is: Remmel HL, Hammer SS, Blackburn SM, Quay SC. (Z)-Endoxifen as a Potential Modulator of Utrophin Pathways in Duchenne Muscular Dystrophy: A Mechanistic and Transcriptomic Perspective. Degener Neurol Neuromuscular Dis. 2026;16:574524 https://doi.org/10.2147/DNND.S574524

 

o
The results support further investigation of (Z)-endoxifen in dystrophin-deficient models, as well as biomarker development. These data also build upon the Company’s previously published manuscript, “A Hypothesized Therapeutic Role of (Z)-Endoxifen in Duchenne Muscular Dystrophy,” also published in Degenerative Neurological and Neuromuscular Disease.

 

o
The Company previously received Orphan Drug Designation (ODD) and RPD designation for (Z)-endoxifen from the FDA for the treatment of DMD.

 

 

 

Oncology

•
The Company Published Manuscript Highlighting the Anti-cancer Activity of (Z)-Endoxifen-related Compounds

 

o
In the peer-reviewed journal, npj Breast Cancer, the Company published an article titled, “Novel (Z)-endoxifen-related new chemical entities exhibit potent anti-cancer activity in ERα+ breast cancer.”

 

o
The investigators evaluated five previously uncharacterized compounds generated during the synthesis of (Z)-endoxifen, alongside (Z)-endoxifen in a broad panel of laboratory assays, as well as in combination with the CDK4/6 inhibitor abemaciclib.

 

o
The publication reported anti-estrogenic and anti-cancer activity across multiple ER-positive (ER+) breast cancer models, including models harboring clinically relevant activating mutations in ESR1.

 

o
In certain experimental settings and models, selected compounds combined with abemaciclib demonstrated additive to synergistic activity that was comparable to or greater than the activity observed with abemaciclib plus (Z)-endoxifen.

 

o
The authors concluded that select compounds warrant further in vivo safety evaluation, as well as efficacy studies, including as potential second- or third-line approaches for recurrent disease.

 

•
Atossa Participated in the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

 

o
In a poster presentation titled, “A Phase 2 Clinical Trial in Progress of (Z)-Endoxifen Plus Goserelin as Neoadjuvant Therapy in Premenopausal Women With ER+/HER2- Breast Cancer (EVANGELINE),” the Company described EVANGELINE (NCT05607004), an ongoing, multicenter, open-label Phase 2 study evaluating daily 40 mg (Z)-endoxifen plus goserelin administered every 28 days as neoadjuvant therapy in premenopausal women with ER+/human epidermal growth factor receptor 2 negative (HER2-), cT2-3, cN0-1 breast cancer. Enrollment in this study was completed as of June 30, 2026.

 

o
In an online publication titled, “Effect of (Z)-endoxifen Demonstrates Robust Estrogen Receptor Signaling Inhibition Across Clinically Relevant ESR1 Mutations,” the Company highlighted new preclinical data demonstrating that (Z)-endoxifen delivers robust ER inhibition across clinically relevant estrogen receptor alpha gene (ESR1) mutations. ESR1 mutations are a major mechanism of acquired endocrine resistance in ER-positive breast cancer and remain associated with limited treatment options despite the emergence of next-generation endocrine therapies. These data support the ongoing clinical development of (Z)-endoxifen, as well as its potential as a promising treatment option for breast cancer patients with limited therapeutic alternatives.

 

Corporate

•
Atossa Strengthened its Balance Sheet with a Registered Direct Offering, Potentially Providing Up to $16.5 Million in Gross Proceeds

 

o
The Company entered into a securities purchase agreement with institutional investors, which provided for the issuance and sale by the Company, in a registered direct offering of (i) 1,363,637 shares of the Company’s common stock and (ii) Series A warrants to purchase up to 1,363,637 shares of common stock and short-term Series B warrants to purchase up to 1,363,637 shares of common stock, raising $4.5 million in upfront gross proceeds, with the potential to receive up to an additional $12 million, assuming the full cash exercise of the warrants. Net proceeds are designated to support the clinical development of (Z)-endoxifen and for general corporate working capital.

 

 

 

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):

 

 

 

For the Three Months Ended June 30,

 

For the Six Months Ended June 30,

 

 

2026

 

 

2025

 

 

Increase (Decrease)

 

 

% Increase (Decrease)

 

2026

 

 

2025

 

 

Increase (Decrease)

 

 

% Increase (Decrease)

Research and Development Expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clinical and non-clinical trials

 

$

3,525

 

 

$

4,089

 

 

$

(564

)

 

(14)%

 

$

7,243

 

 

$

6,836

 

 

$

407

 

 

6%

Compensation

 

 

954

 

 

 

856

 

 

 

98

 

 

11%

 

 

1,888

 

 

 

1,736

 

 

 

152

 

 

9%

Professional fees and other

 

 

418

 

 

 

557

 

 

 

(139

)

 

(25)%

 

 

545

 

 

 

1,087

 

 

 

(542

)

 

(50)%

Research and Development Expense Total

 

$

4,897

 

 

$

5,502

 

 

$

(605

)

 

(11)%

 

$

9,676

 

 

$

9,659

 

 

$

17

 

 

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:

•
Clinical and non-clinical trial expenses decreased $0.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily due to a decrease of $1.0 million in spend on preclinical trials that concluded in the prior period, partially offset by an increase in expense due to higher enrollment in clinical trials of $0.2 million and an increase in drug development costs of $0.3 million in the current period. Clinical and non-clinical trial expenses increased $0.4 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025, due to an increase in expense related to clinical trial enrollments of $1.5 million and an increase in drug development costs of $0.7 million, partially offset by a $1.8 million decrease in expenses related to preclinical work completed in 2025.
•
The increase in R&D compensation expenses of $0.1 million and $0.2 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to increases in non-cash stock-based compensation expense of $0.1 million.
•
The decrease in R&D professional fees and other of $0.1 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was primarily attributable to a decrease in regulatory consulting fees in the 2026 periods related to our (Z)-endoxifen program as compared to the same periods in the prior year.

 

 

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):

 

 

 

For the Three Months Ended June 30,

 

For the Six Months Ended June 30,

 

 

2026

 

 

2025

 

 

Increase (Decrease)

 

 

% Increase (Decrease)

 

2026

 

 

2025

 

 

Increase (Decrease)

 

 

% Increase (Decrease)

General and Administrative Expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Compensation

 

$

1,248

 

 

$

1,564

 

 

$

(316

)

 

(20)%

 

$

2,559

 

 

$

3,026

 

 

$

(467

)

 

(15)%

Professional fees and other

 

 

2,549

 

 

 

1,974

 

 

 

575

 

 

29%

 

 

6,329

 

 

 

3,769

 

 

 

2,560

 

 

68%

General and Administrative Expense Total

 

$

3,797

 

 

$

3,538

 

 

$

259

 

 

7%

 

$

8,888

 

 

$

6,795

 

 

$

2,093

 

 

31%

 

•
The decrease in G&A compensation expenses of $0.3 million and $0.5 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to a decrease in headcount in the current year periods compared to the same periods in the prior year.
•
The increase in G&A professional fees and other of $0.6 million and $2.6 million for the three and six months ended June 30, 2026, respectively, compared to the three and six months ended June 30, 2025, was due primarily to higher legal fees of $0.7 million and $2.5 million, for the three and six months ended June 30, 2026, respectively, related to our patent litigation matters, which have now been settled, as well as fees associated with management of our intellectual property portfolio and legal costs related to our SEC compliance and other stock administration matters incurred during the current year periods.

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. — 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)

 

 

 

 

 

 

 

 

 

 

June 30, 2026

 

 

December 31, 2025

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

26,094

 

 

$

41,299

 

Restricted cash

 

 

110

 

 

 

110

 

Prepaid materials

 

 

3,013

 

 

 

3,081

 

Prepaid expenses and other current assets

 

 

1,793

 

 

 

1,128

 

Total current assets

 

 

31,010

 

 

 

45,618

 

Other assets

 

 

1,271

 

 

 

1,990

 

Total assets

 

$

32,281

 

 

$

47,608

 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

1,976

 

 

$

4,293

 

Accrued expenses

 

 

1,380

 

 

 

1,307

 

Payroll liabilities

 

 

972

 

 

 

1,558

 

Other current liabilities

 

 

1,123

 

 

 

1,097

 

Total current liabilities

 

 

5,451

 

 

 

8,255

 

Total liabilities

 

 

5,451

 

 

 

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 June 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 June 30, 2026 and December 31,
   2025, respectively

 

 

1,796

 

 

 

1,550

 

Additional paid-in capital

 

 

291,151

 

 

 

285,840

 

Treasury stock, at cost; 88,003 shares of common stock at June 30, 2026 and
   December 31, 2025

 

 

(1,475

)

 

 

(1,475

)

Accumulated deficit

 

 

(264,642

)

 

 

(246,562

)

Total stockholders' equity

 

 

26,830

 

 

 

39,353

 

Total liabilities and stockholders' equity

 

$

32,281

 

 

$

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 June 30,

 

 

 

For the Six Months Ended June 30,

 

 

2026

 

 

2025

 

 

 

2026

 

 

2025

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

4,897

 

 

$

5,502

 

 

 

$

9,676

 

 

$

9,659

 

General and administrative

 

 

3,797

 

 

 

3,538

 

 

 

 

8,888

 

 

 

6,795

 

Total operating expenses

 

 

8,694

 

 

 

9,040

 

 

 

 

18,564

 

 

 

16,454

 

Operating loss

 

 

(8,694

)

 

 

(9,040

)

 

 

 

(18,564

)

 

 

(16,454

)

Interest income

 

 

227

 

 

 

645

 

 

 

 

536

 

 

 

1,365

 

Other expense, net

 

 

(24

)

 

 

(28

)

 

 

 

(52

)

 

 

(52

)

Loss before income taxes

 

 

(8,491

)

 

 

(8,423

)

 

 

 

(18,080

)

 

 

(15,141

)

Income tax benefit

 

 

—

 

 

 

—

 

 

 

 

—

 

 

 

—

 

Net loss

 

 

(8,491

)

 

 

(8,423

)

 

 

 

(18,080

)

 

 

(15,141

)

Net loss per share of common stock - basic and diluted

 

$

(0.95

)

 

$

(0.98

)

 

 

$

(2.06

)

 

$

(1.76

)

Weighted average shares outstanding used to compute
   net loss per share - basic and diluted

 

 

8,908,511

 

 

 

8,622,289

 

 

 

 

8,766,191

 

 

 

8,622,289

 

 

 

 

 

Source: View Original Filing on SEC EDGAR

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