SEATTLE, March 25, 2026 /PRNewswire/ -- 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 announces its financial results for the fourth quarter and year ended December 31, 2025 and provides an update on recent corporate developments.
"While we have consistently made meaningful and measurable progress across our $(Z)$-endoxifen development strategy in oncology over the last 12 months, we continue to explore the best opportunities to leverage the technology where it may help to address serious health conditions and unmet medical needs. As we continue to keep a careful eye on opportunities in the breast cancer space, we are also diligently working to advance (Z)-endoxifen in certain rare disease indications, such as Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome $(MAS)$," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics' President and Chief Executive Officer. "To date, we have published work that identifies the opportunity for (Z)-endoxifen, while achieving both FDA Rare Pediatric Disease and Orphan Drug designations. We believe these FDA designations are important for future development as they both help to speed the FDA review process as well as provide potential financial benefits in the future."
"In the meantime, we are consciously aligning our resources with the demands of potential commercialization, even as we have added new professionals to our team to help drive both our rare disease and breast cancer programs forward. With a strong balance sheet and a strategically focused team, we believe we are well-positioned to execute and advance our clinical programs toward key value-creating milestones," concluded Dr. Quay.
Clinical & Regulatory Progress & Announcements
-- Atossa Highlighted Emerging Opportunity for (Z)-Endoxifen in Duchenne
Muscular Dystrophy, Including Symptomatic Female Carriers, Following
Peer-Reviewed Publication and Scientific Presentation - The published
article, "A Hypothesized Therapeutic Role of (Z)-Endoxifen in Duchenne
Muscular Dystrophy (DMD)," surveys the DMD treatment landscape and
details how (Z)-endoxifen's pharmacology could address multiple
downstream drivers of disease, including inflammation, fibrosis, calcium
dysregulation, mitochondrial dysfunction, and lipid abnormalities. The
paper emphasizes (Z)-endoxifen's direct estrogen-receptor (ER) modulation,
allosteric inhibition of PKC (notably PKC-<BETA>1), and effects along
AKT/mTOR and NF-<KAPPA>B axes, mechanisms that together may help slow
disease progression when used as an adjunct to standard care. Notably,
the authors underscore (Z)-endoxifen's potential to deliver more
consistent therapeutic exposures than tamoxifen by bypassing CYP2D6
metabolic variability, an important limitation of the pro-drug approach.
As illustrated in the mechanistic diagram, page 7 of the publication, the
paper maps (Z)-endoxifen's ER-dependent and ER-independent signaling
effects relevant to dystrophic muscle.
-- Atossa Therapeutics Received FDA Rare Pediatric Disease Designation for
(Z)-Endoxifen for Duchenne Muscular Dystrophy - In December 2025, Atossa
announced that the U.S. Food and Drug Administration ("FDA") granted Rare
Pediatric Disease ("RPD") designation to (Z)-endoxifen for the treatment
of DMD. RPD designation is granted to drug candidates intended to treat
serious or life-threatening diseases that primarily affect individuals
from birth to 18 years of age. 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--$200
million.
-- Atossa Therapeutics Won the 2025 Clinical Trials Arena Research and
Development Excellence Award in Precision Endocrine Therapy Category - In
December 2025, Atossa announced that it had been selected as a winner of
the 2025 Clinical Trials Arena Excellence Awards. The Company was honored
with the Research and Development Award in the Precision Endocrine
Therapy category. Atossa earned this recognition for its innovative work
advancing (Z)-endoxifen, its lead precision-engineered endocrine therapy.
(Z)-endoxifen is a potent selective estrogen receptor modulator/degrader
(SERM/D) with additional PKC<BETA>1 inhibition, designed to provide
consistent systemic exposure independent of CYP2D6 metabolism. The
therapy is being evaluated across metastatic, neoadjuvant, adjuvant, and
breast cancer risk-reduction settings, with an emerging application in
DMD.
-- Atossa Therapeutics Received FDA Orphan Drug Designation for
(Z)-Endoxifen for the Treatment of Duchenne Muscular Dystrophy - In
January 2026, Atossa announced that the U.S. Food and Drug Administration
("FDA") Office of Orphan Products Development ("OOPD") granted Orphan
Drug Designation to (Z)-endoxifen for the treatment of DMD. Orphan Drug
Designation is granted by FDA to therapies intended to treat rare
diseases or conditions. The designation is designed to encourage drug
development by offering certain potential incentives, such as regulatory
support and, if the product ultimately receives marketing approval for
the designated indication, eligibility for a period of market
exclusivity.
Atossa Announces Additions to Management Team
-- Atossa Therapeutics Strengthened Clinical Leadership Team with the
Addition of Two Experienced Biopharma Executives - Atossa announced the
engagement of Kathy Puyana Theall, M.D., as Medical Director - Breast
Oncology, and Adebola Giwa, M.D., as Medical Director - Rare Diseases. We
believe the addition of these two highly experienced physicians and
clinical leaders meaningfully strengthens Atossa's ability to execute on
its (Z)-endoxifen development strategy across both breast cancer and rare
disease programs, including DMD and MAS, as the Company advances toward
key clinical and regulatory milestones.
Comparison of Years-Ended December 31, 2025 and 2024
Operating Expenses. Total operating expenses were $37.1 million for the year ended December 31, 2025, which was an increase of $9.5 million, from the year ended December 31, 2024 of $27.6 million. Factors contributing to the increased operating expenses in the year ended December 31, 2025 are explained below.
Research & Development Expenses. The following table provides a breakdown of major categories within R&D expenses for the years ended December 31, 2025 and 2024, together with the dollar change in those categories (dollars in thousands):
For the Year Ended December 31,
2025 2024 Increase Increase (%)
Research and Development Expense
Clinical and non-clinical trials $16,204 $10,107 $6,097 60 %
Compensation 3,206 2,928 278 9 %
Professional fees and other 1,775 1,082 693 64 %
Research and Development Expense
Total $21,185 $14,117 $7,068 50 %
------------------------------------ ------- ------- -------- ------------
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 pre-clinical trial expense increased $6.1 million for the
year ended December 31, 2025 compared to the prior year due to an
increase in spending for the (Z)-endoxifen trials, including an increase
in drug development costs.
-- The increase in R&D compensation expense of $0.3 million for the year
ended December 31, 2025 compared to the prior year was due primarily to
an increase in cash compensation expense of $0.4 million resulting from
an increase in headcount. This increase was partially offset by a
non-cash stock-based compensation expense decrease of $0.1 million
compared to the prior year due to the weighted average fair value of
stock options amortizing in 2025 being lower than 2024.
-- The increase in R&D professional fees and other of $0.7 million for the
year ended December 31, 2025 compared to the prior year was primarily
attributable to higher regulatory consulting fees in 2025 related to our
(Z)-endoxifen program.
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the years ended December 31, 2025 and 2024, together with the dollar change in those categories (dollars in thousands):
For the Year Ended December 31,
Increase Increase (%)
2025 2024 (Decrease) (Decrease)
General and Administrative
Expense
Compensation $6,062 $5,458 $604 11 %
Professional fees and other 9,191 7,164 2,027 28 %
Insurance 703 882 (179) (20) %
General and Administrative
Expense Total $15,956 $13,504 $2,452 18 %
--------------------------------- ------- ------- ----------- ------------
-- The increase in G&A compensation expense of $0.6 million for the year
ended December 31, 2025 compared to the prior year was due to an increase
in both cash compensation expense of $0.2 million and non-cash
stock-based compensation expense of $0.4 million. The increase in cash
compensation expense compared to the prior year was primarily driven by
salary, bonus and severance costs for a former executive of $0.4 million,
partially offset by a decrease in cash bonus related to terminations and
reductions in expected bonus payouts in 2025. The non-cash stock-based
compensation expense increase was driven by an increase in the fair value
of grants to members of our Board of Directors (the Board) which amortize
over one year.
-- G&A professional fees and other expenses increased by $2.0 million for
the year ended December 31, 2025 compared to the prior year due primarily
to an increase in legal fees of $1.8 million for the year ended December
31, 2025 driven by the costs for our ongoing litigation and patent
defense which increased by $1.6 million compared to the prior year.
Investor relations expense increased by $0.3 million for the year ended
December 31, 2025 compared to the prior year due to changes in investor
outreach and broader investor relations strategy. Partially offsetting
the increases, our accounting fees decreased by $0.3 million for the year
ended December 31, 2025 compared to the prior year due to the inclusion
of higher auditor fees associated with our 2024 Registration Statement on
Form S-3 and our at the market offering facility.
-- The decrease in G&A insurance expense of $0.2 million for the year ended
December 31, 2025 compared to the prior year was due primarily to lower
negotiated insurance premiums associated with our Director's and
Officer's insurance and other key insurance policies in 2025.
Interest Income. Interest income of $2.4 million for the year ended December 31, 2025 represented a decrease of $1.7 million compared to the prior year, and was due primarily to a decrease in the average funds invested in our money market account.
Impairment Charge on Investment in Equity Securities. For the year ended December 31, 2024, we wrote down our Investment in equity securities by $1.7 million due to impairment of our investment in Dynamic Cell Therapies, Inc.
About (Z)-Endoxifen
(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'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.
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. 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, including potential Investigational New Drug submissions, the potential indications that the Company may pursue for (Z)-endoxifen, 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 the Rare Pediatric Disease Priority Review Voucher (PRV) program and the value of a 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 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 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 DMD; 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.
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.
ATOSSA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share and per share data)
December 31, 2025 December 31, 2024
Assets
------------------------------------
Current assets
Cash and cash equivalents $ 41,299 $ 71,084
Restricted cash 110 110
Prepaid materials 3,081 2,098
Prepaid expenses and other current
assets 1,128 1,165
--------------- ---------------
Total current assets 45,618 74,457
Other assets 1,990 1,987
Total assets $ 47,608 $ 76,444
------------------------------------ --------------- ---------------
Liabilities and stockholders' equity
------------------------------------
Current liabilities
Accounts payable $ 4,293 $ 679
Accrued expenses 1,307 919
Payroll liabilities 1,558 1,862
Other current liabilities 1,097 1,507
--------------- ---------------
Total current liabilities 8,225 4,967
Total liabilities 8,225 4,967
------------------------------------ --------------- ---------------
Commitments and contingencies
Stockholders' equity
Convertible preferred stock -
$0.001 par value; 10,000,000 shares
authorized; 577 and 582 shares
issued and outstanding as of
December 31, 2025 and December 31,
2024, respectively -- --
Common stock - $0.18 par value;
350,000,000 shares authorized;
8,611,361 and 8,611,266 shares
issued and outstanding as of
December 31, 2025 and December
31, 2024, respectively 1,550 1,550
Additional paid-in capital 285,840 283,194
Treasury stock, at cost; 88,003
shares of common stock at December
31, 2025 and December 31, 2024 (1,475) (1,475)
Accumulated deficit (246,562) (211,792)
Total stockholders' equity 39,353 71,477
------------------------------------ --------------- ---------------
Total liabilities and
stockholders' equity $ 47,608 $ 76,444
------------------------------------ --------------- ---------------
ATOSSA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share data)
For the Year Ended December 31,
2025 2024
Operating expenses
Research and development $ 21,185 $ 14,117
General and administrative 15,956 13,504
Total operating expenses 37,141 27,621
--------------------------------- --------------------- --------------------
Operating loss (37,141) (27,621)
Impairment charge on investment
in equity securities -- (1,710)
Interest income 2,377 4,050
Other expense, net (6) (223)
--------------------- --------------------
Loss before income taxes (34,770) (25,504)
Income tax benefit -- --
--------------------- --------------------
Net loss $ (34,770) $ (25,504)
Net loss per share of common
stock - basic and diluted $ (4.04) $ (3.04)
--------------------- --------------------
Weighted average shares
outstanding used to compute
net loss per share - basic and
diluted 8,611,321 8,6390,618
--------------------- --------------------
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SOURCE Atossa Therapeutics Inc
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March 25, 2026 17:30 ET (21:30 GMT)
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