On 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, reported its financial results for the third quarter ended September 30, 2026 and provided an update on recent corporate developments.
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"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
Stapled Contingent Value Rights (CVR) Agreement
On October 8, 2026, the Company entered into a Stapled Contingent Value Rights Agreement (the CVR Agreement), and the Board of Directors (the Board) declared a dividend of one CVR for each share of Atossa common stock outstanding as of October 19, 2026 and issued thereafter. The CVRs remain attached to the underlying shares and will not trade separately unless the Board elects to detach them.
CVR holders will be entitled, in the aggregate, to 25% of the net proceeds from the sale or other monetization of the first qualifying U.S. Food and Drug Administration (FDA) priority review voucher (PRV) awarded to Atossa, subject to a maximum aggregate payment of $50 million.
No PRV has been awarded to the Company, and there can be no assurance that Atossa will receive or monetize a PRV or that any payment will ultimately be made under the CVR Agreement.
CFO Attendance at Global Genes RARE Drug Development Symposium
Mark Daniel, Atossa’s Chief Financial Officer, attended the Global Genes RARE Drug Development Symposium, held September 9–11, 2026, in Boston, Massachusetts. The symposium brought together patient advocates, researchers and biopharmaceutical industry leaders to explore research strategies, clinical trial readiness and collaboration in rare disease drug development. Atossa’s attendance supported its efforts to understand patient community priorities and explore approaches to advancing its rare disease development programs.
CEO Attendance at NORD Rare Diseases and Orphan Products Breakthrough Summit
Steven C. Quay, M.D., Ph.D., Atossa’s Chairman, President and Chief Executive Officer, attended the National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit, held October 25–27, 2026, in Washington, D.C. The Summit brought together patient advocates, researchers, industry leaders and policymakers to discuss advances in rare disease research, drug development, patient engagement and access to treatments. Atossa’s attendance supported its continued engagement with the rare disease community as the Company advances its (Z)-endoxifen programs in Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome (MAS).
Anticipated Milestones
The Company anticipates Investigational New Drug (IND) application clearance from the FDA for (Z)-endoxifen in MAS and DMD by early 2027, with initiation of Phase 2 clinical trials expected in 2027.
The Karisma trial was completed and the results finalized in the clinical study report. The Company is presenting these data at the San Antonio Breast Cancer Symposium (SABCS) in December 2026, and will publicize the findings thereafter.
The Company anticipates topline data from the Phase 2 EVANGELINE study of (Z)-endoxifen plus goserelin as neoadjuvant therapy in premenopausal women with ER+/HER2- breast cancer in the second quarter of 2027. Enrollment for the study was completed during the second quarter of 2026.
Enrollment in the (Z)-endoxifen plus elagolix and (Z)-endoxifen plus abemaciclib arms of the Phase 2 I-SPY2 study is complete, and select data will be presented at SABCS in December 2026.
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.
Clinical and non-clinical trial expenses decreased $1.8 million and $1.4 million for the three and nine months ended September 30, 2026, respectively, compared to the three and nine months ended September 30, 2025, due primarily to lower spend related to our ongoing (Z)-endoxifen trials for which enrollment was largely completed during the first nine months of 2026.
The increase in R&D compensation expense of $0.2 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025, was due primarily to increases in non-cash stock-based compensation expense.
The decrease in R&D professional fees and other of $0.2 million and $0.7 million for the three and nine months ended September 30, 2026, respectively, compared to the three and nine months ended September 30, 2025, was due primarily to lower regulatory consulting fees related to our (Z)-endoxifen programs during the current year periods.
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 %
The decrease in G&A compensation expenses of $0.3 million and $0.8 million for the three and nine months ended September 30, 2026, respectively, compared to the three and nine months ended September 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 decrease in G&A professional fees and other of $1.0 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025, was due primarily to a decrease in legal fees of $0.8 million related to the resolution of patent litigation matters during the first half of 2026. The increase in G&A professional fees and other of $1.5 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, was due primarily to higher spend on patent litigation matters during the first half of 2026, which have now been settled, and to a lesser extent, higher legal fees associated with management of our intellectual property portfolio and general legal costs related to SEC compliance and other stock administration matters incurred during the current year period.
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.
(Press release, Atossa Therapeutics, NOV 10, 2026, View Source [SID1234674586])