Atossa Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate Update
Rhea-AI Summary
Atossa Therapeutics (Nasdaq: ATOS) reported Q1 2026 results and corporate updates for the quarter ended March 31, 2026. Key developments include FDA Orphan Drug and Rare Pediatric Disease designations for (Z)-endoxifen in DMD and RPD designation for McCune-Albright Syndrome, new preclinical DMD data, senior clinical hires, and a Q1 operating expense increase to $9.9 million.
R&D expenses rose to $4.8M (+15%), G&A to $5.1M (+56%), and interest income fell by $0.4M.
AI-generated analysis. Not financial advice.
Positive
- Orphan Drug designation for (Z)-endoxifen in DMD (Jan 2026)
- Rare Pediatric Disease designation for McCune-Albright Syndrome (May 2026)
- Preclinical DMD data showed improved muscle strength and lean mass
- Strengthened clinical team with two medical directors added
Negative
- Total operating expenses increased to $9.9M in Q1 2026 (+$2.5M)
- R&D expenses increased to $4.8M (+15% YoY)
- G&A expenses increased to $5.1M (+56% YoY) driven by legal fees
- Interest income decreased by $0.4M vs prior year quarter
News Market Reaction – ATOS
On the day this news was published, ATOS declined 1.23%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
ATOS was down 2.24% pre-news with modest volume. Peers showed mixed moves (e.g., ADAG up 0.85%, MGNX down 2.65%), and no names appeared in the momentum scanner, pointing to stock-specific factors.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 25 | Full-year 2025 results | Positive | -13.1% | Year-end 2025 results with higher spend and new rare-disease designations. |
| Nov 12 | Q3 2025 earnings | Positive | -1.7% | Q3 2025 results, higher opex, and IND/Phase 2 planning for (Z)-endoxifen. |
| Aug 12 | Q2 2025 earnings | Positive | +1.2% | Q2 2025 results with positive FDA feedback and strong I-SPY2 data. |
| May 13 | Q1 2025 earnings | Positive | +6.3% | Q1 2025 results and strategic shift to focus on (Z)-endoxifen. |
| Mar 25 | Full-year 2024 results | Positive | -3.3% | 2024 results with focus on metastatic breast cancer and positive trials. |
Earnings and financial updates have often coincided with negative moves, even when operational news was constructive, indicating a tendency for selling on cost and cash-burn concerns.
Recent earnings-related releases highlight Atossa’s focus on (Z)-endoxifen, with rising R&D investment and repeated mentions of higher operating expenses (e.g., $37.1M in 2025 vs $27.6M in 2024). Prior updates also emphasized cash levels, strategic shifts toward metastatic breast cancer, and patent portfolio progress. Today’s Q1 2026 update, showing higher operating and legal costs around patent matters, fits this pattern of spending to advance the lead program while investors weigh burn and going-concern disclosures.
Historical Comparison
Past earnings updates moved ATOS by an average of -2.11%. Today’s pre-news move of -2.24% fits that typical reaction to higher spend and cash concerns.
Earnings releases show a steady ramp in (Z)-endoxifen investment from 2024 through 2025, with growing R&D and legal spend supporting oncology and rare-disease programs while cash levels decline and going-concern language appears.
Market Pulse Summary
This announcement combines higher Q1 2026 operating expenses of $9.9M with continued progress for (Z)-endoxifen in oncology and rare diseases, including FDA orphan and Rare Pediatric Disease designations. Recent SEC filings underscore going-concern risks and ongoing legal and patent costs. Investors may track quarterly burn, cash balances, and execution on breast cancer and DMD/McCune‑Albright programs to assess how effectively the company converts its expanding clinical footprint into longer-term sustainability.
Key Terms
orphan drug designation regulatory
rare pediatric disease designation regulatory
priority review voucher regulatory
(z)-endoxifen medical
AI-generated analysis. Not financial advice.
"During the quarter, we made meaningful progress advancing our (Z)-endoxifen development strategy across both oncology and rare disease indications," stated Dr. Steven Quay, M.D., Ph.D., Atossa Therapeutics' President and Chief Executive Officer. "We continued to advance (Z)-endoxifen in the clinic for the treatment of breast cancer, while also generating data to support its potential in rare diseases, including Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome. Importantly, we secured both Orphan Drug and Rare Pediatric Disease designations from the FDA for (Z)-endoxifen in DMD, and subsequently we've received Rare Pediatric Disease designation from the FDA for McCune-Albright Syndrome, reinforcing the potential of our programs in areas of high unmet need. Building on this momentum, we remain focused on identifying additional indications where our platform can deliver meaningful therapeutic benefit to patients with limited treatment options."
Dr. Quay continued, "Our balance sheet remains strong, positioning us to continue to execute across our strategic plans, and deliver value to shareholders in upcoming quarters."
First Quarter 2026 & Recent Highlights
- Atossa Therapeutics Presented Encouraging Pre-clinical data for (Z)-Endoxifen in DMD at the MDA Clinical & Scientific Conference - In an oral presentation on March 11, 2026, the Company demonstrated that (Z)-endoxifen improved muscle strength, increased lean mass, and reduced biochemical markers of muscle damage in dystrophic mouse models. We believe these data support advancement into the clinical setting.
- Atossa Therapeutics Received FDA Orphan Drug Designation for (Z)-Endoxifen for the Treatment of DMD - 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 the 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. The Company previously received Rare Pediatric Disease (RPD) designation for (Z)-endoxifen for the treatment of DMD. - Atossa Therapeutics Received FDA RPD Designation for (Z)-Endoxifen for McCune-Albright Syndrome - In early May 2026, Atossa announced that the FDA had granted RPD for (Z)-Endoxifen for McCune-Albright Syndrome, which is the Company's second of such designations received in the last 6 months for rare diseases with currently unmet need. 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 to 24 months, disclosed PRV sales have ranged from
$100 –$205 million . - 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 McCune-Albright Syndrome, as the Company advances toward key clinical and regulatory milestones.
Financial Results for the First Quarter Ended March 31, 2026
Operating Expenses. Total operating expenses were
Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three months ended March 31, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
For the Three Months Ended | |||||||||||||||
2026 | 2025 | Increase | % Increase | ||||||||||||
Research and Development | |||||||||||||||
Clinical and pre-clinical trials | $ | 3,718 | $ | 2,747 | $ | 971 | 35 % | ||||||||
Compensation | 934 | 880 | 54 | 6 % | |||||||||||
Professional fees and other | 127 | 530 | (403) | (76) % | |||||||||||
Research and Development | $ | 4,779 | $ | 4,157 | $ | 622 | 15 % | ||||||||
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 increased
$1.0 million - The increase in R&D compensation expenses of
$0.1 million $0.1 million - The decreases in R&D professional fees and other of
$0.4 million
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the quarter ended March 31, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):
For the Three Months Ended | |||||||||||||||
2026 | 2025 | Increase | % Increase | ||||||||||||
General and Administrative | |||||||||||||||
Compensation | $ | 1,311 | $ | 1,462 | $ | (151) | (10) % | ||||||||
Professional fees and other | 3,780 | 1,795 | 1,985 | 111 % | |||||||||||
General and Administrative | $ | 5,091 | $ | 3,257 | $ | 1,834 | 56 % | ||||||||
- The decrease in G&A compensation expenses of
$0.2 million - The increase in G&A professional fees and other of
$2.0 million $1.8 million
Interest Income. Interest income of
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
Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued
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 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 Priority Review Voucher (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 McCune-Albright Syndrome 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.
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.
ATOSSA THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (amounts in thousands, except share and per share data) (Unaudited) | |||||||
March 31, 2026 | December 31, 2025 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 31,718 | $ | 41,299 | |||
Restricted cash | 110 | 110 | |||||
Prepaid materials | 3,013 | 3,081 | |||||
Prepaid expenses and other current assets | 1,827 | 1,128 | |||||
Total current assets | 36,668 | 45,618 | |||||
Other assets | 1,275 | 1,990 | |||||
Total assets | $ | 37,943 | $ | 47,608 | |||
Liabilities and stockholders' equity | |||||||
Current liabilities | |||||||
Accounts payable | $ | 2,569 | $ | 4,293 | |||
Accrued expenses | 2,807 | 1,307 | |||||
Payroll liabilities | 943 | 1,558 | |||||
Other current liabilities | 1,138 | 1,097 | |||||
Total current liabilities | 7,457 | 8,255 | |||||
Total liabilities | 7,457 | 8,255 | |||||
Commitments and contingencies | — | — | |||||
Stockholders' equity | |||||||
Convertible preferred stock - | — | — | |||||
Common stock - | 1,550 | 1,550 | |||||
Additional paid-in capital | 286,562 | 285,840 | |||||
Treasury stock, at cost; 88,003 shares of common stock at March 31, 2026 and | (1,475) | (1,475) | |||||
Accumulated deficit | (256,151) | (246,562) | |||||
Total stockholders' equity | 30,486 | 39,353 | |||||
Total liabilities and stockholders' equity | $ | 37,943 | $ | 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 March 31, | |||||||
2026 | 2025 | ||||||
Operating expenses | |||||||
Research and development | $ | 4,779 | $ | 4,157 | |||
General and administrative | 5,091 | 3,257 | |||||
Total operating expenses | 9,870 | 7,414 | |||||
Operating loss | (9,870) | (7,414) | |||||
Interest income | 309 | 720 | |||||
Other expense, net | (28) | (24) | |||||
Loss before income taxes | (9,589) | (6,718) | |||||
Income tax benefit | — | — | |||||
Net loss | $ | (9,589) | $ | (6,718) | |||
Net loss per share of common stock - basic and diluted | $ | (1.11) | $ | (0.78) | |||
Weighted average shares outstanding used to compute net loss per share - basic and | 8,622,289 | 8,622,289 | |||||
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SOURCE Atossa Therapeutics Inc