Atossa Therapeutics Announces Second Quarter 2025 Financial Results and Provides a Corporate Update
Atossa Therapeutics (NASDAQ:ATOS) reported significant progress in Q2 2025, highlighted by positive FDA feedback for its (Z)-endoxifen breast cancer treatment program. The FDA cleared the path for IND filing in Q4 2025, confirming no additional toxicity studies are required.
The company's I-SPY2 trial showed strong results, with 95% of subjects completing planned dosing and median Ki-67 dropping from 10.5% to 5% by Week 3. Tumor volume decreased by 77.7% from baseline to surgery. Financial results showed R&D expenses increased 55% to $5.5 million in Q2 2025, while G&A expenses remained stable at $3.5 million.
Atossa strengthened its patent portfolio with new U.S. Patent No. 12,281,056, although two patents face challenges. The company maintains a strong cash position and has deliberately avoided using its ATM facility at current share price levels.
Atossa Therapeutics (NASDAQ:ATOS) ha riportato progressi significativi nel secondo trimestre 2025, con un riscontro positivo dalla FDA sul programma di trattamento del cancro al seno con (Z)-endoxifen. La FDA ha autorizzato la presentazione dell'IND nel quarto trimestre 2025, confermando che non sono necessari ulteriori studi di tossicità.
Il trial I-SPY2 ha mostrato risultati solidi: il 95% dei partecipanti ha completato le somministrazioni previste e il valore mediano di Ki-67 è sceso dal 10,5% al 5% entro la terza settimana. Il volume tumorale si è ridotto del 77,7% dal basale all'intervento chirurgico. Sul fronte finanziario, le spese in R&S sono aumentate del 55%, raggiungendo 5,5 milioni di dollari nel Q2 2025, mentre le spese G&A sono rimaste stabili a 3,5 milioni.
Atossa ha rafforzato il portafoglio brevetti con il nuovo brevetto statunitense n. 12,281,056, sebbene due brevetti siano oggetto di contestazioni. La società mantiene una solida posizione di cassa e ha evitato consapevolmente l'utilizzo della sua facility ATM ai livelli attuali del prezzo delle azioni.
Atossa Therapeutics (NASDAQ:ATOS) informó avances significativos en el segundo trimestre de 2025, destacando una retroalimentación positiva de la FDA para su programa de tratamiento del cáncer de mama con (Z)-endoxifen. La FDA autorizó la vía para presentar el IND en el cuarto trimestre de 2025, confirmando que no se requieren estudios adicionales de toxicidad.
El ensayo I-SPY2 mostró resultados sólidos, con el 95% de los sujetos completando la dosificación prevista y la mediana de Ki-67 reduciéndose del 10,5% al 5% en la semana 3. El volumen tumoral disminuyó un 77,7% desde la línea de base hasta la cirugía. En lo financiero, los gastos de I+D aumentaron un 55% hasta 5,5 millones de dólares en el Q2 2025, mientras que los gastos G&A se mantuvieron estables en 3,5 millones.
Atossa fortaleció su cartera de patentes con la nueva patente estadounidense n.º 12.281.056, aunque dos patentes enfrentan impugnaciones. La compañía mantiene una sólida posición de efectivo y ha evitado deliberadamente utilizar su mecanismo ATM con los niveles actuales del precio de la acción.
Atossa Therapeutics (NASDAQ:ATOS)는 2025년 2분기에 괄목할 만한 진전을 보고했으며, (Z)-엔독시펜 유방암 치료제 프로그램에 대해 FDA로부터 긍정적인 피드백을 받았습니다. FDA는 추가 독성 연구가 필요 없음을 확인하며 2025년 4분기 IND 제출을 허용했습니다.
회사 측의 I-SPY2 시험 결과는 강력했으며, 피험자의 95%가 예정된 투약을 완료했고 Ki-67 중앙값은 3주차에 10.5%에서 5%로 감소했습니다. 종양 부피는 기준치에서 수술 시까지 77.7% 감소했습니다. 재무 측면에서는 2025년 2분기 R&D 비용이 55% 증가해 550만 달러가 되었고, G&A 비용은 350만 달러로 안정세를 유지했습니다.
Atossa는 신규 미국 특허(No. 12,281,056)로 특허 포트폴리오를 강화했지만 두 건의 특허는 이의 제기를 받고 있습니다. 회사는 현금 유동성이 견고하며, 현재 주가 수준에서는 ATM 제도를 의도적으로 사용하지 않았습니다.
Atossa Therapeutics (NASDAQ:ATOS) a annoncé des progrès significatifs au 2e trimestre 2025, soulignés par un retour positif de la FDA pour son programme de traitement du cancer du sein par (Z)-endoxifène. La FDA a ouvert la voie au dépôt de l'IND au 4e trimestre 2025, confirmant qu'aucune étude toxique supplémentaire n'est requise.
Son essai I-SPY2 a montré des résultats solides : 95 % des sujets ont complété la posologie prévue et la médiane du Ki-67 est passée de 10,5 % à 5 % à la semaine 3. Le volume tumoral a diminué de 77,7 % entre la valeur initiale et la chirurgie. Sur le plan financier, les dépenses R&D ont augmenté de 55 % pour atteindre 5,5 millions de dollars au T2 2025, tandis que les frais G&A sont restés stables à 3,5 millions.
Atossa a renforcé son portefeuille de brevets avec le nouveau brevet américain n° 12 281 056, bien que deux brevets fassent l'objet de contestations. La société conserve une position de trésorerie solide et a délibérément évité d'utiliser sa facilité ATM aux niveaux actuels du cours de l'action.
Atossa Therapeutics (NASDAQ:ATOS) meldete im 2. Quartal 2025 bedeutende Fortschritte, insbesondere positives Feedback der FDA zu seinem (Z)-Endoxifen-Programm gegen Brustkrebs. Die FDA ebnete den Weg für die IND-Einreichung im 4. Quartal 2025 und bestätigte, dass keine weiteren Toxizitätsstudien erforderlich sind.
Die I-SPY2-Studie zeigte starke Ergebnisse: 95% der Probanden beendeten die geplante Dosierung, und der mediane Ki-67-Wert sank bis Woche 3 von 10,5% auf 5%. Das Tumorvolumen verringerte sich von der Ausgangslage bis zur Operation um 77,7%. Finanzbericht: Die F&E-Ausgaben stiegen im Q2 2025 um 55% auf 5,5 Millionen Dollar, während die Verwaltungs- und Gemeinkosten bei 3,5 Millionen stabil blieben.
Atossa stärkte sein Patentportfolio mit dem neuen US-Patent Nr. 12.281.056, allerdings stehen zwei Patente vor Herausforderungen. Das Unternehmen verfügt über eine solide Cash-Position und hat es bewusst vermieden, seine ATM-Fazilität bei den aktuellen Aktienkursen zu nutzen.
- FDA provided positive feedback for (Z)-endoxifen development with no additional toxicity studies required
- Strong I-SPY2 trial results with 95% patient completion rate and 77.7% tumor volume reduction
- New U.S. Patent issued for (Z)-endoxifen formulations
- Strong balance sheet with disciplined capital management strategy
- Two patents facing post-grant challenges that may result in modification or invalidation
- R&D expenses increased 55% year-over-year to $5.5 million in Q2 2025
- Interest income decreased by $0.5 million due to lower average balance in money market account
Insights
Positive FDA feedback and strong clinical data signal significant advancement for Atossa's (Z)-endoxifen program, substantially derisking the path forward.
The FDA's feedback on Atossa's (Z)-endoxifen program represents a substantial derisking of their clinical development pathway. The agency's confirmation that no additional toxicity studies are required removes a significant potential hurdle and accelerates the timeline to IND filing. This regulatory clarity on the monotherapy arm (Part A) and support for combination therapy approaches (Part B) with established agents like CDK4/6 inhibitors aligns perfectly with current treatment paradigms in metastatic breast cancer.
The I-SPY 2 data demonstrates promising efficacy signals at just 3 weeks of treatment. The Ki-67 reduction from 10.5% to 5% is particularly significant, as prior studies like POETIC have established that patients achieving Ki-67 ≤10% have substantially improved outcomes (8.4% vs 21.5% 5-year recurrence). The 77.7% median reduction in functional tumor volume further supports meaningful anti-tumor activity. Importantly, the safety profile appears manageable with predominantly Grade 1 events.
The faster-than-anticipated enrollment in the combination therapy arm with abemaciclib suggests physician and patient interest in the approach. The company's Q4 2025 timeline for IND submission appears realistic given the regulatory clarity already achieved.
While the patent challenges present some risk, Atossa's broader IP portfolio with over 200 total claims across multiple patents provides reasonable protection. The increased R&D expenses (+55% for Q2) reflect appropriate investment in clinical development as programs advance, though the company appears to maintain financial discipline with minimal change in G&A expenses.
Atossa's regulatory progress and clinical data support advancement toward value-creating milestones, though legal challenges to key patents warrant monitoring.
Atossa's Q2 results and corporate update reveal several positive developments that significantly strengthen the company's strategic position. The FDA's constructive feedback substantially derisks the regulatory pathway for (Z)-endoxifen by eliminating the need for additional toxicity studies, which typically represent significant time and cost burdens in drug development. This accelerates the path to IND filing expected in Q4 2025.
From a financial perspective, Atossa reports a strong balance sheet while demonstrating fiscal discipline by not utilizing its ATM facility at current share prices. This suggests management confidence in the company's intrinsic value and potential near-term catalysts. The financial data shows R&D expenses increased by $1.9 million to $5.5 million in Q2 2025 compared to Q2 2024, reflecting appropriate investment in advancing clinical programs. G&A expenses remained essentially flat year-over-year at $3.5 million, indicating good operational efficiency.
The company's intellectual property position presents a mixed picture. While two patents face post-grant challenges that could potentially limit protection, Atossa maintains four additional patents with over 200 claims covering manufacturing methods, formulations, and stable forms of (Z)-endoxifen. These patent challenges represent a common occurrence for promising pharmaceutical assets but warrant close monitoring.
The clinical data from the I-SPY 2 study provides encouraging biomarker evidence (Ki-67 reduction) and tumor shrinkage data that support the drug's efficacy, while the favorable safety profile enhances the risk/benefit assessment. With multiple catalysts ahead including the IND filing and potential expansion into additional breast cancer indications, Atossa appears well-positioned to execute on its development strategy.
FDA Provides Positive Feedback, Clears Path for Atossa to File IND for (Z)-Endoxifen in Metastatic Breast Cancer; FDA Indicates No Additional Toxicity Studies Required
Strong I-SPY2 Results Reinforce Efficacy of Atossa's Monotherapy at 3-weeks
"Atossa continues to make meaningful and measurable progress across our pipeline, underscored by recent, highly constructive interactions with the FDA that further support our (Z)-endoxifen development strategy in metastatic breast cancer," stated Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics. "With a strong balance sheet, we believe we are well-positioned to execute on our planned upcoming IND submission and advance our metastatic clinical program toward key value-creating milestones. We remain disciplined in our capital strategy and have deliberately chosen not to utilize our ATM facility at recent share price levels, which we believe significantly undervalue the true potential of our Company. As we progress toward multiple upcoming potential catalysts, we are confident that our focused execution, scientific rigor, and unwavering commitment to patients will demonstrate the substantial intrinsic value of Atossa and position (Z)-endoxifen to make a meaningful impact in the treatment of breast cancer."
Clinical & Regulatory Developments
- Positive FDA Feedback on (Z)-Endoxifen Program - In July 2025, Atossa announced it received highly constructive written feedback from the
U.S. Food and Drug Administration (FDA), supporting the Company's proposed dose optimization trial in estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) metastatic breast cancer and allowing the Company to meet the requirements of Project Optimus. The FDA agreed that existing clinical and nonclinical data are sufficient to initiate the monotherapy arm (Part A) of the study and agreed with the scientific rationale for combination therapy arms (Part B) using standard-of-care agents, such as CDK4/6 inhibitors, PI3K inhibitors, mTOR inhibitors, and capecitabine. The Agency also indicated that no additional general toxicity or neurotoxicity studies are required and confirmed that Atossa's cardiac safety assessment monitoring protocol is sufficient for the monotherapy portion of the trial. These developments support the Company's plan to file an Investigational New Drug (IND) application with the FDA, which is expected in Q4 2025.
Clinical Trial Readouts & Scientific Validation
- I‑SPY 2 Endocrine Optimization Sub‑Study Results (Monotherapy with Low-Dose 10 mg (Z)-endoxifen) – In May 2025, Atossa released full results from the Phase 2 pilot within the I‑SPY 2 trial. Among 20 women with stage II/III ER+, HER2‑ breast cancer.
- Primary endpoint achieved with 95 percent of subjects completing at least 75 percent of planned dosing.
- Median Ki‑67 dropped from 10.5 percent at baseline to 5 percent by Week 3, with 65 percent achieving Ki‑67 ≤ 10 percent. Ki-67 is a widely used biomarker in pathology to assess the extent to which cancer cells are dividing and is often correlated with tumor behavior and prognosis. The POETIC (Peri-Operative Endocrine Therapy for individualized Care) trial, a large phase 3 study conducted in the
UK and sponsored by the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust, demonstrated that early changes in Ki-67 are strongly prognostic. Published in 2020, the trial showed that women with ER+/HER2− breast cancer whose Ki-67 levels fell from >10 percent at baseline to ≤10 percent after just two weeks of neoadjuvant aromatase inhibitor therapy had a 5-year recurrence rate of 8.4 percent, compared to 21.5 percent in those whose Ki-67 remained above 10 percent. - Median functional tumor volume, as assessed by MRI, decreased by 77.7 percent from baseline to surgery, and the longest tumor diameter dropped by 36.8 percent from baseline to preoperative MRI.
- Safety was favorable: adverse events were predominantly Grade 1; vasomotor symptoms (hot flushes) and fatigue were most common. Only three Grade 3 events (two skin infections, one post‑procedural infection) occurred in a single patient and were deemed unrelated to the study drug; no Grade 4 or Grade 5 events were reported.
- I-SPY 2 - Endocrine Optimization Pilot Analysis (Combination therapy of 40 mg (Z)-endoxifen and Eli Lilly's abemaciclib)
- Patient recruitment continues at a faster rate than anticipated, with 41 patients initiated as of July 29, 2025.
- Other ongoing Phase 2 Programs - Atossa continues to evaluate (Z)-endoxifen in two other Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and one in women with ER+/HER2- breast cancer, as previously disclosed.
Intellectual Property & Patent Portfolio
- New
U.S. Patents - In mid‑May 2025, Atossa announced the issuance ofU.S. Patent No. 12,281,056, containing 58 claims relating to the enteric oral formulations of (Z)-endoxifen, including features of improved purity, stability, and bioavailability. - Recent Patent Challenges - Two of Atossa's patents are currently the subject of post‑grant challenges (i.e.,
U.S. Patent Nos. 11,261,151 and 12,071,391), which may result in modification or invalidation of certain patent claims; however, such proceedings are common for high‑value pharmaceutical IP, and we remain confident in our ability to vigorously defend these patents. The majority of Atossa's intellectual property is unaffected. Atossa holds four additional issuedU.S. patents with claims to endoxifen—U.S. Patent Nos. 11,680,036, 12,201,591, 12,275,684, and 12,281,056—with over 200 total claims covering proprietary manufacturing methods, stable crystalline forms, and multiple sustained‑release and enteric oral formulations of (Z)‑endoxifen. We believe that these patents, along with pending applications worldwide, provide substantial additional protection for our lead program.
Strategic Outlook & Upcoming Milestones
Atossa remains focused on executing its breast cancer development strategy. Key upcoming deliverables include:
- Announcement of Contract Research Organization (CRO) selected to execute the metastatic dose ranging study in coordination with Atossa clinical personnel.
- Disclosure of dose-ranging trial design, including specifics on patient selection criteria and combination treatment backbone.
- Targeting IND submission in Q4 2025, in alignment with feedback under the FDA Project Optimus initiative.
- Advancing enrollment and data generation from ongoing Phase 2 trials.
- Working with the FDA on regulatory strategies for breast cancer indications beyond metastatic breast cancer, including treating women in the adjuvant setting, patients with DCIS, and in reducing the incidence of breast cancer in high-risk women.
Comparison of Three and Six Months Ended June 30, 2025 and 2024
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 and six months ended June 30, 2025 and 2024, 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, | ||||||||||||||||||||||||||||
2025 | 2024 | Increase (Decrease) | % Increase (Decrease) | 2025 | 2024 | Increase (Decrease) | % Increase (Decrease) | ||||||||||||||||||||||
Research and Development Expense | |||||||||||||||||||||||||||||
Clinical and non-clinical trials | $ | 4,089 | $ | 2,501 | $ | 1,588 | 63 % | $ | 6,836 | $ | 5,384 | $ | 1,452 | 27 % | |||||||||||||||
Compensation | 856 | 679 | 177 | 26 % | 1,736 | 1,305 | 431 | 33 % | |||||||||||||||||||||
Professional fees and other | 557 | 373 | 184 | 49 % | 1,087 | 613 | 474 | 77 % | |||||||||||||||||||||
Research and Development Expense Total | $ | 5,502 | $ | 3,553 | $ | 1,949 | 55 % | $ | 9,659 | $ | 7,302 | $ | 2,357 | 32 % | |||||||||||||||
- Clinical and non-clinical trial expenses increased
$1.6 million $1.5 million - The increases in R&D compensation expenses of
$0.2 million $0.4 million - The increases in R&D professional fees and other of
$0.2 million $0.5 million
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, 2025 and 2024, 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, | ||||||||||||||||||||||||||||
2025 | 2024 | Increase (Decrease) | % Increase (Decrease) | 2025 | 2024 | Increase (Decrease) | % Increase (Decrease) | ||||||||||||||||||||||
General and Administrative Expense | |||||||||||||||||||||||||||||
Compensation | $ | 1,564 | $ | 1,031 | $ | 533 | 52 % | $ | 3,026 | $ | 2,356 | $ | 670 | 28 % | |||||||||||||||
Professional fees and other | 1,794 | 2,269 | (475) | (21) % | 3,408 | 3,949 | (541) | (14 %) | |||||||||||||||||||||
Insurance | 180 | 252 | (72) | (29) % | 361 | 479 | (118) | (25) % | |||||||||||||||||||||
General and Administrative Expense Total | $ | 3,538 | $ | 3,552 | $ | (14) | (0) % | $ | 6,795 | $ | 6,784 | $ | 11 | 0 % | |||||||||||||||
- The increases in G&A compensation expenses of
$0.5 million $0.7 million $0.4 million $0.5 million - The decreases in G&A professional fees and other of
$0.5 million $0.3 million $0.2 million $0.1 million $0.3 million
Interest Income. Interest income was
About (Z)-Endoxifen
(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM) with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels. Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen.
Atossa is developing a proprietary enteric oral formulation of (Z)-endoxifen that bypasses stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa's (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. In over 700 subjects (healthy volunteers and breast cancer patients), doses up to 360 mg/day have been administered with no maximum tolerated dose (MTD) identified, supporting continued dose-ranging exploration.
Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with ER+/HER2- breast cancer. Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide.
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 the Company's development strategy and related milestones, 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, including the potential IND submission and related timing, 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, the Company's progress across its pipeline, the strength of the Company's patent portfolio and expectations regarding related litigation, 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 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.
ATOSSA THERAPEUTICS, INC. | ||||||||
June 30, 2025 | December 31, 2024 | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 57,857 | $ | 71,084 | ||||
Restricted cash | 110 | 110 | ||||||
Prepaid materials | 3,475 | 2,098 | ||||||
Prepaid expenses and other current assets | 1,075 | 1,165 | ||||||
Total current assets | 62,517 | 74,457 | ||||||
Other assets | 1,998 | 1,987 | ||||||
Total assets | $ | 64,515 | $ | 76,444 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 2,010 | $ | 679 | ||||
Accrued expenses | 2,200 | 919 | ||||||
Payroll liabilities | 1,054 | 1,862 | ||||||
Other current liabilities | 1,556 | 1,507 | ||||||
Total current liabilities | 6,820 | 4,967 | ||||||
Total liabilities | 6,820 | 4,967 | ||||||
Commitments and contingencies | — | — | ||||||
Stockholders' equity | ||||||||
Convertible preferred stock - | — | — | ||||||
Common stock - | 23,488 | 23,488 | ||||||
Additional paid-in capital | 262,615 | 261,256 | ||||||
Treasury stock, at cost; 1,320,046 shares of common stock on June 30, 2025 and | (1,475) | (1,475) | ||||||
Accumulated deficit | (226,933) | (211,792) | ||||||
Total stockholders' equity | 57,695 | 71,477 | ||||||
Total liabilities and stockholders' equity | $ | 64,515 | $ | 76,444 | ||||
ATOSSA THERAPEUTICS, INC. | |||||||||||||||||
For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||||||||
Operating expenses | |||||||||||||||||
Research and development | $ | 5,502 | $ | 3,553 | $ | 9,659 | $ | 7,302 | |||||||||
General and administrative | 3,538 | 3,552 | 6,795 | 6,784 | |||||||||||||
Total operating expenses | 9,040 | 7,105 | 16,454 | 14,086 | |||||||||||||
Operating loss | (9,040) | (7,105) | (16,454) | (14,086) | |||||||||||||
Interest income | 645 | 1,073 | 1,365 | 2,211 | |||||||||||||
Other expense, net | (28) | (17) | (52) | (52) | |||||||||||||
Loss before income taxes | (8,423) | (6,049) | (15,141) | (11,927) | |||||||||||||
Income tax benefit | — | — | — | — | |||||||||||||
Net loss | (8,423) | (6,049) | (15,141) | (11,927) | |||||||||||||
Net loss per share of common stock - basic and diluted | $ | (0.07) | $ | (0.05) | $ | (0.12) | $ | (0.10) | |||||||||
Weighted average shares outstanding used to compute | 129,170,425 | 125,732,140 | 129,170,216 | 125,525,959 | |||||||||||||
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SOURCE Atossa Therapeutics Inc
FAQ
What was the FDA's feedback on Atossa's (NASDAQ:ATOS) (Z)-endoxifen program in July 2025?
What were the key results from Atossa's I-SPY 2 trial for (Z)-endoxifen?
How did Atossa Therapeutics' R&D expenses change in Q2 2025?
What is the status of Atossa's patent portfolio for (Z)-endoxifen?
When does Atossa plan to submit its IND application for (Z)-endoxifen?
