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 ov ...

OR Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2025 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from: to Commission File Number: 001-35610 ATOSSA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdicti ...

Previously, Dr. Theall held senior roles at Pfizer Inc., where she contributed to the clinical development of IBRANCE® (palbociclib), including the PALOMA trials that supported both accelerated and full approvals. She began her career in academic medicine, serving in leadership roles at Tufts Medical Center and as a clinical investigator across more than 40 oncology studies. Atossa Therapeutics Strengthens Clinical Leadership Team with the Addition of Two Experienced Biopharma Executives Accessibility State ...

Core Insights - Atossa Therapeutics presented a clinical trial update on (Z)-endoxifen, highlighting its potential to restore muscle performance and lower damage biomarkers in mdx5Cv dystrophic mice at the 2026 MDA Clinical & Scientific Conference [1] Group 1: Clinical Trial Findings - (Z)-endoxifen was well tolerated with no adverse findings observed during the study [1] - Key biochemical and histologic markers of muscle damage were reduced [1] - Favorable changes in body composition were noted, including increased lean mass and reduced fat mass [1] - The treatment enhanced resistance to contraction-induced muscle injury [1] - (Z)-endoxifen improved muscle strength and motor performance in both juvenile and adult dystrophic mice [1] Group 2: Clinical Significance - Duchenne Muscular Dystrophy (DMD) is a progressive and fatal neuromuscular disorder with significant unmet medical needs for additional therapies [1] - Preclinical findings suggest that (Z)-endoxifen may address multiple aspects of DMD pathology, including muscle weakness and functional decline [1] - The results support further clinical investigation of (Z)-endoxifen as a potential new therapeutic option for DMD patients [1] Group 3: About (Z)-Endoxifen - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with activity across multiple mechanisms [1] - The proprietary oral formulation has shown a favorable safety profile and pharmacology distinct from tamoxifen [1] - Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents [1] Group 4: About Atossa Therapeutics - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies in oncology and other areas of significant unmet need [1] - The company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings [1] - Atossa emphasizes disciplined capital allocation to enable future regulatory submissions and potential commercialization [1]

Core Insights - Atos has been recognized as a Leader in the ISG Provider Lens™ 2025 for Cybersecurity – Services and Solutions in the United States, marking its fifth consecutive year in this position [1][2] - The recognition highlights Atos' integrated, end-to-end cybersecurity capabilities, which include advisory strength, advanced security operations, and deep technical expertise [2] Group 1: Recognition and Market Position - Atos has maintained its leadership position in the U.S. cybersecurity market for five consecutive years from 2021 to 2025 [1] - The ISG Provider Lens™ report emphasizes the complexity of the U.S. cybersecurity landscape, where organizations face sophisticated threats and regulatory requirements [2] Group 2: Key Quadrants of Recognition - In the Strategic Security Services quadrant, Atos is noted for its structured consulting approach that aligns cybersecurity strategies with business objectives [3] - The Technical Security Services quadrant highlights Atos' expertise in hybrid cloud security, identity and access management, and infrastructure protection [4] - In the Next-Generation SOC/MDR Services quadrant, Atos is recognized for its AI-driven security operations model, which includes advanced analytics and multi-vector threat detection [5] Group 3: Operational Capabilities - Atos processes over 31 billion security events daily and supports more than 2,000 clients globally, showcasing its extensive operational capabilities [9] - The company operates a global network of 17 Security Operations Centers (SOCs) and employs over 6,500 cybersecurity experts [7] Group 4: Strategic Vision - Atos aims to help organizations build secure digital foundations that support long-term growth, resilience, and innovation in an evolving cyber risk landscape [9] - The company is committed to a secure and decarbonized future, providing tailored AI-powered, end-to-end solutions across various industries [12]

Core Insights - Atossa Therapeutics has made significant progress in advancing its proprietary oral (Z)-endoxifen towards regulatory and clinical milestones in 2025, focusing on oncology and rare disease conditions with unmet needs [1][2] Regulatory and Development Strategy - A major milestone was the completion of a Type C meeting with the FDA on November 17, 2025, which clarified potential expedited pathways for (Z)-endoxifen in breast cancer treatment [2] - The company received feedback on development options for metastatic disease, neoadjuvant treatment, and risk-reduction settings, aiding in the acceleration of development and regulatory review [2] Clinical Trials and Data - Atossa is conducting several "I-SPY 2" studies to investigate (Z)-endoxifen's neoadjuvant activity both as a monotherapy and in combination with abemaciclib and elagolix [3][5] - Preliminary data from the monotherapy arm indicated that (Z)-endoxifen was well tolerated and resulted in reductions in tumor activity markers [4] - Enrollment for combination therapy arms is nearly complete, with data expected in the second half of 2026 [5] Metastatic Breast Cancer Update - The company submitted an IND application for a Phase 2 study in metastatic breast cancer but has decided to pause investment in this area to focus on other oncology and rare disease opportunities [6] Non-Oncology Applications - (Z)-endoxifen shows potential in treating Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome (MAS), with FDA designations received for DMD [9][10][12] - The company is exploring the use of (Z)-endoxifen for symptomatic female carriers of DMD, highlighting its versatility beyond oncology [11][13] Intellectual Property and Team Strengthening - Atossa is reinforcing its intellectual property estate, including a new U.S. patent for enteric oral formulations of (Z)-endoxifen [14] - The company has strengthened its leadership team to support regulatory execution and commercial readiness [15][16] Financial Discipline and Outlook - Atossa entered 2026 with over $40 million in cash, supporting more than one year of working capital, and initiated a reverse stock split to regain Nasdaq compliance [17] - The company plans to focus on regulatory execution, oncology priorities, and non-oncology opportunities while maintaining capital efficiency [18][19][20][21] Business Development Readiness - The company is preparing for business development opportunities and has appointed new leadership to oversee late-stage programs and financial strategy [23][24]

Core Viewpoint - Atossa Therapeutics has reaffirmed its strong market position in the Duchenne Muscular Dystrophy (DMD) program following the reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) Program, which allows for potential future PRV eligibility upon FDA approval of (Z)-endoxifen for DMD treatment [1][3] Group 1: Rare Pediatric Disease Designation - The Rare Pediatric Disease (RPD) designation is granted to drug candidates for serious or life-threatening diseases affecting individuals from birth to 18 years old, allowing for eligibility for a PRV upon FDA approval [2][4] - PRVs can be used for priority review of future applications or sold to other sponsors, with recent PRV sales ranging from $150 million to $200 million [2] Group 2: Company Statements and Insights - The renewal of the PRV program signals congressional recognition of the complexities and financial burdens in drug development, validating the potential of (Z)-endoxifen for DMD treatment [3] - Atossa's leadership emphasizes the urgent need for better treatment options for DMD beyond current therapies, highlighting (Z)-endoxifen's broader treatment approach [3] Group 3: Product and Market Potential - (Z)-endoxifen is a Selective Estrogen Receptor Modulator/Degrader (SERM/D) with a favorable safety profile and distinct pharmacology, currently not approved for any indication [6] - The company is advancing (Z)-endoxifen's development in both oncology and rare diseases, supported by a growing global intellectual property portfolio [7][8]

Core Insights - The Healthcare Technology Report announced the Top Healthcare Technology CEOs of 2025, highlighting the evolving expectations for technology in healthcare, focusing on integration, reliable outcomes, and expansion beyond initial deployments [2][5] Company Performance - Natera reported preliminary 2025 results of approximately $2.3 billion in revenue and processed around 769,700 clinical MRD tests, indicating significant adoption of its Signatera product [3] - BillionToOne, under the leadership of Oguzhan Atay, successfully completed a NASDAQ IPO in November 2025, advancing single-molecule counting to a broader commercial stage [4] - Angle Health, led by Ty Wang, secured a $134 million Series B financing, expanding its healthcare benefits technology platform to over 3,000 employers across 44 states [4] Leadership Recognition - The awardees for the Top Healthcare Technology CEOs of 2025 include notable leaders such as Steve Chapman (Natera), Oguzhan Atay (BillionToOne), and Ty Wang (Angle Health), among others, who have contributed to enhancing healthcare connectivity and efficiency [6][5]

Core Insights - Atossa Therapeutics, Inc. has announced that its Founder and CEO, Dr. Steven Quay, has been recognized as one of "The Top 50 Healthcare Technology CEOs of 2025" for his leadership in advancing innovative biotechnology solutions [1][2][3] Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies in oncology and other areas of significant unmet clinical need [4] - The company's lead product candidate, (Z)-endoxifen, is a precision-engineered endocrine therapy currently undergoing multiple Phase 2 clinical trials [2][4] - Atossa's strategy emphasizes disciplined capital allocation, focusing on programs that can enable future regulatory submissions and potential commercialization [4] Product Development - (Z)-endoxifen has been optimized as a potent selective estrogen receptor modulator/degrader (SERM/D) with additional PKC1 inhibition, designed for consistent systemic exposure independent of CYP2D6 metabolism [2] - The company is also exploring the application of (Z)-endoxifen for Duchenne Muscular Dystrophy (DMD) [2]

Regulatory Developments - Atossa Therapeutics, Inc. (ATOS) received Orphan Drug Designation from the U.S. FDA for (Z)-endoxifen to treat Duchenne muscular dystrophy, leading to a 12.98% increase in stock price to $0.69 [1] - ImmunityBio, Inc. (IBRX) reported that enrollment in its QUILT-2.005 trial for bladder cancer exceeded expectations, with over 85% enrollment, anticipating full enrollment by Q2 2026 and FDA submission by year-end 2026, resulting in a 9.43% stock price increase to $6.04 [2] Financing Updates - Foghorn Therapeutics Inc. (FHTX) closed a $50 million registered direct financing at a 30% premium, contributing to a 4.02% increase in stock price to $6.26 [4] - Femasys Inc. (FEMY) received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement, allowing until July 13, 2026, for compliance, leading to a 10.68% increase in stock price to $0.72 [3] Investor Sentiment - Theravance Biopharma, Inc. (TBPH) saw a 5.00% increase in stock price to $21.01 despite no new announcements [5] - Daré Bioscience, Inc. (DARE) experienced a modest gain of 1.04% to $1.95 without any new news [4]