SEATTLE, Feb. 11, 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 need, today issued a letter to Shareholders from Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer, providing an update on the Company's clinical programs and recent events. The full text of the letter follows: Regulatory and Development Strategy - Clarity ...

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]

Core Insights - Atossa Therapeutics has received Orphan Drug Designation from the FDA for (Z)-endoxifen to treat Duchenne muscular dystrophy (DMD), which is a significant milestone for the company in its development efforts for this serious disease [1][2] Group 1: Company Overview - Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies in oncology and other areas with high unmet medical needs [7] - The company's lead product candidate, (Z)-endoxifen, is being evaluated for its potential applications in oncology and rare diseases [5][7] - Atossa has a growing global intellectual property portfolio supporting the (Z)-endoxifen program, including multiple recently issued U.S. patents and numerous pending applications worldwide [6] Group 2: Product Information - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/SERD) with demonstrated activity across multiple mechanisms of interest, showing a favorable safety profile distinct from tamoxifen [5] - The drug is not yet approved for any indication, and the company plans to continue engaging with the FDA as it advances its development efforts [2][5] Group 3: Disease Context - Duchenne Muscular Dystrophy (DMD) is a rare, progressive, X-linked neuromuscular disorder caused by mutations in the dystrophin gene, leading to severe symptoms and a substantial unmet medical need for effective treatments [4]

Financial Position - As of December 31, 2025, Atossa Therapeutics, Inc. estimated cash and cash equivalents of approximately $40 million[6] - The financial results for the year ended December 31, 2025, are still subject to finalization and should not be solely relied upon[7] Development Strategy - The company is focusing on the development and regulatory strategy for (Z)-Endoxifen, with potential market opportunities being explored[10] Risks and Compliance - Forward-looking statements indicate potential risks and uncertainties related to clinical development timelines and regulatory approvals[11] - The company aims to regain and maintain compliance with Nasdaq listing requirements as part of its strategic objectives[11]

Core Insights - Atossa Therapeutics has received a "Study May Proceed" letter from the FDA for its clinical study of (Z)-endoxifen in metastatic breast cancer, marking a significant regulatory milestone for the company [1][2] Group 1: Product Development - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with demonstrated activity across multiple mechanisms, currently under evaluation for oncology and rare diseases [3] - The proprietary oral formulation of (Z)-endoxifen has shown a favorable safety profile and distinct pharmacology compared to tamoxifen, including ER-targeted effects and PKC inhibition [3] - The (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide [4] Group 2: Company Overview - Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative medicines in oncology and other areas of significant unmet medical need [5] - The company's lead product candidate, (Z)-endoxifen, is currently in development across several clinical settings [5]

Core Insights - Atossa Therapeutics has been awarded the Research and Development Award in the Precision Endocrine Therapy category at the 2025 Clinical Trials Arena Excellence Awards for its work on (Z)-endoxifen [1][3] Group 1: Product Development - (Z)-endoxifen is a selective estrogen receptor modulator/degrader (SERM/D) designed to provide consistent systemic exposure independent of CYP2D6 metabolism, with applications in metastatic, neoadjuvant, adjuvant breast cancer, and Duchenne Muscular Dystrophy (DMD) [2][4] - The therapy has shown a favorable safety profile and pharmacology distinct from tamoxifen, including ER-targeted effects and PKC inhibition [4] Group 2: Company Strategy - Atossa emphasizes disciplined capital allocation, focusing on programs that can enable future regulatory submissions and potential commercialization [6] - The company is supported by a growing global intellectual property portfolio, including multiple recently issued U.S. patents and numerous pending applications worldwide [5] Group 3: Leadership and Innovation - The award reflects the company's commitment to precision endocrine therapy and its integrated approach to developing (Z)-endoxifen for patients with high unmet medical needs [3] - The Clinical Trials Arena Excellence Awards recognize companies demonstrating scientific rigor, innovation, and leadership in clinical research and drug development [3]

Core Insights - Atossa Therapeutics presented four clinical trial updates on (Z)-endoxifen at the San Antonio Breast Cancer Symposium, highlighting its potential in breast cancer treatment and risk reduction [1][2] Clinical Trial Updates - The company emphasized the therapeutic value of (Z)-endoxifen across the breast care continuum, with ongoing enrollment in the Phase 2 EVANGELINE study for neoadjuvant ER+/HER2- breast cancer [2] - Initial results from the RECAST trial suggest that short-term endocrine therapy combined with MRI response assessment may help identify low-risk DCIS patients who can avoid surgery [3][7] - Low-dose (Z)-endoxifen demonstrated excellent tolerability and biological activity, with significant reductions in Ki-67 (–72% median), MRI tumor volume, and ctDNA clearance in 70% of initially ctDNA-positive patients [5][8] - The EVANGELINE trial is the first to evaluate (Z)-endoxifen with ovarian function suppression as a neoadjuvant therapy for premenopausal ER+/HER2- breast cancer, showing strong early biological activity with 86% of patients achieving a Week 4 Ki-67 of 10% [10][15] Mechanistic Insights - (Z)-endoxifen maintains potent ER antagonist activity against key ESR1 mutations, stabilizing inactive receptor conformations and demonstrating strong suppression of ER signaling [6][14] - Transcriptomic analyses indicate that (Z)-endoxifen reverses multiple mutant ESR1-associated oncogenic pathways while restoring beneficial programs, highlighting its therapeutic potential for ER+/ESR1 mutant breast cancer [14]