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Atossa Therapeutics Releases Q3 2026 Financial Results

On November 10, 2026, Atossa Therapeutics, Inc. (Nasdaq: ATOS), a biopharmaceutical company focused on innovative therapies for oncology and rare diseases, announced its financial figures for the third quarter ending September 30, 2026, along with essential corporate updates. This report revealed the company’s strategies and initiatives aimed at enhancing shareholder engagement and participation in potential value derived from its critical rare disease programs.

Key Statements from Leadership

Steven C. Quay, M.D., Ph.D., Atossa's Chairman, President, and CEO, expressed the company's commitment to maximizing shareholder input in its innovative therapeutic developments. He highlighted a newly established contingent value rights agreement, which awards holders a share in 25% of net proceeds, up to $50 million, from the potential sale of a priority review voucher (PRV) linked to their rare disease programs. This mechanism represents a strategic approach for investors, aiming to align their interests with Atossa’s future clinical milestones.

In addition, Atossa continues to advance towards several notable milestones for its key product candidate, (Z)-endoxifen. This investigational drug is poised for impending FDA clearance of its Investigational New Drug (IND) applications targeting Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome (MAS), expected early in 2027.

Recent Highlights for Q3 2026

• - Contingent Value Rights Agreement: Effective October 8, 2026, Atossa established a Stacked Contingent Value Rights (CVR) Agreement, issuing one CVR for each outstanding share of common stock as of October 19, 2026. The CVRs are meant to secure investor participation in the monetization of the PRV, providing an avenue for potential revenue as the company advances its drug development pipeline.

• - Events Participation: Atossa’s CFO, Mark Daniel, attended the Global Genes RARE Drug Development Symposium, providing the company with insights into patient priorities and strategies in the rare disease sector. Around the same time, Dr. Quay represented Atossa at the NORD Rare Diseases and Orphan Products Breakthrough Summit, where he engaged with industry experts and policymakers focused on refining and accelerating rare disease treatments.

Anticipated Milestones

• - IND Clearance: The company projects a successful IND application approval for (Z)-endoxifen regarding DMD and MAS by early 2027, with plans to initiate Phase 2 clinical trials shortly thereafter.
• - Karisma Trial Presentation: Results from the recently concluded Karisma trial will be showcased at the December 2026 San Antonio Breast Cancer Symposium, marking a significant moment for the company's research output.
• - Other Key Studies: Additional trial data regarding (Z)-endoxifen, especially in combination therapies, will also feature at the upcoming symposium, continuing to build on Atossa's commitment to providing innovative treatment options for patients.

Financial Overview

Examining the third quarter's financial outcomes reveals a total operating expense of $5.9 million, a drop from $9.3 million the previous year. Throughout the first nine months of 2026, total operating costs were recorded at $24.5 million compared to $25.7 million in 2025. The decline in expenses highlights Atossa’s enhanced operational efficiencies amid ongoing clinical trials and drug development initiatives.

Research and Development Details

Within R&D expenditures, clinical trial costs were notably reduced, with a comparison showing a decrease from $4.3 million in 2025 to $2.5 million in 2026 for Q3. This drop aligns with completed enrollments for numerous trials, notably those involving (Z)-endoxifen.

Conclusion

In summary, Atossa Therapeutics has shown resilience and a focused commitment towards developing critical therapies for rare diseases while ensuring that its investors are closely aligned with its future successes. As the company advances through 2026, the anticipation of FDA approvals and presentations of its ongoing studies underscore its potential to significantly impact the biopharmaceutical landscape.