Atossa Therapeutics (ATOS) investor relations material

Executive summary

• Advanced (Z)-endoxifen development in oncology and rare diseases, including breast cancer, Duchenne Muscular Dystrophy (DMD), and McCune-Albright Syndrome, with Phase 2 trials ongoing for multiple indications.

• Secured FDA Orphan Drug and Rare Pediatric Disease designations for (Z)-endoxifen in DMD and McCune-Albright Syndrome.

• Strengthened clinical leadership with two new medical directors for breast oncology and rare diseases.

• Settled ongoing patent litigation, preserving key patent rights for (Z)-endoxifen.

• No revenue generated; company remains in research and development phase and expects ongoing losses until commercialization.

Financial highlights

• Net loss of $9.6 million for Q1 2026, compared to $6.7 million in Q1 2025; net loss per share was $1.11 versus $0.78.

• Operating expenses increased 33–34% year-over-year to $9.9 million, driven by higher R&D and legal costs.

• Research & development expenses rose 15% to $4.8 million; general & administrative expenses rose 56% to $5.1 million, mainly due to $1.8 million in higher legal fees.

• Cash and cash equivalents at March 31, 2026 were $31.7 million, down from $41.3 million at year-end 2025.

• Working capital of $29.2 million as of March 31, 2026.

Outlook and guidance

• Substantial doubt exists about ability to continue as a going concern without additional capital; current resources likely insufficient for next 12 months.

• Plans to raise capital through equity offerings or short-term borrowings; no assurance of success.

• Focus remains on advancing (Z)-endoxifen in oncology and rare disease indications and pursuing additional regulatory milestones.

• No revenue expected until pharmaceutical programs are developed and commercialized.