Atossa Therapeutics (ATOS) investor relations material

Executive summary

• Focused on developing proprietary medicines for oncology, especially breast cancer, and rare diseases, with lead candidate (Z)-endoxifen in Phase 2 trials for multiple indications including breast cancer and rare pediatric diseases; advanced clinical and scientific programs, presenting new data at major conferences and in peer-reviewed journals.

• Completed enrollment in key Phase 2 studies, including the EVANGELINE trial for ER+/HER2- breast cancer, and published promising preclinical and clinical data.

• No revenue generated; business remains in research and development phase with ongoing clinical studies and patent portfolio expansion.

• Received FDA Rare Pediatric Disease and Orphan Drug designations for (Z)-endoxifen in Duchenne muscular dystrophy (DMD) and McCune-Albright Syndrome (MAS).

• Strengthened financial position with a registered direct offering, raising $4.5 million upfront and potential for up to $16.5 million in gross proceeds.

Financial highlights

• Net loss of $8.5 million for Q2 2026 and $18.1 million for the six months ended June 30, 2026, compared to $8.4 million and $15.1 million for the same periods in 2025.

• Operating expenses were $8.7 million for Q2 2026 (down $0.3 million year-over-year) and $18.6 million for the six months (up $2.1 million year-over-year).

• Cash and cash equivalents totaled $26.1 million as of June 30, 2026, down from $41.3 million at year-end 2025, with working capital of $25.6 million.

• Net cash used in operating activities was $19.2 million for the six months ended June 30, 2026, up from $13.2 million in the prior year.

• Interest income decreased to $0.2 million for Q2 2026, reflecting lower average cash balances.

Outlook and guidance

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

• Ongoing development of (Z)-endoxifen in oncology and rare diseases, with continued focus on regulatory milestones and potential market opportunities.

• Plans to seek additional funding through equity offerings or short-term borrowings; no revenue expected until successful commercialization of pharmaceutical programs.

• Anticipates further in vivo safety and efficacy studies for new (Z)-endoxifen-related compounds in breast cancer.

• Expects to leverage Rare Pediatric Disease and Orphan Drug designations for potential Priority Review Voucher eligibility.