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Aug 7, 2026, 8:45 AM ETHealthcare

Atossa Therapeutics — Second Quarter 2026 Earnings Summary

ATOSATOSSA THERAPEUTICS INC
Source

Financial Performance

  • Total operating expenses were $8.7 million for the three months ended June 30, 2026, a decrease of $0.3 million (3%) from $9.0 million in the same period in 2025; for the six months ended June 30, 2026, expenses were $18.6 million, an increase of $2.1 million (13%) from $16.5 million in 2025.
  • Research and development (R&D) expenses were $4.9 million for the three months ended June 30, 2026 (down 11% from $5.5 million in 2025) and $9.7 million for the six months ended June 30, 2026 (flat at $9.7 million compared to $9.7 million in 2025).
  • General and administrative (G&A) expenses were $3.8 million for the three months ended June 30, 2026 (up 7% from $3.5 million in 2025) and $8.9 million for the six months ended June 30, 2026 (up 31% from $6.8 million in 2025).
  • Net loss was $8.5 million ($0.95 per share) for the three months ended June 30, 2026, compared to $8.4 million ($0.98 per share) in 2025; for the six months ended June 30, 2026, net loss was $18.1 million ($2.06 per share), compared to $15.1 million ($1.76 per share) in 2025.
  • Interest income was $0.2 million for the three months ended June 30, 2026 (down from $0.6 million in 2025) and $0.5 million for the six months ended June 30, 2026 (down from $1.4 million in 2025).
  • Cash and cash equivalents were $26.1 million as of June 30, 2026, down from $41.3 million as of December 31, 2025.
  • Total stockholders' equity was $26.8 million as of June 30, 2026, down from $39.4 million as of December 31, 2025.
  • Accumulated deficit was $(264.6) million as of June 30, 2026, compared to $(246.6) million as of December 31, 2025.

Business Segments and Product Lines

  • The Company advanced the scientific rationale for its lead candidate, (Z)-endoxifen, in rare pediatric diseases including Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome (MAS).
  • At the 2026 AACR Special Conference, Atossa presented data on (Z)-endoxifen's dual mechanism of action (ER blockade and PKC-β/AKT suppression) for MAS-associated Peripheral Precocious Puberty (MAS-PPP).
  • A manuscript highlighting (Z)-endoxifen's potential to modulate utrophin in DMD was accepted for publication in Degenerative Neurological and Neuromuscular Disease, supporting its potential as a dystrophin mutation-agnostic treatment.
  • In the oncology segment, a manuscript published in npj Breast Cancer reported anti-cancer activity of (Z)-endoxifen-related compounds in ER-positive breast cancer models, including those with ESR1 mutations.
  • Selected (Z)-endoxifen-related compounds combined with abemaciclib demonstrated additive to synergistic activity in preclinical models.
  • Enrollment for the EVANGELINE Phase 2 clinical trial (NCT05607004) evaluating (Z)-endoxifen plus goserelin in premenopausal women with ER+/HER2- breast cancer was completed as of June 30, 2026.
  • New preclinical data demonstrated robust estrogen receptor signaling inhibition across clinically relevant ESR1 mutations.

Other Key Points

  • The Company completed a registered direct offering, issuing 1,363,637 shares of common stock and associated warrants, raising $4.5 million in upfront gross proceeds with the potential to receive up to an additional $12 million upon full cash exercise of warrants, totaling up to $16.5 million in gross proceeds.
  • Net proceeds from the offering are designated to support the clinical development of (Z)-endoxifen and general corporate working capital.
  • Atossa holds Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation from the FDA for (Z)-endoxifen for the treatment of DMD and MAS.
  • The Company noted that RPD designation may make (Z)-endoxifen eligible for a Priority Review Voucher (PRV) upon approval, with disclosed PRV sales in the last 18–24 months ranging from $100 million to $220 million.
  • G&A professional fees increased significantly due to settled patent litigation matters, intellectual property portfolio management, and SEC compliance costs.
  • R&D clinical trial expenses decreased in the quarter due to the conclusion of preclinical trials in the prior period, partially offset by higher enrollment and drug development costs.