Highest-materiality recent filing
Atossa shareholders approve reverse stock split up to 20:1, re-elect directors
Reverse stock split amendment approved: 2,336,815 for, 1,866,873 against, 33,271 abstentions.
Operating expenses $9.9M, up 34% YoY; FDA grants RPD for (Z)-endoxifen in DMD and McCune-Albright
Total operating expenses $9.9M in Q1 2026, up from $7.4M in Q1 2025, driven by higher legal fees for patent litigation (subsequently settled) and R&D costs.
Atossa settles patent disputes with Intas; Endoxifen patents remain enforceable
Entered Settlement Agreement on April 13, 2026 with Intas Pharmaceuticals and Jina Pharmaceuticals to resolve Endoxifen patent disputes.
Atossa Therapeutics Reports Q4 and FY2025 Results, Highlights (Z)-Endoxifen Progress in DMD
Atossa reported FY2025 operating expenses of $37.1M, up from $27.6M; R&D expenses increased 50% to $21.2M.
Atossa Therapeutics regains Nasdaq compliance on minimum bid price requirement
Received Nasdaq letter on Feb 17, 2026 confirming compliance with Listing Rule 5550(a)(2).
Atossa receives FDA Rare Pediatric and Orphan Drug designations for (Z)-endoxifen in DMD; pauses MBC
FDA Rare Pediatric Disease and Orphan Drug designations granted for (Z)-endoxifen in Duchenne Muscular Dystrophy (Dec 2025/Jan 2026).
FDA issued 'Study May Proceed' letter for Atossa's IND for (Z)-Endoxifen in metastatic ER+/HER2- breast cancer.
Atossa advances (Z)-endoxifen regulatory path; Q3 op-ex $9.3M
FDA Type C meeting set Nov 17 to discuss accelerated NDA path for (Z)-endoxifen in breast cancer risk reduction; written comments received.
Atossa appoints Mark Daniel as CFO to lead finance for commercial readiness
Mark Daniel appointed CFO effective Oct 14; Heather Rees transitions to non-officer employee through Nov 15.
Company requested a Type C FDA meeting; expects update by year-end 2025.
Atossa Therapeutics receives Nasdaq extension to Feb 17, 2026 for bid price compliance
Nasdaq notified Atossa on Feb 21, 2025 of non-compliance with $1.00 min bid price rule.
Atossa Q2 operating expenses $9M; FDA clears IND path for (Z)-endoxifen in metastatic breast cancer
Total operating expenses $9.0M in Q2 2025, up 27% YoY from $7.1M; R&D spend rose 55% to $5.5M.
Intas Pharmaceuticals challenges two Atossa endoxifen patents with PGR and IPR petitions at USPTO
Intas filed PGR petition against U.S. Patent No. 12,071,391, titled 'Methods for Making and Using Endoxifen'.
Atossa Therapeutics ends 2024 with $71.1M cash; advances (Z)-endoxifen for metastatic breast cancer
Cash and equivalents $71.1M, no debt; operating expenses fell to $27.6M from $31.4M in 2023.
Strategic decision to pursue metastatic breast cancer indication for (Z)-endoxifen, citing potentially faster regulatory path.
Atossa receives Nasdaq minimum bid price deficiency notice; compliance period through Aug 20, 2025
Received Nasdaq deficiency notice on Feb 21, 2025 for failing to maintain $1.00 minimum bid price for 30 consecutive business days.
PTAB invalidates Atossa's US Patent 11,572,334; new patent 12,201,591 issued
PTAB final decision found all claims of US Patent 11,572,334 unpatentable; Atossa will not appeal.
Atossa presents positive PK/tolerability data from Phase 2 EVANGELINE trial of (Z)-endoxifen
50% of patients on 80 mg (Z)-endoxifen + goserelin met target plasma Css of 500-1,000 ng/mL.
Atossa Therapeutics reports Q3 2024 results, highlights positive Phase 2 data for (Z)-endoxifen
Announced positive topline from KARISMA-Endoxifen Phase 2: MBD reductions of 19.3% (1 mg) and 26.5% (2 mg) vs placebo.
Atossa reports positive Phase 2 data for (Z)-endoxifen reducing breast density by up to 26.5%
Relative MBD reduction of 19.3% (1 mg) and 26.5% (2 mg) vs placebo in KARISMA-Endoxifen trial.
Atossa reports $79.5M cash, no debt; EVANGELINE Phase 2 40mg cohort shows 100% disease control rate
Ended Q2 2024 with $79.5M cash and cash equivalents, no debt; interest income $1.1M in Q2.
Atossa Q1 2024 net loss $5.9M; EVANGELINE 100% disease control at 24 weeks
Net loss of $5.9M (operating expenses $7.0M, interest income $1.1M); cash $84.0M, no debt.
Atossa reports FY2023 results: $88.5M cash, R&D spend up; two Phase 2 trials fully enrolled
Ended FY2023 with $88.5M cash and equivalents, no debt.
Atossa ends FY2023 with $88.5M cash; two Phase 2 studies fully enrolled, data due H2 2024
Cash and equivalents $88.5M as of Dec 31, 2023; no debt outstanding.
On June 27, 2024, the Board of Directors (the “Board”) of the Company appointed Heather Rees, previously the Company’s Senior Vice President, Finance and Accounting, to serve as Chief Financial Officer and to continue serving as principal financial and accounting officer, effective immediately.
Max materiality 0.80 · Median 0.65 · Most common event other_material