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Atossa Q2 2026: OpEx $8.7M, R&D $4.9M; raises up to $16.5M from offering
Total operating expenses $8.7M in Q2 2026, down $0.3M from $9.0M in Q2 2025.
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Atossa raises $4.5M in registered direct offering of stock and warrants
Sold 1,363,638 shares at $3.30/share plus Series A and B warrants for 1,363,638 shares each at $4.40.
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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.
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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.
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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.
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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.
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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).
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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).
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Atossa Therapeutics receives FDA 'Study May Proceed' letter for (Z)-Endoxifen metastatic breast cancer trial
FDA issued 'Study May Proceed' letter for Atossa's IND for (Z)-Endoxifen in metastatic ER+/HER2- breast cancer.
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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.
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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.
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Atossa requests FDA Type C meeting to accelerate low-dose (Z)-endoxifen for breast cancer risk reduction
Company requested a Type C FDA meeting; expects update by year-end 2025.
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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.
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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.
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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'.
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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.
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Atossa to pursue metastatic breast cancer indication; (Z)-endoxifen more than doubled PFS vs tamoxifen (7.2 vs 2.4 mo)
Strategic decision to pursue metastatic breast cancer indication for (Z)-endoxifen, citing potentially faster regulatory path.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Atossa regains Nasdaq minimum bid price compliance; stock remains listed
Received Nasdaq letter on March 15, 2024 confirming regained compliance with Listing Rule 5550(a)(2).
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Atossa receives Nasdaq deficiency notice for bid price below $1 for 30 days
Nasdaq letter dated September 26, 2023, citing non-compliance with Listing Rule 5550(a)(2) for minimum bid price.
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Intas Pharmaceuticals files PGR petition challenging Atossa's endoxifen patent
Intas Pharmaceuticals filed a Post-Grant Review petition with USPTO challenging Atossa's U.S. Patent No. 11,572,334.
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Atossa Therapeutics Q2 2023 net loss $9.8M; clinical enrollment milestones; CFO appointed
Cash at June 30, 2023: $99.4M, down from $110.9M at Dec 31, 2022.
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Atossa Therapeutics regains Nasdaq compliance with minimum bid price requirement
Received Nasdaq notice on July 13, 2023 that it regained compliance with Listing Rule 5550(a)(2).
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Atossa receives Nasdaq non-compliance notice for independent director majority rule
Received notice on June 21, 2023 for failing Nasdaq Listing Rule 5605(b)(1) requiring majority independent directors.
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Atossa Q1 2023: cash $103.9M, no debt; Phase 2 trials initiated/expanded
Ended Q1 2023 with $103.9M cash and cash equivalents, zero debt.