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ATOSSA THERAPEUTICS, INC. (ATOS)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 was execution-focused: OpEx rose on (Z)-endoxifen program ramp (R&D +57% YoY) and higher legal spend, while net loss per share was $(0.07) vs $(0.06) a year ago; interest income declined on lower average cash balances .
  • Regulatory path advanced: FDA Type C meeting set to discuss a potentially accelerated low‑dose (Z)-endoxifen risk‑reduction path (preliminary comments received Nov 6; meeting expected Nov 17; minutes in December) .
  • Development milestones on track: IND for mBC dose‑ranging study targeted for Q4 2025 (dose‑optimization strategy affirmed by FDA; PSI selected as CRO); topline data expected in 2026 .
  • Portfolio/organization strengthened: EVANGELINE Phase 2 design streamlined to non‑registrational to accelerate readouts and reduce cost; key leadership hires in R&D and Finance to support late‑stage execution and commercialization readiness .
  • Near‑term stock catalysts: FDA meeting minutes by Dec‑2025, IND submission in Q4‑2025, and clarity on Phase 2 dose‑ranging initiation and 2026 topline data timing .

What Went Well and What Went Wrong

What Went Well

  • FDA engagement progressed for two tracks: mBC dose optimization (FDA affirmed trial approach; no new tox studies; cardiac monitoring plan accepted) and low‑dose risk‑reduction (Type C meeting scheduled; preliminary comments received) .
  • Operational de‑risking: Selected PSI as global CRO for pivotal dose‑ranging Phase 2, positioning for a smoother transition to Phase 3 and 2026 topline readout .
  • Strategic focus and leadership: EVANGELINE streamlined to speed objective readouts and lower projected costs; added SVP R&D (Janet Rea) and a CFO (Mark Daniel) to drive late‑stage execution and commercial readiness .

Quote: “We continue to make meaningful and measurable progress across our (Z)-endoxifen development strategy in oncology… well‑positioned to execute on our planned upcoming IND submission and advance our clinical programs toward key value‑creating milestones.” — Dr. Steven Quay, CEO .

What Went Wrong

  • Higher OpEx and legal intensity: R&D rose on endoxifen trials; G&A rose on patent and legal matters; net loss per share widened YoY to $(0.07) from $(0.06) .
  • Lower interest income: Down to $0.6M in Q3 from $1.0M in Q3 2024 as average cash balances declined .
  • No revenue and thus no operating leverage yet; the company remains pre‑commercial with expenses rising into 2026 readouts .

Financial Results

P&L summary vs prior year and prior quarter

Metric (USD)Q3 2024Q2 2025Q3 2025
Research & Development Expense$3.412M $5.502M $5.370M
General & Administrative Expense$2.973M $3.538M $3.881M
Total Operating Expenses$6.385M $9.040M $9.251M
Interest Income$1.001M $0.645M $0.570M
Net Loss$(7.230)M $(8.423)M $(8.692)M
Net Loss per Share (basic/diluted)$(0.06) $(0.07) $(0.07)

Notes and drivers:

  • R&D up YoY on increased spend for (Z)-endoxifen trials and drug development; G&A up YoY on patent‑related and other legal fees .
  • Interest income down YoY on lower average money market balances .

Estimates vs actuals (S&P Global consensus)

MetricQ3 2025
EPS (Actual vs Consensus Mean)$(0.07) vs $(0.0667)*
EPS – # of Estimates3*
Revenue (Actual vs Consensus Mean)Pre‑revenue (no product revenue reported) vs $0.00*
Revenue – # of Estimates4*

Values marked with * retrieved from S&P Global.

Balance sheet KPIs (chronological)

Metric (USD)Dec 31, 2024Jun 30, 2025Sep 30, 2025
Cash & Cash Equivalents$71.084M $57.857M $51.845M
Total Current Liabilities$4.967M $6.820M $8.225M
Total Stockholders’ Equity$71.477M $57.695M $49.787M
Weighted Avg Shares (Quarter)125.773M (Q3’24) 125.732M (Q2’25) 129.171M (Q3’25)

Segment breakdown and gross margin: Not applicable; the company reported no product revenue in the period .

Guidance Changes

Metric/TopicPeriodPrevious GuidanceCurrent GuidanceChange
IND submission for (Z)-endoxifen mBC dose‑ranging studyQ4 2025Targeting IND in Q4 2025 Targeting potential IND in Q4 2025 Maintained
FDA Type C meeting (low‑dose risk‑reduction pathway)Q4 2025Type C requested; update expected by YE 2025 Preliminary FDA comments received; meeting Nov 17; minutes expected Dec 2025 Progressed
EVANGELINE Phase 2 study design2026 focusNot specified as non‑registrationalAmended to non‑registrational to accelerate readouts and reduce costs; prioritize 2026 NDA‑enabling activities Refocused
CRO selection and Phase 2 mBC dose‑ranging initiationPost‑INDPSI selected; enrollment to follow IND; topline 2026 Reiterated; topline 2026 remains goal Maintained
Topline data timing for mBC dose‑ranging2026Topline 2026 anticipated Topline 2026 anticipated Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1–Q2 2025)Current Period (Q3 2025)Trend
FDA alignment – mBC dose optimization (Project Optimus)FDA affirmed dose‑optimization strategy; no additional general tox/neurotox studies; agreed cardiac safety plan IND timeline reiterated; CRO selected; topline targeted 2026 Advancing execution
Low‑dose (Z)-endoxifen risk‑reduction regulatory pathNoted strategic evaluation; Type C request later announced Sept 8 Preliminary FDA comments received; meeting scheduled; minutes expected Dec Accelerating pathway clarity
Clinical execution (I‑SPY/EVANGELINE/DCIS)I‑SPY2 pilot met primary endpoint; strong Ki‑67 and MRI response; recruitment ahead of plan in combo cohort EVANGELINE amended to non‑registrational to speed readouts and reduce spend Streamlined for speed/capital efficiency
IP positionAdded new U.S. patents; portfolio >200 claims New Israel patent; ongoing U.S. post‑grant challenges; majority IP unaffected Mixed: portfolio expanded; some challenges
Capital/interest incomeQ1 cash $65.1M; no debt Cash $51.8M at 9/30; interest income down on lower balances Cash draw as programs ramp
Leadership and readiness—Added SVP R&D (Janet Rea) and CFO (Mark Daniel) for late‑stage and commercial readiness Strengthened team

Management Commentary

  • “We continue to make meaningful and measurable progress across our (Z)-endoxifen development strategy… well‑positioned to execute on our planned upcoming IND submission and advance our clinical programs toward key value‑creating milestones.” — Dr. Steven Quay, CEO .
  • “These FDA responses mark a significant milestone… paving the way for a potential IND submission targeted for the fourth quarter of 2025.” — Dr. Steven Quay on FDA feedback for mBC dose optimization .
  • On risk‑reduction path: Atossa “received preliminary written comments from the FDA… expects to meet with the FDA on November 17, 2025… minutes expected in December 2025.” .
  • On operational focus: EVANGELINE “amended… expected to accelerate objective readouts while reducing projected future study costs… concentrate resources on near‑term, NDA‑enabling activities in 2026.” .

Q&A Highlights

  • No Q3 2025 earnings call transcript was available in our document set; key messages were delivered via the 8‑K and press releases .

Estimates Context

  • EPS modestly missed consensus: $(0.07) actual vs $(0.0667) consensus mean; three estimates contributed to EPS; revenue consensus was $0 for a pre‑revenue profile and S&P Global data*.
  • Given higher R&D and legal‑driven G&A, Street models may need to reflect elevated OpEx cadence into 2026 pending regulatory milestones .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Regulatory read‑through in Q4: FDA Type C meeting (risk‑reduction) and IND submission timing (mBC dose‑ranging) are the principal near‑term catalysts .
  • Execution partner in place: PSI CRO selection de‑risks global Phase 2 operations and Phase 3 transition; topline mBC data guided for 2026 .
  • Streamlined development: EVANGELINE redesign prioritizes speed and capital efficiency ahead of 2026 NDA‑enabling activities .
  • Expense trajectory: R&D and G&A are trending higher YoY on program ramp and legal activity; interest income is declining with cash use—watch OpEx run‑rate in models .
  • IP positioning: Portfolio expanded (new Israel patent) while navigating post‑grant challenges; majority of IP unaffected—monitor outcomes given potential strategic impact .
  • Organizational depth: New SVP R&D and CFO appointments support late‑stage execution and commercial readiness should data/approvals progress favorably .
  • Stock setup: A sequence of regulatory updates through year‑end could be stock‑moving; clarity on accelerated pathways and IND acceptance would likely shape sentiment into 2026 .