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ATOSSA THERAPEUTICS, INC. (ATOS)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was operationally steady and pre-revenue, with total operating expenses of $7.4M (+6.2% YoY) and net loss of $6.7M; diluted EPS was $(0.05) and cash/equivalents ended at $65.1M with no debt .
  • EPS modestly beat Wall Street consensus by $0.005 (actual $(0.05) vs $(0.055) estimate); revenue remained at $0 as expected, reflecting clinical-stage status *.
  • Management pivoted lead strategy to metastatic breast cancer for (Z)-endoxifen, citing a potentially more efficient regulatory path; IP strengthened with three new U.S. patents (>200 claims total), and cash runway communicated at nearly two years at current burn rate .
  • Near-term stock reaction catalysts: execution milestones for metastatic registration trial design/CRO selection, ongoing I‑SPY/EVANGELINE readouts, and partner discussions; no financial guidance provided, so investor focus remains on clinical/regulatory progress .

What Went Well and What Went Wrong

What Went Well

  • Strategic clarity: Company elevated metastatic breast cancer as the lead indication for (Z)-endoxifen to pursue a more streamlined regulatory path; CEO emphasized robust tolerability and versatility across disease stages .
  • Strengthened IP: Three new U.S. patents expanded the (Z)-endoxifen portfolio to over 200 claims, bolstering defensibility and optionality .
  • Clinical momentum: Full results from the I‑SPY 2 EOP sub‑study showed rapid Ki‑67 suppression and substantial MRI‑confirmed tumor shrinkage with favorable safety at a low dose, validating bioactivity and informing dose‑response for ongoing higher‑dose cohorts .

What Went Wrong

  • Continued pre-revenue status: No revenue or cost of revenue in Q1 2025, consistent with clinical-stage profile, keeping valuation tied to trial/regulatory execution rather than P&L leverage .
  • Higher OpEx: Total operating expenses rose to $7.4M (+6.2% YoY), driven by R&D (compensation and regulatory consulting) and modest G&A increases, elevating burn as programs advance .
  • Limited pathologic response at low dose: I‑SPY 2 pilot reported no pCR at 10 mg, with RCB skewed to II/III—consistent with design but highlights the need for higher exposures and/or combinations to drive deeper responses .

Financial Results

Income Statement – Year-over-Year (Q1 2025 vs Q1 2024)

Metric ($USD Millions)Q1 2024Q1 2025
Revenues$0.0 $0.0
Research & Development Expense$3.75 $4.16
General & Administrative Expense$3.23 $3.26
Total Operating Expenses$6.98 $7.41
Interest Income$1.14 $0.72
Net Loss$(5.88) $(6.72)
Diluted EPS$(0.05) $(0.05)

Income Statement – Sequential Comparison (Q3 2024 to Q1 2025)

Metric ($USD Millions)Q3 2024Q1 2025
Revenues$0.0 $0.0
Research & Development Expense$3.41 $4.16
General & Administrative Expense$2.97 $3.26
Total Operating Expenses$6.39 $7.41
Interest Income$1.00 $0.72
Net Loss$(7.23) $(6.72)
Diluted EPS$(0.06) $(0.05)

EPS vs Wall Street Consensus (S&P Global)

MetricQ1 2025
EPS Actual ($)$(0.05)
EPS Consensus Mean ($)$(0.055)*
Revenue Actual ($MM)$0.0
Revenue Consensus Mean ($MM)$0.0*
Target Price Consensus Mean ($)$5.69*
# of EPS Estimates2*
# of Revenue Estimates3*
# of Target Price Estimates4*

Values retrieved from S&P Global.*

Balance Sheet – Liquidity and Equity

Metric ($USD Millions)Dec 31, 2024Mar 31, 2025
Cash and Equivalents$71.08 $65.12
Total Assets$76.44 $70.75
Total Liabilities$4.97 $5.43
Total Stockholders’ Equity$71.48 $65.32
Debt$0.00 $0.00

R&D and G&A Breakdown (Q1 2025 vs Q1 2024)

Category ($USD Thousands)Q1 2024Q1 2025
R&D – Clinical & Pre‑Clinical Trials$2,884 $2,747
R&D – Compensation$626 $880
R&D – Professional Fees & Other$238 $530
R&D Total$3,748 $4,157
G&A – Compensation$1,325 $1,462
G&A – Professional Fees & Other$1,680 $1,614
G&A – Insurance$227 $181
G&A Total$3,232 $3,257

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial Guidance (Revenue, EPS, OpEx)FY/Q1 2025None providedNone providedMaintained (no formal guidance)
Cash Runway2025–2026N/A“Nearly two years of runway” at current burn; no debtCommunicated qualitative runway
Lead Program Focus2025Mixed early-stage focusMetastatic breast cancer prioritized for faster regulatory pathRaised strategic focus
Trial Operations2025N/ACRO “bake‑off” ongoing; selecting CRO for international registrational trialOperational update
ATM Program Usage2025ATM in placeNo usage to date; no near‑term intentMaintained conservative stance

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
R&D execution (EVANGELINE/I‑SPY)Positive topline; rapid biomarker reductions; combination arm initiation SABCS data – PK/tolerability; protocol amendments; strong Ki‑67 response rates Full I‑SPY 2 EOP results: rapid Ki‑67 suppression, 77.7% median FTV reduction; enrolling 40 mg and combo arms Building efficacy signal; advancing to higher doses/combos
IP strategyNew patent (U.S. 12,071,391) Portfolio supported by issued patents Three patents added; >200 claims total Strengthening IP moat
Regulatory pathN/AIndicated metastatic path efficiency; ongoing FDA engagement Strategic priority—metastatic indication; FDA dialogue ongoing Clearer, faster path orientation
Manufacturing/supply chainN/AN/AMoved manufacturing to U.S.; prepped CMC; mitigate tariff risk De‑risking ops for registration
Financing/ATMN/AATM established (S‑3) No ATM usage; undervaluation view; two‑year cash runway Conservative capital posture

Management Commentary

  • “Our focus remains firmly on advancing (Z)-endoxifen…with a strategic emphasis on metastatic breast cancer…We are committed to unlocking the full potential of (Z)-endoxifen for patients while delivering value to our shareholders.” — Steven Quay, President & CEO .
  • “These results show that even at a low capsule strength (Z)-endoxifen is bioactive, producing rapid Ki‑67 suppression and meaningful tumor shrinkage, while remaining highly tolerable…It paves the way for our ongoing I‑SPY 2 cohorts evaluating higher…doses…alone and in combination…” — Steven Quay .
  • “We have nearly two years of cash on hand at our current burn rate and zero debt…there is no short‑term intention to use the ATM.” — Management webinar .

Q&A Highlights

  • Registrational execution: CRO selection in process (“bake‑off”), highlighting focus on running an international trial with the right partner and capabilities .
  • Manufacturing/CMC: API and manufacturing moved to the U.S., scale‑up underway; plan to utilize early FDA review pathways for CMC to accelerate timelines .
  • Partnering: Active discussions; prioritizing partnerships for combinations and standalone oncology opportunities (no specifics disclosed) .
  • Capital strategy: ATM unused; management views shares undervalued; intends to preserve runway; no buybacks planned .
  • IP litigation status: Confident in positions; broader portfolio beyond two patents supports exclusivity .

Estimates Context

  • Q1 2025 EPS beat: actual $(0.05) vs consensus $(0.055), a $0.005 upside; revenue in line at $0 reflecting clinical-stage status *.
  • FY 2025 and FY 2026 EPS consensus remain negative (clinical investment phase); target price consensus ~$5.69 with four contributing estimates*.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Strategic inflection to metastatic lead program is designed to accelerate time to market and improve probability of regulatory success; watch for FDA interaction updates and CRO selection announcements .
  • Clinical signals are supportive: low‑dose I‑SPY 2 showed rapid proliferation suppression and substantial tumor shrinkage; higher‑dose and combination cohorts may be pivotal for deeper pathologic responses .
  • Balance sheet supports execution: $65.1M cash, no debt, and management’s stated ~2‑year runway mitigates near‑term financing risk while the ATM remains unused .
  • IP moat expanding: three new patents and >200 claims enhance defensibility and potential partnering attractiveness .
  • Near-term trading catalysts center on clinical/regulatory milestones rather than P&L: positive readouts or FDA‑related clarity could rerate shares; conversely, delays or underwhelming efficacy at higher doses could pressure sentiment .
  • No financial guidance; investor models should anchor to OpEx trajectory, cash burn, and milestone timing rather than revenue/EPS inflections in 2025 .
  • Manufacturing/CMC derisking in the U.S. and early CMC review pathway may compress timelines to registration if clinical data cooperate .