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Azitra, Inc. (AZTR)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered operational progress amid tight liquidity: net loss of $2.89M and EPS of $(0.18), while cash fell to $1.05M; R&D rose on trial activity and G&A declined sequentially .
  • Clinical milestones advanced: ATR‑12 Phase 1b reached ~50% enrollment with encouraging safety; ATR‑04 Phase 1/2 design presented at ASCO with first patient targeted for Q3 2025 .
  • Capital structure actions and funding optionality: company established a $20M equity line in April; later announced a 1‑for‑6.66 reverse split effective Aug 21, 2025, to support listing compliance and capital access .
  • Against limited Street coverage, Q2 EPS of $(0.18) was better than the S&P Global consensus of $(1.40), and revenue was in line at $0, driven largely by lower G&A and much higher share count, rather than top-line strength .
  • Near-term stock catalysts: continued ATR‑12 safety updates, ATR‑04 initial dosing and early signals, plus funding developments; note the subsequent NYSE American non-compliance notice (Oct 3) creates an overhang to monitor .

What Went Well and What Went Wrong

What Went Well

  • ATR‑12 Phase 1b safety data encouraging and trial ~50% enrolled; no severe or serious AEs reported in the initial cohort, supporting continued development .
  • ATR‑04 program advanced with ASCO poster acceptance and trial design disclosures; first patient dosing planned for Q3 2025 (later achieved on Aug 27, 2025) .
  • Funding flexibility improved via a purchase agreement enabling up to $20M of equity sales to Alumni Capital over ~20 months, at market-based prices and controlled timing .

Management quote: “The remainder of 2025 is anticipated to be a milestone-rich period for Azitra during which we look forward to showcasing the potential of ATR‑12 and ATR‑04…” — Francisco Salva, CEO .

What Went Wrong

  • Liquidity tightened: cash fell to $1.05M at quarter-end, amplifying dependency on external financing .
  • No operating revenue; net loss widened year over year (to $2.89M vs. $2.63M), driven by higher R&D expenses as clinical activity progressed .
  • Guidance timing shifted: ATR‑12 topline slipped from YE 2025 to Q1 2026, extending the clinical data catalyst timeline .

Financial Results

MetricQ2 2024Q1 2025Q2 2025
Total Revenue ($USD)$7,500 N/A$0
R&D Expense ($USD Millions)$1.12 $1.25 $1.40
G&A Expense ($USD Millions)$1.55 $1.85 $1.47
Net Loss ($USD Millions)$2.63 $3.07 $2.89
Diluted EPS ($USD)$(2.74) $(0.23) $(0.18)
Cash & Equivalents (period-end, $USD Millions)N/A$3.21 $1.05
Weighted Avg Shares (Basic/Diluted)960,146 13,171,516 16,279,574

Actuals vs S&P Global consensus (Q2 2025):

MetricActual Q2 2025Consensus Q2 2025Surprise
Revenue ($USD)$0 $0*$0
Primary EPS ($USD)$(0.18) $(1.40)*+$1.22

Notes: Values with asterisk (*) retrieved from S&P Global.

Segment breakdown: Not applicable; Azitra is a clinical-stage biopharma with no commercial product revenue reported .

KPIs

KPIQ2 2024Q1 2025Q2 2025
ATR‑12 Phase 1b EnrollmentN/AN/A~50% enrolled
ATR‑12 Phase 1b Safety (initial cohort)N/AN/ANo severe/serious AEs; transient local reactions reported
ATR‑04 Trial StatusPre‑IND activities in 2024 ASCO poster acceptance; trial design First patient dosing targeted Q3

Additional Q3 milestone achieved post‑quarter: ATR‑04 first patient dosed Aug 27, 2025 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ATR‑12 Phase 1b topline dataTimingYE 2025 Q1 2026 Lowered (later timing)
ATR‑04 first patient dosingTiming1H 2025 Q3 2025 plan; achieved Aug 27, 2025 Delayed then Achieved
Financial guidance (Revenue/Margins/OpEx)FY/QtrNot providedNot providedMaintained (none)

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was available.

TopicPrevious Mentions (Q‑2: FY 2024; Q‑1: Q1 2025)Current Period (Q2 2025)Trend
R&D execution: ATR‑12FY 2024: Phase 1b initiated; data expected H1 and YE 2025 ~50% enrolled; encouraging safety in initial cohort Progressing; timing extended
R&D execution: ATR‑04FY 2024: FDA Fast Track; plan to initiate Phase 1/2 in 1H 2025 ASCO poster acceptance; Q3 dosing plan Slight delay; executed post‑quarter
Funding/liquidityFY 2024: multiple offerings; cash $4.6M at YE $20M equity line established; cash $1.05M Liquidity tighter; financing optionality added
Regulatory/legalFast Track designation (ATR‑04); open IND status No new Q2 regulatory updates disclosed Stable
Tech/platformAI/ML‑augmented strain library reiterated Platform reiterated as core differentiation Consistent messaging

Management Commentary

  • “The first half of 2025 was a vital period for Azitra as we hit a key milestone in our first‑in‑class, precision, live biotherapeutic candidates designed for major undertreated dermatological diseases.” — Francisco Salva, CEO .
  • “We expect to dose the first patient in our Phase 1/2 trial in the third quarter of this year.” — Francisco Salva, CEO (ATR‑04 program) .
  • “Dosing the first patient is an important milestone in the advancement of ATR04‑484 … Given the importance of EGFRi treatments across multiple cancers, there is a critical medical need to reduce the impact of the unique dermatologic toxicities…” — Francisco Salva, CEO .

Q&A Highlights

  • No Q2 2025 earnings call transcript found; no Q&A available to analyze.

Estimates Context

  • Q2 2025 EPS of $(0.18) vs S&P Global consensus $(1.40)* represents a positive surprise of +$1.22, driven primarily by lower G&A sequentially and a higher share count, rather than revenue upside (revenue was $0 vs $0*).
  • Coverage remains minimal: Primary EPS (# of estimates) = 1*; Revenue (# of estimates) = 1* for Q2 2025, limiting estimate reliability.
  • FY 2025 S&P Global consensus implies EPS of $(2.67)* and revenue of $0*, consistent with a pre‑commercial profile.

Notes: Values with asterisk (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Execution continues across pipeline with ATR‑12 safety and ATR‑04 clinical initiation; the next 2–3 quarters are data‑light until ATR‑12 Phase 1b topline in Q1 2026, shifting the timing of key catalysts .
  • Liquidity is tight ($1.05M cash at Q2 end) and external financing is likely; the $20M equity line provides optionality but is dilutive; monitor utilization pace alongside trial costs .
  • Capital structure actions (reverse split) aim to support listing compliance and financing access; subsequent NYSE non‑compliance notice underscores listing risk and the importance of equity and program milestones .
  • Financials show disciplined G&A and rising R&D as trials advance; with no revenue, earnings variability will be driven by opex and share count until clinical data inflects the story .
  • Trading implications: near‑term moves likely tied to trial enrollment updates, ATR‑04 initial data signals, and financing events; limited sell‑side coverage increases volatility around company disclosures .
  • Medium‑term thesis: de‑risking via ATR‑12 Phase 1b and ATR‑04 Phase 1/2 data is central; platform breadth (AI/ML strain library) provides optionality for pipeline expansion over 2026+ .
  • Maintain focus on regulatory progression (Fast Track maintained; IND activities) and funding runway as key determinants of execution pace .