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Azitra, Inc. (AZTR)·Q4 2024 Earnings Summary

Executive Summary

  • FY 2024 wrap (Q4 period) emphasized pipeline advancement and liquidity: $4.6M cash at year-end 2024, plus ~$2.2M gross proceeds in Jan–Feb 2025 offerings .
  • ATR-12 Phase 1b safety readout shifted to H1 2025 (from earlier YE 2024/Q1 2025 timelines); topline remains targeted by YE 2025; ATR-04 first patient dosing pushed to H1 2025, reflecting execution sequencing and regulatory pacing .
  • Operating expenses rose YoY (G&A +39%, R&D +31%), but FY net loss improved to $(9.0)M from $(11.3)M on positive warrant fair value and reduced financing-related charges .
  • Catalysts for 2025: ATR-12 Phase 1b safety (H1 2025), ATR-04 Phase 1/2 first patient dosing (H1 2025), and ATR-12 topline (YE 2025); financing activity in Jan–Feb 2025 supports execution .

What Went Well and What Went Wrong

What Went Well

  • FDA clearance and Fast Track designation for ATR-04, validating unmet need and de-risking clinical start .
  • Strengthened IP portfolio; continued platform progress across engineered S. epidermidis programs .
  • Liquidity improved vs FY 2023; year-end cash $4.6M plus ~$2.2M subsequent offerings, and $10M follow-on completed in 2024 .

What Went Wrong

  • Guidance slippage: ATR-12 initial safety moved from YE 2024 → Q1 2025 → H1 2025; ATR-04 first patient dosing moved from YE 2024 → Q1 2025 → H1 2025, highlighting operational timing risk .
  • Revenue effectively zero in Q3 and de minimis for FY; operating expenses increased YoY, underscoring funding dependence until clinical data readouts .
  • No Q4 earnings call transcript available, limiting visibility into detailed Q&A, near-term cash runway commentary, and finer-grain OpEx trajectory [ListDocuments earnings-call-transcript: 0 results].

Financial Results

Quarterly and FY snapshot (oldest → newest)

MetricQ2 2024Q3 2024FY 2024
Revenue ($USD)$7,500 $0 $7,500
Net Loss ($USD)$(2,631,993) $(1,009,491) $(8,967,492)
EPS (basic & diluted, $)$(2.74) $(0.17) $(2.37)
R&D Expense ($USD)$1,118,552 $1,015,807 $4,723,378
G&A Expense ($USD)$1,549,228 $1,913,400 $6,269,262
Total Operating Expenses ($USD)$2,667,780 $2,929,207 $10,992,640
Cash and Cash Equivalents ($USD)$803,082 $7,260,234 $4,554,719

Annual comparison (prior year vs current)

MetricFY 2023FY 2024
Revenue ($USD)$686,000 $7,500
R&D Expense ($USD)$3,643,214 $4,723,378
G&A Expense ($USD)$4,493,332 $6,269,262
Total Operating Expenses ($USD)$8,136,546 $10,992,640
Net Loss ($USD)$(11,283,781) $(8,967,492)
Cash and Cash Equivalents ($USD)$1,795,989 $4,554,719

Segment breakdown: Not applicable; company reports as a single operating entity .

KPIs: Clinical and regulatory progress

KPIQ2 2024Q3 2024Q4/FY 2024
ATR-12 Phase 1b – First patient dosedPlanned Q3 dosing First patient dosed Ongoing; safety H1 2025
ATR-04 IND clearancePlanned Q3 filing/clearance IND cleared; Fast Track granted Phase 1/2 start H1 2025
Cash raises$10M follow-on completed Confirmed $10M follow-on $930k + $1.5M offerings in 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ATR-12 Phase 1b – Initial safety dataH1 2025YE 2024 (Q2 guide) ; Q1 2025 (Q3 guide) H1 2025 Lowered vs Q2; pushed vs Q3
ATR-12 Phase 1b – Topline dataYE 2025Mid 2025 (Q2 guide) YE 2025 Pushed to YE 2025
ATR-04 Phase 1/2 – First patient dosedH1 2025YE 2024 (Q2 guide) ; Q1 2025 (Q3 guide) H1 2025 Pushed
Bayer license updateYE 2024Expected update by YE 2024 (Q2 guide) No update in FY release Slipped/unspecified

Earnings Call Themes & Trends

No Q4 2024 earnings call transcript was available; theme tracking reflects press releases.

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4/FY 2024)Trend
R&D execution (ATR-12)Site activation; dosing expected Q3; initial safety YE 2024 First patient dosed; initial safety Q1 2025 Safety in H1 2025; topline YE 2025 Schedule pushed modestly
Regulatory (ATR-04)IND filing/clearance planned Q3 2024 IND cleared; Fast Track granted Phase 1/2 initiation H1 2025 Milestones achieved; start timed H1 2025
Financing/liquidity$10M follow-on completed Confirmed $10M follow-on $930k and $1.5M offerings in 2025; YE cash $4.6M Liquidity refreshed post-Q4
Partnerships (Bayer)Update expected YE 2024 Mentioned in forward-looking context Not highlighted in FY PR Visibility reduced
Platform/IPPositive preclinical data; IP strengthening Additional preclinical data Continued IP strengthening Consistent progress

Management Commentary

  • “This is a very exciting time in the growth and evolution of Azitra as we seek to drive shareholder value through development of first-in-class drugs to treat dermatological diseases.” — CEO Francisco Salva .
  • “Our lead product, ATR-12… Initial safety data from this trial is expected in the first half of 2025 with topline results by year-end 2025.” — CEO .
  • “ATR-04… being developed for the treatment of EGFR inhibitor associated rash… first patient dosed… expected to occur in the first half of 2025.” — CEO .

Q&A Highlights

  • No Q4 2024 earnings call transcript found for AZTR; Q&A highlights not available [ListDocuments earnings-call-transcript: 0 results].

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 and FY 2024 was unavailable at the time of retrieval; comparisons vs estimates cannot be provided. If required, we can refresh once access is available.

Key Takeaways for Investors

  • Liquidity improved post-year end with ~$2.2M gross proceeds in Jan–Feb 2025, supporting 2025 clinical catalysts; YE cash $4.6M offers base runway .
  • Guidance slippage is modest and operational: ATR-12 safety window shifted to H1 2025; ATR-04 first dosing to H1 2025; topline remains YE 2025, keeping the core 2025 catalyst path intact .
  • Operating spend increased YoY (R&D +31%, G&A +39%); however, FY net loss narrowed vs 2023, aided by fair value adjustments and lower financing-related charges .
  • Regulatory momentum (ATR-04 IND clearance, Fast Track) supports value creation once first patient is dosed in H1 2025 .
  • Revenue remains negligible; equity financing is likely needed ahead of topline data—monitor cadence of offerings and potential non-dilutive sources (e.g., partnerships) .
  • Near-term trading catalysts: confirmation of ATR-12 safety readout window (H1 2025) and ATR-04 first patient dosing (H1 2025); any Bayer licensing updates would be incremental optionality .
  • Without consensus estimates, price reaction may hinge on clinical execution milestones and financing signals rather than financial beats/misses; position sizing should reflect binary clinical readouts and funding timing.

Sources: FY 2024 8-K and Exhibit 99.1 press release ; Q3 2024 8-K and press release ; Q2 2024 8-K ; Q1 2024 8-K ; Jan–Feb 2025 financing press releases .