Sign in

You're signed outSign in or to get full access.

AT

AN2 Therapeutics, Inc. (ANTX)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 GAAP EPS was -$0.56, an improvement from -$0.79 YoY and -$0.57 QoQ; no revenue was reported as AN2 remains pre-commercial .
  • The company reiterated an August 2024 target for Phase 2 topline readout in EBO-301 (TR-MAC), with Phase 3 enrollment paused since February pending Phase 2 review and FDA discussions .
  • Liquidity remained strong with cash, cash equivalents, and investments of $118.1M as of March 31, 2024; management believes funds are sufficient for at least 12 months from the 10-Q issuance date .
  • Street tracking sources indicated EPS beat relative to consensus (-$0.56 vs -$0.62), but S&P Global consensus was unavailable; use third-party references only for context .
  • Key near-term catalyst is the August Phase 2 topline and clarity on Phase 3 resumption after FDA discussions, which will drive narrative and potential stock reaction .

What Went Well and What Went Wrong

What Went Well

  • CEO reinforced conviction in epetraborole’s potential and framed Phase 2 as first clinical efficacy dataset in highly refractory TR-MAC patients: “We hope to see data demonstrating that epetraborole on top of background therapy will show benefit in these toughest to treat patients” .
  • Liquidity and balance sheet remained solid: $118.1M in cash, cash equivalents, and investments at quarter-end, and total assets of $121.3M .
  • Other income, net rose to $1.7M vs $0.7M YoY, reflecting higher yields and balances, partially offsetting OpEx increases .

What Went Wrong

  • Phase 3 enrollment in EBO-301 remains paused due to “potentially lower than expected efficacy” observed in blinded Phase 2 aggregate data; pause not safety-related, but efficacy uncertainty weighs on trial momentum .
  • R&D expenses increased to $14.7M (+22% YoY) on higher clinical trial, personnel, and services, driving net loss to $16.6M vs $15.3M YoY .
  • Management disclosed ongoing material weaknesses in internal control over financial reporting, with remediation still in progress as of Q1 2024 .

Financial Results

EPS and Revenue (Sequential and YoY)

MetricQ3 2023Q4 2023Q1 2024
GAAP Diluted EPS ($)-0.65 -0.57 -0.56
Revenue ($USD)$0 $0 $0

Operating Profile (YoY: Q1 2023 vs Q1 2024)

Metric ($USD Millions)Q1 2023Q1 2024
R&D Expense$12.0 $14.7
G&A Expense$4.1 $3.6
Other Income, net$0.7 $1.7
Net Loss$15.3 $16.6
GAAP Diluted EPS ($)-0.79 -0.56

Liquidity and Balance Sheet

Metric ($USD Millions)Dec 31, 2023Mar 31, 2024
Cash & Cash Equivalents$15.6 $24.7
Short-term Investments$91.6 $89.5
Long-term Investments$27.2 $3.9
Total Assets$138.7 $121.3
Total Liabilities$14.0 $10.7
Stockholders’ Equity$124.7 $110.6

Margins

MetricQ1 2023Q4 2023Q1 2024
Net Income Margin %N/A – no revenue N/A – no revenue N/A – no revenue

KPIs and Trial Status

KPIQ3 2023Q4 2023Q1 2024
EBO-301: Phase 3 enrollment statusInitiated in Sep after Phase 2 fully enrolled Voluntary Phase 3 pause announced in Feb 2024 Phase 3 remains paused; dosing of 97 previously enrolled patients continues
Topline timing (Phase 2)Summer 2024 target Summer 2024 target reaffirmed August 2024 targeted
Cash, cash equivalents & investments$150.2M $134.5M $118.1M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 2 Topline Timing2024Summer 2024 August 2024 Clarified timeline
Phase 3 Enrollment StatusOngoingPhase 3 initiated (Sep 2023) Paused since Feb 2024, decision after Phase 2 unblinding and FDA discussions Lowered (pause)
Liquidity/Runway2023–2025Cash runway through summer 2025 (as of Q3’23) Sufficient to fund operating plan for at least 12 months from 10-Q issuance (as of Q1’24) Updated language; shorter explicit horizon
Financial Guidance (Revenue, Margins, OpEx, OI&E, Tax)Q1 2024Not providedNot providedMaintained (no financial guidance)

Earnings Call Themes & Trends

Note: No Q1 2024 earnings call transcript was available in our document catalog or via company investor site; themes below draw from 8-K/press and 10-Q disclosures .

TopicQ3 2023 MentionsQ4 2023 MentionsQ1 2024 MentionsTrend
Trial Enrollment/ExecutionPhase 2 fully enrolled; Phase 3 initiated Phase 3 paused after blinded efficacy review Phase 3 pause continues; Phase 2 topline August Momentum shift; awaiting efficacy clarity
Regulatory/FDA EngagementPlanning to discuss complex baseline population with FDA Plan to discuss with FDA as part of strategy update Phase 3 decision post FDA discussions Heightened FDA dependency
Cash/Runway$150.2M; runway to summer 2025 $134.5M YE cash/investments $118.1M Q1 cash/investments; ≥12 months runway Runway narrows as spend progresses
Pipeline/Global HealthChagas license; Gates grant; IDWeek data Continued Chagas, melioidosis progress Ongoing non-dilutive grants usage detailed Steady pipeline execution
Internal Controls—Material weaknesses disclosed in 10-K context Material weaknesses persist, remediation ongoing Ongoing remediation

Management Commentary

  • “The Phase 2 topline data, expected to be available in August, will include the first clinical efficacy data for epetraborole in patients with treatment-refractory MAC… We hope to see data demonstrating that epetraborole on top of background therapy will show benefit in these toughest to treat patients.” — Eric Easom, CEO .
  • “AN2’s cash position remains strong… we continue to believe in the potential of epetraborole to become an important component of the backbone therapy for NTM lung disease.” — CEO .
  • “In September, we initiated enrollment in the Phase 3 part of our pivotal Phase 2/3 clinical trial… There is an urgent need for more effective, novel, oral agents for [M. abscessus] disease.” — CEO .
  • Overview: Q1 10-Q reiterates seamless Phase 2/3 design in TR-MAC, August 2024 topline, and Phase 3 enrollment pause following blinded data suggesting lower-than-anticipated efficacy; dosing of existing patients continues under protocol .

Q&A Highlights

  • A Q1 2024 earnings call transcript was not located via company filings or investor site; management communications centered on 8-K/press release and 10-Q. Key clarifications include the non-safety rationale for Phase 3 pause, continued dosing of 97 previously enrolled patients, and the dependency on FDA dialogue post-unblinding .

Estimates Context

  • S&P Global consensus was unavailable at the time of retrieval; therefore, comparisons to Wall Street estimates are limited.
  • Third-party tracking sources indicated Q1 2024 EPS of -$0.56 vs consensus -$0.62 (beat by $0.06–$0.07); revenue was not reported as the company is pre-commercial .
MetricQ1 2024 ActualQ1 2024 Consensus (Non-SPGI)Delta
GAAP EPS ($)-0.56 -0.62 +$0.06
Revenue ($USD)$0 Not availableN/A

Key Takeaways for Investors

  • August 2024 Phase 2 topline is the pivotal catalyst; efficacy strength will likely determine Phase 3 resumption and regulatory path in TR-MAC .
  • The Phase 3 pause is efficacy-driven (not safety), with 97 patients continuing dosing; FDA engagement post-unblinding is critical for strategy .
  • Operating spend is elevated due to trial execution (R&D +22% YoY); liquidity of $118.1M supports ≥12 months of operations, but runway has narrowed vs Q3 2023 .
  • No financial guidance provided; focus remains on clinical execution and regulatory milestones across TR-MAC and broader boron-based pipeline (Chagas, melioidosis) leveraging grants .
  • Internal control material weaknesses persist; continued remediation is a watch item for governance-sensitive investors .
  • Near-term trading setup hinges on Phase 2 effect size and symptom PRO readout; robust efficacy could re-rate the program and catalyze Phase 3 restart, while weak data risks program redesign or delay .
  • Position sizing should reflect binary outcomes tied to August readout and FDA feedback; consider hedging or event-driven strategies around topline timing .