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AN2 Therapeutics, Inc. (ANTX)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 delivered a narrower net loss and lower R&D spend, with cash, cash equivalents, and investments at $104.5M and runway guided through 2027, following discontinuation of the EBO-301 TR-MAC program and restructuring actions .
  • Management terminated both Phase 2 and Phase 3 parts of EBO-301 after Phase 2 showed a PRO signal but no sputum culture conversion benefit at Month 6; epetraborole was generally well-tolerated, and strategic focus shifts to Chagas (AN2-502998) and melioidosis programs targeting clinical starts in 2025 .
  • No product revenue; operating model remains R&D-centric with GAAP net loss per share improving to -$0.48 from -$0.56 in Q1 2024 and -$0.81 in Q2 2023; other income benefited from higher interest rates and investment balances .
  • Post-quarter, the company adopted a limited-duration stockholder rights plan after a 19.3% stake accumulation by BML Investment Partners, which may serve as a governance catalyst for shares and protect against coercive tactics without a control premium .

What Went Well and What Went Wrong

What Went Well

  • Cash runway guided through 2027, supported by restructuring and EBO-301 termination cost savings; Q2 cash, cash equivalents, and investments at $104.5M .
  • Phase 2 met its primary objective for validating a novel PRO tool with higher PRO-based clinical response rates; epetraborole 500 mg daily generally well-tolerated with no safety-related termination .
  • Continued pipeline momentum: AN2-502998 planned for Phase 1 in chronic Chagas disease and a Phase 2 epetraborole study in melioidosis in 2025, plus boron-based oncology research programs .

Management quote: “Despite this setback, we remain well positioned as a company – we have a boron chemistry platform with two development programs that are expected to advance into clinical trials in 2025.” – Eric Easom, CEO .

What Went Wrong

  • EBO-301 Phase 2/3 program for TR-MAC discontinued: sputum culture conversion at Month 6 was similar between treatment arms (13.2% vs. 10.0%; p=0.64), despite PRO signals; efficacy concerns confirmed prior Phase 3 enrollment pause .
  • Operating losses continue amid no product revenue; net loss in Q2 2024 was -$14.4M, albeit improved year over year and sequentially .
  • R&D reduction reflects program termination rather than efficiency gains alone, highlighting near-term transition risks as the pipeline pivots to Chagas and melioidosis .

Financial Results

Quarter-on-Quarter Trend (GAAP)

MetricQ4 2023Q1 2024Q2 2024
R&D Expense ($USD Millions)$14.919 $14.655 $12.149
G&A Expense ($USD Millions)$3.896 $3.641 $3.731
Other Income, Net ($USD Millions)$1.917 $1.679 $1.445
Net Loss ($USD Millions)$(16.898) $(16.617) $(14.435)
Net Loss per Share (Basic/Diluted)$(0.57) $(0.56) $(0.48)
Weighted Avg. Shares29,735,397 29,763,278 29,824,725

Notes: Company reports no product revenue; condensed statements present operating expenses and other income only .

Year-over-Year Comparison (Q2)

MetricQ2 2023Q2 2024
R&D Expense ($USD Millions)$13.538 $12.149
G&A Expense ($USD Millions)$3.063 $3.731
Other Income, Net ($USD Millions)$0.797 $1.445
Net Loss ($USD Millions)$(15.804) $(14.435)
Net Loss per Share (Basic/Diluted)$(0.81) $(0.48)

Balance Sheet Highlights and Liquidity

MetricDec 31, 2023Mar 31, 2024Jun 30, 2024
Cash, Cash Equivalents & Investments ($USD Millions)$134.5 $118.1 $104.5
Total Assets ($USD Millions)$138.744 $121.260 $108.481
Total Liabilities ($USD Millions)$14.043 $10.663 $10.127
Stockholders’ Equity ($USD Millions)$124.701 $110.597 $98.354

Estimates vs Actuals (Q2 2024)

MetricConsensusActual
EPS ($USD)Unavailable*$(0.48)
Revenue ($USD)Unavailable*Not disclosed; no product revenue

*S&P Global consensus values were unavailable due to data access limitations at the time of this analysis. Values would otherwise be retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
EBO-301 (TR-MAC) Program Status2024Phase 3 enrollment paused; topline Phase 2 data expected Aug 2024 Phase 2 and Phase 3 parts terminated after topline Phase 2 results Lowered/Terminated
Cash RunwayMulti-yearNot explicitly guided in Q1; strong cash mentioned Runway anticipated through 2027 (post-restructuring) Raised/Extended
Chagas (AN2-502998)2025Late preclinical development; licensed program Phase 1 initiation planned in 2025 Maintained/Timed
Melioidosis (Epetraborole)2025Program progress indicated at IDWeek Phase 2 initiation planned in 2025 Maintained/Timed
Oncology (Boron platform)2024–2025Early-stage research programs Pipeline programs advancing with several development compounds anticipated within runway Maintained/Expanded

Earnings Call Themes & Trends

Note: A Q2 2024 earnings call transcript could not be located in the company’s filings portal during the period searched [SearchDocuments returned none].

TopicPrevious Mentions (Q4 2023, Q1 2024)Current Period (Q2 2024)Trend
R&D execution (NTM/TR-MAC)Phase 3 pause due to potentially lower-than-expected efficacy in blinded data; Phase 2 topline expected summer/August 2024 Phase 2/3 terminated; PRO validation signal observed but no sputum culture conversion benefit; drug generally well-tolerated Negative on TR-MAC efficacy; pivot to other indications
Pipeline shift (Chagas, melioidosis)Licensing and late preclinical progress for Chagas; melioidosis program presented Clinical starts targeted in 2025 for Chagas (Phase 1) and melioidosis (Phase 2) Execution focus shifting to platform-led programs
Liquidity/runwayStrong cash at $134.5M YE’23; $118.1M Q1’24 $104.5M Q2; runway guided through 2027 with restructuring Adequate runway despite declining cash
Governance/Shareholder defenseNot highlightedLimited-duration rights plan adopted after 19.3% stake by BML Defensive stance; potential stock catalyst
Scientific dataIDWeek 2023 posters/orals (NTM/melioidosis) July publication: epetraborole efficacy in M. abscessus mouse lung model Preclinical support for M. abscessus continues

Management Commentary

  • “Despite this setback, we remain well positioned as a company – we have a boron chemistry platform with two development programs that are expected to advance into clinical trials in 2025.” – Eric Easom, CEO .
  • “The Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel patient-reported outcome (PRO) tool… However, sputum culture conversion at Month 6… was similar between treatment arms.” .
  • “These results are deeply disappointing… In the coming months, we will further evaluate the results from the EBO-301 study and make informed decisions… We plan to embark on a strategic restructuring and expect to extend our cash runway through 2027.” – Eric Easom .
  • “We signed a licensing agreement… to develop a novel therapy for chronic Chagas disease… we are also progressing an IV formulation of epetraborole for melioidosis…” – Eric Easom .

Q&A Highlights

  • No public Q2 2024 earnings call transcript was found; Q&A highlights and any guidance clarifications are unavailable based on company documents retrieved [SearchDocuments returned none].

Estimates Context

  • S&P Global Wall Street consensus estimates were unavailable at the time of analysis due to data access limitations; consequently, comparisons to consensus are not provided here. Actual GAAP EPS for Q2 2024 was -$0.48 .
  • Based on the structural shift from TR-MAC to other indications, forward estimates may need recalibration to reflect reduced near-term TR-MAC costs and timelines, while incorporating new clinical starts for Chagas and melioidosis .

Key Takeaways for Investors

  • Program reset: TR-MAC discontinuation materially changes near-term path; stock reaction likely hinges on credibility of the 2025 clinical starts and pipeline delivery .
  • Cash runway through 2027 reduces financing overhang in the near to medium term, even as quarterly cash declines with ongoing operations .
  • Sequential EPS improvement (-$0.48 vs. -$0.56) and YOY improvement (-$0.48 vs. -$0.81) reflect lower R&D and higher interest income; durability depends on spend levels in new programs .
  • Governance actions (rights plan) suggest heightened vigilance around ownership changes and potential strategic scenarios; could be a volatility catalyst .
  • Scientific/clinical pivot broadens optionality (Chagas, melioidosis, oncology) and leverages boron chemistry platform; execution risk remains but offers diversified avenues for value creation .
  • Near-term milestones: clarity from further EBO-301 data analyses (for learnings), initiation of Phase 1 (Chagas) and Phase 2 (melioidosis) in 2025; monitor for non-dilutive funding and regulatory feedback .
  • With no revenue and ongoing net losses, investment case is tied to clinical progress and capital discipline; watch quarterly opex trajectory and cash utilization against the 2027 runway guide .