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Third Harmonic Bio, Inc. (THRD)·Q3 2024 Earnings Summary

Executive Summary

  • THB335 Phase 1 SAD/MAD remains on track with clinical results expected in 1Q’25; management is preparing to move efficiently into Phase 2 in chronic spontaneous urticaria, framing the next catalyst window .
  • Cash and cash equivalents were $296.1M as of September 30, 2024, extending runway “through at least 2026”; quarterly operating spend rose with program execution .
  • Q3 operating profile: R&D $11.3M (+$5.3M YoY), G&A $5.7M (+$0.8M YoY), net loss $13.8M (vs. $7.3M in Q3’23), driven by THB335 and personnel-related expenses .
  • Stock reaction catalysts near term: Phase 1 PK/PD/tryptase data in 1Q’25; Phase 2 CSU start-up readiness; continued clarity on franchise expansion into additional mast cell-mediated diseases .

What Went Well and What Went Wrong

What Went Well

  • Phase 1 execution momentum: “We are also making excellent progress in preparing to move efficiently into a Phase 2 clinical trial in chronic spontaneous urticaria” — CEO Natalie Holles .
  • Strengthened liquidity: Cash $296.1M at Q3, with runway “through at least 2026,” enabling clinical and franchise execution without near-term financing pressure .
  • Clear differentiation thesis for oral KIT inhibition and PD linkage via serum tryptase reductions, aligned to prior program learnings and CSU efficacy rationale .

What Went Wrong

  • Higher operating losses: Net loss widened to $13.8M in Q3 (vs. $7.3M in Q3’23) on increased R&D and personnel-related G&A .
  • OpEx ramp: R&D increased to $11.3M (vs. $6.0M in Q3’23); G&A to $5.7M (vs. $4.9M), reflecting THB335 progress and executive recruiting .
  • No earnings call transcript available; limited external narrative beyond press releases constrains visibility on Q&A clarifications and market-facing tone shifts (no transcript found via our corpus) [List: earnings-call-transcript returned none].

Financial Results

Quarterly Operating Profile

Metric ($USD Millions unless noted)Q1 2024Q2 2024Q3 2024
R&D Expense$6.2 $8.4 $11.3
G&A Expense$5.1 $5.7 $5.7
Net Loss$7.9 $10.7 $13.8
Cash & Cash Equivalents$262.8 $255.3 $296.1

Notes:

  • Drivers: R&D increases were “primarily due to increased spend related to the THB335 program and increased personnel-related expenses,” with offsets from terminated THB001 costs; G&A increases tied to executive recruiting .
  • THRD is a clinical-stage company; no product revenue was disclosed in the press releases or condensed operating statements we reviewed .

YTD Operating Results

Metric6M 20249M 2024
Total Operating Expenses ($USD Millions)$25.36 $42.43
Net Loss ($USD Millions)$18.56 $32.36
Net Loss per Share (basic & diluted)$0.46 $0.80
Weighted-Average Shares (basic & diluted)40,384,338 40,697,668

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
THB335 Phase 1 clinical results timingInitial first-in-human readout1H’25 (Q1 press release) 1Q’25 (Q2 and Q3 press releases) Refined earlier window (accelerated from 1H to 1Q)
Phase 2 in CSU2024-2025 planningPlanning rapid advancement post-Phase 1 “Preparing to move efficiently into a Phase 2 clinical trial” Maintained, with execution readiness
Cash runway2024-2026“Through at least 2026” “Through at least 2026” Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2024)Previous Mentions (Q2 2024)Current Period (Q3 2024)Trend
Clinical timeline (THB335 Phase 1)IND cleared; Phase 1 initiated; results 1H’25 Results expected in 1Q’25 On track to deliver results in 1Q’25 Improving precision, execution on plan
R&D executionNext-gen KIT program; nonclinical/PD framework; ramping ops Program spend rising; discovery efforts ongoing R&D prioritized; personnel adds; program spend increased Steady ramp as clinical work advances
Cash runway/financing$262.8M; runway ≥2026 $255.3M; runway ≥2026 $296.1M; runway ≥2026 Strengthening liquidity; runway intact
KIT strategy & differentiationOral KIT inhibitor, tryptase PD, CSU burden Same strategy reiterated Reaffirmed optimal oral approach, PD linkage Consistent strategy narrative
Franchise expansionPipeline-in-a-target; severe asthma opportunity Expansion into additional mast cell disorders Continued CSU first, expansion thereafter Consistent; CSU lead, broader applications later

Management Commentary

  • “We are also making excellent progress in preparing to move efficiently into a Phase 2 clinical trial in chronic spontaneous urticaria” — Natalie Holles, CEO .
  • “We are making excellent progress in our Phase 1 SAD/MAD… and now expect to report clinical results during the first quarter of 2025” — Natalie Holles, CEO .
  • “With the initiation of THB335 clinical trials, we are advancing… toward becoming an important treatment for patients living with chronic spontaneous urticaria and other mast-cell mediated inflammatory diseases” — Natalie Holles, CEO .

Q&A Highlights

  • No Q3 2024 earnings call transcript was available in our document catalog; analysis relies on 8-K/press release disclosures, so there were no published Q&A clarifications to track for this period [List: earnings-call-transcript returned none].

Estimates Context

  • Wall Street consensus from S&P Global was unavailable for THRD due to missing CIQ mapping in our SPGI system; therefore, we cannot provide revenue/EPS estimate comparisons for Q3 2024 at this time. Values from S&P Global were not retrieved; consensus comparisons are not available.

Key Takeaways for Investors

  • Phase 1 data in 1Q’25 is the key near-term catalyst; expect focus on safety/tolerability, PK, and PD (serum tryptase reductions) to validate the mechanistic approach and inform Phase 2 design .
  • Liquidity improved to $296.1M with runway into 2026, reducing financing overhang through initial Phase 2 activities; watch cash trends vs. OpEx ramp .
  • Execution risk is tied to timely Phase 2 initiation in CSU and maintaining clean safety signals as dose escalations progress; spend increases reflect program acceleration .
  • The oral KIT inhibitor thesis and PD linkage via tryptase remain central to the potential best-in-disease efficacy narrative in CSU; prior THB001 learnings support biomarker correlation while highlighting design improvements in THB335 .
  • Trading setup: into data, positioning may hinge on perceived PD effect magnitude (tryptase reductions) and the clarity of Phase 2 start timelines; absence of product revenue and rising R&D means valuation sensitivity to clinical de-risking events.
  • Medium-term: CSU serves as lead indication; management continues to message broader mast cell-mediated disease expansion (e.g., severe asthma), implying optionality if clinical signals are strong .
  • Monitor updates around Phase 2 protocol/regulatory interactions and any nonclinical/chronic tox completions that support rapid progression to registrational pathways .