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Third Harmonic Bio, Inc. (THRD)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 focused on clinical execution: THB335 Phase 1 SAD/MAD is progressing and management pulled forward the readout timing to 1Q’25 from prior 1H’25, positioning a potential data catalyst in early 2025 .
  • OpEx rose on program ramp: R&D increased to $8.4M (from $5.3M YoY) and G&A to $5.7M (from $5.4M YoY); net loss widened to $10.7M (from $7.6M YoY), driven primarily by THB335 clinical and next‑gen discovery spend .
  • Balance sheet remains a strength: Cash and cash equivalents were $255.3M at 6/30/24, and runway guidance was reiterated as “through at least 2026” .
  • Near-term stock catalysts: 1Q’25 Phase 1 SAD/MAD data (safety/PK/PD with tryptase biomarker) and rapid progression to a Phase 2 CSU study thereafter, with broader mast cell–mediated indications to follow per plan .

What Went Well and What Went Wrong

  • What Went Well

    • Acceleration of THB335 Phase 1 data timing to 1Q’25; management highlighted active preparation for rapid Phase 2 entry in chronic spontaneous urticaria (CSU) with expansion to other mast cell–mediated diseases .
    • Strong liquidity and runway: $255.3M cash at 6/30/24; runway “through at least 2026” maintained, supporting multi‑program execution without near‑term financing .
    • CEO tone on execution: “We are making excellent progress in our Phase 1 SAD/MAD clinical trial of THB335 and now expect to report clinical results during the first quarter of 2025.”
  • What Went Wrong

    • Higher OpEx on pipeline ramp: R&D rose to $8.4M in Q2 (from $5.3M YoY) as THB335 and next‑gen discovery spending increased; G&A also up to $5.7M (from $5.4M YoY) on personnel additions .
    • Wider quarterly net loss: Q2 net loss increased to $10.7M (from $7.6M YoY), reflecting development investment despite partial offset from interest income .
    • No revenue and early-stage risk persists: Press release and financials focus on operating expenses and net loss (no product/collaboration revenue reported), underscoring development-stage profile .

Financial Results

Operating expenses and net loss by period (oldest → newest):

Metric ($USD Millions)Q2 2023Q1 2024Q2 2024
R&D Expense$5.3 $6.2 $8.4
G&A Expense$5.4 $5.1 $5.7
Net Loss$7.6 $7.9 $10.7

Cash and cash equivalents trend (period-end):

Metric ($USD Millions)Dec 31, 2023Mar 31, 2024Jun 30, 2024
Cash & Cash Equivalents$269.1 $262.8 $255.3

Additional EPS context (reported):

  • Q1 2024 net loss per share: $0.20 (basic/diluted) .
  • H1 2024 net loss per share: $0.46 (basic/diluted); company did not break out Q2 per‑share in the press release .

Notes:

  • No revenue line was reported in the Q1 2024 or Q2 2024 press release financial statements; statements focus on operating expenses and net loss .

Segment and KPI disclosure:

  • No commercial segments. Operational KPIs emphasized include Phase 1 progress, biomarker (serum tryptase) PD readouts planned, and cash runway .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
THB335 Phase 1 SAD/MAD data timingClinical readout1H’25 1Q’25 Accelerated
Cash runwayCorporateThrough at least 2026 Through at least 2026 Maintained
Next step: Phase 2 in CSUDevelopment planPlanned following Phase 1 Preparing to rapidly enter Phase 2 in CSU Reinforced/On track

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was available in the document set; themes below reflect quarter-over-quarter disclosures from press releases and prior update.

TopicPrevious Mentions (Q4 2023)Previous Mentions (Q1 2024)Current Period (Q2 2024)Trend
Clinical timeline for THB335U.S. IND filed; trial start anticipated 2Q’24 IND cleared; Phase 1 SAD/MAD initiated; results expected 1H’25 Phase 1 progressing; results pulled forward to 1Q’25 Accelerating execution
CSU as lead indicationEmphasis on CSU as initial Phase 2 focus Plan for robust Phase 2 in CSU post Phase 1 Preparing to move rapidly into Phase 2 in CSU Consistent prioritization
Expansion to other mast cell diseasesConcept of franchise/pipeline-in-a-target Planned expansion incl. severe asthma Subsequent expansion into additional mast cell–mediated diseases reiterated Broader pipeline vision intact
Biomarker strategy (tryptase)Phase 1 to measure serum tryptase reductions Continue using serum tryptase PD as key measure Consistent PD strategy
Balance sheet and runwayStrong cash position $262.8M; runway through ≥2026 $255.3M; runway through ≥2026 Stable funding outlook

Management Commentary

  • “We are making excellent progress in our Phase 1 SAD/MAD clinical trial of THB335 and now expect to report clinical results during the first quarter of 2025.” — Natalie Holles, CEO .
  • “We are already preparing to move THB335 rapidly into a Phase 2 clinical trial in chronic spontaneous urticaria with subsequent expansion into additional mast cell-mediated diseases.” — Natalie Holles, CEO .

Q&A Highlights

  • No Q2 2024 earnings call transcript was found in the available filings set; therefore, no Q&A highlights are available to report.

Estimates Context

  • Wall Street consensus estimates (S&P Global) for Q2 2024 EPS and revenue were not available via our data connector for this ticker at the time of analysis; as a development‑stage company, THRD typically has limited revenue/EPS consensus utility at this stage. As a result, no estimate beat/miss comparisons are included.

Key Takeaways for Investors

  • Execution trending better than plan: Phase 1 THB335 readout pulled forward to 1Q’25, a potential near-term de‑risking event for the CSU program .
  • Spending inflects with program ramp: R&D increased to $8.4M in Q2; expect OpEx to track clinical cadence as THB335 advances and next‑gen efforts continue .
  • Liquidity and runway reduce financing overhang: $255.3M in cash at 6/30/24 and runway through at least 2026 provide strategic flexibility to reach multi‑milestone inflections (Phase 1 data, Phase 2 start) .
  • Biomarker‑anchored strategy: Serum tryptase PD readouts in Phase 1 are designed to corroborate mechanism and support Phase 2 design in CSU, aligning with prior urticaria biology .
  • Setup into 1H’25: Stock likely to trade on Phase 1 updates, Phase 2 initiation signals, and any expansion indications disclosed; absence of revenue means dataflow and cash runway dominate the narrative .
  • Watch G&A trajectory: Modest G&A increase due to personnel-related items; monitor for scaling commensurate with program breadth .
  • Longer-term thesis: If Phase 1 PK/PD and safety are supportive, the “pipeline‑in‑a‑target” KIT strategy (CSU lead, with potential in other mast cell–mediated diseases) could broaden the opportunity set .

Supporting source documents:

  • Q2 2024 8‑K/Press Release (Aug 8, 2024): program update, quarterly OpEx and net loss, cash, runway .
  • Q1 2024 8‑K/Press Release (May 15, 2024): IND clearance, Phase 1 initiation, prior guidance (1H’25), Q1 OpEx, EPS, cash .
  • Q4/FY 2023 8‑K/Press Release (Mar 26, 2024): IND filed, cash baseline .