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Tvardi Therapeutics, Inc. (TVRD)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 printed a smaller operating profile with R&D $3.60M and G&A $2.34M, driving a net loss of $(5.53)M and EPS of $(0.59); opex declined sequentially from Q2 as TTI-101 costs fell with IPF completion, partly offset by TTI-109 start-up costs .
  • Management disclosed that the Phase 2 REVERT IPF trial did not meet its goals in October and is under analysis, while HCC (TTI-101) remains on track for topline in H1 2026; TTI-109’s healthy volunteer study is underway with results also expected H1 2026 .
  • Liquidity remains adequate with $36.5M in cash, cash equivalents and short-term investments at 9/30, and runway into Q4 2026, consistent with prior quarter commentary .
  • Shares fell over 80% on Oct 13 after the preliminary IPF readout, prompting multiple third-party shareholder investigation press releases—a near-term overhang until the IPF post-mortem and HCC path crystallize .

What Went Well and What Went Wrong

  • What Went Well

    • Sequential opex reduction: R&D fell to $3.60M (from $5.81M in Q2) and G&A to $2.34M (from $3.06M), reflecting lower TTI-101 costs post-IPF completion, partly offset by TTI-109 ramp .
    • HCC remains on schedule: “On track for topline data from Phase 2 trial of TTI-101 in HCC in H1 2026,” with interim data showing “clinically meaningful activity” as mono and combo therapy, per CEO commentary .
    • Pipeline progression: TTI-109 IND is in effect and a healthy volunteer study has started; results targeted for H1 2026, offering an additional catalyst and potential tolerability benefits via a prodrug design .
  • What Went Wrong

    • IPF miss: Preliminary Phase 2 REVERT IPF data “did not meet its goals” in October; the company is conducting further analyses to determine next steps .
    • Legal overhang: Multiple law firm press releases announced investigations after the stock dropped >80% on Oct 13, adding headline risk .
    • Elevated G&A vs last year: G&A rose to $2.34M from $0.88M YoY due to higher legal, accounting/audit, personnel, insurance and rent, reflecting costs of being public and post-merger integration .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
Research & Development ($USD Millions)$4.80 $5.81 $3.60
General & Administrative ($USD Millions)$0.88 $3.06 $2.34
Total Operating Expenses ($USD Millions)$5.68 $8.87 $5.94
Net Income (Loss) ($USD Millions)$(5.51) $4.17 $(5.53)
Basic EPS ($)$(2.14) $0.51 $(0.59)
Diluted EPS ($)$(2.14) $(1.00) $(0.59)
Cash & Short-term Investments ($USD Millions, period-end)$41.0 $36.5

Notes:

  • No product revenue reported; the statement of operations presents only operating expenses and other income (loss) .
  • Q2 net income was driven primarily by a $12.66M other income line (remeasurement gain on Convertible Notes) .

Program-related R&D change detail (YoY, Q3 2025 vs Q3 2024):

ItemChange ($USD Millions)Commentary
TTI-101 HCC trial expense$(1.4) Lower due to changes in patient enrollments and estimated study costs
TTI-101 IPF trial expense$(1.0) Trial completed in Q2 2025
TTI-109 HV study & CMC+$2.0 Healthy volunteer study began in Q3 2025; related CMC costs

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
REVERT IPF Phase 2 topline (TTI-101)IP timing4Q 2025 targeted Trial did not meet goals; additional analyses underway Lowered/Withdrawn
REVERT HCC Phase 2 topline (TTI-101)H1 2026H1 2026 on track H1 2026 on track; interim results clinically meaningful Maintained
TTI-109 healthy volunteer toplineH1 2026IND submitted (timing not given) Results expected H1 2026 Introduced
Cash runwayLiquidityFunded into Q4 2026 Funded into Q4 2026 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
IPF (TTI-101)Q1: on track 2H 2025; Q2: topline in 4Q 2025 Phase 2 REVERT IPF did not meet goals; analyzing options Negative inflection
HCC (TTI-101)H1 2026 topline; continued enrollment On track H1 2026; interim data clinically meaningful mono/combo Steady/constructive
TTI-109Q1: IND planned 1H 2025 ; Q2: IND submitted IND in effect; HV study initiated; results H1 2026 Progressing
Funding runwayQ1: into 2H 2026 ; Q2: into Q4 2026 Into Q4 2026 Stable
Legal/shareholder mattersMultiple shareholder investigation PRs post Oct 13 drop Headwind

Note: No Q3 2025 earnings call transcript was located in the available document set; themes are derived from the 8-K press release .

Management Commentary

  • Strategic posture: “We remain confident in the potential of STAT3 inhibition… Our lead program, TTI-101, has demonstrated encouraging clinical activity in oncology and continues to hold promise across a range of indications where STAT3 is a key driver” .
  • On HCC and pipeline: “We eagerly await data from our ongoing Phase 2 REVERT Liver Cancer trial in the first half of next year… At the same time, we are also advancing our next-generation STAT3 inhibitor, TTI-109… designed to rapidly convert to TTI-101… to improve tolerability” .
  • On balance sheet and focus: “With a balance sheet extending into the fourth quarter of next year, we remain focused on fully realizing the therapeutic potential of STAT3 inhibition across fibrotic diseases” .

Q&A Highlights

  • No Q3 2025 earnings call transcript was found; no Q&A to summarize. Analysis and quotes are sourced from the 8-K press release and attached Exhibit 99.1 .

Estimates Context

MetricPeriodConsensusActualSurprise
EPS (GAAP)Q3 2025N/A*$(0.59) N/A*
RevenueQ3 2025N/A*No revenue reported N/A*

*Consensus data retrieved from S&P Global; no Wall Street consensus estimates were available for TVRD via S&P Global at the time of analysis.

Key Takeaways for Investors

  • IPF failure resets near-term narrative; the stock’s >80% drop on Oct 13 underscores heightened event risk and legal headline sensitivity until management completes the analysis and articulates next steps .
  • HCC becomes the primary value driver with a defined H1 2026 topline; interim data cited as “clinically meaningful” suggests biological activity, but a clear registrational path and effect size will determine re-rating potential .
  • TTI-109 offers a 2026 catalyst and potential tolerability edge through prodrug delivery; successful HV data could de-risk future TTI-101 exposure concerns and broaden the platform .
  • Operating discipline evident: sequential opex down materially (R&D $5.81M → $3.60M; G&A $3.06M → $2.34M), extending runway efficacy; monitor for sustained spend control as programs advance .
  • Liquidity into Q4 2026 provides breathing room to reach HCC and TTI-109 readouts without immediate financing, though outcomes will dictate capital strategy; watch for non-dilutive options .
  • Lack of Street coverage (no SPGI consensus) implies outsized impact from company disclosures; upcoming scientific/clinical updates could drive step-changes in sentiment and valuation.
  • Near-term trading setup: sentiment likely remains pressured by IPF outcome and investigation headlines; potential relief rallies could occur on HCC operational updates, study progress, or clarity on IPF learnings and strategy .