TT
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
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):
Guidance Changes
Earnings Call Themes & Trends
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
*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 .