Tvardi Therapeutics, Inc. (TVRD)·Q2 2025 Earnings Summary

Executive Summary

• Q2 2025 delivered non-operating net income of $4.17M driven by a $12.8M fair value remeasurement gain on convertible notes; operating performance remained loss-making with $(8.87)M loss from operations .
• R&D execution advanced: REVERT IPF Phase 2 enrollment completed with topline data guided for Q4 2025; TTI‑109 IND submitted in June; HCC Phase 1b/2 topline guided for 1H 2026 .
• Cash, cash equivalents and short-term investments were $41.0M at quarter-end; management reiterated cash runway “into Q4 2026,” though the 10‑Q still flags going concern risk, implying potential future financing needs despite stated runway .
• Near-term stock catalysts: Q4’25 IPF readout for TTI‑101; progress on HCC program; potential partnering or financing updates given going concern disclosure .

What Went Well and What Went Wrong

What Went Well

• Completed IPF Phase 2 enrollment; CEO: “We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial” .
• Advanced pipeline breadth: IND submitted for second STAT3 inhibitor TTI‑109 (June 2025) .
• Liquidity improvement: $41.0M cash and investments; management: “well-financed through these potential value inflection points, and into Q4 of next year” (Q4 2026) .

What Went Wrong

• Operating loss widened YoY: $(8.87)M loss from operations vs $(7.18)M in Q2’24; total OpEx up to $8.87M from $7.18M .
• G&A spiked on public-company transition: $3.06M vs $0.65M YoY, driven by ~$1.6M higher professional fees tied to the Cara merger .
• Controls/going concern: Material weaknesses in legacy internal controls remain; 10‑Q states substantial doubt about going concern despite stated runway, indicating dependence on external capital .

Financial Results

P&L summary (YoY comparison)

Notes: Q2 2025 net income primarily from $12.8M remeasurement gain on convertible notes; diluted EPS reflects adjustments per fair value option accounting .

Revenue and EPS vs estimates

Values retrieved from S&P Global where marked with an asterisk; consensus not available for TVRD in Q2 2025 via our feed.

Balance sheet liquidity

R&D program expense breakdown (Quarterly, YoY)

Guidance Changes

Note: Despite runway guidance, the 10‑Q discloses substantial doubt as to going concern, indicating likely capital raises ahead .

Earnings Call Themes & Trends

No earnings call transcript found for Q2 2025 after searching SEC and company investor site; no transcript in our document catalog for TVRD within Aug–Sep 2025. We searched the investor site and press releases and found only the Q2 press release and conference participation notices .

Management Commentary

• CEO on IPF: “We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial… if positive, we believe [it] will further validate our approach of targeting STAT3” .
• CEO on HCC: “Phase 2 REVERT Liver Cancer trial continues to enroll patients… topline results in the first half of 2026” .
• On financing: “We are well-financed through these potential value inflection points, and into Q4 of next year” .
• Q1 remarks: Nasdaq listing “heightened our visibility and potential access to capital… well financed through… IPF and HCC readouts” .

Q&A Highlights

No Q2 2025 earnings call transcript available; we searched the company investor site and SEC and found no call or transcript for the period. Therefore, no analyst Q&A themes, clarifications, or tone comparisons can be provided .

Estimates Context

• S&P Global consensus for Q2 2025 EPS and revenue was unavailable for TVRD in our feed; as such, no beat/miss determination can be made relative to Street estimates*.
• Company remains pre-revenue; results are driven by operating expenses and non-operating items (fair value remeasurement), which are typically not covered by standard revenue/EPS consensus in early-stage biotech .

Values retrieved from S&P Global where applicable; consensus unavailable denoted with an asterisk.

Key Takeaways for Investors

• Pipeline execution is the primary driver: the Q4 2025 IPF Phase 2 topline for TTI‑101 is the key binary catalyst; position sizing should reflect clinical readout risk .
• Q2 profitability was non-core and driven by accounting (fair value gain); underlying operations remain cash-consuming with elevated G&A due to public-company costs .
• Liquidity of $41.0M supports near-term milestones, but going concern disclosure implies likely future raises; watch for financing or partnership signals ahead of Q4 data .
• Execution de-risking: completion of IPF enrollment and TTI‑109 IND reduces some timeline risk; continued HCC enrollment maintains multi-indication optionality .
• Governance/controls: material weaknesses remediation is ongoing; monitor progress to reduce reporting/control risk .
• Trading implications: Expect event-driven volatility into Q4 2025; lack of consensus estimates and call Q&A limits near-term “estimate revision” trading setups; focus on clinical disclosures and any pre-topline updates .
• Medium-term thesis: If IPF efficacy/safety signals are positive, STAT3 approach could unlock further development and partnering leverage; otherwise, financing overhang and control remediation could weigh on the stock .

Additional Source Documents Reviewed

• Q2 2025 8‑K (Item 2.02) and press release, including consolidated financial statements .
• Q2 2025 Form 10‑Q (financials, MD&A, liquidity, risk factors, controls) .
• Q1 2025 8‑K press release (business update; merger close) .
• Press releases: IPF Phase 2 enrollment completion (May 27, 2025); Q2 results (Aug 14, 2025); conference participation (Jul/Aug) .