Tvardi Therapeutics, Inc. (TVRD)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 was primarily a transition quarter post-merger and reflected Cara’s legacy operations: total revenue was $2.57M, net loss was $4.91M, and basic/diluted EPS were $(3.22) . Management emphasized a strengthened balance sheet post-merger and cash runway into 2H 2026 .
• Business highlights centered on STAT3 programs: Phase 2 IPF readout expected in 2H 2025 and HCC readout in 1H 2026; an IND for next-gen STAT3 inhibitor TTI-109 was planned for 1H 2025 .
• Subsequent quarters updated guidance and execution: Q2 2025 cash/short-term investments rose to $41.0M with net income of $4.17M on a large non-cash gain; runway guided into Q4 2026 . In Q3 2025, preliminary IPF Phase 2 did not meet goals, while HCC and TTI-109 timelines remained intact; runway maintained into Q4 2026 .
• No earnings call transcript was available for Q1 2025; investor communications were via the 8-K press release and 10-Q filings .

What Went Well and What Went Wrong

What Went Well

• Cash runway extended: Post-merger cash, equivalents, and short-term investments at closing anticipated to fund operations into the second half of 2026 . In Q2, management reiterated runway into Q4 2026 .
• Pipeline momentum: IPF Phase 2 readout targeted for 2H 2025; HCC Phase 1b/2 topline in 1H 2026; TTI-109 IND planned for 1H 2025 (submitted June 2025) .
• CEO signal on strategy: “With the cash on our balance sheet, we believe we are well financed through meaningful value inflection points… including anticipated Phase 2 readouts of our lead program in IPF as well as our hepatocellular carcinoma program” . In Q2: “We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial” .

What Went Wrong

• Legacy revenue base is non-core: Q1 revenue ($2.57M) derived from Cara’s profit-sharing, clinical compound, and other non-cash royalty components, which were largely divested or terminated post-merger, limiting forward relevance .
• Q3 IPF outcome: Preliminary REVERT IPF Phase 2 did not meet goals, prompting deeper analysis and uncertainty around IPF trajectory .
• Going concern and capital needs: 10-Q flagged substantial doubt about continuing as a going concern and need for additional capital to advance programs despite post-merger cash infusion .

Financial Results

Headline Metrics vs Prior Periods and Estimates

Note: Q1 2025 reflects Cara’s legacy operations pre-merger close (April 15, 2025) per the 10-Q explanatory note . Q2/Q3 statements show operating expense-only presentations (no revenue lines), consistent with clinical-stage status .

Revenue Component Breakdown (Q1 2025 and Prior Year)

Operating Expense KPIs and Liquidity

Guidance Changes

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript; themes compiled from press releases and 10-Q/8-K updates .

Management Commentary

• Q1 2025: “With the cash on our balance sheet, we believe we are well financed through meaningful value inflection points… including anticipated Phase 2 readouts of our lead program in idiopathic pulmonary fibrosis (IPF) as well as our hepatocellular carcinoma program” — Imran Alibhai, CEO .
• Q2 2025: “We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial… we are well-financed through these potential value inflection points, and into Q4 of next year” — Imran Alibhai, CEO .
• Q3 2025: “The REVERT IPF clinical trial did not meet its goals… we remain confident in the potential of STAT3 inhibition… eagerly await data from our ongoing Phase 2 REVERT Liver Cancer trial in the first half of next year” — Imran Alibhai, CEO .

Q&A Highlights

• No Q1 2025 earnings call transcript or Q&A session was available in filings or public transcripts; investor communication relied on the 8-K press release and the 10-Q .

Estimates Context

• Wall Street consensus via S&P Global: Consensus EPS and number of estimates for Q1 2025 were unavailable; consensus revenue also unavailable, and the tool returned only actual revenue (not an estimate). Values retrieved from S&P Global.*
• Implication: No beat/miss vs consensus can be determined for Q1 2025; future estimate revisions likely centered on IPF readout timing (later reported outcome) and runway updates .

Key Takeaways for Investors

• Near-term catalysts: IPF Phase 2 readout (guided for 2H/Q4 2025 in Q1/Q2), which later proved negative in Q3; HCC Phase 1b/2 topline remains due in 1H 2026; TTI-109 HV study topline in 1H 2026 .
• Balance sheet and runway: Post-merger liquidity plus June/Q3 positions support operations into Q4 2026; quarterly cash + ST investments rose to $41.0M in Q2 and stood at $36.5M in Q3 .
• Transitioned revenue profile: Q1 revenue tied to legacy Cara arrangements (profit-share, clinical compound, non-cash royalties), many of which were terminated/assigned post-merger; forward model should focus on R&D spend and non-operating gains/losses rather than product revenue .
• Expense trajectory: Q1 R&D dropped sharply vs prior year (discontinuation of Cara programs); Q2/Q3 R&D/G&A reflect Tvardi’s clinical-stage cadence with step-up around TTI-109 HV initiation and ongoing HCC program .
• Strategy focus: Management is prioritizing STAT3 inhibition across fibrosis and oncology; after IPF setback reported in Q3, HCC and TTI-109 become principal drivers of value .
• Trading lens: Q1 had limited estimate context; subsequent period disclosures (Q2 runway, Q3 IPF outcome) are likely to drive sentiment; positioning should reflect binary nature of upcoming HCC/TTI-109 readouts .
• Governance/controls: Auditor change (EY to Deloitte) and Nasdaq compliance history disclosed; standard going concern language underscores dependence on external financing and trial outcomes .

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Citations:

• Q1 2025 8-K and press release:
• Q1 2025 10-Q financials and MD&A:
• Q2 2025 8-K and press release:
• Q3 2025 8-K and press release:

S&P Global disclaimer: Values retrieved from S&P Global.*