Tvardi Therapeutics, Inc.
TVRD evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for TVRD—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · TVRD
Tvardi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule inhibitors of Signal Transducer and Activator of Transcription 3 (STAT3), with lead candidate TTI-101 in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and hepatocellular carcinoma (HCC), and a preclinical candidate TTI-109. The company has no approved products, no revenue, and has disclosed substantial doubt about its ability to continue as a going concern.
Key risk: Going concern risk
BioSniper Score
Based on 5 of 6 signals
Market Cap
$24.3M
Cash Runway
5.3 moLead Asset
korsuva / kapruvia (Approved)
Next Catalyst
Phase2_Topline · Dec 31, 2026Financial data as of Jun 30, 2026.
Tracking 3 pipeline candidates · 2 clinical trials · 1 catalyst for Tvardi Therapeutics, Inc..
Tvardi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule inhibitors of Signal Transducer and Activator of Transcription 3 (STAT3), with lead candidate TTI-101 in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and hepatocellular carcinoma (HCC), and a preclinical candidate TTI-109. The company has no approved products, no revenue, and has disclosed substantial doubt about its ability to continue as a going concern.
- Tvardi has no approved products and has not generated any revenue from product sales; it has incurred significant operating losses to date [sec_mda · as of 2026-03-31].
- Lead candidate TTI-101 is in Phase 2 clinical trials for IPF and HCC; TTI-109 is in preclinical development [sec · filed 2025-05-30].
- As of June 30, 2026, the company reported cash & equivalents of $15.8M, net income of -$6.5M, and shareholders' equity of $20.9M [sec].
- The company has disclosed that its cash will not be sufficient to fund planned operations for at least one year, raising substantial doubt about its ability to continue as a going concern [sec_mda · as of 2026-08-14].
- Tvardi plans to seek additional funding through equity offerings, debt financings, or strategic alliances, but there is no assurance such funding will be available on acceptable terms [sec_mda · as of 2026-08-14].
What works
- Tvardi has advanced TTI-101 into Phase 2 clinical trials for two indications (IPF and HCC), indicating progress in clinical development [sec · filed 2025-05-30].
- The company completed a merger with Cara in April 2025, receiving approximately $23.8 million in cash and cash equivalents, which provided near-term capital [sec · filed 2025-05-30].
- Tvardi has a second product candidate, TTI-109, in preclinical development, providing a potential pipeline beyond TTI-101 [sec · filed 2025-05-30].
What to weigh
- Tvardi has no approved products, no revenue, and has incurred significant operating losses; it may never generate revenue from product sales [sec_mda · as of 2026-03-31].
- The company has disclosed substantial doubt about its ability to continue as a going concern, as its current cash is insufficient to fund operations for at least one year [sec_mda · as of 2026-08-14].
- Tvardi will require substantial additional capital to complete its ongoing and planned clinical trials, and access to funding on acceptable terms cannot be assured [sec_mda · as of 2026-08-14].
- The company is early in development with only one product candidate in early clinical trials and one in preclinical development, making it highly dependent on the success of TTI-101 [sec · filed 2025-05-30].
From the filings
Quoted directly from source documents.
Tvardi has no approved products and no revenue from product sales.
“we have not generated any revenue from product sales or any other sources and have incurred significant operating losses.”
SEC MD&A · March 31, 2026
The company has substantial doubt about its ability to continue as a going concern.
“not be sufficient to fund its planned operations for at least one year from the issuance date of the unaudited condensed consolidated financial statements, included elsewhere in this Quarterly Report, which raises substantial doubt as to our ability to continue as a going concern.”
SEC MD&A · August 14, 2026
TTI-101 is in Phase 2 clinical trials for IPF and HCC; TTI-109 is in preclinical development.
“The Company is currently conducting Phase 2 clinical trials of TTI-101 in IPF and HCC, has no products that are approved for commercial sale and may never be able to develop marketable products. The Company is early in its development efforts and has only 11 Table of Contents one product candidate, TTI-101, in early clinical development and one product candidate, TTI-109, in preclinical development.”
SEC filings · May 30, 2025
Tvardi plans to seek additional funding but there is no assurance of availability.
“We plan to seek additional funding through equity offerings, including through our ATM Facility, or debt financings, credit or loan facilities, strategic alliances and licensing arrangements. However, there can be no assurance that such funding will be available to us, will be obtained on terms favorable to us, or will provide us with sufficient funds to meet our objectives.”
SEC MD&A · August 14, 2026
Catalyst timeline
- 2026-12-31 · Phase2_Topline · tti-101 — Phase 2 Readout: tti-101 — Topline data from the Phase 2 trial of TTI-101 will be a key value inflection point, determining whether the candidate shows sufficient efficacy and safety to advance to later-stage trials.
Risks & what to watch (4)›
Key risks
- Going concern risk — Cash insufficient to fund operations for at least one year; substantial doubt about ability to continue as a going concern [sec_mda · as of 2026-08-14].
- No revenue or approved products — No revenue from product sales; may never generate revenue or commercialize any product candidate [sec_mda · as of 2026-03-31].
- Dependence on TTI-101 — Only one product candidate in early clinical development; failure of TTI-101 would significantly harm the business [sec · filed 2025-05-30].
- Funding uncertainty — Requires substantial additional capital; no assurance of funding on acceptable terms [sec_mda · as of 2026-08-14].
What to watch
- Phase 2 topline data for TTI-101, expected by December 31, 2026 [upcoming catalysts].
- Ability to secure additional financing to extend cash runway beyond the going concern horizon [sec_mda · as of 2026-08-14].
- Progress of TTI-109 from preclinical into clinical development [sec · filed 2025-05-30].
- Any updates on regulatory interactions or partnership deals for TTI-101 or TTI-109 [sec_mda · as of 2026-08-14].
Sources: SEC filings · SEC MD&A · Generated August 28, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
5.3 months
D/E 1.09 · 0% dilution
Lead: Approved
3 candidates
1 upcoming, next in ~123d
No insider transactions in the last 180 days
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
66
Total value held
$9.5M
| Holder | Shares | Value |
|---|---|---|
| slate path capital lp | 704,118 | $2.2M |
| vanguard capital management llc | 689,416 | $2.2M |
| blackrock, inc. | 388,075 | $1.2M |
| american financial group inc | 223,659 | $711K |
| geode capital management, llc | 182,339 | $580K |
| silvercrest asset management group llc | 101,034 | $321K |
| state street corp | 97,231 | $309K |
| renaissance technologies llc | 92,100 | $293K |
| morgan stanley | 72,894 | $232K |
| ubs group ag | 50,454 | $160K |
Showing top 10 of 66 institutional holders of Tvardi Therapeutics, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 22, 2026- % of float
- 5.5%
- Days to cover
- 9.9
- Shares short
- 508,941
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
TVRD short interestGovernance
Frequently asked questions
What is the AI investment thesis for Tvardi Therapeutics, Inc.?
Tvardi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small molecule inhibitors of Signal Transducer and Activator of Transcription 3 (STAT3), with lead candidate TTI-101 in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and hepatocellular carcinoma (HCC), and a preclinical candidate TTI-109. The company has no approved products, no revenue, and has disclosed substantial doubt about its ability to continue as a going concern.
What is Tvardi Therapeutics, Inc.'s lead drug candidate?
Tvardi Therapeutics, Inc.'s most advanced tracked candidate is korsuva / kapruvia (Approved) for moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis.
What is Tvardi Therapeutics, Inc.'s next catalyst?
Tvardi Therapeutics, Inc.'s next tracked catalyst is a Phase2_Topline event — "Phase 2 Readout: tti-101" — expected December 31, 2026.
Who is the CEO of Tvardi Therapeutics, Inc.?
Dr. Imran Alibhai Ph.D. is the chief executive officer of Tvardi Therapeutics, Inc. (TVRD).
Where is Tvardi Therapeutics, Inc. headquartered?
Tvardi Therapeutics, Inc. (TVRD) is headquartered in Sugar Land, TX, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.