Welcome to our dedicated page for Tvardi Therapeutics SEC filings (Ticker: TVRD), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Tvardi Therapeutics, Inc. (NASDAQ: TVRD) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. Tvardi’s filings describe it as a Delaware corporation and a clinical-stage biopharmaceutical company focused on developing novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need.
Through documents such as Form 8-K current reports, investors can review Tvardi’s announcements regarding financial results, business updates, executive and director changes, compensation arrangements, and key clinical and corporate events. Recent 8-K filings have covered quarterly results, updates on preliminary data from the REVERT IPF Phase 2 trial of TTI-101 in idiopathic pulmonary fibrosis, the availability of updated corporate presentations, and the adoption of a severance and change in control plan and retention equity awards for certain employees.
Registration statements on Form S-1/A offer additional detail on Tvardi’s business following its merger with Legacy Tvardi, the change of name from Cara Therapeutics, Inc. to Tvardi Therapeutics, Inc., and the commencement of trading on The Nasdaq Capital Market under the symbol TVRD. These filings also outline the company’s status as a smaller reporting company and its focus on STAT3-targeted clinical programs, including TTI-101 and TTI-109.
On Stock Titan, Tvardi’s SEC filings are updated as new documents are posted to EDGAR, and AI-powered summaries can help explain the key points in lengthy filings such as registration statements and current reports. Users can quickly identify items related to clinical trial disclosures, capital structure, compensation plans, and other material events, and can also monitor how Tvardi describes the progress and risks associated with its STAT3 inhibitor programs over time.
Tvardi Therapeutics, Inc. is a clinical-stage biopharma developing oral STAT3 inhibitors TTI-101 (in Phase 1b/2 for hepatocellular carcinoma) and TTI-109 (next‑gen prodrug now through a positive Phase 1 healthy‑volunteer trial, with ulcerative colitis selected as its initial indication).
For the quarter ended June 30, 2026, Tvardi reported a net loss of $6.5 million and a six‑month net loss of $13.3 million, with no product revenue. Cash and cash equivalents were $15.8 million, total assets $17.5 million and accumulated deficit $123.7 million. Operating cash outflow for the first six months was $15.1 million.
Management states that these losses, limited cash and the need for significant additional funding raise substantial doubt about Tvardi’s ability to continue as a going concern. The company put in place a $200.0 million shelf registration and an at‑the‑market program, under which it has raised approximately $13.3 million gross through August 11, 2026.
Tvardi Therapeutics reported second-quarter 2026 results and clinical progress on its STAT3 inhibitor programs. The company highlighted topline healthy-volunteer results for next-generation STAT3 inhibitor TTI-109, which confirmed its prodrug design, showed improved tolerability and reductions in disease-relevant immune cell populations. Tvardi also selected ulcerative colitis as the initial indication for TTI-109 and plans a KOL webinar on its clinical potential.
For the quarter ended June 30, 2026, research and development expense was $4.0 million, down from $5.8 million a year earlier, and general and administrative expense was $2.6 million, down from $3.1 million. Tvardi reported a net loss of $6.5 million, versus net income of $4.2 million in the prior-year period, which had included a $12.7 million non-cash gain from revaluation of convertible notes. Cash, cash equivalents and short-term investments totaled $15.8 million at June 30, 2026, compared with $30.8 million at December 31, 2025. Management anticipates existing liquidity will fund operations, as currently planned, through the hepatocellular carcinoma topline readout into the third quarter of 2027, while advancing TTI-109 into ulcerative colitis and additional indications will require further funding and IND clearance.
Tvardi Therapeutics, Inc. has selected ulcerative colitis (UC) as the initial disease indication for its next‑generation oral STAT3 inhibitor TTI‑109. This decision follows a Phase 1 healthy volunteer study in which TTI‑109 modulated multiple STAT3‑driven immune cell populations, including Th17, T follicular helper and B cells implicated in UC pathology, with what the company describes as a differentiated safety profile from JAK inhibitors across more than 400 subjects dosed with its STAT3 inhibitors.
The company plans to initiate a study of TTI‑109 in patients with moderate‑to‑severe UC in 2027, subject to Investigational New Drug clearance and additional funding. Safety will be the primary endpoint, with clinical remission at 12 weeks as a key secondary endpoint and exploratory pharmacodynamic analyses of serum and tissue biomarkers and single nucleotide polymorphisms. Tvardi highlights UC as a large, underserved market with more than 1.25 million diagnosed patients in the United States and an estimated addressable market of approximately $3 billion domestically and $9 billion globally, while it continues to advance related STAT3 inhibitor TTI‑101 in hepatocellular carcinoma and other fibrotic and inflammatory settings.
Tvardi Therapeutics, Inc. filed a prospectus supplement to increase its existing at-the-market offering program, permitting the issuance of up to $9,689,765 in additional shares of common stock under its Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC.
The shares are issued under an effective shelf registration statement on Form S-3 registering up to $12.5 million of common stock. The company is subject to General Instruction I.B.6 of Form S-3, the baby shelf rule, and reports an aggregate market value of non-affiliate common stock of $62,208,945, based on 12,441,789 non-affiliate shares at $5.00 per share. Over the prior twelve-month period, it sold 3,110,769 shares for approximately $11.0 million in gross proceeds under the earlier sales agreement prospectus, and no additional stock will be sold under that earlier prospectus.
Tvardi Therapeutics, Inc. is launching an at-the-market equity program to sell up to $9,689,765 of common stock through JonesTrading under an existing Capital on Demand Sales Agreement. JonesTrading will act as sales agent on a commercially reasonable efforts basis and receive up to 3.0% of gross proceeds as commission.
The company’s non‑affiliate float is valued at $62,208,945 under General Instruction I.B.6 of Form S‑3, and it has sold about $11.0 million of stock in the prior twelve months under this rule. Assuming sales at $3.08 per share, up to 3,146,027 new shares could be issued, increasing shares outstanding from a pro forma 12,492,113 to up to 15,638,140 and causing an illustrated dilution of $0.91 per share. Net proceeds are intended for general corporate purposes, including clinical trial, research and development, general and administrative expenses, capital expenditures and potential in‑licensing or acquisitions.
Tvardi Therapeutics reported Phase 1 results for TTI-109, an oral phosphate prodrug of its STAT3 inhibitor TTI-101, showing it rapidly converts to TTI-101 and achieves dose-proportional exposures above the STAT3 IC₅₀ in healthy volunteers.
Across single and multiple ascending dose cohorts, TTI-109 delivered TTI-101-equivalent systemic exposure at molar-equivalent doses and showed an improved gastrointestinal tolerability profile, with diarrhea rates and duration closer to placebo than TTI-101. Exploratory pharmacodynamic analyses found reductions of up to 60% in STAT3-driven immune cell populations, including Th17, T follicular helper and B cells, which are implicated in inflammatory and proliferative dermatologic and gastrointestinal diseases. Tvardi plans to advance TTI-109 into Phase 2 trials in these indications, subject to IND clearance and additional funding, while continuing its Phase 1b/2 REVERT LIVER CANCER trial of TTI-101 in hepatocellular carcinoma and targeting topline data in the second half of 2026.
Tvardi Therapeutics, Inc. director Susan Shiff, Ph.D. received a grant of stock options covering 6,000 shares of common stock. The options have an exercise price of $2.78 per share and expire on June 8, 2036. 100% of the shares underlying the option vest on the earlier of June 9, 2027 or the company’s next annual meeting of stockholders, subject to her continuous service. Following this grant, she holds 6,000 stock options directly.
Tvardi Therapeutics, Inc. director Cynthia Smith reported receiving a grant of stock options as equity compensation. The award covers 6,000 options to buy Tvardi common stock at an exercise price of $2.78 per share, expiring on June 8, 2036.
All 6,000 underlying shares vest in a single tranche on the earlier of June 9, 2027 or the date of Tvardi’s next annual meeting of stockholders, provided she remains in continuous service through that vesting date. Following this grant, she holds 6,000 derivative securities directly.
Tvardi Therapeutics director Sujal Shah received a stock option grant for 6,000 shares of common stock. The option has an exercise price of $2.78 per share and expires on June 8, 2036. All 6,000 underlying shares will vest on the earlier of June 9, 2027 or the company’s next annual stockholder meeting, assuming he remains in continuous service.
Tvardi Therapeutics, Inc. director Hall Wallace Jr. received a grant of stock options covering 6,000 shares of common stock. The options have an exercise price of $2.78 per share and expire on June 8, 2036.
All 6,000 underlying shares will vest on the earlier of June 9, 2027 or the company’s next annual meeting of stockholders, as long as Wallace continues in service through that date. This is a compensation-related award rather than an open-market purchase or sale.