Tvardi Therapeutics | 8-K: FY2026 Q2 Revenue: USD 0

Revenue: As of FY2026 Q2, the actual value is USD 0.

EPS: As of FY2026 Q2, the actual value is USD -0.69, missing the estimate of USD -0.625.

EBIT: As of FY2026 Q2, the actual value is USD -6.457 M.

Operating Expenses

• Research and development expenses for the three months ended June 30, 2026, were $4.0 million, a decrease from $5.8 million for the comparable period in 2025. For the six months ended June 30, 2026, these expenses were $8.913 million, compared to $8.917 million for the same period in 2025.
• General and administrative expenses were $2.6 million for the three months ended June 30, 2026, a decrease from $3.1 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, these expenses were $4.767 million, an increase from $4.306 million for the same period in 2025.
• Total operating expenses for the three months ended June 30, 2026, were $6.629 million, down from $8.869 million in the comparable 2025 period. For the six months ended June 30, 2026, total operating expenses were $13.680 million, an increase from $13.223 million for the same period in 2025.

Net (Loss) Income

• Loss from operations for the three months ended June 30, 2026, was - $6.629 million, an improvement from - $8.869 million in the comparable 2025 period. For the six months ended June 30, 2026, loss from operations was - $13.680 million, compared to - $13.223 million for the same period in 2025.
• Interest income was $0.172 million for the three months ended June 30, 2026, compared to $0.377 million in the comparable 2025 period. For the six months ended June 30, 2026, interest income was $0.419 million, compared to $0.652 million for the same period in 2025.
• Other income, net was $0 million for the three months ended June 30, 2026, compared to $12.659 million in the comparable 2025 period. For the six months ended June 30, 2026, other income, net was $0 million, compared to $7.159 million for the same period in 2025.
• Net loss for the three months ended June 30, 2026, was - $6.457 million, compared to a net income of $4.167 million for the three months ended June 30, 2025. For the six months ended June 30, 2026, net loss was - $13.261 million, compared to - $5.412 million for the same period in 2025.

Cash Position

• Cash, cash equivalents and short-term investments were $15.8 million as of June 30, 2026, a decrease from $30.8 million as of December 31, 2025.

Balance Sheet (in thousands)

• Total current assets as of June 30, 2026, were $17,069, down from $31,538 as of December 31, 2025.
• Total assets as of June 30, 2026, were $17,517, compared to $32,073 as of December 31, 2025.
• Total current liabilities as of June 30, 2026, were $9,113, compared to $11,042 as of December 31, 2025.
• Total liabilities as of June 30, 2026, were $9,135, compared to $11,127 as of December 31, 2025.
• Total stockholders’ equity as of June 30, 2026, was $8,382, compared to $20,946 as of December 31, 2025.

Operational Metrics and Developments

• Tvardi Therapeutics, Inc. reported topline results from the healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, confirming its prodrug design, improved tolerability, and pharmacodynamic evidence of STAT3 target engagement.
• TTI-109 delivered TTI-101-equivalent exposure with improved tolerability and reductions in cellular and humoral immune populations.
• Ulcerative Colitis (UC) has been selected as the initial disease indication for TTI-109, representing a large, underserved market with over 1.25 million patients diagnosed in the U.S. and an addressable market of approximately $3 billion in the U.S. and $9 billion globally.

Outlook and Guidance

• Tvardi Therapeutics, Inc. anticipates its existing cash, cash equivalents, and short-term investments will fund operations through the TTI-101 HCC topline readout into the third quarter of 2027.
• Key upcoming milestones include a KOL webinar on August 19, 2026, and topline data for TTI-101 Phase 1b/2 HCC in Q4 2026.
• The initiation of a clinical trial for TTI-109 in UC is planned for 2027, subject to Investigational New Drug (IND) application clearance and additional funding.