Tvardi Therapeutics (TVRD 0.21%), a clinical-stage biopharmaceutical company focused on developing new therapies for serious diseases, released its second quarter fiscal 2025 results on August 14, 2025. The headline news was a GAAP diluted loss per share of $(1.00), falling short of analyst estimates, which called for a GAAP loss of $(0.68). The EPS miss was driven by higher operating costs, including merger-related professional fees. Net income was $4.2 million, a sharp move from a $7.0 million loss in the prior-year period, though this swing was driven by non-operating gains and not underlying business momentum. Overall, the period captured the volatility typical of newly public biotechs, with operational execution on key clinical trials, but mixed underlying financials relative to expectations.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) - Diluted | ($1.00) | ($0.68) | ($2.71) | 63.1 % |
| Net Income | $4.2 million | ($7.0 million) | NM | |
| Research & Development Expenses | $5.8 million | $6.5 million | (10.8 %) | |
| General & Administrative Expenses | $3.1 million | N/A | N/A | |
| Cash, Cash Equivalents & Short-term Investments | $41.0 million(as of Jun 30, 2025) | $31.6 million(as of Dec 31, 2024) | 29.7 % |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Strategic Focus
Tvardi Therapeutics is a biopharmaceutical company researching and developing treatments for conditions such as cancer and lung scarring diseases that currently lack effective therapies. Its pipeline is anchored by TTI-101, a STAT3 inhibitor, which is being developed for idiopathic pulmonary fibrosis (IPF) and liver cancer. TTI-101 is an oral medicine designed to block a key protein involved in disease progression.
Tvardi’s strategy centers on advancing clinical trials, partnering for commercialization, and strengthening its financial base through targeted corporate actions. The core drivers for the business are timely achievement of clinical milestones, intellectual property protection, and sound capital management. Strategic transactions, such as the completed merger with Cara Therapeutics, have also become a major focus as the company transitions to a public listing and works to streamline operations for future growth.
Highlights and Key Developments During the Quarter
The quarter was a period of transformation as Tvardi completed a merger with Cara Therapeutics, a move that provided public company status and a boost to its cash position. The merger, while a critical milestone, resulted in $1.6 million in additional professional fees. These costs, reflected in increased general and administrative (G&A) expenses, contributed to the 371.2% year-over-year rise in G&A outlays compared to Q2 2024.
Clinical trial progress continued to anchor the operational narrative. The REVERT Phase 2 study of TTI-101 for IPF completed patient enrollment, keeping it on pace to report top-line results by the fourth quarter of 2025 as previously guided. In liver cancer, enrollment in the Phase 2 REVERT trial of TTI-101 is ongoing, with top-line data expected in the first half of 2026. Interim data from studies of TTI-101 have shown activity both as a standalone and when used alongside established cancer agents, and the company presented mechanistic results at a major international medical conference. These steps deepen external validation of the science underpinning its clinical strategy.
The company is also expanding its pipeline. In June 2025, Tvardi submitted an Investigational New Drug (IND) application for TTI-109, its second clinical-stage candidate, to the US Food and Drug Administration. The IND application process is a regulatory milestone that companies in biotechnology must complete before beginning trials of a new medicine in humans.
On the financial front, The most prominent change was in GAAP net income, which turned positive due to a $12.8 million gain from remeasuring convertible notes after the merger. This accounting gain was not related to actual sales or operational efficiency, so it does not imply regular ongoing profitability. Research and development (R&D) spending decreased by 11.1% compared to the same period in 2024. The cash, cash equivalents, and short-term investments balance increased to $41.0 million as of Q2 2025, supported by inflows from the merger and prior private placement, with management projecting sufficient funding through Q4 2026. Tvardi also eliminated $30.3 million in convertible notes, and increased stockholder equity from negative $91.1 million as of December 31, 2024, to positive $32.9 million as of June 30, 2025, within six months.
Looking Ahead
For the rest of the year and into 2026, the company’s focus will be on executing clinical trial milestones for both IPF and liver cancer. With top-line Phase 2 data for TTI-101 in IPF expected in the last quarter of 2025, and results from liver cancer trials anticipated in the first half of 2026, these clinical events will be critical. No other specific financial or operational guidance was offered by management for upcoming quarters.
Management reiterated that its cash position is enough to fund planned operations into the fourth quarter of 2026, offering a degree of runway for continued R&D programs and corporate initiatives.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
