The newly formed Tvardi Therapeutics, Inc. (NASDAQ: TVRD) announced the completion of its merger with Cara Therapeutics on April 15, 2025, creating a clinical-stage biopharmaceutical company focused on developing novel treatments targeting STAT3 for fibrosis-driven diseases.
The combined entity began trading on the Nasdaq Capital Market on April 16 under the ticker symbol "TVRD," following a 1-for-3 reverse stock split of Cara's outstanding shares. The merger positions Tvardi as a public company with enhanced resources to advance its clinical pipeline.
Financial Position and Leadership
Concurrent with the merger announcement, Tvardi completed a private placement financing of approximately $28 million from new and existing institutional investors. Combined with Cara's approximately $24 million in cash at closing, the company expects to have sufficient funding to support operations into the second half of 2026.
"We are very pleased to have completed this merger and to be transitioning into a publicly traded company with the combined resources of science and capital to positively impact the lives of people suffering from serious, chronic, fibrosis-driven diseases," said Dr. Imran Alibhai, Chief Executive Officer of Tvardi, who will continue to lead the combined company along with the existing Tvardi management team.
Following the transaction, pre-merger Cara shareholders own approximately 15.4% of the combined company on a fully diluted basis, while pre-merger Tvardi shareholders (including investors in the private placement) own approximately 84.6%.
Clinical Pipeline and Development Strategy
Tvardi's clinical development strategy centers on its oral, small molecule STAT3 inhibitor, TTI-101. The company is currently conducting two Phase 2 clinical trials:
- Idiopathic Pulmonary Fibrosis (IPF): Topline data expected in the second half of 2025 (NCT05671835)
- Hepatocellular Carcinoma (HCC): Topline data expected in the first half of 2026 (NCT05440708)
STAT3 represents a compelling therapeutic target as it functions as a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival, and immune suppression. Additionally, STAT3 sits at the intersection of signaling pathways integral to cancer cell survival and immune evasion.
Scientific Progress
Recent scientific developments highlight the potential of Tvardi's approach. The company announced that results from its first-in-human Phase 1 study of TTI-101 in patients with advanced solid tumors were published in the journal Clinical Cancer Research, providing validation for the program's safety profile and preliminary efficacy signals.
Additionally, Tvardi will present new research at the upcoming American Thoracic Society 2025 Annual Conference in San Francisco. The abstract, titled "Single Cell Transcriptomics in A Treatment Status Segregated Cohort Exposes a STAT-3-Regulated Therapeutic Gap in Idiopathic Pulmonary Fibrosis," may provide further insights into the role of STAT3 in IPF pathogenesis and treatment.
Market Opportunity
Tvardi is targeting significant unmet medical needs with its STAT3 inhibitor platform. Idiopathic pulmonary fibrosis affects approximately 100,000 people in the United States, with 30,000-40,000 new cases diagnosed annually. The disease carries a poor prognosis, with a median survival of 3-5 years after diagnosis, and current treatments have limited efficacy and significant side effects.
Hepatocellular carcinoma represents the most common type of primary liver cancer and is the fourth leading cause of cancer-related deaths worldwide. Despite advances in treatment options, the five-year survival rate remains below 20% for most patients with advanced disease.
Looking Forward
"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 as well as our hepatocellular carcinoma program," said Dr. Alibhai in the company's first quarter 2025 financial results announcement on May 13.
The company's near-term focus will be on advancing its clinical programs toward data readouts while potentially exploring additional applications for its STAT3 inhibitor platform in other fibrosis-driven diseases.
As Tvardi transitions to a publicly traded company, it marked the occasion by ringing the Nasdaq Stock Market closing bell on April 16, 2025, symbolizing its entry into the public markets and the beginning of a new chapter in the company's development.
