Cara Therapeutics(US:CARA)2025-05-13 20:10Company Development and Mergers - On April 15, 2025, the company completed a merger with Legacy Tvardi, resulting in Legacy Tvardi becoming a wholly owned subsidiary and the company changing its name to Tvardi Therapeutics, Inc. [179] - Following the merger, approximately 7,805,161 shares of common stock were issued to Legacy Tvardi's stockholders and holders of outstanding convertible promissory notes, resulting in approximately 9.4 million shares being outstanding immediately after the merger [180] - Following the merger with Tvardi on April 15, 2025, Cara's historic business operations ceased, and the company will operate under Legacy Tvardi [197] - The company anticipates significant uncertainties regarding the realization of anticipated benefits from the merger and compliance with Nasdaq listing requirements [172] Financial Performance - Cara's total revenue for the three months ended March 31, 2025, was $2.569 million, representing a 20% increase from $2.135 million in the same period of 2024 [219] - Collaborative revenue increased by 52% to $1.198 million for the three months ended March 31, 2025, compared to $0.788 million in 2024 [220] - There was no commercial supply revenue for the three months ended March 31, 2025, down from $0.640 million in the same period of 2024, indicating a 100% decrease [221] - Clinical compound revenue decreased by 43% to approximately $48,000 for the three months ended March 31, 2025, compared to $84,000 in 2024 [222] - Cara's profit share from CSL Vifor for KORSUVA injection sales was $1.2 million for the three months ended March 31, 2025, compared to $0.8 million in 2024 [205] - Cara recognized non-cash revenue of approximately $1.3 million for the three months ended March 31, 2025, compared to $0.6 million for the same period in 2024, representing a significant increase [223] - Cara incurred net losses of $4.9 million for the three months ended March 31, 2025, significantly reduced from $30.7 million in 2024 [234] - The company had an accumulated deficit of $760.5 million as of March 31, 2025 [234] Cash Flow and Expenses - Cara reported a net cash used in operating activities of $30.5 million for the three months ended March 31, 2025, compared to $4.7 million for the same period in 2024 [250] - The net loss for the three months ended March 31, 2025, was $4.9 million, with a cash outflow of $4.1 million from changes in operating assets and liabilities [251] - Cara's cash and cash equivalents decreased by $5.2 million for the three months ended March 31, 2025, compared to a decrease of $3.7 million in the same period of 2024 [250] - The company had a net cash provided by financing activities of $1.0 million for the three months ended March 31, 2025, primarily from a milestone payment from HCR [255] - There was no net cash provided by investing activities for the three months ended March 31, 2025, compared to $26.0 million in the same period of 2024 [253][254] Research and Development - The company is focused on developing novel oral small molecule therapies targeting STAT3 for fibrosis-driven diseases, with TTI-101 currently in Phase 2 clinical development for idiopathic pulmonary fibrosis (IPF) and hepatocellular carcinoma (HCC) [177] - The company expects to report unblinded data from its Phase 2 IPF clinical trial in the second half of 2025 and preliminary topline data from its Phase 1b/2 HCC clinical trial in the first half of 2026 [177] - The company plans to submit an Investigational New Drug application for TTI-109 in the first half of 2025 [177] - The company is developing a pipeline of STAT3 inhibitors with a differentiated mechanism of action and convenient oral dosing [177] - Total Research and Development (R&D) expenses decreased by 99% to $319,000 for the three months ended March 31, 2025, down from $21.964 million in 2024, primarily due to the discontinuation of all clinical programs [225] Workforce and Restructuring - Cara's workforce was reduced by up to 70% in 2024 as part of a restructuring plan to focus on the development of oral difelikefalin [214] - The company incurred severance payments of approximately $5.7 million to former employees following the merger [247] Stock and Equity - The company conducted a 1-for-3 reverse stock split on April 15, 2025, and increased its authorized shares of common stock to 150,000,000 [178] - Cara's total outstanding common stock was approximately 9.4 million shares following the close of the merger [192] - As of March 31, 2025, Cara had negative stockholders' equity of $8.1 million, failing to meet Nasdaq's Stockholders' Equity Requirement of $2.5 million [193] Future Outlook and Funding - The company plans to seek additional funding through equity offerings or debt financings to finance operations and complete ongoing clinical trials [238] - The company anticipates significant and increasing expenses for the foreseeable future related to product candidate development and corporate infrastructure expansion [240] - Following the Merger, the company expects to incur significant expenses and operating losses as it advances clinical development and incurs costs associated with being a public company [235] Accounts Receivable and Financial Condition - Cara fully reserved approximately $0.4 million of accounts receivable related to CSL Vifor and $1.0 million of other receivables related to Maruishi due to expected future payment issues [268] - Cara's accounts receivable from CSL Vifor increased to approximately $1.2 million as of March 31, 2025, from $0.4 million as of December 31, 2024 [267] - The company did not have any off-balance sheet arrangements that could materially affect its financial condition as of March 31, 2025 [248] - Cara's investment policy aims to preserve principal and maintain liquidity, with no investments in available-for-sale marketable securities as of March 31, 2025 [262][266]