Cara Therapeutics(US:CARA)2025-11-13 21:10Financial Performance - Tvardi reported net losses of $5.5 million and $10.9 million for the three and nine months ended September 30, 2025, respectively, compared to net losses of $5.5 million and $16.7 million for the same periods in 2024[129]. - The accumulated deficit as of September 30, 2025, was $103.2 million, up from $92.2 million as of December 31, 2024[129]. - The net loss for the three months ended September 30, 2025, was $5.5 million, a slight increase of 0.3% compared to a net loss of $5.5 million in 2024[193]. - Total operating expenses for the nine months ended September 30, 2025, were $19.2 million, an increase of 10.7% from $17.3 million in 2024[193]. - General and administrative expenses for the nine months ended September 30, 2025, totaled $6.6 million, a significant increase of 194.1% from $2.3 million in 2024[201]. - The increase in general and administrative expenses was primarily driven by a $2.7 million rise in professional fees due to legal and audit costs associated with the Merger[201]. - Other income, net for the nine months ended September 30, 2025, was $7.2 million, primarily due to a $12.8 million remeasurement gain on Convertible Notes, partially offset by a $4.9 million loss[205]. - Net cash used in operating activities was $17.8 million for the nine months ended September 30, 2025, compared to $13.5 million for the same period in 2024, indicating a 31.6% increase in cash outflow[215]. - Net cash used in investing activities was $15.1 million for the nine months ended September 30, 2025, due to purchases of short-term investments[220]. - The net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $22.7 million, primarily from the Merger and stock option exercises[222]. Research and Development - Preliminary data from the Phase 2 clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF) indicated that the study did not meet its goals, with discontinuation rates of 56.7% and 62.1% for the 400mg and 800mg treatment arms, respectively[138][141]. - The Phase 2 trial enrolled 88 patients, with 58% receiving concomitant therapy, and demonstrated no statistically significant differences in efficacy between treatment arms[140][144]. - Tvardi's second product candidate, TTI-109, is currently in a Phase 1 trial, with topline data expected in the first half of 2026[127][147]. - Research and development expenses are expected to increase substantially as Tvardi continues to invest in the development of TTI-101 and TTI-109[180]. - Research and development expenses decreased to $3.6 million for the three months ended September 30, 2025, from $4.8 million in the same period of 2024, a reduction of 24.9%[194]. - Research and development expenses for the nine months ended September 30, 2025, were $12.5 million, down 16.8% from $15.0 million in 2024[196]. Cash and Investments - As of September 30, 2025, Tvardi had $21.4 million in cash and cash equivalents and $15.0 million in short-term investments[129]. - As of September 30, 2025, there were 551,221 shares of Tvardi's common stock remaining available for grant under the 2025 Equity Incentive Plan[154]. - As of September 30, 2025, Tvardi had $21.4 million in cash and cash equivalents and $15.0 million in short-term investments, down from $31.6 million in cash and cash equivalents as of December 31, 2024[256]. Financing and Capital Structure - The company has historically financed operations through the issuance of preferred stock and convertible debt, raising $28.3 million from Convertible Notes and $83.4 million from preferred stock and convertible debt in 2018 and 2021[128]. - Following the merger with Cara Therapeutics, Tvardi acquired approximately $23.9 million in net assets[129][148]. - Following the Merger, equity holders of Legacy Tvardi owned approximately 84.5% of the outstanding Tvardi common stock on a fully diluted basis[151]. - The Convertible Notes issued by Legacy Tvardi in December 2024 had an aggregate principal amount of approximately $28.3 million, accruing interest at 8% per annum[155]. - Upon the closing of the Merger, the outstanding principal balance of the Convertible Notes converted into 1,265,757 shares of Tvardi common stock, resulting in a gain of $12.8 million recorded in Q2 2025[156]. - Future funding requirements will depend on various factors, including the costs and timing of clinical trials and regulatory approvals[214]. - Tvardi plans to seek additional funding through equity offerings or debt financings following its Merger with Cara in April 2025[210]. Market and Operational Risks - Tvardi has an accumulated deficit of $103.2 million as of September 30, 2025, raising substantial doubt about its ability to continue as a going concern[210]. - The company has incurred significant operating losses since inception and does not expect to generate revenue from product sales for several years[208]. - The fair value of the Convertible Notes at the time of conversion was $23.1 million, with a change in fair value of $12.8 million recorded as other income for Q2 2025[244]. - Tvardi's primary exposure to market risk is interest rate sensitivity, with an immediate 10% change in interest rates expected to have no material effect on fair market value[256]. - Inflation has not had a material effect on Tvardi's results of operations during the reported periods[257]. - The company has not made any material adjustments to its prior estimates of accrued research and development expenses[235]. - Payments under contracts with service providers depend on successful patient enrollment and completion of clinical trial milestones[235].