Latest news with #TvardiTherapeutics
Yahoo
2 days ago
- Business
- Yahoo
Tvardi: Q2 Earnings Snapshot
SUGAR LAND, Texas (AP) — SUGAR LAND, Texas (AP) — Tvardi Therapeutics, Inc. (TVRD) on Thursday reported second-quarter net income of $4.2 million. On a per-share basis, the Sugar Land, Texas-based company said it had net loss of $1. The results missed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 51 cents per share. _____ This story was generated by Automated Insights ( using data from Zacks Investment Research. Access a Zacks stock report on TVRD at Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
San Francisco Chronicle
2 days ago
- Business
- San Francisco Chronicle
Tvardi: Q2 Earnings Snapshot
SUGAR LAND, Texas (AP) — SUGAR LAND, Texas (AP) — Tvardi Therapeutics, Inc. (TVRD) on Thursday reported second-quarter net income of $4.2 million. On a per-share basis, the Sugar Land, Texas-based company said it had net loss of $1. The results missed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 51 cents per share. _____
Business Wire
2 days ago
- Business
- Business Wire
Tvardi Therapeutics Announces Second Quarter 2025 Results and Provides Business Update
HOUSTON--(BUSINESS WIRE)--Tvardi Therapeutics, Inc. ('Tvardi') (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced its financial and operating results for the second quarter ended June 30, 2025, and provided a business update. Second Quarter 2025 Highlights: Announced completion of enrollment in its REVERT IPF clinical trial, a Phase 2 trial of TTI-101, for patients with idiopathic pulmonary fibrosis (IPF); topline data on track for Q4 2025. Submitted an Investigational New Drug (IND) application for its second clinical candidate, TTI-109, with the U.S. Food and Drug Administration (FDA) in June 2025. Announced that an abstract, entitled Single Cell Transcriptomics in A Treatment Status Segregated Cohort Exposes a STAT-3-Regulated Therapeutic Gap in Idiopathic Pulmonary Fibrosis, was presented at the American Thoracic Society (ATS) 2025 Annual Conference. Completed its merger with Cara Therapeutics, transitioning Tvardi into a publicly traded company. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, 'We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial. These data will offer important additional insights into the safety and efficacy of TTI-101, and, if positive, we believe will further validate our approach of targeting STAT3, a central mediator of fibrosis, to treat patients with IPF. 'In parallel, our Phase 2 REVERT Liver Cancer trial continues to enroll patients, and we remain on track to report topline results in the first half of 2026. Prior interim data from this ongoing study demonstrated clinically meaningful activity of TTI-101 as both monotherapy and in combination with established anti-cancer agents across treatment lines. 'Importantly, we are well-financed through these potential value inflection points, and into Q4 of next year. We believe we are very well positioned to bring meaningful innovation to patients living with fibrosis driven-diseases while creating significant value for our company.' Upcoming Milestones: Data from the company's ongoing REVERT IPF Phase 2 clinical trial of TTI-101 anticipated in 4Q 2025 Preliminary topline data from the company's ongoing REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 anticipated in 1H 2026 Second Quarter 2025 Financial Results Research and development expenses for the three months ended June 30, 2025, were $5.8 million as compared to $6.5 million for the comparable period in 2024. The decrease of $0.7 million was primarily driven by clinical, pre-clinical, and CMC costs associated with TTI-101. General and administrative expenses for the three months ended June 30, 2025, were $3.1 million as compared to $650,000 for the comparable period in 2024. The increase of $2.4 million was primarily driven by increases in professional fees of $1.6 million, attributable to increased legal, accounting and audit fees incurred as a result of the merger. The remaining increase was attributable to increases in personnel costs, insurance costs, and other costs. Net income for the three months ended June 30, 2025, was $4.2 million as compared to a net loss of $7.0 million for the comparable period in 2024. The improvement in net income was due primarily to a $12.8 million remeasurement gain on Tvardi's Convertible Notes recognized in the second quarter of 2025. Basic and diluted net income (loss) per share attributable to common shareholders for the three months ended June 30, 2025, were a net gain of $0.51 and net loss of $1.00, respectively, compared to a net loss of $2.71 on a basic and diluted basis for the comparable period in 2024. Cash, cash equivalents and short-term investments as of June 30, 2025, were $41.0 million, as compared to $31.6 million as of December 31, 2024. About Tvardi Therapeutics Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). To learn more, please visit or follow us on LinkedIn and X (Twitter). Cautionary Statement Regarding Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi's product candidates; its ongoing clinical trials; its anticipated cash runway; and other statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi's product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi's ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi's clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi's product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi's product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi's anticipated cash runway; Tvardi's ability to attract, hire, and retain skilled executive officers and employees; Tvardi's ability to protect its intellectual property and proprietary technologies; Tvardi's reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi's filings with the Securities and Exchange Commission, including the 'Risk Factors' section of the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and Tvardi's other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC's website at All forward-looking statements contained in this press release speak only as of the date on which they were made. The combined company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. (Unaudited) As of December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 20,648 $ 31,614 Short-term investments 20,346 — Prepaid expenses and other current assets 2,136 72 Total current assets 43,130 31,686 Property and equipment, net 68 84 Intangible assets, net 354 385 Operating lease right-of-use assets 181 216 Deferred offering costs — 2,811 Other non-current assets 17 17 Total assets $ 43,750 $ 35,199 Liabilities, Redeemable Convertible Preferred Stock, and Stockholders' Equity (Deficit) Current liabilities: Accounts payable $ 2,425 2,186 Accrued expenses 8,144 8,078 Operating lease liabilities, current portion 109 103 Total current liabilities 10,678 10,367 Operating lease liabilities, net of current portion 145 201 Convertible Notes — 30,259 Total liabilities 10,823 40,827 Commitments and contingencies (Note 13) Redeemable convertible preferred stock (Series A, B), $0.001 par value; 0 shares and 29,723,540 shares authorized as of June 30, 2025 and December 31, 2024, respectively; 0 shares and 3,963,910 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively; aggregate liquidation preference of $0 and $85,902 as of June 30, 2025 and December 31, 2024, respectively — 85,503 Stockholders' Equity (Deficit): Common stock, $0.001 par value; 150,000,000 shares and 58,251,629 shares authorized as of June 30, 2025 and December 31, 2024, respectively; 9,373,433, and 2,574,767 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively 9 2 Additional paid-in capital 130,579 1,103 Accumulated other comprehensive loss (13 ) — Accumulated deficit (97,648 ) (92,236 ) Total stockholders' equity (deficit) 32,927 (91,131 ) $ 43,750 $ 35,199 Expand TVARDI THERAPEUTICS Consolidated Statement of Operations (Unaudited) For the Three Months Ended June 30, 2025 2024 Operating expenses: Research and development $ 5,806 $ 6,531 General and administrative 3,063 650 Total operating expenses 8,869 7,181 Loss from operations (8,869 ) (7,181 ) Interest income 377 206 Other income, net 12,659 — Net income (loss) $ 4,167 $ (6,975 ) Net income (loss) per share attributable to common stockholders: Basic $ 0.51 $ (2.71 ) Diluted $ (1.00 ) $ (2.71 ) Weighted-average common shares outstanding: Basic 8,246,582 2,574,767 Diluted 8,455,223 2,574,767 Comprehensive income (loss): Net income (loss) $ 4,167 $ (6,975 ) Unrealized loss on short-term investments (15 ) — Comprehensive income (loss) $ 4,152 $ (6,975 ) Expand
Yahoo
18-07-2025
- Business
- Yahoo
This ‘Strong Buy' Stock Could Be the Next Big Biotech Breakout
Clinical-stage biotech stocks carry significant risks, but also offer explosive upside potential. These companies are built around early stage innovations that, if successful, can evolve into billion-dollar therapies or entire treatment platforms. The company's valuation at this stage is less dependent on fundamentals like revenue or profit and instead hinges on scientific milestones, meaning a single clinical trial result or regulatory approval can send the stock soaring. Valued at $212 million, Tvardi Therapeutics (TVRD) is a clinical-stage biopharmaceutical company developing oral small-molecule drugs targeting STAT3, a protein linked to fibrosis and certain cancers when overactive. Following its merger with Cara Therapeutics, Tvardi has rapidly gained traction in the biotech space. More News from Barchart Insider Trading Alert: Here's Who Bought Nvidia and AMD Stock Before the U.S. Chip Deal with China Dear Tesla Stock Fans, Mark Your Calendars for July 23 Robinhood Keeps Hitting New Highs. How Should You Play HOOD Stock Here? Markets move fast. Keep up by reading our FREE midday Barchart Brief newsletter for exclusive charts, analysis, and headlines. The stock is already up 32% in the year to date, and analysts believe it still has substantial room to run. Setting the Stage for a Strong Pipeline The company's lead candidate, TTI-101, is an oral pill that is designed to block overactive STAT3. It is currently in Phase 2 trials for Idiopathic Pulmonary Fibrosis (IPF), a serious lung-scarring disease, and Hepatocellular Carcinoma (HCC), a type of liver cancer. The REVERT IPF Phase 2 trial is evaluating the efficacy of TTI-101 alone and in combination with the approved drug nintedanib to treat patients with IPF, a progressive and often fatal lung disease with few treatment options. The company completed enrollment for the Phase 2 trial at the end of May and expects top-line data by the fourth quarter of this year. Success in this trial would validate oral STAT3 as a therapeutic mechanism and provide momentum for additional indications such as HCC. What's noteworthy is that the U.S. Food and Drug Administration (FDA) has designated TTI-101 as an orphan drug in both IPF and HCC. This designation is given to drugs that treat rare diseases with significant unmet needs. The FDA has also granted TTI-101 Fast Track Designation for HCC only. This will speed up the candidate's review process. Tvardi also expects top-line data from its REVERT Liver Cancer Phase 1b/2 clinical trial for HCC in the first half of 2026. Additionally, Tvardi has TTI‑109, a next-generation STAT3 inhibitor, in the preclinical stage, which means it has not yet entered human trials. This suggests that it could enter clinical development within 12 months. If pursued, it would broaden Tvardi's fibrosis-related disease portfolio and strengthen its long-term clinical pipeline. The company's products are still in the clinical stage and have not yet been approved for the market. As a result, it generates no revenue and requires external financing to run its operations. The merger with Cara was critical not only for securing a path to a Nasdaq listing, but also for strengthening its financing. With approximately $28.3 million in private placement funding and $23.8 million in net cash from Cara, Tvardi has secured a cash runway until late 2026, covering the critical readout periods of its lead candidate's trials. Tvardi Therapeutics stock represents a typical high-risk, high-reward biotech investment. With no revenue, its valuation is entirely dependent on clinical trial results. The company has breakout potential, which is why Wall Street is optimistic. Tvardi's breakthrough IPF results may spark major collaborations. Furthermore, positive HCC outcomes would broaden its oncology portfolio. On the flip side, risks include clinical trial or safety failures, as well as delays in regulatory approvals. This is why the stock is appropriate for investors who are comfortable with the volatility that comes with clinical-stage biotech stocks. What Does Wall Street Say About Tvardi's Stock? Overall, Wall Street rates the stock a 'Strong Buy.' Of the six analysts covering TVRD stock, five of them rate it as a 'Strong Buy,' with one suggesting a 'Moderate Buy.' The average price target is $58.33, which represents 151% upside from current levels. Its high target price of $78 implies the stock can surge 233% over the next 12 months. On the date of publication, Sushree Mohanty did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
15-07-2025
- Business
- Business Wire
Tvardi Therapeutics to Participate in the BTIG Virtual Biotechnology Conference
HOUSTON--(BUSINESS WIRE)--Tvardi Therapeutics, Inc. ('Tvardi') (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced that the Company's Management will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Wednesday, July 30, 2025 at 4:40 PM ET and participate in one-on-one investor meetings. The webcast of the fireside chat will be accessible on the Tvardi Investors' website. A replay of the webcast will be available for approximately 60 days following the conference. About Tvardi Therapeutics Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). To learn more, please visit or follow us on LinkedIn and X (Twitter).
