Full Press Release Details
Tvardi Therapeutics Announces Second Quarter
2025 Results and Provides Business Update
On track for multiple Phase 2 data readouts
with STAT3 inhibitor, TTI-101, with lead program in IPF expected in Q4 2025
Cash runway anticipated to be sufficient to
fund operations into Q4 2026
HOUSTON, TX - August 14,
2025 - 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:
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:
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 tvarditherapeutics.com
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 www.sec.gov.
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.
Tvardi Investor Relations
Consolidated Balance Sheets
| As of June 30, | 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 | ) | |||||
| Total liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) | $ | 43,750 | $ | 35,199 |
Consolidated Statement of Operations
| 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 | ) |