TVRD on Nasdaq

Tvardi Therapeutics, Inc.

American pharmaceutical preparations company, incorporated in Delaware1

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting Signal Transducer and Activator of Transcription 3 (STAT3) to treat inflammatory and proliferative diseases with significant unmet need. We have been developing TTI-109 for several years, based on our recognition that retaining the full STAT3 inhibition mechanism of TTI-101 while enhancing delivery would broaden the potential utility of our platform across inflammatory and proliferative indications.”3 It is headquartered in Sugar Land, Texas.1 Its shares trade on Nasdaq under the symbol TVRD.1

Price unavailable

Last updated Oct 21, 2026.

Overview

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  • TickerTVRD on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSugar Land, Texas1
  • Incorporated inDE2
  • Business address3 Sugar Creek Ctr. Blvd., Ste 525, Sugar Land, Tx 774782
  • Filer categoryNon-accelerated filer, Smaller reporting company2

We are a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting Signal Transducer and Activator of Transcription 3 (STAT3) to treat inflammatory and proliferative diseases with significant unmet need. Based upon our founders ’ seminal work and deep understanding of the transcription factor STAT3, we have designed an innovative approach to directly inhibit STAT3, a highly validated, yet historically undruggable target. Leveraging this expertise, we are developing a pipeline of STAT3 inhibitors with a differentiated mechanism of action and convenient oral dosing.3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2024

-393.8%Operating margin4
-411.9%Net margin4
-66.0%Revenue growth, 20245
-$19.4MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Research and development100¢$23.6M

Out of $7.1M in revenue.54 The company lost money this year.

Financial statements

Revenue6785$7.1M in 2024−64% since 2019
0$50.0M$100.0M$150.0M2019: $19.9M$19.9M20192020: $135.1M$135.1M2020+579%2021: $23.0M$23.0M2021−83%2022: $41.9M$41.9M2022+82%2023: $21.0M$21.0M2023−50%2024: $7.1M$7.1M2024−66%
Operating income67854-$28.1M in 2024−75% since 2019
-$150.0M-$100.0M-$50.0M0$50.0M2019: -$111.7M-$111.7M20192020: $5.4M$5.4M20202021: -$89.1M-$89.1M20212022: -$87.5M-$87.5M2022−2%2023: -$121.5M-$121.5M2023+39%2024: -$28.1M-$28.1M2024−77%
Net income67854-$29.4M in 2024−72% since 2019
-$150.0M-$100.0M-$50.0M0$50.0M2019: -$106.4M-$106.4M20192020: $8.4M$8.4M20202021: -$88.4M-$88.4M20212022: -$85.5M-$85.5M2022−3%2023: -$118.5M-$118.5M2023+39%2024: -$29.4M-$29.4M2024−75%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Research and development$18.0M$23.6M
General and administrative$8.7M$4.5M
Total operating expenses$26.7M$28.1M
Loss from operations-$26.7M-$28.1M
Interest income$1.4M$747.0K
Other income (expense), net$7.2M-$2.0M
Net loss per share attributable to common stockholders, Basic (in dollars per share)-$2.46-$11.42
Net loss per share attributable to common stockholders, Diluted (in dollars per share)-$3.26-$11.42
Weighted-average common shares outstanding, Basic (in shares)7.4M shares2.6M shares
Weighted-average common shares outstanding, Diluted (in shares)7.8M shares2.6M shares
Net loss-$18.2M-$29.4M
Unrealized gain on short-term investments$8.0K
Comprehensive loss-$18.2M-$29.4M

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Corporate structure

Tvardi Therapeutics, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Tvardi Therapeutics, Inc.

  • Ronald A. Depinho Filed SCHEDULE 13G/A on Tvardi Therapeutics, Inc., latest Feb 17, 2026 (3 filings since Jun 2, 2025)
  • Slate Path Capital LP Filed SCHEDULE 13G on Tvardi Therapeutics, Inc., latest Aug 14, 2025
  • Sporos Bioventures LLC Filed SCHEDULE 13G on Tvardi Therapeutics, Inc., latest Aug 8, 2025
  • Samuel David Tweardy Filed SCHEDULE 13G/A on Tvardi Therapeutics, Inc., latest Aug 5, 2025 (2 filings since May 2, 2025)
  • David John Tweardy Filed SCHEDULE 13G on Tvardi Therapeutics, Inc., latest May 2, 2025
  • Solas Tvardi Sidecar LLC Filed SCHEDULE 13G on Tvardi Therapeutics, Inc., latest Apr 22, 2025
  • Vifor (International) Ltd Filed SCHEDULE 13D/A on Tvardi Therapeutics, Inc., latest Apr 16, 2025 (5 filings since Oct 21, 2021)
  • BlackRock Filed SC 13G/A on Tvardi Therapeutics, Inc., latest Jul 8, 2024 (6 filings since Jan 28, 2022)
  • Bain Capital Life Sciences Opportunities III, LP Filed SC 13G/A on Tvardi Therapeutics, Inc., latest Feb 13, 2024 (2 filings since Nov 18, 2022)
  • VANGUARD GROUP INC Filed SC 13G/A on Tvardi Therapeutics, Inc., latest Feb 13, 2024 (3 filings since Feb 9, 2022)
  • FIRST MANHATTAN CO. LLC. Filed SC 13G/A on Tvardi Therapeutics, Inc., latest Feb 15, 2022
  • RHO Ventures VI LP Filed SC 13G/A on Tvardi Therapeutics, Inc., latest Feb 14, 2022
  • Tvardi Therapeutics, Inc. Sugar Land, Texas

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Tvardi Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, net$52.0K4 Dec 31, 2025$84.0K4 Dec 31, 2024−38.1%
Operating-lease assets (leased space)$144.0K4 Dec 31, 2025$216.0K4 Dec 31, 2024−33.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$20.7M4 Dec 31, 2025$31.6M4 Dec 31, 2024−34.4%
Marketable securities, current$10.1M4 Dec 31, 2025

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$322.0K4 Dec 31, 2025$385.0K4 Dec 31, 2024−16.4%
Finite-lived intangibles, gross$826.0K4 Dec 31, 2025$826.0K4 Dec 31, 20240%
Accumulated amortization$504.0K4 Dec 31, 2025$441.0K4 Dec 31, 2024+14.3%
Finite-lived intangibles, net$322.0K4 Dec 31, 2025$385.0K4 Dec 31, 2024−16.4%

Inventory

ItemLatestA year beforeChange
Inventory, total$900.0K5 Dec 31, 2024$2.8M5 Dec 31, 2023−68.1%
Raw materials$2.1M5 Dec 31, 2024$2.6M5 Dec 31, 2023−19.5%
Work in process$291.0K5 Dec 31, 2024$708.0K5 Dec 31, 2023−58.9%

Properties, in its own words

Our corporate headquarters is located in Sugar Land, Texas, where we lease approximately 5,900 square feet of space. Our lease expires in August 2027 and these facilities are used by our single operating segment. We believe our facilities are adequate and suitable for our current needs and that should it be needed, suitable additional or alternative space will be available to accommodate our operations. See Note 8 of Notes to Consolidated Financial Statements, Leases, in this Annual Report on Form 10-K.

Item 2 of the 10-K filed Mar 31, 2026.3

Leadership

Who has led Tvardi Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (26)

Former names

  • Cara Therapeutics, Inc.Oct 4, 2013 to Apr 11, 20252
  • Cara Therapeutics IncDec 6, 2005 to Jul 21, 20102

Timeline

  1. Aug 14, 20268-K Results of operations44
  2. Jul 30, 20268-K Regulation FD disclosure45
  3. Jul 17, 20268-K Other events46
  4. Jul 7, 20268-K Regulation FD disclosure47
  5. Jun 11, 20268-K Shareholder vote48
  6. May 8, 20268-K Results of operations49
  7. Mar 31, 20268-K Results of operations50
  8. Mar 6, 20268-K Other events51
  9. Jan 16, 20268-K Regulation FD disclosure52
  10. Dec 18, 20258-K Executive or director change53
  11. Nov 19, 20258-K Regulation FD disclosure54
  12. Nov 13, 20258-K Results of operations55
  13. Apr 17, 2025New chief executive Imran Nizamudin Alibhai becomes CEO12
  14. Mar 1, 2022New chief executive Christopher Posner becomes CEO13
  15. Jan 30, 2014New chief executive Derek T. Chalmers becomes CEO14

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.59) a share, on Nov 13, 2025.56

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results44
  2. May 8, 2026Reported quarterly or annual results49
  3. Mar 31, 2026Reported quarterly or annual results50
  4. Nov 13, 2025Reported quarterly or annual results55
  5. Aug 14, 2025Reported quarterly or annual results57
  6. May 13, 2025Reported quarterly or annual results58
  7. May 13, 2024Reported quarterly or annual results59
  8. Mar 4, 2024Reported quarterly or annual results60

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

316 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 69 major events, 142 insider forms, 27 large holders, 58 other. The latest 20:

  1. Aug 14, 202610-Q EDGAR
  2. Aug 14, 20268-K EDGAR
  3. Jul 30, 20268-K EDGAR
  4. Jul 17, 20268-K EDGAR
  5. Jul 17, 2026424B5 EDGAR
  6. Jul 7, 20268-K EDGAR
  7. Jun 11, 20264 EDGAR
  8. Jun 11, 20264 EDGAR
  9. Jun 11, 20264 EDGAR
  10. Jun 11, 20264 EDGAR
  11. Jun 11, 20264 EDGAR
  12. Jun 11, 20268-K EDGAR
  13. May 13, 2026EFFECT EDGAR
  14. May 12, 2026EFFECT EDGAR
  15. May 8, 2026POS AM EDGAR
  16. May 8, 2026CORRESP EDGAR
  17. May 8, 202610-Q EDGAR
  18. May 8, 20268-K EDGAR
  19. May 7, 2026UPLOAD EDGAR
  20. May 1, 2026S-3 EDGAR

The 316 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

52 open-market trades by officers, directors and large owners since October 2021: 0 buys and 52 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Feb 28, 2025Posner ChristopherPRESIDENT AND CEOSale583$4.75$2.8KForm 4
Feb 28, 2025Terrillion ScottSEC'Y; CHIEF COMPLIANCE & G.C.Sale163$4.76$776Form 4
Feb 4, 2025Posner ChristopherPRESIDENT AND CEOSale372$4.72$1.8KForm 4
Nov 4, 2024Posner ChristopherPRESIDENT AND CEOSale3,668$0.29$1.1KForm 4
Aug 1, 2024Posner ChristopherPRESIDENT AND CEOSale4,149$0.35$1.5KForm 4
May 2, 2024Posner ChristopherPRESIDENT AND CEOSale3,936$0.75$3.0KForm 4
Apr 5, 2024Goncalves JoanaCHIEF MEDICAL OFFICERSale2,753$0.83$2.3KForm 4
Apr 5, 2024Terrillion ScottSEC'Y; CHIEF COMPLIANCE & G.C.Sale2,753$0.83$2.3KForm 4
Feb 29, 2024Terrillion ScottSEC'Y; CHIEF COMPLIANCE & G.C.Sale3,293$0.89$2.9KForm 4
Feb 29, 2024Posner ChristopherPRESIDENT AND CEOSale5,834$0.89$5.2KForm 4
Feb 29, 2024Goncalves JoanaCHIEF MEDICAL OFFICERSale3,293$0.89$2.9KForm 4
Feb 8, 2024Posner ChristopherPRESIDENT AND CEOSale35,575$0.53$18.9KForm 4
Feb 1, 2024Posner ChristopherPRESIDENT AND CEOSale4,981$0.55$2.7KForm 4
Nov 2, 2023Posner ChristopherPRESIDENT AND CEOSale3,796$1.22$4.6KForm 4
Aug 3, 2023Posner ChristopherPRESIDENT AND CEOSale4,307$3.07$13.2KForm 4
Jun 23, 2023Terrillion ScottSEC'Y; CHIEF COMPLIANCE & G.C.Sale2,483$3.51$8.7KForm 4
Jun 23, 2023Menzaghi Frederique Ph.D.CHIEF SCIENTIFIC OFF,SVP-R&DSale2,993$3.51$10.5KForm 4
Jun 23, 2023Goncalves JoanaCHIEF MEDICAL OFFICERSale2,723$3.51$9.6KForm 4
May 5, 2023Posner ChristopherPRESIDENT AND CEOSale3,869$4.40$17.0KForm 4
Apr 4, 2023Terrillion ScottSEC'Y; CHIEF COMPLIANCE & G.C.Sale2,481$4.91$12.2KForm 4

All 52 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Imran AlibhaiPh.D.$620.0K$3.1M73
2025Christopher Posner$203.9K$2.6M73
2025John KauhM.D.53$500.0K$1.2M73
2025Dan ConnJ.D., M.B.A.59$450.0K$1.1M73
2025Ryan Maynard$134.0K$1.1M73
2025Scott Terrillion$129.9K$1.1M73
2024Former (Cara) President and Chief Executive Officer$728.0K$1.1M73
2024Chief Executive Officer and Director$551.0K$857.3K73
2024Former (Cara) Chief Financial Officer$478.0K$607.3K73
2024Former (Cara) General CounselSecretary and Chief Compliance Officer$463.8K$592.9K73
2024Chief Medical Officer$412.0K$565.8K73
2024Chief Financial Officer$381.1K$552.6K73

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 58. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Slate Path Capital LP704,118$1.3M0.0%No change
Vanguard Capital Management LLC344,382$654.3K0.0%−326
American Financial Group Inc223,659$425.0K0.1%No change
UBS Group AG111,133$211.2K0.0%+60,679
Silvercrest Asset Management Group LLC101,034$192.0K0.0%No change
BlackRock, Inc.95,478$181.4K0.0%−292,597
Renaissance Technologies LLC91,409$173.7K0.0%−691
Geode Capital Management, LLC90,350$171.7K0.0%−91,989
Morgan Stanley77,845$147.9K0.0%+4,951
Duncan Williams Asset Management, LLC63,241$120.2K0.0%No change
Vanguard Fiduciary Trust Co44,710$84.9K0.0%−2,162
Russell Investments Group, Ltd.43,228$82.1K0.0%+19,921
State Street Corp33,900$64.4K0.0%−63,331
Susquehanna International Group, Llp33,165$63.0K0.0%New
Aqr Capital Management LLC27,096$51.5K0.0%−15,096
Savant Capital, LLC19,462$49.4K0.0%New
Northern Trust Corp21,836$41.5K0.0%−27,245
Diadema Partners LP16,607$31.6K0.0%New
XTX Topco Ltd14,868$28.2K0.0%New
Brown Advisory Inc11,200$21.3K0.0%New
Arax Advisory Partners11,003$20.9K0.0%+2,670
Qube Research & Technologies Ltd10,210$19.4K0.0%New
Persistent Asset Partners Ltd4,253$8.1K0.0%New
PNC Financial Services Group, Inc.3,518$6.7K0.0%+2,999
Vanguard Global Advisers, LLC3,400$6.5K0.0%No change

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Tvardi Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARTvardi Therapeutics, Inc.1
  • CIK0001346830
  • Employer ID (EIN)75-31756933
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address3 Sugar Creek Ctr. Blvd., Ste 525, Sugar Land, TX 774781
  • Phone(713) 489-86541
  • Shares outstanding13,338,943 as of Aug 11, 202610
  • Public float$207.2M as of Jun 30, 20253
  • AuditorDeloitte & Touche LLP, Houston, Texas PCAOB ID 34; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceDec 6, 20051
  • Filings809 in all: 4 (360), 8-K (146), SC 13G/A (42), 10-Q (38), 3 (38), SC 13G (20), CORRESP (16), S-8 (14)1
    All 42 form types

    10-K (13), UPLOAD (12), DEF 14A (11), DEFA14A (11), 424B5 (9), EFFECT (8), 425 (6), SCHEDULE 13G (6), 4/A (5), S-3 (5), 424B3 (4), S-1/A (4), SEC STAFF LETTER (4), 8-K/A (3), ARS (3), CT ORDER (3), REGDEX (3), SCHEDULE 13G/A (3), 424B4 (2), D (2), REGDEX/A (2), S-1 (2), S-4/A (2), SCHEDULE 13D/A (2), 8-A12B (1), CERTNAS (1), DRS (1), POS AM (1), POS EX (1), PRE 14A (1), S-3/A (1), S-3ASR (1), S-4 (1), SC 13D (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Apr 23, 2026
    Latest 8-K (8-K) Aug 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareTVRDThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Tvardi Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 74 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant net losses since inception, and we expect to continue to incur significant net losses for the foreseeable future.
  • We have a limited operating history, which may make it difficult to evaluate our prospects and likelihood of success.
  • We have not generated any revenue to date and may never become or remain profitable.
  • Our financial condition raises substantial doubt as to our ability to continue as a going concern.
  • We will require substantial additional capital to fund our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs, future commercialization efforts or other operations.
  • The amount of our future losses is uncertain, and our quarterly and annual operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
  • Risks Related to Research and Development and the Biopharmaceutical Industry
  • Our business is highly dependent on the success of our product candidates, TTI-101, TTI-109 and any other product candidates that we advance into the clinic. All of our product candidates will require significant additional preclinical and clinical development before we may be able to seek regulatory approval for and launch a product commercially.
  • Preclinical and clinical development involves a lengthy, complex and expensive process, with an uncertain outcome.
  • Our ongoing and future clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in preclinical studies and may result in a safety profile that could delay or prevent regulatory approval or market acceptance of any of our product candidates.
  • We may be subject to additional risks because we intend to evaluate our product candidates in combination with the standard of care for the indications that we are pursuing.
The other 64 risks
  • We may experience delays in initiating, completing or ultimately be unable to complete, the development and commercialization of TTI-101, TTI-109 or any other product candidates.
  • Interim, blinded and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted and as the data are subject to audit and verification procedures that could result in material changes in the final data.
  • Positive results from early preclinical studies and clinical trials of our current or future product candidates are not necessarily predictive of the results of later preclinical studies and clinical trials of our current or future product candidates. If we cannot replicate the positive results from preclinical studies or early clinical trials of our current or future product candidates in future clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize current or future product candidates.
  • If we encounter difficulties enrolling patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • The design or execution of our ongoing and future clinical trials may not support marketing approval.
  • We may not be successful in our efforts to identify or discover additional product candidates in the future.
  • Due to our limited resources and access to capital, we must make decisions on the allocation of resources to certain programs and product candidates; these decisions may prove to be wrong and may adversely affect our business.
  • We may in the future conduct clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such clinical trials.
  • Although we have received U.S. orphan drug designation for TTI-101 for IPF and HCC, we may be unable to obtain and maintain orphan drug designation for our other product candidates and, even if we obtain such designation, we may not be able to realize the benefits of such designation, including potential marketing exclusivity of our product candidates, if approved.
  • Although we have received a Fast Track designation from the FDA for TTI-101 for HCC, we may not benefit from a faster development or regulatory review or approval process, and a Fast Track designation does not increase the likelihood that our product candidates will receive marketing approval.
  • Even if a product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us.
  • Compliance with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization of our products.
  • If product liability lawsuits are brought against us, we may incur substantial financial or other liabilities and may be required to limit commercialization of our product candidates.
  • Risks Related to Marketing, Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance
  • The regulatory approval process is highly uncertain, and we may be unable to obtain, or may be delayed in obtaining, U.S. or foreign regulatory approval and, as a result, unable to commercialize TTI-101, TTI-109 or any current or future product candidates. Even if we believe our current, or planned clinical trials are successful, regulatory authorities may not agree that they provide adequate data on safety or efficacy.
  • Coverage and reimbursement may be limited or unavailable or pricing unfavorable in certain market segments for our product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.
  • Recently enacted legislation, future legislation and other healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize product candidates and may affect the prices we may set.
  • Our operations and relationships with healthcare providers, healthcare organizations, customers and third-party payors will be subject to applicable anti-bribery, anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which could expose us to, among other things, enforcement actions, criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that could materially adversely affect our business.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
  • Inadequate funding for the FDA, the U.S. Securities and Exchange Commission (SEC) and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.
  • Risks Related to Our Intellectual Property
  • Our commercial success depends in part on our and our current or future licensors’, including Baylor College of Medicine (BCM), ability to obtain, maintain, enforce, and otherwise protect our intellectual property and proprietary technology, and if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize similar products and product candidates and our ability to successfully develop and commercialize our products or product candidates may be adversely affected.
  • Pending patent applications cannot be enforced against third parties unless and until a patent issues. Even if we obtain any patents covering our product candidates or our technology, they could nonetheless be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
  • The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we, our licensor or any future collaborators or partners will be successful in protecting our product candidates by obtaining and defending patents.
  • We do not currently own or in-license any composition of matter patent protection for the TTI-101 molecule. As such, we rely solely upon patents related to methods of use, manufacturing and pharmaceutical compositions.
  • It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.
  • Our intellectual property licensed from third parties may be subject to retained rights.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
  • Changes in the interpretation of patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may not be able to seek or obtain patent protection throughout the world or enforce such patent protection once obtained.
  • In order to protect our competitive position around our product candidates, we may become involved in lawsuits to enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful and which may result in our own or in-licensed patents being found invalid or unenforceable.
  • If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
  • Others may challenge inventorship or claim an ownership interest in our intellectual property which could expose us to litigation and have a significant adverse effect on our prospects.
  • We may be subject to claims by third parties asserting that our employees or we have misappropriated our intellectual property or claiming ownership of what we regard as our own intellectual property.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may need to acquire or license additional intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our trademarks of interest and our business may be adversely affected.
  • Intellectual property rights do not necessarily address all potential threats to our business.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third parties to conduct certain aspects of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize any potential product candidates.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Because we rely on third-party manufacturing and supply vendors, including single-source vendors and vendors in foreign jurisdictions, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.
  • If we are unable to enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • The operations of our suppliers, some of which are located outside of the United States, are subject to additional risks that are beyond our control and that could harm our business, financial condition, results of operations and prospects.
  • Our suppliers and any future collaborators may need assurances that our financial resources and stability on a stand-alone basis are sufficient to satisfy their requirements for doing or continuing to do business with us.
  • Risks Related to Managing Our Business and Operations
  • We may encounter difficulties in managing our growth, which could adversely affect our operations.
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
  • If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to develop current product candidates or identify and develop new product candidates will be impaired, could result in loss of markets or market share and could make us less competitive.
  • Our employees, independent contractors, consultants, commercial partners, collaborators and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Risks Related to Ownership of Our Common Stock
  • The market price of our common stock is expected to be volatile.
  • We will incur costs and demands upon management as a result of complying with the laws, rules and regulations affecting public companies.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management.
  • The amended and restated certificate of incorporation of us provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees, and could make it more costly for stockholders to bring a claim against us.
  • We do not anticipate paying any cash dividends in the foreseeable future.
  • An active trading market for our common stock may not develop and our stockholders may not be able to resell their shares of common stock for a profit, if at all.
  • Future sales of shares by existing stockholders could cause our stock price to decline.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
  • If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan.
  • We are expected to take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive to investors.
  • Changes in tax laws may materially adversely affect our business, prospects, financial condition and operating results.

Legal proceedings

Merger Proceedings

Between December 20, 2024 and March 19, 2025, Cara received 13 demands (and three draft complaints) from purported stockholders of Cara (collectively, the Demands) challenging the disclosures in the proxy statement/prospectus (the Proxy Statement/Prospectus) included in the Registration Statement on Form S-4 related to the Merger and asserting claims for violations of Sections 14(a) and 20(a) of the Securities Exchange Act of 1934. In addition, on March 5 and March 6, 2025, two lawsuits were filed by purported stockholders of Cara in the Supreme Court of the State of New York, County of New York. The lawsuits are captioned Joseph Clark v. Cara Therapeutics, Inc., et al., No. 651260/2025 and Michael Kent v. Cara Therapeutics, Inc., et al., No. 651272/2025 (collectively, the Complaints). The Complaints named Cara and the members of the Cara board of directors as defendants, and, like the Demands, challenged the disclosures (under New York state law) in the Proxy Statement/Prospectus.

Cara and the other named defendants deny that they violated any laws or breached any duties to stockholders of Cara, and they believe that no supplemental disclosure was required to the Proxy Statement/Prospectus under any applicable law, rule or regulation. Nevertheless, solely to eliminate the burden and expense of litigation and to avoid any possible disruption to the Merger that could result from such litigation, Cara filed certain supplemental disclosures on March 24, 2025 to moot the disclosure claims alleged in the Demands and the Complaints. On April 15, 2025, the Merger closed. Thereafter, counsel for the purported stockholders (that sent the Demands or filed the Complaints) reached out to counsel for us to discuss a potential mootness fee in connection with the supplemental disclosures filed by Cara. On August 15, 2025, we resolved the fee demand and the matters are now closed.

Other Proceedings

The opening of Item 3, Legal Proceedings.3

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