What the changes say
- Trevi highlights risks around clinical trials for lead candidate Haduvio, shifting regulatory and tax policies, and patent protections.
What changed since the prior 10-K
New
- NewRisks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates
reported treatment emergent adverse events associated with Haduvio were constipation, nausea, somnolence, headache, dizziness, and fatigue
Haduvio treatments caused adverse events like constipation, nausea, somnolence, headache, dizziness, and fatigue, which could force us to abandon or limit development.
- NewRisks Related to Our Dependence on Third Parties
transition period when a new CRO begins work on a clinical trial. As a result, delays would likely occur, which could negatively impact our ability to meet our expected clinical development timelines and harm our business, financial condition and prospects
Transitioning to a new contract research organization for clinical trials could cause delays and negatively impact our development timelines.
- NewRisks Related to Our Intellectual Property
The patent application and approval process is expensive and time-consuming. We may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost, in a timely manner or at all
We may face patent prosecution defects and lack control over licensed patent rights, risking our ability to secure and enforce protection.
- NewRisks Related to Our Intellectual Property
jurisdictions, including significant commercial markets such as Europe, restrict the patentability of methods of treatment of the human body more than U.S. law does
International jurisdictions, including Europe, restrict the patentability of methods of treatment of the human body more than U.S. law.
- NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
the case and, instead, transferred it to federal district court in the Eastern District of Missouri. Depending on the outcome of this litigation, our ability to develop new drug product candidates and to maintain approval of existing drug products could be delayed, undermined or subject to protracted litigation
Supreme Court decisions such as Loper Bright and Corner Post could lead to protracted litigation and delay our drug product development.
- NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
These actions and the resulting recent loss of FDA leadership and personnel could lead to disruptions and delays in FDA guidance, review and approval of our product candidate
Potential HHS workforce reductions and budget cuts could cause disruptions and delays in FDA guidance, review, and approval of our product candidates.
- NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
which any such product candidate is prescribed or used. Indeed, under current legislation, the actual reductions in Medicare payments may vary up to 4%
Actual reductions in Medicare payments under the ACA and other legislation may vary up to 4% for prescribed products.
- NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
states in developing their proposals by further clarifying requirements, enhancing the quality of proposals submitted to the agency and ultimately shortening the review timeline
The Inflation Reduction Act and final HHS regulations delayed the implementation of safe harbor protections for pharmaceutical price reductions until January 2032.
- NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
violate the company’s due process rights under the Constitution. We expect that litigation involving these and other provisions of the IRA will continue, with unpredictable and uncertain results
An executive order issued by President Trump directs HHS to reduce pharmaceutical product prices, potentially impacting our pricing strategies.
- NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
we could be held liable for any resulting damages and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations
We do not maintain insurance for environmental liability or toxic tort claims, and compliance failures could result in substantial fines or sanctions.
- NewRisks Related to Our Common Stock
Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact on our business, financial condition and results of operations
Tariff-related actions initiated by the Trump Administration, including baseline reciprocal tariffs, could adversely impact our financial condition.
- NewRisks Related to Our Common Stock
making tender offers for our common stock, including transactions that may be in your best interests. These provisions may also prevent changes in our management or limit the price that investors are willing to pay for our stock
Our certificate of incorporation designates Delaware Court of Chancery and federal district courts as exclusive forums for certain stockholder disputes.
Dropped
- DroppedRisks Related to Our Financial Position and Need for Additional Capital
We believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the second half of 2026
- DroppedRisks Related to Our Intellectual Property
agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. As a result, the inventorship or ownership of our intellectual property may be challenged in the future
- DroppedRisks Related to Our Intellectual Property
In addition, geopolitical actions in the U.S. and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications and the maintenance, enforcement or defense of our issued patents
- DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
likely result in the need for additional trials, which would be costly and time-consuming and delay or permanently halt our development of Haduvio or the applicable future product candidate
- DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
A Fast Track designation, grant of Priority Review status or Breakthrough Therapy status by the FDA is not assured and, in any event, may not actually lead to a faster development or regulatory review or approval process and, moreover, would not assure FDA approval of Haduvio or any future product candidate
- DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
other things, bring more transparency to pharmaceutical pricing, review the relationship between pricing and manufacturer patient programs and reduce the costs of pharmaceuticals under Medicare and Medicaid
Funding runway estimates into the second half of 2026.
- DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
directly or indirectly, in cash or in kind, to induce or reward or in return for, either the referral of an individual for or the purchase, lease or order of a good, facility, item or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid
- DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
liabilities, our ongoing efforts to comply with evolving laws and regulations at the federal and state level may be costly and require ongoing modifications to our policies, procedures and systems
- DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
assess whether “remedial measures” related to past FCPA actions are warranted. We will need to carefully navigate these developments
- DroppedRisks Related to Our Common Stock
An active trading market for our common stock may not be sustainable
- DroppedRisks Related to Our Common Stock
Sales Agreement as a source of funding will depend on a number of factors, including the prevailing market price of our common stock, general market conditions and the extent to which we are able to secure funds from other sources
- DroppedRisks Related to Our Common Stock
price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities
Reworded
- 91% rewrittenRisks Related to Our Dependence on Third Parties
We rely on third parties to conduct our clinical trials. If they do not perform satisfactorily, our business could be harmed
Expanded on the risks of relying on third parties for clinical trials and potential delays during CRO transitions.
- 88% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
Current and future legislative efforts may limit the prices for our products, if and when they are licensed for marketing and that could materially impact our ability to generate revenues
Added specific references to pharmaceutical pricing transparency and Medicare and Medicaid cost reductions.
- 87% rewrittenRisks Related to Our Common Stock
Moreover, holders of a substantial number of shares of our common stock have rights, subject to specified limitations and conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders
Updated references from generic shelf registration to the 2023 Shelf Registration Statement and its effective date.
- 85% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
injunctions or the imposition of civil or criminal penalties
Added reference to June 2024 Supreme Court actions regarding FDA drug approvals.
- 85% rewrittenRisks Related to Our Intellectual Property
If disputes over intellectual property that we license prevent or impair our ability to maintain those license arrangements on acceptable terms or at all, we may be unable to successfully develop and commercialize any affected product candidates
Shifted focus from general patent protection to risks specifically arising from disputes over licensed intellectual property arrangements.
- 82% rewrittenRisks Related to Our Common Stock
Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition
Replaced old Tax Act references with specific discussion of the Inflation Reduction Act and the OBBBA regarding stock repurchase excise taxes.
- 81% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates
Updated clinical trial programs from CORAL and TIDAL to planned Phase 3 IPF and Phase 2b non-IPF ILD and RCC trials.
- 79% rewrittenRisks Related to Our Common Stock
If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
Expanded on the consequences of Nasdaq delisting, including potential loss of investor confidence and fewer business development opportunities.
- 76% rewrittenRisks Related to Our Common Stock
require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our certificate of incorporation or bylaws
- 69% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
if we acquire or in-license rights to or develop other potential product candidates or technologies and seek regulatory and marketing approvals for Haduvio or any future product candidate that successfully completes clinical trials
- 63% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize Haduvio or any future product candidate and may affect the prices we may obtain
- 59% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
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 harm our business
- 59% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
We will need substantial additional funding and if we are unable to raise sufficient capital when needed on acceptable terms or at all, we could be forced to delay, reduce or abandon our product development programs or commercialization efforts
- 53% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
diminished protection of intellectual property in some countries
- 49% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the U.S. and require us to develop and implement costly compliance programs
- 48% rewrittenRisks Related to Our Intellectual Property
We may not be able to enforce our intellectual property rights throughout the world
- 47% rewrittenRisks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates
We face competition, which may result in others developing or commercializing products before or more successfully than we do
Was: We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do
- 43% rewrittenRisks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates
Adverse events or undesirable side effects caused by, or other unexpected properties of, Haduvio or any future product candidate may be identified during development and could delay or prevent the marketing approval or limit the use of Haduvio or any future product candidate
- 40% rewrittenRisks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates
be required to remove the product from the market after obtaining marketing approval
- 36% rewrittenRisks Related to Our Common Stock
We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards
- 36% rewrittenRisks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates
Our approach to the development and commercialization of Haduvio to treat chronic cough is unproven
- 33% rewrittenRisks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates
The drug label for nalbuphine, the active ingredient in Haduvio, carries an opioid class label warning for serious, life-threatening or fatal respiratory depression and Haduvio, if approved for marketing in any indication, will likely carry a similar opioid class label
- 32% rewrittenRisks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates
Results of preclinical studies and clinical trials may not be predictive of results of later clinical trials
- 29% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
We have incurred significant losses since inception, expect to incur significant and increasing losses for the foreseeable future and may never achieve or maintain profitability
- 27% rewrittenRisks Related to Our Common Stock
If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired
- 27% rewrittenRisks Related to Our Common Stock
Ownership of our common stock is concentrated among our executive officers and directors and their affiliates, who have significant influence over our business, which may prevent new investors from influencing significant corporate decisions
- 27% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
Any delay in obtaining or failure to obtain required approvals and clearances could negatively impact our ability to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price
- 21% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
add equipment and physical infrastructure to support our development program for Haduvio and for any future product candidates
All 85 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Financial Position and Need for Additional Capital
- 01We have incurred significant losses since inception, expect to incur significant and increasing losses for the foreseeable future and may never achieve or maintain profitability29% rewritten
- 02add equipment and physical infrastructure to support our development program for Haduvio and for any future product candidates21% rewritten
- 03We have no products approved for commercial sale, which may make it difficult to evaluate the prospects for our future success and viability
- 04We will need substantial additional funding and if we are unable to raise sufficient capital when needed on acceptable terms or at all, we could be forced to delay, reduce or abandon our product development programs or commercialization efforts59% rewritten
- 05if we acquire or in-license rights to or develop other potential product candidates or technologies and seek regulatory and marketing approvals for Haduvio or any future product candidate that successfully completes clinical trials69% rewritten
- 06Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates81% rewritten
- 07seek regulatory and marketing approvals for Haduvio
Risks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates
- 08our ability to compete with other therapies
- 09Our approach to the development and commercialization of Haduvio to treat chronic cough is unproven36% rewritten
- 10Clinical drug development involves a lengthy and expensive process with an uncertain outcome
- 11the FDA or comparable foreign regulatory authorities may refuse to accept for review any NDA, MAA or other comparable foreign regulatory application that we submit for a product candidate or may conclude after review of our data that our application is insufficient to obtain marketing approval of a product candidate
- 12be required to remove the product from the market after obtaining marketing approval40% rewritten
- 13Our clinical trials may fail to demonstrate adequately the safety and efficacy of Haduvio or any future product candidates, which would likely prevent or delay regulatory approval and commercialization
- 14Use of patient-reported outcome assessments, or PROs, in our clinical trials and high placebo response rates may delay or impair the development of Haduvio or adversely impact our clinical trials
- 15If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
- 16clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications under investigation
- 17Adverse events or undesirable side effects caused by, or other unexpected properties of, Haduvio or any future product candidate may be identified during development and could delay or prevent the marketing approval or limit the use of Haduvio or any future product candidate43% rewritten
- 18reported treatment emergent adverse events associated with Haduvio were constipation, nausea, somnolence, headache, dizziness, and fatigueNew
- 19The drug label for nalbuphine, the active ingredient in Haduvio, carries an opioid class label warning for serious, life-threatening or fatal respiratory depression and Haduvio, if approved for marketing in any indication, will likely carry a similar opioid class label33% rewritten
- 20Many currently approved mu-opioid receptor agonist products are subject to restrictive marketing and distribution regulations which, if applied to Haduvio, could potentially restrict its use and harm our ability to generate profits
- 21Results of preclinical studies and clinical trials may not be predictive of results of later clinical trials32% rewritten
- 22Even if Haduvio or any future product candidate receives marketing approval, we or others may later discover that the product is less effective than previously believed or that it causes undesirable side effects that were not previously identified, which could compromise our ability to market the product
- 23Any of these events could harm our business and operations and could negatively impact our stock price
- 24We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
- 25If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution arrangements with third parties, we may not be successful in commercializing Haduvio or any future product candidates if and when they are approved
- 26We face competition, which may result in others developing or commercializing products before or more successfully than we do47% rewritten
- 27We also expect that Haduvio would compete with a number of therapeutics that are not specifically approved to treat chronic cough including benzonatate, opioids, corticosteroids, proton-pump inhibitors, and neuromodulators
- 28Even if we are able to commercialize a product candidate, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives, any of which could harm our business
- 29Product liability lawsuits could divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop or in-license
- 30the inability to commercialize any products that we may develop
Risks Related to Our Dependence on Third Parties
- 31We rely on third parties to conduct our clinical trials. If they do not perform satisfactorily, our business could be harmed91% rewritten
- 32transition period when a new CRO begins work on a clinical trial. As a result, delays would likely occur, which could negatively impact our ability to meet our expected clinical development timelines and harm our business, financial condition and prospectsNew
- 33the possible misappropriation of our proprietary information, including our trade secrets and know-how
- 34We may seek to establish collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans
- 35If we enter into collaborations with third parties for the development or commercialization of Haduvio or any future product candidate, our prospects with respect to those product candidates will depend in significant part on the success of those collaborations
Risks Related to Our Intellectual Property
- 36If we fail to comply with our obligations under our existing and any future intellectual property licenses with third parties, we could lose license rights that are critical to our business or owe damages to the licensor of such intellectual property
- 37If disputes over intellectual property that we license prevent or impair our ability to maintain those license arrangements on acceptable terms or at all, we may be unable to successfully develop and commercialize any affected product candidates85% rewritten
- 38The patent application and approval process is expensive and time-consuming. We may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost, in a timely manner or at allNew
- 39jurisdictions, including significant commercial markets such as Europe, restrict the patentability of methods of treatment of the human body more than U.S. law doesNew
- 40If we are unable to protect the confidentiality of our trade secrets, the value of our products could be negatively impacted and our business would be harmed
- 41We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful
- 42If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time-consuming, its outcome would be uncertain and it could prevent or delay us from developing or commercializing Haduvio or any future product candidate
- 43Changes to the patent law in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
- 44We may not be able to enforce our intellectual property rights throughout the world48% rewritten
- 45We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property
- 46Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies and our patent protection could be reduced or eliminated for non-compliance with these requirements
- 47If we are unable to obtain licenses from third parties on commercially reasonable terms, our business could be harmed
Risks Related to Regulatory Approval and Other Legal Compliance Matters
- 48Any delay in obtaining or failure to obtain required approvals and clearances could negatively impact our ability to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price27% rewritten
- 49diminished protection of intellectual property in some countries53% rewritten
- 50We may seek PRIME Designation in the E.U. for Haduvio but we might not receive such designations and, even if we do, such designations may not lead to a faster development or regulatory review or approval process
- 51injunctions or the imposition of civil or criminal penalties85% rewritten
- 52the case and, instead, transferred it to federal district court in the Eastern District of Missouri. Depending on the outcome of this litigation, our ability to develop new drug product candidates and to maintain approval of existing drug products could be delayed, undermined or subject to protracted litigationNew
- 53These actions and the resulting recent loss of FDA leadership and personnel could lead to disruptions and delays in FDA guidance, review and approval of our product candidateNew
- 54Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize Haduvio or any future product candidate and may affect the prices we may obtain63% rewritten
- 55which any such product candidate is prescribed or used. Indeed, under current legislation, the actual reductions in Medicare payments may vary up to 4%New
- 56Current and future legislative efforts may limit the prices for our products, if and when they are licensed for marketing and that could materially impact our ability to generate revenues88% rewritten
- 57states in developing their proposals by further clarifying requirements, enhancing the quality of proposals submitted to the agency and ultimately shortening the review timelineNew
- 58violate the company’s due process rights under the Constitution. We expect that litigation involving these and other provisions of the IRA will continue, with unpredictable and uncertain resultsNew
- 59Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the U.S. and require us to develop and implement costly compliance programs49% rewritten
- 60If 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 harm our business59% rewritten
- 61we could be held liable for any resulting damages and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulationsNew
- 62Our business and operations would suffer in the event of system failures
- 63Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data
Risks Related to Employee Matters and Managing our Growth
- 64Our future success depends on our ability to retain our executive team and to attract, retain and motivate qualified personnel
- 65If we expand our organization, we may encounter difficulties in managing our growth, which could disrupt our operations
- 66Our employees, independent contractors and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation
Risks Related to Our Common Stock
- 67The trading price of our common stock is highly volatile, which could result in substantial losses for purchasers of our common stock
- 68other factors and considerations described in this “Risk Factors” section
- 69Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact on our business, financial condition and results of operationsNew
- 70We could be subject to securities class action litigation
- 71If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the trading price and volume of our shares could decline
- 72Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales or the perception in the market that the holders of a large number of shares of our common stock intend to sell their shares, could reduce the trading price of our common stock
- 73Moreover, holders of a substantial number of shares of our common stock have rights, subject to specified limitations and conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders87% rewritten
- 74Ownership of our common stock is concentrated among our executive officers and directors and their affiliates, who have significant influence over our business, which may prevent new investors from influencing significant corporate decisions27% rewritten
- 75impede a merger, consolidation, takeover, sale, other business combination or other significant corporate transaction involving us that other stockholders may desire
- 76We do not anticipate paying any cash dividends on our capital stock in the foreseeable future. Accordingly, stockholders must rely on appreciation in the price of our common stock, if any, for any return on their investment
- 77We are a “smaller reporting company” and the reduced disclosure requirements applicable to us may make our common stock less attractive to investors
- 78We incur increased costs as a result of operating as a public company and our management is required to devote substantial time to compliance initiatives and corporate governance practices
- 79If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired27% rewritten
- 80We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards36% rewritten
- 81Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition82% rewritten
- 82Provisions in our organizational documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management or hinder efforts to acquire a controlling interest in us
- 83require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our certificate of incorporation or bylaws76% rewritten
- 84making tender offers for our common stock, including transactions that may be in your best interests. These provisions may also prevent changes in our management or limit the price that investors are willing to pay for our stockNew
- 85If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted79% rewritten
Other Trevi Therapeutics 10-Ks
- FY2024 10-K risk factors85 risks
Trevi Therapeutics faces significant ongoing net losses, with an accumulated deficit of $287.0 million as of December 31, 2024. The company depends entirely on the clinical success and commercialization of its sole lead product candidate, Haduvio. Financial runway is projected to extend only into the second half of 2026.
Filed Mar 18, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.