Trevi Therapeutics (TRVI) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01We have incurred significant losses since inception, expect to incur significant and increasing losses for the foreseeable future and may never achieve or maintain profitability
2. 02add equipment and physical infrastructure to support our development program for Haduvio and for any future product candidates
3. 03We have no products approved for commercial sale, which may make it difficult to evaluate the prospects for our future success and viability
4. 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 efforts
5. 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 trials
6. 06We 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
7. 07Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates
8. 08seek regulatory and marketing approvals for Haduvio

Risks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates

1. 09our ability to compete with other therapies
2. 10Our approach to the development and commercialization of Haduvio to treat chronic cough is unproven
3. 11Clinical drug development involves a lengthy and expensive process with an uncertain outcome
4. 12the 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
5. 13be required to remove the product from the market after obtaining marketing approval
6. 14Our 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
7. 15Use 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
8. 16If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
9. 17clinicians’ 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
10. 18Adverse 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
11. 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 label
12. 20Many currently approved mu-opioid 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
13. 21Results of preclinical studies and clinical trials may not be predictive of results of later clinical trials
14. 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
15. 23Any of these events could harm our business and operations and could negatively impact our stock price
16. 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
17. 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
18. 26We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do
19. 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
20. 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
21. 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
22. 30the inability to commercialize any products that we may develop

Risks Related to Our Dependence on Third Parties

1. 31We rely on third parties to conduct our clinical trials. If they do not perform satisfactorily, our business could be harmed
2. 32the possible misappropriation of our proprietary information, including our trade secrets and know-how
3. 33We 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
4. 34If 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

1. 35If 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
2. 36If 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
3. 37agreement 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
4. 38If 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
5. 39We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful
6. 40If 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
7. 41Changes 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
8. 42We may not be able to enforce our intellectual property rights throughout the world
9. 43In 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
10. 44We 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
11. 45Obtaining 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
12. 46If 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

1. 47Any 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
2. 48likely 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
3. 49diminished protection of intellectual property in some countries
4. 50A 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
5. 51We 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
6. 52injunctions or the imposition of civil or criminal penalties
7. 53Current 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
8. 54Current 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
9. 55other 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
10. 56directly 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
11. 57liabilities, 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
12. 58Laws 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
13. 59assess whether “remedial measures” related to past FCPA actions are warranted. We will need to carefully navigate these developments
14. 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 business
15. 61Our business and operations would suffer in the event of system failures
16. 62Artificial 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

1. 63Our future success depends on our ability to retain our executive team and to attract, retain and motivate qualified personnel
2. 64If we expand our organization, we may encounter difficulties in managing our growth, which could disrupt our operations
3. 65Our 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

1. 66An active trading market for our common stock may not be sustainable
2. 67The trading price of our common stock is highly volatile, which could result in substantial losses for purchasers of our common stock
3. 68other factors and considerations described in this “Risk Factors” section
4. 69We could be subject to securities class action litigation
5. 70If 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
6. 71Sales 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
7. 72Moreover, 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
8. 73Sales 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
9. 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 decisions
10. 75impede a merger, consolidation, takeover, sale, other business combination or other significant corporate transaction involving us that other stockholders may desire
11. 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
12. 77We are a “smaller reporting company” and the reduced disclosure requirements applicable to us may make our common stock less attractive to investors
13. 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
14. 79If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired
15. 80We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards
16. 81Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition
17. 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
18. 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 bylaws
19. 84If 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
20. 85price 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